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Title 21

Food and Drugs


Parts 1 to 99

Revised as of April 1, 2011

Containing a codification of documents


of general applicability and future effect

As of April 1, 2011

Published by the Office of the Federal Register


National Archives and Records Administration
as a Special Edition of the Federal Register

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U.S. GOVERNMENT OFFICIAL EDITION NOTICE

Legal Status and Use of Seals and Logos


The seal of the National Archives and Records Administration
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the official codification of Federal regulations established under
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contents of the CFR, a special edition of the Federal Register, shall
be judicially noticed. The CFR is prima facie evidence of the origi-
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It is prohibited to use NARA’s official seal and the stylized Code
of Federal Regulations logo on any republication of this material
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in 18 U.S.C. 506, 701, and 1017.

Use of ISBN Prefix


This is the Official U.S. Government edition of this publication
and is herein identified to certify its authenticity. Use of the 0–16
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Table of Contents
Page
Explanation ................................................................................................ v

Title 21:

Chapter I—Food and Drug Administration, Department of Health


and Human Services .................................................................... 3

Finding Aids:

Table of CFR Titles and Chapters ....................................................... 467

Alphabetical List of Agencies Appearing in the CFR ......................... 487

List of CFR Sections Affected ............................................................. 497

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Cite this Code: CFR

To cite the regulations in


this volume use title,
part and section num-
ber. Thus, 21 CFR 1.1
refers to title 21, part 1,
section 1.

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Explanation
The Code of Federal Regulations is a codification of the general and permanent
rules published in the Federal Register by the Executive departments and agen-
cies of the Federal Government. The Code is divided into 50 titles which represent
broad areas subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is further sub-
divided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued
on a quarterly basis approximately as follows:
Title 1 through Title 16..............................................................as of January 1
Title 17 through Title 27 .................................................................as of April 1
Title 28 through Title 41 ..................................................................as of July 1
Title 42 through Title 50 .............................................................as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially noticed (44
U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text
of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual issues
of the Federal Register. These two publications must be used together to deter-
mine the latest version of any given rule.
To determine whether a Code volume has been amended since its revision date
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EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal Reg-
ister since the last revision of that volume of the Code. Source citations for
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actual effective date. In instances where the effective date is beyond the cut-
off date for the Code a note has been inserted to reflect the future effective
date. In those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be inserted following
the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies
to display an OMB control number with their information collection request.

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Many agencies have begun publishing numerous OMB control numbers as amend-
ments to existing regulations in the CFR. These OMB numbers are placed as
close as possible to the applicable recordkeeping or reporting requirements.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on the cover
of each volume are not carried. Code users may find the text of provisions in
effect on a given date in the past by using the appropriate numerical list of
sections affected. For the period before April 1, 2001, consult either the List of
CFR Sections Affected, 1949–1963, 1964–1972, 1973–1985, or 1986–2000, published in
eleven separate volumes. For the period beginning April 1, 2001, a ‘‘List of CFR
Sections Affected’’ is published at the end of each CFR volume.
‘‘[RESERVED]’’ TERMINOLOGY
The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal
Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ loca-
tion at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that
a portion of the CFR was left vacant and not accidentally dropped due to a print-
ing or computer error.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was established
by statute and allows Federal agencies to meet the requirement to publish regu-
lations in the Federal Register by referring to materials already published else-
where. For an incorporation to be valid, the Director of the Federal Register
must approve it. The legal effect of incorporation by reference is that the mate-
rial is treated as if it were published in full in the Federal Register (5 U.S.C.
552(a)). This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the Federal Register
will approve an incorporation by reference only when the requirements of 1 CFR
part 51 are met. Some of the elements on which approval is based are:
(a) The incorporation will substantially reduce the volume of material pub-
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(b) The matter incorporated is in fact available to the extent necessary to
afford fairness and uniformity in the administrative process.
(c) The incorporating document is drafted and submitted for publication in
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What if the material incorporated by reference cannot be found? If you have any
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CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a separate
volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS.
This volume contains the Parallel Table of Authorities and Rules. A list of CFR
titles, chapters, subchapters, and parts and an alphabetical list of agencies pub-
lishing in the CFR are also included in this volume.
An index to the text of ‘‘Title 3—The President’’ is carried within that volume.

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The Federal Register Index is issued monthly in cumulative form. This index
is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to the
revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing in the
Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this volume,
contact the issuing agency. The issuing agency’s name appears at the top of
odd-numbered pages.
For inquiries concerning CFR reference assistance, call 202–741–6000 or write
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ELECTRONIC SERVICES
The full text of the Code of Federal Regulations, the LSA (List of CFR Sections
Affected), The United States Government Manual, the Federal Register, Public
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to NARA’s web site at www.archives.gov/federal-register.

RAYMOND A. MOSLEY,
Director,
Office of the Federal Register.
April 1, 2011.

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THIS TITLE

Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these
volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299,
300–499, 500–599, 600–799, 800–1299 and 1300 to end. The first eight volumes, con-
taining parts 1–1299, comprise Chapter I—Food and Drug Administration, Depart-
ment of Health and Human Services. The ninth volume, containing part 1300 to
end, includes Chapter II—Drug Enforcement Administration, Department of Jus-
tice, and Chapter III—Office of National Drug Control Policy. The contents of
these volumes represent all current regulations codified under this title of the
CFR as of April 1, 2011.

For this volume, Jonn V. Lilyea was Chief Editor. The Code of Federal Regula-
tions publication program is under the direction of Michael L. White, assisted
by Ann Worley.

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Title 21—Food and
Drugs
(This book contains parts 1 to 99)

Part

CHAPTER I—Food and Drug Administration, Department of


Health and Human Services ............................................... 1

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CHAPTER I—FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH
AND HUMAN SERVICES

EDITORIAL NOTE: Nomenclature changes to chapter I appear at 66 FR 56035, Nov. 6, 2001, 69


FR 13717, Mar. 24, 2004, and 69 FR 18803, Apr. 9, 2004.

SUBCHAPTER A—GENERAL

Part Page
1 General enforcement regulations ............................ 5
2 General administrative rulings and decisions ......... 50
3 Product jurisdiction ................................................ 55
5 Organization ............................................................ 60
7 Enforcement policy ................................................. 66
10 Administrative practices and procedures ................ 76
11 Electronic records; electronic signatures ............... 110
12 Formal evidentiary public hearing ......................... 114
13 Public hearing before a public board of inquiry ...... 132
14 Public hearing before a public advisory committee 136
15 Public hearing before the Commissioner ................ 164
16 Regulatory hearing before the Food and Drug Ad-
ministration ......................................................... 166
17 Civil money penalties hearings ............................... 172
19 Standards of conduct and conflicts of interest ....... 188
20 Public information .................................................. 191
21 Protection of privacy .............................................. 222
25 Environmental impact considerations .................... 238
26 Mutual recognition of pharmaceutical good manu-
facturing practice reports, medical device qual-
ity system audit reports, and certain medical de-
vice product evaluation reports: United States
and the European Community ............................. 250
50 Protection of human subjects ................................. 282
54 Financial disclosure by clinical investigators ........ 295
56 Institutional Review Boards ................................... 298
58 Good laboratory practice for nonclinical labora-
tory studies .......................................................... 308
60 Patent term restoration .......................................... 321
3

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21 CFR Ch. I (4–1–11 Edition)

Part Page
70 Color additives ........................................................ 328
71 Color additive petitions .......................................... 336
73 Listing of color additives exempt from certifi-
cation ................................................................... 343
74 Listing of color additives subject to certification .. 394
80 Color additive certification ..................................... 434
81 General specifications and general restrictions for
provisional color additives for use in foods,
drugs, and cosmetics ............................................ 440
82 Listing of certified provisionally listed colors and
specifications ....................................................... 447
83–98 [Reserved]
99 Dissemination of information on unapproved/new
uses for marketed drugs, biologics, and devices ... 452

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SUBCHAPTER A—GENERAL

PART 1—GENERAL ENFORCEMENT ADDITIONAL PROVISIONS


REGULATIONS 1.240 What other registration requirements
apply?
Subpart A—General Provisions 1.241 What are the consequences of failing
to register, update, or cancel your reg-
Sec. istration?
1.1 General. 1.242 What does assignment of a registra-
1.3 Definitions. tion number mean?
1.4 Authority citations.
1.243 Is food registration information avail-
able to the public?
Subpart B—General Labeling Requirements
1.20 Presence of mandatory label informa- Subpart I—Prior Notice of Imported Food
tion.
1.21 Failure to reveal material facts. GENERAL PROVISIONS
1.23 Procedures for requesting variations 1.276 What definitions apply to this sub-
and exemptions from required label part?
statements.
1.277 What is the scope of this subpart?
1.24 Exemptions from required label state-
ments. REQUIREMENTS TO SUBMIT PRIOR NOTICE OF
IMPORTED FOOD
Subparts C–D [Reserved]
1.278 Who is authorized to submit prior no-
Subpart E—Imports and Exports tice?
1.279 When must prior notice be submitted
1.83 Definitions. to FDA?
1.90 Notice of sampling.
1.280 How must you submit prior notice?
1.91 Payment for samples.
1.94 Hearing on refusal of admission. 1.281 What information must be in a prior
1.95 Application for authorization to relabel notice?
and recondition. 1.282 What must you do if information
1.96 Granting of authorization to relabel changes after you have received con-
and recondition. firmation of a prior notice from FDA?
1.97 Bonds.
1.99 Costs chargeable in connection with re- CONSEQUENCES
labeling and reconditioning inadmissible 1.283 What happens to food that is imported
imports. or offered for import without adequate
1.101 Notification and recordkeeping. prior notice?
1.284 What are the other consequences of
Subparts F–G [Reserved]
failing to submit adequate prior notice
Subpart H—Registration of Food Facilities or otherwise failing to comply with this
subpart?
GENERAL PROVISIONS 1.285 What happens to food that is imported
1.225 Who must register under this subpart? or offered for import from unregistered
1.226 Who does not have to register under facilities that are required to register
this subpart? under subpart H of this part?
1.227 What definitions apply to this sub-
part? Subpart J—Establishment, Maintenance,
and Availability of Records
PROCEDURES FOR REGISTRATION OF FOOD
FACILITIES GENERAL PROVISIONS
1.230 When must you register? 1.326 Who is subject to this subpart?
1.231 How and where do you register? 1.327 Who is excluded from all or part of the
1.232 What information is required in the regulations in this subpart?
registration? 1.328 What definitions apply to this sub-
1.233 What optional items are included in part?
the registration form?
1.329 Do other statutory provisions and reg-
1.234 How and when do you update your fa-
ulations apply?
cility’s registration information?
1.235 How and when do you cancel your fa- 1.330 Can existing records satisfy the re-
cility’s registration information? quirements of this subpart?

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§ 1.1 21 CFR Ch. I (4–1–11 Edition)
REQUIREMENTS FOR NONTRANSPORTERS TO ES- HOW DOES FDA ORDER A DETENTION?
TABLISH AND MAINTAIN RECORDS TO IDEN-
1.391 Who approves a detention order?
TIFY THE NONTRANSPORTER AND TRANS-
1.392 Who receives a copy of the detention
PORTER IMMEDIATE PREVIOUS SOURCES OF
order?
FOOD
1.393 What information must FDA include
1.337 What information must nontrans- in the detention order?
porters establish and maintain to iden-
tify the nontransporter and transporter WHAT IS THE APPEAL PROCESS FOR A
DETENTION ORDER?
immediate previous sources of food?
1.401 Who is entitled to appeal?
REQUIREMENTS FOR NONTRANSPORTERS TO ES- 1.402 What are the requirements for submit-
TABLISH AND MAINTAIN RECORDS TO IDEN- ting an appeal?
TIFY THE NONTRANSPORTER AND TRANS- 1.403 What requirements apply to an infor-
PORTER IMMEDIATE SUBSEQUENT RECIPIENTS mal hearing?
OF FOOD 1.404 Who serves as the presiding officer for
1.345 What information must nontrans- an appeal, and for an informal hearing?
porters establish and maintain to iden- 1.405 When does FDA have to issue a deci-
tify the nontransporter and transporter sion on an appeal?
immediate subsequent recipients of food? 1.406 How will FDA handle classified infor-
mation in an informal hearing?
REQUIREMENTS FOR TRANSPORTERS TO AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 19
ESTABLISH AND MAINTAIN RECORDS U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333,
1.352 What information must transporters 334, 335a, 343, 350c, 350d, 352, 355, 360b, 362, 371,
establish and maintain? 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262,
264.
GENERAL REQUIREMENTS EFFECTIVE DATE NOTE: At 75 FR 73953, Nov.
1.360 What are the record retention require- 30, 2010, the authority citation for part 1 was
ments? revised, effective Apr. 14, 2011. For the con-
1.361 What are the record availability re- venience of the user, the revised text is set
quirements? forth as follows:
1.362 What records are excluded from this AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 19
subpart? U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 333, 334,
1.363 What are the consequences of failing 335a, 343, 350c, 350d, 352, 355, 360b, 362, 371, 374,
to establish or maintain records or make 381, 382, 387, 387a, 393; 42 U.S.C. 216, 241, 243,
them available to FDA as required by 262, 264.
this subpart? SOURCE: 42 FR 15553, Mar. 22, 1977, unless
otherwise noted.
COMPLIANCE DATES
1.368 What are the compliance dates for this Subpart A—General Provisions
subpart?
§ 1.1 General.
Subpart K—Administrative Detention of
(a) The provisions of regulations pro-
Food for Human or Animal Consumption
mulgated under the Federal Food,
GENERAL PROVISIONS Drug, and Cosmetic Act with respect to
the doing of any act shall be applicable
1.377 What definitions apply to this sub-
part? also to the causing of such act to be
1.378 What criteria does FDA use to order a done.
detention? (b) The definitions and interpreta-
1.379 How long may FDA detain an article tions of terms contained in section 201
of food? of the Federal Food, Drug, and Cos-
1.380 Where and under what conditions metic Act shall be applicable also to
must the detained article of food be held? such terms when used in regulations
1.381 May a detained article of food be de- promulgated under that act.
livered to another entity or transferred (c) The definition of package in § 1.20
to another location? and of principal display panel in §§ 101.1,
1.382 What labeling or marking require-
201.60, 501.1, 701.10 and 801.60 of this
ments apply to a detained article of food?
1.383 What expedited procedures apply when
chapter; and the requirements per-
FDA initiates a seizure action against a taining to uniform location, lack of
detained perishable food? qualification, and separation of the net
1.384 When does a detention order termi- quantity declaration in §§ 101.105(f),
nate? 201.62(e), 501.105(f), 701.13(f) and 801.62(e)

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Food and Drug Administration, HHS § 1.4

of this chapter to type size require- immediate container of any article, or


ments for net quantity declaration in any such matter affixed to any con-
§§ 101.105(i), 201.62(h), 501.105(i), 701.13(i) sumer commodity or affixed to or ap-
and 801.62(h) of this chapter, to initial pearing upon a package containing any
statement of ounces in the dual dec- consumer commodity.
laration of net quantity in §§ 101.105(j)
and (m), 201.62(i) and (k), 501.105(j) and § 1.4 Authority citations.
(m), 701.13(j) and (m) and 801.62(i) and (a) For each part of its regulations,
(k) of this chapter, to initial statement the Food and Drug Administration in-
of inches in declaration of net quantity cludes a centralized citation of all of
in §§ 201.62(m), 701.13(o) and 801.62(m) of the statutory provisions that provide
this chapter, to initial statement of authority for any regulation that is in-
square inches in declaration of net cluded in that part.
quantity in §§ 201.62(n), 701.13(p) and (b) The agency may rely on any one
801.62(n) of this chapter, to prohibition or more of the authorities that are list-
of certain supplemental net quantity ed for a particular part in imple-
statements in §§ 101.105(o), 201.62(o), menting or enforcing any section in
501.105(o), 701.13(q) and 801.62(o) of this that part.
chapter, and to servings representa- (c) All citations of authority in this
tions in § 501.8 of this chapter are pro- chapter will list the applicable sections
vided for solely by the Fair Packaging in the organic statute if the statute is
and Labeling Act. The other require- the Federal Food, Drug, and Cosmetic
ments of this part are issued under Act, the Public Health Service Act, or
both the Fair Packaging and Labeling the Fair Packaging and Labeling Act.
Act and the Federal Food, Drug, and References to an act or a section there-
Cosmetic Act, or by the latter act sole- of include references to amendments to
ly, and are not limited in their applica- that act or section. These citations
tion by section 10 of the Fair Pack- will also list the corresponding United
aging and Labeling Act. States Code (U.S.C.) sections. For ex-
[42 FR 15553, Mar. 22, 1977, as amended at 58
ample, a citation to section 701 of the
FR 17085, Apr. 1, 1993] Federal Food, Drug, and Cosmetic Act
would be listed: Sec. 701 of the Federal
EFFECTIVE DATE NOTE: At 75 FR 73953, Nov. Food, Drug, and Cosmetic Act (21
30, 2010, § 1.1 was amended by revising (b) and
in the first sentence of paragraph (c), by re-
U.S.C. 371).
moving ‘‘package in § 1.20 and of’’, effective (d) If the organic statute is one other
April 14, 2011. For the convenience of the than those specified in paragraph (c) of
user, the revised text is set forth as follows: this section, the citations of authority
in this chapter generally will list only
§ 1.1 General. the applicable U.S.C. sections. For ex-
ample, a citation to section 552 of the
* * * * * Administrative Procedure Act would be
(b) The definitions and interpretations of listed: 5 U.S.C. 552. The agency may,
terms contained in sections 201 and 900 of the where it determines that such meas-
Federal Food, Drug, and Cosmetic Act (21 ures are in the interest of clarity and
U.S.C. 321 and 387) shall be applicable also to public understanding, list the applica-
such terms when used in regulations promul- ble sections in the organic statute and
gated under that act. the corresponding U.S.C. section in the
same manner set out in paragraph (c)
* * * * * of this section. References to an act or
a section thereof include references to
§ 1.3 Definitions. amendments to that act or section.
(a) Labeling includes all written, (e) Where there is no U.S.C. provi-
printed, or graphic matter accom- sion, the agency will include a citation
panying an article at any time while to the U.S. Statutes at Large. Cita-
such article is in interstate commerce tions to the U.S. Statutes at Large will
or held for sale after shipment or deliv- refer to volume and page.
ery in interstate commerce. (f) The authority citations will in-
(b) Label means any display of writ- clude a citation to executive delega-
ten, printed, or graphic matter on the tions (i.e., Executive Orders), if any,

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§ 1.20 21 CFR Ch. I (4–1–11 Edition)

necessary to link the statutory author- label information as required by this


ity to the agency. part and the unit containers are not in-
tended to be sold separately, the net
[54 FR 39630, Sept. 27, 1989]
weight placement requirement of
§ 101.105(f) applicable to such unit con-
Subpart B—General Labeling tainers is waived if the units are in
Requirements compliance with all the other require-
ments of this part.
§ 1.20 Presence of mandatory label in-
formation. EFFECTIVE DATE NOTE: At 75 FR 73953, Nov.
30, 2010, § 1.20 was amended by revising the
The term package means any con- introductory text, effective Apr. 14, 2011. For
tainer or wrapping in which any food, the convenience of the user, the revised text
drug, device, or cosmetic is enclosed is set forth as follows:
for use in the delivery or display of
§ 1.20 Presence of mandatory label informa-
such commodities to retail purchasers, tion.
but does not include:
Except as otherwise provided by section
(a) Shipping containers or wrappings 900(13) of the Family Smoking Prevention
used solely for the transportation of and Tobacco Control Act (21 U.S.C. 387(13))
any such commodity in bulk or in defining ‘‘package,’’ the term package means
quantity to manufacturers, packers, any container or wrapping in which any
processors, or wholesale or retail dis- food, drug, device, or cosmetic is enclosed for
tributors; use in the delivery or display of such com-
(b) Shipping containers or outer modities to retail purchasers, but does not
include:
wrappings used by retailers to ship or
deliver any such commodity to retail
customers if such containers and wrap- * * * * *
pings bear no printed matter per-
§ 1.21 Failure to reveal material facts.
taining to any particular commodity;
or (a) Labeling of a food, drug, device,
(c) Containers subject to the provi- or cosmetic shall be deemed to be mis-
sions of the Act of August 3, 1912 (37 leading if it fails to reveal facts that
Stat. 250, as amended; 15 U.S.C. 231– are:
233), the Act of March 4, 1915 (38 Stat. (1) Material in light of other rep-
1186, as amended; 15 U.S.C. 234–236), the resentations made or suggested by
Act of August 31, 1916 (39 Stat. 673, as statement, word, design, device or any
amended; 15 U.S.C. 251–256), or the Act combination thereof; or
of May 21, 1928 (45 Stat. 635, as amend- (2) Material with respect to con-
ed; 15 U.S.C. 257–257i). sequences which may result from use of
(d) Containers used for tray pack dis- the article under: (i) The conditions
plays in retail establishments. prescribed in such labeling or (ii) such
(e) Transparent wrappers or con- conditions of use as are customary or
tainers which do not bear written, usual.
printed, or graphic matter obscuring (b) Affirmative disclosure of material
the label information required by this facts pursuant to paragraph (a) of this
part. section may be required, among other
appropriate regulatory procedures, by
A requirement contained in this part (1) Regulations in this chapter pro-
that any word, statement, or other in- mulgated pursuant to section 701(a) of
formation appear on the label shall not the act; or
be considered to be complied with un- (2) Direct court enforcement action.
less such word, statement, or informa- (c) Paragraph (a) of this section does
tion also appears on the outer con- not:
tainer or wrapper of the retail package (1) Permit a statement of differences
of the article, or, as stated in para- of opinion with respect to warnings (in-
graph (e) of this section, such informa- cluding contraindications, precautions,
tion is easily legible by virtue of the adverse reactions, and other informa-
transparency of the outer wrapper or tion relating to possible product haz-
container. Where a consumer com- ards) required in labeling for food,
modity is marketed in a multiunit re- drugs, devices, or cosmetics under the
tail package bearing the mandatory act.

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Food and Drug Administration, HHS § 1.24

(2) Permit a statement of differences § 1.24 Exemptions from required label


of opinion with respect to the effective- statements.
ness of a drug unless each of the opin-
The following exemptions are grant-
ions expressed is supported by substan-
ed from label statements required by
tial evidence of effectiveness as defined
this part:
in sections 505(d) and 512(d) of the act.
(a) Foods. (1) While held for sale, a
§ 1.23 Procedures for requesting vari- food shall be exempt from the required
ations and exemptions from re- declaration of net quantity of contents
quired label statements. specified in this part if said food is re-
Section 403(e) of the act (in this part ceived in bulk containers at a retail es-
1, the term act means the Federal tablishment and is accurately weighed,
Food, Drug, and Cosmetic Act) pro- measured, or counted either within the
vides for the establishment by regula- view of the purchaser or in compliance
tion of reasonable variations and ex- with the purchaser’s order.
emptions for small packages from the (2) Random food packages, as defined
required declaration of net quantity of in § 101.105(j) of this chapter, bearing la-
contents. Section 403(i) of the act pro- bels declaring net weight, price per
vides for the establishment by regula- pound or per specified number of
tion of exemptions from the required pounds, and total price shall be exempt
declaration of ingredients where such from the type size, dual declaration,
declaration is impracticable, or results and placement requirements of § 101.105
in deception or unfair competition. of this chapter if the accurate state-
Section 502(b) of the act provides for ment of net weight is presented con-
the establishment by regulation of rea- spicuously on the principal display
sonable variations and exemptions for panel of the package. In the case of
small packages from the required dec- food packed in random packages at one
laration of net quantity of contents. place for subsequent shipment and sale
Section 602(b) of the act provides for at another, the price sections of the
the establishment by regulation of rea- label may be left blank provided they
sonable variations and exemptions for are filled in by the seller prior to retail
small packages from the required dec- sale. This exemption shall also apply to
laration of net quantity of contents. uniform weight packages of cheese and
Section 5(b) of the Fair Packaging and cheese products labeled in the same
Labeling Act provides for the establish- manner and by the same type of equip-
ment by regulation of exemptions from ment as random food packages exempt-
certain required declarations of net ed by this paragraph (a)(2) except that
quantity of contents, identity of com- the labels shall bear a declaration of
modity, identity and location of manu- price per pound and not price per speci-
facturer, packer, or distributor, and
fied number of pounds.
from declaration of net quantity of
(3) Individual serving-size packages
servings represented, based on a find-
ing that full compliance with such re- of foods containing less than 1⁄2 ounce
quired declarations is impracticable or or less than 1⁄2 fluid ounce for use in
not necessary for the adequate protec- restaurants, institutions, and pas-
tion of consumers, and a further find- senger carriers, and not intended for
ing that the nature, form, or quantity sale at retail, shall be exempt from the
of the packaged consumer commodity required declaration of net quantity of
or other good and sufficient reasons contents specified in this part.
justify such exemptions. The Commis- (4) Individually wrapped pieces of
sioner, on his own initiative or on peti- penny candy and other confectionery of
tion of an interested person, may pro- less than one-half ounce net weight per
pose a variation or exemption based individual piece shall be exempt from
upon any of the foregoing statutory the labeling requirements of this part
provisions, including proposed findings when the container in which such con-
if section 5(b) of the Fair Packaging fectionery is shipped is in conformance
and Labeling Act applies, pursuant to with the labeling requirements of this
parts 10, 12, 13, 14, 15, 16, and 19 of this part. Similarly, when such confec-
chapter. tionery items are sold in bags or boxes,

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§ 1.24 21 CFR Ch. I (4–1–11 Edition)

such items shall be exempt from the la- from the declaration regarding name
beling requirements of this part, in- and place of business required by § 101.5
cluding the required declaration of net of this chapter if the package does not
quantity of contents specified in this obscure the declaration on unit con-
part when the declaration on the bag tainers or if it bears a statement that
or box meets the requirements of this the declaration can be found on the
part. unit containers and the declaration on
(5)(i) Soft drinks packaged in bottles the unit containers complies with
shall be exempt from the placement re- § 101.5 of this chapter. The declaration
quirements for the statement of iden- required by § 101.5 of this chapter may
tity prescribed by § 101.3 (a) and (d) of appear on the top of soft drinks in cans
this chapter if such statement appears if the statement is conspicuous and
conspicuously on the bottle closure. easily legible, provided that when the
When such soft drinks are marketed in declaration is embossed, it shall appear
a multiunit retail package, the multi- in type size at least one-eighth inch in
unit retail package shall be exempt height, or if it is printed, the type size
from the statement of identity declara- shall not be less than one-sixteenth
tion requirements prescribed by § 101.3 inch in height. The declaration may
of this chapter if the statement of iden- follow the curvature of the lid of the
tity on the unit container is not ob- can and shall not be removed or ob-
scured by the multiunit retail package. scured by the tab which opens the can.
(ii) A multiunit retail package for (6)(i) Ice cream, french ice cream, ice
soft drinks shall be exempt from the milk, fruit sherbets, water ices, quies-
declaration regarding name and place cently frozen confections (with or with-
of business required by § 101.5 of this out dairy ingredients), special dietary
chapter if the package does not obscure frozen desserts, and products made in
the declaration on unit containers or if semblance of the foregoing, when
it bears a statement that the declara- measured by and packaged in 1⁄2-liquid
tion can be found on the unit con- pint and 1⁄2-gallon measure-containers,
tainers and the declaration on the unit as defined in the ‘‘Measure Container
containers complies with § 101.5 of this Code of National Bureau of Standards
chapter. The declaration required by Handbook 44,’’ Specifications, Toler-
§ 101.5 of this chapter may appear on ances, and Other Technical Require-
the top or side of the closure of bottled ments for Weighing and Measuring De-
soft drinks if the statement is con- vices, Sec. 4.45 ‘‘Measure-Containers,’’
spicuous and easily legible. which is incorporated by reference, are
(iii) Soft drinks packaged in bottles exempt from the requirements of
which display other required label in- § 101.105(b)(2) of this chapter to the ex-
formation only on the closure shall be tent that net contents of 8–fluid ounces
exempt from the placement require- and 64–fluid ounces (or 2 quarts) may
ments for the declaration of contents be expressed as 1⁄2 pint and 1⁄2 gallon,
prescribed by § 101.105(f) of this chapter respectively. Copies are available from
if the required content declaration is the Center for Food Safety and Applied
blown, formed, or molded into the sur- Nutrition (HFS–150), Food and Drug
face of the bottle in close proximity to Administration, 5100 Paint Branch
the closure. Pkwy., College Park, MD 20740, or at
(iv) Where a trademark on a soft the National Archives and Records Ad-
drink package also serves as, or is, a ministration (NARA). For information
statement of identity, the use of such on the availability of this material at
trademark on the package in lines not NARA, call 202–741–6030, or go to: http://
parallel to the base on which the pack- www.archives.gov/federallregister/
age rests shall be exempted from the codeloflfederallregulations/
requirement of § 101.3(d) of this chapter ibrllocations.html.
that the statement be in lines parallel (ii) The foods named in paragraph
to the base so long as there is also at (a)(6)(i) of this section, when measured
least one statement of identity in lines by and packaged in 1–liquid pint, 1–liq-
generally parallel to the base. uid quart, and 1⁄2-gallon measure-con-
(v) A multiunit retail package for tainers, as defined in the ‘‘Measure
soft drinks in cans shall be exempt Container Code of National Bureau of

10

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Food and Drug Administration, HHS § 1.24

Standards Handbook 44,’’ Specifica- vored milk and milk products, butter-
tions, Tolerances, and Other Technical milk, cultured buttermilk, cultured
Requirements for Weighing and Meas- milk or cultured whole buttermilk,
uring Devices, Sec. 4.45 ‘‘Measure-Con- low-fat milk (0.5 to 2.0 percent but-
tainers,’’ which is incorporated by ref- terfat), and acidified milk and milk
erence, are exempt from the dual net- products, when packaged in containers
contents declaration requirement of of 8– and 64–fluid-ounce capacity, are
§ 101.105(j) of this chapter. Copies are exempt from the requirements of
available from the Center for Food § 101.105(b)(2) of this chapter to the ex-
Safety and Applied Nutrition (HFS– tent that net contents of 8 fluid ounces
150), Food and Drug Administration, and 64 fluid ounces (or 2 quarts) may be
5100 Paint Branch Pkwy., College Park, expressed as 1⁄2 pint and 1⁄2 gallon, re-
MD 20740, or at the National Archives spectively.
and Records Administration (NARA). (ii) The products listed in paragraph
For information on the availability of (a)(7)(i) of this section, when packaged
this material at NARA, call 202–741– in glass or plastic containers of 1⁄2-pint,
6030, or go to: http://www.archives.gov/ 1–pint, 1–quart, 1⁄2-gallon, and 1–gallon
federallregister/ capacities are exempt from the place-
codeloflfederallregulations/ ment requirement of § 101.105(f) of this
ibrllocations.html. chapter that the declaration of net
(iii) The foods named in paragraph contents be located within the bottom
(a)(6)(i) of this section, when measured 30 percent of the principal display
by and packaged in 1⁄2-liquid pint, 1–liq- panel, provided that other required
uid pint, 1–liquid quart, 1⁄2-gallon, and label information is conspicuously dis-
1–gallon measured-containers, as de- played on the cap or outside closure
fined in the ‘‘Measure Container Code and the required net quantity of con-
of National Bureau of Standards Hand- tents declaration is conspicuously
book 44,’’ Specifications, Tolerances, blown, formed, or molded into or per-
and Other Technical Requirements for manently applied to that part of the
Weighing and Measuring Devices, Sec. glass or plastic container that is at or
4.45 ‘‘Measure-Containers,’’ which is in- above the shoulder of the container.
corporated by reference, are exempt (iii) The products listed in paragraph
from the requirement of § 101.105(f) of (a)(7)(i) of this section, when packaged
this chapter that the declaration of net in containers of 1–pint, 1–quart, and 1⁄2-
contents be located within the bottom gallon capacities are exempt from the
30 percent of the principal display dual net-contents declaration require-
panel. Copies are available from the ment of § 101.105(j) of this chapter.
Center for Food Safety and Applied Nu- (8) Wheat flour products, as defined
trition (HFS–150), Food and Drug Ad- by §§ 137.105, 137.155, 137.160, 137.165,
ministration, 5100 Paint Branch Pkwy., 137.170, 137.175, 137.180, 137.185, 137.200,
College Park, MD 20740, or at the Na- and 137.205 of this chapter, packaged:
tional Archives and Records Adminis- (i) In conventional 2–, 5–, 10–, 25–, 50–
tration (NARA). For information on , and 100–pound packages are exempt
the availability of this material at from the placement requirement of
NARA, call 202–741–6030, or go to: http:// § 101.105(f) of this chapter that the dec-
www.archives.gov/federallregister/ laration of net contents be located
codeloflfederallregulations/ within the bottom 30 percent of the
ibrllocations.html. area of the principal display panel of
(7)(i) Milk, cream, light cream, coffee the label; and
or table cream, whipping cream, light (ii) In conventional 2–pound packages
whipping cream, heavy or heavy whip- are exempt from the dual net-contents
ping cream, sour or cultured sour declaration requirement of § 101.105(j)
cream, half-and-half, sour or cultured of this chapter provided the quantity of
half-and-half, reconstituted or recom- contents is expressed in pounds.
bined milk and milk products, con- (9)(i) Twelve shell eggs packaged in a
centrated milk and milk products, carton designed to hold 1 dozen eggs
skim or skimmed milk, vitamin D milk and designed to permit the division of
and milk products, fortified milk and such carton by the retail customer at
milk products, homogenized milk, fla- the place of purchase into two portions

11

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§ 1.24 21 CFR Ch. I (4–1–11 Edition)

of one-half dozen eggs each are exempt the principal display panel and from
from the labeling requirements of this the requirement of § 101.105(j)(1) of this
part with respect to each portion of chapter that such declaration be ex-
such divided carton if the carton, when pressed both in ounces and in pounds to
undivided, is in conformance with the permit declaration of ‘‘1-pound’’ or ‘‘one
labeling requirements of this part. pound,’’ provided an accurate state-
(ii) Twelve shell eggs packaged in a ment of net weight appears conspicu-
carton designed to hold 1 dozen eggs ously on the principal display panel of
are exempt from the placement re- the package.
quirements for the declaration of con- (12) Corn flour and related products,
tents prescribed by § 101.105(f) of this as they are defined by §§ 137.211, 137.215,
chapter if the required content declara- and §§ 137.230 through 137.290 of this
tion is otherwise placed on the prin- chapter, packaged in conventional 5–,
cipal display panel of such carton and 10–, 25–, 50–, and 100–pound bags are ex-
if, in the case of such cartons designed empt from the placement requirement
to permit division by retail customers of § 101.105(f) of this chapter that the
into two portions of one-half dozen declaration of net contents be located
eggs each, the required content dec- within the bottom 30 percent of the
laration is placed on the principal dis- area of the principal display panel of
play panel in such a manner that the the label.
context of the content declaration is (13)(i) Single strength and less than
destroyed upon division of the carton. single strength fruit juice beverages,
(10) Butter as defined in 42 Stat. 1500 imitations thereof, and drinking water
(excluding whipped butter): when packaged in glass or plastic con-
(i) In 8–ounce and in 1–pound pack- tainers of 1⁄2-pint, 1–pint, 1–quart, 1⁄2-
ages is exempt from the requirements gallon, and 1–gallon capacities are ex-
of § 101.105(f) of this chapter that the empt from the placement requirement
net contents declaration be placed of § 101.105(f) of this chapter that the
within the bottom 30 percent of the declaration of net contents be located
area of the principal display panel; within the bottom 30 percent of the
(ii) In 1–pound packages is exempt principal display panel: Provided, That
from the requirements of § 101.105(j)(1) other required label information is
of this chapter that such declaration be conspicuously displayed on the cap or
in terms of ounces and pounds, to per- outside closure and the required net
mit declaration of ‘‘1–pound’’ or ‘‘one quantity of contents declaration is
pound’’; and conspicuously blown, formed, or mold-
(iii) In 4–ounce, 8–ounce, and 1–pound ed into or permanently applied to that
packages with continuous label copy part of the glass or plastic container
wrapping is exempt from the require- that is at or above the shoulder of the
ments of §§ 101.3 and 101.105(f) of this container.
chapter that the statement of identity (ii) Single strength and less than sin-
and net contents declaration appear in gle strength fruit juice beverages, imi-
lines generally parallel to the base on tations thereof, and drinking water
which the package rests as it is de- when packaged in glass, plastic, or
signed to be displayed, provided that paper (fluid milk type) containers of 1–
such statement and declaration are not pint, 1–quart, and 1⁄2-gallon capacities
so positioned on the label as to be mis- are exempt from the dual net-contents
leading or difficult to read as the pack- declaration requirement of § 101.105(j)
age is customarily displayed at retail. of this chapter.
(11) Margarine as defined in § 166.110 (iii) Single strength and less than
of this chapter and imitations thereof single strength fruit juice beverages,
in 1–pound rectangular packages, ex- imitations thereof, and drinking water
cept for packages containing whipped when packaged in glass, plastic, or
or soft margarine or packages that paper (fluid milk type) containers of 8–
contain more than four sticks, are ex- and 64–fluid-ounce capacity, are ex-
empt from the requirement of empt from the requirements of
§ 101.105(f) of this chapter that the dec- § 101.105(b)(2) of this chapter to the ex-
laration of the net quantity of contents tent that net contents of 8 fluid ounces
appear within the bottom 30 percent of and 64 fluid ounces (or 2 quarts) may be

12

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Food and Drug Administration, HHS § 1.91

expressed as 1⁄2 pint (or half pint) and 1⁄2 container is labeled in conformance
gallon (or half gallon), respectively. with all labeling requirements of this
(14) The unit containers in a multi- part.
unit or multicomponent retail food
[42 FR 15553, Mar. 22, 1977, as amended at 47
package shall be exempt from regula- FR 946, Jan. 8, 1982; 47 FR 32421, July 27, 1982;
tions of section 403 (e)(1), (g)(2), (i)(2), 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3,
(k), and (q) of the act with respect to 1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr.
the requirements for label declaration 2, 1996; 66 FR 56035, Nov. 6, 2001]
of the name and place of business of
the manufacturer, packer, or dis- Subparts C–D [Reserved]
tributor; label declaration of ingredi-
ents; and nutrition information when:
(i) The multiunit or multicomponent
Subpart E—Imports and Exports
retail food package labeling meets all § 1.83 Definitions.
the requirements of this part;
(ii) The unit containers are securely For the purposes of regulations pre-
enclosed within and not intended to be scribed under section 801(a), (b), and (c)
separated from the retail package of the Federal Food, Drug, and Cos-
under conditions of retail sale; and metic Act:
(iii) Each unit container is labeled (a) The term owner or consignee
with the statement ‘‘This Unit Not La- means the person who has the rights of
beled For Retail Sale’’ in type size not a consignee under the provisions of sec-
less than one-sixteenth of an inch in tions 483, 484, and 485 of the Tariff Act
height. The word ‘‘Individual’’ may be of 1930, as amended (19 U.S.C. 1483, 1484,
used in lieu of or immediately pre- 1485).
ceding the word ‘‘Retail’’ in the state- (b) The term district director means
ment. the director of the district of the Food
(b) Drugs. Liquid over-the-counter and Drug Administration having juris-
veterinary preparations intended for diction over the port of entry through
injection shall be exempt from the dec- which an article is imported or offered
laration of net quantity of contents in for import, or such officer of the dis-
terms of the U.S. gallon of 231 cubic trict as he may designate to act in his
inches and quart, pint, and fluid-ounce behalf in administering and enforcing
subdivisions thereof as required by the provisions of section 801 (a), (b),
§ 201.62 (b), (i), and (j) of this chapter, and (c).
and from the dual declaration require-
§ 1.90 Notice of sampling.
ments of § 201.62(i) of this chapter, if
such declaration of net quantity of When a sample of an article offered
contents is expressed in terms of the for import has been requested by the
liter and milliliter, or cubic centi- district director, the collector of cus-
meter, with the volume expressed at 68 toms having jurisdiction over the arti-
°F (20 °C). cle shall give to the owner or consignee
(c) Cosmetics. Cosmetics in packages prompt notice of delivery of, or inten-
containing less than one-fourth ounce tion to deliver, such sample. Upon re-
avoirdupois or one-eighth fluid ounce ceipt of the notice, the owner or con-
shall be exempt from compliance with signee shall hold such article and not
the requirements of section 602(b)(2) of distribute it until further notice from
the Federal Food, Drug, and Cosmetic the district director or the collector of
Act and section 4(a)(2) of the Fair customs of the results of examination
Packaging and Labeling Act: of the sample.
(1) When such cosmetics are affixed
to a display card labeled in conform- § 1.91 Payment for samples.
ance with all labeling requirements of The Food and Drug Administration
this part; or will pay for all import samples which
(2) When such cosmetics are sold at are found to be in compliance with the
retail as part of a cosmetic package requirements of the Federal Food,
consisting of an inner and outer con- Drug, and Cosmetic Act. Billing for re-
tainer and the inner container is not imbursement should be made by the
for separate retail sale and the outer owner or consignee to the Food and

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§ 1.94 21 CFR Ch. I (4–1–11 Edition)

Drug Administration district head- the approximate time for their comple-
quarters in whose territory the ship- tion.
ment was offered for import. Payment
for samples will not be made if the ar- § 1.96 Granting of authorization to
ticle is found to be in violation of the relabel and recondition.
act, even though subsequently brought (a) When authorization contemplated
into compliance under the terms of an by § 1.95 is granted, the district director
authorization to bring the article into shall notify the applicant in writing,
compliance or rendered not a food, specifying:
drug, device, or cosmetic as set forth in (1) The procedure to be followed;
§ 1.95. (2) The disposition of the rejected ar-
ticles or portions thereof;
§ 1.94 Hearing on refusal of admission. (3) That the operations are to be car-
ried out under the supervision of an of-
(a) If it appears that the article may ficer of the Food and Drug Administra-
be subject to refusal of admission, the tion or the U.S. Customs Service, as
district director shall give the owner or the case may be;
consignee a written notice to that ef- (4) A time limit, reasonable in the
fect, stating the reasons therefor. The light of the circumstances, for comple-
notice shall specify a place and a pe- tion of the operations; and
riod of time during which the owner or (5) Such other conditions as are nec-
consignee shall have an opportunity to essary to maintain adequate super-
introduce testimony. Upon timely re- vision and control over the article.
quest giving reasonable grounds there- (b) Upon receipt of a written request
for, such time and place may be for extension of time to complete such
changed. Such testimony shall be con- operations, containing reasonable
fined to matters relevant to the admis- grounds therefor, the district director
sibility of the article, and may be in- may grant such additional time as he
troduced orally or in writing. deems necessary.
(b) If such owner or consignee sub- (c) An authorization may be amended
mits or indicates his intention to sub- upon a showing of reasonable grounds
mit an application for authorization to therefor and the filing of an amended
relabel or perform other action to application for authorization with the
bring the article into compliance with district director.
the act or to render it other than a (d) If ownership of an article covered
food, drug, device, or cosmetic, such by an authorization changes before the
testimony shall include evidence in operations specified in the authoriza-
support of such application. If such ap- tion have been completed, the original
plication is not submitted at or prior owner will be held responsible, unless
to the hearing, the district director the new owner has executed a bond and
shall specify a time limit, reasonable obtained a new authorization. Any au-
in the light of the circumstances, for thorization granted under this section
filing such application. shall supersede and nullify any pre-
viously granted authorization with re-
§ 1.95 Application for authorization to spect to the article.
relabel and recondition.
[42 FR 15553, Mar. 22, 1977, as amended at 54
Application for authorization to FR 9033, Mar. 3, 1989]
relabel or perform other action to
bring the article into compliance with § 1.97 Bonds.
the act or to render it other than a (a) The bonds required under section
food, drug, device or cosmetic may be 801(b) of the act may be executed by
filed only by the owner or consignee, the owner or consignee on the appro-
and shall: priate form of a customs single-entry
(a) Contain detailed proposals for or term bond, containing a condition
bringing the article into compliance for the redelivery of the merchandise
with the act or rendering it other than or any part thereof upon demand of the
a food, drug, device, or cosmetic. collector of customs and containing a
(b) Specify the time and place where provision for the performance of condi-
such operations will be carried out and tions as may legally be imposed for the

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Food and Drug Administration, HHS § 1.101

relabeling or other action necessary to 266 percent of the hourly rate of reg-
bring the article into compliance with ular pay of a grade GS–12/4 employee.
the act or rendering it other than a The rate per hour equal to 266 percent
food, drug, device, or cosmetic, in such of the equivalent hourly rate of regular
manner as is prescribed for such bond pay of the supervising officer (GS–11/4)
in the customs regulations in force on and the analyst (GS–12/4) is computed
the date of request for authorization. as follows:
The bond shall be filed with the col-
Hours
lector of customs.
(b) The collector of customs may can- Gross number of working hours in 52 40–hr weeks 2,080
Less:
cel the liability for liquidated damages 9 legal public holidays—New Years Day, Wash-
incurred under the above-mentioned ington’s Birthday, Memorial Day, Independ-
provisions of such a bond, if he receives ence Day, Labor Day, Columbus Day, Vet-
an application for relief therefrom, erans Day, Thanksgiving Day, and Christmas
Day .................................................................. 72
upon the payment of a lesser amount Annual leave—26 d ............................................ 208
or upon such other terms and condi- Sick leave—13 d ................................................ 104
tions as shall be deemed appropriate
Total ..................................................... 384
under the law and in view of the cir- Net number of working hours .............. 1,696
cumstances, but the collector shall not Gross number of working hours in 52 40-hr weeks .. 2,080
act under this regulation in any case Working hour equivalent of Government contribu-
tions for employee retirement, life insurance, and
unless the district director is in full health benefits computed at 81⁄2 pct. of annual
agreement with the action. rate of pay of employee ......................................... 176

§ 1.99 Costs chargeable in connection Equivalent annual working hours ......... 2,256
with relabeling and reconditioning Support required to equal to 1 man-year .................. 2,256
inadmissible imports. Equivalent gross annual working hours
The cost of supervising the relabeling charged to Food and Drug appro-
priation .............................................. 4,512
or other action in connection with an
import of food, drugs, devices, or cos- NOTE: Ratio of equivalent gross annual
metics which fails to comply with the number of working hours charged to Food
Federal Food, Drug, and Cosmetic Act and Drug appropriation to net number of an-
nual working hours 4,512/1,696=266 pct.
shall be paid by the owner or consignee
who files an application requesting (e) The minimum charge for services
such action and executes a bond, pursu- of supervising officers and of analysts
ant to section 801(b) of the act, as shall be not less than the charge for 1
amended. The cost of such supervision hour, and time after the first hour
shall include, but not be restricted to, shall be computed in multiples of 1
the following: hour, disregarding fractional parts less
(a) Travel expenses of the supervising than 1⁄2 hour.
officer.
(b) Per diem in lieu of subsistence of § 1.101 Notification and recordkeeping.
the supervising officer when away from (a) Scope. This section pertains to no-
his home station, as provided by law. tifications and records required for
(c) The charge for the services of the human drug, biological product, device,
supervising officer, which shall include animal drug, food, and cosmetic ex-
administrative support, shall be com- ports under sections 801 or 802 of the
puted at a rate per hour equal to 266 Federal Food, Drug, and Cosmetic Act
percent of the hourly rate of regular (the act) or (21 U.S.C. 381 and 382) or
pay of a grade GS–11/4 employee, except section 351 of the Public Health Service
that such services performed by a cus- Act (42 U.S.C. 262).
toms officer and subject to the provi- (b) Recordkeeping requirements for
sions of the act of February 13, 1911, as human drugs, biological products, devices,
amended (sec. 5, 36 Stat. 901, as amend- animal drugs, foods, and cosmetics ex-
ed (19 U.S.C. 267)), shall be calculated ported under or subject to section 801(e)(1)
as provided in that act. of the act. Persons exporting an article
(d) The charge for the service of the under section 801(e)(1) of the act or an
analyst, which shall include adminis- article otherwise subject to section
trative and laboratory support, shall be 801(e)(1) of the act shall maintain
computed at a rate per hour equal to records as enumerated in paragraphs

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§ 1.101 21 CFR Ch. I (4–1–11 Edition)

(b)(1) through (b)(4) of this section products exported under section 351(h) of
demonstrating that the product meets the Public Health Service Act. In addi-
the requirements of section 801(e)(1) of tion to the requirements in paragraph
the act. Such records shall be main- (b) of this section, persons exporting a
tained for the same period of time as partially processed biological product
required for records subject to good under section 351(h) of the Public
manufacturing practice or quality sys- Health Service Act shall maintain, for
tems regulations applicable to the the same period of time as required for
product, except that records pertaining records subject to good manufacturing
to the export of foods and cosmetics practice or quality systems regulations
under section 801(e)(1) of the act shall applicable to the product, and make
be kept for 3 years after the date of ex- available to FDA, upon request, during
portation. The records shall be made an inspection for review and copying
available to the Food and Drug Admin- by FDA, the following records:
istration (FDA), upon request, during (1) Records demonstrating that the
an inspection for review and copying product for export is a partially proc-
by FDA. essed biological product and not in a
(1) Records demonstrating that the form applicable to the prevention,
product meets the foreign purchaser’s treatment, or cure of diseases or inju-
specifications: The records must con- ries of man;
tain sufficient information to match (2) Records demonstrating that the
the foreign purchaser’s specifications partially processed biological product
to a particular export; was manufactured in conformity with
(2) Records demonstrating that the current good manufacturing practice
product does not conflict with the laws requirements;
of the importing country: This may
(3) Records demonstrating the dis-
consist of either a letter from an ap-
tribution of the exported partially
propriate foreign government agency,
processed biological products; and
department, or other authorized body
stating that the product has marketing (4) Copies of all labeling that accom-
approval from the foreign government panies the exported partially processed
or does not conflict with that country’s biological product and other records
laws, or a notarized certification by a demonstrating that the exported par-
responsible company official in the tially processed biological product is
United States that the product does intended for further manufacture into
not conflict with the laws of the im- a final dosage form outside the United
porting country and that includes a States; this may include a container
statement acknowledging that he or label with the statement, ‘‘Caution: For
she is subject to the provisions of 18 Further Manufacturing Use Only’’ and
U.S.C. 1001; any package insert.
(3) Records demonstrating that the (d) Notification requirements for drugs,
product is labeled on the outside of the biological products, and devices exported
shipping package that it is intended for under section 802 of the act. (1) Persons
export: This may consist of copies of exporting a human drug, biological
any labels or labeling statements, such product, or device under section 802 of
as ‘‘For export only,’’ that are placed on the act, other than a drug, biological
the shipping packages or, if the ex- product, or device for investigational
ported product does not have a ship- use exported under section 802(c) of the
ping package or container, on shipping act, or a drug, biological product, or
invoices or other documents accom- device exported in anticipation of mar-
panying the exported product; and keting authorization under section
(4) Records demonstrating that the 802(d) of the act, shall provide written
product is not sold or offered for sale in notification to FDA. The notification
the United States: This may consist of shall identify:
production and shipping records for the (i) The product’s trade name;
exported product and promotional ma- (ii) If the product is a drug or biologi-
terials. cal product, the product’s abbreviated
(c) Additional recordkeeping require- or proper name or, if the product is a
ments for partially processed biological device, the type of device;

16

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Food and Drug Administration, HHS § 1.225

(iii) If the product is a drug or bio- uct’s lot or control number or, if the
logical product, a description of the product is a device, the product’s
product’s strength and dosage form or, model number;
if the product is a device, the product’s (iv) The consignee’s name and ad-
model number; and dress; and
(iv) If the export is to a country not (v) The date on which the product
listed in section 802(b)(1) of the act, the was exported and the quantity of prod-
country that is to receive the exported uct exported.
article. The notification may, but is
(2) These records shall be kept at the
not required to, identify countries list-
site from which the products were ex-
ed in section 802(b)(1) of the act or
state that the export is intended for a ported or manufactured, and be main-
listed country without identifying the tained for the same period of time as
listed country. required for records subject to good
(2) The notification shall be sent to manufacturing practice or quality sys-
the following addresses: tems regulations applicable to the
(i) For biological products and de- product. The records shall be made
vices regulated by the Center for Bio- available to FDA, upon request, during
logics Evaluation and Research—Divi- an inspection for review and copying
sion of Case Management (HFM–610), by FDA.
Office of Compliance and Biologics
[66 FR 65447, Dec. 19, 2001, as amended at 69
Quality, Center for Biologics Evalua- FR 48774, Aug. 11, 2004; 70 FR 14980, Mar. 24,
tion and Research, Food and Drug Ad- 2005; 74 FR 13112, Mar. 26, 2009; 75 FR 20914,
ministration, 1401 Rockville Pike, suite Apr. 22, 2010]
200N, Rockville, MD 20852–1448.
(ii) For human drug products, bio-
logical products, and devices regulated Subparts F–G [Reserved]
by the Center for Drug Evaluation and
Research—Division of New Drugs and Subpart H—Registration of Food
Labeling Compliance, Center for Drug Facilities
Evaluation and Research, Food and
Drug Administration, 10903 New Hamp- SOURCE: 68 FR 58960, Oct. 10, 2003, unless
shire Ave., Silver Spring, MD 20993– otherwise noted.
0002.
(iii) For devices—Food and Drug Ad- GENERAL PROVISIONS
ministration, Center for Devices and
Radiological Health, Division of Pro- § 1.225 Who must register under this
gram Operations, 10903 New Hampshire subpart?
Ave., Bldg. 66, rm. 5429, Silver Spring, (a) You must register your facility
MD 20993–0002. under this subpart if you are the
(e) Recordkeeping requirements for
owner, operator, or agent in charge of
products subject to section 802(g) of the
either a domestic or foreign facility, as
act. (1) Any person exporting a product
defined in this subpart, and your facil-
under any provision of section 802 of
the act shall maintain records of all ity is engaged in the manufacturing/
drugs, biological products, and devices processing, packing, or holding of food
exported and the countries to which for consumption in the United States,
the products were exported. In addition unless your facility qualifies for one of
to the requirements in paragraph (b) of the exemptions in § 1.226.
this section, such records include, but (b) If you are an owner, operator, or
are not limited to, the following: agent in charge of a domestic facility,
(i) The product’s trade name; you must register your facility wheth-
(ii) If the product is a drug or biologi- er or not the food from the facility en-
cal product, the product’s abbreviated ters interstate commerce.
or proper name or, if the product is a (c) If you are the owner, operator, or
device, the type of device; agent in charge of a facility, you may
(iii) If the product is a drug or bio- authorize an individual to register
logical product, a description of its your facility on your behalf.
strength and dosage form and the prod-

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§ 1.226 21 CFR Ch. I (4–1–11 Edition)

§ 1.226 Who does not have to register manufactures/processes, packs, or


under this subpart? holds food for consumption in the
This subpart does not apply to the United States. Transport vehicles are
following facilities: not facilities if they hold food only in
(a) A foreign facility, if food from the usual course of business as carriers.
such facility undergoes further manu- A facility may consist of one or more
facturing/processing (including pack- contiguous structures, and a single
aging) by another facility outside the building may house more than one dis-
United States. A facility is not exempt tinct facility if the facilities are under
under this provision if the further man- separate ownership. The private resi-
ufacturing/processing (including pack- dence of an individual is not a facility.
aging) conducted by the subsequent fa- Nonbottled water drinking water col-
cility consists of adding labeling or any lection and distribution establishments
similar activity of a de minimis nature; and their structures are not facilities.
(b) Farms; (i) Domestic facility means any facility
(c) Retail food establishments; located in any State or Territory of the
(d) Restaurants; United States, the District of Colum-
(e) Nonprofit food establishments in bia, or the Commonwealth of Puerto
which food is prepared for, or served di- Rico that manufactures/processes,
rectly to, the consumer; packs, or holds food for consumption in
(f) Fishing vessels, including those the United States.
that not only harvest and transport (ii) Foreign facility means a facility
fish but also engage in practices such other than a domestic facility that
as heading, eviscerating, or freezing in- manufactures/processes, packs, or
tended solely to prepare fish for hold- holds food for consumption in the
ing on board a harvest vessel. However, United States.
those fishing vessels otherwise engaged (3) Farm means a facility in one gen-
in processing fish are subject to this eral physical location devoted to the
subpart. For the purposes of this sec- growing and harvesting of crops, the
tion, ‘‘processing’’ means handling, raising of animals (including seafood),
storing, preparing, shucking, changing or both. Washing, trimming of outer
into different market forms, manufac- leaves of, and cooling produce are con-
turing, preserving, packing, labeling, sidered part of harvesting. The term
dockside unloading, holding, or head- ‘‘farm’’ includes:
ing, eviscerating, or freezing other (i) Facilities that pack or hold food,
than solely to prepare fish for holding provided that all food used in such ac-
on board a harvest vessel; tivities is grown, raised, or consumed
(g) Facilities that are regulated ex- on that farm or another farm under the
clusively, throughout the entire facil- same ownership; and
ity, by the U.S. Department of Agri- (ii) Facilities that manufacture/proc-
culture under the Federal Meat Inspec- ess food, provided that all food used in
tion Act (21 U.S.C. 601 et seq.), the Poul- such activities is consumed on that
try Products Inspection Act (21 U.S.C. farm or another farm under the same
451 et seq.), or the Egg Products Inspec- ownership.
tion Act (21 U.S.C. 1031 et seq.); (4) Food has the meaning given in
section 201(f) of the act (21 U.S.C.
§ 1.227 What definitions apply to this 321(f)),
subpart? (i) Except for purposes of this sub-
(a) The act means the Federal Food, part, it does not include:
Drug, and Cosmetic Act. (A) Food contact substances as de-
(b) In addition, for the purposes of fined in section 409(h)(6) of the act (21
this subpart: U.S.C. 348(h)(6)), or
(1) Calendar day means every day (B) Pesticides as defined in 7 U.S.C.
shown on the calendar. 136(u).
(2) Facility means any establishment, (ii) Examples of food include fruits,
structure, or structures under one own- vegetables, fish, dairy products, eggs,
ership at one general physical location, raw agricultural commodities for use
or, in the case of a mobile facility, as food or as components of food, ani-
traveling to multiple locations, that mal feed (including pet food), food and

18

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Food and Drug Administration, HHS § 1.227

feed ingredients, food and feed addi- and nursing home kitchens are res-
tives, dietary supplements and dietary taurants; and
ingredients, infant formula, beverages (ii) Pet shelters, kennels, and veteri-
(including alcoholic beverages and bot- nary facilities in which food is pro-
tled water), live food animals, bakery vided to animals are restaurants.
goods, snack foods, candy, and canned (11) Retail food establishment means an
foods. establishment that sells food products
(5) Holding means storage of food. directly to consumers as its primary
Holding facilities include warehouses, function. A retail food establishment
cold storage facilities, storage silos, may manufacture/process, pack, or
grain elevators, and liquid storage hold food if the establishment’s pri-
tanks. mary function is to sell from that es-
(6) Manufacturing/processing means tablishment food, including food that
making food from one or more ingredi- it manufactures/processes, packs, or
ents, or synthesizing, preparing, treat- holds, directly to consumers. A retail
ing, modifying or manipulating food, food establishment’s primary function
including food crops or ingredients. Ex- is to sell food directly to consumers if
amples of manufacturing/processing ac- the annual monetary value of sales of
tivities are cutting, peeling, trimming, food products directly to consumers ex-
washing, waxing, eviscerating, ren- ceeds the annual monetary value of
dering, cooking, baking, freezing, cool- sales of food products to all other buy-
ing, pasteurizing, homogenizing, mix- ers. The term ‘‘consumers’’ does not in-
ing, formulating, bottling, milling, clude businesses. A ‘‘retail food estab-
grinding, extracting juice, distilling, lishment’’ includes grocery stores, con-
labeling, or packaging. venience stores, and vending machine
(7) Nonprofit food establishment means locations.
a charitable entity that prepares or (12) Trade name means the name or
serves food directly to the consumer or names under which the facility con-
otherwise provides food or meals for ducts business, or additional names by
consumption by humans or animals in which the facility is known. A trade
the United States. The term includes name is associated with a facility, and
central food banks, soup kitchens, and a brand name is associated with a prod-
nonprofit food delivery services. To be uct.
considered a nonprofit food establish- (13) U.S. agent means a person (as de-
ment, the establishment must meet the fined in section 201(e) of the act (21
terms of section 501(c)(3) of the U.S. In- U.S.C. 321(e))) residing or maintaining
ternal Revenue Code (26 U.S.C. a place of business in the United States
501(c)(3)). whom a foreign facility designates as
(8) Packaging (when used as a verb) its agent for purposes of this subpart. A
means placing food into a container U.S. agent cannot be in the form of a
that directly contacts the food and mailbox, answering machine or service,
that the consumer receives. or other place where an individual act-
(9) Packing means placing food into a ing as the foreign facility’s agent is not
container other than packaging the physically present.
food. (i) The U.S. agent acts as a commu-
(10) Restaurant means a facility that nications link between FDA and the
prepares and sells food directly to con- foreign facility for both emergency and
sumers for immediate consumption. routine communications. The U.S.
‘‘Restaurant’’ does not include facilities agent will be the person FDA contacts
that provide food to interstate convey- when an emergency occurs, unless the
ances, central kitchens, and other registration specifies under § 1.233(e)
similar facilities that do not prepare another emergency contact.
and serve food directly to consumers. (ii) FDA will treat representations by
(i) Entities in which food is provided the U.S. agent as those of the foreign
to humans, such as cafeterias, facility, and will consider information
lunchrooms, cafes, bistros, fast food es- or documents provided to the U.S.
tablishments, food stands, saloons, tav- agent the equivalent of providing the
erns, bars, lounges, catering facilities, information or documents to the for-
hospital kitchens, day care kitchens, eign facility.

19

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§ 1.230 21 CFR Ch. I (4–1–11 Edition)

(iii) Having a single U.S. agent for your confirmation and registration
the purposes of this subpart does not number.
preclude facilities from having mul- (b) Registration by mail or fax. If, for
tiple agents (such as foreign suppliers) example, you do not have reasonable
for other business purposes. A firm’s access to the Internet through any of
commercial business in the United the methods described in paragraph (a)
States need not be conducted through of this section, you may register by
the U.S. agent designated for purposes mail or fax.
of this subpart. (1) You must register using Form
(14) You or registrant means the 3537. You may obtain a copy of this
owner, operator, or agent in charge of form by writing to the U.S. Food and
a facility that manufactures/processes, Drug Administration (HFS–681), 5600
packs, or holds food for consumption in Fishers Lane, Rockville, MD 20857 or
the United States. by requesting a copy of this form by
phone at 1–800–216–7331 or 301–575–0156.
PROCEDURES FOR REGISTRATION OF FOOD (2) When you receive the form, you
FACILITIES must fill it out completely and legibly
and either mail it to the address in
§ 1.230 When must you register? paragraph (b)(1) of this section or fax it
The owner, operator, or agent in to 301–436–2804 or 1–800–573–0846.
charge of a facility that manufactures/ (3) If any required information on the
processes, packs or holds food for con- form is incomplete or illegible when
sumption in the United States must FDA receives it, FDA will return the
register the facility no later than De- form to you for revision, provided that
cember 12, 2003. The owner, operator, or your mailing address or fax number is
agent in charge of a facility that be- legible and valid. When returning a
gins to manufacture/process, pack, or registration form for revision, FDA
hold food for consumption in the will use the means by which the form
United States on or after December 12, was received by the agency (i.e., by
2003, must register before the facility mail or fax).
begins such activities. An owner, oper- (4) FDA will enter complete and leg-
ator, or agent in charge of a facility ible mailed and faxed registration sub-
may authorize an individual to register missions into its registration system,
the facility on its behalf. along with CD-ROM submissions, as
soon as practicable, in the order FDA
§ 1.231 How and where do you reg- receives them.
ister? (5) FDA will then mail to the address
(a) Electronic registration. (1) To reg- or fax to the fax number on the reg-
ister electronically, you must register istration form a copy of the registra-
at http://www.fda.gov/furls, which is tion as entered, confirmation of reg-
available for registration 24 hours a istration, and your registration num-
day, 7 days a week. This website is ber. When responding to a registration
available from wherever the Internet is submission, FDA will use the means by
accessible, including libraries, copy which the registration was received by
centers, schools, and Internet cafes. An the agency (i.e., by mail or fax).
individual authorized by the owner, op- (6) If any information you previously
erator, or agent in charge of a facility submitted was incorrect at the time of
may also register a facility electroni- submission, you must immediately up-
cally. date your facility’s registration as
(2) FDA strongly encourages elec- specified in § 1.234.
tronic registration for the benefit of (7) Your facility is considered reg-
both FDA and the registrant. istered once FDA enters your facility’s
(3) Once you complete your elec- registration data into the registration
tronic registration, FDA will auto- system and the system generates a reg-
matically provide you with an elec- istration number.
tronic confirmation of registration and (c) Registration by CD-ROM for mul-
a permanent registration number. tiple submissions. If, for example, you do
(4) You will be considered registered not have reasonable access to the
once FDA electronically transmits Internet through any of the methods

20

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Food and Drug Administration, HHS § 1.232

provided under paragraph (a) of this language except an individual’s name,


section, you may register by CD-ROM. the name of a company, the name of a
(1) Registrants submitting their reg- street, and a trade name may be sub-
istrations in CD-ROM format must use mitted in a foreign language. All infor-
ISO 9660 (CD-R or CD-RW) data format. mation, including these items, must be
(2) These files must be submitted on submitted using the Latin (Roman) al-
a portable document format (PDF) ren- phabet.
dition of the registration form (Form
3537) and be accompanied by one signed [68 FR 58960, Oct. 10, 2003, as amended at 69
FR 29428, May 24, 2004; 73 FR 15883, Mar. 26,
copy of the certification statement
2008]
that appears on the registration form
(Form 3537). § 1.232 What information is required in
(3) Each submission on the CD-ROM the registration?
must contain the same preferred mail-
ing address in the appropriate block on Each registrant must submit the fol-
Form 3537. lowing information through one of the
(4) A CD-ROM may contain registra- methods described in § 1.231:
tions for as many facilities as needed (a) The name, full address, and phone
up to the CD-ROM’s capacity. number of the facility;
(5) The registration on the CD-ROM (b) The name, address, and phone
for each separate facility must have a number of the parent company, if the
unique file name up to 32 characters facility is a subsidiary of the parent
long, the first part of which may be company;
used to identify the parent company. (c) For domestic and foreign facili-
(6) You must mail the CD-ROM to the ties, the names, addresses, and phone
U.S. Food and Drug Administration numbers of the owner, operator, and
(HFS–681), 5600 Fishers Lane, Rock- agent in charge.
ville, MD 20857. (d) For a foreign facility, the name,
(7) If FDA receives a CD-ROM that address, phone number, and, if no
does not comply with these specifica- emergency contact is designated under
tions, it will return the CD-ROM to the § 1.233(e), the emergency contact phone
submitter unprocessed. number of the foreign facility’s U.S.
(8) FDA will enter CD-ROM submis- agent;
sions that comply with these specifica- (e) For a domestic facility, an emer-
tions into its registration system, gency contact phone number;
along with the complete and legible
(f) All trade names the facility uses;
mailed and faxed submissions, as soon
as practicable, in the order FDA re- (g) Applicable food product cat-
ceives them. egories as identified in § 170.3 of this
(9) For each facility on the CD-ROM, chapter, unless you check either ‘‘most/
FDA will mail to the preferred mailing all human food product categories,’’ ac-
address a copy of the registration(s) as cording to § 1.233(j), or ‘‘none of the
entered, confirmation of registration, above mandatory categories’’ because
and each facility’s assigned registra- your facility manufactures/processes,
tion number. packs, or holds a food that is not iden-
(10) If any information you pre- tified in § 170.3 of this chapter;
viously submitted was incorrect at the (h) The name, address, and phone
time of submission, you must imme- number for the owner, operator, or
diately update your facility’s registra- agent in charge;
tion as specified in § 1.234. (i) A statement in which the owner,
(11) Your facility is considered reg- operator, or agent in charge certifies
istered once FDA enters your facility’s that the information submitted is true
registration data into the registration and accurate. If the individual submit-
system and the system generates a reg- ting the form is not the owner, oper-
istration number. ator, or agent in charge of the facility,
(d) Fees. No registration fee is re- the registration must also include a
quired. statement in which the individual cer-
(e) Language. You must submit all tifies that the information submitted
registration information in the English is true and accurate, certifies that he/

21

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§ 1.233 21 CFR Ch. I (4–1–11 Edition)

she is authorized to submit the reg- packs, or holds foods in most or all of
istration, and identifies by name, ad- the categories identified in § 170.3 of
dress, and telephone number, the indi- this chapter;
vidual who authorized submission of (k) Approximate dates of operation,
the registration. Each registration if the facility’s business is seasonal;
must include the name of the indi- (l) The fax number and e-mail address
vidual registering the facility submit- of the owner, operator, or agent in
ting the registration, and the individ- charge; and
ual’s signature (for the paper and CD- (m) The fax number and e-mail ad-
ROM options). dress of the individual who authorized
[68 FR 58960, Oct. 10, 2003, as amended at 69 submission of the registration.
FR 29428, May 24, 2004]
§ 1.234 How and when do you update
§ 1.233 What optional items are in- your facility’s registration informa-
cluded in the registration form? tion?
FDA encourages, but does not re- (a) Update requirements. The owner,
quire, you to submit the following operator, or agent in charge must sub-
items in your facility’s registration. mit an update to a facility’s registra-
These data will enable FDA to commu- tion within 60 calendar days of any
nicate more quickly with facilities change to any of the information pre-
that may be the target of a terrorist viously submitted under § 1.232 (e.g.,
threat or attack, or otherwise affected change of operator, agent in charge, or
by an outbreak of foodborne illness. U.S. agent), except a change of the
This information includes: owner. The owner, operator, or agent
(a) Fax number and e-mail address of in charge may authorize an individual
the facility; to update a facility’s registration.
(b) Preferred mailing address, if dif- (b) Cancellation due to ownership
ferent from that of the facility; changes. If the reason for the update is
(c) Fax number and e-mail address of that the facility has a new owner, the
the parent company, if the facility is a former owner must cancel the facility’s
subsidiary of the parent company; registration as specified in § 1.235 with-
(d) For a domestic facility, emer- in 60 calendar days of the change and
gency contact name, title, and e-mail the new owner must re-register the fa-
address; cility as specified in § 1.231. The former
(e) For a foreign facility, an emer- owner may authorize an individual to
gency contact name, title, phone num- cancel a facility’s registration.
ber and e-mail address. FDA will con- (c) Electronic update. (1) To update
sider the facility’s U.S. agent the fa- your registration electronically, you
cility’s emergency contact unless the must update at http://www.fda.gov/furls.
facility chooses to designate another (2) Once you complete your elec-
person to serve as an emergency con- tronic update, FDA will automatically
tact under this section; provide you with an electronic con-
(f) For a foreign facility, title, fax firmation of your update.
number, and e-mail address of the U.S. (3) Your registration will be consid-
agent; ered updated once FDA transmits your
(g) Type of activity conducted at the update confirmation, unless notified
facility (e.g., manufacturing/processing otherwise.
or holding); (d) Update by mail or fax. If, for exam-
(h) Food categories not identified in ple, you do not have reasonable access
§ 170.3 of this chapter, which are pro- to the Internet through any of the
vided in Form 3537 sections 11a (e.g., methods described in § 1.231(a)), you
infant formula, animal byproducts and may update your facility’s registration
extracts) and 11b (e.g., grain products, by mail or by fax:
amino acids); (1) You must update your registra-
(i) Type of storage, if the facility is tion using Form 3537. You may obtain
primarily a holding facility; a copy of this form by writing to the
(j) A food product category of ‘‘most/ U.S. Food and Drug Administration
all human food product categories,’’ if (HFS–681), 5600 Fishers Lane, Rock-
the facility manufactures/processes, ville, MD 20857 or by requesting the

22

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Food and Drug Administration, HHS § 1.235

form by phone at 1–877–FDA–3882 (1– ing address in the appropriate block on


877–332–3882). Form 3537.
(2) When you receive the form, you (4) The CD-ROM may contain updates
must legibly fill out the sections of the for as many facilities as needed up to
form reflecting your updated informa- the CD-ROM’s capacity.
tion and either mail it to the address (5) The update for each facility on
in paragraph (d)(1) of this section or the CD-ROM must have a unique file
fax it to 301–436–2804 or name up to 32 characters long, the first
1–800–573–0846. part of which may be used to identify
the parent company.
(3) If the information on the form is
(6) You must mail the CD-ROM to
incomplete or illegible when FDA re-
U.S. Food and Drug Administration
ceives it, FDA will return the form to
(HFS–681), 5600 Fishers Lane, Rock-
you for revision, provided that your
ville, MD 20857.
mailing address or fax number is leg-
(7) If FDA receives an update CD-
ible and valid. When returning a reg-
ROM that does not comply with these
istration form for revision, FDA will
specifications, it will return the CD-
use the means by which the registra-
ROM to the registrant unprocessed.
tion was received by the agency (i.e., (8) FDA will enter CD-ROM update
by mail or fax). submissions into its registration sys-
(4) FDA will enter complete and leg- tem, along with the complete and leg-
ible updates into its registration sys- ible mailed and faxed update submis-
tem, along with CD-ROM submissions, sions, as soon as practicable, in the
as soon as practicable, in the order order FDA receives them.
FDA receives them. (9) For each facility on the CD-ROM,
(5) FDA will then mail to the address FDA will mail to the preferred mailing
or fax to the fax number on the reg- address a copy of the update(s) as en-
istration form a copy of the update as tered and confirmation of the update.
entered and confirmation of the up- (10) If any update information you
date. When responding to an update previously submitted was incorrect at
submission, FDA will use the means by the time of submission, you must im-
which the form was received by the mediately resubmit your update.
agency (i.e., by mail or fax). (11) Your registration will be consid-
(6) If any update information you ered updated once FDA enters your fa-
previously submitted was incorrect at cility’s update data into the registra-
the time of submission, you must im- tion system and the system generates
mediately resubmit your update. an update confirmation.
(7) Your registration will be consid-
[68 FR 58960, Oct. 10, 2003 as amended at 73
ered updated once FDA enters your fa- FR 15883, Mar. 26, 2008]
cility’s update data into the registra-
tion system and the system generates § 1.235 How and when do you cancel
an update confirmation. your facility’s registration informa-
(e) Update by CD-ROM for multiple tion?
submissions. If, for example, you do not (a) Notification of registration cancella-
have reasonable access to the Internet tion. A facility canceling its registra-
through any of the methods provided tion must do so within 60 calendar days
under § 1.231(a), you may update your of the reason for cancellation (e.g., fa-
facilities’ registrations by CD-ROM. cility ceases operations, ceases pro-
(1) Registrants submitting their up- viding food for consumption in the
dates in CD-ROM format must use ISO United States, or the facility is sold to
9660 (CD-R or CD-RW) data format. a new owner).
(2) Update files must be submitted on (b) Cancellation requirements. The can-
a PDF rendition of FDA’s registration cellation of a facility’s registration
form (Form 3537) and be accompanied must include the following informa-
by one signed copy of the certification tion:
statement on the registration form (1) The facility’s registration num-
(Form 3537). ber;
(3) Each submission on the CD-ROM (2) Whether the facility is domestic
must contain the same preferred mail- or foreign;

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§ 1.235 21 CFR Ch. I (4–1–11 Edition)

(3) The facility name and address; cellation form a copy of the cancella-
(4) The name, address, and e-mail ad- tion as entered and confirmation of the
dress (if available) of the individual cancellation. When responding to a
submitting the cancellation; and cancellation, FDA will use the means
(5) A statement certifying that the by which the form was received by the
information submitted is true and ac- agency (i.e., by mail or fax).
curate, and that the person submitting (6) If any information you previously
the cancellation is authorized by the submitted was incorrect at the time of
facility to cancel its registration. submission, you must immediately re-
(c) Electronic cancellation. (1) To can- submit your cancellation.
cel your registration electronically, (7) Your registration will be consid-
you must cancel at http://www.fda.gov/ ered cancelled once FDA enters your
furls. facility’s cancellation data into the
(2) Once you complete your elec- registration system and the system
tronic cancellation, FDA will auto- generates a confirmation.
matically provide you with an elec- (e) Cancellation by CD-ROM for mul-
tronic confirmation of your cancella- tiple submissions. If, for example, you do
tion. not have reasonable access to the
(3) Your registration will be consid- Internet through any of the methods
ered cancelled once FDA transmits described in § 1.231(a), you may cancel
your cancellation confirmation. your facilities’ registrations using a
(d) Cancellation by mail or fax. If, for CD-ROM.
example, you do not have reasonable (1) Registrants submitting their can-
access to the Internet through any of cellations in CD-ROM format must use
the methods described in § 1.231(a), you ISO 9660 (CD-R or CD-RW) data format.
may cancel your facility’s registration (2) Cancellation files must be sub-
by mail or fax. mitted on a PDF rendition of the can-
(1) You must cancel your registration cellation form (Form 3537a) and be ac-
using Form 3537a. You may obtain a companied by one signed copy of the
copy of this form by writing to the U.S. certification statement on the can-
Food and Drug Administration (HFS– cellation form.
681), 5600 Fishers Lane, Rockville, MD (3) Each submission on the CD-ROM
20857, or by requesting the form by must contain the same preferred mail-
phone at 1–877–FDA–3882 (1–877–332– ing address in the appropriate block on
3882). Form 3537.
(2) When you receive the form, you (4) The CD-ROM may contain can-
must completely and legibly fill out cellations for as many facilities as
the form and either mail it to the ad- needed up to the CD-ROM’s capacity.
dress in paragraph (d)(1) of this section (5) The cancellation for each facility
or fax it to 301–436–2804 or 1–800–573– on the CD-ROM must have a unique file
0846. name up to 32 characters long, the first
(3) If the information on the form is part of which may be used to identify
incomplete or illegible when FDA re- the parent company.
ceives it, FDA will return the form to (6) You must mail the CD-ROM to
you for revision, provided that your U.S. Food and Drug Administration
mailing address or fax number is leg- (HFS–681), 5600 Fishers Lane, Rock-
ible and valid. When returning a can- ville, MD 20857.
cellation form for revision, FDA will (7) If FDA receives a CD-ROM that
use the means by which the cancella- does not comply with these specifica-
tion was received by the agency (i.e., tions, it will return the CD-ROM to the
by mail or fax). registrant unprocessed.
(4) FDA will enter complete and leg- (8) FDA will enter CD-ROM submis-
ible mailed and faxed cancellations sions that meet the specifications into
into its registration system, along with its registration system, along with
CD-ROM cancellations, as soon as prac- complete and legible mailed and faxed
ticable, in the order FDA receives submissions, as soon as practicable, in
them. the order FDA receives them.
(5) FDA will then mail to the address (9) For each facility on the CD-ROM,
or fax to the fax number on the can- FDA will mail to the preferred mailing

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Food and Drug Administration, HHS § 1.276

address a copy of the cancellation(s) as erator, or agent in charge of the facil-


entered and confirmation of the can- ity fails to cancel the registration, or if
cellation. FDA determines that the registration
(10) If any information you pre- is for a facility that does not exist. If
viously submitted was incorrect at the FDA cancels a facility’s registration,
time of submission, you must imme- FDA will mail a confirmation of the
diately resubmit your cancellation. cancellation to the facility at the ad-
(11) Your registration will be consid- dress provided in the facility’s registra-
ered cancelled once FDA enters your tion.
facility’s cancellation data into the (c) If an article of food is imported or
registration system and the system offered for import into the United
generates a confirmation. States and a foreign facility that man-
ufactured/processed, packed, or held
[68 FR 58960, Oct. 10, 2003 as amended at 73
FR 15883, Mar. 26, 2008] that article of food has not registered
in accordance with this subpart, the
ADDITIONAL PROVISIONS disposition of the article of food shall
be governed by the procedures set out
§ 1.240 What other registration re- in subpart I of this part.
quirements apply?
In addition to the requirements of § 1.242 What does assignment of a reg-
istration number mean?
this subpart, you must comply with the
registration regulations found in part Assignment of a registration number
108 of this chapter, related to emer- to a facility means that the facility is
gency permit control, and any other registered with FDA. Assignment of a
Federal, State, or local registration re- registration number does not in any
quirements that apply to your facility. way convey FDA’s approval or endorse-
ment of a facility or its products.
§ 1.241 What are the consequences of
failing to register, update, or cancel § 1.243 Is food registration information
your registration? available to the public?
(a) Section 301 of the act (21 U.S.C. (a) The list of registered facilities
331) prohibits the doing of certain acts and registration documents submitted
or causing such acts to be done. Under under this subpart are not subject to
section 302 of the act (21 U.S.C. 332), disclosure under 5 U.S.C. 552 (the Free-
the United States can bring a civil ac- dom of Information Act). In addition,
tion in Federal court to enjoin a person any information derived from such list
who commits a prohibited act. Under or registration documents that would
section 303 of the act (21 U.S.C. 333), disclose the identity or location of a
the United States can bring a criminal specific registered person, is not sub-
action in Federal court to prosecute a ject to disclosure under 5 U.S.C. 552
person who is responsible for the com- (the Freedom of Information Act).
mission of a prohibited act. Under sec- (b) Paragraph (a) of this section does
tion 306 of the act (21 U.S.C. 335a), FDA not apply to any information obtained
can seek debarment of any person who by other means or that has previously
has been convicted of a felony relating been disclosed to the public as defined
to importation of food into the United in § 20.81 of this chapter.
States. Failure of an owner, operator,
or agent in charge of a domestic or for- Subpart I—Prior Notice of
eign facility to register its facility, to Imported Food
update required elements of it’s facili-
ty’s registration, or to cancel its reg- SOURCE: 73 FR 66402, November 7, 2008, un-
istration in accordance with the re- less otherwise noted.
quirements of this subpart is a prohib-
ited act under section 301(dd) of the GENERAL PROVISIONS
act.
(b) FDA will cancel a registration if § 1.276 What definitions apply to this
the agency independently verifies that subpart?
the facility is no longer in business or (a) The act means the Federal Food,
has changed owners, and the owner, op- Drug, and Cosmetic Act.

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§ 1.276 21 CFR Ch. I (4–1–11 Edition)

(b) The definitions of terms in sec- commodities for use as food or as com-
tion 201 of the act (21 U.S.C. 321) apply ponents of food, animal feed (including
when the terms are used in this sub- pet food), food and feed ingredients,
part, unless defined in this section. food and feed additives, dietary supple-
(1) Calendar day means every day ments and dietary ingredients, infant
shown on the calendar. formula, beverages (including alcoholic
(2) Country from which the article origi- beverages and bottled water), live food
nates means FDA Country of Produc- animals, bakery goods, snack foods,
tion. candy, and canned foods.
(3) Country from which the article is (6) Full address means the facility’s
shipped means the country in which the street name and number; suite/unit
article of food is loaded onto the con- number, as appropriate; city; Province
veyance that brings it to the United or State as appropriate; mail code as
States or, in the case of food sent by appropriate; and country.
international mail, the country from (7) Grower means a person who en-
which the article is mailed. gages in growing and harvesting or col-
(4) FDA Country of Production means: lecting crops (including botanicals),
(i) For an article of food that is in its raising animals (including fish, which
natural state, the country where the includes seafood), or both.
article of food was grown, including (8) International mail means foreign
harvested or collected and readied for national mail services. International
shipment to the United States. If an mail does not include express consign-
article of food is wild fish, including ment operators or carriers or other pri-
seafood that was caught or harvested vate delivery services unless such serv-
outside the waters of the United States ice is operating under contract as an
by a vessel that is not registered in the agent or extension of a foreign mail
United States, the FDA Country of service.
Production is the country in which the (9) Manufacturer means the last facil-
vessel is registered. If an article of food ity, as that word is defined in
that is in its natural state was grown, § 1.227(b)(2), that manufactured/proc-
including harvested or collected and essed the food. A facility is considered
readied for shipment, in a Territory, the last facility even if the food under-
the FDA Country of Production is the goes further manufacturing/processing
United States. that consists of adding labeling or any
(ii) For an article of food that is no similar activity of a de minimis nature.
longer in its natural state, the country If the food undergoes further manufac-
where the article was made; except turing/processing that exceeds an ac-
that, if an article of food is made from tivity of a de minimis nature, then the
wild fish, including seafood, aboard a subsequent facility that performed the
vessel, the FDA Country of Production additional manufacturing/processing is
is the country in which the vessel is considered the manufacturer.
registered. If an article of food that is (10) No longer in its natural state
no longer in its natural state was made means that an article of food has been
in a Territory, the FDA Country of made from one or more ingredients or
Production is the United States. synthesized, prepared, treated, modi-
(5) Food has the meaning given in fied, or manipulated. Examples of ac-
section 201(f) of the act, except as pro- tivities that render food no longer in
vided in paragraph (b)(5)(i) of this sec- its natural state are cutting, peeling,
tion. trimming, washing, waxing, evis-
(i) For purposes of this subpart, food cerating, rendering, cooking, baking,
does not include: freezing, cooling, pasteurizing, homog-
(A) Food contact substances as de- enizing, mixing, formulating, bottling,
fined in section 409(h)(6) of the act (21 milling, grinding, extracting juice, dis-
U.S.C. 348(h)(6)); or tilling, labeling, or packaging. Crops
(B) Pesticides as defined in 7 U.S.C. that have been cleaned (e.g., dusted,
136(u). washed), trimmed, or cooled attendant
(ii) Examples of food include fruits, to harvest or collection or treated
vegetables, fish, including seafood, against pests, or polished are still in
dairy products, eggs, raw agricultural their natural state for purposes of this

26

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Food and Drug Administration, HHS § 1.279

subpart. Whole fish headed, evis- (b) Notwithstanding paragraph (a) of


cerated, or frozen attendant to harvest this section, this subpart does not
are still in their natural state for pur- apply to:
poses of this subpart. (1) Food for an individual’s personal
(11) Port of arrival means the water, use when it is carried by or otherwise
air, or land port at which the article of accompanies the individual when arriv-
food is imported or offered for import ing in the United States;
into the United States. For an article (2) Food that was made by an indi-
of food arriving by water or air, this is vidual in his/her personal residence and
the port of unloading. For an article of sent by that individual as a personal
food arriving by land, this is the port gift (i.e., for nonbusiness reasons) to an
where the article of food first crosses individual in the United States;
the border into the United States. The (3) Food that is imported then ex-
port of arrival may be different than ported without leaving the port of ar-
the port where consumption or ware- rival until export;
house entry or foreign trade zone ad-
(4) Meat food products that at the
mission documentation is presented to
time of importation are subject to the
the U.S. Customs and Border Protec-
exclusive jurisdiction of the U.S. De-
tion (CBP).
partment of Agriculture (USDA) under
(12) Port of entry, in section 801(m)
the Federal Meat Inspection Act (21
and (l) of the act (21 U.S.C. 381(m) and
U.S.C. 601 et seq.);
(l)), means the port of entry as defined
in 19 CFR 101.1. (5) Poultry products that at the time
of importation are subject to the exclu-
(13) Registration number means the
sive jurisdiction of USDA under the
registration number assigned to a facil-
ity by FDA under section 415 of the act Poultry Products Inspection Act (21
(21 U.S.C. 350d) and subpart H of this U.S.C. 451 et seq.);
part. (6) Egg products that at the time of
(14) Shipper means the owner or ex- importation are subject to the exclu-
porter of the article of food who con- sive jurisdiction of USDA under the
signs and ships the article from a for- Egg Products Inspection Act (21 U.S.C.
eign country or the person who sends 1031 et seq.); and
an article of food by international mail (7) Articles of food subject to Article
or express consignment operators or 27(3) of The Vienna Convention on Dip-
carriers or other private delivery serv- lomatic Relations (1961), i.e., shipped as
ice to the United States. baggage or cargo constituting the dip-
(15) United States means the Customs lomatic bag.
territory of the United States (i.e., the
50 States, the District of Columbia, and REQUIREMENTS TO SUBMIT PRIOR NOTICE
the Commonwealth of Puerto Rico), OF IMPORTED FOOD
but not the Territories.
§ 1.278 Who is authorized to submit
(16) You means the person submitting prior notice?
the prior notice, i.e., the submitter or
the transmitter, if any. A prior notice for an article of food
may be submitted by any person with
§ 1.277 What is the scope of this sub- knowledge of the required information.
part? This person is the submitter. The sub-
(a) This subpart applies to all food mitter also may use another person to
for humans and other animals that is transmit the required information on
imported or offered for import into the his/her behalf. The person who trans-
United States for use, storage, or dis- mits the information is the trans-
tribution in the United States, includ- mitter. The submitter and transmitter
ing food for gifts and trade and quality may be the same person.
assurance/quality control samples, food
for transshipment through the United § 1.279 When must prior notice be sub-
mitted to FDA?
States to another country, food for fu-
ture export, and food for use in a U.S. (a) Except as provided in paragraph
Foreign Trade Zone. (c) of this section, you must submit the

27

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§ 1.280 21 CFR Ch. I (4–1–11 Edition)

prior notice to FDA and the prior no- Customs and Border Protection (CBP)
tice submission must be confirmed by or FDA upon arrival.
FDA for review as follows: (g) The PN Confirmation Number
(1) If the article of food is arriving by must accompany any article of food for
land by road, no less than 2 hours be- which the prior notice was submitted
fore arriving at the port of arrival; through the FDA PNSI when the arti-
(2) If the article of food is arriving by cle arrives in the United States and
land by rail, no less than 4 hours before must be provided to CBP or FDA upon
arriving at the port of arrival; arrival.
(3) If the article of food is arriving by
air, no less than 4 hours before arriving § 1.280 How must you submit prior no-
at the port of arrival; or tice?
(4) If the article of food is arriving by (a) You must submit the prior notice
water, no less than 8 hours before ar- electronically to FDA. You must sub-
riving at the port of arrival. mit all prior notice information in the
(b) Except in the case of an article of English language, except that an indi-
food imported or offered for import by vidual’s name, the name of a company,
international mail: and the name of a street may be sub-
(1) If prior notice is submitted via mitted in a foreign language. All infor-
Automated Broker Interface/Auto- mation, including the items listed in
mated Commercial System (ABI/ACS), the previous sentence, must be sub-
you may not submit prior notice more mitted using the Latin (Roman) alpha-
than 30-calendar days before the antici- bet. Unless paragraph (c) of this sec-
pated date of arrival. tion applies, you must submit prior no-
(2) If prior notice is submitted via the tice through:
FDA Prior Notice System Interface (1) The U.S. Customs and Border Pro-
(FDA PNSI), you may not submit prior tection (CBP) Automated Broker Inter-
notice more than 15-calendar days be- face of the Automated Commercial
fore the anticipated date of arrival. System (ABI/ACS); or
(c) Notwithstanding paragraphs (a) (2) The FDA PNSI at http://
and (b) of this section, if the article of www.access.fda.gov. You must submit
food is arriving by international mail, prior notice through the FDA Prior No-
you must submit the prior notice be- tice System Interface (FDA PNSI) for
fore the article of food is sent to the articles of food imported or offered for
United States. import by international mail, and
(d) FDA will notify you that your other transaction types that cannot be
prior notice has been confirmed for re- made through ABI/ACS. Prior notice
view with a reply message that con- for articles that have been refused
tains a Prior Notice (PN) Confirmation under section 801(m)(1) of the act and
Number. Your prior notice will be con- under this subpart must be submitted
sidered submitted and the prior notice through the FDA PNSI until such time
time will start when FDA has con- as FDA and CBP issue a determination
firmed your prior notice for review. that ACS or its successor system can
(e) The PN Confirmation Number accommodate such transactions.
must accompany any article of food ar- (b) If a customhouse broker’s or self-
riving by international mail. The PN filer’s system is not working or if the
Confirmation Number must appear on ABI/ACS interface is not working,
the Customs Declaration (e.g., CN22 or prior notice must be submitted
CN23 or U.S. equivalent) that accom- through the FDA PNSI.
panies the package. (c) If FDA determines that FDA
(f) A copy of the confirmation, in- PNSI or the Operational and Adminis-
cluding the PN Confirmation Number, tration System for Import Support
must accompany any article of food (OASIS) is not working, FDA will post
that is subject to this subpart when it prominent notification and instruc-
is carried by or otherwise accompanies tions at http://www.fda.gov. FDA will
an individual when arriving in the accept prior notice submissions in the
United States. The copy of the con- format it deems appropriate during the
firmation must be provided to U.S. system(s) outage.

28

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Food and Drug Administration, HHS § 1.281

§ 1.281 What information must be in a (ii) Either the registration number,


prior notice? city, and country of the manufacturer
(a) General. For each article of food or both the full address of the manufac-
that is imported or offered for import turer and the reason the registration
into the United States, except by inter- number is not provided;
national mail, you must submit the in- (7) For an article of food that is in its
formation for the article that is re- natural state, the name and growing
quired in paragraphs (a)(1) through location address of the grower, if
(a)(17) of this section: known. If the submitter does not know
the identity of the grower or, if the ar-
(1) The name of the individual sub-
ticle has been consolidated and the
mitting the prior notice and his/her
submitter does not know the identity
business address, phone number, and e-
of any of the growers, you may provide
mail address, and the name and address
the name and address of the firm that
of the submitting firm, if applicable. If
has consolidated the articles of food
the business address of the individual
from different growers or different
submitting the prior notice is a reg-
growing locations;
istered facility, then the facility’s reg-
(8) The FDA Country of Production;
istration number, city, and country
(9) If the shipper is different from the
may be provided instead of the facili-
manufacturer, the identity of the ship-
ty’s full address;
per, as follows:
(2) If different from the submitter,
(i) The name of the shipper; and
the name of the individual and firm, if
(ii) The full address of the shipper. If
applicable, transmitting the prior no-
the address of the shipper is a reg-
tice on behalf of the submitter and his/
istered facility, you also may submit
her business address, phone number,
the registration number of the ship-
and e-mail address. If the business ad-
per’s registered facility;
dress of the individual transmitting
(10) The country from which the arti-
the prior notice is a registered facility,
cle is shipped;
then the facility’s registration number,
(11) Anticipated arrival information
city, and country may be provided in-
about the article of food being im-
stead of the facility’s full address;
ported or offered for import, as follows:
(3) The entry type; (i) The anticipated port of arrival;
(4) The U.S. Customs and Border Pro- (ii) The anticipated date on which
tection (CBP) entry identifier (e.g., the article of food will arrive at the an-
CBP entry number or in-bond number), ticipated port of arrival;
if available; (iii) The anticipated time of that ar-
(5) The identity of the article of food rival; and
being imported or offered for import, (iv) Notwithstanding paragraphs
as follows: (a)(11)(i) through (a)(11)(iii) of this sec-
(i) The complete FDA product code; tion, if the article of food is arriving by
(ii) The common or usual name or express consignment operator or car-
market name; rier, and neither the submitter nor
(iii) The estimated quantity of food transmitter is the express consignment
that will be shipped, described from operator or carrier, and prior notice is
largest container to smallest package submitted via the FDA PNSI, the ex-
size; and press consignment operator or carrier
(iv) The lot or code numbers or other tracking number may be submitted in
identifier of the food if required by the lieu of the information required in
act or FDA regulations, e.g., low-acid paragraphs (a)(11)(i) through (a)(11)(iii)
canned foods, by § 113.60(c) of this chap- of this section. Until such time as FDA
ter; acidified foods, by § 114.80(b) of this and CBP issue a determination that
chapter; and infant formula, by § 106.90 ACS or its successor system can ac-
of this chapter; commodate such transactions, the
(6) For an article of food that is no tracking number may not be submitted
longer in its natural state, the identity in lieu of information required in para-
of the manufacturer, as follows: graphs (a)(11)(i) through (a)(11)(iii) of
(i) The name of the manufacturer; this section, if the prior notice is sub-
and mitted via ABI/ACS.

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§ 1.281 21 CFR Ch. I (4–1–11 Edition)

(12) The name and full address of the consignment operator or carrier, and
importer. If the business address of the neither the submitter nor transmitter
importer is a registered facility, you is the express consignment operator or
also may submit the registration num- carrier, and the prior notice is sub-
ber of the importer’s registered facil- mitted via the FDA PNSI, the express
ity. The identity of the importer is not consignment operator or carrier track-
required for an article of food that is ing number may be submitted in lieu of
imported or offered for import for the Airway Bill number(s) or Bill of
transshipment through the United Lading number(s), as applicable. Until
States under a Transportation and Ex- such time as FDA and CBP issue a de-
portation entry; termination that ACS or its successor
(13) The name and full address of the system can accommodate such trans-
owner if different from the importer or actions, the tracking number may not
ultimate consignee. If the business ad- be submitted in lieu of the Airway Bill
dress of the owner is a registered facil- number(s) or Bill of Lading number(s),
ity, you also may submit the registra- if the prior notice is submitted via ABI/
tion number of the owner’s registered ACS;
facility. The identity of the owner is (ii) For food arriving by ocean vessel,
not required for an article of food that the vessel name and voyage number;
is imported or offered for import for (iii) For food arriving by air carrier,
transshipment through the United the flight number. If the article of food
States under a Transportation and Ex- is arriving by express consignment op-
portation entry; erator or carrier, and neither the sub-
(14) The name and full address of the mitter nor transmitter is the express
ultimate consignee. If the business ad- consignment operator or carrier, and
dress of the ultimate consignee is a the prior notice is submitted via the
registered facility, you also may sub- FDA PNSI, the express consignment
mit the registration number of the ul-
operator or carrier tracking number
timate consignee’s registered facility.
may be submitted in lieu of the flight
The identity of the ultimate consignee
number. Until such time as FDA and
is not required for an article of food
CBP issue a determination that ACS or
that is imported or offered for import
its successor system can accommodate
for transshipment through the United
such transactions, the tracking num-
States under a Transportation and Ex-
ber may not be submitted in lieu of the
portation entry;
flight number, if the prior notice is
(15) The mode of transportation;
submitted via ABI/ACS;
(16) The Standard Carrier Abbrevia-
tion Code (SCAC) or International Air (iv) For food arriving by truck, bus,
Transportation Association (IATA) or rail, the trip number;
code of the carrier which is, or will be, (v) For food arriving as containerized
carrying the article of food from the cargo by water, air, or land, the con-
country from which the article is tainer number(s). This information is
shipped to the United States to the not required for an article of food when
port of arrival, or if this code is not ap- carried by or otherwise accompanying
plicable, then the name of the carrier. an individual when entering the United
If the carrier is a privately owned vehi- States; and
cle, the license plate number of the ve- (vi) For food arriving by rail, the car
hicle and the State or Province that number. This information is not re-
issued the license plate number; quired for an article of food when car-
(17) Planned shipment information, ried by or otherwise accompanying an
as applicable to the mode of transpor- individual.
tation and when it exists: (b) Articles arriving by international
(i) The Airway Bill number(s) or Bill mail. For each article of food that is
of Lading number(s), as applicable. imported or offered for import into the
This information is not required for an United States by international mail,
article of food when carried by or oth- you must submit the information for
erwise accompanying an individual the article that is required in para-
when entering the United States. If the graphs (b)(1) through (b)(11) of this sec-
article of food is arriving by express tion:

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Food and Drug Administration, HHS § 1.281

(1) The name of the individual sub- the name and address of the firm that
mitting the prior notice and his/her has consolidated the articles of food
business address, phone number, and e- from different growers or different
mail address, and the name and address growing locations;
of the submitting firm, if applicable. If (7) The FDA Country of Production;
the business address of the individual (8) If the shipper is different from the
submitting the prior notice is a reg- manufacturer, the identity of the ship-
istered facility, then the facility’s reg- per, as follows:
istration number, city, and country (i) The name of the shipper; and
may be provided instead of the facili- (ii) The full address of the shipper. If
ty’s full address; the address of the shipper is a reg-
(2) If different from the submitter, istered facility, you also may submit
the name of the individual and firm, if the registration number of the ship-
applicable, transmitting the prior no- per’s registered facility;
tice on behalf of the submitter and his/ (9) The country from which the arti-
her business address, phone number, cle is shipped (i.e., mailed);
and e-mail address. If the business ad- (10) The anticipated date of mailing;
dress of the individual transmitting and
the prior notice is a registered facility, (11) The name and address of the U.S.
then the facility’s registration number, recipient.
city, and country may be provided in- (c) Refused articles. If the article of
stead of the facility’s full address; food has been refused under section
(3) The entry type (which will be a 801(m)(1) of the act and under this sub-
mail entry); part, you must submit the information
(4) The identity of the article of food for the article that is required in para-
being imported or offered for import, graphs (c)(1) through (c)(18) of this sec-
as follows: tion. However, if the refusal is based on
(i) The complete FDA product code; § 1.283(a)(1)(iii) (Untimely Prior No-
(ii) The common or usual name or tice), you do not have to resubmit any
market name; information previously submitted un-
(iii) The estimated quantity of food less it has changed or the article has
that will be shipped, described from been exported and the original prior
largest container to smallest package notice was submitted through ABI/
size; and ACS. If the refusal is based on
(iv) The lot or code numbers or other § 1.283(a)(1)(ii), you should cancel the
identifier of the food if required by the previous submission per § 1.282(b) and
act or FDA regulations, e.g., low-acid (c).
canned foods, by § 113.60(c) of this chap- (1) The name of the individual sub-
ter; acidified foods, by § 114.80(b) of this mitting the prior notice and his/her
chapter; and infant formula, § 106.90 of business address, phone number, and e-
this chapter; mail address, and the name and address
(5) For an article of food that is no of the submitting firm, if applicable. If
longer in its natural state, the identity the business address of the individual
of the manufacturer, as follows: submitting the prior notice is a reg-
(i) The name of the manufacturer; istered facility, then the facility’s reg-
and istration number, city, and country
(ii) Either the registration number, may be provided instead of the facili-
city, and country of the manufacturer ty’s full address;
or both the full address of the manufac- (2) If different from the submitter,
turer and the reason the registration the name of the individual and firm, if
number is not provided; applicable, transmitting the prior no-
(6) For an article of food that is in its tice on behalf of the submitter and his/
natural state, the name and growing her business address, phone number,
location address of the grower, if and e-mail address. If the business ad-
known. If the submitter does not know dress of the individual transmitting
the identity of the grower or, if the ar- the prior notice is a registered facility,
ticle has been consolidated and the then the facility’s registration number,
submitter does not know the identity city, and country may be provided in-
of any of the growers, you may provide stead of the facility’s full address;

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§ 1.281 21 CFR Ch. I (4–1–11 Edition)

(3) The entry type; (ii) The date on which the article of
(4) The CBP entry identifier (e.g., food arrived at the port of arrival.
CBP entry number or in-bond number), (iii) Notwithstanding paragraph
if available; (c)(11) of this section, if the article of
(5) The identity of the article of food food arrived by express consignment
being imported or offered for import, operator or carrier, and neither the
as follows: submitter nor transmitter is the ex-
(i) The complete FDA product code; press consignment operator or carrier,
(ii) The common or usual name or and the prior notice is submitted via
market name; the FDA PNSI, the express consign-
(iii) The quantity of food that was ment operator or carrier tracking num-
shipped, described from largest con- ber may be submitted in lieu of the in-
tainer to smallest package size; and formation required in paragraph (c)(11)
(iv) The lot or code numbers or other of this section. Until such time as FDA
identifier of the food if required by the and CBP issue a determination that
act or FDA regulations, e.g., low-acid ACS or its successor system can ac-
canned foods, by § 113.60(c) of this chap- commodate such transactions, the
ter; acidified foods, by § 114.80(b) of this tracking number may not be submitted
chapter; and infant formula, by § 106.90 in lieu of information required in para-
of this chapter; graph (c)(11) of this section, if the prior
notice is submitted via ABI/ACS;
(6) For an article of food that is no
(12) The name and full address of the
longer in its natural state, the identity
importer. If the business address of the
of the manufacturer, as follows:
importer is a registered facility, you
(i) The name of the manufacturer;
also may submit the registration num-
and
ber of the importer’s registered facil-
(ii) Either the registration number, ity. The identity of the importer is not
city, and country of the manufacturer required for an article of food that is
or both the full address of the manufac- imported or offered for import for
turer and the reason the registration transshipment through the United
number is not provided; States under a Transportation and Ex-
(7) For an article of food that is in its portation entry;
natural state, the name and growing (13) The name and full address of the
location address of the grower, if owner, if different from the importer or
known. If the submitter does not know ultimate consignee. If the business ad-
the identity of the grower or, if the ar- dress of the owner is a registered facil-
ticle has been consolidated and the ity, you also may submit the registra-
submitter does not know any of the tion number of the importer’s reg-
growers, you may provide the name istered facility. The identity of the
and address of the firm that has con- owner is not required for an article of
solidated the articles of food from dif- food that is imported or offered for im-
ferent growers or different growing lo- port for transshipment through the
cations; United States under a Transportation
(8) The FDA Country of Production; and Exportation entry;
(9) If the shipper is different from the (14) The name and full address of the
manufacturer, the identity of the ship- ultimate consignee. If the business ad-
per, as follows: dress of the ultimate consignee is a
(i) The name of the shipper; and registered facility, you also may sub-
(ii) The full address of the shipper. If mit the registration number of the ul-
the address of the shipper is a reg- timate consignee’s registered facility.
istered facility, you also may submit The identity of the ultimate consignee
the registration number of the ship- is not required for an article of food
per’s registered facility; that is imported or offered for import
(10) The country from which the arti- for transshipment through the United
cle is shipped; States under a Transportation and Ex-
(11) Arrival information about the ar- portation entry;
ticle of food being imported or offered (15) The mode of transportation;
for import, as follows: (16) The SCAC or IATA code of the
(i) The port of arrival; and carrier which carried the article of

32

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Food and Drug Administration, HHS § 1.282

food from the country from which the (v) For food that arrived as contain-
article is shipped to the United States erized cargo by water, air, or land, the
to the port of arrival, or if this code is container number(s); however, this in-
not applicable, then the name of the formation is not required for an article
carrier. If the carrier is a privately of food when carried by or otherwise
owned vehicle, the license plate num- accompanying an individual when en-
ber of the vehicle and the State or tering the United States; and
Province that issued the license plate (vi) For food that arrived by rail, the
number; car number; however, this information
(17) Shipment information, as appli- is not required for an article of food
cable to the mode of transportation when carried by or otherwise accom-
and when it exists: panying an individual;
(i) The Airway Bill number(s) or Bill (18) The location and address where
of Lading number(s), as applicable; the article of refused food will be or is
however, this information is not re- being held, the date the article has ar-
quired for an article of food when car- rived or will arrive at that location,
ried by or otherwise accompanying an
and identification of a contact at that
individual when entering the United
location.
States. If the article of food arrived by
express consignment operator or car- § 1.282 What must you do if informa-
rier, and neither the submitter nor tion changes after you have re-
transmitter is the express consignment ceived confirmation of a prior no-
operator or carrier, and the prior no- tice from FDA?
tice is submitted via the FDA PNSI,
(a)(1) If any of the information re-
the express consignment operator or
quired in § 1.281(a), except the informa-
carrier tracking number may be sub-
mitted in lieu of the Airway Bill num- tion required in:
ber(s) or Bill of Lading number(s), as (i) Section 1.281(a)(5)(iii) (quantity),
applicable. Until such time as FDA and (ii) Section 1.281(a)(11) (anticipated
CBP issue a determination that ACS or arrival information), or
its successor system can accommodate (iii) Section 1.281(a)(17) (planned ship-
such transactions, the tracking num- ment information), changes after you
ber may not be submitted in lieu of the receive notice that FDA has confirmed
Airway Bill number(s) or Bill of Lading your prior notice submission for re-
number(s), if the prior notice is sub- view, you must resubmit prior notice
mitted via ABI/ACS; in accordance with this subpart unless
(ii) For food that arrived by ocean the article of food will not be offered
vessel, the vessel name and voyage for import or imported into the United
number; States.
(iii) For food that arrived by air car- (2) If any of the information required
rier, the flight number. If the article of in § 1.281(b), except the information re-
food arrived by express consignment quired in § 1.281(b)(10) (the anticipated
operator or carrier, and neither the date of mailing), changes after you re-
submitter nor transmitter is the ex- ceive notice that FDA has confirmed
press consignment operator or carrier, your prior notice submission for re-
and the prior notice is submitted via view, you must resubmit prior notice
the FDA PNSI, the express consign- in accordance with this subpart, unless
ment operator or carrier tracking num- the article of food will not be offered
ber may be submitted in lieu of the for import or imported into the United
flight number. Until such time as FDA States.
and CBP issue a determination that (b) If you submitted the prior notice
ACS or its successor system can ac-
via the FDA PNSI, you should cancel
commodate such transactions, the
the prior notice via the FDA PNSI.
tracking number may not be submitted
in lieu of the flight number, if the prior (c) If you submitted the prior notice
notice is submitted via ABI/ACS; via ABI/ACS, you should cancel the
(iv) For food that arrived by truck, prior notice via ACS by requesting that
bus, or rail, the trip number; CBP cancel the entry.

33

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§ 1.283 21 CFR Ch. I (4–1–11 Edition)

CONSEQUENCES for the article unless directed by CBP


or FDA.
§ 1.283 What happens to food that is (2) Status and movement of refused
imported or offered for import food. (i) An article of food that has
without adequate prior notice? been refused under section 801(m)(1) of
(a) For each article of food that is the act and paragraph (a) of this sec-
imported or offered for import into the tion shall be considered general order
United States, except for food arriving merchandise as described in section 490
by international mail or food carried of the Tariff Act of 1930, as amended (19
by or otherwise accompanying an indi- U.S.C. 1490).
vidual, the consequences are: (ii) Refused food must be moved
(1) Inadequate prior notice—(i) No prior under appropriate custodial bond un-
notice. If an article of food arrives at less immediately exported under CBP
the port of arrival and no prior notice supervision. If the food is to be held at
has been submitted and confirmed by the port, FDA must be notified of the
FDA for review, the food is subject to location where the food is held at that
refusal of admission under section port before the food is moved there. If
801(m)(1) of the act (21 U.S.C. 381(m)(1)). the food is to be held at a secure facil-
If an article of food is refused for lack ity outside the port, FDA must be noti-
of prior notice, unless U.S. Customs fied of the location of the secure facil-
and Border Protection (CBP) concur- ity before the food is moved there. The
rence is obtained for export and the ar- refused food shall not be entered and
ticle is immediately exported from the shall not be delivered to any importer,
port of arrival under CBP supervision, owner, or ultimate consignee. If the
it must be held within the port of entry food is to be held at a secure facility
for the article unless directed by CBP outside a port, the food must be taken
or FDA. directly to that secure facility.
(ii) Inaccurate prior notice. If prior no- (3) Segregation of refused foods. If an
tice has been submitted and confirmed article of food that is refused is part of
by FDA for review, but upon review of a shipment that contains articles of
the notice or examination of the arti- food that have not been placed under
cle of food, the notice is determined to hold or other merchandise not subject
be inaccurate, the food is subject to re- to this subpart, the refused article of
fusal of admission under section food may be segregated from the rest of
801(m)(1) of the act. If the article of the shipment. This segregation must
food is refused due to inaccurate prior take place where the article is held.
notice, unless CBP concurrence is ob- FDA or CBP may supervise segrega-
tained for export and the article is im- tion. If FDA or CBP determines that
mediately exported from the port of ar- supervision is necessary, segregation
rival under CBP supervision, it must be must not take place without super-
held within the port of entry for the ar- vision.
ticle unless directed by CBP or FDA. (4) Costs. Neither FDA nor CBP are
(iii) Untimely prior notice. If prior no- liable for transportation, storage, or
tice has been submitted and confirmed other expenses resulting from refusal.
by FDA for review, but the full time (5) Export after refusal. An article of
that applies under § 1.279 for prior no- food that has been refused under para-
tice has not elapsed when the article of graph (a) of this section may be ex-
food arrives, the food is subject to re- ported with CBP concurrence and
fusal of admission under section under CBP supervision unless it is
801(m)(1) of the act, unless FDA has al- seized or administratively detained by
ready reviewed the prior notice, deter- FDA or CBP under other authority. If
mined its response to the prior notice, an article of food that has been refused
and advised CBP of that response. If admission under paragraph (a) of this
the article of food is refused due to un- section is exported, the prior notice
timely prior notice, unless CBP concur- should be cancelled within 5-business
rence is obtained for export and the ar- days of exportation.
ticle is immediately exported from the (6) No post-refusal submission or request
port of arrival under CBP supervision, for review. If an article of food is re-
it must be held within the port of entry fused under section 801(m)(1) of the act

34

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Food and Drug Administration, HHS § 1.283

and no prior notice is submitted or re- (2) A request may be submitted only
submitted, no request for FDA review by the carrier, submitter, importer,
is submitted in accordance with para- owner, or ultimate consignee. A re-
graph (d) of this section, or export has quest must identify which one the re-
not occurred in accordance with para- quester is.
graph (a)(5) of this section, the article (3) A request must be submitted in
of food shall be dealt with as set forth writing to FDA and delivered by fax or
in CBP regulations relating to general e-mail. The location for receipt of a re-
order merchandise (19 CFR part 127), quest is listed at http://www.fda.gov—
except that, unless otherwise agreed to see Prior Notice. A request must in-
by CBP and FDA, the article may only clude all factual and legal information
be sold for export or destroyed. necessary for FDA to conduct its re-
(b) Food carried by or otherwise accom- view. Only one request for review may
panying an individual. If food carried by be submitted for each refused article.
or otherwise accompanying an indi- (4) The request must be submitted
vidual arriving in the United States is within 5-calendar days of the refusal.
not for personal use and does not have FDA will review and respond within 5-
adequate prior notice or the individual calendar days of receiving the request.
cannot provide FDA or CBP with a (5) If FDA determines that the article
copy of the prior notice (PN) confirma- is not subject to the requirements of
tion, the food is subject to refusal of this subpart under § 1.277 or that the
admission under section 801(m)(1) of prior notice submission is complete
the act. If before leaving the port, the and accurate, it will notify the re-
individual does not arrange to have the quester, the transmitter, and CBP that
food held at the port or exported, FDA the food is no longer subject to refusal
or CBP may destroy the article of food. under section 801(m)(1) of the act.
(c) Post-Refusal prior notice submis- (e) International mail. If an article of
food arrives by international mail with
sions. (1) If an article of food is refused
inadequate prior notice or the PN con-
under paragraph (a)(1)(i) of this section
firmation number is not affixed as re-
(no prior notice) and the food is not ex-
quired, the parcel will be held by CBP
ported, prior notice must be submitted
for 72 hours for FDA inspection and
in accordance with §§ 1.280 and 1.281(c).
disposition. If FDA refuses the article
(2) If an article of food is refused under section 801(m)(1) of the act and
under paragraph (a)(1)(ii) of this sec- there is a return address, the parcel
tion (inaccurate prior notice) and the may be returned to sender marked ‘‘No
food is not exported, the prior notice Prior Notice—FDA Refused.’’ If the ar-
should be canceled in accordance with ticle is refused and there is no return
§ 1.282 and you must resubmit prior no- address or FDA determines that the ar-
tice in accordance with §§ 1.280 and ticle of food in the parcel appears to
1.281(c). present a hazard, FDA may dispose of
(3) Once the prior notice has been or destroy the parcel at its expense. If
submitted or resubmitted and con- FDA does not respond within 72 hours
firmed by FDA for review, FDA will en- of the CBP hold, CBP may return the
deavor to review and respond to the parcel to the sender or, if there is no
prior notice submission within the return address, destroy the parcel, at
timeframes set out in § 1.279. FDA expense.
(d) FDA review after refusal. (1) If an (f) Prohibitions on delivery and trans-
article of food has been refused admis- fer. (1) Notwithstanding section 801(b)
sion under section 801(m)(1) of the act, of the act, an article of food refused
a request may be submitted asking under section 801(m)(1) of the act may
FDA to review whether the article is not be delivered to the importer,
subject to the requirements of this sub- owner, or ultimate consignee until
part under § 1.277, or whether the infor- prior notice is submitted to FDA in ac-
mation submitted in a prior notice is cordance with this subpart, FDA has
complete and accurate. A request for examined the prior notice, FDA has de-
review may not be used to submit prior termined that the prior notice is ade-
notice or to resubmit an inaccurate quate, and FDA has notified CBP and
prior notice. the transmitter that the article of food

35

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§ 1.284 21 CFR Ch. I (4–1–11 Edition)

is no longer refused admission under (c) Under section 306 of the act (21
section 801(m)(1) of the act. U.S.C. 335a), FDA can seek debarment
(2) During the time an article of food of any person who has been convicted
that has been refused under section of a felony relating to importation of
801(m)(1) of the act is held, the article food into the United States or any per-
may not be transferred by any person son who has engaged in a pattern of
from the port or other designated se- importing or offering for import adul-
cure facility until prior notice is sub- terated food that presents a threat of
mitted to FDA in accordance with this serious adverse health consequences or
subpart, FDA has examined the prior death to humans or animals.
notice, FDA has determined that the § 1.285 What happens to food that is
prior notice is adequate, and FDA has imported or offered for import from
notified CBP and the transmitter that unregistered facilities that are re-
the article of food no longer is refused quired to register under subpart H
admission under section 801(m)(1) of of this part?
the act. After this notification by FDA (a) Consequences. If an article of food
to CBP and transmitter, entry may be from a foreign facility that is not reg-
made in accordance with law and regu- istered as required under section 415 of
lation. the act (21 U.S.C. 350d) and subpart H of
(g) Relationship to other admissibility this part is imported or offered for im-
decisions. A determination that an arti- port into the United States, the food is
cle of food is no longer refused under subject to being held under section
section 801(m)(1) of the act is different 801(l) of the act (21 U.S.C. 381(l)).
than, and may come before, determina- (b) Hold. Unless CBP concurrence is
tions of admissibility under other pro- obtained for export and the article is
visions of the act or other U.S. laws. A immediately exported from the port of
determination that an article of food is arrival, if an article of food has been
no longer refused under section placed under hold under section 801(l)
801(m)(1) of the act does not mean that of the act, it must be held within the
it will be granted admission under port of entry for the article unless di-
other provisions of the act or other rected by CBP or FDA.
U.S. laws. (c) Status and movement of held food.
(1) An article of food that has been
§ 1.284 What are the other con- placed under hold under section 801(l)
sequences of failing to submit ade- of the act shall be considered general
quate prior notice or otherwise fail- order merchandise as described in sec-
ing to comply with this subpart? tion 490 of the Tariff Act of 1930, as
(a) The importing or offering for im- amended (19 U.S.C. 1490).
port into the United States of an arti- (2) Food under hold under section
cle of food in violation of the require- 801(l) of the act must be moved under
ments of section 801(m) of the act, in- appropriate custodial bond unless im-
cluding the requirements of this sub- mediately exported under CBP super-
vision. If the food is to be held at the
part, is a prohibited act under section
port, FDA must be notified of the loca-
301(ee) of the act (21 U.S.C. 331(ee)).
tion where the food is held at the port
(b) Section 301 of the act prohibits before the food is moved there. If the
the doing of certain acts or causing food is to be held at a secure facility
such acts to be done. outside the port, FDA must be notified
(1) Under section 302 of the act (21 of the location of the secure facility
U.S.C. 332), the United States can bring before the food is moved there. The
a civil action in Federal court to en- food subject to hold shall not be en-
join persons who commit a prohibited tered and shall not be delivered to any
act. importer, owner, or ultimate con-
(2) Under sections 301 and 303 of the signee. If the food is to be held at a se-
act (21 U.S.C. 331 and 333), the United cure facility outside a port, the food
States can bring a criminal action in must be taken directly to that secure
Federal court to prosecute persons who facility.
are responsible for the commission of a (d) Segregation of held foods. If an arti-
prohibited act. cle of food that has been placed under

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Food and Drug Administration, HHS § 1.285

hold under section 801(l) of the act is fication must provide the name and
part of a shipment that contains arti- contact information for the person sub-
cles that have not been placed under mitting the information. The notifica-
hold, the food under hold may be seg- tion may be delivered to FDA by fax or
regated from the rest of the shipment. e-mail. The contact information for
This segregation must take place these delivery methods is listed at
where the article is held. FDA or CBP http://www.fda.gov—see Prior Notice.
may supervise segregation. If FDA or The notification should include the ap-
CBP determine that supervision is nec- plicable CBP entry identifier.
essary, segregation must not take (3) If FDA determines that the article
place without supervision. is no longer subject to hold, it will no-
(e) Costs. Neither FDA nor CBP will tify the person who provided the reg-
be liable for transportation, storage, or istration information and CBP that the
other expenses resulting from any hold. food is no longer subject to hold under
(f) Export after hold. An article of food section 801(l) of the act.
that has been placed under hold under (j) FDA review after hold. (1) If an ar-
section 801(l) of the act may be ex- ticle of food has been placed under hold
ported with CBP concurrence and under section 801(l) of the act, a re-
under CBP supervision unless it is quest may be submitted asking FDA to
seized or administratively detained by review whether the facility associated
FDA or CBP under other authority. with the article is subject to the re-
(g) No registration or request for review. quirements of section 415 of the act. A
If an article of food is placed under request for review may not be sub-
hold under section 801(l) of the act and mitted to obtain a registration num-
no registration number or request for ber.
FDA review is submitted in accordance (2) A request may be submitted only
with paragraph (j) of this section or ex- by the carrier, submitter, importer,
port has not occurred in accordance owner, or ultimate consignee of the ar-
with paragraph (f) of this section, the ticle. A request must identify which
food shall be dealt with as set forth in one the requestor is.
CBP regulations relating to general (3) A request must be submitted in
order merchandise, except that, unless writing to FDA and delivered by fax or
otherwise agreed to by CBP and FDA, e-mail. The location for receipt of a re-
the article may only be sold for export quest is listed at http://www.fda.gov—
or destroyed. see Prior Notice. A request must in-
(h) Food carried by or otherwise accom- clude all factual and legal information
panying an individual. If an article of necessary for FDA to conduct its re-
food carried by or otherwise accom- view. Only one request for review may
panying an individual arriving in the be submitted for each article under
United States is not for personal use hold.
and is placed under hold under section (4) The request must be submitted
801(l) of the act because it is from a for- within 5-calendar days of the hold.
eign facility that is not registered as FDA will review and respond within 5-
required under section 415 of the act calendar days of receiving the request.
and subpart H of this part, the indi- (5) If FDA determines that the article
vidual may arrange to have the food is not from a facility subject to the re-
held at the port or exported. If such ar- quirements of section 415 of the act, it
rangements cannot be made, the arti- will notify the requestor and CBP that
cle of food may be destroyed. the food is no longer subject to hold
(i) Post-hold submissions. (1) To re- under section 801(l) of the act.
solve a hold, if an article of food is held (k) International mail. If an article of
under paragraph (b) of this section be- food that arrives by international mail
cause it is from a foreign facility that is from a foreign facility that is not
is not registered, the facility must be registered as required under section 415
registered and a registration number of the act and subpart H of this part,
must be obtained. the parcel will be held by CBP for 72
(2) The FDA Prior Notice Center hours for FDA inspection and disposi-
must be notified of the applicable reg- tion. If the article is placed under hold
istration number in writing. The noti- under section 801(l) of the act and there

37

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§ 1.326 21 CFR Ch. I (4–1–11 Edition)

is a return address, the parcel may be part, but are not required by this sub-
returned to sender marked ‘‘No Reg- part to keep records with respect to ac-
istration—No Admission Permitted.’’ If tivities that fall within one of the ex-
the article is under hold and there is no clusions in § 1.327.
return address or FDA determines that (b) Persons subject to the regulations
the article of food in the parcel appears in this subpart must keep records
to present a hazard, FDA may dispose whether or not the food is being offered
of or destroy the parcel at its expense. for or enters interstate commerce.
If FDA does not respond within 72
hours of the CBP hold, CBP may return § 1.327 Who is excluded from all or
the parcel to the sender marked ‘‘No part of the regulations in this sub-
Registration—No Admission Per- part?
mitted’’ or, if there is no return ad- (a) Farms are excluded from all of
dress, destroy the parcel, at FDA ex- the requirements in this subpart.
pense.
(b) Restaurants are excluded from all
(l) Prohibitions on delivery and trans-
of the requirements in this subpart. A
fer. Notwithstanding section 801(b) of
the act, while an article of food is restaurant/retail facility is excluded
under hold under section 801(l) of the from all of the requirements in this
act, it may not be delivered to the im- subpart if its sales of food it prepares
porter, owner, or ultimate consignee. If and sells to consumers for immediate
an article of food is no longer subject consumption are more than 90 percent
to hold under section 801(l) of the act, of its total food sales.
entry may be made in accordance with (c) Fishing vessels, including those
law and regulation. that not only harvest and transport
(m) Relationship to other admissibility fish but also engage in practices such
provisions. A determination that an ar- as heading, eviscerating, or freezing in-
ticle of food is no longer subject to tended solely to prepare fish for hold-
hold under section 801(l) of the act is ing on board a harvest vessel, are ex-
different than, and may come before, cluded from all of the requirements in
determinations of admissibility under this subpart, except §§ 1.361 and 1.363.
other provisions of the act or other However, those fishing vessels other-
U.S. laws. A determination that an ar- wise engaged in processing fish are sub-
ticle of food is no longer under hold ject to all of the requirements in this
under section 801(l) of the act does not subpart. For the purposes of this sec-
mean that it will be granted admission tion, ‘‘processing’’ means handling,
under other provisions of the act or storing, preparing, shucking, changing
other U.S. laws. into different market forms, manufac-
turing, preserving, packing, labeling,
Subpart J—Establishment, Mainte- dockside unloading, holding or head-
nance, and Availability of ing, eviscerating, or freezing other
Records than solely to prepare fish for holding
on board a harvest vessel.
(d) Persons who distribute food di-
SOURCE: 69 FR 71651, Dec. 9, 2004, unless
otherwise noted. rectly to consumers are excluded from
the requirements in § 1.345 to establish
GENERAL PROVISIONS and maintain records to identify the
nontransporter and transporter imme-
§ 1.326 Who is subject to this subpart? diate subsequent recipients as to those
(a) Persons who manufacture, proc- transactions. The term ‘‘consumers’’
ess, pack, transport, distribute, re- does not include businesses.
ceive, hold, or import food in the (e) Persons who operate retail food
United States are subject to the regu- establishments that distribute food to
lations in this subpart, unless you persons who are not consumers are sub-
qualify for one of the exclusions in ject to all of the requirements in this
§ 1.327. If you conduct more than one subpart. However, the requirements in
type of activity at a location, you are § 1.345 to establish and maintain
required to keep records with respect records to identify the nontransporter
to those activities covered by this sub- and transporter immediate subsequent

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Food and Drug Administration, HHS § 1.328

recipients that are not consumers ap- packaging (the outer packaging of food
plies as to those transactions only to that bears the label and does not con-
the extent the information is reason- tact the food). All other persons who
ably available. manufacture, process, pack, transport,
(1) For purposes of this section, retail distribute, receive, hold, or import
food establishment is defined to mean packaging are excluded from all of the
an establishment that sells food prod- requirements of this subpart.
ucts directly to consumers as its pri- (j) Persons who manufacture, proc-
mary function. The term ‘‘consumers’’ ess, pack, transport, distribute, re-
does not include businesses. ceive, hold, or import food contact sub-
(2) A retail food establishment may stances other than the finished con-
manufacture/process, pack, or hold tainer that directly contacts food are
food if the establishment’s primary excluded from all of the requirements
function is to sell from that establish- of this subpart, except §§ 1.361 and 1.363.
ment food, including food that it man- (k) Persons who place food directly in
ufactures/processes, packs, or holds, di- contact with its finished container are
rectly to consumers. subject to all of the requirements of
(3) A retail food establishment’s pri- this subpart as to the finished con-
mary function is to sell food directly to tainer that directly contacts that food.
consumers if the annual monetary All other persons who manufacture,
value of sales of food products directly process, pack, transport, distribute, re-
to consumers exceeds the annual mone- ceive, hold, or import the finished con-
tary value of sales of food products to tainer that directly contacts the food
all other buyers. are excluded from the requirements of
(4) A ‘‘retail food establishment’’ in- this subpart as to the finished con-
cludes grocery stores, convenience tainer, except §§ 1.361 and 1.363.
stores, and vending machine locations. (l) Nonprofit food establishments are
(f) Retail food establishments that excluded from all of the requirements
employ 10 or fewer full-time equivalent in this subpart, except §§ 1.361 and 1.363.
employees are excluded from all of the (m) Persons who manufacture, proc-
requirements in this subpart, except ess, pack, transport, distribute, re-
§§ 1.361 and 1.363. The exclusion is based ceive, hold, or import food for personal
on the number of full-time equivalent consumption are excluded from all of
employees at each retail food estab- the requirements of this subpart.
lishment and not the entire business, (n) Persons who receive or hold food
which may own numerous retail stores. on behalf of specific individual con-
(g) Persons who manufacture, proc- sumers and who are not also parties to
ess, pack, transport, distribute, re- the transaction and who are not in the
ceive, hold, or import food in the business of distributing food are ex-
United States that is within the exclu- cluded from all of the requirements of
sive jurisdiction of the U.S. Depart- this subpart.
ment of Agriculture (USDA) under the
Federal Meat Inspection Act (21 U.S.C. § 1.328 What definitions apply to this
601 et seq.), the Poultry Products In- subpart?
spection Act (21 U.S.C. 451 et seq.), or The definitions of terms in section
the Egg Products Inspection Act (21 201 of the Federal Food, Drug, and Cos-
U.S.C. 1031 et seq.) are excluded from all metic Act (the act) (21 U.S.C. 321) apply
of the requirements in this subpart to such terms when used in this sub-
with respect to that food while it is part. In addition, for the purposes of
under the exclusive jurisdiction of this subpart:
USDA. Act means the Federal Food, Drug,
(h) Foreign persons, except for for- and Cosmetic Act.
eign persons who transport food in the Farm means a facility in one general
United States, are excluded from all of physical location devoted to the grow-
the requirements of this subpart. ing and harvesting of crops, the raising
(i) Persons who manufacture, proc- of animals (including seafood), or both.
ess, pack, transport, distribute, re- Washing, trimming of outer leaves, and
ceive, hold, or import food are subject cooling produce are considered part of
to §§ 1.361 and 1.363 with respect to its harvesting. The term ‘‘farm’’ includes:

39

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§ 1.328 21 CFR Ch. I (4–1–11 Edition)

(1) Facilities that pack or hold food, central food banks, soup kitchens, and
provided that all food used in such ac- nonprofit food delivery services. To be
tivities is grown, raised, or consumed considered a nonprofit food establish-
on that farm or another farm under the ment, the establishment must meet the
same ownership; and terms of section 501(c)(3) of the U.S. In-
(2) Facilities that manufacture/proc- ternal Revenue Code (26 U.S.C.
ess food, provided that all food used in 501(c)(3)).
such activities is consumed on that Nontransporter means a person who
farm or another farm under the same owns food or who holds, manufactures,
ownership. processes, packs, imports, receives, or
Food has the meaning given in sec- distributes food for purposes other
tion 201(f) of the act. Examples of food than transportation.
include, but are not limited to fruits; Nontransporter immediate previous
vegetables; fish; dairy products; eggs; source means a person that last had
raw agricultural commodities for use food before transferring it to another
as food or as components of food; ani- nontransporter.
mal feed, including pet food; food and Nontransporter immediate subsequent
feed ingredients and additives, includ- recipient means a nontransporter that
ing substances that migrate into food acquires food from another nontrans-
from the finished container and other porter.
articles that contact food; dietary sup- Packaging means the outer packaging
plements and dietary ingredients; in- of food that bears the label and does
fant formula; beverages, including al- not contact the food. Packaging does
coholic beverages and bottled water; not include food contact substances as
live food animals; bakery goods; snack they are defined in section 409(h)(6) of
foods; candy; and canned foods. the act (21 U.S.C. 348(h)(6)).
Full-time equivalent employee means Person includes individual, partner-
all individuals employed by the person ship, corporation, and association.
claiming the exemption. The number of Recipe means the formula, including
full-time equivalent employees is de- ingredients, quantities, and instruc-
termined by dividing the total number tions, necessary to manufacture a food
of hours of salary or wages paid di- product. Because a recipe must have all
rectly to employees of the person and three elements, a list of the ingredients
of all of its affiliates by the number of used to manufacture a product without
hours of work in 1 year, 2,080 hours quantity information and manufac-
(i.e., 40 hours × 52 weeks). turing instructions is not a recipe.
Holding means storage of food. Hold- Restaurant means a facility that pre-
ing facilities include warehouses, cold pares and sells food directly to con-
storage facilities, storage silos, grain sumers for immediate consumption.
elevators, and liquid storage tanks. ‘‘Restaurant’’ does not include facilities
Manufacturing/processing means mak- that provide food to interstate convey-
ing food from one or more ingredients, ances, central kitchens, and other
or synthesizing, preparing, treating, similar facilities that do not prepare
modifying, or manipulating food, in- and serve food directly to consumers.
cluding food crops or ingredients. Ex- (1) Facilities in which food is directly
amples of manufacturing/processing ac- provided to humans, such as cafeterias,
tivities are cutting, peeling, trimming, lunchrooms, cafes, bistros, fast food es-
washing, waxing, eviscerating, ren- tablishments, food stands, saloons, tav-
dering, cooking, baking, freezing, cool- erns, bars, lounges, catering facilities,
ing, pasteurizing, homogenizing, mix- hospital kitchens, day care kitchens,
ing, formulating, bottling, milling, and nursing home kitchens, are res-
grinding, extracting juice, distilling, taurants.
labeling, or packaging. (2) Pet shelters, kennels, and veteri-
Nonprofit food establishment means a nary facilities in which food is directly
charitable entity that prepares or provided to animals are restaurants.
serves food directly to the consumer or Transporter means a person who has
otherwise provides food or meals for possession, custody, or control of an
consumption by humans or animals in article of food in the United States for
the United States. The term includes the sole purpose of transporting the

40

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Food and Drug Administration, HHS § 1.337

food, whether by road, rail, water, or ments. Moreover, persons do not have
air. Transporter also includes a foreign to keep all of the information required
person that transports food in the by this rule in one set of records. If
United States, regardless of whether they have records containing some of
that foreign person has possession, cus- the required information, they may
tody, or control of that food for the keep those existing records and keep,
sole purpose of transporting that food. either separately or in a combined
Transporter’s immediate previous source form, any new information required by
means a person from whom a trans- this rule. There is no obligation to cre-
porter received food. This source can be ate an entirely new record or compila-
either another transporter or a non- tion of records containing both exist-
transporter.
ing and new information, even if the
Transporter’s immediate subsequent re-
records containing some of the re-
cipient means a person to whom a
transporter delivered food. This recipi- quired information were not created at
ent can be either another transporter the time the food was received or re-
or a nontransporter. leased.
You means a person subject to this
REQUIREMENTS FOR NONTRANSPORTERS
subpart under § 1.326.
TO ESTABLISH AND MAINTAIN RECORDS
§ 1.329 Do other statutory provisions TO IDENTIFY THE NONTRANSPORTER
and regulations apply? AND TRANSPORTER IMMEDIATE PRE-
(a) In addition to the regulations in VIOUS SOURCES OF FOOD
this subpart, you must comply with all
other applicable statutory provisions § 1.337 What information must non-
transporters establish and maintain
and regulations related to the estab- to identify the nontransporter and
lishment and maintenance of records transporter immediate previous
for foods except as described in para- sources of food?
graph (b) of this section. For example,
the regulations in this subpart are in (a) If you are a nontransporter, you
addition to existing recordkeeping reg- must establish and maintain the fol-
ulations for low acid canned foods, lowing records for all food you receive:
juice, seafood, infant formula, color ad- (1) The name of the firm, address,
ditives, bottled water, animal feed, and telephone number and, if available, the
medicated animal feed. fax number and e-mail address of the
(b) Records established or maintained nontransporter immediate previous
to satisfy the requirements of this sub- source, whether domestic or foreign;
part that meet the definition of elec- (2) An adequate description of the
tronic records in § 11.3(b)(6) (21 CFR 11.3 type of food received, to include brand
(b)(6)) of this chapter are exempt from name and specific variety (e.g., brand x
the requirements of part 11 of this cheddar cheese, not just cheese; or ro-
chapter. Records that satisfy the re- maine lettuce, not just lettuce);
quirements of this subpart but that are (3) The date you received the food;
also required under other applicable
(4) For persons who manufacture,
statutory provisions or regulations re-
main subject to part 11 of this chapter. process, or pack food, the lot or code
number or other identifier of the food
§ 1.330 Can existing records satisfy the (to the extent this information exists);
requirements of this subpart? (5) The quantity and how the food is
The regulations in this subpart do packaged (e.g., 6 count bunches, 25
not require duplication of existing pound (lb) carton, 12 ounce (oz) bottle,
records if those records contain all of 100 gallon (gal) tank); and
the information required by this sub- (6) The name of the firm, address,
part. If a covered person keeps records telephone number, and, if available,
of all of the information as required by the fax number and e-mail address of
this subpart to comply with other Fed- the transporter immediate previous
eral, State, or local regulations, or for source (the transporter who trans-
any other reason, then those records ported the food to you).
may be used to meet these require-

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§ 1.345 21 CFR Ch. I (4–1–11 Edition)

REQUIREMENTS FOR NONTRANSPORTERS (2) Origin and destination points;


TO ESTABLISH AND MAINTAIN RECORDS (3) Date shipment received and date
TO IDENTIFY THE NONTRANSPORTER released;
AND TRANSPORTER IMMEDIATE SUBSE- (4) Number of packages;
QUENT RECIPIENTS OF FOOD (5) Description of freight;
(6) Route of movement during the
§ 1.345 What information must non- time you transported the food; and
transporters establish and maintain (7) Transfer point(s) through which
to identify the nontransporter and
transporter immediate subsequent shipment moved; or
recipients of food? (b) Establishing and maintaining
records containing the following infor-
(a) If you are a nontransporter, you
mation currently required by the De-
must establish and maintain the fol-
partment of Transportation’s Federal
lowing records for food you release:
Motor Carrier Safety Administration
(1) The name of the firm, address,
(of roadway interstate transporters (49
telephone number, and, if available,
CFR 373.101 and 373.103) as of December
the fax number and e-mail address of
9, 2004:
the nontransporter immediate subse-
(1) Names of consignor and consignee;
quent recipient, whether domestic or
(2) Origin and destination points;
foreign;
(3) Date of shipment;
(2) An adequate description of the
(4) Number of packages;
type of food released, to include brand
(5) Description of freight;
name and specific variety (e.g., brand x
(6) Route of movement and name of
cheddar cheese, not just cheese; or ro-
each carrier participating in the trans-
maine lettuce, not just lettuce);
(3) The date you released the food; portation; and
(4) For persons who manufacture, (7) Transfer points through which
process, or pack food, the lot or code shipment moved; or
number or other identifier of the food (c) Establishing and maintaining
(to the extent this information exists); records containing the following infor-
(5) The quantity and how the food is mation currently required by the De-
packaged (e.g., 6 count bunches, 25 lb partment of Transportation’s Surface
carton, 12 oz bottle, 100 gal tank); Transportation Board of rail and water
(6) The name of the firm, address, interstate transporters (49 CFR 1035.1
telephone number, and, if available, and 1035.2) as of December 9, 2004:
the fax number and e-mail address of (1) Date received;
the transporter immediate subsequent (2) Received from;
recipient (the transporter who trans- (3) Consigned to;
ported the food from you); and (4) Destination;
(b) Your records must include infor- (5) State of;
mation reasonably available to you to (6) County of;
identify the specific source of each in- (7) Route;
gredient used to make every lot of fin- (8) Delivering carrier;
ished product. (9) Car initial;
(10) Car no;
REQUIREMENTS FOR TRANSPORTERS TO (11) Trailer initials/number;
ESTABLISH AND MAINTAIN RECORDS (12) Container initials/number;
(13) No. packages; and
§ 1.352 What information must trans- (14) Description of articles; or
porters establish and maintain? (d) Establishing and maintaining
If you are a transporter, you must es- records containing the following infor-
tablish and maintain the following mation currently required by the War-
records for each food you transport in saw Convention of international air
the United States. You may fulfill this transporters on air waybills:
requirement by either: (1) Shipper’s name and address;
(a) Establishing and maintaining the (2) Consignee’s name and address;
following records: (3) Customs reference/status;
(1) Names of the transporter’s imme- (4) Airport of departure and destina-
diate previous source and transporter’s tion;
immediate subsequent recipient; (5) First carrier; and

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Food and Drug Administration, HHS § 1.361

(6) Description of goods; or only after a minimum of 60 days, but


(e) Entering into an agreement with within 6 months, after the date you re-
the nontransporter immediate previous ceive or release the food.
source located in the United States (d) If you are a nontransporter, you
and/or the nontransporter immediate must retain for 2 years after the dates
subsequent recipient located in the you receive and release the food all re-
United States to establish, maintain, quired records for any food for which a
or establish and maintain, the informa- significant risk of spoilage, loss of
tion in § 1.352(a), (b), (c), or (d). The value, or loss of palatability does not
agreement must contain the following occur sooner than 6 months after the
elements: date you receive or release the food, in-
(1) Effective date; cluding foods preserved by freezing, de-
(2) Printed names and signatures of hydrating, or being placed in a her-
authorized officials; metically sealed container.
(3) Description of the records to be (e) If you are a nontransporter, you
established and/or maintained; must retain for 1 year after the dates
(4) Provision for the records to be you receive and release the food all re-
maintained in compliance with § 1.360, quired records for animal food, includ-
if the agreement provides for mainte- ing pet food.
nance of records; (f) If you are a transporter or non-
(5) Provision for the records to be transporter retaining records on behalf
available to FDA as required by § 1.361, of a transporter, you must retain for 6
if the agreement provides for mainte- months after the dates you receive and
nance of records; release the food all required records for
(6) Acknowledgement that the non- any food having a significant risk of
transporter assumes legal responsi- spoilage, loss of value, or loss of palat-
bility under § 1.363 for establishing and/ ability within 60 days after the date
or maintaining the records as required the transporter receives or releases the
by this subpart; and food. If you are a transporter, or non-
(7) Provision that if the agreement is transporter retaining records on behalf
terminated in writing by either party, of a transporter, you must retain for 1
responsibility for compliance with the year after the dates you receive and re-
applicable establishment, mainte- lease the food, all required records for
nance, and access provisions of this
any food for which a significant risk of
subpart reverts to the transporter as of
spoilage, loss of value, or loss of palat-
the date of termination.
ability occurs only after a minimum of
GENERAL REQUIREMENTS 60 days after the date the transporter
receives or releases the food.
§ 1.360 What are the record retention (g) You must retain all records at the
requirements? establishment where the covered ac-
(a) You must create the required tivities described in the records oc-
records when you receive and release curred (onsite) or at a reasonably ac-
food, except to the extent that the in- cessible location.
formation is contained in existing (h) The maintenance of electronic
records. records is acceptable. Electronic
(b) If you are a nontransporter, you records are considered to be onsite if
must retain for 6 months after the they are accessible from an onsite loca-
dates you receive and release the food tion.
all required records for any food having
a significant risk of spoilage, loss of § 1.361 What are the record avail-
value, or loss of palatability within 60 ability requirements?
days after the date you receive or re- When FDA has a reasonable belief
lease the food. that an article of food is adulterated
(c) If you are a nontransporter, you and presents a threat of serious adverse
must retain for 1 year after the dates health consequences or death to hu-
you receive and release the food all re- mans or animals, any records and other
quired records for any food for which a information accessible to FDA under
significant risk of spoilage, loss of section 414 or 704(a) of the act (21
value, or loss of palatability occurs U.S.C. 350c and 374(a)) must be made

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§ 1.362 21 CFR Ch. I (4–1–11 Edition)

readily available for inspection and 2005. However, the compliance dates for
photocopying or other means of repro- small and very small businesses are
duction. Such records and other infor- contained in paragraphs (a) and (b) of
mation must be made available as soon this section. The size of the business is
as possible, not to exceed 24 hours from determined using the total number of
the time of receipt of the official re- full-time equivalent employees in the
quest, from an officer or employee duly entire business, not each individual lo-
designated by the Secretary of Health cation or establishment. A full-time
and Human Services who presents ap- employee counts as one full-time
propriate credentials and a written no- equivalent employee. Two part-time
tice. employees, each working half time,
count as one full-time equivalent em-
§ 1.362 What records are excluded ployee.
from this subpart? (a) The compliance date for the re-
The establishment and maintenance quirements in this subpart is June 9,
of records as required by this subpart 2006, for small businesses employing
does not extend to recipes for food as fewer that 500, but more than 10 full-
defined in § 1.328; financial data, pricing time equivalent employees.
data, personnel data, research data, or (b) The compliance date for the re-
sales data (other than shipment data quirements in this subpart is December
regarding sales). 11, 2006, for very small businesses that
employ 10 or fewer full-time equivalent
§ 1.363 What are the consequences of employees.
failing to establish or maintain
[69 FR 71651, Dec. 9, 2004, as amended at 70
records or make them available to FR 8727, Feb. 23, 2005]
FDA as required by this subpart?
(a) The failure to establish or main- Subpart K—Administrative Deten-
tain records as required by section
414(b) of the act and this regulation or
tion of Food for Human or Ani-
the refusal to permit access to or mal Consumption
verification or copying of any such re-
quired record is a prohibited act under SOURCE: 69 FR 31701, June 4, 2004, unless
section 301 of the act. otherwise noted.
(b) The failure of a nontransporter GENERAL PROVISIONS
immediate previous source or a non-
transporter immediate subsequent re- § 1.377 What definitions apply to this
cipient who enters an agreement under subpart?
§ 1.352(e) to establish, maintain, or es- The definitions of terms that appear
tablish and maintain, records required in section 201 of the act (21 U.S.C. 321)
under § 1.352(a), (b), (c), or (d), or the re- apply when the terms are used in this
fusal to permit access to or subpart. In addition, for the purposes
verification or copying of any such re- of this subpart:
quired record, is a prohibited act under Act means the Federal Food, Drug,
section 301 of the act. and Cosmetic Act.
(c) The failure of any person to make Authorized FDA representative means
records or other information available an FDA District Director in whose dis-
to FDA as required by section 414 or trict the article of food involved is lo-
704(a) of the act and this regulation is cated or an FDA official senior to such
a prohibited act under section 301 of director.
the act. Calendar day means every day shown
[69 FR 71651, Dec. 9, 2004, as amended at 70 on the calendar.
FR 8726, Feb. 23, 2005] Food has the meaning given in sec-
tion 201(f) of the act (21 U.S.C. 321(f)).
COMPLIANCE DATES Examples of food include, but are not
limited to, fruits, vegetables, fish,
§ 1.368 What are the compliance dates dairy products, eggs, raw agricultural
for this subpart? commodities for use as food or compo-
The compliance date for the require- nents of food, animal feed, including
ments in this subpart is December 9, pet food, food and feed ingredients and

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Food and Drug Administration, HHS § 1.381

additives, including substances that § 1.380 Where and under what condi-
migrate into food from food packaging tions must the detained article of
and other articles that contact food, food be held?
dietary supplements and dietary ingre- (a) You must hold the detained arti-
dients, infant formula, beverages, in- cle of food in the location and under
cluding alcoholic beverages and bottled the conditions specified by FDA in the
water, live food animals, bakery goods, detention order.
snack foods, candy, and canned foods. (b) If FDA determines that removal
Perishable food means food that is not to a secure facility is appropriate, the
heat-treated; not frozen; and not other- article of food must be removed to a se-
wise preserved in a manner so as to cure facility. A detained article of food
prevent the quality of the food from remains under detention before, dur-
being adversely affected if held longer ing, and after movement to a secure fa-
than 7 calendar days under normal cility. FDA will also state in the deten-
shipping and storage conditions. tion order any conditions of transpor-
We means the U.S. Food and Drug tation applicable to the detained arti-
Administration (FDA). cle.
Working day means any day from (c) If FDA directs you to move the
Monday through Friday, excluding detained article of food to a secure fa-
Federal holidays. cility, you must receive a modification
You means any person who received of the detention order under § 1.381(c)
the detention order or that person’s before you move the detained article of
representative. food to a secure facility.
(d) You must ensure that any re-
§ 1.378 What criteria does FDA use to quired tags or labels under § 1.382 ac-
order a detention?
company the detained article during
An officer or qualified employee of and after movement. The tags or labels
FDA may order the detention of any must remain with the article of food
article of food that is found during an until FDA terminates the detention
inspection, examination, or investiga- order or the detention period expires,
tion under the act if the officer or whichever occurs first, unless other-
qualified employee has credible evi- wise permitted by the authorized FDA
dence or information indicating that representative.
the article of food presents a threat of (e) The movement of an article of
serious adverse health consequences or food in violation of a detention order
death to humans or animals. issued under § 1.393 is a prohibited act
under section 301 of the act (21 U.S.C.
§ 1.379 How long may FDA detain an 331).
article of food?
(a) FDA may detain an article of food § 1.381 May a detained article of food
for a reasonable period that may not be delivered to another entity or
exceed 20 calendar days after the deten- transferred to another location?
tion order is issued. However, an arti- (a) An article of food subject to a de-
cle may be detained for 10 additional tention order under this subpart may
calendar days if a greater period of not be delivered under the execution of
time is required to institute a seizure a bond. Notwithstanding section 801(b)
or injunction action. The authorized of the act (21 U.S.C. 381(b)), while any
FDA representative may approve the article of food is subject to a detention
additional 10-calendar day detention order under section 304(h) of the act (21
period at the time the detention order U.S.C. 334(h)), it may not be delivered
is issued, or at any time within the 20- to any of its importers, owners, or con-
calendar day period by amending the signees. This section does not preclude
detention order. movement at FDA’s direction of im-
(b) The entire detention period may ported food to a secure facility under
not exceed 30 calendar days. an appropriate Customs’ bond when
(c) An authorized FDA representative that bond is required by Customs’ law
may, in accordance with § 1.384, termi- and regulation.
nate a detention order before the expi- (b) Except as provided in paragraph
ration of the detention period. (c) of this section, no person may

45

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§ 1.382 21 CFR Ch. I (4–1–11 Edition)

transfer a detained article of food with- article, you must immediately notify
in or from the place where it has been in writing the authorized FDA rep-
ordered detained, or from the place to resentative who approved the modifica-
which it was removed, until an author- tion of the detention order that the ar-
ized FDA representative releases the ticle of food has reached its new loca-
article of food under § 1.384 or the de- tion, and the specific location of the
tention period expires under § 1.379, detained article within the new loca-
whichever occurs first. tion. Such written notification may be
(c) The authorized FDA representa- in the form of a fax, e-mail, or other
tive may approve, in writing, a request form as agreed to by the authorized
to modify a detention order to permit FDA representative.
movement of a detained article of food
(f) You must ensure that any re-
for any of the following purposes:
(1) To destroy the article of food, quired tags or labels under § 1.382 ac-
(2) To move the detained article of company the detained article during
food to a secure facility under the and after movement. The tags or labels
terms of a detention order, must remain with the article of food
(3) To maintain or preserve the integ- until FDA terminates the detention
rity or quality of the article of food, or order or the detention period expires,
(4) For any other purpose that the whichever occurs first, unless other-
authorized FDA representative believes wise permitted by the authorized FDA
is appropriate in the case. representative who approves the modi-
(d) You must submit your request for fication of a detention order under this
modification of the detention order in section.
writing to the authorized FDA rep- (g) The transfer of an article of food
resentative who approved the detention in violation of a detention order issued
order. You must state in your request under § 1.393 is a prohibited act under
the reasons for movement; the exact section 301 of the act.
address of and location in the new fa-
cility (or the new location within the § 1.382 What labeling or marking re-
same facility) where the detained arti- quirements apply to a detained arti-
cle of food will be transferred; an ex- cle of food?
planation of how the new address and The officer or qualified employee of
location will be secure, if FDA has di-
FDA issuing a detention order under
rected that the article be detained in a
§ 1.393 may label or mark the detained
secure facility; and how the article will
article of food with official FDA tags
be held under any applicable conditions
described in the detention order. If you or labels that include the following in-
are requesting modification of a deten- formation:
tion order for the purpose of destroying (a) A statement that the article of
the detained article of food, you also food is detained by FDA in accordance
must submit a verified statement iden- with section 304(h) of the act;
tifying the ownership or proprietary (b) A statement that the article of
interest you have in the detained arti- food must not be consumed, moved, al-
cle of food, in accordance with Supple- tered, or tampered with in any manner
mental Rule C to the ‘‘Federal Rules of for the period shown, without the writ-
Civil Procedure.’’ ten permission of an authorized FDA
(e) If FDA approves a request for representative;
modification of a detention order, the (c) A statement that the violation of
article may be transferred but remains a detention order or the removal or al-
under detention before, during, and teration of the tag or label is a prohib-
after the transfer. FDA will state any ited act, punishable by fine or impris-
conditions of transportation applicable onment or both; and
to the detained article. You may not
(d) The detention order number, the
transfer a detained article of food with-
date and hour of the detention order,
out FDA supervision unless FDA has
the detention period, and the name of
declined in writing to supervise the
transfer. If FDA has declined in writing the officer or qualified employee of
to supervise the transfer of a detained FDA who issued the detention order.

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Food and Drug Administration, HHS § 1.393

§ 1.383 What expedited procedures § 1.392 Who receives a copy of the de-
apply when FDA initiates a seizure tention order?
action against a detained perish- (a) FDA must issue the detention
able food? order to the owner, operator, or agent
If FDA initiates a seizure action in charge of the place where the article
under section 304(a) of the act against of food is located. If the owner of the
a perishable food subject to a detention article of food is different from the
order under this subpart, FDA will send owner, operator, or agent in charge of
the seizure recommendation to the De- the place where the article is detained,
partment of Justice (DOJ) within 4 cal- FDA must provide a copy of the deten-
endar days after the detention order is tion order to the owner of the article of
issued, unless extenuating cir- food if the owner’s identity can be de-
cumstances exist. If the fourth cal- termined readily.
(b) If FDA issues a detention order
endar day is not a working day, FDA
for an article of food located in a vehi-
will advise the DOJ of its plans to rec-
cle or other carrier used to transport
ommend a seizure action on the last the detained article of food, FDA also
working day before the fourth calendar must provide a copy of the detention
day and send the recommendation as order to the shipper of record and the
soon as practicable on the first work- owner and operator of the vehicle or
ing day that follows. For purposes of other carrier, if their identities can be
this section, an extenuating cir- determined readily.
cumstance includes, but is not limited
to, instances when the results of con- § 1.393 What information must FDA in-
firmatory testing or other evidentiary clude in the detention order?
development requires more than 4 cal- (a) FDA must issue the detention
endar days to complete. order in writing, in the form of a deten-
tion notice, signed and dated by the of-
§ 1.384 When does a detention order ficer or qualified employee of FDA who
terminate? has credible evidence or information
If FDA terminates a detention order indicating that such article of food pre-
or the detention period expires, an au- sents a threat of serious adverse health
thorized FDA representative will issue consequences or death to humans or
a detention termination notice releas- animals.
(b) The detention order must include
ing the article of food to any person
the following information:
who received the detention order or
(1) The detention order number;
that person’s representative and will (2) The date and hour of the deten-
remove, or authorize in writing the re- tion order;
moval of, the required labels or tags. If (3) Identification of the detained arti-
FDA fails to issue a detention termi- cle of food;
nation notice and the detention period (4) The period of the detention;
expires, the detention is deemed to be (5) A statement that the article of
terminated. food identified in the order is detained
for the period shown;
HOW DOES FDA ORDER A DETENTION? (6) A brief, general statement of the
reasons for the detention;
§ 1.391 Who approves a detention (7) The address and location where
order? the article of food is to be detained and
An authorized FDA representative, the appropriate storage conditions;
i.e., the FDA District Director in whose (8) Any applicable conditions of
district the article of food involved is transportation of the detained article
located or an FDA official senior to of food;
such director, must approve a deten- (9) A statement that the article of
tion order. If prior written approval is food is not to be consumed, moved, al-
not feasible, prior oral approval must tered, or tampered with in any manner
be obtained and confirmed in writing during the detention period, unless the
detention order is first modified under
as soon as possible.
§ 1.381(c);

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§ 1.401 21 CFR Ch. I (4–1–11 Edition)

(10) The text of section 304(h) of the not be granted a hearing. If you have
act and §§ 1.401 and 1.402; not filed a timely notice of intent to
(11) A statement that any informal request a hearing, you may file an ap-
hearing on an appeal of a detention peal without a hearing request. Wheth-
order must be conducted as a regu- er or not it includes a request for hear-
latory hearing under part 16 of this ing, your appeal must be filed within 10
chapter, with certain exceptions de- calendar days of receipt of the deten-
scribed in § 1.403; tion order.
(12) The mailing address, telephone (b) Your request for appeal must in-
number, e-mail address, and fax num- clude a verified statement identifying
ber of the FDA district office and the your ownership or proprietary interest
name of the FDA District Director in in the detained article of food, in ac-
whose district the detained article of cordance with Supplemental Rule C to
food is located; the ‘‘Federal Rules of Civil Procedure.’’
(13) A statement indicating the man- (c) The process for the appeal of a de-
ner in which approval of the detention tention order under this section termi-
order was obtained, i.e., verbally or in nates if FDA institutes either a seizure
writing; and action under section 304(a) of the act or
(14) The name and the title of the au- an injunction under section 302 of the
thorized FDA representative who ap- act (21 U.S.C. 276) regarding the article
proved the detention order. of food involved in the detention order.
(d) As part of the appeals process,
WHAT IS THE APPEAL PROCESS FOR A you may request an informal hearing.
DETENTION ORDER? Your request for a hearing must be in
writing and must be included in your
§ 1.401 Who is entitled to appeal? request for an appeal specified in para-
Any person who would be entitled to graph (a) of this section. If you request
be a claimant for the article of food, if an informal hearing, and FDA grants
seized under section 304(a) of the act, your request, the hearing will be held
may appeal a detention order as speci- within 2 calendar days after the date
fied in § 1.402. Procedures for estab- the appeal is filed.
lishing entitlement to be a claimant
for purposes of section 304(a) of the act § 1.403 What requirements apply to an
are governed by Supplemental Rule C informal hearing?
to the ‘‘Federal Rules of Civil Proce- If FDA grants a request for an infor-
dure.’’ mal hearing on an appeal of a deten-
tion order, FDA must conduct the
§ 1.402 What are the requirements for hearing in accordance with part 16 of
submitting an appeal? this chapter, except that:
(a) If you want to appeal a detention (a) The detention order under § 1.393,
order, you must submit your appeal in rather than the notice under § 16.22(a)
writing to the FDA District Director, of this chapter, provides notice of op-
in whose district the detained article of portunity for a hearing under this sec-
food is located, at the mailing address, tion and is part of the administrative
e-mail address, or fax number identi- record of the regulatory hearing under
fied in the detention order according to § 16.80(a) of this chapter;
the following applicable timeframes: (b) A request for a hearing under this
(1) Perishable food: If the detained ar- section must be addressed to the FDA
ticle is a perishable food, as defined in District Director in whose district the
§ 1.377, you must file an appeal within 2 article of food involved is located;
calendar days of receipt of the deten- (c) The provision in § 16.22(b) of this
tion order. chapter, providing that a person not be
(2) Nonperishable food: If the detained given less than 3 working days after re-
article is not a perishable food, as de- ceipt of notice to request a hearing,
fined in § 1.377, you must file a notice of does not apply to a hearing under this
an intent to request a hearing within 4 subpart;
calendar days of receipt of the deten- (d) The provision in § 16.24(e) of this
tion order. If the notice of intent is not chapter, stating that a hearing may
filed within 4 calendar days, you will not be required to be held at a time

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Food and Drug Administration, HHS § 1.405

less than 2 working days after receipt (a)(3), and (a)(5), and 1.403(i) constitutes
of the request for a hearing, does not the exclusive record for the presiding
apply to a hearing under this subpart; officer’s final decision on an adminis-
(e) Section 1.406, rather than § 16.24(f) trative detention. For purposes of judi-
of this chapter, describes the state- cial review under § 10.45 of this chapter,
ment that will be provided to an appel- the record of the administrative pro-
lant where a detention order is based ceeding consists of the record of the
on classified information; hearing and the presiding officer’s final
(f) Section 1.404, rather than § 16.42(a) decision.
of this chapter, describes the FDA em-
ployees, e.g., Regional Food and Drug § 1.404 Who serves as the presiding of-
Directors or other officials senior to a ficer for an appeal, and for an infor-
District Director, who preside at hear- mal hearing?
ings under this subpart; The presiding officer for an appeal,
(g) The presiding officer may require and for an informal hearing, must be
that a hearing conducted under this an FDA Regional Food and Drug Direc-
section be completed within 1 calendar tor or another FDA official senior to
day, as appropriate; an FDA District Director.
(h) Section 16.60(e) and (f) of this
chapter does not apply to a hearing § 1.405 When does FDA have to issue a
under this subpart. The presiding offi- decision on an appeal?
cer must prepare a written report of (a) The presiding officer must issue a
the hearing. All written material pre-
written report that includes a proposed
sented at the hearing will be attached
decision confirming or revoking the de-
to the report. The presiding officer
tention by noon on the fifth calendar
must include as part of the report of
day after the appeal is filed; after your
the hearing a finding on the credibility
4 hour opportunity for submitting com-
of witnesses (other than expert wit-
ments under § 1.403(h), the presiding of-
nesses) whenever credibility is a mate-
ficer must issue a final decision within
rial issue, and must include a proposed
the 5-calendar day period after the ap-
decision, with a statement of reasons.
peal is filed. If FDA either fails to pro-
The hearing participant may review
vide you with an opportunity to re-
and comment on the presiding officer’s
report within 4 hours of issuance of the quest an informal hearing, or fails to
report. The presiding officer will then confirm or terminate the detention
issue the final agency decision. order within the 5-calendar day period,
(i) Section 16.80(a)(4) of this chapter the detention order is deemed termi-
does not apply to a regulatory hearing nated.
under this subpart. The presiding offi- (b) If you appeal the detention order,
cer’s report of the hearing and any but do not request an informal hearing,
comments on the report by the hearing the presiding officer must issue a deci-
participant under § 1.403(h) are part of sion on the appeal confirming or revok-
the administrative record. ing the detention within 5 calendar
(j) No party shall have the right, days after the date the appeal is filed.
under § 16.119 of this chapter to petition If the presiding officer fails to confirm
the Commissioner of Food and Drugs or terminate the detention order dur-
for reconsideration or a stay of the pre- ing such 5-calendar day period, the de-
siding officer’s final agency decision. tention order is deemed terminated.
(k) If FDA grants a request for an in- (c) If you appeal the detention order
formal hearing on an appeal of a deten- and request an informal hearing and
tion order, the hearing must be con- your hearing request is denied, the pre-
ducted as a regulatory hearing pursu- siding officer must issue a decision on
ant to regulation in accordance with the appeal confirming or revoking the
part 16 of this chapter, except that detention within 5 calendar days after
§ 16.95(b) does not apply to a hearing the date the appeal is filed. If the pre-
under this subpart. With respect to a siding officer fails to confirm or termi-
regulatory hearing under this subpart, nate the detention order during such 5-
the administrative record of the hear- calendar day period, the detention
ing specified in §§ 16.80(a)(1), (a)(2), order is deemed terminated.

49

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§ 1.406 21 CFR Ch. I (4–1–11 Edition)

(d) If the presiding officer confirms a Subpart F—Caustic Poisons


detention order, the article of food con-
2.110 Definition of ammonia under Federal
tinues to be detained until we termi-
Caustic Poison Act.
nate the detention under § 1.384 or the
detention period expires under § 1.379, Subpart G—Provisions Applicable to Spe-
whichever occurs first. cific Products Subject to the Federal
(e) If the presiding officer terminates Food, Drug, and Cosmetic Act
a detention order, or the detention pe-
riod expires, FDA must terminate the 2.125 Use of ozone-depleting substances in
detention order as specified under foods, drugs, devices, or cosmetics.
§ 1.384. AUTHORITY: 15 U.S.C. 402, 409; 21 U.S.C. 321,
(f) Confirmation of a detention order 331, 335, 342, 343, 346a, 348, 351, 352, 355, 360b,
by the presiding officer is considered a 361, 362, 371, 372, 374; 42 U.S.C. 7671 et seq.
final agency action for purposes of 5 SOURCE: 42 FR 15559, Mar. 22, 1977, unless
U.S.C. 702. otherwise noted.

§ 1.406 How will FDA handle classified Subpart A—General Provisions


information in an informal hearing?
Where the credible evidence or infor- § 2.5 Imminent hazard to the public
mation supporting the detention order health.
is classified under the applicable Exec- (a) Within the meaning of the Fed-
utive order as requiring protection eral Food, Drug, and Cosmetic Act an
from unauthorized disclosure in the in- imminent hazard to the public health
terest of national security (‘‘classified is considered to exist when the evi-
information’’), FDA will not provide dence is sufficient to show that a prod-
you with this information. The pre- uct or practice, posing a significant
siding officer will give you notice of threat of danger to health, creates a
the general nature of the information public health situation (1) that should
and an opportunity to offer opposing be corrected immediately to prevent
evidence or information, if he or she injury and (2) that should not be per-
may do so consistently with safe- mitted to continue while a hearing or
guarding the information and its other formal proceeding is being held.
source. If classified information was The imminent hazard may be declared
used to support the detention, then any at any point in the chain of events
confirmation of such detention will which may ultimately result in harm
state whether it is based in whole or in to the public health. The occurrence of
part on that classified information. the final anticipated injury is not es-
sential to establish that an imminent
hazard of such occurrence exists.
PART 2—GENERAL ADMINISTRATIVE (b) In exercising his judgment on
RULINGS AND DECISIONS whether an imminent hazard exists, the
Commissioner will consider the num-
Subpart A—General Provisions ber of injuries anticipated and the na-
Sec. ture, severity, and duration of the an-
2.5 Imminent hazard to the public health. ticipated injury.
2.10 Examination and investigation sam-
ples. § 2.10 Examination and investigation
2.19 Methods of analysis.
samples.
(a)(1) When any officer or employee
Subpart B—Human and Animal Foods of the Department collects a sample of
a food, drug, or cosmetic for analysis
2.25 Grain seed treated with poisonous sub-
under the act, the sample shall be des-
stances; color identification to prevent
adulteration of human and animal food. ignated as an official sample if records
2.35 Use of secondhand containers for the or other evidence is obtained by him or
shipment or storage of food and animal any other officer or employee of the
feed. Department indicating that the ship-
ment or other lot of the article from
Subparts C–E [Reserved] which such sample was collected was

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Food and Drug Administration, HHS § 2.10

introduced or delivered for introduc- (c) After the Food and Drug Adminis-
tion into interstate commerce, or was tration has completed such analysis of
in or was received in interstate com- an official sample of a food, drug, or
merce, or was manufactured within a cosmetic as it determines, in the
Territory. Only samples so designated course of analysis and interpretation of
by an officer or employee of the De- analytical results, to be adequate to es-
partment shall be considered to be offi- tablish the respects, if any, in which
cial samples. the article is adulterated or mis-
(2) For the purpose of determining branded within the meaning of the act,
whether or not a sample is collected for or otherwise subject to the prohibi-
analysis, the term analysis includes ex- tions of the act, and has reserved an
aminations and tests. amount of the article it estimates to be
(3) The owner of a food, drug, or cos-
adequate for use as exhibits in the trial
metic of which an official sample is
of any case that may arise under the
collected is the person who owns the
act based on the sample, a part of the
shipment or other lot of the article
sample, if any remains available, shall
from which the sample is collected.
(b) When an officer or employee of be provided for analysis, upon written
the Department collects an official request, by any person named on the
sample of a food, drug, or cosmetic for label of the article, or the owner there-
analysis under the act, he shall collect of, or the attorney or agent of such
at least twice the quantity estimated person or owner, except when:
by him to be sufficient for analysis, un- (1) After collection, the sample or re-
less: maining part thereof has become de-
(1) The amount of the article avail- composed or otherwise unfit for anal-
able and reasonably accessible for sam- ysis, or
pling is less than twice the quantity so (2) The request is not made within a
estimated, in which case he shall col- reasonable time before the trial of any
lect as much as is available and reason- case under the act, based on the sample
ably accessible. to which such person or owner is a
(2) The cost of twice the quantity so party. The person, owner, attorney, or
estimated exceeds $150. agent who requests the part of sample
(3) The sample cannot by diligent use shall specify the amount desired. A re-
of practicable preservation techniques quest from an owner shall be accom-
available to the Food and Drug Admin- panied by a showing of ownership, and
istration be kept in a state in which it a request from an attorney or agent by
could be readily and meaningfully ana- a showing of authority from such per-
lyzed in the same manner and for the
son or owner to receive the part of
same purposes as the Food and Drug
sample. When two or more requests for
Administration’s analysis.
parts of the same sample are received
(4) The sample is collected from a
shipment or other lot which is being the requests shall be complied with in
imported or offered for import into the the order in which they were received
United States. so long as any part of the sample re-
(5) The sample is collected from a mains available therefor.
person named on the label of the arti- (d) When an official sample of food,
cle or his agent, and such person is also drug, or cosmetic is the basis of a no-
the owner of the article. tice given under section 305 of the act,
(6) The sample is collected from the or of a case under the act, and the per-
owner of the article, or his agent, and son to whom the notice was given, or
such article bears no label or, if it any person who is a party to the case,
bears a label, no person is named there- has no right under paragraph (c) of this
on. section to a part of the sample, such
In addition to the quantity of sample person or his attorney or agent may
set forth in this paragraph, the officer obtain a part of the sample upon re-
or employee shall, if practicable, col- quest accompanied by a written waiver
lect such further amount as he esti- of right under such paragraph (c) from
mates will be sufficient for use as trial each person named on the label of the
exhibits. article and owner thereof, who has not

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§ 2.19 21 CFR Ch. I (4–1–11 Edition)

exercised his right under such para- are available from the AOAC INTER-
graph (c). The operation of this para- NATIONAL, 481 North Frederick Ave.,
graph shall be subject to the excep- suite 500, Gaithersburg, MD 20877, or at
tions, terms, and conditions prescribed the National Archives and Records Ad-
in paragraph (c) of this section. ministration (NARA). For information
(e) The Food and Drug Administra- on the availability of this material at
tion is authorized to destroy: NARA, call 202–741–6030, or go to: http://
(1) Any official sample when it deter- www.archives.gov/federallregister/
mines that no analysis of such sample codeloflfederallregulations/
will be made; ibrllocations.html. In the absence of an
(2) Any official sample or part there- AOAC method, the Commissioner will
of when it determines that no notice furnish a copy of the particular meth-
under section 305 of the act, and no od, or a reference to the published
case under the act, is or will be based method, that the Food and Drug Ad-
on such sample; ministration will use in its enforce-
(3) Any official sample or part there- ment program. Other methods may be
of when the sample was the basis of a used for quality control, specifications,
notice under section 305 of the act, and contracts, surveys, and similar non-
when, after opportunity for presen- regulatory functions, but it is expected
tation of views following such notice, that they will be calibrated in terms of
it determines that no other such no- the method which the Food and Drug
tice, and no case under the act, is or Administration uses in its enforcement
will be based on such sample; program. Use of an AOAC method does
(4) Any official sample or part there- not relieve the practioner of the re-
of when the sample was the basis of a sponsibility to demonstrate that he
case under the act which has gone to can perform the method properly
final judgment, and when it determines through the use of positive and nega-
that no other such case is or will be tive controls and recovery and repro-
based on such sample; ducibility studies.
(5) Any official sample or part there-
of if the article is perishable; [42 FR 15559, Mar. 22, 1977, as amended at 47
FR 946, Jan. 8, 1982; 54 FR 9034, Mar. 3, 1989;
(6) Any official sample or part there- 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8,
of when, after collection, such sample 2005]
or part has become decomposed or oth-
erwise unfit for analysis;
(7) That part of any official sample
Subpart B—Human and Animal
which is in excess of three times the Foods
quantity it estimates to be sufficient § 2.25 Grain seed treated with poi-
for analysis. sonous substances; color identifica-
[42 FR 15559, Mar. 22, 1977, as amended at 63 tion to prevent adulteration of
FR 51299, Sept. 25, 1998] human and animal food.
(a) In recent years there has devel-
§ 2.19 Methods of analysis. oped increasing use of poisonous treat-
Where the method of analysis is not ments on seed for fungicidal and other
prescribed in a regulation, it is the pol- purposes. Such treated seed, if con-
icy of the Food and Drug Administra- sumed, presents a hazard to humans
tion in its enforcement programs to and livestock. It is not unusual for
utilize the methods of analysis of the stocks of such treated food seeds to re-
AOAC INTERNATIONAL (AOAC) as main on hand after the planting season
published in the latest edition (13th has passed. Despite the cautions re-
Ed., 1980) of their publication ‘‘Official quired by the Federal Seed Act (53
Methods of Analysis of the Association Stat. 1275, as amended 72 Stat. 476, 7
of Official Analytical Chemists,’’ and U.S.C. 1551 et seq.) in the labeling of the
the supplements thereto (‘‘Changes in treated seed, the Food and Drug Ad-
Methods’’ as published in the March ministration has encountered many
issues of the ‘‘Journal of the Associa- cases where such surplus stocks of
tion of Official Analytical Chemists’’), treated wheat, corn, oats, rye, barley,
which are incorporated by reference, and sorghum seed had been mixed with
when available and applicable. Copies untreated seed and sent to market for

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Food and Drug Administration, HHS § 2.35

food or feed use. This has resulted in and animal feed stored or shipped in
livestock injury and in legal actions secondhand containers have been ren-
under the Federal Food, Drug, and Cos- dered dangerous to health. Such con-
metic Act against large quantities of tamination has been the result of the
food adulterated through such admix- original use of these containers for the
ture of poisonous treated seeds with storage and shipment of articles con-
good food. Criminal cases were brought taining or bearing disease organisms or
against some firms and individuals. poisonous or deleterious substances.
Where the treated seeds are promi- (b) The Commissioner concludes that
nently colored, buyers and users or such dangerous or potentially dan-
processors of agricultural food seed for
gerous practices include, but are not
food purposes are able to detect the ad-
limited to, the following:
mixture of the poisonous seed and thus
reject the lots; but most such buyers, (1) Some vegetable growers and pack-
users, and processors do not have the ers employ used poultry crates for
facilities or scientific equipment to de- shipment of fresh vegetables, including
termine the presence of the poisonous cabbage and celery. Salmonella orga-
chemical at the time crops are deliv- nisms are commonly present on dressed
ered, in cases where the treated seeds poultry and in excreta and fluid
have not been so colored. A suitable exudates from dressed birds. Thus
color for this use is one that is in suffi- wooden crates in which dressed poultry
cient contrast to the natural color of has been iced and packed are potential
the food seed as to make admixture of sources of Salmonella or other
treated, denatured seeds with good food enteropathogenic microorganisms that
easily apparent, and is so applied that may contaminate fresh vegetables
it is not readily removed. which are frequently consumed with-
(b) On and after December 31, 1964, out heat treatment.
the Food and Drug Administration will (2) Some potato growers and pro-
regard as adulterated any interstate ducers of animal feeds use secondhand
shipment of the food seeds wheat, corn, bags for shipment of these articles.
oats, rye, barley, and sorghum bearing Such bags may have originally been
a poisonous treatment in excess of a used for shipping or storing pesticide-
recognized tolerance or treatment for
treated seed or other articles bearing
which no tolerance or exemption from
or containing poisonous substances.
tolerance is recognized in regulations
promulgated pursuant to section 408 of Thus these secondhand bags are poten-
the Federal Food, Drug, and Cosmetic tial sources of contamination of the
Act, unless such seeds have been ade- food or animal feed stored or shipped
quately denatured by a suitable color therein.
to prevent their subsequent inad- (c) In a policy statement issued April
vertent use as food for man or feed for 11, 1968, the Food and Drug Administra-
animals. tion declared adulterated within the
(c) Attention is called to the labeling meaning of section 402(a) of the Fed-
requirements of the Federal Hazardous eral Food, Drug, and Cosmetic Act
Substances Act, where applicable to de- shipments of vegetables or other edible
natured seeds in packages suitable for food in used crates or containers that
household use. may render the contents injurious to
health. This policy statement is ex-
§ 2.35 Use of secondhand containers tended so that the Food and Drug Ad-
for the shipment or storage of food
and animal feed. ministration will regard as adulterated
within the meaning of section 402(a) of
(a) Investigations by the Food and the act shipments of vegetables, other
Drug Administration, the National edible food, or animal feed in used
Communicable Disease Center of the crates, bags, or other containers that
U.S. Public Health Service, the Con-
may render the contents injurious to
sumer and Marketing Service of the
health.
U.S. Department of Agriculture, and by
various State public health agencies
have revealed practices whereby food Subparts C–E [Reserved]

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§ 2.110 21 CFR Ch. I (4–1–11 Edition)

Subpart F—Caustic Poisons inhalers containing the following ac-


tive moieties:
§ 2.110 Definition of ammonia under (i)–(iii) [Reserved]
Federal Caustic Poison Act. (iv) Pirbuterol.
For the purpose of determining (v) Epinephrine.
whether an article containing ammo- (3) [Reserved]
nia is subject to the Federal Caustic (4) Other essential uses. (i)–(ii) [Re-
Poison Act, the ammonia content is to served]
be calculated as NH3. (iii) Anesthetic drugs for topical use
on accessible mucous membranes of
humans where a cannula is used for ap-
Subpart G—Provisions Applicable plication.
to Specific Products Subject (iv)–(v) [Reserved]
to the Federal Food, Drug, (vi) Metered-dose atropine sulfate
and Cosmetic Act aerosol human drugs administered by
oral inhalation.
§ 2.125 Use of ozone-depleting sub- (vii) [Reserved]
stances in foods, drugs, devices, or (viii) Metered-dose ipratropium bro-
cosmetics.
mide and albuterol sulfate, in combina-
(a) As used in this section, ozone-de- tion, administered by oral inhalation
pleting substance (ODS) means any class for human use.
I substance as defined in 40 CFR part (ix) Sterile aerosol talc administered
82, appendix A to subpart A, or class II intrapleurally by thoracoscopy for
substance as defined in 40 CFR part 82, human use.
appendix B to subpart A. (f) Any person may file a petition
(b) Except as provided in paragraph under part 10 of this chapter to request
(c) of this section, any food, drug, de- that FDA initiate rulemaking to
vice, or cosmetic that is, consists in amend paragraph (e) of this section to
part of, or is contained in an aerosol add an essential use. FDA may initiate
product or other pressurized dispenser notice-and-comment rulemaking to
that releases an ODS is not an essen- add an essential use on its own initia-
tial use of the ODS under the Clean Air tive or in response to a petition, if
Act. granted.
(c) A food, drug, device, or cosmetic (1) If the petition is to add use of a
that is, consists in part of, or is con- noninvestigational product, the peti-
tained in an aerosol product or other tioner must submit compelling evi-
pressurized dispenser that releases an dence that:
ODS is an essential use of the ODS (i) Substantial technical barriers
under the Clean Air Act if paragraph exist to formulating the product with-
(e) of this section specifies the use of out ODSs;
that product as essential. For drugs, (ii) The product will provide an un-
including biologics and animal drugs, available important public health ben-
and for devices, an investigational ap- efit; and
plication or an approved marketing ap- (iii) Use of the product does not re-
plication must be in effect, as applica- lease cumulatively significant amounts
ble. of ODSs into the atmosphere or the re-
(d) [Reserved] lease is warranted in view of the un-
(e) The use of ODSs in the following available important public health ben-
products is essential: efit.
(1) Metered-dose corticosteroid human (2) If the petition is to add use of an
drugs for oral inhalation. Oral pressur- investigational product, the petitioner
ized metered-dose inhalers containing must submit compelling evidence that:
the following active moieties: (i) Substantial technical barriers
(i)–(ii) [Reserved] exist to formulating the investiga-
(iii) Flunisolide. tional product without ODSs;
(iv)–(v) [Reserved] (ii) A high probability exists that the
(2) Metered-dose short-acting adrenergic investigational product will provide an
bronchodilator human drugs for oral in- unavailable important public health
halation. Oral pressurized metered-dose benefit; and

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Food and Drug Administration, HHS § 3.1

(iii) Use of the investigational prod- tion, and with approximately the same
uct does not release cumulatively sig- level of convenience of use as the ODS
nificant amounts of ODSs into the at- products; and
mosphere or the release is warranted in (ii) The requirements of paragraphs
view of the high probability of an un- (g)(3)(ii), (g)(3)(iii), and (g)(3)(iv) of this
available important public health ben- section are met.
efit.
[67 FR 48384, July 24, 2002, as amended at 71
(g) Any person may file a petition
FR 70873, Dec. 7, 2006; 70 FR 17192, Apr. 4,
under part 10 of this chapter to request 2005; 75 FR 19241, Apr. 14, 2010]
that FDA initiate rulemaking to
amend paragraph (e) of this section to EFFECTIVE DATE NOTES: 1. At 73 FR 69552,
remove an essential use. FDA may ini- Nov. 19, 2008, § 2.125 was amended by remov-
ing and reserving paragraph (e)(2)(v), effec-
tiate notice-and-comment rulemaking tive Dec. 31, 2011.
to remove an essential use on its own 2. At 75 FR 19241, Apr. 14, 2010, § 2.125 was
initiative or in response to a petition, amended by removing and reserving para-
if granted. If the petition is to remove graph (e)(1)(iii) effective June 30, 2011 and re-
an essential use from paragraph (e) of moving and reserving paragraphs (e)(2)(iv)
this section, the petitioner must sub- and (e)(4)(viii), effective Dec. 31, 2013.
mit compelling evidence of any one of
the following criteria: PART 3—PRODUCT JURISDICTION
(1) The product using an ODS is no
longer being marketed; or Subpart A—Assignment of Agency Com-
(2) After January 1, 2005, FDA deter- ponent for Review of Premarket Appli-
mines that the product using an ODS cations
no longer meets the criteria in para-
graph (f) of this section after consulta- Sec.
tion with a relevant advisory com- 3.1 Purpose.
mittee(s) and after an open public 3.2 Definitions.
meeting; or 3.3 Scope.
(3) For individual active moieties 3.4 Designated agency component.
marketed as ODS products and rep- 3.5 Procedures for identifying the des-
ignated agency component.
resented by one new drug application
3.6 Product jurisdiction officer.
(NDA):
3.7 Request for designation.
(i) At least one non-ODS product
3.8 Letter of designation.
with the same active moiety is mar- 3.9 Effect of letter of designation.
keted with the same route of adminis- 3.10 Stay of review time.
tration, for the same indication, and
with approximately the same level of Subpart B [Reserved]
convenience of use as the ODS product
containing that active moiety; AUTHORITY: 21 U.S.C. 321, 351, 353, 355, 360,
(ii) Supplies and production capacity 360c–360f, 360h–360j, 360gg–360ss, 360bbb–2,
for the non-ODS product(s) exist or will 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264.
exist at levels sufficient to meet pa- SOURCE: 56 FR 58756, Nov. 21, 1991, unless
tient need; otherwise noted.
(iii) Adequate U.S. postmarketing
use data is available for the non-ODS
product(s); and
Subpart A—Assignment of Agen-
(iv) Patients who medically required cy Component for Review of
the ODS product are adequately served Premarket Applications
by the non-ODS product(s) containing
that active moiety and other available § 3.1 Purpose.
products; or This regulation relates to agency
(4) For individual active moieties management and organization and has
marketed as ODS products and rep- two purposes. The first is to implement
resented by two or more NDAs: section 503(g) of the act, as added by
(i) At least two non-ODS products section 16 of the Safe Medical Devices
that contain the same active moiety Act of 1990 (Public Law 101–629) and
are being marketed with the same amended by section 204 of the Medical
route of delivery, for the same indica- Device User Fee and Modernization Act

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§ 3.2 21 CFR Ch. I (4–1–11 Edition)

of 2002 (Public Law 107–250), by speci- bined or mixed and produced as a single
fying how FDA will determine the or- entity;
ganizational component within FDA (2) Two or more separate products
designated to have primary jurisdic- packaged together in a single package
tion for the premarket review and reg- or as a unit and comprised of drug and
ulation of products that are comprised device products, device and biological
of any combination of a drug and a de- products, or biological and drug prod-
vice; a device and a biological; a bio- ucts;
logical and a drug; or a drug, a device (3) A drug, device, or biological prod-
and a biological. This determination uct packaged separately that according
will eliminate, in most cases, the need to its investigational plan or proposed
to receive approvals from more than labeling is intended for use only with
one FDA component for such combina- an approved individually specified
tion products. The second purpose of drug, device, or biological product
this regulation is to enhance the effi- where both are required to achieve the
ciency of agency management and op- intended use, indication, or effect and
erations by providing procedures for where upon approval of the proposed
determining which agency component product the labeling of the approved
will have primary jurisdiction for any product would need to be changed, e.g.,
drug, device, or biological product to reflect a change in intended use,
where such jurisdiction is unclear or in dosage form, strength, route of admin-
dispute. Nothing in this section pre- istration, or significant change in dose;
vents FDA from using any agency re- or
sources it deems necessary to ensure (4) Any investigational drug, device,
adequate review of the safety and effec- or biological product packaged sepa-
tiveness of any product, or the substan- rately that according to its proposed
tial equivalence of any device to a labeling is for use only with another
predicate device. individually specified investigational
[56 FR 58756, Nov. 21, 1991, as amended by 68 drug, device, or biological product
FR 37077, June 23, 2003] where both are required to achieve the
intended use, indication, or effect.
§ 3.2 Definitions. (f) Device has the meaning given the
For the purpose of this part: term in section 201(h) of the act.
(a) Act means the Federal Food, (g) Drug has the meaning given the
Drug, and Cosmetic Act. term in section 201(g)(1) of the act.
(b) Agency component means the Cen- (h) FDA means Food and Drug Ad-
ter for Biologics Evaluation and Re- ministration.
search, the Center for Devices and Ra- (i) Letter of designation means the
diological Health, the Center for Drug written notice issued by the product
Evaluation and Research, or alter- jurisdiction officer specifying the agen-
native organizational component of the cy component with primary jurisdic-
agency. tion for a combination product.
(c) Applicant means any person who (j) Letter of request means an appli-
submits or plans to submit an applica- cant’s written submission to the prod-
tion to the Food and Drug Administra- uct jurisdiction officer seeking the des-
tion for premarket review. For pur- ignation of the agency component with
poses of this section, the terms ‘‘spon- primary jurisdiction.
sor’’ and ‘‘applicant’’ have the same (k) Mode of action is the means by
meaning. which a product achieves an intended
(d) Biological product has the meaning therapeutic effect or action. For pur-
given the term in section 351(a) of the poses of this definition, ‘‘therapeutic’’
Public Health Service Act (42 U.S.C. action or effect includes any effect or
262(a)). action of the combination product in-
(e) Combination product includes: tended to diagnose, cure, mitigate,
(1) A product comprised of two or treat, or prevent disease, or affect the
more regulated components, i.e., drug/ structure or any function of the body.
device, biologic/device, drug/biologic, When making assignments of combina-
or drug/device/biologic, that are phys- tion products under this part, the agen-
ically, chemically, or otherwise com- cy will consider three types of mode of

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Food and Drug Administration, HHS § 3.4

action: The actions provided by a bio- tion expected to make the greatest
logical product, a device, and a drug. contribution to the overall intended
Because combination products are therapeutic effects of the combination
comprised of more than one type of product.
regulated article (biological product, (n) Product means any article that
device, or drug), and each constituent contains any drug as defined in section
part contributes a biological product, 201(g)(1) of the act; any device as de-
device, or drug mode of action, com- fined in section 201(h) of the act; or any
bination products will typically have biologic as defined in section 351(a) of
more than one identifiable mode of ac- the Public Health Service Act (42
tion. U.S.C. 262(a)).
(1) A constituent part has a biologi- (o) Product jurisdiction officer is the
cal product mode of action if it acts by person or persons responsible for desig-
means of a virus, therapeutic serum, nating the component of FDA with pri-
toxin, antitoxin, vaccine, blood, blood mary jurisdiction for the premarket re-
component or derivative, allergenic view and regulation of a combination
product, or analogous product applica- product or any product requiring a ju-
ble to the prevention, treatment, or risdictional designation under this
cure of a disease or condition of human part.
beings, as described in section 351(i) of (p) Sponsor means ‘‘applicant’’ (see
the Public Health Service Act. § 3.2(c)).
(2) A constituent part has a device [56 FR 58756, Nov. 21, 1991 as amended at 64
mode of action if it meets the defini- FR 398, Jan. 5, 1999; 64 FR 56447, Oct. 20, 1999;
tion of device contained in section 68 FR 37077, June 23, 2003; 70 FR 49861, Aug.
201(h)(1) to (h)(3) of the act, it does not 25, 2005]
have a biological product mode of ac-
tion, and it does not achieve its pri- § 3.3 Scope.
mary intended purposes through chem- This section applies to:
ical action within or on the body of (a) Any combination product, or
man or other animals and is not de- (b) Any product where the agency
pendent upon being metabolized for the component with primary jurisdiction is
achievement of its primary intended unclear or in dispute.
purposes.
(3) A constituent part has a drug § 3.4 Designated agency component.
mode of action if it meets the defini- (a) To designate the agency compo-
tion of drug contained in section nent with primary jurisdiction for the
201(g)(1) of the act and it does not have premarket review and regulation of a
a biological product or device mode of combination product, the agency shall
action. determine the primary mode of action
(l) Premarket review includes the ex- of the product. Where the primary
amination of data and information in mode of action is that of:
an application for premarket review (1) A drug (other than a biological
described in sections 505, 510(k), 513(f), product), the agency component
515, or 520(g) or 520(l) of the act or sec- charged with premarket review of
tion 351 of the Public Health Service drugs shall have primary jurisdiction;
Act of data and information contained (2) A device, the agency component
in any investigational new drug (IND) charged with premarket review of de-
application, investigational device ex- vices shall have primary jurisdiction;
emption (IDE), new drug application (3) A biological product, the agency
(NDA), biologics license application, component charged with premarket re-
device premarket notification, device view of biological products shall have
reclassification petition, and pre- primary jurisdiction.
market approval application (PMA). (b) In some situations, it is not pos-
(m) Primary mode of action is the sin- sible to determine, with reasonable
gle mode of action of a combination certainty, which one mode of action
product that provides the most impor- will provide a greater contribution
tant therapeutic action of the com- than any other mode of action to the
bination product. The most important overall therapeutic effects of the com-
therapeutic action is the mode of ac- bination product. In such a case, the

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§ 3.5 21 CFR Ch. I (4–1–11 Edition)

agency will assign the combination products. These intercenter agree-


product to the agency component that ments, and any amendments thereto,
regulates other combination products are nonbinding determinations de-
that present similar questions of safety signed to provide useful guidance to
and effectiveness with regard to the the public.
combination product as a whole. When (3) The sponsor of a premarket appli-
there are no other combination prod- cation or required investigational fil-
ucts that present similar questions of ing for a combination or other product
safety and effectiveness with regard to covered by these guidance documents
the combination product as a whole, may contact the designated agency
the agency will assign the combination component identified in the inter-
product to the agency component with center agreement before submitting an
the most expertise related to the most application of premarket review or to
significant safety and effectiveness confirm coverage and to discuss the ap-
questions presented by the combina- plication process.
tion product.
(b) For a combination product not
(c) The designation of one agency
covered by a guidance document or for
component as having primary jurisdic-
a product where the agency component
tion for the premarket review and reg-
ulation of a combination product does with primary jurisdiction is unclear or
not preclude consultations by that in dispute, the sponsor of an applica-
component with other agency compo- tion for premarket review should fol-
nents or, in appropriate cases, the re- low the procedures set forth in § 3.7 to
quirement by FDA of separate applica- request a designation of the agency
tions. component with primary jurisdiction
before submitting the application.
[56 FR 58756, Nov. 21, 1991, as amended at 70
FR 49861, Aug. 25, 2005] [56 FR 58756, Nov. 21, 1991, as amended at 68
FR 24879, May 9, 2003]
§ 3.5 Procedures for identifying the
designated agency component. § 3.6 Product jurisdiction officer.
(a)(1) The Center for Biologics Eval- The Office of Combination Products
uation and Research, the Center for (Food and Drug Administration, 10903
Devices and Radiological Health, and New Hampshire Ave., Bldg. 32, rm. 5129,
the Center for Drug Evaluation and Re- Silver Spring, MD 20993–0002, 301–796–
search have entered into agreements 8930,, e-mail: combination@fda.gov, is
clarifying product jurisdictional issues. the designated product jurisdiction of-
These guidance documents are on dis- ficer.
play in the Division of Dockets Man-
agement (HFA–305), Food and Drug Ad- [68 FR 37077, June 23, 2003, as amended at 71
FR 16033, Mar. 30, 2006; 75 FR 13678, Mar. 23,
ministration, 5630 Fishers Lane, rm. 2010]
1061, Rockville, MD 20852, and are enti-
tled ‘‘Intercenter Agreement Between § 3.7 Request for designation.
the Center for Drug Evaluation and Re-
search and the Center for Devices and (a) Who should file: the sponsor of:
Radiological Health;’’ ‘‘Intercenter (1) Any combination product the
Agreement Between the Center for De- sponsor believes is not covered by an
vices and Radiological Health and the intercenter agreement; or
Center for Biologics Evaluation and (2) Any product where the agency
Research;’’ ‘‘Intercenter Agreement Be- component with primary jurisdiction is
tween the Center for Drug Evaluation unclear or in dispute.
and Research and the Center for Bio- (b) When to file: a sponsor should file
logics Evaluation and Research.’’ The a request for designation before filing
availability of any amendments to any application for premarket review,
these intercenter agreements will be whether an application for marketing
announced by FEDERAL REGISTER no- approval or a required investigational
tice. notice. Sponsors are encouraged to file
(2) These guidance documents de- a request for designation as soon as
scribe the allocation of responsibility there is sufficient information for the
for categories of products or specific agency to make a determination.

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Food and Drug Administration, HHS § 3.8

(c) What to file: an original and two cannot determine with reasonable cer-
copies of the request for designation tainty which mode of action provides
must be filed. The request for designa- the most important therapeutic action
tion must not exceed 15 pages, includ- of the combination product, the spon-
ing attachments, and must set forth: sor’s recommendation must be based
(1) The identity of the sponsor, in- on the assignment algorithm set forth
cluding company name and address, es- in § 3.4(b) and an assessment of the as-
tablishment registration number, com- signment of other combination prod-
pany contact person and telephone ucts the sponsor wishes FDA to con-
number. sider during the assignment of its com-
(2) A description of the product, in- bination product.
cluding: (d) Where to file: all communications
(i) Classification, name of the prod- pursuant to this subpart shall be ad-
uct and all component products, if ap- dressed to the attention of the product
plicable; jurisdiction officer. Such a request, in
(ii) Common, generic, or usual name its mailing cover should be plainly
of the product and all component prod- marked ‘‘Request for Designation.’’
ucts; Concurrent submissions of electronic
(iii) Proprietary name of the product; copies of Requests for Designation may
(iv) Identification of any component be addressed to combination@fda.gov.
of the product that already has re-
ceived premarket approval, is mar- [56 FR 58756, Nov. 21, 1991, as amended at 68
keted as not being subject to pre- FR 37077, June 23, 2003; 70 FR 49861, Aug. 25,
2005]
market approval, or has received an in-
vestigational exemption, the identity § 3.8 Letter of designation.
of the sponsors, and the status of any
discussions or agreements between the (a) Each request for designation will
sponsors regarding the use of this prod- be reviewed for completeness within 5
uct as a component of a new combina- working days of receipt. Any request
tion product. for designation determined to be in-
(v) Chemical, physical, or biological complete will be returned to the appli-
composition; cant with a request for the missing in-
(vi) Status and brief reports of the re- formation. The sponsor of an accepted
sults of developmental work, including request for designation will be notified
animal testing; of the filing date.
(vii) Description of the manufac- (b) Within 60 days of the filing date of
turing processes, including the sources a request for designation, the product
of all components; jurisdiction officer will issue a letter of
(viii) Proposed use or indications; designation to the sponsor, with copies
(ix) Description of all known modes to the centers, specifying the agency
of action, the sponsor’s identification component designated to have primary
of the single mode of action that pro- jurisdiction for the premarket review
vides the most important therapeutic and regulation of the product at issue,
action of the product, and the basis for and any consulting agency compo-
that determination. nents. The product jurisdiction officer
(x) Schedule and duration of use; may request a meeting with the spon-
(xi) Dose and route of administration sor during the review period to discuss
of drug or biologic; the request for designation. If the prod-
(xii) Description of related products, uct jurisdiction officer has not issued a
including the regulatory status of letter of designation within 60 days of
those related products; and the filing date of a request for designa-
(xiii) Any other relevant informa- tion, the sponsor’s recommendation of
tion. the center with primary jurisdiction,
(3) The sponsor’s recommendation as in accordance with § 3.7(c)(3), shall be-
to which agency component should come the designated agency compo-
have primary jurisdiction based on the nent.
mode of action that provides the most (c) Request for reconsideration by
important therapeutic action of the sponsor: If the sponsor disagrees with
combination product. If the sponsor the designation, it may request the

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§ 3.9 21 CFR Ch. I (4–1–11 Edition)

product jurisdiction officer to recon- PART 5—ORGANIZATION


sider the decision by filing, within 15
days of receipt of the letter of designa- SUBPARTS A–L [RESERVED]
tion, a written request for reconsider-
ation not exceeding 5 pages. No new in- SUBPART M—ORGANIZATION
formation may be included in a request Sec.
for reconsideration. The product juris- 5.1100 Headquarters.
diction officer shall review and act on 5.1105 Chief Counsel, Food and Drug Admin-
istration.
the request in writing within 15 days of 5.1110 FDA public information offices.
its receipt.
AUTHORITY: 5 U.S.C. 552; 21 U.S.C. 301–397.
§ 3.9 Effect of letter of designation. SOURCE: 75 FR 16354, Apr. 1, 2010, unless
otherwise noted.
(a) The letter of designation con-
stitutes an agency determination that
is subject to change only as provided in Subparts A–L [Reserved]
paragraph (b) of this section.
(b) The product jurisdiction officer Subpart M—Organization
may change the designated agency
§ 5.1100 Headquarters.
component with the written consent of
the sponsor, or without its consent to The central organization of the Food
protect the public health or for other and Drug Administration consists of
compelling reasons. A sponsor shall be the following:
given 30 days written notice of any pro- OFFICE OF THE COMMISSIONER.1
posed nonconsensual change in des- Office of the Chief Counsel.2
ignated agency component. The spon- Office of the Administrative Law Judge.1
sor may request an additional 30 days
to submit written objections, not to ex- Office of Women’s Health.
ceed 15 pages, to the proposed change, Office of Policy, Planning & Budget.1
and shall be granted, upon request, a Office of Policy.
timely meeting with the product juris- Policy Development and Coordination
diction officer and appropriate center Staff.
officials. Within 30 days of receipt of Regulations Policy and Management
the sponsor’s written objections, the Staff.
product jurisdiction officer shall issue
Regulations Editorial Section.
to the sponsor, with copies to appro-
priate center officials, a written deter- Office of Planning.1
mination setting forth a statement of Planning Staff.
reasons for the proposed change in des- Evaluation Staff.
ignated agency component. A non- Economics Staff.
consensual change in the designated Risk Communication Staff.
agency component requires the concur-
rence of the Principal Associate Com- Business Process Planning Staff.
missioner. Office of Budget.1
Office of Legislation.3
[56 FR 58756, Nov. 21, 1991, as amended at 68
FR 37077, June 23, 2003] Office of the Counselor to the Commis-
sioner.1
§ 3.10 Stay of review time.
1 Mailing address: 10903 New Hampshire
Any filing with or review by the
Ave., Silver Spring, MD 20906.
product jurisdiction officer stays the 2 The Office of the Chief Counsel (also
review clock or other established time known as the Food and Drug Division, Office
periods for agency action for an appli- of the General Counsel, Department of
cation for marketing approval or re- Health and Human Services), while adminis-
quired investigational notice during tratively within the Office of the Commis-
the pendency of the review by the prod- sioner, is part of the Office of the General
uct jurisdiction officer. Counsel of the Department of Health and
Human Services.
3 Mailing address: 5600 Fishers Lane, Rock-

Subpart B [Reserved] ville, MD 20857.

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Food and Drug Administration, HHS § 5.1100

Office of Crisis Management. Business Transformation, Administra-


Office of Emergency Operations. tion and Management Staff.
Office of the Chief Of Staff.1 User Fees Staff.
Executive Secretariat. Financial Systems Support Staff.
Office of Special Medical Programs. Division of Accounting.
Office of Good Clinical Practice. Division of Budget Execution and Con-
Office of Combination Products.4 trol.
Office of Orphan Products Develop- Office of Financial Services.
ment. Division of Payment Services.
Office of Pediatric Therapeutics.3 Division of Travel Services.
Office of International Programs.3 Office of Information Management.6
Office of External Affairs. Division of Business Partnership and
Office of External Relations.3 Support.6
Communications Staff. Division of Chief Information Officer
Office of Public Affairs.1 Support.6
Web Communications Staff. Division of Systems Management.7
Office of Special Health Issues.3 Division of Infrastructure Operations.8
Medwatch Staff. Division of Technology.8
Office of Foods.1 Office of Management.3
Office of the Chief Scientist.1 Ethics and Integrity Staff.
Office of Counter-Terrorism and Office of Business Operations and Human
Emerging Threats.3 Capital Programs.
Office of Critical Path Programs. Office of Management Programs.
Office of Scientific Integrity. Office of Security Operations.
Office of Science and Innovation. Office of White Oak Services.1
Office of International Programs.3 Division of Logistics Services and Fa-
Office of Administration.1 cilities Operations.
Office of Equal Employment Opportunity Division of White Oak Consolidation.
& Diversity Management.3 Office of Shared Services.5
Conflict Prevention and Resolution Office of Real Property Services.
Staff. Jefferson Laboratories Complex Staff.
Compliance Staff. Division of Engineering Services.
Diversity Staff. Environment, Safety And Strategic
Office of Acquisitions and Grants Serv- Initiatives Staff.
ices.5 Division of Facilities Operations.
Division of Acquisition Operations. Portfolio Development Staff.
Division of Acquisition Support and Employee Resource & Information Cen-
Grants. ter.
Division of Acquisition Programs. Office of Public Information and Library
Division of Information Technology. Services.
Office of Executive Operations.1 Division of Dockets Management.
Office of Financial Operations.6 Division of Freedom of Information.
Office of Financial Management.6 FDA Biosciences Library.
Controls, Compliance, and Oversight Public Services Branch.
Staff. Technical Services Branch.
4 Mailing
FDA History Office.
address: 15800 Crabbs Branch
Way, Rockville, MD 20855.
5 Mailing address: 5630 Fishers Lane, Rock- 7 Mailing address: 2094 Gaither Rd., Rock-

ville, MD 20857. ville, MD 20850.


6 Mailing address: 1350 Piccard Dr., Rock- 8 Mailing address: 2098 Gaither Rd., Rock-

ville, MD 20850. ville, MD 20850.

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§ 5.1100 21 CFR Ch. I (4–1–11 Edition)

CENTER FOR BIOLOGICS EVALUA- Division of Clinical Evaluation and


TION AND RESEARCH.9 Pharmacology/Toxicology.
Office of the Center Director. Division of Human Tissues.
Regulations Policy Staff. Office of Communication, Outreach and
Quality Assurance Staff. Development.
Office of Management. Division of Disclosure and Oversight
Management.
Regulatory Information Management
Division of Manufacturers Assistance
Staff.
and Training.
Division of Planning, Evaluation, and
Division of Communication and Con-
Budget.
sumer Affairs.
Division of Veterinary Services. CENTER FOR DEVICES AND RADIO-
Division of Program Services. LOGICAL HEALTH.1
Division of Scientific Advisors & Con- Office of the Center Director.
sultants. Office of Systems and Management.
Building Operations Staff. Division of Ethics and Management Op-
Office of Compliance and Biologics Qual- erations.
ity. Division of Planning, Analysis and Fi-
Division of Case Management. nance.
Division of Inspections and Surveil- Division of Information Dissemination.
lance. Division of Information Technology.
Division of Manufacturing and Product Office of Compliance.
Quality. Promotion and Advertising Policy
Office of Biostatistics and Epidemiology. Staff.
Division of Biostatistics. Division of Bioresearch Monitoring.
Division of Epidemiology. Division of Program Operations.
Office of Information Management. Division of Enforcement A.
Division of Information Operations. Division of Enforcement B.
Division of Information Development. Office of Device Evaluation.
Office of Blood Research and Review. Program Management Staff.
Policy and Publications Staff. Program Operations Staff.
Division of Emerging and Transfusion Division of Cardiovascular Devices.
Transmitted Diseases. Division of Reproductive, Gastro-Renal
Division of Hematology. and Urological Devices.
Division of General, Restorative, and
Division of Blood Applications.
Neurological Devices.
Office of Vaccines Research and Review.
Division of Surgical, Orthopedic and
Program Operation Staff. Restorative Devices.
Division of Product Quality. Division of Ophthalmic, and Ear, Nose
Division of Bacterial, Parasitic, and and Throat Devices.
Allergenic Products. Division of Anesthesiology, General
Division of Viral Products. Hospital, Infection Control, and Dental
Division of Vaccines and Related Prod- Devices.
uct Applications. Office of Science and Engineering Labora-
Office of Cellular, Tissue, and Gene tories.
Therapies. Division of Biology.
Regulatory Management Staff. Management Support Staff.
Division of Cellular and Gene Thera- Standards Management Staff.
pies. Division of Chemistry and Materials
Science.
9 Mailing address: 1401 Rockville Pike, Division of Solid and Fluid Mechanics.
Rockville, MD 20852. Division of Physics.

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Food and Drug Administration, HHS § 5.1100

Division of Imaging and Applied Math- Review and Management Staff.


ematics. Business Process Improvement Staff.
Office of Communication, Education and Regulatory Policy Staff.
Radiation Programs.
Division of Medication Error Preven-
Program Operations Staff. tion and Analysis.
Regulations Staff. Division of Pharmacovigilance I.
Staff College. Division of Pharmacovigilance II.
Division of Device User Programs and Division of Drug Risk Evaluation.
Systems Analysis.
Division of Epidemiology.
Division of Small Manufacturers As-
Office of Compliance.1
sistance.
Division of Compliance Risk Manage-
Division of Mammography Quality and
ment and Surveillance.
Radiation Programs.
Division of New Drugs and Labeling
Division of Communication Media.
Compliance.
Office of Surveillance and Biometrics.
Division of Manufacturing and Product
Issues Management Staff. Quality.
Division of Biostatistics. Division of Scientific Investigations.
Division of Postmarket Surveillance. Office of New Drugs.2
Division of Surveillance Systems. Pediatric and Maternal Health Staff.
Office of In Vitro Diagnostic Device Eval- Program Management Analysis Staff.
uation and Safety.
Office of Drug Evaluation I.
Division of Chemistry and Toxicology
Devices. Division of Cardiorenal Cardiovascular
and Renal Drug Products.
Division of Immunology and Hema-
tology Devices. Division of Neurology Products.
Division of Microbiology Devices. Division of Psychiatry Products.
Division of Radiological Devices. Office of Drug Evaluation II.
CENTER FOR DRUG EVALUATION Division of Metabolism and Endocri-
AND RESEARCH.10 nology Products.
Office of the Center Director. Division of Pulmonary, Allergy and
Rheumatology Products.
Controlled Substance Staff.
Division of Anesthesia and Analgesia
Office of Regulatory Policy. Products.
Division of Regulatory Policy I. Office of Drug Evaluation III.
Division of Regulatory Policy II. Division of Gastroenterology Products.
Division of Regulatory Policy III. Division of Reproductive and Urologic
Division of Information Disclosure Pol- Products.
icy. Division of Dermatology and Dental
Office of Management. Products.
Division of Management and Budget. Office of Antimicrobial Products.
Division of Management Services. Division of Anti-Infective and Ophthal-
Office of Communications. mology Products.
Division of Information Services. Division of Anti-Viral Products.
Division of Public Affairs. Division of Special Pathogen and
Division of Drug Information. Transplant Products.
Office of Surveillance and Epidemiology.11 Office of Drug Evaluation IV.
Division of Nonprescription Clinical
10 Mailing address: 10903 New Hampshire Evaluation.
Ave., White Oak Bldg. 51, Silver Spring, MD Division of Nonprescription Regulation
20993. Development.
11 Mailing address: 10903 New Hampshire
Ave., White Oak Bldg. 22, Silver Spring, MD Division of Medical Imaging Products.
20993. Office of Oncology Drug Products.

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§ 5.1100 21 CFR Ch. I (4–1–11 Edition)

Division of Drug Oncology Products. Office of Translational Sciences.4


Division of Hematology Products. Office of Biostatistics.
Division of Biologic Oncology Prod- Division of Biometrics I.
ucts. Division of Biometrics II.
Office of Pharmaceutical Science.1 Division of Biometrics III.
Program Activities Review Staff. Division of Biometrics IV.
Operations Staff. Division of Biometrics V.
Science and Research Staff Division of Biometrics VI.
New Drug Microbiology Staff. Division of Biometrics VII.
Office of Generic Drugs.12 Office of Clinical Pharmacology.1
Division of Bioequivalence. Division of Clinical Pharmacology I.
Division of Labeling and Program Sup- Division of Clinical Pharmacology II.
port.
Division of Clinical Pharmacology III.
Division of Chemistry I.
Division of Clinical Pharmacology IV.
Division of Chemistry II.
Division of Clinical Pharmacology V.
Division of Chemistry III.
Division of Pharmacometrics.
Office of New Drug Quality Assessment.13
Office of Counter-Terrorism and Emer-
Division of New Drug Quality Assess- gency Coordinator.
ment I.
Office of Planning and Informatics.
Division of New Drug Quality Assess-
ment II. Office of Planning and Analysis.
Branch IV. Planning and Evaluation Staff.
Branch V. Analysis Staff.
Branch VI. Office of Business Informatics.
Division of New Drug Quality Assess- Division of Records Management.
ment III. Division of Regulatory Review Sup-
Branch VII. port.
Branch VIII. Division of Business Analysis and Re-
porting.
Branch IX.
Division of Project Development.
Office of Testing and Research.2
CENTER FOR FOOD SAFETY AND
Laboratory of Clinical Pharmacology.
APPLIED NUTRITION.14
Division of Applied Pharmacology Re-
Office of the Center Director.
search.
Senior Science Advisor Staff.
Division of Pharmaceutical Analysis.
Executive Operations Staff.
Division of Product Quality Research.
International Staff.
Office of Biotechnology Products.4
Office of Management Systems.
Division of Monoclonal Antibodies.
Division of Planning and Financial Re-
Division of Therapeutic Protein.
sources Management.
Office of Medical Policy.2
Division of Program Support Services.
Division of Drug Marketing, Adver-
tising and Communication. Office of Food Defense, Communication
and Emergency Response.
Office of Executive Programs.1
Division of Education and Communica-
Division of Training and Development. tion.
Division of Executive Operations. Division of Public Health and Bio-
Division of Advisory Committee and statistics.
Consultant Management. Office of Food Safety.
12 Mailing address: 7519 Standish Pl., Bldg.
Retail Food and Cooperative Programs
MPN4, Rockville, MD 20855.
Support Staff.
13 Mailing address: 10903 New Hampshire

Ave., White Oak Bldg. 21, Silver Spring, MD 14 Mailing address: 5100 Paint Branch
20993. Pkwy., College Park, MD 20740–3835.

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Food and Drug Administration, HHS § 5.1100

Division of Seafood Science and Tech- NATIONAL CENTER FOR TOXI-


nology. COLOGY RESEARCH.16
Division of Food Processing Science Office of the Center Director.
and Technology. Office of Management.
Division of Plant and Dairy Food Safe- Office of Executive Programs and Serv-
ty. ices.
Division of Seafood Safety. Office of Scientific Coordination.
Office of Cosmetics and Colors. Office of Research.
Cosmetic Staff. Division of Biochemical Toxicology.
Division of Color Certification and
Division of Genetic and Reproductive
Technology.
Toxicology.
Office of Regulatory Science.
Genetic Toxicology Laboratory.
Division of Analytical Chemistry.
Reproductive Toxicology Laboratory.
Division of Microbiology.
Division of Personalized Nutrition and
Division of Bioanalytical Chemistry. Medicine.
Office of Food Additive Safety. Biometry Branch.
Senior Science and Policy Staff. Pharmacogenomics Branch.
Division of Food Contact Notifications.
Division of Microbiology.
Division of Biotechnology and GRAS
Division of Neurotoxicology.
Notice Review.
Division of Veterinary Services.
Office of Compliance.
Division of Enforcement. Division of Systems Toxicology.
Division of Field Programs and Guid- Office of Regulatory Compliance and
ance. Risk Management.
Office of Applied Research and Safety As- OFFICE OF REGULATORY AFFAIRS.3
sessment. Equal Employment Opportunity Staff.
Muirkirk Technical Operations Staff. Office of Resource Management.3
Division of Molecular Biology. Division of Planning, Evaluation, and
Division of Virulence Assessment. Management.
Division of Toxicology. Division of Human Resource Develop-
Office of Regulations, Policy and Social ment.
Sciences. Division of Management Operations.
Regulations and Special Government Division of Personnel Operations.
Employees Management Staff. Office of Information Technology.
Division of Social Sciences. Office of Enforcement.5
Office of Nutrition, Labeling and Dietary Division of Compliance Management
Supplements. and Operations.
Food Labeling and Standards Staff. Division of Compliance Policy.
Nutrition Programs Staff. Division of Compliance Information
Infant Formula and Medical Foods and Quality Assurance.
Staff. Office of Regional Operations.3
Division of Dietary Supplement Pro- Division of Federal-State Relations.
grams.
Division of Field Science.
CENTER FOR TOBACCO PRODUCTS.15
Division of Import Operations and Pol-
Office of the Center Director. icy.
Office of Management. Division of Field Investigations.
Office of Policy. Office of Criminal Investigations.17
Office of Regulations.
Office of Science. 16 Mailing address: 3900 NCTR Rd., Jeffer-

son, AR 72079.
15 Mailing address: 9200 Corporate Blvd., 17 Mailing address: 7500 Standish Pl., Rock-

Rockville, MD 20850. ville, MD 20855.

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§ 5.1105 21 CFR Ch. I (4–1–11 Edition)

Mid-Atlantic Area Office.3 Division of Animal Research.


Midwest Area Office.18 Division of Animal and Food Microbi-
Northeast Area Office.19 ology.
Pacific Area Office.20 Office of Minor Use and Minor Species
Animal Drug Development.28
Southeast Area Office.21
Southwest Area Office.22 § 5.1105 Chief Counsel, Food and Drug
CENTER FOR VETERINARY MEDI- Administration.
CINE.23 The Office of the Chief Counsel’s
Office of the Center Director. mailing address is 5600 Fishers Lane,
Office of Management.24 rm. 6–05, Rockville, MD 20857.1
Management Logistics Staff. § 5.1110 FDA public information of-
Financial Resources Staff. fices.
Human Capital Staff. (a) Division of Dockets Management.
Learning Management Staff. The Division of Dockets Management
public room is located in rm. 1061, 5630
Office of New Animal Drug Evaluation.25
Fishers Lane, Rockville, MD 20852,
Division of Therapeutic Drugs for Non- Telephone: 301–827–6860.
Food Animals. (b) Division of Freedom of Information.
Division of Biometrics and Production The Freedom of Information public
Drugs. room is located in rm. 6–30, Parklawn
Division of Therapeutic Drugs for Food Bldg., 5600 Fishers Lane, Rockville, MD
Animals. 20857, Telephone: 301–827–6567.
(c) Press Relations Staff. Press offices
Division of Human Food Safety.
are located in White Oak Bldg. 1, 10903
Division of Manufacturing Tech- New Hampshire Ave., Silver Spring,
nologies. MD 20993, Telephone: 301–827–6242; and
Division of Scientific Support. at 5100 Paint Branch Pkwy., College
Division of Generic Animal Drugs. Park, MD 20740, Telephone: 301–436–
Office of Surveillance and Compliance.26 2335.
Division of Surveillance.
PART 7—ENFORCEMENT POLICY
Division of Animal Feeds.
Division of Compliance. Subpart A—General Provisions
Division of Epidemiology.
Sec.
Office of Research.27 7.1 Scope.
Administrative Staff 7.3 Definitions.
7.12 Guaranty.
Division of Residue Chemistry. 7.13 Suggested forms of guaranty.

18 Mailing address: 901 Warrenville Rd., Subpart B [Reserved]


Lisle, IL 60532.
19 Mailing address: 10 Exchange Pl., Jersey Subpart C—Recalls (Including Product
City, NJ 07302. Corrections)—Guidance on Policy,
20 Mailing address: 201 Avenida Fabricante,
Procedures, and Industry Responsibil-
San Clemente, CA 92672. ities
21 Mailing address: 865 SW 78th Ave., Plan-

tation, FL 33324. 7.40 Recall policy.


22 Mailing address: 5799 Broadmoor St., Mis- 7.41 Health hazard evaluation and recall
sion, KS 66202. classification.
23 Mailing address: 7519 Standish Pl., Bldg. 28 Mailing address: 7500 Standish Pl., Bldg.
MPN4, rm. 176, Rockville, MD 20855. MPN2, rm. N378, Rockville, MD 20855.
24 Mailing address: 7529 Standish Pl., Bldg. 1 The Office of the Chief Counsel (also

MPN5, rm. 3577, Rockville, MD 20855. known as the Food and Drug Division, Office
25 Mailing address: 7520 Standish Pl., Bldg.
of the General Counsel, Department of
MPN2, rm. 239, Rockville, MD 20855. Health and Human Services), while adminis-
26 Mailing Address: 7519 Standish Pl., Bldg. tratively within the Office of the Commis-
MPN5, rm. 300, Rockville, MD 20855. sioner, is part of the Office of the General
27 Mailing address: 8401 Muirkirk Rd., Bldg. Counsel of the Department of Health and
MOD2, rm. G101, Laurel, MD 20708. Human Services.

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Food and Drug Administration, HHS § 7.3
7.42 Recall strategy. (c) Respondent means a person named
7.45 Food and Drug Administration-re- in a notice who presents views con-
quested recall. cerning an alleged violation either in
7.46 Firm-initiated recall.
7.49 Recall communications. person, by designated representative,
7.50 Public notification of recall. or in writing.
7.53 Recall status reports. (d) Responsible individual includes
7.55 Termination of a recall. those in positions of power or author-
7.59 General industry guidance. ity to detect, prevent, or correct viola-
tions of the Federal Food, Drug, and
Subpart D [Reserved] Cosmetic Act.
Subpart E—Criminal Violations (e) [Reserved]
(f) Product means an article subject
7.84 Opportunity for presentation of views to the jurisdiction of the Food and
before report of criminal violation. Drug Administration, including any
7.85 Conduct of a presentation of views be- food, drug, and device intended for
fore report of criminal violation.
7.87 Records related to opportunities for human or animal use, any cosmetic
presentation of views conducted before and biologic intended for human use,
report of criminal violation. and any item subject to a quarantine
AUTHORITY: 21 U.S.C. 321–393; 42 U.S.C. 241,
regulation under part 1240 of this chap-
262, 263b–263n, 264. ter. Product does not include an elec-
tronic product that emits radiation
SOURCE: 42 FR 15567, Mar. 22, 1977, unless and is subject to parts 1003 and 1004 of
otherwise noted.
this chapter.
(g) Recall means a firm’s removal or
Subpart A—General Provisions correction of a marketed product that
the Food and Drug Administration con-
§ 7.1 Scope.
siders to be in violation of the laws it
This part governs the practices and administers and against which the
procedures applicable to regulatory en- agency would initiate legal action, e.g.,
forcement actions initiated by the seizure. Recall does not include a mar-
Food and Drug Administration pursu- ket withdrawal or a stock recovery.
ant to the Federal Food, Drug, and (h) Correction means repair, modifica-
Cosmetic Act (21 U.S.C. 301 et seq.) and tion, adjustment, relabeling, destruc-
other laws that it administers. This tion, or inspection (including patient
part also provides guidance for manu- monitoring) of a product without its
facturers and distributors to follow physical removal to some other loca-
with respect to their voluntary re- tion.
moval or correction of marketed viola- (i) Recalling firm means the firm that
tive products. This part is promulgated initiates a recall or, in the case of a
to clarify and explain the regulatory Food and Drug Administration-re-
practices and procedures of the Food quested recall, the firm that has pri-
and Drug Administration, enhance pub- mary responsibility for the manufac-
lic understanding, improve consumer ture and marketing of the product to
protection, and assure uniform and be recalled.
consistent application of practices and (j) Market withdrawal means a firm’s
procedures throughout the agency. removal or correction of a distributed
[43 FR 26218, June 16, 1978, as amended at 65 product which involves a minor viola-
FR 56476, Sept. 19, 2000] tion that would not be subject to legal
action by the Food and Drug Adminis-
§ 7.3 Definitions. tration or which involves no violation,
(a) Agency means the Food and Drug e.g., normal stock rotation practices,
Administration. routine equipment adjustments and re-
(b) Citation or cite means a document pairs, etc.
and any attachments thereto that pro- (k) Stock recovery means a firm’s re-
vide notice to a person against whom moval or correction of a product that
criminal prosecution is contemplated has not been marketed or that has not
of the opportunity to present views to left the direct control of the firm, i.e.,
the agency regarding an alleged viola- the product is located on premises
tion. owned by, or under the control of, the

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§ 7.12 21 CFR Ch. I (4–1–11 Edition)

firm and no portion of the lot has been ered by the person who gives the guar-
released for sale or use. anty or undertaking.
(l) Recall strategy means a planned (b) The following are suggested forms
specific course of action to be taken in of guaranty or undertaking under sec-
conducting a specific recall, which ad- tion 303(c)(2) of the act:
dresses the depth of recall, need for (1) Limited form for use on invoice or
public warnings, and extent of effec- bill of sale.
tiveness checks for the recall.
(m) Recall classification means the nu- (Name of person giving the guaranty or un-
dertaking) hereby guarantees that no article
merical designation, i.e., I, II, or III, listed herein is adulterated or misbranded
assigned by the Food and Drug Admin- within the meaning of the Federal Food,
istration to a particular product recall Drug, and Cosmetic Act, or is an article
to indicate the relative degree of which may not, under the provisions of sec-
health hazard presented by the product tion 404, 505, or 512 of the act, be introduced
being recalled. into interstate commerce.
(1) Class I is a situation in which (Signature and post-office address of per-
there is a reasonable probability that son giving the guaranty or undertaking.)
the use of, or exposure to, a violative (2) General and continuing form.
product will cause serious adverse
health consequences or death. The article comprising each shipment or
other delivery hereafter made by (name of
(2) Class II is a situation in which use
person giving the guaranty or undertaking)
of, or exposure to, a violative product to, or in the order of (name and post-office
may cause temporary or medically re- address of person to whom the guaranty or
versible adverse health consequences undertaking is given) is hereby guaranteed,
or where the probability of serious ad- as of the date of such shipment or delivery,
verse health consequences is remote. to be, on such date, not adulterated or mis-
(3) Class III is a situation in which branded within the meaning of the Federal
use of, or exposure to, a violative prod- Food, Drug, and Cosmetic Act, and not an ar-
ticle which may not, under the provisions of
uct is not likely to cause adverse section 404, 505, or 512 of the act, be intro-
health consequences. duced into interstate commerce.
(n) Consignee means anyone who re- (Signature and post-office address of per-
ceived, purchased, or used the product son giving the guaranty of undertaking.)
being recalled.
(c) The application of a guaranty or
[42 FR 15567, Mar. 22, 1977, as amended at 43 undertaking referred to in section
FR 26218, June 16, 1978; 44 FR 12167, Mar. 6, 303(c)(2) of the act to any shipment or
1979] other delivery of an article shall expire
§ 7.12 Guaranty. when such article, after shipment or
delivery by the person who gave such
In case of the giving of a guaranty or guaranty or undertaking, becomes
undertaking referred to in section adulterated or misbranded within the
303(c)(2) or (3) of the act, each person meaning of the act, or becomes an arti-
signing such guaranty or undertaking cle which may not, under the provi-
shall be considered to have given it. sions of section 404, 505, or 512 of the
act, be introduced into interstate com-
§ 7.13 Suggested forms of guaranty. merce.
(a) A guaranty or undertaking re- (d) A guaranty or undertaking re-
ferred to in section 303(c)(2) of the act ferred to in section 303(c)(3) of the act
may be: shall state that the shipment or other
(1) Limited to a specific shipment or delivery of the color additive covered
other delivery of an article, in which thereby was manufactured by a signer
case it may be a part of or attached to thereof. It may be a part of or attached
the invoice or bill of sale covering such to the invoice or bill of sale covering
shipment or delivery, or such color. If such shipment or delivery
(2) General and continuing, in which is from a foreign manufacturer, such
case, in its application to any shipment guaranty or undertaking shall be
or other delivery of an article, it shall signed by such manufacturer and by an
be considered to have been given at the agent of such manufacturer who re-
date such article was shipped or deliv- sides in the United States.

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Food and Drug Administration, HHS § 7.41

(e) The following are suggested forms health and well-being from products
of guaranty or undertaking under sec- that present a risk of injury or gross
tion 303(c)(3) of the act: deception or are otherwise defective.
(1) For domestic manufacturers: This section and §§ 7.41 through 7.59 rec-
(Name of manufacturer) hereby guarantees
ognize the voluntary nature of recall
that all color additives listed herein were by providing guidance so that respon-
manufactured by him, and (where color addi- sible firms may effectively discharge
tive regulations require certification) are their recall responsibilities. These sec-
from batches certified in accordance with tions also recognize that recall is an al-
the applicable regulations promulgated ternative to a Food and Drug Adminis-
under the Federal Food, Drug, and Cosmetic tration-initiated court action for re-
Act. moving or correcting violative, distrib-
(Signature and post-office address of man-
ufacturer.)
uted products by setting forth specific
recall procedures for the Food and
(2) For foreign manufacturers: Drug Administration to monitor re-
(Name of manufacturer and agent) hereby calls and assess the adequacy of a
severally guarantee that all color additives firm’s efforts in recall.
listed herein were manufactured by (name of (b) Recall may be undertaken volun-
manufacturer), and (where color additive tarily and at any time by manufactur-
regulations require certification) are from ers and distributors, or at the request
batches certified in accordance with the ap- of the Food and Drug Administration.
plicable regulations promulgated under the
A request by the Food and Drug Ad-
Federal Food, Drug, and Cosmetic Act.
(Signature and post-office address of man- ministration that a firm recall a prod-
ufacturer.) uct is reserved for urgent situations
(Signature and post-office address of and is to be directed to the firm that
agent.) has primary responsibility for the man-
(f) For the purpose of a guaranty or ufacture and marketing of the product
undertaking under section 303(c)(3) of that is to be recalled.
the act the manufacturer of a shipment (c) Recall is generally more appro-
or other delivery of a color additive is priate and affords better protection for
the person who packaged such color. consumers than seizure, when many
(g) A guaranty or undertaking, if lots of product have been widely dis-
signed by two or more persons, shall tributed. Seizure, multiple seizure, or
state that such persons severally guar- other court action is indicated when a
antee the article to which it applies. firm refuses to undertake a recall re-
(h) No representation or suggestion quested by the Food and Drug Adminis-
that an article is guaranteed under the tration, or where the agency has rea-
act shall be made in labeling. son to believe that a recall would not
be effective, determines that a recall is
ineffective, or discovers that a viola-
Subpart B [Reserved] tion is continuing.
Subpart C—Recalls (Including [43 FR 26218, June 16, 1978, as amended at 65
FR 56476, Sept. 19, 2000]
Product Corrections)—Guid-
ance on Policy, Procedures, § 7.41 Health hazard evaluation and
and Industry Responsibilities recall classification.
(a) An evaluation of the health haz-
SOURCE: 43 FR 26218, June 16, 1978, unless ard presented by a product being re-
otherwise noted. called or considered for recall will be
conducted by an ad hoc committee of
§ 7.40 Recall policy. Food and Drug Administration sci-
(a) Recall is an effective method of entists and will take into account, but
removing or correcting consumer prod- need not be limited to, the following
ucts that are in violation of laws ad- factors:
ministered by the Food and Drug Ad- (1) Whether any disease or injuries
ministration. Recall is a voluntary ac- have already occurred from the use of
tion that takes place because manufac- the product.
turers and distributors carry out their (2) Whether any existing conditions
responsibility to protect the public could contribute to a clinical situation

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§ 7.42 21 CFR Ch. I (4–1–11 Edition)

that could expose humans or animals not delay initiation of a recall pending
to a health hazard. Any conclusion review of its recall strategy.
shall be supported as completely as (b) Elements of a recall strategy. A re-
possible by scientific documentation call strategy will address the following
and/or statements that the conclusion elements regarding the conduct of the
is the opinion of the individual(s) mak- recall:
ing the health hazard determination. (1) Depth of recall. Depending on the
(3) Assessment of hazard to various product’s degree of hazard and extent
segments of the population, e.g., chil- of distribution, the recall strategy will
dren, surgical patients, pets, livestock, specify the level in the distribution
etc., who are expected to be exposed to chain to which the recall is to extend,
the product being considered, with par- as follows:
ticular attention paid to the hazard to (i) Consumer or user level, which
those individuals who may be at great- may vary with product, including any
est risk. intermediate wholesale or retail level;
(4) Assessment of the degree of seri- or
ousness of the health hazard to which (ii) Retail level, including any inter-
the populations at risk would be ex- mediate wholesale level; or
posed. (iii) Wholesale level.
(5) Assessment of the likelihood of
(2) Public warning. The purpose of a
occurrence of the hazard.
public warning is to alert the public
(6) Assessment of the consequences that a product being recalled presents
(immediate or long-range) of occur- a serious hazard to health. It is re-
rence of the hazard. served for urgent situations where
(b) On the basis of this determina- other means for preventing use of the
tion, the Food and Drug Administra- recalled product appear inadequate.
tion will assign the recall a classifica- The Food and Drug Administration in
tion, i.e., Class I, Class II, or Class III, consultation with the recalling firm
to indicate the relative degree of will ordinarily issue such publicity.
health hazard of the product being re- The recalling firm that decides to issue
called or considered for recall. its own public warning is requested to
submit its proposed public warning and
§ 7.42 Recall strategy.
plan for distribution of the warning for
(a) General. (1) A recall strategy that review and comment by the Food and
takes into account the following fac- Drug Administration. The recall strat-
tors will be developed by the agency for egy will specify whether a public warn-
a Food and Drug Administration-re- ing is needed and whether it will issue
quested recall and by the recalling firm as:
for a firm-initiated recall to suit the (i) General public warning through
individual circumstances of the par- the general news media, either na-
ticular recall: tional or local as appropriate, or
(i) Results of health hazard evalua- (ii) Public warning through special-
tion. ized news media, e.g., professional or
(ii) Ease in identifying the product. trade press, or to specific segments of
(iii) Degree to which the product’s the population such as physicians, hos-
deficiency is obvious to the consumer pitals, etc.
or user. (3) Effectiveness checks. The purpose of
(iv) Degree to which the product re- effectiveness checks is to verify that
mains unused in the market-place. all consignees at the recall depth speci-
(v) Continued availability of essen- fied by the strategy have received noti-
tial products. fication about the recall and have
(2) The Food and Drug Administra- taken appropriate action. The method
tion will review the adequacy of a pro- for contacting consignees may be ac-
posed recall strategy developed by a re- complished by personal visits, tele-
calling firm and recommend changes as phone calls, letters, or a combination
appropriate. A recalling firm should thereof. A guide entitled ‘‘Methods for
conduct the recall in accordance with Conducting Recall Effectiveness
an approved recall strategy but need Checks’’ that describes the use of these

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Food and Drug Administration, HHS § 7.46

different methods is available upon re- specify the violation, the health hazard
quest from the Division of Dockets classification of the violative product,
Management (HFA–305), Food and Drug the recall strategy, and other appro-
Administration, 5630 Fishers Lane, rm. priate instructions for conducting the
1061, Rockville, MD 20852. The recalling recall.
firm will ordinarily be responsible for (c) Upon receipt of a request to re-
conducting effectiveness checks, but call, the firm may be asked to provide
the Food and Drug Administration will the Food and Drug Administration any
assist in this task where necessary and or all of the information listed in
appropriate. The recall strategy will § 7.46(a). The firm, upon agreeing to the
specify the method(s) to be used for recall request, may also provide other
and the level of effectiveness checks information relevant to the agency’s
that will be conducted, as follows: determination of the need for the re-
(i) Level A—100 percent of the total call or how the recall should be con-
number of consignees to be contacted; ducted.
(ii) Level B—Some percentage of the [43 FR 26218, June 16, 1978, as amended at 69
total number of consignees to be con- FR 17290, Apr. 2, 2004]
tacted, which percentage is to be deter-
mined on a case-by-case basis, but is § 7.46 Firm-initiated recall.
greater that 10 percent and less than (a) A firm may decide of its own voli-
100 percent of the total number of con- tion and under any circumstances to
signees; remove or correct a distributed prod-
(iii) Level C—10 percent of the total uct. A firm that does so because it be-
number of consignees to be contacted; lieves the product to be violative is re-
(iv) Level D—2 percent of the total quested to notify immediately the ap-
number of consignees to be contacted; propriate Food and Drug Administra-
or tion district office listed in § 5.115 of
(v) Level E—No effectiveness checks. this chapter. Such removal or correc-
[43 FR 26218, June 16, 1978, as amended at 46 tion will be considered a recall only if
FR 8455, Jan. 27, 1981; 59 FR 14363, Mar. 28, the Food and Drug Administration re-
1994; 68 FR 24879, May 9, 2003] gards the product as involving a viola-
tion that is subject to legal action,
§ 7.45 Food and Drug Administration- e.g., seizure. In such cases, the firm
requested recall. will be asked to provide the Food and
(a) The Commissioner of Food and Drug Administration the following in-
Drugs or designee may request a firm formation:
to initiate a recall when the following (1) Identity of the product involved.
determinations have been made: (2) Reason for the removal or correc-
(1) That a product that has been dis- tion and the date and circumstances
tributed presents a risk of illness or in- under which the product deficiency or
jury or gross consumer deception. possible deficiency was discovered.
(2) That the firm has not initiated a (3) Evaluation of the risk associated
recall of the product. with the deficiency or possible defi-
(3) That an agency action is nec- ciency.
essary to protect the public health and (4) Total amount of such products
welfare. produced and/or the timespan of the
(b) The Commissioner or his designee production.
will notify the firm of this determina- (5) Total amount of such products es-
tion and of the need to begin imme- timated to be in distribution channels.
diately a recall of the product. Such (6) Distribution information, includ-
notification will be by letter or tele- ing the number of direct accounts and,
gram to a responsible official of the where necessary, the identity of the di-
firm, but may be preceded by oral com- rect accounts.
munication or by a visit from an au- (7) A copy of the firm’s recall com-
thorized representative of the local munication if any has issued, or a pro-
Food and Drug Administration district posed communication if none has
office, with formal, written confirma- issued.
tion from the Commissioner or his des- (8) Proposed strategy for conducting
ignee afterward. The notification will the recall.

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§ 7.49 21 CFR Ch. I (4–1–11 Edition)

(9) Name and telephone number of tomers who received the product about
the firm official who should be con- the recall.
tacted concerning the recall. (4) Instructions regarding what to do
(b) The Food and Drug Administra- with the product.
tion will review the information sub- (b) Implementation. A recall commu-
mitted, advise the firm of the assigned nication can be accomplished by tele-
recall classification, recommend any grams, mailgrams, or first class letters
appropriate changes in the firm’s strat- conspicuously marked, preferably in
egy for the recall, and advise the firm bold red type, on the letter and the en-
that its recall will be placed in the velope: ‘‘DRUG [or FOOD, BIOLOGIC, etc.]
weekly FDA Enforcement Report. RECALL [or CORRECTION]’’. The letter
Pending this review, the firm need not and the envelope should be also
delay initiation of its product removal marked: ‘‘URGENT’’ for class I and class
or correction. II recalls and, when appropriate, for
(c) A firm may decide to recall a class III recalls. Telephone calls or
product when informed by the Food other personal contacts should ordi-
and Drug Administration that the narily be confirmed by one of the above
agency has determined that the prod- methods and/or documented in an ap-
uct in question violates the law, but propriate manner.
the agency has not specifically re- (c) Contents. (1) A recall communica-
quested a recall. The firm’s action also tion should be written in accordance
is considered a firm-initiated recall with the following guidelines:
and is subject to paragraphs (a) and (b) (i) Be brief and to the point;
of this section. (ii) Identify clearly the product, size,
(d) A firm that initiates a removal or lot number(s), code(s) or serial num-
correction of its product which the ber(s) and any other pertinent descrip-
firm believes is a market withdrawal tive information to enable accurate
should consult with the appropriate and immediate identification of the
Food and Drug Administration district product;
office when the reason for the removal (iii) Explain concisely the reason for
or correction is not obvious or clearly the recall and the hazard involved, if
understood but where it is apparent, any;
e.g., because of complaints or adverse (iv) Provide specific instructions on
reactions regarding the product, that what should be done with respect to
the product is deficient in some re- the recalled products; and
spect. In such cases, the Food and Drug (v) Provide a ready means for the re-
Administration will assist the firm in cipient of the communication to report
determining the exact nature of the to the recalling firm whether it has
problem. any of the product, e.g., by sending a
postage-paid, self-addressed postcard or
§ 7.49 Recall communications.
by allowing the recipient to place a
(a) General. A recalling firm is re- collect call to the recalling firm.
sponsible for promptly notifying each (2) The recall communication should
of its affected direct accounts about not contain irrelevant qualifications,
the recall. The format, content, and ex- promotional materials, or any other
tent of a recall communication should statement that may detract from the
be commensurate with the hazard of message. Where necessary, followup
the product being recalled and the communications should be sent to
strategy developed for that recall. In those who fail to respond to the initial
general terms, the purpose of a recall recall communication.
communication is to convey: (d) Responsibility of recipient. Con-
(1) That the product in question is signees that receive a recall commu-
subject to a recall. nication should immediately carry out
(2) That further distribution or use of the instructions set forth by the recall-
any remaining product should cease ing firm and, where necessary, extend
immediately. the recall to its consignees in accord-
(3) Where appropriate, that the direct ance with paragraphs (b) and (c) of this
account should in turn notify its cus- section.

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Food and Drug Administration, HHS § 7.59

§ 7.50 Public notification of recall. quested by the Food and Drug Adminis-
The Food and Drug Administration tration).
will promptly make available to the (4) Number of products returned or
public in the weekly FDA Enforcement corrected by each consignee contacted
Report a descriptive listing of each new and the quantity of products accounted
recall according to its classification, for.
whether it was Food and Drug Admin- (5) Number and results of effective-
istration-requested or firm-initiated, ness checks that were made.
and the specific action being taken by (6) Estimated time frames for com-
the recalling firm. The Food and Drug pletion of the recall.
Administration will intentionally (c) Recall status reports are to be dis-
delay public notification of recalls of continued when the recall is termi-
certain drugs and devices where the nated by the Food and Drug Adminis-
agency determines that public notifica- tration.
tion may cause unnecessary and harm- § 7.55 Termination of a recall.
ful anxiety in patients and that initial
consultation between patients and (a) A recall will be terminated when
their physicians is essential. The re- the Food and Drug Administration de-
port will not include a firm’s product termines that all reasonable efforts
removals or corrections which the have been made to remove or correct
agency determines to be market with- the product in accordance with the re-
drawals or stock recoveries. The re- call strategy, and when it is reasonable
port, which also includes other Food to assume that the product subject to
and Drug Administration regulatory the recall has been removed and proper
actions, e.g., seizures that were ef- disposition or correction has been
fected and injunctions and prosecu- made commensurate with the degree of
tions that were filed, is available upon hazard of the recalled product. Written
request from the Office of Public Af- notification that a recall is terminated
fairs (HFI–1), Food and Drug Adminis- will be issued by the appropriate Food
tration, 5600 Fishers Lane, Rockville, and Drug Administration district office
MD 20857. to the recalling firm.
(b) A recalling firm may request ter-
§ 7.53 Recall status reports. mination of its recall by submitting a
(a) The recalling firm is requested to written request to the appropriate
submit periodic recall status reports to Food and Drug Adminstration district
the appropriate Food and Drug Admin- office stating that the recall is effec-
istration district office so that the tive in accordance with the criteria set
agency may assess the progress of the forth in paragraph (a) of this section,
recall. The frequency of such reports and by accompanying the request with
will be determined by the relative ur- the most current recall status report
gency of the recall and will be specified and a description of the disposition of
by the Food and Drug Administration the recalled product.
in each recall case; generally the re-
porting interval will be between 2 and § 7.59 General industry guidance.
4 weeks. A recall can be disruptive of a firm’s
(b) Unless otherwise specified or in- operation and business, but there are
appropriate in a given recall case, the several steps a prudent firm can take
recall status report should contain the in advance to minimize this disruptive
following information: effect. Notwithstanding similar spe-
(1) Number of consignees notified of cific requirements for certain products
the recall, and date and method of no- in other parts of this chapter, the fol-
tification. lowing is provided by the Food and
(2) Number of consignees responding Drug Administration as guidance for a
to the recall communication and firm’s consideration:
quatity of products on hand at the (a) Prepare and maintain a current
time it was received. written contingency plan for use in ini-
(3) Number of consignees that did not tiating and effecting a recall in accord-
respond (if needed, the identity of non- ance with §§ 7.40 through 7.49, 7.53, and
responding consignees may be re- 7.55.

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§ 7.84 21 CFR Ch. I (4–1–11 Edition)

(b) Use sufficient coding of regulated (d) Notice of an opportunity to


products to make possible positive lot present views may be by letter, stand-
identification and to facilitate effec- ard form, or other document(s) identi-
tive recall of all violative lots. fying the products and/or conduct al-
(c) Maintain such product distribu- leged to violate the law. The notice
tion records as are necessary to facili- shall—
tate location of products that are being (1) Be sent by registered or certified
recalled. Such records should be main- mail, telegram, telex, personal deliv-
tained for a period of time that exceeds ery, or any other appropriate mode of
the shelf life and expected use of the written communication;
product and is at least the length of (2) Specify the time and place where
time specified in other applicable regu- those named may present their views;
lations concerning records retention. (3) Summarize the violations that
constitute the basis of the con-
Subpart D [Reserved] templated prosecution;
(4) Describe the purpose and proce-
dure of the presentation; and
Subpart E—Criminal Violations (5) Furnish a form on which the legal
status of any person named in the no-
§ 7.84 Opportunity for presentation of
views before report of criminal vio- tice may be designated.
lation. (e) If more than one person is named
in a notice, a separate opportunity for
(a)(1) Except as provided in para- presentation of views shall be sched-
graph (a) (2) and (3) of this section, a uled on request. Otherwise, the time
person against whom criminal prosecu- and place specified in a notice may be
tion under the Federal Food, Drug, and changed only upon a showing of reason-
Cosmetic Act is contemplated by the able grounds. A request for any change
Commissioner of Food and Drugs shall shall be addressed to the Food and
be given appropriate notice and an op- Drug Administration office that issued
portunity to present information and the notice and shall be received in that
views to show cause why criminal pros- office at least 3 working days before
ecution should not be recommended to the date set in the notice.
a United States attorney. (f) A person who has received a notice
(2) Notice and opportunity need not is under no legal obligation to appear
be provided if the Commissioner has or answer in any manner. A person
reason to believe that they may result choosing to respond may appear per-
in the alteration or destruction of evi- sonally, with or without a representa-
dence or in the prospective defendant’s tive, or may designate a representative
fleeing to avoid prosecution. to appear for him or her. Alternatively,
(3) Notice and opportunity need not a person may respond in writing. If a
be provided if the Commissioner con- person elects not to respond on or be-
templates recommending further inves- fore the time scheduled, the Commis-
tigation by the Department of Justice. sioner will, without further notice, de-
(b) If a statute enforced by the Com- cide whether to recommend criminal
missioner does not contain a provision prosecution to a United States attor-
for an opportunity to present views, ney on the basis of the information
the Commissioner need not, but may in available.
the Commissioner’s discretion, provide (g) If a respondent chooses to appear
notice and an opportunity to present solely by designated representative,
views. that representative shall present a
(c) If an apparent violation of the signed statement of authorization. If a
Federal Food, Drug, and Cosmetic Act representative appears for more than
also constitutes a violation of any one respondent, the representative
other Federal statute(s), and the Com- shall submit independent documenta-
missioner contemplates recommending tion of authority to act for each re-
prosecution under such other statute(s) spondent. If a representative appears
as well, the notice of opportunity to without written authorization, the op-
present views will include all viola- portunity to present views with respect
tions. to that respondent may be provided at

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Food and Drug Administration, HHS § 7.85

that time only if the authenticity of (f) If an oral presentation is not re-
the representative’s authority is first corded and transcribed, the agency em-
verified by telephone or other appro- ployee designated to receive views
priate means. shall dictate a written summary of the
[44 FR 12167, Mar. 6, 1979] presentation. A copy of the summary
shall be provided to each respondent.
§ 7.85 Conduct of a presentation of (g) A respondent may comment on
views before report of criminal vio- the summary or may supplement any
lation. response by additional written or docu-
(a) The presentation of views shall be mentary evidence. Any comment or ad-
heard by a designated Food and Drug dition shall be furnished to the Food
Administration employee. Other Food and Drug Administration office where
and Drug Administration employees the respondent’s views were presented.
may be present. If materials are submitted within 10
(b) A presentation of views shall not calendar days after receipt of the copy
be open to the public. The agency em- of the summary or transcription of the
ployee designated to receive views will presentation, as applicable, they will
permit participation of other persons be considered before a final decision as
only if they appear with the respondent to whether or not to recommend pros-
or the respondent’s designated rep- ecution. Any materials received after
resentative, and at the request of, and the supplemental response period gen-
on behalf of, the respondent. erally will be considered only if the
(c) A respondent may present any in- final agency decision has not yet been
formation of any kind bearing on the made.
Commissioner’s determination to rec- (h)(1) When consideration of a crimi-
ommend prosecution. Information may nal prosecution recommendation in-
include statements of persons appear- volving the same violations is closed
ing on the respondent’s behalf, letters, by the Commissioner with respect to
documents, laboratory analyses, if ap- all persons named in the notice, the
plicable, or other relevant information Commissioner will so notify each per-
or arguments. The opportunity to son in writing.
present views shall be informal. The (2) When it is determined that a per-
rules of evidence shall not apply. Any son named in a notice will not be in-
information given by a respondent, in- cluded in the Commissioner’s rec-
cluding statements by the respondent, ommendation for criminal prosecution,
shall become part of the agency’s the Commissioner will so notify that
records concerning the matter and may person, if and when the Commissioner
be used for any official purpose. The concludes that notification will not
Food and Drug Administration is under prejudice the prosecution of any other
no obligation to present evidence or person.
witnesses. (3) When a United States attorney in-
(d) If the respondent holds a ‘‘guar- forms the agency that no persons rec-
anty or undertaking’’ as described in ommended will be prosecuted, the
section 303(c) of the act (21 U.S.C. Commissioner will so notify each per-
333(c)) that is applicable to the notice, son in writing, unless the United
that document, or a verified copy of it, States attorney has already done so.
may be presented by the respondent. (4) When a United States attorney in-
(e) A respondent may have an oral forms the agency of intent to prosecute
presentation recorded and transcribed some, but not all, persons who had
at his or her expense, in which case a been provided an opportunity to
copy of the transcription shall be fur- present views and were subsequently
nished to the Food and Drug Adminis- named in the Commissioner’s rec-
tration office from which the notice ommendation for criminal prosecution,
issued. The employee designated to re- the Commissioner, after being advised
ceive views may order a presentation of by the United States attorney that the
views recorded and transcribed at agen- notification will not prejudice the
cy expense, in which case a copy of prosecution of any other person, will so
such transcription shall be provided to notify those persons eliminated from
each respondent. further consideration, unless the

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§ 7.87 21 CFR Ch. I (4–1–11 Edition)

United States attorney has already (c) Before disclosure of any record
done so. specifically reflecting consideration of
a possible recommendation for crimi-
[44 FR 12168, Mar. 6, 1979]
nal prosecution of any individual, all
§ 7.87 Records related to opportunities names and other information that
for presentation of views conducted would identify an individual whose
before report of criminal violation. prosecution was considered but not rec-
ommended, or who was not prosecuted,
(a) Records related to a section 305 shall be deleted, unless the Commis-
opportunity for presentation of views sioner concludes that there is a com-
constitute investigatory records for pelling public interest in the disclosure
law enforcement purposes and may in- of the names.
clude inter- and intra-agency memo- (d) Names and other information that
randums. would identify a Food and Drug Admin-
(1) Notwithstanding the rule estab- istration employee shall be deleted
lished in § 20.21 of this chapter, no from records related to a section 305
record related to a section 305 presen- presentation of views before public dis-
tation is available for public disclosure closure only under § 20.32 of this chap-
until consideration of criminal pros- ter.
ecution has been closed in accordance
[44 FR 12168, Mar. 6, 1979]
with paragraph (b) of this section, ex-
cept as provided in § 20.82 of this chap-
ter. Only very rarely and only under PART 10—ADMINISTRATIVE
circumstances that demonstrate a PRACTICES AND PROCEDURES
compelling public interest will the
Commissioner exercise, in accordance Subpart A—General Provisions
with § 20.82 of this chapter, the author-
Sec.
ized discretion to disclose records re- 10.1 Scope.
lated to a section 305 presentation be- 10.3 Definitions.
fore the consideration of criminal pros- 10.10 Summaries of administrative prac-
ecution is closed. tices and procedures.
(2) After consideration of criminal 10.19 Waiver, suspension, or modification of
prosecution is closed, the records are procedural requirements.
available for public disclosure in re- Subpart B—General Administrative
sponse to a request under the Freedom Procedures
of Information Act, except to the ex-
tent that the exemptions from disclo- 10.20 Submission of documents to Division
sure in subpart D of part 20 of this of Dockets Management; computation of
chapter are applicable. No statements time; availability for public disclosure.
obtained through promises of confiden- 10.25 Initiation of administrative pro-
ceedings.
tiality shall be available for public dis- 10.30 Citizen petition.
closure. 10.33 Administrative reconsideration of ac-
(b) Consideration of criminal pros- tion.
ecution based on a particular section 10.35 Administrative stay of action.
305 notice of opportunity for presen- 10.40 Promulgation of regulations for the ef-
tation of views shall be deemed to be ficient enforcement of the law.
10.45 Court review of final administrative
closed within the meaning of this sec-
action; exhaustion of administrative
tion and § 7.85 when a final decision has remedies.
been made not to recommend criminal 10.50 Promulgation of regulations and or-
prosecution to a United States attor- ders after an opportunity for a formal
ney based on charges set forth in the evidentiary public hearing.
notice and considered at the presen- 10.55 Separation of functions; ex parte com-
tation, or when such a recommenda- munications.
tion has been finally refused by the 10.60 Referral by court.
10.65 Meetings and correspondence.
United States attorney, or when crimi-
10.70 Documentation of significant deci-
nal prosecution has been instituted and sions in administrative file.
the matter and all related appeals have 10.75 Internal agency review of decisions.
been concluded, or when the statute of 10.80 Dissemination of draft Federal Reg-
limitations has run. ister notices and regulations.

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Food and Drug Administration, HHS § 10.3
10.85 Advisory opinions. tion in the FEDERAL REGISTER unless
10.90 Food and Drug Administration regula- otherwise noted.
tions, recommendations, and agree-
ments. [44 FR 22323, Apr. 13, 1979, as amended at 54
10.95 Participation in outside standard-set- FR 9034, Mar. 3, 1989; 69 FR 17290, Apr. 2, 2004]
ting activities.
10.100 Public calendar. § 10.3 Definitions.
10.105 Representation by an organization. (a) The following definitions apply in
10.110 Settlement proposals. this part and parts 12, 13, 14, 15, 16, and
10.115 Good guidance practices. 19:
Act means the Federal Food, Drug,
Subpart C—Electronic Media Coverage of and Cosmetic Act unless otherwise in-
Public Administrative Proceedings; dicated.
Guideline on Policy and Procedures Administrative action includes every
10.200 Scope. act, including the refusal or failure to
10.203 Definitions. act, involved in the administration of
10.204 General. any law by the Commissioner, except
10.205 Electronic media coverage of public that it does not include the referral of
administrative proceedings. apparent violations to U.S. attorneys
10.206 Procedures for electronic media cov- for the institution of civil or criminal
erage of agency public administrative proceedings or an act in preparation of
proceedings. a referral.
AUTHORITY: 5 U.S.C. 551–558, 701–706; 15
Administrative file means the file or
U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–397, files containing all documents per-
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, taining to a particular administrative
262, 263b, 264. action, including internal working
memoranda, and recommendations.
SOURCE: 44 FR 22323, Apr. 13, 1979, unless
Administrative record means the docu-
otherwise noted.
ments in the administrative file of a
EDITORIAL NOTE: Nomenclature changes to particular administrative action on
part 10 appear at 68 FR 24879, May 9, 2003. which the Commissioner relies to sup-
port the action.
Subpart A—General Provisions Agency means the Food and Drug Ad-
ministration.
§ 10.1 Scope. Chief Counsel means the Chief Coun-
(a) Part 10 governs practices and pro- sel of the Food and Drug Administra-
cedures for petitions, hearings, and tion.
other administrative proceedings and Commissioner means the Commis-
activities conducted by the Food and sioner of Food and Drugs, Food and
Drug Administration, U.S. Department
Drug Administration under the Federal
of Health and Human Services, or the
Food, Drug, and Cosmetic Act, the
Commissioner’s designee.
Public Health Service Act, and other
Department means the U.S. Depart-
laws which the Commissioner of Food
ment of Health and Human Services.
and Drugs administers.
Division of Dockets Management means
(b) If a requirement in another part the Division of Dockets Management,
of title 21 differs from a requirement in Office of Management and Operations
this part, the requirements of this part of the Food and Drug Administration,
apply to the extent that they do not U.S. Department of Health and Human
conflict with the other requirements. Services, 5630 Fishers Lane, rm. 1061,
(c) References in this part and parts Rockville, MD 20852.
12, 13, 14, 15, and 16 to regulatory sec- Ex parte communication means an oral
tions of the Code of Federal Regula- or written communication not on the
tions are to chapter I of title 21 unless public record for which reasonable
otherwise noted. prior notice to all parties is not given,
(d) References in this part and parts but does not include requests for status
12, 13, 14, 15, and 16 to publication, or to reports on a matter.
the day or date of publication, or use of FDA means the Food and Drug Ad-
the phrase to publish, refer to publica- ministration.

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§ 10.3 21 CFR Ch. I (4–1–11 Edition)

Food and Drug Administration em- Proceeding and administrative pro-


ployee or Food and Drug Administration ceeding means any undertaking to
representative includes members of the issue, amend, or revoke a regulation or
Food and Drug Division of the office of order, or to take or refrain from taking
the General Counsel of the Department any other form of administrative ac-
of Health and Human Services. tion.
Formal evidentiary public hearing Public advisory committee or advisory
means a hearing conducted under part committee means any committee, board,
12. commission, council, conference, panel,
Interested person or any person who task force, or other similar group, or
will be adversely affected means a person any subcommittee or other subgroup of
who submits a petition or comment or an advisory committee, that is not
objection or otherwise asks to partici- composed wholly of full-time employ-
pate in an informal or formal adminis- ees of the Federal Government and is
trative proceeding or court action. established or utilized by the Food and
Meeting means any oral discussion, Drug Administration to obtain advice
whether by telephone or in person. or recommendations.
Public Board of Inquiry or Board
Office of the Commissioner includes the
means an administrative law tribunal
offices of the Associate Commissioners
constituted under part 13.
but not the centers or the regional or
Public hearing before a public advisory
district offices.
committee means a hearing conducted
Order means the final agency disposi- under part 14.
tion, other than the issuance of a regu- Public hearing before a Public Board of
lation, in a proceeding concerning any Inquiry means a hearing conducted
matter and includes action on a new under part 13.
drug application, new animal drug ap- Public hearing before the Commissioner
plication, or biological license. means a hearing conducted under part
Participant means any person partici- 15.
pating in any proceeding, including Regulations means an agency rule of
each party and any other interested general or particular applicability and
person. future effect issued under a law admin-
Party means the center of the Food istered by the Commissioner or relat-
and Drug Administration responsible ing to administrative practices and
for a matter involved and every person procedures. In accordance with
who either has exercised a right to re- § 10.90(a), each agency regulation will
quest or has been granted the right by be published in the FEDERAL REGISTER
the Commissioner to have a hearing and codified in the Code of Federal
under part 12 or part 16 or who has Regulations.
waived the right to a hearing to obtain Regulatory hearing before the Food and
the establishment of a Public Board of Drug Administration means a hearing
Inquiry under part 13 and as a result of conducted under part 16.
whose action a hearing or a Public Secretary means the Secretary of
Board of Inquiry has been established. Health and Human Services.
Person includes an individual, part- The laws administered by the Commis-
nership, corporation, association, or sioner or the laws administered by the
other legal entity. Food and Drug Administration means all
Petition means a petition, applica- the laws that the Commissioner is au-
tion, or other document requesting the thorized to administer.
Commissioner to establish, amend, or (b) A term that is defined in section
revoke a regulation or order, or to take 201 of the Federal Food, Drug, and Cos-
or not to take any other form of ad- metic Act or part 1 has the same defi-
ministrative action, under the laws ad- nition in this part.
ministered by the Food and Drug Ad- (c) Words in the singular form in-
ministration. clude the plural, words in the mas-
Presiding officer means the Commis- culine form include the feminine, and
sioner or the Commissioner’s designee vice versa.
or an administrative law judge ap- (d) Whenever a reference is made in
pointed as provided in 5 U.S.C. 3105. this part to a person in FDA, e.g., the

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Food and Drug Administration, HHS § 10.20

director of a center, the reference in- in full and may not be incorporated by
cludes all persons to whom that person reference, unless previously submitted
has delegated the specific function in- in the same proceeding.
volved. (1) A copy of an article or other ref-
erence or source cited must be in-
[44 FR 22323, Apr. 13, 1979, as amended at 46
FR 8455, Jan. 27, 1981; 50 FR 8994, Mar. 6, 1985; cluded, except where the reference or
54 FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3, source is:
1989; 59 FR 14363, Mar. 28, 1994; 69 FR 17290, (i) A reported Federal court case;
Apr. 2, 2004] (ii) A Federal law or regulation;
(iii) An FDA document that is rou-
§ 10.10 Summaries of administrative tinely publicly available; or
practices and procedures. (iv) A recognized medical or sci-
To encourage public participation in entific textbook that is readily avail-
all agency activities, the Commis- able to the agency.
sioner will prepare for public distribu- (2) If a part of the material submitted
tion summaries of FDA administrative is in a foreign language, it must be ac-
practices and procedures in readily un- companied by an English translation
derstandable terms. verified to be complete and accurate,
together with the name, address, and a
§ 10.19 Waiver, suspension, or modi- brief statement of the qualifications of
fication of procedural require- the person making the translation. A
ments. translation of literature or other mate-
The Commissioner or a presiding offi- rial in a foreign language is to be ac-
cer may, either voluntarily or at the companied by copies of the original
request of a participant, waive, sus- publication.
pend, or modify any provision in parts (3) Where relevant information is
12 through 16 applicable to the conduct contained in a document also con-
of a public hearing by announcement taining irrelevant information, the ir-
at the hearing or by notice in advance relevant information is to be deleted
of the hearing if no participant will be and only the relevant information is to
prejudiced, the ends of justice will be submitted.
thereby be served, and the action is in (4) Under § 20.63 (a) and (b), the names
accordance with law. and other information that would iden-
tify patients or research subjects are to
Subpart B—General Administrative be deleted from any record before it is
Procedures submitted to the Division of Dockets
Management in order to preclude a
§ 10.20 Submission of documents to Di- clearly unwarranted invasion of per-
vision of Dockets Management; sonal privacy.
computation of time; availability for (5) Defamatory, scurrilous, or intem-
public disclosure. perate matter is to be deleted from a
(a) A submission to the Division of record before it is submitted to the Di-
Dockets Management of a petition, vision of Dockets Management.
comment, objection, notice, compila- (6) The failure to comply with the re-
tion of information, or any other docu- quirements of this part or with § 12.80
ment is to be filed in four copies except or § 13.20 will result in rejection of the
as otherwise specifically provided in a submission for filing or, if it is filed, in
relevant FEDERAL REGISTER notice or exclusion from consideration of any
in another section of this chapter. The portion that fails to comply. If a sub-
Division of Dockets Management is the mission fails to meet any requirement
agency custodian of these documents. of this section and the deficiency be-
(b) A submission is to be signed by comes known to the Division of Dock-
the person making it, or by an attor- ets Management, the Division of Dock-
ney or other authorized representative ets Management shall not file the sub-
of that person. Submissions by trade mission but return it with a copy of
associations are also subject to the re- the applicable regulations indicating
quirements of § 10.105(b). those provisions not complied with. A
(c) Information referred to or relied deficient submission may be corrected
upon in a submission is to be included or supplemented and subsequently

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§ 10.20 21 CFR Ch. I (4–1–11 Edition)

filed. The office of the Division of true and accurate. All submissions are
Dockets Management does not make subject to the False Reports to the
decisions regarding the confidentiality Government Act (18 U.S.C. 1001) under
of submitted documents. which a willfully false statement is a
(d) The filing of a submission means criminal offense.
only that the Division of Dockets Man- (j) The availability for public exam-
agement has identified no technical de- ination and copying of submissions to
ficiencies in the submission. The filing the Division of Dockets Management is
of a petition does not mean or imply governed by the following rules:
that it meets all applicable require- (1) Except to the extent provided in
ments or that it contains reasonable paragraphs (j)(2) and (3) of this section,
grounds for the action requested or the following submissions, including
that the action requested is in accord- all supporting material, will be on pub-
ance with law. lic display and will be available for
(e) All submissions to the Division of public examination between 9 a.m. and
Dockets Management will be consid- 4 p.m., Monday through Friday. Re-
ered as submitted on the date they are quests for copies of submissions will be
postmarked or, if delivered in person filed and handled in accordance with
during regular business hours, on the subpart C of part 20:
date they are delivered, unless a provi- (i) Petitions.
sion in this part, an applicable FED- (ii) Comments on petitions, on docu-
ERAL REGISTER notice, or an order ments published in the FEDERAL REG-
issued by an administrative law judge ISTER, and on similar public docu-
specifically states that the documents ments.
must be received by a specified date, (iii) Objections and requests for hear-
e.g., § 10.33(g) relating to a petition for ings filed under part 12.
reconsideration, in which case they (iv) Material submitted at a hearing
will be considered submitted on the under § 12.32(a)(2) and parts 12, 13, and
date received. 15.
(f) All submissions are to be mailed (v) Material placed on public display
or delivered in person to the Division under the regulations in this chapter,
of Dockets Management, Food and e.g., agency guidance documents devel-
Drug Administration, 5630 Fishers oped under § 10.115.
Lane, rm. 1061, Rockville, MD 20852. (2)(i) Material prohibited from public
(g) FDA ordinarily will not acknowl- disclosure under § 20.63 (clearly unwar-
edge or give receipt for documents, ex- ranted invasion of personal privacy)
cept: and, except as provided in paragraph
(1) Documents delivered in person or (j)(3) of this section, material sub-
by certified or registered mail with a mitted with objections and requests for
return receipt requested; and hearing filed under part 12, or at a
(2) Petitions for which acknowledg- hearing under part 12 or part 13, or an
ment of receipt of filing is provided by alternative form of public hearing be-
regulation or by customary practice, fore a public advisory committee or a
e.g., § 10.30(c) relating to a citizen peti- hearing under § 12.32(a) (2) or (3), of the
tion. following types will not be on public
(h) Saturdays, Sundays, and Federal display, will not be available for public
legal holidays are included in com- examination, and will not be available
puting the time allowed for the submis- for copying or any other form of ver-
sion of documents, except that when batim transcription unless it is other-
the time for submission expires on a wise available for public disclosure
Saturday, Sunday, or Federal legal hol- under part 20:
iday, the period will be extended to in- (a) Safety and effectiveness informa-
clude the next business day. tion, which includes all studies and
(i) All submissions to the Division of tests of an ingredient or product on
Dockets Management are representa- animals and humans and all studies
tions that, to the best of the knowl- and tests on the ingredient or product
edge, information, and belief of the for identity, stability, purity, potency,
person making the submission, the bioavailability, performance, and use-
statements made in the submission are fulness.

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Food and Drug Administration, HHS § 10.30

(b) A protocol for a test or study. § 10.25 Initiation of administrative


(c) Manufacturing methods or proc- proceedings.
esses, including quality control proce- An administrative proceeding may be
dures. initiated in the following three ways:
(d) Production, sales distribution, (a) An interested person may petition
and similar information, except any the Commissioner to issue, amend, or
compilation of information aggregated revoke a regulation or order, or to take
and prepared in a way that does not re- or refrain from taking any other form
veal confidential information. of administrative action. A petition
(e) Quantitative or semiquantitative must be either: (1) In the form specified
formulas. in other applicable FDA regulations,
(f) Information on product design or e.g., the form for a color additive peti-
construction. tion in § 71.1, for a food additive peti-
(ii) Material submitted under para- tion in § 171.1, for a new drug applica-
graph (j)(2) of this section is to be seg- tion in § 314.50, for a new animal drug
regated from all other submitted mate- application in § 514.1, or (2) in the form
rial and clearly so marked. A person for a citizen petition in § 10.30.
who does not agree that a submission (b) The Commissioner may initiate a
is properly subject to paragraph (j)(2) proceeding to issue, amend, or revoke a
may request a ruling from the Asso- regulation or order or take or refrain
ciate Commissioner for Public Affairs from taking any other form of adminis-
whose decision is final, subject to judi- trative action. FDA has primary juris-
cial review under § 20.48. diction to make the initial determina-
(3) Material listed in paragraph tion on issues within its statutory
(j)(2)(i) (a) and (b) of this section may mandate, and will request a court to
be disclosed under a protective order dismiss, or to hold in abeyance its de-
issued by the administrative law judge termination of or refer to the agency
or other presiding officer at a hearing for administrative determination, any
referenced in paragraph (j)(2)(i). The issue which has not previously been de-
administrative law judge or presiding termined by the agency or which, if it
officer shall permit disclosure of the has previously been determined, the
data only in camera and only to the ex- agency concluded should be reconsid-
tent necessary for the proper conduct ered and subject to a new administra-
of the hearing. The administrative law tive determination. The Commissioner
judge or presiding officer shall direct may utilize any of the procedures es-
to whom the information is to be made tablished in this part in reviewing and
available (e.g., to parties or partici- making a determination on any matter
pants, or only to counsel for parties or initiated under this paragraph.
participants), and persons not specifi- (c) The Commissioner will institute a
cally permitted access to the data will proceeding to determine whether to
be excluded from the in camera part of issue, amend, or revoke a regulation or
the proceeding. The administrative law order, or take or refrain from taking
judge or other presiding officer may any other form of administrative ac-
impose other conditions or safeguards. tion whenever any court, on its own
The limited availability of material initiative, holds in abeyance or refers
under this paragraph does not con- any matter to the agency for an admin-
stitute prior disclosure to the public as istrative determination and the Com-
defined in § 20.81, and no information missioner concludes that an adminis-
subject to a particular order is to be trative determination is feasible with-
submitted to or received or considered in agency priorities and resources.
by FDA in support of a petition or
other request from any other person. [44 FR 22323, Apr. 13, 1979, as amended at 54
FR 9034, Mar. 3, 1989]
[44 FR 22323, Apr. 13, 1979, as amended at 46
FR 8455, Jan. 27, 1981; 49 FR 7363, Feb. 29, § 10.30 Citizen petition.
1984; 54 FR 9034, Mar. 3, 1989; 59 FR 14363,
Mar. 28, 1994; 64 FR 69190, Dec. 10, 1999; 65 FR (a) This section applies to any peti-
56477, Sept. 19, 2000; 66 FR 56035, Nov. 6, 2001; tion submitted by a person (including a
66 FR 66742, Dec. 27, 2001; 68 FR 25285, May 12, person who is not a citizen of the
2003] United States) except to the extent

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§ 10.30 21 CFR Ch. I (4–1–11 Edition)

that other sections of this chapter government, and consumers; (2) productivity
apply different requirements to a par- of wage earners, businesses, or government;
ticular matter. (3) competition; (4) supplies of important
materials, products, or services; (5) employ-
(b) A petition (including any attach-
ment; and (6) energy supply or demand.)
ments) must be submitted in accord-
ance with § 10.20 and in the following E. Certification
form:
The undersigned certifies, that, to the best
(Date) llllllllllllllllllll knowledge and belief of the undersigned, this
petition includes all information and views
Division of Dockets Management, Food
on which the petition relies, and that it in-
and Drug Administration, Department of
cludes representative data and information
Health and Human Services, 5630 Fishers
known to the petitioner which are unfavor-
Lane, rm. 1061, Rockville, MD 20852.
able to the petition.
CITIZEN PETITION (Signature) lllllllllllllllll
(Name of petitioner) llllllllllll
The undersigned submits this petition
(Mailing address) llllllllllllll
under lll (relevant statutory sections, if
(Telephone number) lllllllllllll
known) of the lll (Federal Food, Drug,
and Cosmetic Act or the Public Health Serv- (c) A petition which appears to meet
ice Act or any other statutory provision for the requirements of paragraph (b) of
which authority has been delegated to the
this section and § 10.20 will be filed by
Commissioner of Food and Drugs under 21
CFR 5.10) to request the Commissioner of the Division of Dockets Management,
Food and Drugs to lll (issue, amend, or stamped with the date of filing, and as-
revoke a regulation or order or take or re- signed a docket number. The docket
frain from taking any other form of adminis- number identifies the file established
trative action). by the Division of Dockets Manage-
A. Action requested
ment for all submissions relating to
the petition, as provided in this part.
((1) If the petition requests the Commis- Subsequent submissions relating to the
sioner to issue, amend, or revoke a regula-
matter must refer to the docket num-
tion, the exact wording of the existing regu-
lation (if any) and the proposed regulation or ber and will be filed in the docket file.
amendment requested.) Related petitions may be filed together
((2) If the petition requests the Commis- and given the same docket number.
sioner to issue, amend, or revoke an order, a The Division of Dockets Management
copy of the exact wording of the citation to will promptly notify the petitioner in
the existing order (if any) and the exact writing of the filing and docket number
wording requested for the proposed order.)
of a petition.
((3) If the petition requests the Commis-
sioner to take or refrain from taking any (d) An interested person may submit
other form of administrative action, the spe- written comments to the Division of
cific action or relief requested.) Dockets Management on a filed peti-
tion, which comments become part of
B. Statement of grounds
the docket file. The comments are to
(A full statement, in a well organized for- specify the docket number of the peti-
mat, of the factual and legal grounds on tion and may support or oppose the pe-
which the petitioner relies, including all rel- tition in whole or in part. A request for
evant information and views on which the
petitioner relies, as well as representative
alternative or different administrative
information known to the petitioner which action must be submitted as a separate
is unfavorable to the petitioner’s position.) petition.
(e)(1) The Commissioner shall, in ac-
C. Environmental impact cordance with paragraph (e)(2), rule
(A) Claim for categorical exclusion under upon each petition filed under para-
§§ 25.30, 25.31, 25.32, 25.33, or § 25.34 of this graph (c) of this section, taking into
chapter or an environmental assessment consideration (i) available agency re-
under § 25.40 of this chapter.) sources for the category of subject
D. Economic impact matter, (ii) the priority assigned to the
petition considering both the category
(The following information is to be sub-
mitted only when requested by the Commis- of subject matter involved and the
sioner following review of the petition: A overall work of the agency, and (iii)
statement of the effect of requested action time requirements established by stat-
on: (1) Cost (and price) increases to industry, ute.

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Food and Drug Administration, HHS § 10.30

(2) Except as provided in paragraph (h) In reviewing a petition the Com-


(e)(4) of this section, the Commissioner missioner may use the following proce-
shall furnish a response to each peti- dures:
tioner within 180 days of receipt of the (1) Conferences, meetings, discus-
petition. The response will either: sions, and correspondence under § 10.65.
(i) Approve the petition, in which (2) A hearing under parts 12, 13, 14, 15,
case the Commissioner shall concur- or 16.
rently take appropriate action (e.g., (3) A FEDERAL REGISTER notice re-
publication of a FEDERAL REGISTER no- questing information and views.
tice) implementing the approval; (4) A proposal to issue, amend, or re-
(ii) Deny the petition; or voke a regulation, in accordance with
(iii) Provide a tentative response, in- § 10.40 or § 12.20.
dicating why the agency has been un- (5) Any other specific public proce-
able to reach a decision on the peti- dure established in this chapter and ex-
tion, e.g., because of the existence of pressly applicable to the matter.
other agency priorities, or a need for (i) The record of the administrative
additional information. The tentative proceeding consists of the following:
response may also indicate the likely (1) The petition, including all infor-
ultimate agency response, and may mation on which it relies, filed by the
specify when a final response may be Division of Dockets Management.
furnished. (2) All comments received on the pe-
(3) The Commissioner may grant or tition, including all information sub-
deny such a petition, in whole or in mitted as a part of the comments.
part, and may grant such other relief (3) If the petition resulted in a pro-
or take other action as the petition posal to issue, amend, or revoke a regu-
warrants. The petitioner is to be noti- lation, all of the documents specified
fied in writing of the Commissioner’s in § 10.40(g).
decision. The decision will be placed in (4) The record, consisting of any
the public docket file in the office of transcripts, minutes of meetings, re-
the Division of Dockets Management ports, FEDERAL REGISTER notices, and
and may also be in the form of a notice other documents resulting from the op-
published in the FEDERAL REGISTER. tional procedures specified in para-
(4) The Commissioner shall furnish a graph (h) of this section, except a tran-
response to each petitioner within 90 script of a closed portion of a public ad-
days of receipt of a petition filed under visory committee meeting.
section 505(j)(2)(C) of the act. The re- (5) The Commissioner’s decision on
sponse will either approve or dis- the petition, including all information
approve the petition. Agency action on identified or filed by the Commissioner
a petition shall be governed by § 314.93 with the Division of Dockets Manage-
of this chapter. ment as part of the record supporting
(f) If a petition filed under paragraph the decision.
(c) of this section requests the Com- (6) All documents filed with the Divi-
missioner to issue, amend, or revoke a sion of Dockets Management under
regulation, § 10.40 or § 10.50 also apply. § 10.65(h).
(g) A petitioner may supplement, (7) If a petition for reconsideration or
amend, or withdraw a petition in writ- for a stay of action is filed under para-
ing without agency approval and with- graph (j) of this section, the adminis-
out prejudice to resubmission at any- trative record specified in § 10.33(k) or
time until the Commissioner rules on § 10.35(h).
the petition, unless the petition has (j) The administrative record speci-
been referred for a hearing under parts fied in paragraph (i) of this section is
12, 13, 14, or 15. After a ruling or refer- the exclusive record for the Commis-
ral, a petition may be supplemented, sioner’s decision. The record of the ad-
amended, or withdrawn only with the ministrative proceeding closes on the
approval of the Commissioner. The date of the Commissioner’s decision
Commissioner may approve with- unless some other date is specified.
drawal, with or without prejudice Thereafter any interested person may
against resubmission of the petition. submit a petition for reconsideration

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§ 10.33 21 CFR Ch. I (4–1–11 Edition)

under § 10.33 or a petition for stay of ac- day of publication is the day of deci-
tion under § 10.35. A person who wishes sion.
to rely upon information or views not (Date) llllllllllllllllllll
included in the administrative record
shall submit them to the Commissioner Division of Dockets Management, Food
with a new petition to modify the deci- and Drug Administration, Department of
Health and Human Services, rm. 1–23, 5630
sion in accordance with this section. Fishers Lane, rm. 1061, Rockville, MD 20852.
(k) This section does not apply to the
referral of a matter to a United States PETITION FOR RECONSIDERATION
attorney for the initiation of court en-
[Docket No.]
forcement action and related cor-
respondence, or to requests, sugges- The undersigned submits this petition for
tions, and recommendations made in- reconsideration of the decision of the Com-
missioner of Food and Drugs in Docket No.
formally in routine correspondence re- ll.
ceived by FDA. Routine correspond-
ence does not constitute a petition A. Decision involved
within the meaning of this section un- (A concise statement of the decision of the
less it purports to meet the require- Commissioner which the petitioner wishes to
ments of this section. Action on rou- have reconsidered.)
tine correspondence does not con-
B. Action requested
stitute final administrative action sub-
ject to judicial review under § 10.45. (The decision which the petitioner requests
(l) The Division of Dockets Manage- the Commissioner to make upon reconsider-
ment will maintain a chronological list ation of the matter.)
of each petition filed under this section C. Statement of grounds
and § 10.85, but not of petitions sub-
(A full statement, in a well-organized for-
mitted elsewhere in the agency under mat, of the factual and legal grounds upon
§ 10.25(a)(1), showing: which the petitioner relies. The grounds
(1) The docket number; must demonstrate that relevant information
(2) The date the petition was filed by and views contained in the administrative
the Division of Dockets Management; record were not previously or not adequately
(3) The name of the petitioner; considered by the Commissioner.
(4) The subject matter involved; and (No new information or views may be in-
cluded in a petition for reconsideration.)
(5) The disposition of the petition.
(Signature) lllllllllllllllll
[44 FR 22323, Apr. 13, 1979, as amended at 46 (Name of petitioner) llllllllllll
FR 8455, Jan. 27, 1981; 50 16656, Apr. 26, 1985; (Mailing address) llllllllllllll
54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, (Telephone number) lllllllllllll
1992; 59 FR 14364, Mar. 28, 1994; 62 FR 40592,
July 29, 1997; 66 FR 6467, Jan. 22, 2001; 66 FR (c) A petition for reconsideration re-
12848, Mar. 1, 2001] lating to a petition submitted under
§ 10.25(a)(2) is subject to the require-
§ 10.33 Administrative reconsideration ments of § 10.30 (c) and (d), except that
of action. it is filed in the same docket file as the
(a) The Commissioner may at any petition to which it relates.
time reconsider a matter, on the Com- (d) The Commissioner shall promptly
missioner’s own initiative or on the pe- review a petition for reconsideration.
tition of an interested person. The Commissioner may grant the peti-
(b) An interested person may request tion when the Commissioner deter-
reconsideration of part or all of a deci- mines it is in the public interest and in
sion of the Commissioner on a petition the interest of justice. The Commis-
submitted under § 10.25. Each request sioner shall grant a petition for recon-
for reconsideration must be submitted sideration in any proceeding if the
in accordance with § 10.20 and in the Commissioner determines all of the fol-
following form no later than 30 days lowing apply:
after the date of the decision involved. (1) The petition demonstrates that
The Commissioner may, for good cause, relevant information or views con-
permit a petition to be filed after 30 tained in the administrative record
days. In the case of a decision pub- were not previously or not adequately
lished in the FEDERAL REGISTER, the considered.

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Food and Drug Administration, HHS § 10.35

(2) The petitioner’s position is not eration. The administrative record of


frivolous and is being pursued in good the proceeding is to include all addi-
faith. tional documents relating to such re-
(3) The petitioner has demonstrated consideration.
sound public policy grounds supporting (i) After determining to reconsider a
reconsideration. matter, the Commissioner shall review
(4) Reconsideration is not outweighed and rule on the merits of the matter
by public health or other public inter- under § 10.30(e). The Commissioner may
ests. reaffirm, modify, or overrule the prior
(e) A petition for reconsideration decision, in whole or in part, and may
may not be based on information and grant such other relief or take such
views not contained in the administra- other action as is warranted.
tive record on which the decision was (j) The Commissioner’s reconsider-
made. An interested person who wishes ation of a matter relating to a petition
to rely on information or views not in- submitted under § 10.25(a)(2) is subject
cluded in the administrative record to § 10.30 (f) through (h), (j), and (k).
shall submit them with a new petition (k) The record of the administrative
to modify the decision under § 10.25(a). proceeding consists of the following:
(f) The decision on a petition for re- (1) The record of the original petition
consideration is to be in writing and specified in § 10.30(i).
placed on public display as part of the (2) The petition for reconsideration,
docket file on the matter in the office including all information on which it
of the Division of Dockets Manage- relies, filed by the Division of Dockets
ment. A determination to grant recon- Management.
sideration will be published in the FED- (3) All comments received on the pe-
ERAL REGISTER if the Commissioner’s tition, including all information sub-
original decision was so published. Any mitted as a part of the comments.
other determination to grant or deny (4) The Commissioner’s decision on
reconsideration may also be published the petition under paragraph (f) of this
in the FEDERAL REGISTER. section, including all information iden-
(g) The Commissioner may consider a tified or filed by the Commissioner
petition for reconsideration only before with the Division of Dockets Manage-
the petitioner brings legal action in ment as part of the record supporting
the courts to review the action, except the decision.
that a petition may also be considered (5) Any FEDERAL REGISTER notices or
if the Commissioner has denied a peti- other documents resulting from the pe-
tion for stay of action and the peti- tition.
tioner has petitioned for judicial re- (6) All documents filed with the Divi-
view of the Commissioner’s action and sion of Dockets Management under
requested the reviewing court to grant § 10.65(h).
a stay pending consideration of review. (7) If the Commissioner reconsiders
A petition for reconsideration sub- the matter, the administrative record
mitted later than 30 days after the date relating to reconsideration specified in
of the decision involved will be denied § 10.30(i).
as untimely unless the Commissioner [44 FR 22323, Apr. 13, 1979, as amended at 46
permits the petition to be filed after 30 FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28,
days. A petition for reconsideration 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848,
will be considered as submitted on the Mar. 1, 2001]
day it is received by the Division of
Dockets Management. § 10.35 Administrative stay of action.
(h) The Commissioner may initiate (a) The Commissioner may at any
the reconsideration of all or part of a time stay or extend the effective date
matter at any time after it has been of an action pending or following a de-
decided or action has been taken. If re- cision on any matter.
view of the matter is pending in the (b) An interested person may request
courts, the Commissioner may request the Commissioner to stay the effective
that the court refer the matter back to date of any administrative action. A
the agency or hold its review in abey- stay may be requested for a specific
ance pending administrative reconsid- time period or for an indefinite time

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§ 10.35 21 CFR Ch. I (4–1–11 Edition)

period. A request for stay must be sub- any kind, unless one of the following
mitted in accordance with § 10.20 and in applies:
the following form no later than 30 (1) The Commissioner determines
days after the date of the decision in- that a stay or delay is in the public in-
volved. The Commissioner may, for terest and stays the action.
good cause, permit a petition to be (2) A statute requires that the matter
filed after 30 days. In the case of a deci- be stayed.
sion published in the FEDERAL REG- (3) A court orders that the matter be
ISTER, the day of publication is the
stayed.
date of decision.
(e) The Commissioner shall promptly
(Date) llllllllllllllllllll review a petition for stay of action.
Division of Dockets Management, Food The Commissioner may grant or deny a
and Drug Administration, Department of petition, in whole or in part; and may
Health and Human Services, 5630 Fishers grant such other relief or take such
Lane, rm. 1061, Rockville, MD 20852. other action as is warranted by the pe-
tition. The Commissioner may grant a
PETITION FOR STAY OF ACTION
stay in any proceeding if it is in the
The undersigned submits this petition re- public interest and in the interest of
questing that the Commissioner of Food and justice. The Commissioner shall grant
Drugs stay the effective date of the following
a stay in any proceeding if all of the
matter.
following apply:
A. Decision involved (1) The petitioner will otherwise suf-
(The specific administrative action being fer irreparable injury.
taken by the Commissioner for which a stay (2) The petitioner’s case is not frivo-
is requested, including the docket number or lous and is being pursued in good faith.
other citation to the action involved.) (3) The petitioner has demonstrated
B. Action requested sound public policy grounds supporting
the stay.
(The length of time for which the stay is (4) The delay resulting from the stay
requested, which may be for a specific or in-
definite time period.)
is not outweighted by public health or
other public interests.
C. Statement of grounds (f) The Commissioner’s decision on a
(A full statement, in a well-organized for- petition for stay of action is to be in
mat, of the factual and legal grounds upon writing and placed on public display as
which the petitioner relies for the stay.) part of the file on the matter in the of-
(Signature) lllllllllllllllll fice of the Division of Dockets Manage-
(Name of petitioner) llllllllllll ment. A determination to grant a stay
(Mailing address) llllllllllllll will be published in the FEDERAL REG-
(Telephone number) lllllllllllll ISTER if the Commissioner’s original
decision was so published. Any other
(c) A petition for stay of action relat-
determination to grant or to deny a
ing to a petition submitted under
stay may also be published in the FED-
§ 10.25(a)(2) is subject to the require-
ERAL REGISTER.
ments of § 10.30 (c) and (d), except that
it will be filed in the same docket file (g) A petition for a stay of action
as the petition to which it relates. submitted later than 30 days after the
(d) Neither the filing of a petition for date of the decision involved will be de-
a stay of action nor action taken by an nied as untimely unless the Commis-
interested person in accordance with sioner permits the petition to be filed
any other administrative procedure in after 30 days. A petition for a stay of
this part or in any other section of this action is considered submitted on the
chapter, e.g., the filing of a citizen pe- day it is received by the Division of
tition under § 10.30 or a petition for re- Dockets Management.
consideration under § 10.33 or a request (h) The record of the administrative
for an advisory opinion under § 10.85, proceeding consists of the following:
will stay or otherwise delay any ad- (1) The record of the proceeding to
ministrative action by the Commis- which the petition for stay of action is
sioner, including enforcement action of directed.

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Food and Drug Administration, HHS § 10.40

(2) The petition for stay of action, in- gether with the Commissioner’s pre-
cluding all information on which it re- liminary views on the proposal and any
lies, filed by the Division of Dockets alternative proposal.
Management. (b) Except as provided in paragraph
(3) All comments received on the pe- (e) of this section, each regulation
tition, including all information sub- must be the subject of a notice of pro-
mitted as a part of the comments. posed rulemaking published in the
(4) The Commissioner’s decision on FEDERAL REGISTER. (1) The notice will
the petition under paragraph (e) of this contain:
section, including all information iden- (i) The name of the agency;
tified or filed by the Commissioner (ii) The nature of the action, e.g.,
with the Division of Dockets Manage- proposed rule, or notice;
ment as part of the record supporting (iii) A summary in the first para-
the decision. graph describing the substance of the
(5) Any FEDERAL REGISTER notices or document in easily understandable
other documents resulting from the pe- terms;
tition. (iv) Relevant dates, e.g., comment
(6) All documents filed with the Divi- closing date, and proposed effective
sion of Dockets Management under date(s);
§ 10.65(h).
(v) The name, business address, and
[44 FR 22323, Apr. 13, 1979, as amended at 46 phone number of an agency contact
FR 8455, Jan. 27, 1981; 54 FR 9034, Mar. 3, 1989; person who can provide further infor-
59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22, mation to the public about the notice;
2001; 66 FR 12848, Mar. 1, 2001]
(vi) An address for submitting writ-
§ 10.40 Promulgation of regulations for ten comments;
the efficient enforcement of the (vii) Supplementary information
law. about the notice in the form of a pre-
(a) The Commissioner may propose amble that summarizes the proposal
and promulgate regulations for the ef- and the facts and policy underlying it,
ficient enforcement of the laws admin- includes references to all information
istered by FDA whenever it is nec- on which the Commissioner relies for
essary or appropriate to do so. The the proposal (copies or a full list of
issuance, amendment, or revocation of which are a part of the docket file on
a regulation may be initiated in any of the matter in the office of the Division
the ways specified in § 10.25. of Dockets Management), and cites the
(1) This section applies to any regula- authority under which the regulation
tion: (i) Not subject to § 10.50 and part is proposed;
12, or (ii) if it is subject to § 10.50 and (viii) Either the terms or substance
part 12, to the extent that those provi- of the proposed regulation or a descrip-
sions make this section applicable. tion of the subjects and issues in-
(2) A regulation proposed by an inter- volved;
ested person in a petition submitted (ix) A reference to the existence or
under § 10.25(a) will be published in the lack of need for an environmental im-
FEDERAL REGISTER as a proposal if: pact statement under § 25.52 of this
(i) The petition contains facts dem- chapter; and
onstrating reasonable grounds for the (x) The docket number of the matter,
proposal; and which identifies the docket file estab-
(ii) The petition substantially shows lished by the Division of Dockets Man-
that the proposal is in the public inter- agement for all relevant submissions.
est and will promote the objectives of (2) The proposal will provide 60 days
the act and the agency. for comment, although the Commis-
(3) Two or more alternative proposed sioner may shorten or lengthen this
regulations may be published on the time period for good cause. In no event
same subject to obtain comment on the is the time for comment to be less than
different alternatives. 10 days.
(4) A regulation proposed by an inter- (3) After publication of the proposed
ested person in a petition submitted rule, any interested person may re-
under § 10.25(a) may be published to- quest the Commissioner to extend the

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§ 10.40 21 CFR Ch. I (4–1–11 Edition)

comment period for an additional spec- is material where the degree of public
ified period by submitting a written re- interest is a legitimate factor for con-
quest to the Division of Dockets Man- sideration.
agement stating the grounds for the re- (2) The decision of the Commissioner
quest. The request is submitted under on the matter will be based solely upon
§ 10.35 but should be headed ‘‘REQUEST the administrative record.
FOR EXTENSION OF COMMENT PE- (3) A final regulation published in the
RIOD.’’ FEDERAL REGISTER will have a pre-
(i) A request must discuss the reason amble stating: (i) The name of the
comments could not feasibly be sub- agency, (ii) the nature of the action
mitted within the time permitted, or e.g., final rule, notice, (iii) a summary
that important new information will first paragraph describing the sub-
shortly be available, or that sound pub- stance of the document in easily under-
lic policy otherwise supports an exten- standable terms, (iv) relevant dates,
sion of the time for comment. The e.g., the rule’s effective date and com-
Commissioner may grant or deny the ment closing date, if an opportunity
request or may grant an extension for for comment is provided, (v) the name,
a time period different from that re- business address, and phone number of
quested. An extension may be limited an agency contact person who can pro-
to specific persons who have made and vide further information to the public
justified the request, but will ordi- about the notice, (vi) an address for the
narily apply to all interested persons. submission of written comments when
(ii) A comment time extension of 30 they are permitted, (vii) supple-
days or longer will be published in the mentary information about the regula-
FEDERAL REGISTER and will be applica- tion in the body of the preamble that
ble to all interested persons. A com- contains references to prior notices re-
ment time extension of less than 30 lating to the same matter and a sum-
days will be the subject either of a let-
mary of each type of comment sub-
ter or memorandum filed with the Di-
mitted on the proposal and the Com-
vision of Dockets Management or of a
missioner’s conclusions with respect to
notice published in the FEDERAL REG-
each. The preamble is to contain a
ISTER.
thorough and comprehensible expla-
(4) A notice of proposed rulemaking
nation of the reasons for the Commis-
will request that four copies of all com-
sioner’s decision on each issue.
ments be submitted to the Division of
Dockets Management, except that indi- (4) The effective date of a final regu-
viduals may submit single copies. Com- lation may not be less than 30 days
ments will be stamped with the date of after the date of publication in the
receipt and will be numbered chrono- FEDERAL REGISTER, except for:
logically. (i) A regulation that grants an ex-
(5) Persons submitting comments emption or relieves a restriction; or
critical of a proposed regulation are (ii) A regulation for which the Com-
encouraged to include their preferred missioner finds, and states in the no-
alternative wording. tice good cause for an earlier effective
(c) After the time for comment on a date.
proposed regulation has expired, the (d) The provisions for notice and
Commissioner will review the entire comment in paragraphs (b) and (c) of
administrative record on the matter, this section apply only to the extent
including all comments and, in a no- required by the Administrative Proce-
tice published in the FEDERAL REG- dure Act (5 U.S.C. 551, 552, and 553). As
ISTER, will terminate the proceeding, a matter of discretion, however, the
issue a new proposal, or promulgate a Commissioner may voluntarily follow
final regulation. those provisions in circumstances in
(1) The quality and persuasiveness of which they are not required by the Ad-
the comments will be the basis for the ministrative Procedure Act.
Commissioner’s decision. The number (e) The requirements of notice and
or length of comments will not ordi- public procedure in paragraph (b) of
narily be a significant factor in the de- this section do not apply in the fol-
cision unless the number of comments lowing situations:

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Food and Drug Administration, HHS § 10.40

(1) When the Commissioner deter- that the document is available and
mines for good cause that they are im- specifying the time within which com-
practicable, unnecessary, or contrary ments may be submitted orally or in
to the public interest. In these cases, writing on the tentative final regula-
the notice promulgating the regulation tion. The Commissioner shall mail a
will state the reasons for the deter- copy of the tentative final regulation
mination, and provide an opportunity and the FEDERAL REGISTER notice to
for comment to determine whether the each person who submitted comments
regulation should subsequently be on the proposed regulation if one has
modified or revoked. A subsequent no- been published.
tice based on those comments may, but (7) A final regulation published in the
need not, provide additional oppor- FEDERAL REGISTER that provides an op-
tunity for public comment. portunity for the submission of further
(2) Food additive and color additive comments, in accordance with para-
petitions, which are subject to the pro- graph (e)(1) of this section.
visions of § 12.20(b)(2). (8) Any other public procedure estab-
(3) New animal drug regulations, lished in this chapter and expressly ap-
which are promulgated under section plicable to the matter.
512(i) of the act. (g) The record of the administrative
(f) In addition to the notice and pub- proceeding consists of all of the fol-
lic procedure required under paragraph lowing:
(b) of this section, the Commissioner (1) If the regulation was initiated by
may also subject a proposed or final a petition, the administrative record
regulation, before or after publication specified in § 10.30(i).
in the FEDERAL REGISTER, to the fol-
(2) If a petition for reconsideration or
lowing additional procedures:
for a stay of action is filed, the admin-
(1) Conferences, meetings, discus-
istrative record specified in §§ 10.33(k)
sions, and correspondence under § 10.65.
and 10.35(h).
(2) A hearing under parts 12, 13, 14, or
(3) The proposed rule published in the
15.
FEDERAL REGISTER, including all infor-
(3) A notice published in the FEDERAL
mation identified or filed by the Com-
REGISTER requesting information and
missioner with the Division of Dockets
views before the Commissioner deter-
Management on the proposal.
mines whether to propose a regulation.
(4) A draft of a proposed regulation (4) All comments received on the pro-
placed on public display in the office of posal, including all information sub-
the Division of Dockets Management. mitted as a part of the comments.
If this procedure is used, the Commis- (5) The notice promulgating the final
sioner shall publish an appropriate no- regulation, including all information
tice in the FEDERAL REGISTER stating identified or filed by the Commissioner
that the document is available and with the Division of Dockets Manage-
specifying the time within which com- ment as part of the administrative
ments on the draft proposal may be record of the final regulation.
submitted orally or in writing. (6) The transcripts, minutes of meet-
(5) A revised proposal published in ings, reports, FEDERAL REGISTER no-
the FEDERAL REGISTER, which proposal tices, and other documents resulting
is subject to all the provisions in this from the procedures specified in para-
section relating to proposed regula- graph (f) of this section, but not the
tions. transcript of a closed portion of a pub-
(6) A tentative final regulation or lic advisory committee meeting.
tentative revised final regulation (7) All documents submitted to the
placed on public display in the office of Division of Dockets Management under
the Division of Dockets Management § 10.65(h).
and, if deemed desirable by the Com- (h) The record of the administrative
missioner, published in the FEDERAL proceeding closes on the date of publi-
REGISTER. If the tentative regulation is cation of the final regulation in the
placed on display only, the Commis- FEDERAL REGISTER unless some other
sioner shall publish an appropriate no- date is specified. Thereafter, any inter-
tice in the FEDERAL REGISTER stating ested person may submit a petition for

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§ 10.45 21 CFR Ch. I (4–1–11 Edition)

reconsideration under § 10.33 or a peti- by 5 U.S.C. 701 et seq., and the lack of
tion for stay of action under § 10.35. A an actual controversy as required by 28
person who wishes to rely upon infor- U.S.C. 2201.
mation or views not included in the ad- (c) A request that administrative ac-
ministrative record shall submit it to tion be stayed must first be the subject
the Commissioner with a new petition of an administrative decision based
to modify the final regulation. upon a petition for stay of action sub-
(i) The Division of Dockets Manage- mitted under § 10.35 before a request is
ment shall maintain a chronological made that a court stay the action. If a
list of all regulations proposed and pro- court action is filed requesting a stay
mulgated under this section and § 10.50 of administrative action before the
(which list will not include regulations Commissioner’s decision on a petition
resulting from petitions filed and as- submitted in a timely manner pursuant
signed a docket number under § 10.30) to § 10.35, the Commissioner shall re-
showing— quest dismissal of the court action or
(1) The docket number (for a petition referral to the agency for an initial de-
submitted directly to a center, the list termination on the grounds of a failure
also includes the number or other des- to exhaust administrative remedies,
ignation assigned by the center, e.g., the lack of final agency action as re-
the number assigned to a food additive quired by 5 U.S.C. 701 et seq., and the
petition); lack of an actual controversy as re-
(2) The name of the petitioner, if any; quired by 28 U.S.C. 2201. If a court ac-
(3) The subject matter involved; and tion is filed requesting a stay of admin-
(4) The disposition of the petition. istrative action after a petition for a
stay of action is denied because it was
[44 FR 22323, Apr. 13, 1979, as amended at 52
FR 36401, Sept. 29, 1987; 54 FR 9034, Mar. 3,
submitted after expiration of the time
1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, period provided under § 10.35, or after
July 29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR the time for submitting such a petition
12848, Mar. 1, 2001] has expired, the Commissioner will re-
quest dismissal of the court action on
§ 10.45 Court review of final adminis- the ground of a failure to exhaust ad-
trative action; exhaustion of admin- ministrative remedies.
istrative remedies. (d) Unless otherwise provided, the
(a) This section applies to court re- Commissioner’s final decision con-
view of final administrative action stitutes final agency action (review-
taken by the Commissioner, including able in the courts under 5 U.S.C. 701 et
action taken under §§ 10.25 through seq. and, where appropriate, 28 U.S.C.
10.40 and § 16.1(b), except action subject 2201) on a petition submitted under
to § 10.50 and part 12. § 10.25(a), on a petition for reconsider-
(b) A request that the Commissioner ation submitted under § 10.33, on a peti-
take or refrain from taking any form of tion for stay of action submitted under
administrative action must first be the § 10.35, on an advisory opinion issued
subject of a final administrative deci- under § 10.85, on a matter involving ad-
sion based on a petition submitted ministrative action which is the sub-
under § 10.25(a) or, where applicable, a ject of an opportunity for a hearing
hearing under § 16.1(b) before any legal under § 16.1(b) of this chapter, or on the
action is filed in a court complaining issuance of a final regulation published
of the action or failure to act. If a in accordance with § 10.40, except that
court action is filed complaining of the the agency’s response to a petition
action or failure to act before the sub- filed under section 505(j)(2)(C) of the
mission of the decision on a petition act (21 U.S.C. 355(j)(2)(C)) and § 314.93 of
under § 10.25(a) or, where applicable, a this chapter will not constitute final
hearing under § 16.1(b), the Commis- agency action until any petition for re-
sioner shall request dismissal of the consideration submitted by the peti-
court action or referral to the agency tioner is acted on by the Commis-
for an initial administrative deter- sioner.
mination on the grounds of a failure to (1) It is the position of FDA except as
exhaust administrative remedies, the otherwise provided in paragraph (d)(2)
lack of final agency action as required of this section, that:

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Food and Drug Administration, HHS § 10.45

(i) Final agency action exhausts all Commissioner with a new petition to
administrative remedies and is ripe for modify the action under § 10.25(a).
preenforcement judicial review as of (g) The Commissioner requests that
the date of the final decision, unless all petitions for judicial review of a
applicable law explicitly requires that particular matter be filed in a single
the petitioner take further action be- U.S. District court. If petitions are
fore judicial review is available; filed in more than one jurisdiction, the
(ii) An interested person is affected Commissioner will take appropriate ac-
by, and thus has standing to obtain ju- tion to prevent a multiplicity of suits
dicial review of final agency action; in various jurisdictions, such as:
and (1) A request for transfer of one or
(iii) It is not appropriate to move to more suits to consolidate separate ac-
dismiss a suit for preenforcement judi- tions, under 28 U.S.C. 1404(a) or 28
cial review of final agency action on U.S.C. 2112(a);
the ground that indispenable parties (2) A request that actions in all but
are not joined or that it is an one jurisdiction be stayed pending the
unconsented suit against the United conclusion of one proceeding;
States if the defect could be cured by
(3) A request that all but one action
amending the complaint.
be dismissed pending the conclusion of
(2) The Commissioner shall object to
one proceeding, with the suggestion
judicial review of a matter if:
that the other plaintiffs intervene in
(i) The matter is committed by law
that one suit; or
to the discretion of the Commissioner,
e.g., a decision to recommend or not to (4) A request that one of the suits be
recommend civil or criminal enforce- maintained as a class action in behalf
ment action under sections 302, 303, and of all affected persons.
304 of the act; or (h)(1) For the purpose of 28 U.S.C.
(ii) Review is not sought in a proper 2112(a), a copy of any petition filed in
court. any U.S. Court of Appeals challenging
(e) An interested person may request a final action of the Commissioner
judicial review of a final decision of the shall be sent by certified mail, return
Commissioner in the courts without receipt requested, or by personal deliv-
first petitioning the Commissioner for ery to the Chief Counsel of FDA. The
reconsideration or for a stay of action, petition copy shall be time-stamped by
except that in accordance with para- the clerk of the court when the origi-
graph (c) of this section, the person nal is filed with the court. The petition
shall request a stay by the Commis- copy should be addressed to: Office of
sioner under § 10.35 before requesting a the Chief Counsel (GCF–1), Food and
stay by the court. Drug Administration, 5600 Fishers
(f) The Commissioner shall take the Lane, Rockville, MD 20857. The Chief
position in an action for judicial re- Counsel requests that the purpose of
view under 5 U.S.C. 701 et seq., whether all petitions mailed or delivered to the
or not it includes a request for a de- Office of Chief Counsel to satisfy 28
claratory judgment under 28 U.S.C. U.S.C. 2112(a) be clearly identified in a
2201, or in any other case in which the cover letter.
validity of administrative action is (2) If the Chief Counsel receives two
properly challenged, that the validity or more petitions filed in two or more
of the action must be determined sole- U.S. Courts of Appeals for review of
ly on the basis of the administrative any agency action within 10 days of the
record specified in §§ 10.30(i), 10.33(k), effective date of that action for the
10.35(h), 10.40(g), and 16.80(a) or the ad- purpose of judicial review, the Chief
ministrative record applicable to any Counsel will notify the U.S. Judicial
decision or action under the regula- Panel on Multidistrict Litigation of
tions referenced in § 16.1(b), and that any petitions that were received within
additional information or views may the 10-day period, in accordance with
not be considered. An interested person the applicable rule of the panel.
who wishes to rely upon information or (3) For the purpose of determining
views not included in the administra- whether a petition for review has been
tive record shall submit them to the received within the 10-day period under

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§ 10.50 21 CFR Ch. I (4–1–11 Edition)

paragraph (h)(2) of this section, the pe- § 10.50 Promulgation of regulations


tition shall be considered to be re- and orders after an opportunity for
ceived on the date of delivery, if per- a formal evidentiary public hear-
sonally delivered. If the delivery is ac- ing.
complished by mail, the date of receipt (a) The Commissioner shall promul-
shall be the date noted on the return gate regulations and orders after an op-
receipt card. portunity for a formal evidentiary pub-
(i) Upon judicial review of adminis- lic hearing under part 12 whenever all
trative action under this section: of the following apply:
(1) If a court determines that the ad- (1) The subject matter of the regula-
ministrative record is inadequate to tion or order is subject by statute to an
support the action, the Commissioner opportunity for a formal evidentiary
shall determine whether to proceed public hearing.
with such action. (i) If the Commis- (2) The person requesting the hearing
sioner decides to proceed with the ac- has a right to an opportunity for a
tion, the court will be requested to re- hearing and submits adequate justifica-
mand the matter to the agency to re- tion for the hearing as required by
open the administrative proceeding §§ 12.20 through 12.22 and other applica-
and record, or on the Commissioner’s ble provisions in this chapter, e.g.,
own initiative the administrative pro- §§ 314.200, 514.200, and 601.7(a).
ceeding and record may be reopened (b) The Commissioner may order a
upon receipt of the court determina- formal evidentiary public hearing on
tion. A reopened administrative pro- any matter whenever it would be in the
ceeding will be conducted under the public interest to do so.
provisions of this part and in accord- (c) The provisions of the act, and
ance with any directions of the court. other laws, that afford a person who
would be adversely affected by admin-
(ii) If the Commissioner concludes
istrative action an opportunity for a
that the public interest requires that
formal evidentiary public hearing as
the action remain in effect pending fur-
listed below. The list imparts no right
ther administrative proceedings, the
to a hearing where the statutory sec-
court will be requested not to stay the
tion provides no opportunity for a
matter in the interim and the Commis-
hearing.
sioner shall expedite the further ad-
(1) Section 401 on any action for the
ministrative proceedings.
amendment or repeal of any definition
(2) If a court determines that the ad- and standard of identity for any dairy
ministrative record is adequate, but product (including products regulated
the rationale for the action must be under parts 131, 133, and 135 of this
further explained: chapter) or maple sirup (regulated
(i) The Commissioner shall request under § 168.140 of this chapter).
either that further explanation be pro- (2) Section 403(j) on regulations for
vided in writing directly to the court labeling of foods for special dietary
without further administrative pro- uses.
ceedings, or that the administrative (3) Section 404(a) on regulations for
proceeding be reopened in accordance emergency permit control.
with paragraph (i)(1)(i) of this section; (4) Section 406 on tolerances for poi-
and sonous substances in food.
(ii) If the Commissioner concludes (5) Section 409 (c), (d), and (h) on food
that the public interest requires that additive regulations.
the action remain in effect pending fur- (6) Section 501(b) on tests or methods
ther court or administrative pro- of assay for drugs described in official
ceedings, the court will be requested compendia.
not to stay the matter in the interim (7) [Reserved]
and the Commissioner shall expedite (8) Section 502(h) on regulations des-
the further proceedings. ignating requirements for drugs liable
[44 FR 22323, Apr. 13, 1979, as amended at 54 to deterioration.
FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3, 1989; (9) Section 502(n) on prescription
57 FR 17980, Apr. 28, 1992; 65 FR 56477, Sept. drug advertising regulations.
19, 2000; 69 FR 31705, June 4, 2004] (10)–(11) [Reserved]

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Food and Drug Administration, HHS § 10.55

(12) Section 512(n)(5) on regulations (i) The center responsible for the
for animal antibiotic drugs and certifi- matter is, as a party to the hearing, re-
cation requirements. sponsible for all investigative func-
(13) Section 721 (b) and (c) on regula- tions and for presentation of the posi-
tions for color additive listing and cer- tion of the center at the hearing and in
tification. any pleading or oral argument before
(14) Section 4(a) of the Fair Pack- the Commissioner. Representatives of
aging and Labeling Act on food, drug, the center may not participate or ad-
device, and cosmetic labeling. vise in any decision except as witness
(15) Section 5(c) of the Fair Pack- or counsel in public proceedings. There
aging and Labeling Act on additional is to be no other communication be-
economic regulations for food, drugs, tween representatives of the center and
devices, and cosmetics. representatives of the office of the
(16) Section 505 (d) and (e) on new Commissioner concerning the matter
drug applications. before the decision of the Commis-
(17) Section 512 (d), (e) and (m) (3) and sioner. The Commissioner may, how-
(4) on new animal drug applications. ever, designate representatives of a
(18) Section 515(g) on device pre- center to advise the office of the Com-
market approval applications and prod- missioner, or designate members of
uct development protocols. that office to advise a center. The des-
(19) Section 351(a) of the Public ignation will be in writing and filed
Health Service Act on a biologics li-
with the Division of Dockets Manage-
cense for a biological product.
ment no later than the time specified
(20) Section 306 on debarment, debar-
in paragraph (b)(2) of this section for
ment period and considerations, termi-
the application of separation of func-
nation of debarment under section
tions. All members of FDA other than
306(d)(3), suspension, and termination
of suspension. representatives of the involved center
(except those specifically designated
[44 FR 22323, Apr. 13, 1979, as amended at 54 otherwise) shall be available to advise
FR 9034, Mar. 3, 1989; 58 FR 49190, Sept. 22, and participate with the office of the
1993; 60 FR 38626, July 27, 1995; 63 FR 26697,
Commissioner in its functions relating
May 13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR
56448, Oct. 20, 1999; 67 FR 4906, Feb. 1, 2002] to the hearing and the final decision.
(ii) The Chief Counsel for FDA shall
§ 10.55 Separation of functions; ex designate members of the office of Gen-
parte communications. eral Counsel to advise and participate
(a) This section applies to any matter with the center in its functions in the
subject by statute to an opportunity hearing and members who are to advise
for a formal evidentiary public hear- the office of the Commissioner in its
ing, as listed in § 10.50(c), and any mat- functions related to the hearing and
ter subject to a hearing before a Public the final decision. The members of the
Board of Inquiry under part 13. office of General Counsel designated to
(b) In the case of a matter listed in advise the center may not participate
§ 10.50(c) (1) through (10) and (12) or advise in any decision of the Com-
through (15): missioner except as counsel in public
(1) An interested person may meet or proceedings. The designation is to be in
correspond with any FDA representa- the form of a memorandum filed with
tive concerning a matter prior to publi- the Division of Dockets Management
cation of a notice announcing a formal and made a part of the administrative
evidentiary public hearing or a hearing record in the proceeding. There may be
before a Public Board of Inquiry on the no other communication between those
matter; the provisions of § 10.65 apply members of the office of General Coun-
to the meetings and correspondence; sel designated to advise the office of
and the Commissioner and any other per-
(2) Upon publication of a notice an- sons in the office of General Counsel or
nouncing a formal evidentiary public in the involved center with respect to
hearing or a hearing before a Public the matter prior to the decision of the
Board of Inquiry, the following separa- Commissioner. The Chief Counsel may
tion of functions apply: assign new attorneys to advise either

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§ 10.60 21 CFR Ch. I (4–1–11 Edition)

the center or the office of the Commis- (3) A written communication con-
sioner at any stage of the proceedings. trary to this section must be imme-
The Chief Counsel will ordinarily ad- diately served on all other participants
vise and participate with the office of and filed with the Division of Dockets
the Commissioner in its functions re- Management by the presiding officer at
lating to the hearing and the final deci- the hearing, or by the Commissioner,
sion. depending on who received the commu-
(iii) The office of the Commissioner nication. An oral communication con-
is responsible for the agency review trary to this section must be imme-
and final decision of the matter, with diately recorded in a written memo-
the advice and participation of anyone randum and similarly served on all
in FDA other than representatives of other participants and filed with the
the involved center and those members Division of Dockets Management. A
of the office of General Counsel des- person, including a representative of a
ignated to assist in the center’s func- participant in the hearing, who is in-
tions in the hearing. volved in an oral communication con-
(c) In a matter listed in § 10.50(c) (11) trary to this section, must, if possible,
and (16) through (19), the provisions re- be made available for cross-examina-
lating to separation of functions set tion during the hearing with respect to
forth in §§ 314.200(f), 514.200, and 601.7(a) the substance of that conversation. Re-
are applicable before publication of a buttal testimony pertinent to a writ-
notice announcing a formal evidentiary ten or oral communication contrary to
public hearing or a hearing before a this section will be permitted. Cross-
Public Board of Inquiry. Following examination and rebuttal testimony
publication of the notice of hearing, will be transcribed and filed with the
the rules in paragraph (b)(2) of this sec- Division of Dockets Management.
tion apply. (e) The prohibitions specified in para-
(d) Except as provided in paragraph graph (d) of this section apply to a per-
(e) of this section, between the date son who knows of a notice of hearing in
that separation of functions applies advance of its publication from the
under paragraph (b) or (c) of this sec- time the knowledge is acquired.
tion and the date of the Commis- (f) The making of a communication
sioner’s decision on the matter, com- contrary to this section may, con-
munication concerning the matter in- sistent with the interests of justice and
volved in the hearing will be restricted the policy of the underlying statute,
as follows: result in a decision adverse to the per-
(1) No person outside the agency may son knowingly making or causing the
have an ex parte communication with making of such a communication.
the presiding officer or any person rep- [44 FR 22323, Apr. 13, 1979, as amended at 50
resenting the office of the Commis- FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989;
sioner concerning the matter in the 64 FR 398, Jan. 5, 1999]
hearing. Neither the presiding officer
nor any person representing the office § 10.60 Referral by court.
of the Commissioner may have any ex (a) This section applies when a Fed-
parte communication with a person eral, State, or local court holds in
outside the agency concerning the mat- abeyance, or refers to the Commis-
ter in the hearing. All communications sioner, any matter for an initial ad-
are to be public communications, as ministrative determination under
witness or counsel, under the applica- § 10.25(c) or § 10.45(b).
ble provisions of this part. (b) The Commissioner shall promptly
(2) A participant in the hearing may agree or decline to accept a court refer-
submit a written communication to ral. Whenever feasible in light of agen-
the office of the Commissioner with re- cy priorities and resources, the Com-
spect to a proposal for settlement. missioner shall agree to accept a refer-
These communications are to be in the ral and shall proceed to determine the
form of pleadings, served on all other matter referred.
participants, and filed with the Divi- (c) In reviewing the matter, the Com-
sion of Dockets Management like any missioner may use the following proce-
other pleading. dures:

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Food and Drug Administration, HHS § 10.65

(1) Conferences, meetings, discus- is not an employee of the executive


sions, and correspondence under § 10.65. branch of the Federal Government
(2) A hearing under parts 12, 13, 14, 15, without the agreement of the person
or 16. requesting the meeting. Any person
(3) A notice published in the FEDERAL may attend by mutual consent of the
REGISTER requesting information and person requesting the meeting and
views. FDA.
(4) Any other public procedure estab- (2) FDA will determine which rep-
lished in other sections of this chapter resentatives of the agency will attend
and expressly applicable to the matter the meeting. The person requesting the
under those provisions. meeting may request, but not require
(d) If the Commissioner’s review of or preclude, the attendance of a spe-
the matter results in a proposed rule, cific FDA employee.
the provisions of § 10.40 or § 10.50 also (3) A person who wishes to attend a
apply. private meeting, but who is not invited
§ 10.65 Meetings and correspondence. to attend either by the person request-
ing the meeting or by FDA, or who oth-
(a) In addition to public hearings and erwise cannot attend the meeting, may
proceedings established under this part request a separate meeting with FDA
and other sections of this chapter, to discuss the same matter or an addi-
meetings may be held and correspond- tional matter.
ence may be exchanged between rep- (d) FDA employees have a responsi-
resentatives of FDA and an interested bility to meet with all segments of the
person outside FDA on a matter within public to promote the objectives of the
the jurisdiction of the laws adminis-
laws administered by the agency. In
tered by the Commissioner. Action on
pursuing this responsibility, the fol-
meetings and correspondence does not
lowing general policy applies where
constitute final administrative action
agency employees are invited by per-
subject to judicial review under § 10.45.
sons outside the Federal Government
(b) The Commissioner may conclude
to attend or participate in meetings
that it would be in the public interest
outside agency offices as representa-
to hold an open public meeting to dis-
tives of the agency.
cuss a matter (or class of matters)
pending before FDA, in which any in- (1) A person outside the executive
terested person may participate. branch may invite an agency rep-
(1) The Commissioner shall inform resentative to attend or participate in
the public of the time and place of the a meeting outside agency offices. The
meeting and of the matters to be dis- agency representative is not obligated
cussed. to attend or participate, but may do so
(2) The meeting will be informal, i.e., where it is in the public interest and
any interested person may attend and will promote the objectives of the act.
participate in the discussion without (2) The agency representative may
prior notice to the agency unless the request that the meeting be open if
notice of the meeting specifies other- that would be in the public interest.
wise. The agency representative may decline
(c) Every person outside the Federal to participate in a meeting held as a
Government may request a private private meeting if that will best serve
meeting with a representative of FDA the public interest.
in agency offices to discuss a matter. (3) An agency representative may not
FDA will make reasonable efforts to knowingly participate in a meeting
accommodate such requests. that is closed on the basis of gender,
(1) The person requesting a meeting race, or religion.
may be accompanied by a reasonable (e) An official transcript, recording,
number of employees, consultants, or or memorandum summarizing the sub-
other persons with whom there is a stance of any meeting described in this
commercial arrangement within the section will be prepared by a represent-
meaning of § 20.81(a) of this chapter. ative of FDA when the agency deter-
Neither FDA nor any other person may mines that such documentation will be
require the attendance of a person who useful.

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§ 10.70 21 CFR Ch. I (4–1–11 Edition)

(f) FDA promptly will file in the ap- (1) Relate to the factual, scientific,
propriate administrative file memo- legal or related issues under consider-
randa of meetings prepared by FDA ation;
representatives and all correspondence, (2) Be dated and signed by the au-
including any written summary of a thor;
meeting from a participant, that relate (3) Be directed to the file, to appro-
to a matter pending before the agency. priate supervisory personnel, and to
(g) Representatives of FDA may ini- other appropriate employees, and show
tiate a meeting or correspondence on all persons to whom copies were sent;
any matter concerning the laws admin- (4) Avoid defamatory language, in-
istered by the Commissioner. Unless temperate remarks, undocumented
otherwise required by law, meetings charges, or irrelevant matters (e.g.,
may be public or private at FDA’s dis- personnel complaints);
cretion. (5) If it records the views, analyses,
(h) A meeting of an advisory com- recommendations, or decisions of an
mittee is subject to the requirements agency employee in addition to the au-
of part 14 of this chapter. thor, be given to the other employees;
and
[66 FR 6468, Jan. 22, 2001] (6) Once completed (i.e., typed in
final form, dated, and signed) not be al-
§ 10.70 Documentation of significant tered or removed. Later additions to or
decisions in administrative file. revisions of the document must be
(a) This section applies to every sig- made in a new document.
nificant FDA decision on any matter (d) Memoranda or other documents
under the laws administered by the that are prepared by agency employees
Commissioner, whether it is raised for- and are not in the administrative file
mally, for example, by a petition or in- have no status or effect.
formally, for example, by correspond- (e) FDA employees working on a
ence. matter have access to the administra-
(b) FDA employees responsible for tive file on that matter, as appropriate
handling a matter are responsible for for the conduct of their work. FDA em-
insuring the completeness of the ad- ployees who have worked on a matter
ministrative file relating to it. The file have access to the administrative file
must contain: on that matter so long as attention to
(1) Appropriate documentation of the their assignments is not impeded. Rea-
basis for the decision, including rel- sonable restrictions may be placed
upon access to assure proper cataloging
evant evaluations, reviews, memo-
and storage of documents, the avail-
randa, letters, opinions of consultants,
ability of the file to others, and the
minutes of meetings, and other perti-
completeness of the file for review.
nent written documents; and
(2) The recommendations and deci- § 10.75 Internal agency review of deci-
sions of individual employees, includ- sions.
ing supervisory personnel, responsible (a) A decision of an FDA employee,
for handling the matter. other than the Commissioner, on a
(i) The recommendations and deci- matter, is subject to review by the em-
sions are to reveal significant con- ployee’s supervisor under the following
troversies or differences of opinion and circumstances:
their resolution. (1) At the request of the employee.
(ii) An agency employee working on a (2) On the initiative of the super-
matter and, consistent with the visor.
prompt completion of other assign- (3) At the request of an interested
ments, an agency employee who has person outside the agency.
worked on a matter may record indi- (4) As required by delegations of au-
vidual views on that matter in a writ- thority.
ten memorandum, which is to be placed (b)(1) The review will be made by
in the file. consultation between the employee and
(c) A written document placed in an the supervisor or by review of the ad-
administrative file must: ministrative file on the matter, or

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Food and Drug Administration, HHS § 10.80

both. The review will ordinarily follow § 10.80 Dissemination of draft Federal
the established agency channels of su- Register notices and regulations.
pervision or review for that matter. (a) A representative of FDA may dis-
(2) A sponsor, applicant, or manufac- cuss orally or in writing with an inter-
turer of a drug or device regulated ested person ideas and recommenda-
under the act or the Public Health tions for notices or regulations. FDA
Service Act (42 U.S.C. 262), may request welcomes assistance in developing
review of a scientific controversy by an ideas for, and in gathering the informa-
appropriate scientific advisory panel as tion to support, notices and regula-
described in section 505(n) of the act, or tions.
an advisory committee as described in (b) Notices and proposed regulations. (1)
section 515(g)(2)(B) of the act. The rea- Once it is determined that a notice or
son(s) for any denial of a request for proposed regulation will be prepared,
such review shall be briefly set forth in the general concepts may be discussed
writing to the requester. Persons who by a representative of FDA with an in-
receive a Center denial of their request terested person. Details of a draft of a
under this section may submit a re- notice or proposed regulation may be
quest for review of the denial. The re- discussed with a person outside the ex-
quest should be sent to the Chief Medi- ecutive branch only with the specific
ator and Ombudsman. permission of the Commissioner. The
(c) An interested person outside the permission must be in writing and filed
agency may request internal agency re- with the Division of Dockets Manage-
view of a decision through the estab- ment.
lished agency channels of supervision (2) A draft of a notice or proposed
or review. Personal review of these regulation or its preamble, or a portion
of either, may be furnished to an inter-
matters by center directors or the of-
ested person outside the executive
fice of the Commissioner will occur for
branch only if it is made available to
any of the following purposes: all interested persons by a notice pub-
(1) To resolve an issue that cannot be lished in the FEDERAL REGISTER. A
resolved at lower levels within the draft of a notice or proposed regulation
agency (e.g., between two parts of a made available in this manner may,
center or other component of the agen- without the prior permission of the
cy, between two centers or other com- Commissioner, be discussed with an in-
ponents of the agency, or between the terested person to clarify and resolve
agency and an interested person out- questions raised and concerns ex-
side the agency). pressed about the draft.
(2) To review policy matters requir- (c) After publication of a notice or
ing the attention of center or agency proposed regulation in the FEDERAL
management. REGISTER, and before preparation of a
(3) In unusual situations requiring an draft of the final notice or regulation,
immediate review in the public inter- a representative of FDA may discuss
est. the proposal with an interested person
(4) As required by delegations of au- as provided in paragraph (b)(2) of this
thority. section.
(d) Internal agency review of a deci- (d) Final notices and regulations. (1)
sion must be based on the information Details of a draft of a final notice or
in the administrative file. If an inter- regulation may be discussed with an
interested person outside the executive
ested person presents new information
branch only with the specific permis-
not in the file, the matter will be re-
sion of the Commissioner. The permis-
turned to the appropriate lower level in sion must be in writing and filed with
the agency for reevaluation based on the Division of Dockets Management.
the new information. (2) A draft of a final notice or regula-
[44 FR 22323, Apr. 13, 1979, as amended at 50 tion or its preamble, or any portion of
FR 8994, Mar. 6, 1985; 63 FR 63982, Nov. 18, either, may be furnished to an inter-
1998] ested person outside the executive
branch only if it is made available to

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§ 10.85 21 CFR Ch. I (4–1–11 Edition)

all interested persons by a notice pub- Division of Dockets Management as


lished in the FEDERAL REGISTER, except part of the administrative record of the
as otherwise provided in paragraphs (g) regulation under the provisions of
and (j) of this section. A draft of a final § 10.65.
notice or regulation made available to (h) In accordance with 42 U.S.C 263f,
an interested person in this manner the Commissioner shall consult with
may, without the prior permission of interested persons and with the Tech-
the Commissioner, be discussed as pro- nical Electronic Product Radiation
vided in paragraph (b)(2) of this sec- Safety Standards Committee
tion. (TEPRSSC) before prescribing any per-
(i) The final notice or regulation and formance standard for an electronic
its preamble will be prepared solely on product. Accordingly, the Commis-
the basis of the administrative record. sioner shall publish in the FEDERAL
(ii) If additional technical informa- REGISTER an announcement when a
tion from a person outside the execu- proposed or final performance stand-
tive branch is necessary to draft the ard, including any amendment, is being
final notice or regulation or its pre- considered for an electronic product,
amble, it will be requested by FDA in and any draft of any proposed or final
general terms and furnished directly to standard will be furnished to an inter-
the Division of Dockets Management ested person upon request and may be
to be included as part of the adminis- discussed in detail.
trative record. (i) The provisions of § 10.65 apply to
(iii) If direct discussion by FDA of a meetings and correspondence relating
draft of a final notice or regulation or to draft notices and regulations.
its preamble is required with a person (j) The provisions of this section re-
outside the executive branch, appro- stricting discussion and disclosure of
priate protective procedures will be un- draft notices and regulations do not
dertaken to make certain that a full apply to situations covered by §§ 20.83
and impartial administrative record is through 20.89.
established. Such procedures may in- [44 FR 22323, Apr. 13, 1979, as amended at 54
clude either: FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999]
(a) The scheduling of an open public
meeting under § 10.65(b) at which inter- § 10.85 Advisory opinions.
ested persons may participate in re- (a) An interested person may request
view of and comment on the draft doc- an advisory opinion from the Commis-
ument; or sioner on a matter of general applica-
(b) The preparation of a tentative bility.
final regulation or tentative revised (1) The request will be granted when-
final regulation under § 10.40(f)(6), on ever feasible.
which interested persons will be given (2) The request may be denied if:
an additional period of time for oral (i) The request contains incomplete
and written comment. information on which to base an in-
(e) After a final regulation is pub- formed advisory opinion;
lished, an FDA representative may dis- (ii) The Commissioner concludes that
cuss any aspect of it with an interested an advisory opinion cannot reasonably
person. be given on the matter involved;
(f) In addition to the requirements of (iii) The matter is adequately cov-
this section, the provisions of § 10.55 ered by a prior advisory opinion or a
apply to the promulgation of a regula- regulation;
tion subject to § 10.50 and part 12. (iv) The request covers a particular
(g) A draft of a final food additive product or ingredient or label and does
color additive, or new animal drug reg- not raise a policy issue of broad appli-
ulation may be furnished to the peti- cability; or
tioner for comment on the technical (v) The Commissioner otherwise con-
accuracy of the regulation. Every cludes that an advisory opinion would
meeting with a petitioner relating to not be in the public interest.
the draft will be recorded in a written (b) A request for an advisory opinion
memorandum, and all memoranda and is to be submitted in accordance with
correspondence will be filed with the § 10.20, is subject to the provisions of

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Food and Drug Administration, HHS § 10.85

§ 10.30 (c) through (l), and must be in (e) An advisory opinion represents
the following form: the formal position of FDA on a matter
(Date) llllllllllllllllllll
and except as provided in paragraph (f)
of this section, obligates the agency to
Division of Dockets Management, Food follow it until it is amended or re-
and Drug Administration, Department of voked. The Commissioner may not rec-
Health and Human Services, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
ommend legal action against a person
or product with respect to an action
REQUEST FOR ADVISORY OPINION taken in conformity with an advisory
The undersigned submits this request for opinion which has not been amended or
an advisory opinion of the Commissioner of revoked.
Food and Drugs with respect to lll (the (f) In unusual situations involving an
general nature of the matter involved). immediate and significant danger to
A. Issues involved. health, the Commissioner may take ap-
(A concise statement of the issues and propriate civil enforcement action con-
questions on which an opinion is requested.)
trary to an advisory opinion before
B. Statement of facts and law.
(A full statement of all facts and legal amending or revoking the opinion. This
points relevant to the request.) action may be taken only with the ap-
The undersigned certifies that, to the best proval of the Commissioner, who may
of his/her knowledge and belief, this request not delegate this function. Appropriate
includes all data, information, and views rel- amendment or revocation of the advi-
evant to the matter, whether favorable or sory opinion involved will be expedited.
unfavorable to the position of the under- (g) An advisory opinion may be
signed, which is the subject of the request.
amended or revoked at any time after
(Signature) lllllllllllllllll it has been issued. Notice of amend-
(Person making request) llllllllll ment or revocation will be given in the
(Mailing address) llllllllllllll same manner as notice of the advisory
(Telephone number) lllllllllllll
opinion was originally given or in the
(c) The Commissioner may respond to FEDERAL REGISTER, and will be placed
an oral or written request to the agen- on public display as part of the file on
cy as a request for an advisory opinion, the matter in the office of the Division
in which case the request will be filed of Dockets Management. The Division
with the Division of Dockets Manage- of Dockets Management shall maintain
ment and be subject to this section. a separate chronological index of all
(d) A statement of policy or interpre- advisory opinions filed. The index will
tation made in the following docu- specify the date of the request for the
ments, unless subsequently repudiated advisory opinion, the date of the opin-
by the agency or overruled by a court, ion, and identification of the appro-
will constitute an advisory opinion: priate file.
(1) Any portion of a FEDERAL REG- (h) Action undertaken or completed
ISTER notice other than the text of a in conformity with an advisory opinion
proposed or final regulation, e.g., a no- which has subsequently been amended
tice to manufacturers or a preamble to or revoked is acceptable to FDA unless
a proposed or final regulation. the Commissioner determines that sub-
(2) Trade Correspondence (T.C. Nos. stantial public interest considerations
1–431 and 1A–8A) issued by FDA be- preclude continued acceptance. When-
tween 1938 and 1946. ever possible, an amended or revoked
(3) Compliance policy guides issued advisory opinion will state when action
by FDA beginning in 1968 and codified previously undertaken or completed
in the Compliance Policy Guides man- does not remain acceptable, and any
ual. transition period that may be applica-
(4) Other documents specifically ble.
identified as advisory opinions, e.g., ad- (i) An interested person may submit
visory opinions on the performance written comments on an advisory opin-
standard for diagnostic X-ray systems, ion or modified advisory opinion. Four
issued before July 1, 1975, and filed in a copies of any comments are to be sent
permanent public file for prior advi- to the Division of Dockets Manage-
sory opinions maintained by the Free- ment for inclusion in the public file on
dom of Information Staff (HFI–35). the advisory opinion. Individuals may

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§ 10.90 21 CFR Ch. I (4–1–11 Edition)

submit only one copy. Comments will tions established by the Division of
be considered in determining whether Dockets Management and will be sepa-
further modification of an advisory rated from the guidance documents in
opinion is warranted. the notice of availability published in
(j) An advisory opinion may be used the FEDERAL REGISTER, or be published
in administrative or court proceedings in the FEDERAL REGISTER as regula-
to illustrate acceptable and unaccept- tions under paragraph (a) of this sec-
able procedures or standards, but not tion.
as a legal requirement. (d) Agreements. Formal agreements,
(k) A statement made or advice pro- memoranda of understanding, or other
vided by an FDA employee constitutes similar written documents executed by
an advisory opinion only if it is issued FDA and another person will be in-
in writing under this section. A state- cluded in the public file on agreements
ment or advice given by an FDA em- established by the Freedom of Informa-
ployee orally, or given in writing but tion Staff (HFI–35) under § 20.108. A doc-
not under this section or § 10.90, is an ument not included in the public file is
informal communication that rep- deemed to be rescinded and has no
resents the best judgment of that em- force or effect whatever.
ployee at that time but does not con-
stitute an advisory opinion, does not [44 FR 22323, Apr. 13, 1979, as amended at 54
necessarily represent the formal posi- FR 9035, Mar. 3, 1989; 65 FR 56477, Sept. 19,
2000; 75 FR 16346, Apr. 1, 2010]
tion of FDA, and does not bind or oth-
erwise obligate or commit the agency
§ 10.95 Participation in outside stand-
to the views expressed. ard-setting activities.
[44 FR 22323, Apr. 13, 1979, as amended at 46 (a) General. This section applies to
FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28,
1994; 65 FR 56477, Sept. 19, 2000]
participation by FDA employees in
standard-setting activities outside the
§ 10.90 Food and Drug Administration agency. Standard-setting activities in-
regulations, recommendations, and clude matters such as the development
agreements. of performance characteristics, testing
(a) Regulations. FDA regulations are methodology, manufacturing practices,
issued in the FEDERAL REGISTER under product standards, scientific protocols,
§ 10.40 or § 10.50 and codified in the Code compliance criteria, ingredient speci-
of Federal Regulations. Regulations fications, labeling, or other technical
may contain provisions that will be en- or policy criteria. FDA encourages em-
forced as legal requirements, or which ployee participation in outside stand-
are intended only as guidance docu- ard-setting activities that are in the
ments and recommendations, or both. public interest.
The dissemination of draft notices and (b) Standard-setting activities by other
regulations is subject to § 10.80. Federal Government agencies. (1) An FDA
(b) [Reserved] employee may participate in these ac-
(c) Recommendations. In addition to tivities after approval of the activity
the guidance documents subject to under procedures specified in the cur-
§ 10.115, FDA often formulates and dis- rent agency Staff Manual Guide.
seminates recommendations about (2) Approval forms and all pertinent
matters which are authorized by, but background information describing the
do not involve direct regulatory action activity will be included in the public
under, the laws administered by the file on standard-setting activities es-
Commissioner, e.g., model State and tablished by the Freedom of Informa-
local ordinances, or personnel practices tion Staff.
for reducing radiation exposure, issued (3) If a member of the public is in-
under 42 U.S.C. 243 and 21 U.S.C. 360ii. vited by FDA to present views to, or to
These recommendations may, in the accompany, the FDA employee at a
discretion of the Commissioner, be meeting, the invitations will be ex-
handled under the procedures estab- tended to a representative sampling of
lished in § 10.115, except that the rec- the public, including consumer groups,
ommendations will be included in a industry associations, professional so-
separate public file of recommenda- cieties, and academic institutions.

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Food and Drug Administration, HHS § 10.95

(4) An FDA employee appointed as (ii) That participation by the indi-


the liaison representative to an activ- vidual does not connote FDA agree-
ity shall refer all requests for informa- ment with, or endorsement of, any de-
tion about or participation in the ac- cisions reached; and
tivity to the group or organization re- (iii) That participation by the indi-
sponsible for the activity. vidual precludes service as the deciding
(c) Standard-setting activities by State official on the standard involved if it
and local government agencies and by should later come before FDA. The de-
United Nations organizations and other ciding official is the person who signs a
international organizations and foreign document ruling upon the standard.
governments pursuant to treaty. (1) An (2) The letter requesting official FDA
FDA employee may participate in participation, the approval form, and
these activities after approval of the the Commissioner’s or center director’s
activity under procedures specified in letter, together with all pertinent
the current agency Staff Manual background information describing the
Guide. activities involved, will be included in
(2) Approval forms and all pertinent the public file on standard-setting ac-
background information describing the tivities established by the Freedom of
activity will be included in the public Information Staff (HFI–35).
file on standard-setting activities es- (3) The availability for public disclo-
tablished by the Freedom of Informa- sure of records relating to the activi-
tion Staff (HFI–35). ties will be governed by part 20.
(3) The availability for public disclo- (4) An FDA employee appointed as
sure of records relating to the activity the liaison representative to an activ-
will be governed by part 20. ity shall refer all requests for informa-
(4) If a member of the public is in- tion about or participation in the ac-
vited by FDA to present views to, or to tivity to the group or organization re-
accompany, the FDA employee at a sponsible for the activity.
meeting, the invitation will be ex- (5) The following minimum standards
tended to a representative sampling of apply to an outside private standard-
the public, including consumer groups, setting activity in which FDA employ-
industry associations, professional so- ees participate:
cieties, and academic institutions. (i) The activity will be based upon
(5) An FDA employee appointed as consideration of sound scientific and
the liaison representative to an activ- technological information, will permit
ity shall refer all requests for informa- revision on the basis of new informa-
tion about or participation in the ac- tion, and will be designed to protect
tivity to the group or organization re- the public against unsafe, ineffective,
sponsible for the activity. or deceptive products or practices.
(d) Standard-setting activities by pri- (ii) The activity and resulting stand-
vate groups and organizations. (1) An ards will not be designed for the eco-
FDA employee may engage in these ac- nomic benefit of any company, group,
tivities after approval of the activity or organization, will not be used for
under procedures specified in the cur- such antitrust violations as fixing
rent agency Staff Manual Guide. A re- prices or hindering competition, and
quest for official participation must be will not involve establishment of cer-
made by the group or organization in tification or specific approval of indi-
writing, must describe the scope of the vidual products or services.
activity, and must demonstrate that (iii) The group or organization re-
the minimum standards set out in sponsible for the standard-setting ac-
paragraph (d)(5) of this section are met. tivity must have a procedure by which
Except as provided in paragraph (d)(7) an interested person will have an op-
of this section, a request that is grant- portunity to provide information and
ed will be the subject of a letter from views on the activity and standards in-
the Commissioner or the center direc- volved, without the payment of fees,
tor to the organization stating— and the information and views will be
(i) Whether participation by the indi- considered. How this is accomplished,
vidual will be as a voting or nonvoting including whether the presentation
liaison representative; will be in person or in writing, will be

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§ 10.100 21 CFR Ch. I (4–1–11 Edition)

decided by the group or organization (viii) Conference of State Health and


responsible for the activity. Environmental Managers (COSHEM).
(6) Membership of an FDA employee (ix) Conference of Radiation Control
in an organization that also conducts a Program Directors (CRCPD).
standard-setting activity does not in- (x) International Association of Milk,
voke the provisions of this section un- Food, and Environmental Sanitation,
less the employee participates in the Inc. (IAMFES).
standard-setting activity. Participa- (xi) Interstate Shellfish Sanitation
tion in a standard-setting activity is Conference (ISSC).
subject to this section. (xii) National Association of Boards
(7) The Commissioner may determine of Pharmacy (NABP).
in writing that, because direct involve- (xiii) National Association of Depart-
ment by FDA in a particular standard- ments of Agriculture (NADA).
setting activity is in the public inter- (xiv) National Conference on Inter-
est and will promote the objectives of state Milk Shipments (NCIMS).
the act and the agency, the participa- (xv) National Conference of Local En-
tion is exempt from the requirements vironmental Health Administrators
of paragraph (d)(1) (ii) and/or (iii) of (NCLEHA).
this section. This determination will be (xvi) National Conference on Weights
included in the public file on standard- and Measures (NCWW).
setting activities established by the (xvii) National Environmental Health
Freedom of Information Staff and in Association (NEHA).
any relevant administrative file. The (xviii) National Society of Profes-
activity may include the establishment sional Sanitarians (NSPS).
and validation of analytical methods [44 FR 22323, Apr. 13, 1979, as amended at 46
for regulatory use, drafting uniform FR 8455, Jan. 27, 1981; 52 FR 35064, Sept. 17,
laws and regulations, and the develop- 1987; 54 FR 9035, Mar. 3, 1989; 70 FR 40880,
ment of recommendations concerning July 15, 2005; 70 FR 67651, Nov. 8, 2005]
public health and preventive medicine
practices by national and international § 10.100 Public calendar.
organizations. (a) Public calendar. A public calendar
(8) Because of the close daily co- will be prepared and made publicly
operation between FDA and the asso- available by FDA each week showing,
ciations of State and local government to the extent feasible, significant
officials listed below in this paragraph, events of the previous week, including
and the large number of agency em- significant meetings with persons out-
ployees who are members of or work side the executive branch, that involve
with these associations, participation the representatives of FDA designated
in the activities of these associations is under paragraph (c) of this section.
exempt from paragraphs (d)(1) through (1) Public calendar entries will in-
(7) of this section, except that a list of clude:
the committees and other groups of (i) Significant meetings with mem-
these associations will be included in bers of the judiciary, representatives of
the public file on standard-setting ac- Congress, or staffs of congressional
tivities established by the Freedom of committees when the meeting relates
Information Staff (HFI–35): to a pending court case, administrative
(i) American Association of Food Hy- hearing, or other regulatory action or
giene Veterinarians (AAFHV). decision;
(ii) American Public Health Associa- (ii) Significant meetings, con-
tion (APHA). ferences, seminars, and speeches; and
(iii) Association of American Feed (iii) Social events sponsored by the
Control Officials, Inc. (AAFCO). regulated industry.
(iv) Association of Food and Drug Of- (2) The public calendar will not in-
ficials (AFDO). clude reports of meetings that would
(v) AOAC INTERNATIONAL (AOAC). prejudice law enforcement activities
(vi) Association of State and Terri- (e.g., a meeting with an informant) or
torial Health Officials (ASTHO). invade privacy (e.g., a meeting with a
(vii) Conference for Food Protection candidate for possible employment at
(CFP). FDA), meetings with members of the

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Food and Drug Administration, HHS § 10.115

press, or meetings with onsite contrac- zation wishing to file an objection or


tors. request for hearing must do so individ-
(b) Calendar entries. The calendar will ually.
specify for each entry the date, per- (e) In a court proceeding in which an
son(s), and subject matter involved. If organization participates, the Commis-
a large number of persons are in at- sioner will take appropriate legal
tendance, the name of each individual measures to have the case brought or
need not be specified. When more than considered as a class action or other-
one FDA representative is in attend-
wise as binding upon all members of
ance, the most senior agency official
the organization except those specifi-
will report the meeting on the public
cally excluded by name. Regardless of
calendar.
(c) Affected persons. The following whether the case is brought or consid-
FDA representatives are subject to the ered as a class action or as otherwise
requirements of this section: binding upon all members of the orga-
(1) Commissioner of Food and Drugs. nization except those specifically ex-
(2) Senior Associate Commissioners. cluded by name, the Commissioner will
(3) Deputy Commissioners. take the position in any subsequent
(4) Associate Commissioner for Regu- suit involving the same issues and a
latory Affairs. member of the organization that the
(5) Center Directors. issues are precluded from further liti-
(6) Chief Counsel for the Food and gation by the member under the doc-
Drug Administration. trines of collateral estoppel or res judi-
(d) Public display. The public calendar cata.
will be placed on public display at the
following locations: § 10.110 Settlement proposals.
(1) Division of Dockets Management.
(2) Office of the Associate Commis- At any time in the course of a pro-
sioner for Public Affairs. ceeding subject to this part, a person
(3) The FDA home page, to the extent may propose settlement of the issues
feasible. involved. A participant in a proceeding
will have an opportunity to consider a
[66 FR 6468, Jan. 22, 2001]
proposed settlement. Unaccepted pro-
§ 10.105 Representation by an organi- posals of settlement and related mat-
zation. ters, e.g., proposed stipulations not
(a) An organization may represent its agreed to, will not be admissible in evi-
members by filing petitions, com- dence in an FDA administrative pro-
ments, and objections, and otherwise ceeding. FDA will oppose the admission
participating in an administrative pro- in evidence of settlement information
ceeding subject to this part. in a court proceeding or in another ad-
(b) A petition, comment, objection, ministrative proceeding.
or other representation by an organiza-
tion will not abridge the right of a § 10.115 Good guidance practices.
member to take individual action of a (a) What are good guidance practices?
similar type, in the member’s own Good guidance practices (GGP’s) are
name. FDA’s policies and procedures for de-
(c) It is requested that each organiza- veloping, issuing, and using guidance
tion participating in FDA administra- documents.
tive proceedings file annually with the (b) What is a guidance document? (1)
Division of Dockets Management a cur-
Guidance documents are documents
rent list of all of the members of the
prepared for FDA staff, applicants/
organization.
(d) The filing by an organization of sponsors, and the public that describe
an objection or request for hearing the agency’s interpretation of or policy
under §§ 12.20 through 12.22 does not on a regulatory issue.
provide a member a legal right with re- (2) Guidance documents include, but
spect to the objection or request for are not limited to, documents that re-
hearing that the member may individ- late to: The design, production, label-
ually exercise. A member of an organi- ing, promotion, manufacturing, and

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§ 10.115 21 CFR Ch. I (4–1–11 Edition)

testing of regulated products; the proc- (e) Can FDA use means other than a
essing, content, and evaluation or ap- guidance document to communicate new
proval of submissions; and inspection agency policy or a new regulatory ap-
and enforcement policies. proach to a broad public audience? The
(3) Guidance documents do not in- agency may not use documents or
clude: Documents relating to internal other means of communication that
FDA procedures, agency reports, gen- are excluded from the definition of
eral information documents provided guidance document to informally com-
to consumers or health professionals, municate new or different regulatory
speeches, journal articles and edi- expectations to a broad public audience
torials, media interviews, press mate- for the first time. These GGP’s must be
rials, warning letters, memoranda of followed whenever regulatory expecta-
understanding, or other communica- tions that are not readily apparent
tions directed to individual persons or from the statute or regulations are
firms. first communicated to a broad public
(c) What other terms have a special audience.
meaning? (1) ‘‘Level 1 guidance docu- (f) How can you participate in the de-
ments’’ include guidance documents velopment and issuance of guidance docu-
that: ments? (1) You can provide input on
(i) Set forth initial interpretations of guidance documents that FDA is devel-
statutory or regulatory requirements; oping under the procedures described in
(ii) Set forth changes in interpreta- paragraph (g) of this section.
tion or policy that are of more than a (2) You can suggest areas for guid-
minor nature; ance document development. Your sug-
(iii) Include complex scientific issues; gestions should address why a guidance
or document is necessary.
(iv) Cover highly controversial
(3) You can submit drafts of proposed
issues.
guidance documents for FDA to con-
(2) ‘‘Level 2 guidance documents’’ are
sider. When you do so, you should
guidance documents that set forth ex-
mark the document ‘‘Guidance Docu-
isting practices or minor changes in in-
terpretation or policy. Level 2 guidance ment Submission’’ and submit it to Di-
documents include all guidance docu- vision of Dockets Management (HFA–
ments that are not classified as Level 305), 5630 Fishers Lane, rm. 1061, Rock-
1. ville, MD 20852.
(3) ‘‘You’’ refers to all affected parties (4) You can, at any time, suggest that
outside of FDA. FDA revise or withdraw an already ex-
(d) Are you or FDA required to follow a isting guidance document. Your sug-
guidance document? (1) No. Guidance gestion should address why the guid-
documents do not establish legally en- ance document should be revised or
forceable rights or responsibilities. withdrawn and, if applicable, how it
They do not legally bind the public or should be revised.
FDA. (5) Once a year, FDA will publish,
(2) You may choose to use an ap- both in the FEDERAL REGISTER and on
proach other than the one set forth in the Internet, a list of possible topics
a guidance document. However, your for future guidance document develop-
alternative approach must comply with ment or revision during the next year.
the relevant statutes and regulations. You can comment on this list (e.g., by
FDA is willing to discuss an alter- suggesting alternatives or making rec-
native approach with you to ensure ommendations on the topics that FDA
that it complies with the relevant stat- is considering).
utes and regulations. (6) To participate in the development
(3) Although guidance documents do and issuance of guidance documents
not legally bind FDA, they represent through one of the mechanisms de-
the agency’s current thinking. There- scribed in paragraphs (f)(1), (f)(2), or
fore, FDA employees may depart from (f)(4) of this section, you should con-
guidance documents only with appro- tact the center or office that is respon-
priate justification and supervisory sible for the regulatory activity cov-
concurrence. ered by the guidance document.

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Food and Drug Administration, HHS § 10.115

(7) If FDA agrees to draft or revise a follow the steps in paragraphs (g)(1)(ii),
guidance document, under a suggestion (g)(1)(iii), and (g)(1)(iv) of this section.
made under paragraphs (f)(1), (f)(2), (2) FDA will not seek your comment
(f)(3) or (f)(4) of this section, you can before it implements a Level 1 guid-
participate in the development of that ance document if the agency deter-
guidance document under the proce- mines that prior public participation is
dures described in paragraph (g) of this not feasible or appropriate.
section. (3) FDA will use the following proce-
(g) What are FDA’s procedures for de- dures for developing and issuing Level
veloping and issuing guidance documents? 1 guidance documents under the cir-
(1) FDA’s procedures for the develop- cumstances described in paragraph
ment and issuance of Level 1 guidance (g)(2) of this section:
documents are as follows: (i) After FDA prepares a guidance
(i) Before FDA prepares a draft of a document, FDA will:
Level 1 guidance document, FDA can (A) Publish a notice in the FEDERAL
seek or accept early input from indi- REGISTER announcing that the guid-
viduals or groups outside the agency. ance document is available;
For example, FDA can do this by par- (B) Post the guidance document on
ticipating in or holding public meet- the Internet and make it available in
ings and workshops. hard copy;
(ii) After FDA prepares a draft of a (C) Immediately implement the guid-
Level 1 guidance document, FDA will: ance document; and
(A) Publish a notice in the FEDERAL (D) Invite your comment when it
REGISTER announcing that the draft issues or publishes the guidance docu-
guidance document is available; ment. Paragraph (h) of this section
(B) Post the draft guidance document tells you how to submit your com-
on the Internet and make it available ments.
in hard copy; and (ii) If FDA receives comments on the
(C) Invite your comment on the draft guidance document, FDA will review
guidance document. Paragraph (h) of those comments and revise the guid-
this section tells you how to submit ance document when appropriate.
your comments. (4) FDA will use the following proce-
(iii) After FDA prepares a draft of a dures for developing and issuing Level
Level 1 guidance document, FDA also 2 guidance documents:
can: (i) After it prepares a guidance docu-
(A) Hold public meetings or work- ment, FDA will:
shops; or (A) Post the guidance document on
(B) Present the draft guidance docu- the Internet and make it available in
ment to an advisory committee for re- hard copy;
view. (B) Immediately implement the guid-
(iv) After providing an opportunity ance document, unless FDA indicates
for public comment on a Level 1 guid- otherwise when the document is made
ance document, FDA will: available; and
(A) Review any comments received (C) Invite your comment on the Level
and prepare the final version of the 2 guidance document. Paragraph (h) of
guidance document that incorporates this section tells you how to submit
suggested changes, when appropriate; your comments.
(B) Publish a notice in the FEDERAL (ii) If FDA receives comments on the
REGISTER announcing that the guid- guidance document, FDA will review
ance document is available; those comments and revise the docu-
(C) Post the guidance document on ment when appropriate. If a version is
the Internet and make it available in revised, the new version will be placed
hard copy; and on the Internet.
(D) Implement the guidance docu- (5) You can comment on any guid-
ment. ance document at any time. Paragraph
(v) After providing an opportunity (h) of this section tells you how to sub-
for comment, FDA may decide that it mit your comments. FDA will revise
should issue another draft of the guid- guidance documents in response to
ance document. In this case, FDA will your comments when appropriate.

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§ 10.115 21 CFR Ch. I (4–1–11 Edition)

(h) How should you submit comments approved by appropriate senior FDA of-
on a guidance document? (1) If you ficials.
choose to submit comments on any (k) How will FDA review and revise ex-
guidance document under paragraph (g) isting guidance documents? (1) The agen-
of this section, you must send them to cy will periodically review existing
the Division of Dockets Management guidance documents to determine
(HFA–305), 5630 Fishers Lane, rm. 1061, whether they need to be changed or
Rockville, MD 20852. withdrawn.
(2) Comments should identify the (2) When significant changes are
docket number on the guidance docu- made to the statute or regulations, the
ment, if such a docket number exists. agency will review and, if appropriate,
For documents without a docket num- revise guidance documents relating to
ber, the title of the guidance document that changed statute or regulation.
should be included. (3) As discussed in paragraph (f)(3) of
(3) Comments will be available to the this section, you may at any time sug-
public in accordance with FDA’s regu- gest that FDA revise a guidance docu-
lations on submission of documents to ment.
the Division of Dockets Management
(l) How will FDA ensure that FDA staff
specified in § 10.20(j).
are following GGP’s? (1) All current and
(i) What standard elements must FDA
new FDA employees involved in the de-
include in a guidance document? (1) A
velopment, issuance, or application of
guidance document must:
guidance documents will be trained re-
(i) Include the term ‘‘guidance,’’
garding the agency’s GGP’s.
(ii) Identify the center(s) or office(s)
(2) FDA centers and offices will mon-
issuing the document,
itor the development and issuance of
(iii) Identify the activity to which
guidance documents to ensure that
and the people to whom the document
GGP’s are being followed.
applies,
(iv) Prominently display a statement (m) How can you get copies of FDA’s
of the document’s nonbinding effect, guidance documents? FDA will make
(v) Include the date of issuance, copies available in hard copy and, as
(vi) Note if it is a revision to a pre- feasible, through the Internet.
viously issued guidance and identify (n) How will FDA keep you informed of
the document that it replaces, and the guidance documents that are avail-
(vii) Contain the word ‘‘draft’’ if the able? (1) FDA will maintain on the
document is a draft guidance. Internet a current list of all guidance
(2) Guidance documents must not in- documents. New documents will be
clude mandatory language such as added to this list within 30 days of
‘‘shall,’’ ‘‘must,’’ ‘‘required,’’ or ‘‘require- issuance.
ment,’’ unless FDA is using these words (2) Once a year, FDA will publish in
to describe a statutory or regulatory the FEDERAL REGISTER its comprehen-
requirement. sive list of guidance documents. The
(3) When issuing draft guidance docu- comprehensive list will identify docu-
ments that are the product of inter- ments that have been added to the list
national negotiations (e.g., guidances or withdrawn from the list since the
resulting from the International Con- previous comprehensive list.
ference on Harmonisation), FDA need (3) FDA’s guidance document lists
not apply paragraphs (i)(1) and (i)(2) of will include the name of the guidance
this section. However, any final guid- document, issuance and revision dates,
ance document issued according to this and information on how to obtain cop-
provision must contain the elements in ies of the document.
paragraphs (i)(1) and (i)(2) of this sec- (o) What can you do if you believe that
tion. someone at FDA is not following these
(j) Who, within FDA, can approve GGP’s? If you believe that someone at
issuance of guidance documents? Each FDA did not follow the procedures in
center and office must have written this section or that someone at FDA
procedures for the approval of guidance treated a guidance document as a bind-
documents. Those procedures must en- ing requirement, you should contact
sure that issuance of all documents is that person’s supervisor in the center

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Food and Drug Administration, HHS § 10.204

or office that issued the guidance docu- (c) Electronic recording as used in this
ment. If the issue cannot be resolved, guideline means any visual or audio re-
you should contact the next highest su- cording made by videotape recording
pervisor. You can also contact the cen- equipment or moving film camera, and/
ter or office ombudsman for assistance or other electronic recording equip-
in resolving the issue. If you are unable ment.
to resolve the issue at the center or of- [49 FR 14726, Apr. 13, 1984, as amended at 54
fice level or if you feel that you are not FR 9035, Mar. 3, 1989]
making progress by going through the
chain of command, you may ask the § 10.204 General.
Office of the Chief Mediator and Om- (a) FDA has for many years willingly
budsman to become involved. committed itself to a policy of open-
[65 FR 56477, Sept. 19, 2000] ness. In many instances FDA has
sought to make the open portions of
agency public administrative pro-
Subpart C—Electronic Media Cov- ceedings more accessible to public par-
erage of Public Administrative ticipation. Similarly, FDA has sought,
Proceedings; Guideline on wherever possible, to allow full written
Policy and Procedures media access to its proceedings, so that
members of the press would have the
SOURCE: 49 FR 14726, Apr. 13, 1984, unless opportunity to provide first-hand re-
otherwise noted. ports. However, because electronic
media coverage presents certain dif-
§ 10.200 Scope. ficulties that are easier to resolve with
advance notice to the agency and all
This guideline describes FDA’s policy
participants, FDA believes that codi-
and procedures applicable to electronic
fication of its policy will facilitate and
media coverage of agency public ad-
further increase media access to its
ministrative proceedings. It is a guide-
public administrative proceedings. The
line intended to clarify and explain agency intends to refer to this guide-
FDA’s policy on the presence and oper- line when notices of hearing, or indi-
ation of electronic recording equip- vidual advisory committee meetings,
ment at such proceedings and to assure are published in the FEDERAL REG-
uniform and consistent application of ISTER. Thus, all parties to a proceeding
practices and procedures throughout will be on notice that the proceeding
the agency. may be recorded electronically and any
person interested in videotaping or
§ 10.203 Definitions.
otherwise recording the proceeding will
(a) Public administrative proceeding as be notified that there are established
used in this guideline means any FDA procedures to be followed.
proceeding which the public has a right (b) The designated presiding officer
to attend. This includes a formal evi- of a public administrative proceeding
dentiary public hearing as set forth in retains the existing discretionary au-
part 12, a public hearing before a Pub- thority set forth in specific regulations
lic Board of Inquiry as set forth in part pertaining to each type of administra-
13, a public hearing before a Public Ad- tive proceeding to regulate the conduct
visory Committee as set forth in part of the proceeding over which he or she
14, a public hearing before the Commis- presides. The responsibilities of the
sioner as set forth in part 15, a regu- presiding officer, established elsewhere
latory hearing before FDA as set forth in parts 10 through 16, include an obli-
in part 16, consumer exchange meet- gation to be concerned with the timely
ings, and Commissioner’s public meet- conduct of a hearing, the limited avail-
ings with health professionals. ability of certain witnesses, and reduc-
(b) Advance notice as used in this ing disruptions to the proceeding which
guideline means written or telephone may occur. Each proceeding varies, and
notification to FDA’s Office of Public the presiding officer cannot anticipate
Affairs (Press Relations Staff) of intent all that might occur. Discretionary au-
to electronically record an agency pub- thority to regulate conduct at a pro-
lic administrative proceeding. ceeding has traditionally been granted

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§ 10.204 21 CFR Ch. I (4–1–11 Edition)

to presiding officers to enable them to by the established networks’ pooling


fulfill their responsibility to maintain system. However, the agency has a
a fair and orderly hearing conducted in strong commitment to ensuring that
an expeditious manner. media representatives other than the
(c) This guideline provides the pre- major networks also be able to obtain
siding officer with a degree of flexi- a copy of the tape at cost. FDA is con-
bility in that it sets forth the agency’s cerned that if the network pool rep-
policy as well as the procedures that resentative wishes to record only a
presiding officers should ordinarily fol- short portion of a proceeding, but an
low, but from which they may depart excluded party wishes to record the en-
in particular situations if necessary, tire proceeding, confusion will result.
subject to the presumption of openness The agency expects the interested
of public proceedings to electronic media representatives to negotiate a
media coverage. The presiding officer’s
suitable agreement among themselves
discretion to establish additional pro-
before commencement of the pro-
cedures or to limit electronic coverage
ceeding. For example, the network pool
is to be exercised only in the unusual
representatives might agree to record a
circumstances defined in this guide-
line. Even though a presiding officer portion of the proceeding up to a break
may establish additional procedures or in the proceeding, at which time, while
limits as may be required in a par- the network representative is dis-
ticular situation, he or she will be assembling equipment, another media
guided by the policy expressed in this representative might set up to con-
guideline in establishing these condi- tinue recording. If an agreement can-
tions. The presiding officer may also be not be reached before the proceeding,
less restrictive, taking into account the agency will use the time of receipt
such factors as the duration of a hear- of any advance notice to determine the
ing and the design of the room. representation for each category of
(d) If a portion or all of a proceeding media, e.g., one network reporter, one
is closed to the public because material independent reporter. The agency rec-
is to be discussed that is not ommends that parties intending to vid-
disclosable to the public under applica- eotape provide as much advance notice
ble laws, the proceeding also will be as possible, so that the agency may
closed to electronic media coverage. best respond to the needs of the elec-
(e) The agency requests advance no- tronic media.
tice of intent to record a proceeding (g) To ensure the timely conduct of
electronically to facilitate the orderly agency hearings and to prevent disrup-
conduct of the proceeding. Knowledge tions, equipment is to be stationary
of anticipated media coverage will during a proceeding and should be set
allow the presiding officer to make any up and taken down when the pro-
special arrangements required by the ceeding is not in progress. As noted
circumstances of the proceeding. The previously, the presiding officer may,
agency believes that this guideline es-
at his or her discretion, be less restric-
tablishes sufficiently specific criteria
tive if appropriate.
to promote uniformity.
(f) The agency would like to allow all (h) The agency recognizes that elec-
interested media representatives to tronic media representatives may de-
videotape a proceeding in which they sire only short footage of a proceeding,
have an interest. However, should a facsimile of the proceeding, and/or
space limitations preclude a multitude interview opportunities and may be un-
of cameras, the presiding officer may necessarily restricted by requirements
require pool sharing. In such a case, for setting up before a proceeding and
pool sharing arrangements of the re- then waiting until a break in the pro-
sulting videotape should be made be- ceeding before being permitted to take
tween those allowed to film and those down their equipment. To accommo-
who were excluded. Arrangements for date this possibility, FDA’s Press Rela-
who is designated to present the pool tions Staff will attempt to make ar-
and a method of distributing the re- rangements to respond to such needs
sulting film or tape may be determined by, for example, requesting that the

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Food and Drug Administration, HHS § 10.206

presiding officer provide a break short- those outlined in this subpart. The pre-
ly after commencement of the pro- siding officer will not deny access for
ceeding to permit take down of equip- failure to provide a 48-hour advance no-
ment. tice. Any advance notice may describe
(i) The agency is making a full com- the intended length of recording if
mitment to allowing, whenever pos- known, the amount and type of equip-
sible, electronic coverage of its public ment to be used, and any special needs
administrative proceedings subject to such as interviews.
the limited restrictions established in (b) Cameras should be completely set
this guideline. up before a proceeding is scheduled to
begin or during a break in the pro-
§ 10.205 Electronic media coverage of ceeding and should remain standing in
public administrative proceedings. the area designated for electronic
(a) A person may record electroni- media equipment. Cameras may be
cally any open public administrative taken down only during breaks or after
proceeding, subject to the procedures the hearing is over. Roving cameras
specified in this guideline. The proce- will not be permitted during the pro-
dures include a presumption that agen- ceeding. Any artificial lighting should
cy public proceedings are open to the be unobtrusive. Microphones, like cam-
electronic media. Whenever possible, eras, should be in place before the start
FDA will permit all interested persons of a proceeding and may be taken down
access to record agency public adminis- as indicated in this paragraph.
trative proceedings. Restrictions other (c) When space in the hearing room is
than those listed in § 10.206 will be im- limited, the presiding officer may re-
posed only under exceptional cir- strict the number of cameras or the
cumstances. equipment present. Should such a re-
(b) A videotape recording of an FDA striction become necessary, the pool
public administrative proceeding is not arrangements are the responsibility of
an official record of the proceeding. the participating media. The agency
The only official record is the written encourages the network pool to make
transcript of the proceeding, which is copies of the tape, film, or other prod-
taken by the official reporter. uct available at cost to nonpool par-
ticipants. However, if this is not pos-
§ 10.206 Procedures for electronic sible, the agency may need to use the
media coverage of agency public time of receipt of any advance notice
administrative proceedings. to determine the representation for
(a) To facilitate the agency’s re- each category, e.g., one network re-
sponse to media needs, a person intend- porter, one independent reporter, etc.
ing to videotape an FDA public admin- (d) Off the record portions of a pro-
istrative proceeding should, whenever ceeding may not be videotaped.
possible, provide advance notice to the (e) Before or during the proceeding,
Press Relations Staff (HFI–20), Office of the presiding officer may establish
Public Affairs, Food and Drug Adminis- other conditions specific to the pro-
tration, 5600 Fishers Lane, Rockville, ceeding for which the request is being
MD 20857, in writing or by telephone made. These conditions may be more or
(telephone 301–443–4177), at least 48 less restrictive than those stated in
hours in advance of the proceeding. this guideline, except that the pre-
The Press Relations Staff will inform siding officer shall observe the agen-
the presiding officer that the pro- cy’s presumption of openness of its
ceeding will be attended by representa- public proceedings to the electronic
tives of the electronic media, and as- media. Only a substantial and clear
certain whether any special provisions threat to the agency’s interests in
in addition to those set forth in this order, fairness, and timeliness author-
subpart are required by the presiding izes the presiding officer to impose ad-
officer. If so, the Press Relations Staff ditional restrictions. This threat must
will function as a liaison between the outweigh the public interest in elec-
presiding officer and the person intend- tronic media coverage of agency pro-
ing to record the proceeding in facili- ceedings. Additional restrictions shall
tating any procedures in addition to be narrowly drawn to the particular

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Pt. 11 21 CFR Ch. I (4–1–11 Edition)

circumstances. The following factors est in electronic media coverage of the


are listed to assist presiding officers in proceedings before additional restric-
determining whether the agency’s in- tions are imposed on the electronic
terest is sufficiently compelling to call media during the course of the pro-
for the unusual step of imposing addi- ceedings. The factors noted in para-
tional restrictions. Generally this step graph (e) of this section indicate the
is justified when one of the following kind of substantial threat to the agen-
factors is met: cy interests that may require imposing
(1) Electronic recording would result additional restrictions during the
in a substantial likelihood of disrup- course of the proceedings. If additional
tion that clearly cannot be contained requirements are established during
by the procedures established in para- the hearing, the presiding officer shall
graphs (a) through (d) of this section. notify immediately the Deputy Com-
(2) Electronic recording would result missioner of Food and Drugs of that
in a substantial likelihood of preju- fact by telephone and submit a written
dicial impact on the fairness of the pro- explanation of the circumstances that
ceeding or the substantive discussion necessitated such an action within 24
in a proceeding. hours or sooner if requested by the
(3) There is a substantial likelihood Deputy Commissioner. In the absence
that a witness’ ability to testify may or unavailability of the Deputy Com-
be impaired due to unique personal cir- missioner, the presiding officer shall
cumstances such as the age or psycho- notify the Associate Commissioner for
logical state of the witness or the par- Regulatory Affairs.
ticularly personal or private nature of (h) A decision by a presiding officer,
the witness’ testimony, if the witness’ made either before the proceeding or
testimony were electronically re- during the course of a proceeding, to
corded. establish requirements in addition to
(f) Before the proceeding, the Press the minimum standards set forth in
Relations Staff will, upon request, pro- this guideline may be appealed by any
vide written copies of any additional adversely affected person who intends
conditions imposed by the presiding of- to record the proceeding electronically.
ficer (as described in paragraph (e) of Appeals may be made in writing or by
this section) to requesting members of phone to the Deputy Commissioner or,
the media. Any appeals should be made in his or her absence, to the Associate
in accordance with paragraph (h) of
Commissioner for Regulatory Affairs.
this section.
The filing of an appeal, whether before
(g) The presiding officer retains au-
or during a proceeding, does not re-
thority to restrict or discontinue
quire the presiding officer to interrupt
videotaping or other recording of a pro-
the proceeding. However, the Deputy
ceeding, or parts of a proceeding,
Commissioner or, in his or her absence,
should such a decision become nec-
the Associate Commissioner for Regu-
essary. The presiding officer’s responsi-
latory Affairs will resolve an appeal as
bility to conduct the hearing includes
expeditiously as possible so as to pre-
the right and duty to remove a source
serve, to the extent possible, the re-
of substantial disruption. In exercising
porters’ opportunity to record the pro-
his or her authority, the presiding offi-
ceedings.
cer shall observe the presumption that
agency public proceedings are open to [49 FR 14726, Apr. 13, 1984, as amended at 54
the electronic media. The presiding of- FR 9035, Mar. 3, 1989]
ficer shall exercise his or her discretion
to restrict or discontinue electronic PART 11—ELECTRONIC RECORDS;
coverage of a public proceeding, or por- ELECTRONIC SIGNATURES
tions of a public proceeding, only if he
or she determines that the agency’s in- Subpart A—General Provisions
terest in the fair and orderly adminis-
trative process is substantially threat- Sec.
ened. A clear and substantial threat to 11.1 Scope.
the integrity of agency proceedings 11.2 Implementation.
must clearly outweigh the public inter- 11.3 Definitions.

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Food and Drug Administration, HHS § 11.2

Subpart B—Electronic Records (e) Computer systems (including


hardware and software), controls, and
11.10 Controls for closed systems.
11.30 Controls for open systems. attendant documentation maintained
11.50 Signature manifestations. under this part shall be readily avail-
11.70 Signature/record linking. able for, and subject to, FDA inspec-
tion.
Subpart C—Electronic Signatures (f) This part does not apply to
11.100 General requirements. records required to be established or
11.200 Electronic signature components and maintained by §§ 1.326 through 1.368 of
controls. this chapter. Records that satisfy the
11.300 Controls for identification codes/pass- requirements of part 1, subpart J of
words.
this chapter, but that also are required
AUTHORITY: 21 U.S.C. 321–393; 42 U.S.C. 262. under other applicable statutory provi-
SOURCE: 62 FR 13464, Mar. 20, 1997, unless sions or regulations, remain subject to
otherwise noted. this part.
[62 FR 13464, Mar. 20, 1997, as amended at 69
Subpart A—General Provisions FR 71655, Dec. 9, 2004]
§ 11.1 Scope. § 11.2 Implementation.
(a) The regulations in this part set (a) For records required to be main-
forth the criteria under which the
tained but not submitted to the agen-
agency considers electronic records,
cy, persons may use electronic records
electronic signatures, and handwritten
signatures executed to electronic in lieu of paper records or electronic
records to be trustworthy, reliable, and signatures in lieu of traditional signa-
generally equivalent to paper records tures, in whole or in part, provided
and handwritten signatures executed that the requirements of this part are
on paper. met.
(b) This part applies to records in (b) For records submitted to the
electronic form that are created, modi- agency, persons may use electronic
fied, maintained, archived, retrieved, records in lieu of paper records or elec-
or transmitted, under any records re- tronic signatures in lieu of traditional
quirements set forth in agency regula- signatures, in whole or in part, pro-
tions. This part also applies to elec- vided that:
tronic records submitted to the agency (1) The requirements of this part are
under requirements of the Federal met; and
Food, Drug, and Cosmetic Act and the (2) The document or parts of a docu-
Public Health Service Act, even if such ment to be submitted have been identi-
records are not specifically identified fied in public docket No. 92S–0251 as
in agency regulations. However, this being the type of submission the agen-
part does not apply to paper records
cy accepts in electronic form. This
that are, or have been, transmitted by
docket will identify specifically what
electronic means.
types of documents or parts of docu-
(c) Where electronic signatures and
their associated electronic records ments are acceptable for submission in
meet the requirements of this part, the electronic form without paper records
agency will consider the electronic sig- and the agency receiving unit(s) (e.g.,
natures to be equivalent to full hand- specific center, office, division, branch)
written signatures, initials, and other to which such submissions may be
general signings as required by agency made. Documents to agency receiving
regulations, unless specifically ex- unit(s) not specified in the public dock-
cepted by regulation(s) effective on or et will not be considered as official if
after August 20, 1997. they are submitted in electronic form;
(d) Electronic records that meet the paper forms of such documents will be
requirements of this part may be used considered as official and must accom-
in lieu of paper records, in accordance pany any electronic records. Persons
with § 11.2, unless paper records are spe-
cifically required.

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§ 11.3 21 CFR Ch. I (4–1–11 Edition)

are expected to consult with the in- preserved. The scripted name or legal
tended agency receiving unit for de- mark, while conventionally applied to
tails on how (e.g., method of trans- paper, may also be applied to other de-
mission, media, file formats, and tech- vices that capture the name or mark.
nical protocols) and whether to proceed (9) Open system means an environ-
with the electronic submission. ment in which system access is not
controlled by persons who are respon-
§ 11.3 Definitions. sible for the content of electronic
(a) The definitions and interpreta- records that are on the system.
tions of terms contained in section 201
of the act apply to those terms when Subpart B—Electronic Records
used in this part.
(b) The following definitions of terms § 11.10 Controls for closed systems.
also apply to this part:
Persons who use closed systems to
(1) Act means the Federal Food, Drug,
create, modify, maintain, or transmit
and Cosmetic Act (secs. 201–903 (21
electronic records shall employ proce-
U.S.C. 321–393)).
dures and controls designed to ensure
(2) Agency means the Food and Drug
the authenticity, integrity, and, when
Administration.
appropriate, the confidentiality of elec-
(3) Biometrics means a method of
tronic records, and to ensure that the
verifying an individual’s identity based
signer cannot readily repudiate the
on measurement of the individual’s
signed record as not genuine. Such pro-
physical feature(s) or repeatable ac-
cedures and controls shall include the
tion(s) where those features and/or ac-
following:
tions are both unique to that indi-
vidual and measurable. (a) Validation of systems to ensure
(4) Closed system means an environ- accuracy, reliability, consistent in-
ment in which system access is con- tended performance, and the ability to
trolled by persons who are responsible discern invalid or altered records.
for the content of electronic records (b) The ability to generate accurate
that are on the system. and complete copies of records in both
(5) Digital signature means an elec- human readable and electronic form
tronic signature based upon cryp- suitable for inspection, review, and
tographic methods of originator au- copying by the agency. Persons should
thentication, computed by using a set contact the agency if there are any
of rules and a set of parameters such questions regarding the ability of the
that the identity of the signer and the agency to perform such review and
integrity of the data can be verified. copying of the electronic records.
(6) Electronic record means any com- (c) Protection of records to enable
bination of text, graphics, data, audio, their accurate and ready retrieval
pictorial, or other information rep- throughout the records retention pe-
resentation in digital form that is cre- riod.
ated, modified, maintained, archived, (d) Limiting system access to author-
retrieved, or distributed by a computer ized individuals.
system. (e) Use of secure, computer-gen-
(7) Electronic signature means a com- erated, time-stamped audit trails to
puter data compilation of any symbol independently record the date and time
or series of symbols executed, adopted, of operator entries and actions that
or authorized by an individual to be create, modify, or delete electronic
the legally binding equivalent of the records. Record changes shall not ob-
individual’s handwritten signature. scure previously recorded information.
(8) Handwritten signature means the Such audit trail documentation shall
scripted name or legal mark of an indi- be retained for a period at least as long
vidual handwritten by that individual as that required for the subject elec-
and executed or adopted with the tronic records and shall be available
present intention to authenticate a for agency review and copying.
writing in a permanent form. The act (f) Use of operational system checks
of signing with a writing or marking to enforce permitted sequencing of
instrument such as a pen or stylus is steps and events, as appropriate.

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Food and Drug Administration, HHS § 11.100

(g) Use of authority checks to ensure (2) The date and time when the signa-
that only authorized individuals can ture was executed; and
use the system, electronically sign a (3) The meaning (such as review, ap-
record, access the operation or com- proval, responsibility, or authorship)
puter system input or output device, associated with the signature.
alter a record, or perform the operation (b) The items identified in para-
at hand. graphs (a)(1), (a)(2), and (a)(3) of this
(h) Use of device (e.g., terminal) section shall be subject to the same
checks to determine, as appropriate, controls as for electronic records and
the validity of the source of data input shall be included as part of any human
or operational instruction.
readable form of the electronic record
(i) Determination that persons who (such as electronic display or printout).
develop, maintain, or use electronic
record/electronic signature systems § 11.70 Signature/record linking.
have the education, training, and expe-
rience to perform their assigned tasks. Electronic signatures and hand-
(j) The establishment of, and adher- written signatures executed to elec-
ence to, written policies that hold indi- tronic records shall be linked to their
viduals accountable and responsible for respective electronic records to ensure
actions initiated under their electronic that the signatures cannot be excised,
signatures, in order to deter record and copied, or otherwise transferred to fal-
signature falsification. sify an electronic record by ordinary
(k) Use of appropriate controls over means.
systems documentation including:
(1) Adequate controls over the dis- Subpart C—Electronic Signatures
tribution of, access to, and use of docu-
mentation for system operation and § 11.100 General requirements.
maintenance. (a) Each electronic signature shall be
(2) Revision and change control pro- unique to one individual and shall not
cedures to maintain an audit trail that be reused by, or reassigned to, anyone
documents time-sequenced develop-
else.
ment and modification of systems doc-
(b) Before an organization estab-
umentation.
lishes, assigns, certifies, or otherwise
§ 11.30 Controls for open systems. sanctions an individual’s electronic
signature, or any element of such elec-
Persons who use open systems to cre- tronic signature, the organization shall
ate, modify, maintain, or transmit
verify the identity of the individual.
electronic records shall employ proce-
dures and controls designed to ensure (c) Persons using electronic signa-
the authenticity, integrity, and, as ap- tures shall, prior to or at the time of
propriate, the confidentiality of elec- such use, certify to the agency that the
tronic records from the point of their electronic signatures in their system,
creation to the point of their receipt. used on or after August 20, 1997, are in-
Such procedures and controls shall in- tended to be the legally binding equiv-
clude those identified in § 11.10, as ap- alent of traditional handwritten signa-
propriate, and additional measures tures.
such as document encryption and use (1) The certification shall be sub-
of appropriate digital signature stand- mitted in paper form and signed with a
ards to ensure, as necessary under the traditional handwritten signature, to
circumstances, record authenticity, in- the Office of Regional Operations
tegrity, and confidentiality. (HFC–100), 5600 Fishers Lane, Rock-
ville, MD 20857.
§ 11.50 Signature manifestations. (2) Persons using electronic signa-
(a) Signed electronic records shall tures shall, upon agency request, pro-
contain information associated with vide additional certification or testi-
the signing that clearly indicates all of mony that a specific electronic signa-
the following: ture is the legally binding equivalent
(1) The printed name of the signer; of the signer’s handwritten signature.

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§ 11.200 21 CFR Ch. I (4–1–11 Edition)

§ 11.200 Electronic signature compo- mation, and to issue temporary or per-


nents and controls. manent replacements using suitable,
(a) Electronic signatures that are not rigorous controls.
based upon biometrics shall: (d) Use of transaction safeguards to
(1) Employ at least two distinct iden- prevent unauthorized use of passwords
tification components such as an iden- and/or identification codes, and to de-
tification code and password. tect and report in an immediate and
(i) When an individual executes a se- urgent manner any attempts at their
ries of signings during a single, contin- unauthorized use to the system secu-
uous period of controlled system ac- rity unit, and, as appropriate, to orga-
cess, the first signing shall be executed nizational management.
using all electronic signature compo- (e) Initial and periodic testing of de-
nents; subsequent signings shall be exe- vices, such as tokens or cards, that
cuted using at least one electronic sig- bear or generate identification code or
nature component that is only execut- password information to ensure that
able by, and designed to be used only they function properly and have not
by, the individual. been altered in an unauthorized man-
(ii) When an individual executes one ner.
or more signings not performed during
a single, continuous period of con- PART 12—FORMAL EVIDENTIARY
trolled system access, each signing PUBLIC HEARING
shall be executed using all of the elec-
tronic signature components. Subpart A—General Provisions
(2) Be used only by their genuine
Sec.
owners; and 12.1 Scope.
(3) Be administered and executed to
ensure that attempted use of an indi- Subpart B—Initiation of Proceedings
vidual’s electronic signature by anyone
other than its genuine owner requires 12.20 Initiation of a hearing involving the
issuance, amendment, or revocation of a
collaboration of two or more individ-
regulation.
uals. 12.21 Initiation of a hearing involving the
(b) Electronic signatures based upon issuance, amendment, or revocation of
biometrics shall be designed to ensure an order.
that they cannot be used by anyone 12.22 Filing objections and requests for a
other than their genuine owners. hearing on a regulation or order.
12.23 Notice of filing of objections.
§ 11.300 Controls for identification 12.24 Ruling on objections and requests for
codes/passwords. hearing.
12.26 Modification or revocation of regula-
Persons who use electronic signa- tion or order.
tures based upon use of identification 12.28 Denial of hearing in whole or in part.
codes in combination with passwords 12.30 Judicial review after waiver of hearing
shall employ controls to ensure their on a regulation.
security and integrity. Such controls 12.32 Request for alternative form of hear-
shall include: ing.
12.35 Notice of hearing; stay of action.
(a) Maintaining the uniqueness of 12.37 Effective date of a regulation.
each combined identification code and 12.38 Effective date of an order.
password, such that no two individuals
have the same combination of identi- Subpart C—Appearance and Participation
fication code and password.
12.40 Appearance.
(b) Ensuring that identification code
12.45 Notice of participation.
and password issuances are periodically 12.50 Advice on public participation in hear-
checked, recalled, or revised (e.g., to ings.
cover such events as password aging).
(c) Following loss management pro- Subpart D—Presiding Officer
cedures to electronically deauthorize
12.60 Presiding officer.
lost, stolen, missing, or otherwise po- 12.62 Commencement of functions.
tentially compromised tokens, cards, 12.70 Authority of presiding officer.
and other devices that bear or generate 12.75 Disqualification of presiding officer.
identification code or password infor- 12.78 Unavailability of presiding officer.

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Food and Drug Administration, HHS § 12.20

Subpart E—Hearing Procedures Subpart B—Initiation of


12.80 Filing and service of submissions. Proceedings
12.82 Petition to participate in forma
pauperis. § 12.20 Initiation of a hearing involv-
12.83 Advisory opinions. ing the issuance, amendment, or
12.85 Disclosure of data and information by revocation of a regulation.
the participants. (a) A proceeding under section 409(f),
12.87 Purpose; oral and written testimony; 502(n), 512(n)(5), 701(e), or 721(d) of the
burden of proof. act or section 4 or 5 of the Fair Pack-
12.89 Participation of nonparties. aging and Labeling Act may be initi-
12.90 Conduct at oral hearings or con- ated—
ferences.
(1) By the Commissioner on the Com-
12.91 Time and place of prehearing con-
ference. missioner’s own initiative, e.g., as pro-
12.92 Prehearing conference procedure. vided in § 170.15 for food additives; or
12.93 Summary decisions. (2) By a petition—
12.94 Receipt of evidence. (i) In the form specified elsewhere in
12.95 Official notice. this chapter, e.g., the form for a color
12.96 Briefs and argument. additive petition in § 71.1; or
12.97 Interlocutory appeal from ruling of (ii) If no form is specified, by a peti-
presiding officer. tion under § 10.30.
12.98 Official transcript. (b) If the Commissioner receives a pe-
12.99 Motions. tition under paragraph (a)(2) of this
section, the Commissioner will—
Subpart F—Administrative Record
(1) If it involves any matter subject
12.100 Administrative record of a hearing. to section 701(e) of the act or section 4
12.105 Examination of record. or 5 of the Fair Packaging and Label-
ing Act, and meets the requirements
Subpart G—Initial and Final Decisions for filing, follow the provisions of
12.120 Initial decision.
§ 10.40 (b) through (f);
12.125 Appeal from or review of initial deci- (2) If it involves a color additive or
sion. food additive, and meets the require-
12.130 Decision by Commissioner on appeal ments for filing in §§ 71.1 and 71.2, or in
or review of initial decision. §§ 171.1, 171.6, 171.7, and 171.100, publish
12.139 Reconsideration and stay of action. a notice of filing of the petition within
30 days after the petition is filed in-
Subpart H—Judicial Review stead of a notice of proposed rule-
12.140 Review by the courts. making.
12.159 Copies of petitions for judicial re- (c) [Reserved]
view. (d) The notice promulgating the reg-
ulation will describe how to submit ob-
AUTHORITY: 21 U.S.C. 141–149, 321–393, 467f,
jections and requests for hearing.
679, 821, 1034; 42 U.S.C. 201, 262, 263b–263n, 264;
15 U.S.C. 1451–1461; 5 U.S.C. 551–558, 701–721; 28 (e) On or before the 30th day after the
U.S.C. 2112. date of publication of a final regula-
tion, or of a notice withdrawing a pro-
SOURCE: 44 FR 22339, Apr. 13, 1979, unless posal initiated by a petition under
otherwise noted.
§ 10.25(a), a person may submit to the
Commissioner written objections and a
Subpart A—General Provisions request for a hearing. The 30-day period
may not be extended except that addi-
§ 12.1 Scope. tional information supporting an objec-
The procedures in this part apply tion may be received after 30 days upon
when— a showing of inadvertent omission and
(a) A person has a right to an oppor- hardship, and if review of the objection
tunity for a hearing under the laws and request for hearing will not there-
specified in § 10.50; or by be impeded. If, after a final color ad-
(b) The Commissioner concludes that ditive regulation is published, a peti-
it is in the public interest to hold a for- tion or proposal relating to the regula-
mal evidentiary public hearing on any tion is referred to an advisory com-
matter before FDA. mittee in accordance with section

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§ 12.21 21 CFR Ch. I (4–1–11 Edition)

721(b)(5)(C) of the act, objections and mitted to the Division of Dockets Man-
requests for a hearing may be sub- agement and will be accepted for filing
mitted on or before the 30th day after if they meet the following conditions:
the date on which the order confirming (1) They are submitted within the
or modifying the Commissioner’s pre- time specified in § 12.20(e).
vious order is published. (2) Each objection is separately num-
[44 FR 22339, Apr. 13, 1979, as amended at 64 bered.
FR 399, Jan. 5, 1999] (3) Each objection specifies with par-
ticularity the provision of the regula-
§ 12.21 Initiation of a hearing involv- tion or proposed order objected to.
ing the issuance, amendment, or (4) Each objection on which a hearing
revocation of an order.
is requested specifically so states. Fail-
(a) A proceeding under section 505 (d) ure to request a hearing on an objec-
or (e), 512 (d), (e), (m) (3) or (4), of sec- tion constitutes a waiver of the right
tion 515(g)(1) of the act, or section to a hearing on that objection.
351(a) of the Public Health Service Act, (5) Each objection for which a hear-
may be initiated— ing is requested includes a detailed de-
(1) By the Commissioner on the Com- scription and analysis of the factual in-
missioner’s own initiative; formation to be presented in support of
(2) By a petition in the form specified the objection. Failure to include a de-
elsewhere in this chapter, e.g., § 314.50 scription and analysis for an objection
for new drug applications, § 514.1 for constitutes a waiver of the right to a
new animal drug applications, § 514.2 hearing on that objection. The descrip-
for applications for animal feeds, or tion and analysis may be used only for
§ 601.3 for licenses for biologic products; the purpose of determining whether a
or hearing has been justified under § 12.24,
(3) By a petition under § 10.30. and do not limit the evidence that may
(b) A notice of opportunity for hear- be presented if a hearing is granted.
ing on a proposal to deny or revoke ap-
(i) A copy of any report, article, sur-
proval of all or part of an order will be
vey, or other written document relied
published together with an explanation
upon must be submitted, except if the
of the grounds for the proposed action.
document is—
The notice will describe how to submit
(a) An FDA document that is rou-
requests for hearing. A person subject
tinely publicly available; or
to the notice has 30 days after its
issuance to request a hearing. The 30- (b) A recognized medical or scientific
day period may not be extended. textbook that is readily available to
(c) The Commissioner may use an op- the agency.
tional procedure specified in § 10.30(h) (ii) A summary of the nondocumen-
to consider issuing, amending, or re- tary testimony to be presented by any
voking an order. witnesses relied upon must be sub-
(d) In a proceeding under sections mitted.
505(e), 512(e) or (m), or 515(e) of the act (b) Requests for hearing submitted
in which a party wishes to apply for re- under § 12.21 will be submitted to the
imbursement of certain expenses under Division of Dockets Management and
the Equal Access to Justice Act (5 will be accepted for filing if they meet
U.S.C. 504 and 504 note), FDA will fol- the following conditions:
low the Department of Health and (1) They are submitted on or before
Human Services’ regulations in 45 CFR the 30th day after the date of publica-
part 13. tion of the notice of opportunity for
hearing.
[44 FR 22339, Apr. 13, 1979, as amended at 47
FR 25734, June 15, 1982; 54 FR 9035, Mar. 3, (2) They comply with §§ 314.200,
1989] 514.200, or 601.7(a).
(c) If an objection or request for a
§ 12.22 Filing objections and requests public hearing fails to meet the re-
for a hearing on a regulation or quirements of this section and the defi-
order. ciency becomes known to the Division
(a) Objections and requests for a of Dockets Management, the Division
hearing under § 12.20(d) must be sub- of Dockets Management shall return it

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Food and Drug Administration, HHS § 12.24

with a copy of the applicable regula- (1) There is a genuine and substantial
tions, indicating those provisions not issue of fact for resolution at a hear-
complied with. A deficient objection or ing. A hearing will not be granted on
request for a hearing may be supple- issues of policy or law.
mented and subsequently filed if sub- (2) The factual issue can be resolved
mitted within the 30-day time period by available and specifically identified
specified in § 12.20(e) or § 12.21(b). reliable evidence. A hearing will not be
(d) If another person objects to a reg- granted on the basis of mere allega-
ulation issued in response to a petition tions or denials or general descriptions
submitted under § 12.20(a)(2), the peti- of positions and contentions.
tioner may submit a written reply to (3) The data and information sub-
the Division of Dockets Management. mitted, if established at a hearing,
[44 FR 22339, Apr. 13, 1979, as amended at 54 would be adequate to justify resolution
FR 9035, Mar. 3, 1989; 64 FR 69190, Dec. 10, of the factual issue in the way sought
1999] by the person. A hearing will be denied
if the Commissioner concludes that the
§ 12.23 Notice of filing of objections.
data and information submitted are in-
As soon as practicable after the expi- sufficient to justify the factual deter-
ration of the time for filing objections mination urged, even if accurate.
to and requests for hearing on agency (4) Resolution of the factual issue in
action involving the issuance, amend- the way sought by the person is ade-
ment, or revocation of a regulation quate to justify the action requested. A
under sections 502(n), 701(e), or 721(d) of hearing will not be granted on factual
the act or sections 4 or 5 of the Fair issues that are not determinative with
Packaging and Labeling Act, the Com- respect to the action requested, e.g., if
missioner shall publish a notice in the the Commissioner concludes that the
FEDERAL REGISTER specifying those action would be the same even if the
parts of the regulation that have been
factual issue were resolved in the way
stayed by the filing of proper objec-
sought, or if a request is made that a
tions and, if no objections have been
final regulation include a provision not
filed, stating that fact. The notice does
not constitute a determination that a reasonably encompassed by the pro-
hearing is justified on any objections posal. A hearing will be granted upon
or requests for hearing that have been proper objection and request when a
filed. When to do so will cause no food standard or other regulation is
undue delay, the notice required by shown to have the effect of excluding
this section may be combined with the or otherwise affecting a product or in-
notices described in §§ 12.28 and 12.35. gredient.
(5) The action requested is not incon-
§ 12.24 Ruling on objections and re- sistent with any provision in the act or
quests for hearing. any regulation in this chapter particu-
(a) As soon as possible the Commis- larizing statutory standards. The prop-
sioner will review all objections and re- er procedure in those circumstances is
quests for hearing filed under § 12.22 for the person requesting the hearing
and determine— to petition for an amendment or waiver
(1) Whether the regulation should be of the regulation involved.
modified or revoked under § 12.26; (6) The requirements in other appli-
(2) Whether a hearing has been justi- cable regulations, e.g., §§ 10.20, 12.21,
fied; and 12.22, 314.200, 514.200, and 601.7(a), and in
(3) Whether, if requested, a hearing the notice promulgating the final regu-
before a Public Board of Inquiry under lation or the notice of opportunity for
part 13 or before a public advisory com- hearing are met.
mittee under part 14 or before the Com- (c) In making the determination in
missioner under part 15 has been justi- paragraph (a) of this section, the Com-
fied. missioner may use any of the optional
(b) A request for a hearing will be procedures specified in § 10.30(h) or in
granted if the material submitted other applicable regulations, e.g.,
shows the following: §§ 314.200, 514.200, and 601.7(a).

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§ 12.26 21 CFR Ch. I (4–1–11 Edition)

(d) If it is uncertain whether a hear- lic hearing in whole or in part on an


ing has been justified under the prin- objection or request for hearing con-
ciples in paragraph (b) of this section, sists of the following:
and the Commissioner concludes that (1) If the proceeding involves a regu-
summary decision against the person lation—
requesting a hearing should be consid- (i) The documents specified in
ered, the Commissioner may serve § 10.40(g);
upon the person by registered mail a (ii) The objections and requests for
proposed order denying a hearing. The hearing filed by the Division of Dock-
person has 30 days after receipt of the ets Management;
proposed order to demonstrate that the
(iii) If the proceeding involves a color
submission justifies a hearing.
additive regulation referred to an advi-
[44 FR 22339, Apr. 13, 1979, as amended at 54 sory committee in accordance with
FR 9035, Mar. 3, 1989; 64 FR 399, Jan. 5, 1999] section 721(b)(5)(C) of the act, the com-
mittee’s report and the record of the
§ 12.26 Modification or revocation of committee’s proceeding; and
regulation or order.
(iv) The notice denying a formal evi-
If the Commissioner determines upon dentiary public hearing.
review of an objection or request for (2) If the proceeding involves an
hearing that the regulation or order order—
should be modified or revoked, the
(i) The notice of opportunity for
Commissioner will promptly take such
hearing;
action by notice in the FEDERAL REG-
ISTER. Further objections to or re-
(ii) The requests for hearing filed by
quests for hearing on the modification the Division of Dockets Management;
or revocation may be submitted under (iii) The transcripts, minutes of
§§ 12.20 through 12.22 but no further meetings, reports, FEDERAL REGISTER
issue may be taken with other provi- notices, and other documents consti-
sions in the regulation or order. Objec- tuting the record of any of the optional
tions and requests for hearing that are procedures specified in § 12.24(c) used by
not affected by the modification or rev- the Commissioner, but not the tran-
ocation will remain on file and be script of a closed portion of a public ad-
acted upon in due course. visory committee meeting; and
(iv) The notice denying the hearing.
§ 12.28 Denial of hearing in whole or (c) The record specified in paragraph
in part. (b) of this section is the exclusive
If the Commissioner determines upon record for the Commissioner’s decision
review of the objections or requests for on the complete or partial denial of a
hearing that a hearing is not justified, hearing. The record of the proceeding
in whole or in part, a notice of the de- will be closed as of the date of the
termination will be published. Commissioner’s decision unless an-
(a) The notice will state whether the other date is specified. A person who
hearing is denied in whole or in part. If requested and was denied a hearing
the hearing is denied in part, the no- may submit a petition for reconsider-
tice will be combined with the notice ation under § 10.33 or a petition for stay
of hearing required by § 12.35, and will of action under § 10.35. A person who
specify the objections and requests for wishes to rely upon information or
hearing that have been granted and de- views not included in the administra-
nied. tive record shall submit them to the
(1) Any denial will be explained. A de- Commissioner with a petition under
nial based on an analysis of the infor- § 10.25(a) to modify the final regulation
mation submitted to justify a hearing or order.
will explain the inadequacy of the in- (d) Denial of a request for a hearing
formation. in whole or in part is final agency ac-
(2) The notice will confirm or modify tion reviewable in the courts, under
or stay the effective date of the regula- the statutory provisions governing the
tion or order involved. matter involved, as of the date of pub-
(b) The record of the administrative lication of the denial in the FEDERAL
proceeding relating to denial of a pub- REGISTER.

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Food and Drug Administration, HHS § 12.32

(1) Before requesting a court for a publication of the Commissioner’s rul-


stay of action pending review, a person ing on the objections.
shall first submit a petition for a stay
of action under § 10.35. § 12.32 Request for alternative form of
(2) Under 28 U.S.C. 2112(a), FDA will hearing.
request consolidation of all petitions (a) A person with a right to request a
on a particular matter. hearing may waive that right and re-
(3) The time for filing a petition for quest one of the following alternatives:
judicial review of a denial of a hearing (1) A hearing before a Public Board of
on an objection or issue begins on the Inquiry under part 13.
date the denial is published in the FED- (2) A hearing before a public advisory
ERAL REGISTER, (i) When an objection committee under part 14.
or issues relates to a regulation, if a (3) A hearing before the Commis-
hearing is denied on all objections and sioner under part 15.
issues concerning a part of the proposal (b) The request—
the effectiveness of which has not been (1) May be on the person’s own initia-
deferred pending a hearing on other tive or at the suggestion of the Com-
parts of the proposal; or (ii) when an missioner.
issue relates to an order, if a hearing is (2) Must be submitted in the form of
denied on all issues relating to a par- a citizen petition under § 10.30 before
ticular new drug application, new ani- publication of a notice of hearing under
mal drug application, device premarket § 12.35 or a denial of hearing under
approval application or product devel- § 12.28; and
opment protocol, or biologics license. (3) Must be—
The failure to file a petition for judi- (i) In lieu of a request for a hearing
cial review within the period estab- under this part; or
lished in the statutory provision gov- (ii) If submitted after or with a re-
erning the matter involved constitutes quest for hearing, in the form of a
a waiver of the right to judicial review waiver of the right to request a hearing
of the objection or issue, regardless conditioned on an alternative form of
whether a hearing has been granted on hearing. Upon acceptance by the Com-
other objections and issues. missioner, the waiver becomes binding
and may be withdrawn only by waiving
§ 12.30 Judicial review after waiver of any right to any form of hearing unless
hearing on a regulation.
the Commissioner determines other-
(a) A person with a right to submit wise.
objections and a request for hearing (c) When more than one person re-
under § 12.20(d) may submit objections quests and justifies a hearing under
and waive the right to a hearing. The this part, an alternative form of hear-
waiver may be either an explicit state- ing may by used only if all the persons
ment, or a failure to request a hearing, concur and waive their right to request
as provided in 12.22(a)(4). a hearing under this part.
(b) If a person waives the right to a (d) The Commissioner will determine
hearing, the Commissioner will rule whether an alternative form of hearing
upon the person’s objections under should be used, and if so, which alter-
§§ 12.24 through 12.28. As a matter of native is acceptable, after considering
discretion, the Commissioner may also the requests submitted and the appro-
order a hearing on the matter under priateness of the alternatives for the
any of the provisions of this part. issues raised in the objections. The
(c) If the Commissioner rules ad- Commissioner’s acceptance is binding
versely on a person’s objection, the unless, for good cause, the Commis-
person may petition for judicial review sioner determines otherwise.
in a U.S. Court of Appeals under the (e) The Commissioner will publish a
act. notice of an alternative form of hear-
(1) The record for judicial review is ing setting forth the following informa-
the record designated in § 12.28(b)(1). tion:
(2) The time for filing a petition for (1) The regulation or order that is the
judicial review begins as of the date of subject of the hearing.

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§ 12.35 21 CFR Ch. I (4–1–11 Edition)

(2) A statement specifying any part plications and product development


of the regulation or order that has been protocols. Advisory committee hearing
stayed by operation of law or in the procedures are found in part 14.
Commissioner’s discretion.
(3) The time, date, and place of the § 12.35 Notice of hearing; stay of ac-
hearing, or a statment that such infor- tion.
mation will be contained in a later no- (a) If the Commissioner determines
tice. upon review of the objections and re-
(4) The parties to the hearing. quests for hearing that a hearing is jus-
(5) The issues at the hearing. The tified on any issue, the Commissioner
statement of issues determines the will publish a notice setting forth the
scope of the hearing. following:
(6) If the hearing will be conducted (1) The regulation or order that is the
by a Public Board of Inquiry, the time subject of the hearing.
within which— (2) A statement specifying any part
(i) The parties should submit nomi- of the regulation or order that has been
nees for the Board under § 13.10(b); stayed by operation of law or in the
(ii) A notice of participation under Commissioner’s discretion.
§ 12.45 should be filed; and (3) The parties to the hearing.
(iii) Participants should submit writ-
(4) The issues of fact on which a hear-
ten information under § 13.25. The no-
ing has been justified.
tice will list the contents of the por-
tions of the administrative record rel- (5) A statement of any objections or
evant to the issues at the hearing be- requests for hearing for which a hear-
fore the Board. The portions listed will ing has not been justified, which are
be placed on public display in the office subject to § 12.28.
of the Division of Dockets Management (6) The presiding officer, or a state-
before the notice is published. Addi- ment that the presiding officer will be
tional copies of material already sub- designated in a later notice.
mitted under § 13.25 need not be in- (7) The time within which notices of
cluded with any later submissions. participation should be filed under
(f)(1) The decision of a hearing before § 12.45.
a Public Board of Inquiry or a public (8) The date, time, and place of the
advisory committee under this section prehearing conference, or a statement
has legal status of and will be handled that the date, time, and place will be
as an initial decision under § 12.120. announced in a later notice. The pre-
(2) The decision of a public hearing hearing conference may not commence
before the Commissioner under this until after the time expires for filing
section will be issued as a final order. the notice of participation required by
The final order will have the same con- § 12.45(a).
tent as an initial decision, as specified (9) The time within which partici-
in § 12.120 (b) and (c). pants should submit written informa-
(3) Thereafter, the participants in the tion and views under § 12.85. The notice
proceeding may pursue the administra- will list the contents of the portions of
tive and court remedies specified in the administrative record relevant to
§§ 12.120 through 12.159. the issues at the hearing. The portions
(g) If a hearing before a public advi- listed will be placed on public display
sory committee or a hearing before the in the office of the Division of Dockets
Commissioner is used as an alternative Management before the notice is pub-
form of hearing, all submissions will be lished. Additional copies of material
made to the Division of Dockets Man- already submitted under § 12.85 need
agement, and § 10.20(j) governs their not be included with any later submis-
availability for public examination and sions.
copying. (b) The statement of the issues deter-
(h) This section does not affect the mines the scope of the hearing and the
right to an opportunity for a hearing matters on which evidence may be in-
before a public advisory committee troduced. The issues may be revised by
under section 515(g)(2) of the act re- the presiding officer. A participant
garding device premarket approval ap- may obtain interlocutory review by the

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Food and Drug Administration, HHS § 12.45

Commissioner of a decision by the pre- Subpart C—Appearance and


siding officer to revise the issues to in- Participation
clude an issue on which the Commis-
sioner has not granted a hearing or to § 12.40 Appearance.
eliminate an issue on which a hearing (a) A person who has filed a notice of
has been granted. participation under § 12.45 may appear
(c) A hearing is deemed to begin on in person or by counsel or other rep-
the date of publication of the notice of resentative in any hearing and, subject
hearing. to § 12.89, may be heard concerning all
[44 FR 22339, Apr. 13, 1979, as amended at 47 relevant issues.
FR 26375, June 18, 1982] (b) The presiding officer may strike a
person’s appearance for violation of the
§ 12.37 Effective date of a regulation. rules of conduct in § 12.90.
(a) If no objections are filed and no § 12.45 Notice of participation.
hearing is requested on a regulation
under § 12.20(e), the regulation is effec- (a) Within 30 days after publication
of the notice of hearing under § 12.35, a
tive on the date specified in the regula-
person desiring to participate in a
tion as promulgated.
hearing is to file with the Division of
(b) The Commissioner shall publish a Dockets Management under § 10.20 a
confirmation of the effective date of notice of participation in the following
the regulation. The FEDERAL REGISTER form:
document confirming the effective date
of the regulation may extend the time (Date)
for compliance with the regulation. Division of Dockets Management, Food
and Drug Administration, Department of
§ 12.38 Effective date of an order. Health and Human Services, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
(a) If a person who is subject to a no-
tice of opportunity for hearing under NOTICE OF PARTICIPATION
§ 12.21(b) does not request a hearing,
Docket No. ll
the Commissioner will—
(1) Publish a final order denying or Under 21 CFR part 12, please enter the par-
withdrawing approval of an NDA, ticipation of:
NADA, device premarket approval ap- (Name) llllllllllllllll
plication, or biologics license, in whole (Street address) llllllllllll
or in part, or revoking a device product (City and State) llllllllllll
development protocol or notice of com- (Telephone number) llllllllll
pletion, or declaring that such a pro- Service on the above will be accepted by:
tocol has not been completed, and stat- (Name) llllllllllllllll
ing the effective date of the order; and (Street address) llllllllllll
(2) If the order involves withdrawal of (City and State) llllllllllll
approval of an NADA, forthwith re- (Telephone number) llllllllll
voke, in whole or in part, the applica- The following statements are made as part
ble regulation, under section 512(i) of of this notice of participation:
the act. A. Specific interests. (A statement of the
(b) If a person who is subject to a no- specific interest of the person in the pro-
tice of opportunity for hearing under ceeding, including the specific issues of fact
§ 12.21(b) requests a hearing and others concerning which the person desires to be
heard. This part need not be completed by a
do not, the Commissioner may issue a party to the proceeding.)
final order covering all the drug or de- B. Commitment to participate. (A statement
vice products at once or may issue that the person will present documentary
more than one final order covering dif- evidence or testimony at the hearing and
ferent drug or device products at dif- will comply with the requirements of 21 CFR
ferent times. 12.85, or, in the case of a hearing before a
Public Board of Inquiry, with the require-
ments of 21 CFR 13.25.)
(Signed) llllllllllllllll

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§ 12.50 21 CFR Ch. I (4–1–11 Edition)

(b) An amendment to a notice of par- answer questions about the strengths


ticipation should be filed with the Di- or weaknesses of a party’s position at a
vision of Dockets Management and hearing, litigation strategy, or similar
served on all participants. matters.
(c) No person may participate in a (d) Role of the office of the Chief Coun-
hearing who has not filed a written no- sel. Under no circumstances will the of-
tice of participation or whose partici- fice of the Chief Counsel of FDA di-
pation has been stricken under para- rectly provide advice about a hearing
graph (e) of this section.
to any person who is participating or
(d) The presiding officer may permit
may participate in the hearing. In
the late filing of a notice of participa-
tion upon a showing of good cause. every hearing, certain attorneys in the
(e) The presiding officer may strike office are designated to represent the
the participation of a person for non- center or centers whose action is the
participation in the hearing or failure subject of the hearing. Other members
to comply with any requirement of this of the office, including ordinarily the
subpart, e.g., disclosure of information Chief Counsel, are designated to advise
as required by § 12.85 or the prehearing the Commissioner on a final decision in
order issued under § 12.92. Any person the matter. It is not compatible with
whose participation is stricken may pe- these functions, nor would it be profes-
tition the Commissioner for interlocu- sionally responsible, for the attorneys
tory review. in the office of the Chief Counsel also
[44 FR 22339, Apr. 13, 1979, as amended at 46 to advise other participants in a hear-
FR 8456, Jan. 27, 1981; 59 FR 14364, Mar. 28, ing, or for any attorney who may be
1994; 68 FR 24879, May 9, 2003] called on to advise the Commissioner
to respond to inquiries from other par-
§ 12.50 Advice on public participation ticipants in the hearing, for such par-
in hearings.
ticipants may be urging views contrary
(a) Designated agency contact. All in- to those of the center involved or to
quiries from the public about sched- what may ultimately be the final con-
uling, location, and general procedures clusions of the Commissioner. Accord-
should be addressed to the Deputy ingly, members of the office of the
Commissioner for Policy (HF–22), Food Chief Counsel, other than the attor-
and Drug Administration, 5600 Fishers neys responsible for representing the
Lane, Rockville, MD 20857, or telephone
center whose action is the subject of
301–443–3480. The staff of the Associate
the hearing, will not answer questions
Commissioner for Regulatory Affairs
about the hearing from any participant
will attempt to respond promptly to all
inquiries from members of the public, or potential participant.
as well as to simple requests for infor- (e) Communication between participants
mation from participants in hearings. and attorneys. Participants in a hearing
(b) Hearing schedule changes. Requests may communicate with the attorneys
by hearing participants for changes in responsible for representing the center
the schedule of a hearing or for filing whose action is the subject of the hear-
documents, briefs, or other pleadings ing, in the same way that they may
should be made in writing directly to communicate with counsel for any
the Administrative Law Judge (HF–3), other party in interest about the pres-
Food and Drug Administration, 5600 entation of matters at the hearing. It
Fishers Lane, Rockville, MD 20857. would be inappropriate to bar discus-
(c) Legal advice to individuals. FDA sion of such matters as stipulations of
does not have the resources to provide fact, joint presentation of witnesses, or
legal advice to members of the public possible settlement of hearing issues.
concerning participation in hearings. Members of the public, including par-
Furthermore, to do so would com- ticipants at hearings, are advised, how-
promise the independence of the Com- ever, that all such communications, in-
missioner’s office and invite charges of
cluding those by telephone, will be re-
improper interference in the hearing
corded in memoranda that can be filed
process. Accordingly, the Deputy Com-
missioner for Policy (HF–22) will not

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Food and Drug Administration, HHS § 12.80

with the Division of Dockets Manage- (m) Waive, suspend, or modify any
ment. rule in this subpart under § 10.19 if the
[44 FR 22329, Apr. 13, 1979, as amended at 50
presiding officer determines that no
FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989; party will be prejudiced, the ends of
58 FR 17096, Apr. 1, 1993] justice will be served, and the action is
in accordance with law;
Subpart D—Presiding Officer (n) Strike the participation of any
person under § 12.45(e) or exclude any
§ 12.60 Presiding officer. person from the hearing under § 12.90,
The presiding officer in a hearing or take other reasonable disciplinary
will be the Commissioner, a member of action; and
the Commissioner’s office to whom the (o) Take any action for the fair, expe-
responsibility for the matter involved ditious, and orderly conduct of the
has been delegated, or an administra- hearing.
tive law judge qualified under 5 U.S.C.
3105. § 12.75 Disqualification of presiding of-
ficer.
§ 12.62 Commencement of functions. (a) A participant may request the
The functions of the presiding officer presiding officer to disqualify himself/
begin upon designation and end upon herself and withdraw from the pro-
the filing of the initial decision. ceeding. The ruling on any such re-
quest may be appealed in accordance
§ 12.70 Authority of presiding officer. with § 12.97(b).
The presiding officer has all powers (b) A presiding officer who is aware of
necessary to conduct a fair, expedi- grounds for disqualification shall with-
tious, and orderly hearing, including draw from the proceeding.
the power to—
(a) Specify and change the date, § 12.78 Unavailability of presiding offi-
time, and place of oral hearings and cer.
conferences; (a) If the presiding officer is unable
(b) Establish the procedures for use to act for any reason, the Commis-
in developing evidentiary facts, includ- sioner will assign the powers and du-
ing the procedures in § 12.92(b) and to ties to another presiding officer. The
rule on the need for oral testimony and substitution will not affect the hear-
cross-examination under § 12.87(b); ing, except as the new presiding officer
(c) Prepare statements of the areas of may order.
factual disagreement among the par- (b) Any motion based on the substi-
ticipants; tution must be made within 10 days.
(d) Hold conferences to settle, sim-
plify, or determine the issues in a hear-
ing or to consider other matters that Subpart E—Hearing Procedures
may expedite the hearing;
§ 12.80 Filing and service of submis-
(e) Administer oaths and affirma- sions.
tions;
(f) Control the course of the hearing (a) Submissions, including pleadings
and the conduct of the participants; in a hearing, are to be filed with the
(g) Examine witnesses and strike Division of Dockets Management under
their testimony if they fail to respond § 10.20 except that only two copies need
fully to proper questions; be filed. To determine compliance with
(h) Rule on, admit, exclude, or limit filing deadlines in a hearing, a submis-
evidence; sion is considered submitted on the
(i) Set the time for filing pleadings; date it is actually received by the Divi-
(j) Rule on motions and other proce- sion of Dockets Management. When
dural matters; this part allows a response to a submis-
(k) Rule on motions for summary de- sion and prescribes a period of time for
cision under § 12.93; the filing of the response, an additional
(l) Conduct the hearing in stages if 3 days are allowed for the filing of the
the number of parties is large or the response if the submission is served by
issues are numerous and complex; mail.

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§ 12.82 21 CFR Ch. I (4–1–11 Edition)

(b) The person making a submission whether any regulation or order under
shall serve copies of it on the other consideration in the proceeding applies
participants. Submissions of documen- to a specific situation.
tary data and information are not re-
quired to be served on each participant, § 12.85 Disclosure of data and informa-
but any accompanying transmittal let- tion by the participants.
ter, pleading, summary, statement of (a) Before the notice of hearing is
position, certification under paragraph published under § 12.35, the director of
(d) of this section, or similar document the center responsible for the matters
must be served on each participant. involved in the hearing shall submit
(c) Service is accomplished by mail- the following to the Division of Dock-
ing a submission to the address shown ets Management:
in the notice of participation or by per- (1) The relevant portions of the ad-
sonal delivery. ministrative record of the proceeding.
(d) All submissions are to be accom- Portions of the administrative record
panied by a certificate of service, or a not relevant to the issues in the hear-
statement that service is not required. ing are not part of the administrative
(e) No written submission or other record.
portion of the administrative record (2) All documents in the director’s
may be held in confidence, except as files containing factual information,
provided in § 12.105. whether favorable or unfavorable to
the director’s position, which relate to
§ 12.82 Petition to participate in forma the issues involved in the hearing. Files
pauperis. means the principal files in the center
(a) A participant who believes that in which documents relating to the
compliance with the filing and service issues in the hearing are ordinarily
requirements of this section con- kept, e.g., the food additive master file
stitutes an unreasonable financial bur- and the food additive petition in the
den may submit to the Commissioner a case of issues concerning a food addi-
petition to participate in forma tive, or the new drug application in the
pauperis. case of issues concerning a new drug.
(b) The petition will be in the form Internal memoranda reflecting the de-
specified in § 10.30 except that the head- liberative process, and attorney work
ing will be ‘‘Request to Participate in product and material prepared specifi-
Forma Pauperis, Docket No. ll.’’ Fil- cally for use in connection with the
ing and service requirements for the hearing, are not required to be sub-
petition are described in paragraph (c) mitted.
of this section, whether or not the peti- (3) All other documentary data and
tion is granted. The petition must dem- information relied upon.
onstrate that either: (1) The person is (4) A narrative position statement on
indigent and a strong public interest the factual issues in the notice of hear-
justifies participation, or (2) the per- ing and the type of supporting evidence
son’s participation is in the public in- the director intends to introduce.
terest because it can be considered of (5) A signed statement that, to the
primary benefit to the general public. director’s best knowledge and belief,
(c) The Commissioner may grant or the submission complies with this sec-
deny the petition. If the petition is tion.
granted, the participant need file only (b) Within 60 days of the publication
one copy of each submission with the of the notice of hearing or, if no partic-
Division of Dockets Management. The ipant will be prejudiced, within an-
Division of Dockets Management will other period of time set by the pre-
make sufficient additional copies for siding officer, each participant shall
the administrative record, and serve a submit to the Division of Dockets Man-
copy on each other participant. agement all data and information spec-
ified in paragraph (a)(2) through (5) of
§ 12.83 Advisory opinions. this section, and any objections that
Before or during a hearing, a person the administrative record filed under
may, under § 10.85, request the Commis- paragraph (a)(1) of this section is in-
sioner for an advisory opinion on complete. With respect to the data and

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Food and Drug Administration, HHS § 12.87

information specified in paragraph the safety or effectiveness of a class of


(a)(2) of this section, participants shall drug products, the safety of a food or
exercise reasonable diligence in identi- color additive, or a definition and
fying documents in files comparable to standard of identity for a food; or the
those described in that paragraph. issues may have specific applicability
(c) Submissions required by para- to past action and depend upon par-
graphs (a) and (b) of this section may ticular facts concerning only that
be supplemented later in the pro- party, e.g., the applicability of a grand-
ceeding, with the approval of the pre- father clause to a particular brand of a
siding officer, upon a showing that the drug or the failure of a particular man-
material contained in the supplement
ufacturer to meet required manufac-
was not reasonably known or available
turing and processing specifications or
when the submission was made or that
other general standards.
the relevance of the material contained
in the supplement could not reasonably (i) If the proceeding involves general
have been forseen. issues, direct testimony will be sub-
(d) A participant’s failure to comply mitted in writing, except on a showing
substantially and in good faith with that written direct testimony is insuf-
this section constitutes a waiver of the ficient for a full and true disclosure of
right to participate further in the hear- relevant facts and that the participant
ing; failure of a party to comply con- will be prejudiced if unable to present
stitutes a waiver of the right to a hear- oral direct testimony. If the proceeding
ing. involves particular issues, each party
(e) Participants may reference each may determine whether, and the extent
other’s submissions. To reduce duplica- to which, each wishes to present direct
tive submissions, participants are en- testimony orally or in writing.
couraged to exchange and consolidate (ii) Oral cross-examination of wit-
lists of documentary evidence. If a par- nesses will be permitted if it appears
ticular document is bulky or in limited that alternative means of developing
supply and cannot reasonably be repro- the evidence are insufficient for a full
duced, and it constitutes relevant evi- and true disclosure of the facts and
dence, the presiding officer may au- that the party requesting oral cross-ex-
thorize submission of a reduced number amination will be prejudiced by denial
of copies. of the request or that oral cross-exam-
(f) The presiding officer will rule on ination is the most effective and effi-
questions relating to this section.
cient means to clarify the matters at
[44 FR 22339, Apr. 13, 1979, as amended at 54 issue.
FR 9035, Mar. 3, 1989] (2) Witnesses shall give testimony
§ 12.87 Purpose; oral and written testi- under oath.
mony; burden of proof. (c) Except as provided in paragraph
(d) of this section, in a hearing involv-
(a) The objective of a formal evi-
ing issuing, amending, or revoking a
dentiary hearing is the fair determina-
regulation or order, the originator of
tion of relevant facts consistent with
the right of all interested persons to the proposal or petition or of any sig-
participate and the public interest in nificant modification will be, within
promptly settling controversial mat- the meaning of 5 U.S.C. 556(d), the pro-
ters affecting the public health and ponent of the regulation or order, and
welfare. will have the burden of proof. A partic-
(b) Accordingly, the evidence at a ipant who proposes to substitute a new
hearing is to be developed to the max- provision for a provision objected to
imum extent through written submis- has the burden of proof in relation to
sions, including written direct testi- the new provision.
mony, which may be in narrative or in (d) At a hearing involving issuing,
question-and-answer form. amending, or revoking a regulation or
(1) In a hearing, the issues may have order relating to the safety or effec-
general applicability and depend on tiveness of a drug, device, food addi-
general facts that do not concern par- tive, or color additive, the participant
ticular action of a specific party, e.g., who is contending that the product is

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§ 12.89 21 CFR Ch. I (4–1–11 Edition)

safe or effective or both and who is re- duct during any hearing, constitute
questing approval or contesting with- grounds for immediate exclusion from
drawal of approval has the burden of the proceeding by the presiding officer.
proof in establishing safety or effec-
tiveness or both and thus the right to § 12.91 Time and place of prehearing
approval. The burden of proof remains conference.
on that participant in an amendment A prehearing conference will com-
or revocation proceeding. mence at the date, time, and place an-
[44 FR 22339, Apr. 13, 1979 as amended at 64 nounced in the notice of hearing, or in
FR 399, Jan. 5, 1999] a later notice, or as specified by the
presiding officer in a notice modifying
§ 12.89 Participation of nonparties. a prior notice. At that conference the
(a) A nonparty participant may— presiding officer will establish the
(1) Attend all conferences (including methods and procedures to be used in
the prehearing conference), oral pro- developing the evidence, determine
ceedings, and arguments; reasonable time periods for the conduct
(2) Submit written testimony and of the hearing, and designate the times
documentary evidence for inclusion in and places for the production of wit-
the record; nesses for direct and cross-examination
(3) File written objections, briefs, and if leave to conduct oral examination is
other pleadings; and granted on any issue, as far as prac-
(4) Present oral argument. ticable at that time.
(b) A nonparty participant may not—
(1) Submit written interrogatories; § 12.92 Prehearing conference proce-
and dure.
(2) Conduct cross-examination.
(a) Participants in a hearing are to
(c) A person whose petition is the
appear at the prehearing conference
subject of the hearing has the same
right as a party. prepared to discuss and resolve all mat-
(d) A nonparty participant will be ters specified in paragraph (b) of this
permitted additional rights if the pre- section.
siding officer concludes that the par- (1) To expedite the hearing, partici-
ticipant’s interests would not be ade- pants are encouraged to prepare in ad-
quately protected otherwise or that vance for the prehearing conference.
broader participation is required for a Participants should cooperate with
full and true disclosure of the facts, each other, and request information
but the rights of a nonparty partici- and begin preparation of testimony at
pant may not exceed the rights of a the earliest possible time. Failure of a
party. participant to appear at the prehearing
conference or to raise matters that
[44 FR 22339, Apr. 13, 1979, as amended at 48
FR 51770, Nov. 14, 1983]
could reasonably be anticipated and re-
solved at that time will not delay the
§ 12.90 Conduct at oral hearings or progress of the hearing, and con-
conferences. stitutes a waiver of the rights of the
All participants in a hearing will participant regarding such matters as
conduct themselves with dignity and objections to the agreements reached,
observe judicial standards of practice actions taken, or rulings issued by the
and ethics. They may not indulge in presiding officer and may be grounds
personal attacks, unseemly wrangling, for striking the participation under
or intemperate accusations or charac- § 12.45.
terizations. Representatives of parties (2) Participants shall bring to the
shall, to the extent possible, restrain prehearing conference the following
clients from improprieties in connec- specific information, which will be
tion with any proceeding. Disrespect- filed with the Division of Dockets Man-
ful, disorderly, or contumacious lan- agement under § 12.80:
guage or conduct, refusal to comply (i) Any additional information to
with directions, use of dilatory tactics, supplement the submission filed under
or refusal to adhere to reasonable § 12.85, which may be filed if approved
standards of orderly and ethical con- under § 12.85(c).

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Food and Drug Administration, HHS § 12.93

(ii) A list of all witnesses whose testi- (iv) Written requests for the produc-
mony will be offered, orally or in writ- tion of additional documentation, data,
ing, at the hearing, with a full cur- or other relevant information;
riculum vitae for each. Additional wit- (v) Submission of written questions
nesses may later be identified, with the to be asked by the presiding officer of
approval of the presiding officer, on a a specific witness; and
showing that the witness was not rea- (vi) Identification of facts for which
sonably available at the time of the oral examination and/or cross-exam-
prehearing conference or the relevance ination is appropriate.
of the witness’ views could not reason- (3) To group participants with sub-
ably have been foreseen at that time. stantially like interests for presenting
(iii) All prior written statements in- evidence, making motions and objec-
tions, including motions for summary
cluding articles and any written state-
decision, filing briefs, and presenting
ment signed or adopted, or a recording
oral argument.
or transcription of an oral statement
(4) To hear and rule on objections to
made, by persons identified as wit-
admitting into evidence information
nesses if— submitted under § 12.85.
(a) The statement is available with- (5) To obtain stipulations and admis-
out making request of the witness or sions of facts.
any other person; (6) To take other action that may ex-
(b) The statement relates to the sub- pedite the hearing.
ject matter of the witness’ testimony; (c) The presiding officer shall issue,
and orally or in writing, a prehearing order
(c) The statement either was made reciting the actions taken at the pre-
before the time the person agreed to hearing conference and setting forth
become a witness or has been made the schedule for the hearing. The order
publicly available by the person. will control the subsequent course of
(b) The presiding officer will conduct the hearing unless modified by the pre-
a prehearing conference for the fol- siding officer for good cause.
lowing purposes:
§ 12.93 Summary decisions.
(1) To determine the areas of factual
disagreement to be considered at the (a) After the hearing commences, a
hearing. The presiding officer may hold participant may move, with or without
conferences off the record in an effort supporting affidavits, for a summary
to reach agreement on disputed factual decision on any issue in the hearing.
questions. Any other participant may, within 10
(2) To identify the most appropriate days after service of the motion, which
techniques for developing evidence on time may be extended for an additional
issues in controversy and the manner 10 days for good cause, serve opposing
and sequence in which they will be affidavits or countermove for summary
used, including, where oral examina- decision. The presiding officer may set
the matter for argument and call for
tion is to be conducted, the sequence in
the submission of briefs.
which witnesses will be produced for,
(b) The presiding officer will grant
and the time and place of, oral exam-
the motion if the objections, requests
ination. The presiding officer may con-
for hearing, other pleadings, affidavits,
sider— and other material filed in connection
(i) Submission of narrative state- with the hearing, or matters officially
ments of position on factual issues in noticed, show that there is no genuine
controversy; issue as to any material fact and that
(ii) Submission of evidence or identi- a participant is entitled to summary
fication of previously submitted evi- decision.
dence to support such statements, such (c) Affidavits should set forth facts
as affidavits, verified statements of that would be admissible in evidence
fact, data, studies, and reports; and show affirmatively that the affiant
(iii) Exchange of written interrog- is competent to testify to the matters
atories directed to particular wit- stated. When a properly supported mo-
nesses; tion for summary decision is made, a

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§ 12.94 21 CFR Ch. I (4–1–11 Edition)

participant opposing the motion may (ii) Exclusion of part or all of the
not rest upon mere allegations or deni- written evidence of a participant is
als or general descriptions of positions necessary to enforce the requirements
and contentions; affidavits or other re- of this subpart; or
sponses must set forth specific facts (iii) The evidence was not submitted
showing that there is a genuine issue of as required by § 12.85.
fact for the hearing. (2) Items of written evidence are to
(d) Should it appear from the affida- be submitted as separate documents,
vits of a participant opposing the mo- sequentially numbered, except that a
tion that for sound reasons stated, voluminous document may be sub-
facts essential to justify the opposition mitted in the form of a cross-reference
cannot be presented by affidavit, the to the documents filed under § 12.85.
presiding officer may deny the motion (3) Written evidence excluded by the
for summary decision, order a continu- presiding officer as inadmissible re-
ance to permit affidavits or additional mains a part of the administrative
evidence to be obtained, or issue other record, as an offer of proof, for judicial
just order. review.
(e) If on motion under this section a (d) Testimony, whether on direct or
summary decision is not rendered upon on cross-examination, is admissible as
the whole case or for all the relief evidence unless a participant objects
asked. and evidentiary facts need to be and the presiding officer excludes it.
developed, the presiding officer will (1) The presiding officer may exclude
issue an order specifying the facts that oral evidence as inadmissible only if—
appear without substantial controversy (i) The evidence is irrelevant, imma-
and directing further evidentiary pro- terial, unreliable, or repetitive; or
ceedings. The facts so specified will be
(ii) Exclusion of part or all of the evi-
deemed established.
dence is necessary to enforce the re-
(f) A participant may obtain inter- quirements of this part.
locutory review by the Commissioner
(2) If oral evidence is excluded as in-
of a summary decision of the presiding
admissible, the participant may take
officer.
written exception to the ruling in a
§ 12.94 Receipt of evidence. brief to the Commissioner, without
taking oral exception at the hearing.
(a) A hearing consists of the develop- Upon review, the Commissioner may
ment of evidence and the resolution of reopen the hearing to permit the evi-
factual issues as set forth in this sub- dence to be admitted if the Commis-
part and in the prehearing order. sioner determines that its exclusion
(b) All orders, transcripts, written was erroneous and prejudicial.
statements of position, written direct (e) The presiding officer may sched-
testimony, written interrogatories and ule conferences as needed to monitor
responses, and any other written mate- the program of the hearing, narrow and
rial submitted in the proceeding is a simplify the issues, and consider and
part of the administrative record of the rule on motions, requests, and other
hearing, and will be promptly placed on matters concerning the development of
public display in the office of the Divi- the evidence.
sion of Dockets Management, except as (f) The presiding officer will conduct
provided in § 12.105. such proceedings as are necessary for
(c) Written evidence, identified as the taking of oral testimony, for the
such, is admissible unless a participant oral examination of witnesses by the
objects and the presiding officer ex- presiding officer on the basis of written
cludes it on objection of a participant questions previously submitted by the
or on the presiding officer’s own initia- parties, and for the conduct of cross-ex-
tive. amination of witnesses by the parties.
(1) The presiding officer may exclude The presiding officer shall exclude ir-
written evidence as inadmissible only relevant or repetitious written ques-
if— tions and limit oral cross-examination
(i) The evidence is irrelevant, imma- to prevent irrelevant or repetitious ex-
terial, unreliable, or repetitive; amination.

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Food and Drug Administration, HHS § 12.99

(g) The presiding officer shall order presiding officer may not be appealed
the proceedings closed for the taking of to the Commissioner before the Com-
oral testimony relating to matters missioner’s consideration of the entire
specified in § 10.20(j)(2)(i) (a) and (b). record of the hearing.
Such closed proceedings will be con- (b) A ruling of the presiding officer is
ducted in accordance with § 10.20(j)(3). subject to interlocutory appeal to the
Participation in closed proceedings Commissioner if the presiding officer
will be limited to the witness, the wit- certifies on the record or in writing
ness’ counsel, and Federal Government that immediate review is necessary to
executive branch employees and spe- prevent exceptional delay, expense, or
cial government employees. Closed pro- prejudice to any participant, or sub-
ceedings will be permitted only for, and stantial harm to the public interest.
will be limited to, oral testimony di- (c) When an interlocutory appeal is
rectly relating to matters specified in made to the Commissioner, a partici-
§ 10.20(j)(3). pant may file a brief with the Commis-
sioner only if specifically authorized
§ 12.95 Official notice. by the presiding officer or the Commis-
(a) Official notice may be taken of sioner, and if such authorization is
such matters as might be judicially no- granted, within the period the Commis-
ticed by the courts of the United sioner directs. If a participant is au-
States or of any other matter pecu- thorized to file a brief, any other par-
liarly within the general knowledge of ticipant may file a brief in opposition,
FDA as an expert agency. within the period the Commissioner di-
(b) If official notice is taken of a ma- rects. If no briefs are authorized, the
terial fact not appearing in the evi- appeal will be presented as an oral ar-
dence of record, a participant, on time- gument to the Commissioner. The oral
ly request, will be afforded an oppor- argument will be transcribed. If briefs
tunity to show the contrary. are authorized, oral argument will be
heard only at the discretion of the
§ 12.96 Briefs and arguments. Commissioner.
(a) Promptly after the taking of evi-
dence is completed, the presiding offi- § 12.98 Official transcript.
cer will announce a schedule for the fil- (a) The presiding officer will arrange
ing of briefs. Briefs are to be filed ordi- for a verbatim stenographic transcript
narily within 45 days of the close of the of oral testimony and for necessary
hearing. Briefs must include a state- copies of the transcript.
ment of position on each issue, with (b) One copy of the transcript will be
specific and complete citations to the placed on public display in the office of
evidence and points of law relied on. the Division of Dockets Management
Briefs must contain proposed findings upon receipt.
of fact and conclusions of law. (c) Except as provided in § 12.105, cop-
(b) The presiding officer may, as a ies of the transcript may be obtained
matter of discretion, permit oral argu- by application to the official reporter
ment after the briefs are filed. and payment of costs thereof or under
(c) Briefs and oral argument are to part 20.
refrain from disclosing specific details (d) Witnesses, participants, and coun-
of written and oral testimony and doc- sel have 30 days from the time the
uments relating to matters specified in transcript becomes available to pro-
§ 10.20(j)(2)(i)(a) and (b), except as spe- pose corrections in the transcript of
cifically authorized in a protective oral testimony. Corrections are per-
order issued under § 10.20(j)(3). mitted only for transcription errors.
The presiding officer shall promptly
§ 12.97 Interlocutory appeal from rul- order justified corrections.
ing of presiding officer.
(a) Except as provided in paragraph § 12.99 Motions.
(b) of this section and in §§ 12.35(b), (a) A motion on any matter relating
12.45(e), 12.93(f), and 12.99(d), when an to the proceeding is to be filed under
interlocutory appeal is specifically au- § 12.80, and must include a draft order,
thorized by this subpart, rulings of the except one made in the course of an

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§ 12.100 21 CFR Ch. I (4–1–11 Edition)

oral hearing before the presiding offi- (1) With respect to the taking of evi-
cer. dence, when specified by the presiding
(b) A response may be filed within 10 officer; and
days of service of a motion. The time (2) With respect to pleadings, at the
may be shortened or extended by the time specified in § 12.96(a) for the filing
presiding officer for good cause shown. of briefs.
(c) The moving party has no right to (c) The presiding officer may reopen
reply, except as permitted by the pre- the record to receive further evidence
siding officer. at any time before the filing of the ini-
(d) The presiding officer shall rule tial decision.
upon the motion and may certify that
ruling to the Commissioner for inter- § 12.105 Examination of record.
locutory review. Documents in the record will be pub-
licly available in accordance with
Subpart F—Administrative Record § 10.20(j). Documents available for ex-
amination or copying will be placed on
§ 12.100 Administrative record of a public display in the office of the Divi-
hearing. sion of Dockets Management promptly
(a) The record of a hearing consists upon receipt in that office.
of—
(1) The order or regulation or notice Subpart G—Initial and Final
of opportunity for hearing that gave Decisions
rise to the hearing;
(2) All objections and requests for § 12.120 Initial decision.
hearing filed by the Division of Dock- (a) The presiding officer shall prepare
ets Management under §§ 12.20 through and file an initial decision as soon as
12.22; possible after the filing of briefs and
(3) The notice of hearing published oral argument.
under § 12.35; (b) The initial decision must con-
(4) All notices of participation filed tain—
under § 12.45; (1) Findings of fact based issued upon
(5) All FEDERAL REGISTER notices relevant, material, and reliable evi-
pertinent to the proceeding; dence of record;
(6) All submissions filed under § 12.82, (2) Conclusions of law;
e.g., the submissions required by § 12.85, (3) A discussion of the reasons for the
all other documentary evidence and findings and conclusions, including a
written testimony, pleadings, state- discussion of the significant conten-
ments of position, briefs, and other tions made by any participant;
similar documents; (4) Citations to the record supporting
(7) The transcript, written order, and the findings and conclusions;
all other documents relating to the (5) An appropriate regulation or
prehearing conference, prepared under order supported by substantial evi-
§ 12.92; dence of record and based upon the
(8) All documents relating to any mo- findings of fact and conclusions of law;
tion for summary decision under § 12.93; and
(9) All documents of which official (6) An effective date for the regula-
notice is taken under § 12.95; tion or order.
(10) All pleadings filed under § 12.96; (c) The initial decision must refrain
(11) All documents relating to any in- from disclosing specific details of mat-
terlocutory appeal under § 12.97; ters specified in § 10.20(j)(2)(i) (a) and
(12) All transcripts prepared under (b), except as specifically authorized in
§ 12.98; and a protective order issued pursuant to
(13) Any other document relating to § 10.20(j)(3).
the hearing and filed with the Division (d) The initial decision is to be filed
of Dockets Management by the pre- with the Division of Dockets Manage-
siding officer or any participant; ment and served upon all participants.
(b) The record of the administrative Once the initial decision is filed with
proceeding is closed— the Division of Dockets Management,

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Food and Drug Administration, HHS § 12.139

the presiding officer has no further ju- each participant, and the issues to be
risdiction over the matter, and any addressed.
motions or requests filed with the Divi- (f) Within 10 days following the expi-
sion of Dockets Management will be ration of the time for filing exceptions
decided by the Commissioner. (including any extensions), the Com-
(e) The initial decision becomes the missioner may file with the Division of
final decision of the Commissioner by Dockets Management, and serve on the
operation of law unless a participant participants, a notice of the Commis-
files exceptions with the Division of sioner’s determination to review the
Dockets Management under § 12.125(a) initial decision. The Commissioner
or the Commissioner files a notice of may invite the participants to file
review under § 12.125(f). briefs or present oral argument on the
(f) Notice that an initial decision has matter. The time for filing briefs or
become the decision of the Commis- presenting oral argument will be speci-
sioner without appeal to or review by fied in that or a later notice.
the Commissioner will be published in
the FEDERAL REGISTER, or the Commis- [44 FR 22339, Apr. 13, 1979, as amended at 53
sioner may publish the decision when FR 29453, Aug. 5, 1988]
it is of widespread interest.
§ 12.130 Decision by Commissioner on
§ 12.125 Appeal from or review of ini- appeal or review of initial decision.
tial decision. (a) On appeal from or review of the
(a) A participant may appeal an ini- initial decision, the Commissioner has
tial decision to the Commissioner by all the powers given to make the ini-
filing exceptions with the Division of tial decision. On the Commissioner’s
Dockets Management, and serving own initiative or on motion, the Com-
them on the other participants, within missioner may remand the matter to
60 days of the date of the initial deci- the presiding officer for any further ac-
sion. tion necessary for a proper decision.
(b) Exceptions must specifically iden- (b) The scope of the issues on appeal
tify alleged errors in the findings of is the same as the scope of the issues at
fact or conclusions of law in the initial the public hearing unless the Commis-
decision, and provide supporting cita- sioner specifies otherwise.
tions to the record. Oral argument be- (c) As soon as possible after the filing
fore the Commissioner may be re- of briefs and any oral argument, the
quested in the exceptions. Commissioner will issue a final deci-
(c) Any reply to the exceptions is to sion in the proceeding, which meets the
be filed and served within 60 days of requirements established in § 12.120 (b)
the end of the period for filing excep- and (c).
tions.
(d) The Commissioner may adopt the
(d) The Commissioner may extend initial decision as the final decision.
the time for filing exceptions under
(e) Notice of the Commissioner’s de-
paragraph (a) of this section or replies
cision will be published in the FEDERAL
to exceptions under paragraph (c) of
this section only upon a showing by a REGISTER, or the Commissioner may
participant of extraordinary cir- publish the decision when it is of wide-
cumstances. Such an extension shall be spread interest.
requested by filing a written request
§ 12.139 Reconsideration and stay of
with the Commissioner’s Executive
action.
Secretariat (HF–40) and serving copies
of the request on the Division of Dock- Following notice or publication of
ets Management (HFA–305), the Chief the final decisions, a participant may
Counsel (GCF–1), and all hearing par- petition the Commissioner for recon-
ticipants. sideration of any part or all of the deci-
(e) If the Commissioner decides to sion under § 10.33 or may petition for a
hear oral argument, the participants stay of the decision under § 10.35.
will be informed of the date, time, and
place, the amount of time allotted to

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§ 12.140 21 CFR Ch. I (4–1–11 Edition)

Subpart H—Judicial Review Subpart A—General Provisions


§ 12.140 Review by the courts. § 13.1 Scope.
(a) The Commissioner’s final decision The procedures in this part apply
constitutes final agency action from when—
which a participant may petition for (a) The Commissioner concludes, as a
judicial review under the statutes gov- matter of discretion, that it is in the
erning the matter involved. Before re- public interest to hold a public hearing
questing an order from a court for a before a Public Board of Inquiry
stay of action pending review, a partic- (Board) with respect to any matter be-
ipant shall first submit a petition for a fore FDA;
stay of action under § 10.35. (b) Under specific sections of this
(b) Under 28 U.S.C. 2112(a), FDA will chapter a matter before FDA is subject
request consolidation of all petitions to a hearing before a Board; or
related to a particular matter. (c) Under § 12.32, a person who has a
right to an opportunity for a formal
§ 12.159 Copies of petitions for judicial evidentiary public hearing waives that
review. opportunity and requests that a Board
The Chief Counsel for FDA has been act as an administrative law tribunal
designated by the Secretary as the offi- concerning the matters involved, and
cer on whom copies of petitions of judi- the Commissioner decides to accept
cial review are to be served. This offi- this request.
cer is responsible for filing the record
on which the final decision is based. § 13.5 Notice of a hearing before a
Board.
The record of the proceeding is cer-
tified by the Commissioner. If the Commissioner determines that
a Board should be established to con-
PART 13—PUBLIC HEARING BEFORE duct a hearing on any matter, a notice
of hearing will be published in the FED-
A PUBLIC BOARD OF INQUIRY
ERAL REGISTER setting forth the fol-
lowing information:
Subpart A—General Provisions
(a) If the hearing is under § 13.1 (a) or
Sec. (b), all applicable information de-
13.1 Scope. scribed in § 12.32(e).
13.5 Notice of a hearing before a Board. (1) Any written document that is to
13.10 Members of a Board. be the subject matter of the hearing
13.15 Separation of functions; ex parte com- will be published as a part of the no-
munications; administrative support.
tice, or the notice will refer to it if the
document has already been published
Subpart B—Hearing Procedures
in the FEDERAL REGISTER or state that
13.20 Submissions to a Board. the document is available from the Di-
13.25 Disclosure of data and information by vision of Dockets Management or an
the participants. agency employee designated in the no-
13.30 Proceedings of a Board. tice.
(2) For purposes of a hearing under
Subpart C—Records of a Hearing Before a § 13.1 (a) or (b), all participants who file
Board
a notice of participation under
13.40 Administrative record of a Board. § 12.32(e)(6)(ii) are deemed to be parties
13.45 Examination of administrative record. and entitled to participate in selection
13.50 Record for administrative decision. of the Board under § 13.15(b).
AUTHORITY: 5 U.S.C. 551–558, 701–721; 15
(b) If the hearing is in lieu of a for-
U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–393, mal evidentiary hearing, as provided in
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, § 13.1(c), all of the information de-
262, 263b–263n, 264. scribed in § 12.32(e).
SOURCE: 44 FR 22348, Apr. 13, 1979, unless [44 FR 22348, Apr. 13, 1979, as amended at 47
otherwise noted. FR 26375, June 18, 1982]

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Food and Drug Administration, HHS § 13.10

§ 13.10 Members of a Board. tial but is available for judicial review


(a) All members of a Board are to in the event that it becomes relevant
have medical, technical, scientific, or to any issue before a court.
other qualifications relevant to the (c) After reviewing the lists of nomi-
issues to be considered, are subject to nees and any comments, the Commis-
the conflict of interest rules applicable sioner will choose three qualified per-
to special Government employees, and sons as members of a Board. One mem-
are to be free from bias or prejudice ber will be from the lists of nominees
concerning the issues involved. A mem- submitted by the director of the center
ber of a Board may be a full-time or and by any person whose petition was
part-time Federal Government em- granted and is the subject of the hear-
ployee or may serve on an FDA advi- ing. The second will be from the lists of
sory committee but, except with the nominees submitted by the other par-
agreement of all parties, may not cur- ties. The Commissioner may choose the
rently be a full-time or part-time em- third member from any source. That
ployee of FDA or otherwise act as a member is the Chairman of the Board.
special Government employee of FDA.
(b) Within 30 days of publication of (1) If the Commissioner is unable to
the notice of hearing, the director of find a qualified person with no conflict
the center of FDA responsible for a of interest from among a list of nomi-
matter before a Board, the other par- nees or if additional information is
ties to the proceeding, and any person needed, the Commissioner will request
whose petition was granted and is the the submission of the required addi-
subject of the hearing, shall each sub- tional nominees or information.
mit to the Division of Dockets Manage- (2) If a person fails to submit a list of
ment the names and full curricula nominees as required by paragraph (b)
vitae of five nominees for members of of this section, the Commissioner may
the Board. Nominations are to state choose a qualified member without fur-
that the nominee is aware of the nomi- ther consultation with that person.
nation, is interested in becoming a (3) The Commissioner will announce
member of the Board, and appears to the members of a Board by filing a
have no conflict of interest. memorandum in the record of the pro-
(1) Any two or more persons entitled
ceeding and sending a copy to all par-
to nominate members may agree upon
ticipants.
a joint list of five qualified nominees.
(2) The lists of nominees must be sub- (d) Instead of using the selection
mitted to the persons entitled to sub- method in paragraphs (b) and (c) of this
mit a list of nominees under this para- section, the director of the center, the
graph but not to all participants. With- other parties to the proceeding, and
in 10 days of receipt of the lists of any person whose petition was granted
nominees, such persons may submit and is the subject of the hearing, may,
comments to the Division of Dockets with the approval of the Commissioner,
Management on whether the nominees agree that a standing advisory com-
of the other persons meet the criteria mittee listed in § 14.80 constitutes the
established in paragraph (a) of this sec- Board for a particular proceeding, or
tion. A person submitting comments to that another procedure is to be used for
the Division of Dockets Management selection of the members of the Board,
shall submit them to all persons enti- or that the Board consists of a larger
tled to submit a list of nominees. number of members.
(3) The lists of nominees and com- (e) The members of a Board serve as
ments on them are to be held in con- consultants to the Commissioner and
fidence by the Division of Dockets are special Government employees or
Management as part of the administra-
Government employees. A Board func-
tive record of the proceeding and are
tions as an administrative law tribunal
not to be made available for public dis-
closure, and all persons who submit or in the proceeding and is not an advi-
receive them shall similarly hold them sory committee subject to the require-
in confidence. This portion of the ad- ments of the Federal Advisory Com-
ministrative record remains confiden- mittee Act or part 14.

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§ 13.15 21 CFR Ch. I (4–1–11 Edition)

(f) The Chairman of the Board has this section constitutes an unreason-
the authority of a presiding officer set able financial burden may submit to
out in § 12.70. the Commissioner a petition to partici-
[44 FR 22348, Apr. 13, 1979, as amended at 50 pate in forma pauperis in the form and
FR 8994, Mar. 6, 1985] manner specified in § 12.82.

§ 13.15 Separation of functions; ex § 13.25 Disclosure of data and informa-


parte communications; administra- tion by the participants.
tive support. (a) Before the notice of hearing is
(a) The proceeding of a Board are published under § 13.5, the director of
subject to the provisions of § 10.55 relat- the center responsible for the matters
ing to separation of functions and ex involved in the hearing must submit to
parte communications. Representa- the Division of Dockets Management—
tives of the participants in any pro- (1) The relevant portions of the exist-
ceeding before a Board, including any ing administrative record of the pro-
members of the office of the Chief ceeding. Portions of the administrative
Counsel of FDA assigned to advise the record not relevant to the issues in the
center responsible for the matter, may
hearing are not part of the administra-
have no contact with the members of
tive record;
the Board, except as participants in the
proceeding, and may not participate in (2) A list of all persons whose views
the deliberations of the Board. will be presented orally or in writing at
(b) Administrative support for a the hearing;
Board is to be provided only by the of- (3) All documents in the director’s
fice of the Commissioner and the office files containing factual information,
of the Chief Counsel for FDA. whether favorable or unfavorable to
the director’s position, which relate to
[44 FR 22348, Apr. 13, 1979, as amended at 54
the issues involved in the hearing. Files
FR 9035, Mar. 3, 1989]
means the principal files in the center
in which documents relating to the
Subpart B—Hearing Procedures issues in the hearing are ordinarily
§ 13.20 Submissions to a Board. kept, e.g., the food additive master file
and the food additive petition in the
(a) Submissions are to be filed with case of issues concerning a food addi-
the Division of Dockets Management tive, or the new drug application in the
under § 10.20. case of issues concerning a new drug.
(b) The person making a submission Internal memoranda reflecting the de-
shall serve copies of it on each partici- liberative process, and attorney work
pant in the proceeding, except as pro- product and material prepared specifi-
vided in §§ 13.10(b)(2) and 13.45. Submis- cally for use in connection with the
sions of documentary data and infor- hearing, are not required to be sub-
mation need not be sent to each partic-
mitted;
ipant, but any accompanying trans-
(4) All other documentary informa-
mittal letter, summary, statement of
position, certification under paragraph tion relied on; and
(d) of this section, or similar document (5) A signed statement that, to the
must be. best of the director’s knowledge and
(c) A submission must be mailed to belief, the submission complies with
the address shown in the notice of ap- this section.
pearance or personally delivered. (b) Within the time prescribed in the
(d) All submissions are to be accom- notice of hearing published under § 13.5,
panied by a certificate of service, or a each participant shall submit to the
statement that service is not required. Division of Dockets Management all
(e) No written submission or other information specified in paragraph
portion of the administrative record (a)(2) through (5) of this section and
may be held in confidence, except as any objections that the administrative
provided in §§ 13.10(b)(2) and 13.45. record filed under paragraph (a)(1) of
(f) A participant who believes that this section is incomplete. With re-
compliance with the requirements of spect to the information specified in

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Food and Drug Administration, HHS § 13.30

paragraph (a)(3) of this section, partici- terrupt a presentation, but members of


pants are to exercise reasonable dili- the Board may ask questions. At the
gence in identifying documents in files conclusion of a presentation, each of
comparable to those described in that the other participants may briefly
paragraph. comment on the presentation and may
(c) The submissions required by para- request that the Board conduct further
graphs (a) and (b) of this section may questioning on specified matters. Mem-
be supplemented later in the pro- bers of the Board may then ask further
ceeding, with the approval of the questions. Any other participant may
Board, on a showing that the views of be permitted to ask questions if the
the persons or the material contained Chairman determines that it will help
in the supplement was not known or resolve the issues.
reasonably available when the initial (d) The hearing is informal and the
submission was made or that the rel- rules of evidence do not apply. No mo-
evance of the views of the persons or tions or objections relating to the ad-
the material contained in the supple- missibility of information and views
ment could not reasonably have been may be made or considered, but other
foreseen. participants may comment upon or
(d) The failure to comply substan- rebut all such information and views.
tially and in good faith with this sec- No participant may interrupt the pres-
tion in the case of a participant con- entation of another participant for any
stitutes a waiver of the right to par- reason.
ticipate further in the hearing and in (e) Within the time specified by the
the case of a party constitutes a waiver Board after its first hearing, partici-
of the right to a hearing. pants may submit written rebuttal in-
(e) The Chairman rules on questions formation and views in accordance
relating to this section. Any partici- with § 13.20. The Chariman will then
pant dissatisfied with a ruling may pe- schedule a second hearing, if requested
tition the Commissioner for interlocu- and justified by a participant. A second
tory review. hearing, and any subsequent hearing,
[44 FR 22348, Apr. 13, 1979, as amended at 50 will be called only if the Chairman con-
FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989] cludes that it is needed to fully and
fairly present information that cannot
§ 13.30 Proceedings of a Board. otherwise adequately be considered and
(a) The purpose of a Board is to re- to properly resolve the issues. Notice of
view medical, scientific, and technical the time and location of any hearing is
issues fairly and expeditiously. The to be published at least 15 days in ad-
proceedings of a Board are conducted vance. The hearing is open to the pub-
as a scientific inquiry rather than a lic.
legal trial. (f) A Board may consult with any
(b) A Board may not hold its first person who it concludes may have in-
hearing until after all participants formation or views relevant to the
have submitted the information re- issues.
quired by § 13.25. (1) The consultation may occur only
(c) The Chairman calls the first hear- at an announced hearing of a Board.
ing of the Board. Notice of the time Participants have the right to suggest
and location of the first hearing is to or, with the permission of the Chair-
be published at least 15 days in advance man, ask questions of the consultant
and the hearing will be open to the and present rebuttal information and
public. All participants will have an views, as provided in paragraphs (c)
opportunity at the first hearing to and (d) of this section except that writ-
make an oral presentation of the infor- ten statements may be submitted to
mation and views which in their opin- the Board with the consent of all par-
ion are pertinent to the resolution of ticipants.
the issues being considered by a Board. (2) A participant may submit a re-
A participant’s presentation may be quest that the Board consult with a
made by more than one person. The specific person who may have informa-
Chairman determines the order of the tion or views relevant to the issues.
presentation. Participants may not in- The request will state why the person

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§ 13.40 21 CFR Ch. I (4–1–11 Edition)

should be consulted and why the per- (2) All written submissions under
son’s views cannot be furnished to the § 13.20.
Board by means other than having (3) The transcripts of all hearings of
FDA arrange for the person’s appear- the Board.
ance. The Board may, in its discretion, (4) The initial decision of the Board.
grant or deny the request. (b) The record of the administrative
(g) All hearings are to be transcribed. proceeding is closed—
All hearings are open to the public, ex- (1) Relevant to receiving information
cept that a hearing under § 10.20(j)(3) is and data, at the time specified in
closed to all persons except those per- § 13.30(i); and
sons making and participating in the (2) Relevant to pleadings, at the time
presentation and Federal Government specified in § 13.30(i) for filing a written
executive branch employees and spe- statement of position with proposed
cial Government employees. At least a findings and conclusions.
majority of Board members are to be (c) The Board may, in its discretion,
present at every hearing. The executive reopen the record to receive further
sessions of a Board, during which a evidence at any time before filing an
Board deliberates on the issues, are to initial decision.
be closed and are not transcribed. All
§ 13.45 Examination of administrative
members of the Board shall vote on the record.
report of the Board.
(h) All legal questions are to be re- (a) The availability for public exam-
ferred to the Chief counsel for FDA for ination and copying of each document
resolution. The Chief Counsel’s advice which is a part of the administrative
on any matter of procedure or legal au- record of the hearing is governed by
thority is to be transmitted in writing § 10.20(j). Each document available for
and made a part of the record or pre- public examination or copying is
sented in open session and transcribed. placed on public display in the office of
(i) At the conclusion of all public the Division of Dockets Management
hearings the Board will announce that promptly upon receipt in that office.
(b) Lists of nominees and comments
the record is closed to receiving infor-
submitted on them under § 13.10(b)(3)
mation. The Board will provide an op-
are not subject to disclosure unless
portunity for participants to submit
they become an issue in a court pro-
written statements of their positions,
ceeding.
with proposed findings and conclusions,
and may in its discretion, provide an § 13.50 Record for administrative deci-
opportunity for participants to summa- sion.
rize their positions orally.
The administrative record of the
(j) The Board will prepare a decision hearing specified in § 13.40(a) con-
on all issues. The decision is to include stitutes the exclusive record for deci-
specific findings and references sup- sion.
porting and explaining the Board’s con-
clusions, and a detailed statement of
the reasoning on which the conclusions PART 14—PUBLIC HEARING BEFORE
are based. Any member of the Board A PUBLIC ADVISORY COMMITTEE
may file a separate report stating addi-
tional or dissenting views. Subpart A—General Provisions.
Sec.
Subpart C—Records of a Hearing 14.1 Scope.
Before a Board 14.5 Purpose of proceedings before an advi-
sory committee.
14.7 Administrative remedies.
§ 13.40 Administrative record of a 14.10 Applicability to Congress.
Board. 14.15 Committees working under a contract
(a) The administrative record of a with FDA.
hearing before a Board consists of the
following: Subpart B—Meeting Procedures
(1) All relevant FEDERAL REGISTER 14.20 Notice of hearing before an advisory
notices. committee.

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Food and Drug Administration, HHS § 14.1
14.22 Meetings of an advisory committee. 14.130 Conduct of TEPRSSC meetings;
14.25 Portions of advisory committee meet- availability of TEPRSSC records.
ings.
14.27 Determination to close portions of ad- Subpart H—Color Additive Advisory
visory committee meetings. Committees
14.29 Conduct of a hearing before an advi-
sory committee. 14.140 Establishment of a color additive ad-
14.30 Chairman of an advisory committee. visory committee.
14.31 Consultation by an advisory com- 14.142 Functions of a color additive advisory
mittee with other persons. committee.
14.33 Compilation of materials for members 14.145 Procedures of a color additive advi-
of an advisory committee. sory committee.
14.35 Written submissions to an advisory 14.147 Membership of a color additive advi-
committee. sory committee.
14.39 Additional rules for a particular advi-
14.155 Fees and compensation pertaining to
sory committee.
a color additive advisory committee.
Subpart C—Establishment of Advisory
Subpart I—Advisory Committees for
Committees
Human Prescription Drugs
14.40 Establishment and renewal of advisory
committees. 14.160 Establishment of standing technical
14.55 Termination of advisory committees. advisory committees for human prescrip-
tion drugs.
Subpart D—Records of Meetings and 14.171 Utilization of an advisory committee
Hearings Before Advisory Committees on the initiative of FDA.
14.172 Utilization of an advisory committee
14.60 Minutes and reports of advisory com- at the request of an interested person.
mittee meetings. 14.174 Advice and recommendations in writ-
14.61 Transcripts of advisory committee ing.
meetings.
14.65 Public inquiries and requests for advi- AUTHORITY: 5 U.S.C. App. 2; 15 U.S.C. 1451–
sory committee records. 1461, 21 U.S.C. 41–50, 141–149, 321–394, 467f, 679,
14.70 Administrative record of a public 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b
hearing before an advisory committee. 264; Pub. L. 107–109; Pub. L. 108–155.
14.75 Examination of administrative record SOURCE: 44 FR 22351, Apr. 13, 1979, unless
and other advisory committee records. otherwise noted.
Subpart E—Members of Advisory
Committees Subpart A—General Provisions
14.80 Qualifications for members of standing § 14.1 Scope.
policy and technical advisory commit-
tees.
(a) This part governors the proce-
14.82 Nominations of voting members of dures when any of the following ap-
standing advisory committees. plies:
14.84 Nominations and selection of non- (1) The Commissioner concludes, as a
voting members of standing technical ad- matter of discretion, that it is in the
visory committees. public interest for a standing or ad hoc
14.86 Rights and responsibilities of non- policy or technical public advisory
voting members of advisory committees.
14.90 Ad hoc advisory committee members. committee (advisory committee or com-
14.95 Compensation of advisory committee mittee) to hold a public hearing and to
members. review and make recommendations on
any matter before FDA and for inter-
Subpart F—Standing Advisory Committees ested persons to present information
14.100 List of standing advisory committees.
and views at an oral public hearing be-
fore the advisory committee.
Subpart G—Technical Electronic Products (2) Under specific provisions in the
Radiation Safety Standards Committee act or other sections of this chapter, a
matter is subject to a hearing before an
14.120 Establishment of the Technical Elec- advisory committee. The specific pro-
tronic Product Radiation Safety Stand-
visions are—
ards Committee (TEPRSSC).
14.122 Functions of TEPRSSC. (i) Section 14.120 on review of a per-
14.125 Procedures of TEPRSSC. formance standard for an electronic
14.127 Membership of TEPRSSC. product by the Technical Electronic

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§ 14.1 21 CFR Ch. I (4–1–11 Edition)

Product Radiation Safety Standards sory committee separate from the par-
Committee (TEPRSSC); ent committee.
(ii) Section 14.140 on review of the (4) A committee composed entirely of
safety of color additives; full-time Federal Government employ-
(iii) Section 14.160 on review of the ees is not an advisory committee.
safety and effectiveness of human pre- (5) An advisory committee ordinarily
scription drugs; has a fixed membership, a defined pur-
(iv) Section 330.10 on review of the pose of providing advice to the agency
safety and effectiveness of over-the- on a particular subject, regular or peri-
counter drugs; odic meetings, and an organizational
(v) Section 601.25 on review of the structure, for example, a chairman and
safety and effectiveness of biological staff, and serves as a source of inde-
drugs; pendent expertise and advice rather
(vi) Part 860, on classification of de- than as a representative of or advocate
vices; for any particular interest. The fol-
(vii) Section 514(g)(5) of the act on es- lowing groups are not advisory com-
tablishment, amendment, or revoca- mittees:
tion of a device performance standard; (i) A group of persons convened on an
(viii) Section 515 of the act on review ad hoc basis to discuss a matter of cur-
of device premarket approval applica- rent interest to FDA, but which has no
tions and product development proto- continuing function or organization
cols; and and does not involve substantial spe-
(ix) Section 520(f) of the act on review cial preparation.
of device good manufacturing practice (ii) A group of two or more FDA con-
regulations. sultants meeting with the agency on
(3) A person who has a right to an op- an ad hoc basis.
portunity for a formal evidentiary pub- (iii) A group of experts who are em-
lic hearing under part 12 waives that
ployed by a private company or a trade
opportunity and instead under § 12.32
association which has been requested
requests a hearing before an advisory
by FDA to provide its views on a regu-
committee, and the Commissioner, as a
latory matter pending before FDA.
matter of discretion, accepts the re-
quest. (iv) A consulting firm hired by FDA
(b) In determining whether a group is to provide advice regarding a matter.
a public advisory committee as defined in (6) An advisory committee that is
§ 10.3(a) and thus subject to this part utilized by FDA is subject to this sub-
and to the Federal advisory Committee part even though it was not established
Act, the following guidelines will be by FDA. In general, a committee is uti-
used: lized when FDA requests advice or rec-
(1) An advisory committee may be a ommendations from the committee on
standing advisory committee or an ad a specific matter in order to obtain an
hoc advisory committee. All standing independent review and consideration
advisory committees are listed in of the matter, and not when FDA is
§ 14.100. merely seeking the comments of all in-
(2) An advisory committee may be a terested persons or of persons who have
policy advisory committee or a tech- a specific interest in the matter.
nical advisory committee. A policy ad- (i) A committee formed by an inde-
visory committee advises on broad and pendent scientific or technical organi-
general matters. A technical advisory zation is utilized if FDA requests ad-
committee advises on specific tech- vice of that committee rather than of
nical or scientific issues, which may re- the parent organization, or if the cir-
late to regulatory decisions before cumstances show that the advice given
FDA. is that of the committee and not of the
(3) An advisory committee includes parent organization. A committee
any of its subgroups when the subgroup formed by an independent scientific or
is working on behalf of the committee. technical organization is not utilized if
Section 14.40(d) describes when a sub- FDA requests advice of the organiza-
group will be established as an advi- tion rather than of a committee and if

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Food and Drug Administration, HHS § 14.7

the recommendations of any com- tions, or other similar activities do not


mittee formed in response to the re- constitute a meeting.
quest are subject to substantial inde- (d) An advisory committee that is
pendent policy and factual review by utilized but not established by FDA is
the governing body of the parent orga- subject to this part only to the extent
nization. of such utilization, and not concerning
(ii) A committee is not utilized by any other activities of such committee.
FDA if it provides only information, as (e) Any conference or meeting be-
contrasted with advice or opinions or tween an employee of FDA and a com-
recommendations. mittee or group which is not an advi-
(iii) FDA is charged with seeking out sory committee shall be subject to
the views of all segments of the public § 10.65 or other provisions specifically
on enforcement of the laws adminis- applicable to the committee or group,
tered by the Commissioner. The fact for example, part 13 for a Public Board
that a group of individuals or a com- of Inquiry.
mittee meets regularly with FDA, for
(f) This part applies to all FDA advi-
example, a monthly meeting with con-
sory committees, except to the extent
sumer representatives, does not make
that specific statutes require otherwise
that group or committee an advisory
committee. Thus, this subpart does not for a particular committee, for exam-
apply to routine meetings, discussions, ple, TEPRSSC, the Board of Tea Ex-
and other dealings, including ex- perts, and advisory committees estab-
changes of views, between FDA and lished under the Medical Device
any committee representing or advo- Amendments of 1976.
cating the particular interests of con- [44 FR 22351, Apr. 13, 1979, as amended at 54
sumers, industry, professional organi- FR 9035, Mar. 3, 1989]
zations, or others.
(7) The inclusion of one or two FDA § 14.5 Purpose of proceedings before
consultants who are special Govern- an advisory committee.
ment employees on an internal FDA (a) An advisory committee is utilized
committee does not make that com- to conduct public hearings on matters
mittee an advisory committee. of importance that come before FDA,
(8) A Public Board of Inquiry estab- to review the issues involved, and to
lished under part 13, or other similar provide advice and recommendations
group convened by agreement between to the Commissioner.
the parties to a regulatory proceeding (b) The Commissioner has sole discre-
pending before FDA to review and pre- tion concerning action to be taken and
pare an initial decision on the issues in
policy to be expressed on any matter
lieu of a formal evidentiary public
considered by an advisory committee.
hearing, is acting as an administrative
law tribunal and is not an advisory § 14.7 Administrative remedies.
committee.
(9) An open public conference or A person who alleges noncompliance
meeting conducted under § 10.65(b) is by the Commissioner or an advisory
not an advisory committee meeting. committee with any provision of this
(10) An FDA committee that pri- part or the Federal Advisory Com-
marily has operational responsibility mittee Act may pursue the following
rather than that of providing advice administrative remedies:
and recommendations is not an advi- (a) If the person objects to any ac-
sory committee, for example, the Re- tion, including a failure to act, other
search Involving Human Subjects Com- than denial of access to an advisory
mittee (RIHSC). committee document, the person shall
(c) This part applies only when a submit a petition in the form and in
committee convenes to conduct com- accordance with the requirements of
mittee business. Site visits, social § 10.30. The provisions of § 10.45 relating
gatherings, informal discussions by to exhaustion of administrative rem-
telephone or during meals or while edies are applicable.
traveling or at other professional func-

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§ 14.10 21 CFR Ch. I (4–1–11 Edition)

(1) If the person objects to past ac- (b) The following minimum standards
tion, the person shall submit the peti- apply to any committee of an inde-
tion within 30 days after the action ob- pendent scientific or technical organi-
jected to. If the Commissioner deter- zation which is working under a con-
mines that there was noncompliance tract initially executed with FDA after
with any provision of this subpart or of July 1, 1975, but which is determined
the Federal Advisory Committee Act, not to be an advisory committee:
the Commissioner will grant any ap- (1) The committee shall give public
propriate relief and take appropriate notice of its meetings and agenda, and
steps to prevent its future recurrence. provide interested persons an oppor-
(2) If the person objects to proposed tunity to submit relevant information
future action, the Commissioner will and views in writing at any time, and
expedite the review of the petition and orally at specified times. The notice
make a reasonable effort to render a may be published in the FEDERAL REG-
decision before the action concerned in ISTER or disseminated by other reason-
the petition. able means. It is in any event to be
(3) If the person objects to action filed with the Division of Dockets Man-
that is imminent or occurring and agement not less than 15 days before
which could not reasonably have been the meeting. The time for oral presen-
anticipated, e.g., the closing of a por- tations and the extent to which the
tion of a meeting which is made known committee meets in open session other
for the first time on the day of the than for such oral presentations is in
meeting, the matter may be handled by the discretion of the committee.
an oral petition in lieu of a written pe- (2) Minutes of open sessions are to be
tition. maintained, with all written submis-
(b) If the person objects to a denial of sions attached which were made to the
access to an advisory committee docu- committee in open session. After ap-
ment, administrative review is in ac- proval, the minutes are to be forwarded
cordance with the procedures estab- to the Division of Dockets Manage-
lished by the Department of Health and ment and placed on public display. The
Human Services under 45 CFR 5.34. extent to which the committee main-
[44 FR 22351, Apr. 13, 1979, as amended at 55 tains minutes of closed sessions is in
FR 1404, Jan. 16, 1990] the discretion of the committee.
(3) In selecting the members of the
§ 14.10 Applicability to Congress. committee, the organization involved
This part applies to Congress, indi- is to apply the principles relating to
vidual Members of Congress, and other conflicts of interest that FDA uses in
employees or representatives of Con- establishing a public advisory com-
gress in the same way that they apply mittee. Those principles are set out or
to any other member of the public, ex- cross-referenced in this part and in
cept that disclosure of advisory com- part 19. Upon request, FDA will assist
mittee records to Congress is governed or provide guidance to any organiza-
by § 20.87. tion in meeting this requirement.

§ 14.15 Committees working under a Subpart B—Meeting Procedures


contract with FDA.
(a) FDA may enter into contracts § 14.20 Notice of hearing before an ad-
with independent scientific or tech- visory committee.
nical organizations to obtain advice (a) Before the first of each month,
and recommendations on particular and at least 15 days in advance of a
matters, and these organizations may meeting, the Commissioner will pub-
in turn undertake such work through lish a notice in the FEDERAL REGISTER
existing or new committees. Whether a of all advisory committee meetings to
particular committee working under be held during the month. Any advi-
such a contract is an advisory com- sory committee meetings for that
mittee subject to the Federal Advisory month called after the publication of
Committee Act and this subpart de- the general monthly notice are to be
pends upon application of the criteria announced in the FEDERAL REGISTER on
and principles in § 14.1(b). an individual basis at least 15 days in

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Food and Drug Administration, HHS § 14.22

advance. The Commissioner may au- press by the Associate Commissioner


thorize an exception to these notice re- for Public Affairs.
quirements in an emergency or for [44 FR 22351, Apr. 13, 1979, as amended at 47
other reasons requiring an immediate FR 26375, June 1, 1982; 54 FR 9035, Mar. 3,
meeting of an advisory committee, in 1989; 66 FR 6469, Jan. 22, 2001; 66 FR 12850,
which case public notice will be given Mar. 1, 2001]
at the earliest time and in the most ac-
cessible form feasible including, when- § 14.22 Meetings of an advisory com-
ever possible, publication in the FED- mittee.
ERAL REGISTER. (a) No advisory committee may con-
(b) The FEDERAL REGISTER notice duct a meeting except at the call or
will include— with the advance approval of, and with
(1) The name of the committee; an agenda approved by, the designated
(2) The date, time, and place of the Federal employee or alternate. No
meeting; meeting may be held in the absence of
(3) The general function of the com- the designated Federal employee.
mittee; (1) If any matter is added to the
(4) A list of all agenda items, showing agenda after its publication in the FED-
whether each will be discussed in an ERAL REGISTER under § 14.20(b)(4), an at-
open or closed portion of the meeting; tempt is to be made to inform persons
(5) If any portion of the meeting is known to be interested in the matter,
closed, a statement of the time of the and the change is to be announced at
open and closed portions; the beginning of the open portion of
the meeting.
(6) The nature of the subjects to be
(2) The advisory committee meeting
discussed during, and the reasons for
is to be conducted in accordance with
closing, any closed portion of the meet-
the approved final agenda insofar as
ing;
practical.
(7) The time set aside for oral state- (b) Advisory committee meetings
ments and other public participation; will be held at places that are reason-
(8) The name, address, and telephone ably accessible to the public. All advi-
number of the advisory committee ex- sory committee meetings will be held
ecutive secretary and any other agency in Washington, DC, or Rockville, MD,
employee designated as responsible for or the immediate vicinity, unless the
the administrative support for the ad- Commissioner receives and approves a
visory committee; written request from the advisory com-
(9) A statement that written submis- mittee for a different location. A dif-
sions may be made to the advisory ferent location may be approved when
committee through the executive sec- one or more of the following applies:
retary at any time, unless a cutoff date (1) The total cost of the meeting to
has been established under § 14.35(d)(2); the Government will be reduced.
(10) When a notice is published in the (2) A substantial number of the com-
FEDERAL REGISTER less than 15 days be- mittee members will be at the location
fore a meeting, an explanation for the at no expense to FDA for other reasons,
lateness of the notice; and e.g., for a meeting of a professional as-
(c) If a public hearing before an advi- sociation.
sory committee is used in lieu of a for- (3) It is a central location more read-
mal evidentiary public hearing under ily accessible to committee members.
§ 14.1(a)(3), an initial notice of hearing (4) There is a need for increased par-
is to be published separately in the ticipation available at that location.
FEDERAL REGISTER containing all the (5) The committee wishes to review
information described in § 12.32(e). This work or facilities in a specific location.
procedure may be used for any other (6) The committee is concerned with
hearing before an advisory committee matters that functionally or histori-
when the Commissioner concludes, as a cally occur in some other location, e.g.,
matter of discretion, that it would be the Board of Tea Experts and the
informative to the public. Science Advisory Board of the National
(d) A list of advisory committee Center for Toxicological Research will
meetings will be distributed to the generally hold meetings in Brooklyn,

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§ 14.25 21 CFR Ch. I (4–1–11 Edition)

NY, and in the Little Rock, AR, vicin- will be held after the conclusion of the
ity, respectively. open portion whenever practicable.
(c) Advisory committee members (i) Any committee member may take
may, with the approval of FDA, con- notes during meetings and report and
duct onsite visits relevant to their discuss committee deliberations after a
work. meeting is completed and before offi-
(d) Unless the committee charter pro- cial minutes or a report are available,
vides otherwise, a quorum for an advi- within the rules and regulations adopt-
sory committee is a majority of the ed by FDA and by the advisory com-
current voting members of the com- mittee with the concurrence of FDA,
mittee, except as provided in § 14.125(c) including all of the following:
for TEPRSSC. Any matter before the (1) There may be no attribution of in-
advisory committee is to be decided by dividual views expressed in a closed
a majority vote of the voting members session or revealing of numerical votes.
present at the time, except that the (2) There may be no reporting or dis-
designated Federal official may require cussion of any particular matter if the
that any final report be voted upon by committee or FDA specifically so di-
all current voting members of the com- rects, e.g., where deliberations are in-
mittee. Any current voting member of complete or involve a sensitive regu-
the committee may file a separate re- latory decision that requires prepara-
port with additional or minority views. tion or implementation.
(e) If space is available, any inter- (3) There may be no reporting or dis-
ested person may attend any portion of cussion of information prohibited from
any advisory committee meeting which public disclosure under § 14.75.
is not closed. (4) Notes or minutes kept or reports
(f) Whenever feasible, meetings are to prepared by a committee member have
be held in government facilities or no status or effect unless adopted into
other facilities involving the least ex- the official minutes or report by the
pense to the public. The size of the committee. It is the responsibility of
meeting room is to be reasonable, con- each committee member to make cer-
sidering such factors as the size of the tain that the official minutes and re-
committee, the number of persons ex- ports are complete and accurate and
pected to attend a meeting, and the re- fully reflect what happened at any
sources and facilities available. meeting the committee member at-
(g) The Commissioner may authorize tended.
a meeting to be held by conference
telephone call. For these meetings, a [44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept.
speaker phone will be provided in a 12, 1983, as amended at 54 FR 9035, Mar. 3,
conference room located in Wash- 1989]
ington, DC, or Rockville, MD, or the
§ 14.25 Portions of advisory committee
immediate vicinity, to permit public meetings.
participation in open portions of the
meetings, as provided in §§ 14.25 and An advisory committee meeting has
14.29. These meetings generally will be the following portions:
brief, and authorized— (a) The open public hearing. Every
(1) For the purpose of taking final committee meeting includes an open
votes or otherwise confirming actions portion, which constitutes a public
taken by the committee at other meet- hearing during which interested per-
ings; or sons may present relevant information
(2) Where time does not permit a or views orally or in writing. The hear-
meeting to be held at a central loca- ing is conducted in accordance with
tion. § 14.29.
(h) Any portion of a meeting will be (b) The open committee discussion. A
closed by the committee chairman committee discusses any matter pend-
only when matters are to be discussed ing before it in an open portion of its
which the Commissioner has deter- meeting unless the meeting has been
mined may be considered in closed ses- closed for that matter under § 14.27. To
sion under § 14.27(b). If a portion of the the maximum extent feasible, con-
meeting is closed, the closed portion sistent with the policy expressed in

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Food and Drug Administration, HHS § 14.27

§ 14.27, a committee conducts its discus- ments or similar preexisting internal


sion of pending matters in an open por- agency documents, but only if their
tion. No public participation is permis- premature disclosure would signifi-
sible during this portion of the meeting cantly impede proposed agency action;
except with the consent of the com- review of trade secrets and confidential
mittee chairman. commercial or financial information;
(c) The closed presentation of data. In- consideration of matters involving in-
formation prohibited from public dis- vestigatory files compiled for law en-
closure under part 20 and the regula- forcement purposes; and review of mat-
tions referenced therein is presented to ters, the disclosure of which would con-
the committee in a closed portion of its stitute a clearly unwarranted invasion
meeting. However, if information is in of personal privacy.
the form of a summary that is not pro- (4) Portions of meetings ordinarily
hibited from public disclosure, the may not be closed if they concern re-
presentation is to be made in an open view, discussion, and evaluation of gen-
portion of a meeting. eral preclinical and clinical test proto-
(d) The closed committee deliberations. cols and procedures for a class of drugs
Deliberations about matters before an or devices; consideration of labeling re-
advisory committee may be held in a quirements for a class of marketed
closed portion of a meeting only upon drugs and devices; review of informa-
an appropriate determination by the tion on specific investigational or mar-
Commissioner under § 14.27. keted drugs and devices that have pre-
viously been made public; presentation
§ 14.27 Determination to close portions
of advisory committee meetings. of any other information not exempt
from public disclosure under 5 U.S.C.
(a) No committee meeting may be en- 552b(c); the formulation of advice and
tirely closed. A portion of a meeting recommendations to FDA on matters
may be closed only in accordance with that do not independently justify clos-
a written determination by the Com- ing.
missioner under this section.
(5) No portion of a meeting devoted
(b) The executive secretary or other
to matters other than those designated
designated agency employee shall pre-
in paragraph (b) (1) through (3) of this
pare the initial request for a deter-
section may be closed.
mination to close a portion of a meet-
ing, specifying the matter(s) to be dis- (6) A matter which is properly con-
cussed during the closed portion and sidered in an open portion of a meeting
the reasons why the portion should be may instead be considered in a closed
closed. The Commissioner, based upon portion only if it is so inextricably
this request and with the concurrence intertwined with matters to be dis-
of the Chief Counsel, will determine cussed in a closed portion that it is not
whether to close a portion of a meet- feasible to separate them or discussion
ing. The reasons for closing a portion of the matter in an open portion would
of a meeting will be announced in the compromise the matters to be dis-
FEDERAL REGISTER notice of the meet- cussed in the closed portion.
ing under § 14.20 in accordance with the (c) Attendance at a closed portion of
following rules: a meeting is governed by the following
(1) Any determination to close a por- rules:
tion of a meeting restricts the closing (1) A portion of a meeting closed for
to the shortest possible time consistent the presentation or discussion of infor-
with the policy in this section. mation that constitutes a trade secret
(2) A portion of a meeting may be or confidential commercial or financial
closed only if the Commissioner deter- information as defined in § 20.61 may be
mines that the closing is permitted attended only by voting advisory com-
under 5 U.S.C. 552b(c), and that the mittee members, nonvoting members
closing is necessary. representing consumer interests who
(3) Portions of meetings may ordi- are also special government employees
narily be closed if they concern the re- as provided in § 14.80(b), the executive
view, discussion, and evaluation of secretary of the advisory committee, a
drafts or regulations, guidance docu- transcriber, consultants, and such

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§ 14.29 21 CFR Ch. I (4–1–11 Edition)

other regular employees of FDA (in- open to attendance by any interested


cluding members of the Office of the person.
Chief Counsel) as the chairman of the
[44 FR 22351, Apr. 13, 1979, as amended at 65
advisory committee may invite, and by
FR 56479, Sept. 19, 2000]
those persons authorized to be present
under § 14.25(c), for presentation of in- § 14.29 Conduct of a hearing before an
formation prohibited from public dis- advisory committee.
closure. A person making a presen-
tation described in § 14.25(c) may be ac- (a) For each meeting, the open por-
companied by a reasonable number of tion for public participation, which
employees, consultants, or other per- constitutes a public hearing under
sons in a commercial arrangement § 14.25(a), will be at least 1 hour, unless
within the meaning of § 20.81(a). public participation does not last that
(2) A portion of a meeting that has long, and may last for whatever longer
been closed for consideration of exist- time the committee chairman deter-
ing internal agency documents falling mines will facilitate the work of the
within § 20.62 where premature disclo- committee. The FEDERAL REGISTER no-
sure is likely to significantly impede tice published under § 14.20 will des-
proposed agency action; personnel, ignate the time specifically reserved
medical, and similar files, disclosure of for the hearing, which is ordinarily the
which would be a clearly unwarranted first portion of the meeting. Further
invasion of personal privacy within the public participation in any open por-
meaning of § 20.63; or investigatory tion of the meeting under § 14.25(b) is
records compiled for law enforcement solely at the discretion of the chair-
purposes as defined in § 20.64 may be at- man.
tended only by committee members (b) An interested person who wishes
(voting and nonvoting), the executive to be assured of the right to make an
secretary of the committee, a tran- oral presentation at a meeting shall in-
scriber, and other regular employees of form the executive secretary or other
FDA (including members of the Office designated agency employee, orally or
of the Chief Counsel) whom the chair- in writing, before the meeting.
man of the committee may invite. Con- (1) The person shall state the general
sultants, individuals performing per- nature of the presentation and the ap-
sonal service contracts, employees of proximate time desired. Whenever pos-
other Federal agencies, and the general sible, all written information to be dis-
public may not attend such portions. cussed by that person at the meeting
(3) If a person other than a person
should be furnished in advance to the
permitted to attend in accordance with
executive secretary or other designated
paragraph (c) (1) and (2) of this section
agency employee. This material may
attempts to attend a closed portion of
be distributed or mailed by FDA to the
a meeting without the approval of the
committee members in advance of the
executive secretary and the chairman,
and the matter is brought to their at- meeting if time permits, and otherwise
tention, the person will be required to will be distributed to the members
leave the meeting immediately. This when they arrive for the meeting. The
inadvertent and unauthorized attend- mailing or distribution may be under-
ance does not enable other unauthor- taken only by FDA unless FDA grants
ized persons to attend, nor does it, of permission to a person to mail or dis-
itself, constitute grounds for release of tribute the material
transcripts of closed portions or any (2) Before the meeting, the executive
other documents otherwise exempt secretary or other designated agency
from disclosure under § 14.75 and part employee shall determine the amount
20. of time allocated to each person for
(4) If a person other than a person oral presentation and the time that the
permitted to attend in accordance with presentation is to begin. Each person
paragraphs (c) (1) and (2) of this section will be so informed in writing, if time
is allowed by the executive secretary permits, or by telephone. FDA may re-
and the chairman to attend a closed quire persons with common interests
portion of a meeting, that portion is to make joint presentations.

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Food and Drug Administration, HHS § 14.31

(c) The chairman of the committee (b) If the chairman is not a full-time
shall preside at the meeting in accord- employee of FDA, the executive sec-
ance with § 14.30 and be accompanied by retary or other designated agency em-
other committee members, who serve ployee, or alternate, is to be the des-
as a panel in conducting the hearing ignated Federal employee who is as-
portion of the meeting. signed to the advisory committee. The
(d) Each person may use the allotted designated Federal employee is also
time as desired, consistent with an or- authorized to adjourn a hearing or
derly hearing. A person may be accom- meeting if the employee determines ad-
panied by additional persons, and may journment to be in the public interest.
present any written information or
views for inclusion in the record of the § 14.31 Consultation by an advisory
hearing, subject to the requirements of committee with other persons.
§ 14.35(c). (a) A committee may confer with any
(e) If a person is absent at the time person who may have information or
specified for that person’s presen- views relevant to any matter pending
tation, the persons following will ap- before the committee.
pear in order. An attempt will be made (b) An interested person may submit
to hear the person at the conclusion of to the committee a written request
the hearing. Interested persons attend- that it confer with specific persons
ing the hearing who did not request an about any matter pending before the
opportunity to make an oral presen- committee. The request is to contain
tation may be given an opportunity to adequate justification. The committee
do so at the discretion of the chairman. may, in its discretion, grant the re-
(f) The chairman and other members quest.
may question a person concerning that (c) A committee may confer with a
person’s presentation. No other person, person who is not a Federal Govern-
however, may question the person. The ment executive branch employee only
chairman may allot additional time during the open portions of a meeting.
when it is in the public interest, but The person may, however, submit
may not reduce the time allotted with- views in writing to the committee as
out consent of the person. part of the administrative record under
(g) Participants may question a com- § 14.70. The person may participate at
mittee member only with that mem- the closed portions of a meeting only if
ber’s permission and only about mat- appointed as a special Government em-
ters before the committee. ployee by the Commissioner as pro-
(h) The hearing is informal, and the vided in paragraph (e) of this section.
rules of evidence do not apply. No mo- This paragraph (c) is not intended to
tions or objections relating to the ad- bar the testimony of a person during a
missibility of information and views closed portion of a meeting about mat-
may be made or considered, but other ters prohibited from public disclosure
participants may comment upon or under §§ 14.25(c) and 14.27(c).
rebut matters presented. No partici- (d) To prevent inadvertent violation
pant may interrrupt the presentation of Federal conflict of interest laws and
of another participant. laws prohibiting disclosure of trade se-
crets (18 U.S.C. 208, 21 U.S.C. 331(j), 18
§ 14.30 Chairman of an advisory com- U.S.C. 1905), Federal executive branch
mittee. employees who are not employees of
(a) The advisory committee chair- the Department may not confer, tes-
man has the authority to conduct hear- tify, or otherwise participate (other
ings and meetings, including the au- than as observers) at any portion of an
thority to adjourn a hearing or meet- advisory committee meeting unless
ing if the chairman determines that ad- they are appointed as special Govern-
journment is in the public interest, to ment employees by the Commissioner
discontinue discussion of a matter, to under paragraph (e) of this section. this
conclude the open portion of a meeting, paragraph does not apply to Federal
or to take any other action to further executive branch employees who are
a fair and expeditious hearing or meet- appointed as members of TEPRSSC, as
ing. provided in § 14.127.

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§ 14.33 21 CFR Ch. I (4–1–11 Edition)

(e) The Commissioner may appoint § 14.35 Written submissions to an advi-


persons as special Government employ- sory committee.
ees to be consultants to an advisory (a) Ten copies of written submissions
committee. Consultants may be ap- to a committee are to be sent to the
pointed to provide expertise, generally executive secretary unless an applica-
concerning a highly technical matter, ble FEDERAL REGISTER notice or other
not readily available from the mem- regulations in this chapter specify oth-
bers of the committee. Consultants erwise. Submissions are subject to the
may be either from outside the Govern- provisions of § 10.20, except that it is
ment or from agencies other than the not necessary to send copies to the Di-
Food and Drug Administration. Re- vision of Dockets Management.
ports, data, information, and other (b) At the request of a committee, or
written submissions made to a public on the Commissioner’s own initiative,
advisory committee by a consultant the Commissioner may issue in the
are part of the administrative record FEDERAL REGISTER a notice requesting
itemized in § 14.70. the submission to the committee of
[44 FR 22351, Apr. 13, 1979, as amended at 55 written information and views perti-
FR 42703, Oct. 23, 1990] nent to a matter being reviewed by the
committee. The notice may specify the
§ 14.33 Compilation of materials for manner in which the submission should
members of an advisory committee. be made.
The Commissioner shall prepare and (c) At the request of a committee, or
provide to all committee members a on the Commissioner’s own initiative,
compilation of materials bearing upon the Commissioner may at any time re-
members’ duties and responsibilities, quest the applicant or sponsor of an ap-
including— plication or petition about a specific
(a) All applicable conflict of interest product on which action is pending be-
laws and regulations and a summary of fore FDA, and is being reviewed by an
their principal provisions; advisory committee, to present or dis-
cuss safety, effectiveness, or other data
(b) All applicable laws and regula-
concerning the product during a regu-
tions relating to trade secrets and con-
larly scheduled meeting of the com-
fidential commercial or financial infor-
mittee. The request may be for an oral
mation that may not be disclosed pub-
presentation or for a concise, well-or-
licly and a summary of their principal
ganized written summary of pertinent
provisions;
information for review by the com-
(c) All applicable laws, regulations,
mittee members before the meeting, or
and guidance documents relating to
both. Unless specified otherwise, one
the subject matter covered by the advi-
copy of the written summary along
sory committee and a summary of
with a proposed agenda outlining the
their principal provisions;
topics to be covered and identifying the
(d) All applicable laws, regulations,
participating industry staff members
including the regulations in part 20 of
or consultants that will present each
this chapter, advisory committee char-
topic is to be submitted to the execu-
ters, FEDERAL REGISTER notices, cur-
tive secretary or other designated
ricula vitae, rules adopted by the advi-
agency employee at least 3 weeks be-
sory committee, and other material re-
fore the meeting.
lating to the formation, composition,
(d) An interested person may submit
and operation of the advisory com-
to a committee written information or
mittee, and a summary of their prin-
views on any matter being reviewed.
cipal provisions;
Voluminous data is to be accompanied
(e) Instructions on whom to contact by a summary. A submission is to be
when questions arise; and made to the executive secretary and
(f) Other material relating to FDA not directly to a committee member.
and the subject matter covered by the (1) FDA will distribute submissions
committee which may facilitate the to each member, either by mail or at
work of the committee. the next meeting. Submissions will be
[44 FR 22351, Apr. 13, 1979, as amended at 65 considered by the committee in its re-
FR 56479, Sept. 19, 2000] view of the matter.

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Food and Drug Administration, HHS § 14.40

(2) A committee may establish, and at least 15 days before the filing of the
give public notice of, a cutoff date advisory committee charter under
after which submissions about a mat- paragraph (c) of this section. A notice
ter will no longer be received or consid- of renewal does not require the 15-day
ered. notice.
(e) The Commissioner will provide (c) No committee may meet or take
the committee all information the action until its charter is prepared and
Commissioner deems relevant. A mem- filed as required by section 9(c) of the
ber will, upon request, also be provided Federal Advisory Committee Act. This
any material available to FDA which requirement is to be met by an advi-
the member believes appropriate for an sory committee utilized by FDA, even
independent judgment on the matter, though it is not established by the
e.g., raw data underlying a summary or agency, prior to utilization.
report, or a briefing on the legal as- (d) The regulations of the Depart-
pects of the matter. ment cited in paragraph (a) of this sec-
tion provide that the charter of a par-
§ 14.39 Additional rules for a par- ent committee may incorporate infor-
ticular advisory committee.
mation concerning activities of a sub-
(a) In addition to these rules, an ad- group. In such instances, a subgroup
visory committee may, with the con- will not be established as a committee
currence of the designated Federal em- distinct from the parent committee.
ployee, adopt additional rules which However, a subgroup will be estab-
are not inconsistent with this subpart lished as a separate committee when
or with other legal requirements. the charter of the parent committee
(b) Any additional rules will be in- does not incorporate the activities of
cluded in the minutes of the meeting the subgroup, or when the subgroup in-
when adopted and in the materials cludes members who are not all drawn
compiled under § 14.33 and will be avail- from the parent committee.
able for public disclosure under (e) An advisory committee not re-
§ 14.65(c). quired to be established by law will be
established or utilized only if it is in
Subpart C—Establishment of the public interest and only if its func-
Advisory Committees tions cannot reasonably be performed
by other existing advisory committees
§ 14.40 Establishment and renewal of or by FDA.
advisory committees. (f) An advisory committee must meet
(a) An advisory committee may be the following standards:
established or renewed whenever it is (1) Its purpose is clearly defined.
necessary or appropriate for the com- (2) Its membership is balanced fairly
mittee to hold a public hearing and to in terms of the points of view rep-
review and make recommendations on resented in light of the functions to be
any matter pending before FDA. Ex- performed. Although proportional rep-
cept for committees established by resentation is not required, advisory
statute, before a committee is estab- committee members are selected with-
lished or renewed it must first be ap- out regard to race, color, national ori-
proved by the Department pursuant to gin, religion, age, or sex.
45 CFR part 11 and by the General (3) It is constituted and utilizes pro-
Services Administration. cedures designed to assure that its ad-
(b) When an advisory committee is vice and recommendations are the re-
established or renewed, the Commis- sult of the advisory committee’s inde-
sioner will issue a FEDERAL REGISTER pendent judgment.
notice certifying that the establish- (4) Its staff is adequate. The Commis-
ment or renewal is in the public inter- sioner designates an executive sec-
est and stating the structure, function, retary and alternate for every advisory
and purposes of the committee and, if committee, who are employees of FDA.
it is a standing advisory committee, The executive secretary is responsible
shall amend § 14.100 to add it to the list for all staff support unless other agen-
of standing advisory committees. A no- cy employees are designated for this
tice of establishment will be published function.

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§ 14.55 21 CFR Ch. I (4–1–11 Edition)

(5) Whenever feasible, or required by requirements of the Federal Advisory


statute, it includes representatives of Committee Act and of this part.
the public interest.
EFFECTIVE DATE NOTE: At 75 FR 73953, Nov.
[44 FR 22351, Apr. 13, 1979, as amended at 55 30, 2010, § 14.55 was amended by adding para-
FR 42703, Oct. 23, 1990] graph (f), effective Apr. 14, 2011. For the con-
venience of the user, the added text is set
§ 14.55 Termination of advisory com- forth as follows:
mittees.
§ 14.55 Termination of advisory committees.
(a) Except as provided in paragraph
(c) of this section, a standing advisory
committee is terminated when it is no * * * * *
longer needed, or not later than 2 years (f) The Tobacco Products Scientific Advi-
after its date of establishment unless it sory Committee is a permanent statutory
is renewed for an additional 2-year pe- advisory committee established by section
riod. A committee may be renewed for 917 of the Family Smoking Prevention and
Tobacco Control Act (21 U.S.C. 387q) (Pub. L.
as many 2-year periods as the public in-
111–31) and is not subject to termination and
terest requires. The requirements for renewal under paragraph (a) of this section.
establishment of a committee under
§ 14.40 also apply to its renewal.
(b) FDA will issue a FEDERAL REG- Subpart D—Records of Meetings
ISTER notice announcing the reasons and Hearings Before Advisory
for terminating a committee and, if it Committees
is a standing committee, amending
§ 14.100 to delete it from the list. § 14.60 Minutes and reports of advi-
(c) TEPRSSC is a permanent statu- sory committee meetings.
tory advisory committee established (a) The executive secretary or other
by section 358(f)(1)(A) of the Public designated agency employee prepares
Health Service Act (42 U.S.C. detailed minutes of all advisory com-
263f(f)(1)(A), as added by the Radiation mittee meetings, except that less de-
Control for Health and Safety Act of tailed minutes may be prepared for
1968, and is not subject to termination open portions of meetings which under
and renewal under paragraph (a) of this § 14.61, must be transcribed or recorded
section, except that a new charter is by the agency. Their accuracy is ap-
prepared and filed at the end of each 2- proved by the committee and certified
year period as provided in § 14.40(c). by the chairman. The approval and cer-
Also, the statutory medical device tification may be accomplished by mail
classification panels established under or by telephone.
section 513(b)(1) of the act and part 860, (b) The minutes include the fol-
and the statutory medical device good lowing:
manufacturing practice advisory com- (1) The time and place of the meet-
mittees established under section ing.
520(f)(3) of the act, are specifically ex- (2) The members, committee staff,
empted from the normal 2-year dura- and agency employees present, and the
tion period. names and affiliations or interests of
(d) The Board of Tea Experts is a per- public participants.
manent statutory advisory committee (3) A copy of or reference to all writ-
established by the Tea Importation Act ten information made available for
(21 U.S.C. 42) and is not subject to ter- consideration by the committee at the
mination and renewal under paragraph proceedings.
(a) of this section, except that a new (4) A complete and accurate descrip-
charter is prepared and filed at the end tion of matters discussed and conclu-
of each 2-year period as provided in sions reached. A description is to be
§ 14.40(c). kept separately for the following por-
(e) Color additive advisory commit- tions of the meeting to facilitate their
tees are required to be established public disclosure: The open portions
under the circumstances specified in specified in § 14.25 (a) and (b), any
section 721(b)(5) (C) and (D) of the act. closed portion during which a presen-
A color additive advisory committee is tation is made under § 14.25(c), and any
subject to the termination and renewal closed deliberative portion under

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Food and Drug Administration, HHS § 14.70

§ 14.25(d). The minutes of a closed delib- (d) Any transcript or recording of a


erative portion of a meeting may not meeting or portion thereof which is
refer to members by name, except upon publicly available under this section
their request, or to data or information will be available at actual cost of du-
described in § 14.75(b). Any inadvertent plication, which will be, where applica-
references that occur are to be deleted ble, the fees established in § 20.45. FDA
before public disclosure. may furnish the requested transcript
(5) A copy of or reference to all re- or recording for copying to a private
ports received, issued, or approved by contractor who shall charge directly
the committee. for the cost of copying under § 20.53.
(6) The extent to which the meeting (e) A person attending any open por-
was open to the public. tion of a meeting may, consistent with
(7) The extent of public participation, the orderly conduct of the meeting,
including a list of members of the pub- record or otherwise take a transcript of
lic who presented oral or written state- the meeting. This transcription will
ments. not be part of the administrative
(c) For a meeting that has a closed record.
portion, either (1) the minutes of the (f) Only FDA may make a transcript
closed portion are available for public or recording of a closed portion of a
disclosure under § 14.75(a)(6)(i), or (2) if meeting.
under § 14.75(a)(6)(ii) they are not [44 FR 22351, Apr. 13, 1979, as amended at 68
promptly available, the executive sec- FR 25285, May 12, 2003]
retary or other designated agency em-
ployee shall prepare a brief summary § 14.65 Public inquiries and requests
of the matters considered in an inform- for advisory committee records.
ative manner to the public, consistent (a) Public inquiries on general com-
with 5 U.S.C. 552(b). mittee matters, except requests for
(d) Where a significant portion of the records, are to be directed to: Com-
meeting of a committee is closed, the mittee Management Officer (HFA–306),
committee will issue a report at least Office of Management and Operations,
annually setting forth a summary of Food and Drug Administration, De-
its activities and related matters in- partment of Health and Human Serv-
formative to the public consistent with ices, 5600 Fishers Lane, Rockville, MD
5 U.S.C. 552(b). This report is to be a 20857.
compilation of or be prepared from the (b) Public inquiries on matters relat-
individual reports on closed portions of ing to a specific committee, except re-
meeting prepared under paragraph (c) quests for records, are to be directed to
of this section. the executive secretary or the des-
[44 FR 22351, Apr. 13, 1979, as amended at 45 ignated agency employee listed in the
FR 85725, Dec. 30, 1980] FEDERAL REGISTER notices published
under § 14.20.
§ 14.61 Transcripts of advisory com- (c) Requests for public advisory com-
mittee meetings. mittee records, including minutes, are
(a) The agency will arrange for a to be made, to FDA’s Freedom of Infor-
transcript or recording to be made for mation Staff (HFI–35) under § 20.40 and
each portion of a meeting. the related provisions of part 20.
(b) A transcript or recording of an [44 FR 22351, Apr. 13, 1979, as amended at 46
open portion of a meeting made by FR 8456, Jan. 27, 1981]
FDA is to be included in the record of
the committee proceedings. § 14.70 Administrative record of a pub-
(c) A transcript or recording of any lic hearing before an advisory com-
closed portion of a meeting made by mittee.
FDA will not be included in the admin- (a) Advice or recommendations of an
istrative record of the committee pro- advisory committee may be given only
ceedings. The transcript or recording on matters covered in the administra-
will be retained as confidential by tive record of the committee’s pro-
FDA, and will not be discarded or ceedings. Except as specified in other
erased. FDA regulations, the administrative

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§ 14.75 21 CFR Ch. I (4–1–11 Edition)

record consists of all the following Commissioner, or upon a determina-


items relating to the matter: tion by the Commissioner that such
(1) Any transcript or recording of an minutes or portions thereof may be
open portion of a meeting. made available for public disclosure
(2) The minutes of all portions of all without undue interference with agen-
meetings, after any deletions under cy or advisory committee operations.
§ 14.60(b)(4). (7) Formal advice or a report of the
(3) All written submissions to and in- committee: After it has been acted
formation considered by the com- upon, i.e., approved, disapproved, or re-
mittee. jected as inadequate, by the Commis-
(4) All reports made by the com- sioner, or upon a determination by the
mittee. Commissioner that such formal advice
(5) Any reports prepared by a con- or report may be made available for
sultant under § 14.31(e). public disclosure without undue inter-
(b) The record of the proceeding is ference with agency or committee op-
closed at the time the advisory com- erations. Such formal advice or report
mittee renders its advice or rec- may be retained as confidential while
ommendations or at any earlier time it is under active advisement.
specified by the committee or in other
(8) Any other committee records re-
sections in this chapter.
lating to the matter, except transcripts
§ 14.75 Examination of administrative and recordings of closed portions of
record and other advisory com- meetings: After the advice or report of
mittee records. the committee relevant to those
(a) The administrative record and records is acted upon by the Commis-
other committee records are available sioner, or upon a determination by the
for public disclosure under part 20, ex- Commissioner that the records may be
cept as provided in paragraph (b) of made available for public disclosure
this section, at the following times: without undue interference with agen-
(1) The written information for con- cy or committee operations.
sideration by the committee at any (b) The following information con-
meeting: at the same time it is made tained in the administrative record is
available to the committee. not available for public examination or
(2) The transcript or recording of any copying except as provided in § 12.32(g):
open portion of a meeting: as soon as it (1) Material provided to the com-
is available. mittee by FDA that is exempt from
(3) The minutes of any open portion public disclosure under part 20 and the
of a meeting: after they have been ap- regulations referenced there.
proved by the committee and certified (2) Material provided to the advisory
by the chairman. committee by a person making a pres-
(4) The brief summary of any closed entation described in § 14.25(c) and
portion of a meeting prepared under which is prohibited from public disclo-
§ 14.60(c): as soon as it is available. sure under part 20 and the regulations
(5) All written information or views referenced there.
submitted to the committee at an open (c) The Division of Dockets Manage-
portion of a meeting: as soon as they ment (HFA–305) will maintain a file for
are submitted. each committee containing the fol-
(6) The minutes or portions thereof of lowing principal records for ready ac-
a closed portion of a meeting— cess by the public:
(i) For a matter not directed to be (1) The committee charter.
maintained as confidential under (2) A list of committee members and
§ 14.22(i)(2): After they have been ap- their curricula vitae.
proved by the committee and certified
(3) The minutes of committee meet-
by the chairman; and
ings.
(ii) For a matter directed to be main-
tained as confidential under § 14.22(i)(2): (4) Any formal advice or report of the
After the advice or report of the com- committee.
mittee relevant to those minutes or [44 FR 22351, Apr. 13, 1979, as amended at 54
portions thereof is acted upon by the FR 9035, Mar. 3, 1989]

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Food and Drug Administration, HHS § 14.82

Subpart E—Members of Advisory of and liaison with interested organiza-


Committees tions. Nonvoting members—
(i) Shall be selected by the interested
§ 14.80 Qualifications for members of organizations, as provided in § 14.84;
standing policy and technical advi- technical expertise in the subject mat-
sory committees. ter with which the committee is in-
(a) Members of a policy advisory volved is not a requirement; and
committee— (ii) May be special Government em-
(1) Shall have diverse interests, edu- ployees subject to the conflict of inter-
cation, training, and experience; spe- est laws and regulations, except as pro-
cific technical expertise is not a re- vided in § 14.84(e).
quirement; (c) A person may serve as a voting or
(2) Are subject to the conflict of in- nonvoting member on only one FDA
terest laws and regulations either as advisory committee unless the Com-
special Government employees or as missioner determines in writing that
members of the uniformed services, in- dual membership will aid the work of
cluding the Commissioned Corps of the the committees involved and is in the
Public Health Service (the Commis- public interest.
sioner has determined that, because (d) Members of FDA advisory com-
members representing particular inter- mittees, and the chairman, are ap-
ests, e.g., a representative of labor, in- pointed from among those nominated
dustry, consumers, or agriculture, are under §§ 14.82 and 14.84 and from any
included on advisory committees spe- other sources by the Secretary, or, by
cifically for the purpose of rep- delegation of authority, by the Assist-
resenting these interests, any financial ant Secretary for Health, or the Com-
interest covered by 18 U.S.C. 208(a) in missioner.
the class which the member represents (e) Members appointed to an advisory
is irrelevant to the services which the committee serve for the duration of the
Government expects from them and committee, or until their terms of ap-
thus is hereby exempted under 18 pointment expire, they resign, or they
U.S.C. 208(b) as too remote and incon- are removed from membership by the
sequential to affect the integrity of Commissioner.
their services); and (f) A committee member may be re-
(3) Shall be voting members. moved from membership for good
(b) Technical advisory committee.(1) cause. Good cause includes excessive
Voting members of technical advisory absenteeism from committee meetings,
committees— a demonstrated bias that interferes
(i) Shall have expertise in the subject with the ability to render objective ad-
matter with which the committee is vice, failure to abide by the procedures
concerned and have diverse profes- established in this subpart, or violation
sional education, training, and experi- of other applicable rules and regula-
ence so that the committee will reflect tions, e.g., for nonvoting members, the
a balanced composition of sufficient provisions of § 14.86(c).
scientific expertise to handle the prob-
(g) Consultants appointed under
lems that come before it; and
§ 14.31(e) are not members of advisory
(ii) Except for members of the Tech-
committees.
nical Electronic Product Radiation
Safety Standards Committee [44 FR 22351, Apr. 13, 1979, as amended at 53
(TEPRSSC), are subject to the conflict FR 50949, Dec. 19, 1988; 54 FR 9035, Mar. 3,
of interest laws and regulations either 1989]
as special Government employees or as
members of the uniformed services, in- § 14.82 Nominations of voting members
cluding the Commissioned Corps of the of standing advisory committees.
Public Health Service. (a) The Commissioner will publish
(2) The Commissioner shall, when re- one or more notices in the FEDERAL
quired by statute, and may when not REGISTER each year requesting nomi-
required by statute, provide for non- nations for voting members of all exist-
voting members of a technical advisory ing standing advisory committees. The
committee to serve as representatives notice will invite the submission of

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§ 14.84 21 CFR Ch. I (4–1–11 Edition)

nominations for voting members from their nominations through consumer


both individuals and organizations. organizations as defined in paragraph
(b) The notice announcing the estab- (c)(3) of this section. Nominations of
lishment of a new committee under qualified persons for general consider-
§ 14.40(b) will invite the submission of ation as nonvoting members of unspec-
nominations for voting members. ified advisory committees or sub-
(c) A person may nominate one or committees may be made at any time.
more qualified persons to an advisory All nominations are to be submitted in
committee. Nominations will specify writing to Advisory Committee Over-
the advisory committee for which the sight and Management Staff, Food and
nominee is recommended and will in- Drug Administration, 10903 New Hamp-
clude a complete curriculum vitae of shire Ave., Bldg. 32, rm. 1503, Silver
the nominee. Nominations are to state Spring, MD 20993.
that the nominee is aware of the nomi- (2) A complete curriculum vitae of
nation, is willing to serve as a member any nominee is to be included. Nomina-
of the advisory committee, and appears tions must state that the nominee is
to have no conflict of interest that aware of the nomination, is willing to
would preclude membership. serve as a member of an advisory com-
(d) Voting members serve as individ- mittee, and appears to have no conflict
uals and not as representatives of any of interest. The nomination must state
group or organization which nominated whether a nominee is interested only
them or with which they may be affili- in a particular advisory committee or
ated. subcommittee, or whether the nominee
is interested in becoming a member of
§ 14.84 Nominations and selection of any advisory committee or sub-
nonvoting members of standing committee. Nominations that do not
technical advisory committees. comply with the requirements of this
(a) This section applies when the paragraph will not be considered.
Commissioner concludes that a tech- (3) The Advisory Committee Over-
nical advisory committee should in- sight and Management Staff will com-
clude nonvoting members to represent pile a list of organizations whose objec-
and serve as a liaison with interested tives are to promote, encourage, and
individuals and organizations. contribute to the advancement of con-
(b) Except when the Commissioner sumer education and to the resolution
concludes otherwise, nonvoting mem- of consumer problems. All organiza-
bers of a technical advisory committee tions listed are entitled to vote upon
are selected in accordance with para- the nominees. The list will include or-
graphs (c) and (d) of this section and ganizations representing the public in-
are normally limited to one person se- terest, consumer advocacy groups, and
lected by consumer groups and organi- consumer/health branches of Federal,
zations and one person selected by in- State, and local governments. Any or-
dustry groups and organizations. ganization that meets the criteria may
(c) To select a nonvoting member to be included on such list on request.
represent consumer interests, except as (4) The executive secretary, or other
provided in paragraph (c)(5) of this sec- designated agency employee, will re-
tion, the Commissioner publishes a no- view the list of nominees and select
tice in the FEDERAL REGISTER request- three to five qualified nominees to be
ing nominations for each specific com- placed on a ballot. Names not selected
mittee, or subcommittee, for which will remain on a list of eligible nomi-
nonvoting members are to be ap- nees and be reviewed periodically by
pointed. the Advisory Committee Oversight and
(1) A period of 30 days will be per- Management Staff to determine con-
mitted for submission of nominations tinued interest. Upon selection of the
for that committee or subcommittee. nominees to be placed on the ballot,
Interested persons may nominate one the curriculum vitae for each of the
or more qualified persons to represent nominees will be sent to each of the or-
consumer interests. Although nomina- ganizations on the list complied under
tions from individuals will be accepted, paragraph (c)(3) of this section, to-
individuals are encouraged to submit gether with a ballot to be filled out and

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Food and Drug Administration, HHS § 14.86

returned within 30 days. After the time mittee for which the Commissioner has
for return of the ballots has expired, determined to appoint a nonvoting
the ballots will be counted and the member, a notice requesting that,
nominee who has received the highest within 30 days, any industry organiza-
number of votes will be selected as the tion interested in participating in the
nonvoting member representing con- selection of an appropriate nonvoting
sumer interests for that particular ad- member to represent industry interests
visory committee or subcommittee. In send a letter stating that interest to
the event of a tie, the Commissioner the FDA employee designated in the
will select the winner by lot from notice. After 30 days, a letter will be
among those tied for the highest num- sent to each organization that has ex-
ber of votes pressed an interest, attaching a com-
(5) If a member representing con- plete list of all such organizations, and
sumer interests resigns or is removed stating that it is their responsibility to
before termination of the committee consult with each other in selecting,
on which the member is serving, the within 60 days after receipt of the let-
following procedures will be used to ap- ter, a single nonvoting member to rep-
point a replacement to serve out the resent industry interests for that com-
term of the former member: mittee. If no individual is selected
(i) The Commissioner will appoint within 60 days, the Commissioner will
the runner-up, in order of number of select the nonvoting member rep-
ballots received, on the original ballot resenting industry interests.
submitted under paragraph (c)(4) of (e) The Commissioner has determined
this section to fill the vacancy. If the that, because nonvoting members rep-
runner-up is no longer willing to serve resenting consumer and industry inter-
as a member, then the next runner-up ests are included on advisory commit-
will be appointed. tees specifically for the purpose of rep-
(ii) If none of the nominees on the resenting such interests and have no
original ballot is willing to serve, or if vote, any financial interest covered by
there was only one nominee on the 18 U.S.C. 208(a) in the class which the
original ballot, the Advisory Com- member represents is irrelevant to the
mittee Oversight and Management services the Government expects from
Staff will contact by telephone eligible them and thus is hereby exempted
individuals whose names have been under 18 U.S.C. 208(b) as too remote
submitted in the past as candidates for and inconsequential to affect the integ-
membership as representatives of con- rity of their services.
sumer interests. A list of persons who
are interested in serving on an advi- [44 FR 22351, Apr. 13, 1979, as amended at 54
sory committee will then be prepared. FR 9035, Mar. 3, 1989; 75 FR 15342, Mar. 29,
The curricula vitae of these persons, 2010]
together with a ballot, will be sent to
a representative number of consumer § 14.86 Rights and responsibilities of
nonvoting members of advisory
organizations that have been deter- committees.
mined to be eligible to vote for con-
sumer representatives in accordance (a) A nonvoting member of an advi-
with paragraph (c)(3) of this section. sory committee selected to represent
After 4 days have elapsed, the Advisory and serve as a liaison with interested
Committee Oversight and Management individuals, associations, and organiza-
Staff will contact the consumer organi- tions has the same rights as any other
zations by telephone and elicit their committee member except that—
votes. The candidate who has received (1) A nonvoting member may vote
the highest number of votes will be se- only on procedural matters such as ad-
lected. In the event of a tie, the Com- ditional rules adopted under § 14.39(a),
missioner will select the winner by lot approval of minutes under § 14.60(a), de-
from among those tied for the highest cisions on transcripts under § 14.61(b),
number of votes. and future meeting dates;
(d) To select a nonvoting member to (2) A nonvoting member who is a rep-
represent industry interests, the Com- resentative of industry interest may
missioner will publish, for each com- have access to data and information

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§ 14.90 21 CFR Ch. I (4–1–11 Edition)

that constitute a trade secret or con- but may discuss any matter in general
fidential commercial or financial infor- terms. All presentations and discus-
mation as defined in § 20.61 only if the sions of scientific data and their inter-
person has been appointed as a special pretation on behalf of a company will
Government employee under § 14.80(b). occur in open session, except as pro-
(b) A nonvoting member of an advi- vided in § 14.25(c).
sory committee is subject to, and shall (5) A nonvoting member of an advi-
abide by, all rules and regulations sory committee may not make any
adopted by FDA and the committee. presentation to that advisory com-
(c) It is the responsibility of the non- mittee during a hearing conducted by
voting consumer and industry members that committee.
of an advisory committee to represent (6) Although a nonvoting member
the consumer and industry interests in serves in a representative capacity, the
all deliberations. nonvoting member shall exercise re-
(1) A nonvoting member does not rep- straint in performing such functions
resent any particular organization or and may not engage in unseemly advo-
group, but rather represents all inter- cacy or attempt to exert undue influ-
ested persons within the class which ence over the other members of the
the member is selected to represent. committee.
Accordingly, an interested person with- (d) A nonvoting member of an advi-
in the class represented by that non-
sory committee may be removed by the
voting member may, upon request,
Commissioner for failure to comply
have access to all written statements
with this section as well as § 14.80(f).
or oral briefings concerning the com-
mittee prepared by the nonvoting § 14.90 Ad hoc advisory committee
member for distribution to any person members.
outside the committee. When docu-
ments are prepared with non-Govern- In selecting members of an ad hoc ad-
ment funds, persons desiring copies visory committee, the Commissioner
may be required to pay a reasonable fee may use the procedures in §§ 14.82 and
to cover printing and similar costs. 14.84 or any other procedure deemed ap-
(2) The nonvoting member reviews all propriate.
official committee minutes to assure
their completeness and accuracy. § 14.95 Compensation of advisory com-
mittee members.
(3) The nonvoting member acts as a
liaison between the committee and the (a)(1) Except as provided in para-
interested persons whom that member graphs (a) (2) and (3) of this section, all
represents, and transmits requests for voting advisory committee members
information from the committee and shall, and nonvoting members may, be
relevant information and views to the appointed as special Government em-
committee. The nonvoting member ployees and receive a consultant fee
takes the initiative in contacting in- and be reimbursed for travel expenses,
terested persons whom the member including per diem in lieu of subsist-
represents to seek out relevant infor- ence, unless such compensation and re-
mation and views and to relate the imbursement are waived.
progress of the advisory committee. (2) Members of the Technical Elec-
(4) A nonvoting industry member rep- tronic Product Radiation Safety
resents all members of the industry, Standards Committee (TEPRSSC) are
and not any particular association, not appointed as special Government
company, product, or ingredient. If a employees. Any member of TEPRSSC
matter comes before the committee who is not a Federal employee or mem-
that directly or indirectly affects the ber of the uniformed services, includ-
company employing the nonvoting in- ing the Commissioned Corps of the
dustry member, the member shall so Public Health Service, shall receive a
inform the committee but need not be consultant fee and be reimbursed for
absent during the discussion or decline travel expenses, including per diem in
to participate in the discussion. a non- lieu of subsistence, unless such com-
voting industry member may not dis- pensation and reimbursement are
cuss the company’s position as such, waived.

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Food and Drug Administration, HHS § 14.100

(3) Voting and nonvoting advisory own assignment, can be compensated.


committee members who are members Should this preparatory work by mem-
of the uniformed services, including bers collectively result in an end prod-
the Commissioned Corps of the Public uct of the committee, this is to be con-
Health Service, provide service on sidered normal meeting preparation
Food and Drug Administration advi- and committee members are not to be
sory committees as part of their as- compensated for this work.
signed functions, are not appointed as (d) Salary while in travel status is
special government employees, but are authorized when a committee mem-
reimbursed by the Food and Drug Ad- ber’s ordinary pursuits are interrupted
ministration for travel expenses.
for the substantial portion of an addi-
(b) Notwithstanding the member’s
tional day beyond the day or days
primary residence, an advisory com-
mittee member, while attending meet- spent in performing those services, and
ings of the full committee or a sub- as a consequence the committee mem-
committee, will be paid whether the ber loses some regular compensation.
meetings are held in the Washington, This applies on weekends and holidays
DC, area or elsewhere. if the special Government employee
(c) A committee member who partici- loses income that would otherwise be
pates in any agency-directed assign- earned on that day. For travel pur-
ment will be paid at an hourly rate poses, a substantial portion of a day is
when doing assigned work at home, a defined as 50 percent of the working
place of business, or in an FDA facility day, and the traveler will be paid at a
located within the member’s com- daily rate.
muting area, and at a daily rate when
[44 FR 22351, Apr. 13, 1979, as amended at 53
required to travel outside of that com-
FR 50949, Dec. 19, 1988]
muting area to perform the assign-
ment. A committee member will not be
paid for time spent on normal prepara- Subpart F—Standing Advisory
tion for a committee meeting. Committees
(1) An agency-directed assignment is
an assignment that meets the fol- § 14.100 List of standing advisory com-
lowing criteria: mittees.
(i) An activity that requires under- Standing advisory committees and
taking a definitive study. The activity the dates of their establishment are as
must produce a tangible end product, follows:
usually a written report. Examples are: (a) Office of the Commissioner—
(a) An analysis of the risks and bene- (1) Board of Tea Experts.
fits of the use of a class of drugs or a
(i) Date established: March 2, 1897.
report on a specific problem generated
by an IND or NDA; (ii) Function: Advises on establish-
(b) The performance of similar inves- ment of uniform standards of purity,
tigations or analysis of complex indus- quality, and fitness for consumption of
try submissions to support advisory all tea imported into the United States
committee deliberations other than under 21 U.S.C. 42.
normal meeting preparation; (2) Science Board to the Food and Drug
(c) The preparation of a statistical Administration.
analysis leading to an estimate of (i) Date established: June 26, 1992.
toxicologically safe dose levels; and (ii) Function: The board shall provide
(d) The design or analysis of animal advice primarily to the agency’s Senior
studies of toxicity, mutagenicity, Science Advisor and, as needed, to the
teratogenicity, or carcinogenicity. Commissioner and other appropriate
(ii) The performance of an IND or officials on specific complex and tech-
NDA review or similar review. nical issues as well as emerging issues
(2) A committee member who under- within the scientific community in in-
takes a special assignment, the end dustry and academia. Additionally, the
product of which does not represent the
board will provide advice to the agency
end product of the advisory committee,
but rather of the committee member’s

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§ 14.100 21 CFR Ch. I (4–1–11 Edition)

on keeping pace with technical and sci- produce dependence on the tobacco
entific evolutions in the fields of regu- product involved; and any application
latory science; on formulating an ap- submitted by a manufacturer for a
propriate research agenda; and on up- modified risk tobacco product. The
grading its scientific and research fa- committee may provide recommenda-
cilities to keep pace with these tions to the Secretary of Health and
changes. It will also provide the means Human Services regarding any regula-
for critical review of agency sponsored tions to be issued under the Federal
intramural and extramural scientific Food, Drug, and Cosmetic Act and may
research programs. review any applications for new to-
(3) Pediatric Advisory Committee. bacco products or petitions for exemp-
(i) Date established: June 18, 2004. tion under section 906(e) of the Family
(ii) Function: Advises on pediatric Smoking Prevention and Tobacco Con-
therapeutics, pediatric research, and trol Act. The committee may consider
other matters involving pediatrics for and provide recommendations on any
which the Food and Drug Administra- other matter as provided in the Family
tion has regulatory responsibility. Smoking Prevention and Tobacco Con-
(4) Risk Communication Advisory Com- trol Act.
mittee. (b) Center for Biologics Evaluation and
(i) Date rechartered: July 9, 2009. Research—
(ii) Function: The committee reviews (1) Allergenic Products Advisory Com-
and evaluates strategies and programs mittee.
designed to communicate with the pub- (i) Date established: July 9, 1984.
lic about the risks and benefits of FDA- (ii) Function: Reviews and evaluates
regulated products so as to facilitate data on the safety and effectiveness of
optimal use of these products. The allergenic biological products intended
committee also reviews and evaluates for use in the diagnosis, prevention, or
research relevant to such communica- treatment of human disease.
tion to the public by both FDA and (2) Cellular, Tissue and Gene Therapies
other entities. It also facilitates inter- Advisory Committee.
actively sharing risk and benefit infor- (i) Date established: October 28, 1988.
mation with the public to enable peo- (ii) Function: Reviews and evaluates
ple to make informed independent available data relating to the safety,
judgments about use of FDA-regulated effectiveness, and appropriate use of
products. human cells, human tissues, gene
(5) Tobacco Products Scientific Advisory transfer therapies and
Committee. xenotransplantation products which
(i) Date Established: August 12, 2009. are intended for transplantation, im-
(ii) Function: The committee reviews plantation, infusion, and transfer in
and evaluates safety, dependence, and the prevention and treatment of a
health issues relating to tobacco prod- broad spectrum of human diseases and
ucts and provides appropriate advice, in the reconstruction, repair or re-
information, and recommendations to placement of tissues for various condi-
the Commissioner of Food and Drugs. tions. The Committee also considers
Specifically, the committee will sub- the quality and relevance of FDA’s re-
mit reports and recommendations on search program which provides sci-
tobacco-related topics, including: The entific support for the regulation of
impact of the use of menthol in ciga- these products, and makes appropriate
rettes on the public health, including recommendations to the Commissioner
such use among children, African of Food and Drugs.
Americans, Hispanics and other racial (3) Blood Products Advisory Committee.
and ethnic minorities; the nature and (i) Date established: May 13, 1980.
impact of the use of dissolvable to- (ii) Function: Reviews and evaluates
bacco products on the public health, in- data on the safety and effectiveness,
cluding such use on children; the ef- and appropriate use of blood products
fects of the alteration of nicotine intended for use in the diagnosis, pre-
yields from tobacco products and vention, or treatment of human dis-
whether there is a threshold level eases.
below which nicotine yields do not (4) [Reserved]

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Food and Drug Administration, HHS § 14.100

(5) Vaccines and Related Biological drugs for use in cardiovascular and
Products Advisory Committee—(i) Date renal disorders.
established: December 31, 1979. (6) Dermatologic and Ophthalmic Drugs
(ii) Function: Reviews and evaluates Advisory Committee.
data on the safety and effectiveness of (i) Date established: October 7, 1980.
vaccines intended for use in the diag- (ii) Function: Reviews and evaluates
nosis, prevention, or treatment of available data concerning the safety
human diseases. and effectiveness of marketed and in-
(6) Transmissible Spongiform vestigational human drug products for
Encephalopathies Advisory Committee— use in the treatment of dermatologic
(i) Date established: June 21, 1995. and ophthalmic disorders.
(ii) Function: Reviews and evaluates (7) Drug Safety and Risk Management
available scientific data concerning the Advisory Committee.
safety of products which may be at risk (i) Date established: May 31, 1978.
for transmission of spngiform (ii) Function: Reviews and evaluates
encephalopathies having an impact on data on risk management plans, pro-
the public health. vides active surveillance methodolo-
(c) Center for Drug Evaluation and Re- gies, trademark studies, methodologies
search— for risk management communication,
(1) Anesthetic and Life Support Drugs and related issues.
Advisory Committee. (8) Endocrinologic and Metabolic Drugs
(i) Date established: May 1, 1978. Advisory Committee.
(ii) Function: Reviews and evaluates (i) Date established: August 27, 1970.
data on the safety and effectiveness of
(ii) Function: Reviews and evaluates
marketed and investigational human
data on the safety and effectiveness of
drugs for use in the field of anesthesi-
marketed and investigational human
ology and surgery.
drugs for use in endocrine and meta-
(2) Anti-Infective Drugs Advisory Com-
bolic disorders.
mittee.
(9) Advisory Committee for Reproductive
(i) Date established: October 7, 1980.
Health Drugs.
(ii) Function: Reviews and evaluates
(i) Date established: March 23, 1978.
available data concerning the safety
and effectiveness of marketed and in- (ii) Function: Reviews and evaluates
vestigational human drug products for data on the safety and effectiveness of
use in the treatment of infectious dis- marketed and investigational human
eases and disorders. drugs for use in the practice of obstet-
(3) Antiviral Drugs Advisory Committee. rics, gynecology, and related special-
(i) Date established: February 15, 1989. ties.
(ii) Function: Reviews and evaluates (10) Gastrointestinal Drugs Advisory
available data concerning the safety Committee.
and effectiveness of marketed and in- (i) Date established: March 3, 1978.
vestigational human drug products for (ii) Function: Reviews and evaluates
use in the treatment of acquired im- data on the safety and effectiveness of
mune deficiency syndrome (AIDS), marketed and investigational human
AIDS-related complex (ARC), and other drugs for use in gastrointestinal dis-
viral, fungal, and mycobacterial infec- eases.
tions. (11) Oncologic Drugs Advisory Com-
(4) Arthritis Advisory Committee. mittee.
(i) Date established: April 5, 1974. (i) Date established: September 1,
(ii) Function: Reviews and evaluates 1978.
data on the safety and effectiveness of (ii) Function: Reviews and evaluates
marketed and investigational human data on the safety and effectiveness of
drugs for use in arthritic conditions. marketed and investigational human
(5) Cardiovascular and Renal Drugs Ad- drugs for use in treatment of cancer.
visory Committee. (12) Peripheral and Central Nervous
(i) Date established: August 27, 1970. System Drugs Advisory Committee.
(ii) Function: Reviews and evaluates (i) Date established: June 4, 1974.
data on the safety and effectiveness of (ii) Function: Reviews and evaluates
marketed and investigational human data on the safety and effectiveness of

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§ 14.100 21 CFR Ch. I (4–1–11 Edition)

marketed and investigational human (ii) Functions: The committee re-


drugs for use in neurological disease. views and evaluates available data con-
(13) Psychopharmacologic Drugs Advi- cerning the safety and effectiveness of
sory Committee. over-the-counter (nonprescription)
(i) Date established: June 4, 1974. human drug products for use in the
(ii) Function: Reviews and evaluates treatment of a broad spectrum of
data on the safety and effectiveness of human symptoms and diseases.
marketed and investigational human (18) Pharmacy Compounding Advisory
drugs for use in the practice of psychi- Committee.
atry and related fields. (i) Date established: February 12,
(14) Pulmonary-Allergy Drugs Advisory 1998.
Committee. (ii) Function: Provides advice on sci-
(i) Date established: February 17, entific, technical, and medical issues
1972. concerning drug compounding by phar-
(ii) Function: Reviews and evaluates macists and licensed practitioners.
data on the safety and effectiveness of
(d) Center for Devices and Radiological
marketed and investigational human
Health—
drugs for use in the treatment of pul-
monary disease and diseases with aller- (1) Medical Devices Advisory Committee.
gic and/or immunologic mechanisms. (i) Date established: October 27, 1990.
(15) Medical Imaging Drugs Advisory (ii) Function: Reviews and evaluates
Committee. data on the safety and effectiveness of
(i) Date established: August 30, 1967. marketed and investigational devices
(ii) Function: Reviews and evaluates and makes recommendations for their
data concerning the safety and effec- regulation.
tiveness of marketed and investiga- (2) Device Good Manufacturing Practice
tional human drug products for use in Advisory Committee.
diagnostic and therapeutic procedures (i) Date established: May 17, 1987.
using radioactive pharmaceuticals and (ii) Function: Reviews proposed regu-
contrast media used in diagnostic radi- lations for good manufacturing prac-
ology. tices governing the methods used in,
(16) Advisory Committee for Pharma- and the facilities and controls used for,
ceutical Science and Clinical Pharma- the manufacture, packing, storage, and
cology. installation of devices, and makes rec-
(i) Date established: January 22, 1990. ommendations on the feasibility and
(ii) Function: The committee shall reasonableness of the proposed regula-
provide advice on scientific, clinical tions.
and technical issues related to safety (3) Technical Electronic Product Radi-
and effectiveness of drug products for ation Safety Standards Committee.
use in the treatment of a broad spec- (i) Date established: October 18, 1968.
trum of human diseases, the quality
(ii) Function: Advises on technical
characteristics which such drugs pur-
feasibility, reasonableness, and prac-
port or are represented to have and as
ticability of performance standards for
required, any other product for which
electronic products to control the
the Food and Drug Administration has
emission of radiation under 42 U.S.C.
regulatory responsibility, and make
263f(f)(1)(A).
appropriate recommendations to the
Commissioner of Food and Drugs. The (4) National Mammography Quality As-
Committee may also review agency surance Advisory Committee.
sponsored intramural and extramural (i) Date established: July 6, 1993.
biomedical research programs in sup- (ii) Function: Advises on developing
port of FDA’s drug regulatory respon- appropriate quality standards and reg-
sibilities and its critical path initia- ulations for the use of mammography
tives related to improving the efficacy facilities.
and safety of drugs and improving the (e) National Center for Toxicological
efficiency of drug development. Research—Science Advisory Board.
(17) Nonprescription Drugs Advisory (1) Date established: June 2, 1973.
Committee. (2) Function: Advises on establish-
(i) Date established: August 27, 1991. ment and implementation of a research

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Food and Drug Administration, HHS § 14.127

program that will assist the Commis- (3) May make recommendations to
sioner of Food and Drugs tofulfill regu- the Commissioner on any other mat-
latory responsibilities. ters it deems necessary or appropriate
(f) Center for Veterinary Medicine. in fulfilling the purposes of the act.
Veterinary Medicine Advisory Com- (b) Responsibility for action on per-
mittee. formance standards under 42 U.S.C. 263f
(1) Date established: April 24, 1984. rests with the Commissioner, after re-
(2) Function: Reviews and evaluates ceiving the advice of TEPRSSC.
available data concerning safety and
effectiveness of marketed and inves- § 14.125 Procedures of TEPRSSC.
tigational new animal drugs, feeds, and (a) When the Commissioner is consid-
devices for use in the treatment and ering promulgation of a performance
prevention of animal disease and in- standard for an electronic product, or
creased animal production. an amendment of an existing standard,
(g) Center for Food Safety and Applied before issuing a proposed regulation in
Nutrition—Food Advisory Committee. the FEDERAL REGISTER the Commis-
(1) Date established: December 15, sioner will submit to TEPRSSC the
1991. proposed standard or amendment under
(2) Function: The committee provides consideration, together with other rel-
advice on emerging food safety, food evant information to aid TEPRSSC in
science, and nutrition issues that FDA its deliberations.
considers of primary importance in the (b) The agenda and other material to
next decade. be considered at any meeting will be
sent to members whenever possible at
[54 FR 9036, Mar. 3, 1989] least 2 weeks before the meeting.
EDITORIAL NOTE: For FEDERAL REGISTER ci- (c) Ten members constitute a
tations affecting § 14.100, see the List of CFR quorum, provided at least three mem-
Sections Affected, which appears in the bers are present from each group speci-
Finding Aids section of the printed volume fied in 42 U.S.C. 263f(f)(1)(A) and in
and at www.fdsys.gov. § 14.127(a), i.e., Government, industry,
and the public.
Subpart G—Technical Electronic (d) The chairman of TEPRSSC will
Products Radiation Safety ordinarily submit a report to the Com-
Standards Committee missioner of the committee’s consider-
ation of any proposed performance
§ 14.120 Establishment of the Tech- standard for an electronic product
nical Electronic Product Radiation within 60 days after consideration. If
Safety Standards Committee the chairman believes that more time
(TEPRSSC). is needed, the chairman will inform the
The Technical Electronic Product Director of the Center for Devices and
Radiation Safety Standards Committee Radiological Health in writing, in
(TEPRSSC), consisting of 15 members, which case an additional 30 days will be
is established in accordance with the allowed to make the report.
Radiation Control for Health and Safe- (e) Sections 14.1 through 14.7 apply to
ty Act of 1968 (42 U.S.C. 263f(f)(1)(A)) to TEPRSSC, except where other provi-
provide consultation before the Com- sions are specifically included in
missioner prescribes any performance §§ 14.120 through 14.130.
standard for an electronic product. [44 FR 22351, Apr. 13, 1979, as amended at 54
FR 9037, Mar. 3, 1989]
§ 14.122 Functions of TEPRSSC.
(a) In performing its function of ad- § 14.127 Membership of TEPRSSC.
vising the Commissioner, TEPRSSC— (a) The Commissioner will appoint
(1) May propose electronic product the members after consultation with
radiation safety standards to the Com- public and private organizations con-
missioner for consideration; cerned with the technical aspect of
(2) Provides consultation to the Com- electronic product radiation safety.
missioner on all performance standards TEPRSSC consists of 15 members, each
proposed for consideration under 42 of whom is technically qualified by
U.S.C. 263f; and training and experienced in one or

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§ 14.130 21 CFR Ch. I (4–1–11 Edition)

more fields of science or engineering which may be contrary to the condi-


applicable to electronic product radi- tions of the appointment.
ation safety, as follows: (g) Members of TEPRSSC who are
(1) Five members selected from gov- not full-time officers or employees of
ernment agencies, including State and the United States receive compensa-
Federal Governments. tion under § 14.95, in accordance with 42
(2) Five members selected from the U.S.C. 210(c).
affected industries after consultation
with industry representatives. § 14.130 Conduct of TEPRSSC meeting;
availability of TEPRSSC records.
(3) Five members selected from the
general public, of whom at least one (a) In accordance with 42 U.S.C.
shall be a representative of organized 263f(f)(1)(B), all proceedings of
labor. TEPRSSC are recorded, and the record
(b) The Commissioner will appoint a of each proceeding is available for pub-
committee member as chairman of lic inspection.
TEPRSSC. (b) All proceedings of TEPRSSC are
(c) Appointments of members are for open except when the Commissioner
a term of 3 years or as specified by the has determined, under § 14.27, that a
Commissioner. portion of a meeting may be closed.
(1) The chairman is appointed for a
term concurrent with the chairman’s Subpart H—Color Additive
term as a member of TEPRSSC. If the Advisory Committees
chairmanship becomes vacant without
adequate notice, the executive sec- § 14.140 Establishment of a color addi-
retary may appoint a committee mem- tive advisory committee.
ber as temporary chairman pending ap- The Commissioner will establish a
pointment of a new chairman by the color additive advisory committee
Commissioner. under the following circumstances:
(2) Members may not be reappointed (a) The Commissioner concludes, as a
for a second consecutive full term. matter of discretion, that it would be
(d) A person otherwise qualified for in the public interest for a color addi-
membership is not eligible for selection tive advisory committee to review and
as a member of TEPRSSC from Gov- make recommendations about the safe-
ernment agencies or the general public ty of a color additive on which impor-
if the Commissioner determines that tant issues are pending before FDA and
the person does not meet the require- for interested persons to present infor-
ments of the conflict of interest laws mation and views at an oral public
and regulations. hearing before a color additive advi-
(e) Retention of membership is condi- sory committee.
tioned upon the following: (b) There is an issue arising under
(1) Continued status as a member of section 721(b)(5)(B) of the act con-
the group from which the member was cerning the safety of a color additive,
selected as specified in paragraph (a) of including its potential or actual car-
this section. cinogenicity, that requires the exercise
(2) Absence of any conflict of interest of scientific judgment and a person
during the term of membership as spec- who would be adversely affected by the
ified in paragraph (d) of this section. issuance, amendment, or repeal of a
(3) Active participation in TEPRSSC regulation listing a color additive re-
activities. quests that the matter, or the Commis-
(f) Appointment as a member of sioner as a matter of discretion deter-
TEPRSSC is conditioned on certifi- mines that the matter should, be re-
cation that the prospective member: ferred to a color additive advisory com-
(1) Agrees to the procedures and cri- mittee.
teria specified in this subpart. (1) Paragraph (b) does not apply to
(2) Has no conflict of interest as spec- any issue arising under the transi-
ified in paragraph (d) of this section. tional provisions in section 203 of the
(3) Will notify the executive sec- Color Additive Amendments of 1960 re-
retary of TEPRSSC before any change lating to provisional listing of com-
in representative status on TEPRSSC mercially established colors. A color

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Food and Drug Administration, HHS § 14.147

additive advisory committee to con- (c) The date of the first meeting of a
sider any such matter will be estab- color additive advisory committee, fol-
lished under paragraph (a) of this sec- lowing receipt of the administrative
tion. record by each of the committee mem-
(2) A request for establishment of a bers, is designated as the beginning of
color additive advisory committee is to the period allowed for consideration of
be made in accordance with § 10.30. The the matter by the committee. Within
Commissioner may deny any petition if 60 days after the first meeting, unless
inadequate grounds are stated for es- the time is extended as provided in
tablishing a color additive advisory paragraph (d) of this section, the chair-
committee. A request for establish- man of the committee shall certify to
ment of a color additive advisory com- the Commissioner the report con-
mittee may not rest on mere allega- taining the recommendations of the
tions or denials, but must set forth spe- committee, including any minority re-
cific facts showing that there is a gen- port. The report states the rec-
uine and substantial issue of fact that ommendations of the committee and
requires scientific judgment and justi- the reasons or basis for them. The re-
fies a hearing before a color additive port includes copies of all material
advisory committee. When it conclu- considered by the committee in addi-
sively appears from the request for a tion to the administrative record fur-
color additive advisory committee that nished to it.
the matter is premature or that it does (d) If the chairman concludes that
not involve an issue arising under sec- the color additive advisory committee
tion 721(b)(5)(B) of the act or that there needs additional time, the chairman
is no genuine and substantial issue of shall so inform the Commissioner in
fact requiring scientific judgment, or writing and may certify the report of
for any other reason a color additive the committee to the Commissioner
advisory committee is not justified, within 90 days instead of 60 days.
the Commissioner may deny the estab-
(e) More than one matter may be
lishment of a color additive advisory
handled concurrently by a color addi-
committee.
tive advisory committee.
(3) Establishment of a color additive
advisory committee on the request of § 14.145 Procedures of a color additive
an interested person is conditioned advisory committee.
upon receipt of the application fee
specified in § 14.155. (a) A color additive advisory com-
(4) Any person adversely affected mittee is subject to all the require-
may request referral of the matter to a ments of the Federal Advisory Com-
color additive advisory committee at mittee Act and this part.
any time before, or within 30 days (b) All interested persons have a
after, publication of an order of the right to consult with the color additive
Commissioner acting upon a color ad- advisory committee reviewing a mat-
ditive petition or proposal. ter and to submit information and
views to a color additive advisory com-
§ 14.142 Functions of a color additive mittee, in accordance with the proce-
advisory committee. dures in this part.
(a) A color additive advisory com-
mittee reviews all available informa- § 14.147 Membership of a color addi-
tive advisory committee.
tion relating to the matter referred to
it, including all information contained (a) The members of a color additive
in any pertinent color additive petition advisory committee are selected in the
and in FDA files. All information re- following manner:
viewed is placed on public display and (1) If a color additive advisory com-
is available for review at the office of mittee is established for purposes that
the Division of Dockets Management. do not include review of an issue aris-
(b) The Commissioner specifies to the ing under section 721(b)(5)(B) of the act,
color additive advisory committee, in or is established on the initiative of
writing, the issues on which review and the Commissioner, the Commissioner
recommendations are requested. may use the procedure in paragraph

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§ 14.155 21 CFR Ch. I (4–1–11 Edition)

(a)(2) of this section to select the mem- Committee Act and this subpart, ex-
bers or may use an existing standing cept that no member of a color additive
advisory committee listed in § 14.100, or advisory committee may by reason of
may establish a new advisory com- such membership alone be a special
mittee under this subpart. Once the government employee or be subject to
Commissioner has established a color the conflict of interest laws and regula-
additive advisory committee under this tions.
paragraph and has referred to it a mat-
ter relating to a color additive, no in- § 14.155 Fees and compensation per-
terested person may subsequently re- taining to a color additive advisory
quest that an additional or different committee.
color additive advisory committee be (a) When a matter is referred to a
established to review and make rec- color additive advisory committee, all
ommendations about that color addi- related costs, including personal com-
tive. pensation of committee members, trav-
(2) If the Commissioner established a el, materials, and other costs, are
color additive advisory committee to borne by the person requesting the re-
review an issue arising under section ferral, such costs to be assessed on the
721(b)(5)(B) of the act on the request of basis of actual cost to the government.
an interested person, it shall be estab- The compensation of such costs in-
lished under the following require- cludes personal compensation of com-
ments: mittee members at a rate not to exceed
(i) Except as provided in paragraph $128.80 per member per day.
(a)(2) (ii) and (iii) of this section, the
(b) In the case of a request for refer-
Commissioner will request the Na-
ral to a color additive advisory com-
tional Academy of Sciences to select
mittee, a special advance deposit is to
the members of a color additive advi-
be made in the amount of $2,500. Where
sory committee from among experts
required, further advances in incre-
qualified in the subject matter to be re-
ments of $2,500 each are to be made
viewed by the committee, and of ade-
upon request of the Commissioner. All
quately diversified professional back-
deposits for referrals to a color addi-
grounds. The Commissioner will ap-
point one of the members as the chair- tive advisory committee in excess of
man. actual expenses will be refunded to the
(ii) If the National Academy of depositor.
Sciences is unable or refuses to select (c) All deposits and fees required by
the members of a color additive advi- this section are to be paid by money
sory committee, the Commissioner will order, bank draft, or certified check
select the members. drawn to the order of the Food and
(iii) If the Commissioner and the re- Drug Administration, collectable at
questing party agree, section par in Washington, DC. All deposits
721(b)(5)(D) of the act may be waived and fees are to be forwarded to the As-
and the matter may be referred to any sociate Commissioner for Management
standing advisory committee listed in and Operations, Food and Drug Admin-
§ 14.100 or to any advisory committee istration, 5600 Fishers Lane, Rockville,
established under any other procedure MD 20857, and after appropriate record
that is mutually agreeable. Once the of them is made, they will be trans-
Commissioner has established a color mitted to the Treasurer of the United
additive advisory committee and has States for deposit in the special ac-
referred to it a matter relating to a count ‘‘Salaries and Expenses, Certifi-
color additive, no interested person cation, Inspection, and Other Services,
may subsequently request that an addi- Food and Drug Administration.’’
tional or different color additive advi- (d) The Commissioner may waive or
sory committee be established to re- refund such fees in whole or in part
view and make recommendations about when, in the Commissioner’s judgment,
that color additive. such action will promote the public in-
(b) Members of a color additive advi- terest. Any person who believes that
sory committee are subject to the re- payment of these fees will be a hard-
quirements of the Federal Advisory ship may petition the Commissioner

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Food and Drug Administration, HHS § 14.171

under § 10.30 to waive or refund the the following types of human prescrip-
fees. tion drugs:
(1) Investigational drugs which are
Subpart I—Advisory Committees potential therapeutic advances over
for Human Prescription Drugs currently marketed products from the
standpoint of safety or effectiveness, or
§ 14.160 Establishment of standing which pose significant safety hazards,
technical advisory committees for or which present narrow benefit-risk
human prescription drugs. considerations requiring a close
judgmental decision on approval for
The standing technical advisory com-
marketing, or which have a novel de-
mittees for human prescription drugs
livery system or formulation, or which
are established to advise the Commis-
are the subject of major scientific or
sioner:
public controversy, or which may be
(a) Generally on the safety and effec-
subject to special regulatory require-
tiveness, including the labeling and ad-
ments such as a limitation on clinical
vertising, and regulatory control of the
trials, a patient followup requirement,
human prescription drugs falling with-
postmarketing Phase IV studies, dis-
in the pharmacologic class covered by
tributional controls, or boxed warn-
the advisory committee and on the sci-
ings.
entific standards appropriate for a de-
(2) Marketed drugs for which an im-
termination of safety and effectiveness
portant new use has been discovered or
in that class of drugs.
which pose newly discovered safety
(b) Specifically on any particular hazards, or which are the subject of
matter involving a human prescription major scientific or public controversy,
drug pending before FDA, including or which may be subject to important
whether the available information is regulatory actions such as withdrawal
adequate to support a determination of approval for marketing, boxed warn-
that— ings, distributional controls, or newly
(1) A particular IND study may prop- required scientific studies.
erly be conducted; (c) The committee may request the
(2) A particular drug meets the statu- Commissioner for an opportunity to
tory standard for proof of safety and ef- hold a public hearing and to review any
fectiveness necessary for approval or matter involving a human prescription
continued approval for marketing; or drug which falls within the pharmaco-
(3) A particular drug is properly clas- logic class covered by the committee.
sified as a new drug, an old drug, or a The Commissioner may, after con-
banned drug. sulting with the committtee on such
request, grant or deny the request in
§ 14.171 Utilization of an advisory com- light of the priorities of the other mat-
mittee on the initiative of FDA.
ters pending before the committee.
(a) Any matter involving a human Whenever feasible, consistent with the
prescription drug under review within other work of the committee, the re-
the agency may, in the discretion of quest will be granted.
the Commissioner, be the subject of a (d) For a drug that meets any of the
public hearing and continuing or peri- criteria established in paragraph (b) of
odic review by the appropriate stand- this section, one or more members of
ing technical advisory committee for or consultants to the appropriate advi-
human prescription drugs. The Com- sory committee may be selected for
missioner’s determinations on the more detailed monitoring of the mat-
agenda of the committee are based ter and consultation with FDA on be-
upon the priorities of the various mat- half of the committee. The member or
ters pending before the agency which consultant may be invited to attend
fall within the pharmacologic class appropriate meetings and shall assist
covered by that committee. the center in any briefing of the com-
(b) High priority for such hearing and mittee on that matter.
review by the appropriate standing (e) An advisory committee may ob-
technical advisory committee for tain advice and recommendations from
human prescription drugs are given to other agency advisory committees,

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§ 14.172 21 CFR Ch. I (4–1–11 Edition)

consultants, and experts which the ad- PART 15—PUBLIC HEARING BEFORE
visory committee and the center con- THE COMMISSIONER
clude would facilitate the work of the
advisory committee. Subpart A—General Provisions
(f) Presentation of all relevant infor-
mation about the matter will be made Sec.
15.1 Scope.
in open session unless it relates to an
IND the existence of which has not pre- Subpart B—Procedures for Public Hearing
viously been disclosed to the public as Before the Commissioner
defined in § 20.81 or is otherwise prohib-
ited from public disclosure under part 15.20 Notice of a public hearing before the
20 and the regulations referenced there- Commissioner.
15.21 Notice of participation; schedule for
in. Sections 314.430 and 601.51 deter- hearing.
mine whether, and the extent to which, 15.25 Written submissions.
relevant information may be made 15.30 Conduct of a public hearing before the
available for public disclosure, summa- Commissioner.
rized and discussed in open session but
not otherwise made available for public Subpart C—Records of a Public Hearing
disclosure, or not in any way discussed Before the Commissioner
or disclosed in open session or other- 15.40 Administrative record.
wise disclosed to the public. 15.45 Examination of administrative record.
[44 FR 22351, Apr. 13, 1979, as amended at 54 AUTHORITY: 5 U.S.C. 553; 15 U.S.C. 1451–1461;
FR 9037, Mar. 3, 1989] 21 U.S.C. 141–149, 321–393, 467f, 679, 821, 1034; 28
U.S.C. 2112; 42 U.S.C. 201, 262, 263b–263n, 264.
§ 14.172 Utilization of an advisory com- SOURCE: 44 FR 22366, Apr. 13, 1979, unless
mittee at the request of an inter- otherwise noted.
ested person.
Any interested person may request, Subpart A—General Provisions
under § 10.30, that a specific matter re-
lating to a particular human prescrip- § 15.1 Scope.
tion drug be submitted to an appro- The procedures in this part apply
priate advisory committee for a hear- when:
ing and review and recommendations. (a) The Commissioner concludes, as a
The request must demonstrate the im- matter of discretion, that it is in the
portance of the matter and the reasons public interest to permit persons to
why it should be submitted for a hear- present information and views at a
ing at that time. The Commissioner public hearing on any matter pending
may grant or deny the request. before the Food and Drug
Administation.
§ 14.174 Advice and recommendations (b) The act or regulation specifically
in writing. provides for a public hearing before the
Advice and recommendations given Commissioner on a matter, e.g.,
by a committee on a specific drug or a § 330.10(a)(8) relating to over-the-
class of drugs are ordinarily in the counter drugs and sections 520 (b) and
form of a written report. The report (f)(1)(B), and 521 of the act relating to
may consist of the approved minutes of proposals to allow persons to order cus-
tom devices, to proposed device good
the meeting or a separate written re-
manufacturing practice regulations,
port. The report responds to the spe-
and to proposed exemptions from pre-
cific issues or questions which the emption of State and local device re-
Commissioner has addressed to the ad- quirements under § 808.25(e).
visory committee, and states the basis (c) A person who has right to an op-
of the advice and recommendations of portunity for a formal evidentiary pub-
the committee. lic hearing under part 12 waives that
opportunity and instead requests under
§ 12.32 a public hearing before the Com-
missioner, and the Commissioner, as a

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Food and Drug Administration, HHS § 15.25

matter of discretion, accepts the re- § 15.21 Notice of participation; sched-


quest. ule for hearing.
(a) The notice of hearing will provide
Subpart B—Procedures for Public persons an opportunity to file a writ-
Hearing Before the Commissioner ten notice of participation with the Di-
vision of Dockets Management within
§ 15.20 Notice of a public hearing be- a specified period of time containing
fore the Commissioner. the information specified in the notice,
(a) If the Commissioner determines e.g., name of participant, address,
that a public hearing should be held on phone number, affiliation, if any, topic
of presentation and approximate
a matter, the Commissioner will pub-
amount of time requested for the pres-
lish a notice of hearing in the FEDERAL
entation. If the public interest re-
REGISTER setting forth the following
quires, e.g., a hearing is to be con-
information:
ducted within a short period of time or
(1) If the hearing is under § 15.1 (a) or is to be primarily attended by individ-
(b), the notice will state the following: uals without an organizational affili-
(i) The purpose of the hearing and the ation, the notice may name a specific
subject matter to be considered. If a FDA employee and telephone number
written document is to be the subject to whom an oral notice of participation
matter of the hearing, it will be pub- may be given or provide for submitting
lished as part of the notice, or ref- notices of participation at the time of
erence made to it if it has already been the hearing. A written or oral notice of
published in the FEDERAL REGISTER, or participation must be received by the
the notice will state that the document designated person by the close of busi-
is available from an agency office iden- ness of the day specified in the notice.
tified in the notice. (b) Promptly after expiration of the
(ii) The time, date, and place of the time for filing a notice, the Commis-
hearing, or a statement that the infor- sioner will determine the amount of
mation will be contained in a subse- time allotted to each person and the
quent notice. approximate time that oral presen-
(2) If the hearing is in lieu of a formal tation is scheduled to begin. If more
evidentiary public hearing under than one hearing is held on the same
§ 15.1(c), all of the information de- subject, a person will ordinarily be al-
scribed in § 12.32(e). lotted time for a presentation at only
(b) The scope of the hearing is deter- one hearing.
mined by the notice of hearing and any (c) Individuals and organizations
regulation under which the hearing is with common interests are urged to
held. If a regulation, e.g., § 330.10(a)(10), consolidate or coordinate their presen-
limits a hearing to review of an exist- tations and to request time for a joint
ing administrative record, information presentation. The Commissioner may
not already in the record may not be require joint presentations by persons
considered at the hearing. with common interests.
(d) The Commissioner will prepare a
(c) The notice of hearing may require
hearing schedule showing the persons
participants to submit the text of their
making oral presentations and the
presentations in advance of the hearing
time alloted to each person, which will
if the Commissioner determines that
be filed with the Division of Dockets
advance submissions are necessary for Management and mailed or telephoned
the panel to formulate useful questions before the hearing to each participant.
to be posed at the hearing under (e) The hearing schedule will state
§ 15.30(e). The notice may provide for whether participants must be present
the submission of a comprehensive out- by a specified time to be sure to be
line as an alternative to the submis- heard in case the absence of partici-
sion of the text if the Commissioner de- pants advances the schedule.
termines that submission of an outline
will be sufficient. § 15.25 Written submissions.
[44 FR 22366, Apr. 13, 1979, as amended at 47 A person may submit information or
FR 26375, June 18, 1982] views on the subject of the hearing in

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§ 15.30 21 CFR Ch. I (4–1–11 Edition)

writing to the Division of Dockets tions to be submitted to the presiding


Management, under § 10.20. The record officer or panel for response by them or
of the hearing will remain open for 15 by persons attending the hearing.
days after the hearing is held for any (f) The hearing is informal in nature,
additional written submissions, unless and the rules of evidence do not apply.
the notice of the hearing specifies oth- No motions or objections relating to
erwise or the presiding officer rules the admissibility of information and
otherwise. views may be made or considered, but
other participants may comment upon
§ 15.30 Conduct of a public hearing be- or rebut all such information and
fore the Commissioner. views. No participant may interrupt
(a) The Commissioner or a designee the presentation of another participant
may preside at the hearing, except at any hearing for any reason.
where a regulation provides that the (g) The hearing may end early only if
Commissioner will preside personally. all persons scheduled for a later presen-
The presiding officer may be accom- tation have already appeared or it is
panied by other FDA employees or past the time specified in the hearing
other Federal Government employees schedule, under § 15.21(e), by which par-
designated by the Commissioner, who ticipants must be present.
may serve as a panel in conducting the (h) The Commissioner or the pre-
hearing. siding officer may, under § 10.19, sus-
(b) The hearing will be transcribed. pend, modify, or waive any provision of
(c) Persons may use their alloted this part.
time in whatever way they wish, con-
sistent with a reasonable and orderly Subpart C—Records of a Public
hearing. A person may be accompanied
by any number of additional persons, Hearing Before the Commissioner
and may present any written informa- § 15.40 Administrative record.
tion or views for inclusion in the
record of the hearing, subject to the re- (a) The administrative record of a
quirements of § 15.25. The presiding offi- public hearing before the Commis-
cer may allot additional time to any sioner consists of the following:
person when the officer concludes that (1) All relevant FEDERAL REGISTER
it is in the public interest, but may not notices, including any documents to
reduce the time allotted for any person which they refer.
without the consent of the person. (2) All written submissions under
(d) If a person is not present at the § 15.25.
time specified for the presentation, the (3) The transcript of the oral hearing.
persons following will appear in order, (b) The record of the administrative
with adjustments for those appearing proceeding will be closed at the time
at their scheduled time. An attempt specified in § 15.25.
will be made to hear any person who is
late at the conclusion of the hearing. § 15.45 Examination of administrative
Other interested persons attending the record.
hearing who did not request an oppor- Section 10.20(j) governs the avail-
tunity to make an oral presentation ability for public examination and
will be given an opportunity to make copying of each document in the ad-
an oral presentation at the conclusion ministrative record of the hearing
of the hearing, in the discretion of the
presiding officer, to the extent that PART 16—REGULATORY HEARING
time permits.
(e) The presiding officer and any
BEFORE THE FOOD AND DRUG
other persons serving on a panel may ADMINISTRATION
question any person during or at the
conclusion of the presentation. No Subpart A—General Provisions
other person attending the hearing Sec.
may question a person making a pres- 16.1 Scope.
entation. The presiding officer may, as 16.5 Inapplicability and limited applica-
a matter of discretion, permit ques- bility.

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Food and Drug Administration, HHS § 16.1

Subpart B—Initiation of Proceedings under this part or provides an oppor-


tunity for a hearing for which no pro-
16.22 Initiation of regulatory hearing.
16.24 Regulatory hearing required by the
cedures are specified by regulation.
act or a regulation. Listed below are the statutory and reg-
16.26 Denial of hearing and summary deci- ulatory provisions under which regu-
sion. latory hearings are available:
(1) Statutory provisions:
Subpart C—Commissioner and Presiding
Section 304(g) of the act relating to the ad-
Officer
ministrative detention of devices (see
16.40 Commissioner. § 800.55(g) of this chapter).
16.42 Presiding officer. Section 304(h) of the act relating to the ad-
16.44 Communication to presiding officer ministrative detention of food for human
and Commissioner. or animal consumption (see part 1, subpart
k of this chapter).
Subpart D—Procedures for Regulatory Section 515(e)(1) of the act relating to the
Hearing proposed withdrawal of approval of a de-
vice premarket approval application.
16.60 Hearing procedure. Section 515(e)(3) of the act relating to the
16.62 Right to counsel. temporary suspension of approval of a pre-
market approval application.
Subpart E—Administrative Record and Section 515(f)(6) of the act relating to a pro-
Decision posed order revoking a device product de-
velopment protocol or declaring a protocol
16.80 Administrative record of a regulatory not completed.
hearing. Section 515(f)(7) of the act relating to revoca-
16.85 Examination of administrative record. tion of a notice of completion of a product
16.95 Administrative decision and record for development protocol.
decision. Section 516 of the act relating to a proposed
banned device regulations (see § 895.21(d) of
Subpart F—Reconsideration and Stay this chapter).
Section 518(b) of the act relating to a deter-
16.119 Reconsideration and stay of action. mination that a device is subject to a re-
pair, replacement, or refund order or that
Subpart G—Judicial Review a correction plan, or revised correction
16.120 Judicial review. plan, submitted by a manufacturer, im-
porter, or distributor is inadequate.
AUTHORITY: 15 U.S.C. 1451–1461; 21 U.S.C. Section 518(e) of the act relating to a cease
141–149, 321–394, 467f, 679, 821, 1034; 28 U.S.C. distribution and notification order or man-
2112; 42 U.S.C. 201–262, 263b, 364. datory recall order concerning a medical
SOURCE: 44 FR 22367, Apr. 13, 1979, unless device for human use.
otherwise noted. Section 520(f)(2)(D) of the act relating to ex-
emptions or variances from device current
good manufacturing practice requirements
Subpart A—General Provisions (see § 820.1(d)).
Section 520(g)(4) and (g)(5) of the act relating
§ 16.1 Scope. to disapproval and withdrawal of approval
The procedures in this part apply of an application from an investigational
when: device exemption (see §§ 812.19(c), 812.30(c),
(a) The Commissioner is considering 813.30(d), and 813.35(c) of this chapter).
any regulatory action, including a re- (2) Regulatory provisions:
fusal to act, and concludes, as a matter
§ 56.121(a), relating to disqualifying an insti-
of discretion, on the Commissioner’s tutional review board or an institution.
initiative or at the suggestion of any § 71.37(a), relating to use of food containing a
person, to offer an opportunity for a color additive.
regulatory hearing to obtain additional § 80.31(b), relating to refusal to certify a
information before making a decision batch of a color additive.
or taking action. § 80.34(b), relating to suspension of certifi-
(b) The act or a regulation provides a cation service for a color additive.
§ 99.401(c), relating to a due diligence deter-
person with an opportunity for a hear-
mination concerning the conduct of studies
ing on a regulatory action, including necessary for a supplemental application
proposed action, and the act or a regu- for a new use of a drug or device.
lation either specifically provides an § 130.17(1), relating to a temporary permit to
opportunity for a regulatory hearing vary from a food standard.

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§ 16.5 21 CFR Ch. I (4–1–11 Edition)
§ 170.17(b), relating to use of food containing 5 of the Federal Import Milk Act and
an investigational food additive. § 1210.31.
§ 202.1(j)(5), relating to approval of prescrip- (2) A hearing on a refusal of admis-
tion drug advertisements.
§ 312.70, relating to whether an investigator
sion of a food, drug, device, or cosmetic
is entitled to receive investigational new under section 801(a) of the act and
drugs. § 1.94, or of an electronic product under
§ 312.70(d) and 312.44, relating to termination section 360(a) of the Public Health
of an IND for a sponsor. Service Act and § 1005.20.
§ 312.160(b), relating to termination of an IND (3) Factory inspections, recalls (ex-
for tests in vitro and in laboratory re- cept mandatory recalls of medical de-
search animals for a sponsor.
vices intended for human use), regu-
§ 511.1(b)(5), relating to use of food containing
an investigational new animal drug.
latory letters, and similar compliance
§ 511.1(c)(1), relating to termination of an activities related to law enforcement.
INAD for an investigator. (4) A hearing on an order for re-
§ 511.1(c) (4) and (d), relating to termination labeling, diversion, or destruction of
of an INAD for a sponsor. shell eggs under section 361 of the Pub-
§ 814.46(c) relating to withdrawal of approval lic Health Service Act (42 U.S.C. 264)
of a device premarket approval applica- and §§ 101.17(h) and 115.50 of this chap-
tion.
ter.
§ 900.7, relating to approval, reapproval, or
withdrawal of approval of mammography (5) A hearing on an order for diver-
accreditation bodies or rejection of a pro- sion or destruction of shell eggs under
posed fee for accreditation. section 361 of the Public Health Service
§ 900.14, relating to suspension or revocation Act (42 U.S.C. 264), and § 118.12 of this
of a mammography certificate. chapter.
§ 900.25, relating to approval or withdrawal of (b) If a regulation provides a person
approval of certification agencies.
with an opportunity for hearing and
§ 1003.11(a)(3), relating to the failure of an
electronic product to comply with an ap- specifies some procedures for the hear-
plicable standard or to a defect in an elec- ing but not a comprehensive set of pro-
tronic product. cedures, the procedures in this part
§ 1003.31(d), relating to denial of an exemp- apply to the extent that they are sup-
tion from notification requirements for an plementary and not in conflict with
electronic product which fails to comply the other procedures specified for the
with an applicable standard or has a de- hearing. Thus, the procedures in sub-
fect.
part A of part 108 relating to emer-
§ 1004.6, relating to plan for repurchase, re-
pair, or replacement of an electronic prod- gency permit control are supplemented
uct. by the nonconflicting procedures in
§ 1210.30, relating to denial, suspension, or this part, e.g., the right to counsel,
revocation of a permit under the Federal public notice of the hearing, reconsid-
Import Milk Act. eration and stay, and judicial review.
§ 1270.43(e), relating to the retention, recall,
and destruction of human tissue. [44 FR 22367, Apr. 13, 1979, as amended at 57
§ 1271.440(e) relating to the retention, recall, FR 58403, Dec. 10, 1992; 65 FR 76110, Dec. 5,
and destruction of human cells, tissues, 2000; 74 FR 33095, July 9, 2009]
and cellular and tissue-based products
(HCT/Ps), and/or the cessation of manufac- Subpart B—Initiation of
turing HCT/Ps.
Proceedings
EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 16.1, see the List of CFR § 16.22 Initiation of regulatory hear-
Sections Affected, which appears in the ing.
Finding Aids section of the printed volume
and at www.fdsys.gov. (a) A regulatory hearing is initiated
by a notice of opportunity for hearing
§ 16.5 Inapplicability and limited ap- from FDA. The notice will—
plicability. (1) Be sent by mail, telegram, telex,
(a) This part does not apply to the personal delivery, or any other mode of
following: written communication;
(1) Informal presentation of views be- (2) Specify the facts and the action
fore reporting a criminal violation that are the subject of the opportunity
under section 305 of the act and section for a hearing;

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Food and Drug Administration, HHS § 16.26

(3) State that the notice of oppor- hearing under paragraph (d) of this sec-
tunity for hearing and the hearing are tion.
governed by this part; and (d) The Commissioner may take such
(4) State the time within which a action pending a hearing under this
hearing may be requested, and state section as the Commissioner concludes
the name, address, and telephone num- is necessary to protect the public
ber of the FDA employee to whom any health, except where expressly prohib-
request for hearing is to be addressed. ited by statute or regulation. A hear-
(5) Refer to FDA’s guideline on elec- ing to consider action already taken,
tronic media coverage of its adminis- and not stayed by the Commissioner,
trative proceedings (21 CFR part 10, will be conducted on an expedited
subpart C). basis.
(b) A person offered an opportunity (e) The hearing may not be required
for a hearing has the amount of time to be held at a time less than 2 working
specified in the notice, which may not days after receipt of the request for
be less than 3 working days after re- hearing.
ceipt of the notice, within which to re- (f) Before the hearing, FDA will give
quest a hearing. The request may be to the party requesting the hearing
filed by mail, telegram, telex, personal reasonable notice of the matters to be
delivery, or any other mode of written considered at the hearing, including a
communication, addressed to the des- comprehensive statement of the basis
ignated FDA employee. If no response for the decision or action taken or pro-
is filed within that time, the offer is posed that is the subject of the hearing
deemed to have been refused and no and a general summary of the informa-
hearing will be held. tion that will be presented by FDA at
(c) If a hearing is requested, the Com- the hearing in support of the decision
missioner will designate a presiding of- or action. This information may be
ficer, and the hearing will take place at given orally or in writing, in the dis-
a time and location agreed upon by the cretion of FDA.
party requesting the hearing, the FDA, (g) FDA and the party requesting the
and the presiding officer or, if agree- hearing will, if feasible, at least 1 day
ment cannot be reached, at a reason- before the hearing provide to each
able time and location designated by other written notice of any published
the presiding officer. articles or written information to be
presented at or relied on at the hear-
(d) A notice of opportunity for hear-
ing. A copy will also be provided in ad-
ing under this section will not operate
vance if the other participant could not
to delay or stay any administrative ac-
reasonably be expected to have or be
tion, including enforcement action by
able to obtain a copy. If written notice
the agency unless the Commissioner,
or a copy is not provided, the presiding
as a matter of discretion, determines
officer may, if time permits, allow the
that delay or a stay is in the public in-
party who did not receive the notice or
terest.
copy additional time after the close of
[44 FR 22367, Apr. 13, 1979, as amended at 49 the hearing to make a submission con-
FR 32173, Aug. 13, 1984] cerning the article or information.
§ 16.24 Regulatory hearing required by [44 FR 22367, Apr. 13, 1979, as amended at 47
the act or a regulation. FR 26375, June 18, 1982; 54 FR 9037, Mar. 3,
1989]
(a) A regulatory hearing required by
the act or a regulation under § 16.1(b) § 16.26 Denial of hearing and summary
will be initiated in the same manner as decision.
other regulatory hearings subject to (a) A request for a hearing may be de-
the additional procedures in this sec- nied, in whole or in part, if the Com-
tion. missioner or the FDA official to whom
(b) [Reserved] authority is delegated to make the
(c) The notice will state whether any final decision on the matter deter-
action concerning the matter that is mines that no genuine and substantial
the subject of the opportunity for hear- issue of fact has been raised by the ma-
ing is or is not being taken pending the terial submitted. If the Commissioner

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§ 16.40 21 CFR Ch. I (4–1–11 Edition)

or his or her delegate determines that subordinate to a person, other than the
a hearing is not justified, written no- Commissioner, who has participated in
tice of the determination will be given such investigation or action.
to the parties explaining the reason for (c)(1) The Commissioner or the dele-
denial. gate under § 16.40 is not precluded by
(b) After a hearing commences, the this section from prior participation in
presiding officer may issue a summary the investigation or action that is the
decision on any issue in the hearing if subject of the hearing. If there has
the presiding officer determines from been prior participation, the Commis-
the material submitted in connection sioner or the delegate should, if fea-
with the hearing, or from matters offi- sible, designate a presiding officer for
cially noticed, that there is no genuine the hearing who is not a subordinate.
and substantial issue of fact respecting Thus, if the Commissioner’s authority
that issue. For the purpose of this to make a final decision has been dele-
paragraph, a hearing commences upon gated to a center director, the pre-
the receipt by FDA of a request for siding officer may be an official in an-
hearing submitted under § 16.22(b). other center or the office of the Com-
(c) The Commissioner or his or her missioner. The exercise of general su-
delegate may review any summary de- pervisory responsibility, or the des-
cision of the presiding officer issued ignation of the presiding officer, does
under paragraph (b) of this section at not constitute prior participation in
the request of a party or on the Com- the investigation or action that is the
missioner’s or his or her delegate’s own subject of the hearing so as to preclude
initiative. the Commissioner or delegate from
[53 FR 4615, Feb. 17, 1988, as amended at 69 designating a subordinate as the pre-
FR 17290, Apr. 2, 2004] siding officer.
(2) The party requesting a hearing
may make a written request to have
Subpart C—Commissioner and the Commissioner or the delegate
Presiding Officer under § 16.40 be the presiding officer,
§ 16.40 Commissioner. notwithstanding paragraph (c)(1) of
this section. If accepted, as a matter of
Whenever the Commissioner has del- discretion, by the Commissioner or the
egated authority on a matter for which delegate, the request is binding upon
a regulatory hearing is available under the party making the request.
this part, the functions of the Commis- (3) A different presiding officer may
sioner under this part may be per- be substituted for the one originally
formed by any of the officials to whom designated under § 16.22 without notice
the authority has been delegated, e.g., to the parties.
a center director.
[44 FR 22367, Apr. 13, 1979, as amended at 54
[69 FR 17290, Apr. 2, 2004] FR 9037, Mar. 3, 1989; 67 FR 53306, Aug. 15,
2002]
§ 16.42 Presiding officer.
(a) An FDA employee to whom the § 16.44 Communication to presiding of-
Commissioner delegates such author- ficer and Commissioner.
ity, or any other agency employee des- (a) Regulatory hearings are not sub-
ignated by an employee to whom such ject to the separation of functions
authority is delegated, or, consistent rules in § 10.55.
with 5 CFR 930.209(b) or (c), an adminis- (b) Those persons who are directly in-
trative law judge to whom such author- volved in the investigation or presen-
ity is delegated, may serve as the pre- tation of the position of FDA or any
siding officer and conduct a regulatory party at a regulatory hearing that is
hearing under this part. required by the act or a regulation
(b) In a regulatory hearing required should avoid any off-the-record com-
by the act or a regulation, the pre- munication on the matter to the pre-
siding officer is to be free from bias or siding officer or the Commissioner or
prejudice and may not have partici- their advisors if the communication is
pated in the investigation or action inconsistent with the requirement of
that is the subject of the hearing or be § 16.95(b)(1) that the administrative

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Food and Drug Administration, HHS § 16.60

record be the exclusive record for deci- any oral or written information rel-
sion. If any communication of this type evant to the hearing. All parties may
occurs, it is to be reduced to writing confront and conduct reasonable cross-
and made part of the record, and the examination of any person (except for
other party provided an opportunity to the presiding officer and counsel for
respond. the parties) who makes any statement
(c) A copy of any letter or memo- on the matter at the hearing.
randum of meeting between a partici- (c) The hearing is informal in nature,
pant in the hearing and the presiding and the rules of evidence do not apply.
officer or the Commissioner, e.g., a re- No motions or objections relating to
sponse by the presiding officer to a re- the admissibility of information and
quest for a change in the time of the views will be made or considered, but
hearing, is to be sent to all partici- any other party may comment upon or
pants by the person writing the letter rebut all such data, information, and
or the memorandum. views.
(d) The presiding officer may order
Subpart D—Procedures for the hearing to be transcribed. The
Regulatory Hearing party requesting the hearing may have
the hearing transcribed, at the party’s
§ 16.60 Hearing procedure. expense, in which case a copy of the
(a) A regulatory hearing is public, ex- transcript is to be furnished to FDA.
cept when the Commissioner deter- Any transcript of the hearing will be
mines that all or part of a hearing included with the presiding officer’s re-
should be closed to prevent a clearly port of the hearing.
unwarranted invasion of personal pri- (e) The presiding officer shall prepare
vacy; to prevent the disclosure of a a written report of the hearing. All
trade secret or confidential commer- written material presented at the hear-
cial or financial information that is ing will be attached to the report.
not available for public disclosure Whenever time permits, the parties to
under § 20.61; or to protect investiga- the hearing will be given the oppor-
tory records complied for law enforce- tunity to review and comment on the
ment purposes that are not available presiding officer’s report of the hear-
for public disclosure under § 20.64. ing.
(1) The Commissioner may determine (f) The presiding officer shall include
that a regulatory hearing is closed ei- as part of the report of the hearing a
ther on the Commissioner’s initiative finding on the credibility of witnesses
or on a request by the party asking for (other than expert witnesses) whenever
a regulatory hearing, in the request for credibility is a material issue, and
the hearing. shall include a recommended decision,
(2) If the hearing is a private hearing, with a statement of reasons, unless the
no persons other than the party re- Commissioner directs otherwise.
questing the hearing, counsel and wit- (g) The presiding officer has the
nesses, and an employee or consultant power to take such actions and make
or other person subject to a commer- such rulings as are necessary or appro-
cial arrangement as defined in § 20.81(a) priate to maintain order and to con-
and FDA representatives with a direct duct a fair, expeditious, and impartial
professional interest in the subject hearing, and to enforce the require-
matter of the proceeding are entitled ments of this part concerning the con-
to attend. duct of hearings. The presiding officer
(b) A regulatory hearing will be con- may direct that the hearing be con-
ducted by a presiding officer. Employ- ducted in any suitable manner per-
ees of FDA will first give a full and mitted by law and these regulations.
complete statement of the action (h) The Commissioner or the pre-
which is the subject of the hearing, to- siding officer has the power under
gether with the information and rea- § 10.19 to suspend, modify, or waive any
sons supporting it, and may present provision of this part.
any oral or written information rel- [44 FR 22367, Apr. 13, 1979, as amended at 66
evant to the hearing. The party re- FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1,
questing the hearing may then present 2001]

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§ 16.62 21 CFR Ch. I (4–1–11 Edition)

§ 16.62 Right to counsel. stitutes the exclusive record for deci-


Any party to a hearing under this sion;
part has the right at all times to be ad- (2) On the basis of the administrative
vised and accompanied by counsel. record of the hearing, the Commis-
sioner shall issue a written decision
stating the reasons for the Commis-
Subpart E—Administrative Record sioner’s administrative action and the
and Decision basis in the record; and
(3) For purposes of judicial review
§ 16.80 Administrative record of a reg-
ulatory hearing. under § 10.45, the record of the adminis-
trative proceeding consists of the
(a) The administrative record of the record of the hearing and the Commis-
regulatory hearing consists of the fol- sioner’s decision.
lowing:
(1) The notice of opportunity for
hearing and the response. Subpart F—Reconsideration and
(2) All written information and views Stay
submitted to the presiding officer at
§ 16.119 Reconsideration and stay of
the hearing or after if specifically per- action.
mitted by the presiding officer.
(3) Any transcript of the hearing. After any final administrative action
(4) The presiding officer’s report of that is the subject of a hearing under
the hearing and comments on the re- this part, any party may petition the
port under § 16.60(e). Commissioner for reconsideration of
(5) All letters and memoranda of any part or all of the decision or action
meetings or communications between under § 10.33 or may petition for a stay
participants and the presiding officer of the decision or action under § 10.35.
or the Commissioner referred to in [44 FR 22367, Apr. 13, 1979, as amended at 54
§ 16.44(c). FR 9037, Mar. 3, 1989]
(b) The record of the regulatory hear-
ing is closed to the submission of infor- Subpart G—Judicial Review
mation and views, at the close of the
hearing, unless the presiding officer § 16.120 Judicial review.
specifically permits additional time for
a further submission. Section 10.45 governs the availability
of judicial review concerning any regu-
§ 16.85 Examination of administrative latory action which is the subject of a
record. hearing under this part
Part 20 governs the availability for
public disclosure of each document PART 17—CIVIL MONEY PENALTIES
that is a part of the administrative HEARINGS
record of a regulatory hearing.
Sec.
§ 16.95 Administrative decision and 17.1 Scope.
record for decision. 17.2 Maximum penalty amounts.
(a) With respect to a regulatory hear- 17.3 Definitions.
17.5 Complaint.
ing at the Commissioner’s initiative 17.7 Service of complaint.
under § 16.1(a), the Commissioner shall 17.9 Answer.
consider the administrative record of 17.11 Default upon failure to file an answer.
the hearing specified in § 16.80(a) to- 17.13 Notice of hearing.
gether with all other relevant informa- 17.15 Parties to the hearing.
tion and views available to FDA in de- 17.17 Summary decisions.
termining whether regulatory action 17.18 Interlocutory appeal from ruling of
should be taken and, if so, in what presiding officer.
17.19 Authority of the presiding officer.
form.
17.20 Ex parte contacts.
(b) With respect to a regulatory hear- 17.21 Prehearing conferences.
ing required by the act or a regulation 17.23 Discovery.
under § 16.1(b)— 17.25 Exchange of witness lists, witness
(1) The administrative record of the statements, and exhibits.
hearing specified in § 16.80(a) con- 17.27 Hearing subpoenas.

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Food and Drug Administration, HHS § 17.1
17.28 Protective order. quirements, and risk evaluation and
17.29 Fees. mitigation strategies for drugs.
17.30 Computation of time. (d) Section 303(g)(1) of the act author-
17.31 Form, filing, and service of papers.
izing civil money penalties for certain
17.32 Motions.
17.33 The hearing and burden of proof. violations of the act that relate to dis-
17.34 Determining the amount of penalties semination of direct-to-consumer ad-
and assessments. vertisements for approved drugs or bio-
17.35 Sanctions. logical products.
17.37 Witnesses. (e) Section 307 of the act authorizing
17.39 Evidence. civil money penalties for certain ac-
17.41 The administrative record. tions in connection with an abbre-
17.43 Posthearing briefs. viated new drug application or certain
17.45 Initial decision.
actions in connection with a person or
17.47 Appeals.
17.48 Harmless error. individual debarred under section 306 of
17.51 Judicial review. the act.
17.54 Deposit in the Treasury of the United (f) Section 539(b)(1) of the act author-
States. izing civil money penalties for certain
AUTHORITY: 21 U.S.C. 331, 333, 337, 351, 352,
violations of the act that relate to
355, 360, 360c, 360f, 360i, 360j, 371; 42 U.S.C. 262, electronic products.
263b, 300aa–28; 5 U.S.C. 554, 555, 556, 557. (g) Section 351(d)(2) of the Public
Health Service Act (the PHS Act) au-
SOURCE: 60 FR 38626, July 27, 1995, unless
otherwise noted.
thorizing civil money penalties for vio-
lations of biologic recall orders.
EDITORIAL NOTE: Nomenclature changes to (h) Section 354(h)(3) of the PHS Act,
part 17 appear at 68 FR 24879, May 9, 2003. as amended by the Mammography
Quality Standards Act of 1992 and the
§ 17.1 Scope.
Mammography Quality Standards Act
This part sets forth practices and of 1998, authorizing civil money pen-
procedures for hearings concerning the alties for failure to obtain a certificate
administrative imposition of civil and failure to comply with established
money penalties by FDA. Listed below standards, among other things.
are the statutory provisions that au- (i) Section 2128(b)(1) of the PHS Act
thorize civil money penalties that are authorizing civil money penalties for
governed by these procedures. intentionally destroying, altering, fal-
(a) Section 303(b)(2) and (b)(3) of the sifying, or concealing any record or re-
Federal Food, Drug, and Cosmetic Act port required to be prepared, main-
(the act) authorizing civil money pen- tained, or submitted by vaccine manu-
alties for certain violations of the act facturers under section 2128 of the PHS
that relate to prescription drug mar- Act.
keting practices.
(b) Section 303(f)(1) of the act author- [60 FR 38626, July 27, 1995, as amended at 69
FR 43301, July 20, 2004; 73 FR 66752, Nov. 12,
izing civil money penalties for certain
2008]
violations of the act that relate to
medical devices and section 303(f)(2) of EFFECTIVE DATE NOTE: At 75 FR 73953, Nov.
the act authorizing civil money pen- 30, 2010, § 17.1 was amended by adding para-
graph (j), effective Apr. 14, 2011. For the con-
alties for certain violations of the act
venience of the user, the added text is set
that relate to pesticide residues. forth as follows:
(c) Section 303(f)(3) of the act author-
izing civil money penalties for certain § 17.1 Scope.
violations relating to the submission of
certifications and/or clinical trial in- * * * * *
formation to the clinical trial data (j) Section 303(f) of the act authorizing
bank and section 303(f)(4) of the act au- civil money penalties for any person who
thorizing civil money penalties for cer- violates a requirement of the Family Smok-
tain violations of the act relating to ing Prevention and Tobacco Control Act
postmarket studies, clinical trial re- which relates to tobacco products.

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§ 17.2 21 CFR Ch. I (4–1–11 Edition)

§ 17.2 Maximum penalty amounts.


The following table shows maximum civil monetary penalties associated with
the statutory provisions authorizing civil monetary penalties under the act or
the Public Health Service Act.

CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY
AMOUNTS
Adjusted
Former Max- Date of Last Maximum
imum Penalty
U.S.C. Section Assessment Method Penalty Figure or Penalty
Amount (in dol- Adjustment Amount (in
lars) dollars)

21 U.S.C.

333(b)(2)(A) 55,000 For each of the first two violations in any 10- 2008 60,000
year period

333(b)(2)(B) 1,100,000 For each violation after the second conviction in 2008 1,200,000
any 10-year period

333(b)(3) 110,000 Per violation 2008 120,000

333(f)(1)(A) 16,500 Per violation 2008 16,500 (not


adjusted)

333(f)(1)(A) 1,100,000 For the aggregate of violations 2008 1,200,000

333(f)(2)(A) 55,000 Per individual 2008 60,000

333(f)(2)(A) 275,000 Per ‘‘any other person’’ 2008 300,000

333(f)(2)(A) 550,000 For all violations adjudicated in a single pro- 2008 600,000
ceeding

333(f)(3)(A) 10,000 For all violations adjudicated in a single pro- 2007 10,000 (not
ceeding adjusted)

333(f)(3)(B) 10,000 For each day the violation is not corrected after 2007 10,000 (not
a 30-day period following notification until the adjusted)
violation is corrected

333(f)(4)(A)(i) 250,000 Per violation 2007 250,000


(not
adjusted)

333(f)(4)(A)(i) 1,000,000 For all violations adjudicated in a single pro- 2007 1,000,000
ceeding (not
adjusted)

333(f)(4)(A)(ii) 250,000 For the first 30-day period (or any portion there- 2007 250,000
of) of continued violation following notification (not
adjusted)

333(f)(4)(A)(ii) 1,000,000 For any 30-day period, where the amount dou- 2007 1,000,000
bles for every 30-day period of continued vio- (not
lation after the first 30-day period adjusted)

333(f)(4)(A)(ii) 10,000,000 For all violations adjudicated in a single pro- 2007 10,000,000
ceeding (not
adjusted)

333(g)(1) 250,000 For the first violation in any 3-year period 2007 250,000
(not
adjusted)

333(g)(1) 500,000 For each subsequent violation in any 3-year pe- 2007 500,000
riod (not
adjusted)

335b(a) 275,000 Per violation for an individual 2008 300,000

335b(a) 1,100,000 Per violation for ‘‘any other person’’ 2008 1,200,000

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Food and Drug Administration, HHS § 17.2, Nt.

CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY
AMOUNTS—Continued
Adjusted
Former Max- Date of Last Maximum
imum Penalty
U.S.C. Section Assessment Method Penalty Figure or Penalty
Amount (in dol- Adjustment Amount (in
lars) dollars)

360pp(b)(1) 1,100 Per violation per person 2008 1,100 (not


adjusted)

360pp(b)(1) 330,000 For any related series of violations 2008 355,000

42 U.S.C.

263b(h)(3) 11,000 Per violation 2008 11,000 (not


adjusted)

300aa–28(b)(1) 110,000 Per occurrence 2008 120,000

[73 FR 66752, Nov. 12, 2008]


EFFECTIVE DATE NOTE: At 75 FR 73954, Nov. 30, 2010, § 17.2 was revised, effective Apr. 14, 2011.
For the convenience of the user, the revised text is set forth as follows:

§ 17.2 Maximum penalty amounts.


The following table shows maximum civil monetary penalties associated with the statutory
provisions authorizing civil monetary penalties under the act or the Public Health Service
Act.

CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY
AMOUNTS
Adjusted
Former max- Date of last pen- maximum
imum penalty
U.S.C. Section Assessment method alty figure or ad- penalty
amount justment amount
(in dollars)1 (in dollars)

21 U.S.C.

333(b)(2)(A) 55,000 For each of the first two violations in any 10- 2008 60,000.
year period
333(b)(2)(B) 1,100,000 For each violation after the second conviction in 2008 1,200,000.
any 10-year period
333(b)(3) 110,000 Per violation 2008 120,000.
333(f)(1)(A) 16,500 Per violation 2008 16,500 (not
adjusted).
333(f)(1)(A) 1,100,000 For the aggregate of violations 2008 1,200,000.
333(f)(2)(A) 55,000 Per individual 2008 60,000.
333(f)(2)(A) 275,000 Per ‘‘any other person’’ 2008 300,000.
333(f)(2)(A) 550,000 For all violations adjudicated in a single pro- 2008 600,000.
ceeding
333(f)(3)(A) 10,000 For all violations adjudicated in a single pro- 2007 10,000 (not
ceeding adjusted).
333(f)(3)(B) 10,000 For each day the violation is not corrected after 2007 10,000 (not
a 30-day period following notification until the adjusted).
violation is corrected
333(f)(4)(A)(i) 250,000 Per violation 2007 250,000
(not
adjusted).
333(f)(4)(A)(i) 1,000,000 For all violations adjudicated in a single pro- 2007 1,000,000
ceeding (not
adjusted).
333(f)(4)(A)(ii) 250,000 For the first 30-day period (or any portion there- 2007 250,000
of) of continued violation following notification (not
adjusted).
333(f)(4)(A)(ii) 1,000,000 For any 30-day period, where the amount dou- 2007 1,000,000
bles for every 30-day period of continued vio- (not
lation after the first 30-day period adjusted).
333(f)(4)(A)(ii) 10,000,000 For all violations adjudicated in a single pro- 2007 10,000,000
ceeding (not
adjusted).

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§ 17.2, Nt. 21 CFR Ch. I (4–1–11 Edition)

CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY
AMOUNTS—Continued
Adjusted
Former max- Date of last pen- maximum
imum penalty
U.S.C. Section Assessment method alty figure or ad- penalty
amount justment amount
(in dollars)1 (in dollars)

333(f)(9)(A) 1 N/A Per violation 2009 15,000 (not


adjusted).
333(f)(9)(A) N/A For all violations adjudicated in a single pro- 2009 1,000,000
ceeding (not
adjusted).
333(f)(9)(B)(i)(I) N/A Per violation 2009 250,000
(not
adjusted).
333(f)(9)(B)(i)(I) N/A For all violations adjudicated in a single pro- 2009 1,000,000
ceeding (not
adjusted).
333(f)(9)(B)(i)(II) N/A For the first 30-day period (or any portion there- 2009 250,000
of) of continued violation following notification (not
adjusted).
333(f)(9)(B)(i)(II) N/A For any 30-day period, where the amount dou- 2009 1,000,000
bled for every 30-day period of continued vio- (not
lation after the first 30-day period adjusted).
333(f)(9)(B)(i)(II) N/A For all violations adjudicated in a single pro- 2009 10,000,000
ceeding (not
adjusted).
333(f)(9)(B)(ii)(I) N/A Per violation 2009 250,000
(not
adjusted).
333(f)(9)(B)(ii)(I) N/A For all violations adjudicated in a single pro- 2009 1,000,000
ceeding (not
adjusted).
333(f)(9)(B)(ii)(II) N/A For the first 30-day period (or any portion there- 2009 250,000
of) of continued violation following notification (not
adjusted).
333(f)(9)(B)(ii)(II) N/A For any 30-day period, where the amount dou- 2009 1,000,000
bled for every 30-day period of continued vio- (not
lation after the first 30-day period adjusted).
333(f)(9)(B)(ii)(II) N/A For all violations adjudicated in a single pro- 2009 10,000,000
ceeding (not
adjusted).
333(g)(1) 250,000 For the first violation in any 3-year period 2007 250,000
(not
adjusted).
333(g)(1) 500,000 For each subsequent violation in any 3-year pe- 2007 500,000
riod (not
adjusted).
333 note N/A For the second violation (following a first viola- 2009 250 (not
tion with warning) within a 12-month period by adjusted).
a retailer with an approved training program
333 note N/A For the third violation within a 24-month period 2009 500 (not
by a retailer with an approved training pro- adjusted).
gram
333 note N/A For the fourth violation within a 24-month period 2009 2,000 (not
by a retailer with an approved training pro- adjusted).
gram
333 note N/A For the fifth violation within a 36-month period 2009 5,000 (not
by a retailer with an approved training pro- adjusted).
gram
333 note N/A For the six or subsequent violation within a 48- 2009 10,000 (not
month period by a retailer with an approved adjusted).
training program
333 note N/A For the first violation by a retailer without an ap- 2009 250 (not
proved training program adjusted).
333 note N/A For the second violation within a 12-month pe- 2009 500 (not
riod by a retailer without an approved training adjusted).
program
333 note N/A For the third violation within a 24-month period 2009 1,000 (not
by a retailer without an approved training pro- adjusted).
gram
333 note N/A For the fourth violation within a 24-month period 2009 2,000 (not
by a retailer without an approved training pro- adjusted).
gram

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Food and Drug Administration, HHS § 17.5

CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY
AMOUNTS—Continued
Adjusted
Former max- Date of last pen- maximum
imum penalty
U.S.C. Section Assessment method alty figure or ad- penalty
amount justment amount
(in dollars)1 (in dollars)

333 note N/A For the fifth violation within a 36-month period 2009 5,000 (not
by a retailer without an approved training pro- adjusted).
gram
333 note N/A For the six or subsequent violation within a 48- 2009 10,000 (not
month period by a retailer without an ap- adjusted).
proved training program
335b(a) 275,000 Per violation for an individual 2008 300,000.
335b(a) 1,100,000 Per violation for ‘‘any other person’’ 2008 1,200,000.
360pp(b)(1) 1,100 Per violation per person 2008 1,100 (not
adjusted).
360pp(b)(1) 330,000 For any related series of violations 2008 355,000.

42 U.S.C.

263b(h)(3) 11,000 Per violation 2008 11,000 (not


adjusted).
300aa–28(b)(1) 110,000 Per occurrence 2008 120,000.
1 Maximum penalties assessed under The Family Smoking Prevention and Tobacco Control Act do not have a ‘‘former max-
imum penalty.’’

§ 17.3 Definitions. (b) Person or respondent includes an


The following definitions are applica- individual, partnership, corporation,
ble in this part: association, scientific or academic es-
(a) For specific acts giving rise to tablishment, government agency or or-
civil money penalty actions brought ganizational unit thereof, or other
under 21 U.S.C. 333(g)(1): legal entity, or as may be defined in
(1) Significant departure, for the pur- the act or regulation pertinent to the
pose of interpreting 21 U.S.C. civil penalty action being brought.
333(g)(1)(B)(i), means a departure from (c) Presiding officer means an admin-
requirements that is either a single istrative law judge qualified under 5
major incident or a series of incidents U.S.C. 3105.
that collectively are consequential. (d) Any term that is defined in the
(2) Knowing departure, for the pur- act has the same definition for civil
poses of interpreting 21 U.S.C. money penalty actions that may be
333(g)(1)(B)(i), means a departure from brought under that act.
a requirement taken: (a) With actual (e) Any term that is defined in Title
knowledge that the action is such a de- 21 of the Code of Federal Regulations
parture, or (b) in deliberate ignorance has the same definition for civil money
of a requirement, or (c) in reckless dis- penalty actions that may arise from
regard of a requirement. the application of the regulation(s).
(3) Minor violations, for the purposes (f) Any term that is defined in the
of interpreting 21 U.S.C. 333(g)(1)(B)(ii), PHS Act has the same definition for
means departures from requirements civil money penalty actions that may
that do not rise to a level of a single be brought under that act.
major incident or a series of incidents (g) Departmental Appeals Board (DAB)
that are collectively consequential. means the Departmental Appeals
(4) Defective, for the purposes of inter- Board of the Department of Health and
preting 21 U.S.C. 333(g)(1)(B)(iii), in- Human Services.
cludes any defect in performance, man-
ufacture, construction, components, § 17.5 Complaint.
materials, specifications, design, in- (a) The Center with principal juris-
stallation, maintenance, or service of a diction over the matter involved shall
device, or any defect in mechanical, begin all administrative civil money
physical, or chemical properties of a penalty actions by serving on the re-
device. spondent(s) a complaint signed by the

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§ 17.7 21 CFR Ch. I (4–1–11 Edition)

Office of the Chief Counsel attorney for (3) Written acknowledgment of re-
the Center and by filing a copy of the ceipt by the respondent or by the re-
complaint with the Division of Dockets spondent’s counsel or authorized rep-
Management (HFA–305), Food and Drug resentative or agent.
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. § 17.9 Answer.
(b) The complaint shall state: (a) The respondent may request a
(1) The allegations of liability hearing by filing an answer with the
against the respondent, including the Division of Dockets Management
statutory basis for liability, the identi- (HFA–305), Food and Drug Administra-
fication of violations that are the basis tion, 5630 Fishers Lane, rm. 1061, Rock-
for the alleged liability, and the rea- ville, MD 20852, within 30 days of serv-
sons that the respondent is responsible ice of the complaint. Unless stated oth-
for the violations; erwise, an answer shall be deemed to be
(2) The amount of penalties and as- a request for hearing.
sessments that the Center is seeking; (b) In the answer, the respondent:
(3) Instructions for filing an answer (1) Shall admit or deny each of the
to request a hearing, including a spe- allegations of liability made in the
cific statement of the respondent’s complaint; allegations not specifically
right to request a hearing by filing an denied in an answer are deemed admit-
answer and to retain counsel to rep- ted;
resent the respondent; and (2) Shall state all defenses on which
(4) That failure to file an answer the respondent intends to rely;
within 30 days of service of the com- (3) Shall state all reasons why the re-
plaint will result in the imposition of spondent contends that the penalties
the proposed amount of penalties and and assessments should be less than
assessments, as provided in § 17.11. the requested amount; and
(c) The Center may, on motion, sub- (4) Shall state the name, address, and
sequently amend its complaint to con- telephone number of the respondent’s
form with the evidence adduced during counsel, if any.
the administrative process, as justice (c) If the respondent is unable to file
may require. an answer meeting the requirements of
(d) The presiding officer will be as- paragraph (b) of this section within the
signed to the case upon the filing of the time provided, the respondent shall, be-
complaint under this part. fore the expiration of 30 days from
service of the complaint, file a request
§ 17.7 Service of complaint. for an extension of time within which
(a) Service of a complaint may be to file an answer that meets the re-
made by: quirements of paragraph (b) of this sec-
(1) Certified or registered mail or tion. The presiding officer may, for
similar mail delivery service with a re- good cause shown, grant the respond-
turn receipt record reflecting receipt; ent up to 30 additional days within
or which to file an answer that meets the
(2) Delivery in person to: requirements of paragraph (b) of this
(i) An individual respondent; or section.
(ii) An officer or managing or general (d) The respondent may, on motion,
agent in the case of a corporation or amend its answer to conform with the
unincorporated business. evidence as justice may require.
(b) Proof of service, stating the name
and address of the person on whom the § 17.11 Default upon failure to file an
complaint was served, and the manner answer.
and date of service, may be made by: (a) If the respondent does not file an
(1) Affidavit or declaration under answer within the time prescribed in
penalty of perjury of the individual § 17.9 and if service has been effected as
serving the complaint by personal de- provided in § 17.7, the presiding officer
livery; shall assume the facts alleged in the
(2) A United States Postal Service or complaint to be true, and, if such facts
similar mail delivery service return re- establish liability under the relevant
ceipt record reflecting receipt; or statute, the presiding officer shall

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Food and Drug Administration, HHS § 17.17

issue an initial decision within 30 days (c) A description of the procedures


of the time the answer was due, impos- for the conduct of the hearing;
ing: (d) The names, addresses, and tele-
(1) The maximum amount of pen- phone numbers of the representatives
alties provided for by law for the viola- of the government and of the respond-
tions alleged; or ent, if any; and
(2) The amount asked for in the com- (e) Such other matters as the Center
plaint, whichever amount is smaller. or the presiding officer deems appro-
(b) Except as otherwise provided in priate.
this section, by failing to file a timely § 17.15 Parties to the hearing.
answer, the respondent waives any
right to a hearing and to contest the (a) The parties to the hearing shall
amount of the penalties and assess- be the respondent and the Center(s)
ments imposed under paragraph (a) of with jurisdiction over the matter at
this section, and the initial decision issue. No other person may participate.
shall become final and binding upon (b) The parties may at any time prior
the parties 30 days after it is issued. to a final decision by the entity decid-
(c) If, before such a decision becomes ing any appeal agree to a settlement of
final, the respondent files a motion all or a part of the matter. The settle-
seeking to reopen on the grounds that ment agreement shall be filed in the
extraordinary circumstances prevented docket and shall constitute complete
the respondent from filing an answer, or partial resolution of the administra-
the initial decision shall be stayed tive case as so designated by the settle-
pending a decision on the motion. ment agreement. The settlement docu-
ment shall be effective upon filing in
(d) If, on such motion, the respondent
the docket and need not be ratified by
can demonstrate extraordinary cir-
the presiding officer or the Commis-
cumstances excusing the failure to file
sioner of Food and Drugs.
an answer in a timely manner, the pre-
(c) The parties may be represented by
siding officer may withdraw the deci-
counsel, who may be present at the
sion under paragraph (a) of this sec-
hearing.
tion, if such a decision has been issued,
and shall grant the respondent an op- § 17.17 Summary decisions.
portunity to answer the complaint as
provided in § 17.9(a). (a) At any time after the filing of a
complaint, a party may move, with or
(e) If the presiding officer decides
without supporting affidavits (which,
that the respondent’s failure to file an
for purposes of this part, shall include
answer in a timely manner is not ex-
declarations under penalty of perjury),
cused, he or she shall affirm the deci-
for a summary decision on any issue in
sion under paragraph (a) of this sec-
the hearing. The other party may,
tion, and the decision shall become
within 30 days after service of the mo-
final and binding upon the parties 30
tion, which may be extended for an ad-
days after the presiding officer issues
ditional 10 days for good cause, serve
the decision on the respondent’s mo-
opposing affidavits or countermove for
tion filed under paragraph (c) of this
summary decision.
section.
The presiding officer may set the
§ 17.13 Notice of hearing. matter for argument and call for the
submission of briefs.
After an answer has been filed, the (b) The presiding officer shall grant
Center shall serve a notice of hearing the motion if the pleadings, affidavits,
on the respondent. Such notice shall and other material filed in the record,
include: or matters officially noticed, show that
(a) The date, time, and place of a pre- there is no genuine issue as to any ma-
hearing conference, if any, or the date, terial fact and that the party is enti-
time, and place of the hearing if there tled to summary decision as a matter
is not to be a prehearing conference; of law.
(b) The nature of the hearing and the (c) Affidavits shall set forth only
legal authority and jurisdiction under such facts as would be admissible in
which the hearing is to be held; evidence and shall show affirmatively

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§ 17.18 21 CFR Ch. I (4–1–11 Edition)

that the affiant is competent to testify entity deciding the appeal (currently
to the matters stated. When a motion the DAB). The deadline for filing an in-
for summary decision is made and sup- terlocutory appeal is subject to the dis-
ported as provided in this regulation, a cretion of the presiding officer.
party opposing the motion may not
rest on mere allegations or denials or § 17.19 Authority of the presiding offi-
general descriptions of positions and cer.
contentions; affidavits or other re- (a) The presiding officer shall con-
sponses must set forth specific facts duct a fair and impartial hearing, avoid
showing that there is a genuine issue of delay, maintain order, and assure that
material fact for the hearing. a record of the proceeding is made.
(d) If, on motion under this section, a (b) The presiding officer has the au-
summary decision is not rendered on thority to:
all issues or for all the relief asked, and (1) Set and change the date, time,
if additional facts need to be developed, and place of the hearing on reasonable
the presiding officer will issue an order notice to the parties;
specifying the facts that appear with- (2) Continue or recess the hearing in
out substantial controversy and direct- whole or in part for a reasonable time;
ing further evidentiary proceedings on (3) Require parties to attend con-
facts still at issue. The facts specified ferences for settlement, to identify or
not to be at issue shall be deemed es- simplify the issues, or to consider
tablished. other matters that may aid in the ex-
(e) Except as provided in § 17.18, a peditious disposition of the proceeding;
party may not obtain interlocutory re- (4) Administer oaths and affirma-
view by the entity deciding the appeal tions;
(currently the DAB) of a partial sum- (5) Issue subpoenas requiring the at-
mary decision of the presiding officer. tendance and testimony of witnesses
A review of final summary decisions on and the production of evidence that re-
all issues may be had through the pro- lates to the matter under investiga-
cedure set forth in § 17.47. tion;
§ 17.18 Interlocutory appeal from rul- (6) Rule on motions and other proce-
ing of presiding officer. dural matters;
(7) Regulate the scope and timing of
(a) Except as provided in paragraph
discovery consistent with § 17.23;
(b) of this section, rulings of the pre-
siding officer may not be appealed be- (8) Regulate the course of the hearing
fore consideration on appeal of the en- and the conduct of the parties;
tire record of the hearing. (9) Examine witnesses;
(b) A ruling of the presiding officer is (10) Upon motion of a party for good
subject to interlocutory appeal to the cause shown, the presiding officer may
entity deciding the appeal (currently allow a witness to be recalled for addi-
the DAB) if the presiding officer cer- tional testimony;
tifies on the record or in writing that (11) Receive, rule on, exclude, or
immediate review is necessary to pre- limit evidence;
vent exceptional delay, expense, or (12) Upon motion of a party or on the
prejudice to any participant, or sub- presiding officer’s own motion, take of-
stantial harm to the public interest. ficial notice of facts;
(c) When an interlocutory appeal is (13) Upon motion of a party, decide
made, a participant may file a brief on cases, in whole or in part, by summary
the appeal only if specifically author- decision when there is no genuine issue
ized by the presiding officer or the en- of material fact;
tity deciding the appeal (currently the (14) Conduct any conference, argu-
DAB), and if such authorization is ment, or hearing on motions in person
granted, only within the period allowed or by telephone;
by the presiding officer or the entity (15) Consolidate related or similar
deciding the appeal. If a participant is proceedings or sever unrelated matters;
authorized to file a brief, any other (16) Limit the length of pleadings;
participant may file a brief in opposi- (17) Waive, suspend, or modify any
tion, within the period allowed by the rule in this part if the presiding officer

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Food and Drug Administration, HHS § 17.23

determines that no party will be preju- (8) Discovery and scheduling dates
diced, the ends of justice will be served, for completion of discovery;
and the action is in accordance with (9) The date, time, and place for the
law; hearing; and
(18) Issue protective orders pursuant (10) Such other matters as may tend
to § 17.28; and to expedite the fair and just disposition
(19) Exercise such other authority as of the proceedings.
is necessary to carry out the respon- (d) The presiding officer shall issue
sibilities of the presiding officer under an order containing all matters agreed
this part. upon by the parties or ordered by the
(c) The presiding officer does not presiding officer at a prehearing con-
have the authority to find Federal ference.
statutes or regulations invalid.
§ 17.23 Discovery.
§ 17.20 Ex parte contacts. (a) No later than 60 days prior to the
No party or person (except employees hearing, unless otherwise ordered by
of the presiding officer’s office) shall the presiding officer, a party may
communicate in any way with the pre- make a request to another party for
siding officer on any matter at issue in production, inspection, and copying of
a case, unless on notice and oppor- documents that are relevant to the
tunity for all parties to participate. issues before the presiding officer. Doc-
This provision does not prohibit a per- uments must be provided no later than
son or party from inquiring about the 30 days after the request has been
status of a case or asking routine ques- made.
tions concerning administrative func- (b) For the purpose of this part, the
tions or procedures. term documents includes information,
reports, answers, records, accounts, pa-
§ 17.21 Prehearing conferences. pers and other data and documentary
(a) The presiding officer may sched- evidence. Nothing contained in this
ule prehearing conferences as appro- section may be interpreted to require
priate. the creation of a document, except that
(b) Upon the motion of any party, the requested data stored in an electronic
presiding officer shall schedule at least data storage system must be produced
one prehearing conference at a reason- in a form readily accessible to the re-
able time in advance of the hearing. questing party.
(c) The presiding officer may use a (c) Requests for documents, requests
prehearing conference to discuss the for admissions, written interrogatories,
following: depositions, and any forms of dis-
(1) Simplification of the issues; covery, other than those permitted
(2) The necessity or desirability of under paragraphs (a) and (e) of this sec-
amendments to the pleadings, includ- tion, are not authorized.
ing the need for a more definite state- (d)(1) Within 10 days of service of a
ment; request for production of documents, a
(3) Stipulations and admissions of party may file a motion for a protec-
fact as to the contents and authen- tive order.
ticity of documents; (2) The presiding officer may grant a
(4) Whether the parties can agree to motion for a protective order, in whole
submission of the case on a stipulated or in part, if he or she finds that the
record; discovery sought:
(5) Whether a party chooses to waive (i) Is unduly costly or burdensome,
appearance at an oral hearing and to (ii) Will unduly delay the proceeding,
submit only documentary evidence or
(subject to the objection of the other (iii) Seeks privileged information.
party) and written argument; (3) The burden of showing that a pro-
(6) Limitation of the number of wit- tective order is necessary shall be on
nesses; the party seeking the order.
(7) Scheduling dates for the exchange (4) The burden of showing that docu-
of witness lists and of proposed exhib- ments should be produced is on the
its; party seeking their production.

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§ 17.25 21 CFR Ch. I (4–1–11 Edition)

(e) The presiding officer shall order exchanged in accordance with para-
depositions upon oral questions only graph (a) of this section will be deemed
upon a showing that: to be authentic for the purpose of ad-
(1) The information sought cannot be missibility at the hearing.
obtained by alternative methods, and
(2) There is a substantial reason to § 17.27 Hearing subpoenas.
believe that relevant and probative evi- (a) A party wishing to procure the
dence may otherwise not be preserved appearance and testimony of any indi-
for presentation by a witness at the vidual at the hearing may, when au-
hearing. thorized by law, request that the pre-
siding officer issue a subpoena.
§ 17.25 Exchange of witness lists, wit-
ness statements, and exhibits. (b) A subpoena requiring the attend-
ance and testimony of an individual
(a) At least 30 days before the hear- may also require the individual to
ing, or by such other time as is speci- produce documents at the hearing.
fied by the presiding officer, the par-
(c) A party seeking a subpoena shall
ties shall exchange witness lists, copies
file a written request therefor not less
of prior written statements of proposed
than 20 days before the date fixed for
witnesses, and copies of proposed hear-
the hearing unless otherwise allowed
ing exhibits, including written testi-
by the presiding officer, upon a show-
mony.
ing by the party of good cause. Such
(b)(1) If a party objects to the pro-
request shall specify any documents to
posed admission of evidence not ex-
be produced and shall designate the
changed in accordance with paragraph
witnesses and describe the address and
(a) of this section, the presiding officer
location thereof with sufficient par-
will exclude such evidence if he or she
ticularity to permit such witnesses to
determines that the failure to comply
be found.
with paragraph (a) of this section
(d) The subpoena shall specify the
should result in its exclusion.
time and place at which the witness is
(2) Unless the presiding officer finds
to appear and any documents the wit-
that extraordinary circumstances jus-
ness is to produce.
tified the failure to make a timely ex-
change of witness lists under paragraph (e) The party seeking the subpoena
(a) of this section, he or she must ex- shall serve it in the manner prescribed
clude from the party’s hearing evidence for service of a complaint in § 17.7.
the testimony of any witness whose (f) If a party or the individual to
name does not appear on the witness whom the subpoena is directed believes
list. a subpoena to be unreasonable, oppres-
(3) If the presiding officer finds that sive, excessive in scope, or unduly bur-
extraordinary circumstances existed, densome, or if it wishes to raise any
the presiding officer must then deter- other objection or privilege recognized
mine whether the admission of the tes- by law, the party or individual may file
timony of any witness whose name a motion to quash the subpoena within
does not appear on the witness lists ex- 10 days after service or on or before the
changed under paragraph (a) of this time specified in the subpoena for com-
section would cause substantial preju- pliance if it is less than 10 days after
dice to the objecting party. If the pre- service. Such a filing will state the
siding officer finds that there is not basis for the motion to quash. The pre-
substantial prejudice, the evidence siding officer may quash or modify the
may be admitted. If the presiding offi- subpoena or order it implemented, as
cer finds that there is substantial prej- justice may require.
udice, the presiding officer may ex-
clude the evidence, or at his or her dis- § 17.28 Protective order.
cretion, may postpone the hearing for (a) A party or a prospective witness
such time as is necessary for the ob- may file a motion for a protective
jecting party to prepare and respond to order with respect to discovery sought
the evidence. by a party or with respect to the hear-
(c) Unless a party objects within 5 ing, seeking to limit the availability or
days prior to the hearing, documents disclosure of evidence.

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Food and Drug Administration, HHS § 17.32

(b) When issuing a protective order, days, Sundays, and Federal holidays
the presiding officer may make any shall be excluded from the computa-
order which justice requires to protect tion.
a party or person from oppression or (c) When a document has been served
undue burden or expense, or to protect or issued by placing it in the mail, an
trade secrets or confidential commer- additional 5 days will be added to the
cial information, as defined in § 20.61 of time permitted for any response.
this chapter, information the disclo-
sure of which would constitute a clear- § 17.31 Form, filing, and service of pa-
ly unwarranted invasion of personal pers.
privacy, or other information that (a) Form. (1) Documents filed with the
would be withheld from public disclo- Division of Dockets Management
sure under 21 CFR part 20. Such orders (HFA–305), Food and Drug Administra-
may include, but are not limited to, tion, 5630 Fishers Lane, rm. 1061, Rock-
one or more of the following: ville, MD 20852, shall include an origi-
(1) That the discovery not be had; nal and two copies.
(2) That the discovery may be had (2) The first page of every pleading
only on specified terms and conditions, and paper filed in the proceeding shall
including a designation of the time or contain a caption setting forth the
place; title of the action, the case number as-
(3) That the discovery may be had signed by the Office of the Chief Coun-
only through a method of discovery sel, and designation of the pleading or
provided for by this part other than paper (e.g., ‘‘motion to quash sub-
that requested; poena’’).
(4) That certain matters not be in- (3) Every pleading shall be signed by,
quired into, or that the scope of dis- and shall contain the address and tele-
covery be limited to certain matters; phone number of, the party or the per-
(5) That the contents of discovery or son on whose behalf the pleading was
evidence be sealed; filed, or his or her counsel.
(6) That the information not be dis- (4) Pleadings or papers are considered
closed to the public or be disclosed filed when they are received by the Di-
only in a designated way; or vision of Dockets Management.
(7) That the parties simultaneously (b) Service. A party filing a document
file specified documents or information with the Division of Dockets Manage-
enclosed in sealed envelopes to be ment under this part shall, no later
opened as directed by the presiding of- than the time of filing, serve a copy of
ficer. such document on every other party.
Service upon any party of any docu-
§ 17.29 Fees. ment, other than service of a com-
The party requesting a subpoena plaint, shall be made by delivering a
shall pay the cost of the fees and mile- copy personally or by placing a copy of
age of any witness subpoenaed in the the document in the United States
amounts that would be payable to a mail or express delivery service, post-
witness in a proceeding in a United age prepaid and addressed, to the par-
States District Court. A check for wit- ty’s last known address. When a party
ness fees and mileage shall accompany is represented by counsel, service shall
the subpoena when served. be made on such counsel in lieu of the
actual party.
§ 17.30 Computation of time. (c) Proof of service. A certificate of
(a) In computing any period of time the individual serving the document by
under this part or in an order issued personal delivery or by mail, setting
thereunder, the time begins with the forth the time and manner of service,
day following the act or event, and in- shall be proof of service.
cludes the last day of the period, unless
either such day is a Saturday, Sunday, § 17.32 Motions.
or Federal holiday, in which event the (a) Any application to the presiding
time includes the next business day. officer for an order or ruling shall be
(b) When the period of time allowed by motion. Motions shall state the re-
is less than 7 days, intermediate Satur- lief sought, the authority relied upon,

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§ 17.33 21 CFR Ch. I (4–1–11 Edition)

and the facts alleged, and shall be filed § 17.34 Determining the amount of
with the Division of Dockets Manage- penalties and assessments.
ment (HFA–305), Food and Drug Ad- (a) When determining an appropriate
ministration, 5630 Fishers Lane, rm. amount of civil money penalties and
1061, Rockville, MD 20852, delivered to assessments, the presiding officer and
the presiding officer, and served on all the Commissioner of Food and Drugs or
other parties. entity designated by the Commissioner
(b) Except for motions made during a to decide the appeal (currently the
prehearing conference or at the hear- DAB) shall evaluate any circumstances
ing, all motions shall be in writing. that mitigate or aggravate the viola-
The presiding officer may require that tion and shall articulate in their opin-
oral motions be reduced to writing. ions the reasons that support the pen-
(c) Within 15 days after a written mo- alties and assessments imposed.
tion is served, or such other time as (b) The presiding officer and the enti-
may be fixed by the presiding officer, ty deciding the appeal shall refer to the
any party may file a response to such factors identified in the statute under
motion. which the penalty is assessed for pur-
(d) The presiding officer may not poses of determining the amount of
grant a written motion before the time penalty.
for filing responses thereto has expired, (c) Nothing in this section shall be
except upon consent of the parties or construed to limit the presiding officer
following a hearing on the motion, but or the entity deciding the appeal from
may overrule or deny such motion considering any other factors that in
without awaiting a response. any given case may mitigate or aggra-
vate the offense for which penalties
§ 17.33 The hearing and burden of and assessments are imposed.
proof.
§ 17.35 Sanctions.
(a) The presiding officer shall con-
duct a hearing on the record to deter- (a) The presiding officer may sanc-
mine whether the respondent is liable tion a person, including any party or
for a civil money penalty and, if so, the counsel for:
appropriate amount of any such civil (1) Failing to comply with an order,
money penalty considering any aggra- subpoena, rule, or procedure governing
vating or mitigating factors. the proceeding;
(b) In order to prevail, the Center (2) Failing to prosecute or defend an
must prove respondent’s liability and action; or
the appropriateness of the penalty (3) Engaging in other misconduct
under the applicable statute by a pre- that interferes with the speedy, or-
ponderance of the evidence. derly, or fair conduct of the hearing.
(c) The respondent must prove any (b) Any such sanction, including, but
not limited to, those listed in para-
affirmative defenses and any miti-
graphs (c), (d), and (e) of this section,
gating factors by a preponderance of
shall reasonably relate to the severity
the evidence.
and nature of the failure or mis-
(d) The hearing shall be open to the conduct.
public unless otherwise ordered by the
(c) When a party fails to comply with
presiding officer, who may order clo- a discovery order, including discovery
sure only to protect trade secrets or and subpoena provisions of this part,
confidential commercial information, the presiding officer may:
as defined in § 20.61 of this chapter, in- (1) Draw an inference in favor of the
formation the disclosure of which requesting party with regard to the in-
would constitute a clearly unwarranted formation sought;
invasion of personal privacy, or other (2) Prohibit the party failing to com-
information that would be withheld ply with such order from introducing
from public disclosure under part 20 of evidence concerning, or otherwise rely-
this chapter. ing upon, testimony relating to the in-
formation sought; and

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Food and Drug Administration, HHS § 17.39

(3) Strike any part of the pleadings ined on relevant matters without re-
or other submissions of the party fail- gard to the scope of his or her direct
ing to comply with such request. examination. To the extent permitted
(d) The presiding officer may exclude by the presiding officer, a witness may
from participation in the hearing any be cross-examined on relevant matters
legal counsel, party, or witness who re- with regard to the scope of his or her
fuses to obey an order of the presiding direct examination. To the extent per-
officer. In the case of repeated refusal, mitted by the presiding officer, cross-
the presiding officer may grant judg- examination on matters outside the
ment to the opposing party. scope of direct examination shall be
(e) If a party fails to prosecute or de- conducted in the manner of direct ex-
fend an action under this part after amination and may proceed by leading
service of a notice of hearing, the pre- questions only if the witness is a hos-
siding officer may dismiss the action or tile witness, an adverse party, or a wit-
may issue an initial decision imposing ness identified with an adverse party.
penalties and assessments. (f) Upon motion of any party, the
(f) The presiding officer may refuse presiding officer may order witnesses
to consider any motion, request, re- excluded so that they cannot hear the
sponse, brief, or other document that is testimony of the other witnesses. This
not filed in a timely fashion or in com- rule does not authorize exclusion of:
pliance with the rules of this part. (1) A party who is an individual;
(g) Sanctions imposed under this sec- (2) In the case of a party that is not
tion may be the subject of an inter- an individual, an officer or employee of
locutory appeal as allowed in § 17.18(b), the party designated to be the party’s
provided that no such appeal will stay sole representative for purposes of the
or delay a proceeding. hearing; or
(3) An individual whose presence is
§ 17.37 Witnesses. shown by a party to be essential to the
(a) Except as provided in paragraph presentation of its case, including an
(b) of this section, testimony at the individual employed by a party en-
hearing shall be given orally by wit- gaged in assisting counsel for the
nesses under oath or affirmation. party.
(b) Direct testimony shall be admit- (g) If a witness’ testimony is sub-
ted in the form of a written declaration mitted in writing prior to cross-exam-
submitted under penalty of perjury. ination, the cross-examining party
Any such written declaration must be need not subpoena the witness or pay
provided to all other parties along with for his or her travel to the hearing. The
the last known address of the witness. sponsoring party is responsible for pro-
Any prior written statements of wit- ducing the witness at its own expense,
nesses proposed to testify at the hear- and failure to do so shall result in the
ing shall be exchanged as provided in striking of the witness’ testimony.
§ 17.25(a).
(c) The presiding officer shall exer- § 17.39 Evidence.
cise reasonable control over the man- (a) The presiding officer shall deter-
ner and order of questioning witnesses mine the admissibility of evidence.
and presenting evidence so as to: (b) Except as provided in this part,
(1) Make the examination and presen- the presiding officer shall not be bound
tation effective for the ascertainment by the ‘‘Federal Rules of Evidence.’’
of the truth; However, the presiding officer may
(2) Avoid undue consumption of time; apply the ‘‘Federal Rules of Evidence’’
and when appropriate, e.g., to exclude unre-
(3) Protect witnesses from harass- liable evidence.
ment or undue embarrassment. (c) The presiding officer shall exclude
(d) The presiding officer shall permit evidence that is not relevant or mate-
the parties to conduct such cross-ex- rial.
amination as may be required for a full (d) Relevant evidence may be ex-
disclosure of the facts. cluded if its probative value is substan-
(e) At the discretion of the presiding tially outweighed by the danger of un-
officer, a witness may be cross-exam- fair prejudice, confusion of the issues,

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§ 17.41 21 CFR Ch. I (4–1–11 Edition)

or by considerations of undue delay or Food and Drugs to decide the appeal,


needless presentation of cumulative currently the DAB.
evidence. (c) The administrative record may be
(e) Relevant evidence may be ex- inspected and copied (upon payment of
cluded if it is privileged under Federal a reasonable fee) by anyone unless oth-
law. erwise ordered by the presiding officer,
(f) Evidence of furnishing or offering who shall upon motion of any party
or promising to furnish, or accepting or order otherwise when necessary to pro-
offering or promising to accept, a valu- tect trade secrets or confidential com-
able consideration in settling or at- mercial information, as defined in
tempting to settle a civil money pen- § 20.61 of this chapter, information the
alty assessment which was disputed as disclosure of which would constitute a
to either validity or amount, is not ad- clearly unwarranted invasion of per-
missible to prove liability for or inva- sonal privacy, or other information
lidity of the civil money penalty or its that would be withheld from public dis-
amount. Evidence of conduct or state- closure under part 20.
ments made in settlement negotiations
is likewise not admissible. This rule § 17.43 Posthearing briefs.
does not require the exclusion of any Any party may file a posthearing
evidence otherwise discoverable merely brief. The presiding officer shall fix the
because it is presented in the course of time for filing such briefs (which shall
settlement negotiations. This rule also be filed simultaneously), which shall
does not require exclusion when the not exceed 60 days from the date the
evidence is offered for another purpose, parties received the transcript of the
such as proving bias or prejudice of a hearing or, if applicable, the stipulated
witness or opposing a contention of record. Such briefs may be accom-
undue delay. panied by proposed findings of fact and
(g) The presiding officer may in his conclusions of law. The presiding offi-
or her discretion permit the parties to cer may permit the parties to file re-
introduce rebuttal witnesses and evi- sponsive briefs. No brief may exceed 30
dence. pages (exclusive of proposed findings
(h) All documents and other evidence and conclusions) unless the presiding
offered or taken for the record shall be officer has previously found that the
open to examination by all parties, un- issues in the proceeding are so com-
less otherwise ordered by the presiding plex, or the administrative record is so
officer pursuant to § 17.28. voluminous, as to justify longer briefs,
in which case the presiding officer may
§ 17.41 The administrative record. set a longer page limit. Proposed find-
(a) The hearing will be recorded and ings of fact and conclusions of law
transcribed. Witnesses, participants, shall not exceed 30 pages unless the
and counsel have 30 days from the time presiding officer has previously found
the transcript becomes available to that the issues in the proceeding are so
propose corrections in the transcript of complex, or the administrative record
oral testimony. Corrections are per- is so voluminous, as to justify longer
mitted only for transcription errors. proposed findings and conclusions, in
The presiding officer shall promptly which case the presiding officer may
order justified corrections. Transcripts set a longer page limit.
may be obtained following the hearing
from the Division of Dockets Manage- § 17.45 Initial decision.
ment at a cost not to exceed the actual (a) The presiding officer shall issue
cost of duplication. an initial decision based only on the
(b) The transcript of testimony, ex- administrative record. The decision
hibits, and other evidence admitted at shall contain findings of fact, conclu-
the hearing and all papers and requests sions of law, and the amount of any
filed in the proceeding constitute the penalties and assessments imposed.
administrative record for the decision (b) The findings of fact shall include
by the presiding officer and the entity a finding on each of the following
designated by the Commissioner of issues:

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Food and Drug Administration, HHS § 17.47

(1) Whether the allegations in the Fishers Lane, rm. 1061, Rockville, MD
complaint are true, and, if so, whether 20852, in accordance with this section.
respondent’s actions identified in the (b)(1) A notice of appeal may be filed
complaint violated the law; at any time within 30 days after the
(2) Whether any affirmative defenses presiding officer issues an initial deci-
are meritorious; and sion or decision granting summary de-
(3) If the respondent is liable for pen- cision.
alties or assessments, the appropriate (2) The Commissioner or the entity
amount of any such penalties or assess- designated by the Commissioner to
ments, considering any mitigating or hear appeals may, within his or her dis-
aggravating factors that he or she finds cretion, extend the initial 30-day period
in the case. for an additional period of time if the
(c) The presiding officer shall serve Center or any respondent files a re-
the initial decision or the decision quest for an extension within the ini-
granting summary decision on all par- tial 30-day period and shows good
ties within 90 days after the time for cause.
submission of posthearing briefs and (c) A notice of appeal shall be accom-
responsive briefs (if permitted) has ex- panied by a written brief of no greater
pired. If the presiding officer believes length than that allowed for the
that he or she cannot meet the 90-day posthearing brief. The notice must
deadline, he or she shall notify the identify specific exceptions to the ini-
Commissioner of Food and Drugs or tial decision, must support each excep-
other entity designated by the Com- tion with citations to the record, and
missioner to decide the appeal of the must explain the basis for each excep-
reason(s) therefor, and the Commis- tion.
sioner or that entity may then set a (d) The opposing party may file a
new deadline. brief of no greater length than that al-
(d) Unless the initial decision or the lowed for the posthearing brief in oppo-
decision granting summary decision of sition to exceptions within 30 days of
the presiding officer is timely ap- receiving the notice of appeal and ac-
pealed, the initial decision or the deci- companying brief, unless such time pe-
sion granting summary decision shall riod is extended by the Commissioner
constitute the final decision of FDA or the entity designated by the Com-
and shall be final and binding on the missioner to hear appeals on request of
parties 30 days after it is issued by the the opposing party for good cause
presiding officer. shown. Any brief in opposition to ex-
ceptions shall be filed with the Divi-
§ 17.47 Appeals. sion of Dockets Management and the
(a) Either the Center or any respond- DAB (addresses above).
ent may appeal an initial decision, in- (e) The appellant may file a reply
cluding a decision not to withdraw a brief not more than 10 pages in length
default judgment, or a decision grant- within 10 days of being served with ap-
ing summary decision to the Commis- pellee’s brief.
sioner of Food and Drugs or other enti- (f) There is no right to appear person-
ty the Commissioner designates to de- ally before the Commissioner of Food
cide the appeal. The Commissioner has and Drugs or other entity deciding the
currently designated the Departmental appeal (currently the DAB).
Appeals Board (DAB) to decide appeals (g) The entity deciding the appeal
under this part. Parties may appeal to will consider only those issues raised
the DAB by filing a notice of appeal before the presiding officer, except that
with the DAB, Appellate Division the appellee may make any argument
MS6127, Departmental Appeals Board, based on the record in support of the
United States Department of Health initial decision or decision granting
and Human Services, 330 Independence summary decision.
Ave. SW., Cohen Bldg., rm. G–644, (h) If on appeal the entity deciding
Washington, DC 20201, and the Division the appeal considers issues not ade-
of Dockets Management (HFA–305), quately briefed by the parties, the enti-
Food and Drug Administration, 5630 ty may ask for additional briefing.

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§ 17.48 21 CFR Ch. I (4–1–11 Edition)

However, no such additional briefs will DAB) to be inconsistent with substan-


be considered unless so requested. tial justice. The presiding officer and
(i) If any party demonstrates to the the entity deciding the appeal at every
satisfaction of the entity deciding the stage of the proceeding will disregard
appeal (currently the DAB) that addi- any error or defect in the proceeding
tional evidence not presented at the that does not affect the substantial
hearing is relevant and material and rights of the parties.
that there were reasonable grounds for
the failure to adduce such evidence at § 17.51 Judicial review.
the hearing, the entity deciding the ap- (a) The final decision of the Commis-
peal may remand the matter to the sioner of Food and Drugs or other enti-
presiding officer for consideration of ty deciding the appeal (currently the
the additional evidence. DAB) constitutes final agency action
(j) The Commissioner of Food and from which a respondent may petition
Drugs or other entity deciding the ap- for judicial review under the statutes
peal (currently the DAB) will issue a governing the matter involved. Al-
decision on the appeal within 60 days, though the filing of a petition for judi-
if practicable, of the due date for sub- cial review does not stay a decision
mission of the appellee’s brief. In the under this part, a respondent may file
decision, the entity deciding the appeal a petition for stay of such decision
may decline to review the case, affirm under § 10.35 of this chapter.
the initial decision or decision grant-
(b) The Chief Counsel of FDA has
ing summary decision (with or without
been designated by the Secretary of
an opinion), or reverse the initial deci-
Health and Human Services as the offi-
sion or decision granting summary de-
cer on whom copies of petitions for ju-
cision, or increase, reduce, reverse, or
dicial review are to be served. This offi-
remand any civil money penalty deter-
cer is responsible for filing the record
mined by the presiding officer in the
on which the final decision is based.
initial decision. If the entity deciding
the appeal declines to review the case, The record of the proceeding is cer-
the initial decision or the decision tified by the entity deciding the appeal
granting summary decision shall con- (currently the DAB).
stitute the final decision of FDA and (c) Exhaustion of an appeal to the en-
shall be final and binding on the par- tity deciding the appeal (currently the
ties 30 days after the declination by the DAB) is a jurisdictional prerequisite to
entity deciding the appeal. judicial review.
(k) The standard of review on a dis- § 17.54 Deposit in the Treasury of the
puted issue of fact is whether the ini- United States.
tial decision is supported by substan-
tial evidence on the whole record. The All amounts assessed pursuant to
standard of review on a disputed issue this part shall be delivered to the Di-
of law is whether the initial decision is rector, Division of Financial Manage-
erroneous. ment (HFA–100), Food and Drug Ad-
ministration, rm. 11–61, 5600 Fishers
[60 FR 38626, July 27, 1995, as amended at 71 Lane, Rockville, MD 20857, and shall be
FR 5979, Feb. 6, 2006] deposited as miscellaneous receipts in
§ 17.48 Harmless error. the Treasury of the United States.
No error in either the admission or
the exclusion of evidence, and no error PART 19—STANDARDS OF CON-
or defect in any ruling or order or in DUCT AND CONFLICTS OF INTER-
any act done or omitted by the pre- EST
siding officer or by any of the parties is
grounds for vacating, modifying, or Subpart A—General Provisions
otherwise disturbing an otherwise ap- Sec.
propriate ruling or order or act, unless 19.1 Scope.
refusal to take such action appears to 19.5 Reference to Department regulations.
the presiding officer or the Commis- 19.6 Code of ethics for government service.
sioner of Food and Drugs or other enti- 19.10 Food and Drug Administration Con-
ty deciding the appeal (currently the flict of Interest Review Board.

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Food and Drug Administration, HHS § 19.10

Subpart B—Reporting of Violations 4. Seek to find and employ more efficient


and economical ways of getting tasks accom-
19.21 Duty to report violations. plished.
5. Never discriminate unfairly by the dis-
Subpart C—Disqualification Conditions pensing of special favors or privileges to any-
one, whether for remuneration or not; and
19.45 Temporary disqualification of former never accept, for himself or his family, fa-
employees. vors or benefits under circumstances which
19.55 Permanent disqualification of former might be construed by reasonable persons as
employees. influencing the performance of his govern-
AUTHORITY: 21 U.S.C. 371. mental duties.
6. Make no private promises of any kind
SOURCE: 42 FR 15615, Mar. 22, 1977, unless
binding upon the duties of office, since a
otherwise noted.
Government employee has no private word
which can be binding on public duty.
Subpart A—General Provisions 7. Engage in no business with the Govern-
ment, either directly or indirectly, which is
§ 19.1 Scope. inconsistent with the conscientious perform-
ance of his governmental duties.
This part governs the standards of
8. Never use any information coming to
conduct for, and establishes regula- him confidentially in the performance of
tions to prevent conflicts of interest governmental duties as a means for making
by, all Food and Drug Administration private profit.
employees. 9. Expose corruption wherever discovered.
10. Uphold these principles, ever conscious
§ 19.5 Reference to Department regula- that public office is a public trust.
tions.
(a) The provisions of 45 CFR part 73, § 19.10 Food and Drug Administration
establishing standards of conduct for Conflict of Interest Review Board.
all Department employees, are fully (a) The Commissioner shall establish
applicable to all Food and Drug Admin- a permanent five-member Conflict of
istration employees, except that such Interest Review Board, which shall re-
regulations shall be applicable to spe- view and make recommendations to
cial government employees, i.e., con- the Commissioner on all specific or
sultants to the Food and Drug Admin- policy matters relating to conflicts of
istration, only to the extent stated in interest arising within the Food and
subpart L of 45 CFR part 73. Drug Administration that are for-
(b) The provisions of 45 CFR part 73a warded to it by: (1) The Associate Com-
supplement the Department standards missioner for Management and Oper-
of conduct and apply only to Food and ations or (2) anyone who is the subject
Drug Administration employees except of an adverse determination by the As-
special government employees. sociate Commissioner for Management
and Operations on any matter arising
§ 19.6 Code of ethics for government under the conflict of interest laws, ex-
service. cept a determination of an apparent
The following code of ethics, adopted violation of law. The Director, Division
by Congress on July 11, 1958, shall of Ethics and Program Integrity, Office
apply to all Food and Drug Administra- of Management and Operations, shall
tion employees: serve as executive secretary of the Re-
view Board.
CODE OF ETHICS FOR GOVERNMENT SERVICE
(b) It shall be the responsibility of
Any person in Government service should: every Food and Drug Administration
1. Put loyalty to the highest moral prin- employee with whom any specific or
ciples and to country above loyalty to per- policy issue relating to conflicts of in-
sons, party, or Government department. terest is raised, or who otherwise wish-
2. Uphold the Constitution, laws, and legal es to have any such matter resolved, to
regulations of the United States and of all
governments therein and never be a party to
forward the matter to the Associate
their evasion. Commissioner for Management and Op-
3. Give a full day’s labor for a full day’s erations for resolution, except that re-
pay; giving to the performance of his duties porting of apparent violations of law
his earnest effort and best thought. are governed by § 19.21.

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§ 19.21 21 CFR Ch. I (4–1–11 Edition)

(c) All general policy relating to con- ance of the Office of Internal Affairs,
flicts of interest shall be established in be reduced to writing, and shall be
guidance documents pursuant to the promptly investigated.
provisions of § 10.90(b) of this chapter (c) Any report pursuant to paragraph
and whenever feasible shall be incor- (b) of this section and any records re-
porated in regulations in this subpart. lating to an investigation of such re-
(d) All decisions relating to specific ports shall be maintained in strict con-
individuals shall be placed in a public fidence in the files of the Office of In-
file established for this purpose by the ternal Affairs, shall be exempt from
Freedom of Information Staff, e.g., a public disclosure, and may be reviewed
determination that a consultant may only by authorized Food and Drug Ad-
serve on an advisory committee with ministration employees who are re-
specific limitations or with public dis- quired to do so in the performance of
closure of stock holdings, except that their duties.
such determination shall be written in [42 FR 15615, Mar. 22, 1977, as amended at 46
a way that does not identify the indi- FR 8456, Jan. 27, 1981; 50 FR 52278, Dec. 23,
vidual in the following situations: 1985; 60 FR 47478, Sept. 13, 1995]
(1) A determination that an employee
must dispose of prohibited financial in- Subpart C—Disqualification
terests or refrain from incompatible
outside activities in accordance with Conditions
established Department or agency reg- § 19.45 Temporary disqualification of
ulations. former employees.
(2) A determination that a proposed
consultant is not eligible for employ- Within 1 year after termination of
ment by the agency. employment with the Food and Drug
(3) A determination that public dis- Administration, no former Food and
closure of any information would con- Drug Administration employee, includ-
ing a special government employee,
stitute an unwarranted invasion of per-
shall appear personally before the Food
sonal privacy in violation of § 20.63 of
and Drug Administration or other fed-
this chapter.
eral agency or court as agent or attor-
[42 FR 15615, Mar. 22, 1977, as amended at 46 ney for any person other than the
FR 8456, Jan. 27, 1981; 50 FR 52278, Dec. 23, United States in connection with any
1985; 55 FR 1404, Jan. 16, 1990; 65 FR 56479, proceeding or matter in which the
Sept. 19, 2000] United States is a party or has a direct
and substantial interest and which was
Subpart B—Reporting of Violations under his official responsibility at any
time within one year preceding termi-
§ 19.21 Duty to report violations. nation of such responsibility. The term
(a) The Office of Internal Affairs, Of- official responsibility means the direct
fice of the Commissioner, is responsible administrative or operating authority,
for obtaining factual information for whether intermediate or final, and ei-
the Food and Drug Administration on ther exercisable alone or with others,
any matter relating to allegations of and either personally or through subor-
misconduct, impropriety, conflict of dinates, to approve, disapprove, or oth-
interest, or other violations of Federal erwise direct government action.
statutes by agency personnel.
(b) Any Food and Drug Administra- § 19.55 Permanent disqualification of
tion employee who has factual infor- former employees.
mation showing or who otherwise be- No former Food and Drug Adminis-
lieves that any present or former Food tration employee, including a special
and Drug Administration employee has government employee, shall knowingly
violated or is violating any provision of act as agent or attorney for anyone
this subpart or of 45 CFR parts 73 or 73a other than United States in connection
or of any statute listed in appendix A with any judicial or other proceeding,
to 45 CFR part 73 should report such in- application, request for a ruling or
formation directly to the Office of In- other determination, contract, claim,
ternal Affairs. Any such reports shall controversy, charge, accusation, or
be in writing or shall with the assist- other particular matter involving a

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Food and Drug Administration, HHS Pt. 20

specific party or parties in which the 20.52 Availability of records at National


United States is a party or has a direct Technical Information Service.
and substantial interest and in which 20.53 Use of private contractor for copying.
20.54 Request for review without copying.
he participated personally and substan-
20.55 Indexing trade secrets and confidential
tially through decision, approval, dis- commercial or financial information.
approval, recommendation, rendering
of advice, investigation, or otherwise Subpart D—Exemptions
as a Food and Drug Administration
employee. 20.60 Applicability of exemptions.
20.61 Trade secrets and commercial or fi-
nancial information which is privileged
PART 20—PUBLIC INFORMATION or confidential.
20.62 Inter- or intra-agency memoranda or
Subpart A—Official Testimony and letters.
Information 20.63 Personnel, medical, and similar files,
disclosure of which constitutes a clearly
Sec. unwarranted invasion of personal pri-
20.1 Testimony by Food and Drug Adminis- vacy.
tration employees. 20.64 Records or information compiled for
20.2 Production of records by Food and Drug law enforcement purposes.
Administration employees. 20.65 National defense and foreign policy.
20.3 Certification and authentication of 20.66 Internal personnel rules and practices.
Food and Drug Administration records. 20.67 Records exempted by other statutes.

Subpart B—General Policy Subpart E—Limitations on Exemptions


20.20 Policy on disclosure of Food and Drug 20.80 Applicability of limitations on exemp-
Administration records. tions.
20.21 Uniform access to records. 20.81 Data and information previously dis-
20.22 Partial disclosure of records. closed to the public.
20.23 Request for existing records. 20.82 Discretionary disclosure by the Com-
20.24 Preparation of new records. missioner.
20.25 Retroactive application of regulations. 20.83 Disclosure required by court order.
20.26 Indexes of certain records. 20.84 Disclosure to consultants, advisory
20.27 Submission of records marked as con- committees, State and local government
fidential. officials commissioned pursuant to 21
20.28 Food and Drug Administration deter- U.S.C. 372(a), and other special govern-
minations of confidentiality. ment employees.
20.29 Prohibition on withdrawal of records 20.85 Disclosure to other Federal govern-
from Food and Drug Administration ment departments and agencies.
files. 20.86 Disclosure in administrative or court
20.30 Food and Drug Administration Free- proceedings.
dom of Information Staff. 20.87 Disclosure to Congress.
20.31 Retention schedule of requests for 20.88 Communications with State and local
Food and Drug Administration records. government officials.
20.32 Disclosure of Food and Drug Adminis- 20.89 Communications with foreign govern-
tration employee names. ment officials.
20.33 Form or format of response. 20.90 Disclosure to contractors.
20.34 Search for records. 20.91 Use of data or information for admin-
istrative or court enforcement action.
Subpart C—Procedures and Fees
Subpart F—Availability of Specific
20.40 Filing a request for records. Categories of Records
20.41 Time limitations.
20.42 Aggregation of certain requests. 20.100 Applicability; cross-reference to
20.43 Multitrack processing. other regulations.
20.44 Expedited processing. 20.101 Administrative enforcement records.
20.45 Fees to be charged. 20.102 Court enforcement records.
20.46 Waiver or reduction of fees. 20.103 Correspondence.
20.47 Situations in which confidentiality is 20.104 Summaries of oral discussions.
uncertain. 20.105 Testing and research conducted by or
20.48 Judicial review of proposed disclosure. with funds provided by the Food and
20.49 Denial of a request for records. Drug Administration.
20.50 Nonspecific and overly burdensome re- 20.106 Studies and reports prepared by or
quests. with funds provided by the Food and
20.51 Referral to primary source of records. Drug Administration.

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§ 20.1 21 CFR Ch. I (4–1–11 Edition)
20.107 Food and Drug Administration manu- grounds that it is prohibited by this
als. section.
20.108 Agreements between the Food and
Drug Administration and other depart-
(c) A person who desires testimony
ments, agencies, and organizations. from any employee may make written
20.109 Data and information obtained by request therefor, verified by oath, di-
contract. rected to the Commissioner setting
20.110 Data and information about Food and forth his interest in the matter sought
Drug Administration employees. to be disclosed and designating the use
20.111 Data and information submitted vol-
untarily to the Food and Drug Adminis- to which such testimony will be put in
tration. the event of compliance with such re-
20.112 Voluntary drug experience reports quest: Provided, That a written request
submitted by physicians and hospitals. therefor made by a health, food, or
20.113 Voluntary product defect reports. drug officer, prosecuting attorney, or
20.114 Data and information submitted pur- member of the judiciary of any State,
suant to cooperative quality assurance
agreements. Territory, or political subdivision
20.115 Product codes for manufacturing or thereof, acting in his official capacity,
sales dates. need not be verified by oath. If it is de-
20.116 Drug and device listing information. termined by the Commissioner, or any
20.117 New drug information. other officer or employee of the Food
20.118 Advisory committee records. and Drug Administration whom he
20.119 Lists of names and addresses.
20.120 Records available in Feed and Drug may designate to act on his behalf for
Administration Public Reading Rooms. the purpose, that such testimony will
be in the public interest and will pro-
AUTHORITY: 5 U.S.C. 552; 18 U.S.C. 1905; 19
U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401–1403; mote the objectives of the act and the
42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, agency, the request may be granted.
263b–263n, 264, 265, 300u–300u–5, 300aa–1. Where a request for testimony is grant-
SOURCE: 42 FR 15616, Mar. 22, 1977, unless
ed, one or more employees of the Food
otherwise noted. and Drug Administration may be des-
ignated to appear, in response to a sub-
poena, and testify with respect thereto.
Subpart A—Official Testimony and
Information § 20.2 Production of records by Food
and Drug Administration employ-
§ 20.1 Testimony by Food and Drug ees.
Administration employees.
(a) No officer or employee of the (a) Any request for records of the
Food and Drug Administration or of Food and Drug Administration, wheth-
any other office or establishment in er it be by letter or by a subpena duces
the Department of Health and Human tecum or by any other writing, shall be
Services, except as authorized by the handled pursuant to the procedures es-
Commissioner of Food and Drugs pur- tablished in subpart B of this part, and
suant to this section or in the dis- shall comply with the rules governing
charge of his official duties under the public disclosure established in sub-
laws administered by the Food and parts C, D, E, and F of this part and in
Drug Administration, shall give any other regulations cross-referenced in
testimony before any tribunal per- § 20.100(c).
taining to any function of the Food and (b) Whenever a subpoena duces
Drug Administration or with respect to tecum, in appropriate form, has been
any information acquired in the dis- lawfully served upon an officer or em-
charge of his official duties. ployee of the Food and Drug Adminis-
(b) Whenever a subpoena, in appro- tration commanding the production of
priate form, has been lawfully served any record, such officer or employee
upon an officer or employee of the shall appear in response thereto, re-
Food and Drug Administration com- spectfully decline to produce the
manding the giving of any testimony, record on the ground that it is prohib-
such officer or employee shall, unless ited by this section, and state that the
otherwise authorized by the Commis- production of the record(s) involved
sioner, appear in response thereto and will be handled by the procedures es-
respectfully decline to testify on the tablished in this part.

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Food and Drug Administration, HHS § 20.22

§ 20.3 Certification and authentication (3) The disclosure is one that is dis-
of Food and Drug Administration cretionary, i.e., not required under this
records. part.
(a) Upon request, the Food and Drug (e) ‘‘Record’’ and any other term used
Administration will certify the authen- in this section in reference to informa-
ticity of copies of records that are re- tion includes any information that
would be an agency record subject to
quested to be disclosed pursuant to this
the requirements of this part when
part or will authenticate copies of
maintained by the agency in any for-
records previously disclosed.
mat, including an electronic format.
(b) A request for certified copies of
records or for authentication of records [42 FR 15616, Mar. 22, 1977, as amended at 68
shall be sent in writing to the Freedom FR 25285, May 12, 2003]
of Information Staff (HFI–35), Food and § 20.21 Uniform access to records.
Drug Administration, Room 12A–16,
5600 Fishers Lane, Rockville, MD 20857. Any record of the Food and Drug Ad-
ministration that is disclosed in an au-
[42 FR 15616, Mar. 22, 1977, as amended at 46 thorized manner to any member of the
FR 8456, Jan. 27, 1981] public is available for disclosure to all
members of the public, except that:
Subpart B—General Policy (a) Data and information subject to
the exemptions established in § 20.61 for
§ 20.20 Policy on disclosure of Food trade secrets and confidential commer-
and Drug Administration records. cial or financial information, and in
(a) The Food and Drug Administra- § 20.63 for personal privacy, shall be dis-
tion will make the fullest possible dis- closed only to the persons for the pro-
closure of records to the public, con- tection of whom these exemptions
sistent with the rights of individuals to exist.
privacy, the property rights of persons (b) The limited disclosure of records
in trade secrets and confidential com- permitted in § 7.87(c) of this chapter for
section 305 hearing records, in § 20.80(b)
mercial or financial information, and
regarding certain limitations on ex-
the need for the agency to promote
emptions, in § 20.103(b) for certain cor-
frank internal policy deliberations and
respondence, and in § 20.104(b) for cer-
to pursue its regulatory activities tain summaries of oral discussions,
without disruption. shall be subject to the special rules
(b) Except where specifically exempt stated therein.
pursuant to the provisions of this part, (c) Disclosure of a record about an in-
all Food and Drug Administration dividual, as defined in § 21.3(a) of this
records shall be made available for chapter, that is retrieved by the indi-
public disclosure. vidual’s name or other personal identi-
(c) Except as provided in paragraph fier and is contained in a Privacy Act
(d) of this section, all nonexempt Record System, as defined in § 21.3(c) of
records shall be made available for this chapter, shall be subject to the
public disclosure upon request regard- special requirements of part 21 of this
less whether any justification or need chapter. Disclosure of such a record to
for such records have been shown. an individual who is the subject of the
(d) Under § 21.71 of this chapter, a record does not invoke the rule estab-
statement of the purposes to which the lished in this section that such records
record requested is to be put, and a cer- shall be made available for disclosure
tification that the record will be so to all members of the public.
used, may be requested when: [42 FR 15616, Mar. 22, 1977, as amended at 54
(1) The requested record is contained FR 9037, Mar. 3, 1989]
in a Privacy Act Record System as de-
fined in § 21.3(c) of this chapter; § 20.22 Partial disclosure of records.
(2) The requester is a person other (a) If a record contains both
than the individual who is the subject disclosable and nondisclosable informa-
of the record that is so retrieved or a tion, the nondisclosable information
person acting on his behalf; and will be deleted and the remaining

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§ 20.23 21 CFR Ch. I (4–1–11 Edition)

record will be disclosed unless the two (b) The Commissioner may, in his
are so inextricably intertwined that it discretion, prepare new records in
is not feasible to separate them or re- order to respond adequately to a re-
lease of the disclosable information quest for information when he con-
would compromise or impinge upon the cludes that it is in the public interest
nondisclosable portion of the record. and promotes the objectives of the act
(b)(1) Whenever information is de- and the agency.
leted from a record that contains both
disclosable and nondisclosable informa- § 20.25 Retroactive application of regu-
tion, the amount of information de- lations.
leted shall be indicated on the portion The provisions of this part apply to
of the record that is made available, all records in Food and Drug Adminis-
unless including that indication would tration files.
harm an interest protected by an ex-
emption under the Freedom of Infor- § 20.26 Indexes of certain records.
mation Act. (a) Indexes shall be maintained, and
(2) When technically feasible, the revised at least quarterly, for the fol-
amount of information deleted shall be lowing Food and Drug Administration
indicated at the place in the record records:
where the deletion is made. (1) Final orders published in the FED-
[42 FR 15616, Mar. 22, 1977, as amended at 68 ERAL REGISTER with respect to every
FR 25285, May 12, 2003] denial or withdrawal of approval of a
new drug application or a new animal
§ 20.23 Request for existing records. drug application for which a public
(a) Any written request to the Food hearing has been requested.
and Drug Administration for existing (2) Statements of policy and interpre-
records not prepared for routine dis- tation adopted by the agency and still
tribution to the public shall be deemed in force and not published in the FED-
to be a request for records pursuant to ERAL REGISTER.
the Freedom of Information Act, (3) Administrative staff manuals and
whether or not the Freedom of Infor- instructions to staff that affect a mem-
mation Act is mentioned in the re- ber of the public.
quest, and shall be governed by the (4) Records that have been released
provisions of this part. to any person in response to a Freedom
(b) Records or documents prepared by of Information request and that the
the Food and Drug Administration for agency has determined have become, or
routine public distribution, e.g., pam- are likely to become, the subject of
phlets, speeches, and educational mate- subsequent requests for substantially
rials, shall be furnished free of charge the same records.
upon request as long as the supply (b) Each such index will be made
lasts. The provisions of this part shall available through the Internet at http://
not be applicable to such requests ex- www.fda.gov. A printed copy of each
cept when the supply of such material index is available by writing to the
is exhausted and it is necessary to re- Freedom of Information Staff (HFI–35),
produce individual copies upon specific Food and Drug Administration, 5600
request. Fishers Lane, rm. 12A–16, Rockville,
(c) All existing Food and Drug Ad- MD 20857, or by visiting the Freedom of
ministration records are subject to Information Public Reading Room in
routine destruction according to stand- rm. 12A–30 at the same address.
ard record retention schedules. [42 FR 15616, Mar. 22, 1977, as amended at 46
FR 8456, Jan. 27, 1981; 68 FR 25285, May 12,
§ 20.24 Preparation of new records. 2003]
(a) The Freedom of Information Act
and the provisions of this part apply § 20.27 Submission of records marked
only to existing records that are rea- as confidential.
sonably described in a request filed Marking records submitted to the
with the Food and Drug Administra- Food and Drug Administration as con-
tion pursuant to the procedures estab- fidential, or with any other similar
lished in subpart C of this part. term, raises no obligation by the Food

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Food and Drug Administration, HHS § 20.33

and Drug Administration to regard Schedule 14, FPMR 101–11–4, January


such records as confidential, to return 10, 1977, as follows:
them to the person who has submitted (1) Files created by the receipt of and
them, to withhold them from disclo- response to freedom of information re-
sure to the public, or to advise the per- quests, except denials and/or appeals,
son submitting them when a request may be destroyed 2 years from date of
for their public disclosure is received final response.
or when they are in fact disclosed. (2) Files created by a freedom of in-
[42 FR 15616, Mar. 22, 1977, as amended at 68 formation request which was wholly or
FR 25285, May 12, 2003] partially denied may be destroyed 5
years after the denial letter was issued.
§ 20.28 Food and Drug Administration (3) Files created by a freedom of in-
determinations of confidentiality.
formation request which was wholly or
A determination that data or infor- partially denied and which denial was
mation submitted to the Food and subsequently appealed to the Depart-
Drug Administration will be held in ment of Health and Human Services
confidence and will not be available for may be destroyed 4 years after final de-
public disclosure shall be made only in termination by FDA or 3 years after
the form of a regulation published or final adjudication by courts, whichever
cross-referenced in this part. is later.
[42 FR 15616, Mar. 22, 1977, as amended at 68 (b) This destruction schedule will
FR 25285, May 12, 2003] automatically be revised whenever the
time limits pertaining to these records
§ 20.29 Prohibition on withdrawal of are revised by the GSA General
records from Food and Drug Ad- Records Schedule.
ministration files.
No person may withdraw records sub- [47 FR 24277, June 4, 1982]
mitted to the Food and Drug Adminis-
tration. All Food and Drug Administra- § 20.32 Disclosure of Food and Drug
Administration employee names.
tion records shall be retained by the
agency until disposed of pursuant to The names of Food and Drug Admin-
routine record disposal procedures. istration employees will not be deleted
from disclosable records except where
[42 FR 15616, Mar. 22, 1977, as amended at 68
FR 25285, May 12, 2003] such deletion is necessary to prevent
disclosure of an informant or danger to
§ 20.30 Food and Drug Administration the life or physical safety of the em-
Freedom of Information Staff. ployee or under other extraordinary
(a) The Office responsible for agency circumstances.
compliance with the Freedom of Infor-
mation Act and this part is: § 20.33 Form or format of response.
(a) The Food and Drug Administra-
Freedom of Information Staff (HFI–35), Food
and Drug Administration, Room 12A–16, tion shall make reasonable efforts to
5600 Fishers Lane, Rockville, MD 20857. provide a record in any requested form
or format if the record is readily repro-
(b) All requests for agency records ducible by the agency in that form or
shall be sent in writing to this office. format.
[42 FR 15616, Mar. 22, 1977, as amended at 46 (b) If the agency determines that a
FR 8456, Jan. 27, 1981] record is not readily reproducible in
the requested form or format, the agen-
§ 20.31 Retention schedule of requests
for Food and Drug Administration cy may notify the requester of alter-
records. native forms and formats that are
available. If the requester does not ex-
(a) Unless unusual circumstances dic- press a preference for an alternative in
tate otherwise, the Food and Drug Ad- response to such notification, the agen-
ministration shall maintain and dis- cy may provide its response in the form
pose of files of requests and reponses
and format of the agency’s choice.
furnished thereto within the time lim-
its authorized by GSA General Records [68 FR 25285, May 12, 2003]

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§ 20.34 21 CFR Ch. I (4–1–11 Edition)

§ 20.34 Search for records. date(s) any records are subsequently


furnished.
(a) In responding to a request for (d) A request by an individual, as de-
records, the Food and Drug Adminis- fined in § 21.3(a) of this chapter, for a
tration shall make reasonable efforts record about himself shall be subject
to search for records kept in electronic to:
form or format, except when such ef- (1) The special requirements of part
forts would significantly interfere with 21 of this chapter (the privacy regula-
the operation of the agency’s auto- tions), and not to the provisions of this
mated information systems. subpart, if the record requested is re-
(b) The term ‘‘search’’ means to re- trieved by the individual’s name or
view, manually or by automated other personal identifier and is con-
means, agency records for the purpose tained in a Privacy Act Record Sys-
of locating those records that are re- tem, as defined in § 21.3(c) of this chap-
sponsive to the request. ter.
[68 FR 25285, May 12, 2003] (2) The provisions of this subpart if
the record requested is not retrieved by
the individual’s name or other personal
Subpart C—Procedures and Fees identifier, whether or not the record is
contained in a Privacy Act Record Sys-
§ 20.40 Filing a request for records.
tem.
(a) All requests for Food and Drug
[42 FR 15616, Mar. 22, 1977, as amended at 46
Administration records shall be made FR 8456, Jan. 27, 1981; 68 FR 25285, May 12,
in writing by mailing or delivering the 2003]
request to the Freedom of Information
Staff (HFI–35), Food and Drug Adminis- § 20.41 Time limitations.
tration, rm. 12A–16, 5600 Fishers Lane, (a) All time limitations prescribed
Rockville, MD 20857, or by faxing it to pursuant to this section shall begin as
301–443–1726. All requests must contain of the time at which a request for
the postal address and telephone num- records is logged in by the Freedom of
ber of the requester and the name of Information Staff pursuant to § 20.40(c).
the person responsible for payment of An oral request for records shall not
any fees that may be charged. begin any time requirement. A written
(b) A request for Food and Drug Ad- request for records sent elsewhere
ministration records shall reasonably within the agency shall not begin any
describe the records being sought, in a time requirement until it is redirected
way that they can be identified and lo- to the Freedom of Information Staff
cated. A request should include all per- and is logged in there in accordance
tinent details that will help identify with § 20.40(c).
the records sought. (b) Within 20 working days (excluding
(1) If the description is insufficient to Saturdays, Sundays, and legal public
locate the records requested, the Food holidays) after a request for records is
and Drug Administration will so notify logged in at the Freedom of Informa-
the person making the request and in- tion Staff, the agency shall send a let-
dicate the additional information need- ter to the requester providing the agen-
ed to identify the records requested. cy’s determination as to whether, or
(2) Every reasonable effort shall be the extent to which, the agency will
made by the Food and Drug Adminis- comply with the request, and, if any
tration to assist in the identification records are denied, the reasons for the
and location of the records sought. denial.
(c) Upon receipt of a request for (1) If all of the records requested have
records, the Freedom of Information been located and a final determination
Staff shall enter it in a public log. The has been made with respect to disclo-
log shall state the date received, the sure of all of the records requested, the
name of the person making the re- letter shall so state.
quest, the nature of the record re- (2) If all of the records have not been
quested, the action taken on the re- located or a final determination has
quest, the date of determination letter not yet been made with respect to dis-
sent pursuant to § 20.41(b), and the closure of all of the records requested,

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Food and Drug Administration, HHS § 20.43

e.g., because it is necessary to consult Staff of the request and the required
the person affected pursuant to § 20.47, documentation of compelling need in
the letter shall state the extent to accordance with § 20.44(b).
which the records involved shall be dis-
[42 FR 15616, Mar. 22, 1977, as amended at 46
closed pursuant to the rules estab-
FR 8456, Jan. 27, 1981; 55 FR 1405, Jan. 16,
lished in this part. 1990; 59 FR 533, Jan. 5, 1994; 68 FR 25285, May
(3)(i) In unusual circumstances, the 12, 2003]
agency may extend the time for send-
ing the letter for an additional period. § 20.42 Aggregation of certain re-
(A) The agency may provide for an quests.
extension of up to 10 working days by
The Food and Drug Administration
providing written notice to the re-
may aggregate certain requests by the
quester setting out the reasons for the
same requester, or by a group of re-
extension and the date by which a de-
questers acting in concert, if the re-
termination is expected to be sent.
quests involve clearly related matters
(B) The agency may provide for an
and the agency reasonably believes
extension of more than 10 working days
that such requests actually constitute
by providing written notice to the re-
a single request which would otherwise
quester setting out the reasons for the
extension. The notice also will give the satisfy the unusual circumstances
requester an opportunity to limit the specified in § 20.41(b)(3)(ii)(B). FDA may
scope of the request so that it may be extend the time for processing aggre-
processed in a shorter time and/or an gated requests in accordance with the
opportunity to agree on a timeframe unusual circumstances provisions of
longer than the 10 extra working days § 20.41.
for processing the request. [68 FR 25286, May 12, 2003]
(ii) Unusual circumstances may exist
under any of the following conditions: § 20.43 Multitrack processing.
(A) There is a need to search for and (a) Each Food and Drug Administra-
collect the requested records from field
tion component is responsible for de-
facilities or other components that are
termining whether to use a multitrack
separate from the agency component
system to process requests for records
responsible for processing the request;
maintained by that component. A mul-
(B) There is a need to search for, col-
titrack system provides two or more
lect, and appropriately examine a volu-
tracks for processing requests, based
minous amount of separate and dis-
on the amount of work and/or time re-
tinct records that are demanded in a
quired for a request to be processed.
single request; or
The availability of multitrack proc-
(C) There is need for consultation,
essing does not affect expedited proc-
which shall be conducted with all prac-
ticable speed, with another agency hav- essing in accordance with § 20.44.
ing a substantial interest in the deter- (b) If multitrack processing is not
mination of the request, or among two adopted by a particular agency compo-
or more components of the Food and nent, that component will process all
Drug Administration having substan- requests in a single track, ordinarily
tial subject-matter interest in the de- on a first-in, first-out basis.
termination. (c) If a multitrack processing system
(4) If any record is denied, the letter is established by a particular agency
shall state the right of the person re- component, that component may deter-
questing such records to appeal any ad- mine how many tracks to establish and
verse determination to the Assistant the specific criteria for assigning re-
Secretary for Health, Department of quests to each track. Multiple tracks
Health and Human Services, in accord- may be established for requests based
ance with the provisions of 45 CFR 5.34. on the amount of work and/or time re-
(c) The Food and Drug Administra- quired for a request to be processed.
tion shall provide a determination of (d) Requests assigned to a given
whether to provide expedited proc- track will ordinarily be processed on a
essing within 10 calendar days of re- first-in, first-out basis within that
ceipt by the Freedom of Information track.

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§ 20.44 21 CFR Ch. I (4–1–11 Edition)

(e) If a request does not qualify for or activities of the Federal Govern-
the fastest processing track, the re- ment.
quester may be provided an oppor- (d) All requests for expedited proc-
tunity to limit the scope of the request essing shall be filed in writing as pro-
in order to qualify for faster proc- vided by § 20.40. Each such request shall
essing. include information that demonstrates
a reasonable basis for concluding that
[68 FR 25286, May 12, 2003]
a compelling need exists within the
§ 20.44 Expedited processing. meaning of paragraph (a) of this sec-
tion and a certification that the infor-
(a) The Food and Drug Administra- mation provided in the request is true
tion will provide expedited processing and correct to the best of the request-
of a request for records when the re- er’s knowledge and belief. Any state-
quester demonstrates a compelling ments made in support of a request for
need, or in other cases as determined expedited processing are subject to the
by the agency. A compelling need ex- False Reports to the Government Act
ists when: (18 U.S.C. 1001).
(1) A failure to obtain requested (e) The Assistant Commissioner for
records on an expedited basis could rea- Public Affairs (or delegatee) will deter-
sonably be expected to pose an immi- mine whether to grant a request for ex-
nent threat to the life or physical safe- pedited processing within 10 days of re-
ty of an individual; or ceipt by the Freedom of Information
(2) With respect to a request made by Staff of all information required to
a person primarily engaged in dissemi- make a decision.
nating information, there is a dem- (f) If the agency grants a request for
onstrated urgency to inform the public expedited processing, the agency shall
concerning actual or alleged Federal process the request as soon as prac-
Government activity. ticable.
(b) A request for expedited processing (g) If the agency denies a request for
made under paragraph (a)(1) of this sec- expedited processing, the agency shall
tion must be made by the specific indi- process the request with other non-
vidual who is subject to an imminent expedited requests.
threat, or by a family member, medical (h) If the agency denies a request for
or health care professional, or other expedited processing, the requester
authorized representative of the indi- may appeal the agency’s decision by
vidual, and must demonstrate a reason- writing to the official identified in the
able basis for concluding that failure to denial letter.
obtain the requested records on an ex- [68 FR 25286, May 12, 2003]
pedited basis could reasonably be ex-
pected to pose a specific and identifi- § 20.45 Fees to be charged.
able imminent threat to the life or (a) Categories of requests. Paragraphs
safety of the individual. (a) (1) through (3) of this section state,
(c) A request for expedited processing for each category of request, the type
made under paragraph (a)(2) of this sec- of fees that the Food and Drug Admin-
tion must demonstrate that: istration will generally charge. How-
(1) The requester is primarily en- ever, for each of these categories, the
gaged in disseminating information to fees may be limited, waived, or reduced
the general public and not merely to a for the reasons given in paragraphs (b)
narrow interest group; and (c) of this section and in § 20.46 or
(2) There is an urgent need for the re- for other reasons.
quested information and that it has a (1) Commercial use request. If the re-
particular value that will be lost if not quest is for a commercial use, the Food
obtained and disseminated quickly; and Drug Administration will charge
however, a news media publication or for the costs of search, review, and du-
broadcast deadline alone does not qual- plication.
ify as an urgent need, nor does a re- (2) Educational and scientific institu-
quest for historical information; and tions and news media. If the request is
(3) The request for records specifi- from an educational institution or a
cally concerns identifiable operations noncommercial scientific institution,

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Food and Drug Administration, HHS § 20.45

operated primarily for scholarly or sci- (6) Interest will be charged on unpaid
entific research, or a representative of bills beginning on the 31st day fol-
the news media, and the request is not lowing the day the bill was sent. Provi-
for a commercial use, the Food and sions in 45 CFR part 30, the Depart-
Drug Administration will charge only ment of Health and Human Services
for the duplication of documents. Also, regulations governing claims collec-
the Food and Drug Administration will tion, will be used in assessing interest,
not charge the copying costs for the administrative costs, and penalties,
first 100 pages of duplication. and in taking actions to encourage
(3) Other requests. If the request is not payment.
the kind described in paragraph (a)(1) (c) Fee schedule. The Food and Drug
or (a)(2) of this section, then the Food Administration charges the following
and Drug Administration will charge fees in accordance with the regulations
only for the search and the duplication. of the Department of Health and
Also, the Food and Drug Administra- Human Services at 45 CFR part 5.
tion will not charge for the first 2 (1) Manual searching for or reviewing
hours of search time or for the copying of records. When the search or review is
costs of the first 100 pages of duplica- performed by employees at grade GS–1
tion. through GS–8, an hourly rate based on
(b) General provisions. (1) The Food the salary of a GS–5, step 7, employee;
and Drug Administration may charge when done by a GS–9 through GS–14, an
search fees even if the records found hourly rate based on the salary of a
are exempt from disclosure or if no GS–12, step 4, employee; and when done
records are found. by a GS–15 or above, an hourly rate
based on the salary of a GS–15, step 7,
(2) If, under paragraph (a)(3) of this
employee. In each case, the hourly rate
section, there is no charge for the first
will be computed by taking the current
2 hours of search time, and those 2
hourly rate for the specified grade and
hours are spent on a computer search,
step, adding 16 percent of that rate to
then the 2 free hours are the first 2
cover benefits, and rounding to the
hours of the operator’s own operation.
nearest whole dollar. When a search in-
If the operator spends less than 2 hours volves employees at more than one of
on the search, the total search fees will these levels, the Food and Drug Admin-
be reduced by the average hourly rate istration will charge the rate appro-
for the operator’s time, multiplied by priate for each.
2. (2) Computer searching and printing.
(3) If, under paragraph (a)(2) or (a)(3) The actual cost of operating the com-
of this section, there is no charge for puter plus charges for the time spent
the first 100 pages of duplication, then by the operator, at the rates given in
those 100 pages are the first 100 pages paragraph (c)(1) of this section.
of photocopies of standard size pages, (3) Photocopying standard size pages.
or the first 100 pages of computer print- $0.10 per page. Freedom of Information
out. If this method to calculate the fee Officers may charge lower fees for par-
reduction cannot be used, then the ticular documents where:
total duplication fee will be reduced by (i) The document has already been
the normal charge for photocopying a printed in large numbers;
standard size page, multiplied by 100. (ii) The program office determines
(4) No charge will be made if the that using existing stock to answer
costs of routine collection and proc- this request, and any other anticipated
essing of the fee are likely to equal or Freedom of Information requests, will
exceed the amount of the fee. not interfere with program require-
(5) If it is determined that a re- ments; and
quester (acting either alone or together (iii) The Freedom of Information Of-
with others) is breaking down a single ficer determines that the lower fee is
request into a series of requests in adequate to recover the prorated share
order to avoid (or reduce) the fees of the original printing costs.
charged, all these requests may be ag- (4) Photocopying odd-size documents
gregated for purposes of calculating (such as punchcards or blueprints), or re-
the fees charged. producing other records (such as tapes).

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§ 20.46 21 CFR Ch. I (4–1–11 Edition)

The actual costs of operating the ma- the requester over payment of fees, or
chine, plus the actual cost of the mate- a decision that fee waiver or reduction
rials used, plus charges for the time is appropriate.
spent by the operator, at the rates (3) Billing and payment. Ordinarily,
given in paragraph (c)(1) of this sec- the requester will be required to pay
tion. all fees before the Food and Drug Ad-
(5) Certifying that records are true cop- ministration will furnish the records.
ies. This service is not required by the At its discretion, the Food and Drug
Freedom of Information Act. If the Administration may send the requester
Food and Drug Administration agrees a bill along with or following the
to provide certification, there is a $10 records. For example, the Food and
charge per certification. Drug Administration may do this if the
(6) Sending records by express mail or requester has a history of prompt pay-
other special methods. This service is not ment. The Food and Drug Administra-
required by the Freedom of Informa- tion may also, at its discretion, aggre-
tion Act. If the Food and Drug Admin- gate the charges for certain time peri-
istration agrees to provide this service, ods in order to avoid sending numerous
the requester will be required to di- small bills to frequent requesters, or to
rectly pay, or be directly charged by, businesses or agents representing re-
the courier. The agency will not agree questers. For example, the Food and
to any special delivery method that Drug Administration might send a bill
does not permit the requester to di- to such a requester once a month. Fees
rectly pay or be directly charged for should be paid in accordance with the
the service. instructions furnished by the person
(7) Performing any other special service who responds to the request.
in connection with a request to which the [59 FR 533, Jan. 5, 1994. Redesignated and
Food and Drug Administration has amended at 68 FR 25286, May 12, 2003]
agreed. Actual costs of operating any
machinery, plus actual cost of any ma- § 20.46 Waiver or reduction of fees.
terials used, plus charges for the time (a) Standard. The Assistant Commis-
of the Food and Drug Administration’s sioner for Public Affairs (or delegatee)
employees, at the rates given in para- will waive or reduce the fees that
graph (c)(1) of this section. would otherwise be charged if disclo-
(d) Procedures for assessing and col- sure of the information meets both of
lecting fees—(1) Agreement to pay. The the following tests:
Food and Drug Administration gen- (1) Is in the public interest because it
erally assumes that a requester is will- is likely to contribute significantly to
ing to pay the fees charged for services public understanding of the operations
associated with the request. The re- or activities of the Government; and
quester may specify a limit on the (2) It is not primarily in the commer-
amount to be spent. If it appears that cial interest of the requester. These
the fees will exceed the limit, the Food two tests are explained in paragraphs
and Drug Administration will consult (b) and (c) of this section.
the requester to determine whether to (b) Public interest. Disclosure of infor-
proceed with the search. mation satisfies the first test only if it
(2) Advance payment. If a requester furthers the specific public interest of
has failed to pay previous bills in a being likely to contribute significantly
timely fashion, or if the Food and Drug to public understanding of Government
Administration’s initial review of the operations or activities, regardless of
request indicates that the charges will any other public interest it may fur-
exceed $250, the requester will be re- ther. In analyzing this question, the
quired to pay past due fees and/or the Food and Drug Administration will
estimated fees, or a deposit, before the consider the following factors:
search for the requested records begins. (1) Whether the records to be dis-
In such cases, the requester will be no- closed pertain to the operations or ac-
tified promptly upon receipt of the re- tivities of the Federal Government;
quest, and the administrative time (2) Whether disclosure of the records
limits prescribed in § 20.41 will begin would reveal any meaningful informa-
only after there is an agreement with tion about Government operations or

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Food and Drug Administration, HHS § 20.48

activities that is not already public vancement of the public interest as de-
knowledge; fined in paragraph (b) of this section.
(3) Whether disclosure will advance (d) Deciding between waiver and reduc-
the understanding of the general public tion. If the disclosure of the informa-
as distinguished from a narrow seg- tion requested passes both tests de-
ment of interested persons. Under this scribed in paragraphs (b) and (c) of this
factor, the Food and Drug Administra- section, the Food and Drug Adminis-
tion may consider whether the re- tration will normally waive fees. How-
quester is in a position to contribute to ever, in some cases the Food and Drug
public understanding. For example, the Administration may decide only to re-
Food and Drug Administration may duce the fees. For example, the Food
consider whether the requester has and Drug Administration may do this
such knowledge or expertise as may be when disclosure of some but not all of
necessary to understand the informa- the requested records passes the tests.
tion, and whether the requester’s in- (e) Procedure for requesting a waiver or
tended use of the information would be reduction. A requester must request a
likely to disseminate the information waiver or reduction of fees at the same
to the public. An unsupported claim to time as the request for records. The re-
be doing research for a book or article quester should explain why a waiver or
does not demonstrate that likelihood, reduction is proper under the factors
while such a claim by a representative set forth in paragraphs (a) through (d)
of the news media is better evidence; of this section. Only the Associate
and Commissioner for Public Affairs may
(4) Whether the contribution to pub- make the decision whether to waive or
lic understanding will be a significant reduce the fees. If the Food and Drug
one, i.e., will the public’s under- Administration does not completely
standing of the Government’s oper- grant the request for a waiver or reduc-
ations be substantially greater as a re- tion, the denial letter will designate a
sult of the disclosure. review official. The requester may ap-
(c) Not primarily in the requester’s com- peal the denial to that official. The ap-
mercial interest. If disclosure passes the peal letter should address reasons for
test of furthering the specific public in- the Associate Commissioner’s decision
terest described in paragraph (b) of this that are set forth in the denial letter.
section, the Food and Drug Adminis- [59 FR 534, Jan. 5, 1994. Redesignated and
tration will determine whether disclo- amended at 68 FR 25286, 25287, May 12, 2003]
sure also furthers the requester’s com-
mercial interest and, if so, whether § 20.47 Situations in which confiden-
tiality is uncertain.
this effect outweighs the advancement
of that public interest. In applying this In situations where the confiden-
second test, the Food and Drug Admin- tiality of data or information is uncer-
istration will consider the following tain and there is a request for public
factors: disclosure, the Food and Drug Adminis-
(1) Whether disclosure would further tration will consult with the person
a commercial interest of the requester, who has submitted or divulged the data
or of someone on whose behalf the re- or information or who would be af-
quester is acting. Commercial interests fected by disclosure before determining
include interests relating to business, whether or not such data or informa-
trade, and profit. Both profit and non- tion is available for public disclosure.
profit-making corporations have com- [42 FR 15616, Mar. 22, 1977. Redesignated at 68
mercial interests, as well as individ- FR 25286, May 12, 2003]
uals, unions, and other associations.
The interest of a representative of the § 20.48 Judicial review of proposed
news media in using the information disclosure.
for news dissemination purposes will Where the Food and Drug Adminis-
not be considered a commercial inter- tration consults with a person who will
est. be affected by a proposed disclosure of
(2) If disclosure would further a com- data or information contained in Food
mercial interest of the requester, and Drug Administration records pur-
whether that effect outweighs the ad- suant to § 20.47, and rejects the person’s

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§ 20.49 21 CFR Ch. I (4–1–11 Edition)

request that part or all of the records § 20.50 Nonspecific and overly burden-
not be made available for public disclo- some requests.
sure, the decision constitutes final The Food and Drug Administration
agency action that is subject to judi- will make every reasonable effort to
cial review pursuant to 5 U.S.C. chap-
comply fully with all requests for dis-
ter 7. The person affected will be per-
closure of nonexempt records. Nonspe-
mitted 5 days after receipt of notifica-
cific requests or requests for a large
tion of such decision within which to
number of documents that require the
institute suit in a United States Dis-
deployment of a substantial amount of
trict Court to enjoin release of the
agency man-hours to search for and
records involved. If suit is brought, the
compile will be processed taking into
Food and Drug Administration will not
account the staff-hours required, the
disclose the records involved until the
tasks from which these resources must
matter and all related appeals have
be diverted, the impact that this diver-
been concluded.
sion will have upon the agency’s con-
[42 FR 15616, Mar. 22, 1977. Redesignated and sumer protection activities, and the
amended at 68 FR 25286, 25287, May 12, 2003] public policy reasons justifying the re-
quests. A decision on the processing of
§ 20.49 Denial of a request for records. such a request for information shall be
(a) A denial of a request for records, made after balancing the public benefit
in whole or in part, shall be signed by to be gained by the disclosure against
the Assistant Commissioner for Public the public loss that will result from di-
Affairs (or delegatee). verting agency personnel from their
(b) The name and title or position of other responsibilities. In any situation
each person who participated in the de- in which it is determined that a re-
nial of a request for records shall be set quest for voluminous records would un-
forth in the letter denying the request. duly burden and interfere with the op-
This requirement may be met by at- erations of the Food and Drug Admin-
taching a list of such individuals to the istration, the person making the re-
letter. quest will be asked to be more specific
(c) A letter denying a request for and to narrow the request, and to agree
records, in whole or in part, shall state on an orderly procedure for the produc-
the reasons for the denial and shall tion of the requested records, in order
state that an appeal may be made to to satisfy the request without dis-
the Deputy Assistant Secretary for proportionate adverse effects on agen-
Public Affairs (Media), Department of cy operations.
Health and Human Services. The agen-
[42 FR 15616, Mar. 22, 1977. Redesignated at 68
cy will also make a reasonable effort to
FR 25286, May 12, 2003]
include in the letter an estimate of the
volume of the records denied, unless § 20.51 Referral to primary source of
providing such an estimate would harm records.
an interest protected by an exemption
under the Freedom of Information Act. Upon receipt of a request for a record
This estimate will ordinarily be pro- or document which is contained in
vided in terms of the approximate Food and Drug Administration files
number of pages or some other reason- but which is available elsewhere at a
able measure. This estimate will not be lower cost, the person requesting the
provided if the volume of records de- record or document shall be referred to
nied is otherwise indicated through de- the primary source of the record or
letions on records disclosed in part. document.
(d) Minor deletions of nondisclosable [42 FR 15616, Mar. 22, 1977. Redesignated at 68
data and information from disclosable FR 25286, May 12, 2003]
records shall not be deemed to be a de-
nial of a request for records. § 20.52 Availability of records at Na-
tional Technical Information Serv-
[42 FR 15616, Mar. 22, 1977, as amended at 46 ice.
FR 8457, Jan. 27, 1981; 55 FR 1405, Jan. 16,
1990. Redesignated and amended at 68 FR The Food and Drug Administration is
25286, 25287, May 12, 2003] furnishing a number of records to the

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Food and Drug Administration, HHS § 20.60

National Technical Information Serv- § 20.55 Indexing trade secrets and con-
ice (NTIS), 5285 Port Royal Rd., Spring- fidential commercial or financial in-
field, VA 22162, which reproduces and formation.
distributes such information to the Whenever the Food and Drug Admin-
public at cost. A single copy of each istration denies a request for a record
such record shall be available for pub- or portion thereof on the grounds that
lic review at the Food and Drug Ad- the record or portion thereof is exempt
ministration. All persons requesting from public disclosure as trade secret
copies of such records shall be an- or confidential commercial or financial
swered by referring the person request- data and information under § 20.61, and
ing the records to NTIS. the person requesting the record subse-
quently contests the denial in the
[42 FR 15616, Mar. 22, 1977, as amended at 54 courts, the Food and Drug Administra-
FR 9038, Mar. 3, 1989. Redesignated at 68 FR tion will so inform the person affected,
25286, May 12, 2003]
i.e., the person who submitted the
record, and will require that such per-
§ 20.53 Use of private contractor for
copying. son intervene to defend the exempt sta-
tus of the record. If a court requires
The Food and Drug Administration the Food and Drug Administration to
may furnish requested records to a pri- itemize and index such records, the
vate contractor for copying after dele- Food and Drug Administration will so
tion of all nondisclosable data and in- inform the person affected and will re-
formation. Under these circumstances, quire that such person undertake the
the Food and Drug Administration will itemization and indexing of the
charge the person requesting the records. If the affected person fails to
records for all of the fees involved pur- intervene to defend the exempt status
suant to § 20.45. of the records and to itemize and index
the disputed records, the Food and
[42 FR 15616, Mar. 22, 1977. Redesignated and Drug Administration will take this
amended at 68 FR 25286, 25287, May 12, 2003] failure into consideration in deciding
whether that person has waived such
§ 20.54 Request for review without
copying. exemption so as to require the Food
and Drug Administration to promptly
(a) A person requesting disclosure of make the records available for public
records shall be permitted an oppor- disclosure.
tunity to review them without the ne-
[42 FR 15616, Mar. 22, 1977, as amended at 59
cessity for copying them where the FR 535, Jan. 5, 1994. Redesignated at 68 FR
records involved contain only 25286, May 12, 2003]
disclosable data and information.
Under these circumstances, the Food Subpart D—Exemptions
and Drug Administration will charge
only for the costs of searching for the § 20.60 Applicability of exemptions.
records.
(a) The exemptions established in
(b) Where a request is made for re- this subpart shall apply to all Food and
view of records without copying, and Drug Administration records, except as
the records involved contain both provided in subpart E of this part. Ac-
disclosable and nondisclosable informa- cordingly, a record that is ordinarily
tion, the records containing available for public disclosure in ac-
nondisclosable information shall first cordance with the provisions in subpart
be copied with the nondisclosable in- F of this part or of another regulation
formation blocked out and the Food cross-referenced in § 20.100(c) is not
and Drug Administration will charge available for such disclosure to the ex-
for the costs of searching and copying. tent that it falls within an exemption
contained in this subpart, except as
[42 FR 15616, Mar. 22, 1977. Redesignated at 68
provided by the limitations on exemp-
FR 25286, May 12, 2003]
tions specified in subpart E of this
part. For example, correspondence that
is ordinarily disclosable under § 20.103

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§ 20.61 21 CFR Ch. I (4–1–11 Edition)

is not disclosable to the extent that it tion. These procedures also apply to
contains trade secrets exempt from dis- records that were submitted to the
closure under § 20.61 and is not subject Food and Drug Administration when
to discretionary release under § 20.82. the agency has substantial reason to
(b) Where application of one or more believe that information in the records
exemptions results in a record being could reasonably be considered exempt
disclosable in part and nondisclosable under exemption 4 of the Freedom of
in part, the rule established in § 20.22 Information Act. Certain exceptions to
shall apply. these procedures are set forth in para-
graph (f) of this section.
§ 20.61 Trade secrets and commercial (1) When the Food and Drug Adminis-
or financial information which is tration receives a request for such
privileged or confidential. records and determines that disclosure
(a) A trade secret may consist of any may be required, the Food and Drug
commercially valuable plan, formula, Administration will make reasonable
process, or device that is used for the efforts to notify the submitter about
making, preparing, compounding, or these facts. The notice will include a
processing of trade commodities and copy of the request, and it will inform
that can be said to be the end product the submitter about the procedures and
of either innovation or substantial ef- time limits for submission and consid-
fort. There must be a direct relation- eration of objections to disclosure. If
ship between the trade secret and the the Food and Drug Administration
productive process. must notify a large number of submit-
(b) Commercial or financial informa- ters, notification may be done by post-
tion that is privileged or confidential ing or publishing a notice in a place
means valuable data or information where the submitters are reasonably
which is used in one’s business and is of likely to become aware of it.
a type customarily held in strict con- (2) The submitter has 5 working days
fidence or regarded as privileged and from receipt of the notice to object to
not disclosed to any member of the disclosure of any part of the records
public by the person to whom it be- and to state all bases for its objections.
longs. (3) The Food and Drug Administra-
(c) Data and information submitted tion will give consideration to all bases
or divulged to the Food and Drug Ad- that have been stated in a timely man-
ministration which fall within the defi- ner by the submitter. If the Food and
nitions of a trade secret or confidential Drug Administration decides to dis-
commercial or financial information close the records, the Food and Drug
are not available for public disclosure. Administration will notify the sub-
(d) A person who submits records to mitter in writing. This notice will
the Government may designate part or briefly explain why the agency did not
all of the information in such records sustain the submitter’s objections. The
as exempt from disclosure under ex- Food and Drug Administration will in-
emption 4 of the Freedom of Informa- clude with the notice a copy of the
tion Act. The person may make this records about which the submitter ob-
designation either at the time the jected, as the agency proposes to dis-
records are submitted to the Govern- close them. The notice will state that
ment or within a reasonable time the Food and Drug Administration in-
thereafter. The designation must be in tends to disclose the records 5 working
writing. Where a legend is required by days after the submitter receives the
a request for proposals or request for notice unless a U.S. District Court or-
quotations, pursuant to 48 CFR 352.215– ders the agency not to release them.
12, then that legend is necessary for (4) If a requester files suit under the
this purpose. Any such designation will Freedom of Information Act to obtain
expire 10 years after the records were records covered by this paragraph, the
submitted to the Government. Food and Drug Administration will
(e) The procedures in this paragraph promptly notify the submitter.
apply to records on which the sub- (5) Whenever the Food and Drug Ad-
mitter has designated information as ministration sends a notice to a sub-
provided in paragraph (d) of this sec- mitter under paragraph (e)(1) of this

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Food and Drug Administration, HHS § 20.63

section, the Food and Drug Adminis- ment which are in written form or
tration will notify the requester that which are subsequently reduced to
the Food and Drug Administration is writing may be withheld from public
giving the submitter a notice and an disclosure except that factual informa-
opportunity to object. Whenever the tion which is reasonably segregable in
Food and Drug Administration sends a accordance with the rule established in
notice to a submitter under paragraph § 20.22 is available for public disclosure.
(e)(3) of this section, the Food and
Drug Administration will notify the re- § 20.63 Personnel, medical, and similar
quester of this fact. files, disclosure of which con-
(f) The notice requirements in para- stitutes a clearly unwarranted inva-
graph (e) of this section do not apply in sion of personal privacy.
the following situations: (a) The names or other information
(1) The Food and Drug Administra- which would identify patients or re-
tion decided not to disclose the search subjects in any medical or simi-
records; lar report, test, study, or other re-
(2) The information has previously search project shall be deleted before
been published or made generally the record is made available for public
available; disclosure.
(3) Disclosure is required by a regula- (b) The names and other information
tion issued after notice and oppor- which would identify patients or re-
tunity for public comment, that speci- search subjects should be deleted from
fies narrow categories of records that any record before it is submitted to the
are to be disclosed under the Freedom Food and Drug Administration. If the
of Information Act, but in this case a Food and Drug Administration subse-
submitter may still designate records quently needs the names of such indi-
as described in paragraph (d) of this viduals, a separate request will be
section, and in exceptional cases, the made.
Food and Drug Administration may, at (c) Requests for deletion of business
its discretion, follow the notice proce- or product names prior to disclosure of
dures in paragraph (e) of this section; any record to the public shall not be
(4) The information requested has not granted on the ground of privacy, but
been designated by the submitter as ex- such deletion may be justified under
empt from disclosure when the sub- another exemption established in this
mitter had an opportunity to do so at subpart, e.g., the exemption for trade
the time of submission of the informa- secrets and confidential commercial or
tion or within a reasonable time there- financial information under § 20.61.
after, unless the Food and Drug Admin- (d) Names of individuals conducting
istration has substantial reason to be- investigations, studies, or tests on
lieve that disclosure of the information products or ingredients shall not be de-
would result in competitive harm; or leted prior to disclosure of any record
(5) The designation appears to be ob- to the public unless extraordinary cir-
viously frivolous, but in this case the cumstances are shown.
Food and Drug Administration will (e) A request for all records relating
still give the submitter the written no- to a specific individual will be denied
tice required by paragraph (e)(3) of this as a clearly unwarranted invasion of
section (although this notice need not personal privacy unless accompanied
explain our decision or include a copy by the written consent of the indi-
of the records), and the Food and Drug vidual named.
Administration will notify the re- (f) The names and any information
quester as described in paragraph (e)(5) that would identify the voluntary re-
of this section. porter or any other person associated
[42 FR 15616, Mar. 22, 1977, as amended at 59 with an adverse event involving a
FR 535, Jan. 5, 1994] human drug, biologic, or medical de-
vice product shall not be disclosed by
§ 20.62 Inter- or intra-agency memo- the Food and Drug Administration or
randa or letters. by a manufacturer in possession of
All communications within the Exec- such reports in response to a request,
utive Branch of the Federal govern- demand, or order. Information that

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§ 20.64 21 CFR Ch. I (4–1–11 Edition)

would identify the voluntary reporter (2) Would deprive a person to a right
or persons identified in the report in- to a fair trial or an impartial adjudica-
cludes, but is not limited to, the name, tion;
address, institution, or any other infor- (3) Could reasonably be expected to
mation that would lead to the identi- constitute an unwarranted invasion of
ties of the reporter or persons identi- personal privacy;
fied in a report. This provision does not (4) Could reasonably be expected to
affect disclosure of the identities of re- disclose the identity of a confidential
porters required by a Federal statute source, including a State, local, or for-
or regulation to make adverse event re- eign agency or authority or any pri-
ports. Disclosure of the identities of vate institution which furnished infor-
such reporters is governed by the appli- mation on a confidential basis; and in-
cable Federal statutes and regulations. formation furnished by a confidential
(1) Exceptions. (i) Identities may be source in the case of a record compiled
disclosed if both the voluntary reporter by the Food and Drug Administration
and the person identified in an adverse or any other criminal law enforcement
event report or that person’s legal rep- authority in the course of a criminal
resentative consent in writing to dis- investigation or by an agency con-
closure, but neither FDA nor any man- ducting a lawful national security in-
ufacturer in possession of such reports telligence investigation;
shall be required to seek consent for (5) Would disclose techniques and
disclosure from the voluntary reporter procedures for law enforcement inves-
or the person identified in the adverse tigations or prosecutions or would dis-
event report or that person’s legal rep- close guidelines for law enforcement
resentative; or investigations or prosecutions, if such
(ii) Identities of the voluntary re- disclosure could reasonably be ex-
porter and the person who experienced pected to risk circumvention of the
the reported adverse event may be dis- law; or
closed pursuant to a court order in the (6) Could reasonably be expected to
course of medical malpractice litiga- endanger the life or physical safety of
tion involving both parties; or (iii) The any individual.
report, excluding the identities of any
(b) Records include all records relat-
other individuals, shall be disclosed to
ing to regulatory enforcement action,
the person who is the subject of the re-
including both administrative and
port upon request.
court action, which have not been dis-
(2) Preemption. No State or local gov- closed to any member of the public, in-
erning entity shall establish or con- cluding any person who is the subject
tinue in effect any law, rule, regula- of the investigation.
tion, or other requirement that per-
(c) Any record which is disclosed to
mits or requires disclosure of the iden-
any person, including any person who
tities of the voluntary reporter or
is the subject of a Food and Drug Ad-
other person identified in an adverse
ministration investigation, and any
event report except as provided in this
data or information received from any
section.
person who is the subject of a Food and
[42 FR 15616, Mar. 22, 1977, as amended at 60 Drug Administration investigation re-
FR 16968, Apr. 3, 1995] lating to such investigation, is avail-
able for public disclosure at that time
§ 20.64 Records or information com- in accordance with the rule established
piled for law enforcement purposes. in § 20.21, except that:
(a) Records or information compiled (1) Disclosure of such records shall be
for law enforcement purposes may be subject to the other exemptions estab-
withheld from public disclosure pursu- lished in this subpart and to the limi-
ant to the provisions of this section to tations on exemptions established in
the extent that disclosure of such subpart E of this part.
records or information: (2) The record of a section 305 hearing
(1) Could reasonably be expected to shall be available for public disclosure
interfere with enforcement pro- only in accordance with the provisions
ceedings; of § 7.87 of this chapter.

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Food and Drug Administration, HHS § 20.67

(d) Records for law enforcement pur- compelling public interest in the dis-
poses shall be subject to the following closure of such names.
rules: (e) Names and other information that
(1) No such record is available for would identify a Food and Drug Admin-
public disclosure prior to the consider- istration employee shall be deleted
ation of regulatory enforcement action from records prior to public disclosure
based upon that record’s being closed, only pursuant to § 20.32.
except as provided in § 20.82. The Com-
missioner will exercise his discretion [42 FR 15616, Mar. 22, 1977, as amended at 59
FR 536, Jan. 5, 1994]
to disclose records relating to possible
criminal prosecution pursuant to § 20.82
§ 20.65 National defense and foreign
prior to consideration of criminal pros- policy.
ecution being closed only very rarely
and only under circumstances that (a) Records or information may be
demonstrate a compelling public inter- withheld from public disclosure if they
est. are:
(2) After the consideration of regu- (1) Specifically authorized under cri-
latory enforcement action is closed, teria established by an Executive order
such records shall be made available to be kept secret in the interest of na-
for public disclosure except to the ex- tional defense or foreign policy; and
tent that other exemptions from dis- (2) In fact properly classified under
closure in this subpart are applicable. such Executive order.
No statements of witnesses obtained (b) [Reserved]
through promises of confidentiality are
available for public disclosure. [70 FR 41958, July 21, 2005]
(3) The consideration of regulatory § 20.66 Internal personnel rules and
enforcement action based upon a par- practices.
ticular record shall be deemed to be
closed within the meaning of this sec- Records or information may be with-
tion: held from public disclosure if they are
(i) If it relates to administrative ac- related solely to the internal personnel
tion, when a final decision has been rules and practices of the Food and
made not to take such action or such Drug Administration (FDA). Under this
action has been taken and the matter exemption, FDA may withhold records
has been concluded. or information about routine internal
(ii) If it relates to court action, when agency practices and procedures. Under
a final decision has been made not to this exemption, the agency may also
recommend such action to a United withhold internal records whose re-
States attorney based upon that lease would help some persons cir-
record, or a recommendation has been cumvent the law.
finally refused by a United States at-
[70 FR 41958, July 21, 2005]
torney, or court action has been insti-
tuted and the matter and all related § 20.67 Records exempted by other
appeals have been concluded, or the statutes.
statute of limitations runs.
(iii) If it relates to both administra- Records or information may be with-
tive and court action, when the events held from public disclosure if a statute
described in both paragraph (d)(3) (i) specifically allows the Food and Drug
and (ii) of this section have occurred. Administration (FDA) to withhold
(4) Prior to disclosure of any record them. FDA may use another statute to
specifically reflecting consideration of justify withholding records and infor-
possible criminal prosecution of any mation only if it absolutely prohibits
individual, all names and other infor- disclosure, sets forth criteria to guide
mation that would identify an indi- our decision on releasing material, or
vidual who was considered for criminal identifies particular types of matters
prosecution but who was not pros- to be withheld.
ecuted shall be deleted unless the Com-
[70 FR 41958, July 21, 2005]
missioner concludes that there is a

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§ 20.80 21 CFR Ch. I (4–1–11 Edition)

Subpart E—Limitations on himself that is retrieved by the indi-


Exemptions vidual’s name or other personal identi-
fier and is contained in a Privacy Act
§ 20.80 Applicability of limitations on Record System shall be subject to the
exemptions. special requirements of part 21 of this
(a) The limitations on exemptions es- chapter (the privacy regulations) and
tablished in this subpart shall apply to shall not be subject to the exemptions
all Food and Drug Administration in subpart D of this part except that
records, except as specifically provided where the system is exempt and the re-
herein. Accordingly, a record that is quested record is not available under
ordinarily exempt from public disclo- § 21.61 of this chapter, the provisions of
sure in accordance with the provisions this part shall apply.
in subpart D of this part is available (2) The availability of a record about
for such disclosure to the extent that it an individual to persons other than the
falls within a limitation on the exemp- individual who is the subject of the
tion contained in this subpart. For ex- record shall be subject to the special
ample, an investigatory record that is
requirements of part 21, subpart G, of
ordinarily exempt from disclosure
this chapter (restrictions on disclosure
under § 20.64 is disclosable to Congress
in the privacy regulations), and shall
in accordance with the provisions of
§ 20.87. not be subject to the limitations on ex-
(b) Disclosure of a record to any emptions in this subpart except as pro-
member of the public pursuant to the vided in part 21, subpart G, of this
provisions in § 20.81, data and informa- chapter.
tion previously disclosed to the public,
in § 20.82, discretionary disclosure by § 20.81 Data and information pre-
viously disclosed to the public.
the Commissioner, and in § 20.83, disclo-
sure pursuant to a court order, shall in- (a) Any Food and Drug Administra-
volve the rule established in § 20.21 that tion record that is otherwise exempt
the record shall be made available for from public disclosure pursuant to sub-
disclosure to all members of the public part D of this part is available for pub-
who request it. Disclosure of a record lic disclosure to the extent that it con-
only to the limited categories of per- tains data or information that have
sons and under the conditions specified previously been disclosed in a lawful
in § 20.84, special government employ- manner to any member of the public,
ees, in § 20.85, other Federal govern- other than an employee or consultant
ment departments and agencies, in or pursuant to other commerical ar-
§ 20.86, in camera disclosure in adminis- rangements with appropriate safe-
trative or court proceedings, in guards for secrecy.
§ 20.87(b), Congress, in § 20.88, State and (1) For purposes of this section, an
local government officials, in § 20.89, individual shall be deemed to be a con-
foreign government officials, and in
sultant only if disclosure of the infor-
§ 20.90, contractors, which does not re-
mation was necessary in order to per-
sult in disclosure of the record to any
form that specific consulting service
member of the public in an authorized
and the purpose of the disclosure was
manner, shall not invoke the rule es-
solely to obtain that service. The num-
tablished in § 20.21.
(c) Disclosure to government employ- ber of consultants who have received
ees and special government employees such information shall have been lim-
of records exempt from public disclo- ited to the number reasonably needed
sure shall subject those persons to the to perform that particular consulting
same restrictions with respect to the service.
disclosure of such records as any Food (2) For purposes of this section, other
and Drug Administration employee. commercial arrangements shall include
(d) In the case of a record in a Pri- licenses, contracts, and similar legal
vacy Act Record System, as defined in relationships between business associ-
§ 21.3(c) of this chapter: ates.
(1) The availability to an individual, (3) For purposes of this section, data
as defined in § 21.3(a), of a record about and information disclosed to clinical

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Food and Drug Administration, HHS § 20.84

investigators or members of institu- shall be disclosed to any person who re-


tional review committees, whether re- quests it pursuant to § 20.21, but shall
quired by regulations of the Food and not set a precedent for discretionary
Drug Administration, or made volun- disclosure of any similar or related
tarily, if accompanied by appropriate record and shall not obligate the Com-
safeguards to assure secrecy and other- missioner to exercise his discretion to
wise in accordance with this section, disclose any other record that is ex-
are not deemed to have been previously empt from disclosure.
disclosed to any member of the public [42 FR 15616, Mar. 22, 1977, as amended at 70
within the meaning of paragraph (a) of FR 41958, July 21, 2005]
this section.
(b) Any statement relating to prior § 20.83 Disclosure required by court
public disclosure is subject to the False order.
Reports to the Government Act, 18 (a) Records of the Food and Drug Ad-
U.S.C. 1001. ministration which the Commissioner
[42 FR 15616, Mar. 22, 1977, as amended at 54 has determined are not available for
FR 9038, Mar. 3, 1989; 59 FR 536, Jan. 5, 1994; public disclosure, in the form of a regu-
68 FR 25287, May 12, 2003] lation published or cross-referenced in
this part, shall nevertheless be made
§ 20.82 Discretionary disclosure by the available for public disclosure in com-
Commissioner. pliance with a final court order requir-
(a) Except as provided in paragraph ing such disclosure.
(b) of this section, the Commissioner (b) Where the Food and Drug Admin-
may, in his discretion, disclose part or istration record ordered disclosed
all of any Food and Drug Administra- under paragraph (a) of this section is a
tion record that is otherwise exempt record about an individual that is not
from disclosure pursuant to subpart D available for public disclosure under
of this part. The Commissioner shall § 20.63, the Food and Drug Administra-
exercise his discretion to disclose such tion shall attempt to notify the indi-
records whenever he determines that vidual who is the subject of the record
such disclosure is in the public inter- of the disclosure, by sending a notice
est, will promote the objectives of the to the individual’s last known address.
act and the agency, and is consistent (c) Paragraph (b) of this section shall
with the rights of individuals to pri- not apply where the name or other per-
vacy, the property rights of persons in sonal identifying information is de-
trade secrets, and the need for the leted prior to disclosure.
agency to promote frank internal pol-
[42 FR 15616, Mar. 22, 1977, as amended at 68
icy deliberations and to pursue its reg- FR 25287, May 12, 2003]
ulatory activities without disruption.
(b) The Commissioner shall not make § 20.84 Disclosure to consultants, advi-
available for public disclosure any sory committees, State and local
record that is: government officials commissioned
(1) Exempt from public disclosure pursuant to 21 U.S.C. 372(a), and
pursuant to § 20.61. other special government employ-
(2) Exempt from public disclosure ees.
pursuant to § 20.63. Data and information otherwise ex-
(3) Prohibited from public disclosure empt from public disclosure may be
under statute. disclosed to Food and Drug Adminis-
(4) Contained in a Privacy Act tration consultants, advisory commit-
Record System where disclosure would tees, State and local government offi-
constitute a clearly unwarranted inva- cials commissioned pursuant to 21
sion of personal privacy or is otherwise U.S.C. 372(a), and other special govern-
in violation of 5 U.S.C. 552a(b), as ap- ment employees for use only in their
plied in part 21, subpart G, of this chap- work with the Food and Drug Adminis-
ter (restrictions on disclosure in the tration. Such persons are thereafter
privacy regulations). subject to the same restrictions with
(c) Discretionary disclosure of a respect to the disclosure of such data
record pursuant to this section shall and information as any other Food and
invoke the requirement that the record Drug Administration employee.

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§ 20.85 21 CFR Ch. I (4–1–11 Edition)

§ 20.85 Disclosure to other Federal that apply to any other member of the
government departments and agen- public.
cies. [42 FR 15616, Mar. 22, 1977, as amended at 59
Any Food and Drug Administration FR 536, Jan. 5, 1994]
record otherwise exempt from public
§ 20.88 Communications with State
disclosure may be disclosed to other and local government officials.
Federal government departments and
agencies, except that trade secrets and (a) A State or local government offi-
confidential commercial or financial cial commissioned by the Food and
Drug Administration pursuant to 21
information prohibited from disclosure
U.S.C. 372(a) shall have the same status
by 21 U.S.C. 331(j), 21 U.S.C. 360(j)(c), 42
with respect to disclosure of Food and
U.S.C. 263g(d) and 42 U.S.C. 263i(e) may Drug Administration records as any
be released only as provided by those special government employee.
sections. Any disclosure under this sec- (b) Communications with State and
tion shall be pursuant to a written local government officials with respect
agreement that the record shall not be to law enforcement activities under-
further disclosed by the other depart- taken pursuant to a contract between
ment or agency except with the writ- the Food and Drug Administration and
ten permission of the Food and Drug such officials shall be subject to the
Administration. rules for public disclosure established
in § 20.64.
[47 FR 10804, Mar. 12, 1982, as amended at 59
(c) Communications with State and
FR 536, Jan. 5, 1994]
local government officials who are not
§ 20.86 Disclosure in administrative or commissioned pursuant to 21 U.S.C.
court proceedings. 372(a) or under a contract to perform
law enforcement activities shall have
Data and information otherwise ex- the same status as communications
empt from public disclosure may be re- with any member of the public, except
vealed in Food and Drug Administra- that:
tion administrative proceedings pursu- (1) Investigatory records compiled for
ant to parts 10, 12, 13, 14, 15, 17, and 19 law enforcement purposes by State and
of this chapter or court proceedings, local government officials who perform
where data or information are rel- counterpart functions to the Food and
evant. The Food and Drug Administra- Drug Administration at the State and
tion will take appropriate measures, or local level, and trade secrets and con-
request that appropriate measures be fidential commercial or financial infor-
taken, to reduce disclosure to the min- mation obtained by such officials,
imum necessary under the cir- which are voluntarily disclosed to the
cumstances. Food and Drug Administration as part
of cooperative law enforcement and
[42 FR 15616, Mar. 22, 1977, as amended at 60 regulatory efforts, shall be exempt
FR 38633, July 27, 1995] from public disclosure to the same ex-
tent to which the records would be so
§ 20.87 Disclosure to Congress. exempt pursuant to §§ 20.61 and 20.64, as
(a) All records of the Food and Drug if they had been prepared by or sub-
Administration shall be disclosed to mitted directly to Food and Drug Ad-
Congress upon an authorized request. ministration employees, except that
(b) An authorized request for Food investigatory records shall be exempt
and Drug Administration records by from disclosure for a longer period of
Congress shall be made by the chair- time if the State or local government
man of a committee or subcommittee officials so require as a condition of
of Congress acting pursuant to com- their furnishing the information to the
Food and Drug Administration.
mittee business.
(2) Disclosure of investigatory
(c) An individual member of Congress records compiled for law enforcement
who requests a record for his own use purposes by the Food and Drug Admin-
or on behalf of any constituent shall be istration to State and local govern-
subject to the same rules in this part ment officials who perform counterpart

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Food and Drug Administration, HHS § 20.88

functions to the Food and Drug Drug Administration requires the vis-
Administratrion at the State and local iting State government scientist to
level as part of cooperative law en- sign a written commitment to protect
forcement efforts does not invoke the the confidentiality of the information,
rule established in § 20.21 that such and the visiting State government sci-
records shall be made available for dis- entist provides a written assurance
closure to all members of the public. that he or she has no financial interest
(d)(1) The Commissioner of Food and in the regulated industry of the type
Drugs, or any other officer or employee that would preclude participation in
of the Food and Drug Administration the review of the matter if the indi-
whom the Commissioner may designate vidual were subject to the conflict of
to act on his or her behalf for the pur- interest rules applicable to the Food
pose, may authorize the disclosure of and Drug Administration advisory
confidential commercial information committee members under § 14.80(b)(1)
submitted to the Food and Drug Ad- of this chapter. Subject to all the fore-
ministration, or incorporated into going conditions, a visiting State gov-
agency-prepared records, to State gov- ernment scientist may have access to
ernment officials as part of cooperative trade secret information, entitled to
law enforcement or regulatory efforts, protection under section 301(j) of the
provided that: act, in those cases where such disclo-
(i) The State government agency has sures would be a necessary part of the
provided both a written statement es- joint review or training.
tablishing its authority to protect con- (2) Except as provided under para-
fidential commercial information from graph (d)(1)(ii)(C) of this section, this
public disclosure and a written com- provision does not authorize the disclo-
mitment not to disclose any such infor- sure to State government officials of
mation provided without the written trade secret information concerning
permission of the sponsor or written manufacturing methods and processes
confirmation by the Food and Drug Ad- prohibited from disclosure by section
ministration that the information no 301(j) of the act, unless pursuant to an
longer has confidential status; and express written authorization provided
(ii) The Commissioner of Food and by the submitter of the information.
Drugs or the Commissioner’s designee (3) Any disclosure under this section
makes one or more of the following de- of information submitted to the Food
terminations: and Drug Administration or incor-
(A) The sponsor of the product appli- porated into agency-prepared records
cation has provided written authoriza- does not invoke the rule established in
tion for the disclosure; § 20.21 that such records shall be made
(B) Disclosure would be in the inter- available to all members of the public.
est of public health by reason of the (e)(1) The Senior Associate Commis-
State government’s possessing infor- sioner for Policy, Planning, and Legis-
mation concerning the safety, effec- lation, or the Deputy Commissioner for
tiveness, or quality of a product or in- International and Constituent Rela-
formation concerning an investigation, tions, or any other officer or employee
or by reason of the State government of the Food and Drug Administration
being able to exercise its regulatory whom the Senior Associate Commis-
authority more expeditiously than the sioner for Policy, Planning, and Legis-
Food and Drug Administration; or lation or the Deputy Commissioner for
(C) The disclosure is to a State gov- International and Constituent Rela-
ernment scientist visiting the Food tions may designate to act on their be-
and Drug Administration on the agen- half for the purpose, may authorize the
cy’s premises as part of a joint review disclosure to, or receipt from, an offi-
or long-term cooperative training ef- cial of a State government agency of
fort authorized under section 708 of the nonpublic, predecisional documents
Federal Food, Drug, and Cosmetic Act concerning the Food and Drug Admin-
(the act), the review is in the interest istration’s or the other government
of public health, the Food and Drug agency’s regulations or other regu-
Administration retains physical con- latory requirements, or other non-
trol over the information, the Food and public information relevant to either

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§ 20.89 21 CFR Ch. I (4–1–11 Edition)

agency’s activities, as part of efforts to obtained by such officials, which are


improve Federal-State uniformity, co- voluntarily disclosed to the Food and
operative regulatory activities, or im- Drug Administration as part of cooper-
plementation of Federal-State agree- ative law enforcement and regulatory
ments, provided that: efforts, shall be exempt from public
(i) The State government agency has disclosure to the same extent to which
the authority to protect such non- the records would be so exempt pursu-
public documents from public disclo- ant to §§ 20.61 and 20.64, as if they had
sure and will not disclose any such doc- been prepared by or submitted directly
uments provided without the written to Food and Drug Administration em-
confirmation by the Food and Drug Ad- ployees, except that investigatory
ministration that the documents no records shall be exempt from disclosure
longer have nonpublic status; and for a longer period of time if the for-
(ii) The Senior Associate Commis- eign government officials so require as
sioner for Policy, Planning, and Legis- a condition of their furnishing the in-
lation or the Deputy Commissioner for formation to the Food and Drug Ad-
International and Constituent Rela- ministration.
tions or their designee makes the de- (b) Disclosure of investigatory
termination that the exchange is rea- records compiled for law enforcement
sonably necessary to improve Federal- purposes by the Food and Drug Admin-
State uniformity, cooperative regu- istration to foreign government offi-
latory activities, or implementation of cials who perform counterpart func-
Federal-State agreements. tions to the Food and Drug Adminis-
(2) Any exchange under this section tration in a foreign country as part of
of nonpublic documents does not in- cooperative law enforcement efforts
voke the rule established at § 20.21 that does not invoke the rule established in
such records shall be made available to § 20.21 that such records shall be made
all members of the public. available for disclosure to all members
(3) For purposes of this paragraph, of the public.
the term official of a State government (c)(1) The Commissioner of Food and
agency includes, but is not limited to, Drugs, or any other officer or employee
an agent contracted by the State gov- of the Food and Drug Administration
ernment, and an employee of an orga- whom the Commissioner may designate
nization of State officials having re- to act on his or her behalf for the pur-
sponsibility to facilitate harmoni- pose, may authorize the disclosure of
zation of State standards and require- confidential commercial information
ments in FDA’s areas of responsibility. submitted to the Food and Drug Ad-
For such officials, the statement and ministration, or incorporated into
commitment required by paragraph agency-prepared records, to foreign
(e)(1)(i) of this section shall be provided government officials who perform
by both the organization and the indi- counterpart functions to the Food and
vidual. Drug Administration as part of cooper-
[42 FR 15616, Mar. 22, 1977, as amended at 60 ative law enforcement or regulatory ef-
FR 63381, Dec. 8, 1995; 65 FR 11887, Mar. 7, forts, provided that:
2000] (i) The foreign government agency
has provided both a written statement
§ 20.89 Communications with foreign establishing its authority to protect
government officials. confidential commercial information
Communications with foreign gov- from public disclosure and a written
ernment officials shall have the same commitment not to disclose any such
status as communications with any information provided without the writ-
member of the public, except that: ten permission of the sponsor or writ-
(a) Investigatory records compiled ten confirmation by the Food and Drug
for law enforcement purposes by for- Administration that the information
eign government officials who perform no longer has confidential status; and
counterpart functions to the Food and (ii) The Commissioner of Food and
Drug Administration in a foreign coun- Drugs or the Commissioner’s designee
try, and trade secrets and confidential makes one or more of the following de-
commercial or financial information terminations:

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Food and Drug Administration, HHS § 20.89

(A) The sponsor of the product appli- (d)(1) The Senior Associate Commis-
cation has provided written authoriza- sioner for Policy, Planning, and Legis-
tion for the disclosure; lation, or the Deputy Commissioner for
(B) Disclosure would be in the inter- International and Constituent Rela-
est of public health by reason of the tions, or any other officer or employee
foreign government’s possessing infor- of the Food and Drug Administration
mation concerning the safety, efficacy, whom the Senior Associate Commis-
or quality of a product or information sioner for Policy, Planning, and Legis-
concerning an investigation; or lation or the Deputy Commissioner for
(C) The disclosure is to a foreign sci- International and Constituent Rela-
entist visiting the Food and Drug Ad- tions may designate to act on their be-
ministration on the agency’s premises half for the purpose, may authorize the
as part of a joint review or long-term disclosure to, or receipt from, an offi-
cooperative training effort authorized cial of a foreign government agency of
under section 708 of the act, the review nonpublic, predecisional documents
is in the interest of public health, the concerning the Food and Drug Admin-
Food and Drug Administration retains istration’s or the other government
physical control over the information, agency’s regulations or other regu-
the Food and Drug Administration re- latory requirements, or other non-
quires the visiting foreign scientist to public information relevant to either
sign a written commitment to protect agency’s activities, as part of coopera-
the confidentiality of the information, tive efforts to facilitate global harmo-
and the scientist provides a written as- nization of regulatory requirements,
surance that he or she has no financial cooperative regulatory activities, or
interest in the regulated industry of implementation of international agree-
the type that would preclude participa- ments, provided that:
tion in the review of the matter if the (i) The foreign government agency
individual were subject to the conflict
has the authority to protect such non-
of interest rules applicable to the Food
public documents from public disclo-
and Drug Administration advisory
sure and will not disclose any such doc-
committee members under § 14.80(b)(1)
uments provided without the written
of this chapter. Subject to all of the
confirmation by the Food and Drug Ad-
foregoing conditions, visiting foreign
ministration that the documents no
scientists may have access to trade se-
cret information, entitled to protec- longer have nonpublic status; and
tion under section 301(j) of the Federal (ii) The Senior Associate Commis-
Food, Drug, and Cosmetic Act (the sioner for Policy, Planning, and Legis-
act), in those cases where such disclo- lation or the Deputy Commissioner for
sures would be a necessary part of the International and Constituent Rela-
joint review or training. tions or their designee makes the de-
(2) Except as provided under para- termination that the exchange is rea-
graph (c)(1)(ii)(C) of this section, this sonably necessary to facilitate global
provision does not authorize the disclo- harmonization of regulatory require-
sure to foreign government officials of ments, cooperative regulatory activi-
other countries of trade secret infor- ties, or implementation of inter-
mation concerning manufacturing national agreements.
methods and processes prohibited from (2) Any exchange under this section
disclosure by section 301(j) of the act, of nonpublic documents does not in-
unless pursuant to an express written voke the rule established in § 20.21 that
authorization provided by the sub- such records shall be made available to
mitter of the information. all members of the public.
(3) Any disclosure under this section (e) For purposes of this section, the
of information submitted to the Food term ‘‘official of a foreign government
and Drug Administration or incor- agency’’ includes, but is not limited to,
porated into agency-prepared records employees (whether temporary or per-
does not invoke the rule established in manent) of and agents contracted by
§ 20.21 that such records shall be made the foreign government, or by an inter-
available to all members of the public. national organization established by

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§ 20.90 21 CFR Ch. I (4–1–11 Edition)

law, treaty, or other governmental ac- (7) Methods of destroying source doc-
tion and having responsibility to facili- uments or related waste material; and
tate global or regional harmonization (8) The period during which the con-
of standards and requirements in tractor may retain such data and infor-
FDA’s areas of responsibility or to pro- mation.
mote and coordinate public health ef-
forts. For such officials, the statement § 20.91 Use of data or information for
and commitment required by para- administrative or court enforce-
graph (c)(1)(i) of this section shall be ment action.
provided on behalf of both the organi-
Nothing in this part or this chapter
zation and the individual.
shall prevent the Food and Drug Ad-
[42 FR 15616, Mar. 22, 1977, as amended at 58 ministration from using any data or in-
FR 61603, Nov. 19, 1993; 60 FR 63382, Dec. 8, formation, whether obtained volun-
1995; 65 FR 11888, Mar. 7, 2000]
tarily or involuntarily and whether or
§ 20.90 Disclosure to contractors. not it is available for public disclosure,
as the basis for taking any administra-
(a) Data and information otherwise
tive or court enforcement action with-
exempt from public disclosure may be
disclosed to contractors with the Food in its jurisdiction. Data and informa-
and Drug Administration and their em- tion otherwise exempt from public dis-
ployees for use only in their work for closure are nevertheless available for
the Food and Drug Administration. public disclosure to the extent nec-
Contractors and their employees are essary to effectuate such action, e.g.,
thereafter subject to the same legal re- the brand name, code designation, and
strictions and penalties with respect to distribution information are released
the disclosure of such data and infor- when a product is recalled.
mation as Food and Drug Administra-
tion employees. Subpart F—Availability of Specific
(b) A written agreement between the Categories of Records
Food and Drug Administration and any
contractor shall be entered into before § 20.100 Applicability; cross-reference
data and information otherwise exempt to other regulations.
from public disclosure may be disclosed
to the contractor. The contractor shall (a) The provisions set forth in this
agree to establish and follow security subpart or cross-referenced in para-
precautions considered by the Food and graph (c) of this section state the way
Drug Administration to be necessary in which specific categories of Food
to ensure proper and confidential han- and Drug Administration records are
dling of the data and information. The handled upon a request for public dis-
written agreement shall include, where closure. The exemptions established in
appropriate, provisions establishing: subpart D of this part and the limita-
(1) Restrictions on access to the data tions on exemptions established in sub-
and information by the contractor, its part E of this part shall be applicable
employees, or other persons; to all Food and Drug Administration
(2) Physical storage requirements; records, as provided in §§ 20.60 and 20.80.
(3) Requirements for the handling Accordingly, a record that is ordinarily
and accountability of the data and in- available for public disclosure in ac-
formation by the contractor and its cordance with this part or under other
employees; regulations is not available for such
(4) Limitations on reproduction, disclosure to the extent that it falls
transmission, and disclosure of the within an exemption contained in sub-
data and information;
part D of this part except as provided
(5) A requirement of advance ap-
by the limitations on exemptions spec-
proval by the Food and Drug Adminis-
tration of the use by the contractor of ified in subpart E of this part.
subcontractors, vendors, or suppliers; (b) The Commissioner, on his own
(6) Procedures to be followed when initiative or on the petition of any in-
the contractor employs time-shared terested person, may amend this sub-
computer operations; part or promulgate and cross-reference

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Food and Drug Administration, HHS § 20.100

additional regulations to state the sta- (19) Data and information submitted
tus of additional categories of docu- for OTC drug review, in § 330.10(a)(2) of
ments to settle pending questions or to this chapter.
reflect court decisions. (20) Investigational new drug notice
(c) In addition to the provisions of for an antibiotic drug, in § 431.70 of this
this part, rules on the availability of chapter.
the following specific categories of (21) Antibiotic drug file, in § 314.430 of
Food and Drug Administration records this chapter.
are established by regulations in this (22) Data and information submitted
chapter: for biologics review, in § 601.25(b)(2) of
(1) Section 305 hearing records, in this chapter.
§ 7.87(c) of this chapter. (23) Investigational new drug notice
(2) Flavor ingredient records and for a biological product, in § 601.50 of
notes, in § 101.22(i)(4)(iv) of this chap- this chapter.
ter. (24) Applications for biologics li-
(3) Environmental assessments; find- censes for biological products, in
ing of no significant impact, in § 25.51 § 601.51 of this chapter.
of this chapter, or draft and final envi- (25) Cosmetic establishment registra-
ronmental impact statements, in § 25.52 tions, in § 710.7 of this chapter.
of this chapter. (26) Cosmetic product ingredient and
(4) Color additive petitions, in § 71.15 cosmetic raw material composition
of this chapter. statements, § 720.8 of this chapter.
(5) Food standard temporary permits, (27) Cosmetic product experience re-
in § 130.17(k) of this chapter. ports, in § 730.7 of this chapter.
(6) Information on thermal proc- (28) Device premarket notification
essing of low-acid foods packaged in submissions, in § 807.95 of this chapter.
hermetically sealed containers, in (29) Electronic product information,
§ 108.35(l) of this chapter. in §§ 1002.4 and 1002.42 of this chapter.
(7) Food additive petitions, in (30) Data and information submitted
§§ 171.1(h) and 571.1(h) of this chapter. to the Commissioner or to classifica-
(8) Action levels for natural and un- tion panels in connection with the clas-
avoidable defects in food for human sification or reclassification of devices
use, in § 110.110(e) of this chapter. intended for human use, in § 860.5 of
(9) Drug establishment registrations this chapter.
and drug listings, in § 207.37 of this (31) Data and information submitted
chapter. in offers to develop a proposed perform-
(10) Investigational new animal drug ance standard for medical devices, in
notices, in § 514.12 of this chapter. § 861.26 of this chapter.
(11) New animal drug application (32) Investigational device exemp-
files, in § 514.11 of this chapter. tions in § 812.38 of this chapter.
(12) Investigational new animal drug (33) Health claims petitions, in
notice and a new animal drug applica- § 101.70 of this chapter.
tion file for an antibiotic drug, in (34) Premarket approval application,
§ 514.10 of this chapter. in § 814.9 of this chapter.
(13) Methadone patient records, in (35) Report of certain adverse experi-
§ 291.505(g) of this chapter. ences with a medical device, in § 803.9 of
(14) Investigational new drug notice, this chapter.
in § 312.130 of this chapter. (36) Disqualification determination of
(15) Labeling for and lists of approved an institutional review board, in
new drug applications, in § 314.430 of § 56.122 of this chapter.
this chapter. (37) Disqualification determination of
(16) Master file for a new drug appli- a nonclinical laboratory, in § 58.213 of
cation, in § 312.420 of this chapter. this chapter.
(17) New drug application file, in (38) Minutes or records regarding a
§ 314.430 of this chapter. public advisory committee, in § 14.65(c)
(18) Data and information submitted of this chapter.
for in vitro diagnostic products, in (39) Data submitted regarding per-
§ 809.4 of this chapter. sons receiving an implanted pacemaker

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§ 20.101 21 CFR Ch. I (4–1–11 Edition)

device or lead, in § 805.25 of this chap- § 20.102 Court enforcement records.


ter.
(40) Humanitarian device exemption (a) All records and documents filed in
application, in § 814.122 of this chapter. the courts are available for public dis-
(41) Premarket notifications for food closure unless the court orders other-
contact substances, in § 170.102 of this wise. The Food and Drug Administra-
chapter. tion will make available for public dis-
(42) Registration of food facilities, in closure such records or documents if
§ 1.243 of this chapter. the agency can determine that it has
(43) Minor-use or minor-species an accurate copy of the actual record
(MUMS) drug designations, in § 516.52 of or document filed in the court. If the
this chapter. Food and Drug Administration cannot
(44) Minor-species drug index listings, determine whether it has an accurate
in § 516.171 of this chapter. copy of such a record or document, the
[42 FR 15616, Mar. 22, 1977, as amended at 42 person requesting a copy shall be re-
FR 19989, Apr. 15, 1977; 42 FR 42526, Aug. 28, ferred to the court involved.
1977; 42 FR 58889, Nov. 11, 1977; 43 FR 32993, (b) After a recommendation for court
July 28, 1978; 51 FR 22475, June 19, 1986; 54 FR action has been finally refused by a
9038, Mar. 3, 1989; 58 FR 2533, Jan. 6, 1993; 59 United States attorney, the cor-
FR 536, Jan. 5, 1994; 61 FR 33244, June 26, 1996;
62 FR 40592, July 29, 1997; 64 FR 56448, Oct. 20, respondence with the United States at-
1999; 67 FR 13717, Mar. 26, 2002; 67 FR 35729, torney and the Department of Justice
May 21, 2002; 68 FR 58965, Oct. 10, 2003; 72 FR with respect to that recommendation,
41017, July 26, 2007; 72 FR 69118, Dec. 6, 2007] including the pleadings recommended
for filing with the court, is available
§ 20.101 Administrative enforcement
records. for public disclosure. Prior to disclo-
sure of any record specifically reflect-
(a) All Food and Drug Administra- ing consideration of possible criminal
tion records relating to administrative prosecution of any individual, all
enforcement action disclosed to any names and other information that
member of the public, including the
would identify an individual who was
person who is the subject of such ac-
considered for criminal prosecution but
tion, are available for public disclosure
who was not prosecuted shall be de-
at the time such disclosure is first
leted unless the Commissioner con-
made. Such records include correspond-
ence with companies following factory cludes that there is a compelling public
inspection, recall or detention re- interest in the disclosure of such
quests, notice of refusal of admission of names.
an imported product, regulatory let-
§ 20.103 Correspondence.
ters, information letters, Forms FD–483
and FD–2275 furnished to companies (a) All correspondence to and from
after factory inspection, and similar members of the public, members of
records. Congress, organization or company of-
(b) To the extent that any of such ficials, or other persons, except mem-
records fall within the exemption for bers of the Executive Branch of the
investigatory records established in Federal Government and special gov-
§ 20.64, the Commissioner determines ernment employees, is available for
that they are subject to discretionary public disclosure.
release pursuant to § 20.82. (b) Any such correspondence is avail-
(c) Records relating to administra- able for public disclosure at the time
tive enforcement action that are not that it is sent or received by the Food
disclosed to any member of the public and Drug Administration unless a dif-
constitute investigatory records that ferent time for such disclosure is speci-
are subject to the rules for disclosure
fied in other rules established or cross-
established in § 20.64. For example, an
referenced in this part, e.g., cor-
establishment inspection report is an
respondence relating to an IND notice
investigatory record and thus subject
to § 20.64 except insofar as the Commis- or an NDA in § 314.430 of this chapter.
sioner exercises his discretion to re- [42 FR 15616, Mar. 22, 1977, as amended at 54
lease it pursuant to § 20.82. FR 9038, Mar. 3, 1989]

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Food and Drug Administration, HHS § 20.107

§ 20.104 Summaries of oral discussions. (d) Access to all raw data, slides,
(a) All written summaries of oral dis- worksheets, and other similar working
cussions, whether in person or by tele- materials shall be provided at the same
phone, with members of the public, time that the final report is disclosed.
members of Congress, organization or § 20.106 Studies and reports prepared
company officials, or other persons, ex- by or with funds provided by the
cept members of the Executive Branch Food and Drug Administration.
of the Federal government or special
(a) The following types of reports and
government employees, are available
studies prepared by or with funds pro-
for public disclosure.
vided by the Food and Drug Adminis-
(b) Any such summary is available
tration are available for public disclo-
for public disclosure at the time that it
sure upon their acceptance by the re-
is prepared by the Food and Drug Ad-
sponsible agency official:
ministration unless a different time for
(1) Quarterly and annual reports of
such disclosure is specified in other
the agency.
rules established or cross-referenced in
(2) External investigations or review
this part, e.g., summaries of oral dis-
of agency needs and performance.
cussions relating to a food additive pe-
(3) Surveys, compilations, and sum-
tition in § 171.1(h)(3) of this chapter.
maries of data and information.
(c) If more than one summary of an
(4) Consumer surveys.
oral discussion exists in a Food and
(5) Compliance surveys.
Drug Administration file, all such sum- (6) Compliance programs, except that
maries shall be disclosed in response to names of specific firms, the location of
any request for such summary. specific activities, and details about
§ 20.105 Testing and research con- sampling numbers or sizes shall be de-
ducted by or with funds provided leted until implementation of the pro-
by the Food and Drug Administra- gram is completed.
tion. (7) Work plans prepared by Food and
(a) Any list that may be prepared by Drug Administration centers, field of-
the Food and Drug Administration of fices, and other components, except
testing and research being conducted that names of specific firms, the loca-
by or with funds provided by the Food tion of specific activities, and details
and Drug Administration is available about sampling numbers or sizes shall
for public disclosure. be deleted until implementation of the
(b) Any contract relating to agency plan is completed.
testing and research, and any progress (b) The following types of reports and
report relating thereto, is available for studies prepared by or with funds pro-
public disclosure. vided by the Food and Drug Adminis-
(c) The results of all testing or re- tration are not available for public dis-
search conducted by or with funds pro- closure:
vided by the Food and Drug Adminis- (1) Internal audits of agency needs
tration, such as toxicological testing, and performance.
compliance assays, methodology stud- (2) Records relating to the internal
ies, and product testing, are available planning and budget process.
for public disclosure when the final re- (3) Legislative proposals or com-
port is complete and accepted by the ments prior to submission to Congress.
responsible Food and Drug Administra- [42 FR FR 15616, Mar. 22, 1977, as amended at
tion official, after deletion of any in- 50 FR 8995, Mar. 6, 1985]
formation that would reveal confiden-
tial investigative techniques and pro- § 20.107 Food and Drug Administration
cedures, e.g., the use of ‘‘markers’’ to manuals.
document adulteration of a product. If (a) Food and Drug Administration
such results are disclosed in an author- administrative staff manuals and in-
ized manner to any member of the pub- structions that affect a member of the
lic before the final report is available, public are available for public disclo-
they are immediately available for sure. An index of all such manuals is
public disclosure to any member of the available by writing to the Freedom of
public who requests them. Information Staff (HFI–35), Food and

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§ 20.108 21 CFR Ch. I (4–1–11 Edition)

Drug Administration, rm. 12A–16, 5600 listing all such agreements and memo-
Fishers Lane, Rockville, MD 20857, or randa of understanding currently in ef-
by visiting the Freedom of Information fect between FDA and State or local
Public Reading Room, located in rm. government agencies.
12A–30 at the same address. The index (d) Agreements and understandings
and all manuals created by the agency signed by officials of FDA with respect
on or after November 1, 1996, will be to activities of the Office of Criminal
made available through the Internet at Investigations are exempt from the re-
http://www.fda.gov. quirements set forth in paragraphs (b)
(b) Manuals relating solely to inter- and (c) of this section. Although such
nal personnel rules and practices are agreements and understandings will
not available for public disclosure ex- not be put on display in FDA’s Free-
cept to the extent that the Commis- dom of Information Public Room or
sioner determines that they should be published in the FEDERAL REGISTER,
disclosed pursuant to § 20.82. these agreements will be available for
(c) All Food and Drug Administration disclosure in response to a request
action levels which are used to deter- from the public after deletion of infor-
mine when the agency will take regu- mation that would disclose confiden-
latory action against a violative prod- tial investigative techniques or proce-
uct, limits of sensitivity and varia- dures, or information that would dis-
bility of analytical methods which are close guidelines for law enforcement
used in determining whether a product investigations if such disclosure could
violates the law, and direct reference reasonably be expected to risk cir-
levels above which Food and Drug Ad- cumvention of the law.
ministration field offices may request [42 FR 15616, Mar. 22, 1977, as amended at 46
legal action directly to the office of the FR 8457, Jan. 27, 1981; 58 FR 48794, 48796, Sept.
General Counsel, are available for pub- 20, 1993]
lic disclosure.
§ 20.109 Data and information ob-
[42 FR 15616, Mar. 22, 1977, as amended at 46 tained by contract.
FR 8457, Jan. 27, 1981; 46 FR 14340, Feb. 27,
1981; 68 FR 25287, May 12, 2003] (a) All data and information obtained
by the Food and Drug Administration
§ 20.108 Agreements between the Food by contract, including all progress re-
and Drug Administration and other ports pursuant to a contract, are avail-
departments, agencies, and organi- able for public disclosure when accept-
zations.
ed by the responsible agency official
(a) All written agreements and un- except to the extent that they remain
derstandings signed by the Food and subject to an exemption established in
Drug Administration and other depart- subpart D of this part, e.g., they relate
ments, agencies, and organizations are to law enforcement matters as pro-
available for public disclosure. vided in § 20.88(b).
(b) A permanent file of all such (b) Upon the awarding of a contract
agreements and understandings is by the Food and Drug Administration,
available for public review during the technical proposal submitted by
working hours in the Food and Drug the successful offeror will be available
Administration’s Freedom of Informa- for public disclosure. All cost proposals
tion Public Room. and the technical proposals of unsuc-
(c) All such agreements and under- cessful offerors submitted in response
standings shall be published in the to a request for proposals are exempt
FEDERAL REGISTER, except those agree- from disclosure as confidential com-
ments and memoranda of under- mercial or financial information pursu-
standing between FDA and State or ant to § 20.61.
local government agencies that are co-
operative work-sharing agreements. In § 20.110 Data and information about
lieu of publication of the complete text Food and Drug Administration em-
of these agreements and under- ployees.
standings, FDA will publish in the FED- (a) The name, title, grade, position
ERAL REGISTER periodically, but not description, salary, work address, and
less than once every 2 years, a notice work telephone number for every Food

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Food and Drug Administration, HHS § 20.111

and Drug Administration employee are would identify the person submitting
available for public disclosure. The the information.
home address and home telephone (ii) If submitted by the manufacturer
number of any such employee are not of the product, the record is available
available for public disclosure. for public disclosure after deletion of:
(b) Statistics on the prior employ- (a) Names and any information that
ment experience of present agency em- would identify the person using the
ployees, and subsequent employment of product.
past agency employees, are available (b) Names and any information that
for public disclosure. would identify any third party involved
with the report, such as a physician or
§ 20.111 Data and information sub- hospital or other institution.
mitted voluntarily to the Food and (c) Names and any other information
Drug Administration. that would identify the manufacturer
(a) The provisions of this section or the brand designation of the prod-
shall apply only to data and informa- uct, but not the type of product or its
tion submitted voluntarily to the Food ingredients.
and Drug Administration, whether in (iii) If submitted by a third party,
the course of a factory inspection or at such as a physician or hospital or other
any other time, and not as a part of institution, the record is available for
any petition, application, master file, public disclosure after deletion of:
or other required submission or request (a) Names and any information that
for action. Data and information that would identify the person using the
may be required to be submitted to the product.
Food and Drug Administration but (b) Names and any information that
that are submitted voluntarily instead would identify any third party involved
are not subject to the provisions of this with the report, such as a physician or
section and will be handled as if they hospital or other institution.
had been required to be submitted. (iv) If obtained through a Food and
(b) A determination that data or in- Drug Administration investigation, the
formation submitted voluntarily will record shall have the same status as
be held in confidence and will not be the initial report which led to the in-
available for public disclosure shall be vestigation, i.e., it shall be disclosed in
made only in the form of a regulation accordance with paragraph (c)(3)(i)
published or cross-referenced in this through (iii) of this section.
part. (v) Any compilation of data, informa-
(c) The following data and informa- tion, and reports prepared in a way
tion submitted voluntarily to the Food that does not reveal data or informa-
and Drug Administration are available tion which is not available for public
for public disclosure unless extraor- disclosure under this section is avail-
dinary circumstances are shown: able for public disclosure.
(1) All safety, effectiveness, and (vi) If a person requests a copy of any
functionality data and information for such record relating to a specific indi-
a marketed ingredient or product, ex- vidual or a specific incident, such re-
cept as provided in § 330.10(a)(2) of this quest will be denied unless accom-
chapter for OTC drugs. panied by the written consent to such
(2) A protocol for a test or study, un- disclosure of the person who submitted
less it is shown to fall within the ex- the report to the Food and Drug Ad-
emption established in § 20.61 for trade ministration and the individual who is
secrets and confidential commercial or the subject of the report. The record
financial information. will be disclosed to the individual who
(3) Adverse reaction reports, product is the subject of the report upon re-
experience reports, consumer com- quest.
plaints, and other similar data and in- (4) A list of all ingredients contained
formation shall be disclosed as follows: in a food or cosmetic, whether or not it
(i) If submitted by a consumer or is in descending order of predominance,
user of the product, the record is avail- or a list of all active ingredients and
able for public disclosure after deletion any inactive ingredients previously
of names and other information that disclosed to the public as defined in

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§ 20.112 21 CFR Ch. I (4–1–11 Edition)

§ 20.81 contained in a drug, or a list of vidual or a specific incident, such re-


all ingredients or components in a de- quest will be denied unless accom-
vice. panied by the written consent to such
(5) An assay method or other analyt- disclosure of the person who submitted
ical method, unless it serves no regu- the report to the Food and Drug Ad-
latory or compliance purpose and is ministration and the individual who is
shown to fall within the exemption es- the subject of the report.
tablished in § 20.61. [42 FR 15616, Mar. 22, 1977, as amended at 54
(d) The following data and informa- FR 9038, Mar. 3, 1989; 62 FR 52249, Oct. 7, 1997]
tion submitted voluntarily to the Food
and Drug Administration are not avail- § 20.113 Voluntary product defect re-
able for public disclosure unless they ports.
have been previously disclosed to the Voluntary reports of defects in prod-
public as defined in § 20.81 or they re- ucts subject to the jurisdiction of the
late to a product or ingredient that has Food and Drug Administration are
been abandoned and they no longer rep- available for public disclosure:
resent a trade secret or confidential (a) If the report is submitted by the
commercial or financial information as manufacturer, after deletion of data
defined in § 20.61: and information falling within the ex-
(1) All safety, effectiveness, and emptions established in § 20.61 for trade
functionality data and information for secrets and confidential commercial or
a developmental ingredient or product financial information and in § 20.63 for
that has not previously been disclosed personal privacy.
to the public as defined in § 20.81. (b) If the report is submitted by any
(2) Manufacturing methods or proc- person other than the manufacturer,
esses, including quality control proce- after deletion of names and other infor-
dures. mation that would identify the person
(3) Production, sales, distribution, submitting the report and any data or
and similar data and information, ex- information falling within the exemp-
cept that any compilation of such data tion established in § 20.63 for personal
and information aggregated and pre- privacy.
pared in a way that does not reveal
data or information which is not avail- § 20.114 Data and information sub-
able for public disclosure under this mitted pursuant to cooperative
provision is available for public disclo- quality assurance agreements.
sure. Data and information submitted to
(4) Quantitative or semiquantitative the Food and Drug Administration pur-
formulas. suant to a cooperative quality assur-
(e) For purposes of this regulation, ance agreement shall be handled in ac-
safety, effectiveness, and functionality cordance with the rules established in
data include all studies and tests of an § 20.111.
ingredient or a product on animals and
humans and all studies and tests on the § 20.115 Product codes for manufac-
ingredient or product for identity, sta- turing or sales dates.
bility, purity, potency, bioavailability, Data or information in Food and
performance, and usefulness. Drug Administration files which pro-
[42 FR 15616, Mar. 22, 1977, as amended at 68 vide a means for deciphering or decod-
FR 25287, May 12, 2003] ing a manufacturing date or sales date
or use date contained on the label or in
§ 20.112 Voluntary drug experience re- labeling or otherwise used in connec-
ports submitted by physicians and tion with a product subject to the ju-
hospitals. risdiction of the Food and Drug Admin-
(a) A voluntary drug experience re- istration are available for public dis-
port to the Food and Drug Administra- closure.
tion on FDA Form 3500 shall be han-
dled in accordance with the rules es- § 20.116 Drug and device listing infor-
tablished in § 20.111(c)(3)(iii). mation.
(b) If a person requests a copy of any Information submitted to the Food
such record relating to a specific indi- and Drug Administration pursuant to

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Food and Drug Administration, HHS § 20.120

section 510 (a)–(j) of the act shall be ited from disclosure under §§ 20.61,
subject only to the special disclosure 312.130, and 314.430 of this chapter.
provisions established in §§ 207.37 and [42 FR 15616, Mar. 22, 1977, as amended at 45
807.37 of this chapter. FR 72608, Oct. 31, 1980; 46 FR 8457, Jan. 27,
1981; 54 FR 9038, Mar. 3, 1989; 64 FR 399, Jan.
[42 FR 42526, Aug. 23, 1977]
5, 1999]
§ 20.117 New drug information. § 20.118 Advisory committee records.
(a) The following computer printouts All advisory committee records shall
are available for public inspection in be handled in accordance with the rules
the Food and Drug Administration’s established in parts 10, 12, 13, 14, 15, 16,
Freedom of Information Public Room: and 19 of this chapter.
(1) A numerical listing of all new
drug applications and abbreviated new § 20.119 Lists of names and addresses.
drug applications approved since 1938, Names and addresses of individuals in
showing the NDA number, the trade Food and Drug Administration records
name, the applicant, the approval date, shall not be sold or rented. Names and
and, where applicable, the date the ap- addresses shall not be disclosed if dis-
proval was withdrawn and the date the closure is prohibited as a clearly un-
Food and Drug Administration was no- warranted invasion of personal privacy,
tified that marketing of the product e.g., lists of names and home addresses
was discontinued. of Food and Drug Administration em-
ployees, which shall not be disclosed
(2) A numerical listing of all new
under § 20.110.
drug applications and abbreviated new
drug applications approved since 1938 § 20.120 Records available in Food and
which are still approved, showing the Drug Administration Public Read-
same information as is specified in ing Rooms.
paragraph (a)(1) of this section except (a) The Food and Drug Administra-
that it does not show a withdrawal tion operates two public reading
date. rooms. The Freedom of Information
(3) A listing of new drug applications, Staff’s Public Reading Room is located
abbreviated new drug applications, in rm. 12A–30, Parklawn Bldg., 5600
which were approved since 1938 and Fishers Lane, Rockville, MD 20857, the
which are still approved, covering mar- phone number is 301–827–6500. The Divi-
keted prescription drug products ex- sion of Dockets Management’s Public
cept prescription drug products covered Reading Room is located in rm. 1061,
by applications deemed approved under 5630 Fishers Lane, Rockville, MD 20852;
the Drug Amendments of 1962 and not the phone number is 301–827–6860. Both
yet determined to be effective in the public reading rooms are open from 9
Drug Efficacy Study Implementation a.m. to 4 p.m., Monday through Friday,
excluding legal public holidays.
program. The listing includes the name
(b) The following records are avail-
of the active ingredient, the type of
able at the Freedom of Information
dosage form, the route of administra- Staff’s Public Reading Room:
tion, the trade name of the product, (1) A guide for making requests for
the name of the application holder, and records or information from the Food
the strength or potency of the product. and Drug Administration;
The listing also includes, for each ac- (2) Administrative staff manuals and
tive ingredient in a particular dosage instructions to staff that affect a mem-
form for which there is more than one ber of the public;
approved application, an evaluation of (3) Food and Drug Administration
the therapeutic equivalence of the drug records which have been released to
products covered by such applications. any person in response to a Freedom of
(b) Other computer printouts con- Information request and which the
taining IND and NDA information are agency has determined have become or
available to the extent that they do are likely to become the subject of sub-
not reveal data or information prohib- sequent requests for substantially the
same records;

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Pt. 21 21 CFR Ch. I (4–1–11 Edition)

(4) Indexes of records maintained in Subpart C—Requirements for Specific


the Freedom of Information Staff’s Categories of Records
Public Reading Room; and
21.30 Records of contractors.
(5) Such other records and informa-
21.31 Records stored by the National Ar-
tion as the agency determines are ap- chives and Records Administration.
propriate for inclusion in the public 21.32 Personnel records.
reading room. 21.33 Medical records.
(c) The following records are avail-
able in the Division of Dockets Man- Subpart D—Procedures for Notification of
agement’s Public Reading Room: and Access to Records in Privacy Act
(1) Final opinions, including concur- Record Systems
ring and dissenting opinions, as well as
21.40 Procedures for submitting requests for
orders, made in the adjudication of
notification and access.
cases; 21.41 Processing of requests.
(2) Statements of policy and interpre- 21.42 Responses to requests.
tation adopted by the agency that are 21.43 Access to requested records.
still in force and not published in the 21.44 Verification of identity.
FEDERAL REGISTER; 21.45 Fees.
(3) Indexes of records maintained in
the Division of Dockets Management’s Subpart E—Procedures for Requests for
Public Reading Room; and Amendment of Records
(4) Such other records and informa-
21.50 Procedures for submitting requests for
tion as the agency determines are ap- amendment of records.
propriate for inclusion in the public 21.51 Responses to requests for amendment
reading room. of records.
(d) The agency will make reading 21.52 Administrative appeals of refusals to
room records created by the Food and amend records.
Drug Administration on or after No- 21.53 Notation and disclosure of disputed
vember 1, 1996, available electronically records.
through the Internet at the agency’s 21.54 Amended or disputed records received
World Wide Web site which can be from other agencies.
found at http://www.fda.gov. At the
agency’s discretion, the Food and Drug Subpart F—Exemptions
Administration may also make avail- 21.60 Policy.
able through the Internet such addi- 21.61 Exempt systems.
tional records and information it be- 21.65 Access to records in exempt systems.
lieves will be useful to the public.
Subpart G—Disclosure of Records in Pri-
[68 FR 25287, May 12, 2003; 68 FR 65392, Nov.
20, 2003]
vacy Act Record Systems to Persons
Other Than the Subject Individual
PART 21—PROTECTION OF 21.70 Disclosure and intra-agency use of
PRIVACY records in Privacy Act Record Systems;
no accounting required.
21.71 Disclosure of records in Privacy Act
Subpart A—General Provisions
Record Systems; accounting required.
Sec. 21.72 Individual consent to disclosure of
21.1 Scope. records to other persons.
21.3 Definitions. 21.73 Accuracy, completeness, timeliness,
21.10 Policy concerning records about indi- and relevance of records disclosed from
viduals. Privacy Act Record Systems.
21.74 Providing notice that a record is dis-
Subpart B—Food and Drug Administration puted.
Privacy Act Record Systems 21.75 Rights of legal guardians.
AUTHORITY: 21 U.S.C. 371; 5 U.S.C. 552, 552a.
21.20 Procedures for notice of Food and
Drug Administration Privacy Act Record SOURCE: 42 FR 15626, Mar. 22, 1977, unless
Systems. otherwise noted.
21.21 Changes in systems and new systems.

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Food and Drug Administration, HHS § 21.3

Subpart A—General Provisions Administration, except as provided in


§ 21.32. Such records are subject to reg-
§ 21.1 Scope. ulations of the Office of Personnel
(a) This part establishes procedures Management in 5 CFR parts 293, 294,
to implement the Privacy Act of 1974 (5 and 297.
U.S.C. 552a). It applies to records about [42 FR 15626, Mar. 22, 1977, as amended at 46
individuals that are maintained, col- FR 8457, Jan. 27, 1981; 50 FR 52278, Dec. 23,
lected, used, or disclosed by the Food 1985]
and Drug Administration and con-
tained in Privacy Act Record Systems. § 21.3 Definitions.
(b) This part does not:
As used in this part:
(1) Apply to Food and Drug Adminis-
tration record systems that are not (a) Individual means a natural living
Privacy Act Record Systems or make person who is a citizen of the United
available to an individual records that States or an alien lawfully admitted
may include references to him but that for permanent residence. Individual
are not retrieved by his name or other does not include sole proprietorships,
personal identifier, whether or not con- partnerships, or corporations engaged
tained in a Privacy Act Record Sys- in the production or distribution of
tem. part 20 of this chapter (the public products regulated by the Food and
information regulations) and other reg- Drug Administration or with which the
ulations referred to therein determine Food and Drug Administration has
when records are made available in business dealings. Any such business
such cases. enterprise that is identified by the
(2) Make any records available to name of one or more individuals is not
persons other than (i) individuals who an individual within the meaning of
are the subjects of the records, (ii) per- this part. Employees of regulated busi-
sons accompanying such individuals ness enterprises are considered individ-
under § 21.43, (iii) persons provided uals. Accordingly, physicians and other
records pursuant to individual consent health professionals who are engaged
under § 21.72, or (iv) persons acting on in business as proprietors of establish-
behalf of such individuals as legal ments regulated by the Food and Drug
guardians under § 21.75. Part 20 of this Administration are not considered in-
chapter (the public information regula- dividuals; however, physicians and
tions) and other regulations referred to other health professionals who are en-
therein determine when Food and Drug gaged in clinical investigations, em-
Administration records are disclosable ployed by regulated enterprises, or the
to members of the public generally. subjects of records concerning their
Subpart G of this part limits the provi- own health, e.g., exposure to excessive
sions of part 20 of this chapter with re- radiation, are considered individuals.
spect to disclosures of records about in- Food and Drug Administration employ-
dividuals from Privacy Act Record Sys- ees, consultants, and advisory com-
tems to persons other than individuals mittee members, State and local offi-
who are the subjects of the records. cials, and consumers are considered in-
(3) Make available information com- dividuals.
piled by the Food and Drug Adminis- (b) Records about individuals means
tration in reasonable anticipation of items, collections, or groupings of in-
court litigation or formal administra- formation about individuals contained
tive proceedings. The availability of in Privacy Act Record Systems, includ-
such information to any member of the ing, but not limited to education, fi-
public, including any subject indi- nancial transactions, medical history,
vidual or party to such litigation or criminal history, or employment his-
proceeding shall be governed by appli- tory, that contain names or personal
cable constitutional principles, rules of identifiers.
discovery, and part 20 of this chapter (c) Privacy Act Record System means a
(the public information regulations). system of records about individuals
(4) Apply to personnel records main- under the control of the Food and Drug
tained by the Division of Human Re- Administration from which informa-
sources Management, Food and Drug tion is retrieved by individual names or

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§ 21.10 21 CFR Ch. I (4–1–11 Edition)

other personal identifiers. The term in- Act Record System as defined in
cludes such a system of records wheth- § 21.3(c) that is not covered by a notice
er subject to a notice published by the published by the Department, the Of-
Food and Drug Administration, the De- fice of Personnel Management, or an-
partment, or another agency. Where other agency.
records are retrieved only by personal (b) The notice shall include the fol-
identifiers other than individual lowing information:
names, a system of records is not a Pri- (1) The name and location(s) of the
vacy Act Record System if the Food system.
and Drug Administration cannot, by (2) The categories of individuals
reference to information under its con- about whom records are maintained in
trol, or by reference to records of con- the system.
tractors that are subject to this part (3) The categories of records main-
under § 21.30, ascertain the identity of tained in the system.
individuals who are the subjects of the (4) The authority for the system.
records. (5) Each routine use of the records
(d) Personal identifiers includes indi- contained in the system (i.e., use out-
vidual names, identifying numbers, side the Department of Health and
symbols, or other identifying designa- Human Services that is compatible
tions assigned to individuals. Personal with the purpose for which the records
identifiers does not include names, num- were collected and described in the no-
bers, symbols, or other identifying des- tice) including the categories of users
ignations that identify products, estab- and the purposes of such use.
lishments, or actions. (6) The policies and practices of the
(e) Personnel records means any per- Food and Drug Administration regard-
sonal information maintained in a Pri- ing storage, retrievability (i.e., how the
vacy Act Record System that is needed records are indexed and what intra-
for personnel management programs or agency uses are made of the records),
processes such as staffing, employee access controls, retention, and disposal
development, retirement, and griev- of the records in that system.
ances and appeals. (7) The title and business address of
(f) Department means Department of the official who is responsible for the
Health and Human Services. system of records.
(8) The notification procedure, i.e.,
§ 21.10 Policy concerning records the address of the FDA Privacy Act Co-
about individuals. ordinator, whom any individual can
Information about individuals in contact to seek notification whether
Food and Drug Administration records the system contains a record about
shall be collected, maintained, used, him/her.
and disseminated so as to protect the (9) The record access and contest pro-
right to privacy of the individual to cedures, which shall be the same as the
the fullest possible extent consistent notification procedure except that a
with laws relating to disclosure of in- reference shall be included to any ex-
formation to the general public, the emption from access and contest.
law enforcement responsibilities of the (10) Where any records in the system
agency, and administrative and pro- are subject to an exemption under
gram management needs. § 21.61, a reference to this exemption.
(11) The categories of sources of
Subpart B—Food and Drug Ad- records in the system.
ministration Privacy Act [42 FR 15626, Mar. 22, 1977, as amended at 46
Record Systems FR 8457, Jan. 27, 1981]

§ 21.20 Procedures for notice of Food § 21.21 Changes in systems and new
and Drug Administration Privacy systems.
Act Record Systems. (a) The Food and Drug Administra-
(a) The Food and Drug Administra- tion shall notify the designated De-
tion shall issue in the FEDERAL REG- partment official, the Office of Man-
ISTER on or before August 30 of each agement and Budget (Information Sys-
year a notice concerning each Privacy tems Division), and the Congress of

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Food and Drug Administration, HHS § 21.30

proposals to change or establish Pri- Drug Administration functions, from


vacy Act Record Systems in accord- which information is retrieved by indi-
ance with procedures of the Depart- vidual names or other personal identi-
ment and the Office of Management fiers, may be subject to the provisions
and Budget. of this part. If the contract is agreed to
(b) The Food and Drug Administra- on or after September 27, 1975, the
tion shall issue a notice, in accordance criminal penalties set forth in 5 U.S.C.
with paragraph (d) of this section and 552a(i) are applicable to such con-
§ 21.20(b), of any change in a Privacy tractor, and any employee of such con-
Act Record System which: tractor, for disclosures prohibited in
(1) Increases the number or types of § 21.71 or for maintenance of a system
individuals about whom records are of records without notice as required in
maintained; § 21.20.
(2) Expands the type or amount of in- (b) A contract is considered to ac-
formation about individuals that is complish a Food and Drug Administra-
maintained; tion function if the proposal or activity
(3) Increases the number of cat- it supports is principally operated on
egories of agencies or other persons behalf of and is under the direct man-
who may have access to those records; agement of the Food and Drug Admin-
(4) Alters the manner in which the istration. Systems of records from
records are organized so as to change which information is retrieved by indi-
the nature or scope of those records, vidual names or other personal identi-
such as the combining of two or more fiers and that are operated under con-
existing systems; tracts to accomplish Food and Drug
(5) Modifies the way in which the sys- Administration functions are deemed
tem operates or its location(s) in a to be maintained by the agency and
manner that alters the process by shall be subject to the procedures and
which individuals can exercise their requirements of this part.
rights under this part, such as the ways (c) A contract is not considered to ac-
in which they seek access or request complish a Food and Drug Administra-
amendment of a record; or tion function if the program or activity
(6) Changes the equipment configura- it supports is not principally operated
tion on which the system is operated so on behalf of, or is not under the direct
as to create the potential for greater management of, the Food and Drug Ad-
access, such as adding a telecommuni- ministration. For example, this part
cations capability. does not apply to systems of records:
(c) The Food and Drug Administra- (1) Operated under contract with the
tion shall issue a notice of its intention Food and Drug Administration by
to establish new Privacy Act Record State or local government agencies, or
Systems in accordance with paragraph organizations representing such agen-
(d) of this section and § 21.20(b). cies, when such agencies or organiza-
(d) Notices under paragraphs (b) and tions are also performing State or local
(c) of this section shall be published in government functions.
the FEDERAL REGISTER for comment at (2) Operated by contractors with the
least 30 days prior to implementation Food and Drug Administration by indi-
of the proposed changes or establish- viduals or organizations whose primary
ment of new systems. Interested per- function is delivery of health services,
sons shall have the opportunity to sub- such as hospitals, physicians, phar-
mit written data, views, or arguments macists, and other health profes-
on such proposed new uses or systems. sionals, and that report information
concerning products, e.g., injuries or
Subpart C—Requirements for product defects, to the Food and Drug
Specific Categories of Records Administration. Before such contrac-
tors submit information to the Food
§ 21.30 Records of contractors. and Drug Administration, the names
(a) Systems of records that are re- and other personal identifiers of pa-
quired to be operated, or as a matter of tients or research subjects in any med-
practical necessity must be operated, ical or similar report, test, study, or
by contractors to accomplish Food and other research project shall be deleted,

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§ 21.31 21 CFR Ch. I (4–1–11 Edition)

unless the contract provides otherwise. § 21.31 Records stored by the National
If the Food and Drug Administration Archives and Records Administra-
subsequently needs the names of such tion.
individuals, a separate request will be (a) Food and Drug Administration
made. records that are stored, processed, and
(3) Relating to individuals whom the serviced by the National Archives and
contractor employs, or with whom the Records Administration in accordance
contractor otherwise deals, in the with 44 U.S.C. 3103 shall be considered
course of providing goods and services to be maintained by the Food and Drug
to the Food and Drug Administration. Administration. The National Archives
(4) Operated under grants. and Records Administration shall not
disclose the record except to author-
(d) The requirements of this part
ized Food and Drug Administration
shall apply when a contractor who op- employees.
erates a system of records not subject (b) Each Food and Drug Administra-
to this part reports to the Food and tion record pertaining to an identifi-
Drug Administration information that able individual that was transferred to
is a system of records about individuals the National Archives of the United
from which personal information is re- States as a record determined by the
trieved by names or other personal National Archives to have sufficient
identifiers. Where the information historical or other value to warrant its
would be a new Privacy Act Record continued preservation shall be consid-
System, or a change in an existing Pri- ered to be maintained by the National
vacy Act Record System of a type de- Archives and shall not be subject to
scribed in § 21.21, the Food and Drug the provisions of this part.
Administration shall comply with the [42 FR 15626, Mar. 22, 1977, as amended at 50
requirements of § 21.21. FR 52278, Dec. 23, 1985]
(e) The Food and Drug Administra-
tion will review all contracts before § 21.32 Personnel records.
award to determine whether operation (a) Present and former Food and
of a system from which information is Drug Administration employees desir-
retrieved by individual names or other ing access to personnel records about
personal identifiers will be required of themselves should consult system no-
the contractor, by the terms of the tices applicable to the agency’s per-
contract or as a matter of practical ne- sonnel records that are published by
the Office of Personnel Management
cessity. If such operation will be re-
and the Department as well as any no-
quired, the solicitation and contract
tice issued by the Food and Drug Ad-
shall include the following clause, or a ministration.
clause of similar effect: (b)(1) The procedures of the Office of
Whenever the contractor or any of his em- Personnel Management at 5 CFR parts
ployees is required by this contract to oper- 293, 294, and 297 rather than the proce-
ate a system of records from which informa- dures in § 21.33 and subparts D through
tion is retrieved by individual names or F of this part, govern systems of per-
other personal identifiers in order to accom- sonnel records about Food and Drug
plish a Food and Drug Administration func- Administration employees that are
tion, the contractor and every employee is subject to notice published by the Of-
considered to be an employee of the Food fice of Personnel Management, i.e.,
and Drug Administration and shall operate systems that:
such system of records in accordance with (i) The Office of Personnel Manage-
the Privacy Act of 1974 (5 U.S.C. 552a), regu- ment maintains.
lations of the Food and Drug Administration
(ii) Are maintained by the Division of
in 21 CFR part 21, and rules of conduct that
Human Resources Management, Food
apply to Food and Drug Administration em-
ployees who work with such systems of and Drug Administration.
records. The contractor and his employees (iii) Are maintained by Department
are subject to the criminal penalties set Regional Offices, concerning field em-
forth in 5 U.S.C. 552a(i) for violations of the ployees.
Privacy Act. (2) The Office of Personnel Manage-
ment’s procedures may, if necessary, be

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Food and Drug Administration, HHS § 21.32

supplemented in the Food and Drug tained by the operating offices of the
Administration Staff Manual Guide. Food and Drug Administration in
Current Food and Drug Administration which employees work:
employees should mail or deliver writ- (1) An employee shall upon request be
ten requests under the Privacy Act for told whether records about him are
access to personnel records described in maintained. An employee shall be
this paragraph to the Office of Per- given access to records about himself
sonnel Management in accordance with that are subject to this paragraph in
5 CFR 297.106, the Director, Division of response to an oral or written request
Human Resources Management (HFA– and through informal procedures, rath-
400), Food and Drug Administration, er than the procedures specified in
5600 Fishers Lane, Rockville, MD 20857, §§ 21.40 through 21.43.
or the personnel officer in the servicing (2) Employee identity may be
HHS Regional Personnel Office. An em- verified, if necessary, by an FDA ID
ployee may consult with or direct his card rather than in accordance with
or her request to the FDA Privacy Act § 21.44.
Coordinator (HFI–30). Requests for ac- (3) Generally no fee shall be charged
cess to personnel records of former em- for records requested under this para-
ployees that are located in Federal graph. However, in cases where the
Records Centers should be directed to records requested are voluminous, a fee
the Office of Personnel Management. may be charged in accordance with
Requests under the Privacy Act for § 21.45.
amendment of personnel records should (4) Records that are subject to this
be directed to these same officials who paragraph shall be available for access
are responsibile for access to personnel to an individual, except to the extent
records under this paragraph. that access is refused by the Associate
(3) With respect to records subject to Commissioner for Management and Op-
paragraph (b)(1) of this section: erations or his or her designate on the
(i) Refusal to grant access to a grounds that the record is subject to an
record, or refusal to amend a record exemption under § 21.61 or 5 CFR
upon request of an employee, shall only 297.111.
be made by the Associate Commis-
(5) Requests under the Privacy Act
sioner for Management and Operations
for amendment of records subject to
or his or her designate; and
this paragraph should be directed to
(ii) Appeals of refusals under para-
the Director, Division of Human Re-
graph (b)(3)(i) of this section may be
sources Management (HFA–400). Such
made to the Office of Personnel Man-
requests shall be reviewed in accord-
agement in accordance with 5 CFR
ance with subpart E of this part. Re-
297.108(g)(3) and 297.113(b).
fusal to amend a record subject to this
(c) Any other Privacy Act Record
paragraph (d)(5) shall only be made by
Systems that contain personnel
the Associate Commissioner for Man-
records, or records that otherwise con-
agement and Operations or his or her
cern agency employees, that are main-
designate.
tained by offices of the Food and Drug
Administration rather than the Divi- (6) Appeals of refusals under para-
sion of Human Resources Management graph (d) (4) or (5) of this section may
but which are not subject to the De- be made to the Commissioner of Food
partment’s notice for personnel records and Drugs, except where the Associate
in operating offices are subject to this Commissioner for Management and Op-
part, except that refusals under this erations or his or her designate indi-
part to grant access to or amend cates with his or her refusal that the
records about present or former em- appeal should be made to the Office of
ployees shall be made by the Associate Personnel Management.
Commissioner for Management and Op- (7) Disclosures of records subject to
erations rather than the Associate this paragraph are subject to subpart G
Commissioner for Public Affairs. of this part.
(d) The following procedures shall [42 FR 15626, Mar. 22, 1977, as amended at 46
govern requests under the Privacy Act FR 8457, Jan. 27, 1981; 50 FR 52278, Dec. 23,
for personnel records that are main- 1985]

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§ 21.33 21 CFR Ch. I (4–1–11 Edition)

§ 21.33 Medical records. vacy Act Coordinator (HFI–30), Food


and Drug Administration, 5600 Fishers
(a) In general, an individual is enti-
Lane, Rockville, MD 20857.
tled to have access to any medical
(c) Requests shall be in writing and
records about himself in Privacy Act
shall name the Privacy Act Record
Record Systems maintained by the
System or Systems concerning which
Food and Drug Administration.
the individual requests notification of
(b) The Food and Drug Administra-
whether there are records about him
tion may apply the following special
that are retrieved by reference to his
procedures in disclosing medical
name or other personal identifier. To
records to an individual:
help assure a prompt response, an indi-
(1) The agency may review the
vidual should indicate that he is mak-
records to determine whether disclo-
ing a ‘‘Privacy Act Request’’ on the en-
sure of the record to the individual who
velope and in a prominent manner in
is the subject of the records might have
the letter.
an adverse effect on him. If it is deter-
(d) An individual who merely wishes
mined that disclosure is not likely to
to be notified whether a Privacy Act
have an adverse effect on the indi-
Record System contains a record about
vidual, the record shall be disclosed to
him ordinarily need not provide any
him. If it is determined that disclosure
verification of his identity other than
is very likely to have an adverse effect
his name. The mere fact that the Food
on the individual, he may be requested
and Drug Administration has a record
to designate, in writing, a representa-
about an individual in any of its Pri-
tive to whom the record shall be dis-
vacy Act Records Systems would not
closed. Such representative may be a
be likely to constitute a clearly unwar-
physician, other health professional, or
ranted invasion of personal privacy.
other responsible person who would be
Where mere disclosure of the fact that
willing to review the record and discuss
a record about the individual exists
it with the individual.
would be a clearly unwarranted inva-
(2) The availability of the record may
sion of personal privacy, further
be subject to any procedures for disclo-
verification of the identity of the indi-
sure to an individual of medical
vidual shall be required.
records about himself under part 20 of
(e) An individual who requests that
this chapter, in addition to or in lieu of
he be given access to a copy of records
the procedures in paragraph (b)(1), that
about himself, if any exist, should indi-
are not inconsistent with § 21.41(f).
cate whether he prefers (1) to have cop-
ies of any such records mailed to him
Subpart D—Procedures for Notifi- in accordance with § 21.43(a)(1), which
cation of and Access to may involve a fee under § 21.45, includ-
Records in Privacy Act Record ing information to verify his identity
Systems under § 21.44 or (2) to use the procedures
for access in person under § 21.43(a)(2).
§ 21.40 Procedures for submitting re- (f) A request for notification and ac-
quests for notification and access. cess may be submitted under this sub-
(a) An individual may request that part concerning any Privacy Act
the Food and Drug Administration no- Record System that is exempt under
tify him whether a Privacy Act Record § 21.61, as indicated in the notice for the
System contains records about him system. An individual seeking access
that are retrieved by reference to his to records under § 21.65(b)(2) to inves-
name or other personal identifier. An tigatory records compiled for law en-
individual may at the same time, or forcement purposes other than crimi-
after receiving notification that such a nal law enforcement purposes should
record about him exists, requests that submit a description of the right, ben-
he be given access to the record. efit, or privilege that he believes he
(b) An individual desiring notifica- was denied as the result of the Food
tion or access to records shall mail or and Drug Administration’s mainte-
deliver a request for records in any nance of the records. Where the system
Food and Drug Administration Privacy is exempt under § 21.61, and access to
Act Records System to the FDA Pri- the requested records is not granted

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Food and Drug Administration, HHS § 21.42

under § 21.65, the request shall be han- (f) Except as provided in § 21.32, an in-
dled under the provisions of part 20 of dividual’s access to records about him/
this chapter (the public information herself that are retrieved by his/her
regulations). name or other personal identifiers and
[42 FR 15626, Mar. 22, 1977, as amended at 46 contained in any Privacy Act Record
FR 8458, Jan. 27, 1981; 50 FR 52278, Dec. 23, System may only be denied by the As-
1985] sociate Commissioner for Public Af-
fairs or his or her designate. An indi-
§ 21.41 Processing of requests. vidual shall not be denied access to any
(a) An individual or his guardian record that is otherwise available to
under § 21.75 shall not be required to him/her under this part except on the
show any justification or need to ob- grounds that it is exempt under
tain notification under § 21.42 or access § 21.65(a)(2), that it was compiled in rea-
to a record under § 21.43. sonable anticipation of court litigation
(b) The Food and Drug Administra- of formal administrative proceedings,
tion will determine whether a request or to the extent that it is exempt or
by an individual for records about him- prohibited from disclosure because it
self is appropriately treated as a re- includes a trade secret or commercial
quest under this subpart, or under the or financial information that is privi-
provision of part 20 of this chapter (the leged or confidential information the
public information regulations), or disclosure of which would constitute a
both. Where appropriate, the Food and clearly unwarranted invasion of per-
Drug Administration will consult with sonal privacy of another individual.
the individual concerning the appro- (g) The FDA Privacy Act Coordinator
priate treatment of the request. shall ensure that records are main-
(c) The FDA Privacy Act Coordinator tained of the number, status, and dis-
(HFI–30) in the Freedom of Information position of requests under this subpart,
Staff shall be responsibile for the han- including the number of requests for
dling of Privacy Act requests received records exempt from access under this
by the Food and Drug Administration. subpart and other information required
Requests mailed or delivered to any for purposes of the annual report to
other office shall be promptly redi- Congress under the Privacy Act. These
rected to the FDA Privacy Act Coordi- temporary administrative management
nator. Where this procedure would un- records shall not be considered to be
duly delay the agency’s response, how- Privacy Act Record Systems. All
ever, the agency employee who re- records required to be kept under this
ceived the request should consult with paragraph shall only include request-
the FDA Privacy Act Coordinator and ing individuals’ names or personal
obtain advice as to whether the em- identifiers for so long as any request
ployee can respond to the request di- for notification, access, or amendment
rectly. is pending. The identity of individuals
(d) Upon receipt of a request by the making request under this subpart
FDA Privacy Act Coordinator, a record shall be regarded as confidential and
shall promptly be made that a request shall not be disclosed under part 20 of
has been received and the date. this chapter (the public information
(e) A letter in accordance with § 21.42 regulations) to any other person or
responding to the request for notifica- agency except as is necessary for the
tion shall issue as promptly as possible processing of requests under this sub-
after receipt of the request by the Food part.
and Drug Administration. Upon deter-
mination by the Freedom of Informa- [42 FR 15626, Mar. 22, 1977, as amended at 46
tion Staff that a request for access to FR 8458, Jan. 27, 1981]
records is appropriately treated as a re-
quest under part 20 of this chapter § 21.42 Responses to requests.
rather than part 21, or under both (a) The FDA shall respond to an indi-
parts, the time limitations prescribed vidual’s request for notification as to
in § 21.41 shall apply. In any case, ac- whether a Privacy Act Record System
cess to available records shall be pro- contains records about him that are re-
vided as promptly as possible. trieved by his name or other personal

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§ 21.43 21 CFR Ch. I (4–1–11 Edition)

identifier by sending a letter under this were compiled in reasonable anticipa-


paragraph. tion of court litigation or formal ad-
(1) If there are no records about the ministrative proceedings or are other-
individual that are retrieved by his wise not available under § 21.41(b).
name or other personal identifier in Where appropriate, the letter shall also
the named Privacy Act Record System, indicate whether the records are avail-
or the requester is not an ‘‘individual’’ able under part 20 of this chapter (the
under § 21.3(a), the letter shall so state. public information regulations), and it
Where appropriate, the letter shall in- may disclose the records in accordance
dicate that the Food and Drug Admin- with part 20.
istration’s public information regula- (4) If the named Privacy Act Record
tions in part 20 of this chapter pre- System contains records about the in-
scribe general rules governing the dividual that are retrieved by his name
availability of information to members or other personal identifier, but a final
of the public, and that a request may determination has not yet been made
be made in accordance with part 20 of with respect to disclosure of all of the
this chapter for records that are not re- records covered by the request, e.g., be-
trieved by the requester’s name or cause it is necessary to consult another
other personal identifier from a Pri- person or agency having an interest in
vacy Act Record System. the confidentiality of the records, the
(2) If there are records about the indi- letter shall explain the circumstances
vidual that are retrieved by his name and indicate when a final answer will
or other personal identifier and the be given.
named Privacy Act Record System is (b) Except as provided in § 21.32, ac-
not exempt from individual access and cess to a record may only be denied by
contest under § 21.61, or the system is the Associate Commissioner for Public
exempt but access is allowed or re- Affairs or his or her designate. If access
quired under § 21.65, the letter shall in- to any record is denied wholly or in
form him that the records exist and substantial part, the letter shall state
shall either: the right of the individual to appeal to
(i) Enclose a copy of the records the Commissioner of Food and Drugs.
under § 21.43(a)(1) or indicate that the (c) If a request for a copy of the
records will be sent under separate records will result in a fee of more than
cover, where there has been adequate $25, the letter shall specify or estimate
verification of the identity of the indi- the fee involved. Where the individual
vidual under § 21.44 and the fees under has requested a copy of any records
§ 21.45 do not exceed $25, or about him and copying the records
(ii) Inform the individual of the pro- would result in a fee of over $50, the
cedures to obtain access to the records Food and Drug Administration shall
by mail or in person under § 21.43(a)(2), require advance deposit as well as pay-
as well as the approximate dates by ment of any amount not yet received
which the requested records can be pro- as a result of any previous request by
vided (if the records are not then avail- the individual for a record about him-
able), the locations at which access in self, under this subpart or part 20 of
person may be had, and the informa- this chapter (the public information
tion needed, if any, to verify the iden- regulations) before the records are
tity of the individual under § 21.44. made available. If the fee is less than
(3) If the named Privacy Act Record $50, prepayment shall not be required
System contains records about the in- unless payment has not yet been re-
dividual that are retrieved by his name ceived for records disclosed as a result
or other personal identifier, and the of a previous request by the individual
system is exempt from individual ac- for a record about himself under this
cess and contest under § 21.61 and ac- subpart or part 20 of this chapter.
cess is not allowed or required under [42 FR 15626, Mar. 22, 1977, as amended at 46
§ 21.65, the letter should inform him FR 8458, Jan. 27, 1981]
that the records are exempted from ac-
cess and contest by § 21.61. The letter § 21.43 Access to requested records.
shall also inform him if the records (a) Access may be granted to re-
sought are not available because they quested records by:

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Food and Drug Administration, HHS § 21.45

(1) Mailing a copy of the records to No identification shall be required to


the requesting individual, or receive access to information that is
(2) Permitting the requesting indi- required to be disclosed to any member
vidual to review the records in person of the public under part 20 of this chap-
between 9 a.m. and 4 p.m. at the office ter (the public information regula-
of the FDA Privacy Act Coordinator, tions).
at the Freedom of Information Staff (b) An individual who appears in per-
public room at the address shown in son for access to records about himself
§ 20.30 of this chapter, or at any Food shall be required to provide at least
and Drug Administration field office, one document to identify himself, e.g.,
listed in part 5, subpart M of this chap- driver’s license, passport, or alien or
ter, or at another location or time voter registration card to verify his
upon which the Food and Drug Admin- identity. If an individual does not have
istration and the individual agree. Ar- any such document or requests access
rangement for such review can be made to records about himself without ap-
by consultation between the FDA Pri- pearing in person under circumstances
vacy Act Coordinator and the indi- in which his identity cannot be verified
vidual. An individual seeking to review from the request itself, he shall be re-
records in person shall generally be quired to certify in writing that he is
permitted access to the file copy, ex- the individual he claims to be and that
cept that where the records include he understands that the knowing and
nondisclosable information, a copy willful request for or acquisition of a
shall be made of that portion of the record pertaining to an individual
records, with the nondisclosable infor- under false pretenses is a criminal of-
mation blocked out. Where the indi- fense subject to a $5,000 fine.
vidual is not given a copy of the record (c) In making requests under § 21.75, a
to retain, no charge shall be made for parent of a minor child or legal guard-
the cost of copying a record to make it ian of an incompetent individual may
available to an individual who reviews be required to verify his relationship to
a record in person under this para- the minor child or the incompetent in-
graph. dividual, in addition to verifying his
(b) An individual may request that a own identity, by providing a copy of
record be disclosed to or discussed in the minor’s birth certificate, a court
the presence of another individual, order, or other evidence of guardian-
such as an attorney. The individual ship.
may be required to furnish a written (d) Where an individual seeks access
statement authorizing the disclosure to particularly sensitive records, such
or discussion in such other individual’s as medical records, the individual may
presence. be required to provide additional infor-
(c) The Food and Drug Administra- mation beyond that specified in para-
tion will make every reasonable effort graph (b) or (c) of this section, such as
to assure that records made available the individual’s years of attendance at
under this section can be understood a particular educational institution,
by the individual, such as by providing rank attained in the uniformed serv-
an oral or written explanation of the ices, date or place of birth, names of
records. parents, an occupation, or the specific
[42 FR 15626, Mar. 22, 1977, as amended at 46 times the individual received medical
FR 8458, Jan. 27, 1981; 69 FR 17290, Apr. 2, treatment.
2004]
§ 21.45 Fees.
§ 21.44 Verification of identity. (a) Where applicable, fees for copying
(a) An individual seeking access to records shall be charged in accordance
records in a Privacy Act Record Sys- with the schedule set forth in this sec-
tem may be required to comply with tion. Fees may only be charged where
reasonable requirements to enable the an individual has requested that a copy
Food and Drug Administration to de- be made of a record to which he is
termine his identity. The identifica- granted access. No fee may be charged
tion required shall be suitable consid- for making a search of a Privacy Act
ering the nature of the records sought. Record System whether the search is

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§ 21.50 21 CFR Ch. I (4–1–11 Edition)

manual, mechanical, or electronic. ready been the subject of any such pro-
Where a copy of the record must be ceedings.
made to provide access to the record, (2) If the accuracy, relevancy, timeli-
e.g., computer printout where no ness, or completeness of the records
screen reading is available, the copy may be contested in any other pending
shall be made available to the indi- or imminent agency proceeding, the
vidual without cost. Where a medical Food and Drug Administration may
record is made available to a represent- refer the individual to the other pro-
ative designated by the individual ceeding as the appropriate means to
under § 21.33, no fee will be charged. obtain relief. If the accuracy, rel-
(b) The fee schedule is as follows: evance, timeliness, or completeness of
(1) Copying of records susceptible to a record is, or has been, an issue in an-
photocopying—$.10 per page. other agency proceeding, the request
(2) Copying of records not susceptible under this section shall be disposed of
to photocopying, e.g., punch cards or in accordance with the decision in the
magnetic tapes—at actual cost to the other proceeding, absent unusual cir-
determined on a case-by-case basis. cumstances.
(3) No charge will be made if the (c) Requests to amend records shall
total amount of copying for an indi- be submitted, in writing, to the FDA
vidual does not exceed $25. Privacy Act Coordinator in accordance
(c) When a fee is to be assessed, the with § 21.40(b). Such requests shall in-
individual shall be notified prior to the clude information sufficient to enable
processing of the copies, and be given the Food and Drug Administration to
an opportunity to amend his request. locate the record, a brief description of
Payment shall be made by check or the items of information requested to
money order made payable to the be amended, and the reasons why the
‘‘Food and Drug Administration,’’ and record should be amended together
shall be sent to the Accounting Branch with any appropriate documentation or
(HFA–120), Food and Drug Administra- arguments in support of the requested
tion, 5600 Fishers Lane, Rockville, MD amendment. An edited copy of the
20857. Advance deposit shall be required record showing the described amend-
where the total amount exceeds $50. ment may be included. Verification of
[42 FR 15626, Mar. 22, 1977, as amended at 54 identity should be provided in accord-
FR 9038, Mar. 3, 1989] ance with § 21.44.
(d) Written acknowledgement of the
Subpart E—Procedures for Re- receipt of a request to amend a record
shall be provided within 10 working
quests for Amendment of days to the individual who requested
Records the amendment. Such acknowledge-
§ 21.50 Procedures for submitting re- ment may request any additional infor-
quests for amendment of records. mation needed to verify identity or
make a determination. No acknowl-
(a) An individual who received access edgement need be made if the request
to a record about himself under sub- can be reviewed, processed, and the in-
part D of this part may request that dividual notified of the agency’s agree-
the record be amended if he believes ment with the request or refusal within
that the record or an item of informa- the 10-day period.
tion is not accurate, relevant to a Food
and Drug Administration purpose, [42 FR 15626, Mar. 22, 1977, as amended at 46
timely, or complete. FR 8459, Jan. 27, 1981]
(b) Amendments under this subpart
shall not violate existing statute, regu- § 21.51 Responses to requests for
amendment of records.
lation, or administrative procedure.
(1) This subpart does not permit al- (a) The Food and Drug Administra-
teration of evidence presented in the tion shall take one of the following ac-
course of judicial proceedings or Food tions on a request for amendment of
and Drug Administration adjudicatory records as promptly as possible:
or rule making proceedings or collat- (1) Amend any portion of the record
eral attack upon that which has al- which the agency has determined,

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Food and Drug Administration, HHS § 21.52

based upon a preponderance of the evi- under § 21.71(a), provide a copy of the
dence, is not accurate, relevant to a record as amended, to all previous re-
Food and Drug Administration pur- cipients of the record.
pose, timely, or complete, and, in ac-
[42 FR 15626, Mar. 22, 1977, as amended at 46
cordance with paragraph (d)(3) of this
FR 8459, Jan. 27, 1981]
section, inform the individual and pre-
vious recipients of the record that has § 21.52 Administrative appeals of re-
been amended of the amendment. fusals to amend records.
(2) Inform the individual of its re-
fusal to amend any portion of the (a) If an individual disagrees with a
record in the manner requested, the refusal under § 21.51(a)(2) to amend a
reason for the refusal, and the oppor- record, he or she may appeal that re-
tunity for administrative appeal to the fusal to the Commissioner of Food and
Commissioner of Food and Drugs. Ex- Drugs, Rm. 14–71, 5600 Fishers Lane,
cept as provided in § 21.32, such refusal Rockville, MD 20857.
may only be issued by the Associate (b) If, upon appeal, the Commissioner
Commissioner for Public Affairs or his upholds the refusal to amend the
or her designate. record as requested, he shall inform the
(3) Where another agency was the individual:
source of and has control of the record, (1) Of his decision and the reasons for
refer the request to that agency. it.
(b) The agency may, for good cause, (2) Of the individual’s right to file
extend the period for taking action an with the Food and Drug Administra-
additional 30 working days if notice is tion a concise statement of the individ-
provided to the individual explaining ual’s reasons for disagreeing with the
the circumstances of the delay. agency’s decision not to amend the
(c) The officials charged with review- record as requested.
ing a record to determine how to re- (3) That the statement of disagree-
spond to a request to amend it, shall ment will be made available to all per-
assess its accuracy, relevance to a sons listed in an accounting as having
Food and Drug Administration pur- previously received the record and any
pose, timeliness, or completeness. The person to whom the record is subse-
determination shall be made in the
quently disclosed together with, in the
light of the purpose for which the
discretion of the Food and Drug Ad-
records or system is used, the agency’s
ministration, a brief statement sum-
need for the record, and the possible
marizing its reasons for refusing to
adverse consequences to the individual
amend the record. Any individual who
from the record if not amended. When-
includes false information in the state-
ever the Food and Drug Administration
ment of disagreement filed with the
receives a request for deletion of a
record, or portions of a record, it shall Food and Drug Administration may be
consider anew whether the contested subject to penalties under 18 U.S.C.
information in the record is relevant 1001, the False Reports to the Govern-
and necessary to a Food and Drug Ad- ment Act.
ministration purpose. (4) That the individual has a right to
(d) If the Food and Drug Administra- seek judicial review of the refusal to
tion agrees with an individual’s re- amend the record.
quest, it shall take the following ac- (c) If the Commissioner on adminis-
tions: trative appeal or a court on judicial re-
(1) So inform the individual in writ- view determines that the record should
ing. be amended in accordance with the in-
(2) In accordance with statute, regu- dividual’s request, the Food and Drug
lation, or procedure, amend the record Administration shall proceed in ac-
to make it accurate, relevant to a Food cordance with § 21.51(d).
and Drug Administration purpose, (d) A final determination on the indi-
timely, or complete, making note of vidual’s administrative appeal of the
the date and fact of the amendment. initial refusal to amend the record
(3) If an accounting was made under shall be concluded within 30 working
§ 21.71(d) of a disclosure of the record days of the request for such review

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§ 21.53 21 CFR Ch. I (4–1–11 Edition)

under paragraph (a) of this section, un- statement of disagreement and the
less the Commissioner extends such pe- agency statement, if any.
riod for good cause and informs the in-
dividual in writing of the reasons for Subpart F—Exemptions
the delay and of the approximate date
on which a decision of the appeal can § 21.60 Policy.
be expected. It is the policy of the Food and Drug
[42 FR 15626, Mar. 22, 1977, as amended at 50 Administration that record systems
FR 52278, Dec. 23, 1985] should be exempted from the Privacy
Act only to the extent essential to the
§ 21.53 Notation and disclosure of dis- performance of law enforcement func-
puted records. tions under the laws that are adminis-
When an individual has filed a state- tered and enforced by the Food and
ment of disagreement under Drug Administration or that govern
§ 21.52(b)(2), the Food and Drug Admin- the agency.
istration shall: § 21.61 Exempt systems.
(a) Mark any portion of the record
that is disputed to assure that the (a) Investigatory records compiled
record will clearly show that portion is for law enforcement purposes, includ-
disputed whenever the record is dis- ing criminal law enforcement purposes,
closed. in the Food and Drug Administration
Privacy Act Record Systems listed in
(b) In any subsequent disclosure
paragraph (b) of this section are ex-
under § 21.70 or § 21.71(a), provide a copy
empt from the following provisions of
of the statement of disagreement and,
the Privacy Act (5 U.S.C. 552a) and of
if the Food and Drug Administration
this part:
deems it appropriate, a concise state-
(1) Such records are exempt from 5
ment of the agency’s reasons for not U.S.C. 552a(c)(3) and § 21.71(e)(4), requir-
making the amendment(s) requested. ing that an individual be provided with
While the individual shall have access the accounting of disclosures of records
to any such statement, it shall not be about himself from a Privacy Act
subject to a request for amendment Record System.
under § 21.50. (2) Except where access is required
(c) If an accounting was made under under 5 U.S.C. 552a(k)(2) and
§ 21.71(d) and (e) of a disclosure of the § 21.65(a)(2), (such records are exempt
record under § 21.71(a), provide to all from 5 U.S.C. 552a(d)(1) through (4) and
previous recipients of the record a copy (f)) and §§ 21.40 through 21.54, requiring
of the statement of disagreement and procedures for an individual to be given
the agency statement, if any. notification of and access to records
about himself in a Privacy Act Record
§ 21.54 Amended or disputed records
received from other agencies. System and to be allowed to challenge
the accuracy, relevance, timeliness,
Whenever the Food and Drug Admin- and completeness of such records.
istration is notified that a record that (3) Such records are exempt from 5
it received from another agency was U.S.C. 552a(e)(4)(G) and (H) and
amended or is the subject of a state- § 21.20(b)(1) requiring inclusion in the
ment of disagreement, the Food and notice for the system of information
Drug Administration shall: about agency procedures for notifica-
(a) Discard the record, or clearly note tion, access, and contest.
the amendment or the fact of disagree- (4) Such records are exempt from 5
ment in its copy of the record, and U.S.C. 552a(e)(3) requiring that individ-
(b) Refer persons who subsequently uals asked to supply information be
request the record to the agency that provided a form outlining the author-
provided it. ity for the request, the purposes for
(c) If an accounting was made under which the information will be used, the
§ 21.71 (d) and (e) of the disclosure of routine uses in the notice for the Pri-
the record under § 21.71(a), inform all vacy Act Record System, and the con-
previous recipients of the record about sequences to the individual of not pro-
the amendment or provide to them the viding the information, but only with

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Food and Drug Administration, HHS § 21.65

respect to records compiled by the exist and request access to such


Food and Drug Administration in a records where they are retrieved by his
criminal law enforcement investiga- name or other personal identifier.
tion where the conduct of the inves- (b) An individual making a request
tigation would be prejudiced by such under paragraph (a) of this section;
procedures. (1) May be given access to the records
(b) Records in the following Food and where available under part 20 of this
Drug Administration Privacy Act
chapter (the public information regula-
Record Systems that concern individ-
tions) or the Commissioner may, in his
uals who are subject to Food and Drug
discretion, entertain a request under
Administration enforcement action
and consist of investigatory records any or all of the provisions of §§ 21.40
compiled for law enforcement purposes, through 21.54; and
including criminal law enforcement (2) Shall be given access upon request
purposes, are exempt under 5 U.S.C. if the records requested are subject to
552a(j)(2) and (k)(2) from the provisions 5 U.S.C. 552a(k)(2) and not to 5 U.S.C.
enumerated in paragraph (a) of this 552a(j)(2) (i.e., because they consist of
section: investigatory material compiled for
(1) Bio-research Monitoring Informa- law enforcement purposes other than
tion System—HHS/FDA/09–10–0010. criminal law enforcement purposes)
(2) Regulated Industry Employee En- and maintenance of the records re-
forcement Records—HHS/FDA/ACMO/ sulted in denial to the individual of
09–10–002. any right, benefit, or privilege to which
(3) Employee Conduct Investigative he would otherwise be entitled by Fed-
Records—HHS/FDA/ACMO/09–10–0013. eral law, or for which he would other-
(c) The system described in para- wise be eligible. An individual given
graph (b)(3) of this section includes in- access to a record under this paragraph
vestigatory records compiled solely for (b)(2) is not entitled to seek amend-
the purpose of determining suitability,
ment under subpart E of this part. The
eligibility, or qualification for Federal
FDA may refuse to disclose a record
civilian employment, military service,
Federal contracts, and access to classi- that would reveal the identity of a
fied information. These records are ex- source who furnished information to
empt from disclosure under 5 U.S.C. the Government under a promise of
552a(k)(5) to the extent that the disclo- confidentiality, which must be an ex-
sure would reveal the identity of a press promise if the information was
source who furnished information to furnished on or after September 27,
the Government under a promise of 1975. Any individual refused access to a
confidentiality, which must be an ex- record that would reveal a confidential
press promise if the information was source shall be advised in a general
furnished after September 27, 1975. Any way that the record contains informa-
individual who is refused access to a tion that would reveal a confidential
record that would reveal a confidential source.
source shall be advised in a general (c) The Commissioner shall not make
way that the record includes informa- available any record that is prohibited
tion that would reveal a confidential from public disclosure under § 20.82(b)
source. of this chapter.
[42 FR 15626, Mar. 22, 1977, as amended at 46 (d) Discretionary disclosure of a
FR 8459, Jan. 27, 1981; 50 FR 52278, Dec. 23, record pursuant to paragraph (b)(1) of
1985] this section shall not set a precedent
for discretionary disclosure of a simi-
§ 21.65 Access to records in exempt
systems. lar or related record and shall not obli-
gate the Commissioner to exercise his
(a) Where a Privacy Act Record Sys-
discretion to disclose any other record
tem is exempt and the requested
in a system that is exempt under
records are unavailable under § 21.61, an
individual may nevertheless make a re- § 21.61.
quest under § 21.40 for notification con-
cerning whether any records about him

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§ 21.70 21 CFR Ch. I (4–1–11 Edition)

Subpart G—Disclosure of Records § 21.71 Disclosure of records in Pri-


in Privacy Act Record Systems vacy Act Record Systems; account-
ing required.
to Persons Other Than the
(a) Except as provided in § 21.70, a
Subject Individual record about an individual that is con-
§ 21.70 Disclosure and intra-agency tained in a Privacy Act Record System
use of records in Privacy Act shall not be disclosed by any method of
Record Systems; no accounting re- communication except under any of
quired. the following circumstances, which are
subject to the limitations of para-
(a) A record about an individual graphs (b) and (c) of this section and to
which is contained in a Privacy Act the accounting requirement of para-
Record System may be disclosed: graph (d) of this section:
(1) To the individual who is the sub- (1) To those officers and employees of
ject of the record, or his legal guardian the agency which maintains the record
under § 21.75; who have a need for the record in the
(2) To a third party pursuant to a perfomance of their duties;
written request by, or within a written (2) Required under section 552 of the
consent of, the individual to whom the Freedom of Information Act;
record pertains, or his legal guardian (3) For a routine use as described in
under § 21.75; the routine use section of each specific
(3) To any person: system notice;
(i) Where the names and other identi- (4) To the Bureau of Census for pur-
poses of planning or carrying out a cen-
fying information are first deleted, and
sus or survey or related activity pursu-
under circumstances in which the re-
ant to the provisions of title 13 of the
cipient is unlikely to know the iden-
U.S. Code;
tity of the subject of the record; (5) To a recipient who has provided
(ii) Where disclosure is required by the agency with advance adequate
part 20 of this chapter (the public infor- written assurance that the record will
mation regulations); or be used solely as a statistical research
(4) Within the Department of Health or reporting record, and that the
and Human Services to officers and em- record is to be transferred in a form
ployees who have a need for the record that is not individually identifiable;
in the performance of their duties in (6) To the National Archives and
connection with the laws administered Records Administration of the United
and enforced by the Food and Drug Ad- States as a record which has sufficient
ministration or that govern the agen- historical or other value to warrant its
cy. For purposes of this section, offi- continued preservation by the U.S.
cers or employees of the Department Government, or to the Archivist of the
shall include the following categories United States or his or her designee for
of individuals, who shall thereafter be evaluation to determine whether the
subject to the same restrictions with record has such value;
(7) To another agency or to an instru-
respect to disclosure as any Food and
mentality of any government jurisdic-
Drug Administration employee: Food
tion within or under the control of the
and Drug Administration consultants
United States for a civil or criminal
and advisory committees, State and law enforcement activity if the activ-
local government employees for use ity is authorized by law, and if the
only in their work with the Food and head of the agency or instrumentality
Drug Administration, and contractors has made a written request to the
and their employees to the extent that agency which maintains the record
the records of such contractors are sub- specifying the particular portion de-
ject to the requirements of this part sired and the law enforcement activity
under § 21.30. for which the record is sought;
(b) No accounting is required for any (8) To a person pursuant to a showing
disclosure or use under paragraph (a) of of compelling circumstances affecting
this section. the health or safety of an individual if,
upon such disclosure, notification is

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Food and Drug Administration, HHS § 21.72

transmitted to the last known address (e) Where an accounting is required


of such individual; under paragraph (d) of this section, the
(9) To either House of Congress or, to Food and Drug Administration shall:
the extent of matter within its juris- (1) Record the name and address of
diction, any committee or sub- the person or agency to whom the dis-
committee thereof, any joint com- closure is made and the date, nature,
mittee of Congress or subcommittee of and purpose of the disclosure. The ac-
any such joint committee; counting shall not be considered a Pri-
(10) To the Comptroller General, or vacy Act Record System.
any of his or her authorized representa- (2) Retain the accounting for 5 years
tives in the course of the performance or for the life of the record, whichever
of the duties of the General Accounting is longer, following the disclosure.
(3) Notify those recipients listed in
Office;
the accounting of amendments or dis-
(11) Pursuant to the order of a court
putes concerning the records pre-
of competent jurisdiction; or viously disclosed to them pursuant to
(12) To a consumer reporting agency § 21.51(d)(3), § 21.53(c), or § 21.54(c).
in accordance with section 3(d) of the (4) Except when the record is exempt
Federal Claims Collection Act of 1966 from individual access and contest
(31 U.S.C. 952(d)). (This ‘‘Special Disclo- under § 21.61 or to the extent that the
sure’’ statement does not apply to any accounting describes a transfer for a
FDA system of records.) law enforcement purpose pursuant to
(b) The Food and Drug Administra- paragraph (a)(7) of this section, make
tion may in its discretion refuse to the accounting available to the indi-
make a disclosure permitted under vidual to whom the record pertains, in
paragraph (a) of this section, if the dis- accordance with procedures of subpart
closure would in the judgment of the D of this part.
agency, invade the privacy of the indi- (f) A single accounting may be used
vidual or be inconsistent with the pur- to cover disclosure(s) that consist of a
pose for which the information was col- continuing dialogue between two agen-
lected. cies over a prolonged period, such as
(c) The Food and Drug Administra- discussion of an enforcement action be-
tion may require any person requesting tween the Food and Drug Administra-
a disclosure of a record under para- tion and the Department of Justice. In
graph (a) of this section to provide: such cases, a general notation may be
(1) Information about the purposes to made that, as of a certain date, con-
which the disclosed record is to be put, tract was initiated, to continue until
and resolution of the matter.
(2) A written statement certifying [42 FR 15626, Mar. 22, 1977, as amended at 50
that the record will be used only for FR 52278, Dec. 23, 1985; 54 FR 9038, Mar. 3,
the stated purposes and will not be fur- 1989]
ther disclosed without the written per-
mission of the Food and Drug Adminis- § 21.72 Individual consent to disclo-
sure of records to other persons.
tration.
(a) Individuals may consent to disclo-
Under 5 U.S.C. 552a(i)(3), any person sure of records about themselves to
who knowingly or willfully requests or other persons in several ways, for ex-
obtains any record concerning an indi- ample:
vidual from an agency under false pre- (1) An individual may give consent at
tenses shall be guilty of a misdemeanor the time that the information is col-
and fined not more than $5,000. Such lected for disclosure for specific pur-
person may also be subject to prosecu- poses or to specific persons.
tion under the False Reports to the (2) An individual may give consent
Government Act, 18 U.S.C. 1001. for disclosure of his records to a spe-
(d) An accounting shall be made, in cific person.
accordance with paragraph (e) of this (3) An individual may request the
section, of any disclosure under para- Food and Drug Administration to tran-
graph (a) of this section of a record scribe a specific record for submission
that is not a disclosure under § 21.70. to another person.

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§ 21.73 21 CFR Ch. I (4–1–11 Edition)

(b) In each case the consent shall be the agency, if one has been prepared, of
in writing and shall specify the indi- the reasons for not making the amend-
vidual, organizational unit, or class of ment(s) requested.
individuals or organizational units to
whom the record may be disclosed, § 21.75 Rights of legal guardians.
which record may be disclosed, and, if For the purposes of this part, the par-
applicable, for what time period. A ent of any individual who is a minor or
blanket consent to release all of an in- the legal guardian of any individual
dividual’s records to unspecified indi- who has been declared to be incom-
viduals or organizational units will not
petent due to physical or mental inca-
be honored. Verification of the identity
pacity or age by a court of competent
of the individual and, where applicable,
jurisdiction may act on behalf of the
of the person to whom the record is to
individual.
be disclosed shall be made in accord-
ance with § 21.44. Consent documents
shall be retained for a period of at least PART 25—ENVIRONMENTAL
2 years. If such documents are used as IMPACT CONSIDERATIONS
a means of accounting for the disclo-
sure, they shall be retained as provided Subpart A—General Provisions
in § 21.71(e)(2).
Sec.
§ 21.73 Accuracy, completeness, timeli- 25.1 Purpose.
ness, and relevance of records dis- 25.5 Terminology.
closed from Privacy Act Record 25.10 Policies and NEPA planning.
Systems.
(a) The Food and Drug Administra- Subpart B—Agency Actions Requiring
tion shall make reasonable efforts to Environmental Consideration
assure that a record about an indi- 25.15 General procedures.
vidual in a Privacy Act Record System 25.16 Public health and safety emergencies.
is accurate, relevant to a Food and 25.20 Actions requiring preparation of an
Drug Administration purpose, timely, environmental assessment.
and complete before such record is dis- 25.21 Extraordinary circumstances.
closed under § 21.71. 25.22 Actions requiring the preparation of
(b) Paragraph (a) of this section shall an environmental impact statement.
not apply to disclosures that are re-
quired under part 20 of this chapter Subpart C—Categorical Exclusions
(the public information regulations) or
25.30 General.
made to other Federal Government de-
25.31 Human drugs and biologics.
partments and agencies. Where appro- 25.32 Foods, food additives, and color addi-
priate, the letter disclosing the infor- tives.
mation shall indicate that the Food 25.33 Animal drugs.
and Drug Administration has not re- 25.34 Devices and electronic products.
viewed the record to assure that it is
accurate, relevant, timely, and com- Subpart D—Preparation of Environmental
plete. Documents
§ 21.74 Providing notice that a record 25.40 Environmental assessments.
is disputed. 25.41 Findings of no significant impact.
Whenever an individual has filed a 25.42 Environmental impact statements.
statement of disagreement with the 25.43 Records of decision.
Food and Drug Administration con- 25.44 Lead and cooperating agencies.
cerning a refusal to amend a record 25.45 Responsible agency official.
under § 21.51(a)(2) or with another agen-
Subpart E—Public Participation and
cy that provides the record to the Food
Notification of Environmental Documents
and Drug Administration, the Food and
Drug Administration shall in any sub- 25.50 General information.
sequent disclosure under this subpart 25.51 Environmental assessments and find-
provide a copy of the statement of dis- ings of no significant impact.
agreement and a concise statement by 25.52 Environmental impact statements.

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Food and Drug Administration, HHS § 25.5

Subpart F—Other Requirements (5) Environmental assessment (EA)


(40 CFR 1508.9).
25.60 Environmental effects abroad of major
agency actions.
(6) Environmental document (40 CFR
1508.10).
AUTHORITY: 21 U.S.C. 321–393; 42 U.S.C. 262, (7) Environmental impact statement
263b–264; 42 U.S.C. 4321, 4332; 40 CFR parts
(EIS) (40 CFR 1508.11).
1500–1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971
Comp., p. 531–533 as amended by E.O. 11991, 42 (8) Federal agency (40 CFR 1508.12).
FR 26967, 3 CFR, 1978 Comp., p. 123–124 and (9) Finding of no significant impact
E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. (40 CFR 1508.13).
356–360. (10) Human environment (40 CFR
SOURCE: 62 FR 40592, July 29, 1997, unless 1508.14).
otherwise noted. (11) Lead agency (40 CFR 1508.16).
(12) Legislation (40 CFR 1508.17).
Subpart A—General Provisions (13) Major Federal action (40 CFR
1508.18).
§ 25.1 Purpose. (14) Mitigation (40 CFR 1508.20).
The National Environmental Policy (15) NEPA process (40 CFR 1508.21).
Act of 1969 (NEPA), as amended, directs (16) Notice of intent (40 CFR 1508.22).
that, to the fullest extent possible, the (17) Proposal (40 CFR 1508.23).
policies, regulations, and public laws of (18) Scope (40 CFR 1508.25).
the United States shall be interpreted (19) Significantly (40 CFR 1508.27).
and administered in accordance with (b) The following terms are defined
the policies set forth in NEPA. All solely for the purpose of implementing
agencies of the Federal Government the supplemental procedures provided
shall comply with the procedures in by this part and are not necessarily ap-
section 102(2) of NEPA except where plicable to any other statutory or regu-
compliance would be inconsistent with latory requirements:
other statutory requirements. The reg- (1) Abbreviated application applies to
ulations in this part implement section an abbreviated new drug application
102(2) of NEPA in a manner that is con- and an abbreviated new animal drug
sistent with FDA’s authority under the application.
Federal Food, Drug, and Cosmetic Act (2) Active moiety means the molecule
and the Public Health Service Act. or ion, excluding those appended por-
This part also supplements the regula- tions of the molecule that cause the
tions for implementing the procedural drug to be an ester, salt (including a
provisions of NEPA that were pub- salt with hydrogen or coordination
lished by the Council on Environ- bonds), or other noncovalent derivative
mental Quality (CEQ) in 40 CFR parts (such as a complex chelate or clath-
1500 through 1508 and the procedures in- rate) of the molecule responsible for
cluded in the ‘‘HHS General Adminis- the physiological or pharmacological
tration Manual, part 30: Environmental action of the drug substance.
Protection’’ (45 FR 76519 to 76534, No- (3) Agency means the Food and Drug
vember 19, 1980). Administration (FDA).
(4) Increased use of a drug or biologic
§ 25.5 Terminology. product may occur if the drug will be
(a) Definitions that apply to the administered at higher dosage levels,
terms used in this part are set forth in for longer duration or for different in-
the CEQ regulations under 40 CFR part dications than were previously in ef-
1508. The terms and the sections of 40 fect, or if the drug is a new molecular
CFR part 1508 in which they are defined entity. The term ‘‘use’’ also encom-
follow: passes disposal of FDA-regulated arti-
(1) Categorical exclusion (40 CFR cles by consumers.
1508.4). (5) Responsible agency official means
(2) Cooperating agency (40 CFR the agency decisionmaker designated
1508.5). in the delegated authority for the un-
(3) Cumulative impact (40 CFR derlying actions.
1508.7). (c) The following acronyms are used
(4) Effects (40 CFR 1508.8). in this part:

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§ 25.10 21 CFR Ch. I (4–1–11 Edition)

(1) CEQ—Council on Environmental from an applicant or petitioner an EA


Quality. or a claim that a categorical exclusion
(2) CGMP—Current good manufac- applies, or when FDA personnel consult
turing practice. with applicants or petitioners on the
(3) EA—Environmental assessment. NEPA-related aspects of their re-
(4) EIS—Environmental impact state- quested actions. FDA may issue a pub-
ment. lic call for environmental data or oth-
(5) The act—Federal Food, Drug, and erwise consult with affected individ-
Cosmetic Act. uals or groups when a contemplated ac-
(6) FIFRA—Federal Insecticide, Fun- tion in which it is or may be involved
gicide, and Rodenticide Act. poses potential significant environ-
(7) FONSI—Finding of no significant mental effects.
impact.
(d) Environmental documents shall
(8) GLP—Good laboratory practice.
concentrate on timely and significant
(9) GRAS—Generally recognized as
issues, not amass needless detail.
safe.
(10) HACCP—Hazard analysis critical (e) If a proposed action for which an
control point. EIS will be prepared involves possible
(11) IDE—Investigational device ex- environmental effects that are required
emption. to be considered under statutes or Ex-
(12) IND—Investigational new drug ecutive Orders other than those re-
application. ferred to under ‘‘Authority’’ in this
(13) INAD—Investigational new ani- part, these effects shall be considered
mal drug application. in the NEPA review, consistent with 40
(14) NADA—New animal drug applica- CFR 1502.25 and the HHS General Ad-
tion. ministration Manual, part 30: Environ-
(15) NDA—New drug application. mental Protection.
(16) NEPA—National Environmental
Policy Act of 1969. Subpart B—Agency Actions Re-
(17) OTC—Over-the-counter.
(18) PDP—Product development pro-
quiring Environmental Consid-
tocol. eration
(19) PMA—Premarket approval appli-
§ 25.15 General procedures.
cation.
(a) All applications or petitions re-
[62 FR 40592, July 29, 1997, as amended at 64
FR 399, Jan. 5, 1999; 69 FR 17291, Apr. 2, 2004] questing agency action require the sub-
mission of an EA or a claim of categor-
§ 25.10 Policies and NEPA planning. ical exclusion. A claim of categorical
(a) All FDA’s policies and programs exclusion shall include a statement of
will be planned, developed, and imple- compliance with the categorical exclu-
mented to achieve the policies declared sion criteria and shall state that to the
by NEPA and required by CEQ’s regula- applicant’s knowledge, no extraor-
tions to ensure responsible stewardship dinary circumstances exist. Failure to
of the environment for present and fu- submit an adequate EA for an applica-
ture generations. tion or petition requesting action by
(b) Assessment of environmental fac- the agency of a type specified in § 25.20,
tors continues throughout planning unless the agency can determine that
and is integrated with other program the action qualifies for exclusion under
planning at the earliest possible time §§ 25.30, 25.31, 25.32, 25.33, or 25.34, is suf-
to ensure that planning and decisions ficient grounds for FDA to refuse to
reflect environmental values, to avoid file or approve the application or peti-
delays later in the process, and to tion. An EA adequate for filing is one
avoid potential conflicts. that addresses the relevant environ-
(c) For actions initiated by the agen- mental issues. An EA adequate for ap-
cy, the NEPA process will begin when proval is one that contains sufficient
the agency action under consideration information to enable the agency to de-
is first identified. For actions initiated termine whether the proposed action
by applicants or petitioners, NEPA may significantly affect the quality of
planning begins when FDA receives the human environment.

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Food and Drug Administration, HHS § 25.20

(b) The responsible agency officials § 25.20 Actions requiring preparation


will evaluate the information con- of an environmental assessment.
tained in the EA to determine whether Any proposed action of a type speci-
it is accurate and objective, whether fied in this section ordinarily requires
the proposed action may significantly at least the preparation of an EA, un-
affect the quality of the human envi- less it is an action in a specific class
ronment, and whether an EIS will be that qualifies for exclusion under
prepared. If significant effects requir- §§ 25.30, 25.31, 25.32, 25.33, or 25.34:
ing the preparation of an EIS are iden- (a) Major recommendations or re-
tified, FDA will prepare an EIS for the ports made to Congress on proposals
action in accordance with the proce- for legislation in instances where the
dures in subparts D and E of this part. agency has primary responsibility for
If significant effects requiring the the subject matter involved.
preparation of an EIS are not identi- (b) Destruction or other disposition
fied, resulting in a decision not to pre- of articles condemned after seizure or
pare an EIS, the responsible agency of- whose distribution or use has been en-
ficial will prepare a FONSI in accord- joined, unless categorically excluded in
ance with § 25.41. §§ 25.30(d) or 25.32(h).
(c) Classes of actions that individ- (c) Destruction or other disposition
ually or cumulatively do not signifi- of articles following detention or recall
cantly affect the quality of the human at agency request, unless categorically
environment ordinarily are excluded excluded in §§ 25.30(d) or 25.32(h).
from the requirement to prepare an EA (d) Disposition of FDA laboratory
or an EIS. The classes of actions that waste materials, unless categorically
excluded in § 25.30(m).
qualify as categorical exclusions are
set forth in §§ 25.30, 25.31, 25.32, 25.33, or (e) Intramural and extramural re-
search supported in whole or in part
25.34.
through contracts, other agreements,
(d) A person submitting an applica- or grants, unless categorically ex-
tion or petition of a type subject to cluded in § 25.30 (e) or (f).
categorical exclusion under §§ 25.30, (f) Establishment by regulation of la-
25.31, 25.32, 25.33, or 25.34, or proposing beling requirements, a standard, or a
to dispose of an article as provided in monograph, unless categorically ex-
§ 25.30(d) or 25.32(h), is not required to cluded in §§ 25.30(k) or 25.31 (a), (b), (c),
submit an EA if the person states that (h), (i), or (j), or 25.32 (a) or (p).
the action requested qualifies for a cat- (g) Issuance, amendment, and en-
egorical exclusion, citing the par- forcement of FDA regulations, or an
ticular categorical exclusion that is exemption or variance from FDA regu-
claimed, and states that to the appli- lations, unless categorically excluded
cant’s knowledge, no extraordinary cir- in § 25.30 (h), (i), or (j), or § 25.32 (e), (g),
cumstances exist. (n), or (p).
(h) Withdrawal of existing approvals
§ 25.16 Public health and safety emer- of FDA-approved articles, unless cat-
gencies. egorically excluded in §§ 25.31 (d) or (k),
There are certain regulatory actions 25.32(m), or 25.33 (g) or (h).
that, because of their immediate im- (i) Approval of food additive petitions
portance to the public health or safety, and color additive petitions, approval
may make full adherence to the proce- of requests for exemptions for inves-
dural provisions of NEPA and CEQ’s tigational use of food additives, the
regulations impossible. For such ac- granting of requests for exemption
tions, the responsible agency official from regulation as a food additive
shall consult with CEQ about alter- under § 170.39 of this chapter, and al-
lowing notifications submitted under
native arrangements before the action
21 U.S.C. 348(h) to become effective, un-
is taken, or after the action is taken, if
less categorically excluded in § 25.32(b),
time does not permit prior consulta-
(c), (i), (j), (k), (l), (o), (q), or (r).
tion with CEQ.
(j) Establishment of a tolerance for
unavoidable poisonous or deleterious

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§ 25.21 21 CFR Ch. I (4–1–11 Edition)

substances in food or in packaging ma- protection under some other Federal


terials to be used for food. law.
(k) Affirmation of a food substance as
GRAS for humans or animals, on § 25.22 Actions requiring the prepara-
FDA’s initiative or in response to a pe- tion of an environmental impact
tition, under parts 182, 184, 186, or 582 of statement.
this chapter and establishment or (a) There are no categories of agency
amendment of a regulation for a prior- actions that routinely significantly af-
sanctioned food ingredient, as defined fect the quality of the human environ-
in §§ 170.3(l) and 181.5(a) of this chapter, ment and that therefore ordinarily re-
unless categorically excluded in § 25.32 quire the preparation of an EIS.
(f), (k), or (r). (b) EIS’s are prepared for agency ac-
(l) Approval of NDA’s, abbreviated tions when evaluation of data or infor-
applications, applications for mar- mation in an EA or otherwise available
keting approval of a biologic product, to the agency leads to a finding by the
supplements to such applications, and responsible agency official that a pro-
actions on IND’s, unless categorically posed action may significantly affect
excluded in § 25.31 (a), (b), (c), (e), or (l). the quality of the human environment.
(m) Approval of NADA’s, abbreviated
applications, supplements, actions on Subpart C—Categorical
INAD’s, and granting of requests for Exclusions
determination of eligibility for index-
ing, unless categorically excluded § 25.30 General.
under § 25.33 (a), (c), (d), or (e). The classes of actions listed in this
(n) Approval of PMA’s for medical de- section and §§ 25.31 through 25.34 are
vices, notices of completion of PDP’s categorically excluded and, therefore,
for medical devices, authorizations to ordinarily do not require the prepara-
commence clinical investigation under tion of an EA or an EIS:
an approved PDP, or applications for (a) Routine administrative and man-
an IDE, unless categorically excluded agement activities, including inspec-
in § 25.34. tions, and issuance of field compliance
[62 FR 40592, July 29, 1997, as amended at 65 programs, program circulars, or field
FR 30355, May 11, 2000; 72 FR 69118, Dec. 6, investigative assignments.
2007] (b) Recommendation for an enforce-
ment action to be initiated in a Fed-
§ 25.21 Extraordinary circumstances. eral court.
As required under 40 CFR 1508.4, FDA (c) Agency requests for initiation of
will require at least an EA for any spe- recalls.
cific action that ordinarily would be (d) Destruction or disposition of any
excluded if extraordinary cir- FDA-regulated article condemned after
cumstances indicate that the specific seizure or the distribution or use of
proposed action may significantly af- which has been enjoined or following
fect the quality of the human environ- detention or recall at agency request if
ment (see 40 CFR 1508.27 for examples the method of destruction or disposi-
of significant impacts). Examples of tion of the article, including packaging
such extraordinary circumstances in- material, is in compliance with all
clude: Federal, State, and local requirements.
(a) Actions for which available data (e) Extramural contracts, other
establish that, at the expected level of agreements, or grants for statistical
exposure, there is the potential for se- and epidemiological studies, surveys
rious harm to the environment; and and inventories, literature searches,
(b) Actions that adversely affect a and report and manual preparation, or
species or the critical habitat of a spe- any other studies that will not result
cies determined under the Endangered in the production or distribution of any
Species Act or the Convention on substance and, therefore, will not re-
International Trade in Endangered sult in the introduction of any sub-
Species of Wild Flora and Fauna to be stance into the environment.
endangered or threatened or wild flora (f) Extramural contracts, other
or fauna that are entitled to special agreements, and grants for research for

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Food and Drug Administration, HHS § 25.31

such purposes as to develop analytical ministered by FDA, if the waste is dis-


methods or other test methodologies. posed of in compliance with all applica-
(g) Activities of voluntary Federal- ble Federal, State, and local require-
State cooperative programs, including ments.
issuance of model regulations proposed
for State adoption. [62 FR 40592, July 29, 1997, as amended at 65
FR 56479, Sept. 19, 2000]
(h) Issuance, amendment, or revoca-
tion of procedural or administrative
§ 25.31 Human drugs and biologics.
regulations and guidance documents,
including procedures for submission of The classes of actions listed in this
applications for product development, section are categorically excluded and,
testing and investigational use, and ap- therefore, ordinarily do not require the
proval. preparation of an EA or an EIS:
(i) Corrections and technical changes (a) Action on an NDA, abbreviated
in regulations. application, application for marketing
(j) Issuance of CGMP regulations, approval of a biologic product, or a
HACCP regulations, establishment supplement to such applications, or ac-
standards, emergency permit control tion on an OTC monograph, if the ac-
regulations, GLP regulations, and tion does not increase the use of the
issuance or denial of permits, exemp- active moiety.
tions, variances, or stays under these
(b) Action on an NDA, abbreviated
regulations.
application, or a supplement to such
(k) Establishment or repeal by regu-
lation of labeling requirements for applications, or action on an OTC
marketed articles if there will be no in- monograph, if the action increases the
crease in the existing levels of use or use of the active moiety, but the esti-
change in the intended uses of the mated concentration of the substance
product or its substitutes. at the point of entry into the aquatic
(l) Routine maintenance and minor environment will be below 1 part per
construction activities such as: billion.
(1) Repair to or replacement of equip- (c) Action on an NDA, abbreviated
ment or structural components (e.g., application, application for marketing
door, roof, or window) of facilities con- approval of a biologic product, or a
trolled by FDA; supplement to such applications, or ac-
(2) Lease extensions, renewals, or tion on an OTC monograph, for sub-
succeeding leases; stances that occur naturally in the en-
(3) Construction or lease construc- vironment when the action does not
tion of 10,000 square feet or less of oc- alter significantly the concentration or
cupiable space; distribution of the substance, its me-
(4) Relocation of employees into ex- tabolites, or degradation products in
isting owned or currently leased space; the environment.
(5) Acquisition of 20,000 square feet or (d) Withdrawal of approval of an NDA
less of occupiable space in a structure
or an abbreviated application.
that was substantially completed be-
fore the issuance of solicitation for of- (e) Action on an IND.
fers; and (f) Testing and release by the Food
(6) Acquisition of between 20,000 and Drug Administration of lots or
square feet and 40,000 square feet of oc- batches of a licensed biologic product.
cupiable space if it constitutes less (g) Establishment of bioequivalence
than 40 percent of the occupiable space requirements for a human drug or a
in a structure that was substantially comparability determination for a bio-
completed before the solicitation for logic product subject to licensing.
offers. (h) Issuance, revocation, or amend-
(m) Disposal of low-level radioactive ment of a standard for a biologic prod-
waste materials (as defined in the Nu- uct.
clear Regulatory Commission regula- (i) Revocation of a license for a bio-
tions at 10 CFR 61.2) and chemical logic product.
waste materials generated in the lab-
oratories serviced by the contracts ad-

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§ 25.32 21 CFR Ch. I (4–1–11 Edition)

(j) Action on an application for mar- than 5 percent-by-weight and is ex-


keting approval for marketing of a bio- pected to remain with finished food-
logic product for transfusable human packaging material through use by
blood or blood components and plasma. consumers or when the substance is a
[62 FR 40592, July 29, 1997, as amended at 63
component of a coating of a finished
FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; food-packaging material.
70 FR 14980, Mar. 24, 2005] (j) Approval of a food additive peti-
tion or GRAS affirmation petition, the
§ 25.32 Foods, food additives, and color granting of a request for exemption
additives. from regulation as a food additive
The classes of actions listed in this under § 170.39 of this chapter, or allow-
section are categorically excluded and, ing a notification submitted under 21
therefore, ordinarily do not require the U.S.C. 348(h) to become effective, when
preparation of an EA or an EIS: the substance is to be used as a compo-
(a) Issuance, amendment, or repeal of nent of a food-contact surface of per-
a food standard. manent or semipermanent equipment
(b) Action on a request for exemption or of another food-contact article in-
for investigational use of a food addi- tended for repeated use.
tive if the food additive to be shipped (k) Approval of a food additive peti-
under the request is intended to be tion, color additive petition, or GRAS
used for clinical studies or research. affirmation petition, or allowing a no-
(c) Approval of a color additive peti- tification submitted under 21 U.S.C.
tion to change a provisionally listed 348(h) to become effective, for sub-
color additive to permanent listing for stances added directly to food that are
use in food, drugs, devices, or cos- intended to remain in food through in-
metics. gestion by consumers and that are not
(d) Testing and certification of intended to replace macronutrients in
batches of a color additive. food.
(e) Issuance of an interim food addi- (l) Approval of a petition for color ad-
tive regulation. ditives used in contact lenses, sutures,
(f) Affirmation of a food substance as filaments used as supporting haptics in
GRAS for humans or animals on FDA’s intraocular lenses, bone cement, and in
initiative or in response to a petition, other FDA-regulated products having
under parts 182, 184, 186, or 582 of this similarly low levels of use.
chapter, and establishment or amend- (m) Action to prohibit or otherwise
ment of a regulation for a prior-sanc- restrict or reduce the use of a sub-
tioned food ingredient, as defined in stance in food, food packaging, or cos-
§§ 170.3(l) and 181.5(a) of this chapter, if metics.
the substance or food ingredient is al- (n) Issuance, amendment, or revoca-
ready marketed in the United States tion of a regulation pertaining to in-
for the proposed use. fant formulas.
(g) Issuance and enforcement of regu- (o) Approval of a food additive peti-
lations relating to the control of com- tion for the intended expression prod-
municable diseases or to interstate uct(s) present in food derived from new
conveyance sanitation under parts 1240 plant varieties.
and 1250 of this chapter. (p) Issuance, amendment, or revoca-
(h) Approval of a request for diver- tion of a regulation in response to a
sion of adulterated or misbranded food reference amount petition as described
for humans or animals to use as animal in § 101.12(h) of this chapter, a nutrient
feeds. content claim petition as described in
(i) Approval of a food additive peti- § 101.69 of this chapter, a health claim
tion or GRAS affirmation petition, the petition as described in § 101.70 of this
granting of a request for exemption chapter, or a petition pertaining to the
from regulation as a food additive label declaration of ingredients as de-
under § 170.39 of this chapter, or allow- scribed in § 101.103 of this chapter.
ing a notification submitted under 21 (q) Approval of a food additive peti-
U.S.C. 348(h) to become effective, when tion, the granting of a request for ex-
the substance is present in finished emption from regulation as a food ad-
food-packaging material at not greater ditive under § 170.39 of this chapter, or

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Food and Drug Administration, HHS § 25.34

allowing a notification submitted stances that occur naturally in the en-


under 21 U.S.C. 348(h) to become effec- vironment when the action does not
tive for a substance registered by the alter significantly the concentration or
Environmental Protection Agency distribution of the substance, its me-
under FIFRA for the same use re- tabolites, or degradation products in
quested in the petition, request for ex- the environment.
emption, or notification. (d) Action on an NADA, abbreviated
(r) Approval of a food additive peti- application, request for determination
tion, color additive, GRAS affirmation of eligibility for indexing, a supple-
petition, or allowing a notification sub- ment to such applications, or a modi-
mitted under 21 U.S.C. 348(h) to become fication of an index listing, for:
effective for a substance that occurs (1) Drugs intended for use in nonfood
naturally in the environment, when animals;
the action does not alter significantly (2) Anesthetics, both local and gen-
the concentration or distribution of eral, that are individually adminis-
the substance, its metabolites, or deg- tered;
radation products in the environment. (3) Nonsystemic topical and oph-
[62 FR 40592, July 29, 1997, as amended at 65 thalmic animal drugs;
FR 30355, May 11, 2000] (4) Drugs for minor species, including
wildlife and endangered species, when
§ 25.33 Animal drugs. the drug has been previously approved
The classes of actions listed in this for use in another or the same species
section are categorically excluded and, where similar animal management
therefore, ordinarily do not require the practices are used; and
preparation of an EA or an EIS: (5) Drugs intended for use under pre-
(a) Action on an NADA, abbreviated scription or veterinarian’s order for
application, request for determination therapeutic use in terrestrial species.
of eligibility for indexing, a supple- (e) Action on an INAD.
ment to such applications, or a modi- (f) Action on an application sub-
fication of an index listing, if the ac- mitted under section 512(m) of the act.
tion does not increase the use of the (g) Withdrawal of approval of an
drug. Actions to which this categorical NADA or an abbreviated NADA or re-
exclusion applies may include: moval of a new animal drug from the
(1) An animal drug to be marketed index.
under the same conditions of approval (h) Withdrawal of approval of a food
as a previously approved animal drug; additive petition that reduces or elimi-
(2) A combination of previously ap- nates animal feed uses of a food addi-
proved animal drugs; tive.
(3) A new premix or other formula- [62 FR 40592, July 29, 1997, as amended at 71
tion of a previously approved animal FR 74782, Dec. 13, 2006; 72 FR 69119, Dec. 6,
drug; 2007]
(4) Changes specified in § 514.8(b)(3),
(b)(4), or (c)(3) of this chapter; § 25.34 Devices and electronic prod-
(5) A change of sponsor; ucts.
(6) A previously approved animal The classes of actions listed in this
drug to be contained in medicated feed section are categorically excluded and,
blocks under § 510.455 of this chapter or therefore, ordinarily do not require the
as a liquid feed supplement under § 558.5 preparation of an EA or an EIS:
of this chapter; or (a) Action on a device premarket no-
(7) Approval of a drug for use in ani- tification submission under subpart E
mal feeds if such drug has been ap- of part 807 of this chapter.
proved under § 514.2 or 514.9 of this (b) Classification or reclassification
chapter for other uses. of a device under part 860 of this chap-
(b) [Reserved] ter, including the establishment of spe-
(c) Action on an NADA, abbreviated cial controls, if the action will not re-
application, request for determination sult in increases in the existing levels
of eligibility for indexing, a supple- of use of the device or changes in the
ment to such applications, or a modi- intended use of the device or its sub-
fication of an index listing, for sub- stitutes.

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§ 25.40 21 CFR Ch. I (4–1–11 Edition)

(c) Issuance, amendment, or repeal of FDA-regulated articles and shall be a


a standard for a class II medical device concise, objective, and well-balanced
or an electronic product, and issuance document that allows the public to un-
of exemptions or variances from such a derstand the agency’s decision. If po-
standard. tentially adverse environmental im-
(d) Approval of a PMA or a notice of pacts are identified for an action or a
completion of a PDP or amended or group of related actions, the EA shall
supplemental applications or notices discuss any reasonable alternative
for a class III medical device if the de- course of action that offers less envi-
vice is of the same type and for the ronmental risk or that is environ-
same use as a previously approved de- mentally preferable to the proposed ac-
vice. tion. The use of a scientifically justi-
(e) Changes in the PMA or a notice of fied tiered testing approach, in which
completion of a PDP for a class III testing may be stopped when the re-
medical device that do not require sub- sults suggest that no significant im-
mission of an amended or supplemental
pact will occur, is an acceptable ap-
application or notice.
proach.
(f) Issuance of a restricted device reg-
ulation if it will not result in increases (b) Generally, FDA requires an appli-
in the existing levels of use or changes cant to prepare an EA and make nec-
in the intended uses of the product or essary corrections to it. Ultimately,
its substitutes. FDA is responsible for the scope and
(g) Action on an application for an content of EA’s and may include addi-
IDE or an authorization to commence a tional information in environmental
clinical investigation under an ap- documents when warranted.
proved PDP. (c) Information concerning the na-
(h) Issuance of a regulation exempt- ture and scope of information that an
ing from preemption a requirement of applicant or petitioner shall submit in
a State or political subdivision con- an EA may be obtained from the center
cerning a device, or a denial of an ap- or other office of the agency having re-
plication for such exemption. sponsibility for the action that is the
(i) Approval of humanitarian device subject of the environmental evalua-
exemption under subpart H of part 814 tion. Applicants and petitioners are en-
of this chapter. couraged to submit proposed protocols
[62 FR 40592, July 29, 1997, as amended at 70 for environmental studies for technical
FR 69277, Nov. 15, 2005] review by agency staff. Applicants and
petitioners also are encouraged to con-
Subpart D—Preparation of sult applicable FDA EA guidance docu-
ments, which provide additional advice
Environmental Documents on how to comply with FDA regula-
§ 25.40 Environmental assessments. tions.
(d) Consistent with 40 CFR 1500.4(j)
(a) As defined by CEQ in 40 CFR
and 1502.21, EA’s may incorporate by
1508.9, an EA is a concise public docu-
ment that serves to provide sufficient reference information presented in
evidence and analysis for an agency to other documents that are available to
determine whether to prepare an EIS FDA and to the public.
or a FONSI. The EA shall include brief (e) The agency evaluates the infor-
discussions of the need for the pro- mation contained in an EA and any
posal, of alternatives as required by public input to determine whether it is
section 102(2)(E) of NEPA, of the envi- accurate and objective, whether the
ronmental impacts of the proposed ac- proposed action may significantly af-
tion and alternatives, and a listing of fect the quality of the human environ-
agencies and persons consulted. An EA ment, and whether an EIS or a FONSI
shall be prepared for each action not will be prepared. The responsible agen-
categorically excluded in §§ 25.30, 25.31, cy official examines the environmental
25.32, 25.33, or 25.34. The EA shall focus risks of the proposed action and the al-
on relevant environmental issues relat- ternative courses of action, selects a
ing to the use and disposal from use of course of action, and ensures that any

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Food and Drug Administration, HHS § 25.45

necessary mitigating measures are im- § 25.43 Records of decision.


plemented as a condition for approving
(a) In cases requiring environmental
the selected course of action.
impact statements, at the time of its
[62 FR 40592, July 29, 1997, as amended at 69 decision, the agency shall prepare a
FR 17291, Apr. 2, 2004] concise public record of decision.
(b) The record of decision shall:
§ 25.41 Findings of no significant im-
pact. (1) State what the decision was;
(2) Identify and discuss alternatives
(a) As defined by the CEQ regulations considered by the agency in reaching
(40 CFR 1508.13), a FONSI is a document its decision;
prepared by a Federal agency stating (3) State whether all practicable
briefly why an action, not otherwise means to avoid or minimize environ-
excluded, will not significantly affect
mental harm have been adopted, and if
the human environment and for which,
not, why not; and
therefore, an EIS will not be prepared.
A FONSI includes the EA or a sum- (4) Summarize the program for moni-
mary of it and a reference to any other toring and enforcing the practicable
related environmental documents. means adopted to avoid or minimize
(b) The agency official(s) responsible the environmental harm.
for approving the FONSI will sign the § 25.44 Lead and cooperating agencies.
document, thereby establishing that
the official(s) approve(s) the conclusion For actions requiring the preparation
not to prepare an EIS for the action of an EIS, FDA and other affected Fed-
under consideration. eral agencies will agree which will be
the lead agency and which will be the
§ 25.42 Environmental impact state- cooperating agencies. The responsibil-
ments. ities of lead agencies and cooperating
(a) As defined by CEQ regulations (40 agencies are described in the CEQ regu-
CFR 1508.11) and section 102(2)(C) of lations (40 CFR 1501.5 and 1501.6, respec-
NEPA, an EIS should be a clear, con- tively). If an action affects more than
cise, and detailed written statement one center within FDA, the Commis-
describing: sioner of Food and Drugs will designate
(1) The environmental impacts of a one of these units to be responsible for
proposed action; coordinating the preparation of any re-
(2) Any adverse effects that cannot be quired environmental documentation.
avoided if the action is implemented;
(3) Alternatives to the action; § 25.45 Responsible agency official.
(4) The relationship between local (a) The responsible agency official
short-term uses of the environment prepares the environmental documents
and the maintenance and enhancement or ensures that they are prepared.
of long-term productivity; and (b) The responsible agency official
(5) Any irreversible and irretrievable will weigh any environmental impacts
commitments of resources that would of each alternative course of action, in-
be involved in the proposed action cluding possible mitigation measures,
should it be implemented. and will balance environmental im-
(b) The CEQ regulations (40 CFR pacts with the agency’s objectives in
1501.7 and part 1502) describe the proc- choosing an appropriate course of ac-
ess for determining the scope of an EIS tion. The weighing of any environ-
and provide detailed requirements for mental impacts of alternatives in se-
the preparation of draft and final lecting a final course of action will be
EIS’s. CEQ format and procedures for reflected in the agency’s record of for-
preparing EIS shall be followed. mal decisionmaking as required by 40
(c) Under the conditions prescribed in CFR 1505.2.
40 CFR 1502.9, the agency will prepare a
supplement for a draft or final EIS and [62 FR 40592, July 29, 1997, as amended at 69
introduce the supplement into the ad- FR 17291, Apr. 2, 2004]
ministrative record.

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§ 25.50 21 CFR Ch. I (4–1–11 Edition)

Subpart E—Public Participation in a confidential section and shall sum-


and Notification of Environ- marize the confidential data and infor-
mental Documents mation in the EA to the extent pos-
sible.
§ 25.50 General information. (b) FONSI’s and EA’s will be avail-
able to the public in accordance with 40
(a) To the extent actions are not pro-
CFR 1506.6 as follows:
tected from disclosure by existing law
(1) When the proposed action is the
applicable to the agency’s operation,
subject of a notice of proposed rule-
FDA will involve the public in pre-
paring and implementing its NEPA making or a notice of filing published
procedures and will provide public no- in the FEDERAL REGISTER, the notice
tice of NEPA-related hearings, public shall state that no EIS is necessary
meetings, and the availability of envi- and that the FONSI and the EA are
ronmental documents. available for public inspection at
(b) Many FDA actions involving in- FDA’s Division of Dockets Manage-
vestigations, review, and approval of ment. If the responsible agency official
applications, and premarket notifica- is unable to complete environmental
tions for human drugs, animal drugs, consideration of the proposed action
biologic products, and devices are pro- before a notice of filing of a food or
tected from disclosure under the Trade color additive petition is required to be
Secret Act, 18 U.S.C. 1905, and 301(j) of published under the act, and if the sub-
the act. These actions are also pro- sequent environmental analysis leads
tected from disclosure under FDA’s to the conclusion that no EIS is nec-
regulations including part 20, essary, the final regulation rather than
§§ 312.130(a), 314.430(b), 514.11(b), the notice of filing shall state that no
514.12(a), 601.50(a), 601.51(a), 807.95(b), EIS is necessary and that the FONSI
812.38(a), and 814.9(b) of this chapter. and the EA are available upon request
Even the existence of applications for and filed in FDA’s Division of Dockets
human drugs, animal drugs, biologic Management.
products, and devices is protected from (2) For actions for which notice is not
disclosure under these regulations. published in the FEDERAL REGISTER,
Therefore, unless the existence of ap- the FONSI and the EA shall be made
plications for human drugs, animal available to the public upon request ac-
drugs, biologic products, or premarket cording to the procedures in 40 CFR
notification for devices has been made 1506.6.
publicly available, the release of the (3) For a limited number of actions,
environmental document before ap- the agency may make the FONSI and
proval of human drugs, animal drugs, EA available for public review (includ-
biologic products, and devices is incon- ing review by State and areawide infor-
sistent with statutory requirements mation clearinghouses) for 30 days be-
imposed on FDA. Appropriate environ- fore the agency makes its final deter-
mental documents, comments, and re- mination whether to prepare an EIS
sponses will be included in the admin- and before the action may begin, as de-
istrative record to the extent allowed scribed in 40 CFR 1501.4(e). This proce-
by applicable laws. dure will be followed when the pro-
posed action is, or is closely similar to,
§ 25.51 Environmental assessments one that normally requires an EIS or
and findings of no significant im- when the proposed action is one with-
pact. out precedent.
(a) Data and information that are
protected from disclosure by 18 U.S.C. § 25.52 Environmental impact state-
1905 or 21 U.S.C. 331(j) or 360j(c) shall ments.
not be included in the portion of envi- (a) If FDA determines that an EIS is
ronmental documents that is made necessary for an action involving in-
public. When such data and informa- vestigations or approvals for drugs,
tion are pertinent to the environ- animal drugs, biologic products, or de-
mental review of a proposed action, an vices, an EIS will be prepared but will
applicant or petitioner shall submit become available only at the time of
such data and information separately the approval of the product. Disclosure

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Food and Drug Administration, HHS § 25.60

will be made in accordance with 40 CFR with or otherwise involved in an FDA


1506.6 and part 20 of this chapter. The activity.
EIS will in all other respects conform (3) The export of products (or emis-
to the requirements for EIS’s as speci- sions) that in the United States are
fied in 40 CFR part 1502 and 1506.6(f). prohibited or strictly regulated be-
(b) Comments on the EIS may be sub- cause their effects on the environment
mitted after the approval of the drug, create a serious public health risk.
animal drug, biologic product, or de-
(4) Potential environmental effects
vice. Those comments can form the
on natural and ecological resources of
basis for the agency to consider begin-
ning an action to withdraw the ap- global importance designated under the
proval of applications for a drug, ani- Executive Order.
mal drug, or biologic product, or to (b) Before deciding on any action
withdraw premarket notifications or falling into the categories specified in
premarket approval applications for paragraph (a) of this section, the re-
devices. sponsible agency official shall deter-
(c) In those cases where the existence mine, in accordance with section 2–3 of
of applications and premarket notifica- the Executive Order, whether such ac-
tions for drugs, animal drugs, biologic tions may have a significant environ-
products, or devices has already been mental effect abroad.
disclosed before the agency approves (c) If the responsible agency official
the action, the agency will make dili- determines that an action may have a
gent effort (40 CFR 1506.6) to involve significant environmental effect
the public in preparing and imple- abroad, the responsible agency official
menting the NEPA procedures for
shall determine, in accordance with
EIS’s while following its own disclo-
section 2–4 (a) and (b) of the Executive
sure requirements including those list-
ed in part 20, §§ 312.130(b), 314.430(d), Order, whether the subject action calls
514.11(d), 514.12(b), 601.51(d), 807.95(e), for:
812.38(b), and 814.9(d) of this chapter. (1) An EIS;
(d) Draft and final EIS’s, comments, (2) A bilateral or multilateral envi-
and responses will be included in the ronmental study; or
administrative record and will be (3) A concise environmental review.
available from the Division of Dockets (d) In preparing environmental docu-
Management (HFA–305), Food and Drug ments under this subpart, the respon-
Administration, 5630 Fishers Lane, rm. sible official shall:
1061, Rockville, MD 20852. (1) Determine, as provided in section
[62 FR 40592, July 29, 1997, as amended at 68 2–5 of the Executive Order, whether
FR 24879, May 9, 2003] proposed actions are subject to the ex-
emptions, exclusions, and modification
Subpart F—Other Requirements in contents, timing, and availability of
documents.
§ 25.60 Environmental effects abroad (2) Coordinate all communications
of major agency actions.
with foreign governments concerning
(a) In accordance with Executive environmental agreements and other
Order 12114, ‘‘Environmental Effects arrangements in implementing the Ex-
Abroad of Major Federal Actions’’ of ecutive Order.
January 4, 1979 (44 FR 1957, January 9,
1979), the responsible agency official, in
analyzing actions under his or her pro-
gram, shall consider the environmental
effects abroad, including whether the
actions involve:
(1) Potential environmental effects
on the global commons and areas out-
side the jurisdiction of any nation, e.g.,
oceans and the upper atmosphere.
(2) Potential environmental effects
on a foreign nation not participating

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Pt. 26 21 CFR Ch. I (4–1–11 Edition)

PART 26—MUTUAL RECOGNITION 26.33 Product coverage.


26.34 Regulatory authorities.
OF PHARMACEUTICAL GOOD 26.35 Length and purpose of transition pe-
MANUFACTURING PRACTICE RE- riod.
PORTS, MEDICAL DEVICE QUAL- 26.36 Listing of CAB’s.
26.37 Confidence building activities.
ITY SYSTEM AUDIT REPORTS, AND 26.38 Other transition period activities.
CERTAIN MEDICAL DEVICE 26.39 Equivalence assessment.
PRODUCT EVALUATION REPORTS: 26.40 Start of the operational period.
UNITED STATES AND THE EURO- 26.41 Exchange and endorsement of quality
system evaluation reports.
PEAN COMMUNITY 26.42 Exchange and endorsement of product
evaluation reports.
Sec. 26.43 Transmission of quality system eval-
26.0 General. uation reports.
26.44 Transmission of product evaluation re-
Subpart A—Specific Sector Provisions for ports.
Pharmaceutical Good Manufacturing 26.45 Monitoring continued equivalence.
Practices 26.46 Listing of additional CAB’s.
26.47 Role and composition of the Joint Sec-
26.1 Definitions. toral Committee.
26.2 Purpose. 26.48 Harmonization.
26.3 Scope. 26.49 Regulatory cooperation.
26.4 Product coverage. 26.50 Alert system and exchange of
26.5 Length of transition period. postmarket vigilance reports.
26.6 Equivalence assessment.
APPENDIX A TO SUBPART B—RELEVANT LEGIS-
26.7 Participation in the equivalence assess-
LATION, REGULATIONS, AND PROCEDURES.
ment and determination.
APPENDIX B TO SUBPART B—SCOPE OF PROD-
26.8 Other transition activities.
UCT COVERAGE.
26.9 Equivalence determination.
APPENDICES C–F TO SUBPART B [RESERVED]
26.10 Regulatory authorities not listed as
currently equivalent.
Subpart C—‘‘Framework’’ Provisions
26.11 Start of operational period.
26.12 Nature of recognition of inspection re- 26.60 Definitions.
ports. 26.61 Purpose of this part.
26.13 Transmission of postapproval inspec- 26.62 General obligations.
tion reports. 26.63 General coverage of this part.
26.14 Transmission of preapproval inspec- 26.64 Transitional arrangements.
tion reports. 26.65 Designating authorities.
26.15 Monitoring continued equivalence. 26.66 Designation and listing procedures.
26.16 Suspension. 26.67 Suspension of listed conformity as-
26.17 Role and composition of the Joint Sec- sessment bodies.
toral Committee. 26.68 Withdrawal of listed conformity as-
26.18 Regulatory collaboration. sessment bodies.
26.19 Information relating to quality as- 26.69 Monitoring of conformity assessment
pects. bodies.
26.20 Alert system. 26.70 Conformity assessment bodies.
26.21 Safeguard clause. 26.71 Exchange of information.
APPENDIX A TO SUBPART A—LIST OF APPLICA- 26.72 Sectoral contact points.
BLE LAWS, REGULATIONS, AND ADMINIS- 26.73 Joint Committee.
TRATIVE PROVISIONS. 26.74 Preservation of regulatory authority.
APPENDIX B TO SUBPART A—LIST OF AU- 26.75 Suspension of recognition obligations.
THORITIES. 26.76 Confidentiality.
APPENDIX C TO SUBPART A—INDICATIVE LIST 26.77 Fees.
OF PRODUCTS COVERED BY SUBPART A. 26.78 Agreements with other countries.
APPENDIX D TO SUBPART A—CRITERIA FOR AS- 26.79 Territorial application.
SESSING EQUIVALENCE FOR POST- AND 26.80 Entry into force, amendment, and ter-
PREAPPROVAL. mination.
APPENDIX E TO SUBPART A—ELEMENTS TO BE 26.81 Final provisions.
CONSIDERED IN DEVELOPING A TWO-WAY AUTHORITY: 5 U.S.C. 552; 15 U.S.C. 1453, 1454,
ALERT SYSTEM. 1455; 18 U.S.C. 1905; 21 U.S.C. 321, 331, 351, 352,
355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h,
Subpart B—Specific Sector Provisions for 360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 393;
Medical Devices 42 U.S.C. 216, 241, 242l, 262, 264, 265.
26.31 Purpose. SOURCE: 63 FR 60141, Nov. 6, 1998, unless
26.32 Scope. otherwise noted.

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Food and Drug Administration, HHS § 26.1

§ 26.0 General. (b) Equivalence of the regulatory sys-


This part substantially reflects rel- tems means that the systems are suffi-
evant provisions of the framework ciently comparable to assure that the
agreement and its sectoral annexes on process of inspection and the ensuing
pharmaceutical good manufacturing inspection reports will provide ade-
practices (GMP’s) and medical devices quate information to determine wheth-
of the ‘‘Agreement on Mutual Recogni- er respective statutory and regulatory
tion Between the United States of requirements of the authorities have
America and the European Commu- been fulfilled. Equivalence does not re-
nity’’ (the MRA), signed at London May quire that the respective regulatory
18, 1998. For codification purposes, cer- systems have identical procedures.
tain provisions of the MRA have been (c) Good Manufacturing Practices
modified for use in this part. This (GMP’s). [The United States has clari-
modification is done for purposes of fied its interpretation that under the
clarity only and shall not affect the MRA, paragraph (c)(1) of this section
text of the MRA concluded between the has to be understood as the U.S. defini-
United States and the European Com- tion and paragraph (c)(2) as the EC def-
munity (EC), or the rights and obliga- inition.]
tions of the United States or the EC
(1) GMP’s mean the requirements
under that agreement. Whereas the
found in the legislations, regulations,
parties to the MRA are the United
States and EC, this part is relevant and administrative provisions for
only to the Food and Drug Administra- methods to be used in, and the facili-
tion’s (FDA’s) implementation of the ties or controls to be used for, the man-
MRA, including the sectoral annexes ufacturing, processing, packing, and/or
reflected in subparts A and B of this holding of a drug to assure that such
part. This part does not govern imple- drug meets the requirements as to safe-
mentation of the MRA by the EC, ty, and has the identity and strength,
which will implement the MRA in ac- and meets the quality and purity char-
cordance with its internal procedures, acteristics that it purports or is rep-
nor does this part address implementa- resented to possess.
tion of the MRA by other concerned (2) GMP’s are that part of quality as-
U.S. Federal agencies. For purposes of surance which ensures that products
this part, the terms ‘‘party’’ or ‘‘par- are consistently produced and con-
ties,’’ where relevant to FDA’s imple- trolled to quality standards. For the
mentation of the MRA, should be con- purpose of this subpart, GMP’s include,
sidered as referring to FDA only. If the therefore, the system whereby the
parties to the MRA subsequently manufacturer receives the specifica-
amend or terminate the MRA, FDA tions of the product and/or process
will modify this part accordingly, from the marketing authorization/
using appropriate administrative pro-
product authorization or license holder
cedures.
or applicant and ensures the product is
made in compliance with its specifica-
Subpart A—Specific Sector Provi- tions (qualified person certification in
sions for Pharmaceutical the EC).
Good Manufacturing Prac- (d) Inspection means an onsite evalua-
tices tion of a manufacturing facility to de-
termine whether such manufacturing
§ 26.1 Definitions.
facility is operating in compliance
(a) Enforcement means action taken with GMP’s and/or commitments made
by an authority to protect the public as part of the approval to market a
from products of suspect quality, safe- product.
ty, and effectiveness or to assure that
(e) Inspection report means the writ-
products are manufactured in compli-
ten observations and GMP’s compli-
ance with appropriate laws, regula-
tions, standards, and commitments ance assessment completed by an au-
made as part of the approval to market thority listed in appendix B of this sub-
a product. part.

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§ 26.2 21 CFR Ch. I (4–1–11 Edition)

(f) Regulatory system means the body nary immunologicals (under 9 CFR
of legal requirements for GMP’s, in- 101.2, ‘‘veterinary immunologicals’’ are
spections, and enforcements that en- referred to as ‘‘veterinary biologicals’’)
sure public health protection and legal are excluded from the scope of this sub-
authority to assure adherence to these part. Human plasma derivatives (such
requirements. as immunoglobulins and albumin), in-
[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5,
vestigational medicinal products/new
1999] drugs, human radiopharmaceuticals,
and medicinal gases are also excluded
§ 26.2 Purpose. during the transition phase; their situ-
The provisions of this subpart govern ation will be reconsidered at the end of
the exchange between the parties and the transition period. Products regu-
normal endorsement by the receiving lated by the Food and Drug Adminis-
regulatory authority of official good tration’s Center for Biologics Evalua-
manufacturing practices (GMP’s) in- tion and Research or Center for Drug
spection reports after a transitional pe- Evaluation and Research as devices are
riod aimed at determination of the not covered under this subpart.
equivalence of the regulatory systems (c) Appendix C of this subpart con-
of the parties, which is the cornerstone tains an indicative list of products cov-
of this subpart. ered by this subpart.
[63 FR 60141, Nov. 6, 1998, as amended at 70
§ 26.3 Scope. FR 14980, Mar. 24, 2005]
(a) The provisions of this subpart
shall apply to pharmaceutical inspec- § 26.5 Length of transition period.
tions carried out in the United States A 3-year transition period will start
and Member States of the European immediately after the effective date
Community (EC) before products are described in § 26.80(a).
marketed (hereafter referred to as
‘‘preapproval inspections’’) as well as § 26.6 Equivalence assessment.
during their marketing (hereafter re- (a) The criteria to be used by the par-
ferred to as ‘‘postapproval inspec- ties to assess equivalence are listed in
tions’’). appendix D of this subpart. Informa-
(b) Appendix A of this subpart names tion pertaining to the criteria under
the laws, regulations, and administra- European Community (EC) competence
tive provisions governing these inspec- will be provided by the EC.
tions and the good manufacturing prac- (b) The authorities of the parties will
tices (GMP’s) requirements. establish and communicate to each
(c) Appendix B of this subpart lists other their draft programs for assess-
the authorities participating in activi- ing the equivalence of the respective
ties under this subpart. regulatory systems in terms of quality
(d) Sections 26.65, 26.66, 26.67, 26.68, assurance of the products and con-
26.69, and 26.70 of subpart C of this part sumer protection. These programs will
do not apply to this subpart. be carried out, as deemed necessary by
the regulatory authorities, for post-
§ 26.4 Product coverage. and preapproval inspections and for
(a) The provisions of this subpart will various product classes or processes.
apply to medicinal products for human (c) The equivalence assessment shall
or animal use, intermediates and start- include information exchanges (includ-
ing materials (as referred to in the Eu- ing inspection reports), joint training,
ropean Community (EC)) and to drugs and joint inspections for the purpose of
for human or animal use, biological assessing regulatory systems and the
products for human use, and active authorities’ capabilities. In conducting
pharmaceutical ingredients (as referred the equivalence assessment, the parties
to in the United States), only to the will ensure that efforts are made to
extent they are regulated by the au- save resources.
thorities of both parties as listed in ap- (d) Equivalence assessment for au-
pendix B of this subpart. thorities added to appendix B of this
(b) Human blood, human plasma, subpart after the effective date de-
human tissues and organs, and veteri- scribed in § 26.80(a) will be conducted as

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Food and Drug Administration, HHS § 26.12

described in this subpart, as soon as its provisions apply to inspection re-


practicable. ports generated by authorities listed as
equivalent for the inspections per-
§ 26.7 Participation in the equivalence formed in their territory.
assessment and determination. (b) In addition, when an authority is
The authorities listed in appendix B not listed as equivalent based on ade-
of this subpart will actively participate quate experience gained during the
in these programs to build a sufficient transition period, the Food and Drug
body of evidence for their equivalence Administration (FDA) will accept for
determination. Both parties will exer- normal endorsement (as provided in
cise good faith efforts to complete § 26.12) inspection reports generated as
equivalence assessment as expedi- a result of inspections conducted joint-
tiously as possible to the extent the re- ly by that authority on its territory
sources of the authorities allow. and another authority listed as equiva-
lent, provided that the authority of the
§ 26.8 Other transition activities. Member State in which the inspection
As soon as possible, the authorities is performed can guarantee enforce-
will jointly determine the essential in- ment of the findings of the inspection
formation which must be present in in- report and require that corrective
spection reports and will cooperate to measures be taken when necessary.
develop mutually agreed inspection re- FDA has the option to participate in
port format(s). these inspections, and based on experi-
ence gained during the transition pe-
§ 26.9 Equivalence determination. riod, the parties will agree on proce-
(a) Equivalence is established by hav- dures for exercising this option.
ing in place regulatory systems cov- (c) In the European Community (EC),
ering the criteria referred to in appen- the qualified person will be relieved of
dix D of this subpart, and a dem- responsibility for carrying the controls
onstrated pattern of consistent per- laid down in Article 22 paragraph 1(b)
formance in accordance with these cri- of Council Directive 75/319/EEC (see ap-
teria. A list of authorities determined pendix A of this subpart) provided that
as equivalent shall be agreed to by the these controls have been carried out in
Joint Sectoral Committee at the end of the United States and that each batch/
the transition period, with reference to lot is accompanied by a batch certifi-
any limitation in terms of inspection cate (in accordance with the World
type (e.g., postapproval or preapproval) Health Organization Certification
or product classes or processes. Scheme on the Quality of Medicinal
(b) The parties will document insuffi- Products) issued by the manufacturer
cient evidence of equivalence, lack of certifying that the product complies
opportunity to assess equivalence or a with requirements of the marketing
determination of nonequivalence, in authorization and signed by the person
sufficient detail to allow the authority responsible for releasing the batch/lot.
being assessed to know how to attain
equivalence. § 26.12 Nature of recognition of inspec-
tion reports.
§ 26.10 Regulatory authorities not list- (a) Inspection reports (containing in-
ed as currently equivalent. formation as established under § 26.8),
Authorities not currently listed as including a good manufacturing prac-
equivalent, or not equivalent for cer- tice (GMP) compliance assessment,
tain types of inspections, product prepared by authorities listed as equiv-
classes or processes may apply for re- alent, will be provided to the authority
consideration of their status once the of the importing party. Based on the
necessary corrective measures have determination of equivalence in light
been taken or additional experience is of the experience gained, these inspec-
gained. tion reports will normally be endorsed
by the authority of the importing
§ 26.11 Start of operational period. party, except under specific and delin-
(a) The operational period shall start eated circumstances. Examples of such
at the end of the transition period and circumstances include indications of

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§ 26.13 21 CFR Ch. I (4–1–11 Edition)

material inconsistencies or inadequa- § 26.15 Monitoring continued equiva-


cies in an inspection report, quality de- lence.
fects identified in the postmarket sur- Monitoring activities for the purpose
veillance or other specific evidence of of maintaining equivalence shall in-
serious concern in relation to product clude review of the exchange of inspec-
quality or consumer safety. In such tion reports and their quality and
cases, the authority of the importing timeliness; performance of a limited
party may request clarification from number of joint inspections; and the
the authority of the exporting party conduct of common training sessions.
which may lead to a request for rein-
spection. The authorities will endeavor § 26.16 Suspension.
to respond to requests for clarification (a) Each party has the right to con-
in a timely manner. test the equivalence of a regulatory au-
(b) Where divergence is not clarified thority. This right will be exercised in
in this process, an authority of the im- an objective and reasoned manner in
porting country may carry out an in- writing to the other party.
spection of the production facility. (b) The issue shall be discussed in the
Joint Sectoral Committee promptly
§ 26.13 Transmission of postapproval upon such notification. Where the
inspection reports. Joint Sectoral Committee determines
that verification of equivalence is re-
Postapproval good manufacturing quired, it may be carried out jointly by
practice (GMP) inspection reports con- the parties in a timely manner, under
cerning products covered by this sub- § 26.6.
part will be transmitted to the author- (c) Efforts will be made by the Joint
ity of the importing country within 60- Sectoral Committee to reach unani-
calendar days of the request. Should a mous consent on the appropriate ac-
new inspection be needed, the inspec- tion. If agreement to suspend is
tion report will be transmitted within reached in the Joint Sectoral Com-
90-calendar days of the request. mittee, an authority may be suspended
immediately thereafter. If no agree-
§ 26.14 Transmission of preapproval ment is reached in the Joint Sectoral
inspection reports. Committee, the matter is referred to
(a) A preliminary notification that the Joint Committee as described in
an inspection may have to take place § 26.73. If no unanimous consent is
will be made as soon as possible. reached within 30 days after such noti-
(b) Within 15-calendar days, the rel- fication, the contested authority will
evant authority will acknowledge re- be suspended.
(d) Upon the suspension of authority
ceipt of the request and confirm its
previously listed as equivalent, a party
ability to carry out the inspection. In
is no longer obligated to normally en-
the European Community (EC), re-
dorse the inspection reports of the sus-
quests will be sent directly to the rel-
pended authority. A party shall con-
evant authority, with a copy to the Eu-
tinue to normally endorse the inspec-
ropean Agency for the Evaluation of tion reports of that authority prior to
Medicinal Products (EMEA). If the au- suspension, unless the authority of the
thority receiving the request cannot receiving party decides otherwise based
carry out the inspection as requested, on health or safety considerations. The
the requesting authority shall have the suspension will remain in effect until
right to conduct the inspection. unanimous consent has been reached
(c) Reports of preapproval inspec- by the parties on the future status of
tions will be sent within 45-calendar that authority.
days of the request that transmitted
the appropriate information and de- § 26.17 Role and composition of the
tailed the precise issues to be addressed Joint Sectoral Committee.
during the inspection. A shorter time (a) A Joint Sectoral Committee is set
may be necessary in exceptional cases up to monitor the activities under both
and these will be described in the re- the transitional and operational phases
quest. of this subpart.

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Food and Drug Administration, HHS Pt. 26, Subpt. A, App. A

(b) The Joint Sectoral Committee § 26.20 Alert system.


will be cochaired by a representative of (a) The details of an alert system will
the Food and Drug Administration be developed during the transitional
(FDA) for the United States and a rep- period. The system will be maintained
resentative of the European Commu- in place at all times. Elements to be
nity (EC) who each will have one vote. considered in developing such a system
Decisions will be taken by unanimous are described in appendix E of this sub-
consent. part.
(c) The Joint Sectoral Committee’s (b) Contact points will be agreed be-
functions will include: tween both parties to permit authori-
(1) Making a joint assessment, which ties to be made aware with the appro-
must be agreed by both parties, of the priate speed in case of quality defect,
equivalence of the respective authori- recalls, counterfeiting, and other prob-
ties; lems concerning quality, which could
necessitate additional controls or sus-
(2) Developing and maintaining the
pension of the distribution of the prod-
list of equivalent authorities, including uct.
any limitation in terms of inspecting
type or products, and communicating § 26.21 Safeguard clause.
the list to all authorities and the Joint Each party recognizes that the im-
Committee; porting country has a right to fulfill
(3) Providing a forum to discuss its legal responsibilities by taking ac-
issues relating to this subpart, includ- tions necessary to ensure the protec-
ing concerns that an authority may be tion of human and animal health at the
no longer equivalent and opportunity level of protection it deems appro-
to review product coverage; and priate. This includes the suspension of
(4) Consideration of the issue of sus- the distribution, product detention at
pension. the border of the importing country,
(d) The Joint Sectoral Committee withdrawal of the batches and any re-
shall meet at the request of either quest for additional information or in-
party and, unless the cochairs other- spection as provided in § 26.12.
wise agree, at least once each year. The APPENDIX A TO SUBPART A OF PART 26—
Joint Committee will be kept informed LIST OF APPLICABLE LAWS, REGULA-
of the agenda and conclusions of meet- TIONS, AND ADMINISTRATIVE PROVI-
ings of the Joint Sectoral Committee. SIONS

§ 26.18 Regulatory collaboration. 1. For the European Community (EC):

(a) The parties and authorities shall [Copies of EC documents may be obtained
from the European Document Research, 1100
inform and consult one another, as per-
17th St. NW., suite 301, Washington, DC 20036.
mitted by law, on proposals to intro- EC documents may be viewed on the Euro-
duce new controls or to change existing pean Commission Pharmaceuticals Units
technical regulations or inspection web site at http://dg3.eudra.org.]
procedures and to provide the oppor- Council Directive 65/65/EEC of 26 January
1965 on the approximation of provisions laid
tunity to comment on such proposals.
down by law, regulation, or administrative
(b) The parties shall notify each action relating to proprietary medicinal
other in writing of any changes to ap- products as extended, widened, and amended.
pendix B of this subpart. Council Directive 75/319/EEC of 20 May 1975
on the approximation of provisions laid down
§ 26.19 Information relating to quality by law, regulation or administrative action
aspects. relating to proprietary medicinal products
as extended, widened and amended.
The authorities will establish an ap- Council Directive 81/851/EEC of 28 September
propriate means of exchanging infor- 1981 on the approximation of the laws of the
mation on any confirmed problem re- Member States relating to veterinary medic-
ports, corrective actions, recalls, re- inal products, as widened and amended.
Commission Directive 91/356/EEC of 13 June
jected import consignments, and other 1991 laying down the principles and guide-
regulatory and enforcement problems lines of good manufacturing practice for me-
for products subject to this subpart. dicinal products for human use.

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Pt. 26, Subpt. A, App. B 21 CFR Ch. I (4–1–11 Edition)
Commission Directive 91/412/EEC of 23 July veterinary use: Ministerio de Agricultura,
1991 laying down the principles and guide- Pesca y Alimentación (MAPA), Dirección
lines of good manufacturing practice for vet- General de la Producción Agraria.
erinary medicinal products. France: For medicinal products for human
Council Regulation EEC No 2309/93 of 22 July use: Agence du Médicament. For veterinary
1993 laying down Community procedures for medicinal products: Agence Nationale du
the authorization and supervision of medic- Médicament Vétérinaire.
inal products for human and veterinary use
Ireland: Irish Medicines Board.
and establishing a European Agency for the
Italy: For medicinal products for human use:
Evaluation of Medicinal Products.
Council Directive 92/25/EEC of 31 March 1992 Ministero della Sanità, Dipartimento
on the wholesale distribution of medicinal Farmaci e Farmacovigilanza. For medicinal
products for human use. products for veterinary use: Ministero della
Guide to Good Distribution Practice (94/C 63/ Sanità, Dipartimento alimenti e nutrizione e
03). sanità pubblica veterinaria-Div. IX.
Current version of the Guide to Good Manu- Luxembourg: Division de la Pharmacie et
facturing Practice, Rules Governing Medic- des Médicaments.
inal Products in the European Community, Netherlands: Staat der Nederlanden.
Volume IV. Austria: Bundesministerium für Arbeit, Ge-
sundheit und Soziales.
2. For the United States:
Portugal: Instituto da Farmácia e do
[Copies of FDA documents may be obtained Medicamento (INFARMED).
from the Government Printing Office, 1510 H Finland: Lääkelaitos/Läkemedelsverket (Na-
St. NW., Washington, DC 20005. FDA docu- tional Agency for Medicines).
ments, except the FDA Compliance Program Sweden: Läkemedelsverket-Medical Prod-
Guidance Manual, may be viewed on FDA’s ucts Agency.
Internet web site at http://www.fda.gov.]
United Kingdom: For human use and veteri-
Relevant sections of the United States Fed-
nary (non-immunologicals): Medicines Con-
eral Food, Drug, and Cosmetic Act and the
United States Public Health Service Act. trol Agency. For veterinary immunologicals:
Relevant sections of Title 21, United States Veterinary Medicines Directorate.
Code of Federal Regulations (CFR) Parts 1– European Community: Commission of the
99, Parts 200–299, Parts 500–599, and Parts 600– European Communities. European Agency
799. for the Evaluation of Medicinal Products
Relevant sections of the FDA Investigations (EMEA).
Operations Manual, the FDA Regulatory
Procedures Manual, the FDA Compliance APPENDIX C TO SUBPART A OF PART 26—
Policy Guidance Manual, the FDA Compli- INDICATIVE LIST OF PRODUCTS COV-
ance Program Guidance Manual, and other ERED BY SUBPART A
FDA guidances.
Recognizing that precise definition of medic-
APPENDIX B TO SUBPART A OF PART 26— inal products and drugs are to be found in
LIST OF AUTHORITIES the legislation referred to above, an indic-
ative list of products covered by this ar-
1. For the United States: In the United
rangement is given below:
States, the regulatory authority is the
Food and Drug Administration. —human medicinal products including pre-
scription and nonprescription drugs;
2. For the European Community: In the Eu- —human biologicals including vaccines,
ropean Community, the regulatory au- and immunologicals;
thorities are the following: —veterinary pharmaceuticals, including
Belgium: Inspection générale de la prescription and nonprescription drugs,
Pharmacie, Algemene Farmaceutische with the exclusion of veterinary
Inspectie. immunologicals (Under 9 CFR 101.2 ‘‘vet-
Denmark: Laegemiddelstyrelsen. erinary immunologicals’’ are referred to
Germany: Bundesministerium für Gesund- as ‘‘veterinary biologicals’’);
heit for immunologicals: Paul-Ehrlich- —premixes for the preparation of veteri-
Institut, Federal Agency for Sera and Vac- nary medicated feeds (EC), Type A medi-
cines. cated articles for the preparation of vet-
Greece: EqnιkwV WrganιsμwV Farμakwu, Min- erinary medicated feeds (United States);
istry of Health and Welfare, National Drug —intermediate products and active phar-
Organization (E.O.F). maceutical ingredients or bulk pharma-
Spain: For medicinal products for human ceuticals (United States)/starting mate-
use: Ministerio de Sanidad y Consumo, rials (EC).
Subdirección General de Control
Farmacéutico. For medicinal products for

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Food and Drug Administration, HHS Pt. 26, Subpt. A, App. E

APPENDIX D TO SUBPART A OF PART 26— V. Execution of regulatory enforcement ac-


CRITERIA FOR ASSESSING EQUIVA- tions to achieve corrections, designed to
LENCE FOR POST- AND prevent future violations, and to remove
products found in violation of require-
PREAPPROVAL
ments from the market.
I. Legal/Regulatory authority and structures
VI. Effective use of surveillance systems:
and procedures providing for post- and
preapproval: A. Sampling and analysis.
B. Recall monitoring.
A. Appropriate statutory mandate and juris-
C. Product defect reporting system.
diction.
D. Routine surveillance inspections.
B. Ability to issue and update binding re-
E. Verification of approved manufacturing
quirements on GMP’s and guidance docu-
process changes to marketing authoriza-
ments.
tions/approved applications.
C. Authority to make inspections, review
and copy documents, and to take samples VII. Additional specific criteria for
and collect other evidence. preapproval inspections:
D. Ability to enforce requirements and to re-
move products found in violation of such re- A. Satisfactory demonstration through a
quirements from the market. jointly developed and administered training
E. Substantive current good manufacturing program and joint inspections to assess the
requirements. regulatory authorities’ capabilities.
B. Preinspection preparation includes the re-
F. Accountability of the regulatory author-
view of appropriate records, including site
ity.
plans and drug master file or similar docu-
G. Inventory of current products and manu-
mentation to enable adequate inspections.
facturers.
C. Ability to verify chemistry, manufac-
H. System for maintaining or accessing in- turing, and control data supporting an appli-
spection reports, samples and other analyt- cation is authentic and complete.
ical data, and other firm/product informa- D. Ability to assess and evaluate research
tion relating to matters covered by subpart and development data as scientifically
A of this part. sound, especially transfer technology of
II. Mechanisms in place to assure appro- pilot, scale up and full scale production
priate professional standards and avoid- batches.
ance of conflicts of interest. E. Ability to verify conformity of the onsite
processes and procedures with those de-
III. Administration of the regulatory scribed in the application.
authority: F. Review and evaluate equipment installa-
tion, operational and performance qualifica-
A. Standards of education/qualification and tion data, and evaluate test method valida-
training. tion.
B. Effective quality assurance systems meas-
ures to ensure adequate job performance. APPENDIX E TO SUBPART A OF PART 26—
C. Appropriate staffing and resources to en- ELEMENTS TO BE CONSIDERED IN DE-
force laws and regulations. VELOPING A TWO-WAY ALERT SYS-
IV. Conduct of inspections: TEM

A. Adequate preinspection preparation, in- 1. Documentation


cluding appropriate expertise of investigator/ —Definition of a crisis/emergency and under
team, review of firm/product and databases, what circumstances an alert is required
and availability of appropriate inspection —Standard Operating Procedures (SOP’s)
equipment.
—Mechanism of health hazards evaluation
B. Adequate conduct of inspection, including and classification
statutory access to facilities, effective re- —Language of communication and trans-
sponse to refusals, depth and competence of mission of information
evaluation of operations, systems and docu-
mentation; collection of evidence; appro- 2. Crisis Management System
priate duration of inspection and complete-
ness of written report of observations to firm —Crisis analysis and communication mecha-
management. nisms
C. Adequate postinspection activities, in- —Establishment of contact points
cluding completeness of inspectors’ report, —Reporting mechanisms
inspection report review where appropriate,
3. Enforcement Procedures
and conduct of followup inspections and
other activities where appropriate, assurance —Followup mechanisms
of preservation and retrieval of records. —Corrective action procedures

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§ 26.31 21 CFR Ch. I (4–1–11 Edition)
4. Quality Assurance System lowing types of reports from con-
—Pharmacovigilance programme formity assessment bodies (CAB’s) as-
—Surveillance/monitoring of implementa- sessed to be equivalent:
tion of corrective action (1) Under the U.S. system, surveil-
lance/postmarket and initial/
5. Contact Points
preapproval inspection reports;
For the purpose of subpart A of this part, the (2) Under the U.S. system, premarket
contact points for the alert system will be: (510(k)) product evaluation reports;
A. For the European Community: (3) Under the European Community
(EC) system, quality system evaluation
the Executive Director of the European
Agency for the Evaluation of Medicinal
reports; and
Products, 7, Westferry Circus, Canary Wharf, (4) Under the EC system, EC type ex-
UK - London E14 4HB, England. Telephone amination and verification reports.
44–171–418 8400, Fax 418–8416. (b) Appendix A of this subpart names
the legislation, regulations, and re-
B. For the United States : lated procedures under which:
Biologics: Director, Office of Compliance and (1) Products are regulated as medical
Biologics Quality (HFM–600), 1401 Rockville devices by each party;
Pike, Rockville, MD 20852, phone: 301–827– (2) CAB’s are designated and con-
6190, fax: 301–594-1944.
firmed; and
Human Drugs: Director, Office of Compli-
ance, 10903 New Hampshire Ave., Silver (3) These reports are prepared.
Spring, MD 20993–0002, phone: 301–796–3100, (c) For purposes of this subpart,
fax: 301–847–8747. equivalence means that: CAB’s in the
Veterinary Drugs: Director, Office of Sur- EC are capable of conducting product
veillance and Compliance (HFV–200), MPN II, and quality systems evaluations
7500 Standish Pl., Rockville, MD 20855–2773, against U.S. regulatory requirements
phone: 301–827–6644, fax: 301–594–1807.
in a manner equivalent to those con-
[63 FR 60141, Nov. 6, 1998, as amended at 69 ducted by FDA; and CAB’s in the
FR 48775, Aug. 11, 2004; 74 FR 13112, Mar. 26, United States are capable of con-
2009] ducting product and quality systems
evaluations against EC regulatory re-
Subpart B—Specific Sector quirements in a manner equivalent to
Provisions for Medical Devices those conducted by EC CAB’s.
§ 26.31 Purpose. § 26.33 Product coverage.
(a) The purpose of this subpart is to (a) There are three components to
specify the conditions under which a this subpart each covering a discrete
party will accept the results of quality range of products:
system-related evaluations and inspec- (1) Quality System Evaluations. U.S.-
tions and premarket evaluations of the type surveillance/postmarket and ini-
other party with regard to medical de- tial/preapproval inspection reports and
vices as conducted by listed conformity European Community (EC)-type qual-
assessment bodies (CAB’s) and to pro- ity system evaluation reports will be
vide for other related cooperative ac- exchanged with regard to all products
tivities. regulated under both U.S. and EC law
(b) This subpart is intended to evolve as medical devices.
as programs and policies of the parties (2) Product Evaluation. U.S.-type pre-
evolve. The parties will review this market (510(k)) product evaluation re-
subpart periodically, in order to assess ports and EC-type-testing reports will
progress and identify potential en- be exchanged only with regard to those
hancements to this subpart as Food products classified under the U.S. sys-
and Drug Administration (FDA) and tem as Class I/Class II-Tier 2 medical
European Community (EC) policies devices which are listed in appendix B
evolve over time. of this subpart.
(3) Postmarket Vigilance Reports.
§ 26.32 Scope. Postmarket vigilance reports will be
(a) The provisions of this subpart exchanged with regard to all products
shall apply to the exchange and, where regulated under both U.S. and EC law
appropriate, endorsement of the fol- as medical devices.

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Food and Drug Administration, HHS § 26.39

(b) Additional products and proce- tem or product evaluations to the spec-
dures may be made subject to this sub- ifications of the parties.
part by agreement of the parties. (b) The joint confidence building pro-
gram should include the following ac-
§ 26.34 Regulatory authorities. tions and activities:
The regulatory authorities shall have (1) Seminars designed to inform the
the responsibility of implementing the parties and CAB’s about each party’s
provisions of this subpart, including regulatory system, procedures, and re-
the designation and monitoring of con- quirements;
formity assessment bodies (CAB’s). (2) Workshops designed to provide the
Regulatory authorities will be speci- parties with information regarding re-
fied in appendix C of this subpart. Each quirements and procedures for the des-
party will promptly notify the other ignation and surveillance of CAB’s;
party in writing of any change in the (3) Exchange of information about re-
regulatory authority for a country. ports prepared during the transition
period;
§ 26.35 Length and purpose of transi- (4) Joint training exercises; and
tion period. (5) Observed inspections.
There will be a 3-year transition pe- (c) During the transition period, any
riod immediately following the date significant problem that is identified
described in § 26.80(a). During the tran- with a CAB may be the subject of coop-
sition period, the parties will engage in erative activities, as resources allow
confidence-building activities for the and as agreed to by the regulatory au-
purpose of obtaining sufficient evi- thorities, aimed at resolving the prob-
dence to make determinations con- lem.
cerning the equivalence of conformity (d) Both parties will exercise good
assessment bodies (CAB’s) of the other faith efforts to complete the confidence
party with respect to the ability to building activities as expeditiously as
perform quality system and product possible to the extent that the re-
evaluations or other reviews resulting sources of the parties allow.
in reports to be exchanged under this (e) Both the parties will each prepare
subpart. annual progress reports which will de-
scribe the confidence building activi-
§ 26.36 Listing of CAB’s. ties undertaken during each year of the
Each party shall designate con- transition period. The form and con-
formity assessment bodies (CAB’s) to tent of the reports will be determined
participate in confidence building ac- by the parties through the Joint Sec-
tivities by transmitting to the other toral Committee.
party a list of CAB’s which meet the
criteria for technical competence and § 26.38 Other transition period activi-
independence, as identified in appendix ties.
A of this subpart. The list shall be ac- (a) During the transition period, the
companied by supporting evidence. parties will jointly determine the nec-
Designated CAB’s will be listed in ap- essary information which must be
pendix D of this subpart for participa- present in quality system and product
tion in the confidence building activi- evaluation reports.
ties once confirmed by the importing (b) The parties will jointly develop a
party. Nonconfirmation would have to notification and alert system to be
be justified based on documented evi- used in case of defects, recalls, and
dence. other problems concerning product
quality that could necessitate addi-
§ 26.37 Confidence building activities. tional actions (e.g., inspections by the
(a) At the beginning of the transi- parties of the importing country) or
tional period, the Joint Sectoral Group suspension of the distribution of the
will establish a joint confidence build- product.
ing program calculated to provide suf-
ficient evidence of the capabilities of § 26.39 Equivalence assessment.
the designated conformity assessment (a) In the final 6 months of the tran-
bodies (CAB’s) to perform quality sys- sition period, the parties shall proceed

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§ 26.40 21 CFR Ch. I (4–1–11 Edition)

to a joint assessment of the equiva- will provide FDA with reports of qual-
lence of the conformity assessment ity system evaluations, as follows:
bodies (CAB’s) that participated in the (1) For preapproval quality system
confidence building activities. CAB’s evaluations, EC CAB’s will provide full
will be determined to be equivalent reports; and
provided they have demonstrated pro- (2) For surveillance quality system
ficiency through the submission of a evaluations, EC CAB’s will provide ab-
sufficient number of adequate reports. breviated reports.
CAB’s may be determined to be equiva- (b) Listed U.S. CAB’s will provide to
lent with regard to the ability to per-
the EC Notified Body of the manufac-
form any type of quality system or
turer’s choice:
product evaluation covered by this sub-
part and with regard to any type of (1) Full reports of initial quality sys-
product covered by this subpart. The tem evaluations;
parties shall develop a list contained in (2) Abbreviated reports of quality
appendix E of this subpart of CAB’s de- systems surveillance audits.
termined to be equivalent, which shall (c) If the abbreviated reports do not
contain a full explanation of the scope provide sufficient information, the im-
of the equivalency determination, in- porting party may request additional
cluding any appropriate limitations, clarification from the CAB.
with regard to performing any type of (d) Based on the determination of
quality system or product evaluation. equivalence in light of the experience
(b) The parties shall allow CAB’s not gained, the quality system evaluation
listed for participation in this subpart, reports prepared by the CAB’s listed as
or listed for participation only as to equivalent will normally be endorsed
certain types of evaluations, to apply by the importing party, except under
for participation in this subpart once specific and delineated circumstances.
the necessary measures have been Examples of such circumstances in-
taken or sufficient experience has been clude indications of material inconsist-
gained, in accordance with § 26.46. encies or inadequacies in a report,
(c) Decisions concerning the equiva- quality defects identified in
lence of CAB’s must be agreed to by postmarket surveillance or other spe-
both parties. cific evidence of serious concern in re-
§ 26.40 Start of the operational period. lation to product quality or consumer
safety. In such cases, the importing
(a) The operational period will start party may request clarification from
at the end of the transition period after the exporting party which may lead to
the parties have developed the list of a request for reinspection. The parties
conformity assessment bodies (CAB’s) will endeavor to respond to requests for
found to be equivalent. The provisions clarification in a timely manner.
of §§ 26.40, 26.41, 26.42, 26.43, 26.44, 26.45, Where divergence is not clarified in
and 26.46 will apply only with regard to this process, the importing party may
listed CAB’s and only to the extent of
carry out the quality system evalua-
any specifications and limitations con-
tion.
tained on the list with regard to a
CAB. § 26.42 Exchange and endorsement of
(b) The operational period will apply product evaluation reports.
to quality system evaluation reports
and product evaluation reports gen- (a) European Community (EC) con-
erated by CAB’s listed in accordance formity assessment bodies (CAB’s) list-
with this subpart for the evaluations ed for this purpose will, subject to the
performed in the respective territories specifications and limitations on the
of the parties, except if the parties list, provide to FDA 510(k) premarket
agree otherwise. notification assessment reports pre-
pared to U.S. medical device require-
§ 26.41 Exchange and endorsement of ments.
quality system evaluation reports. (b) U.S. CAB’s will, subject to the
(a) Listed European Community (EC) specifications and limitations on the
conformity assessment bodies (CAB’s) list, provide to the EC Notified Body of

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Food and Drug Administration, HHS § 26.48

the manufacturer’s choice, type exam- lence using the procedures and criteria
ination, and verification reports pre- described in §§ 26.36, 26.37, and 26.39,
pared to EC medical device require- taking into account the level of con-
ments. fidence gained in the overall regu-
(c) Based on the determination of latory system of the other party.
equivalence in light of the experience (b) Once a designating authority con-
gained, the product evaluation reports siders that such CAB’s, having under-
prepared by the CAB’s listed as equiva- gone the procedures of §§ 26.36, 26.37,
lent will normally be endorsed by the and 26.39, may be determined to be
importing party, except under specific equivalent, it will then designate those
and delineated circumstances. Exam- bodies on an annual basis. Such proce-
ples of such circumstances include in- dures satisfy the procedures of § 26.66(a)
dications of material inconsistencies, and (b).
inadequacies, or incompleteness in a (c) Following such annual designa-
product evaluation report, or other tions, the procedures for confirmation
specific evidence of serious concern in of CAB’s under § 26.66(c) and (d) shall
relation to product safety, perform- apply.
ance, or quality. In such cases, the im-
porting party may request clarification § 26.47 Role and composition of the
from the exporting party which may Joint Sectoral Committee.
lead to a request for a reevaluation. (a) The Joint Sectoral Committee for
The parties will endeavor to respond to this subpart is set up to monitor the
requests for clarification in a timely activities under both the transitional
manner. Endorsement remains the re- and operational phases of this subpart.
sponsibility of the importing party. (b) The Joint Sectoral Committee
will be cochaired by a representative of
§ 26.43 Transmission of quality system the Food and Drug Administration
evaluation reports. (FDA) for the United States and a rep-
Quality system evaluation reports resentative of the European Commu-
covered by § 26.41 concerning products nity (EC) who will each have one vote.
covered by this subpart shall be trans- Decisions will be taken by unanimous
mitted to the importing party within consent.
60-calendar days of a request by the im- (c) The Joint Sectoral Committee’s
porting party. Should a new inspection functions will include:
be requested, the time period shall be (1) Making a joint assessment of the
extended by an additional 30-calendar equivalence of conformity assessment
days. A party may request a new in- bodies (CAB’s);
spection, for cause, identified to the (2) Developing and maintaining the
other party. If the exporting party can- list of equivalent CAB’s, including any
not perform an inspection within a limitation in terms of their scope of
specified period of time, the importing activities and communicating the list
party may perform an inspection on its to all authorities and the Joint Com-
own. mittee described in subpart C of this
part;
§ 26.44 Transmission of product eval- (3) Providing a forum to discuss
uation reports. issues relating to this subpart, includ-
Transmission of product evaluation ing concerns that a CAB may no longer
reports will take place according to the be equivalent and opportunity to re-
importing party’s specified procedures. view product coverage; and
(4) Consideration of the issue of sus-
§ 26.45 Monitoring continued equiva- pension.
lence.
Monitoring activities will be carried § 26.48 Harmonization.
out in accordance with § 26.69. During both the transitional and
operational phases of this subpart,
§ 26.46 Listing of additional CAB’s. both parties intend to continue to par-
(a) During the operational period, ad- ticipate in the activities of the Global
ditional conformity assessment bodies Harmonization Task Force (GHTF) and
(CAB’s) will be considered for equiva- utilize the results of those activities to

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§ 26.49 21 CFR Ch. I (4–1–11 Edition)

the extent possible. Such participation Annex 4


involves developing and reviewing doc- Annex 5
uments developed by the GHTF and b. Council Directive 93/42/EEC of 14 June 1993
jointly determining whether they are on Medical Devices OJ No. L 169,12.7.1993, p.1.
Conformity assessment procedures.
applicable to the implementation of
Annex 2 (with the exception of section 4)
this subpart. Annex 3
Annex 4
§ 26.49 Regulatory cooperation. Annex 5
(a) The parties and authorities shall Annex 6
inform and consult with one another,
as permitted by law, of proposals to in- 2. For the United States, the following
legislation applies to § 26.32(a):
troduce new controls or to change ex-
isting technical regulations or inspec- [Copies of FDA documents may be obtained
tion procedures and to provide the op- from the Government Printing Office, 1510 H
portunity to comment on such pro- St. NW., Washington, DC 20005. FDA docu-
ments may be viewed on FDA’s Internet web
posals.
site at http://www.fda.gov.]
(b) The parties shall notify each a. The Federal Food, Drug and Cosmetic Act,
other in writing of any changes to ap- 21 U.S.C. 321 et seq.
pendix A of this subpart. b. The Public Health Service Act, 42 U.S.C.
201 et seq.
§ 26.50 Alert system and exchange of c. Regulations of the United States Food and
postmarket vigilance reports. Drug Administration found at 21 CFR, in
(a) An alert system will be set up particular, Parts 800 to 1299.
during the transition period and main- d. Medical Devices; Third Party Review of
tained thereafter by which the parties Selected Premarket Notifications; Pilot Pro-
gram, 61 FR 14789–14796 (April 3, 1996).
will notify each other when there is an
e. Draft Guidance Document on Accredited
immediate danger to public health. Persons Program, 63 FR 28392 (May 22, 1998).
Elements of such a system will be de- f. Draft Guidance for Staff, Industry and
scribed in an appendix F of this sub- Third Parties, Third Party Programs under
part. As part of that system, each the Sectoral Annex on Medical Devices to
party shall notify the other party of the Agreement on Mutual Recognition Be-
any confirmed problem reports, correc- tween the United States of America and the
tive actions, or recalls. These reports European Community (MRA), 63 FR 36240
are regarded as part of ongoing inves- (July 2, 1998).
tigations. g. Guidance Document on Use of Standards,
63 FR 9561 (February 25, 1998).
(b) Contact points will be agreed be-
tween both parties to permit authori- APPENDIX B TO SUBPART B OF PART 26—
ties to be made aware with the appro- SCOPE OF PRODUCT COVERAGE
priate speed in case of quality defect,
batch recalls, counterfeiting and other 1. Initial Coverage of the Transition Period
problems concerning quality, which Upon entry into force of this subpart as de-
could necessitate additional controls scribed in § 26.80 (it is understood that the
or suspension of the distribution of the date of entry into force will not occur prior
product. to June 1, 1998, unless the parties decide oth-
erwise), products qualifying for the transi-
APPENDIX A TO SUBPART B OF PART 26— tional arrangements under this subpart in-
RELEVANT LEGISLATION, REGULA- clude:
TIONS, AND PROCEDURES. a. All Class I products requiring premarket
evaluations in the United States—see
1. For the European Community (EC) the fol- Table 1.
lowing legislation applies to § 26.42(a) of b. Those Class II products listed in Table 2.
this subpart:
2. During the Transition Period
[Copies of EC documents may be obtained
from the European Document Research, 1100 The parties will jointly identify additional
17th St. NW., suite 301, Washington, DC product groups, including their related ac-
20036.] cessories, in line with their respective prior-
a. Council Directive 90/385/EEC of 20 June ities as follows:
1990 on active implantable medical devices a. Those for which review may be based
OJ No. L 189, 20.7. 1990, p. 17. Conformity primarily on written guidance which the
assessment procedures. parties will use their best efforts to pre-
Annex 2 (with the exception of section 4) pare expeditiously; and

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Food and Drug Administration, HHS Pt. 26, Subpt. B, App. B
b. Those for which review may be based FDA’s ability to write guidance docu-
primarily on international standards, in ments if the device pilot for the third
order for the parties to gain the requisite party review of medical devices is suc-
experience. cessful. The MRA will cover to the max-
The corresponding additional product lists imum extent feasible all Class II devices
will be phased in on an annual basis. The listed in Table 3 for which FDA-accred-
parties may consult with industry and other ited third party review is available in the
interested parties in determining which
United States.
products will be added.
3. Commencement of the Operational Period 4. Unless explicitly included by joint deci-
sion of the parties, this part does not cover
a. At the commencement of the oper- any U.S. Class II-tier 3 or any Class III
ational period, product coverage shall ex- product under either system.
tend to all Class I/II products covered
during the transition period. [The lists of medical devices included in
b. FDA will expand the program to cat- these tables are subject to change as a result
egories of Class II devices as is consistent of the Food and Drug Administration Mod-
with the results of the pilot, and with ernization Act of 1997.]
TABLE 1—CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES,
INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD 1
21 CFR Section No. Regulation Name

Product Code—Device Name

Anesthesiology Panel (21 CFR part 868)


868.1910 Esophageal Stethoscope
BZW—Stethoscope, Esophageal
868.5620 Breathing Mouthpiece
BYP—Mouthpiece, Breathing
868.5640 Medicinal Nonventilatory Nebulizer (Atomizer)
CCQ—Nebulizer, Medicinal, Nonventilatory (Atomizer)
868.5675 Rebreathing Device
BYW—Device, Rebreathing
868.5700 Nonpowered Oxygen Tent
FOG—Hood, Oxygen, Infant
BYL—Tent, Oxygen
868.6810 Tracheobronchial Suction Catheter
BSY—Catheters, Suction, Tracheobronchial
Cardiovascular Panel
(None)
Dental Panel (21 CFR part 872)
872.3400 Karaya and Sodium Borate With or Without Acacia Denture
Adhesive
KOM—Adhesive, Denture, Acacia and Karaya With Sodium
Borate
872.3700 Dental Mercury (U.S.P.)
ELY—Mercury
872.4200 Dental Handpiece and Accessories
EBW—Controller, Food, Handpiece and Cord
EFB—Handpiece, Air-Powered, Dental
EFA—Handpiece, Belt and/or Gear Driven, Dental
EGS—Handpiece, Contra- and Right-Angle Attachment,
Dental
EKX—Handpiece, Direct Drive, AC-Powered
EKY—Handpiece, Water-Powered
872.6640 Dental Operative Unit and Accessories
EIA—Unit, Operative Dental
Ear, Nose, and Throat Panel (21 CFR part 874)
874.1070 Short Increment Sensitivity Index (SISI) Adapter
ETR—Adapter, Short Increment Sensitivity Index (SISI)
874.1500 Gustometer
ETM—Gustometer
874.1800 Air or Water Caloric Stimulator
KHH—Stimulator, Caloric-Air
ETP—Stimulator, Caloric-Water
874.1925 Toynbee Diagnostic Tube
ETK—Tube, Toynbee Diagnostic
874.3300 Hearing Aid
LRB—Face Plate Hearing-Aid
ESD—Hearing-aid, Air-Conduction
874.4100 Epistaxis Balloon
EMX—Balloon, Epistaxis

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Pt. 26, Subpt. B, App. B 21 CFR Ch. I (4–1–11 Edition)

TABLE 1—CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES,


INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD 1—Continued
21 CFR Section No. Regulation Name

Product Code—Device Name

874.5300 ENT Examination and Treatment Unit


ETF—Unit, Examining/Treatment, ENT
874.5550 Powered Nasal Irrigator
KMA—Irrigator, Powered Nasal
874.5840 Antistammering Device
KTH—Device, Anti-Stammering
Gastroenterology—Urology Panel (21 CFR part 876)
876.5160 Urological Clamp for Males
FHA—Clamp, Penile
876.5210 Enema Kit
FCE—Kit, Enema, (for Cleaning Purpose)
876.5250 Urine Collector and Accessories
FAQ—Bag, Urine Collection, Leg, for External Use
General Hospital Panel (21 CFR part 880)
880.5270 Neonatal Eye Pad
FOK—Pad, Neonatal Eye
880.5420 Pressure Infusor for an I.V. Bag
KZD—Infusor, Pressure, for I.V. Bags
880.5680 Pediatric Position Holder
FRP—Holder, Infant Position
880.6250 Patient Examination Glove
LZB—Finger Cot
FMC—Glove, Patient Examination
LYY—Glove, Patient Examination, Latex
LZA—Glove, Patient Examination, Poly
LZC—Glove, Patient Examination, Speciality
LYZ—Glove, Patient Examination, Vinyl
880.6375 Patient Lubricant
KMJ—Lubricant, Patient
880.6760 Protective Restraint
BRT—Restraint, Patient, Conductive
FMQ—Restraint, Protective
Neurology Panel (21 CFR part 882)
882.1030 Ataxiagraph
GWW—Ataxiagraph
882.1420 Electroencephalogram (EEG) Signal Spectrum Analyzer
GWS—Analyzer, Spectrum, Electroencephalogram Signal
882.4060 Ventricular Cannula
HCD—Cannula, Ventricular
882.4545 Shunt System Implantation Instrument
GYK—Instrument, Shunt System Implantation
882.4650 Neurosurgical Suture Needle
HAS—Needle, Neurosurgical Suture
882.4750 Skull Punch
GXJ—Punch, Skull
Obstetrics and Gynecology Panel
(None)
Ophthalmology Panel (21 CFR part 886)
886.1780 Retinoscope
HKM—Retinoscope, Battery-Powered
886.1940 Tonometer Sterilizer
HKZ—Sterilizer, Tonometer
886.4070 Powered Corneal Burr
HQS—Burr, Corneal, AC-Powered
HOG—Burr, Corneal, Battery-Powered
HRG—Engine, Trephine, Accessories, AC-Powered
HFR—Engine, Trephine, Accessories, Battery-Powered
HLD—Engine, Trephine, Accessories, Gas-Powered
886.4370 Keratome
HNO—Keratome, AC-Powered
HMY—Keratome, Battery-Powered
886.5850 Sunglasses (Nonprescription)
HQY—Sunglasses (Nonprescription Including Photosensi-
tive)
Orthopedic Panel (21 CFR part 888)
888.1500 Goniometer
KQX—Goniometer, AC-Powered
888.4150 Calipers for Clinical Use
KTZ—Caliper

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Food and Drug Administration, HHS Pt. 26, Subpt. B, App. B

TABLE 1—CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES,


INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD 1—Continued
21 CFR Section No. Regulation Name

Product Code—Device Name

Physical Medicine Panel (21 CFR part 890)


890.3850 Mechanical Wheelchair
LBE—Stroller, Adaptive
IOR—Wheelchair, Mechanical
890.5180 Manual Patient Rotation Bed
INY—Bed, Patient Rotation, Manual
890.5710 Hot or Cold Disposable Pack
IMD—Pack, Hot or Cold, Disposable
Radiology Panel (21 CFR part 892)
892.1100 Scintillation (Gamma) Camera
IYX—Camera, Scintillation (Gamma)
892.1110 Positron Camera
IZC—Camera, Positron
892.1300 Nuclear Rectilinear Scanner
IYW—Scanner, Rectilinear, Nuclear
892.1320 Nuclear Uptake Probe
IZD—Probe, Uptake, Nuclear
892.1330 Nuclear Whole Body Scanner
JAM—Scanner, Whole Body, Nuclear
892.1410 Nuclear Electrocardiograph Synchronizer
IVY—Synchronizer, Electrocardiograph, Nuclear
892.1890 Radiographic Film Illuminator
IXC—Illuminator, Radiographic-Film
JAG—Illuminator, Radiographic-Film, Explosion-Proof
892.1910 Radiographic Grid
IXJ—Grid, Radiographic
892.1960 Radiographic Intensifying Screen
EAM—Screen, Intensifying, Radiographic
892.1970 Radiographic ECG/Respirator Synchronizer
IXO—Synchronizer, ECG/Respirator, Radiographic
892.5650 Manual Radionuclide Applicator System
IWG—System, Applicator, Radionuclide, Manual
General and Plastic Surgery Panel (21 CFR part 878)
878.4200 Introduction/Drainage Catheter and Accessories
KGZ—Accessories, Catheter
GCE—Adaptor, Catheter
FGY—Cannula, Injection
GBA—Catheter, Balloon Type
GBZ—Catheter, Cholangiography
GBQ—Catheter, Continuous Irrigation
GBY—Catheter, Eustachian, General & Plastic Surgery
JCY—Catheter, Infusion
GBX—Catheter, Irrigation
GBP—Catheter, Multiple Lumen
GBO—Catheter, Nephrostomy, General & Plastic Surgery
GBN—Catheter, Pediatric, General & Plastic Surgery
GBW—Catheter, Peritoneal
GBS—Catheter, Ventricular, General & Plastic Surgery
GCD—Connector, Catheter
GCC—Dilator, Catheter
GCB—Needle, Catheter
878.4320 Removable Skin Clip
FZQ—Clip, Removable (Skin)
878.4460 Surgeon’s Gloves
KGO—Surgeon’s Gloves
878.4680 Nonpowered, Single Patient, Portable Suction Apparatus
GCY—Apparatus, Suction, Single Patient Use, Portable,
Nonpowered
878.4760 Removable Skin Staple
GDT—Staple, Removable (Skin)
878.4820 AC-Powered, Battery-Powered, and Pneumatically Pow-
ered Surgical Instrument Motors and Accessories/Attach-
ments
GFG—Bit, Surgical
GFA—Blade, Saw, General & Plastic Surgery
DWH—Blade, Saw, Surgical, Cardiovascular
BRZ—Board, Arm (With Cover)
GFE—Brush, Dermabrasion
GFF—Bur, Surgical, General & Plastic Surgery

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Pt. 26, Subpt. B, App. B 21 CFR Ch. I (4–1–11 Edition)

TABLE 1—CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES,


INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD 1—Continued
21 CFR Section No. Regulation Name

Product Code—Device Name

KDG—Chisel (Osteotome)
GFD—Dermatome
GFC—Driver, Surgical, Pin
GFB—Head, Surgical, Hammer
GEY—Motor, Surgical Instrument, AC-Powered
GET—Motor, Surgical Instrument, Pneumatic Powered
DWI—Saw, Electrically Powered
KFK—Saw, Pneumatically Powered
HAB—Saw, Powered, and Accessories
878.4960 Air or AC-Powered Operating Table and Air or AC-Pow-
ered Operating Chair & Accessories
GBB—Chair, Surgical, AC-Powered
FQO—Table, Operating-Room, AC-Powered
GDC—Table, Operating-Room, Electrical
FWW—Table, Operating-Room, Pneumatic
JEA—Table, Surgical with Orthopedic Accessories, AC-
Powered
880.5090 Liquid Bandage
KMF—Bandage, Liquid
1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA’s Internet
Web Site at http://www.fda.gov/cdrh/prodcode.html.

TABLE 2—CLASS II MEDICAL DEVICES INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING


OF TRANSITION PERIOD (UNITED STATES TO DEVELOP GUIDANCE DOCUMENTS IDENTIFYING U.S. RE-
QUIREMENTS AND EUROPEAN COMMUNITY (EC) TO IDENTIFY STANDARDS NEEDED TO MEET EC RE-
QUIREMENTS) 1

Panel 21 CFR Section No. Regulation Name

Product Code—Device Name

RA 892.1000 Magnetic Resonance Diagnostic Device


MOS—COIL, Magnetic Resonance, Specialty
LNH—System, Nuclear Magnetic Resonance Imaging
LNI—System, Nuclear Magnetic Resonance Spectroscopic
Diagnostic Ultrasound:
RA 892.1540 Nonfetal Ultrasonic Monitor
JAF—Monitor, Ultrasonic, Nonfetal
RA 892.1550 Ultrasonic Pulsed Doppler Imaging System
IYN—System, Imaging, Pulsed Doppler, Ultrasonic
RA 892.1560 Ultrasonic Pulsed Echo Imaging System
IYO—System, Imaging, Pulsed Echo, Ultrasonic
RA 892.1570 Diagnostic Ultrasonic Transducer
ITX—Transducer, Ultrasonic, Diagnostic
Diagnostic X-Ray Im-
aging Devices (ex-
cept mammographic
x-ray systems):
RA 892.1600 Angiographic X-Ray System
IZI—System, X-Ray, Angiographic
RA 892.1650 Image-Intensified Fluoroscopic X-Ray System
MQB—Solid State X-Ray Imager (Flat Panel/Digital Imager)
JAA—System, X-Ray, Fluoroscopic, Image-Intensified
RA 892.1680 Stationary X-Ray System
KPR—System, X-Ray, Stationary
RA 892.1720 Mobile X-Ray System
IZL—System, X-Ray, Mobile
RA 892.1740 Tomographic X-Ray System
IZF—System, X-Ray, Tomographic
RA 892.1750 Computed Tomography X-Ray System
JAK—System, X-Ray, Tomography, Computed
ECG-Related Devices:
CV 870.2340 Electrocardiograph
DPS—Electrocardiograph
MLC—Monitor, ST Segment
CV 870.2350 Electrocardiograph Lead Switching Adaptor
DRW—Adaptor, Lead Switching, Electrocardiograph

266

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Food and Drug Administration, HHS Pt. 26, Subpt. B, App. B

TABLE 2—CLASS II MEDICAL DEVICES INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING


OF TRANSITION PERIOD (UNITED STATES TO DEVELOP GUIDANCE DOCUMENTS IDENTIFYING U.S. RE-
QUIREMENTS AND EUROPEAN COMMUNITY (EC) TO IDENTIFY STANDARDS NEEDED TO MEET EC RE-
QUIREMENTS) 1—Continued

Panel 21 CFR Section No. Regulation Name

Product Code—Device Name

CV 870.2360 Electrocardiograph Electrode


DRX—Electrode, Electrocardiograph
CV 870.2370 Electrocardiograph Surface Electrode Tester
KRC—Tester, Electrode, Surface, Electrocardiographic
NE 882.1400 Electroencephalograph
GWQ—Electroencephalograph
HO 880.5725 Infusion Pump (external only)
MRZ—Accessories, Pump, Infusion
FRN—Pump, Infusion
LZF—Pump, Infusion, Analytical Sampling
MEB—Pump, Infusion, Elastomeric
LZH—Pump, Infusion, Enteral
MHD—Pump, Infusion, Gallstone Dissolution
LZG—Pump, Infusion, Insulin
MEA—Pump, Infusion, PCA
Ophthalmic Instru-
ments:
OP 886.1570 Ophthalmoscope
HLI—Ophthalmoscope, AC-Powered
HLJ—Ophthalmoscope, Battery-Powered
OP 886.1780 Retinoscope
HKL—Retinoscope, AC-Powered
OP 886.1850 AC-Powered Slit-Lamp Biomicroscope
HJO—Biomicroscope, Slit-Lamp, AC-Powered
OP 886.4150 Vitreous Aspiration and Cutting Instrument
MMC—Dilator, Expansive Iris (Accessory)
HQE—Instrument, Vitreous Aspiration and Cutting, AC-Powered
HKP—Instrument, Vitreous Aspiration and Cutting, Battery-Powered
MLZ—Vitrectomy, Instrument Cutter
OP 886.4670 Phacofragmentation System
HQC—Unit, Phacofragmentation
SU 878.4580 Surgical Lamp
HBI—Illuminator, Fiberoptic, Surgical Field
FTF—Illuminator, Nonremote
FTG—Illuminator, Remote
HJE—Lamp, Fluorescein, AC-Powered
FQP—Lamp, Operating-Room
FTD—Lamp, Surgical
GBC—Lamp, Surgical, Incandescent
FTA—Light, Surgical, Accessories
FSZ—Light, Surgical, Carrier
FSY—Light, Surgical, Ceiling Mounted
FSX—Light, Surgical, Connector
FSW—Light, Surgical, Endoscopic
FST—Light, Surgical, Fiberoptic
FSS—Light, Surgical, Floor Standing
FSQ—Light, Surgical, Instrument
NE 882.5890 Transcutaneous Electrical Nerve Stimulator for Pain Relief
GZJ—Stimulator, Nerve, Transcutaneous, For Pain Relief
Noninvasive Blood Pressure Measurement Devices:
CV 870.1120 Blood Pressure Cuff
DXQ—Cuff, Blood-Pressure
CV 870.1130 Noninvasive Blood Pressure Measurement System (except
nonoscillometric)
DXN—System, Measurement, Blood-Pressure, Noninvasive
HO 880.6880 Steam Sterilizer (greater than 2 cubic feet)
FLE—Sterilizer, Steam
Clinical Thermometers:
HO 880.2910 Clinical Electronic Thermometer (except tympanic or pacifier)
FLL—Thermometer, Electronic, Clinical
AN 868.5630 Nebulizer
CAF—Nebulizer (Direct Patient Interface)

267

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Pt. 26, Subpt. B, App. B 21 CFR Ch. I (4–1–11 Edition)

TABLE 2—CLASS II MEDICAL DEVICES INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING


OF TRANSITION PERIOD (UNITED STATES TO DEVELOP GUIDANCE DOCUMENTS IDENTIFYING U.S. RE-
QUIREMENTS AND EUROPEAN COMMUNITY (EC) TO IDENTIFY STANDARDS NEEDED TO MEET EC RE-
QUIREMENTS) 1—Continued

Panel 21 CFR Section No. Regulation Name

Product Code—Device Name

Hypodermic Needles
and Syringes (ex-
cept antistick and
self-destruct):
HO 880.5570 Hypodermic Single Lumen Needle
MMK—Container, Sharpes
FMI—Needle, Hypodermic, Single Lumen
MHC—Port, Intraosseous, Implanted
HO 880.5860 Piston Syringe
FMF—Syringe, Piston
Selected Dental Mate-
rials:
DE 872.3060 Gold-Based Alloys and Precious Metal Alloys for Clinical Use
EJT—Alloy, Gold Based, For Clinical Use
EJS—Alloy, Precious Metal, For Clinical Use
DE 872.3200 Resin Tooth Bonding Agent
KLE—Agent, Tooth Bonding, Resin
DE 872.3275 Dental Cement
EMA—Cement, Dental
EMB—Zinc Oxide Eugenol
DE 872.3660 Impression Material
ELW—Material, Impression
DE 872.3690 Tooth Shade Resin Material
EBF—Material, Tooth Shade, Resin
DE 872.3710 Base Metal Alloy
EJH—Metal, Base
Latex Condoms:
OB 884.5300 Condom
HIS—Condom
1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA’s Internet
Web Site at http://www.fda.gov/cdrh/prodcode.html.

TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1
Product Family 21 CFR Section No Device Name Tier

Anesthesiology Panel
Anesthesia Devices 868.5160 Gas machine for anesthesia 2
or analgesia
868.5270 Breathing system heater 2
868.5440 Portable oxygen generator 2
868.5450 Respiratory gas humidifier 2
868.5630 Nebulizer 2
868.5710 Electrically powered oxygen 2
tent
868.5880 Anesthetic vaporizer 2
Gas Analyser 868.1040 Powered Algesimeter 2
868.1075 Argon gas analyzer 2
868.1400 Carbon dioxide gas analyzer 2
868.1430 Carbon monoxide gas ana- 2
lyzer
868.1500 Enflurane gas analyzer 2
868.1620 Halothane gas analyzer 2
868.1640 Helium gas analyzer 2
868.1670 Neon gas analyzer 2
868.1690 Nitrogen gas analyzer 2
868.1700 Nitrous oxide gas analyzer 2
868.1720 Oxygen gas analyzer 2
868.1730 Oxygen uptake computer 2
Peripheral Nerve 868.2775 Electrical peripheral nerve 2
Stimulators stimulator
Respiratory Monitoring 868.1750 Pressure plethysmograph 2
868.1760 Volume plethysmograph 2
868.1780 Inspiratory airway pressure 2
meter

268

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Food and Drug Administration, HHS Pt. 26, Subpt. B, App. B

TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1—Continued
Product Family 21 CFR Section No Device Name Tier

868.1800 Rhinoanemometer 2
868.1840 Diagnostic spirometer 2
868.1850 Monitoring spirometer 2
868.1860 Peak-flow meter for 2
spirometry
868.1880 Pulmonary-function data cal- 2
culator
868.1890 Predictive pulmonary-function 2
value calculator
868.1900 Diagnostic pulmonary-function 2
interpretation calculator
868.2025 Ultrasonic air embolism mon- 2
itor
868.2375 Breathing frequency monitor 2
(except apnea detectors)
868.2480 Cutaneous carbon dioxide 2
(PcCO2) monitor
868.2500 Cutaneous oxygen monitor 2
(for an infant not under gas
anesthesia)
868.2550 Pneumotachomometer 2
868.2600 Airway pressure monitor 2
868.5665 Powered percussor 2
868.5690 Incentive spirometer 2
Ventilator 868.5905 Noncontinuous ventilator 2
(IPPB)
868.5925 Powered emergency ventilator 2
868.5935 External negative pressure 2
ventilator
868.5895 Continuous ventilator 2
868.5955 Intermittent mandatory ventila- 2
tion attachment
868.6250 Portable air compressor 2
Cardiovascular Panel
Cardiovascular Diagnostic 870.1425 Programmable diagnostic 2
computer
870.1450 Densitometer 2
870.2310 Apex cardiograph 2
(vibrocardiograph)
870.2320 Ballistocardiograph 2
870.2340 Electrocardiograph 2
870.2350 Electrocardiograph lead 1
switching adaptor
870.2360 Electrocardiograph electrode 2
870.2370 Electrocardiograph surface 2
electrode tester
870.2400 Vectorcardiograph 1
870.2450 Medical cathode-ray tube dis- 1
play
870.2675 Oscillometer 2
870.2840 Apex cardiographic transducer 2
870.2860 Heart sound transducer 2
Cardiovascular Monitoring Valve, pressure relief,
cardiopulmonary bypass
870.1100 Blood pressure alarm 2
870.1110 Blood pressure computer 2
870.1120 Blood pressure cuff 2
870.1130 Noninvasive blood pressure 2
measurement system
870.1140 Venous blood pressure ma- 2
nometer
870.1220 Electrode recording catheter 2
or electrode recording
probe
870.1270 Intracavitary phonocatheter 2
system
870.1875 Stethoscope (electronic) 2
870.2050 Biopotential amplifier and sig- 2
nal conditioner
870.2060 Transducer signal amplifier 2
and conditioner

269

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Pt. 26, Subpt. B, App. B 21 CFR Ch. I (4–1–11 Edition)

TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1—Continued
Product Family 21 CFR Section No Device Name Tier

870.2100 Cardiovascular blood flow- 2


meter
870.2120 Extravascular blood flow 2
probe
870.2300 Cardiac monitor (including 2
cardiotachometer and rate
alarm)
870.2700 Oximeter 2
870.2710 Ear oximeter 2
870.2750 Impedance phlebograph 2
870.2770 Impedance plethysmograph 2
870.2780 Hydraulic, pneumatic, or pho- 2
toelectric plethysmographs
870.2850 Extravascular blood pressure 2
transducer
870.2870 Catheter tip pressure trans- 2
ducer
870.2880 Ultrasonic transducer 2
870.2890 Vessel occlusion transducer 2
870.2900 Patient transducer and elec- 2
trode cable (including con-
nector)
870.2910 Radiofrequency physiological 2
signal transmitter and re-
ceiver
870.2920 Telephone electrocardiograph 2
transmitter and receiver
870.4205 Cardiopulmonary bypass bub- 2
ble detector
870.4220 Cardiopulmonary bypass 2
heart-lung machine console
870.4240 Cardiovascular bypass heat 2
exchanger
870.4250 Cardiopulmonary bypass tem- 2
perature controller
870.4300 Cardiopulmonary bypass gas 2
control unit
870.4310 Cardiopulmonary bypass cor- 2
onary pressure gauge
870.4330 Cardiopulmonary bypass on- 2
line blood gas monitor
870.4340 Cardiopulmonary bypass level 2
sensing monitor and/or con-
trol
870.4370 Roller-type cardiopulmonary 2
bypass blood pump
870.4380 Cardiopulmonary bypass 2
pump speed control
870.4410 Cardiopulmonary bypass in- 2
line blood gas sensor
Cardiovascular Thera- 870.5050 Patient care suction apparatus 2
peutic
870.5900 Thermal regulation system 2
Defibrillator 870.5300 DC-defibrillator (including pad- 2
dles)
870.5325 Defibrillator tester 2
Echocardiograph 870.2330 Echocardiograph 2
Pacemaker & Acces- 870.1750 External programmable pace- 2
sories maker pulse generator
870.3630 Pacemaker generator function 2
analyzer
870.3640 Indirect pacemaker generator 2
function analyzer
870.3720 Pacemaker electrode function 2
tester
Miscellaneous 870.1800 Withdrawal-infusion pump 2
870.2800 Medical magnetic tape re- 2
corder
None Batteries, rechargeable, class
II devices

270

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Food and Drug Administration, HHS Pt. 26, Subpt. B, App. B

TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1—Continued
Product Family 21 CFR Section No Device Name Tier

Dental Panel
Dental Equipment 872.1720 Pulp tester 2
872.1740 Caries detection device 2
872.4120 Bone cutting instrument and 2
accessories
872.4465 Gas-powered jet injector 2
872.4475 Spring-powered jet injector 2
872.4600 Intraoral ligature and wire lock 2
872.4840 Rotary scaler 2
872.4850 Ultrasonic scaler 2
872.4920 Dental electrosurgical unit and 2
accessories
872.6070 Ultraviolet activator for polym- 2
erization
872.6350 Ultraviolet detector 2
Dental Material 872.3050 Amalgam alloy 2
872.3060 Gold-based alloys and pre- 2
cious metal alloys for clin-
ical use
872.3200 Resin tooth bonding agent 2
872.3250 Calcium hydroxide cavity liner 2
872.3260 Cavity varnish 2
872.3275 Dental cement (other than 2
zinc oxide-eugenol)
872.3300 Hydrophilic resin coating for 2
dentures
872.3310 Coating material for resin fill- 2
ings
872.3590 Preformed plastic denture 2
tooth
872.3660 Impression material 2
872.3690 Tooth shade resin material 2
872.3710 Base metal alloy 2
872.3750 Bracket adhesive resin and 2
tooth conditioner
872.3760 Denture relining, repairing, or 2
rebasing resin
872.3765 Pit and fissure sealant and 2
conditioner
872.3770 Temporary crown and bridge 2
resin
872.3820 Root canal filling resin (other 2
than chloroform use)
872.3920 Porcelain tooth 2
Dental X-ray 872.1800 Extraoral source x-ray system 2
872.1810 Intraoral source x-ray system 2
Dental Implants 872.4880 Intraosseous fixation screw or 2
wire
872.3890 Endodontic stabilizing splint 2
Orthodontic 872.5470 Orthodontic plastic bracket 2
Ear/Nose/Throat Panel
Diagnostic Equipment 874.1050 Audiometer 2
874.1090 Auditory impedance tester 2
874.1120 Electronic noise generator for 2
audiometric testing
874.1325 Electroglottograph 2
874.1820 Surgical nerve stimulator/loca- 2
tor
Hearing Aids 874.3300 Hearing aid (for bone-conduc- 2
tion)
874.3310 Hearing aid calibrator and 2
analysis system
874.3320 Group hearing aid or group 2
auditory trainer
874.3330 Master hearing aid 2
Surgical Equipment 874.4250 Ear, nose, and throat electric 1
or pneumatic surgical drill
874.4490 Argon laser for otology, rhi- 2
nology, and laryngology

271

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Pt. 26, Subpt. B, App. B 21 CFR Ch. I (4–1–11 Edition)

TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1—Continued
Product Family 21 CFR Section No Device Name Tier

874.4500 Ear, nose, and throat micro- 2


surgical carbon dioxide
laser
Gastroenterology/Urology
Panel
Endoscope (including 876.1500 Endoscope and accessories 2
angioscopes,
laparscopes, oph-
thalmic endoscopes)
876.4300 Endoscopic electrosurgical 2
unit and accessories
Gastroenterology 876.1725 Gastrointestinal motility moni- 1
toring system
Hemodialysis 876.5600 Sorbent regenerated dialysate 2
delivery system for hemo-
dialysis
876.5630 Peritoneal dialysis system and 2
accessories
876.5665 Water purification system for 2
hemodialysis
876.5820 Hemodialysis system and ac- 2
cessories
876.5830 Hemodialyzer with disposable 2
insert (kiil-type)
Lithotriptor 876.4500 Mechanical lithotriptor 2
Urology Equipment 876.1620 Urodynamics measurement 2
system
876.5320 Nonimplanted electrical con- 2
tinence device
876.5880 Isolated kidney perfusion and 2
transport system and ac-
cessories
General Hospital Panel
Infusion Pumps and Sys- 880.2420 Electronic monitor for gravity 2
tems flow infusion systems
880.2460 Electrically powered spinal 2
fluid pressure monitor
880.5430 Nonelectrically powered fluid 2
injector
880.5725 Infusion pump 2
Neonatal Incubators 880.5400 Neonatal incubator 2
880.5410 Neonatal transport incubator 2
880.5700 Neonatal phototherapy unit 2
Piston Syringes 880.5570 Hypodermic single lumen nee- 1
dle
880.5860 Piston syringe (except 1
antistick)
880.6920 Syringe needle introducer 2
Miscellaneous 880.2910 Clinical electronic thermom- 2
eter
880.2920 Clinical mercury thermometer 2
880.5100 AC-powered adjustable hos- 1
pital bed
880.5500 AC-powered patient lift 2
880.6880 Steam sterilizer (greater than 2
2 cubic feet)
Neurology Panel
882.1020 Rigidity analyzer 2
882.1610 Alpha monitor 2
Neuro-Diagnostic 882.1320 Cutaneous electrode 2
882.1340 Nasopharyngeal electrode 2
882.1350 Needle electrode 2
882.1400 Electroencephalograph 2
882.1460 Nystagmograph 2
882.1480 Neurological endoscope 2
882.1540 Galvanic skin response meas- 2
urement device
882.1550 Nerve conduction velocity 2
measurement device
882.1560 Skin potential measurement 2
device

272

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Food and Drug Administration, HHS Pt. 26, Subpt. B, App. B

TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1—Continued
Product Family 21 CFR Section No Device Name Tier

882.1570 Powered direct-contact tem- 2


perature measurement de-
vice
882.1620 Intracranial pressure moni- 2
toring device
882.1835 Physiological signal amplifier 2
882.1845 Physiological signal condi- 2
tioner
882.1855 Electroencephalogram (EEG) 2
telemetry system
882.5050 Biofeedback device 2
Echoencephalography 882.1240 Echoencephalograph 2
RPG 882.4400 Radiofrequency lesion gener- 2
ator
Neuro Surgery none Electrode, spinal epidural 2
882.4305 Powered compound cranial 2
drills, burrs, trephines, and
their accessories
882.4310 Powered simple cranial drills 2
burrs, trephines, and their
accessories
882.4360 Electric cranial drill motor 2
882.4370 Pneumatic cranial drill motor 2
882.4560 Stereotaxic instrument 2
882.4725 Radiofrequency lesion probe 2
882.4845 Powered rongeur 2
882.5500 Lesion temperature monitor 2
Stimulators 882.1870 Evoked response electrical 2
stimulator
882.1880 Evoked response mechanical 2
stimulator
882.1890 Evoked response photic stim- 2
ulator
882.1900 Evoked response auditory 2
stimulator
882.1950 Tremor transducer 2
882.5890 Transcutaneous electrical 2
nerve stimulator for pain re-
lief
Obstetrics/Gynecology Panel
Fetal Monitoring 884.1660 Transcervical endoscope 2
(amnioscope) and acces-
sories
884.1690 Hysteroscope and acces- 2
sories (for performance
standards)
884.2225 Obstetric-gynecologic ultra- 2
sonic imager
884.2600 Fetal cardiac monitor 2
884.2640 Fetal phonocardiographic 2
monitor and accessories
884.2660 Fetal ultrasonic monitor and 2
accessories
884.2675 Fetal scalp circular (spiral) 1
electrode and applicator
884.2700 Intrauterine pressure monitor 2
and accessories
884.2720 External uterine contraction 2
monitor and accessories
884.2740 Perinatal monitoring system 2
and accessories
884.2960 Obstetric ultrasonic transducer 2
and accessories
Gynecological Surgery 884.1720 Gynecologic laparoscope and 2
Equipment accessories
884.4160 Unipolar endoscopic coagu- 2
lator-cutter and accessories
884.4550 Gynecologic surgical laser 2
884.4120 Gynecologic electrocautery 2
and accessories
884.5300 Condom 2

273

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Pt. 26, Subpt. B, App. B 21 CFR Ch. I (4–1–11 Edition)

TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1—Continued
Product Family 21 CFR Section No Device Name Tier

Ophthalmic Implants 886.3320 Eye sphere implant 2


Contact Lens 886.1385 Polymethylmethacrylate 2
(PMMA) diagnostic contact
lens
886.5916 Rigid gas permeable contact 2
lens (daily wear only)
Diagnostic Equipment 886.1120 Opthalmic camera 1
886.1220 Corneal electrode 1
886.1250 Euthyscope (AC-powered) 1
886.1360 Visual field laser instrument 1
886.1510 Eye movement monitor 1
886.1570 Ophthalmoscope 1
886.1630 AC-powered photostimulator 1
886.1640 Ophthalmic preamplifier 1
886.1670 Ophthalmic isotope uptake 2
probe
886.1780 Retinoscope (AC-powered de- 1
vice)
886.1850 AC-powered slit lamp bio- 1
microscope
886.1930 Tonometer and accessories 2
886.1945 Transilluminator (AC-powered 1
device)
886.3130 Ophthalmic conformer 2
(Diagnostic/Surgery 886.4670 Phacofragmentation system 2
Equipment)
Ophthalmic Implants 886.3340 Extraocular orbital implant 2
886.3800 Scleral shell 2
Surgical Equipment 880.5725 Infusion pump (performance 2
standards)
886.3100 Ophthalmic tantalum clip 2
886.3300 Absorbable implant (scleral 2
buckling method)
886.4100 Radiofrequency 2
electrosurgical cautery ap-
paratus
886.4115 Thermal cautery unit 2
886.4150 Vitreous aspiration and cutting 2
instrument
886.4170 Cryophthalmic unit 2
886.4250 Ophthalmic electrolysis unit 1
(AC-powered device)
886.4335 Operating headlamp (AC-pow- 1
ered device)
886.4390 Ophthalmic laser 2
886.4392 Nd:YAG laser for posterior 2
capsulotomy
886.4400 Electronic metal locator 1
886.4440 AC-powered magnet 1
886.4610 Ocular pressure applicator 2
886.4690 Ophthalmic photocoagulator 2
886.4790 Ophthalmic sponge 2
886.5100 Ophthalmic beta radiation 2
source
none Ophthalmoscopes, replace- 1
ment batteries, hand-held
Orthopedic Panel
Implants 888.3010 Bone fixation cerclage 2
888.3020 Intramedullary fixation rod 2
888.3030 Single/multiple component 2
metallic bone fixation appli-
ances and accessories
888.3040 Smooth or threaded metallic 2
bone fixation fastener
888.3050 Spinal interlaminal fixation or- 2
thosis
888.3060 Spinal intervertebral body fixa- 2
tion orthosis
Surgical Equipment 888.1240 AC-powered dynamometer 2
888.4580 Sonic surgical instrument and 2
accessories/attachments

274

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Food and Drug Administration, HHS Pt. 26, Subpt. B, App. B

TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1—Continued
Product Family 21 CFR Section No Device Name Tier

none Accessories, fixation, spinal 2


interlaminal
none Accessories, fixation, spinal 2
intervertebral body
none Monitor, pressure, 1
intracompartmental
none Orthosis, fixation, spinal 2
intervertebral fusion
none Orthosis, spinal pedicle fixa-
tion
none System, cement removal ex- 1
traction
Physical Medicine Panel
Diagnostic Equipment or 890.1225 Chronaximeter 2
(Therapy) Therapeutic
Equipment
890.1375 Diagnostic electromyograph 2
890.1385 Diagnostic electromyograph 2
needle electrode
890.1450 Powered reflex hammer 2
890.1850 Diagnostic muscle stimulator 2
or (Therapy) 890.5850 Powered muscle stimulator 2
Therapeutic Equipment 890.5100 Immersion hydrobath 2
890.5110 Paraffin bath 2
890.5500 Infrared lamp 2
890.5720 Water circulating hot or cold 2
pack
890.5740 Powered heating pad 2
Radiology Panel
MRI 892.1000 Magnetic resonance diag- 2
nostic device
Ultrasound Diagnostic 884.2660 Fetal ultrasonic monitor and 2
accessories
892.1540 Nonfetal ultrasonic monitor
892.1560 Ultrasonic pulsed echo imag- 2
ing system
892.1570 Diagnostic ultrasonic trans- 2
ducer
892.1550 Ultrasonic pulsed doppler im-
aging system
Angiographic 892.1600 Angiographic x-ray system 2
Diagnostic X-Ray 892.1610 Diagnostic x-ray beam-limiting 2
device
892.1620 Cine or spot fluorographic x- 2
ray camera
892.1630 Electrostatic x-ray imaging 2
system
892.1650 Image-intensified fluoroscopic 2
x-ray system
892.1670 Spot film device 2
892.1680 Stationary x-ray system 2
892.1710 Mammographic x-ray system 2
892.1720 Mobile x-ray system 2
892.1740 Tomographic x-ray system 1
892.1820 Pneumoencephalographic 2
chair
892.1850 Radiographic film cassette 1
892.1860 Radiographic film/cassette 1
changer
892.1870 Radiographic film/cassette 2
changer programmer
892.1900 Automatic radiographic film 2
processor
892.1980 Radiologic table 1
CT Scanner 892.1750 Computed tomography x-ray 2
system
Radiation Therapy 892.5050 Medical charged-particle radi- 2
ation therapy system
892.5300 Medical neutron radiation 2
therapy system

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§ 26.60 21 CFR Ch. I (4–1–11 Edition)

TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1—Continued
Product Family 21 CFR Section No Device Name Tier

892.5700 Remote controlled radio- 2


nuclide applicator system
892.5710 Radiation therapy beam-shap- 2
ing block
892.5730 Radionuclide brachytherapy 2
source
892.5750 Radionuclide radiation therapy 2
system
892.5770 Powered radiation therapy pa- 2
tient support assembly
892.5840 Radiation therapy simulation 2
system
892.5930 Therapeutic x-ray tube hous- 1
ing assembly
Nuclear Medicine 892.1170 Bone densitometer 2
892.1200 Emission computed tomog- 2
raphy system
892.1310 Nuclear tomography system 1
892.1390 Radionuclide rebreathing sys- 2
tem
General/Plastic Surgery Panel
Surgical Lamps 878.4630 Ultraviolet lamp for dermato- 2
logic disorders
890.5500 Infrared lamp 2
878.4580 Surgical lamp 2
Electrosurgical Cutting 878.4810 Laser surgical instrument for 2
Equipment use in general and plastic
surgery and in dermatology
878.4400 Electrosurgical cutting and co- 2
agulation device and acces-
sories
Miscellaneous 878.4780 Powered suction pump 2
1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA’s Internet
Web Site at http://www.fda.gov/cdrh/prodcode.html.

[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]

APPENDICES C–F TO SUBPART B OF PART tion to ensure that products marketed


26 [RESERVED] within its jurisdiction comply with
legal requirements.
Subpart C—‘‘Framework’’ (b) Other terms concerning con-
Provisions formity assessment used in this part
shall have the meaning given elsewhere
§ 26.60 Definitions. in this part or in the definitions con-
(a) The following terms and defini- tained in ‘‘Guide 2: Standardization and
tions shall apply to this subpart only: Related Activities—General Vocabu-
(1) Designating Authority means a lary of the International Organization
body with power to designate, monitor, for Standardization (ISO) and the
suspend, remove suspension of, or with- International Electrotechnical Com-
draw conformity assessment bodies as mission (IEC)’’ (ISO/IEC Guide 2) (1996
specified under this part. edition), which is incorporated by ref-
(2) Designation means the identifica- erence in accordance with 5 U.S.C.
tion by a designating authority of a 552(a) and 1 CFR part 51. Copies are
conformity assessment body to perform available from the International Orga-
conformity assessment procedures nization for Standardization, 1, rue de
under this part. Varembé, Case postale 56, CH–1211
(3) Regulatory Authority means a gov- Genève 20, Switzerland, or on the Inter-
ernment agency or entity that exer- net at http://www.iso.ch or may be ex-
cises a legal right to control the use or amined at the Food and Drug Adminis-
sale of products within a party’s juris- tration’s Medical Library, 5600 Fishers
diction and may take enforcement ac- Lane, rm. 11B–40, Rockville, MD 20857,

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Food and Drug Administration, HHS § 26.63

or at the National Archives and of the EC and its Member States, pro-
Records Administration (NARA). For duced by the other party’s CAB’s and/
information on the availability of this or authorities.
material at NARA, call 202–741–6030, or (c) Where sectoral transition ar-
go to: http://www.archives.gov/ rangements have been specified in sub-
federallregister/ parts A and B of this part, the obliga-
codeloflfederallregulations/ tions in paragraphs (a) and (b) of this
ibrllocations.html. In the event of an section will apply following the suc-
inconsistency between the ISO/IEC cessful completion of those sectoral
Guide 2 and definitions in this part, the transition arrangements, with the un-
definitions in this part shall prevail. derstanding that the conformity as-
sessment procedures utilized assure
§ 26.61 Purpose of this part. conformity to the satisfaction of the
This part specifies the conditions by receiving party, with applicable legis-
which each party will accept or recog- lative, regulatory, and administrative
nize results of conformity assessment provisions of that party, equivalent to
procedures, produced by the other par- the assurance offered by the receiving
ty’s conformity assessment bodies party’s own procedures.
(CAB’s) or authorities, in assessing
conformity to the importing party’s re- § 26.63 General coverage of this part.
quirements, as specified on a sector- (a) This part applies to conformity
specific basis in subparts A and B of assessment procedures for products
this part, and to provide for other re- and/or processes and to other related
lated cooperative activities. The objec- cooperative activities as described in
tive of such mutual recognition is to this part.
provide effective market access (b) Subparts A and B of this part may
throughout the territories of the par- include:
ties with regard to conformity assess- (1) A description of the relevant leg-
ment for all products covered under islative, regulatory, and administra-
this part. If any obstacles to such ac- tive provisions pertaining to the con-
cess arise, consultations will promptly formity assessment procedures and
be held. In the absence of a satisfactory technical regulations;
outcome of such consultations, the (2) A statement on the product scope
party alleging its market access has and coverage;
been denied may, within 90 days of (3) A list of designating authorities;
such consultation, invoke its right to (4) A list of agreed conformity assess-
terminate the ‘‘Agreement on Mutual ment bodies (CAB’s) or authorities or a
Recognition Between the United States source from which to obtain a list of
of America and the European Commu- such bodies or authorities and a state-
nity,’’ from which this part is derived, ment of the scope of the conformity as-
in accordance with § 26.80. sessment procedures for which each has
been agreed;
§ 26.62 General obligations. (5) The procedures and criteria for
(a) The United States shall, as speci- designating the CAB’s;
fied in subparts A and B of this part, (6) A description of the mutual rec-
accept or recognize results of specified ognition obligations;
procedures, used in assessing con- (7) A sectoral transition arrange-
formity to specified legislative, regu- ment;
latory, and administrative provisions (8) The identity of a sectoral contact
of the United States, produced by the point in each party’s territory; and
other party’s conformity assessment (9) A statement regarding the estab-
bodies (CAB’s) and/or authorities. lishment of a Joint Sectoral Com-
(b) The European Community (EC) mittee.
and its Member States shall, as speci- (c) This part shall not be construed
fied in subparts A and B of this part, to entail mutual acceptance of stand-
accept or recognize results of specified ards or technical regulations of the
procedures, used in assessing con- parties and, unless otherwise specified
formity to specified legislative, regu- in subpart A or B of this part, shall not
latory, and administrative provisions entail the mutual recognition of the

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§ 26.64 21 CFR Ch. I (4–1–11 Edition)

equivalence of standards or technical evidence the technical competence or


regulations. compliance of a proposed CAB, or indi-
cates in writing that it requires an ad-
§ 26.64 Transitional arrangements. ditional 30 days to more fully verify
The parties agree to implement the such evidence, such CAB shall not be
transitional commitments on con- included on the list of CAB’s in subpart
fidence building as specified in sub- B of this part. In this instance, the
parts A and B of this part. Joint Committee may decide that the
(a) The parties agree that each sec- body concerned be verified. After the
toral transitional arrangement shall completion of such verification, the
specify a time period for completion. proposal to list the CAB in subpart B
(b) The parties may amend any tran- may be resubmitted to the other party.
sitional arrangement by mutual agree-
ment. § 26.67 Suspension of listed conformity
(c) Passage from the transitional assessment bodies.
phase to the operational phase shall The following procedures shall apply
proceed as specified in subparts A and with regard to the suspension of a con-
B of this part, unless either party docu- formity assessment body (CAB) listed
ments that the conditions provided in in subpart B of this part.
such subpart for a successful transition (a) A party shall notify the other
are not met. party of its contestation of the tech-
§ 26.65 Designating authorities. nical competence or compliance of a
CAB listed in subpart B of this part
The parties shall ensure that the des- and the contesting party’s intent to
ignating authorities specified in sub- suspend such CAB. Such contestation
part B of this part have the power and shall be exercised when justified in an
competence in their respective terri- objective and reasoned manner in writ-
tories to carry out decisions under this
ing to the other party;
part to designate, monitor, suspend, re-
(b) The CAB shall be given prompt
move suspension of, or withdraw con-
notice by the other party and an oppor-
formity assessment bodies (CAB’s).
tunity to present information in order
§ 26.66 Designation and listing proce- to refute the contestation or to correct
dures. the deficiencies which form the basis of
The following procedures shall apply the contestation;
with regard to the designation of con- (c) Any such contestation shall be
formity assessment bodies (CAB’s) and discussed between the parties in the
the inclusion of such bodies in the list Joint Sectoral Committee described in
of CAB’s in subpart B of this part: subpart B of this part. If there is no
(a) The designating authority identi- Joint Sectoral Committee, the con-
fied in subpart B of this part shall des- testing party shall refer the matter di-
ignate CAB’s in accordance with the rectly to the Joint Committee. If
procedures and criteria set forth in agreement to suspend is reached by the
subpart B of this part; Joint Sectoral Committee or, if there
(b) A party proposing to add a CAB to is no Joint Sectoral Committee, by the
the list of such bodies in subpart B of Joint Committee, the CAB shall be sus-
this part shall forward its proposal of pended;
one or more designated CAB’s in writ- (d) Where the Joint Sectoral Com-
ing to the other party with a view to a mittee or Joint Committee decides
decision by the Joint Committee; that verification of technical com-
(c) Within 60 days following receipt of petence or compliance is required, it
the proposal, the other party shall in- shall normally be carried out in a time-
dicate its position regarding either its ly manner by the party in whose terri-
confirmation or its opposition. Upon tory the body in question is located,
confirmation, the inclusion in subpart but may be carried out jointly by the
B of this part of the proposed CAB or parties in justified cases;
CAB’s shall take effect; and (e) If the matter has not been re-
(d) In the event that the other party solved by the Joint Sectoral Com-
contests on the basis of documented mittee within 10 days of the notice of

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Food and Drug Administration, HHS § 26.69

contestation, the matter shall be re- the list of CAB’s in subpart B of this
ferred to the Joint Committee for a de- part. In this instance, the Joint Sec-
cision. If there is no Joint Sectoral toral Committee or the Joint Com-
Committee, the matter shall be re- mittee may decide to carry out a joint
ferred directly to the Joint Committee. verification of the body concerned.
If no decision is reached by the Joint After the completion of such
Committee within 10 days of the refer- verification, the proposal for with-
ral to it, the CAB shall be suspended drawal of the CAB may be resubmitted
upon the request of the contesting to the other party; and
party; (e) Subsequent to the withdrawal of a
(f) Upon the suspension of a CAB list- CAB listed in subpart B of this part, a
ed in subpart B of this part, a party is party shall continue to accept the re-
no longer obligated to accept or recog- sults of conformity assessment proce-
nize the results of conformity assess- dures performed by that CAB prior to
ment procedures performed by that withdrawal, unless a regulatory au-
CAB subsequent to suspension. A party thority of the party decides otherwise
shall continue to accept the results of based on health, safety, and environ-
conformity assessment procedures per- mental considerations or failure to sat-
formed by that CAB prior to suspen- isfy other requirements within the
sion, unless a regulatory authority of scope of subpart B of this part.
the party decides otherwise based on
health, safety or environmental consid- § 26.69 Monitoring of conformity as-
erations or failure to satisfy other re- sessment bodies.
quirements within the scope of subpart The following shall apply with regard
B of this part; and to the monitoring of conformity assess-
(g) The suspension shall remain in ef- ment bodies (CAB’s) listed in subpart B
fect until agreement has been reached of this part:
by the parties upon the future status of (a) Designating authorities shall as-
that body. sure that their CAB’s listed in subpart
B of this part are capable and remain
§ 26.68 Withdrawal of listed conformity capable of properly assessing con-
assessment bodies. formity of products or processes, as ap-
The following procedures shall apply plicable, and as covered in subpart B of
with regard to the withdrawal from this part. In this regard, designating
subpart B of this part of a conformity authorities shall maintain, or cause to
assessment body (CAB): maintain, ongoing surveillance over
(a) A party proposing to withdraw a their CAB’s by means of regular audit
CAB listed in subpart B of this part or assessment;
shall forward its proposal in writing to (b) The parties undertake to compare
the other party; methods used to verify that the CAB’s
(b) Such CAB shall be promptly noti- listed in subpart B of this part comply
fied by the other party and shall be with the relevant requirements of sub-
provided a period of at least 30 days part B of this part. Existing systems
from receipt to provide information in for the evaluation of CAB’s may be
order to refute or to correct the defi- used as part of such comparison proce-
ciencies which form the basis of the dures;
proposed withdrawal; (c) Designating authorities shall con-
(c) Within 60 days following receipt of sult as necessary with their counter-
the proposal, the other party shall in- parts, to ensure the maintenance of
dicate its position regarding either its confidence in conformity assessment
confirmation or its opposition. Upon procedures. With the consent of both
confirmation, the withdrawal from the parties, this consultation may include
list in subpart B of this part of the CAB joint participation in audits/inspec-
shall take effect; tions related to conformity assessment
(d) In the event the other party op- activities or other assessments of
poses the proposal to withdraw by sup- CAB’s listed in subpart B of this part;
porting the technical competence and and
compliance of the CAB, the CAB shall (d) Designating authorities shall con-
not at that time be withdrawn from sult, as necessary, with the relevant

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§ 26.70 21 CFR Ch. I (4–1–11 Edition)

regulatory authorities of the other § 26.73 Joint Committee.


party to ensure that all technical re-
(a) A Joint Committee consisting of
quirements are identified and are satis-
representatives of the United States
factorily addressed.
and the European Community (EC) will
§ 26.70 Conformity assessment bodies. be established. The Joint Committee
shall be responsible for the effective
Each party recognizes that the con- functioning of the ‘‘Agreement on Mu-
formity assessment bodies (CAB’s) list- tual Recognition Between the United
ed in subpart B of this part fulfill the States of America and the European
conditions of eligibility to assess con- Community,’’ from which this part is
formity in relation to its requirements
derived.
as specified in subpart B of this part.
(b) The Joint Committee may estab-
The parties shall specify the scope of
lish Joint Sectoral Committees com-
the conformity assessment procedures
prised of appropriate regulatory au-
for which such bodies are listed.
thorities and others deemed necessary.
§ 26.71 Exchange of information. (c) The United States and the EC
shall each have one vote in the Joint
(a) The parties shall exchange infor- Committee. The Joint Committee shall
mation concerning the implementation make its decisions by unanimous con-
of the legislative, regulatory, and ad- sent. The Joint Committee shall deter-
ministrative provisions identified in
mine its own rules and procedures.
subparts A and B of this part.
(d) The Joint Committee may con-
(b) Each party shall notify the other
sider any matter relating to the effec-
party of legislative, regulatory, and ad-
tive functioning of that agreement. In
ministrative changes related to the
particular it shall be responsible for:
subject matter of this part at least 60
(1) Listing, suspension, withdrawal
days before their entry into force.
and verification of conformity assess-
Where considerations of safety, health
ment bodies (CAB’s) in accordance with
or environmental protection require
more urgent action, a party shall no- that agreement;
tify the other party as soon as prac- (2) Amending transitional arrange-
ticable. ments in the sectoral annexes to that
(c) Each party shall promptly notify agreement;
the other party of any changes to its (3) Resolving any questions relating
designating authorities and/or con- to the application of that agreement
formity assessment bodies (CAB’s). not otherwise resolved in the respec-
(d) The parties shall exchange infor- tive Joint Sectoral Committees;
mation concerning the procedures used (4) Providing a forum for discussion
to ensure that the listed CAB’s under of issues that may arise concerning the
their responsibility comply with the implementation of that agreement;
legislative, regulatory, and administra- (5) Considering ways to enhance the
tive provisions outlined in subpart B of operation of that agreement;
this part. (6) Coordinating the negotiation of
(e) Regulatory authorities identified additional sectoral annexes to that
in subparts A and B of this part shall agreement; and
consult as necessary with their coun- (7) Considering whether to amend
terparts, to ensure the maintenance of that agreement in accordance with
confidence in conformity assessment § 26.80.
procedures and to ensure that all tech- (e) When a party introduces new or
nical requirements are identified and additional conformity assessment pro-
are satisfactorily addressed. cedures affecting a sectoral annex to
that agreement, the parties shall dis-
§ 26.72 Sectoral contact points. cuss the matter in the Joint Com-
Each party shall appoint and confirm mittee with a view to bringing such
in writing contact points to be respon- new or additional procedures within
sible for activities under subparts A the scope of that agreement and the
and B of this part. relevant sectoral annex.

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Food and Drug Administration, HHS § 26.78

§ 26.74 Preservation of regulatory au- ments have not been recognized by the
thority. party implementing the requirements;
(a) Nothing in this part shall be con- or
strued to limit the authority of a party (c) The other party fails to maintain
to determine, through its legislative, legal and regulatory authorities capa-
regulatory, and administrative meas- ble of implementing the provisions of
ures, the level of protection it con- this part.
siders appropriate for safety; for pro-
tection of human, animal, or plant life § 26.76 Confidentiality.
or health; for the environment; for con- (a) Each party agrees to maintain, to
sumers; and otherwise with regard to the extent required under its laws, the
risks within the scope of the applicable confidentiality of information ex-
subpart A or B of this part. changed under this part.
(b) Nothing in this part shall be con-
(b) In particular, neither party shall
strued to limit the authority of a regu-
disclose to the public, nor permit a
latory authority to take all appro-
conformity assessment body (CAB) to
priate and immediate measures when-
ever it ascertains that a product may: disclose to the public, information ex-
(1) Compromise the health or safety changed under this part that con-
of persons in its territory; stitutes trade secrets, confidential
(2) Not meet the legislative, regu- commercial or financial information,
latory, or administrative provisions or information that relates to an ongo-
within the scope of the applicable sub- ing investigation.
part A or B of this part; or (c) A party or a CAB may, upon ex-
(3) Otherwise fail to satisfy a require- changing information with the other
ment within the scope of the applicable party or with a CAB of the other party,
subpart A or B of this part. Such meas- designate the portions of the informa-
ures may include withdrawing the tion that it considers to be exempt
products from the market, prohibiting from disclosure.
their placement on the market, re- (d) Each party shall take all pre-
stricting their free movement, initi- cautions reasonably necessary to pro-
ating a product recall, and preventing tect information exchanged under this
the recurrence of such problems, in- part from unauthorized disclosure.
cluding through a prohibition on im-
ports. If the regulatory authority takes § 26.77 Fees.
such action, it shall inform its counter- Each party shall endeavor to ensure
part authority and the other party that fees imposed for services under
within 15 days of taking such action, this part shall be commensurate with
providing its reasons. the services provided. Each party shall
§ 26.75 Suspension of recognition obli- ensure that, for the sectors and con-
gations. formity assessment procedures covered
under this part, it shall charge no fees
Either party may suspend its obliga-
tions under subpart A or B of this part, with respect to conformity assessment
in whole or in part, if: services provided by the other party.
(a) A party suffers a loss of market
§ 26.78 Agreements with other coun-
access for the party’s products within tries.
the scope of subpart A or B of this part
as a result of the failure of the other Except where there is written agree-
party to fulfill its obligations under ment between the parties, obligations
this part; contained in mutual recognition agree-
(b) The adoption of new or additional ments concluded by either party with a
conformity assessment requirements as party not a party to the agreement
referenced in § 26.73(e) results in a loss from which this part is derived (a third
of market access for the party’s prod- party) shall have no force and effect
ucts within the scope of subpart B of with regard to the other party in terms
this part because conformity assess- of acceptance of the results of con-
ment bodies (CAB’s) designated by the formity assessment procedures in the
party in order to meet such require- third party.

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§ 26.79 21 CFR Ch. I (4–1–11 Edition)

§ 26.79 Territorial application. cept the results of conformity assess-


The agreement from which this part ment procedures performed by con-
is derived shall apply, on the one hand, formity assessment bodies under that
to the territories in which the Treaty agreement prior to termination, unless
establishing the European Community a regulatory authority in the party de-
(EC) is applied, and under the condi- cides otherwise based on health, safety
tions laid down in that Treaty and, on and environmental considerations or
the other hand, to the territory of the failure to satisfy other requirements
United States. within the scope of the applicable sec-
toral annex.
§ 26.80 Entry into force, amendment,
and termination. § 26.81 Final provisions.
(a) The ‘‘Agreement on Mutual Rec- (a) The sectoral annexes referred to
ognition Between the United States of in § 26.80(a), as well as any new sectoral
America and the European Commu- annexes added pursuant to § 26.80(b),
nity,’’ from which this part is derived, shall form an integral part of the
including its sectoral annexes on tele- ‘‘Agreement on Mutual Recognition Be-
communication equipment, electro- tween the United States of America
magnetic compatibility, electrical and the European Community,’’ from
safety, recreational craft, pharma- which this part is derived.
ceutical Good Manufacturing Practices (b) For a given product or sector, the
(GMP) inspections, and medical devices provisions contained in subparts A and
shall enter into force on the first day B of this part shall apply in the first
of the second month following the date place, and the provisions of subpart C
on which the parties have exchanged of this part in addition to those provi-
letters confirming the completion of sions. In the case of any inconsistency
their respective procedures for the between the provisions of subpart A or
entry into force of that agreement. B of this part and subpart C of this
(b) That agreement including any part, subpart A or B shall prevail, to
sectoral annex may, through the Joint the extent of that inconsistency.
Committee, be amended in writing by (c) The agreement from which this
the parties to that agreement. Those part is derived shall not affect the
parties may add a sectoral annex upon rights and obligations of the parties
the exchange of letters. Such annex under any other international agree-
shall enter into force 30 days following ment.
the date on which those parties have (d) In the case of subpart B of this
exchanged letters confirming the com- part, the parties shall review the sta-
pletion of their respective procedures tus of such subpart at the end of 3
for the entry into force of the sectoral years from the date described in
annex. § 26.80(a).
(c) Either party to that agreement
may terminate that agreement in its
entirety or any individual sectoral
PART 50—PROTECTION OF HUMAN
annex thereof by giving the other party SUBJECTS
to that agreement 6-months notice in
writing. In the case of termination of Subpart A—General Provisions
one or more sectoral annexes, the par- Sec.
ties to that agreement will seek to 50.1 Scope.
achieve by consensus to amend that 50.3 Definitions.
agreement, with a view to preserving
the remaining Sectoral Annexes, in ac- Subpart B—Informed Consent of Human
cordance with the procedures in this Subjects
section. Failing such consensus, that
50.20 General requirements for informed
agreement shall terminate at the end consent.
of 6 months from the date of notice. 50.23 Exception from general requirements.
(d) Following termination of that 50.24 Exception from informed consent re-
agreement in its entirety or any indi- quirements for emergency research.
vidual sectoral annex thereof, a party 50.25 Elements of informed consent.
to that agreement shall continue to ac- 50.27 Documentation of informed consent.

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Food and Drug Administration, HHS § 50.3

Subpart C [Reserved] filed with the Food and Drug Adminis-


tration pursuant to sections 403, 406,
Subpart D—Additional Safeguards for 409, 412, 413, 502, 503, 505, 510, 513–516,
Children in Clinical Investigations 518–520, 721, and 801 of the Federal
50.50 IRB duties. Food, Drug, and Cosmetic Act and sec-
50.51 Clinical investigations not involving tions 351 and 354–360F of the Public
greater than minimal risk. Health Service Act.
50.52 Clinical investigations involving (b) References in this part to regu-
greater than minimal risk but presenting
the prospect of direct benefit to indi-
latory sections of the Code of Federal
vidual subjects. Regulations are to chapter I of title 21,
50.53 Clinical investigations involving unless otherwise noted.
greater than minimal risk and no pros-
pect of direct benefit to individual sub- [45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27,
jects, but likely to yield generalizable 1981, as amended at 63 FR 26697, May 13, 1998;
knowledge about the subjects’ disorder 64 FR 399, Jan. 5, 1999; 66 FR 20597, Apr. 24,
or condition. 2001]
50.54 Clinical investigations not otherwise
approvable that present an opportunity § 50.3 Definitions.
to understand, prevent, or alleviate a se- As used in this part:
rious problem affecting the health or
welfare of children. (a) Act means the Federal Food,
50.55 Requirements for permission by par- Drug, and Cosmetic Act, as amended
ents or guardians and for assent by chil- (secs. 201–902, 52 Stat. 1040 et seq. as
dren. amended (21 U.S.C. 321–392)).
50.56 Wards. (b) Application for research or mar-
AUTHORITY: 21 U.S.C 321, 343, 346, 346a, 348, keting permit includes:
350a, 350b, 352, 353, 355, 360, 360c–360f, 360h– (1) A color additive petition, de-
360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b– scribed in part 71.
263n.
(2) A food additive petition, described
SOURCE: 45 FR 36390, May 30, 1980, unless in parts 171 and 571.
otherwise noted.
(3) Data and information about a sub-
stance submitted as part of the proce-
Subpart A—General Provisions dures for establishing that the sub-
§ 50.1 Scope. stance is generally recognized as safe
for use that results or may reasonably
(a) This part applies to all clinical in- be expected to result, directly or indi-
vestigations regulated by the Food and rectly, in its becoming a component or
Drug Administration under sections otherwise affecting the characteristics
505(i) and 520(g) of the Federal Food, of any food, described in §§ 170.30 and
Drug, and Cosmetic Act, as well as 570.30.
clinical investigations that support ap-
(4) Data and information about a food
plications for research or marketing
additive submitted as part of the proce-
permits for products regulated by the
dures for food additives permitted to be
Food and Drug Administration, includ-
used on an interim basis pending addi-
ing foods, including dietary supple-
tional study, described in § 180.1.
ments, that bear a nutrient content
claim or a health claim, infant for- (5) Data and information about a sub-
mulas, food and color additives, drugs stance submitted as part of the proce-
for human use, medical devices for dures for establishing a tolerance for
human use, biological products for unavoidable contaminants in food and
human use, and electronic products. food-packaging materials, described in
Additional specific obligations and section 406 of the act.
commitments of, and standards of con- (6) An investigational new drug appli-
duct for, persons who sponsor or mon- cation, described in part 312 of this
itor clinical investigations involving chapter.
particular test articles may also be (7) A new drug application, described
found in other parts (e.g., parts 312 and in part 314.
812). Compliance with these parts is in- (8) Data and information about the
tended to protect the rights and safety bioavailability or bioequivalence of
of subjects involved in investigations drugs for human use submitted as part

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§ 50.3 21 CFR Ch. I (4–1–11 Edition)

of the procedures for issuing, amend- (22) Data and information about an
ing, or repealing a bioequivalence re- electronic product submitted as part of
quirement, described in part 320. the procedures for granting, amending,
(9) Data and information about an or extending an exemption from a radi-
over-the-counter drug for human use ation safety performance standard, as
submitted as part of the procedures for described in § 1010.5.
classifying these drugs as generally (23) Data and information about a
recognized as safe and effective and not clinical study of an infant formula
misbranded, described in part 330. when submitted as part of an infant
(10) Data and information about a formula notification under section
prescription drug for human use sub- 412(c) of the Federal Food, Drug, and
mitted as part of the procedures for Cosmetic Act.
classifying these drugs as generally (24) Data and information submitted
recognized as safe and effective and not in a petition for a nutrient content
misbranded, described in this chapter. claim, described in § 101.69 of this chap-
(11) [Reserved] ter, or for a health claim, described in
(12) An application for a biologics li- § 101.70 of this chapter.
cense, described in part 601 of this (25) Data and information from inves-
chapter. tigations involving children submitted
(13) Data and information about a bi- in a new dietary ingredient notifica-
ological product submitted as part of
tion, described in § 190.6 of this chapter.
the procedures for determining that li-
(c) Clinical investigation means any
censed biological products are safe and
experiment that involves a test article
effective and not misbranded, described
in part 601. and one or more human subjects and
(14) Data and information about an in that either is subject to requirements
vitro diagnostic product submitted as for prior submission to the Food and
part of the procedures for establishing, Drug Administration under section
amending, or repealing a standard for 505(i) or 520(g) of the act, or is not sub-
these products, described in part 809. ject to requirements for prior submis-
(15) An Application for an Investiga- sion to the Food and Drug Administra-
tional Device Exemption, described in tion under these sections of the act,
part 812. but the results of which are intended to
(16) Data and information about a be submitted later to, or held for in-
medical device submitted as part of the spection by, the Food and Drug Admin-
procedures for classifying these de- istration as part of an application for a
vices, described in section 513. research or marketing permit. The
(17) Data and information about a term does not include experiments that
medical device submitted as part of the are subject to the provisions of part 58
procedures for establishing, amending, of this chapter, regarding nonclinical
or repealing a standard for these de- laboratory studies.
vices, described in section 514. (d) Investigator means an individual
(18) An application for premarket ap- who actually conducts a clinical inves-
proval of a medical device, described in tigation, i.e., under whose immediate
section 515. direction the test article is adminis-
(19) A product development protocol tered or dispensed to, or used involv-
for a medical device, described in sec- ing, a subject, or, in the event of an in-
tion 515. vestigation conducted by a team of in-
(20) Data and information about an dividuals, is the responsible leader of
electronic product submitted as part of that team.
the procedures for establishing, amend- (e) Sponsor means a person who initi-
ing, or repealing a standard for these ates a clinical investigation, but who
products, described in section 358 of the does not actually conduct the inves-
Public Health Service Act. tigation, i.e., the test article is admin-
(21) Data and information about an istered or dispensed to or used involv-
electronic product submitted as part of ing, a subject under the immediate di-
the procedures for obtaining a variance rection of another individual. A person
from any electronic product perform- other than an individual (e.g., corpora-
ance standard, as described in § 1010.4. tion or agency) that uses one or more

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Food and Drug Administration, HHS § 50.3

of its own employees to conduct a clin- particpation in the procedure(s) in-


ical investigation it has initiated is volved in the research.
considered to be a sponsor (not a spon- (m) Family member means any one of
sor-investigator), and the employees the following legally competent per-
are considered to be investigators. sons: Spouse; parents; children (includ-
(f) Sponsor-investigator means an indi- ing adopted children); brothers, sisters,
vidual who both initiates and actually and spouses of brothers and sisters; and
conducts, alone or with others, a clin- any individual related by blood or af-
ical investigation, i.e., under whose im- finity whose close association with the
mediate direction the test article is ad- subject is the equivalent of a family re-
ministered or dispensed to, or used in-
lationship.
volving, a subject. The term does not
include any person other than an indi- (n) Assent means a child’s affirmative
vidual, e.g., corporation or agency. agreement to participate in a clinical
(g) Human subject means an indi- investigation. Mere failure to object
vidual who is or becomes a participant may not, absent affirmative agree-
in research, either as a recipient of the ment, be construed as assent.
test article or as a control. A subject (o) Children means persons who have
may be either a healthy human or a pa- not attained the legal age for consent
tient. to treatments or procedures involved
(h) Institution means any public or in clinical investigations, under the ap-
private entity or agency (including plicable law of the jurisdiction in
Federal, State, and other agencies). which the clinical investigation will be
The word facility as used in section conducted.
520(g) of the act is deemed to be syn- (p) Parent means a child’s biological
onymous with the term institution for or adoptive parent.
purposes of this part. (q) Ward means a child who is placed
(i) Institutional review board (IRB) in the legal custody of the State or
means any board, committee, or other other agency, institution, or entity,
group formally designated by an insti-
consistent with applicable Federal,
tution to review biomedical research
State, or local law.
involving humans as subjects, to ap-
prove the initiation of and conduct (r) Permission means the agreement of
periodic review of such research. The parent(s) or guardian to the participa-
term has the same meaning as the tion of their child or ward in a clinical
phrase institutional review committee as investigation. Permission must be ob-
used in section 520(g) of the act. tained in compliance with subpart B of
(j) Test article means any drug (in- this part and must include the ele-
cluding a biological product for human ments of informed consent described in
use), medical device for human use, § 50.25.
human food additive, color additive, (s) Guardian means an individual who
electronic product, or any other article is authorized under applicable State or
subject to regulation under the act or local law to consent on behalf of a
under sections 351 and 354–360F of the child to general medical care when
Public Health Service Act (42 U.S.C. 262 general medical care includes partici-
and 263b–263n). pation in research. For purposes of sub-
(k) Minimal risk means that the prob- part D of this part, a guardian also
ability and magnitude of harm or dis- means an individual who is authorized
comfort anticipated in the research are to consent on behalf of a child to par-
not greater in and of themselves than ticipate in research.
those ordinarily encountered in daily
life or during the performance of rou- [45 FR 36390, May 30, 1980, as amended at 46
tine physical or psychological exami- FR 8950, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989;
nations or tests. 56 FR 28028, June 18, 1991; 61 FR 51528, Oct. 2,
(l) Legally authorized representative 1996; 62 FR 39440, July 23, 1997; 64 FR 399, Jan.
means an individual or judicial or 5, 1999; 64 FR 56448, Oct. 20, 1999; 66 FR 20597,
Apr. 24, 2001]
other body authorized under applicable
law to consent on behalf of a prospec-
tive subject to the subject’s

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§ 50.20 21 CFR Ch. I (4–1–11 Edition)

Subpart B—Informed Consent of (3) Time is not sufficient to obtain


Human Subjects consent from the subject’s legal rep-
resentative.
(4) There is available no alternative
SOURCE: 46 FR 8951, Jan. 27, 1981, unless
otherwise noted.
method of approved or generally recog-
nized therapy that provides an equal or
§ 50.20 General requirements for in- greater likelihood of saving the life of
formed consent. the subject.
Except as provided in §§ 50.23 and (b) If immediate use of the test arti-
50.24, no investigator may involve a cle is, in the investigator’s opinion, re-
human being as a subject in research quired to preserve the life of the sub-
covered by these regulations unless the ject, and time is not sufficient to ob-
investigator has obtained the legally tain the independent determination re-
effective informed consent of the sub- quired in paragraph (a) of this section
ject or the subject’s legally authorized in advance of using the test article, the
representative. An investigator shall determinations of the clinical investi-
seek such consent only under cir- gator shall be made and, within 5 work-
cumstances that provide the prospec- ing days after the use of the article, be
tive subject or the representative suffi- reviewed and evaluated in writing by a
cient opportunity to consider whether physician who is not participating in
or not to participate and that minimize the clinical investigation.
the possibility of coercion or undue in- (c) The documentation required in
fluence. The information that is given paragraph (a) or (b) of this section
to the subject or the representative shall be submitted to the IRB within 5
shall be in language understandable to working days after the use of the test
the subject or the representative. No article.
informed consent, whether oral or writ- (d)(1) Under 10 U.S.C. 1107(f) the
ten, may include any exculpatory lan- President may waive the prior consent
guage through which the subject or the requirement for the administration of
representative is made to waive or ap- an investigational new drug to a mem-
pear to waive any of the subject’s legal ber of the armed forces in connection
rights, or releases or appears to release with the member’s participation in a
the investigator, the sponsor, the insti- particular military operation. The
tution, or its agents from liability for statute specifies that only the Presi-
negligence. dent may waive informed consent in
this connection and the President may
[46 FR 8951, Jan. 27, 1981, as amended at 64
FR 10942, Mar. 8, 1999]
grant such a waiver only if the Presi-
dent determines in writing that obtain-
§ 50.23 Exception from general re- ing consent: Is not feasible; is contrary
quirements. to the best interests of the military
(a) The obtaining of informed consent member; or is not in the interests of
shall be deemed feasible unless, before national security. The statute further
use of the test article (except as pro- provides that in making a determina-
vided in paragraph (b) of this section), tion to waive prior informed consent
both the investigator and a physician on the ground that it is not feasible or
who is not otherwise participating in the ground that it is contrary to the
the clinical investigation certify in best interests of the military members
writing all of the following: involved, the President shall apply the
(1) The human subject is confronted standards and criteria that are set
by a life-threatening situation necessi- forth in the relevant FDA regulations
tating the use of the test article. for a waiver of the prior informed con-
(2) Informed consent cannot be ob- sent requirements of section 505(i)(4) of
tained from the subject because of an the Federal Food, Drug, and Cosmetic
inability to communicate with, or ob- Act (21 U.S.C. 355(i)(4)). Before such a
tain legally effective consent from, the
subject.

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Food and Drug Administration, HHS § 50.23

determination may be made that ob- (A) The context in which the inves-
taining informed consent from mili- tigational drug will be administered,
tary personnel prior to the use of an in- e.g., the setting or whether it will be
vestigational drug (including an anti- self-administered or it will be adminis-
biotic or biological product) in a spe- tered by a health professional;
cific protocol under an investigational (B) The nature of the disease or con-
new drug application (IND) sponsored dition for which the preventive or
by the Department of Defense (DOD) therapeutic treatment is intended; and
and limited to specific military per- (C) To the extent there are existing
sonnel involved in a particular mili- data or information available, informa-
tary operation is not feasible or is con- tion on conditions that could alter the
trary to the best interests of the mili- effects of the investigational drug.
tary members involved the Secretary (vii) DOD’s recordkeeping system is
of Defense must first request such a de- capable of tracking and will be used to
termination from the President, and track the proposed treatment from
certify and document to the President supplier to the individual recipient.
that the following standards and cri- (viii) Each member involved in the
teria contained in paragraphs (d)(1) military operation will be given, prior
through (d)(4) of this section have been to the administration of the investiga-
met. tional new drug, a specific written in-
(i) The extent and strength of evi- formation sheet (including information
dence of the safety and effectiveness of required by 10 U.S.C. 1107(d)) con-
the investigational new drug in rela- cerning the investigational new drug,
tion to the medical risk that could be the risks and benefits of its use, poten-
encountered during the military oper- tial side effects, and other pertinent in-
ation supports the drug’s administra- formation about the appropriate use of
tion under an IND. the product.
(ii) The military operation presents a (ix) Medical records of members in-
substantial risk that military per- volved in the military operation will
sonnel may be subject to a chemical, accurately document the receipt by
biological, nuclear, or other exposure members of the notification required
likely to produce death or serious or by paragraph (d)(1)(viii) of this section.
life-threatening injury or illness. (x) Medical records of members in-
(iii) There is no available satisfac- volved in the military operation will
tory alternative therapeutic or preven- accurately document the receipt by
tive treatment in relation to the in- members of any investigational new
tended use of the investigational new drugs in accordance with FDA regula-
drug. tions including part 312 of this chapter.
(iv) Conditioning use of the inves- (xi) DOD will provide adequate fol-
tigational new drug on the voluntary lowup to assess whether there are bene-
participation of each member could ficial or adverse health consequences
significantly risk the safety and health that result from the use of the inves-
of any individual member who would tigational product.
decline its use, the safety of other mili- (xii) DOD is pursuing drug develop-
tary personnel, and the accomplish- ment, including a time line, and mar-
ment of the military mission. keting approval with due diligence.
(v) A duly constituted institutional (xiii) FDA has concluded that the in-
review board (IRB) established and op- vestigational new drug protocol may
erated in accordance with the require- proceed subject to a decision by the
ments of paragraphs (d)(2) and (d)(3) of President on the informed consent
this section, responsible for review of waiver request.
the study, has reviewed and approved (xiv) DOD will provide training to the
the investigational new drug protocol appropriate medical personnel and po-
and the administration of the inves- tential recipients on the specific inves-
tigational new drug without informed tigational new drug to be administered
consent. DOD’s request is to include prior to its use.
the documentation required by (xv) DOD has stated and justified the
§ 56.115(a)(2) of this chapter. time period for which the waiver is
(vi) DOD has explained: needed, not to exceed one year, unless

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§ 50.23 21 CFR Ch. I (4–1–11 Edition)

separately renewed under these stand- tential interactions, and other perti-
ards and criteria. nent considerations; and
(xvi) DOD shall have a continuing ob- (iv) An informed consent form as re-
ligation to report to the FDA and to quired by part 50 of this chapter, in
the President any changed cir- those circumstances in which DOD de-
cumstances relating to these standards termines that informed consent may be
and criteria (including the time period obtained from some or all personnel in-
referred to in paragraph (d)(1)(xv) of volved.
this section) or that otherwise might (4) DOD is to submit to FDA sum-
affect the determination to use an in- maries of institutional review board
vestigational new drug without in- meetings at which the proposed pro-
formed consent. tocol has been reviewed.
(xvii) DOD is to provide public notice (5) Nothing in these criteria or stand-
as soon as practicable and consistent ards is intended to preempt or limit
with classification requirements FDA’s and DOD’s authority or obliga-
through notice in the FEDERAL REG- tions under applicable statutes and
ISTER describing each waiver of in-
regulations.
formed consent determination, a sum-
(e)(1) Obtaining informed consent for
mary of the most updated scientific in-
investigational in vitro diagnostic de-
formation on the products used, and
vices used to identify chemical, bio-
other pertinent information.
logical, radiological, or nuclear agents
(xviii) Use of the investigational drug
will be deemed feasible unless, before
without informed consent otherwise
use of the test article, both the investi-
conforms with applicable law.
gator (e.g., clinical laboratory director
(2) The duly constituted institutional
or other responsible individual) and a
review board, described in paragraph
physician who is not otherwise partici-
(d)(1)(v) of this section, must include at
pating in the clinical investigation
least 3 nonaffiliated members who
make the determinations and later cer-
shall not be employees or officers of
tify in writing all of the following:
the Federal Government (other than
(i) The human subject is confronted
for purposes of membership on the IRB)
by a life-threatening situation necessi-
and shall be required to obtain any
tating the use of the investigational in
necessary security clearances. This
vitro diagnostic device to identify a
IRB shall review the proposed IND pro-
chemical, biological, radiological, or
tocol at a convened meeting at which a
nuclear agent that would suggest a ter-
majority of the members are present
rorism event or other public health
including at least one member whose
emergency.
primary concerns are in nonscientific
areas and, if feasible, including a ma- (ii) Informed consent cannot be ob-
jority of the nonaffiliated members. tained from the subject because:
The information required by (A) There was no reasonable way for
§ 56.115(a)(2) of this chapter is to be pro- the person directing that the specimen
vided to the Secretary of Defense for be collected to know, at the time the
further review. specimen was collected, that there
(3) The duly constituted institutional would be a need to use the investiga-
review board, described in paragraph tional in vitro diagnostic device on
(d)(1)(v) of this section, must review that subject’s specimen; and
and approve: (B) Time is not sufficient to obtain
(i) The required information sheet; consent from the subject without risk-
(ii) The adequacy of the plan to dis- ing the life of the subject.
seminate information, including dis- (iii) Time is not sufficient to obtain
tribution of the information sheet to consent from the subject’s legally au-
potential recipients, on the investiga- thorized representative.
tional product (e.g., in forms other (iv) There is no cleared or approved
than written); available alternative method of diag-
(iii) The adequacy of the information nosis, to identify the chemical, biologi-
and plans for its dissemination to cal, radiological, or nuclear agent that
health care providers, including poten- provides an equal or greater likelihood
tial side effects, contraindications, po- of saving the life of the subject.

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Food and Drug Administration, HHS § 50.24

(2) If use of the investigational device that is different from, or in addition to,
is, in the opinion of the investigator the requirements of this regulation.
(e.g., clinical laboratory director or [46 FR 8951, Jan. 27, 1981, as amended at 55
other responsible person), required to FR 52817, Dec. 21, 1990; 64 FR 399, Jan. 5, 1999;
preserve the life of the subject, and 64 FR 54188, Oct. 5, 1999; 71 FR 32833, June 7,
time is not sufficient to obtain the 2006]
independent determination required in
paragraph (e)(1) of this section in ad- § 50.24 Exception from informed con-
sent requirements for emergency
vance of using the investigational de- research.
vice, the determinations of the investi-
(a) The IRB responsible for the re-
gator shall be made and, within 5 work-
view, approval, and continuing review
ing days after the use of the device, be
of the clinical investigation described
reviewed and evaluated in writing by a
in this section may approve that inves-
physician who is not participating in tigation without requiring that in-
the clinical investigation. formed consent of all research subjects
(3) The investigator must submit the be obtained if the IRB (with the con-
documentation required in paragraph currence of a licensed physician who is
(e)(1) or (e)(2) of this section to the IRB a member of or consultant to the IRB
within 5 working days after the use of and who is not otherwise participating
the device. in the clinical investigation) finds and
(4) An investigator must disclose the documents each of the following:
investigational status of the in vitro (1) The human subjects are in a life-
diagnostic device and what is known threatening situation, available treat-
about the performance characteristics ments are unproven or unsatisfactory,
of the device in the report to the sub- and the collection of valid scientific
ject’s health care provider and in any evidence, which may include evidence
report to public health authorities. The obtained through randomized placebo-
investigator must provide the IRB with controlled investigations, is necessary
the information required in § 50.25 (ex- to determine the safety and effective-
cept for the information described in ness of particular interventions.
§ 50.25(a)(8)) and the procedures that (2) Obtaining informed consent is not
feasible because:
will be used to provide this information
(i) The subjects will not be able to
to each subject or the subject’s legally
give their informed consent as a result
authorized representative at the time of their medical condition;
the test results are provided to the sub- (ii) The intervention under investiga-
ject’s health care provider and public tion must be administered before con-
health authorities. sent from the subjects’ legally author-
(5) The IRB is responsible for ensur- ized representatives is feasible; and
ing the adequacy of the information re- (iii) There is no reasonable way to
quired in section 50.25 (except for the identify prospectively the individuals
information described in § 50.25(a)(8)) likely to become eligible for participa-
and for ensuring that procedures are in tion in the clinical investigation.
place to provide this information to (3) Participation in the research
each subject or the subject’s legally au- holds out the prospect of direct benefit
thorized representative. to the subjects because:
(6) No State or political subdivision (i) Subjects are facing a life-threat-
of a State may establish or continue in ening situation that necessitates inter-
effect any law, rule, regulation or vention;
other requirement that informed con- (ii) Appropriate animal and other
sent be obtained before an investiga- preclinical studies have been con-
tional in vitro diagnostic device may ducted, and the information derived
be used to identify chemical, biologi- from those studies and related evidence
support the potential for the interven-
cal, radiological, or nuclear agent in
tion to provide a direct benefit to the
suspected terrorism events and other
individual subjects; and
potential public health emergencies (iii) Risks associated with the inves-
tigation are reasonable in relation to

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§ 50.24 21 CFR Ch. I (4–1–11 Edition)

what is known about the medical con- clinical investigation to apprise the
dition of the potential class of subjects, community and researchers of the
the risks and benefits of standard ther- study, including the demographic char-
apy, if any, and what is known about acteristics of the research population,
the risks and benefits of the proposed and its results;
intervention or activity. (iv) Establishment of an independent
(4) The clinical investigation could data monitoring committee to exercise
not practicably be carried out without oversight of the clinical investigation;
the waiver. and
(5) The proposed investigational plan (v) If obtaining informed consent is
defines the length of the potential not feasible and a legally authorized
therapeutic window based on scientific representative is not reasonably avail-
evidence, and the investigator has com- able, the investigator has committed,
mitted to attempting to contact a le- if feasible, to attempting to contact
gally authorized representative for within the therapeutic window the sub-
each subject within that window of
ject’s family member who is not a le-
time and, if feasible, to asking the le-
gally authorized representative, and
gally authorized representative con-
asking whether he or she objects to the
tacted for consent within that window
subject’s participation in the clinical
rather than proceeding without con-
investigation. The investigator will
sent. The investigator will summarize
summarize efforts made to contact
efforts made to contact legally author-
family members and make this infor-
ized representatives and make this in-
mation available to the IRB at the
formation available to the IRB at the
time of continuing review.
time of continuing review.
(6) The IRB has reviewed and ap- (b) The IRB is responsible for ensur-
proved informed consent procedures ing that procedures are in place to in-
and an informed consent document form, at the earliest feasible oppor-
consistent with § 50.25. These proce- tunity, each subject, or if the subject
dures and the informed consent docu- remains incapacitated, a legally au-
ment are to be used with subjects or thorized representative of the subject,
their legally authorized representa- or if such a representative is not rea-
tives in situations where use of such sonably available, a family member, of
procedures and documents is feasible. the subject’s inclusion in the clinical
The IRB has reviewed and approved investigation, the details of the inves-
procedures and information to be used tigation and other information con-
when providing an opportunity for a tained in the informed consent docu-
family member to object to a subject’s ment. The IRB shall also ensure that
participation in the clinical investiga- there is a procedure to inform the sub-
tion consistent with paragraph (a)(7)(v) ject, or if the subject remains incapaci-
of this section. tated, a legally authorized representa-
(7) Additional protections of the tive of the subject, or if such a rep-
rights and welfare of the subjects will resentative is not reasonably available,
be provided, including, at least: a family member, that he or she may
(i) Consultation (including, where ap- discontinue the subject’s participation
propriate, consultation carried out by at any time without penalty or loss of
the IRB) with representatives of the benefits to which the subject is other-
communities in which the clinical in- wise entitled. If a legally authorized
vestigation will be conducted and from representative or family member is
which the subjects will be drawn; told about the clinical investigation
(ii) Public disclosure to the commu- and the subject’s condition improves,
nities in which the clinical investiga- the subject is also to be informed as
tion will be conducted and from which soon as feasible. If a subject is entered
the subjects will be drawn, prior to ini- into a clinical investigation with
tiation of the clinical investigation, of waived consent and the subject dies be-
plans for the investigation and its risks fore a legally authorized representative
and expected benefits; or family member can be contacted, in-
(iii) Public disclosure of sufficient in- formation about the clinical investiga-
formation following completion of the tion is to be provided to the subject’s

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Food and Drug Administration, HHS § 50.25

legally authorized representative or purposes of the research and the ex-


family member, if feasible. pected duration of the subject’s partici-
(c) The IRB determinations required pation, a description of the procedures
by paragraph (a) of this section and the to be followed, and identification of
documentation required by paragraph any procedures which are experi-
(e) of this section are to be retained by mental.
the IRB for at least 3 years after com- (2) A description of any reasonably
pletion of the clinical investigation, foreseeable risks or discomforts to the
and the records shall be accessible for subject.
inspection and copying by FDA in ac- (3) A description of any benefits to
cordance with § 56.115(b) of this chap- the subject or to others which may rea-
ter. sonably be expected from the research.
(d) Protocols involving an exception (4) A disclosure of appropriate alter-
to the informed consent requirement native procedures or courses of treat-
under this section must be performed ment, if any, that might be advan-
under a separate investigational new tageous to the subject.
drug application (IND) or investiga- (5) A statement describing the ex-
tional device exemption (IDE) that tent, if any, to which confidentiality of
clearly identifies such protocols as pro- records identifying the subject will be
tocols that may include subjects who maintained and that notes the possi-
are unable to consent. The submission bility that the Food and Drug Adminis-
of those protocols in a separate IND/ tration may inspect the records.
IDE is required even if an IND for the (6) For research involving more than
same drug product or an IDE for the minimal risk, an explanation as to
same device already exists. Applica- whether any compensation and an ex-
tions for investigations under this sec- planation as to whether any medical
tion may not be submitted as amend- treatments are available if injury oc-
ments under §§ 312.30 or 812.35 of this curs and, if so, what they consist of, or
chapter. where further information may be ob-
(e) If an IRB determines that it can- tained.
not approve a clinical investigation be- (7) An explanation of whom to con-
cause the investigation does not meet tact for answers to pertinent questions
the criteria in the exception provided about the research and research sub-
under paragraph (a) of this section or jects’ rights, and whom to contact in
because of other relevant ethical con- the event of a research-related injury
cerns, the IRB must document its find- to the subject.
ings and provide these findings prompt- (8) A statement that participation is
ly in writing to the clinical investi- voluntary, that refusal to participate
gator and to the sponsor of the clinical
will involve no penalty or loss of bene-
investigation. The sponsor of the clin-
fits to which the subject is otherwise
ical investigation must promptly dis-
entitled, and that the subject may dis-
close this information to FDA and to
continue participation at any time
the sponsor’s clinical investigators who
without penalty or loss of benefits to
are participating or are asked to par-
which the subject is otherwise entitled.
ticipate in this or a substantially
(b) Additional elements of informed con-
equivalent clinical investigation of the
sent. When appropriate, one or more of
sponsor, and to other IRB’s that have
the following elements of information
been, or are, asked to review this or a
shall also be provided to each subject:
substantially equivalent investigation
(1) A statement that the particular
by that sponsor.
treatment or procedure may involve
[61 FR 51528, Oct. 2, 1996] risks to the subject (or to the embryo
or fetus, if the subject is or may be-
§ 50.25 Elements of informed consent. come pregnant) which are currently
(a) Basic elements of informed consent. unforeseeable.
In seeking informed consent, the fol- (2) Anticipated circumstances under
lowing information shall be provided to which the subject’s participation may
each subject: be terminated by the investigator
(1) A statement that the study in- without regard to the subject’s con-
volves research, an explanation of the sent.

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§ 50.27 21 CFR Ch. I (4–1–11 Edition)

(3) Any additional costs to the sub- time of consent. A copy shall be given
ject that may result from participation to the person signing the form.
in the research. (b) Except as provided in § 56.109(c),
(4) The consequences of a subject’s the consent form may be either of the
decision to withdraw from the research following:
and procedures for orderly termination (1) A written consent document that
of participation by the subject. embodies the elements of informed
(5) A statement that significant new consent required by § 50.25. This form
findings developed during the course of may be read to the subject or the sub-
the research which may relate to the ject’s legally authorized representa-
subject’s willingness to continue par- tive, but, in any event, the investigator
ticipation will be provided to the sub- shall give either the subject or the rep-
ject. resentative adequate opportunity to
(6) The approximate number of sub- read it before it is signed.
jects involved in the study.
(2) A short form written consent docu-
(c) When seeking informed consent
ment stating that the elements of in-
for applicable clinical trials, as defined
formed consent required by § 50.25 have
in 42 U.S.C. 282(j)(1)(A), the following
been presented orally to the subject or
statement shall be provided to each
the subject’s legally authorized rep-
clinical trial subject in informed con-
resentative. When this method is used,
sent documents and processes. This
there shall be a witness to the oral
will notify the clinical trial subject
presentation. Also, the IRB shall ap-
that clinical trial information has been
prove a written summary of what is to
or will be submitted for inclusion in
be said to the subject or the represent-
the clinical trial registry databank
ative. Only the short form itself is to
under paragraph (j) of section 402 of the
be signed by the subject or the rep-
Public Health Service Act. The state-
resentative. However, the witness shall
ment is: ‘‘A description of this clinical
sign both the short form and a copy of
trial will be available on http://
the summary, and the person actually
www.ClinicalTrials.gov, as required by
obtaining the consent shall sign a copy
U.S. Law. This Web site will not in-
of the summary. A copy of the sum-
clude information that can identify
mary shall be given to the subject or
you. At most, the Web site will include
the representative in addition to a
a summary of the results. You can
copy of the short form.
search this Web site at any time.’’
(d) The informed consent require- [46 FR 8951, Jan. 27, 1981, as amended at 61
ments in these regulations are not in- FR 57280, Nov. 5, 1996]
tended to preempt any applicable Fed-
eral, State, or local laws which require Subpart C [Reserved]
additional information to be disclosed
for informed consent to be legally ef-
fective. Subpart D—Additional Safeguards
(e) Nothing in these regulations is in- for Children in Clinical Inves-
tended to limit the authority of a phy- tigations
sician to provide emergency medical
care to the extent the physician is per- SOURCE: 66 FR 20598, Apr. 24, 2001, unless
mitted to do so under applicable Fed- otherwise noted.
eral, State, or local law.
§ 50.50 IRB duties.
[46 FR 8951, Jan. 27, 1981, as amended at 76
FR 270, Jan. 4, 2011] In addition to other responsibilities
assigned to IRBs under this part and
§ 50.27 Documentation of informed part 56 of this chapter, each IRB must
consent. review clinical investigations involving
(a) Except as provided in § 56.109(c), children as subjects covered by this
informed consent shall be documented subpart D and approve only those clin-
by the use of a written consent form ical investigations that satisfy the cri-
approved by the IRB and signed and teria described in § 50.51, § 50.52, or
dated by the subject or the subject’s le- § 50.53 and the conditions of all other
gally authorized representative at the applicable sections of this subpart D.

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Food and Drug Administration, HHS § 50.54

§ 50.51 Clinical investigations not in- (b) The intervention or procedure


volving greater than minimal risk. presents experiences to subjects that
Any clinical investigation within the are reasonably commensurate with
scope described in §§ 50.1 and 56.101 of those inherent in their actual or ex-
this chapter in which no greater than pected medical, dental, psychological,
minimal risk to children is presented social, or educational situations;
may involve children as subjects only (c) The intervention or procedure is
if the IRB finds and documents that likely to yield generalizable knowledge
adequate provisions are made for solic- about the subjects’ disorder or condi-
iting the assent of the children and the tion that is of vital importance for the
permission of their parents or guard- understanding or amelioration of the
ians as set forth in § 50.55. subjects’ disorder or condition; and
(d) Adequate provisions are made for
§ 50.52 Clinical investigations involv- soliciting the assent of the children
ing greater than minimal risk but and permission of their parents or
presenting the prospect of direct guardians as set forth in § 50.55.
benefit to individual subjects.
Any clinical investigation within the § 50.54 Clinical investigations not oth-
erwise approvable that present an
scope described in §§ 50.1 and 56.101 of opportunity to understand, prevent,
this chapter in which more than mini- or alleviate a serious problem af-
mal risk to children is presented by an fecting the health or welfare of chil-
intervention or procedure that holds dren.
out the prospect of direct benefit for If an IRB does not believe that a clin-
the individual subject, or by a moni- ical investigation within the scope de-
toring procedure that is likely to con- scribed in §§ 50.1 and 56.101 of this chap-
tribute to the subject’s well-being, may ter and involving children as subjects
involve children as subjects only if the meets the requirements of § 50.51,
IRB finds and documents that: § 50.52, or § 50.53, the clinical investiga-
(a) The risk is justified by the antici- tion may proceed only if:
pated benefit to the subjects; (a) The IRB finds and documents that
(b) The relation of the anticipated the clinical investigation presents a
benefit to the risk is at least as favor- reasonable opportunity to further the
able to the subjects as that presented understanding, prevention, or allevi-
by available alternative approaches; ation of a serious problem affecting the
and health or welfare of children; and
(c) Adequate provisions are made for (b) The Commissioner of Food and
soliciting the assent of the children
Drugs, after consultation with a panel
and permission of their parents or
of experts in pertinent disciplines (for
guardians as set forth in § 50.55.
example: science, medicine, education,
§ 50.53 Clinical investigations involv- ethics, law) and following opportunity
ing greater than minimal risk and for public review and comment, deter-
no prospect of direct benefit to in- mines either:
dividual subjects, but likely to yield (1) That the clinical investigation in
generalizable knowledge about the fact satisfies the conditions of § 50.51,
subjects’ disorder or condition. § 50.52, or § 50.53, as applicable, or
Any clinical investigation within the (2) That the following conditions are
scope described in §§ 50.1 and 56.101 of met:
this chapter in which more than mini- (i) The clinical investigation presents
mal risk to children is presented by an a reasonable opportunity to further the
intervention or procedure that does not understanding, prevention, or allevi-
hold out the prospect of direct benefit ation of a serious problem affecting the
for the individual subject, or by a mon- health or welfare of children;
itoring procedure that is not likely to (ii) The clinical investigation will be
contribute to the well-being of the sub- conducted in accordance with sound
ject, may involve children as subjects ethical principles; and
only if the IRB finds and documents (iii) Adequate provisions are made
that: for soliciting the assent of children and
(a) The risk represents a minor in- the permission of their parents or
crease over minimal risk; guardians as set forth in § 50.55.

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§ 50.55 21 CFR Ch. I (4–1–11 Edition)

§ 50.55 Requirements for permission permission of one parent is sufficient,


by parents or guardians and for as- if consistent with State law, for clin-
sent by children. ical investigations to be conducted
(a) In addition to the determinations under § 50.51 or § 50.52.
required under other applicable sec- (2) Where clinical investigations are
tions of this subpart D, the IRB must covered by § 50.53 or § 50.54 and permis-
determine that adequate provisions are sion is to be obtained from parents,
made for soliciting the assent of the both parents must give their permis-
children when in the judgment of the sion unless one parent is deceased, un-
IRB the children are capable of pro- known, incompetent, or not reasonably
viding assent. available, or when only one parent has
(b) In determining whether children legal responsibility for the care and
are capable of providing assent, the custody of the child if consistent with
IRB must take into account the ages, State law.
maturity, and psychological state of (f) Permission by parents or guard-
the children involved. This judgment ians must be documented in accordance
may be made for all children to be in- with and to the extent required by
volved in clinical investigations under § 50.27.
a particular protocol, or for each child, (g) When the IRB determines that as-
as the IRB deems appropriate. sent is required, it must also determine
(c) The assent of the children is not a whether and how assent must be docu-
necessary condition for proceeding mented.
with the clinical investigation if the
IRB determines: § 50.56 Wards.
(1) That the capability of some or all (a) Children who are wards of the
of the children is so limited that they State or any other agency, institution,
cannot reasonably be consulted, or or entity can be included in clinical in-
(2) That the intervention or proce- vestigations approved under § 50.53 or
dure involved in the clinical investiga- § 50.54 only if such clinical investiga-
tion holds out a prospect of direct ben- tions are:
efit that is important to the health or
(1) Related to their status as wards;
well-being of the children and is avail-
or
able only in the context of the clinical
(2) Conducted in schools, camps, hos-
investigation.
(d) Even where the IRB determines pitals, institutions, or similar settings
that the subjects are capable of assent- in which the majority of children in-
ing, the IRB may still waive the assent volved as subjects are not wards.
requirement if it finds and documents (b) If the clinical investigation is ap-
that: proved under paragraph (a) of this sec-
(1) The clinical investigation in- tion, the IRB must require appoint-
volves no more than minimal risk to ment of an advocate for each child who
the subjects; is a ward.
(2) The waiver will not adversely af- (1) The advocate will serve in addi-
fect the rights and welfare of the sub- tion to any other individual acting on
jects; behalf of the child as guardian or in
(3) The clinical investigation could loco parentis.
not practicably be carried out without (2) One individual may serve as advo-
the waiver; and cate for more than one child.
(4) Whenever appropriate, the sub- (3) The advocate must be an indi-
jects will be provided with additional vidual who has the background and ex-
pertinent information after participa- perience to act in, and agrees to act in,
tion. the best interest of the child for the
(e) In addition to the determinations duration of the child’s participation in
required under other applicable sec- the clinical investigation.
tions of this subpart D, the IRB must (4) The advocate must not be associ-
determine that the permission of each ated in any way (except in the role as
child’s parents or guardian is granted. advocate or member of the IRB) with
(1) Where parental permission is to be the clinical investigation, the investi-
obtained, the IRB may find that the gator(s), or the guardian organization.

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Food and Drug Administration, HHS § 54.2

PART 54—FINANCIAL DISCLOSURE the agency’s assessment of the reli-


BY CLINICAL INVESTIGATORS ability of the data.
§ 54.2 Definitions.
Sec.
54.1 Purpose. For the purposes of this part:
54.2 Definitions. (a) Compensation affected by the out-
54.3 Scope. come of clinical studies means compensa-
54.4 Certification and disclosure require- tion that could be higher for a favor-
ments. able outcome than for an unfavorable
54.5 Agency evaluation of financial inter- outcome, such as compensation that is
ests.
explicitly greater for a favorable result
54.6 Recordkeeping and record retention.
or compensation to the investigator in
AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, the form of an equity interest in the
355, 360, 360c–360j, 371, 372, 373, 374, 375, 376, sponsor of a covered study or in the
379; 42 U.S.C. 262.
form of compensation tied to sales of
SOURCE: 63 FR 5250, Feb. 2, 1998, unless oth- the product, such as a royalty interest.
erwise noted. (b) Significant equity interest in the
sponsor of a covered study means any
§ 54.1 Purpose. ownership interest, stock options, or
(a) The Food and Drug Administra- other financial interest whose value
tion (FDA) evaluates clinical studies cannot be readily determined through
submitted in marketing applications, reference to public prices (generally,
required by law, for new human drugs interests in a nonpublicly traded cor-
and biological products and marketing poration), or any equity interest in a
applications and reclassification peti- publicly traded corporation that ex-
tions for medical devices. ceeds $50,000 during the time the clin-
(b) The agency reviews data gen- ical investigator is carrying out the
erated in these clinical studies to de- study and for 1 year following comple-
termine whether the applications are tion of the study.
approvable under the statutory re- (c) Proprietary interest in the tested
quirements. FDA may consider clinical product means property or other finan-
studies inadequate and the data inad- cial interest in the product including,
equate if, among other things, appro- but not limited to, a patent, trade-
priate steps have not been taken in the mark, copyright or licensing agree-
design, conduct, reporting, and anal- ment.
ysis of the studies to minimize bias. (d) Clinical investigator means only a
One potential source of bias in clinical listed or identified investigator or sub-
studies is a financial interest of the investigator who is directly involved in
clinical investigator in the outcome of the treatment or evaluation of re-
the study because of the way payment search subjects. The term also includes
is arranged (e.g., a royalty) or because the spouse and each dependent child of
the investigator has a proprietary in- the investigator.
terest in the product (e.g., a patent) or (e) Covered clinical study means any
because the investigator has an equity study of a drug or device in humans
interest in the sponsor of the covered submitted in a marketing application
study. This section and conforming or reclassification petition subject to
regulations require an applicant whose this part that the applicant or FDA re-
submission relies in part on clinical lies on to establish that the product is
data to disclose certain financial ar- effective (including studies that show
rangements between sponsor(s) of the equivalence to an effective product) or
covered studies and the clinical inves- any study in which a single investi-
tigators and certain interests of the gator makes a significant contribution
clinical investigators in the product to the demonstration of safety. This
under study or in the sponsor of the would, in general, not include phase l
covered studies. FDA will use this in- tolerance studies or pharmacokinetic
formation, in conjunction with infor- studies, most clinical pharmacology
mation about the design and purpose of studies (unless they are critical to an
the study, as well as information ob- efficacy determination), large open
tained through on-site inspections, in safety studies conducted at multiple

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§ 54.3 21 CFR Ch. I (4–1–11 Edition)

sites, treatment protocols, and parallel sponsor of each covered study. The ap-
track protocols. An applicant may con- plicant must also completely and accu-
sult with FDA as to which clinical rately disclose or certify information
studies constitute ‘‘covered clinical concerning the financial interests of a
studies’’ for purposes of complying with clinical investigator who is not a full-
financial disclosure requirements. time or part-time employee of the
(f) Significant payments of other sorts sponsor for each covered clinical study.
means payments made by the sponsor Clinical investigators subject to inves-
of a covered study to the investigator tigational new drug or investigational
or the institution to support activities device exemption regulations must
of the investigator that have a mone- provide the sponsor of the study with
tary value of more than $25,000, exclu- sufficient accurate information needed
sive of the costs of conducting the clin- to allow subsequent disclosure or cer-
ical study or other clinical studies, tification. The applicant is required to
(e.g., a grant to fund ongoing research,
submit for each clinical investigator
compensation in the form of equipment
who participates in a covered study, ei-
or retainers for ongoing consultation
ther a certification that none of the fi-
or honoraria) during the time the clin-
nancial arrangements described in § 54.2
ical investigator is carrying out the
exist, or disclose the nature of those
study and for 1 year following the com-
pletion of the study. arrangements to the agency. Where the
(g) Applicant means the party who applicant acts with due diligence to ob-
submits a marketing application to tain the information required in this
FDA for approval of a drug, device, or section but is unable to do so, the ap-
biologic product. The applicant is re- plicant shall certify that despite the
sponsible for submitting the appro- applicant’s due diligence in attempting
priate certification and disclosure to obtain the information, the appli-
statements required in this part. cant was unable to obtain the informa-
(h) Sponsor of the covered clinical study tion and shall include the reason.
means the party supporting a par- (a) The applicant (of an application
ticular study at the time it was carried submitted under sections 505, 506,
out. 510(k), 513, or 515 of the Federal Food,
Drug, and Cosmetic Act, or section 351
[63 FR 5250, Feb. 2, 1998, as amended at 63 FR
72181, Dec. 31, 1998]
of the Public Health Service Act) that
relies in whole or in part on clinical
§ 54.3 Scope. studies shall submit, for each clinical
investigator who participated in a cov-
The requirements in this part apply
to any applicant who submits a mar- ered clinical study, either a certifi-
keting application for a human drug, cation described in paragraph (a)(1) of
biological product, or device and who this section or a disclosure statement
submits covered clinical studies. The described in paragraph (a)(3) of this
applicant is responsible for making the section.
appropriate certification or disclosure (1) Certification: The applicant cov-
statement where the applicant either ered by this section shall submit for all
contracted with one or more clinical clinical investigators (as defined in
investigators to conduct the studies or § 54.2(d)), to whom the certification ap-
submitted studies conducted by others plies, a completed Form FDA 3454 at-
not under contract to the applicant. testing to the absence of financial in-
terests and arrangements described in
§ 54.4 Certification and disclosure re- paragraph (a)(3) of this section. The
quirements. form shall be dated and signed by the
For purposes of this part, an appli- chief financial officer or other respon-
cant must submit a list of all clinical sible corporate official or representa-
investigators who conducted covered tive.
clinical studies to determine whether (2) If the certification covers less
the applicant’s product meets FDA’s than all covered clinical data in the ap-
marketing requirements, identifying plication, the applicant shall include in
those clinical investigators who are the certification a list of the studies
full-time or part-time employees of the covered by this certification.

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Food and Drug Administration, HHS § 54.6

(3) Disclosure Statement: For any § 54.5 Agency evaluation of financial


clinical investigator defined in § 54.2(d) interests.
for whom the applicant does not sub- (a) Evaluation of disclosure statement.
mit the certification described in para- FDA will evaluate the information dis-
graph (a)(1) of this section, the appli- closed under § 54.4(a)(2) about each cov-
cant shall submit a completed Form ered clinical study in an application to
FDA 3455 disclosing completely and ac- determine the impact of any disclosed
curately the following: financial interests on the reliability of
(i) Any financial arrangement en- the study. FDA may consider both the
tered into between the sponsor of the size and nature of a disclosed financial
covered study and the clinical investi- interest (including the potential in-
gator involved in the conduct of a cov- crease in the value of the interest if
ered clinical trial, whereby the value of the product is approved) and steps that
the compensation to the clinical inves- have been taken to minimize the po-
tigator for conducting the study could tential for bias.
be influenced by the outcome of the (b) Effect of study design. In assessing
study; the potential of an investigator’s finan-
(ii) Any significant payments of cial interests to bias a study, FDA will
other sorts from the sponsor of the cov- take into account the design and pur-
ered study, such as a grant to fund on- pose of the study. Study designs that
going research, compensation in the utilize such approaches as multiple in-
form of equipment, retainer for ongo- vestigators (most of whom do not have
ing consultation, or honoraria; a disclosable interest), blinding, objec-
(iii) Any proprietary interest in the tive endpoints, or measurement of
tested product held by any clinical in- endpoints by someone other than the
vestigator involved in a study; investigator may adequately protect
(iv) Any significant equity interest in against any bias created by a
the sponsor of the covered study held disclosable financial interest.
by any clinical investigator involved in (c) Agency actions to ensure reliability
any clinical study; and of data. If FDA determines that the fi-
(v) Any steps taken to minimize the nancial interests of any clinical inves-
potential for bias resulting from any of tigator raise a serious question about
the disclosed arrangements, interests, the integrity of the data, FDA will
or payments. take any action it deems necessary to
(b) The clinical investigator shall ensure the reliability of the data in-
provide to the sponsor of the covered cluding:
study sufficient accurate financial in- (1) Initiating agency audits of the
formation to allow the sponsor to sub- data derived from the clinical investi-
mit complete and accurate certifi- gator in question;
cation or disclosure statements as re- (2) Requesting that the applicant
quired in paragraph (a) of this section. submit further analyses of data, e.g., to
The investigator shall promptly update evaluate the effect of the clinical in-
this information if any relevant vestigator’s data on overall study out-
changes occur in the course of the in- come;
vestigation or for 1 year following com- (3) Requesting that the applicant
pletion of the study. conduct additional independent studies
to confirm the results of the ques-
(c) Refusal to file application. FDA
tioned study; and
may refuse to file any marketing appli-
(4) Refusing to treat the covered clin-
cation described in paragraph (a) of
ical study as providing data that can
this section that does not contain the
be the basis for an agency action.
information required by this section or
a certification by the applicant that § 54.6 Recordkeeping and record re-
the applicant has acted with due dili- tention.
gence to obtain the information but (a) Financial records of clinical inves-
was unable to do so and stating the tigators to be retained. An applicant who
reason. has submitted a marketing application
[63 FR 5250, Feb. 2, 1998; 63 FR 35134, June 29, containing covered clinical studies
1998, as amended at 64 FR 399, Jan. 5, 1999] shall keep on file certain information

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Pt. 56 21 CFR Ch. I (4–1–11 Edition)

pertaining to the financial interests of 56.114 Cooperative research.


clinical investigators who conducted
studies on which the application relies Subpart D—Records and Reports
and who are not full or part-time em- 56.115 IRB records.
ployees of the applicant, as follows:
(1) Complete records showing any fi- Subpart E—Administrative Actions for
nancial interest or arrangement as de- Noncompliance
scribed in § 54.4(a)(3)(i) paid to such
56.120 Lesser administrative actions.
clinical investigators by the sponsor of 56.121 Disqualification of an IRB or an insti-
the covered study. tution.
(2) Complete records showing signifi- 56.122 Public disclosure of information re-
cant payments of other sorts, as de- garding revocation.
scribed in § 54.4(a)(3)(ii), made by the 56.123 Reinstatement of an IRB or an insti-
sponsor of the covered clinical study to tution.
the clinical investigator. 56.124 Actions alternative or additional to
(3) Complete records showing any fi- disqualification.
nancial interests held by clinical inves- AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
tigators as set forth in § 54.4(a)(3)(iii) 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
and (a)(3)(iv). 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
(b) Requirements for maintenance of 263b–263n.
clinical investigators’ financial records. SOURCE: 46 FR 8975, Jan. 27, 1981, unless
(1) For any application submitted for a otherwise noted.
covered product, an applicant shall re-
tain records as described in paragraph Subpart A—General Provisions
(a) of this section for 2 years after the
date of approval of the application. § 56.101 Scope.
(2) The person maintaining these (a) This part contains the general
records shall, upon request from any standards for the composition, oper-
properly authorized officer or employee ation, and responsibility of an Institu-
of FDA, at reasonable times, permit tional Review Board (IRB) that reviews
such officer or employee to have access clinical investigations regulated by the
to and copy and verify these records. Food and Drug Administration under
sections 505(i) and 520(g) of the act, as
PART 56—INSTITUTIONAL REVIEW well as clinical investigations that sup-
BOARDS port applications for research or mar-
keting permits for products regulated
Subpart A—General Provisions by the Food and Drug Administration,
including foods, including dietary sup-
Sec. plements, that bear a nutrient content
56.101 Scope.
claim or a health claim, infant for-
56.102 Definitions.
56.103 Circumstances in which IRB review is mulas, food and color additives, drugs
required. for human use, medical devices for
56.104 Exemptions from IRB requirement. human use, biological products for
56.105 Waiver of IRB requirement. human use, and electronic products.
56.106 Registration. Compliance with this part is intended
to protect the rights and welfare of
Subpart B—Organization and Personnel human subjects involved in such inves-
56.107 IRB membership. tigations.
(b) References in this part to regu-
Subpart C—IRB Functions and Operations latory sections of the Code of Federal
Regulations are to chapter I of title 21,
56.108 IRB functions and operations.
56.109 IRB review of research. unless otherwise noted.
56.110 Expedited review procedures for cer- [46 FR 8975, Jan. 27, 1981, as amended at 64
tain kinds of research involving no more FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
than minimal risk, and for minor
changes in approved research. § 56.102 Definitions.
56.111 Criteria for IRB approval of research.
56.112 Review by institution. As used in this part:
56.113 Suspension or termination of IRB ap- (a) Act means the Federal Food,
proval of research. Drug, and Cosmetic Act, as amended

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Food and Drug Administration, HHS § 56.102

(secs. 201–902, 52 Stat. 1040 et seq., as (13) Data and information regarding a
amended (21 U.S.C. 321–392)). medical device for human use sub-
(b) Application for research or mar- mitted as part of the procedures for
keting permit includes: classifying such devices, described in
(1) A color additive petition, de- part 860.
scribed in part 71. (14) Data and information regarding a
(2) Data and information regarding a medical device for human use sub-
substance submitted as part of the pro- mitted as part of the procedures for es-
cedures for establishing that a sub- tablishing, amending, or repealing a
stance is generally recognized as safe standard for such device, described in
for a use which results or may reason- part 861.
ably be expected to result, directly or (15) An application for premarket ap-
indirectly, in its becoming a compo- proval of a medical device for human
nent or otherwise affecting the charac- use, described in section 515 of the act.
teristics of any food, described in (16) A product development protocol
§ 170.35. for a medical device for human use, de-
(3) A food additive petition, described scribed in section 515 of the act.
in part 171.
(17) Data and information regarding
(4) Data and information regarding a
an electronic product submitted as
food additive submitted as part of the
part of the procedures for establishing,
procedures regarding food additives
amending, or repealing a standard for
permitted to be used on an interim
such products, described in section 358
basis pending additional study, de-
of the Public Health Service Act.
scribed in § 180.1.
(18) Data and information regarding
(5) Data and information regarding a
an electronic product submitted as
substance submitted as part of the pro-
part of the procedures for obtaining a
cedures for establishing a tolerance for
variance from any electronic product
unavoidable contaminants in food and
performance standard, as described in
food-packaging materials, described in
§ 1010.4.
section 406 of the act.
(6) An investigational new drug appli- (19) Data and information regarding
cation, described in part 312 of this an electronic product submitted as
chapter. part of the procedures for granting,
(7) A new drug application, described amending, or extending an exemption
in part 314. from a radiation safety performance
(8) Data and information regarding standard, as described in § 1010.5.
the bioavailability or bioequivalence of (20) Data and information regarding
drugs for human use submitted as part an electronic product submitted as
of the procedures for issuing, amend- part of the procedures for obtaining an
ing, or repealing a bioequivalence re- exemption from notification of a radi-
quirement, described in part 320. ation safety defect or failure of compli-
(9) Data and information regarding ance with a radiation safety perform-
an over-the-counter drug for human ance standard, described in subpart D
use submitted as part of the procedures of part 1003.
for classifying such drugs as generally (21) Data and information about a
recognized as safe and effective and not clinical study of an infant formula
misbranded, described in part 330. when submitted as part of an infant
(10) An application for a biologics li- formula notification under section
cense, described in part 601 of this 412(c) of the Federal Food, Drug, and
chapter. Cosmetic Act.
(11) Data and information regarding a (22) Data and information submitted
biological product submitted as part of in a petition for a nutrient content
the procedures for determining that li- claim, described in § 101.69 of this chap-
censed biological products are safe and ter, and for a health claim, described in
effective and not misbranded, as de- § 101.70 of this chapter.
scribed in part 601 of this chapter. (23) Data and information from inves-
(12) An Application for an Investiga- tigations involving children submitted
tional Device Exemption, described in in a new dietary ingredient notifica-
part 812. tion, described in § 190.6 of this chapter.

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§ 56.102 21 CFR Ch. I (4–1–11 Edition)

(c) Clinical investigation means any ing, a subject) or, in the event of an in-
experiment that involves a test article vestigation conducted by a team of in-
and one or more human subjects, and dividuals, is the responsible leader of
that either must meet the require- that team.
ments for prior submission to the Food (i) Minimal risk means that the prob-
and Drug Administration under section ability and magnitude of harm or dis-
505(i) or 520(g) of the act, or need not comfort anticipated in the research are
meet the requirements for prior sub- not greater in and of themselves than
mission to the Food and Drug Adminis- those ordinarily encountered in daily
tration under these sections of the act, life or during the performance of rou-
but the results of which are intended to
tine physical or psychological exami-
be later submitted to, or held for in-
nations or tests.
spection by, the Food and Drug Admin-
istration as part of an application for a (j) Sponsor means a person or other
research or marketing permit. The entity that initiates a clinical inves-
term does not include experiments that tigation, but that does not actually
must meet the provisions of part 58, re- conduct the investigation, i.e., the test
garding nonclinical laboratory studies. article is administered or dispensed to,
The terms research, clinical research, or used involving, a subject under the
clinical study, study, and clinical inves- immediate direction of another indi-
tigation are deemed to be synonymous vidual. A person other than an indi-
for purposes of this part. vidual (e.g., a corporation or agency)
(d) Emergency use means the use of a that uses one or more of its own em-
test article on a human subject in a ployees to conduct an investigation
life-threatening situation in which no that it has initiated is considered to be
standard acceptable treatment is avail- a sponsor (not a sponsor-investigator),
able, and in which there is not suffi- and the employees are considered to be
cient time to obtain IRB approval. investigators.
(e) Human subject means an indi- (k) Sponsor-investigator means an in-
vidual who is or becomes a participant dividual who both initiates and actu-
in research, either as a recipient of the ally conducts, alone or with others, a
test article or as a control. A subject
clinical investigation, i.e., under whose
may be either a healthy individual or a
immediate direction the test article is
patient.
administered or dispensed to, or used
(f) Institution means any public or
private entity or agency (including involving, a subject. The term does not
Federal, State, and other agencies). include any person other than an indi-
The term facility as used in section vidual, e.g., it does not include a cor-
520(g) of the act is deemed to be syn- poration or agency. The obligations of
onymous with the term institution for a sponsor-investigator under this part
purposes of this part. include both those of a sponsor and
(g) Institutional Review Board (IRB) those of an investigator.
means any board, committee, or other (l) Test article means any drug for
group formally designated by an insti- human use, biological product for
tution to review, to approve the initi- human use, medical device for human
ation of, and to conduct periodic re- use, human food additive, color addi-
view of, biomedical research involving tive, electronic product, or any other
human subjects. The primary purpose article subject to regulation under the
of such review is to assure the protec- act or under sections 351 or 354–360F of
tion of the rights and welfare of the the Public Health Service Act.
human subjects. The term has the (m) IRB approval means the deter-
same meaning as the phrase institu- mination of the IRB that the clinical
tional review committee as used in sec- investigation has been reviewed and
tion 520(g) of the act.
may be conducted at an institution
(h) Investigator means an individual
within the constraints set forth by the
who actually conducts a clinical inves-
tigation (i.e., under whose immediate
direction the test article is adminis-
tered or dispensed to, or used involv-

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Food and Drug Administration, HHS § 56.106

IRB and by other institutional and which meets the FDA requirements in
Federal requirements. effect before July 27, 1981.
[46 FR 8975, Jan. 27, 1981, as amended at 54
(b) Any investigation commenced be-
FR 9038, Mar. 3, 1989; 56 FR 28028, June 18, fore July 27, 1981 and was not otherwise
1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct. subject to requirements for IRB review
20, 1999; 65 FR 52302, Aug. 29, 2000; 66 FR 20599, under Food and Drug Administration
Apr. 24, 2001; 74 FR 2368, Jan. 15, 2009] regulations before that date.
(c) Emergency use of a test article,
§ 56.103 Circumstances in which IRB provided that such emergency use is re-
review is required. ported to the IRB within 5 working
(a) Except as provided in §§ 56.104 and days. Any subsequent use of the test
56.105, any clinical investigation which article at the institution is subject to
must meet the requirements for prior IRB review.
submission (as required in parts 312, (d) Taste and food quality evalua-
812, and 813) to the Food and Drug Ad- tions and consumer acceptance studies,
ministration shall not be initiated un- if wholesome foods without additives
less that investigation has been re- are consumed or if a food is consumed
viewed and approved by, and remains that contains a food ingredient at or
subject to continuing review by, an below the level and for a use found to
IRB meeting the requirements of this be safe, or agricultural, chemical, or
part. environmental contaminant at or
(b) Except as provided in §§ 56.104 and below the level found to be safe, by the
56.105, the Food and Drug Administra- Food and Drug Administration or ap-
tion may decide not to consider in sup- proved by the Environmental Protec-
port of an application for a research or tion Agency or the Food Safety and In-
marketing permit any data or informa- spection Service of the U.S. Depart-
tion that has been derived from a clin- ment of Agriculture.
ical investigation that has not been ap-
proved by, and that was not subject to [46 FR 8975, Jan. 27, 1981, as amended at 56
initial and continuing review by, an FR 28028, June 18, 1991]
IRB meeting the requirements of this
§ 56.105 Waiver of IRB requirement.
part. The determination that a clinical
investigation may not be considered in On the application of a sponsor or
support of an application for a research sponsor-investigator, the Food and
or marketing permit does not, how- Drug Administration may waive any of
ever, relieve the applicant for such a the requirements contained in these
permit of any obligation under any regulations, including the require-
other applicable regulations to submit ments for IRB review, for specific re-
the results of the investigation to the search activities or for classes of re-
Food and Drug Administration. search activities, otherwise covered by
(c) Compliance with these regula- these regulations.
tions will in no way render inapplicable
pertinent Federal, State, or local laws Subpart B—Organization and
or regulations. Personnel
[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27,
1981] § 56.106 Registration.
(a) Who must register? Each IRB in the
§ 56.104 Exemptions from IRB require- United States that reviews clinical in-
ment.
vestigations regulated by FDA under
The following categories of clinical sections 505(i) or 520(g) of the act and
investigations are exempt from the re- each IRB in the United States that re-
quirements of this part for IRB review: views clinical investigations that are
(a) Any investigation which com- intended to support applications for re-
menced before July 27, 1981 and was search or marketing permits for FDA-
subject to requirements for IRB review regulated products must register at a
under FDA regulations before that site maintained by the Department of
date, provided that the investigation Health and Human Services (HHS). (A
remains subject to review of an IRB research permit under section 505(i) of

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§ 56.107 21 CFR Ch. I (4–1–11 Edition)

the act is usually known as an inves- through http://ohrp.cit.nih.gov/efile. If an


tigational new drug application (IND), IRB lacks the ability to register elec-
while a research permit under section tronically, it must send its registration
520(g) of the act is usually known as an information, in writing, to the Good
investigational device exemption Clinical Practice Program (HF–34), Of-
(IDE).) An individual authorized to act fice of Science and Health Coordina-
on the IRB’s behalf must submit the tion, Food and Drug Administration,
registration information. All other 5600 Fishers Lane, Rockville, MD 20857.
IRBs may register voluntarily. (e) How does an IRB revise its registra-
(b) What information must an IRB reg- tion information? If an IRB’s contact or
ister? Each IRB must provide the fol- chair person information changes, the
lowing information: IRB must revise its registration infor-
(1) The name, mailing address, and mation by submitting any changes in
street address (if different from the that information within 90 days of the
mailing address) of the institution op- change. An IRB’s decision to review
erating the IRB and the name, mailing new types of FDA-regulated products
address, phone number, facsimile num- (such as a decision to review studies
ber, and electronic mail address of the pertaining to food additives whereas
senior officer of that institution who is the IRB previously reviewed studies
responsible for overseeing activities pertaining to drug products), or to dis-
performed by the IRB; continue reviewing clinical investiga-
(2) The IRB’s name, mailing address, tions regulated by FDA is a change
street address (if different from the that must be reported within 30 days of
mailing address), phone number, fac- the change. An IRB’s decision to dis-
simile number, and electronic mail ad- band is a change that must be reported
dress; each IRB chairperson’s name, within 30 days of permanent cessation
phone number, and electronic mail ad- of the IRB’s review of research. All
dress; and the name, mailing address, other information changes may be re-
phone number, facsimile number, and ported when the IRB renews its reg-
electronic mail address of the contact istration. The revised information
person providing the registration infor- must be sent to FDA either electroni-
mation. cally or in writing in accordance with
(3) The approximate number of active paragraph (d) of this section.
protocols involving FDA-regulated
products reviewed. For purposes of this [74 FR 2368, Jan. 15, 2009]
rule, an ‘‘active protocol’’ is any pro-
tocol for which an IRB conducted an § 56.107 IRB membership.
initial review or a continuing review at (a) Each IRB shall have at least five
a convened meeting or under an expe- members, with varying backgrounds to
dited review procedure during the pre- promote complete and adequate review
ceding 12 months; and of research activities commonly con-
(4) A description of the types of FDA- ducted by the institution. The IRB
regulated products (such as biological shall be sufficiently qualified through
products, color additives, food addi- the experience and expertise of its
tives, human drugs, or medical devices) members, and the diversity of the
involved in the protocols that the IRB members, including consideration of
reviews. race, gender, cultural backgrounds, and
(c) When must an IRB register? Each sensitivity to such issues as commu-
IRB must submit an initial registra- nity attitudes, to promote respect for
tion. The initial registration must its advice and counsel in safeguarding
occur before the IRB begins to review a the rights and welfare of human sub-
clinical investigation described in jects. In addition to possessing the pro-
paragraph (a) of this section. Each IRB fessional competence necessary to re-
must renew its registration every 3 view the specific research activities,
years. IRB registration becomes effec- the IRB shall be able to ascertain the
tive after review and acceptance by acceptability of proposed research in
HHS. terms of institutional commitments
(d) Where can an IRB register? Each and regulations, applicable law, and
IRB may register electronically standards or professional conduct and

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Food and Drug Administration, HHS § 56.109

practice. The IRB shall therefore in- which projects require review more
clude persons knowledgeable in these often than annually and which projects
areas. If an IRB regularly reviews re- need verification from sources other
search that involves a vulnerable cat- than the investigator that no material
egory of subjects, such as children, changes have occurred since previous
prisoners, pregnant women, or handi- IRB review; (3) for ensuring prompt re-
capped or mentally disabled persons, porting to the IRB of changes in re-
consideration shall be given to the in- search activity; and (4) for ensuring
clusion of one or more individuals who that changes in approved research, dur-
are knowledgeable about and experi- ing the period for which IRB approval
enced in working with those subjects. has already been given, may not be ini-
(b) Every nondiscriminatory effort tiated without IRB review and ap-
will be made to ensure that no IRB proval except where necessary to elimi-
consists entirely of men or entirely of nate apparent immediate hazards to
women, including the instituton’s con- the human subjects.
sideration of qualified persons of both (b) Follow written procedures for en-
sexes, so long as no selection is made suring prompt reporting to the IRB,
to the IRB on the basis of gender. No appropriate institutional officials, and
IRB may consist entirely of members the Food and Drug Administration of:
of one profession. (1) Any unanticipated problems involv-
(c) Each IRB shall include at least ing risks to human subjects or others;
one member whose primary concerns (2) any instance of serious or con-
are in the scientific area and at least tinuing noncompliance with these reg-
one member whose primary concerns ulations or the requirements or deter-
are in nonscientific areas. minations of the IRB; or (3) any sus-
(d) Each IRB shall include at least pension or termination of IRB ap-
one member who is not otherwise affili- proval.
ated with the institution and who is (c) Except when an expedited review
not part of the immediate family of a procedure is used (see § 56.110), review
person who is affiliated with the insti- proposed research at convened meet-
tution. ings at which a majority of the mem-
(e) No IRB may have a member par- bers of the IRB are present, including
ticipate in the IRB’s initial or con- at least one member whose primary
tinuing review of any project in which concerns are in nonscientific areas. In
the member has a conflicting interest, order for the research to be approved,
except to provide information re- it shall receive the approval of a ma-
quested by the IRB. jority of those members present at the
(f) An IRB may, in its discretion, in- meeting.
vite individuals with competence in
special areas to assist in the review of [46 FR 8975, Jan. 27, 1981, as amended at 56
complex issues which require expertise FR 28028, June 18, 1991; 67 FR 9585, Mar. 4,
2002]
beyond or in addition to that available
on the IRB. These individuals may not § 56.109 IRB review of research.
vote with the IRB.
(a) An IRB shall review and have au-
[46 FR 8975, Jan 27, 1981, as amended at 56 FR thority to approve, require modifica-
28028, June 18, 1991; 56 FR 29756, June 28, 1991]
tions in (to secure approval), or dis-
approve all research activities covered
Subpart C—IRB Functions and by these regulations.
Operations (b) An IRB shall require that infor-
mation given to subjects as part of in-
§ 56.108 IRB functions and operations. formed consent is in accordance with
In order to fulfill the requirements of § 50.25. The IRB may require that infor-
these regulations, each IRB shall: mation, in addition to that specifically
(a) Follow written procedures: (1) For mentioned in § 50.25, be given to the
conducting its initial and continuing subjects when in the IRB’s judgment
review of research and for reporting its the information would meaningfully
findings and actions to the investigator add to the protection of the rights and
and the institution; (2) for determining welfare of subjects.

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§ 56.110 21 CFR Ch. I (4–1–11 Edition)

(c) An IRB shall require documenta- exception to informed consent under


tion of informed consent in accordance § 50.24 of this chapter a copy of infor-
with § 50.27 of this chapter, except as mation that has been publicly disclosed
follows: under § 50.24(a)(7)(ii) and (a)(7)(iii) of
(1) The IRB may, for some or all sub- this chapter. The IRB shall provide
jects, waive the requirement that the this information to the sponsor
subject, or the subject’s legally author- promptly so that the sponsor is aware
ized representative, sign a written con- that such disclosure has occurred.
sent form if it finds that the research Upon receipt, the sponsor shall provide
presents no more than minimal risk of copies of the information disclosed to
harm to subjects and involves no proce- FDA.
dures for which written consent is nor- (h) When some or all of the subjects
mally required outside the research in a study are children, an IRB must
context; or determine that the research study is in
(2) The IRB may, for some or all sub- compliance with part 50, subpart D of
jects, find that the requirements in this chapter, at the time of its initial
§ 50.24 of this chapter for an exception review of the research. When some or
from informed consent for emergency all of the subjects in a study that is on-
research are met. going on April 30, 2001 are children, an
(d) In cases where the documentation IRB must conduct a review of the re-
requirement is waived under paragraph search to determine compliance with
(c)(1) of this section, the IRB may re- part 50, subpart D of this chapter, ei-
quire the investigator to provide sub- ther at the time of continuing review
jects with a written statement regard- or, at the discretion of the IRB, at an
ing the research. earlier date.
(e) An IRB shall notify investigators
[46 FR 8975, Jan. 27, 1981, as amended at 61
and the institution in writing of its de- FR 51529, Oct. 2, 1996; 66 FR 20599, Apr. 24,
cision to approve or disapprove the pro- 2001]
posed research activity, or of modifica-
tions required to secure IRB approval § 56.110 Expedited review procedures
of the research activity. If the IRB de- for certain kinds of research involv-
cides to disapprove a research activity, ing no more than minimal risk, and
it shall include in its written notifica- for minor changes in approved re-
tion a statement of the reasons for its search.
decision and give the investigator an (a) The Food and Drug Administra-
opportunity to respond in person or in tion has established, and published in
writing. For investigations involving the FEDERAL REGISTER, a list of cat-
an exception to informed consent under egories of research that may be re-
§ 50.24 of this chapter, an IRB shall viewed by the IRB through an expe-
promptly notify in writing the investi- dited review procedure. The list will be
gator and the sponsor of the research amended, as appropriate, through peri-
when an IRB determines that it cannot odic republication in the FEDERAL REG-
approve the research because it does ISTER.
not meet the criteria in the exception (b) An IRB may use the expedited re-
provided under § 50.24(a) of this chapter view procedure to review either or both
or because of other relevant ethical of the following: (1) Some or all of the
concerns. The written notification research appearing on the list and
shall include a statement of the rea- found by the reviewer(s) to involve no
sons for the IRB’s determination. more than minimal risk, (2) minor
(f) An IRB shall conduct continuing changes in previously approved re-
review of research covered by these search during the period (of 1 year or
regulations at intervals appropriate to less) for which approval is authorized.
the degree of risk, but not less than Under an expedited review procedure,
once per year, and shall have authority the review may be carried out by the
to observe or have a third party ob- IRB chairperson or by one or more ex-
serve the consent process and the re- perienced reviewers designated by the
search. IRB chairperson from among the mem-
(g) An IRB shall provide in writing to bers of the IRB. In reviewing the re-
the sponsor of research involving an search, the reviewers may exercise all

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Food and Drug Administration, HHS § 56.113

of the authorities of the IRB except volving vulnerable populations, such as


that the reviewers may not disapprove children, prisoners, pregnant women,
the research. A research activity may handicapped, or mentally disabled per-
be disapproved only after review in ac- sons, or economically or educationally
cordance with the nonexpedited review disadvantaged persons.
procedure set forth in § 56.108(c). (4) Informed consent will be sought
(c) Each IRB which uses an expedited from each prospective subject or the
review procedure shall adopt a method subject’s legally authorized representa-
for keeping all members advised of re- tive, in accordance with and to the ex-
search proposals which have been ap- tent required by part 50.
proved under the procedure. (5) Informed consent will be appro-
(d) The Food and Drug Administra- priately documented, in accordance
tion may restrict, suspend, or termi- with and to the extent required by
nate an institution’s or IRB’s use of § 50.27.
the expedited review procedure when (6) Where appropriate, the research
necessary to protect the rights or wel- plan makes adequate provision for
fare of subjects. monitoring the data collected to en-
[46 FR 8975, Jan. 27, 1981, as amended at 56 sure the safety of subjects.
FR 28029, June 18, 1991] (7) Where appropriate, there are ade-
quate provisions to protect the privacy
§ 56.111 Criteria for IRB approval of of subjects and to maintain the con-
research. fidentiality of data.
(a) In order to approve research cov- (b) When some or all of the subjects,
ered by these regulations the IRB shall such as children, prisoners, pregnant
determine that all of the following re- women, handicapped, or mentally dis-
quirements are satisfied: abled persons, or economically or edu-
(1) Risks to subjects are minimized: cationally disadvantaged persons, are
(i) By using procedures which are con- likely to be vulnerable to coercion or
sistent with sound research design and undue influence additional safeguards
which do not unnecessarily expose sub- have been included in the study to pro-
jects to risk, and (ii) whenever appro- tect the rights and welfare of these
priate, by using procedures already subjects.
being performed on the subjects for di- (c) In order to approve research in
agnostic or treatment purposes. which some or all of the subjects are
(2) Risks to subjects are reasonable children, an IRB must determine that
in relation to anticipated benefits, if all research is in compliance with part
any, to subjects, and the importance of 50, subpart D of this chapter.
the knowledge that may be expected to [46 FR 8975, Jan. 27, 1981, as amended at 56
result. In evaluating risks and benefits, FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
the IRB should consider only those 2001]
risks and benefits that may result from
the research (as distinguished from § 56.112 Review by institution.
risks and benefits of therapies that Research covered by these regula-
subjects would receive even if not par- tions that has been approved by an IRB
ticipating in the research). The IRB may be subject to further appropriate
should not consider possible long-range review and approval or disapproval by
effects of applying knowledge gained in officials of the institution. However,
the research (for example, the possible those officials may not approve the re-
effects of the research on public policy) search if it has not been approved by
as among those research risks that fall an IRB.
within the purview of its responsi-
bility. § 56.113 Suspension or termination of
(3) Selection of subjects is equitable. IRB approval of research.
In making this assessment the IRB An IRB shall have authority to sus-
should take into account the purposes pend or terminate approval of research
of the research and the setting in that is not being conducted in accord-
which the research will be conducted ance with the IRB’s requirements or
and should be particularly cognizant of that has been associated with unex-
the special problems of research in- pected serious harm to subjects. Any

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§ 56.114 21 CFR Ch. I (4–1–11 Edition)

suspension or termination of approval (7) Statements of significant new


shall include a statement of the rea- findings provided to subjects, as re-
sons for the IRB’s action and shall be quired by § 50.25.
reported promptly to the investigator, (b) The records required by this regu-
appropriate institutional officials, and lation shall be retained for at least 3
the Food and Drug Administration. years after completion of the research,
and the records shall be accessible for
§ 56.114 Cooperative research. inspection and copying by authorized
In complying with these regulations, representatives of the Food and Drug
institutions involved in multi-institu- Administration at reasonable times
tional studies may use joint review, re- and in a reasonable manner.
liance upon the review of another (c) The Food and Drug Administra-
qualified IRB, or similar arrangements tion may refuse to consider a clinical
aimed at avoidance of duplication of ef- investigation in support of an applica-
fort. tion for a research or marketing per-
mit if the institution or the IRB that
Subpart D—Records and Reports reviewed the investigation refuses to
allow an inspection under this section.
§ 56.115 IRB records.
[46 FR 8975, Jan. 27, 1981, as amended at 56
(a) An institution, or where appro- FR 28029, June 18, 1991; 67 FR 9585, Mar. 4,
priate an IRB, shall prepare and main- 2002]
tain adequate documentation of IRB
activities, including the following: Subpart E—Administrative Actions
(1) Copies of all research proposals re-
viewed, scientific evaluations, if any, for Noncompliance
that accompany the proposals, ap- § 56.120 Lesser administrative actions.
proved sample consent documents,
progress reports submitted by inves- (a) If apparent noncompliance with
tigators, and reports of injuries to sub- these regulations in the operation of an
jects. IRB is observed by an FDA investi-
(2) Minutes of IRB meetings which gator during an inspection, the inspec-
shall be in sufficient detail to show at- tor will present an oral or written sum-
tendance at the meetings; actions mary of observations to an appropriate
taken by the IRB; the vote on these ac- representative of the IRB. The Food
tions including the number of members and Drug Administration may subse-
voting for, against, and abstaining; the quently send a letter describing the
basis for requiring changes in or dis- noncompliance to the IRB and to the
approving research; and a written sum- parent institution. The agency will re-
mary of the discussion of controverted quire that the IRB or the parent insti-
issues and their resolution. tution respond to this letter within a
(3) Records of continuing review ac- time period specified by FDA and de-
tivities. scribe the corrective actions that will
(4) Copies of all correspondence be- be taken by the IRB, the institution, or
tween the IRB and the investigators. both to achieve compliance with these
(5) A list of IRB members identified regulations.
by name; earned degrees; representa- (b) On the basis of the IRB’s or the
tive capacity; indications of experience institution’s response, FDA may sched-
such as board certifications, licenses, ule a reinspection to confirm the ade-
etc., sufficient to describe each mem- quacy of corrective actions. In addi-
ber’s chief anticipated contributions to tion, until the IRB or the parent insti-
IRB deliberations; and any employ- tution takes appropriate corrective ac-
ment or other relationship between tion, the agency may:
each member and the institution; for (1) Withhold approval of new studies
example: full-time employee, part-time subject to the requirements of this part
employee, a member of governing panel that are conducted at the institution
or board, stockholder, paid or unpaid or reviewed by the IRB;
consultant. (2) Direct that no new subjects be
(6) Written procedures for the IRB as added to ongoing studies subject to
required by § 56.108 (a) and (b). this part;

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Food and Drug Administration, HHS § 56.124

(3) Terminate ongoing studies subject of the disqualification to the IRB and
to this part when doing so would not the parent institution. Other parties
endanger the subjects; or with a direct interest, such as sponsors
(4) When the apparent noncompliance and clinical investigators, may also be
creates a significant threat to the sent a notice of the disqualification. In
rights and welfare of human subjects, addition, the agency may elect to pub-
notify relevant State and Federal regu- lish a notice of its action in the FED-
latory agencies and other parties with ERAL REGISTER.
a direct interest in the agency’s action (d) The Food and Drug Administra-
of the deficiencies in the operation of tion will not approve an application for
the IRB. a research permit for a clinical inves-
(c) The parent institution is pre- tigation that is to be under the review
sumed to be responsible for the oper- of a disqualified IRB or that is to be
ation of an IRB, and the Food and Drug conducted at a disqualified institution,
Administration will ordinarily direct and it may refuse to consider in sup-
any administrative action under this port of a marketing permit the data
subpart against the institution. How- from a clinical investigation that was
ever, depending on the evidence of re- reviewed by a disqualified IRB as con-
sponsibility for deficiencies, deter- ducted at a disqualified institution, un-
mined during the investigation, the less the IRB or the parent institution
Food and Drug Administration may re- is reinstated as provided in § 56.123.
strict its administrative actions to the
IRB or to a component of the parent § 56.122 Public disclosure of informa-
institution determined to be respon- tion regarding revocation.
sible for formal designation of the IRB. A determination that the Food and
Drug Administration has disqualified
§ 56.121 Disqualification of an IRB or an institution and the administrative
an institution. record regarding that determination
(a) Whenever the IRB or the institu- are disclosable to the public under part
tion has failed to take adequate steps 20.
to correct the noncompliance stated in
the letter sent by the agency under § 56.123 Reinstatement of an IRB or an
§ 56.120(a), and the Commissioner of institution.
Food and Drugs determines that this An IRB or an institution may be re-
noncompliance may justify the dis- instated if the Commissioner deter-
qualification of the IRB or of the par- mines, upon an evaluation of a written
ent institution, the Commissioner will submission from the IRB or institution
institute proceedings in accordance that explains the corrective action
with the requirements for a regulatory that the institution or IRB plans to
hearing set forth in part 16. take, that the IRB or institution has
(b) The Commissioner may disqualify provided adequate assurance that it
an IRB or the parent institution if the will operate in compliance with the
Commissioner determines that: standards set forth in this part. Notifi-
(1) The IRB has refused or repeatedly cation of reinstatement shall be pro-
failed to comply with any of the regu- vided to all persons notified under
lations set forth in this part, and § 56.121(c).
(2) The noncompliance adversely af-
fects the rights or welfare of the § 56.124 Actions alternative or addi-
human subjects in a clinical investiga- tional to disqualification.
tion. Disqualification of an IRB or of an
(c) If the Commissioner determines institution is independent of, and nei-
that disqualification is appropriate, ther in lieu of nor a precondition to,
the Commissioner will issue an order other proceedings or actions authorized
that explains the basis for the deter- by the act. The Food and Drug Admin-
mination and that prescribes any ac- istration may, at any time, through
tions to be taken with regard to ongo- the Department of Justice institute
ing clinical research conducted under any appropriate judicial proceedings
the review of the IRB. The Food and (civil or criminal) and any other appro-
Drug Administration will send notice priate regulatory action, in addition to

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Pt. 58 21 CFR Ch. I (4–1–11 Edition)

or in lieu of, and before, at the time of, Subpart J—Records and Reports
or after, disqualification. The agency
may also refer pertinent matters to an- 58.185 Reporting of nonclinical laboratory
study results.
other Federal, State, or local govern-
58.190 Storage and retrieval of records and
ment agency for any action that that data.
agency determines to be appropriate. 58.195 Retention of records.

PART 58—GOOD LABORATORY Subpart K—Disqualification of Testing


PRACTICE FOR NONCLINICAL Facilities
LABORATORY STUDIES 58.200 Purpose.
58.202 Grounds for disqualification.
Subpart A—General Provisions 58.204 Notice of and opportunity for hearing
on proposed disqualification.
Sec.
58.1 Scope. 58.206 Final order on disqualification.
58.3 Definitions. 58.210 Actions upon disqualification.
58.10 Applicability to studies performed 58.213 Public disclosure of information re-
under grants and contracts. garding disqualification.
58.15 Inspection of a testing facility. 58.215 Alternative or additional actions to
disqualification.
Subpart B—Organization and Personnel 58.217 Suspension or termination of a test-
ing facility by a sponsor.
58.29 Personnel. 58.219 Reinstatement of a disqualified test-
58.31 Testing facility management. ing facility.
58.33 Study director.
AUTHORITY: 21 U.S.C. 342, 346, 346a, 348, 351,
58.35 Quality assurance unit.
352, 353, 355, 360, 360b–360f, 360h–360j, 371, 379e,
381; 42 U.S.C. 216, 262, 263b–263n.
Subpart C—Facilities
SOURCE: 43 FR 60013, Dec. 22, 1978, unless
58.41 General. otherwise noted.
58.43 Animal care facilities.
58.45 Animal supply facilities.
58.47 Facilities for handling test and con- Subpart A—General Provisions
trol articles.
58.49 Laboratory operation areas. § 58.1 Scope.
58.51 Specimen and data storage facilities. (a) This part prescribes good labora-
tory practices for conducting nonclin-
Subpart D—Equipment ical laboratory studies that support or
58.61 Equipment design. are intended to support applications
58.63 Maintenance and calibration of equip- for research or marketing permits for
ment. products regulated by the Food and
Drug Administration, including food
Subpart E—Testing Facilities Operation and color additives, animal food addi-
58.81 Standard operating procedures.
tives, human and animal drugs, med-
58.83 Reagents and solutions. ical devices for human use, biological
58.90 Animal care. products, and electronic products.
Compliance with this part is intended
Subpart F—Test and Control Articles to assure the quality and integrity of
the safety data filed pursuant to sec-
58.105 Test and control article characteriza- tions 406, 408, 409, 502, 503, 505, 506, 510,
tion.
512–516, 518–520, 721, and 801 of the Fed-
58.107 Test and control article handling.
eral Food, Drug, and Cosmetic Act and
58.113 Mixture of articles with carriers.
sections 351 and 354–360F of the Public
Subpart G—Protocol for and Conduct of a Health Service Act.
Nonclinical Laboratory Study (b) References in this part to regu-
latory sections of the Code of Federal
58.120 Protocol. Regulations are to chapter I of title 21,
58.130 Conduct of a nonclinical laboratory unless otherwise noted.
study.
[43 FR 60013, Dec. 22, 1978, as amended at 52
Subparts H–I [Reserved] FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999]

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Food and Drug Administration, HHS § 58.3

§ 58.3 Definitions. basis pending additional study, de-


As used in this part, the following scribed in § 180.1.
terms shall have the meanings speci- (5) An investigational new drug appli-
fied: cation, described in part 312 of this
(a) Act means the Federal Food, chapter.
Drug, and Cosmetic Act, as amended (6) A new drug application, described
(secs. 201–902, 52 Stat. 1040 et seq., as in part 314.
amended (21 U.S.C. 321–392)). (7) Data and information regarding
(b) Test article means any food addi- an over-the-counter drug for human
tive, color additive, drug, biological use, submitted as part of the proce-
product, electronic product, medical dures for classifying such drugs as gen-
device for human use, or any other ar- erally recognized as safe and effective
ticle subject to regulation under the and not misbranded, described in part
act or under sections 351 and 354–360F 330.
of the Public Health Service Act. (8) Data and information about a sub-
(c) Control article means any food ad- stance submitted as part of the proce-
ditive, color additive, drug, biological dures for establishing a tolerance for
product, electronic product, medical unavoidable contaminants in food and
device for human use, or any article food-packaging materials, described in
other than a test article, feed, or water parts 109 and 509.
that is administered to the test system (9) [Reserved]
in the course of a nonclinical labora- (10) A Notice of Claimed Investigational
tory study for the purpose of estab- Exemption for a New Animal Drug, de-
lishing a basis for comparison with the scribed in part 511.
test article. (11) A new animal drug application, de-
(d) Nonclinical laboratory study means scribed in part 514.
in vivo or in vitro experiments in (12) [Reserved]
which test articles are studied prospec- (13) An application for a biologics li-
tively in test systems under laboratory cense, described in part 601 of this chap-
conditions to determine their safety. ter.
The term does not include studies uti- (14) An application for an investiga-
lizing human subjects or clinical stud- tional device exemption, described in
ies or field trials in animals. The term part 812.
does not include basic exploratory (15) An Application for Premarket Ap-
studies carried out to determine proval of a Medical Device, described in
whether a test article has any poten- section 515 of the act.
tial utility or to determine physical or (16) A Product Development Protocol for
chemical characteristics of a test arti- a Medical Device, described in section
cle. 515 of the act.
(e) Application for research or mar- (17) Data and information regarding a
keting permit includes: medical device submitted as part of the
(1) A color additive petition, de- procedures for classifying such devices,
scribed in part 71. described in part 860.
(2) A food additive petition, described (18) Data and information regarding a
in parts 171 and 571. medical device submitted as part of the
(3) Data and information regarding a procedures for establishing, amending,
substance submitted as part of the pro- or repealing a performance standard
cedures for establishing that a sub- for such devices, described in part 861.
stance is generally recognized as safe (19) Data and information regarding
for use, which use results or may rea- an electronic product submitted as
sonably be expected to result, directly part of the procedures for obtaining an
or indirectly, in its becoming a compo- exemption from notification of a radi-
nent or otherwise affecting the charac- ation safety defect or failure of compli-
teristics of any food, described in ance with a radiation safety perform-
§§ 170.35 and 570.35. ance standard, described in subpart D
(4) Data and information regarding a of part 1003.
food additive submitted as part of the (20) Data and information regarding
procedures regarding food additives an electronic product submitted as
permitted to be used on an interim part of the procedures for establishing,

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§ 58.10 21 CFR Ch. I (4–1–11 Edition)

amending, or repealing a standard for (j) Specimen means any material de-
such product, described in section 358 rived from a test system for examina-
of the Public Health Service Act. tion or analysis.
(21) Data and information regarding (k) Raw data means any laboratory
an electronic product submitted as worksheets, records, memoranda,
part of the procedures for obtaining a notes, or exact copies thereof, that are
variance from any electronic product the result of original observations and
performance standard as described in activities of a nonclinical laboratory
§ 1010.4. study and are necessary for the recon-
(22) Data and information regarding struction and evaluation of the report
an electronic product submitted as of that study. In the event that exact
part of the procedures for granting, transcripts of raw data have been pre-
amending, or extending an exemption pared (e.g., tapes which have been tran-
from any electronic product perform- scribed verbatim, dated, and verified
ance standard, as described in § 1010.5. accurate by signature), the exact copy
(23) A premarket notification for a or exact transcript may be substituted
food contact substance, described in for the original source as raw data.
part 170, subpart D, of this chapter. Raw data may include photographs,
microfilm or microfiche copies, com-
(f) Sponsor means:
puter printouts, magnetic media, in-
(1) A person who initiates and sup- cluding dictated observations, and re-
ports, by provision of financial or other corded data from automated instru-
resources, a nonclinical laboratory ments.
study; (l) Quality assurance unit means any
(2) A person who submits a nonclin- person or organizational element, ex-
ical study to the Food and Drug Ad- cept the study director, designated by
ministration in support of an applica- testing facility management to per-
tion for a research or marketing per- form the duties relating to quality as-
mit; or surance of nonclinical laboratory stud-
(3) A testing facility, if it both initi- ies.
ates and actually conducts the study. (m) Study director means the indi-
(g) Testing facility means a person vidual responsible for the overall con-
who actually conducts a nonclinical duct of a nonclinical laboratory study.
laboratory study, i.e., actually uses the (n) Batch means a specific quantity
test article in a test system. Testing fa- or lot of a test or control article that
cility includes any establishment re- has been characterized according to
quired to register under section 510 of § 58.105(a).
the act that conducts nonclinical lab- (o) Study initiation date means the
oratory studies and any consulting lab- date the protocol is signed by the study
oratory described in section 704 of the director.
act that conducts such studies. Testing (p) Study completion date means the
facility encompasses only those oper- date the final report is signed by the
ational units that are being or have study director.
been used to conduct nonclinical lab-
[43 FR 60013, Dec. 22, 1978, as amended at 52
oratory studies. FR 33779, Sept. 4, 1987; 54 FR 9039, Mar. 3,
(h) Person includes an individual, 1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729,
partnership, corporation, association, May 21, 2002]
scientific or academic establishment,
government agency, or organizational § 58.10 Applicability to studies per-
unit thereof, and any other legal enti- formed under grants and contracts.
ty. When a sponsor conducting a non-
(i) Test system means any animal, clinical laboratory study intended to
plant, microorganism, or subparts be submitted to or reviewed by the
thereof to which the test or control ar- Food and Drug Administration utilizes
ticle is administered or added for the services of a consulting laboratory,
study. Test system also includes appro- contractor, or grantee to perform an
priate groups or components of the sys- analysis or other service, it shall no-
tem not treated with the test or con- tify the consulting laboratory, con-
trol articles. tractor, or grantee that the service is

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Food and Drug Administration, HHS § 58.31

part of a nonclinical laboratory study tion of test and control articles and
that must be conducted in compliance test systems.
with the provisions of this part. (e) Personnel engaged in a nonclin-
ical laboratory study shall wear cloth-
§ 58.15 Inspection of a testing facility. ing appropriate for the duties they per-
(a) A testing facility shall permit an form. Such clothing shall be changed
authorized employee of the Food and as often as necessary to prevent micro-
Drug Administration, at reasonable biological, radiological, or chemical
times and in a reasonable manner, to contamination of test systems and test
inspect the facility and to inspect (and and control articles.
in the case of records also to copy) all (f) Any individual found at any time
records and specimens required to be to have an illness that may adversely
maintained regarding studies within affect the quality and integrity of the
the scope of this part. The records in- nonclinical laboratory study shall be
spection and copying requirements excluded from direct contact with test
shall not apply to quality assurance systems, test and control articles and
unit records of findings and problems, any other operation or function that
or to actions recommended and taken. may adversely affect the study until
(b) The Food and Drug Administra- the condition is corrected. All per-
tion will not consider a nonclinical lab- sonnel shall be instructed to report to
oratory study in support of an applica- their immediate supervisors any health
tion for a research or marketing per- or medical conditions that may reason-
mit if the testing facility refuses to ably be considered to have an adverse
permit inspection. The determination effect on a nonclinical laboratory
that a nonclinical laboratory study study.
will not be considered in support of an
application for a research or marketing § 58.31 Testing facility management.
permit does not, however, relieve the
For each nonclinical laboratory
applicant for such a permit of any obli-
study, testing facility management
gation under any applicable statute or
shall:
regulation to submit the results of the
study to the Food and Drug Adminis- (a) Designate a study director as de-
tration. scribed in § 58.33, before the study is
initiated.
(b) Replace the study director
Subpart B—Organization and promptly if it becomes necessary to do
Personnel so during the conduct of a study.
§ 58.29 Personnel. (c) Assure that there is a quality as-
surance unit as described in § 58.35.
(a) Each individual engaged in the (d) Assure that test and control arti-
conduct of or responsible for the super- cles or mixtures have been appro-
vision of a nonclinical laboratory study priately tested for identity, strength,
shall have education, training, and ex- purity, stability, and uniformity, as
perience, or combination thereof, to applicable.
enable that individual to perform the (e) Assure that personnel, resources,
assigned functions. facilities, equipment, materials, and
(b) Each testing facility shall main- methodologies are available as sched-
tain a current summary of training and uled.
experience and job description for each
(f) Assure that personnel clearly un-
individual engaged in or supervising
derstand the functions they are to per-
the conduct of a nonclinical laboratory
form.
study.
(c) There shall be a sufficient number (g) Assure that any deviations from
of personnel for the timely and proper these regulations reported by the qual-
conduct of the study according to the ity assurance unit are communicated
protocol. to the study director and corrective ac-
(d) Personnel shall take necessary tions are taken and documented.
personal sanitation and health pre- [43 FR 60013, Dec. 22, 1978, as amended at 52
cautions designed to avoid contamina- FR 33780, Sept. 4, 1987]

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§ 58.33 21 CFR Ch. I (4–1–11 Edition)

§ 58.33 Study director. the sponsor, and name of the study di-
rector.
For each nonclinical laboratory
study, a scientist or other professional (2) Maintain copies of all protocols
pertaining to all nonclinical laboratory
of appropriate education, training, and
experience, or combination thereof, studies for which the unit is respon-
sible.
shall be identified as the study direc-
tor. The study director has overall re- (3) Inspect each nonclinical labora-
sponsibility for the technical conduct tory study at intervals adequate to as-
of the study, as well as for the inter- sure the integrity of the study and
pretation, analysis, documentation and maintain written and properly signed
reporting of results, and represents the records of each periodic inspection
single point of study control. The showing the date of the inspection, the
study director shall assure that: study inspected, the phase or segment
(a) The protocol, including any of the study inspected, the person per-
change, is approved as provided by forming the inspection, findings and
§ 58.120 and is followed. problems, action recommended and
(b) All experimental data, including taken to resolve existing problems, and
observations of unanticipated re- any scheduled date for reinspection.
sponses of the test system are accu- Any problems found during the course
rately recorded and verified. of an inspection which are likely to af-
fect study integrity shall be brought to
(c) Unforeseen circumstances that
the attention of the study director and
may affect the quality and integrity of
the nonclinical laboratory study are management immediately.
noted when they occur, and corrective (4) Periodically submit to manage-
action is taken and documented. ment and the study director written
(d) Test systems are as specified in status reports on each study, noting
the protocol. any problems and the corrective ac-
tions taken.
(e) All applicable good laboratory
practice regulations are followed. (5) Determine that no deviations
from approved protocols or standard
(f) All raw data, documentation, pro-
operating procedures were made with-
tocols, specimens, and final reports are
out proper authorization and docu-
transferred to the archives during or at
mentation.
the close of the study.
(6) Review the final study report to
[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. assure that such report accurately de-
23, 1979] scribes the methods and standard oper-
ating procedures, and that the reported
§ 58.35 Quality assurance unit. results accurately reflect the raw data
(a) A testing facility shall have a of the nonclinical laboratory study.
quality assurance unit which shall be (7) Prepare and sign a statement to
responsible for monitoring each study be included with the final study report
to assure management that the facili- which shall specify the dates inspec-
ties, equipment, personnel, methods, tions were made and findings reported
practices, records, and controls are in to management and to the study direc-
conformance with the regulations in tor.
this part. For any given study, the (c) The responsibilities and proce-
quality assurance unit shall be entirely dures applicable to the quality assur-
separate from and independent of the ance unit, the records maintained by
personnel engaged in the direction and the quality assurance unit, and the
conduct of that study. method of indexing such records shall
(b) The quality assurance unit shall: be in writing and shall be maintained.
(1) Maintain a copy of a master These items including inspection dates,
schedule sheet of all nonclinical lab- the study inspected, the phase or seg-
oratory studies conducted at the test- ment of the study inspected, and the
ing facility indexed by test article and name of the individual performing the
containing the test system, nature of inspection shall be made available for
study, date study was initiated, cur- inspection to authorized employees of
rent status of each study, identity of the Food and Drug Administration.

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Food and Drug Administration, HHS § 58.61

(d) A designated representative of the festation, odors, disease hazards, and


Food and Drug Administration shall environmental contamination.
have access to the written procedures
[43 FR 60013, Dec. 22, 1978, as amended at 52
established for the inspection and may FR 33780, Sept. 4, 1987]
request testing facility management to
certify that inspections are being im- § 58.45 Animal supply facilities.
plemented, performed, documented,
There shall be storage areas, as need-
and followed-up in accordance with
ed, for feed, bedding, supplies, and
this paragraph.
equipment. Storage areas for feed and
[43 FR 60013, Dec. 22, 1978, as amended at 52 bedding shall be separated from areas
FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4, housing the test systems and shall be
2002] protected against infestation or con-
tamination. Perishable supplies shall
Subpart C—Facilities be preserved by appropriate means.
§ 58.41 General. [43 FR 60013, Dec. 22, 1978, as amended at 52
FR 33780, Sept. 4, 1987]
Each testing facility shall be of suit-
able size and construction to facilitate § 58.47 Facilities for handling test and
the proper conduct of nonclinical lab- control articles.
oratory studies. It shall be designed so (a) As necessary to prevent contami-
that there is a degree of separation nation or mixups, there shall be sepa-
that will prevent any function or activ- rate areas for:
ity from having an adverse effect on (1) Receipt and storage of the test
the study. and control articles.
[52 FR 33780, Sept. 4, 1987] (2) Mixing of the test and control ar-
ticles with a carrier, e.g., feed.
§ 58.43 Animal care facilities. (3) Storage of the test and control ar-
(a) A testing facility shall have a suf- ticle mixtures.
ficient number of animal rooms or (b) Storage areas for the test and/or
areas, as needed, to assure proper: (1) control article and test and control
Separation of species or test systems, mixtures shall be separate from areas
(2) isolation of individual projects, (3) housing the test systems and shall be
quarantine of animals, and (4) routine adequate to preserve the identity,
or specialized housing of animals. strength, purity, and stability of the
(b) A testing facility shall have a articles and mixtures.
number of animal rooms or areas sepa-
rate from those described in paragraph § 58.49 Laboratory operation areas.
(a) of this section to ensure isolation of Separate laboratory space shall be
studies being done with test systems or provided, as needed, for the perform-
test and control articles known to be ance of the routine and specialized pro-
biohazardous, including volatile sub- cedures required by nonclinical labora-
stances, aerosols, radioactive mate- tory studies.
rials, and infectious agents.
[52 FR 33780, Sept. 4, 1987]
(c) Separate areas shall be provided,
as appropriate, for the diagnosis, treat- § 58.51 Specimen and data storage fa-
ment, and control of laboratory animal cilities.
diseases. These areas shall provide ef-
fective isolation for the housing of ani- Space shall be provided for archives,
mals either known or suspected of limited to access by authorized per-
being diseased, or of being carriers of sonnel only, for the storage and re-
disease, from other animals. trieval of all raw data and specimens
(d) When animals are housed, facili- from completed studies.
ties shall exist for the collection and
disposal of all animal waste and refuse Subpart D—Equipment
or for safe sanitary storage of waste be-
fore removal from the testing facility. § 58.61 Equipment design.
Disposal facilities shall be so provided Equipment used in the generation,
and operated as to minimize vermin in- measurement, or assessment of data

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§ 58.63 21 CFR Ch. I (4–1–11 Edition)

and equipment used for facility envi- satisfied are adequate to insure the
ronmental control shall be of appro- quality and integrity of the data gen-
priate design and adequate capacity to erated in the course of a study. All de-
function according to the protocol and viations in a study from standard oper-
shall be suitably located for operation, ating procedures shall be authorized by
inspection, cleaning, and maintenance. the study director and shall be docu-
mented in the raw data. Significant
[52 FR 33780, Sept. 4, 1987]
changes in established standard oper-
§ 58.63 Maintenance and calibration of ating procedures shall be properly au-
equipment. thorized in writing by management.
(b) Standard operating procedures
(a) Equipment shall be adequately in-
shall be established for, but not limited
spected, cleaned, and maintained.
to, the following:
Equipment used for the generation, (1) Animal room preparation.
measurement, or assessment of data (2) Animal care.
shall be adequately tested, calibrated (3) Receipt, identification, storage,
and/or standardized. handling, mixing, and method of sam-
(b) The written standard operating pling of the test and control articles.
procedures required under § 58.81(b)(11) (4) Test system observations.
shall set forth in sufficient detail the (5) Laboratory tests.
methods, materials, and schedules to (6) Handling of animals found mori-
be used in the routine inspection, bund or dead during study.
cleaning, maintenance, testing, cali- (7) Necropsy of animals or post-
bration, and/or standardization of mortem examination of animals.
equipment, and shall specify, when ap- (8) Collection and identification of
propriate, remedial action to be taken specimens.
in the event of failure or malfunction (9) Histopathology.
of equipment. The written standard op- (10) Data handling, storage, and re-
erating procedures shall designate the trieval.
person responsible for the performance (11) Maintenance and calibration of
of each operation. equipment.
(c) Written records shall be main- (12) Transfer, proper placement, and
tained of all inspection, maintenance, identification of animals.
testing, calibrating and/or standard- (c) Each laboratory area shall have
izing operations. These records, con- immediately available laboratory
taining the date of the operation, shall manuals and standard operating proce-
describe whether the maintenance op- dures relative to the laboratory proce-
erations were routine and followed the dures being performed. Published lit-
written standard operating procedures. erature may be used as a supplement to
Written records shall be kept of non- standard operating procedures.
routine repairs performed on equip- (d) A historical file of standard oper-
ment as a result of failure and mal- ating procedures, and all revisions
function. Such records shall document thereof, including the dates of such re-
the nature of the defect, how and when visions, shall be maintained.
the defect was discovered, and any re-
[43 FR 60013, Dec. 22, 1978, as amended at 52
medial action taken in response to the
FR 33780, Sept. 4, 1987]
defect.
[43 FR 60013, Dec. 22, 1978, as amended at 52 § 58.83 Reagents and solutions.
FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4, All reagents and solutions in the lab-
2002] oratory areas shall be labeled to indi-
cate identity, titer or concentration,
Subpart E—Testing Facilities storage requirements, and expiration
Operation date. Deteriorated or outdated re-
agents and solutions shall not be used.
§ 58.81 Standard operating procedures.
(a) A testing facility shall have § 58.90 Animal care.
standard operating procedures in writ- (a) There shall be standard operating
ing setting forth nonclinical laboratory procedures for the housing, feeding,
study methods that management is handling, and care of animals.

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Food and Drug Administration, HHS § 58.105

(b) All newly received animals from pose or conduct of the study and shall
outside sources shall be isolated and be changed as often as necessary to
their health status shall be evaluated keep the animals dry and clean.
in accordance with acceptable veteri- (i) If any pest control materials are
nary medical practice. used, the use shall be documented.
(c) At the initiation of a nonclinical Cleaning and pest control materials
laboratory study, animals shall be free that interfere with the study shall not
of any disease or condition that might be used.
interfere with the purpose or conduct
[43 FR 60013, Dec. 22, 1978, as amended at 52
of the study. If, during the course of FR 33780, Sept. 4, 1987; 54 FR 15924, Apr. 20,
the study, the animals contract such a 1989; 56 FR 32088, July 15, 1991; 67 FR 9585,
disease or condition, the diseased ani- Mar. 4, 2002]
mals shall be isolated, if necessary.
These animals may be treated for dis-
ease or signs of disease provided that
Subpart F—Test and Control
such treatment does not interfere with Articles
the study. The diagnosis, authoriza- § 58.105 Test and control article char-
tions of treatment, description of acterization.
treatment, and each date of treatment
shall be documented and shall be re- (a) The identity, strength, purity,
tained. and composition or other characteris-
(d) Warm-blooded animals, excluding tics which will appropriately define the
suckling rodents, used in laboratory test or control article shall be deter-
procedures that require manipulations mined for each batch and shall be docu-
and observations over an extended pe- mented. Methods of synthesis, fabrica-
riod of time or in studies that require tion, or derivation of the test and con-
the animals to be removed from and re- trol articles shall be documented by
turned to their home cages for any rea- the sponsor or the testing facility. In
son (e.g., cage cleaning, treatment, those cases where marketed products
etc.), shall receive appropriate identi- are used as control articles, such prod-
fication. All information needed to spe- ucts will be characterized by their la-
cifically identify each animal within beling.
an animal-housing unit shall appear on (b) The stability of each test or con-
the outside of that unit. trol article shall be determined by the
(e) Animals of different species shall testing facility or by the sponsor ei-
be housed in separate rooms when nec- ther: (1) Before study initiation, or (2)
essary. Animals of the same species, concomitantly according to written
but used in different studies, should standard operating procedures, which
not ordinarily be housed in the same provide for periodic analysis of each
room when inadvertent exposure to batch.
control or test articles or animal (c) Each storage container for a test
mixup could affect the outcome of ei- or control article shall be labeled by
ther study. If such mixed housing is name, chemical abstract number or
necessary, adequate differentiation by code number, batch number, expiration
space and identification shall be made. date, if any, and, where appropriate,
(f) Animal cages, racks and accessory storage conditions necessary to main-
equipment shall be cleaned and sani- tain the identity, strength, purity, and
tized at appropriate intervals. composition of the test or control arti-
(g) Feed and water used for the ani- cle. Storage containers shall be as-
mals shall be analyzed periodically to signed to a particular test article for
ensure that contaminants known to be the duration of the study.
capable of interfering with the study (d) For studies of more than 4 weeks’
and reasonably expected to be present duration, reserve samples from each
in such feed or water are not present at batch of test and control articles shall
levels above those specified in the pro- be retained for the period of time pro-
tocol. Documentation of such analyses vided by § 58.195.
shall be maintained as raw data. [43 FR 60013, Dec. 22, 1978, as amended at 52
(h) Bedding used in animal cages or FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4,
pens shall not interfere with the pur- 2002]

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§ 58.107 21 CFR Ch. I (4–1–11 Edition)

§ 58.107 Test and control article han- dicates the objectives and all methods
dling. for the conduct of the study. The pro-
Procedures shall be established for a tocol shall contain, as applicable, the
system for the handling of the test and following information:
control articles to ensure that: (1) A descriptive title and statement
(a) There is proper storage. of the purpose of the study.
(b) Distribution is made in a manner (2) Identification of the test and con-
designed to preclude the possibility of trol articles by name, chemical ab-
contamination, deterioration, or dam- stract number, or code number.
age. (3) The name of the sponsor and the
(c) Proper identification is main- name and address of the testing facil-
tained throughout the distribution ity at which the study is being con-
process. ducted.
(d) The receipt and distribution of (4) The number, body weight range,
each batch is documented. Such docu- sex, source of supply, species, strain,
mentation shall include the date and substrain, and age of the test system.
quantity of each batch distributed or (5) The procedure for identification of
returned. the test system.
(6) A description of the experimental
§ 58.113 Mixtures of articles with car- design, including the methods for the
riers. control of bias.
(a) For each test or control article (7) A description and/or identification
that is mixed with a carrier, tests by of the diet used in the study as well as
appropriate analytical methods shall solvents, emulsifiers, and/or other ma-
be conducted: terials used to solubilize or suspend the
(1) To determine the uniformity of test or control articles before mixing
the mixture and to determine, periodi- with the carrier. The description shall
cally, the concentration of the test or include specifications for acceptable
control article in the mixture. levels of contaminants that are reason-
(2) To determine the stability of the ably expected to be present in the die-
test and control articles in the mixture tary materials and are known to be ca-
as required by the conditions of the pable of interfering with the purpose or
study either: conduct of the study if present at lev-
(i) Before study initiation, or els greater than established by the
(ii) Concomitantly according to writ- specifications.
ten standard operating procedures (8) Each dosage level, expressed in
which provide for periodic analysis of milligrams per kilogram of body
the test and control articles in the weight or other appropriate units, of
mixture. the test or control article to be admin-
(b) [Reserved] istered and the method and frequency
(c) Where any of the components of of administration.
the test or control article carrier mix- (9) The type and frequency of tests,
ture has an expiration date, that date analyses, and measurements to be
shall be clearly shown on the con- made.
tainer. If more than one component has (10) The records to be maintained.
an expiration date, the earliest date (11) The date of approval of the pro-
shall be shown. tocol by the sponsor and the dated sig-
[43 FR 60013, Dec. 22, 1978, as amended at 45 nature of the study director.
FR 24865, Apr. 11, 1980; 52 FR 33781, Sept. 4, (12) A statement of the proposed sta-
1987] tistical methods to be used.
(b) All changes in or revisions of an
Subpart G—Protocol for and Con- approved protocol and the reasons
duct of a Nonclinical Labora- therefore shall be documented, signed
tory Study by the study director, dated, and main-
tained with the protocol.
§ 58.120 Protocol.
[43 FR 60013, Dec. 22, 1978, as amended at 52
(a) Each study shall have an ap- FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4,
proved written protocol that clearly in- 2002]

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Food and Drug Administration, HHS § 58.185

§ 58.130 Conduct of a nonclinical lab- which the study was initiated and com-
oratory study. pleted.
(a) The nonclinical laboratory study (2) Objectives and procedures stated
in the approved protocol, including any
shall be conducted in accordance with
changes in the original protocol.
the protocol.
(3) Statistical methods employed for
(b) The test systems shall be mon-
analyzing the data.
itored in conformity with the protocol.
(4) The test and control articles iden-
(c) Specimens shall be identified by tified by name, chemical abstracts
test system, study, nature, and date of number or code number, strength, pu-
collection. This information shall be rity, and composition or other appro-
located on the specimen container or priate characteristics.
shall accompany the specimen in a (5) Stability of the test and control
manner that precludes error in the re- articles under the conditions of admin-
cording and storage of data. istration.
(d) Records of gross findings for a (6) A description of the methods used.
specimen from postmortem observa- (7) A description of the test system
tions should be available to a patholo- used. Where applicable, the final report
gist when examining that specimen shall include the number of animals
histopathologically. used, sex, body weight range, source of
(e) All data generated during the con- supply, species, strain and substrain,
duct of a nonclinical laboratory study, age, and procedure used for identifica-
except those that are generated by tion.
automated data collection systems, (8) A description of the dosage, dos-
shall be recorded directly, promptly, age regimen, route of administration,
and legibly in ink. All data entries and duration.
shall be dated on the date of entry and (9) A description of all
signed or initialed by the person enter- cirmcumstances that may have af-
ing the data. Any change in entries fected the quality or integrity of the
shall be made so as not to obscure the data.
original entry, shall indicate the rea- (10) The name of the study director,
son for such change, and shall be dated the names of other scientists or profes-
and signed or identified at the time of sionals, and the names of all super-
the change. In automated data collec- visory personnel, involved in the study.
tion systems, the individual respon- (11) A description of the trans-
sible for direct data input shall be iden- formations, calculations, or operations
tified at the time of data input. Any performed on the data, a summary and
change in automated data entries shall analysis of the data, and a statement
be made so as not to obscure the origi- of the conclusions drawn from the
nal entry, shall indicate the reason for analysis.
change, shall be dated, and the respon- (12) The signed and dated reports of
sible individual shall be identified. each of the individual scientists or
[43 FR 60013, Dec. 22, 1978, as amended at 52 other professionals involved in the
FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, study.
2002] (13) The locations where all speci-
mens, raw data, and the final report
Subparts H–I [Reserved] are to be stored.
(14) The statement prepared and
signed by the quality assurance unit as
Subpart J—Records and Reports described in § 58.35(b)(7).
(b) The final report shall be signed
§ 58.185 Reporting of nonclinical lab- and dated by the study director.
oratory study results.
(c) Corrections or additions to a final
(a) A final report shall be prepared report shall be in the form of an
for each nonclinical laboratory study amendment by the study director. The
and shall include, but not necessarily amendment shall clearly identify that
be limited to, the following: part of the final report that is being
(1) Name and address of the facility added to or corrected and the reasons
performing the study and the dates on for the correction or addition, and

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§ 58.190 21 CFR Ch. I (4–1–11 Edition)

shall be signed and dated by the person the nonclinical laboratory study were
responsible. submitted, is approved by the Food and
[43 FR 60013, Dec. 22, 1978, as amended at 52
Drug Administration. This require-
FR 33781, Sept. 4, 1987] ment does not apply to studies sup-
porting investigational new drug appli-
§ 58.190 Storage and retrieval of cations (IND’s) or applications for in-
records and data. vestigational device exemptions
(a) All raw data, documentation, pro- (IDE’s), records of which shall be gov-
tocols, final reports, and specimens erned by the provisions of paragraph
(except those specimens obtained from (b)(2) of this section.
mutagenicity tests and wet specimens (2) A period of at least 5 years fol-
of blood, urine, feces, and biological lowing the date on which the results of
fluids) generated as a result of a non- the nonclinical laboratory study are
clinical laboratory study shall be re- submitted to the Food and Drug Ad-
tained. ministration in support of an applica-
(b) There shall be archives for orderly tion for a research or marketing per-
storage and expedient retrieval of all mit.
raw data, documentation, protocols, (3) In other situations (e.g., where
specimens, and interim and final re- the nonclinical laboratory study does
ports. Conditions of storage shall mini- not result in the submission of the
mize deterioration of the documents or study in support of an application for a
specimens in accordance with the re- research or marketing permit), a pe-
quirements for the time period of their riod of at least 2 years following the
retention and the nature of the docu- date on which the study is completed,
ments or specimens. A testing facility terminated, or discontinued.
may contract with commercial ar-
(c) Wet specimens (except those
chives to provide a repository for all
specimens obtained from mutagenicity
material to be retained. Raw data and
tests and wet specimens of blood,
specimens may be retained elsewhere
provided that the archives have spe- urine, feces, and biological fluids),
cific reference to those other locations. samples of test or control articles, and
(c) An individual shall be identified specially prepared material, which are
as responsible for the archives. relatively fragile and differ markedly
(d) Only authorized personnel shall in stability and quality during storage,
enter the archives. shall be retained only as long as the
(e) Material retained or referred to in quality of the preparation affords eval-
the archives shall be indexed to permit uation. In no case shall retention be re-
expedient retrieval. quired for longer periods than those set
forth in paragraphs (a) and (b) of this
[43 FR 60013, Dec. 22, 1978, as amended at 52 section.
FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4,
2002] (d) The master schedule sheet, copies
of protocols, and records of quality as-
§ 58.195 Retention of records. surance inspections, as required by
(a) Record retention requirements set § 58.35(c) shall be maintained by the
forth in this section do not supersede quality assurance unit as an easily ac-
the record retention requirements of cessible system of records for the pe-
any other regulations in this chapter. riod of time specified in paragraphs (a)
(b) Except as provided in paragraph and (b) of this section.
(c) of this section, documentation (e) Summaries of training and experi-
records, raw data and specimens per- ence and job descriptions required to be
taining to a nonclinical laboratory maintained by § 58.29(b) may be re-
study and required to be made by this tained along with all other testing fa-
part shall be retained in the archive(s) cility employment records for the
for whichever of the following periods length of time specified in paragraphs
is shortest: (a) and (b) of this section.
(1) A period of at least 2 years fol- (f) Records and reports of the mainte-
lowing the date on which an applica- nance and calibration and inspection of
tion for a research or marketing per- equipment, as required by § 58.63(b) and
mit, in support of which the results of (c), shall be retained for the length of

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Food and Drug Administration, HHS § 58.206

time specified in paragraph (b) of this (a) The testing facility failed to com-
section. ply with one or more of the regulations
(g) Records required by this part may set forth in this part (or any other reg-
be retained either as original records ulations regarding such facilities in
or as true copies such as photocopies, this chapter);
microfilm, microfiche, or other accu- (b) The noncompliance adversely af-
rate reproductions of the original fected the validity of the nonclinical
records. laboratory studies; and
(h) If a facility conducting nonclin- (c) Other lesser regulatory actions
ical testing goes out of business, all (e.g., warnings or rejection of indi-
raw data, documentation, and other vidual studies) have not been or will
material specified in this section shall probably not be adequate to achieve
be transferred to the archives of the compliance with the good laboratory
sponsor of the study. The Food and practice regulations.
Drug Administration shall be notified
in writing of such a transfer. § 58.204 Notice of and opportunity for
hearing on proposed disqualifica-
[43 FR 60013, Dec. 22, 1978, as amended at 52 tion.
FR 33781, Sept. 4, 1987; 54 FR 9039, Mar. 3,
1989] (a) Whenever the Commissioner has
information indicating that grounds
exist under § 58.202 which in his opinion
Subpart K—Disqualification of justify disqualification of a testing fa-
Testing Facilities cility, he may issue to the testing fa-
cility a written notice proposing that
§ 58.200 Purpose.
the facility be disqualified.
(a) The purposes of disqualification (b) A hearing on the disqualification
are: shall be conducted in accordance with
(1) To permit the exclusion from con- the requirements for a regulatory hear-
sideration of completed studies that ing set forth in part 16 of this chapter.
were conducted by a testing facility
which has failed to comply with the re- § 58.206 Final order on disqualifica-
quirements of the good laboratory tion.
practice regulations until it can be (a) If the Commissioner, after the
adequately demonstrated that such regulatory hearing, or after the time
noncompliance did not occur during, or for requesting a hearing expires with-
did not affect the validity or accept- out a request being made, upon an
ability of data generated by, a par- evaulation of the administrative record
ticular study; and of the disqualification proceeding,
(2) To exclude from consideration all makes the findings required in § 58.202,
studies completed after the date of dis- he shall issue a final order disquali-
qualification until the facility can sat- fying the facility. Such order shall in-
isfy the Commissioner that it will con- clude a statement of the basis for that
duct studies in compliance with such determination. Upon issuing a final
regulations. order, the Commissioner shall notify
(b) The determination that a nonclin- (with a copy of the order) the testing
ical laboratory study may not be con- facility of the action.
sidered in support of an application for (b) If the Commissioner, after a regu-
a research or marketing permit does latory hearing or after the time for re-
not, however, relieve the applicant for questing a hearing expires without a
such a permit of any obligation under request being made, upon an evalua-
any other applicable regulation to sub- tion of the administrative record of the
mit the results of the study to the disqualification proceeding, does not
Food and Drug Administration. make the findings required in § 58.202,
he shall issue a final order terminating
§ 58.202 Grounds for disqualification. the disqualification proceeding. Such
The Commissioner may disqualify a order shall include a statement of the
testing facility upon finding all of the basis for that determination. Upon
following: issuing a final order the Commissioner

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§ 58.210 21 CFR Ch. I (4–1–11 Edition)

shall notify the testing facility and lieves that such disclosure would fur-
provide a copy of the order. ther the public interest or would pro-
mote compliance with the good labora-
§ 58.210 Actions upon disqualification. tory practice regulations set forth in
(a) Once a testing facility has been this part. Such notice, if given, shall
disqualified, each application for a re- include a copy of the final order issued
search or marketing permit, whether under § 58.206(a) and shall state that the
approved or not, containing or relying disqualification constitutes a deter-
upon any nonclinical laboratory study mination by the Food and Drug Admin-
conducted by the disqualified testing istration that nonclinical laboratory
facility may be examined to determine studies performed by the facility will
whether such study was or would be es- not be considered by the Food and
sential to a decision. If it is determined Drug Administration in support of any
that a study was or would be essential, application for a research or marketing
the Food and Drug Administration permit. If such notice is sent to an-
shall also determine whether the study other Federal Government agency, the
is acceptable, notwithstanding the dis- Food and Drug Administration will
qualification of the facility. Any study recommend that the agency also con-
done by a testing facility before or sider whether or not it should accept
after disqualification may be presumed
nonclinical laboratory studies per-
to be unacceptable, and the person re-
formed by the testing facility. If such
lying on the study may be required to
notice is sent to any other person, it
establish that the study was not af-
shall state that it is given because of
fected by the circumstances that led to
the disqualification, e.g., by submit- the relationship between the testing fa-
ting validating information. If the cility and the person being notified and
study is then determined to be unac- that the Food and Drug Administra-
ceptable, such data will be eliminated tion is not advising or recommending
from consideration in support of the that any action be taken by the person
application; and such elimination may notified.
serve as new information justifying the (b) A determination that a testing fa-
termination or withdrawal of approval cility has been disqualified and the ad-
of the application. ministrative record regarding such de-
(b) No nonclinical laboratory study termination are disclosable to the pub-
begun by a testing facility after the lic under part 20 of this chapter.
date of the facility’s disqualification
shall be considered in support of any § 58.215 Alternative or additional ac-
application for a research or marketing tions to disqualification.
permit, unless the facility has been re- (a) Disqualification of a testing facil-
instated under § 58.219. The determina- ity under this subpart is independent
tion that a study may not be consid- of, and neither in lieu of nor a pre-
ered in support of an application for a condition to, other proceedings or ac-
research or marketing permit does not, tions authorized by the act. The Food
however, relieve the applicant for such and Drug Administration may, at any
a permit of any obligation under any time, institute against a testing facil-
other applicable regulation to submit ity and/or against the sponsor of a non-
the results of the study to the Food clinical laboratory study that has been
and Drug Administration. submitted to the Food and Drug Ad-
[43 FR 60013, Dec. 22, 1978, as amended at 59 ministration any appropriate judicial
FR 13200, Mar. 21, 1994] proceedings (civil or criminal) and any
other appropriate regulatory action, in
§ 58.213 Public disclosure of informa- addition to or in lieu of, and prior to,
tion regarding disqualification. simultaneously with, or subsequent to,
(a) Upon issuance of a final order dis- disqualification. The Food and Drug
qualifying a testing facility under Administration may also refer the
§ 58.206(a), the Commissioner may no- matter to another Federal, State, or
tify all or any interested persons. Such local government law enforcement or
notice may be given at the discretion regulatory agency for such action as
of the Commissioner whenever he be- that agency deems appropriate.

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Food and Drug Administration, HHS Pt. 60

(b) The Food and Drug Administra- Commissioner reasons why it believes
tion may refuse to consider any par- it should be reinstated and a detailed
ticular nonclinical laboratory study in description of the corrective actions it
support of an application for a research has taken or intends to take to assure
or marketing permit, if it finds that that the acts or omissions which led to
the study was not conducted in accord- its disqualification will not recur. The
ance with the good laboratory practice Commissioner may condition rein-
regulations set forth in this part, with- statement upon the testing facility
out disqualifying the testing facility being found in compliance with the
that conducted the study or under- good laboratory practice regulations
taking other regulatory action. upon an inspection. If a testing facility
is reinstated, the Commissioner shall
§ 58.217 Suspension or termination of so notify the testing facility and all or-
a testing facility by a sponsor.
ganizations and persons who were noti-
Termination of a testing facility by a fied, under § 58.213 of the disqualifica-
sponsor is independent of, and neither tion of the testing facility. A deter-
in lieu of nor a precondition to, pro- mination that a testing facility has
ceedings or actions authorized by this been reinstated is disclosable to the
subpart. If a sponsor terminates or sus- public under part 20 of this chapter.
pends a testing facility from further
participation in a nonclinical labora- PART 60—PATENT TERM
tory study that is being conducted as
part of any application for a research RESTORATION
or marketing permit that has been sub-
Subpart A—General Provisions
mitted to any Center of the Food and
Drug Administration (whether ap- Sec.
proved or not), it shall notify that Cen- 60.1 Scope.
ter in writing within 15 working days 60.2 Purpose.
of the action; the notice shall include a 60.3 Definitions.
statement of the reasons for such ac-
Subpart B—Eligibility Assistance
tion. Suspension or termination of a
testing facility by a sponsor does not 60.10 FDA assistance on eligibility.
relieve it of any obligation under any
other applicable regulation to submit Subpart C—Regulatory Review Period
the results of the study to the Food Determinations
and Drug Administration. 60.20 FDA action on regulatory review pe-
[43 FR FR 60013, Dec. 22, 1978, as amended at riod determinations.
50 FR 8995, Mar. 6, 1985] 60.22 Regulatory review period determina-
tions.
§ 58.219 Reinstatement of a disquali- 60.24 Revision of regulatory review period
fied testing facility. determinations.
60.26 Final action on regulatory review pe-
A testing facility that has been dis- riod determinations.
qualified may be reinstated as an ac- 60.28 Time frame for determining regu-
ceptable source of nonclinical labora- latory review periods.
tory studies to be submitted to the
Food and Drug Administration if the Subpart D—Due Diligence Petitions
Commissioner determines, upon an 60.30 Filing, format, and content of peti-
evaluation of the submission of the tions.
testing facility, that the facility can 60.32 Applicant response to petition.
adequately assure that it will conduct 60.34 FDA action on petitions.
future nonclinical laboratory studies in 60.36 Standard of due diligence.
compliance with the good laboratory
practice regulations set forth in this Subpart E—Due Diligence Hearings
part and, if any studies are currently 60.40 Request for hearing.
being conducted, that the quality and 60.42 Notice of hearing.
integrity of such studies have not been 60.44 Hearing procedures.
seriously compromised. A disqualified 60.46 Administrative decision.
testing facility that wishes to be so re- AUTHORITY: 21 U.S.C. 348, 355, 360e, 360j, 371,
instated shall present in writing to the 379e; 35 U.S.C. 156; 42 U.S.C. 262.

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§ 60.1 21 CFR Ch. I (4–1–11 Edition)
SOURCE: 53 FR 7305, Mar. 7, 1988, unless oth- United States Patent and Trademark
erwise noted. Office to implement those parts of the
EDITORIAL NOTE: Nomenclature changes to law which are under that agency’s ju-
part 60 appear at 68 FR 24879, May 9, 2003. risdiction. These regulations shall be
construed in light of these objectives.
Subpart A—General Provisions
§ 60.3 Definitions.
§ 60.1 Scope.
(a) The definitions contained in 35
(a) This part sets forth procedures U.S.C. 156 apply to those terms when
and requirements for the Food and used in this part.
Drug Administration’s review of appli- (b) The following definitions of terms
cations for the extension of the term of
apply to this part:
certain patents under 35 U.S.C. 156.
Patent term restoration is available (1) The term Act means the Federal
for certain patents related to drug Food, Drug, and Cosmetic Act (secs.
products (as defined in 35 U.S.C. 201–901, 52 Stat. 1040 et seq. as amended
156(f)(2)), and to medical devices, food (21 U.S.C. 301–392)).
additives, or color additives subject to (2) Active ingredient means any com-
regulation under the Federal Food, ponent that is intended to furnish
Drug, and Cosmetic Act or the Public pharmacological activity or other di-
Health Service Act. Food and Drug Ad- rect effect in the diagnosis, cure, miti-
ministration actions in this area in- gation, treatment, or prevention of dis-
clude: ease, or to affect the structure or any
(1) Assisting the United States Pat- function of the body of man or of ani-
ent and Trademark Office in deter- mals. The term includes those compo-
mining eligibility for patent term res- nents that may undergo chemical
toration; change in the manufacture of the drug
(2) Determining the length of a prod-
product and be present in the drug
uct’s regulatory review period;
product in a modified form intended to
(3) If petitioned, reviewing and ruling
on due diligence challenges to the Food furnish the specified activity or effect.
and Drug Administration’s regulatory (3) Applicant means any person who
review period determinations; and submits an application or an amend-
(4) Conducting hearings to review ini- ment or supplement to an application
tial Food and Drug Administration under 35 U.S.C. 156 seeking patent term
findings on due diligence challenges. restoration.
(b) References in this part to the (4) Application means an application
Code of Federal Regulations are to for patent term restoration submitted
chapter I of title 21, unless otherwise under 35 U.S.C. 156.
noted. (5) Clinical investigation or study
[53 FR 7305, Mar. 7, 1988, as amended at 57 FR means any experiment that involves a
56261, Nov. 27, 1992] test article and one or more subjects
and that is either subject to require-
§ 60.2 Purpose. ments for prior submission to the Food
(a) The purpose of this part is to es- and Drug Administration under section
tablish a thorough yet efficient process 505(i), 512(j), or 520(g) of the Federal
for the Food and Drug Administration Food, Drug, and Cosmetic Act, or is
review of patent term restoration ap- not subject to the requirements for
plications. To achieve this purpose, the prior submission to FDA under those
regulations are intended to: sections of the Federal Food, Drug, and
(1) Facilitate determinations of pat- Cosmetic Act, but the results of which
ent term restoration eligibility and
are intended to be submitted later to,
regulatory review period length, and
(2) Ensure that parties interested in or held for inspection by, FDA as part
due diligence challenges will have an of an application for a research or mar-
opportunity to participate in that keting permit. The term does not in-
process, including informal hearings. clude experiments that are subject to
(b) The regulations are intended to the provisions of part 58 regarding non-
complement those promulgated by the clinical laboratory studies.

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Food and Drug Administration, HHS § 60.10

(6) Color additive means any sub- (16) Animal drug product means the
stance that meets the definition in sec- active ingredient of a new animal drug
tion 201(t) of the Act and which is sub- (as that term is used in the Act) that is
ject to premarketing approval under not primarily manufactured using re-
section 721 of the Act. combinant deoxyribonucleic acid
(7) Due diligence petition means a peti- (DNA), recombinant ribonucleic acid
tion submitted under § 60.30(a). (RNA), hybridoma technology, or other
(8) FDA means the Food and Drug processes involving site-specific ge-
Administration. netic manipulation techniques, includ-
(9) Food additive means any substance ing any salt or ester of the active in-
that meets the definition in section gredient, as a single entity or in com-
201(s) of the Act and which is subject to bination with another active ingre-
premarketing approval under section dient.
409 of the Act. [53 FR 7305, Mar. 7, 1988, as amended at 57 FR
(10) Human drug product means the 56261, Nov. 27, 1992; 64 FR 399, Jan. 5, 1999]
active ingredient of a new drug or
human biologic product (as those terms Subpart B—Eligibility Assistance
are used in the Act and the Public
Health Service Act), including any salt § 60.10 FDA assistance on eligibility.
or ester of the active ingredient, as a (a) Upon written request from the
single entity or in combination with U.S. Patent and Trademark Office,
another active ingredient. FDA will assist the U.S. Patent and
(11) Marketing applicant means any Trademark Office in determining
person who submits an application for whether a patent related to a product
premarketing approval by FDA under: is eligible for patent term restoration
(i) Section 505(b) of the Act or section as follows:
351 of the Public Health Service Act (1) Verifying whether the product
(human drug products); was subject to a regulatory review pe-
(ii) Section 515 of the Act (medical riod before its commercial marketing
devices); or use;
(iii) Section 409 or 721 of the Act (2) For human drug products, food ad-
(food and color additives); or ditives, color additives, and medical
(iv) Section 512 of the Act (animal devices, determining whether the per-
drug products). mission for commercial marketing or
(12) Marketing application means an use of the product after the regulatory
application for: review period is the first permitted
(i) Human drug products submitted commercial marketing or use of the
under section 505(b) of the Act or sec- product either:
tion 351 of the Public Health Service (i) Under the provision of law under
Act; which the regulatory review period oc-
(ii) Medical devices submitted under curred; or
section 515 of the Act; (ii) Under the process claimed in the
(iii) Food and color additives sub- patent when the patent claims a meth-
mitted under section 409 or 721 of the od of manufacturing the product that
Act; or primarily uses recombinant
(iv) Animal drug products submitted deoxyribonucleic acid (DNA) tech-
under section 512 of the Act. nology in the manufacture of the prod-
(13) Medical device means any article uct;
that meets the definition in section (3) For animal drug products, deter-
201(h) of the Act and which is subject mining whether the permission for
to premarketing approval under sec- commercial marketing or use of the
tion 515 of the Act. product after the regulatory review pe-
(14) Product means a human drug riod:
product, animal drug product, medical (i) Is the first permitted commercial
device, food additive, or color additive, marketing or use of the product; or
as those terms are defined in this sec- (ii) Is the first permitted commercial
tion. marketing or use of the product for ad-
(15) PTO means the United States ministration to a food-producing ani-
Patent and Trademark Office. mal, whichever is applicable, under the

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§ 60.20 21 CFR Ch. I (4–1–11 Edition)

provision of law under which the regu- (c) FDA will also publish the regu-
latory review period occurred; latory review period determination in
(4) Informing the U.S. Patent and the FEDERAL REGISTER. The notice will
Trademark Office whether the patent include the following:
term restoration application was sub- (1) The name of the applicant;
mitted within 60 days after the product (2) The trade name and generic name
was approved for marketing or use, or, (if applicable) of the product;
if the product is an animal drug ap- (3) The number of the patent for
proved for use in a food-producing ani- which an extension of the term is
mal, verifying whether the application sought;
was filed within 60 days of the first ap- (4) The approved indications or uses
proval for marketing or use in a food- for the product;
producing animal; and (5) An explanation of any discrep-
ancies between the dates in the appli-
(5) Providing the U.S. Patent and
cation and FDA records;
Trademark Office with any other infor-
(6) Where appropriate, an explanation
mation relevant to the U.S. Patent and
that FDA has no record in which to re-
Trademark Office’s determination of
view the date(s) contained in the appli-
whether a patent related to a product
cation; and
is eligible for patent term restoration. (7) The regulatory review period de-
(b) FDA will notify the U.S. Patent termination, including a statement of
and Trademark Office of its findings in the length of the testing and approval
writing, send a copy of this notifica- phases and the dates used in calcu-
tion to the applicant, and file a copy of lating each phase.
the notification in the docket estab-
lished for the application in FDA’s Di- [53 FR 7305, Mar. 7, 1988, as amended at 59 FR
14364, Mar. 28, 1994]
vision of Dockets Management (HFA–
305), 5630 Fishers Lane, rm. 1061, Rock- § 60.22 Regulatory review period de-
ville, MD 20852. terminations.
[57 FR 56261, Nov. 27, 1992] In determining a product’s regu-
latory review period, which consists of
Subpart C—Regulatory Review the sum of the lengths of a testing
Period Determinations phase and an approval phase, FDA will
review the information in each applica-
§ 60.20 FDA action on regulatory re- tion using the following definitions of
view period determinations. the testing phase and the approval
phase for that class of products.
(a) FDA will consult its records and (a) For human drugs:
experts to verify the dates contained in (1) The testing phase begins on the
the application and to determine the date an exemption under section 505(i)
length of the product’s regulatory re- of the Act becomes effective (or the
view period under § 60.22. The applica- date an exemption under former sec-
tion shall contain information relevant tion 507(d) of the Act became effective)
to the determination of the regulatory for the approved human drug product
review period as stated in the ‘‘Guide- and ends on the date a marketing ap-
lines for Extension of Patent Term plication under section 351 of the Pub-
Under 35 U.S.C. 156’’ published on Octo- lic Health Service Act or section 505 of
ber 9, 1984, in PTO’s Official Gazette and the act is initially submitted to FDA
as required by 37 CFR chapter I. (or was initially submitted to FDA
(b) After determining the length of under former section 507 of the Act),
the regulatory review period, FDA will and
notify PTO in writing of its determina- (2) The approval phase begins on the
tion, send a copy of this determination date a marketing application under
to the applicant, and file a copy of the section 351 of the Public Health Service
determination in the docket estab- Act or section 505(b) of the Act is ini-
lished for the application in FDA’s Di- tially submitted to FDA (or was ini-
vision of Dockets Management (HFA– tially submitted under former section
305), 5630 Fishers Lane, rm. 1061, Rock- 507 of the Act) and ends on the date the
ville, MD 20852. application is approved.

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Food and Drug Administration, HHS § 60.22

(b) For food and color additives: the Act and ends on the date the appli-
(1) The testing phase begins on the cation is approved; or
date a major health or environmental (ii) Begins on the date a notice of
effects test is begun and ends on the completion of a product development
date a petition relying on the test and protocol is initially submitted under
requesting the issuance of a regulation section 515 of the Act and ends on the
for use of the additive under section 409 date the protocol is declared to be com-
or 721 of the Act is initially submitted pleted.
to FDA. (d) For animal drugs:
(2) The approval phase begins on the (1) The testing phase begins on the
date a petition requesting the issuance date a major health or environmental
of a regulation for use of the additive effects test is begun or the date on
under section 409 or 721 of the Act is which the agency acknowledges the fil-
initially submitted to FDA and ends ing of a notice of claimed investiga-
upon whichever of the following occurs tional exemption for a new animal
last: drug, whichever is earlier, and ends on
(i) The regulation for the additive be- the date a marketing application under
comes effective; or section 512 of the Act is initially sub-
(ii) Objections filed against the regu- mitted to FDA.
lation that result in a stay of effective- (2) The approval phase begins on the
ness are resolved and commercial mar- date a marketing application under
keting is permitted; or section 512 of the Act is initially sub-
(iii) Proceedings resulting from ob- mitted to FDA and ends on the date
jections to the regulation, after com- the application is approved.
mercial marketing has been permitted (e) For purposes of this section, a
and later stayed pending resolution of ‘‘major health or environmental effects
the proceedings, are finally resolved test’’ may be any test which:
and commercial marketing is per- (1) Is reasonably related to the eval-
mitted. uation of the product’s health or envi-
(c) For medical devices: ronmental effects, or both:
(1) The testing phase begins on the (2) Produces data necessary for mar-
date a clinical investigation on humans keting approval; and
is begun and ends on the date an appli- (3) Is conducted over a period of no
cation for premarket approval of the less than 6 months duration, excluding
device or a notice of completion of a time required to analyze or evaluate
product development protocol is ini- test results.
tially submitted under section 515 of (f) For purposes of determining the
the Act. For purposes of this part, a regulatory review period for any prod-
clinical investigation is considered to uct, a marketing application, a notice
begin on whichever of the following of completion of a product develop-
dates applies: ment protocol, or a petition is initially
(i) If an investigational device ex- submitted on the date it contains suffi-
emption (IDE) under section 520(g) of cient information to allow FDA to
the Act is required, the effective date commence review of the application. A
of the exemption. marketing application, a notice of
(ii) If an IDE is not required, but in- completion of a product development
stitutional review board (IRB) approval protocol, or a petition is approved on
under section 520(g)(3) of the Act is re- the date FDA sends the applicant a let-
quired, the IRB approval date. ter informing it of the approval or, by
(iii) If neither an IDE nor IRB ap- order declares a product development
proval is required, the date on which protocol to be completed, or, in the
the device is first used with human case of food and color additives, on the
subjects as part of a clinical investiga- effective date of the final rule listing
tion to be filed with FDA to secure pre- the additive for use as published in the
market approval of the device. FEDERAL REGISTER or, in the case of a
(2) The approval phase either: new animal drug in a Category II Type
(i) Begins on the date an application A medicated article, on the date of
for premarket approval of the device is publication in the FEDERAL REGISTER
initially submitted under section 515 of of the notice of approval pursuant to

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§ 60.24 21 CFR Ch. I (4–1–11 Edition)

section 512(i) of the Act. For purposes ISTER, including a statement giving the
of this section, the regulatory review reasons for the revision.
period for an animal drug shall mean
[53 FR 7305, Mar. 7, 1988, as amended at 59 FR
either the regulatory review period re- 14364, Mar. 28, 1994; 67 FR 9585, Mar. 4, 2002]
lating the drug’s approval for use in
nonfood-producing animals or the regu- § 60.26 Final action on regulatory re-
latory review period relating to the view period determinations.
drug’s approval for use in food-pro- (a) FDA will consider a regulatory re-
ducing animals, whichever is applica- view period determination to be final
ble. upon expiration of the 180-day period
[53 FR 7305, Mar. 7, 1988, as amended at 57 FR for filing a due diligence petition under
56262, Nov. 27, 1992; 64 FR 400, Jan. 5, 1999] § 60.30 unless FDA receives:
(1) New information from PTO
§ 60.24 Revision of regulatory review records, FDA records, or FDA centers
period determinations. that affects the regulatory review pe-
(a) Any person may request a revi- riod determination;
sion of the regulatory review period de- (2) A request under § 60.24 for revision
termination within 60 days after its of the regulatory review period deter-
initial publication in the FEDERAL mination;
REGISTER. The request shall be sent to (3) A due diligence petition filed
the Division of Dockets Management under § 60.30; or
(HFA–305), Food and Drug Administra- (4) A request for a hearing filed under
tion, 5630 Fishers Lane, rm. 1061, Rock- § 60.40.
ville, MD 20852. The request shall speci- (b) FDA will notify PTO that the reg-
fy the following: ulatory review period determination is
(1) The type of action requested; final upon:
(2) The identity of the product; (1) The expiration of the 180-day pe-
(3) The identity of the applicant; riod for filing a due diligence petition;
(4) The FDA docket number; and or
(5) The basis for the request for revi- (2) If FDA has received a request for
sion, including any documentary evi- a revision, a due diligence petition, or
dence. a request for a hearing, upon resolution
(b) Unless the applicant is the person of the request for a revision, the peti-
requesting the revision, the applicant tion, or the hearing, whichever is later.
shall respond to the request within 15 FDA will send a copy of the notifica-
tion to the applicant and file a copy of
days. In responding to the request, the
the notification in the docket estab-
applicant may submit information
lished for the application in FDA’s Di-
which is relevant to the events during
vision of Dockets Management (HFA–
the regulatory review period but which
305), 5630 Fishers Lane, rm. 1061, Rock-
was not included in the original patent
ville, MD 20852.
term restoration application. A request
for a revision is not equivalent to a due [53 FR 7305, Mar. 7, 1988, as amended at 59 FR
diligence petition under § 60.30 or a re- 14364, Mar. 28, 1994]
quest for a hearing under § 60.40. If no
response is submitted, FDA will decide § 60.28 Time frame for determining
the matter on the basis of the informa- regulatory review periods.
tion in the patent term restoration ap- (a) FDA will determine the regu-
plication, request for revision, and latory review period for a product
FDA records. within 30 days of the receipt of a writ-
(c) FDA shall apply the provisions of ten request from PTO for such a deter-
§ 60.22 in considering the request for a mination and a copy of the patent term
revision of the regulatory review pe- restoration application.
riod determination. lf FDA revises its (b) FDA may extend the 30-day period
prior determination, FDA will notify if:
PTO of the revision, send a copy of this (1) A related FDA action that may af-
notification to the applicant, and pub- fect the regulatory review period deter-
lish the revision in the FEDERAL REG- mination is pending; or

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Food and Drug Administration, HHS § 60.34

(2) PTO requests that FDA tempo- § 60.32 Applicant response to petition.
rarily suspend the determination proc-
(a) The applicant shall file with FDA
ess; or
a written response to the petition no
(3) PTO or FDA receives new infor-
later than 30 days after the applicant’s
mation about the product that war-
receipt of a copy of the petition.
rants an extension of the time required
for the determination of the regulatory (b) The applicant’s response may
review period. present additional facts and cir-
(c) This section does not apply to ap- cumstances to address the assertions in
plications withdrawn by the applicant the petition, but shall be limited to the
or applications that PTO determines issue of whether the applicant acted
are ineligible for patent term restora- with due diligence during the regu-
tion. latory review period. The applicant’s
response may include documents that
were not in the original patent exten-
Subpart D—Due Diligence sion application.
Petitions (c) If the applicant does not respond
§ 60.30 Filing, format, and content of to the petition, FDA will decide the
petitions. matter on the basis of the information
submitted in the patent term restora-
(a) Any person may file a petition tion application, due diligence peti-
with FDA, no later than 180 days after tion, and FDA records.
the publication of a regulatory review
period determination under § 60.20, that § 60.34 FDA action on petitions.
challenges FDA’s determination by al-
leging that the applicant for patent (a) Within 90 days after FDA receives
term restoration did not act with due a petition filed under § 60.30(a), the
diligence in seeking FDA approval of agency will either deny the petition
the product during the regulatory re- under paragraph (b) or (c) of this sec-
view period. tion or investigate and determine
(b) The petition shall be filed in ac- under § 60.36 whether the applicant
cordance with § 10.20, under the docket acted with due diligence during the
number of the FEDERAL REGISTER no- regulatory review period. FDA will
tice of the agency’s regulatory review publish its due diligence determination
period determination, and shall be in in the FEDERAL REGISTER, notify PTO
the format specified in § 10.30. The peti- of the due diligence determination in
tion shall contain the information writing, and send copies of the notice
specified in § 10.30 and any additional to PTO, the applicant, and the peti-
information required by this subpart. If tioner.
any provision of § 10.20 or § 10.30 is in- (b) FDA may deny a due diligence pe-
consistent with any provision of this tition without considering the merits
part, FDA will consider the petition in of the petition if:
accordance with this part. (1) The petition is not filed in accord-
(c) The petition shall claim that the ance with § 60.30;
applicant did not act with due dili- (2) The petition is not filed in accord-
gence during some part of the regu- ance with § 10.20;
latory review period and shall set forth (3) The petition does not contain the
sufficient facts, including dates if pos- information required by § 10.30;
sible, to merit an investigation by FDA (4) The petition fails to contain infor-
of whether the applicant acted with mation or allegations upon which it
due diligence. may reasonably be determined that the
(d) The petition shall contain a cer- applicant did not act with due dili-
tification that the petitioner has gence during the applicable regulatory
served a true and complete copy of the review period; or
petition upon the applicant by certified (5) The petition fails to allege a suffi-
or registered mail (return receipt re- cient total amount of time during
quested) or by personal delivery. which the applicant did not exercise
[53 FR 7305, Mar. 7, 1988, as amended at 67 FR due diligence such that, even if the pe-
9585, Mar. 4, 2002] tition were granted, the petition would

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§ 60.36 21 CFR Ch. I (4–1–11 Edition)

not affect the maximum patent exten- mail (return receipt requested) or by
sion the applicant sought in the appli- personal delivery.
cation. (c) The request shall state whether
the requesting party seeks a hearing
§ 60.36 Standard of due diligence. within 30 days or 60 days of FDA’s re-
(a) In determining the due diligence ceipt of the request.
of an applicant, FDA will examine the
[53 FR 7305, Mar. 7, 1988, as amended at 67 FR
facts and circumstances of the appli- 9585, Mar. 4, 2002]
cant’s actions during the regulatory re-
view period to determine whether the § 60.42 Notice of hearing.
applicant exhibited that degree of at-
tention, continuous directed effort, and Ten days before the hearing, FDA
timeliness as may reasonably be ex- will notify the requesting party, the
pected from, and are ordinarily exer- applicant, and the petitioner, orally or
cised by, a person during a regulatory in writing, of the date, time, and loca-
review period. FDA will take into con- tion of the hearing. The agency will
sideration all relevant factors, such as provide the requesting party, the appli-
the amount of time between the ap- cant, and the petitioner with an oppor-
proval of an investigational exemption tunity to participate as a party in the
or research permit and the commence- hearing.
ment of a clinical investigation and
§ 60.44 Hearing procedures.
the amount of time required to conduct
a clinical investigation. The due diligence hearing shall be
(b) For purposes of this part, the ac- conducted in accordance with this part,
tions of the marketing applicant shall supplemented by the nonconflicting
be imputed to the applicant for patent procedures in part 16. During the due
term restoration. The actions of an diligence hearing, the applicant and
agent, attorney, contractor, employee, the petitioner shall enjoy all the rights
licensee, or predecessor in interest of and privileges accorded a person re-
the marketing applicant or applicant questing a hearing under part 16. The
for patent term restoration shall be standard of due diligence set forth in
imputed to the applicant for patent § 60.36 will apply in the due diligence
term restoration. hearing. The party requesting the due
diligence hearing shall have the burden
Subpart E—Due Diligence of proof at the hearing.
Hearings § 60.46 Administrative decision.
§ 60.40 Request for hearing. Within 30 days after the completion
(a) Any person may request, not later of the due diligence hearing, the Com-
than 60 days after the publication missioner will affirm or revise the de-
under § 60.34(a) of FDA’s due diligence termination made under § 60.34(a) and
determination, that FDA conduct an will publish the due diligence redeter-
informal hearing on the due diligence mination in the FEDERAL REGISTER, no-
determination. tify PTO of the redetermination, and
(b) The request for a hearing under send copies of the notice to PTO and to
this section shall: the requesting party, the applicant,
(1) Be sent by mail, personal delivery, and the petitioner.
or any other mode of written commu-
nication to the Division of Dockets PART 70—COLOR ADDITIVES
Management and filed under the rel-
evant product file; Subpart A—General Provisions
(2) Specify the facts and the action
that are the subject of the hearing; Sec.
70.3 Definitions.
(3) Provide the name and address of
70.5 General restrictions on use of color ad-
the person requesting the hearing; and ditives.
(4) Certify that the requesting party 70.10 Color additives in standardized foods
has served a true and complete copy of and new drugs.
the request upon the petitioner and the 70.11 Related substances.
applicant by certified or registered 70.19 Fees for listing.

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Food and Drug Administration, HHS § 70.3

Subpart B—Packaging and Labeling less the customary or reasonably fore-


seeable handling or use of the con-
70.20 Packaging requirements for straight
colors (other than hair dyes).
tainer may reasonably be expected to
70.25 Labeling requirements for color addi- result in the transmittal of the color to
tives (other than hair dyes). the contents of the package or any part
thereof. Food ingredients such as cher-
Subpart C—Safety Evaluation ries, green or red peppers, chocolate,
and orange juice which contribute
70.40 Safety factors to be considered.
70.42 Criteria for evaluating the safety of their own natural color when mixed
color additives. with other foods are not regarded as
70.45 Allocation of color additives. color additives; but where a food sub-
70.50 Application of the cancer clause of stance such as beet juice is delib-
section 721 of the act. erately used as a color, as in pink lem-
70.51 Advisory committee on the applica- onade, it is a color additive. Food ingre-
tion of the anticancer clause.
dients as authorized by a definitions
70.55 Request for scientific studies.
and standard of identity prescribed by
AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, regulations pursuant to section 401 of
351, 360b, 361, 371, 379e. the act are color additives, where the in-
SOURCE: 42 FR 15636, Mar. 22, 1977, unless gredients are specifically designated in
otherwise noted. the definitions and standards of iden-
tity as permitted for use for coloring
Subpart A—General Provisions purposes. An ingredient of an animal
feed whose intended function is to im-
§ 70.3 Definitions. part, through the biological processes
(a) Secretary means the Secretary of of the animal, a color to the meat,
Health and Human Services. milk, or eggs of the animal is a color
(b) Department means the Department additive and is not exempt from the re-
of Health and Human Services. quirements of the statute. This defini-
(c) Commissioner means the Commis- tion shall apply whether or not such
sioner of Food and Drugs. ingredient has nutritive or other func-
(d) Act means the Federal Food, tions in addition to the property of im-
Drug, and Cosmetic Act as amended. parting color. An ingested drug the in-
(e) Color Certification Branch means tended function of which is to impart
the unit established within the Food color to the human body is a color addi-
and Drug Administration located in tive. For the purposes of this part, the
the Center for Food Safety and Applied term color includes black, white, and
Nutrition, charged with the responsi- intermediate grays, but substances in-
bility for the mechanics of the certifi- cluding migrants from packaging ma-
cation procedure hereinafter described, terials which do not contribute any
and including the examination of sam- color apparent to the naked eye are not
ples of color additives subject to cer- color additives.
tification. (g) For a material otherwise meeting
(f) A color additive is any material, the definition of color additive to be ex-
not exempted under section 201(t) of empt from section 721 of the act, on the
the act, that is a dye, pigment, or basis that it is used (or intended to be
other substance made by a process of used) solely for a purpose or purposes
synthesis or similar artifice, or ex- other than coloring, the material must
tracted, isolated, or otherwise derived, be used in a way that any color im-
with or without intermediate or final parted is clearly unimportant insofar
change of identity, from a vegetable, as the appearance, value, market-
animal, mineral, or other source and ability, or consumer acceptability is
that, when added or applied to a food, concerned. (It is not enough to warrant
drug, or cosmetic or to the human body exemption if conditions are such that
or any part thereof, is capable (alone or the primary purpose of the material is
through reaction with another sub- other than to impart color.)
stance) of imparting a color thereto. (h) The exemption that applies to a
Substances capable of imparting a pesticide chemical, soil or plant nutri-
color to a container for foods, drugs, or ent, or other agricultural chemical,
cosmetics are not color additives un- where its coloring effect results solely

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§ 70.3 21 CFR Ch. I (4–1–11 Edition)

from its aiding, retarding, or otherwise pose of obtaining certification of such


affecting directly or indirectly, the quantity.
growth or other natural physiological (q) The term batch number means the
processes of produce of the soil, applies number assigned to a batch by the per-
only to color developed in such product son who requests certification thereof.
through natural physiological proc- (r) The term lot number means an
esses such as enzymatic action. If the identifying number or symbol assigned
pesticide chemical, soil or plant nutri- to a batch by the Food and Drug Ad-
ent, or other agricultural chemical ministration.
itself acts as a color or carries as an in-
(s) The term area of the eye means the
gredient a color, and because of this
area enclosed with in the circum-
property colors the produce of the soil,
ference of the supra-orbital ridge and
it is a color additive and is not exempt.
(i) Safe means that there is con- the infra-orbital ridge, including the
vincing evidence that establishes with eyebrow, the skin below the eyebrow,
reasonable certainty that no harm will the eyelids and the eyelashes, and con-
result from the intended use of the junctival sac of the eye, the eyeball,
color additive. and the soft areolar tissue that lies
(j) The term straight color means a within the perimeter of the infra-or-
color additive listed in parts 73, 74, and bital ridge.
81 of this chapter, and includes lakes (t) The term package means the im-
and such substances as are permitted mediate container in which a color ad-
by the specifications for such color. ditive or color additive mixture has
(k) The term mixture means a color been packed for shipment or delivery.
additive made by mixing two or more If the package is then packed in a ship-
straight colors, or one or more straight ping carton or other protective con-
colors and one or more diluents. tainer, such container shall not be con-
(l) The term lake means a straight sidered to be the immediate container.
color extended on a substratum by ad- In the case of color additive mixtures
sorption, coprecipitation, or chemical for household use containing less than
combination that does not include any 15 percent pure color, when two or
combination of ingredients made by more containers of 3 ounces each or
simple mixing process. less, each containing a different color,
(m) The term diluent means any com- are distributed as a unit, the imme-
ponent of a color additive mixture that diate container for such unit shall be
is not of itself a color additive and has considered to be the package as defined
been intentionally mixed therein to fa- in this section.
cilitate the use of the mixture in color-
(u) The hair dye exemption in section
ing foods, drugs, or cosmetics or in
601(a) of the act applies to coal tar hair
coloring the human body. The diluent
dyes intended for use in altering the
may serve another functional purpose
in the foods, drugs, or cosmetics, as for color of the hair and which are, or
example sweetening, flavoring, which bear or contain, color additives
emulsifying, or stabilizing, or may be a derived from coal tar with the sen-
functional component of an article in- sitization potential of causing skin ir-
tended for coloring the human body. ritation in certain individuals and pos-
(n) The term substratum means the sible blindness when used for dyeing
substance on which the pure color in a the eyelashes or eyebrows. The exemp-
lake is extended. tion is permitted with the condition
(o) The term pure color means the that the label of any such article bear
color contained in a color additive, ex- conspicuously the statutory caution
clusive of any intermediate or other and adequate directions for prelimi-
component, or of any diluent or sub- nary patch-testing. The exemption
stratum contained therein. does not apply to coloring ingredients
(p) The term batch means a homo- in hair dyes not derived from coal tar,
geneous lot of color additive or color and it does not extend to poisonous or
additive mixture produced by an iden- deleterious diluents that may be intro-
tified production operation, which is duced as wetting agents, hair condi-
set apart and held as a unit for the pur- tions, emulsifiers, or other components

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Food and Drug Administration, HHS § 70.10

in a color shampoo, rinse, tint, or simi- color additive does not provide for such
lar dual-purpose cosmetic that alter use, shall be considered to be a color
the color of the hair. additive not listed under parts 73, 74,
(v) The terms externally applied drugs and 81 of this chapter, even though
and externally applied cosmetics mean such color additive is certified and/or
drugs or cosmetics applied only to ex- listed for other uses.
ternal parts of the body and not to the
lips or any body surface covered by mu- § 70.10 Color additives in standardized
cous membrane. foods and new drugs.
[42 FR 15636, Mar. 22, 1977, as amended at 61 (a) Standardized foods. (1) Where a pe-
FR 14478, Apr. 2, 1996] tition is received for issuance or
amendment of a regulation estab-
§ 70.5 General restrictions on use of lishing a definition and standard of
color additives.
identity for a food under section 401 of
(a) Color additives for use in the area of the act, which proposes the inclusion of
the eye. No listing or certification of a a color additive in the standardized
color additive shall be considered to food, the provisions of the regulations
authorize the use of any such color ad- in part 71 of this chapter shall apply
ditive in any article intended for use in with respect to the information that
the area of the eye unless such listing must be submitted with respect to the
or certification of such color additive safety of the color additive (if such in-
specifically provides for such use. Any formation has not previously been sub-
color additive used in or on any article mitted and safety of the color additive
intended for use in the area of the eye, for the intended use has not been al-
the listing or certification of which ready established), and the petition
color additive does not provide for such must show also that the use of the
use, shall be considered to be a color color additive in the standardized food
additive not listed under parts 73, 74, would be in conformance with section
and 81 of this chapter, even though 401 of the act or with the terms of a
such color additive is certified and/or temporary permit issued under § 130.17
listed for other uses. of this chapter.
(b) Color additives for use in injections.
(2) If a petition for a definition and
No listing or certification of a color ad-
standard of identity contains a pro-
ditive shall be considered to authorize
the use of any such color additive in posal for a color additive regulation,
any article intended for use in injec- and the petitioner fails to designate it
tions unless such listing or certifi- as such, the Commissioner, upon deter-
cation of such color additive specifi- mining that the petition includes a
cally provides for such use. Any color proposal for a color additive regula-
additive used in or on any article in- tion, shall so notify the petitioner and
tended for use in injections, the listing shall thereafter proceed in accordance
or certification of which color additive with the regulations in part 71 of this
does not provide for such use, shall be chapter.
considered to be a color additive not (3) A regulation will not be issued al-
listed under parts 73, 74, and 81 of this lowing the use of a color additive in a
chapter, even though such color addi- food for which a definition and stand-
tive is certified and/or listed for other ard of identity is established, unless its
uses. issuance is in conformance with sec-
(c) Color additives for use in surgical tion 401 of the act or with the terms of
sutures. No listing or certification of a a temporary permit issued under
color additive shall be considered to § 130.17 of this chapter. When the con-
authorize the use of any such color ad- templated use of such additive com-
ditive in any article intended for use as plies with the terms of a temporary
a surgical suture unless such listing or permit, the color additive regulation
certification of such color additive spe- will be conditioned on such compliance
cifically provides for such use. Any and will expire with the expiration of
color additive used in or on any article the temporary permit.
intended for use as a surgical suture, (b) New drugs. (1) Where an applica-
the listing or certification of which tion for a new drug is received and this

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§ 70.11 21 CFR Ch. I (4–1–11 Edition)

application proposes, for coloring pur- cholinesterase inhibition) produced by


poses only, the inclusion of a color ad- such substance.
ditive, the provisions of the regulations
in part 71 of this chapter shall apply § 70.19 Fees for listing.
with respect to the information that (a) Each petition for the listing of a
must be submitted about the safety of color additive shall be accompanied by
the color additive, if such information a deposit of $3,000.00 if the proposal is
has not previously been submitted and for listing the color additive for use
safety of the color additive for the in- generally in or on foods, in or on drugs,
tended use has not already been estab- and in or on cosmetics.
lished. (b) If the petition for the listing is for
(2) If an application for a new drug use in or on foods only, the deposit
inferentially contains a proposal for a shall be $3,000.00.
color additive regulation, and the ap- (c) If the petition for the listing is for
plicant fails to designate it as such, the use in or on drugs and/or cosmetics
Commissioner, upon determining that only, the deposit shall be $2,600.00.
the application includes a proposal for (d) The provisions of paragraphs (a),
a color additive regulation, shall so no- (b), and (c) of this section shall be ap-
tify the applicant and shall thereafter plicable, whether or not the proposal
proceed in accordance with the regula- contemplates any tolerances, limita-
tions in part 71 of this chapter. tions, or other restrictions placed upon
(3) Where a petition for a color addi- the use of the color additive.
tive must be filed in accordance with (e) If a petition proposing the
paragraph (b)(2) of this section, the issuance of a regulation is withdrawn
date of filing of the color additive peti- before it is finally accepted for filing,
tion shall be considered as the date of the deposit, less a $600.00 fee for cler-
filing of the new-drug application. ical handling and administrative and
[42 FR 15636, Mar. 22, 1977, as amended at 64 technical review, shall be returned to
FR 400, Jan. 5, 1999] the petitioner.
(f) If a petition proposing the
§ 70.11 Related substances. issuance of a regulation is withdrawn
(a) Different color additives may within 30 days after filing, the deposit,
cause similar or related pharma- less $1,800.00 if the petition is covered
cological or biological effects, and, in by paragraph (a) or (b) of this section,
the absence of evidence to the con- and less $1,600.00, if the petition is cov-
trary, those that do so will be consid- ered by paragraph (c) of this section,
ered to have additive toxic effects. shall be returned to the petitioner.
(b) Food additives may also cause (g) When a petition is withdrawn
pharmacological or biological effects after filing and resubmitted within 6
similar or related to such effects months, it shall be accompanied by a
caused by color additives, and, in the deposit of $1,800.00 for a petition filed
absence of evidence to the contrary, under paragraph (a) or (b) of this sec-
those that do so will be considered as tion, and $1,600.00 for a petition filed
having additive toxic effects. under paragraph (c) of this section. If a
(c) Pesticide chemicals may also petition is resubmitted after 6 months,
cause pharmacological or biological ef- it shall be accompanied by the deposit
fects similar or related to such effects that would be required if it were being
caused by color additives, and, in the submitted for the first time.
absence of evidence to the contrary, (h) When the resubmission pertains
those that do so will be considered to to a petition that had been withdrawn
have additive toxic effects. before acceptance for filing, a new ad-
(d) In establishing tolerances for vance deposit shall be made in full as
color additives, the Commissioner will prescribed in paragraph (a), (b), or (c)
take into consideration, among other of this section.
things, the amount of any common (i) After a color additive has been
component permitted in other color ad- listed, any request for an amendment
ditives, in food additives, and in pes- or additional tolerance shall be accom-
ticide chemical residues as well as the panied by a deposit of $1,800.00 for use
similar biological activity (such as in the items specified in paragraphs (a)

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Food and Drug Administration, HHS § 70.25

and (b) of this section, or $1,600.00 for Food and Drug Administration, collect-
use in items specified in paragraph (c) able at par at Washington, DC All de-
of this section. posits and fees shall be forwarded to
(j) The fee for services in listing a the Center for Food Safety and Applied
diluent under § 80.35 for use in color ad- Nutrition (HFS–200), Food and Drug
ditive mixtures shall be $250.00. Administration, 5100 Paint Branch
(k) Objections and request for public Pkwy., College Park, MD 20740, where-
hearing under section 721(d) of the act upon after making appropriate record
or section 203(d)(2)(C) of Pub. L. 86–618 thereof they will be transmitted to the
(74 Stat. 404; 21 U.S.C. 379e, note) shall Treasurer of the United States for de-
be accompanied by a filing fee of posit in the special account ‘‘Salaries
$250.00. and Expenses, Certification, Inspec-
(l) In the event of a referral of a peti- tion, and Other Services, Food and
tion under this section to an advisory Drug Administration.’’
committee, all costs related thereto (q) The Commissioner of Food and
(including personal compensation of Drugs may waive or refund such fees in
committee members, travel materials, whole or in part when in his judgment
and other costs) shall be borne by the such action will promote the public in-
person or organization requesting the terest.
referral, such costs to be assessed on (r) Any person who believes that pay-
the basis of actual cost to the Govern- ment of these fees will work a hardship
ment: Provided, That the compensation on him may petition the Commissioner
of such costs shall include personal of Food and Drugs to waive or refund
compensation of advisory committee the fees.
members at a rate not to exceed $75.00 [42 FR 15636, Mar. 22, 1977, as amended at 54
per member per day. FR 24890, June 12, 1989; 61 FR 14478, Apr. 2,
(m) In the case of requests of refer- 1996; 66 FR 56035, Nov. 6, 2001]
rals to advisory committees, a special
advance deposit shall be made in the Subpart B—Packaging and
amount of $2,500.00. Where required, Labeling
further advance in increments of
$2,500.00 each shall be made upon re- § 70.20 Packaging requirements for
quest of the Commissioner of Food and straight colors (other than hair
Drugs. All deposits for referrals to ad- dyes).
visory committees in excess of actual Straight colors shall be packaged in
expenses shall be refunded to the de- containers which prevent changes in
positor. composition. Packages shall be sealed
(n) All requests for pharmacological so that they cannot be opened without
or other scientific studies shall be ac- breaking the seal. An unavoidable
companied by an advance deposit of change in moisture content caused by
$5,000.00. Further advance deposits the ordinary and customary exposure
shall be made upon request of the Com- that occurs in good storage, packing,
missioner of Food and Drugs when nec- and distribution practice is not consid-
essary to prevent arrears in such cost. ered a change in composition. If the
Any deposits in excess of actual ex- packaging material is a food additive it
penses will be refunded to the deposi- shall be authorized by an appropriate
tor. If a request is denied the advance regulation in parts 170 through 189 of
deposit will be refunded less such costs this chapter.
as are incurred for review of the re-
quest. § 70.25 Labeling requirements for
(o) The person who files a petition for color additives (other than hair
judicial review of an order under sec- dyes).
tion 721(d) of the act shall pay the (a) General labeling requirements. All
costs of preparing a transcript of the color additives shall be labeled with
record on which the order is based. sufficient information to assure their
(p) All deposits and fees required by safe use and to allow a determination
the regulations in this section shall be of compliance with any limitations im-
paid by money order, bank draft or cer- posed by this part and parts 71, 73, 74,
tified check drawn to the order of the 80, and 81 of this chapter. In addition to

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§ 70.40 21 CFR Ch. I (4–1–11 Edition)

all other information required by the Subpart C—Safety Evaluation


act, labels for color additives, except
those in a form suitable for coloring § 70.40 Safety factors to be considered.
the human body, shall state: In accordance with section
(1) The name of the straight color or 721(b)(5)(A)(iii) of the act, the following
the name of each ingredient com- safety factor will be applied in deter-
prising the color additive, if it is a mining whether the proposed use of a
mixture. color additive will be safe: Except
(2) A statement indicating general where evidence is submitted which jus-
limitations for the use of the color ad- tifies use of a different safety factor, a
ditive, such as ‘‘for food use only’’; ‘‘for safety factor of 100 to 1 will be used in
food, drug, and cosmetic use’’; ‘‘for use applying animal experimentation data
in drugs for external application only.’’ to man; that is, a color additive for use
(3) Where regulations issued impose by man will not be granted a tolerance
quantitative limitations for a general that will exceed 1/100th of the max-
or specific use of a straight color, the imum no-effect level for the most sus-
amount of each such straight color in ceptible experimental animals tested.
terms of weight per unit/volume or per- The various species of experimental
cent by weight. animals used in the tests shall conform
(4) An expiration date if stability to good pharmacological practice.
data require it.
(b) Special labeling for color additives § 70.42 Criteria for evaluating the safe-
with tolerances. Where tolerances are ty of color additives.
imposed for a general or specific use of (a) In deciding whether a petition is
a color additive, the label shall in addi- complete and suitable for filing and in
tion provide directions for use of the reaching a decision on any petition
color additive which if followed will filed, the Commissioner will apply the
preclude the food, drug, or cosmetic to ‘‘safe-for-use’’ principle. This will re-
which it is added from containing an quire the presentation of all needed
amount of the color additive in excess scientific data in support of a proposed
of the tolerance. listing to assure that each listed color
(c) Special labeling for color additives additive will be safe for its intended
with other limitations. If use of the color use or uses in or on food, drugs, or cos-
additive is subject to other limitations metics. The Commissioner may list a
prescribed in this part, such limita- color additive for use generally in or on
tions shall be stated on the label of the food, in or on drugs, or in or on cos-
color additive by a plain and con- metics when he finds from the data
spicuous statement. Examples of such presented that such additive is suitable
limitation statements are: ‘‘Do not use and may safely be employed for such
in products used in the area of the eye’’; general use; he may list an additive
‘‘Do not use for coloring drugs for injec- only for more limited use or uses for
tion.’’ which it is proven suitable and may
(d) Special labeling for color additives safely be employed; and he is author-
not exempt from certification. Color addi- ized to prescribe broadly the conditions
tives not exempt from the certification under which the additive may be safely
procedures shall in addition include in employed for such use or uses. This
the labeling the lot number assigned by may allow the use of a particular dye,
the Color Certification Branch, except pigment, or other substance with cer-
that in the case of any mixture for tain diluents, but not with others, or at
household use which contains not more a higher concentration with some than
than 15 percent of pure color and which with others.
is in packages containing not more (b) The safety for external color addi-
than 3 ounces there appears on the tives will normally be determined by
label, a code number which the manu- tests for acute oral toxicity, primary
facturer has identified with the lot irritation, sensitization, subacute der-
number by giving to the Food and Drug mal toxicity on intact and abraded
Administration written notice that skin, and carcinogenicity by skin ap-
such code number will be used in lieu plication. The Commissioner may
of the lot number. waive any of such tests if data before

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Food and Drug Administration, HHS § 70.50

him otherwise establish that such test whether the color additive, including
is not required to determine safety for its components or impurities, was the
the use proposed. causative substance. If it is his judg-
(c) Upon written request describing ment that the data do not establish
the proposed use of a color additive and these facts, the cancer clause is not ap-
the proposed experiments to determine plicable; and if the data considered as a
its safety, the Commissioner will ad- whole establish that the color additive
vise a person who wishes to establish will be safe under the conditions that
the safety of a color additive whether can be specified in the applicable regu-
he believes the experiments planned lation, it may be listed for such use.
will yield data adequate for an evalua- But if in the judgment of the Commis-
tion of the safety of the additive. sioner, based on information from
§ 70.45 Allocation of color additives. qualified scientists, cancer has been in-
duced, no regulation may issue which
Whenever, in the consideration of a
permits its use.
petition or a proposal to list a color ad-
(b) Color additives that will not be in-
ditive or to alter an existing listing,
the data before the Commissioner fail gested. Whenever the scientific data be-
to show that it would be safe to list the fore the Commissioner suggest the pos-
color additive for all the uses proposed sibility that the color additive, includ-
or at the levels proposed, the Commis- ing its components or impurities, has
sioner will notify the petitioner and induced cancer in man or animals by
other interested persons by publication routes other than ingestion, the Com-
in the FEDERAL REGISTER that it is nec- missioner shall determine whether,
essary to allocate the safe tolerance for based on the judgment of appropriately
the straight color in the color additive qualified scientists, the test suggesting
among the competing needs. This no- the possibility of carcinogenesis is ap-
tice shall call for the presentation of propriate for the evaluation of the
data by all interested persons on which color additive for a use which does not
the allocation can be made in accord- involve ingestion, cancer has been in-
ance with section 721(b)(8) of the act. duced, and the color additive, including
The time for acting upon the petition its components or impurities, was the
shall be stayed until such data are pre- causative substance. If it is his judg-
sented, whereupon the time limits ment that the data do not establish
shall begin to run anew. As promptly these facts, the cancer clause is not ap-
as possible after presentation of the plicable to preclude external drug and
data, the Commissioner will, by order, cosmetic uses, and if the data as a
announce the allocation and the toler- whole establish that the color additive
ance limitations. will be safe under conditions that can
be specified in the regulations, it may
§ 70.50 Application of the cancer
clause of section 721 of the act. be listed for such use. But if, in the
judgment of the Commissioner, based
(a) Color additives that may be ingested.
on information from qualified sci-
Whenever (1) the scientific data before
entists, the test is an appropriate one
the Commissioner (either the reports
for the consideration of safety for the
from the scientific literature or the re-
proposed external use, and cancer has
sults of biological testing) suggest the
possibility that the color additive in- been induced by the color additive, in-
cluding its components or impurities cluding its components or impurities,
has induced cancer when ingested by no regulation may issue which permits
man or animal; or (2) tests which are its use in external drugs and cosmetics.
appropriate for the evaluation of the (c) Color additives for use as an ingre-
safety of additives in food suggest that dient of feed for animals that are raised
the color additive, including its compo- for food production. Color additives that
nents or impurities, induces cancer in are an ingredient of the feed for ani-
man or animal, the Commissioner shall mals raised for food production and
determine whether, based on the judg- that have the potential to contaminate
ment of appropriately qualified sci- human food with residues whose con-
entists, cancer has been induced and sumption could present a risk of cancer

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§ 70.51 21 CFR Ch. I (4–1–11 Edition)

to people must satisfy the require- 71.26 Revocation of exemption from certifi-
ments of subpart E of part 500 of this cation.
chapter. 71.27 Listing and exemption from certifi-
cation on the Commissioner’s initiative.
[42 FR 15636, Mar. 22, 1977, as amended at 43 71.30 Procedure for filing objections to regu-
FR 22675, May 26, 1978; 52 FR 49586, Dec. 31, lations.
1987] 71.37 Exemption of color additives for inves-
tigational use.
§ 70.51 Advisory committee on the ap- AUTHORITY: 21 U.S.C. 321, 342, 348, 351, 355,
plicability of the anticancer clause. 360, 360b–360f, 360h–360j, 361, 371, 379e, 381; 42
All requests for and procedures gov- U.S.C. 216, 262.
erning any advisory committee on the SOURCE: 42 FR 15639, Mar. 22, 1977, unless
anticancer clause shall be subject to otherwise noted.
the provisions of part 14 of this chap-
ter, and particularly subpart H of that Subpart A—General Provisions
part.
§ 71.1 Petitions.
§ 70.55 Request for scientific studies.
(a) Any interested person may pro-
The Commissioner will consider re- pose the listing of a color additive for
quests by any interested person who use in or on any food, drug, or cosmetic
desires the Food and Drug Administra- or for coloring the human body. Such
tion to conduct scientific studies to proposal shall be made in a petition in
support a petition for a regulation for the form prescribed in paragraph (c) of
a color additive. If favorably acted this section. The petition shall be sub-
upon, such studies will be limited to mitted in triplicate (quadruplicate, if
pharmacological investigations, stud- intended uses include uses in meat,
ies of the chemical and physical struc- meat food product, or poultry product).
ture of the color additive, and methods If any part of the material submitted is
of analysis of the pure color additive in a foreign language, it shall be ac-
(including impurities) and its identi- companied by an accurate and com-
fication and determination in foods, plete English translation. The peti-
drugs, or cosmetics, as the case may tioner shall state the post-office ad-
be. All requests for such studies shall dress in the United States to which
be accompanied by the fee prescribed published notices or orders issued or
in § 70.19. objections filed pursuant to section 721
of the act may be sent.
PART 71—COLOR ADDITIVE (b) Pertinent information may be in-
PETITIONS corporated in, and will be considered as
part of, a petition on the basis of spe-
Subpart A—General Provisions cific reference to such information sub-
mitted to and retained in the files of
Sec. the Food and Drug Administration.
71.1 Petitions. However, any reference to unpublished
71.2 Notice of filing of petition. information furnished by a person
71.4 Samples; additional information.
other than the applicant will not be
71.6 Extension of time for studying peti-
tions; substantive amendments; with- considered unless use of such informa-
drawal of petitions without prejudice. tion is authorized in a written state-
71.15 Confidentiality of data and informa- ment signed by the person who sub-
tion in color additive petitions. mitted the information. Any reference
71.18 Petition for exemption from certifi- to published information offered in
cation. support of a color additive petition
should be accompanied by reprints or
Subpart B—Administrative Action on photostatic copies of such references.
Petitions (c) Petitions shall include the fol-
71.20 Publication of regulation. lowing data and be submitted in the
71.22 Deception as a basis for refusing to following form:
issue regulations; deceptive use of a color
lllllllll (Date)
additive for which a regulation has
issued. Name of petitioner lllllllllllll
71.25 Condition for certification. Post-office address lllllllllllll

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Food and Drug Administration, HHS § 71.1
Name of color additive and proposed use ll Reasonable alternatives for any listed sub-
stance may be specified.
Office of Food Additive Safety (HFS–200),
Center for Food Safety and Applied Nutri- If the petitioner does not himself perform
tion, all the manufacturing, processing, and pack-
Food and Drug Administration, ing operations for a color additive, the peti-
5100 Paint Branch Pkwy., tioner shall identify each person who will
College Park, MD 20740 perform a part of such operations and des-
Dear Sir: ignate the part.
Petitioner submits this pursuant to sec- The petition shall include stability data,
tion 721(b)(1) of the Federal Food, Drug, and and, if the data indicate that it is needed to
Cosmetic Act requesting listing by the Com- insure the identity, strength, quality, or pu-
missioner of the color additive lllll as rity of the color additive, the expiration pe-
suitable and safe for use in or on lllll riod that will be employed as well as any
subject to the conditions that lllllll. packaging and labeling precautions needed
[Petitioner may propose a listing for general to preserve stability.
use in food, drugs, or cosmetics or, if such B. The amount of the color additive pro-
general listing is not believed suitable and posed for use and the color effect intended to
safe, the petitioner shall describe the condi- be achieved, together with all directions,
tions under which he believes the additive recommendations, and suggestions regarding
can be safely used and for which it will be the proposed use, as well as specimens of the
suitable. These conditions may include toler- labeling proposed for the color additive. If
ance limitations, specifications as to the the color effect results or may reasonably be
manner in which the additive may be added expected to result from use of the color addi-
or used, and directions and other labeling or tive in packaging material, the petitioner
packaging safeguards that should be applied. shall show how this may occur and what res-
The level of use proposed should not be high- idues may reasonably be anticipated.
er than reasonably required to accomplish Typewritten or other draft-labeling copy
the intended color effect.] will be accepted for consideration of the pe-
Attached hereto, in triplicate (quadru- tition provided final printed labeling iden-
plicate, if intended uses include uses in tical in content to the draft copy is sub-
meat, meat food product, or poultry prod- mitted as soon as available, and prior to the
uct), and constituting a part of this petition marketing of the color additive. The printed
are the following: labeling shall conform in prominence and
A. The name and all pertinent information conspicuousness with the requirements of
concerning the color additive, including the act.
chemical identity and composition of the If the color additive is one for which a tol-
color additive, its physical, chemical, and bi- erance limitation is required to assure its
ological properties, and specifications pre- safety, the level of use proposed should be no
scribing its component(s) and identifying higher than the amount reasonably required
and limiting the reaction byproducts and to accomplish the intended physical or other
other impurities. technical effect, even though the safety data
The petition shall contain a description of may support a higher tolerance. If the safety
the chemical and physical tests relied upon data will not support the use of the amount
to identify the color additive and shall con- of the color additive reasonably needed to
tain a full description of the methods used accomplish the desired color effect, the re-
in, and the facilities and controls used for, quested tolerance will not be established. Pe-
the production of the color additive. These titioners are expected to propose the use of
shall establish that it is a substance of re- color additives in accordance with sound
producible composition. Alternative methods color chemistry.
and controls and variations in methods and C.1. A description of practicable methods
controls, within reasonable limits, that do to determine the pure color and all inter-
not affect the characteristics of the sub- mediates, subsidiary colors, and other com-
stance or the reliability of the controls may ponents of the color additive.
be specified. 2. A description of practicable methods to
The petition shall supply a list of all sub- determine the amount of the color additive
stances used in the synthesis, extraction, or in any raw, processed, and/or finished food,
other method of preparation of any straight drug, or cosmetic in which use of the color
color, regardless of whether they undergo additive is proposed. (The tests proposed
chemical change in the process. Each sub- shall be those that can be used for food, drug,
stance should be identified by its common or or cosmetic control purposes and can be ap-
usual name and its complete chemical name, plied with consistent results by any properly
using structural formulas when necessary for equipped laboratory and trained personnel.)
specific identification. If any proprietary 3. A description of methods for identifica-
preparation is used as a component, the pro- tion and determination of any substance
prietary name should be followed by a com- formed in or on such food, drug, or cosmetic
plete quantitive statement of composition. because of the use of the color additive. (If it

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§ 71.1 21 CFR Ch. I (4–1–11 Edition)
is the petitioner’s view that any such meth- mental assessment under § 25.40 of this chap-
od would not be needed, under the terms of ter.
section 721(b)(5)(A)(iv), a statement shall be
submitted in lieu of methods as to the basis (d) The petitioner will be notified of
for such view.) the date on which his petition is filed;
D. Full reports of investigation made with and an incomplete petition, or one that
respect to the safety of the color additive. has not been submitted in triplicate,
(A petition will be regarded as incomplete will be retained but not filed. A peti-
unless it includes full reports of adequate tion shall be retained but shall not be
tests reasonably applicable to show whether filed if any of the data listed in the
or not the color additive will be safe for its above form are lacking or are not set
intended use. The reports ordinarily should
forth so as to be readily understood or
include detailed data derived from appro-
priate animal and other biological experi- if the prescribed fee has not been sub-
ments in which the methods used and the re- mitted. The petitioner will be notified
sults obtained are clearly set forth. The peti- in what respects his petition is incom-
tion shall not omit without explanation any plete.
data that would influence the evaluation of (e) The petition must be signed by
the safety of the color additive). the petitioner or by his attorney or au-
E. Complete data which will allow the thorized agent, who is a resident of the
Commissioner to consider, among other United States.
things, the probable consumption of, and/or
(f) The data specified under the sev-
other relevant exposure from the additive
and of any substance formed in or on food, eral lettered headings should be sub-
drugs, or cosmetics because of such additive; mitted on separate sheets or sets of
and the cumulative effect, if any, of such ad- sheets, suitably identified. If such data
ditive in the diet of man or animals, taking have already been submitted with an
into account the same or any chemically or earlier application, the present peti-
pharmacologically related substance or sub- tion may incorporate it by specific ref-
stances in the diet including, but not limited erence to the earlier petition.
to food additives and pesticide chemicals for
(g) If nonclinical laboratory studies
which tolerances or exemptions from toler-
ances have been established. are involved, petitions filed with the
F. Proposed tolerances and other limita- Commissioner under section 721(b) of
tions on the use of the color additive, if tol- the act shall include with respect to
erances and limitations are required in order each nonclinical study contained in the
to insure its safety. A petitioner may include petition, either a statement that the
a proposed regulation. study was conducted in compliance
G. If exemption from batch certification is with the good laboratory practice regu-
requested, the reasons why it is believed lations set forth in part 58 of this chap-
such certification is not necessary (including
supporting data to establish the safety of the
ter, or, if the study was not conducted
intended use). in compliance with such regulations, a
H. If submitting a petition to alter an ex- brief statement of the reason for the
isting regulation issued pursuant to section noncompliance.
721(b) of the act, full information on each (h) [Reserved]
proposed change that is to be made in the (i) If clinical investigations involving
original regulation must be submitted. The human subjects are involved, petitions
petition may omit statements made in the filed with the Commissioner under sec-
original petition concerning which no tion 721(b) of the act shall include
change is proposed. A supplemental petition
must be submitted for any change beyond
statements regarding each such clin-
the variations provided for in the original ical investigation contained in the pe-
petition and the regulation issued on the tition that it either was conducted in
basis of the original petition. compliance with the requirements for
I. The prescribed fee of $llllll for ad- institutional review set forth in part 56
mitting the color additive to listing is en- of this chapter, or was not subject to
closed (unless there is an advance deposit such requirements in accordance with
adequate to cover the fee). §§ 56.104 or 56.105, and that it was con-
Yours very truly, ducted in compliance with the require-
(Petitioner) lllllllllllllllll ments for informed consent set forth in
By lllllll (Indicate authority) part 50 of this chapter.
J. The petitioner is required to submit ei- (j)(1) If intended uses of the color ad-
ther a claim for categorical exclusion under ditive include uses in meat, meat food
§ 25.30 or 25.32 of this chapter or an environ- product, or poultry product subject to

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Food and Drug Administration, HHS § 71.6

regulation by the U.S. Department of scription of the proposal in general


Agriculture (USDA) under the Poultry terms. A copy of the notice will be
Products Inspection Act (PPIA) (21 mailed to the petitioner when the
U.S.C. 451 et seq.) or the Federal Meat original document is signed.
Inspection Act (FMIA) (21 U.S.C. 601 et [42 FR 15639, Mar. 22, 1977, as amended at 64
seq.), FDA shall, upon filing of the peti- FR 400, Jan. 5, 1999]
tion, forward a copy of the petition or
relevant portions thereof to the Food § 71.4 Samples; additional information.
Safety and Inspection Service, USDA, The Commissioner may request sam-
for simultaneous review under the ples of the color additive, articles used
PPIA and FMIA. as components thereof, or of the food,
(2) FDA will ask USDA to advise drug, or cosmetic in which the color
whether the proposed meat and poultry additive is proposed to be used, or
uses comply with the FMIA and PPIA which comprises the color additive, and
or, if not, whether use of the substance any additional information needed to
would be permitted in products under clarify a submitted method or other as-
USDA jurisdiction under specified con- pect of a petition at any time while a
ditions or restrictions. petition is under consideration. The
[42 FR 15639, Mar. 22, 1977, as amended at 43 Commissioner shall specify in the re-
FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27, quest for a sample of the color addi-
1981; 50 FR 7491, Feb. 22, 1985; 50 FR 16668, tive, or articles used as components
Apr. 26, 1985; 54 FR 24890, June 12, 1989; 61 FR thereof, or of the food, drug, or cos-
14478, Apr. 2, 1996; 62 FR 40598, July 29, 1997; metic in which the color additive is
65 FR 51762, Aug. 25, 2000; 66 FR 56035, Nov. 6, proposed to be used, or which com-
2001]
prises the color additive, a quantity
§ 71.2 Notice of filing of petition. deemed adequate to permit tests of an-
alytical methods to determine quan-
(a) Except where the petition in- tities of the color additive present in
volves a new drug, the Commissioner, products for which it is intended to be
within 15 days after receipt, will notify used or adequate for any study or in-
the petitioner of acceptance or non- vestigation reasonably required with
acceptance of a petition, and if not ac- respect to the safety of the color addi-
cepted the reasons therefor. If accept- tive or the physical or technical effect
ed, the date of the notification letter it produces. The date used for com-
sent to petitioner becomes the date of puting the 90-day limit for the purposes
filing for the purposes of section of section 721(d)(1) of the act shall be
721(d)(1) of the act. If the petitioner de- moved forward 1 day for each day, after
sires, he may supplement a deficient mailing date of the request, taken by
petition after being notified regarding the petitioner to submit the informa-
deficiencies. If the supplementary ma- tion and/or sample. If the information
terial or explanation of the petition is or sample is requested a reasonable
deemed acceptable, petitioner shall be time in advance of the 180 days, but is
notified. The date of such notification not submitted within such 180 days
becomes the date of filing. If the peti- after filing of the petition, the petition
tioner does not wish to supplement or will be considered withdrawn without
explain the petition and requests in prejudice.
writing that it be filed as submitted,
the petition shall be filed and the peti- § 71.6 Extension of time for studying
tioner so notified. The date of such no- petitions; substantive amendments;
tification becomes the date of filing. withdrawal of petitions without
Where the petition involves a new prejudice.
drug, notification to the petitioner will (a) Extension of time for studying peti-
be made in accordance with § 70.10(b)(3) tions. If the Commissioner determines
of this chapter. that additional time is needed to study
(b) The Commissioner will cause to and investigate the petition, he shall
be published in the FEDERAL REGISTER by written notice to the petitioner ex-
within 30 days from the date of filing of tend the 90-day period for not more
such petition a notice of the filing, the than 180 days after the filing of the pe-
name of the petitioner, and a brief de- tition.

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§ 71.15 21 CFR Ch. I (4–1–11 Edition)

(b) Substantive amendments. After a filing. Upon refiling, the time limita-
petition has been filed, the petitioner tion will begin to run anew.
may submit additional information or
[42 FR 15636, Mar. 22, 1977, as amended at 43
data in support thereof. In such cases, FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27,
if the Commissioner determines that 1981; 50 FR 7491, Feb. 22, 1985]
the additional information or data
amounts to a substantive amendment, § 71.15 Confidentiality of data and in-
the petition as amended will be given a formation in color additive peti-
new filing date, and the time limita- tions.
tion will begin to run anew. If nonclin- (a) The following data and informa-
ical laboratory studies are involved, tion in a color additive petition are
additional information and data sub- available for public disclosure, unless
mitted in support of filed petitions extraordinary circumstances are
shall include, with respect to each non- shown, after the notice of filing of the
clinical laboratory study contained in petition is published in the FEDERAL
the petition, either a statement that REGISTER or, if the petition is not
the study was conducted in compliance promptly filed because of deficiencies
with the requirements set forth in part in it, after the petitioner is informed
58 of this chapter, or, if the study was that it will not be filed because of the
not conducted in compliance with such deficiencies involved:
regulations, a brief statement of the
(1) All safety and functionality data
reason for the noncompliance. If clin-
and information submitted with or in-
ical investigations involving human
corporated by reference in the petition.
subjects are involved, additional infor-
(2) A protocol for a test or study, un-
mation or data submitted in support of
less it is shown to fall within the ex-
filed petitions shall include statements
emption established for trade secrets
regarding each such clinical investiga-
and confidential commercial informa-
tion from which the information or
tion in § 20.61 of this chapter.
data are derived, that it either was
conducted in compliance with the re- (3) Adverse reaction reports, product
quirements for institutional review set experience reports, consumer com-
forth in part 56 of this chapter, or was plaints, and other similar data and in-
not subject to such requirements in ac- formation, after deletion of:
cordance with § 56.104 or § 56.105, and (i) Names and any information that
that it was conducted in compliance would identify the person using the
with the requirements for informed product.
consent set forth in part 50 of this (ii) Names and any information that
chapter. would identify any third party involved
(c) Withdrawal of petitions without with the report, such as a physician or
prejudice. (1) In some cases the Com- hospital or other institution.
missioner may notify the petitioner (4) A list of all ingredients contained
that the petition, while technically in a color additive, whether or not it is
complete, is inadequate to justify the in descending order of predominance. A
establishment of a regulation or the particular ingredient or group of ingre-
regulation requested by petitioner. dients shall be deleted from any such
This may be due to the fact that the list prior to public disclosure if it is
data are not sufficiently clear or com- shown to fall within the exemption es-
plete. In such cases, the petitioner may tablished in § 20.61 of this chapter, and
withdraw the petition pending its clari- a notation shall be made that any such
fication or the obtaining of additional ingredient list is incomplete.
data. This withdrawal will be without (5) An assay method or other analyt-
prejudice to a future filing. Upon re- ical method, unless it serves no regu-
filing, the time limitation will begin to latory or compliance purpose and is
run anew from the date of refiling. shown to fall within the exemption es-
(2) At any time before the order pro- tablished in § 20.61 of this chapter.
vided for in § 71.20 has been forwarded (6) All records showing the Food and
to the FEDERAL REGISTER for publica- Drug Administration’s testing of or ac-
tion the petitioner may withdraw the tion on a particular lot of a certifiable
petition without prejudice to a future color additive.

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Food and Drug Administration, HHS § 71.20

(b) The following data and informa- tion (or within 180 days if the time is
tion in a color additive petition are not extended as provided for in section
available for public disclosure unless 721(d)(1) of the act):
they have been previously disclosed to (a) A regulation listing in part 73 or
the public as defined in § 20.81 of this 74 of this chapter the color additive on
chapter or they relate to a product or the appropriate list or lists as provided
ingredient that has been abandoned under section 721(b)(1).
and they no longer represent a trade (1) Such a regulation may list the
secret or confidential commercial or fi- color additive for use generally in or on
nancial information as defined in § 20.61 foods, drugs, or cosmetics or for use in
of this chapter: coloring the human body, as the case
(1) Manufacturing methods or proc- may be, or may prescribe the condi-
esses, including quality control proce- tions under which the color additive
dures.
may be safely used (including, but not
(2) Production, sales, distribution,
limited to, specifications as to the par-
and similar data and information, ex-
ticular food, drug, or cosmetic or class-
cept that any compilation of such data
es of food, drugs, or cosmetics in or on
and information aggregated and pre-
pared in a way that does not reveal which such color additive may be used,
data or information which is not avail- or for the material intended for color-
able for public disclosure under this ing the human body; the maximum
provision is available for public disclo- quantity of any straight color or dil-
sure. uent that may be used or permitted to
(3) Quantitative or semiquantitative remain in or on such food, drug, or cos-
formulas. metic or article intended for coloring
(c) All correspondence and written the human body; the manner in which
summaries of oral discussions relating such color additive may be added to or
to a color additive petition are avail- used in or on such food, drug, or cos-
able for public disclosure in accordance metic or for coloring the human body;
with the provisions of part 20 of this and any directions or other labeling or
chapter when the color additive regula- packing requirements for such color
tion is published in the FEDERAL REG- additives deemed necessary to assure
ISTER. the safety of such use).
(d) For purposes of this regulation, (2) Such regulations shall list the
safety and functionality data include color additive only for the use or uses
all studies and tests of a color additive for which it has been found suitable
on animals and humans and all studies and for which it may safely be em-
and tests on a color additive for iden- ployed. Alternatively, the Commis-
tity, stability, purity, potency, per- sioner shall by order deny the petition,
formance, and usefulness. and notify the petitioner of such order
and the reasons therefor.
§ 71.18 Petition for exemption from (3) The regulation shall list any use
certification.
or uses in meat, meat food product, or
A manufacturer, packer, or dis- poultry product subject to the Federal
tributor of a color additive or color ad- Meat Inspection Act (FMIA) (21 U.S.C.
ditive mixture may petition for an ex- 601 et seq.) or the Poultry Products In-
emption from certification pursuant to spection (PPIA) (21 U.S.C. 451 et seq.)
part 10 of this chapter. Any such peti- for which the color additive has been
tion shall show why such certification found suitable and for which it may
is not necessary for the protection of safely be employed.
public health. (b) Whenever the Commissioner finds
that batch certification is not nec-
Subpart B—Administrative Action essary for the protection of the public
on Petitions health he will, by order, exempt the
color additive from the certification
§ 71.20 Publication of regulation. procedure. In determining whether cer-
The Commissioner will forward for tification of a color additive is nec-
publication in the FEDERAL REGISTER, essary, the Commissioner will consider
within 90 days after filing of the peti- the composition of the additive, its

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§ 71.22 21 CFR Ch. I (4–1–11 Edition)

manufacturing process, possible impu- § 71.26 Revocation of exemption from


rities, its toxic potential, control and certification.
analytical procedures necessary to as- If information becomes available to
sure compliance with the listing speci- the Commissioner that a color additive
fications, and the variability of its that has been granted exemption from
composition. certification should not, for the protec-
tion of the public health, be so exempt-
[42 FR 15639, Mar. 22, 1977, as amended at 65
FR 51762, Aug. 25, 2000]
ed, such exemption will be canceled by
a notice published in the FEDERAL REG-
§ 71.22 Deception as a basis for refus- ISTER.
ing to issue regulations; deceptive
use of a color additive for which a § 71.27 Listing and exemption from
certification on the Commissioner’s
regulation has issued. initiative.
The Commissioner shall refuse to Where a petition for a regulation to
issue a regulation listing a color addi- list a color additive has not been re-
tive, if in his judgment the data before ceived and the Commissioner has avail-
him show that such proposed use would able facts which demonstrate that a
promote deception of the consumer or color additive should be listed and/or
would result in misbranding or adulter- that certification procedure is not nec-
ation within the meaning of the act. essary in order to protect the public
Such a finding shall be by order pub- health, he may list such color additive
lished in the FEDERAL REGISTER sub- by appropriate regulation and listing
ject to the filing of objections and a re- in part 73 or 74 of this chapter.
quest for a hearing by adversely af-
fected parties. The issuance of a regu- § 71.30 Procedure for filing objections
to regulations.
lation for a color additive authorizing
its use generally in or on a food, drug, (a) Objections and hearings relating
or cosmetic shall not be construed as to color additive regulations under sec-
authorization to use the color additive tion 721 (b) and (c) of the act shall be
in a manner that may promote decep- governed by parts 10, 12, 13, 14, 15, 16,
and 19 of this chapter.
tion or conceal damage or inferiority.
(b) The fees specified in § 70.19 of this
The use of a color additive to promote
chapter shall be applicable.
deception or conceal damage or inferi-
ority shall be considered as the use of § 71.37 Exemption of color additives
a color additive for which no regula- for investigational use.
tion has issued pursuant to section (a) A shipment or other delivery of a
721(b) of the act, even though the regu- color additive or of a food, drug, or cos-
lation is effective for other uses. metic containing such a color additive
for investigational use by experts
§ 71.25 Condition for certification. qualified to determine safety shall be
(a) When the Commissioner cannot exempt from the requirements of sec-
conclude from the information before tion 402(c), 501(a), or 601(e) of the act,
him that there is a basis for exempting provided that the color additive or the
a color additive from the requirement food, drug, or cosmetic containing the
of batch certification, he will so order color additive bears a label which
by appropriate listing in part 74 of this states prominently, ‘‘Caution—Con-
chapter. The Commissioner’s order tains new color additive—For inves-
shall state in detail the specifications tigational use only.’’ No animals used
in such investigations, or their prod-
that shall be met by the color additive.
ucts, such as milk or eggs, shall be
(b) Each order shall state a period of used for food purposes, unless the spon-
time after which use of a color additive sor or the investigator has submitted
subject to batch certification but not to the Commissioner data dem-
from a batch certified by procedure onstrating that such use will be con-
prescribed in this section would result sistent with the public health, and the
in adulteration of the product in which Commissioner, proceeding as he would
it is used. in a matter involving section 409(i) of

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Food and Drug Administration, HHS Pt. 73

the act, has notified the sponsor or in- 73.352 Paracoccus pigment.
vestigator that the proposed disposi- 73.355 Phaffia yeast.
tion for food is authorized. Any person 73.450 Riboflavin.
73.500 Saffron.
who contests a refusal to grant such 73.575 Titanium dioxide.
authorization shall have an oppor- 73.585 Tomato lycopene extract; tomato ly-
tunity for a regulatory hearing before copene concentrate.
the Food and Drug Administration pur- 73.600 Turmeric.
suant to part 16 of this chapter. 73.615 Turmeric oleoresin.
(b) The person who introduced such
shipment or who delivers the color ad- Subpart B—Drugs
ditive or a food, drug, or cosmetic con- 73.1001 Diluents in color additive mixtures
taining such an additive into interstate for drug use exempt from certification.
commerce shall maintain adequate 73.1010 Alumina (dried aluminum hydrox-
records showing the name and post-of- ide).
fice address of the expert to whom the 73.1015 Chromium-cobalt-aluminum oxide.
color additive is shipped, date, quan- 73.1025 Ferric ammonium citrate.
73.1030 Annatto extract.
tity, and batch or code mark of each
73.1070 Calcium carbonate.
shipment and delivery for a period of 2 73.1075 Canthaxanthin.
years after such shipment and delivery. 73.1085 Caramel.
Upon the request of a properly author- 73.1095 b-Carotene.
ized employee of the Department, at 73.1100 Cochineal extract; carmine.
reasonable times, he shall make such 73.1125 Potassium sodium copper
records available for inspection and chlorophyllin (chlorophyllin-copper com-
copying. plex).
73.1150 Dihydroxyacetone.
73.1162 Bismuth oxychloride.
PART 73—LISTING OF COLOR AD- 73.1200 Synthetic iron oxide.
DITIVES EXEMPT FROM CERTIFI- 73.1298 Ferric ammonium ferrocyanide.
CATION 73.1299 Ferric ferrocyanide.
73.1326 Chromium hydroxide green.
73.1327 Chromium oxide greens.
Subpart A—Foods 73.1329 Guanine.
Sec. 73.1350 Mica-based pearlescent pigments.
73.1 Diluents in color additive mixtures for 73.1375 Pyrogallol.
food use exempt from certification. 73.1400 Pyrophyllite.
73.30 Annatto extract. 73.1410 Logwood extract.
73.35 Astaxanthin. 73.1496 Mica.
73.37 Astaxanthin dimethyldisuccinate. 73.1550 Talc.
73.40 Dehydrated beets (beet powder). 73.1575 Titanium dioxide.
73.50 Ultramarine blue. 73.1645 Aluminum powder.
73.75 Canthaxanthin. 73.1646 Bronze powder.
73.85 Caramel. 73.1647 Copper powder.
73.90 b-Apo-8′-carotenal. 73.1991 Zinc oxide.
73.95 b-Carotene.
73.100 Cochineal extract; carmine. Subpart C—Cosmetics
73.125 Sodium copper chlorophyllin.
73.140 Toasted partially defatted cooked 73.2030 Annatto.
cottonseed flour. 73.2085 Caramel.
73.160 Ferrous gluconate. 73.2087 Carmine.
73.165 Ferrous lactate. 73.2095 b-Carotene.
73.169 Grape color extract. 73.2110 Bismuth citrate.
73.170 Grape skin extract (enocianina). 73.2120 Disodium EDTA-copper.
73.185 Haematococcus algae meal. 73.2125 Potassium sodium copper
73.200 Synthetic iron oxide. chlorophyllin (chlorophyllin-copper com-
73.250 Fruit juice. plex).
73.260 Vegetable juice. 73.2150 Dihydroxyacetone.
73.275 Dried algae meal. 73.2162 Bismuth oxychloride.
73.295 Tagetes (Aztec marigold) meal and 73.2180 Guaiazulene.
extract. 73.2190 Henna.
73.300 Carrot oil. 73.2250 Iron oxides.
73.315 Corn endosperm oil. 73.2298 Ferric ammonium ferrocyanide.
73.340 Paprika. 73.2299 Ferric ferrocyanide.
73.345 Paprika oleoresin. 73.2326 Chromium hydroxide green.
73.350 Mica-based pearlescent pigments. 73.2327 Chromium oxide greens.

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§ 73.1 21 CFR Ch. I (4–1–11 Edition)
73.2329 Guanine. 73.3124 Phthalocyanine green.
73.2396 Lead acetate. 73.3125 Iron oxides.
73.2400 Pyrophyllite. 73.3126 Titanium dioxide.
73.2496 Mica. 73.3127 Vinyl alcohol/methyl methacrylate-
73.2500 Silver. dye reaction products.
73.2575 Titanium dioxide.
73.2645 Aluminum powder. 73.3128 Mica-based pearlescent pigments.
73.2646 Bronze powder. AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348,
73.2647 Copper powder. 351, 352, 355, 361, 362, 371, 379e.
73.2725 Ultramarines.
73.2775 Manganese violet. SOURCE: 42 FR 15643, Mar. 22, 1977, unless
73.2991 Zinc oxide. otherwise noted.
73.2995 Luminescent zinc sulfide.
EDITORIAL NOTE: Nomenclature changes to
Subpart D—Medical Devices part 73 appear at 66 FR 66742, Dec. 27, 2001.

73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-
anthracenedione bis(2-propenoic)ester co-
Subpart A—Foods
polymers.
73.3105 1,4–Bis[(2-methylphenyl)amino]-9,10- § 73.1 Diluents in color additive mix-
anthracenedione. tures for food use exempt from cer-
73.3106 1,4-Bis[4-(2-methacryloxyethyl) tification.
phenylamino]anthraquinone copolymers. The following substances may be
73.3107 Carbazole violet. safely used as diluents in color additive
73.3110 Chlorophyllin-copper complex, oil
soluble. mixtures for food use exempt from cer-
73.3110a Chromium-cobalt-aluminum oxide. tification, subject to the condition that
73.3111 Chromium oxide greens. each straight color in the mixture has
73.3112 C.I. Vat Orange 1. been exempted from certification or, if
73.3115 2-[[2,5-Diethoxy-4-[(4- not so exempted, is from a batch that
methylphenyl)thiol]phenyl]azo]-1,3,5- has previously been certified and has
benzenetriol.
73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] not changed in composition since cer-
naphth [2′,3′:6,7] indolo [2,3-c] carbazole- tification. If a specification for a par-
5,10,15,17,22,24-hexone. ticular diluent is not set forth in this
73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5- part 73, the material shall be of a pu-
anthracenediyl) bisbenzamide. rity consistent with its intended use.
73.3119 7,16-Dichloro–6,15-dihydro-5,9,14,18-
(a) General use. (1) Substances that
anthrazinetetrone.
73.3120 16,17-Dimethoxydinaphtho [1,2,3- are generally recognized as safe under
cd:3′,2′,1′-lm] perylene-5,10-dione. the conditions set forth in section
73.3121 Poly(hydroxyethyl methacrylate)- 201(s) of the act.
dye copolymers. (2) Substances meeting the defini-
73.3122 4-[(2,4-dimethylphenyl)azo]-2,4- tions and specifications set forth under
dihydro-5-methyl-2-phenyl-3H-pyrazol-3-
subchapter B of this chapter, and
one.
73.3123 6-Ethoxy-2-(6-ethoxy-3- which are used only as prescribed by
oxobenzo[b]thien-2(3H)-ylidene) such regulations.
benzo[b]thiophen-3 (2H)-one. (3) The following:
Substances Definitions and specifications Restrictions

Calcium disodium EDTA (calcium diso- Contains calcium disodium ethyl- May be used in aqueous solutions and
dium ethyl- enediamine- tetraacetate). enediamine- tetraacetate dihydrate aqueous dispersions as a preservative
(CAS Reg. No. 6766–87–6) as set and sequestrant in color additive mixtures
forth in the Food Chemicals Codex, intended only for ingested use; the color
3d ed., p. 50, 1981. additive mixture (solution or dispersion)
may contain not more than 1 percent by
weight of the diluent (calculated as anhy-
drous calcium disodium ethyl-
enediamine-tetraacetate).
Castor oil ................................................. As set forth in U.S.P. XVI ..................... Not more than 500 p.p.m. in the finished
food. Labeling of color additive mixtures
containing castor oil shall bear adequate
directions for use that will result in a food
meeting this restriction.

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Food and Drug Administration, HHS § 73.1

Substances Definitions and specifications Restrictions

Dioctylsodium sulfosuccinate .................. As set forth in sec. 172.810 of this Not more than 9 p.p.m. in the finished food.
chapter. Labeling of color additive mixtures con-
taining dioctylsodium sulfosuccinate shall
bear adequate directions for use that will
result in a food meeting this restriction.
Disodium EDTA (disodium ethyl- Contains disodium ethyl- enediamine- May be used in aqueous solutions and
enediamine- tetraacetate). tetraacetate dihydrate (CAS Reg. No. aqueous dispersions as a preservative
6381–92–6) as set forth in the Food and sequestrant in color additive mixtures
Chemicals Codex, 3d ed., p. 104, intended only for ingested use; the color
1981. additive mixture (solution or dispersion)
may contain not more than 1 percent by
weight of the diluent (calculated as anhy-
drous disodium ethyl- enediamine-
tetraacetate).

(b) Special use—(1) Diluents in color let form, gum, and confectionery. Items
additive mixtures for marking food—(i) listed in paragraph (a) of this section
Inks for marking food supplements in tab- and the following:
Substances Definitions and specifications Restrictions

Alcohol, SDA–3A .................................... As set forth in 26 CFR pt. 212 ............. No residue.
n-Butyl alcohol ........................................ ............................................................... Do.
Cetyl alcohol ........................................... As set forth in N.F. XI ........................... Do.
Cyclohexane ........................................... ............................................................... Do.
Ethyl cellulose ......................................... As set forth in sec. 172.868 of this
chapter.
Ethylene glycol monoethyl ether ............. ............................................................... Do.
Isobutyl alcohol ....................................... ............................................................... Do.
Isopropyl alcohol ..................................... ............................................................... Do.
Polyoxyethylene sorbitan monooleate As set forth in sec. 172.840 of this
(polysorbate 80). chapter.
Polyvinyl acetate ..................................... Molecular weight, minimum 2,000.
Polyvinylpyrrolidone ................................ As set forth in sec. 173.55 of this chap-
ter.
Rosin and rosin derivatives .................... As set forth in sec. 172.615 of this
chapter.
Shellac, purified ...................................... Food grade.

(ii) Inks for marking fruit and vegeta-


bles. Items listed in paragraph (a) of
this section and the following:
Substances Definitions and specifications Restrictions

Acetone ................................................... As set forth in N.F. XI ........................... No residue.


Alcohol, SDA–3A .................................... As set forth in 26 CFR pt. 212 ............. Do.
Benzoin ................................................... As set forth in U.S.P. XVI.
Copal, Manila .......................................... .
Ethyl acetate ........................................... As set forth in N.F. XI ........................... Do.
Ethyl cellulose ......................................... As set forth in sec. 172.868 of this
chapter.
Methylene chloride .................................. ............................................................... Do.
Polyvinylpyrrolidone ................................ As set forth in sec. 173.55 of this chap-
ter.
Rosin and rosin derivatives .................... As set forth in sec. 172.615 of this
chapter.
Silicon dioxide ......................................... As set forth in sec. 172.480 of this Not more than 2 pct of the ink solids.
chapter.
Terpene resins, natural ........................... As set forth in sec. 172.615 of this
chapter.
Terpene resins, synthetic ........................ Polymers of a- and b-pinene.

(2) Diluents in color additive mixtures paragraph (a) of this section and the
for coloring shell eggs. Items listed in following, subject to the condition that

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§ 73.30 21 CFR Ch. I (4–1–11 Edition)

there is no penetration of the color ad- Limed rosin.


ditive mixture or any of its compo- Naphtha.
nents through the eggshell into the Pentaerythritol ester of fumaric acid-rosin
egg: adduct.
Polyethylene glycol 6000 (as identified in
Alcohol, denatured, formula 23A (26 CFR § 172.820 of this chapter).
part 212), Internal Revenue Service. Polyvinyl alcohol.
Damar gum (resin).
Diethylene glycol distearate. Rosin and rosin derivatives (as identified in
Dioctyl sodium sulfosuccinate. § 172.615 of this chapter).
Ethyl cellulose (as identified in § 172.868 of (3) Miscellaneous special uses. Items
this chapter).
Ethylene glycol distearate. listed in paragraph (a) of this section
Japan wax. and the following:
Substances Definitions and specifications Restrictions

Polyvinylpyrrolidone ................................ As set forth in sec. 173.55 of this chap- In or as food-tablet coatings; limit, not more
ter. than 0.1 pct in the finished food; labeling
of color additive mixtures containing
polyvinylpyrrolidone shall bear adequate
directions for use that will result in a food
meeting this restriction.

[42 FR 15643, Mar. 22, 1977, as amended at 57 (b) Specifications. Annatto extract, in-
FR 32175, July 21, 1992; 69 FR 24511, May 4, cluding pigments precipitated there-
2004] from, shall conform to the following
specifications:
§ 73.30 Annatto extract.
(1) Arsenic (as As), not more than 3
(a) Identity. (1) The color additive parts per million; lead as Pb, not more
annatto extract is an extract prepared than 10 parts per million.
from annatto seed, Bixa orellana L., (2) When solvents listed under para-
using any one or an appropriate com- graph (a)(1)(ii) of this section are used,
bination of the food-grade extractants annatto extract shall contain no more
listed in paragraph (a)(1) (i) and (ii) of solvent residue than is permitted of the
this section: corresponding solvents in spice
(i) Alkaline aqueous solution, alka- oleoresins under applicable food addi-
line propylene glycol, ethyl alcohol or tive regulations in parts 170 through
alkaline solutions thereof, edible vege- 189 of this chapter.
table oils or fats, mono- and (c) Uses and restrictions. Annatto ex-
diglycerides from the glycerolysis of tract may be safely used for coloring
edible vegetable oils or fats. The alka- foods generally, in amounts consistent
line alcohol or aqueous extracts may with good manufacturing practice, ex-
be treated with food-grade acids to pre- cept that it may not be used to color
cipitate annatto pigments, which are foods for which standards of identity
separated from the liquid and dried, have been promulgated under section
with or without intermediate recrys- 401 of the act unless added color is au-
tallization, using the solvents listed thorized by such standards.
under paragraph (a)(1)(ii) of this sec- (d) Labeling. The label of the color ad-
tion. Food-grade alkalis or carbonates ditive and any mixtures prepared
may be added to adjust alkalinity. therefrom and intended solely or in
(ii) Acetone, ethylene dichloride, part for coloring purposes shall con-
hexane, isopropyl alcohol, methyl alco- form to the requirements of § 70.25 of
hol, methylene chloride, trichloro- this chapter. Labels shall bear informa-
ethylene. tion showing that the color is derived
(2) Color additive mixtures for food from annatto seed. The requirements of
use made with annatto extract may § 70.25(a) of this chapter that all ingre-
contain only diluents that are suitable dients shall be listed by name shall not
and that are listed in this subpart as be construed as requiring the declara-
safe in color additive mixtures for tion of residues of solvents listed in
coloring foods. paragraph (a)(1)(ii) of this section.

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Food and Drug Administration, HHS § 73.37

(e) Exemption from certification. Cer- by § 70.25 of this chapter, and adequate
tification of this color additive is not directions to prepare a final product
necessary for the protection of the pub- complying with the limitations pre-
lic health and therefore batches thereof scribed in paragraph (c) of this section.
are exempt from the certification re- (2) The presence of the color additive
quirements of section 721(c) of the act. in finished fish feed prepared according
to paragraph (c) of this section shall be
§ 73.35 Astaxanthin. declared in accordance with § 501.4 of
(a) Identity. (1) The color additive this chapter.
astaxanthin is 3, 3′-dihydroxy-b, b-caro- (3) The presence of the color additive
tene-4, 4′-dione. in salmonid fish that have been fed
(2) Astaxanthin may be added to the feeds containing astaxanthin shall be
fish feed only as a component of a sta- declared in accordance with
bilized color additive mixture. Color §§ 101.22(k)(2) and 101.100(a)(2) of this
additive mixtures for fish feed use chapter.
made with astaxanthin may contain (e) Exemption from certification. Cer-
only those diluents that are suitable tification of this color additive is not
and are listed in this subpart as safe necessary for the protection of the pub-
for use in color additive mixtures for lic health, and therefore batches there-
coloring foods. of are exempt from the certification re-
(b) Specifications. Astaxanthin shall quirements of section 721(c) of the act.
conform to the following specifications [60 FR 18738, Apr. 13, 1995]
and shall be free from impurities other
than those named to the extent that § 73.37 Astaxanthin dimethyl-
such impurities may be avoided by disuccinate.
good manufacturing practice: (a) Identity. (1) The color additive
Physical state, solid. astaxanthin dimethyldisuccinate is
0.05 percent solution in chloroform, complete 3,3′-bis(4-methoxy-1,4-dioxobutoxy)-b,b-
and clear. carotene–4,4′-dione.
Absorption maximum wavelength 484–493 (2) Astaxanthin dimethyldisuccinate
nanometers (in chloroform). may be added to the fish feed only as a
Residue on ignition, not more than 0.1 per- component of a stabilized mixture.
cent.
Total carotenoids other than astaxanthin, Color additive mixtures for fish feed
not more than 4 percent. use made with astaxanthin
Lead, not more than 5 parts per million. dimethyldisuccinate may contain only
Arsenic, not more than 2 parts per million. those diluents that are suitable and are
Mercury, not more than 1 part per million. listed in this subpart as safe for use in
Heavy metals, not more than 10 parts per color additive mixtures for coloring
million. foods.
Assay, minimum 96 percent.
(b) Specifications. Astaxanthin
(c) Uses and restrictions. Astaxanthin dimethyldisuccinate shall conform to
may be safely used in the feed of the following specifications and shall
salmonid fish in accordance with the be free from impurities other than
following prescribed conditions: those named to the extent that such
(1) The color additive is used to en- impurities may be avoided by good
hance the pink to orange-red color of manufacturing practice:
the flesh of salmonid fish. (1) Physical state, solid.
(2) The quantity of color additive in (2) 0.05 percent solution in chloro-
feed is such that the color additive form, complete and clear.
shall not exceed 80 milligrams per kilo- (3) Absorption maximum wavelength
gram (72 grams per ton) of finished 484–493 nanometers (in chloroform).
feed. (4) Residue on ignition, not more
(d) Labeling requirements. (1) The la- than 0.1 percent.
beling of the color additive and any (5) Total carotenoids other than
premixes prepared therefrom shall bear astaxanthin dimethyldisuccinate, not
expiration dates for the sealed and more than 4 percent.
open container (established through (6) Lead, not more than 5 milligrams
generally accepted stability testing per kilogram (mg/kg) (5 parts per mil-
methods), other information required lion).

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§ 73.40 21 CFR Ch. I (4–1–11 Edition)

(7) Arsenic, not more than 2 mg/kg (2 § 73.40 Dehydrated beets (beet pow-
parts per million). der).
(8) Mercury, not more than 1 mg/kg (1 (a) Identity. (1) The color additive de-
part per million). hydrated beets is a dark red powder
(9) Heavy metals, not more than 10 prepared by dehydrating sound, ma-
mg/kg (10 parts per million). ture, good quality, edible beets.
(10) Assay including astaxanthin (2) Color additive mixtures made
dimethyldisuccinate, astaxanthin with dehydrated beets may contain as
monomethylsuccinate, and diluents only those substances listed in
astaxanthin, minimum 96 percent. this subpart as safe and suitable for use
(c) Uses and restrictions. Astaxanthin in color additive mixtures for coloring
dimethyldisuccinate may be safely foods.
used in the feed of salmonid fish in ac- (b) Specifications. The color additive
cordance with the following prescribed shall conform to the following speci-
conditions: fications:
(1) The color additive is used to en- Volatile matter, not more than 4 percent.
hance the pink to orange-red color of Acid insoluble ash, not more than 0.5 per-
the flesh of salmonid fish. cent.
(2) The quantity of astaxanthin Lead (as Pb), not more than 10 parts per mil-
lion.
dimethyldisuccinate in the finished Arsenic (as As), not more than 1 part per
feed, when used alone or in combina- million.
tion with other astaxanthin color addi- Mercury (as Hg), not more than 1 part per
tive sources listed in this part 73, shall million.
not exceed 110 milligrams per kilogram (c) Uses and restrictions. Dehydrated
(mg/kg), which is equivalent to 80 mg/ beets may be safely used for the color-
kg astaxanthin (72 grams per ton). ing of foods generally in amounts con-
(d) Labeling requirements. (1) The la- sistent with good manufacturing prac-
beling of the color additive and any tice, except that it may not be used to
premixes prepared therefrom shall bear color foods for which standards of iden-
expiration dates for the sealed and tity have been promulgated under sec-
open container (established through tion 401 of the act, unless the use of
generally accepted stability testing added color is authorized by such
methods), other information required standards.
by § 70.25 of this chapter, and adequate (d) Labeling. The label of the color ad-
directions to prepare a final product ditive and any mixtures prepared
complying with the limitations pre- therefrom intended solely or in part for
scribed in paragraph (c) of this section. coloring purposes shall conform to the
(2) The presence of the color additive requirements of § 70.25 of this chapter.
in finished fish feed prepared according (e) Exemption from certification. Cer-
to paragraph (c) of this section shall be tification of this color additive is not
declared in accordance with § 501.4 of necessary for the protection of the pub-
this chapter. lic health, and therefore batches there-
of are exempt from the certification re-
(3) The presence of the color additive
quirements of section 721(c) of the act.
in salmonid fish that have been fed
feeds containing astaxanthin § 73.50 Ultramarine blue.
dimethyldisuccinate shall be declared
(a) Identity. The color additive ultra-
in accordance with §§ 101.22(b), (c), and
marine blue is a blue pigment obtained
(k)(2), and 101.100(a)(2) of this chapter.
by calcining a mixture of kaolin, sul-
(e) Exemption from certification. Cer- fur, sodium carbonate, and carbon at
tification of this color additive is not temperatures above 700 °C. Sodium sul-
necessary for the protection of the pub- fate and silica may also be incor-
lic health, and therefore batches there- porated in the mixture in order to vary
of are exempt from the certification re- the shade. The pigment is a complex
quirements of section 721(c) of the act. sodium aluminum sulfo-silicate having
[74 FR 57251, Nov. 5, 2009] the approximate formula Na7Ai6Si6O24
S3.

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Food and Drug Administration, HHS § 73.75

(b) Specifications. Ultramarine blue used for coloring foods generally sub-
shall conform to the following speci- ject to the following restrictions:
fications: (i) The quantity of canthaxanthin
does not exceed 30 milligrams per
Lead (as Pb), not more than 10 parts per mil-
lion. pound of solid or semisolid food or per
Arsenic (as As), not more than 1 part per pint of liquid food; and
million. (ii) It may not be used to color foods
Mercury (as Hg), not more than 1 part per for which standards of identity have
million. been promulgated under section 401 of
(c) Uses and restrictions. The color ad- the act unless added color is authorized
ditive ultramarine blue may be safely by such standards.
used for coloring salt intended for ani- (2) Canthaxanthin may be safely used
mal feed subject to the restriction that in broiler chicken feed to enhance the
the quantity of ultramarine blue does yellow color of broiler chicken skin in
not exceed 0.5 percent by weight of the accordance with the following condi-
salt. tions: The quantity of canthaxanthin
(d) Labeling requirements. The color incorporated in the feed shall not ex-
additive shall be labeled in accordance ceed 4.41 milligrams per kilogam (4
with the requirements of § 70.25 of this grams per ton) of complete feed to sup-
chapter. plement other known sources of xan-
(e) Exemption from certification. Cer- thophyll and associated carotenoids to
tification of this color additive is not accomplish the intended effect.
necessary for the protection of the pub- (3) Canthaxanthin may be safely used
lic health, and therefore batches there- in the feed of salmonid fish in accord-
of are exempt from the certification re- ance with the following prescribed con-
quirements of section 721(c) of the act. ditions:
(i) Canthaxanthin may be added to
§ 73.75 Canthaxanthin. the fish feed only in the form of a sta-
bilized color additive mixture;
(a) Identity. (1) The color additive
(ii) The color additive is used to en-
canthaxanthin is b-carotene-4,4′-dione.
hance the pink to orange-red color of
(2) Color additive mixtures for food
the flesh of salmonid fish; and
use made with canthaxanthin may con-
(iii) The quantity of color additive in
tain only those diluents that are suit-
feed shall not exceed 80 milligrams per
able and that are listed in this subpart
kilogram (72 grams per ton) of finished
as safe for use in color additive mix-
feed.
tures for coloring foods.
(d) Labeling requirements. (1) The la-
(b) Specifications. Canthaxanthin
beling of the color additive and any
shall conform to the following speci-
mixture prepared therefrom intended
fications and shall be free from impuri-
solely or in part for coloring purposes
ties other than those named to the ex-
shall conform to the requirements of
tent that such other impurities may be
§ 70.25 of this chapter.
avoided by good manufacturing prac-
(2) For purposes of coloring fish, the
tice:
labeling of the color additive and any
Physical state, solid. premixes prepared therefrom shall bear
1 percent solution in chloroform, complete expiration dates (established through
and clear. generally accepted stability testing
Melting range (decomposition), 207 °C. to 212 methods) for the sealed and open con-
°C. (corrected).
tainer, other information required by
Loss on drying, not more than 0.2 percent.
Residue on ignition, not more than 0.2 per- § 70.25 of this chapter, and adequate di-
cent. rections to prepare a final product
Total carotenoids other than trans- complying with the limitations pre-
canthaxanthin, not more than 5 percent. scribed in paragraph (c)(3) of this sec-
Lead, not more than 10 parts per million. tion.
Arsenic, not more than 3 parts per million. (3) The presence of the color additive
Mercury, not more than 1 part per million. in finished fish feed prepared according
Assay, 96 to 101 percent.
to paragraph (c)(3) of this section shall
(c) Use and restrictions. (1) The color be declared in accordance with § 501.4 of
additive canthaxanthin may be safely this chapter.

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§ 73.85 21 CFR Ch. I (4–1–11 Edition)

(4) The presence of the color additive that are listed in this subpart as safe in
in salmonid fish that have been fed color additive mixtures for coloring
feeds containing canthaxanthin shall foods.
be declared in accordance with (b) Specifications. Caramel shall con-
§§ 101.22(b), (c), and (k)(2), and form to the following specifications:
101.100(a)(2) of this chapter.
(e) Exemption from certification. Cer- Lead (as Pb), not more than 10 parts per mil-
lion.
tification of this color additive is not
Arsenic (as As), not more than 3 parts per
necessary for the protection of the pub- million.
lic health, and therefore batches there- Mercury (as Hg), not more than 0.1 part per
of are exempt from the certification re- million.
quirements of section 721(c) of the act.
(c) Uses and restrictions. Caramel may
[42 FR 15643, Mar. 22, 1977, as amended at 50 be safely used for coloring foods gen-
FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27,
erally, in amounts consistent with
1998]
good manufacturing practice, except
§ 73.85 Caramel. that it may not be used to color foods
for which standards of identity have
(a) Identity. (1) The color additive
been promulgated under section 401 of
caramel is the dark-brown liquid or
the act unless added color is authorized
solid material resulting from the care-
by such standards.
fully controlled heat treatment of the
(d) Labeling. The label of the color ad-
following food-grade carbohydrates:
ditive and any mixtures prepared
Dextrose. therefrom and intended solely or in
Invert sugar. part for coloring purposes shall con-
Lactose.
form to the requirements of § 70.25 of
Malt sirup.
Molasses. this chapter.
Starch hydrolysates and fractions thereof. (e) Exemption from certification. Cer-
Sucrose. tification of this color additive is not
(2) The food-grade acids, alkalis, and necessary for the protection of the pub-
salts listed in this subparagraph may lic health and therefore batches thereof
be employed to assist caramelization, are exempt from the certification re-
in amounts consistent with good manu- quirements of section 721(c) of the act.
facturing practice. § 73.90 β-Apo-8′-carotenal.
(i) Acids:
(a) Identity. (1) The color additive is
Acetic acid.
Citric acid.
b-apo-8′-carotenal.
Phosphoric acid. (2) Color additive mixtures for food
Sulfuric acid. use made with b-apo-8′-carotenal may
Sulfurous acid. contain only diluents that are suitable
(ii) Alkalis: and that are listed in this subpart as
safe in color additive mixtures for
Ammonium hydroxide. coloring foods.
Calcium hydroxide U.S.P.
Potassium hydroxide.
(b) Specifications. b-Apo-8′-carotenal
Sodium hydroxide. shall conform to the following speci-
fications:
(iii) Salts: Ammonium, sodium, or
potassium carbonate, bicarbonate, Physical state, solid.
phosphate (including dibasic phosphate 1 percent solution in chloroform, clear.
and monobasic phosphate), sulfate, and Melting point (decomposition), 136 °C.–140 °C.
sulfite. (corrected).
Loss of weight on drying, not more than 0.2
(3) Polyglycerol esters of fatty acids,
percent.
identified in § 172.854 of this chapter,
Residue on ignition, not more than 0.2 per-
may be used as antifoaming agents in cent.
amounts not greater than that re- Lead (as Pb), not more than 10 parts per mil-
quired to produce the intended effect. lion.
(4) Color additive mixtures for food Arsenic (as As), not more than 1 part per
use made with caramel may contain million.
only diluents that are suitable and Assay (spectrophotometric), 96–101 percent.

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Food and Drug Administration, HHS § 73.100

(c) Uses and restrictions. The color ad- act unless added color is authorized by
ditive b-apo-8′-carotenal may be safely such standards.
used for coloring foods generally, sub- (d) Labeling. The label of the color ad-
ject to the following restrictions: ditive and any mixtures prepared
(1) The quantity of b-apo-8′-carotenal therefrom and intended solely or in
does not exceed 15 milligrams per part for coloring purposes shall con-
pound of solid or semisolid food or 15 form to the requirements of § 70.25 of
milligrams per pint of liquid food. this chapter.
(2) It may not be used to color foods (e) Exemption from certification. Cer-
for which standards of identity have tification of this color additive is not
been promulgated under section 401 of necessary for the protection of the pub-
the act unless added color is authorized lic health and therefore batches thereof
by such standards. are exempt from the certification re-
(d) Labeling. The label of the color ad- quirements of section 721(c) of the act.
ditive and any mixtures prepared § 73.100 Cochineal extract; carmine.
therefrom and intended solely or in
part for coloring purposes shall con- (a) Identity. (1) The color additive
form to the requirements of § 70.25 of cochineal extract is the concentrated
this chapter. solution obtained after removing the
(e) Exemption from certification. Cer- alcohol from an aqueous-alcoholic ex-
tification of this color additive is not tract of cochineal (Dactylopius coccus
necessary for the protection of the pub- costa (Coccus cacti L.)). The coloring
lic health and therefore batches thereof principle is chiefly carminic acid.
(2) The color additive carmine is the
are exempt from the certification re-
aluminum or calcium-aluminum lake
quirements of section 721(c) of the act.
on an aluminum hydroxide substrate of
§ 73.95 β-Carotene. the coloring principles, chiefly car-
minic acid, obtained by an aqueous ex-
(a) Identity. (1) The color additive is traction of cochineal (Dactylopius coc-
b-carotene prepared synthetically or cus costa (Coccus cacti L.)).
obtained from natural sources. (3) Color additive mixtures for food
(2) Color additive mixtures for food use made with cochineal extract or car-
use made with b-carotene may contain mine may contain only diluents that
only diluents that are suitable and are suitable and that are listed in this
that are listed in this subpart as safe in subpart as safe in color additive mix-
color additive mixtures for coloring tures for coloring foods.
foods. (b) Specifications. (1) Cochineal ex-
(b) Specifications. b-carotene shall tract shall conform to the following
conform to the following specifica- specifications:
tions:
pH, not less than 5.0 and not more than 5.5 at
Physical state, solid. 25 °C.
1 percent solution in chloroform, clear. Protein (N × 6.25), not more than 2.2 percent.
Loss of weight on drying, not more than 0.2 Total solids, not less than 5.7 and not more
percent. than 6.3 percent.
Residue on ignition, not more than 0.2 per- Methyl alcohol, not more than 150 parts per
cent. million.
Lead (as Pb), not more than 10 parts per mil-
Lead (as Pb), not more than 10 parts per mil-
lion.
lion.
Arsenic (as As), not more than 1 part per
Arsenic (as As), not more than 3 parts per million.
million. Carminic acid, not less than 1.8 percent.
Assay (spectrophotometric), 96–101 percent.
(2) Carmine shall conform to the fol-
(c) Uses and restrictions. The color ad- lowing specifications:
ditive b-carotene may be safely used
for coloring foods generally, in Volatile matter (at 135 °C. for 3 hours), not
amounts consistent with good manu- more than 20.0 percent.
Ash, not more than 12.0 percent.
facturing practice, except that it may Lead (as Pb), not more than 10 parts per mil-
not be used to color those foods for lion.
which standards of identity have been Arsenic (as As), not more than 1 part per
promulgated under section 401 of the million.

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§ 73.125 21 CFR Ch. I (4–1–11 Edition)
Carminic acid, not less than 50.0 percent. § 73.125 Sodium copper chlorophyllin.
Carmine and cochineal extract shall be (a) Identity. (1) The color additive so-
pasteurized or otherwise treated to de- dium copper chlorophyllin is a green to
stroy all viable Salmonella microorga- black powder prepared from chloro-
nisms. Pasteurization or such other phyll by saponification and replace-
treatment is deemed to permit the add- ment of magnesium by copper. Chloro-
ing of safe and suitable substances phyll is extracted from alfalfa
(other than chemical preservatives) (Medicago sativa) using any one or a
that are essential to the method of pas- combination of the solvents acetone,
teurization or other treatment used. ethanol, and hexane.
For the purposes of this paragraph, (2) Color additive mixtures made
safe and suitable substances are those with sodium copper chlorophyllin may
substances that perform a useful func- contain only those diluents that are
tion in the pasteurization or other suitable and are listed in this subpart
treatment to render the carmine and as safe for use in color additive mix-
cochineal extract free of viable Sal- tures for coloring foods.
monella microorganisms, which sub- (b) Specifications. Sodium copper
stances are not food additives as de- chlorophyllin shall conform to the fol-
fined in section 201(s) of the act or, if lowing specifications and shall be free
they are food additives as so defined, from impurities other than those
are used in conformity with regula- named to the extent that such impuri-
tions established pursuant to section ties may be avoided by good manufac-
409 of the act. turing practice:
(c) Uses and restrictions. Carmine and (1) Moisture, not more than 5.0 per-
cochineal extract may be safely used cent.
for coloring foods generally in amounts
(2) Solvent residues (acetone, eth-
consistent with good manufacturing
anol, and hexane), not more than 50
practice, except that they may not be
parts per million, singly or, in com-
used to color foods for which standards
bination.
of identity have been promulgated
under section 401 of the act unless (3) Total copper, not less than 4 per-
added color is authorized by such cent and not more than 6 percent.
standards. (4) Free copper, not more than 200
(d) Labeling requirements. (1) The label parts per million.
of the color additives and any mixtures (5) Lead (as Pb), not more than 10
intended solely or in part for coloring parts per million.
purposes prepared therefrom shall con- (6) Arsenic (as As), not more than 3
form to the requirements of § 70.25 of parts per million.
this chapter. (7) Mercury (as Hg), not more than
(2) The label of food products in- 0.5 part per million.
tended for human use, including but- (8) Ratio of absorbance at 405 nano-
ter, cheese, and ice cream, that contain meters (nm) to absorbance at 630 nm,
cochineal extract or carmine shall spe- not less than 3.4 and not more than 3.9.
cifically declare the presence of the (9) Total copper chlorophyllins, not
color additive by listing its respective less than 95 percent of the sample dried
common or usual name, ‘‘cochineal ex- at 100 °C for 1 hour.
tract’’ or ‘‘carmine,’’ in the statement of (c) Uses and restrictions. Sodium cop-
ingredients in accordance with § 101.4 of per chlorophyllin may be safely used to
this chapter. color citrus-based dry beverage mixes
(e) Exemption from certification. Cer- in an amount not exceeding 0.2 percent
tification of these color additives is in the dry mix.
not necessary for the protection of the (d) Labeling requirements. The label of
public health, and therefore batches the color additive and any mixtures
thereof are exempt from the certifi- prepared therefrom shall conform to
cation requirements of section 721(c) of the requirements of § 70.25 of this chap-
the act. ter.
[42 FR 15643, Mar. 22, 1977, as amended at 74 (e) Exemption from certification. Cer-
FR 216, Jan 5, 2009] tification of this color additive is not

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Food and Drug Administration, HHS § 73.165

necessary for the protection of the pub- lic health and therefore batches thereof
lic health, and therefore batches there- are exempt from the certification re-
of are exempt from the certification re- quirements of section 721(c) of the act.
quirements of section 721(c) of the act.
§ 73.160 Ferrous gluconate.
[67 FR 35431, May 20, 2002]
(a) Identity. The color additive fer-
§ 73.140 Toasted partially defatted rous gluconate is the ferrous gluconate
cooked cottonseed flour. defined in the Food Chemicals Codex,
(a) Identity. (1) The color additive 3d Ed. (1981), pp. 122–123, which is incor-
toasted partially defatted cooked cot- porated by reference. Copies may be
tonseed flour is a product prepared as obtained from the National Academy
follows: Food quality cottonseed is Press, 2101 Constitution Ave. NW.,
delinted and decorticated; the meats Washington, DC 20418, or at the Na-
are screened, aspirated, and rolled; tional Archives and Records Adminis-
moisture is adjusted, the meats heated, tration (NARA). For information on
and the oil expressed; the cooked meats the availability of this material at
are cooled, ground, and reheated to ob- NARA, call 202–741–6030, or go to: http://
tain a product varying in shade from www.archives.gov/federallregister/
light to dark brown. codeloflfederallregulations/
(2) Color additive mixtures for food ibrllocations.html.
use made with toasted partially (b) Specifications. Ferrous gluconate
defatted cooked cottonseed flour may shall meet the specifications given in
contain only diluents that are suitable the Food Chemicals Codex, 3d Ed.
and that are listed in this subpart as (1981), which is incorporated by ref-
safe in color additive mixtures for erence. The availability of this incor-
coloring foods. poration by reference is given in para-
(b) Specifications. Toasted partially graph (a) of this section.
defatted cooked cottonseed flour shall (c) Uses and restrictions. Ferrous glu-
conform to the following specifica- conate may be safely used in amounts
tions: consistent with good manufacturing
practice for the coloring of ripe olives.
Arsenic: It contains no added arsenic com- (d) Labeling. The label of the color ad-
pound and therefore may not exceed a ditive shall conform to the require-
maximum natural background level of 0.2 ments of § 70.25 of this chapter.
part per million total arsenic, calculated
as As.
(e) Exemption from certification. Cer-
Lead (as Pb), not more than 10 parts per mil- tification of this color additive is not
lion. necessary for the protection of the pub-
Free gossypol content, not more than 450 lic health, and therefore batches there-
parts per million. of are exempt from the certification re-
(c) Uses and restrictions. The color ad- quirements of section 721(c) of the act.
ditive toasted partially defatted [42 FR 15643, Mar. 22, 1977, as amended at 47
cooked cottonseed flour may be safely FR 946, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984]
used for coloring foods generally, in
amounts consistent with good manu- § 73.165 Ferrous lactate.
facturing practice, except that it may (a) Identity. The color additive fer-
not be used to color foods for which rous lactate is the ferrous lactate de-
standards of identity have been pro- fined in § 184.1311 of this chapter.
mulgated under section 401 of the act, (b) Specifications. Ferrous lactate
unless added color is authorized by shall meet the specifications given in
such standards. the Food Chemicals Codex, 4th ed.
(d) Labeling. The label of the color ad- (1996), pp. 154 to 155, which is incor-
ditive and any mixtures prepared porated by reference in accordance
therefrom and intended solely or in with 5 U.S.C. 552(a) and 1 CFR part 51.
part for coloring purposes shall con- Copies are available from the National
form to the requirements of § 70.25 of Academy Press, 2101 Constitution Ave.
this chapter. NW., Washington, DC 20418, or may be
(e) Exemption from certification. Cer- examined at the Center for Food Safety
tification of this color additive is not and Applied Nutrition’s Library, 5100
necessary for the protection of the pub- Paint Branch Pkwy., College Park,

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§ 73.169 21 CFR Ch. I (4–1–11 Edition)

MD, or at the National Archives and 10 parts per million. Arsenic (as As),
Records Administration (NARA). For not more than 1 part per million.
information on the availability of this (c) Uses and restrictions. Grape color
material at NARA, call 202–741–6030, or extract may be safely used for the
go to: http://www.archives.gov/ coloring of nonbeverage food, except
federallregister/ that it may not be used to color foods
codeloflfederallregulations/ for which standards of identity have
ibrllocations.html. been promulgated under section 401 of
(c) Uses and restrictions. Ferrous lac- the act, unless the use of added color is
tate may be safely used in amounts authorized by such standards.
consistent with good manufacturing (d) Labeling. The color additive and
practice for the coloring of ripe olives. any mixtures prepared therefrom in-
(d) Labeling. The label of the color ad- tended solely or in part for coloring
ditive shall conform to the require- purposes shall bear, in addition to the
ments of § 70.25 of this chapter. other information required by the act,
(e) Exemption from certification. Cer- labeling in accordance with the provi-
tification of this color additive is not sions of § 70.25 of this chapter.
necessary for the protection of the pub- (e) Exemption from certification. Cer-
tification of this color additive is not
lic health, and therefore batches there-
necessary for the protection of the pub-
of are exempt from the certification re-
lic health, and therefore batches are
quirements of section 721(c) of the Fed-
exempt from the certification require-
eral Food, Drug, and Cosmetic Act (the
ments of section 721(c) of the Act.
act).
[46 FR 47532, Sept. 29, 1981]
[61 FR 40319, Aug. 2, 1996, as amended at 66
FR 66742, Dec. 27, 2001] § 73.170 Grape skin extract
(enocianina).
§ 73.169 Grape color extract.
(a) Identity. (1) The color additive
(a) Identity. (1) The color additive grape skin extract (enocianina) is a
grape color extract is an aqueous solu- purplish-red liquid prepared by the
tion of anthocyanin grape pigments aqueous extraction (steeping) of the
made from Concord grapes or a dehy- fresh deseeded marc remaining after
drated water soluble powder prepared grapes have been pressed to produce
from the aqueous solution. The aque- grape juice or wine. It contains the
ous solution is prepared by extracting common components of grape juice;
the pigments from precipitated lees namely, anthocyanins, tartaric acid,
produced during the storage of Concord tannins, sugars, minerals, etc., but not
grape juice. It contains the common in the same proportions as found in
components of grape juice, namely grape juice. During the steeping proc-
anthocyanins, tartrates, malates, sug- ess, sulphur dioxide is added and most
ars, and minerals, etc., but not in the of the extracted sugars are fermented
same proportion as found in grape to alcohol. The extract is concentrated
juice. The dehydrated water soluble by vacuum evaporation, during which
powder is prepared by spray drying the practically all of the alcohol is re-
aqueous solution containing added moved. A small amount of sulphur di-
malto-dextrin. oxide may be present.
(2) Color additive mixtures for food (2) Color additive mixtures for food
use made with grape color extract may use made with grape skin extract
contain only those diluents listed in (enocianina) may contain only those
this subpart as safe and suitable in diluents listed in this subpart as safe
color additive mixtures for coloring and suitable in color additive mixtures
foods. for coloring foods.
(b) Specifications. Grape color extract (b) Specifications. Grape skin extract
shall conform to the following speci- (enocianina) shall conform to the fol-
fications: Pesticide residues, not more lowing specifications:
than permitted in or on grapes by regu- Pesticide residues, not more than permitted
lations promulgated under section 408 in or on grapes by regulations promulgated
of the Federal Food, Drug, and Cos- under section 408 of the Federal Food,
metic Act. Lead (as Pb), not more than Drug, and Cosmetic Act.

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Food and Drug Administration, HHS § 73.200
Lead (as Pb), not more than 10 parts per mil- Mercury, not more than 1 part per million.
lion. Heavy metals (as Pb), not more than 10 parts
Arsenic (as As), not more than 1 part per per million.
million. Astaxanthin, not less than 1.5 percent.
(c) Uses and restrictions. Grape skin (c) Uses and restrictions.
extract (enocianina) may be safely Haematococcus algae meal may be
used for the coloring of still and car- safely used in the feed of salmonid fish
bonated drinks and ades, beverage in accordance with the following pre-
bases, and alcoholic beverages subject scribed conditions:
to the following restrictions: (1) The color additive is used to en-
(1) It may not be used to color foods hance the pink to orange-red color of
for which standards of identity have the flesh of salmonid fish.
been promulgated under section 401 of (2) The quantity of astaxanthin in
the act unless artificial color is author- finished feed, from haematococcus
ized by such standards. algae meal when used alone or in com-
(2) Its use in alcoholic beverages bination with other astaxanthin color
shall be in accordance with the provi- additive sources listed in this part 73,
sions of parts 4 and 5, title 27 CFR. shall not exceed 80 milligrams per kilo-
(d) Labeling requirements. The label of gram (72 grams per ton) of finished
the color additive and any mixtures feed.
prepared therefrom intended solely or (d) Labeling requirements. (1) The la-
in part for coloring purposes shall con- beling of the color additive and any
form to the requirements of § 70.25 of premixes prepared therefrom shall bear
this chapter. The common or usual expiration dates for the sealed and
name of the color additive is ‘‘grape open container (established through
skin extract’’ followed, if desired, by generally accepted stability testing
‘‘(enocianina)’’. methods), other information required
(e) Exemption from certification. Cer- by § 70.25 of this chapter, and adequate
tification of this color additive is not directions to prepare a final product
necessary for the protection of the pub- complying with the limitations pre-
lic health, and therefore batches there- scribed in paragraph (c) of this section.
of are exempt from the certification re- (2) The presence of the color additive
quirements of section 721(c) of the act. in finished fish feed prepared according
to paragraph (c) of this section shall be
§ 73.185 Haematococcus algae meal. declared in accordance with § 501.4 of
(a) Identity. (1) The color additive this chapter.
haematococcus algae meal consists of (3) The presence of the color additive
the comminuted and dried cells of the in salmonid fish that have been fed
alga Haematococcus pluvialis. feeds containing haematococcus algae
(2) Haematococcus algae meal may meal shall be declared in accordance
be added to the fish feed only as a com- with §§ 101.22(b), (c), and (k)(2), and
ponent of a stabilized color additive 101.100(a)(2) of this chapter.
mixture. Color additive mixtures for (e) Exemption from certification. Cer-
fish feed use made with haematococcus tification of this color additive is not
algae meal may contain only those necessary for the protection of the pub-
diluents that are suitable and are list- lic health, and therefore batches there-
ed in this subpart as safe for use in of are exempt from the certification re-
color additive mixtures for coloring quirements of section 721(c) of the act.
foods. [65 FR 41584, July 6, 2000]
(b) Specifications. Haematococcus
algae meal shall conform to the fol- § 73.200 Synthetic iron oxide.
lowing specifications and shall be free (a) Identity. (1) The color additive
from impurities other than those synthetic iron oxide consists of any
named to the extent that such impuri- one or any combination of syn-
ties may be avoided by good manufac- thetically prepared iron oxides, includ-
turing practice: ing the hydrated forms. It is free from
Physical state, solid. admixture with other substances.
Lead, not more than 5 parts per million. (2) Color additive mixtures for food
Arsenic, not more than 2 parts per million. use made with synthetic iron oxide

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§ 73.250 21 CFR Ch. I (4–1–11 Edition)

may contain only those diluents that identity under section 401 of the act.
are suitable and that are listed in this However, where a standard of identity
subpart as safe for use in color additive for a particular fruit juice has been
mixtures for coloring foods. promulgated under section 401 of the
(b) Specifications. (1) Synthetic iron act, it shall conform to such standard.
oxide for human food use shall conform (2) Color additive mixtures made
to the following specifications: with fruit juice may contain as
diluents only those substances listed in
Arsenic (as As), not more than 3 parts per
million.
this subpart as safe and suitable in
Lead (as Pb), not more than 10 parts per mil- color additive mixtures for coloring
lion. foods.
Mercury (as Hg) , not more than 1 part per (b) Uses and restrictions. Fruit juice
million. may be safely used for the coloring of
foods generally, in amounts consistent
(2) Synthetic iron oxide for dog and
with good manufacturing practice, ex-
cat food use shall conform to the fol-
cept that it may not be used to color
lowing specifications:
foods for which standards of identity
Arsenic (as As), not more than 5 parts per have been promulgated under section
million. 401 of the act, unless the use of added
Lead (as Pb), not more than 20 parts per mil- color is authorized by such standards.
lion. (c) Labeling. The color additive and
Mercury (as Hg), not more than 3 parts per
million.
any mixtures intended solely or in part
for coloring purposes prepared there-
(c) Uses and restrictions. (1) Synthetic from shall bear, in addition to the
iron oxide may be safely used for the other information required by the act,
coloring of sausage casings intended labeling in accordance with the provi-
for human consumption in an amount sions of § 70.25 of this chapter.
not exceeding 0.10 percent by weight of (d) Exemption from certification. Cer-
the finished food. tification of this color additive is not
(2) Synthetic iron oxide may be safe- necessary for the protection of the pub-
ly used for the coloring of dog and cat lic health, and therefore batches there-
foods in an amount not exceeding 0.25 of are exempt from the certification re-
percent by weight of the finished food. quirements of section 721(c) of the act.
(d) Labeling requirements. The label of
[42 FR 15643, Mar. 22, 1977, as amended at 60
the color additive and any mixture pre- FR 52629, Oct. 10, 1995]
pared therefrom intended solely or in
part for coloring purposes shall con- § 73.260 Vegetable juice.
form to the requirements of § 70.25 of
(a) Identity. (1) The color additive
this chapter.
vegetable juice is prepared either by
(e) Exemption from certification. Cer-
expressing the juice from mature vari-
tification of this color additive is not
eties of fresh, edible vegetables, or by
necessary for the protection of the pub-
the water infusion of the dried vege-
lic health, and therefore batches there-
table. The color additive may be con-
of are exempt from the certification re-
centrated or dried. The definition of
quirements of section 721(c) of the act.
vegetable juice in this paragraph is for
[42 FR 15643, Mar. 22, 1977, as amended at 59 the purpose of identity as a color addi-
FR 10578, Mar. 7, 1994] tive only, and shall not be construed as
a standard of identity under section 401
§ 73.250 Fruit juice. of the act. However, where a standard
(a) Identity. (1) The color additive of identity for a particular vegetable
fruit juice is prepared either by ex- juice has been promulgated under sec-
pressing the juice from mature vari- tion 401 of the act, it shall conform to
eties of fresh, edible fruits, or by the such standard.
water infusion of the dried fruit. The (2) Color additive mixtures made
color additive may be concentrated or with vegetable juice may contain as
dried. The definition of fruit juice in diluents only those substances listed in
this paragraph is for the purpose of this subpart as safe and suitable in
identity as a color additive only and color additive mixtures for coloring
shall not be construed as a standard of foods.

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Food and Drug Administration, HHS § 73.295

(b) Uses and restrictions. Vegetable information required by § 70.25 of this


juice may be safely used for the color- chapter.
ing of foods generally, in amounts con- (1) A statement of the concentrations
sistent with good manufacturing prac- of xanthophyll and ethoxyquin con-
tice, except that it may not be used to tained therein.
color foods for which standards of iden- (2) Adequate directions to provide a
tity have been promulgated under sec- final product complying with the limi-
tion 401 of the act, unless the use of tations prescribed in paragraph (b) of
added color is authorized by such this section.
standards. (d) Exemption from certification. Cer-
(c) Labeling. The color additive and tification of this color additive is not
any mixtures intended solely or in part necessary for the protection of the pub-
for coloring purposes prepared there- lic health and therefore batches thereof
from shall bear, in addition to the are exempt from the certification re-
other information required by the act, quirements of section 721(c) of the act.
labeling in accordance with the provi-
sions of § 70.25 of this chapter. § 73.295 Tagetes (Aztec marigold) meal
(d) Exemption from certification. Cer- and extract.
tification of this color additive is not (a) Identity. (1) The color additive
necessary for the protection of the pub- tagetes (Aztec marigold) meal is the
lic health, and therefore batches there- dried, ground flower petals of the Aztec
of are exempt from the certification re- marigold (Tagetes erecta L.) mixed with
quirements of section 721(c) of the act. not more than 0.3 percent ethoxyquin.
[42 FR 15643, Mar. 22, 1977, as amended at 60 (2) The color additive tagetes (Aztec
FR 52629, Oct. 10, 1995] marigold) extract is a hexane extract
of the flower petals of the Aztec mari-
§ 73.275 Dried algae meal. gold (Tagetes erecta L.). It is mixed with
(a) Identity. The color additive dried an edible vegetable oil, or with an edi-
algae meal is a dried mixture of algae ble vegetable oil and a hydrogenated
cells (genus Spongiococcum, separated edible vegetable oil, and not more than
from its culture broth), molasses, 0.3 percent ethoxyquin. It may also be
cornsteep liquor, and a maximum of 0.3 mixed with soy flour or corn meal as a
percent ethoxyquin. The algae cells are carrier.
produced by suitable fermentation, (b) Specifications. (1) Tagetes (Aztec
under controlled conditions, from a marigold) meal is free from admixture
pure culture of the genus with other plant material from
Spongiococcum. Tageteserecta L. or from plant material
(b) Uses and restrictions. The color ad- or flowers of any other species of
ditive dried algae meal may be safely plants.
used in chicken feed in accordance (2) Tagetes (Aztec marigold) extract
with the following prescribed condi- shall be prepared from tagetes (Aztec
tions: marigold) petals meeting the specifica-
(1) The color additive is used to en- tions set forth in paragraph (b)(1) of
hance the yellow color of chicken skin this section and shall conform to the
and eggs. following additional specifications:
(2) The quantity of the color additive Melting point .......................... 53.5–55.0 °C.
Iodine value ........................... 132–145.
incorporated in the feed is such that Saponification value ............... 175–200.
the finished feed: Acid value .............................. 0.60–1.20.
(i) Is supplemented sufficiently with Titer ........................................ 35.5°–37.0 °C.
Unsaponifiable matter ............ 23.0 percent–27.0 percent.
xanthophyll and associated carotenoids Hexane residue ...................... Not more than 25 p.p.m.
so as to accomplish the intended effect
described in paragraph (b)(1) of this All determinations, except the hexane
section; and residue, shall be made on the initial ex-
(ii) Meets the tolerance limitation tract of the flower petals (after drying
for ethoxyquin in animal feed pre- in a vacuum oven at 60 °C. for 24 hours)
scribed in § 573.380 of this chapter. prior to the addition of the oils and
(c) Labeling. The label of the color ad- ethoxyquin. The hexane determination
ditives and any premixes prepared shall be made on the color additive
therefrom shall bear in addition to the after the addition of the vegetable oils,

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§ 73.300 21 CFR Ch. I (4–1–11 Edition)

hydrogenated vegetable oils, and (2) Color additive mixtures for food
ethoxyquin. use made with carrot oil may contain
(c) Uses and restrictions. The color ad- only those diluents listed in this sub-
ditives tagetes (Aztec marigold) meal part as safe and suitable in color addi-
and extract may be safely used in tive mixtures for coloring foods.
chicken feed in accordance with the (b) Specifications. Carrot oil shall con-
following prescribed conditions: tain no more than 25 parts per million
(1) The color additives are used to en- of hexane.
hance the yellow color of chicken skin (c) Uses and restrictions. Carrot oil
and eggs. may be safely used for coloring foods
(2) The quantity of the color addi- generally, in amounts consistent with
tives incorporated in the feed is such good manufacturing practice, except
that the finished feed: that it may not be used to color foods
for which standards of identity have
(i) Is supplemented sufficiently with
been promulgated under section 401 of
xanthophyll and associated carotenoids
the act unless the use of added color is
so as to accomplish the intended effect
authorized by such standards.
described in paragraph (c)(1) of this (d) Labeling requirements. The label of
section; and the color additive and any mixtures
(ii) Meets the tolerance limitation prepared therefrom intended solely or
for ethoxyquin in animal feed pre- in part for coloring purposes shall con-
scribed in § 573.380 of this chapter. form to the requirements of § 70.25 of
(d) Labeling requirements. The label of this chapter.
the color additives and any premixes (e) Exemption from certification. Cer-
prepared therefrom shall bear, in addi- tification of this color additive is not
tion to the information required by necessary for the protection of the pub-
§ 70.25 of this chapter: lic health, and therefore batches there-
(1) A statement of the concentrations of are exempt from the certification re-
of xanthophyll and ethoxyquin con- quirements of section 721(c) of the act.
tained therein.
(2) Adequate directions to provide a § 73.315 Corn endosperm oil.
final product complying with the limi- (a) Identity. (1) The color additive
tations prescribed in paragraph (c) of corn endosperm oil is a reddish-brown
this section. liquid composed chiefly of glycerides,
(e) Exemption from certification. Cer- fatty acids, sitosterols, and carotenoid
tification of this color additive is not pigments obtained by isopropyl alcohol
necessary for the protection of the pub- and hexane extraction from the gluten
lic health, and therefore batches there- fraction of yellow corn grain. The defi-
of are exempt from the certification re- nition of corn endosperm oil in this
quirements of section 721(c) of the act. paragraph is for the purpose of defini-
tion as a color additive only and shall
§ 73.300 Carrot oil. not be construed as a food standard of
(a) Identity. (1) The color additive identity under section 401 of the act.
carrot oil is the liquid or the solid por- (2) Color additive mixtures for food
use made with corn endosperm oil may
tion of the mixture or the mixture
contain only those diluents listed in
itself obtained by the hexane extrac-
this subpart as safe and suitable in
tion of edible carrots (Daucus carota L.)
color additive mixtures for coloring
with subsequent removal of the hexane
foods.
by vacuum distillation. The resultant
(b) Specifications. Corn endosperm oil
mixture of solid and liquid extractives
conforms to the following specifica-
consists chiefly of oils, fats, waxes, and
tions:
carrotenoids naturally occurring in
carrots. The definition of carrot oil in Total fatty acids, not less than 85 percent.
this paragraph is for the purpose of Iodine value, 118 to 134.
identity as a color additive only and Saponification value, 165 to 185.
Unsaponifiable matter, not more than 14 per-
shall not be construed as setting forth cent.
an official standard for carrot oil or Hexane, not more than 25 narts per millimn.
carrot oleoresin under section 401 of Isopropyl alcohol, not more than 100 parts
the act. per million.

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Food and Drug Administration, HHS § 73.345

(c) Uses and restrictions. The color ad- labeling in accordance with the provi-
ditive corn endosperm oil may be safe- sions of § 70.25 of this chapter.
ly used in chicken feed in accordance (d) Exemption from certification. Cer-
with the following prescribed condi- tification of this color additive is not
tions: necessary for the protection of the pub-
(1) The color additive is used to en- lic health, and therefore batches there-
hance the yellow color of chicken skin of are exempt from the certification re-
and eggs. quirements of section 721(c) of the act.
(2) The quantity of the color additive
incorporated in the feed is such that § 73.345 Paprika oleoresin.
the finished feed is supplemented suffi- (a) Identity. (1) The color additive pa-
ciently with xanthophyll and associ- prika oleoresin is the combination of
ated carotenoids so as to accomplish flavor and color principles obtained
the intended effect described in para- from paprika (Capsicum annuum L.) by
graph (c)(1) of this section. extraction, using any one or a com-
(d) Labeling requirements. The label of bination of the following solvents:
the color additive and any premixes
prepared therefrom shall bear, in addi- Acetone Isopropyl alcohol
Ethyl alcohol Methyl alcohol
tion to the information required by
Ethylene dichloride Methylene chloride
§ 70.25 of this chapter, a statement of Hexane Trichloroethylene
the concentration of xanthophyll con-
tained therein. The definition of paprika oleoresin in
(e) Exemption from certification. Cer- this paragraph is for the purpose of
tification of this color additive is not identity as a color additive only, and
necessary for the protection of the pub- shall not be construed as setting forth
lic health, and therefore batches there- an official standard for paprika oleo-
of are exempt from the certification re- resin under section 401 of the act.
quirements of section 721(c) of the act. (2) Color additive mixtures made
with paprika oleoresin may contain as
§ 73.340 Paprika. diluents only those substances listed in
(a) Identity. (1) The color additive pa- this subpart as safe and suitable in
prika is the ground dried pod of mild color additive mixtures for coloring
capsicum (Capsicum annuum L.). The foods.
definition of paprika in this paragraph (b) Specifications. Paprika oleoresin
is for the purpose of identity as a color shall contain no more residue of the
additive only and shall not be con- solvents listed in paragraph (a)(1) of
strued as setting forth an official this section than is permitted of the
standard for paprika under section 401 corresponding solvents in spice
of the act. oleoresins under applicable food addi-
(2) Color additive mixtures made tive regulations in parts 170 through
with paprika may contain as diluents 189 of this chapter.
only those substances listed in this (c) Uses and restrictions. Paprika oleo-
subpart as safe and suitable in color resin may be safely used for the color-
additive mixtures for coloring foods. ing of foods generally in amounts con-
(b) Uses and restrictions. Paprika may sistent with good manufacturing prac-
be safely used for the coloring of foods tice, except that it may not be used to
generally, in amounts consistent with color foods for which standards of iden-
good manufacturing practice, except tity have been promulgated under sec-
that it may not be used to color foods tion 401 of the act, unless the use of
for which standards of identity have added color is authorized by such
been promulgated under section 401 of standards.
the act, unless the use of added color is (d) Labeling. The color additive and
authorized by such standards. any mixtures intended solely or in part
(c) Labeling. The color additive and for coloring purposes prepared there-
any mixtures intended solely or in part from shall bear, in addition to the
for coloring purposes prepared there- other information required by the act,
from shall bear, in addition to the labeling in accordance with the provi-
other information required by the act, sions of § 70.25 of this chapter.

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§ 73.350 21 CFR Ch. I (4–1–11 Edition)

(e) Exemption from certification. Cer- (e) Exemption from certification. Cer-
tification of this color additive is not tification of this color additive is not
necessary for the protection of the pub- necessary for the protection of the pub-
lic health, and therefore batches there- lic health and therefore batches thereof
of are exempt from the certification re- are exempt from the certification re-
quirements of section 721(c) of the act. quirements of section 721(c) of the act.
[71 FR 31929, June 2, 2006]
§ 73.350 Mica-based pearlescent pig-
ments.
§ 73.352 Paracoccus pigment.
(a) Identity. (1) The color additive is (a) Identity. (1) The color additive
formed by depositing titanium salts paracoccus pigment consists of the
onto mica, followed by heating to heat-killed, dried cells of a nonpatho-
produce titanium dioxide on mica. genic and nontoxicogenic strain of the
Mica used to manufacture the color ad- bacterium Paracoccus carotinifaciens
ditive shall conform in identity to the and may contain added calcium car-
requirements of § 73.1496(a)(1). bonate to adjust the astaxanthin level.
(2) Color additive mixtures for food (2) Color additive mixtures for fish
use made with mica-based pearlescent feed use made with paracoccus pigment
pigments may contain only those may contain only those diluents that
diluents listed in this subpart as safe are suitable and are listed in this sub-
and suitable for use in color additive part as safe for use in color additive
mixtures for coloring food. mixtures for coloring foods.
(b) Specifications. Mica-based pearl- (b) Specifications. Paracoccus pigment
escent pigments shall conform to the shall conform to the following speci-
following specifications and shall be fications and shall be free from impuri-
free from impurities other than those ties, other than those named, to the ex-
named to the extent that such other tent that such impurities may be
impurities may be avoided by good avoided by good manufacturing prac-
manufacturing practice: tice:
(1) Lead (as Pb), not more than 4 (1) Physical state, solid.
parts per million (ppm). (2) Lead, not more than 5 milligrams
(2) Arsenic (as As), not more than 3 per kilogram (mg/kg) (5 parts per mil-
ppm. lion (ppm)).
(3) Mercury (as Hg), not more than 1 (3) Arsenic, not more than 2 mg/kg (2
ppm. ppm).
(c) Uses and restrictions. (1) The sub- (4) Mercury, not more than 1 mg/kg (1
stance listed in paragraph (a) of this ppm).
section may be safely used as a color (5) Heavy metals (as Pb), not more
additive in amounts up to 1.25 percent, than 10 mg/kg (10 ppm).
by weight, in the following foods: (6) Astaxanthin, not less than 1.75
(i) Cereals. percent.
(ii) Confections and frostings. (c) Uses and restrictions. Paracoccus
(iii) Gelatin desserts. pigment may be safely used in the feed
(iv) Hard and soft candies (including of salmonid fish in accordance with the
lozenges). following prescribed conditions:
(v) Nutritional supplement tablets (1) The color additive is used to en-
and gelatin capsules. hance the pink to orange-red color of
(vi) Chewing gum. the flesh of salmonid fish.
(2) The color additive may not be (2) The quantity of astaxanthin in
used to color foods for which standards finished feed, from paracoccus pigment
of identity have been issued under sec- when used alone or in combination
tion 401 of the act, unless the use of the with other astaxanthin color additive
added color is authorized by such sources listed in this part 73, shall not
standards. exceed 80 mg/kg (72 grams per ton) of
(d) Labeling. The label of the color ad- finished feed.
ditive and of any mixture prepared (d) Labeling requirements. (1) The la-
therefrom intended solely or in part for beling of the color additive and any
coloring purposes shall conform to the premixes prepared therefrom shall bear
requirements of § 70.25 of this chapter. expiration dates for the sealed and

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Food and Drug Administration, HHS § 73.450

open container (established through (1) The color additive is used to en-
generally accepted stability testing hance the pink to orange-red color of
methods), other information required the flesh of salmonid fish.
by § 70.25 of this chapter, and adequate (2) The quantity of astaxanthin in
directions to prepare a final product finished feed, from phaffia yeast when
complying with the limitations pre- used alone or in combination with
scribed in paragraph (c) of this section. other astaxanthin color additive
(2) The presence of the color additive sources listed in this part 73, shall not
in finished fish feed prepared according exceed 80 milligrams per kilogram (72
to paragraph (c) of this section shall be grams per ton) of finished feed.
declared in accordance with § 501.4 of (d) Labeling requirements. (1) The la-
this chapter. beling of the color additive and any
(3) The presence of the color additive premixes prepared therefrom shall bear
in salmonid fish that have been fed expiration dates for the sealed and
feeds containing paracoccus pigment open container (established through
shall be declared in accordance with generally accepted stability testing
§§ 101.22(b), (c), and (k)(2), and methods), other information required
101.100(a)(2) of this chapter. by § 70.25 of this chapter, and adequate
(e) Exemption from certification. Cer- directions to prepare a final product
tification of this color additive is not complying with the limitations pre-
necessary for the protection of the pub- scribed in paragraph (c) of this section.
lic health, and therefore, batches (2) The presence of the color additive
thereof are exempt from the certifi- in finished fish feed prepared according
cation requirements of section 721(c) of to paragraph (c) of this section shall be
the act. declared in accordance with § 501.4 of
[74 FR 58845, Nov. 16, 2009]
this chapter.
(3) The presence of the color additive
§ 73.355 Phaffia yeast. in salmonid fish that have been fed
feeds containing phaffia yeast shall be
(a) Identity. (1) The color additive declared in accordance with §§ 101.22(b),
phaffia yeast consists of the killed, (c), and (k)(2) and 101.100(a)(2) of this
dried cells of a nonpathogenic and chapter.
nontoxicogenic strain of the yeast (e) Exemption from certification. Cer-
Phaffia rhodozyma. tification of this color additive is not
(2) Phaffia yeast may be added to the necessary for the protection of the pub-
fish feed only as a component of a sta- lic health, and therefore batches there-
bilized color additive mixture. Color of are exempt from the certification re-
additive mixtures for fish feed use quirements of section 721(c) of the act.
made with phaffia yeast may contain
only those diluents that are suitable [65 FR 41587, July 6, 2000]
and are listed in this subpart as safe
for use in color additive mixtures for § 73.450 Riboflavin.
coloring foods. (a) Identity. (1) The color additive ri-
(b) Specifications. Phaffia yeast shall boflavin is the riboflavin defined in the
conform to the following specifications Food Chemicals Codex, 3d Ed. (1981),
and shall be free from impurities other pp. 262–263, which is incorporated by
than those named to the extent that reference. Copies may be obtained from
such impurities may be avoided by the National Academy Press, 2101 Con-
good manufacturing practice: stitution Ave. NW., Washington, DC
Physical state, solid. 20418, or at the National Archives and
Lead, not more than 5 parts per million. Records Administration (NARA). For
Arsenic, not more than 2 parts per million. information on the availability of this
Mercury, not more than 1 part per million. material at NARA, call 202–741–6030, or
Heavy metals (as Pb), not more than 10 parts go to: http://www.archives.gov/
per million. federallregister/
Astaxanthin, not less than 0.4 percent.
codeloflfederallregulations/
(c) Uses and restrictions. Phaffia yeast ibrllocations.html.
may be safely used in the feed of (2) Color additive mixtures made
salmonid fish in accordance with the with riboflavin may contain as diluents
following prescribed conditions: only those substances listed in this

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§ 73.500 21 CFR Ch. I (4–1–11 Edition)

subpart as safe and suitable for use in labeling in accordance with the provi-
color additive mixtures for coloring sions of § 70.25 of this chapter.
foods. (d) Exemption from certification. Cer-
(b) Specifications. Riboflavin shall tification of this color additive is not
meet the specifications given in the necessary for the protection of the pub-
Food Chemicals Codex, 3d Ed. (1981), lic health, and therefore batches there-
which is incorporated by reference. The of are exempt from the certification re-
availability of this incorporation by quirements of section 721(c) of the act.
reference is given in paragraph (a)(1) of
this section. § 73.575 Titanium dioxide.
(c) Uses and restrictions. Riboflavin (a) Identity. (1) The color additive ti-
may be safely used for the coloring of tanium dioxide is synthetically pre-
foods generally, in amounts consistent pared TiO2, free from admixture with
with good manufacturing practice; ex- other substances.
cept that it may not be used to color (2) Color additive mixtures for food
foods for which standards of identity use made with titanium dioxide may
have been promulgated under section contain only those diluents that are
401 of the act, unless the use of added
suitable and that are listed in this sub-
color is authorized by such standards.
part as safe in color additive mixtures
(d) Labeling. The label of the color ad-
for coloring foods, and the following:
ditive shall conform to the require-
Silicon dioxide, SiO2 and/or aluminum
ments of § 70.25 of this chapter.
oxide, Al2 O3, as dispersing aids—not
(e) Exemption from certification. Cer-
more than 2 percent total.
tification of this color additive is not
necessary for the protection of the pub- (b) Specifications. Titanium dioxide
lic health, and therefore batches there- shall conform to the following speci-
of are exempt from the certification re- fications:
quirements of section 721(c) of the Act. Lead (as Pb), not more than 10 parts per mil-
lion.
[42 FR 15643, Mar. 22, 1977, as amended at 47
Arsenic (as As), not more than 1 part per
FR 947, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984]
million.
Antimony (as Sb), not more than 2 parts per
§ 73.500 Saffron.
million.
(a) Identity. (1) The color additive saf- Mercury (as Hg), not more than 1 part per
fron is the dried stigma of Crocus million.
sativus L. The definition of saffron in Loss on ignition at 800 °C. (after drying for 3
this paragraph is for the purpose of hours at 105 °C.), not more than 0.5 percent.
identity as a color additive only, and Water soluble substances, not more than 0.3
percent.
shall not be construed as setting forth
Acid soluble substances, not more than 0.5
an official standard for saffron under percent.
section 401 of the act. TiO2, not less than 99.0 percent after drying
(2) Color additive mixtures made for 3 hours at 105 °C.
with saffron may contain as diluents
only those substances listed in this Lead, arsenic, and antimony shall be
subpart as safe and suitable in color determined in the solution obtained by
additive mixtures for coloring foods. boiling 10 grams of the titanium diox-
(b) Uses and restrictions. Saffron may ide for 15 minutes in 50 milliliters of
be safely used for the coloring of foods 0.5N hydrochloric acid.
generally, in amounts consistent with (c) Uses and restrictions. The color ad-
good manufacturing practice, except ditive titanium dioxide may be safely
that it may not be used to color foods used for coloring foods generally, sub-
for which standards of identity have ject to the following restrictions:
been promulgated under section 401 of (1) The quantity of titanium dioxide
the act, unless the use of added color is does not exceed 1 percent by weight of
authorized by such standards. the food.
(c) Labeling. The color additive and (2) It may not be used to color foods
any mixtures intended solely or in part for which standards of identity have
for coloring purposes prepared there- been promulgated under section 401 of
from shall bear, in addition to the the act unless added color is authorized
other information required by the act, by such standards.

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Food and Drug Administration, HHS § 73.600

(d) Labeling. The label of the color ad- Pkwy., College Park, MD 20740. You
ditive and any mixtures intended sole- may inspect a copy at the Center for
ly or in part for coloring purposes pre- Food Safety and Applied Nutrition’s
pared therefrom shall conform to the Library, 5100 Paint Branch Pkwy., Col-
requirements of § 70.25 of this chapter. lege Park, MD, or at the National Ar-
(e) Exemption from certification. Cer- chives and Records Administration
tification of this color additive is not (NARA). For information on the avail-
necessary for the protection of the pub- ability of this material at NARA, call
lic health and therefore batches thereof 202–741–6030, or go to: http://
are exempt from the certification re- www.archives.gov/federallregister/
quirements of section 721(c) of the act. codeloflfederallregulations/
ibrllocations.html
§ 73.585 Tomato lycopene extract; to- (2) Tomato lycopene concentrate
mato lycopene concentrate. shall conform to the following speci-
(a) Identity. (1) The color additive to- fication: Lycopene, not less than 60
mato lycopene extract is a red to dark percent of oleoresin as determined by
brown viscous oleoresin extracted with the method identified in paragraph
ethyl acetate from tomato pulp fol- (b)(1) of this section.
lowed by removal of the solvent by (c) Uses and restrictions. Tomato lyco-
evaporation. The pulp is produced from pene extract and tomato lycopene con-
fresh, edible varieties of the tomato by centrate may be safely used for color-
removing the liquid. The main coloring ing foods generally in amounts con-
component is lycopene. sistent with good manufacturing prac-
(2) The color additive tomato lyco- tice, except that they may not be used
pene concentrate is a powder prepared to color foods for which standards of
from tomato lycopene extract by re- identity have been issued under section
moving most of the tomato lipids with 401 of the act, unless the use of added
ethyl acetate and then evaporating off color is authorized by such standards.
the solvent. (d) Labeling. The label of the color ad-
(3) Color additive mixtures made ditive shall conform to the require-
with tomato lycopene extract or to- ments of § 70.25 of this chapter.
mato lycopene concentrate may con- (e) Exemption from certification. Cer-
tain only those diluents listed in this tification of this color additive is not
subpart as safe and suitable for use in necessary for the protection of the pub-
color additive mixtures for coloring lic health, and therefore batches there-
food. of are exempt from the certification re-
quirements of section 721(c) of the act.
(b) Specifications. (1) Tomato lycopene
extract shall conform to the following [70 FR 43045, July 26, 2005]
specification: Lycopene, not less than
5.5 percent of oleoresin as determined § 73.600 Turmeric.
by the method entitled ‘‘Qualitative (a) Identity. (1) The color additive
Analysis of Lycopene, Its Isomers and turmeric is the ground rhizome of
Other Carotenoids in Different Con- Curcuma longa L. The definition of
centrations of Lyc-O-Mato® (Tomato turmeric in this paragraph is for the
Oleoresin) and in Tomato Pulp by High purpose of identity as a color additive
Performance Liquid Chromatography only, and shall not be construed as set-
(HPLC),’’ S.O.P. number : Lab/119/01, ting forth an official standard for tur-
Revision 01, dated May 30, 2001, pub- meric under section 401 of the act.
lished by LycoRed Natural Products (2) Color additive mixtures made
Industries, which is incorporated by with turmeric may contain as diluents
reference, or an equivalent method. only those substances listed in this
The Director of the Office of the Fed- subpart as safe and suitable in color
eral Register approves this incorpora- additive mixtures for coloring foods.
tion by reference in accordance with 5 (b) Uses and restrictions. Turmeric
U.S.C. 552(a) and 1 CFR part 51. You may be safely used for the coloring of
may obtain a copy of the method from foods generally, in amounts consistent
the Center for Food Safety and Applied with good manufacturing practice, ex-
Nutrition (HFS–200), Food and Drug cept that it may not be used to color
Administration, 5100 Paint Branch foods for which standards of identity

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§ 73.615 21 CFR Ch. I (4–1–11 Edition)

have been promulgated under section ing of foods generally, in amounts con-
401 of the act, unless the use of added sistent with good manufacturing prac-
color is authorized by such standards. tice, except that it may not be used to
(c) Labeling. The color additive and color foods for which standards of iden-
any mixtures intended solely or in part tity have been promulgated under sec-
for coloring purposes prepared there- tion 401 of the act, unless the use of
from shall bear, in addition to the added color is authorized by such
other information required by the act, standards.
labeling in accordance with the provi- (d) Labeling. The color additive and
sions of § 70.25 of this chapter. any mixtures intended solely or in part
(d) Exemption from certification. Cer- for coloring purposes prepared there-
tification of this color additive is not
from shall bear, in addition to the
necessary for the protection of the pub-
other information required by the act,
lic health, and therefore batches there-
labeling in accordance with the provi-
of are exempt from the certification re-
quirements of section 721(c) of the act. sions of § 70.25 of this chapter.
(e) Exemption from certification. Cer-
§ 73.615 Turmeric oleoresin. tification of this color additive is not
(a) Identity. (1) The color additive necessary for the protection of the pub-
turmeric oleoresin is the combination lic health, and therefore batches there-
of flavor and color principles obtained of are exempt from the certification re-
from turmeric (Curcuma longa L.) by quirements of section 721(c) of the act.
extraction using any one or a combina-
tion of the following solvents: Subpart B—Drugs
Acetone Isopropyl alcohol
Ethyl alcohol Methyl alcohol § 73.1001 Diluents in color additive
Ethylene dichloride Methylene chloride mixtures for drug use exempt from
Hexane Trichloroethylene certification.
The following diluents may be safely
The definition of turmeric oleoresin in
used in color additive mixtures that
this paragraph is for the purpose of
are exempt from certification and
identity as a color additive only, and
which are to be used for coloring drugs,
shall not be construed as setting forth
an official standard for turmeric oleo- subject to the condition that each
resin under section 401 of the act. straight color in the mixture has been
(2) Color additive mixtures made exempted from certification or, if not
with turmeric oleoresin may contain as so exempted, is from a batch that has
diluents only those substances listed in previously been certified and has not
this subpart as safe and suitable in changed in composition since certifi-
color additive mixtures for coloring cation. Such listing of diluents is not
foods. to be construed as superseding any of
(b) Specifications. Turmeric oleoresin the other requirements of the Federal
shall contain no more residue of the Food, Drug, and Cosmetic Act with re-
solvents listed under paragraph (a)(1) spect to drugs, including new drugs. If
of this section than is permitted for a definition and specification for a par-
the corresponding solvents in spice ticular diluent is not set forth in this
oleoresins under applicable food addi- subpart, the material shall be of a pu-
tive regulation in parts 170 through 189 rity consistent with its intended use.
of this chapter. (a) Ingested drugs—(1) General use.
(c) Uses and restrictions. Turmeric ole- Diluents listed in § 73.1(a) and the fol-
oresin may be safely used for the color- lowing:
Substances Definitions and specifications Restrictions

Alcohol, specially denatured .............................. As set forth in 26 CFR, pt. 212 .......... As set forth in 26 CFR, pt. 211.
Cetyl alcohol ....................................................... As set forth in N.F. XI.
Isopropyl alcohol ................................................ ........................................................ In color coatings for pharmaceutical
forms, no residue.
Polyoxyethylene (20) sorbitan monostearate As set forth in sec. 172.836 of this
(Polysorbate 60). chapter.
Polyoxyethylene (20) sorbitan tristearate (Poly- As set forth in sec. 172.838 of this
sorbate 65). chapter.

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Food and Drug Administration, HHS § 73.1015

Substances Definitions and specifications Restrictions

Polysorbate 80 ................................................... As set forth in sec. 172.840 of this


chapter.
Polyvinyl-pyrrolidone .......................................... As set forth in sec. 173.55 of this
chapter.
Sorbitan monooleate.
Sorbitan monostearate ....................................... As set forth in sec. 172.842 of this
chapter.
Sorbitan trioleate.

(2) Special use; inks for branding phar- (c) Uses and restrictions. Alumina
maceutical forms. Items listed in para- (dried aluminum hydroxide) may be
graph (a)(1) of this section, safely used in amounts consistent with
§ 73.1(b)(1)(i), and the following: good manufacturing practice to color
drugs generally.
Ethyl lactate
(d) Labeling requirements. The label of
Polyoxyethylene sorbitan monolaurate (20)
the color additive and of any mixtures
(b) Externally applied drugs. Diluents prepared therefrom intended solely or
listed in paragraph (a)(1) of this section in part for coloring purposes shall con-
and the following: form to the requirements of § 70.25 of
this chapter.
Substances Definitions and specifications (e) Exemption from certification. Cer-
Benzyl alcohol ............... As set forth in N.F. XI.
tification of this color additive is not
Ethyl cellulose ............... As set forth in § 172.868 of this necessary for the protection of the pub-
chapter. lic health, and therefore batches there-
Hydroxyethyl cellulose. of are exempt from the certification re-
Hydroxypropyl cellulose As set forth in § 172.870 of this quirements of section 721(c) of the act.
chapter.
§ 73.1015 Chromium-cobalt-aluminum
§ 73.1010 Alumina (dried aluminum hy- oxide.
droxide). (a) Identity. The color additive chro-
(a) Identity. (1) The color additive mium-cobalt-aluminum oxide is a blue-
alumina (dried aluminum hydroxide) is green pigment obtained by calcining a
a white, odorless, tasteless, amorphous mixture of chromium oxide, cobalt car-
powder consisting essentially of alu- bonate, and aluminum oxide. It may
minum hydroxide (Al2 O3· XH2 O). contain small amounts (less than 1 per-
(2) Color additive mixtures for drug cent each) of oxides of barium, boron,
use made with alumina (dried alu- silicon, and nickel.
minum hydroxide) may contain only (b) Specifications. Chromium-cobalt-
those diluents listed in this subpart as aluminum oxide shall conform to the
safe and suitable for use in color addi- following specifications:
tive mixtures for coloring drugs. Chromium, calculated as Cr2 O3, 34–37 per-
(b) Specifications. Alumina (dried alu- cent.
minum hydroxide) shall conform to the Cobalt, calculated as CoO, 29–34 percent.
following specifications: Aluminum, calculated as AL2 O3, 29–35 per-
cent.
Acidity or alkalinity: Agitate 1 gram of the Lead (as Pb), not more than 30 parts per mil-
color additive with 25 milliliters of water lion.
and filter. The filtrate shall be neutral to Arsenic (as As), not more than 3 parts per
litmus paper. million.
Matter insoluble in dilute hydrochloric acid, Total oxides of aluminum, chromium, and
not more than 0.5 percent. cobalt not less than 97 percent.
Lead (as Pb), not more than 10 parts per mil-
lion. Lead and arsenic shall be determined
Arsenic (as As), not more than 1 part per in the solution obtained by boiling 10
million. grams of the chromium-cobalt-alu-
Mercury (as Hg), not more than 1 part per minum oxide for 15 minutes in 50 milli-
million. liters of 0.5 N hydrochloric acid.
Aluminum oxide (Al2 O3), not less than 50 (c) Uses and restrictions. The color ad-
percent. ditive chromium-cobalt-aluminum

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§ 73.1025 21 CFR Ch. I (4–1–11 Edition)

oxide may be safely used for coloring (c) Uses and restrictions. Ferric ammo-
linear polyethylene surgical sutures, nium citrate may be safely used in
United States Pharmacopeia (U.S.P.), combination with pyrogallol (as listed
for use in general surgery, subject to in § 73.1375), for coloring plain and chro-
the following restrictions: mic catgut sutures for use in general
(1) For coloring procedure, the color and ophthalmic surgery subject to the
additive is blended with the poly- following conditions:
ethylene resin. The mixture is heated (1) The dyed suture shall conform in
to a temperature of 500°–550 °F. and ex- all respects to the requirements of the
truded through a fixed orifice. The fila- United States Pharmacopeia XX (1980).
ments are cooled, oriented by drawing, (2) The level of the ferric ammonium
and set by annealing. citrate-pyrogallol complex shall not
(2) The quantity of the color additive exceed 3 percent of the total weight of
does not exceed 2 percent by weight of the suture material.
the suture material. (3) When the sutures are used for the
(3) The dyed suture shall conform in purposes specified in their labeling,
all respects to the requirements of the there is no migration of the color addi-
U.S.P. XX (1980). tive to the surrounding tissue.
(4) When the sutures are used for the (4) If the suture is a new drug, an ap-
purpose specified in their labeling, proved new drug application, pursuant
there is no migration of the color addi- to section 505 of the act, is in effect for
tive to the surrounding tissue. it.
(5) If the suture is a new drug, an ap- (d) Labeling. The labeling of the
proved new drug application, pursuant color-additive shall conform to the re-
to section 505 of the Federal Food, quirements of § 70.25 of this chapter.
Drug, and Cosmetic Act, is in effect for (e) Exemption from certification. Cer-
it. tification of this color additive is not
(d) Labeling. The label of the color ad- necessary for the protection of the pub-
ditive shall conform to the require- lic health and therefore batches thereof
ments of § 70.25 of this chapter. are exempt from the requirements of
(e) Exemption from certification. Cer- section 721(c) of the act.
tification of this color additive is not
[42 FR 15643, Mar. 22, 1977, as amended at 49
necessary for the protection of the pub- FR 10089, Mar. 19, 1984]
lic health, and batches thereof are ex-
empt from the certification require- § 73.1030 Annatto extract.
ments of section 721(c) of the act.
(a) Identity and specifications. (1) The
[42 FR 15643, Mar. 22, 1977, as amended at 49 color additive annatto extract shall
FR 10089, Mar. 19, 1984] conform in identity and specifications
to the requirements of § 73.30(a)(1) and
§ 73.1025 Ferric ammonium citrate. (b).
(a) Identity. The color additive ferric (2) Color additive mixtures for drug
ammonium citrate consists of complex use made with annatto extract may
chelates prepared by the interaction of contain only those diluents that are
ferric hydroxide with citric acid in the suitable and that are listed in this sub-
presence of ammonia. The complex part as safe in color additive mixtures
chelates occur in brown and green for coloring ingested drugs.
forms, are deliquescent in air, and are (b) Uses and restrictions. Annatto ex-
reducible by light. tract may be safely used for coloring
(b) Specifications. Ferric ammonium drugs generally, including those in-
citrate shall conform to the following tended for use in the area of the eye, in
specifications and shall be free from amounts consistent with good manu-
impurities other than those named to facturing practice.
the extent that such impurities may be (c) Labeling. The label of the color ad-
avoided by good manufacturing prac- ditive and any mixtures prepared
tice: therefrom and intended solely or in
Iron (as Fe), not less than 14.5 percent and part for coloring purposes shall con-
not more than 18.5 percent. form to the requirements of § 70.25 of
Lead (as Pb), not more than 20 p/m. this chapter. Labels shall bear informa-
Arsenic (as As), not more than 3 p/m. tion showing that the color is derived

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Food and Drug Administration, HHS § 73.1095

from annatto seed. The requirements of diluents that are suitable and that are
§ 70.25(a) of this chapter that all ingre- listed in this subpart as safe in color
dients shall be listed by name shall not additive mixtures for coloring ingested
be construed as requiring the declara- drugs.
tion of residues of solvents listed in (b) Uses and restrictions.
§ 73.30(a)(1)(ii) of this chapter. Canthaxanthin may be safely used for
(d) Exemption from certification. Cer- coloring ingested drugs generally in
tification of this color additive is not amounts consistent with good manu-
necessary for the protection of the pub- facturing practice.
lic health and therefore batches thereof (c) Labeling requirements. The label of
are evempt from the certification re- the color additive and of any mixtures
quirements of section 721(c) of the act. prepared therefrom intended solely or
in part for coloring purposes shall con-
[42 FR 15643, Mar. 22, 1977, as amended at 42
FR 36994, July 19, 1977]
form to the requirements of § 70.25 of
this chapter.
§ 73.1070 Calcium carbonate. (d) Exemption from certification. Cer-
tification of this color additive is not
(a) Identity. (1) The color additive cal- necessary for the protection of the pub-
cium carbonate is a fine, white, syn- lic health, and therefore batches there-
thetically prepared powder consisting of are exempt from the certification re-
essentially of precipitated calcium car- quirements of section 721(c) of the act.
bonate (CaCO3).
(2) Color additive mixtures for drug § 73.1085 Caramel.
use made with calcium carbonate may
(a) Identity and specifications. (1) The
contain only those diluents listed in
color additive caramel shall conform in
this subpart as safe and suitable for use
identity and specifications to the re-
in color additive mixtures for coloring
quirements of § 73.85(a) (1), (2), and (3)
drugs.
and (b).
(b) Specifications. Calcium carbonate
(2) The diluents in color additive
shall meet the specifications for pre-
mixtures for drug use containing car-
cipitated calcium carbonate in the
amel shall be limited to those listed in
United States Pharmacopeia XX (1980).
this subpart as safe and suitable in
(c) Uses and restrictions. Calcium car-
color additive mixtures for coloring
bonate may be safely used in amounts
drugs.
consistent with good manudacturing (b) Uses and restrictions. Caramel may
practice to color drugs generally. be used for coloring ingested and topi-
(d) Labeling requirements. The label of cally applied drugs generally in
the color additive and of any mixtures amounts consistent with good manu-
prepared therefrom intended solely or facturing practice.
in part for coloring purposes shall con- (c) Exemption from certification. Cer-
form to the requirements of § 70.25 of tification of this color additive is not
this chapter. necessary for the protection of the pub-
(e) Exemption from certification. Cer- lic health and therefore batches thereof
tification of this color additive is not are exempt from the certification re-
necessary for the protection of the pub- quirement of section 721(c) of the act.
lic health, and therefore batches there-
of are exempt from the certification re- § 73.1095 β-Carotene.
quirements of section 721(c) of the act.
(a) Identity and specifications. (1) The
[42 FR 15643, Mar. 22, 1977, as amended at 49 color additive b-carotene shall conform
FR 10089, Mar. 19, 1984] in identity and specifications to the re-
quirements of § 73.95(a)(1) and (b).
§ 73.1075 Canthaxanthin. (2) The diluents in color additive
(a) Identity and specifications. (1) The mixtures for drug use containing b-car-
color additive canthaxanthin shall con- otene are limited to those listed in this
form in identity and specifications to subpart as safe and suitable in color
the requirements of § 73.75(a)(1) and (b). additive mixtures for coloring ingested
(2) Color additive mixtures for in- drugs.
gested drug use made with (b) Uses and restrictions. The color ad-
canthaxanthin may contain only those ditive b-carotene may be safely used in

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§ 73.1100 21 CFR Ch. I (4–1–11 Edition)

coloring drugs generally, including The source of the chlorophyll is dehy-


those intended for use in the area of drated alfalfa.
the eye, in amounts consistent with (2) Color additive mixtures for drug
good manufacturing practice. use made with potassium sodium cop-
(c) Labeling requirements. The labeling per chlorophyllin may contain only
of the color additive and any mixtures those diluents that are suitable and
intended solely or in part for coloring that are listed in this subpart as safe
purposes prepared therefrom shall con- for use in color additive mixtures for
form to the requirements of § 70.25 of coloring drugs.
this chapter. (b) Specifications. Potassium sodium
(d) Exemption from certification. Cer- copper chlorophyllin shall conform to
tification of this color additive is not the following specifications and shall
necessary for the protection of the pub- be free from impurities other than
lic health, and therefore batches there- those named to the extent that such
of are exempt from the certification re- other impurities may be avoided by
quirements of section 721(c) of the act. good manufacturing practice:
[42 FR 15643, Mar. 22, 1977, as amended at 42 Moisture, not more than 5.0 percent.
FR 33722, July 1, 1977] Nitrogen, not more than 5.0 percent.
pH of 1 percent solution, 9 to 11.
§ 73.1100 Cochineal extract; carmine. Total copper, not less than 4 percent and not
(a) Identity and specifications. (1) The more than 6 percent.
color additives cochineal extract and Free copper, not more than 0.25 percent.
carmine shall conform in identity and Iron, not more than 0.5 percent.
specifications to the requirements of Lead (as Pb)), not more than 20 parts per
§ 73.100(a) (1) and (2) and (b). million.
Arsenic (as As), not more than 5 parts per
(2) Color additive mixtures for drug
million.
use made with carmine and cochineal Ratio, absorbance at 405 mμ to absorbance at
extract may contain only those 630 mμ, not less than 3.4 and not more than
diluents that are suitable and that are 3.9.
listed in this subpart as safe in color Total color, not less than 75 percent.
additive mixtures for coloring drugs.
(b) Uses and restrictions. Cochineal ex- (c) Uses and restrictions. Potassium
tract and carmine may be safely used sodium copper chlorophyllin may be
for coloring ingested and externally ap- safely used for coloring dentifrices that
plied drugs in amounts consistent with are drugs at a level not to exceed 0.1
good manufacturing practice. percent. Authorization for this use
(c) Labeling requirements. The label of shall not be construed as waiving any
the color additives and any mixtures of the requirements of section 505 of
intended solely or in part for coloring the act with respect to the drug in
purposes prepared therefrom shall con- which it is used.
form to the requirements of § 70.25 of (d) Labeling. The label of the color ad-
this chapter. ditive and any mixtures prepared
(d) Exemption from certification. Cer- therefrom intended solely or in part for
tification of these color additives is coloring purposes shall conform to the
not necessary for the protection of the requirements of § 70.25 of this chapter.
public health, and therefore batches (e) Exemption from certification. Cer-
thereof are exempt from the certifi- tification of this color additive is not
cation requirements of section 721(c) of necessary for the protection of the pub-
the act. lic health and therefore batches thereof
are exempt from the certification re-
§ 73.1125 Potassium sodium copper quirements of section 721(c) of the act.
chloropyhllin (chlorophyllin-copper
complex). § 73.1150 Dihydroxyacetone.
(a) Identity. (1) The color additive po- (a) Identity. (1) The color additive
tassium sodium copper chlorophyllin is dihydroxyacetone is 1,3-dihydroxy-2-
a green to black powder obtained from propanone.
chlorophyll by replacing the methyl (2) Color additive mixtures for drug
and phytyl ester groups with alkali and use made with dihydroxyacetone may
replacing the magnesium with copper. contain only those diluents that are

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Food and Drug Administration, HHS § 73.1200

listed in this subpart as safe and suit- (b) Specifications. The color additive
able in color additive mixtures for bismuth oxychloride shall conform to
coloring externally applied drugs. the following specifications and shall
(b) Specifications. Dihydroxyacetone be free from impurities other than
shall conform to the following speci- those named to the extent that such
fications and shall be free from impuri- other impurities may be avoided by
ties other than those named to the ex- good manufacturing practice:
tent that such impurities may be
Volatile matter, not more than 0.5 percent.
avoided by good manufacturing prac-
Lead (as Pb), not more than 20 parts per mil-
tice: lion.
Volatile matter (at 34.6 °C. for 3 hours at a Arsenic (as As), not more than 3 parts per
pressure of not more than 30 mm. mer- million.
cury), not more than 0.5 percent. Mercury (as Hg), not more than 1 part per
Residue on ignition, not more than 0.4 per- million.
cent. Bismuth oxychloride, not less than 98 per-
Lead (as Pb), not more than 20 parts per mil- cent.
lion.
Arsenic (as As), not more than 3 parts per (c) Uses and restrictions. The color ad-
million. ditive bismuth oxychloride may be
Iron (as Fe), not more than 25 parts per mil- safely used in coloring externally ap-
lion. plied drugs, including those intended
1,3-dihydroxy-2-propanone, not less than 98 for use in the area of the eye, in
percent. amounts consistent with good manu-
(c) Uses and restrictions. facturing practice.
Dihydroxyacetone may be safely used (d) Labeling. The color additive and
in amounts consistent with good manu- any mixture prepared therefrom in-
facturing practice in externally applied tended solely or in part for coloring
drugs intended solely or in part to im- purposes shall bear, in addition to any
part a color to the human body. Au- information required by law, labeling
thorization for this use shall not be in accordance with the provisions of
construed as waiving any of the re- § 70.25 of this chapter.
quirements of section 505 of the act (e) Exemption from certification. Cer-
with respect to the drug in which it is tification of this color additive is not
used. necessary for the protection of the pub-
(d) Labeling requirements. The label of lic health, and therefore batches there-
the color additive and any mixtures of are exempt from certification pursu-
prepared therefrom intended solely or ant to section 721(c) of the act.
in part for coloring purposes shall con-
form to the requirements of § 70.25 of [42 FR 52394, Sept. 30, 1977]
this chapter. § 73.1200 Synthetic iron oxide.
(e) Exemption from certification. Cer-
tification of this color additive is not (a) Identity. (1) The color additive
necessary for the protection of the pub- synthetic iron oxide consists of any
lic health and therefore batches thereof one or any combination of syn-
are exempt from the certification re- thetically prepared iron oxides, includ-
quirements of section 721(c) of the act. ing the hydrated forms. It is free from
admixture with other substances.
§ 73.1162 Bismuth oxychloride. (2) Color additive mixtures for drug
(a) Identity. (1) The color additive bis- use made with synthetic iron oxide
muth oxychloride is a synthetically may contain only those diluents listed
prepared white or nearly white amor- in this subpart as safe and suitable in
phous or finely crystalline, odorless color additive mixtures for coloring
powder consisting principally of BiOCl. drugs.
(2) Color additive mixtures for drug (b) Specifications. Synthetic iron
use made with bismuth oxychloride oxide shall conform to the following
may contain only those diluents that specifications, all on an ‘‘as is’’ basis:
are suitable and that are listed in this Arsenic (as As), not more than 3 parts per
subpart as safe in color additive mix- million.
tures for coloring externally applied Lead (as Pb), not more than 10 parts per mil-
drugs. lion.

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§ 73.1298 21 CFR Ch. I (4–1–11 Edition)
Mercury (as Hg), not more than 3 parts per Water soluble cyanide, not more than 10
million. parts per million.
Volatile matter, not more than 4 percent.
(c) Uses and restrictions. The color ad- Lead (as Pb), not more than 20 parts per mil-
ditive synthetic iron oxide may be lion.
safely used to color ingested or topi- Arsenic (as As), not more than 3 parts per
cally applied drugs generally subject to million.
the restriction that if the color addi- Nickel (as Ni), not more than 200 parts per
tive is used in drugs ingested by man million.
the amount consumed in accordance Cobalt (as Co), not more than 200 parts per
with labeled or prescribed dosages shall million.
not exceed 5 milligrams, calculated as Mercury (as Hg), not more than 1 part per
elemental iron, per day. million.
Total iron (as Fe corrected for volatile mat-
(d) Labeling requirements. The label of ter), not less than 33 percent and not more
the color additive and any mixtures in- than 39 percent.
tended solely or in part for coloring
purposes prepared therefrom shall con- (c) Uses and restrictions. Ferric ammo-
form to the requirements of § 70.25 of nium ferrocyanide may be safely used
this chapter. in amounts consistent with good manu-
(e) Exemption from certification. Cer- facturing practice to color externally
tification of this color additive is not applied drugs, including those for use
necessary for the protection of the pub- in the area of the eye.
lic health, and therefore batches there- (d) Labeling requirements. The label of
of are exempt from certification re- the color additive and of any mixtures
quirements of section 721(c) of the act. prepared therefrom intended solely or
in part for coloring purposes shall con-
§ 73.1298 Ferric ammonium ferrocya- form to the requirements of § 70.25 of
nide. this chapter.
(a) Identity. (1) The color additive fer- (e) Exemption from certification. Cer-
ric ammonium ferrocyanide is the blue tification of this color additive is not
pigment obtained by oxidizing under necessary for the protection of the pub-
acidic conditions with sodium dichro- lic health, and therfore batches thereof
mate the acid digested precipitate re- are exempt from the certification re-
sulting from mixing solutions of fer- quirements of section 721(c) of the act.
rous sulfate and sodium ferrocyanide in [42 FR 38562, July 29, 1977, as amended at 44
the presence of ammonium sulfate. The FR 28322, May 15, 1979]
oxidized product is filtered, washed,
and dried. The pigment consists prin- § 73.1299 Ferric ferrocyanide.
cipally of ferric ammonium ferrocya- (a) Identity. (1) The color additive fer-
nide with smaller amounts of ferric fer- ric ferrocyanide is a ferric
rocyanide and ferric sodium ferrocya- hexacyanoferrate pigment character-
nide. ized by the structual formula
(2) Color additive mixtures for drug Fe4[Fe(CN)6]3·XH2O, which may contain
use made with ferric ammonium ferro- small amounts of ferric sodium ferro-
cyanide may contain only those cyanide and ferric potassium ferrocya-
diluents listed in this subpart as safe nide.
and suitable for use in color additive (2) Color additive mixtures for drug
mixtures for coloring drugs. use made with ferric ferrocyanide may
(b) Specifications. Ferric ammonium contain only those diluents listed in
ferrocyanide shall conform to the fol- this subpart as safe and suitable for use
lowing specifications and shall be free in color additive mixtures for coloring
of impurities other than those named drugs.
to the extent that the other impurities (b) Specifications. Ferric ferrocyanide
may be avoided by good manufacturing shall conform to the following speci-
practice: fications and shall be free from impuri-
Oxalic acid or its salts, not more than 0.1 ties other than those named to the ex-
percent. tent that such impurities may be
Water soluble matter, not more than 3 per- avoided by good manufacturing prac-
cent. tice:

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Food and Drug Administration, HHS § 73.1327
Water soluble cyanide, not more than 10 Chromium in 2% NaOH extract, not more
parts per million. than 0.1% as Cr2O3 (based on sample
Lead (as Pb), not more than 20 parts per mil- weight).
lion. Boron (as B2O3), not more than 8 percent.
Arsenic (as As), not more than 3 parts per Total volatile matter at 1000 °C, not more
million. than 20%.
Nickel (as Ni), not more than 200 parts per Cr2O3 not less than 75%.
million. Lead (as Pb), not more than 20 parts per mil-
lion.
Cobalt (as Co), not more than 200 parts per
Arsenic (as As), not more than 3 parts per
million.
million.
Mercury (as Hg), not more than 1 part per
Mercury (as Hg), not more than 1 part per
million. million.
Oxalic acid, not more than 0.1 percent.
Water soluble matter, not more than 3 per- (c) Uses and restrictions. Chromium
cent. hydroxide green may be safely used in
Volatile matter, not more than 10 percent. amounts consistent with good manu-
Total iron (as Fe corrected for volatile mat- facturing practice to color externally
ter), not less than 37 percent and not more applied drugs, including those for use
than 45 percent. in the area of the eye.
(c) Uses and restrictions. Ferric ferro- (d) Labeling requirements. The label of
cyanide may be safely used in amounts the color additive and of any mixtures
consistent with good manufacturing prepared therefrom lintended solely or
practice to color externally applied in part for coloring purposes shall con-
drugs including those intended for use form to the requirements of § 70.25 of
in the area of the eye. this chapter.
(d) Labeling requirements. The label of (e) Exemption from certification. Cer-
the color additive and of any mixtures tification of this color additive is not
prepared therefrom intended solely or necessary for the protection of the pub-
in part for coloring purposes shall con- lic health, and therefore batches there-
form to the requirements of § 70.25 of of are exempt from the certification re-
this chapter. quirements of section 721(c) of the act.
(e) Exemption from certification. Cer- [42 FR 36451, July 15, 1977, as amended at 42
tification of this color additive is not FR 59852, Nov. 22, 1977]
necessary for the protection of the pub-
lic health, and therefore batches there- § 73.1327 Chromium oxide greens.
of are exempt from certification re- (a) Identity. (1) The color additive
quirements of section 721(c) of the act. chromium oxide greens is principally
chromic sesquioxide (Cr2O3).
[43 FR 54235, Nov. 21, 1978]
(2) Color additive mixtures for drug
§ 73.1326 Chromium hydroxide green. use made with chromium oxide greens
may contain only those diluents listed
(a) Identity. (1) The color additive in this subpart as safe and suitable for
chromium hydroxide green is prin- use in color additive mixtures for
cipally hydrated chromic sesquioxide coloring drugs.
(Cr2O3·XH2O). (b) Specifications. the color additive
(2) Color additive mixtures for drug chormium oxide greens shall conform
use made with chromium hydroxide to the following specifications and
green may contain only those diluents shall be free from impurities other
listed in this subpart as safe and suit- than those named to the extent that
able for use in color additive mixtures such impurities may be avoided by
for coloring drugs. good manufacturing practice:
(b) Specifications. Chromium hydrox- Chromium in 2% NaOH extract, not more
ide green shall conform to the fol- than 0.075% as Cr2O3 (based on sample
lowing specifications and shall be free weight).
from impurities other than those Arsenic (as As), not more than 3 parts per
named to the extent that such impuri- million.
ties may be avoided by good manufac- Lead (as Pb), not more than 20 parts per mil-
turing practice: lion.
Mercury (as Hg), not more than 1 part per
Water soluble matter, not more than 2.5%. million.

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§ 73.1329 21 CFR Ch. I (4–1–11 Edition)
Cr2O3, not less than 95%. plied drugs, including those intended
(c) Uses and restrictions. Chromium for use in the area of the eye, in
oxide greens is safe for use in coloring amounts consistent with good manu-
externally applied drugs, including facturing practice.
those intended for use in the area of (d) Labeling. The color additive and
eye, in amounts consistent with good any mixture prepared therefrom in-
manufacturing practice. tended solely or in part for coloring
(d) Labeling. The color additive and purposes shall bear, in addition to any
any mixture prepared therefrom in- information required by law, labeling
tended solely or in part for coloring in accordance with § 70.25 of this chap-
purposes shall bear, in addition to any ter.
information required by law, labeling (e) Exemption from certification. Cer-
in accordance with § 70.25 of this chap- tification of this color additive is not
ter. necessary for the protection of the pub-
(e) Exemption from certification. Cer- lic health, and therefore batches therof
tification of this color additive is not are exempt from certification pursuant
necessary for the protection of the pub- to section 721(c) of the act.
lic health, and therefore batches therof [42 FR 37537, July 22, 1977]
are exempt from certification pursuant
to section 721(c) of the act. § 73.1350 Mica-based pearlescent pig-
ments.
[42 FR 36451, July 15, 1977]
(a) Identity. (1) The color additive is
§ 73.1329 Guanine. formed by depositing titanium and/or
(a) Identity. (1) The color additive iron salts onto mica, followed by heat-
guanine is the crystalline material ob- ing to produce one of the following
tained from fish scales and consists combinations: Titanium dioxide on
principally of the two purines, guanine mica; iron oxide on mica; titanium di-
and hypoxanthine. The guanine con- oxide and iron oxide on mica. Mica
tent will vary from 75 to 97 percent, used to manufacture the color additive
and the hypoxanthine will vary from 3 shall conform in identity to the re-
to 25 percent, depending on the par- quirements of § 73.1496(a)(1).
ticular fish and tissue from which the (2) Color additive mixtures for drug
crystals are derived. use made with mica-based pearlescent
(2) Color additive mixtures for drug pigments may contain only those
use made with guanine may contain diluents listed in this subpart as safe
only those diluents listed in this sub- and suitable for use in color additive
part as safe and suitable for use in mixtures for coloring ingested drugs.
color additive mixtures for coloring ex- (b) Specifications. Mica-based pearl-
ternally applied drugs. escent pigments shall conform to the
(b) Specifications. The color additive following specifications and shall be
guanine shall conform to the following free from impurities other than those
specifications and shall be free from named to the extent that such other
impurities other than those named to impurities may be avoided by good
the extent that such other impurities manufacturing practice:
may be avoided by good manufacturing (1) Lead (as Pb), not more than 4
practice: parts per million (ppm).
(2) Arsenic (as As), not more than 3
Guanine, not less than 75 percent. ppm.
Hypoxanthine, not more than 25 percent. (3) Mercury (as Hg), not more than 1
Ash (ignition at 800 °C), not more than 2 per-
cent.
ppm.
Lead (as Pb), not more than 20 parts per mil- (c) Uses and restrictions. Mica-based
lion. pearlescent pigments may be safely
Arsenic (as As), not more than 3 parts per used to color ingested drugs in
million. amounts up to 3 percent, by weight, of
Assay, not less than 96 percent total purines. the final drug product. The maximum
Mercury (as Hg), not more than 1 part per amount of iron oxide to be used in pro-
million.
ducing said pigments is not to exceed
(c) Uses and restrictions. Guanine is 55 percent, by weight, in the finished
safe for use in coloring externally ap- pigment.

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Food and Drug Administration, HHS § 73.1410

(d) Labeling. The label of the color ad- are exempt from the certification re-
ditive and of any mixture prepared quirements of section 721(c) of the act.
therefrom intended solely or in part for [42 FR 15643, Mar. 22, 1977, as amended at 49
coloring purposes shall conform to the FR 10089, Mar. 19, 1984]
requirements of § 70.25 of this chapter.
(e) Exemption from certification. Cer- § 73.1400 Pyrophyllite.
tification of this color additive is not (a) Identity. (1) The color additive
necessary for the protection of the pub- pyrophyllite is a naturally occurring
lic health, and therefore batches there- mineral substance consisting predomi-
of are exempt from the certification re- nantly of a hydrous aluminum silicate,
quirements of section 721(c) of the Fed-
Al2O3·4SiO2·H2 O, intimately mixed
eral Food, Drug, and Cosmetic Act.
with lesser amounts of finely divided
[70 FR 42273, July 22, 2005. Redesignated at 72 silica, SiO2. Small amounts, usually
FR 10357, Mar. 8, 2007] less than 3 percent, of other silicates,
such as potassium aluminum silicate,
§ 73.1375 Pyrogallol. may be present. Pyrophyllite may be
(a) Identity. The color additive pyro- identified and semiquantitatively de-
gallol is 1,2,3-trihydroxybenzene. termined by its characteristic X-ray
(b) Specifications. Pyrogallol shall powder diffraction pattern and by its
conform to the following specifications optical properties.
and shall be free from impurities other (2) Color additive mixtures made
than those named to the extent that with pyrophyllite are limited to those
such impurities may be avoided by listed in this subpart as safe and suit-
good manufacturing practice: able in color additive mixtures for
Melting point, between 130° and 133 °C. coloring externally applied drugs.
Residue on ignition, not more than 0.1 per- (b) Specifications. Pyrophyllite shall
cent. conform to the following specifica-
Lead (as Pb), not more than 20 p/m (parts per tions:
million).
Arsenic (as As), not more than 3 p/m. Lead (as Pb), not more than 20 parts per mil-
lion.
(c) Uses and restrictions. Pyrogallol Arsenic (as As), not more than 3 parts per
may be safely used in combination million.
with ferric ammonium citrate (as list-
ed in § 73.1025), for coloring plain and Lead and arsenic shall be determined
chromic catgut sutures for use in gen- in the solution obtained by boiling 10
eral and ophthalmic surgery, subject to grams of the pyrophyllite for 15 min-
the following restrictions: utes in 50 milliliters of 0.5N hydro-
(1) The dyed suture shall conform in chloric acid.
all respects to the requirements of the (c) Uses and restrictions. Pyrophyllite
United States Pharmacopeia XX (1980). may be safely used in amounts con-
(2) The level of the ferric ammonium sistent with good manufacturing prac-
citrate-pyrogallol complex shall not tice to color drugs that are to be exter-
exceed 3 percent of the total weight of nally applied.
the suture material. (d) Labeling requirements. The labeling
(3) When the sutures are used for the of the color additive and any mixtures
purposes specified in their labeling, prepared therefrom intended solely or
there is no migration of the color addi- in part for coloring purposes shall con-
tive to the surrounding tissues. form to the requirements of § 70.25 of
(4) If the suture is a new drug, an ap- this chapter.
proved new drug application, pursuant (e) Exemption from certification. Cer-
to section 505 of the act, is in effect for tification of this color additive is not
it. necessary for the protection of the pub-
(d) Labeling. The label of the color ad- lic health, and therefore batches there-
ditive shall conform to the require- of are exempt from the certification re-
ments of § 70.25 of this chapter. quirements of section 721(c) of the act.
(e) Exemption from certification. Cer-
tification of this color additive is not § 73.1410 Logwood extract.
necessary for the protection of the pub- (a) Identity. The color additive
lic health and therefore batches thereof logwood extract is a reddish brown-to-

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§ 73.1496 21 CFR Ch. I (4–1–11 Edition)

black solid material extracted from the § 73.1496 Mica.


heartwood of the leguminous tree (a) Identity. (1) The color additive
Haematoxylon campechianum. The ac- mica is a white powder obtained from
tive colorant substance is principally the naturally occurring mineral, mus-
hematein. The latent coloring material covite mica, consisting predominantly
is the unoxidized or leuco form of he- of a potassium aluminum silicate,
matein called hematoxylin. The leuco K2Al4(Al2Si6O20)(OH)4 or, alternatively,
form is oxidized by air. H2KAl3 (SiO4)3. Mica may be identified
(b) Specifications. Logwood extract and semiquantitatively determined by
shall conform to the following speci- its characteristic X-ray diffraction pat-
fications and shall be free from impuri- tern and by its optical properties.
ties other than those named to the ex- (2) Color additive mixtures for drug
tent that such imnurities may be use made with mica may contain only
avoided by good manufacturing prac- those diluents listed in this subpart as
tice: safe and suitable for use in color addi-
tive mixtures for coloring drugs.
Volatile matter (at 110 °C), not more than 15 (b) Specifications. Mica shall conform
percent.
to the following specifications and
Sulfated ash, not more than 20 percent.
shall be free from impurities other
Hematein, not less than 5 percent and not
than those named to the extent that
more than 20 percent.
such other impurities may be avoided
Lead (as Pb), not more than 70 parts per mil-
lion.
by good manufacturing practice:
Arsenic (as As), not more than 4 parts per Fineness, 100 percent shall pass through a
million. 100-mesh sieve.
Mercury (as Hg), not more than 3 parts per Loss on ignition at 600–650 °C, not more than
million. 2 percent.
Lead (as Pb), not more than 20 parts per mil-
(c) Use and restrictions. Logwood ex- lion.
tract may be safely used to color nylon Arsenic (as As), not more than 3 parts per
66 (the copolymer of million.
hexamethylenediamine and adipic Mercury (as Hg), not more than 1 part per
million.
acid), nylon 6 (the polymer of e-
caprolactam), or silk non-absorable su- (c) Uses and restrictions. Mica may be
tures for use in general and ophthalmic safely used in amounts consistent with
surgery subject to the following re- good manufacturing practice to color
strictions: dentifrices and externally applied
(1) The quantity of color additive drugs, including those for use in the
does not exceed 1.0 percent by weight area of the eye.
of the suture. (d) Labeling requirements. The label of
(2) When the sutures are used for the the color additive and of any mixture
purposes specified in their labeling, prepared therefrom intended solely or
there is no migration of the color addi- in part for coloring purposes shall con-
tive to the surrounding tissue. form to the requirements of § 70.25 of
this chapter.
(3) If the suture is a new drug, an ap-
(e) Exemption from certification. Cer-
proved new drug application, pursuant tification of this color additive is not
to section 505 of the act, is in effect for necessary for the protection of the pub-
it. lic health, and therefore batches therof
(d) Labeling. The label of the color ad- are exempt from the certification re-
ditive shall conform to the require- quirements of section 721(c) of the act.
ments of § 70.25 of this chapter.
[42 FR 38561, July 29, 1977, as amended at 52
(e) Exemption from certification. Cer-
FR 29665, Aug. 11, 1987]
tification of this color additive is not
necessary for the protection of the pub- § 73.1550 Talc.
lic health, and therefore batches there-
(a) Identity. (1) The color additive
of are exempt from the certification re-
talc is a finely powdered, native, hy-
quirements of section 721(c) of the act.
drous magnesium silicate sometimes
[42 FR 52393, Sept. 30, 1977; 43 FR 1490, Jan. containing a small proportion of alu-
10, 1978] minum silicate.

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Food and Drug Administration, HHS § 73.1645

(2) Color additive mixtures for drug (c) Labeling. The label of the color ad-
use made with talc may contain only ditive and any mixtures prepared
those diluents listed in this subpart as therefrom and intended solely or in
safe and suitable for use in color addi- part for coloring purposes shall con-
tive mixtures for coloring drugs. form to the requirements of § 70.25 of
(b) Specifications. Talc shall meet the the chapter.
specifications for talc in the United (d) Exemption from certification. Cer-
States Pharmacopeia XX (1980) and the tification of this color additive is not
following: necessary for the protection of the pub-
Lead (as Pb), not more than 20 parts per mil- lic health and therefore batches thereof
lion. are exempt from the certification re-
Arsenic (as As), not more than 3 parts per quirements of section 721(c) of the act.
million.
§ 73.1645 Aluminum powder.
Lead and arsenic shall be determined
in the solution obtained by boiling 10 (a) Identity. (1) The color additive
grams of the talc for 15 minutes in 50 aluminum powder shall be composed of
milliliters of 0.5N hydrochloric acid. finely divided particles of aluminum
(c) Uses and restrictions. Talc may be prepared from virgin aluminum. It is
safely used in amounts consistent with free from admixture with other sub-
good manufacturing practice to color stances.
drugs generally. (2) Color additive mixtures for exter-
(d) Labeling requirements. The label of nal drug use made with aluminum pow-
the color additive and of any mixtures der may contain only those diluents
prepared therefrom intended solely or listed in this subpart as safe and suit-
in part for coloring purposes shall con- able in color additive mixtures for
form to the requirements of § 70.25 of coloring externally applied drugs.
this chapter. (b) Specifications. Aluminum powder
(e) Exemption from certification. Cer- shall conform to the following speci-
tification of this color additive is not fications and shall be free from impuri-
necessary for the protection of the pub- ties other than those named to the ex-
lic health, and therefore batches there- tent that such impurities may be
of are exempt from the certification re- avoided by good manufacturing prac-
quirements of section 721(c) of the act. tice:
[42 FR 15643, Mar. 22, 1977, as amended at 49 Fineness, 100 percent shall pass through a
FR 10089, Mar. 19, 1984) 200-mesh screen and 95 percent shall pass
through a 325-mesh screen.
§ 73.1575 Titanium dioxide.
Mercury, not more than 1 part per million.
(a) Identity and specifications. (1) The Arsenic, not more than 3 parts per million.
color additive titanium dioxide shall Lead, not more than 20 parts per million.
conform in identity and specifications Aluminum, not less than 99 percent.
to the requirements of § 73.575(a)(1) and
(b). (c) Uses and restrictions. Aluminum
(2) Color additive mixtures for drug powder is safe for use in externally ap-
use made with titanium dioxide may plied drugs, including those intended
contain only those diluents that are for use in the area of the eye, in
suitable and that are listed in this sub- amounts consistent with good manu-
part as safe in color additive mixtures facturing practice.
for coloring drugs, and the following: (d) Labeling. The color additive and
Silicon dioxide, SiO2, and/or aluminum any mixture prepared therefrom in-
oxide, Al2O3, as dispersing aids—not tended solely or in part for coloring
more than 2 percent total. purposes shall bear, in addition to any
(b) Uses and restrictions. The color ad- information required by law, labeling
ditive titanium dioxide may be used for in accordance with § 70.25 of this chap-
coloring ingested and externally ap- ter.
plied drugs generally, in amounts con- (e) Exemption from certification. Cer-
sistent with good manufacturing prac- tification of this color additive is not
tice. External application includes use necessary for the protection of the pub-
in the area of the eye. lic health, and therefore batches therof

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§ 73.1646 21 CFR Ch. I (4–1–11 Edition)

are exempt from certification pursuant necessary for the protection of the pub-
to section 721(c) of the act. lic health, and therefore batches there-
[42 FR 38563, July 29, 1977] of are exempt from the certification re-
quirements of section 721(c) of the act.
§ 73.1646 Bronze powder. [42 FR 33723, July 1, 1977]
(a) Identity. (1) The color additive
bronze powder is a very fine metallic § 73.1647 Copper powder.
powder prepared from alloys consisting (a) Identity. (1) The color additive
principally of virgin electrolytic cop- copper powder is a very fine free-flow-
per and zinc with small amounts of the ing metallic powder prepared from vir-
virgin metals aluminum and tin. It gin electrolytic copper. It contains
contains small amounts of stearic or
small amounts of stearic or oleic acid
oleic acid as lubricants.
as lubricants.
(2) Color additive mixtures for drug
use made with bronze powder may con- (2) Color additive mixtures for drug
tain only those diluents listed in this use made with copper powder may con-
subpart as safe and suitable for use in tain only those diluents listed in this
color additive mixtures for coloring ex- subpart as safe and suitable for use in
ternally applied drugs. color additive mixtures for coloring ex-
(b) Specifications. Bronze powder shall ternally applied drugs.
conform to the following specifications (b) Specifications. Copper powder shall
and shall be free from impurities other conform to the following specifications
than those named to the extent that and shall be free from impurities other
such impurities may be avoided by than those named to the extent that
good manufacturing practice: such impurities may be avoided by
good manufacturing practice:
Stearic or oleic acid, not more than 5 per-
cent. Stearic or oleic acid, not more than 5 per-
Cadmium (as Cd), not more than 15 parts per cent.
million. Cadmium (as Cd), not more than 15 parts per
Lead (as Pb), not more than 20 parts per mil- million.
lion. Lead (as Pb), not more than 20 parts per mil-
Arsenic (as As), not more than 3 parts per lion.
million.
Arsenic (as As), not more than 3 parts per
Mercury (as Hg), not more than 1 part per
million.
million
Aluminum (as Al), not more than 0.5 percent. Mercury (as Hg), not more than 1 part per
Tin (as Sn), not more than 0.5 percent. million.
Copper (as Cu), not more than 95 percent and Copper (as Cu), not less than 95 percent.
not less than 70 percent. Maximum particle size 45μ (95 percent min-
Zinc (as Zn), not more than 30 percent. imum).
Maximum particle size 45μ (95 percent min-
imum). (c) Uses and restrictions. Copper pow-
der may be safely used in coloring ex-
Aluminum, zinc, tin, and copper con- ternally applied drugs, including those
tent shall be based on the weight of the intended for use in the area of the eye,
dried powder after being thoroughly in amounts consistent with good manu-
washed with ether. facturing practice.
(c) Uses and restrictions. Bronze pow- (d) Labeling. The color additive and
der may be safely used in color exter- any mixture prepared therefrom in-
nally applied drugs, including those in- tended solely or in part for coloring
tended for use in the area of the eye, in purposes shall conform to the require-
amounts consistent with good manu- ments of § 70.25 of this chapter.
facturing practice. (e) Exemption from certification. Cer-
(d) Labeling. The color additive and tification of the color additive is not
any mixture prepared therefrom in- necessary for the protection of the pub-
tended solely or in part for coloring lic health, and therefore batches there-
purposes shall conform to the require- of are exempt from the certification re-
ments of § 70.25 of this chapter.
quirements of section 721(c) of the act.
(e) Exemption from certification. Cer-
tification of the color additive is not [42 FR 33723, July 1, 1977]

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Food and Drug Administration, HHS § 73.2087

§ 73.1991 Zinc oxide. identify and specification to the re-


quirements for annatto extract in
(a) Identity. (1) The color additive
§ 73.30(a) (1) and (b).
zinc oxide is a white or yellow-white
(b) Use and restriction. The color addi-
amorphous powder manufactured by
tive annatto may be safely used in
the French process (described as the in-
coloring cosmetics generally, including
direct process whereby zinc metal iso-
cosmetics intended for use in the area
lated from the zinc-containing ore is
of the eye, in amounts consistent with
vaporized and then oxidized). It is prin-
good manufacturing practice.
cipally composed of Zn.
(c) Labeling. The color additive and
(2) Color additive mixtures for drug
any mixture prepared therefrom in-
use made with zinc oxide may contain
tended solely or in part for coloring
only those diluents listed in this sub-
purposes shall bear, in addition to any
part as safe and suitable in color addi-
information required by law, labeling
tive mixtures for coloring externally
in accordance with the provisions of
applied drugs.
§ 70.25 of this chapter.
(b) Specifications. Zinc oxide shall
(d) Exemption from certification. Cer-
conform to the following specifications
tification of this color additive is not
and shall be free from impurities other
necessary for the protection of the pub-
than those named to the extent that
lic health, and therefore batches there-
such impurities may be avoided by
of are exempt from the certification re-
good manufacturing practice:
quirements of section 721(c) of the act.
Zinc oxide (as ZnO), not less than 99 percent.
Loss on ignition at 800 °C, not more than 1 [42 FR 36994, July 19, 1977]
percent.
Cadmium (as Cd), not more than 15 parts per
§ 73.2085 Caramel.
million. (a) Identity and specifications. The
Mercury (as Hg), not more than 1 part per color additive caramel shall conform in
million. identity and specifications to the re-
Arsenic (as As), not more than 3 parts per quirements of § 73.85(a)(1), (2), and (3)
million.
Lead (as Pb), not more than 20 parts per mil-
and (b).
lion. (b) Uses and restrictions. Caramel is
safe for use in coloring cosmetics gen-
(c) Uses and restrictions. The color ad- erally, including cosmetics applied to
ditive zinc oxide may be safely used for the area of the eye, in amounts con-
coloring externally applied drugs, in- sistent with good manufacturing prac-
cluding those used in the area of the tice.
eye, in amounts consistent with good (c) Labeling requirements. The label of
manufacturing practice. the color additive and any mixtures in-
(d) Labeling. The color additive and tended solely or in part for coloring
any mixtues prepared therefrom in- purposes prepared therefrom shall con-
tended solely or in part for coloring form to the requirements of § 70.25 of
purposes shall bear, in addition to any this chapter.
information required by law, labeling (d) Exemption from certification. Cer-
in accordance with the provisions of tification of this color additive is not
§ 70.25 of this chapter. necessary for the protection of the pub-
(e) Exemption from certification. Cer- lic health, and therefore batches there-
tification of this color additive is not of are exempt from the certification re-
necessary for the protection of the pub- quirement of section 721(c) of the act.
lic health, and therefore batches therof
are exempt from the certifiation pursu- [46 FR 38501, July 28, 1981]
ant to section 721(c) of the act. § 73.2087 Carmine.
[42 FR 37537, July 22, 1977] (a) Identity and specifications. The
color additive carmine shall conform in
Subpart C—Cosmetics identity and specifications to the re-
quirements of § 73.100 (a)(2) and (b)(2).
§ 73.2030 Annatto. (b) Use and restrictions. Carmine may
(a) Identity and specification. The be safely used in cosmetics generally,
color additive annatto shall conform in including cosmetics intended for use in

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§ 73.2095 21 CFR Ch. I (4–1–11 Edition)

the area of the eye, in amounts con- (b) Specifications. The color additive
sistent with good manufacturing prac- bismuth citrate shall conform to the
tices. following specifications and shall be
(c) Labeling. (1) The color additive free from impurities other than those
and any mixture prepared therefrom named to the extent that those impuri-
intended solely or in part for coloring ties may be avoided by good manufac-
purposes shall bear, in addition to any turing practice:
information required by law, labeling Bismuth citrate, not less than 97 percent.
in accordance with the provisions of Mercury (as Hg), not more than 1 part per
§ 70.25 of this chapter. million.
(2) Cosmetics containing carmine Arsenic (as As), not more than 3 parts per
that are not subject to the require- million.
ments of § 701.3 of this chapter shall Lead (as Pb), not more than 20 parts per mil-
specifically declare the presence of car- lion.
mine prominently and conspicuously at Volatile matter, not more than 1 percent.
least once in the labeling. For example: (c) Uses and restrictions. The color ad-
‘‘Contains carmine as a color additive.’’ ditive bismuth citrate may be safely
(d) Exemption from certification. Cer- used in cosmetics intended for coloring
tification of this color additive is not hair on the scalp, subject to the fol-
necessary for the protection of the pub- lowing restrictions:
lic health, and therefore batches there- (1) The amount of bismuth citrate in
of are exempt from the certification the cosmetic shall not be in excess of
pursuant to section 721(c) of the act. 2.0 percent (w/v).
[42 FR 32228, June 24, 1977, as amended at 74 (2) The cosmetic may not be used for
FR 216, Jan 5, 2009] coloring eyelashes, eyebrows, or hair
on parts of the body other than the
§ 73.2095 β-Carotene. scalp.
(a) Identity and specifications. The (d) Labeling. (1) The label of the color
color additive b-carotene shall conform additive bismuth citrate shall bear, in
in identity and specifications to the re- addition to any information required
quirements of § 73.95(a)(1) and (b). by law, labeling in accordance with the
(b) Uses and restrictions. The color ad- provisions of § 70.25 of this chapter.
ditive b-carotene may be safely used in (2) The label of a cosmetic containing
coloring cosmetics generally, including the color additive bismuth citrate shall
cosmetics intended for use in the area bear, in addition to other information
of the eye, in amounts consistent with required by law, the following state-
good manufacturing practices. ment, conspicuously displayed thereon:
(c) Labeling. The color additive and Keep this product out of children’s reach.
any mixture prepared therefrom in- Do not use on cut or abraded scalp. Do not
tended solely or in part for coloring use to color eyelashes, eyebrows, or hair on
purposes shall bear, in addition to any parts of the body other than the scalp. Wash
information required by law, labeling hands thoroughly after each use.
in accordance with the provisions of (e) Exemption from certification. Cer-
§ 70.25 of this chapter. tification of this color additive for the
(d) Exemption from certification. Cer- prescribed use is not necessary for the
tification of this color additive is not protection of the public health, and,
necessary for the protection of the pub- therefore, batches thereof are exempt
lic health, and therefore batches therof from certification requirements of sec-
are exempt from the certification pur- tion 721(c) of the act.
suant to section 721(c) of the act.
[43 FR 44831, Sept. 29, 1978, as amended at 75
[42 FR 33722, July 1, 1977] FR 14493, Mar. 26, 2010]

§ 73.2110 Bismuth citrate. § 73.2120 Disodium EDTA-copper.


(a) Identity. The color additive bis- (a) Identity. The color additive diso-
muth citrate is the synthetically pre- dium EDTA-copper is disodium [[N,N′-
pared crystalline salt of bismuth and 1,2- ethanediylbis[N - (carboxymethyl)
citric acid, consisting principally of glycinato]] (4-)-N,N′,O,O′,ON,ON′]
BiC6H5O7. cuprate (2-).

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Food and Drug Administration, HHS § 73.2162

(b) Specifications. Disodium EDTA- Calcium carbonate.


copper shall conform to the following Calcium phosphate, dibasic.
specifications and shall be free from Sodium N-lauroyl sarcosinate.
impurities other than those named to Artificial sweeteners that are generally rec-
ognized as safe or that are authorized
the extent that such impurities may be
under subchapter B of this chapter.
avoided by good manufacturing prac- Flavors that are generally recognized as safe
tice: or that are authorized under subchapter B
Total copper, not less than 13.5 percent. of this chapter.
Total (ethylene-dinitrilo) tetracetic acid, Preservatives that are generally recognized
not less than 62.5 percent. as safe or that are authorized under sub-
Free copper, not more than 100 parts per mil- chapter B of this chapter.
lion.
(c) Labeling. The label of the color ad-
Free disodium salt of (ethylene-dinitrilo)
tetraacetic acid, not more than 1.0 percent. ditive shall conform to the require-
Moisture, not more than 15 percent. ments of § 70.25 of this chapter.
Water insoluble matter, not more than 0.2 (d) Exemption from certification. Cer-
percent. tification of this color additive is not
Lead (as Pb), not more than 20 parts per mil- necessary for the protection of the pub-
lion. lic health and therefore batches thereof
Arsenic (as As), not more than 3 parts per
are exempt from the certification re-
million.
quirements of section 721(c) of the act.
(c) Uses and restrictions. Disodium
EDTA-copper may be safely used in § 73.2150 Dihydroxyacetone.
amounts consistent with good manu- (a) Identity and specifications. The
facturing practices in the coloring of color additive dihydroxyacetone shall
shampoos which are cosmetics. conform in identity and specifications
(d) Labeling requirements. The labeling to the requirements of § 73.1150 (a)(1)
of the color additive shall conform to and (b).
the requirements of § 70.25 of this chap- (b) Uses and restrictions.
ter. Dihydroxyacetone may be safely used
(e) Exemption from certification. Cer- in amounts consistent with good manu-
tification of this color additive is not facturing practice in externally applied
necessary for the protection of the pub- cosmetics intended solely or in part to
lic health and therefore batches thereof impart a color to the human body.
are exempt from the requirements of (c) Labeling requirements. The labeling
section 721(c) of the act. of the color additive and any mixtures
§ 73.2125 Potassium sodium copper prepared therefrom intended solely or
chlorophyllin (chlorophyllin-copper in part for coloring purposes shall con-
complex). form to the requirements of § 70.25 of
this chapter.
(a) Identity and specifications. The
color additive potassium sodium cop- (d) Exemption from certification. Cer-
per chlorophyllin shall conform in tification of this color additive is not
identity and specifications to the re- necessary for the protection of the pub-
quirements of § 73.1125(a)(1) and (b). lic health and therefore batches thereof
(b) Uses and restrictions. Potassium are exempt from the requirements of
sodium copper chlorophyllin may be section 721(c) of the act.
safely used for coloring dentifrices that § 73.2162 Bismuth oxychloride.
are cosmetics subject to the following
conditions: (a) Identity and specifications. (1) The
(1) It shall not be used at a level in color additive bismuth oxychloride
excess of 0.1 percent. shall conform in identity and specifica-
(2) It may be used only in combina- tions to the requirements of
tion with the following substances: § 73.1162(a)(1) and (b).
(2) Color additive mixtures of bis-
Water. muth oxychloride may contain the fol-
Glycerin.
Sodium carboxymethylcellulose. lowing diluents:
Tetrasodium pyrophosphate. (i) For coloring cosmetics generally,
Sorbitol. only those diluents listed under
Magnesium phosphate, tribasic. § 73.1001(a)(1);

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§ 73.2180 21 CFR Ch. I (4–1–11 Edition)

(ii) For coloring externally applied (d) Labeling. The label of the color ad-
cosmetics, only those diluents listed in ditive and any mixtures prepared
§ 73.1001(b) and, in addition, nitrocellu- therefrom intended solely or in part for
lose. coloring purposes shall conform to the
(b) Uses and restrictions. The color ad- requirements of § 70.25 of this chapter.
ditive bismuth oxychloride may be (e) Exemption from certification. Cer-
safely used in coloring cosmetics gen- tification of this color additive for the
erally, including cosmetics intended prescribed use is not necessary for the
for use in the area of the eye, in protection of the public health and
amounts consistent with good manu- therefore batches thereof are exempt
facturing practice. from the certification requirements of
(c) Labeling. The color additive and section 721(c) of the act.
any mixture prepared therefrom in-
tended solely or in part for coloring § 73.2190 Henna.
purposes shall bear, in addition to any (a) Identity. The color additive henna
information required by law, labeling is the dried leaf and petiole of Lawsonia
in accordance with the provisions of alba Lam. (Lawsonia inermis L.). It may
§ 70.25 of this chapter. be identified by its characteristic odor
(d) Exemption from certification. Cer- and by characteristic plant histology.
tification of this color additive is not (b) Specifications. Henna shall con-
necessary for the protection of the pub- form to the following specifications:
lic health, and therefore batches there-
It shall not contain more than 10 percent of
of are exempt from certification pursu-
plant material from Lawsonia alba Lam.
ant to section 721(c) of the act. (Lawsonia inermis L.) other than the leaf
[42 FR 52394, Sept. 30, 1977] and petiole, and shall be free from admix-
ture with material from any other species
§ 73.2180 Guaiazulene. of plant.
Moisture, not more than 10 percent.
(a) Identity. (1) The color additive, Total ash, not more than 15 percent.
guaiazulene, is principally 1,4-di- Acid-insoluble ash, not more than 5 percent.
methyl-7-isopropyl-azulene. Lead (as Pb), not more than 20 parts per mil-
(2) Color additive mixtures of lion.
guaiazulene for cosmetic use may con- Arsenic (as As), not more than 3 parts per
million.
tain the following diluent:
(c) Uses and restrictions. The color ad-
Polyethylene glycol-40 castor oil (PEG–40
castor oil). ditive henna may be safely used for
Saponification No., 60 to 70. coloring hair only. It may not be used
Hydroxyl No., 63 to 78. for coloring the eyelashes or eyebrows,
Acid No., 2. or generally in the area of the eye.
Specific gravity, 1.05 to 1.07. (d) Labeling. The label for henna shall
bear the information required by § 70.25
(b) Specifications. Guaiazulene shall of this chapter and the following state-
conform to the following specifications ments or their equivalent:
and shall be free from impurities, other
than those named, to the extent that ‘‘Do not use in the area of the eye.’’
such other impurities may be avoided ‘‘Do not use on cut or abraded scalp.’’
by good manufacturing practice. (e) Exemption from certification. Cer-
Melting point, 30.5 °C to 31.5 °C. tification of this color additive for the
Lead (as Pb), not more than 20 parts per mil- prescribed use is not necessary for the
lion. protection of the public health and
Arsenic (as As), not more than 3 parts per therefore batches thereof are exempt
million. from the certification requirements of
Mercury (as Hg), not more than 1 part per section 721(c) of the act.
million.
Total color, not less than 99 percent. § 73.2250 Iron oxides.
(c) Uses and restrictions. Guaiazulene (a) Identity. The color additives iron
may be safely used in externally ap- oxides consist of any one or any com-
plied cosmetics in amounts consistent bination of synthetically prepared iron
with good manufacturing practice. oxides, including the hydrated forms.

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Food and Drug Administration, HHS § 73.2327

It is free from admixture with other § 73.2299 Ferric ferrocyanide.


substances.
(a) Identity and specifications. The
(b) Specifications. Iron oxides shall
color additive ferric ferrocyanide shall
conform to the following specifica-
conform in identity and specifications
tions, all on an ‘‘as is’’ basis:
to the requirements of § 73.1299(a)(1)
Arsenic (as As), not more than 3 parts per and (b).
million. (b) Uses and restrictions. Ferric ferro-
Lead (as Pb), not more than 10 parts per mil-
cyanide is safe for use in coloring ex-
lion.
Mercury (as Hg), not more than 3 parts per ternally applied cosmetics, including
million. cosmetics applied to the area of the
eye, in amounts consistent with good
(c) Uses and restrictions. Iron oxides manufacturing practice.
are safe for use in coloring cosmetics (c) Labeling. The color additive and
generally, including cosmetics applied any mixture prepared therefrom in-
to the area of the eye, in amounts con- tended solely or in part for coloring
sistent with good manufacturing prac- purposes shall bear, in addition to any
tice.
information required by law, labeling
(d) Labeling. The color additive and
in accordance with § 70.25 of this chap-
any mixture prepared therefrom in-
ter.
tended solely or in part for coloring
(d) Exemption from certification. Cer-
purposes shall bear, in addition to any
information required by law, labeling tification of this color additive is not
in accordance with § 70.25 of this chap- necessary for the protection of the pub-
ter. lic health, and therefore batches there-
(e) Exemption from certification. Cer- of are exempt from certification under
tification of this color additive is not section 721(c) of the act.
necessary for the protection of the pub- [43 FR 54236, Nov. 21, 1978]
lic health, and therefore batches there-
of are exempt from certification pursu- § 73.2326 Chromium hydroxide green.
ant to section 721(c) of the act. (a) Identity and specifications.The
color additive chromium hydroxide
§ 73.2298 Ferric ammonium ferrocya-
nide. green shall conform in identity and
specifications to the requirements of
(a) Identity and specifications.The § 73.1326 (a)(1) and (b).
color additive ferric ammonium ferro- (b) Uses and restrictions. Chromium
cyanide shall conform in identify and hydroxide green is safe for use in color-
specifications to the requirements of ing externally applied cosmetics, in-
§ 73.1298 (a)(1) and (b). cluding those intended for use in the
(b) Uses and restrictions. Ferric ammo-
area of the eye, in amounts consistent
nium ferrocyanide is safe for use in
with good manufacturing practice.
coloring externally applied cosmetics,
(c) Labeling. The color additive and
including cosmetics applied to the area
any mixture prepared therefrom in-
of the eye, in amounts consistent with
tended solely or in part for coloring
good manufacturing practice.
(c) Labeling. The color additive and purposes shall bear, in addition to any
any mixture prepared therefrom in- information required by law, labeling
tended solely or in part for coloring in accordance with § 70.25 of this chap-
purposes shall bear, in addition to any ter.
information required by law, labeling (d) Exemption from certification. Cer-
in accordance with § 70.25 of this chap- tification of this color additive is not
ter. necessary for the protection of the pub-
(d) Exemption from certification. Cer- lic health, and therefore batches there-
tification of this color additive is not of are exempt from certification pursu-
necessary for the protection of the pub- ant to section 721(c) of the act.
lic health, and therefore batches there- [42 FR 36452, July 15, 1977]
of are exempt from the certification
pursuant to section 721(c) of the act. § 73.2327 Chromium oxide greens.
[42 FR 38562, July 29, 1977, as amended at 43 (a) Identity and specifications. The
FR 6939, Feb. 17, 1978] color additive chromium oxide greens

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§ 73.2329 21 CFR Ch. I (4–1–11 Edition)

shall conform in identify and specifica- of are exempt from the certification
tions to the requirements of § 73.1327 pursuant to section 721(c) of the act.
(a)(1) and (b).
[42 FR 37537, July 22, 1977]
(b) Uses and restrictions. The color ad-
ditive chromium oxide greens may be § 73.2396 Lead acetate.
safely used in externally applied cos-
(a) Identity. The color additive lead
metics, including cosmetics intended
acetate is the trihydrate of lead (2+)
for use in the area of the eye, in
salt of acetic acid. The color additive
amounts consistent with good manu-
has the chemical formula Pb
facturing practice.
(OOCCH3)2·3H2O).
(c) Labeling requirements. The color
(b) Specifications. Lead acetate shall
additive and any mixtures prepared
conform to the following specifications
therefrom intended solely or in part for
and shall be free from impurities other
coloring purposes shall bear, in addi- than those named to the extent that
tion to any information required by such impurities may be avoided by
law, labeling in accordance with the good manufacturing practice:
provisions of § 70.25 of this chapter.
(d) Exemption from certification. Cer- Water-insoluble matter, not more than 0.02
tification of this color additive is not percent.
pH (30 percent solution weight to volume at
necessary for the protection of the pub-
25 °C), not less than 4.7 and not more than
lic health, and therefore batches there- 5.8.
of are exempt from the certification Arsenic (as As), not more than 3 parts per
pursuant to section 721(c) of the act. million.
Lead acetate, not less than 99 percent.
[42 FR 36452, July 15, 1977]
Mercury (as Hg), not more than 1 part per
million.
§ 73.2329 Guanine.
(a) Identity and specifications. (1) The (c) Uses and restrictions. The color ad-
color additive guanine shall conform in ditive lead acetate may be safely used
identity and specifications to the re- in cosmetics intended for coloring hair
on the scalp only, subject to the fol-
quirements of § 73.1329 (a)(1) and (b).
lowing restrictions:
(2) Color additive mixtures of gua-
(1) The amount of the lead acetate in
nine may contain the following
the cosmetic shall be such that the
diluents:
lead content, calculated as Pb, shall
(i) For coloring cosmetics generally, not be in excess of 0.6 percent (weight
only those diluents listed under to volume).
§ 73.1001(a)(1); (2) The cosmetic is not to be used for
(ii) For coloring externally applied coloring mustaches, eyelashes, eye-
cosmetics, only those diluents listed in brows, or hair on parts of the body
§ 73.1001(b) and, in addition, nitrocellu- other than the scalp.
lose. (d) Labeling requirements. (1) The label
(b) Use and restrictions. The color ad- of the color additive lead acetate shall
ditive guanine may be safely used in conform to the requirements of § 70.25
cosmetics generally, including cos- of this chapter, and bear the following
metics intended for use in the area of statement or equivalent:
the eye, in amounts consistent with
good manufacturing practice. Wash thoroughly if the product comes into
contact with the skin.
(c) Labeling requirements. The color
additive and any mixtures prepared (2) The label of the cosmetic con-
therefrom intended solely or in part for taining the color additive lead acetate,
coloring purposes shall bear, in addi- in addition to other information re-
tion to any information required by quired by the act, shall bear the fol-
law, labeling in accordance with the lowing cautionary statement, con-
provisions of § 70.25 of this chapter. spicuously displayed thereon:
(d) Exemption from certification. Cer- CAUTION: Contains lead acetate. For exter-
tification of this color additive is not nal use only. Keep this product out of chil-
necessary for the protection of the pub- dren’s reach. Do not use on cut or abraded
lic health, and therefore batches there- scalp. If skin irritation develops, discontinue

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Food and Drug Administration, HHS § 73.2575
use. Do not use to color mustaches, eye- necessary for the protection of the pub-
lashes, eyebrows, or hair on parts of the body lic health, and therefore batches there-
other than the scalp. Do not get in eyes. Fol- of are exempt from the certification
low instructions carefully and wash hands
thoroughly after each use.
pursuant to section 721(c) of the act.
[42 FR 38561, July 29, 1977]
(e) Exemption for certification. Certifi-
cation of this color additive for the § 73.2500 Silver.
prescribed use is not necessary for the
protection of the public health and (a) Identity. (1) The color additive,
therefore batches thereof are exempt silver, is a crystalline powder of high
from the certification requirements of purity silver prepared by the reaction
section 721(c) of the act. of silver nitrate with ferrous sulfate in
the presence of nitric, phosphoric and
[45 FR 72117, Oct. 31, 1980, as amended at 72 sulfuric acids. Polyvinyl alcohol is
FR 10357, Mar. 8, 2007]
used to prevent the agglomeration of
§ 73.2400 Pyrophyllite. crystals and the formation of amor-
phous silver.
(a) Identity and specifications. The (2) Color additive mixtures of silver
color additive pyrophyllite shall con- may contain only those diluents listed
form in identity and specifications to in § 73.1001(b) and, in addition, nitro-
the requirements of § 73.1400 (a)(1) and cellulose.
(b). (b) Specifications. Silver shall con-
(b) Uses and restrictions. Pyrophyllite form to the following specifications
may be safely used for coloring exter- and shall be free from impurities other
nally applied cosmetics, in amounts than those named to the extent that
consistent with good manufacturing such other impurities may be avoided
practice. by good manufacturing practice:
(c) Labeling requirements. The labeling
of the color additive and any mixtures Lead (as Pb), not more than 10 parts per mil-
prepared therefrom intended solely or lion.
Arsenic (as As), not more than 5 parts per
in part for coloring purposes shall con-
million.
form to all applicable requirements of Mercury (as Hg), not more than 1 part per
law, including the requirements of million.
§ 70.25 of this chapter. Silver (as Ag), not less than 99.9 percent.
(d) Exemption from certification. Cer-
(c) Uses and restrictions. The color ad-
tification of this color additive is not
ditive silver may be safely used for
necessary for the protection of the pub-
coloring fingernail polish at a level not
lic health and therefore batches thereof
to exceed 1 percent of the final product.
are exempt from the certification re-
(d) Labeling. The color additive and
quirements of section 721(c) of the act.
any mixtures prepared therefrom in-
§ 73.2496 Mica. tended solely or in part for coloring
purposes shall bear, in addition to any
(a) Identity and specifications. The
other information required by law, la-
color additive mica shall conform in
beling in accordance with the provi-
identity and specifications to the re-
sions of § 70.25 of this chapter.
quirements of § 73.1496(a)(1) and (b). (e) Exemption from certification. Cer-
(b) Uses and restrictions. Mica is safe
tification of this color additive is not
for use in coloring cosmetics generally,
necessary for the protection of the pub-
including cosmetics applied to the area
lic health and therefore batches thereof
of the eye, in amounts consistent with
are exempt from the certification re-
good manufacturing practice.
quirements of section 721(c) of the act.
(c) Labeling. The color additive and
any mixture prepared therefrom in- [44 FR 65974, Nov. 16, 1979]
tended solely or in part for coloring
purposes shall bear, in addition to any § 73.2575 Titanium dioxide.
information required by law, labeling (a) Identity and specifications. The
in accordance with of § 70.25 of this color additive titanium dioxide shall
chapter. conform in identity and specifications
(d) Exemption from certification. Cer- to the requirements on § 73.575 (a)(1)
tification of this color additive is not and (b).

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§ 73.2645 21 CFR Ch. I (4–1–11 Edition)

(b) Uses and restrictions. The color ad- (c) Labeling. The color additive and
ditive titanium dioxide may be safely any mixture prepared therefrom in-
used in cosmetics, including cosmetics tended solely or in part for coloring
intended for use in the area of the eye, purposes shall conform to the require-
in amounts consistent with good manu- ments of § 70.25 of this chapter.
facturing practice. (d) Exemption from certification. Cer-
(c) Labeling requirements. The color tification of the color additive is not
additive and any mixtures prepared necessary for the protection of the pub-
therefrom intended solely or in part for lic health, and therefore batches there-
coloring purposes shall bear, in addi- of are exempt from the certification re-
tion to any other information required quirements of section 721(c) of the act.
by law, labeling in accordance with the
[42 FR 33724, July 1, 1977]
provisions of § 70.25 of this chapter.
(d) Exemption from certification. Cer- § 73.2647 Copper powder.
tification of this color additive is not
necessary for the protection of the pub- (a) Identity and specifications. The
lic health, and therefore batches there- color additive copper powder shall con-
of are exempt from certification pursu- form in identity and specifications to
ant to section 721(c) of the act. the requirements of § 73.1647 (a)(1) and
(b).
§ 73.2645 Aluminum powder. (b) Uses and restrictions. Copper pow-
(a) Identity and specifications. The der may be safely used in coloring cos-
color additive aluminum powder shall metics generally, including cosmetics
conform in identity and specifications intended for use in the area of the eye,
to the requirements of § 73.1645 (a)(1) in amounts consistent with good manu-
and (b). facturing practice.
(b) Uses and restrictions. Aluminum (c) Labeling. The color additive and
powder may be safely used in coloring any mixture prepared therefrom in-
externally applied cosmetics, including tended solely or in part for coloring
cosmetics intended for use in the area purposes shall conform to the require-
of the eye, in amounts consistent with ments of § 70.25 of this chapter.
good manufacturing practice. (d) Exemption from certification. Cer-
(c) Labeling. The color additive and tification of the color additive is not
any mixture prepared therefrom in- necessary for the protection of the pub-
tended solely or in part for coloring lic health, and therefore batches there-
purposes shall bear, in addition to any of are exempt from the certification re-
information required by law, labeling quirements of section 721(c) of the act.
in accordance with the provisions of [42 FR 33724, July 1, 1977]
§ 70.25 of this chapter.
(d) Exemption from certification. Cer- § 73.2725 Ultramarines.
tification of this color additive is not (a) Identity. The color additives,
necessary for the protection of the pub- ultramarines (blue, green, pink, red,
lic health, and therefore batches there- and violet) are pigments obtained by
of are exempt from the certification calcining at temperatures above 700 °C.
pursuant to section 721(c) of the act.
a mixture of kaolin, sulfur, sodium car-
[42 FR 38563, July 29, 1977] bonate, silicious matter, sodium sul-
fate, and carbonaceous matter, but not
§ 73.2646 Bronze powder. necessarily all these substances, to
(a) Identity and specifications. The produce a single color. The
color additive bronze powder shall con- ultramarines are complex sodium alu-
form in identity and specifications to minum sulfosilicates having a typical
the requirements of § 73.1646 (a)(1) and formula Na(AlSiO)S with proportions
(b). of each element varying with each
(b) Uses and restrictions. Bronze pow- color.
der may be safely used in coloring cos- (b) Specifications. The ultramarines
metics generally, including cosmetics shall conform to the following speci-
intended for use in the area of the eye, fications and shall be free from impuri-
in amounts consistent with good manu- ties other than those named, to the ex-
facturing practice. tent that such other impurities may be

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Food and Drug Administration, HHS § 73.2995

avoided by good manufacturing prac- Mercury (as Hg), not more than 1 part per
tice. million.
Total color, based on Mn content in ‘‘as is’’
Lead (as Pb), not more than 20 parts per mil- sample, not less than 93 percent.
lion.
Arsenic (as As), not more than 3 parts per (c) Uses and restrictions. Manganese
million. violet is safe for use in coloring cos-
Mercury (as Hg), not more than 1 part per metics generally, including cosmetics
million. applied to the area of the eye, in
(c) Uses and restrictions. The ultra- amounts consistent with good manu-
marine pigments may be safely used facturing practice.
for coloring externally applied cos- (d) Labeling. The color additive and
metics, including cosmetics intended any mixture prepared therefrom in-
for use in the area of the eye, in tended solely or in part for coloring
amounts consistent with good manu- purposes shall bear, in addition to any
facturing practice. information required by law, labeling
(d) Labeling requirements. The color in accordance with § 70.25 of this chap-
additives and any mixtures prepared ter.
therefrom intended solely or in part for (e) Exemption from certification. Cer-
coloring purposes shall bear, in addi- tification of this color additive is not
tion to any other information required necessary for the protection of the pub-
by law, labeling in accordance with lic health, and therefore batches there-
§ 70.25 of this chapter. of are exempt from certification pursu-
(e) Exemption from certification. Cer- ant to section 721(c) of the act.
tification of this color additive is not § 73.2991 Zinc oxide.
necessary for the protection of the pub-
lic health, and therefore batches there- (a) Identity and specifications. The
of are exempt from certification pursu- color additive zinc oxide shall conform
ant to section 721(c) of the act. in identity and specifications to the re-
quirements of § 73.1991 (a)(1) and (b).
§ 73.2775 Manganese violet. (b) Uses and restrictions. Zinc oxide
(a) Identity. The color additive man- may be safely used in cosmetics, in-
cluding cosmetics intended for use in
ganese violet is a violet pigment ob-
the area of the eye, in amounts con-
tained by reacting phosphoric acid, am-
sistent with good manufacturing prac-
monium dihydrogen orthophosphate,
tice.
and manganese dioxide at tempera-
(c) Labeling. The color additive and
tures above 450 °F. The pigment is a
any mixture prepared therefrom in-
manganese ammonium pyrophosphate
tended solely or in part for coloring
complex having the approximate for-
purposes shall bear, in addition to any
mula: Mn(III)NH4P2O7. information required by law, labeling
(b) Specifications. Manganese violet
in accordance with § 70.25 of this chap-
shall conform to the following speci- ter.
fications and shall be free from impuri- (d) Exemption from certification. Cer-
ties other than those named, to the ex- tification of this color additive is not
tent that such other impurities may be necessary for the protection of the pub-
avoided by good manufacturing prac- lic health, and therefore batches there-
tice: of are exempt from the certification
Ash (at 600 °C), not less than 81 percent. pursuant to section 721(c) of the act.
Volatile matter at 135 °C for 3 hours, not
more than 1 percent. [42 FR 37538, July 22, 1977]
Water soluble substances, not more than 6
percent. § 73.2995 Luminescent zinc sulfide.
pH of filtrate of 10 grams color additive (a) Identity. The color additive lumi-
(shaken occasionally for 2 hours with 100 nescent zinc sulfide is zinc sulfide con-
milliliters of freshly boiled distilled taining a copper activator. Following
water), not more than 4.7 and not less than
excitation by daylight or a suitable ar-
2.5.
Lead (as Pb), not more than 20 parts per mil- tificial light, luminescent zinc sulfide
lion. produces a yellow-green phosphores-
Arsenic (as As), not more than 3 parts per cence with a maximum at 530 nano-
million. meters.

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§ 73.3100 21 CFR Ch. I (4–1–11 Edition)

(b) Specifications. Luminescent zinc Subpart D—Medical Devices


sulfide shall conform to the following
specifications and shall be free from § 73.3100 1,4-Bis[(2-hydroxy-
impurities other than those named to ethyl)amino]-9,10-anthracenedione
the extent that such impurities may be bis(2-propenoic)ester copolymers.
avoided by good manufacturing prac- (a) Identity. The color additives are
tice: 1,4-bis[(2-hydroxyethyl)amino]-9,10-
Zinc sulfide, not less than 99.8 percent. anthracenedione bis(2-propenoic)ester
Copper, 100±5 parts per million. (CAS Reg. No. 109561–07–1) copolym-
Lead, not more than 20 parts per million. erized either with glyceryl methacry-
Arsenic, not more than 3 parts per million. late, methyl methacrylate, and ethyl-
Mercury, not more than 1 part per million. ene glycol dimethacrylate monomers,
Cadmium, not more than 15 parts per mil- or with N, N-dimethyl acrylamide,
lion. methyl methacrylate, and ethylene
(c) Uses and restrictions. The color ad- glycol dimethacrylate monomers to
ditive luminescent zinc sulfide may be form the contact lens material.
safely used for coloring externally ap- (b) Uses and restrictions. (1) The sub-
plied facial makeup preparations and stances listed in paragraph (a) of this
nail polish included under section may be used in amounts not to
§ 720.4(c)(7)(ix) and (c)(8)(v) of this chap- exceed the minimum reasonably re-
ter, respectively, to the following re- quired to accomplish the intended
strictions: coloring effect.
(1) The amount of luminescent zinc (2) Authorization and compliance
sulfide in facial makeup preparations with these uses shall not be construed
shall not exceed 10 percent by weight of as waiving any of the requirements of
the final product. sections 510(k), 515, and 520(g) of the
(2) Facial makeup preparations con- Federal Food, Drug, and Cosmetic Act
taining luminescent zinc sulfide are in- (the act) with respect to the contact
tended for use only on limited, infre- lens made from the color additives.
quent occasions, e.g., Halloween, and (c) Labeling. The label of the color ad-
not for regular or daily use. ditives shall conform to the require-
(d) Labeling requirements. (1) The label ments of § 70.25 of this chapter.
of the color additive and any mixtures (d) Exemption from certification. Cer-
prepared therefrom shall bear expira- tification of these color additives is
tion dates for the sealed and open con- not necessary for the protection of the
tainer (established through generally public health and therefore the color
accepted stability testing methods), additives are exempt from the certifi-
other information required by § 70.25 of cation requirements of section 721(c) of
this chapter, and adequate directions the act.
to prepare a final product complying [61 FR 51586, Oct. 3, 1996]
with the limitations prescribed in para-
graph (c) of this section. § 73.3105 1,4-Bis[(2-
(2) The label of a facial makeup prep- methylphenyl)amino]-9,10-
aration containing the color additive anthracenedione.
shall bear, in addition to other infor- (a) Identity. The color additive is 1,4-
mation required by the law, the fol- bis[(2-methylphenyl)amino]-9,10-
lowing statement conspicuously dis- anthracenedione (CAS Reg. No. 6737–68–
played: 4).
Do not use in the area of the eye. (b) Uses and restrictions. (1) The sub-
(e) Exemption from certification. Cer- stance listed in paragraph (a) of this
tification of this color additive is not section may be used as a color additive
necessary for the protection of the pub- in contact lenses in amounts not to ex-
lic health, and therefore batches there- ceed the minimum reasonably required
of are exempt from the certification re- to accomplish the intended coloring ef-
quirements of section 721(c) of the act. fect.
[65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1, (2) Authorization and compliance
2000] with this use shall not be construed as

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Food and Drug Administration, HHS § 73.3110

waiving any of the requirements of sec- (c) Labeling. The label of the color ad-
tions 510(k), 515, and 520(g) of the Fed- ditives shall conform to the require-
eral Food, Drug, and Cosmetic Act (the ments of § 70.25 of this chapter.
act). A person intending to introduce a (d) Exemption from certification. Cer-
device containing 1,4-bis[(2- tification of these color additives is
methylphenyl)amino]-9,10- not necessary for the protection of the
anthracenedione listed under this sec- public health and, therefore, the color
tion into commerce shall submit to the additives are exempt from the certifi-
Food and Drug Administration either a cation requirements of section 721(c) of
premarket notification in accordance the act.
with subpart E of part 807 of this chap- [58 FR 17507, Apr. 5, 1993, as amended at 60
ter, if the device is not subject to pre- FR 10497, Feb. 27, 1995]
market approval, or submit and receive
approval of an original or supplemental § 73.3107 Carbazole violet.
premarket approval application if the (a) Identity. The color additive is car-
device is subject to premarket ap- bazole violet (Pigment Violet 23) (CAS
proval. Reg. No. 6358–30–1, Colour Index No.
(c) Labeling. The label of the color ad- 51319).
ditive shall conform to the require- (b) Uses and restrictions. (1) The sub-
ments of § 70.25 of this chapter. stance listed in paragraph (a) of this
(d) Exemption from certification. Cer- section may be used as a color additive
tification of this color additive is not in contact lenses in amounts not to ex-
necessary for the protection of the pub- ceed the minimum reasonably required
lic health, and therefore the color addi- to accomplish the intended coloring ef-
tive is exempt from the certification fect.
requirements of section 721(c) of the (2) Authorization for this use shall
act. not be construed as waiving any of the
[49 FR 30066, July 26, 1984] requirements of sections 510(k), 515,
and 520(g) of the Federal Food, Drug,
§ 73.3106 1,4-Bis[4-(2- and Cosmetic Act (the act) with re-
methacryloxyethyl) spect to the contact lens in which the
phenylamino]anthraquinone co- color additive is used.
polymers. (c) Labeling. The label of the color ad-
(a) Identity. The color additive is 1,4- ditive shall conform to the require-
bis[4-(2-methacryloxyethyl) ments of § 70.25 of this chapter.
phenylamino]anthraquinone (CAS Reg. (d) Exemption from certification. Cer-
No. 121888–69–5), copolymerized with tification of this color additive is not
hydroxyethyl methacrylate monomer, necessary for the protection of the pub-
or a blend of hydroxyethyl methacry- lic health, and therefore the color addi-
late and N-vinyl pyrrolidone mono- tive is exempt from the certification
mers, or a blend of 3- requirements of section 721(c) of the
[tris(trimethylsiloxy)silyl]propyl vinyl act.
carbamate (CAS Reg. No. 134072–99–4) [53 FR 41324, Oct. 21, 1988]
and N-vinyl pyrrolidone monomers to
form the contact lens material. § 73.3110 Chlorophyllin-copper com-
(b) Uses and restrictions. (1) The sub- plex, oil soluble.
stances listed in paragraph (a) of this (a) Identity. The color additve is
section may be used in amounts not to chlorophyllin-copper complex, oil solu-
exceed the minimum reasonably re- ble. The chlorophyllin is obtained by
quired to accomplish the intended extraction from a mixture of fescue
coloring effect. and rye grasses. The chlorophyll is
(2) Authorization and compliance acid-treated to remove chelated mag-
with these uses shall not be construed nesium which is replaced with hydro-
as waiving any of the requirements of gen, which is turn is replaced with cop-
sections 510(k), 515, and 520(g) of the per. This mixture is diluted to a 5 per-
Federal Food, Drug, and Cosmetic Act cent concentration with a mixture of
(the act) with respect to contact lenses palm oil, peanut oil, and hydrogenated
made from the color additives. peanut oil.

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§ 73.3110a 21 CFR Ch. I (4–1–11 Edition)

(b) Specifications. The color additive (b) Uses and restrictions. (1) The sub-
chlorophyllin-copper complex, oil solu- stance listed in paragraph (a) of this
ble (5 percent in palm oil, peanut oil, section may be used as a color additive
and hydrogenated peanut oil), shall in contact lenses in amounts not to ex-
conform to the following specifications ceed the minimum reasonably required
and shall be free from impurities other to accomplish the intended coloring ef-
than those named to the extent that fect.
such other impurities may be avoided (2) Authorization for this use shall
by current good manufacturing prac- not be construed as waiving any of the
tice: requirements of sections 510(k), 515,
Moisture, not more than 0.5 percent.
and 520(g) of the Federal Food, Drug,
Nitrogen, not less than 0.2 percent and not and Cosmetic Act (the act) with re-
more than 0.3 percent. spect to the contact lens in which the
Total copper, not less than 0.2 percent and color additive is used.
not more than 0.4 percent. (c) Labeling. The label of the color ad-
Free copper, not more than 200 parts per mil- ditive shall conform to the require-
lion. ments of § 70.25 of this chapter.
Lead, not more than 20 parts per million. (d) Exemption from certification. Cer-
Arsenic, not more than 5 parts per million.
Sulfated ash, not more than 2.5 percent. tification of this color additive is not
Total color, not less than 4.5 percent and not necessary for the protection of the pub-
more than 5.5 percent. lic health, and therefore the color addi-
tive is exempt from the certification
(c) Uses and restrictions. (1) The color requirements of section 721(c) of the
additive chlorophyllin-copper complex, act.
oil soluble (5 percent in palm oil, pea-
nut oil, and hydrogenated peanut oil), [53 FR 41325, Oct. 21, 1988]
may be safely used to color
polymethylmethacrylate bone cement. § 73.3111 Chromium oxide greens.
Chlorophyllin-copper complex may be (a) Identity and specifications. The
used at levels that do not exceed 0.003 color additive chromium oxide greens
percent by weight of the bone cement. (chromic oxide) (CAS Reg. No. 1308–38–
(2) Authorization for this use shall 9), Color Index No. 77288, shall conform
not be construed as waiving any of the in identity and specifications to the re-
requirements of sections 510(k), 515, quirements of § 73.1327 (a)(1) and (b).
and 520(g) of the Federal Food, Drug, (b) Uses and restrictions. (1) The sub-
and Cosmetic Act with respect to the stance listed in paragraph (a) of this
polymethylmethacrylate bone cement section may be used as a color additive
in which chlorophyllin-copper complex, in contact lenses in amounts not to ex-
oil soluble, is used. ceed the minimum reasonably required
(d) Labeling. The label of the color ad- to accomplish the intended coloring ef-
ditive shall conform to the require- fect.
ments of § 70.25 of this chapter. (2) Authorization and compliance
(e) Exemption from certification. Cer- with this use shall not be construed as
tification of this color additive is not waiving any of the requirements of sec-
necessary for the protection of the pub- tions 510(k), 515, and 520(g) of the Fed-
lic health, and therefore the color addi- eral Food, Drug, and Cosmetic Act
tive is exempt from the certification with respect to the contact lenses in
requirements of section 721(c) of the which the additive is used.
act. (c) Labeling. The label of the color ad-
ditive shall conform to the require-
[48 FR 56370, Dec. 21, 1983]
ments of § 70.25 of this chapter.
§ 73.3110a Chromium-cobalt-aluminum (d) Exemption from certification. Cer-
oxide. tification of this color additive is not
necessary for the protection of the pub-
(a) Identity. The color additive chro-
lic health, and therefore the color addi-
mium-cobalt-aluminum oxide (Pigment
tive is exempt from the certification
Blue 36) (CAS Reg. No. 68187–11–1, Col-
requirements of section 721(c) of the
our Index No. 77343) shall conform in
act.
identity and specifications to the re-
quirements of § 73.1015 (a) and (b). [51 FR 24816, July 9, 1986]

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Food and Drug Administration, HHS § 73.3117

§ 73.3112 C.I. Vat Orange 1. (1) The quantity of the color additive
does not exceed 1.1×10¥7 grams in a soft
(a) Identity. The color additive is C.I.
(hydrophilic) contact lens.
Vat Orange 1, Colour Index No. 59105.
(2) When used as specified in the la-
(b) Uses and restrictions. (1) The sub-
beling, there is no measurable migra-
stance listed in paragraph (a) of this
tion of the color additive from the con-
section may be used as a color additive
tact lens to the surrounding ocular tis-
in contact lenses in amounts not to ex-
ceed the minimum reasonably required sue.
to accomplish the intended coloring ef- (3) Authorization for this use shall
fect. not be construed as waiving any of the
(2) Authorization for this use shall requirements of section 510(k) and 515
not be construed as waiving any of the of the Federal Food, Drug, and Cos-
requirements of sections 510(k), 515, metic Act with respect to the contact
and 520(g) of the Federal Food, Drug, lens in which the color additive is used.
and Cosmetic Act (the act) with re- (c) Labeling. The label of the color ad-
spect to the contact lens in which the ditive shall conform to the require-
color additive is used. A person intend- ments of § 70.25 of this chapter.
ing to introduce a device containing (d) Exemption from certification. Cer-
C.I. Vat Orange 1 into commerce shall tification of this color additive is not
submit to the Food and Drug Adminis- necessary for the protection of the pub-
tration either a premarket notification lic health, and therefore the color addi-
in accordance with subpart E of part tive is exempt from the certification
807 of this chapter, if the device is not requirements of section 721(c) of the
subject to premarket approval, or sub- act.
mit and receive approval of an original [48 FR 22706, May 20, 1983]
or supplemental premarket approval
application if the device is subject to § 73.3117 16,23-Dihydrodinaphtho[2,3-
premarket approval. a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-
(c) Labeling. The label of the color ad- c] carbazole-5,10,15,17,22,24-hexone.
ditive shall conform to the require- (a) Identity. The color additive is
ments of § 70.25 of this chapter. 16,23-dihydrodinaphtho [2,3- a:2′,3′-i]
(d) Exemption from certification. Cer- napth [2′,3′:6,7] indolo [2, 3-c] carbazole-
tification of this color additive is not 5,10, 15,17,22,24-hexone (CAS Reg. No.
necessary for the protection of the pub- 2475–33–4), Colour Index No. 70800.
lic health, and therefore the color addi- (b) Uses and restrictions. (1) The sub-
tive is exempt from the certification stance listed in paragraph (a) of this
requirements of section 721(c) of the section may be used as a color additive
act. in contact lenses in amounts not to ex-
[50 FR 20407, May 16, 1985] ceed the minimum reasonably required
to accomplish the intended coloring ef-
§ 73.3115 2-[[2,5-Diethoxy-4-[(4- fect.
methylphenyl)thiol]phenyl]azo]- (2) Authorization for this use shall
1,3,5-benzenetriol. not be construed as waiving any of the
(a) Identity. The color additive2-[[2,5- requirements of sections 510(k), 515,
diethoxy-4-[(4- and 520(g) of the Federal Food, Drug,
methylphenyl)thio]phenyl]azo]-1,3,5- and Cosmetic Act with respect to the
benzenetriol is formed in situ in soft contact lens in which the color addi-
(hydrophilic) contact lenses. tive is used.
(b) Uses and restrictions. The color ad- (c) Labeling. The label of the color ad-
ditive 2-[[2,5-diethoxy-4-[(4- ditive shall conform to the require-
methylphenyl)thio]phenyl]azo]-1,3,5- ments of § 70.25 of this chapter.
benzenetriol may be safely used to (d) Exemption from certification. Cer-
mark soft (hydrophilic) contact lenses tification of this color additive is not
with the letter R or the letter L for necessary for the protection of the pub-
identification purposes subject to the lic health, and therefore the color addi-
following restrictions: tive is exempt from the certification

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§ 73.3118 21 CFR Ch. I (4–1–11 Edition)

requirements of section 721(c) of the (c) Labeling. The label of the color ad-
act. ditive shall conform to the require-
ments of § 70.25 of this chapter.
[48 FR 31375, July 8, 1983]
(d) Exemption from certification. Cer-
§ 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo- tification of this color additive is not
1,5-anthracenediyl) bisbenzamide. necessary for the protection of the pub-
lic health, and therefore the color addi-
(a) Identity. The color additive is tive is exempt from the certification
N,N′-(9,10-dihydro-9,10-dioxo-1,5- requirements of section 721(c) of the
anthracenediyl) bisbenzamide (CAS act.
Reg. No. 82–18–8), Colour Index No.
61725. [48 FR 31376, July 8, 1983]
(b) Uses and restrictions. (1) The sub- § 73.3120 16,17-Dimethoxydinaphtho
stance listed in paragraph (a) of this [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-
section may be used as a color additive dione.
in contact lenses in amounts not to ex-
ceed the minimum reasonably required (a) Identity. The color additive is
to accomplish the intended coloring ef- 16,17-dimethoydinaphtho[1,2,3,-
fect. cd:3′,2′,1′-lm]perylene-5,10-dione (CAS
Reg. No. 128–58–5), Colour Index No.
(2) Authorization for this use shall
59825.
not be construed as waiving any of the
(b) Uses and restrictions. (1) The sub-
requirements of sections 510(k), 515,
stance listed in paragraph (a) of this
and 520(g) of the Federal Food, Drug,
section may be used as a color additive
and Cosmetic Act with respect to the
in contact lenses in amounts not to ex-
contact lens in which the color addi-
ceed the minimum reasonably required
tive is used.
to accomplish the intended coloring ef-
(c) Labeling. The label of the color ad- fect.
ditive shall conform to the require- (2) Authorization for this use shall
ments of § 70.25 of this chapter. not be construed as waiving any of the
(d) Exemption from certification. Cer- requirements of sections 510(k), 515,
tification of this color additive is not and 520(g) of the Federal Food, Drug,
necessary for the protection of the pub- and Cosmetic Act with respect to the
lic health, and therefore the color addi- contact lens in which the color addi-
tive is exempt from the certification tive is used.
requirements of section 721(c) of the (c) Labeling. The label of the color ad-
act. ditive shall conform to the require-
[48 FR 31375, July 8, 1983] ments of § 70.25 of this chapter.
(d) Exemption from certification. Cer-
§ 73.3119 7,16-Dichloro–6,15-dihydro- tification of this color additive is not
5,9,14,18-anthrazinetetrone. necessary for the protection of the pub-
(a) Identity. The color additive is 7,16- lic health, and therefore the color addi-
dichloro-6,15-dihydro-5,9,14,18- tive is exempt from the certification
anthrazinetetrone (CAS Reg. No. 130– requirements of section 721(c) of the
20–1), Colour Index No. 69825. act.
(b) Uses and restrictions. (1) The sub- [48 FR 31376, July 8, 1983]
stance listed in paragraph (a) of this
section may be used as a color additive § 73.3121 Poly(hydroxyethyl methacry-
in contact lenses in amounts not to ex- late)-dye copolymers.
ceed the minimum reasonably required (a) Identity. The color additives are
to accomplish the intended coloring ef- formed by reacting one or more of the
fect. reactive dyes listed in this paragraph
(2) Authorization for this use shall with poly(hydroxyethyl methacrylate),
not be construed as waiving any of the so that the sulfate group (or groups) or
requirements of sections 510(k), 515, chlorine substituent of the dye is re-
and 520(g) of the Federal Food, Drug, placed by an ether linkage to
and Cosmetic Act with respect to the poly(hydroxyethyl methacrylate). The
contact lens in which the color addi- dyes that may be used alone or in com-
tive is used. bination are

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Food and Drug Administration, HHS § 73.3122

(1) Reactive Black 5 [2,7- (b) Uses and restrictions. (1) The sub-
naphthalenedisulfonic acid, 4-amino-5- stances listed in paragraph (a) of this
hydroxy-3,6-bis((4-((2- section may be used to color contact
(sulfooxy)ethyl)sulfonyl)phenyl)azo)- lenses in amounts not to exceed the
tetrasodium salt] (CAS Reg. No. 17095– minimum reasonably required to ac-
24–8); complish the intended coloring effect.
(2) Reactive Blue 21 [copper, (29H,31H- (2) As part of the manufacturing
phthalocyaninato(2-)-N29,N30,N31,N32)-, process, the lenses containing the color
sulfo((4-((2- additives are thoroughly washed to re-
sulfooxy)ethyl)sulfonyl)phenyl)amino) move unbound reactive dyes.
sulfonyl derivs] (CAS Reg. No. 73049–92– (3) Authorization and compliance
0); with this use shall not be construed as
(3) Reactive Orange 78 [2- waiving any of the requirements of sec-
naphthalenesulfonic acid, 7- tions 510(k), 515, and 520(g) of the Fed-
(acetylamino)-4-hydroxy-3-((4-((2- eral Food, Drug, and Cosmetic Act (the
(sulfooxy)ethyl) sulfonyl)phenyl)azo)-] act). A person intending to introduce a
CAS Reg. No. 68189–39–9); device containing a poly(hydroxyethyl
(4) Reactive Yellow 15 methacrylate)-dye copolymer listed
[benzensulfonic acid, 4-(4,5-dihydro-4- under this section into commerce shall
((2-methoxy-5-methyl-4-((2- submit to the Food and Drug Adminis-
(sulfooxy)ethyl) sulfonyl)phenyl)azo)-3- tration either a premarket notification
methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS in accordance with subpart E of part
Reg. No. 60958–41–0); 807 of this chapter, if the device is not
(5) Reactive Blue No. 19 [2-anthra- subject to premarket approval, or sub-
cene-sulfonic acid, 1-amino-9,10- mit and receive approval of an original
dihydro-9,10-dioxo-4-((3-((2- or supplemental premarket approval
(sulfooxy)ethyl)sulfonyl)phenyl)amino) application if the device is subject to
-, disodium salt] (CAS Reg. No. 2580–78–
premarket approval.
1);
(c) Labeling. The label of the color ad-
(6) Reactive Blue No. 4 [2-
ditives shall conform to the require-
anthracenesulfonic acid, 1-amino-4-(3-
((4,6-dichloro-s-triazin-2-yl)amino)-4- ments of § 70.25 of this chapter.
sulfoanilino)-9,10-dihydro-9,10-dioxo, di- (d) Exemption from certification. Cer-
sodium salt] (CAS Reg. No. 4499–01–8); tification of these color additives is
(7) C.I. Reactive Red 11 [5-((4,6- not necessary for the protection of the
dichloro-1,3,5-triazin-2-yl)amino)-4-hy- public health, and therefore these color
droxy-3-((1-sulfo-2-naphthalenyl)azo)-2, additives are exempt from the certifi-
7-naphthalenedisulfonic acid, tri- cation requirements of section 721(c) of
sodium salt] (CAS Reg. No. 12226–08–3); the act.
(8) C.I. Reactive Yellow 86 [1,3- [49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10,
benzenedisulfonic acid, 4-((5- 1984, as amended at 50 FR 9425, Mar. 8, 1985;
aminocarbonyl-1-ethyl-1,6-dihydro-2- 50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept.
hydroxy-4-methyl-6-oxo-3- 18, 1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541,
pyridinyl)azo)-6-(4,6-dichloro-1,3,5- Feb. 22, 1993]
triazin-2-yl)amino)-, disodium salt]
(CAS Reg. No. 61951–86–8); § 73.3122 4-[(2,4-dimethylphenyl)azo]-
(9) C.I. Reactive Blue 163 2,4-dihydro-5-methyl-2-phenyl-3H-
pyrazol-3-one.
[triphenodioxazinedisulfonic acid, 6,13-
dichloro-3, 10-bis((4-((4.6-dichloro-1,3,5- (a) Identity. The color additive is 4-
triazin-2-yl)amino) sulfophenyl)amino)- [(2,4-dimethylphenyl)azo]-2,4-dihydro-5-
, tetrasodium salt] (CAS Reg. No. methyl-2-phenyl-3H- pyrazol-3-one
72847–56–4); and (CAS Reg. No. 6407–78–9).
(10) C.I. Reactive Red 180 [5- (b) Uses and restrictions. (1) The sub-
(benzoylamino)-4-hydroxy-3-((1-sulfo-6- stances listed in paragraph (a) of this
((2-(sulfooxy)ethyl)sulfonyl)-2- section may be used as a color additive
naphthalenyl)azo)-2,7- in contact lenses in amounts not to ex-
naphthalenedisulfonic acid, ceed the minimum reasonably required
tetrasodium salt] (CAS Reg. No. 98114– to accomplish the intended coloring ef-
32–0). fect.

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§ 73.3123 21 CFR Ch. I (4–1–11 Edition)

(2) Authorization for this use shall (b) Uses and restrictions. (1) The sub-
not be construed as waiving any of the stance listed in paragraph (a) of this
requirements of sections 510(k), 515, section may be used as a color additive
and 520(g) of the Federal Food, Drug, in contact lenses in amounts not to ex-
and Cosmetic Act with respect to the ceed the minimum reasonably required
contact lens in which the color addi- to accomplish the intended coloring ef-
tive is used. fect.
(c) Labeling. The label of the color ad- (2) Authorization for this use shall
ditive shall conform to the require- not be construed as waiving any of the
ments of § 70.25 of this chapter. requirements of sections 510(k), 515,
(d) Exemption from certification. Cer- and 520(g) of the Federal Food, Drug,
tification of this color additive is not and Cosmetic Act with respect to the
necessary for the protection of the pub- contact lens in which the additive is
lic health, and therefore the color addi- used.
tive is exempt from the certification
(c) Labeling. The label of the color ad-
requirements of section 721(c) of the
ditive shall conform to the require-
act.
ments of § 70.25 of this chapter.
[51 FR 11432, Apr. 3, 1986] (d) Exemption from certification. Cer-
tification of this color additive is not
§ 73.3123 6-Ethoxy-2-(6-ethoxy-3- necessary for the protection of the pub-
oxobenzo[b]thien-2(3H)-ylidene)
benzo[b]thiophen-3 (2H)-one. lic health, and therefore the color addi-
tive is exempt from the certification
(a) Identity. The color additive is 6- requirements of section 721(c) of the
ethoxy-2-(6-ethoxy-3-oxobenzo [b]thien- act.
2(3H)-ylidene)benzo[b]thiophen-3(2H)-
one (CAS Reg. No. 3263–31–8), Colour [51 FR 11433, Apr. 3, 1986]
Index No. 73335.
(b) Uses and restrictions. (1) The sub- § 73.3125 Iron oxides.
stance listed in paragraph (a) of this (a) Identity and specifications. The
section may be used as a color additive color additive iron oxides (CAS Reg.
in contact lenses in amounts not to ex- No. 1332–37–2), Color Index No. 77491,
ceed the minimum reasonably required shall conform in identity and specifica-
to accomplish the intended coloring ef- tions to the requirements of § 73.2250 (a)
fect. and (b).
(2) Authorization for this use shall (b) Uses and restrictions. (1) The sub-
not be construed as waiving any of the stance listed in paragraph (a) of this
requirements of sections 510(k), 515, section may be used as a color additive
and 520(g) of the Federal Food, Drug, in contact lenses in amounts not to ex-
and Cosmetic Act with respect to the
ceed the minimum reasonably required
contact lens in which the color addi-
to accomplish the intended coloring ef-
tive is used.
fect.
(c) Labeling. The label of the color ad-
(2) Authorization and compliance
ditive shall conform to the require-
ments of § 70.25 of this chapter. with this use shall not be construed as
waiving any of the requirements of sec-
(d) Exemption from certification. Cer-
tification of this color additive is not tions 510(k), 515, and 520(g) of the Fed-
necessary for the protection of the pub- eral Food, Drug, and Cosmetic Act
lic health, and therefore the color addi- with respect to the contact lens in
tive is exempt from the certification which the additive is used.
requirements of section 721(c) of the (c) Labeling. The label of the color ad-
act. ditive shall conform to the require-
ments of § 70.25 of this chapter.
[51 FR 11436, Apr. 3, 1986]
(d) Exemption from certification. Cer-
§ 73.3124 Phthalocyanine green. tification of this color additive is not
necessary for the protection of the pub-
(a) Identity. The color additive is lic health, and therefore the color addi-
phthalocyanine green (CAS Reg. No. tive is exempt from the certification
1328–53–6), Colour Index No. 74260.

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Food and Drug Administration, HHS § 73.3127

requirements of section 721(c) of the (sulfooxy)ethyl)sulfonyl)phenyl)azo)-,


act. tetrasodium salt] (CAS Reg. No. 17095–
24–8).
[51 FR 24816, July 9, 1986, as amended at 69
FR 24511, May 4, 2004] (3) C.I. Reactive Orange 78 [2-
naphthalenesulfonic acid, 7-
§ 73.3126 Titanium dioxide. (acetylamino)-4-hydroxy-3-((4-((2-
(sulfooxy)ethyl)sulfonyl)phenyl)azo)-]
(a) Identity and specifications. The
(CAS Reg. No. 68189–39–9).
color additive titanium dioxide (CAS
(4) C.I. Reactive Yellow 15
Reg. No. 13463–67–7), Color Index No.
[benzenesulfonic acid, 4-(4,5-dihydro-4-
77891, shall conform in identity and
((2-methoxy-5-methyl-4-((2-
specifications to the requirements of
(sulfooxy)ethyl)sulfonyl)phenyl)azo)-3-
§ 73.575(a)(1) and (b).
methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS
(b) Uses and restrictions. (1) The sub-
Reg. No. 60958–41–0).
stance listed in paragraph (a) of this
(5) C.I. Reactive Blue No. 19 [2-
section may be used as a color additive
anthracenesulfonic acid, 1-amino-9,10-
in contact lenses in amounts not to ex-
dihydro-9,10-dioxo-4-((3-((2-
ceed the minimum reasonably required
(sulfooxy)ethyl)sulfonyl)phenyl)amino)
to accomplish the intended coloring ef-
-, disodium salt] (CAS Reg. No. 2580–78–
fect.
1).
(2) Authorization and compliance
(6) C.I. Reactive Blue 21 [copper,
with this use shall not be construed as
(29H,31H-phthalocyaninato(2-)-N29, N30,
waiving any of the requirements of sec- 31
N , N32)-, sulfo((4-((2-(sulfooxy)
tions 510(k), 515, and 520(g) of the Fed-
ethyl)sulfonyl)phenyl)amino)sulfonyl
eral Food, Drug, and Cosmetic Act
derivatives] (CAS Reg. No. 73049–92–0).
with respect to the contact lenses in
(b) Uses and restrictions. (1) The sub-
which the additive is used.
stances listed in paragraph (a) of this
(c) Labeling. The label of the color ad-
section may be used to color contact
ditive shall conform to the require-
lenses in amounts not to exceed the
ments of § 70.25 of this chapter.
minimum reasonably required to ac-
(d) Exemption from certification. Cer-
complish the intended coloring effect.
tification of this color additive is not
(2) As part of the manufacturing
necessary for the protection of the pub-
process, the lenses containing the color
lic health, and therefore the color addi-
additives are thoroughly washed to re-
tive is exempt from the certification
move unbound reactive dye.
requirements of section 721(c) of the
(3) Authorization and compliance
act.
with this use shall not be construed as
[51 FR 24816, July 9, 1986] waiving any of the requirements of sec-
tions 510(k), 515, and 520(g) of the Fed-
§ 73.3127 Vinyl alcohol/methyl meth- eral Food, Drug, and Cosmetic Act (the
acrylate-dye reaction products. act). A person intending to introduce a
(a) Identity. The color additives are device containing a vinyl alcohol/meth-
formed by reacting the dyes, either yl methacrylate-dye reaction product
alone or in combination, with a vinyl listed under this section into com-
alcohol/methyl methacrylate copoly- merce shall submit to the Food and
mer, so that the sulfate groups of the Drug Administration either a pre-
dyes are replaced by ether linkages to market notification in accordance with
the vinyl alcohol/methyl methacrylate subpart E of part 807 of this chapter, if
copolymer. The dyes are: the device is not subject to premarket
(1) C.I. Reactive Red 180 [5- approval, or submit and receive ap-
(benzoylamino)-4-hydroxy-3-((1-sulfo-6- proval of an original or supplemental
((2-(sulfooxy)ethyl)sulfonyl)-2- premarket approval application if the
naphthalenyl)azo)-2,7- device is subject to premarket ap-
naphthalenedisulfonic acid, proval.
tetrasodium salt] (CAS Reg. No. 98114– (c) Labeling. The label of the color ad-
32–0). ditive shall conform to the require-
(2) C.I. Reactive Black 5 [2,7- ments of § 70.25 of this chapter.
naphthalenedisulfonic acid, 4-amino-5- (d) Exemption from certification. Cer-
hydroxy-3,6-bis((4-((2- tification of this color additive is not

393

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§ 73.3128 21 CFR Ch. I (4–1–11 Edition)

necessary for the protection of the pub- 74.705 FD&C Yellow No. 5.
lic health, and therefore, this color ad- 74.706 FD&C Yellow No. 6.
ditive is exempt from the certification
Subpart B—Drugs
requirements of section 721(c) of the
act. 74.1101 FD&C Blue No. 1.
74.1102 FD&C Blue No. 2.
[58 FR 3227, Jan. 8, 1993, as amended at 58 FR
74.1104 D&C Blue No. 4.
17510, Apr. 5, 1993] 74.1109 D&C Blue No. 9.
74.1203 FD&C Green No. 3.
§ 73.3128 Mica-based pearlescent pig- 74.1205 D&C Green No. 5.
ments. 74.1206 D&C Green No. 6.
(a) Identity and specifications. The 74.1208 D&C Green No. 8.
color additive is formed by depositing 74.1254 D&C Orange No. 4.
titanium or iron salts from a basic so- 74.1255 D&C Orange No. 5.
74.1260 D&C Orange No. 10.
lution onto mica, followed by calci-
74.1261 D&C Orange No. 11.
nation to produce titanium dioxide or 74.1303 FD&C Red No. 3.
iron oxides on mica. Mica used to man- 74.1304 FD&C Red No. 4.
ufacture the color additive shall con- 74.1306 D&C Red No. 6.
form in identity and specifications to 74.1307 D&C Red No. 7.
the requirements of § 73.1496(a)(1) and 74.1317 D&C Red No. 17.
(b). 74.1321 D&C Red No. 21.
(b) Uses and restrictions. (1) Mica- 74.1322 D&C Red No. 22.
74.1327 D&C Red No. 27.
based pearlescent pigments listed in
74.1328 D&C Red No. 28.
paragraph (a) of this section may be 74.1330 D&C Red No. 30.
used as a color additive in contact 74.1331 D&C Red No. 31.
lenses in amounts not to exceed the 74.1333 D&C Red No. 33.
minimum reasonably required to ac- 74.1334 D&C Red No. 34.
complish the intended coloring effect. 74.1336 D&C Red No. 36.
(2) Authorization and compliance 74.1339 D&C Red No. 39.
with this use shall not be construed as 74.1340 FD&C Red No. 40.
74.1602 D&C Violet No. 2.
waiving any of the requirements of sec-
74.1705 FD&C Yellow No. 5.
tions 510(k), 515, and 520(g) of the Fed- 74.1706 FD&C Yellow No. 6.
eral Food, Drug, and Cosmetic Act (the 74.1707 D&C Yellow No. 7.
act) with respect to the contact lenses 74.1707a Ext. D&C Yellow No. 7.
in which the additive is used. 74.1708 D&C Yellow No. 8.
(c) Labeling. The label of the color ad- 74.1710 D&C Yellow No. 10.
ditive shall conform to the require- 74.1711 D&C Yellow No. 11.
ments in § 70.25 of this chapter.
Subpart C—Cosmetics
(d) Exemption from certification. Cer-
tification of this color additive is not 74.2052 D&C Black No. 2.
necessary for the protection of the pub- 74.2053 D&C Black No. 3.
lic health, and therefore batches there- 74.2101 FD&C Blue No. 1.
of are exempt from the certification re- 74.2104 D&C Blue No. 4.
quirements of section 721(c) of the act. 74.2151 D&C Brown No. 1.
74.2203 FD&C Green No. 3.
[67 FR 65312, Oct. 24, 2002] 74.2205 D&C Green No. 5.
74.2206 D&C Green No. 6.
74.2208 D&C Green No. 8.
PART 74—LISTING OF COLOR AD- 74.2254 D&C Orange No. 4.
DITIVES SUBJECT TO CERTIFI- 74.2255 D&C Orange No. 5.
CATION 74.2260 D&C Orange No. 10.
74.2261 D&C Orange No. 11.
Subpart A—Foods 74.2304 FD&C Red No. 4.
74.2306 D&C Red No. 6.
Sec. 74.2307 D&C Red No. 7.
74.101 FD&C Blue No. 1. 74.2317 D&C Red No. 17.
74.102 FD&C Blue No. 2. 74.2321 D&C Red No. 21.
74.203 FD&C Green No. 3. 74.2322 D&C Red No. 22.
74.250 Orange B. 74.2327 D&C Red No. 27.
74.302 Citrus Red No. 2. 74.2328 D&C Red No. 28.
74.303 FD&C Red No. 3. 74.2330 D&C Red No. 30.
74.340 FD&C Red No. 40. 74.2331 D&C Red No. 31.

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Food and Drug Administration, HHS § 74.102
74.2333 D&C Red No. 33. ties other than those named to the ex-
74.2334 D&C Red No. 34. tent that such other impurities may be
74.2336 D&C Red No. 36. avoided by current good manufacturing
74.2340 FD&C Red No. 40.
74.2602 D&C Violet No. 2. practice:
74.2602a Ext. D&C Violet No. 2. Sum of volatile matter (at 135 °C) and
74.2705 FD&C Yellow No. 5. chlorides and sulfates (calculated as so-
74.2706 FD&C Yellow No. 6. dium salts), not more than 15.0 percent.
74.2707 D&C Yellow No. 7. Water-insoluble matter, not more than 0.2
74.2707a Ext. D&C Yellow No. 7. percent.
74.2708 D&C Yellow No. 8. Leuco base, not more than 5 percent.
74.2710 D&C Yellow No. 10. Sum of o-, m-, and p-sulfobenzaldehydes, not
74.2711 D&C Yellow No. 11. more than 1.5 percent.
N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not
Subpart D—Medical Devices more than 0.3 percent.
74.3045 [Phthalocyaninato(2-)] copper. Subsidiary colors, not more than 6.0 percent.
74.3102 FD&C Blue No. 2. Chromium (as Cr), not more than 50 parts
74.3106 D&C Blue No. 6. per million.
74.3206 D&C Green No. 6. Manganese (as Mn), not more than 100 parts
74.3230 D&C Red No. 17. per million.
74.3602 D&C Violet No. 2. Arsenic (as As), not more than 3 parts per
74.3710 D&C Yellow No. 10. million.
Lead (as Pb), not more than 10 parts per mil-
APPENDIX A TO PART 74—THE PROCEDURE FOR
lion.
DETERMINING ETHER SOLUBLE MATERIAL
Total color, not less than 85.0 percent.
IN D&C RED NOS. 6 AND 7

AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, (c) Uses and restrictions. FD&C Blue
351, 352, 355, 361, 362, 371, 379e. No. 1 may be safely used for coloring
foods (including dietary supplements)
SOURCE: 42 FR 15654, Mar. 22, 1977, unless
otherwise noted.
generally in amounts consistent with
good manufacturing practice except
that it may not be used to color foods
Subpart A—Foods for which standards of identity have
§ 74.101 FD&C Blue No. 1. been promulgated under section 401 of
the act unless added color is authorized
(a) Identity. (1) The color additive by such standards.
FD&C Blue No. 1 is principally the di- (d) Labeling. The label of the color ad-
sodium salt of ethyl [4-[p-[ethyl (m- ditive and any mixtures prepared
sulfobenzyl) amino]-a-(o-sulfophenyl) therefrom intended solely or in part for
benzylidene] - 2,5 -cyclohexadien - 1 - coloring purposes shall conform to the
ylidene] (m-sulfobenzyl) ammonium hy- requirements of § 70.25 of this chapter.
droxide inner salt with smaller (e) Certification. All batches of FD&C
amounts of the isomeric disodium salts Blue No. 1 shall be certified in accord-
of ethyl [4-[p-[ethyl(p-sulfobenzyl) ance with regulations in part 80 of this
amino]-a-(o-sulfophenyl) benzylidene]- chapter.
2,5-cyclohexadien-1-ylidene] (p-
sulfobenzyl) ammonium hydroxide [42 FR 15654, Mar. 22, 1977, as amended at 58
inner salt and ethyl [4-[p-[ethyl (o- FR 17511, Apr. 5, 1993]
sulfobenzyl) amino] - a - (o
-sulfophenyl) benzylidene]-2,5- § 74.102 FD&C Blue No. 2.
cyclohexadien-1-ylidene] (o- (a) Identity. (1) The color additive
sulfobenzyl) ammonium hydroxide FD&C Blue No. 2 is principally the di-
inner salt. sodium salt of 2-(1,3-dihydro-3-oxo-5-
(2) Color additive mixtures for food sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-
use (including dietary supplements) oxo-1H-indole-5-sulfonic acid (CAS Reg.
made with FD&C Blue No. 1 may con- No. 860–22–0) with smaller amounts of
tain only those diluents that are suit- the disodium salt of 2-(1,3-dihydro-3-
able and that are listed in part 73 of oxo-7-sulfo-2H-indol-2-ylidene)-2,3-
this chapter as safe for use in color ad- dihydro-3-oxo-1H-indole-5-sulfonic acid
ditive mixtures for coloring foods. (CAS Reg. No. 54947–75–0) and the so-
(b) Specifications. FD&C Blue No. 1 dium salt of 2-(1,3-dihydro-3-oxo-2H-
shall conform to the following speci- indol-2-ylidene)-2,3-dihydro-3-oxo-1H-
fications and shall be free from impuri- indole-5-sulfonic acid (CAS Reg. No.

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§ 74.203 21 CFR Ch. I (4–1–11 Edition)

605–18–5). Additionally, FD&C Blue No. unless added color is authorized by


2 is obtained by heating indigo (or in- such standards.
digo paste) in the presence of sulfuric (d) Labeling. The label of the color ad-
acid. The color additive is isolated and ditive and any mixtures prepared
subjected to purification procedures. therefrom intended solely or in part for
The indigo (or indigo paste) used above coloring purposes shall conform to the
is manufactured by the fusion of N- requirements of § 70.25 of this chapter.
phenylglycine (prepared from aniline (e) Certification. All batches of FD&C
and formaldehyde) in a molten mixture Blue No. 2 shall be certified in accord-
of sodamide and sodium and potassium ance with regulations in part 80 of this
hydroxides under ammonia pressure. chapter.
The indigo is isolated and subjected to
purification procedures prior to [48 FR 5260, Feb. 4, 1983]
sulfonation.
(2) Color additive mixtures for food § 74.203 FD&C Green No. 3.
use (including dietary supplements) (a) Identity. (1) The color additive
made with FD&C Blue No. 2 may con- FD&C Green No. 3 is principally the
tain only those diluents that are suit- inner salt disodium salt of N-ethyl-N-
able and that are listed in part 73 of [4-[[4-[ethyl[(3-
this chapter as safe for use in color ad- sulfophenyl)methyl]amino]phenyl](4-
ditive mixtures for coloring foods. hydroxy-2-sulfophenyl)methylene]-2,5-
(b) Specifications. The color additive cyclohexadien-1-ylidene]-3-
FD&C Blue No. 2 shall conform to the sulfobenzenemethanaminium hydrox-
following specifications and shall be ide (CAS Reg. No. 2353–45–9); with
free from impurities other than those smaller amounts of the isomeric inner
named to the extent that such other salt disodium salt of N-ethyl-N-[4-[[4-
impurities may be avoided by current [ethyl[(3-sulfophenyl)methyl]
good manufacturing practice: amino]phenyl](4-hydroxy-2-
Sum of volatile matter at 135 °C (275 °F) and sulfophenyl)methylene]-2,5-
chlorides and sulfates (calculated as so- cyclohexadien-1-ylidene]-4-
dium salts), not more than 15 percent. sulfobenzenemethanaminium hydrox-
Water insoluble matter, not more than 0.4 ide; of N-ethyl-N-[4-[[4-[ethyl[(4-
percent. sulfophenyl)methyl]amino]phenyl](4-
Isatin-5-sulfonic acid, not more than 0.4 per-
hydroxy-2-sulfophenyl)methylene]-2,5-
cent.
5-Sulfoanthranilic acid, not more than 0.2 cyclohexadien-1-ylidene]-4-
percent. sulfobenzenemethanaminium hydrox-
Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo- ide and of N-ethyl-N-[4-[[4-[ethyl[(2-
2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H- sulfophenyl)methyl]amino]phenyl](4-
indole-5-sulfonic acid, not more than 18 hydroxy-2-sulfophenyl)methylene]-2,5-
percent. cyclohexadien-1-ylidene]-3-
Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-
sulfobenzenemethanaminium hydrox-
2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-
sulfonic acid, not more than 2 percent. ide. Additionally, FD&C Green No. 3 is
Lead (as Pb), not more than 10 parts per mil- manufactured by the acid catalyzed
lion. condensation of one molecule of 2-
Arsenic (as As), not more than 3 parts per formyl-5-hydroxybenzenesulfonic acid
million. with two molecules from a mixture
Mercury (as Hg), not more than 1 part per consisting principally of 3-
million. [(ethylphenylamino)methyl]
Total color, not less than 85 percent.
benzensulfonic acid, and smaller
(c) Uses and restrictions. The color ad- amounts of 4-
ditive FD&C Blue No. 2 may be safely [(ethylphenylamino)methyl]
used for coloring foods (including die-
tary supplements) generally in benzenesulfonic acid and 2-
amounts consistent with current good [(ethylphenylamino)methyl]
manufacturing practice except that it benzenesulfonic acid to form the leuco
may not be used to color foods for base. The leuco base is then oxidized
which standards of identity have been with lead dioxide and acid or with di-
promulgated under section 401 of the chromate and acid to form the dye. The
Federal Food, Drug, and Cosmetic Act intermediate 2-formyl-5-

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Food and Drug Administration, HHS § 74.250

hydroxybenzenesulfonic acid is pre- coloring purposes shall conform to the


pared by the potassium permanganate requirements of § 70.25 of this chapter.
oxidation of 2,2′-(1,2-ethenediyl)-bis(5- (e) Certification. All batches of FD&C
aminobenzenesulfonic acid) to sodium Green No. 3 shall be certified in accord-
5-amino-2-formylbenzenesulfonate. ance with regulations in part 80 of this
This amine is diazotized and the result- chapter.
ing diazonium salt is hydrolyzed to the [47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec.
desired 2-formyl-5- 17, 1982]
hydroxybenzenesulfonic acid.
(2) Color additive mixtures for food § 74.250 Orange B.
use (including dietary supplements) (a) Identity. (1) The color additive Or-
made with FD&C Green No. 3 may con- ange B is principally the disodium salt
tain only those diluents that are suit- of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4-
able and that are listed in part 73 of sulfonaphthylazo)-5-hydro-xypyrazole.
this chapter as safe for use in color ad- (2) The diluents in color additive
ditive mixtures for coloring food. mixtures for food use containing Or-
(b) Specifications. The color additive ange B are limited to those listed in
FD&C Green No. 3 shall conform to the part 73 of this chapter as safe and suit-
following specifications and shall be able in color additive mixtures for
free from impurities other than those coloring foods.
named to the extent that such other (b) Specifications. Orange B shall con-
impurities may be avoided by current form to the following specifications:
good manufacturing practice:
Volatile matter (at 135 °C.), not more than
Sum of volatile matter at 135 °C (275 °F) and 6.0 percent.
chlorides and sulfates (calculated as so- Chlorides and sulfates (calculated as the so-
dium salts), not more than 15 percent. dium salts), not more than 7.0 percent.
Water-insoluble matter, not more than 0.2 Water insoluble matter, not more than 0.2
percent. percent.
Leuco base, not more than 5 percent. 1-(4-Sulfophenyl)-3-ethylcarboxy-5-
Sum of 2-,3-,4-formylbenzenesulfonic acids, hydroxypyrazolone and 1-(4-sulfophenyl)-3-
sodium salts, not more than 0.5 percent. carboxy-5-hydroxypyrazolone, not more
Sum of 3- and 4-[[ethyl(4- than 0.7 percent.
sulfophenyl)amino]methyl] Naphthionic acid, not more than 0.2 percent.
benzenesulfonic acid, disodium salts, not Phenylhydrazine-p-sulfonic acid, not more
more than 0.3 percent. than 0.2 percent.
2-Formyl-5-hydroxybenzenesulfonic acid, so- The trisodium salt of 1-(4-sulfophenyl)-3-
dium salt, not more than 0.5 percent. carboxy-4-(4-sulfonaphthylazo)-5-
Subsidiary colors, not more than 6 percent. hydroxypyrazole, not more than 6.0 per-
Chromium (as Cr), not more than 50 parts cent.
per million. Other subsidiary dyes, not more than 1.0 per-
Arsenic (as As), not more than 3 parts per cent.
million. Lead (as Pb), not more than 10 parts per mil-
Lead (as Pb), not more than 10 parts per mil- lion.
lion. Arsenic (as As), not more than 1 part per
Mercury (as Hg), not more than 1 part per million.
million. Total color, not less than 87.0 percent.
Total color, not less than 85 percent.
(c) Uses and restrictions. Orange B
(c) Uses and restrictions. The color ad- may be safely used for coloring the cas-
ditive FD&C Green No. 3 may be safely ings or surfaces of frankfurters and
used for coloring foods (including die- sausages subject to the restriction that
tary supplements) generally in the quantity of the color additive does
amounts consistent with current good not exceed 150 parts per million by
manufacturing practice except that it weight of the finished food.
may not be used to color foods for (d) Labeling requirements. The label of
which standards of identity have been the color additive and any mixtures in-
promulgated under section 401 of the tended solely or in part for coloring
act unless added color is authorized by purposes prepared therefrom shall con-
such standards. form to the requirements of § 70.25 of
(d) Labeling. The label of the color ad- this chapter.
ditive and any mixtures prepared (e) Certification. All batches of Orange
therefrom intended solely or in part for B shall be certified in accordance with

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§ 74.302 21 CFR Ch. I (4–1–11 Edition)

regulations promulgated under part 80 form to the requirements of § 70.25 of


of this chapter. this chapter. To meet the requirements
of § 70.25 (b) and (c) of this chapter the
§ 74.302 Citrus Red No. 2. label shall bear:
(a) Identity. (1) The color additive (1) The statement (or its equivalent)
Citrus Red No. 2 is principally 1–(2,5– ‘‘To be used only for coloring skins of
dimethoxyphenylazo)-2-naphthol. oranges.’’
(2) The following diluents may be (2) Directions for use to limit the
used in aqueous suspension, in the per- amount of the color additive to not
centages specified, to facilitate appli- more than 2.0 parts per million, cal-
cation to oranges in accordance with culated on the basis of the weight of
paragraph (c)(1) of this section: the whole fruit.
(i) Suitable diluents used in accord- (e) Certification. All batches of Citrus
ance with § 73.1(a) of this chapter. Red No. 2 shall be certified in accord-
(ii) Volatile solvents that leave no ance with regulations in part 80 of this
residue after application to the orange. chapter.
(iii) Salts of fatty acids meeting the
requirements of § 172.863 of this chap- § 74.303 FD&C Red No. 3.
ter. (a) Identity. (1) The color additive
(iv) Sodium tripolyphosphate, not FD&C Red No. 3 is principally the
more than 0.05 percent. monohydrate of 9 (o- carboxyphenyl)-6-
(b) Specifications. Citrus Red No. 2 hydroxy - 2,4,5,7-tetraiodo-3H-xanthen-
shall conform to the following speci- 3-one, disodium salt, with smaller
fications and shall be free from impuri- amounts of lower imdinated
ties, other than those named, to the ex- fluoresceins.
tent that such other impurities may be (2) Color additive mixtures for food
avoided by good manufacturing prac- use made with FD&C Red No. 3 may
tice: contain only those diluents that are
Volatile matter (at 100 °C.), not more than suitable and that are listed in part 73
0.5 percent. of this chapter as safe for use in color
Water-soluble matter, not more than 0.3 per- additive mixtures for coloring foods.
cent. (b) Specifications. FD&C Red No. 3
Matter insoluble in carbon tetrachloride, not
more than 0.5 percent.
shall conform to the following speci-
Uncombined intermediates, not more than fications and shall be free from impuri-
0.05 percent. ties other than those named to the ex-
Subsidiary dyes, not more than 2.0 percent. tent that such other impurities may be
Lead (as Pb), not more than 10 parts per mil- avoided by good manufacturing prac-
lion. tice:
Arsenic (as As), not more than 1 part per
million. Volatile matter (at 135 °C.) and chlorides and
Total color, not less than 98 percent. sulfates (calculated as the sodium salts),
total not more than 13 percent.
(c) Uses and restrictions. (1) Citrus Red Water-insoluble matter, not more than 0.2
No. 2 shall be used only for coloring the percent.
skins of oranges that are not intended Unhalogenated intermediates, total not
or used for processing (or if so used are more than 0.1 percent.
designated in the trade as Packinghouse Sodium iodide, not more than 0.4 percent.
elimination) and that meet minimum Triiodoresorcinol, not more than 0.2 percent.
maturity standards established by or 2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic
acid, not more than 0.2 percent.
under the laws of the States in which Monoiodofluoresceins not more than 1.0 per-
the oranges are grown. cent.
(2) Oranges colored with Citrus Red Other lower iodinated fluoresceins, not more
No. 2 shall bear not more than 2.0 parts than 9.0 percent.
per million of such color additive, cal- Lead (as Pb), not more than 10 parts per mil-
culated on the basis of the weight of lion.
the whole fruit. Arsenic (as As), not more than 3 parts per
(d) Labeling. The label of the color ad- million.
Total color, not less than 87.0 percent.
ditive and any mixtures prepared
therefrom and intended solely or in (c) Uses and restrictions. FD&C Red
part for coloring purposes shall con- No. 3 may be safely used for coloring

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Food and Drug Administration, HHS § 74.705

foods generally (including dietary sup- Sodium salt of 6-hydroxy-2-


plements) in amounts consistent with naphthalenesulfonic acid (Schaeffer’s salt),
good manufacturing practice except not more than 0.3 percent.
4-Amino-5-methoxy-o- toluenesulfonic acid,
that it may not be used to color foods not more than 0.2 percent.
for which standards of identity have Disodium salt of 6,6′-oxybis (2-naphthalene-
been promulgated under section 401 of sulfonic acid), not more than 1.0 percent.
the act unless added color is authorized Lead (as Pb), not more than 10 parts per mil-
by such standards. lion.
(d) Labeling. The label of the color ad- Arsenic (as As), not more than 3 parts per
ditive and any mixtures prepared million.
Total color, not less than 85.0 percent.
therefrom intended solely or in part for
coloring purposes shall conform to the (c) Uses and restrictions. FD&C Red
requirements of § 70.25 of this chapter. No. 40 may be safely used for coloring
(e) Certification. All batches of FD&C foods (including dietary supplements)
Red No. 3 shall be certified in accord- generally in amounts consistent with
ance with regulations in part 80 of this good manufacturing practice except
chapter. that it may not be used to color foods
for which standards of identity have
§ 74.340 FD&C Red No. 40. been promulgated under section 401 of
the act unless added color is authorized
(a) Identity. (1) The color additive
by such standards.
FD&C Red No. 40 is principally the di-
(d) Labeling. The label of the color ad-
sodium salt of 6-hydroxy-5-[(2-
ditive and any lakes or mixtures pre-
methoxy-5-methyl-4-sulfophenyl)azo]-2-
pared therefrom intended solely or in
naphthalenesulfonic acid.
part for coloring purposes shall con-
(2) Color additive mixtures for food
form to the requirements of § 70.25 of
use (including dietary supplements)
this chapter.
made with FD&C Red No. 40 may con- (e) Certification. All batches of FD&C
tain only those diluents that are suit- Red No. 40 and lakes thereof shall be
able and that are listed in part 73 of certified in accordance with regula-
this chapter as safe for use in color ad- tions in part 80 of this chapter.
ditive mixtures for coloring foods.
(3) The listing of this color additive § 74.705 FD&C Yellow No. 5.
includes lakes prepared as described in
(a) Identity. (1) The color additive
§ 82.51 of this chapter, except that the
FD&C Yellow No. 5 is principally the
color additive used is FD&C Red No. 40
trisodium salt of 4,5-dihydro-5-oxo-1-(4-
and the resultant lakes meet the speci-
sulfophenyl)-4-[4-sulfophenyl-azo]-1H-
fication and labeling requirements pre- pyrazole-3-carboxylic acid (CAS Reg.
scribed by § 82.51 of this chapter. No. 1934–21–0). To manufacture the ad-
(b) Specifications. FD&C Red No. 40 ditive, 4-amino-benzenesulfonic acid is
shall conform to the following speci- diazotized using hydrochloric acid and
fications and shall be free from impuri- sodium nitrite. The diazo compound is
ties other than those named to the ex- coupled with 4,5-dihydro-5-oxo-1-(4-
tent that such other impurities may be sulfophenyl)-1H-pyrazole-3-carboxylic
avoided by good manufacturing prac- acid or with the methyl ester, the
tice: ethyl ester, or a salt of this carboxylic
Sum of volatile matter (at 135 °C.) and acid. The resulting dye is purified and
chlorides and sulfates (calculated as so- isolated as the sodium salt.
dium salts), not more than 14.0 percent. (2) Color additive mixtures for food
Water-insoluble matter, not more than 0.2 use made with FD&C Yellow No. 5 may
percent. contain only those diluents that are
Higher sulfonated subsidiary colors (as so- suitable and that are listed in part 73
dium salts), not more than 1.0 percent. of this chapter as safe for use in color
Lower sulfonated subsidiary colors (as so-
additive mixtures for coloring foods.
dium salts), not more than 1.0 percent.
(b) Specifications. FD&C Yellow No. 5
Disodium salt of 6-hydroxy-5-[(2-methoxy-5-
methyl-4-sulfophenyl) azo] -8-(2-methoxy-5- shall conform to the following speci-
methyl-4-sulfophenoxy)-2- fications and shall be free from impuri-
naphthalenesulfonic acid, not more than ties other than those named to the ex-
1.0 percent. tent that such other impurities may be

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§ 74.706 21 CFR Ch. I (4–1–11 Edition)

avoided by good manufacturing prac- (d) Labeling requirements. (1) The label
tice: of the color additive and any mixtures
intended solely or in part for coloring
Sum of volatile matter at 135 °C (275 °F) and
chlorides and sulfates (calculated as so- purposes prepared therefrom shall con-
dium salts), not more than 13 percent. form to the requirements of § 70.25 of
Water-insoluble matter, not more than 0.2 this chapter.
percent. (2) Foods for human use that contain
4,4′-[4,5-Dihydro-5-oxo-4-[(4- FD&C Yellow No. 5, including butter,
sulfophenyl)hydrazono]-1H-pyrazol-1,3- cheese, and ice cream, shall specifi-
diyl]bis[benzenesulfonic acid], trisodium cally declare the presence of FD&C
salt, not more than 1 percent.
Yellow No. 5 by listing the color addi-
4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-
4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr- tive as FD&C Yellow No. 5 among the
azole-3-carboxylic acid, tetrasodium salt, list of ingredients.
not more than 1 percent. (e) Certification. All batches of FD&C
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4- Yellow No. 5 shall be certified in ac-
sulfophenyl)-4-[(4-sulfophenyl)hydrazono]- cordance with regulations in part 80 of
1H-pyrazole-3-carboxylate, disodium salt, this chapter.
not more than 1 percent.
Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4- [42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar.
sulfophenyl)azo]-1H-pyrazole-3-carboxylic 23, 1979, as amended at 44 FR 37220, June 26,
acid, disodium salt, and 4,5-dihydro-5-oxo- 1979; 51 FR 24519, July 7, 1986]
4-(phenylazo)-1-(4-sulfophenyl)-1H-pyr-
azole-3-carboxylic acid, disodium salt, not § 74.706 FD&C Yellow No. 6.
more than 0.5 percent.
4-Aminobenzenesulfonic acid, sodium salt, (a) Identity. (1) The color additive
not more than 0.2 percent. FD&C Yellow No. 6 is principally the
4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr- disodium salt of 6-hydroxy-5-[(4-
azole-3-carboxylic acid, disodium salt, not sulfophenyl)azo]-2-naphthalenesulfonic
more than 0.2 percent. acid (CAS Reg. No. 2783–94–0). The tri-
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4- sodium salt of 3-hydroxy-4-[(4-
sulfophenyl)-1H-pyrazole-3-carboxylate, so- sulfophenyl)azo]-2,7-
dium salt, not more than 0.1 percent.
naphthalenedisulfonic acid (CAS Reg.
4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic
acid], disodium salt, not more than 0.05
No. 50880–65–4) may be added in small
percent. amounts. The color additive is manu-
4-Aminoazobenzene, not more than 75 parts factured by diazotizing 4-
per billion. aminobenzenesulfonic acid using hy-
4-Aminobiphenyl, not more than 5 parts per drochloric acid and sodium nitrite or
billion. sulfuric acid and sodium nitrite. The
Aniline, not more than 100 parts per billion. diazo compound is coupled with 6-hy-
Azobenzene, not more than 40 parts per bil- droxy-2-naphthalene-sulfonic acid. The
lion. dye is isolated as the sodium salt and
Benzidine, not more than 1 part per billion.
dried. The trisodium salt of 3-hydroxy-
1,3-Diphenyltriazene, not more than 40 parts
per billion. 4-[(4-sulfophenyl)azo]-2,7-
Lead (as Pb), not more than 10 parts per mil- naphthalenedisulfonic acid which may
lion. be blended with the principal color is
Arsenic (as As), not more than 3 parts per prepared in the same manner except
million. the diazo benzenesulfonic acid is cou-
Mercury (as Hg), not more than 1 part per pled with 3-hydroxy-2,7-
million. naphthalenedisulfonic acid.
Total color, not less than 87 percent. (2) Color additive mixtures for food
(c) Uses and restrictions. FD&C Yellow use made with FD&C Yellow No. 6 may
No. 5 may be safely used for coloring contain only those diluents that are
foods (including dietary supplements) suitable and that are listed in part 73
generally in amounts consistent with of this chapter as safe for use in color
good manufacturing practice, except additive mixtures for coloring foods.
that it may not be used to color foods (b) Specifications. The color additive
for which standards of identity have FD&C Yellow No. 6 shall conform to
been promulgated under section 401 of the following specifications and shall
the act unless added color is authorized be free from impurities other than
by such standards. those named to the extent that such

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Food and Drug Administration, HHS § 74.1101

other impurities may be avoided by (2) [Reserved]


current good manufacturing practice: (e) Certification. All batches of FD&C
Sum of volatile matter (at 135 °C) and Yellow No. 6 shall be certified in ac-
chlorides and sulfates (calculated as so- cordance with regulations in part 80 of
dium salts), not more than 13 percent. this chapter.
Water insoluble matter, not more than 0.2
percent. [51 FR 41782, Nov. 19, 1986, as amended at 52
Sodium salt of 4-aminobenzenesulfonic acid, FR 21508, June 8, 1987; 53 FR 49138, Dec. 6,
not more than 0.2 percent. 1988]
Sodium salt of 6-hydroxy-2-
naphthalenesulfonic acid, not more than
0.3 percent.
Subpart B—Drugs
Disodium salt of 6,6′-oxybis[2-
naphthalenesulfonic acid], not more than 1 § 74.1101 FD&C Blue No. 1
percent. (a) Identity. (1) For ingested drugs,
Disodium salt of 4,4′-(1-triazene-1,3- the color additive FD&C Blue No. 1
diyl)bis[benzenesulfonic acid], not more
than 0.1 percent.
shall conform in identity to the re-
Sum of the sodium salt of 6-hydroxy-5- quirements of § 74.101(a)(1).
(phenylazo)-2-naphthalenesulfonic acid and (2) For externally applied drugs, the
the sodium salt of 4-[(2-hydroxy-1- color additive FD&C Blue No. 1 shall
naphthalenyl)azo]benzenesulfonic acid, not conform in identity to the require-
more than 1 percent.
ments of § 74.2101(a).
Sum of the trisodium salt of 3-hydroxy-4-[(4-
sulfophenyl)azo]-2,7-naphthalenedisulfonic (3) Color additive mixtures for drug
acid and other higher sulfonated subsidi- use made with FD&C Blue No. 1 may
aries, not more than 5 percent. contain only those diluents that are
4-Aminoazobenzene, not more than 50 parts suitable and that are listed in part 73
per billion. of this chapter as safe for use in color
4-Aminobiphenyl, not more than 15 parts per
billion. additive mixtures for coloring drugs.
Aniline, not more than 250 parts per billion. (b) Specifications. (1) The color addi-
Azobenzene, not more than 200 parts per bil- tive FD&C Blue No. 1 for use in color-
lion. ing drugs generally shall conform in
Benzidine, not more than 1 part per billion. specifications to the requirements of
1,3-Diphenyltriazene, not more than 40 parts
per billion.
§ 74.101(b).
1-(Phenylazo)-2-naphthalenol, not more than (2) FD&C Blue No. 1 Aluminum Lake
10 parts per million. shall be prepared in accordance with
Lead (as Pb), not more than 10 parts per mil- the requirements of § 82.51 of this chap-
lion. ter.
Arsenic (as As), not more than 3 parts per
million.
(c) Uses and restrictions. (1) FD&C
Mercury (as Hg), not more than 1 part per Blue No. 1 may be safely used for color-
million. ing drugs, including drugs intended for
Total color, not less than 87 percent. use in the area of the eye, in amounts
(c) Uses and restrictions. The color ad- consistent with current good manufac-
ditive FD&C Yellow No. 6 may be safe- turing practice.
ly used for coloring foods (including di- (2) FD&C Blue No. 1 Aluminum Lake
etary supplements) generally in may be safely used for coloring drugs
amounts consistent with current good intended for use in the area of the eye,
manufacturing practice, except that it in amounts consistent with current
may not be used to color foods for good manufacturing practice, subject
which standards of identity have been to the restrictions on the use of color
promulgated under section 401 of the additives in § 70.5(b) and (c) of this
act unless added color is authorized by chapter.
such standards. (d) Labeling. The label of the color ad-
(d) Labeling requirements. (1) The label ditive and any mixtures prepared
of the color additive and any mixtures therefrom intended solely or in part for
intended solely or in part for coloring coloring purposes shall conform to the
purposes prepared therefrom shall con- requirements of § 70.25 of this chapter.
form to the requirements of § 70.25 of
this chapter.

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§ 74.1102 21 CFR Ch. I (4–1–11 Edition)

(e) Certification. All batches of FD&C ylidene] (o- sulfobenzyl) ammonium


Blue No. 1 shall be certified in accord- hydroxide inner salt.
ance with regulations in part 80 of this (2) Color additive mixtures for use in
chapter. externally applied drugs made with
D&C Blue No. 4 may contain only those
[47 FR 42565, Sept. 28, 1982, as amended at 59
diluents that are suitable and that are
FR 7638, Feb. 16, 1994]
listed in part 73 of this chapter for use
§ 74.1102 FD&C Blue No. 2. in color additive mixtures for coloring
externally applied drugs.
(a) Identity. (1) The color additive (b) Specifications. D&C Blue No. 4
FD&C Blue No. 2 shall conform in iden- shall conform to the following speci-
tity to the requirements of fications and shall be free from impuri-
§ 74.102(a)(1). ties other than those named to the ex-
(2) Color additive mixtures for use in tent that such impurities may be
ingested drugs made with FD&C Blue avoided by good manufacturing prac-
No. 2 may contain only those diluents tice:
that are suitable and that are listed in
Sum of volatile matter (at 135 °C) and
part 73 of this chapter as safe for use in
chlorides and sulfates (calculated as so-
color additive mixtures for coloring dium salts), not more than 15 percent.
drugs. Water-insoluble matter, not more than 0.2
(b) The color additive FD&C Blue No. percent.
2 for use in coloring ingested drugs Leuco base, not more than 5 percent.
shall conform to the specifications in Sum of o-, m, and p- sulfobenzaldehydes, am-
§ 74.102(b). monium salt, not more than 1.5 percent.
N-ethyl, N-(m- sulfobenzyl) sulfanilic acid
(c) The color additive FD&C Blue No. ammonium salt, not more than 0.3 percent.
2 may be safely used for coloring in- Subsidiary colors, not more than 6 percent.
gested drugs in amounts consistent Chromium (as Cr), not more than 50 parts
with current good manufacturing prac- per million.
tice. Lead (as Pb), not more than 20 parts per mil-
(d) Labeling. The label of the color ad- lion.
ditive and any mixtures prepared Arsenic (as As), not more than 3 parts per
million.
therefrom intended solely or in part for
Mercury (as Hg), not more than 1 part per
coloring purposes shall conform to the million.
requirements of § 70.25 of this chapter. Total color, not less than 85 percent.
(e) Certification. All batches of FD&C
Blue No. 2 shall be certified in accord- (c) Uses and restrictions. D&C Blue No.
ance with regulations in part 80 of this 4 may be safely used in externally ap-
chapter. plied drugs in amounts consistent with
good manufacturing practice.
[48 FR 5260, Feb. 4, 1983, as amended at 49 FR (d) Labeling. The label of the color ad-
10090, Mar. 19, 1984; 64 FR 48290, Sept. 3, 1999] ditive and any mixtures prepared
therefrom intended solely or in part for
§ 74.1104 D&C Blue No. 4. coloring purposes shall conform to the
(a) Identity. (1) The color additive requirements of § 70.25 of this chapter.
D&C Blue No. 4 is principally the (e) Certification. All batches of D&C
diammonium salt of ethyl[4-[p[ethyl(m- Blue No. 4 shall be certified in accord-
sulfobenzyl)ami-no]-a-(o- ance with regulations in part 80 of this
sulfophenyl)benzylidene]-2,5-cyclo- chapter.
hexadien-1-ylidene] (m- sulfobenzyl)
ammonium hydroxide inner salt with § 74.1109 D&C Blue No. 9.
smaller amounts of the isomeric (a) Identity. The color additive D&C
diammonium salts of ethyl [4-[p- Blue No. 9 is principally 7,16-dichloro-
[ethyl(p- sulfobenzyl) amino]-a-(o- 6,15 - dihydro - 5,9,14,18 - anthrazine-
sulfophenyl) benzylidene]-2,5- tetrone.
cyclohexadien - 1-ylidene](p- (b) Specifications. D&C Blue No. 9
sulfobenzyl) ammonium hydroxide shall conform to the following speci-
inner salt and ethyl[4-[p-[ethyl (o- fications and shall be free from impuri-
sulfobenzyl)amino]-a-(o- sulfophenyl) ties other than those named to the ex-
benzylidene]-2,5-cyclohexadien-1- tent that such impurities may be

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Food and Drug Administration, HHS § 74.1205

avoided by good manufacturing prac- amounts consistent with current good


tice: manufacturing practice.
(c) Labeling. The label of the color ad-
Volatile matter (at 135 °C.), not more than 3
percent. ditive and any mixtures prepared
Matter extractable by alcoholic HCl (0.1 ml therefrom intended solely or in part for
of concentrated hydrochloric acid per 50 ml coloring purposes shall conform to the
of 95 percent ethyl alcohol), not more than requirements of § 70.25 of this chapter.
1 percent. (d) Certification. All batches of FD&C
2-Amino anthraquinone, not more than 0.2 Green No. 3 shall be certified in accord-
percent. ance with regulations in part 80 of this
Organically combined chlorine in pure dye, chapter.
13.0–14.8 percent.
Lead (as Pb), not more than 20 p/m. [47 FR 52144, Nov. 19, 1982]
Arsenic (as As), not more than 3 p/m.
Total color, not less than 97 percent. § 74.1205 D&C Green No. 5.
(c) Uses and restrictions. D&C Blue No. (a) Identity. (1) The color additive
9 may be safely used for coloring cot- D&C Green No. 5 is principally the di-
ton and silk surgical sutures, including sodium salt of 2,2′-[(9,10-dihydro-9,10-
sutures for ophthalmic use, subject to dioxo-1,4-anthracenediyl)diimino]bis-
the following restrictions: [5-methylbenzenesulfonic acid] (CAS
(1) The dyed suture shall conform in Reg. No. 4403–90–1).
all respects to the requirements of the (2) Color additive mixtures for use in
United States Pharmacopeia XX (1980). drugs made with D&C Green No. 5 may
(2) The quantity of the color additive contain only those diluents that are
does not exceed 2.5 percent by weight suitable and those that are listed in
of the suture. part 73 of this chapter for use in color
(3) When the sutures are used for the additive mixtures for coloring drugs.
purposes specified in their labeling, the (b) Specifications. (1) D&C Green No. 5
color additive does not migrate to the for use in coloring surgical sutures
surrounding tissue. shall conform to the following speci-
(4) If the suture is a new drug, a new- fications and shall be free from impuri-
drug application approved pursuant to ties other than those named to the ex-
section 505 of the act is in effect for it. tent that such impurities may be
(d) Labeling. The label of the color ad- avoided by current good manufacturing
ditive shall conform to the require- practice:
ments of § 70.25 of this chapter. Sum of volatile matter (at 135 °C) and
(e) Certification. All batches of D&C chlorides and sulfates (calculated as so-
Blue No. 9 shall be certified in accord- dium salts), not more than 20 percent.
ance with regulations in part 80 of this Water insoluble matter, not more than 0.2
chapter. percent.
1,4-Dihydroxyanthraquinone, not more than
[42 FR 15654, Mar. 22, 1977, as amended at 49 0.2 percent.
FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1, 2-Amino-m-toluenesulfonic acid, not more
1993] than 0.2 percent.
Subsidiary colors, not more than 5 percent.
§ 74.1203 FD&C Green No. 3. Lead (as Pb), not more than 10 parts per mil-
(a) Identity and specifications. (1) The lion.
Arsenic (as As), not more than 3 parts per
color additive FD&C Green No. 3 shall
million.
conform in identity and specifications Total color, not less than 80 percent.
to the requirements of § 74.203(a)(1) and
(b). (2) D&C Green No. 5 for use in color-
(2) Color additive mixtures for drug ing drugs shall conform to the fol-
use made with FD&C Green No. 3 may lowing specifications and shall be free
contain only those diluents that are from impurities other than those
suitable and that are listed in part 73 named to the extent that such other
of this chapter as safe for use in color impurities may be avoided by current
additive mixtures for coloring drugs. good manufacturing practice:
(b) Uses and restrictions. The color ad- Sum of volatile matter (at 135 °C) and
ditive FD&C Green No. 3 may be safely chlorides and sulfates (calculated as so-
used for coloring drugs generally in dium salts), not more than 20 percent.

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§ 74.1206 21 CFR Ch. I (4–1–11 Edition)
Water-insoluble matter, not more than 0.2 ternally applied drugs shall conform to
percent. the following specifications and shall
1,4-Dihydroxyanthraquinone, not more than be free from impurities other than
0.2 percent.
those named to the extent that such
Sulfonated toluidines, total not more than
0.2 percent. other impurities may be avoided by
p-Toluidine, not more than 0.0015 percent. current good manufacturing practice:
Sum of monosulfonated D&C Green No. 6 and Volatile matter (at 135 °C), not more than 2.0
Ext. D&C Violet No. 2, not more than 3 per- percent.
cent. Water-soluble matter, not more than 0.3 per-
Lead (as Pb), not more than 20 parts per mil- cent.
lion. Matter insoluble in carbon tetrachloride, not
Arsenic (as As), not more than 3 parts per more than 1.5 percent.
million. p-Toluidine, not more than 0.1 percent.
Mercury (as Hg), not more than 1 part per 1,4-Dihydroxyanthraquinone, not more than
million. 0.2 percent.
Total color, not less than 80 percent. 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-
anthracenedione, not more than 5.0 per-
(c) Use and restrictions. (1) D&C Green
cent.
No. 5 may be safely used to color nylon Lead (as Pb), not more than 20 parts per mil-
66 (the copolymer of adipic acid and lion.
hexamethylenediamine) and/or nylon Arsenic (as As), not more than 3 parts per
6[poly-(e-caprolactam)]nonabsorbable million.
surgical sutures for use in general sur- Mercury (as Hg), not more than 1 part per
gery, subject to the following restric- million.
tions: Total color, not less than 96.0 percent.
(i) The quantity of color additive (c) Uses and restrictions. The color ad-
does not exceed 0.6 percent by weight ditive D&C Green No. 6 may be safely
of the suture. used for coloring externally applied
(ii) When the sutures are used for the drugs in amounts consistent with cur-
purposes specified in their labeling, rent good manufacturing practice.
there is no migration of the color addi- (d) Labeling. The label of the color ad-
tive to the surrounding tissue. ditive shall conform to the require-
(iii) If the suture is a new drug, an ments of § 70.25 of this chapter.
approved new drug application, under (e) Certification. All batches of D&C
section 505 of the act, is in effect for it. Green No. 6 shall be certified in accord-
(2) D&C Green No. 5 may be safely ance with regulations promulgated
used for coloring drugs generally, in- under part 80 of this chapter.
cluding drugs intended for use in the
[42 FR 15654, Mar. 22, 1977, as amended at 47
area of the eye, in amounts consistent FR 14146, Apr.2, 1982; 47 FR 24278, June 4,
with current good manufacturing prac- 1982; 51 FR 9784, Mar. 21, 1986]
tice.
(d) Labeling. The label of the color ad- § 74.1208 D&C Green No. 8.
ditive shall conform to the require- (a) Identity. (1) The color additive
ments of § 70.25 of this chapter. D&C Green No. 8 is principally the tri-
(e) Certification. All batches of D&C sodium salt of 8-hydroxy-1,3,6-pyrene-
Green No. 5 shall be certified in accord- trisulfonic acid.
ance with regulations in part 80 of this (2) Color additive mixtures for use in
chapter. externally applied drugs made with
[47 FR 24284, June 4, 1982; 47 FR 27551, June D&C Green No. 8 may contain only
25, 1982, as amended at 59 FR 40805, Aug. 10, those diluents that are suitable and
1994] that are listed in part 73 of this chapter
for use in color additive mixtures for
§ 74.1206 D&C Green No. 6. coloring externally applied drugs.
(a) Identity. The color additive D&C (b) Specifications. D&C Green No. 8
Green No. 6 is 1,4-bis[(4- shall conform to the following speci-
methylphenyl)amino]-9,10- fications and shall be free from impuri-
anthracenedione (CAS. Reg. No. 128–80– ties other than those named to the ex-
3). tent that such impurities may be
(b) Specifications. The color additive avoided by good manufacturing prac-
D&C Green No. 6 for use in coloring ex- tices:

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Food and Drug Administration, HHS § 74.1255
Volatile matter (at 135 °C), not more than 15 Subsidiary colors, not more than 3 percent.
percent. 4,4′-(Diazoamino)-dibenzenesulfonic acid, not
Water-insoluble matter, not more than 0.2 more than 0.1 percent.
percent. Lead (as Pb), not more than 20 parts per mil-
Chlorides and sulfates (calculated as sodium lion.
salt), not more than 20 percent. Arsenic (as As), not more than 3 parts per
The trisodium salt of 1,3,6-pyrenetrisulfonic million.
acid, not more than 6 percent. Mercury (as Hg), not more than 1 part per
The tetrasodium salt of 1,3,6,8- million.
pyrenetetrasulfonic acid, not more than 1 Total color, not less than 87 percent.
percent.
Pyrene, not more than 0.2 percent. (c) Uses and restrictions. D&C Orange
Lead (as Pb), not more than 20 parts per mil- No. 4 may be safely used for coloring
lion. externally applied drugs in amounts
Arsenic (as As), not more than 3 parts per consistent with good manufacturing
million. practice.
Mercury (as Hg), not more than 1 part per (d) Labeling. The label of the color ad-
million.
ditive and any mixtures prepared
Total color, not less than 65 percent.
therefrom intended solely or in part for
(c) Uses and restrictions. D&C Green coloring purposes shall conform to the
No. 8 may be safely used in externally requirements of § 70.25 of this chapter.
applied drugs in amounts not exceeding (e) Certification. All batches of D&C
0.01 percent by weight of the finished Orange No. 4 shall be certified in ac-
product. cordance with regulations in part 80 of
(d) Labeling. The label of the color ad- this chapter.
ditive and any mixtures prepared
[42 FR 52396, Sept. 30, 1977, as amended at 43
therefrom intended solely or in part for
FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27,
coloring purposes shall conform to the 1981]
requirements of § 70.25 of this chapter.
(e) Certification. All batches of D&C § 74.1255 D&C Orange No. 5.
Green No. 8 shall be certified in accord- (a) Identity. (1) the color additive
ance with regulations in part 80 of this D&C Orange No. 5 is a mixture con-
chapter. sisting principally the sodium salt of
§ 74.1254 D&C Orange No. 4. 4′,5′-dibromofluorescein (CAS Reg. No.
596–03–2) and 2′,4′,5′-tribromofluorescein
(a) Identity. (1) the color additive (CAS Reg. No. 25709–83–5) and 2′,4′,5′,7′-
D&C Orange No. 4 is principally the so- tetrabromofluorescein (CAS Reg. No.
dium salt of 4-[(2-hydroxy-1- 15086–94–9). D&C Orange No. 5 is manu-
naphthalenyl)azo]benzenesulfonic acid. factured by brominating fluorescein
(2) Color additive mixtures for use in with elemental bromine. The fluores-
externally applied drugs made with cein is manufactured by the acid con-
D&C Orange No. 4 may contain only densation of resorcinol and phthalic
those diluents that are suitable and acid or its anhydride. The fluorescein
that are listed in part 73 of this chapter is isolated and partially purified prior
for use in color additive mixtures for to bromination.
coloring externally applied drugs. (2) Color additive mixtures for drug
(b) Specifications. D&C Orange No. 4 use made with D&C Orange No. 5 may
shall conform to the following speci- contain only those diluents that are
fications and shall be free from impuri- suitable and that are listed in part 73
ties other than those named to the ex- of this chapter for use in color additive
tent that such impurities may be mixtures for coloring drugs.
avoided by good manufacturing prac- (b) Specifications. D&C Orange No. 5
tice. shall conform to the following speci-
Sum of volatile matter (at 135 °C) and fications and shall be free from impuri-
chlorides and sulfates (calculated as so- ties other than those named to the ex-
dium salts), not more than 13 percent. tent that such impurities may be
Water-insoluble matter, not more than 0.2 avoided by good manufacturing prac-
percent. tice.
2-Naphthol, not more than 0.4 percent.
Sulfanilic acid, sodium salt, not more than 4′,5′-dibromofluorescein, not less than 50 per-
0.2 percent. cent and not more than 65 percent.

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§ 74.1260 21 CFR Ch. I (4–1–11 Edition)
2′,4′,5′-tribromofluorescein, not less than 30 (b) Specifications. D&C Orange No. 10
percent and not more than 40 percent. shall conform to the following speci-
2′,4′,5′,7′-tetrabromofluorescein, not more fications and shall be free from impuri-
than 10 percent.
ties other than those named to the ex-
Sum of 2′,4′-dibromofluorescein and 2′,5′-
dibromofluorescein, not more than 2 per- tent that such other impurities may be
cent. avoided by good manufacturing prac-
4′–Bromofluorescein, not more than 2 per- tice:
cent.
Sum of volatile matter (at 135 °C) and halides
Fluorescein, not more than 1 percent.
and sulfates (calculated as sodium salts),
Phthalic acid, not more than 1 percent.
not more than 8 percent.
2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic
Insoluble matter (alkaline solution), not
acid, not more than 0.5 percent.
more than 0.5 percent.
Brominated resorcinol, not more than 0.4
Phthalic acid, not more than 0.5 percent.
percent.
2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic
Sum of volatile matter (at 135 °C) and halides
acid, not more than 0.5 percent.
and sulfates (calculated as sodium salts),
Fluorescein, not more than 1 percent.
not more than 10 percent.
4′-Iodofluorescein, not more than 3 percent.
Insoluble matter (alkaline solution), not
2′,4′-Diiodofluorescein and 2′,5′-
more than 0.3 percent.
diiodofluorescein, not more than 2 percent.
Lead (as Pb), not more than 20 parts per mil-
2′,4′,5′-Triiodofluorescein, not more than 35
lion.
percent.
Arsenic (as As), not more than 3 parts per
2′,4′,5′,7′-Tetraiodofluorescein, not more than
million.
10 percent.
Mercury (as Hg), not more than 1 part per
4′,5′-Diiodofluorescein, not less than 60 per-
million.
cent and not more than 95 percent.
Total color, not less than 90 percent.
Lead (as Pb), not more than 20 parts per mil-
(c) Uses and restrictions. D&C Orange lion.
No. 5 may be safely used for coloring Arsenic (as As), not more than 3 parts per
mouthwashes and dentifrices that are million.
Mercury (as Hg), not more than 1 part per
ingested drugs in amounts consistent
million.
with current good manufacturing prac- Total color, not less than 92 percent.
tice. D&C Orange No. 5 may be safely
used in externally applied drugs in (c) Uses and restrictions. D&C Orange
amounts not exceeding 5 milligrams No. 10 may be safely used for coloring
per daily dose of the drug. externally applied drugs in amounts
(d) Labeling. The label of the color ad- consistent with good manufacturing
ditive and any mixtures prepared practice.
therefrom intended solely or in part for (d) Labeling requirements. The label of
coloring purposes shall conform to the the color additive and any mixtures
requirements of § 70.25 of this chapter. prepared therefrom intended solely or
(e) Certification. All batches of D&C in part for coloring purposes shall con-
Orange No. 5 shall be certified in ac- form to the requirements of § 70.25 of
cordance with regulations in part 80 of this chapter.
this chapter. (e) Certification. All batches of D&C
Orange No. 10 shall be certified in ac-
[47 FR 44635, Nov. 2, 1982, as amended at 49
cordance with regulations in part 80 of
FR 13342, Apr. 4, 1984]
this chapter.
§ 74.1260 D&C Orange No. 10. [46 FR 18953, Mar. 27, 1981]
(a) Identity. (1) The color additive
D&C Orange No. 10 is a mixture con- § 74.1261 D&C Orange No. 11.
sisting principally of 4′,5′- (a) Identity. (1) The color additive
diiodofluorescein, 2′,4′,5′- D&C Orange No. 11 is a mixture con-
triiodofluorescein, and 2′,4′,5′,7′- sisting principally of the disodium
tetraiodofluorescein. salts of 4′,5′-diiodofluorescein, 2′,4′,5′-
(2) Color additive mixtures for drug triiodofluorescein and 2′,4′,5′,7′-
use made with D&C Orange No. 10 may tetraiodofluorescein.
contain only those diluents listed in (2) Color additive mixtures for drug
this subpart as safe and suitable for use use made with D&C Orange No. 11 may
in color additive mixtures for coloring contain only those diluents listed in
externally applied drugs. this subpart as safe and suitable for use

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Food and Drug Administration, HHS § 74.1304

in color additive mixtures for coloring (2) Color additive mixtures for in-
externally applied drugs. gested drug used made with FD&C Red
(b) Specifications. The color additive No. 3 may contain only those diluents
D&C Orange No. 11 shall conform to that are suitable and that are listed in
the following specifications and shall part 73 of this chapter as safe for use in
be free from impurities other than color additive mixtures for coloring in-
those named to the extent that such gested drugs.
impurities may be avoided by good (b) Uses and restrictions. FD&C Red
manufacturing practice: No. 3 may be safely used for coloring
Sum of volatile matter (at 135 °C) and halides
ingested drugs in amounts consistent
and sulfates (calculated as sodium salts), with good manufacturing practice.
not more than 8 percent. (c) Labeling. The label of the color ad-
Water-insoluble matter, not more than 0.5 ditive and any mixtures prepared
percent. therefrom intended solely or in part for
Phthalic acid, not more than 0.5 percent. coloring purposes shall conform to the
2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic requirements of § 70.25 of this chapter.
acid, sodium salt, not more than 0.5 per- (d) Certification. All batches of FD&C
cent.
Fluorescein, disodium salt, not more than 1 Red No. 3 shall be certified in accord-
percent. ance with regulations in part 80 of this
4′-Iodofluorescein, disodium salt, not more chapter.
than 3 percent.
2′,4′-Diiodofluorescein and 2′,5′- § 74.1304 FD&C Red No. 4.
diiodofluorescein, not more than 2 percent. (a) Identity. (1) The color additive
2′,4′,5′-Triiodofluorescein, not more than 35
FD&C Red No. 4 is principally the diso-
percent.
2′,4′,5′,7′-Tetraiodofluorescein, disodium salt, dium salt of 3-[(2,4-dimethyl-5-
not more than 10 percent. sulfophenyl)azo] -4-hydroxy-1-
4′,5′-Diiodofluorescein, disodium salt, not naphthalenesulfonic acid.
less than 60 percent and not more than 95 (2) Color additive mixtures for use in
percent. externally applied drugs made with
Lead (as Pb), not more than 20 parts per mil- FD&C Red No. 4 may contain only
lion. those diluents that are suitable and
Arsenic (as As), not more than 3 parts per
million.
that are listed in part 73 of this chapter
Mercury (as Hg), not more than 1 part per for use in color additive mixtures for
million. coloring externally applied drugs.
Total color, not less than 92 percent. (b) Specifications. FD&C Red No. 4
shall conform to the following speci-
(c) Uses and restrictions. D&C Orange
fications and shall be free from impuri-
No. 11 may be safely used for coloring
ties other than those named to the ex-
externally applied drugs in amounts
tent that such impurities may be
consistent with good manufacturing
avoided by good manufacturing prac-
practice.
tice:
(d) Labeling requirements. The label of
the color additive and any mixtures Sum of volatile matter (at 135 °C.) and
prepared therefrom intended solely or chlorides and sulfates (calculated as so-
in part for coloring purposes shall con- dium salts), not more than 13 percent.
Water-insoluble matter, not more than 0.2
form to the requirements of § 70.25 of
percent.
this chapter. 5-Amino-2,4-dimethyl-1-benzenesulfonic acid,
(e) Certification. All batches of D&C sodium salt, not more than 0.2 percent.
Orange No. 11 shall be certified in ac- 4-Hydroxy-1-naphthalenesulfonic acid, so-
cordance with regulations in part 80 of dium salt, not more than 0.2 percent.
this chapter. Subsidiary colors, not more than 2 percent.
Lead (as Pb), not more than 10 parts per mil-
[46 FR 18953, Mar. 27, 1981] lion.
Arsenic (as As), not more than 3 parts per
§ 74.1303 FD&C Red No. 3. million.
(a) Identity and specifications. (1) The Mercury (as Hg), not more than 1 part per
color additive FD&C Red No. 3 shall million.
Total color, not less than 87 percent.
conform in identity and specifications
to the requirements of § 74.303(a)(1) and (c) Uses and restrictions. FD&C Red
(b). No. 4 may be safely used in externally

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§ 74.1306 21 CFR Ch. I (4–1–11 Edition)

applied drugs in amounts consistent Mercury (as Hg), not more than 1 part per
with good manufacturing practice. million.
(d) Labeling. The label of the color ad- Total color, not less than 90 percent.
ditive and any mixtures prepared (c) Uses and restrictions. The color ad-
therefrom intended solely or in part for ditive D&C Red No. 6 may be safely
coloring purposes shall conform to the used for coloring drugs such that the
requirements of § 70.25 of this chapter. combined total of D&C Red No. 6 and
(e) Certification. All batches of FD&C D&C Red No. 7 does not exceed 5 milli-
Red No. 4 shall be certified in accord- grams per daily dose of the drug.
ance with regulations in part 80 of this (d) Labeling. The label of the color ad-
chapter. ditive and any mixtures prepared
therefrom intended solely or in part for
§ 74.1306 D&C Red No. 6. coloring purposes shall conform to the
(a) Identity. (1) The color additive requirements of § 70.25 of this chapter.
D&C Red No. 6 is principally the diso- (e) Certification. All batches of D&C
dium salt of 3-hydroxy-4-[(4-methyl-2- Red No. 6 shall be certified in accord-
sulfophenyl)azo]-2- ance with regulations in part 80 of this
naphthalenecarboxylic acid (CAS Reg. chapter.
No. 5858–81–1). To manufacture the ad- [47 FR 57687, Dec. 28, 1982]
ditive, 2-amino-5-
methylbenzenesulfonic acid is § 74.1307 D&C Red No. 7.
diazotized with hydrochloric acid and (a) Identity. (1) The color additive
sodium nitrite. The diazo compound is D&C Red No. 7 is principally the cal-
coupled in alkaline medium with 3-hy- cium salt of 3-hydroxy-4-[(4-methyl-2-
droxy-2-naphthalenecarboxylic acid. sulfophenyl)azo]-2-
The resulting dye precipitates as the naphthalenecarboxylic acid (CAS Reg.
disodium salt. No. 5281–04–9). To manufacture the ad-
(2) Color additive mixtures for drug ditive, 2-amino-5-
use made with D&C Red No. 6 may con- methylbenzenesulfonic acid is
tain only those diluents that are suit- diazotized with hydrochloric acid and
able and that are listed in part 73 of sodium nitrite. The diazo compound is
this chapter as safe for use in color ad- coupled in alkaline medium with 3-hy-
ditive mixtures for coloring drugs. droxy-2-naphthalenecarboxylic acid
(b) Specifications. The color additive and the resulting dye converted to the
D&C Red No. 6 shall conform to the fol- calcium salt with calcium chloride.
lowing specifications and shall be free (2) Color additive mixtures for drug
from impurities other than those use made with D&C Red No. 7 may con-
named to the extent that such impuri- tain only those diluents that are suit-
ties may be avoided by current good able and that are listed in part 73 of
manufacturing practice: this chapter as safe for use in color ad-
Sum of volatile matter (at 135 °C) and ditive mixtures for coloring drugs.
chlorides and sulfates (calculated as so- (b) Specifications. The color additive
dium salts), not more than 10 percent. D&C Red No. 7 shall conform to the fol-
Ether-soluble matter, passes test entitled lowing specifications and shall be free
‘‘The Procedure for Determining Ether- from impurities other than those
Soluble Material in D&C Red Nos. 6 and 7,’’ named to the extent that such impuri-
which is an appendix A to part 74.
ties may be avoided by current good
2-Amino-5-methylbenzenesulfonic acid, so-
dium salt, not more than 0.2 percent.
manufacturing practice:
3-Hydroxy-2-naphthalenecarboxylic acid, so- Sum of volatile matter (at 135 °C) and
dium salt, not more than 0.4 percent. chlorides and sulfates (calculated as so-
3-Hydroxy-4-[(4-methylphenyl)azo]-2- dium salts), not more than 10 percent.
naphthalenecarboxylic acid, sodium salt, Ether-soluble matter, passes test entitled
not more than 0.5 percent. ‘‘The Procedure for Determining Ether-
p- Toluidine, not more than 15 parts per mil- soluble Material in D&C Red Nos. 6 and 7,’’
lion. which is an appendix A to part 74.
Lead (as Pb), not more than 20 parts per mil- 2-Amino-5-methylbenzenesulfonic acid, cal-
lion. cium salt, not more than 0.2 percent.
Arsenic (as As), not more than 3 parts per 3-Hydroxy-2-naphthalenecarboxylic acid, cal-
million. cium salt, not more than 0.4 percent.

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Food and Drug Administration, HHS § 74.1321
3-Hydroxy-4-[(4-methylphenyl)azo]-2- 1-(Phenylazo)-2-naphthol, not more than 3
naphthalenecarboxylic acid, calcium salt, percent.
not more than 0.5 percent. 1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol,
p-Toluidine, not more than 15 parts per mil- not more than 2 percent.
lion. Lead (as Pb), not more than 20 parts per mil-
Lead (as Pb), not more than 20 parts per mil- lion.
lion. Arsenic (as As), not more than 3 parts per
Arsenic (as As), not more than 3 parts per million.
million. Mercury (as Hg), not more than 1 part per
Mercury (as Hg), not more than 1 part per million.
million. Total color, not less than 90 percent.
Total color, not less than 90 percent.
(c) Uses and restrictions. D&C Red No.
(c) Uses and restrictions. The color ad- 17 may be safely used in externally ap-
ditive D&C Red No. 7 may be safely plied drugs in amounts consistent with
used for coloring drugs such that the good manufacturing practice.
combined total of D&C Red No. 6 and (d) Labeling. The label of the color ad-
D&C Red No. 7 does not exceed 5 milli- ditive and any mixtures prepared
grams per daily dose of the drug.
therefrom intended solely or in part for
(d) Labeling. The label of the color ad-
coloring purposes shall conform to the
ditive and any mixtures prepared
requirements of § 70.25 of this chapter.
therefrom intended solely or in part for
(e) Certification. All batches of D&C
coloring purposes shall conform to the
Red No. 17 shall be certified in accord-
requirements of § 70.25 of this chapter.
ance with regulations in part 80 of this
(e) Certification. All batches of D&C
chapter.
Red No. 7 shall be certified in accord-
ance with regulations in part 80 of this [42 FR 15654, Mar. 22, 1977, as amended at 42
chapter. FR 27225, May 27, 1977]
[47 FR 57687, Dec. 28, 1982] § 74.1321 D&C Red No. 21.
§ 74.1317 D&C Red No. 17. (a) Identity. (1) The color additive
(a) Identity. (1) The color additive D&C Red No. 21 is principally 2′,4′,5′,7′-
D&C Red No. 17 is principally 1-[[4- tetrabromofluorescein (CAS Reg. No.
(phenylazo)phenyl]azo]-2-naphthalenol. 15086–94–9), and may contain smaller
(2) Color additive mixtures for drug amounts of 2′,4′,5′-tribromofluorescein
use made with D&C Red No. 17 may (CAS Reg. No. 25709–83–5) and 2′,4′,7′-
contain only those diluents that are tribromofluorescein (CAS Reg. No.
suitable and that are listed in part 73 25709–84–6). The color additive is manu-
of this chapter as safe for use in color factured by brominating fluorescein
additive mixtures for coloring exter- with elemental bromine. The fluores-
nally applied drugs. cein is manufactured by the acid con-
(b) Specifications. D&C Red No. 17 densation of resorcinol and phthalic
shall conform to the following speci- acid or its anhydride. The fluorescein
fications and shall be free from impuri- is isolated and partially purified prior
ties, other than those named, to the ex- to bromination.
tent that such other impurities may be (2) Color additive mixtures for drug
avoided by good manufacturing prac- use made with D&C Red No. 21 may
tice: contain only those diluents that are
suitable and that are listed in part 73
Volatile matter (at 135 °C), not more than 5 of this chapter as safe for use in color
percent. additive mixtures for coloring drugs.
Matter insoluble in both toluene and water
(color additive mixed in toluene and the
(b) Specifications. The color additive
resultant residue isolated and mixed with D&C Red No. 21 shall conform to the
water to obtain the matter insoluble in following specifications and shall be
both toluene and water), not more than 0.5 free from impurities other than those
percent. named to the extent that such impuri-
Chlorides and sulfates (calculated as sodium ties may be avoided by current good
salts), not more than 3 percent. manufacturing practice:
Aniline, not more than 0.2 percent.
4-Aminoazobenzene, not more than 0.1 per- Sum of volatile matter (at 135°C) and halides
cent. and sulfates (calculated as sodium salts),
2-Naphthol, not more than 0.2 percent. not more than 10 percent.

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§ 74.1322 21 CFR Ch. I (4–1–11 Edition)
Insoluble matter (alkaline solution), not and that are listed in part 73 of this
more than 0.5 percent. chapter as safe for use in color additive
Phthalic acid, not more than 1 percent. mixtures for coloring drugs.
2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic
acid, not more than 0.5 percent.
(b) Specifications. The color additive
2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, D&C Red No. 22 shall conform to the
not more than 1 percent. following specifications and shall be
Brominated resorcinol, not more than 0.4 free from impurities other than those
percent. named to the extent that such impuri-
Fluorescein, not more than 0.2 percent. ties may be avoided by current good
Sum of mono- and dibromofluoresceins, not manufacturing practice:
more than 2 percent.
Tribromofluoresceins, not more than 11 per- Sum of volatile matter (at 135°C) and halides
cent. and sulfates (calculated as soduim salts),
2′,4′,5′,7′-Tetrabromofluorescein, not less not more than 10 percent.
than 87 percent. Water-insoluble matter not more than 0.5
Lead (as Pb), not more than 20 parts per mil- percent.
lion. Disodium salt of phthalic acid, not more
Arsenic (as As), not more than 3 parts per than 1 percent.
million. Sodium salt of 2-(3,5-Dibromo-2,4-
Mercury (as Hg), not more than 1 part per dihydroxybenzoyl)benzoic acid, not more
million. than 0.5 percent.
Total color, not less than 90 percent. 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester,
not more than 1 percent.
(c) Uses and restrictions. The color ad-
Brominated resorcinol, not more than 0.4
ditive D&C Red No. 21 may be safely percent.
used for coloring drugs generally in Sum of disodium salts of mono- and
amounts consistent with current good dibromofluoresceins, not more than 2 per-
manufacturing practice. cent.
(d) Labeling. The label of the color ad- Sum of disodium salts of
ditive and any mixtures prepared tribromofluoresceins, not more than 25
therefrom intended solely or in part for percent.
Disodium salt of 2′,4′,5′,7′-
coloring purposes shall conform to the
Tetrabromofluorescein, not less than 72
requirements of § 70.25 of this chapter. percent.
(e) Certification. All batches of D&C Lead (as Pb), not more than 20 parts per mil-
Red No. 21 shall be certified in accord- lion.
ance with regulations in part 80 of this Arsenic (as As), not more than 3 parts per
chapter. million.
Mercury (as Hg), not more than 1 part per
[47 FR 53846, Nov. 30, 1982] million.
Total color, not less than 90 percent.
§ 74.1322 D&C Red No. 22.
(c) Uses and restrictions. The color ad-
(a) Identity. (1) The color additive
ditive D&C Red No. 22 may be safely
D&C Red No. 22 is principally the diso-
used for coloring drugs generally in
dium salt of 2′,4′,5′7′-
amounts consistent with current good
tetrabromofluorescein (CAS Reg. No.
manufacturing practice.
17372–87–1) and may contain smaller
(d) Labeling. The label of the color ad-
amounts of the disodium salts of 2′,4′,5′-
ditive and any mixtures prepared
tribromofluorescein and 2′,4′,7′-
therefrom intended solely or in part for
tribromofluorescein. The color additive
coloring purposes shall conform to the
is manufactured by alkaline hydrolysis
requirements of § 70.25 of this chapter.
of 2′,4′,5′,7′-tetrabromofluorescein.
(e) Certification. All batches of D&C
2′,4′,5′,7′-Tetrabromofluorescein is man-
Red No. 22 shall be certified in accord-
ufactured by brominating fluorescein
ance with regulations in part 80 of this
with elemental bromine. The fluores-
chapter.
cein is manufactured by the acid con-
densation of resorcinol and phthalic [47 FR 53846, Nov. 30, 1982]
acid or its anhydride. Fluorescein is
isolated and partially purified prior to § 74.1327 D&C Red No. 27.
bromination. (a) Identity. (1) The color additive
(2) Color additive mixtures for drug D&C Red No. 27 is principally 2′,4′,5′,7′-
use made with Red No. 22 may contain tetrabromo-4,5,6,7-
only those diluents that are suitable tetrachlorofluorescein (CAS Reg. No.

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Food and Drug Administration, HHS § 74.1328

13473-26-2). The color additive is manu- ance with regulations in part 80 of this
factured by brominating 4,5,6,7- chapter.
tetrachlorofluorescein with elemental [47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov.
bromine. The 4,5,6,7- 12, 1982]
tetrachlorofluorescein is manufactured
by the acid condensation of resorcinol § 74.1328 D&C Red No. 28.
and tetrachlorophthalic acid or its an- (a) Identity. (1) The color additive
hydride. The 4,5,6,7- D&C Red No. 28 is principally the diso-
tetrachlorofluorescein is isolated and dium salt of 2′,4′,5′,7′-tetrabromo-4,5,6,7-
partially purified prior to bromination. tetrachlorofluorescein (CAS Reg. No.
(2) Color additive mixtures for drug 18472–87–2) formed by alkaline hydrol-
use made with D&C Red No. 27 may ysis of the parent
contain only those diluents that are tetrabromotetrachlorofluorescein.
suitable and that are listed in part 73 (2) Color additive mixtures for drug
of this chapter as safe for use in color use made with D&C Red No. 28 may
additive mixtures for coloring drugs. contain only those diluents that are
(b) Specifications. D&C Red No. 27 suitable and that are listed in part 73
shall conform to the following speci- of this chapter as safe for use in color
fications and shall be free from impuri- additive mixtures for coloring drugs.
ties other than those named to the ex- (b) Specifications. D&C Red No. 28
tent that such impurities may be shall conform to the following speci-
avoided by current good manufacturing fications and shall be free from impuri-
practice: ties other than those named to the ex-
Sum of volatile matter (at 135 °C) and halides
tent that such impurities may be
and sulfates (calculated as sodium salts), avoided by current good manufacturing
not more than 10 percent. practice:
Insoluble matter (alkaline solution), not Sum of volatile matter (at 135 °C) and halides
more than 0.5 percent. and sulfates (calculated as sodium salts),
Tetrachlorophthalic acid, not more than 1.2 not more than 15 percent.
percent. Insoluble matter (alkaline solution), not
Brominated resorcinol, not more than 0.4 more than 0.5 percent.
percent. Tetrachlorophthalic acid, not more than 1.2
2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4- percent.
dihydroxybenzoyl) benzoic acid, not more Brominated resorcinol, not more than 0.4
than 0.7 percent. percent.
2′,4′,5′,7′-Tetrabromo-4,5,6,7- 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-
tetrachlorofluorescein, ethyl ester, not dihydroxybenzoyl)benzoic acid, not more
more than 2 percent. than 0.7 percent.
Lower halogenated subsidiary colors, not 2′,4′,5′,7′-Tetrabromo-4,5,6,7-
more than 4 percent. tetrachlorofluorescein, ethyl ester, not
Lead (as Pb), not more than 20 parts per mil- more than 2 percent.
lion. Lower halogenated subsidiary colors, not
Arsenic (as As), not more than 3 parts per more than 4 percent.
million. Lead (as Pb), not more than 20 parts per mil-
Mercury (as Hg), not more than 1 part per lion.
million. Arsenic (as As), not more than 3 parts per
million.
Total color, not less than 90 percent.
Mercury (as Hg), not more than 1 part per
(c) Uses and restrictions. D&C Red No. million.
27 may be safely used for coloring Total color, not less than 85 percent.
drugs generally in amounts consistent (c) Uses and restrictions. D&C Red No.
with current good manufacturing prac- 28 may be safely used for coloring
tice. drugs generally in amounts consistent
(d) Labeling. The label of the color ad- with current good manufacturing prac-
ditive and any mixtures prepared tice.
therefrom intended solely or in part for (d) Labeling. The label of the color ad-
coloring purposes shall conform to the ditive and any mixtures prepared
requirements of § 70.25 of this chapter. therefrom intended solely or in part for
(e) Certification. All batches of D&C coloring purposes shall conform to the
Red No. 27 shall be certified in accord- requirements of § 70.25 of this chapter.

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§ 74.1330 21 CFR Ch. I (4–1–11 Edition)

(e) Certification. All batches of D&C cium salt of 3-hydroxy-4-(phenylazo)-2-


Red No. 28 shall be certified in accord- naphthalenecarboxylic acid.
ance with regulations in part 80 of this (2) Color additive mixtures for drug
chapter. use made with D&C Red No. 31 may
contain only those diluents that are
[47 FR 42568, Sept. 28, 1982]
suitable and that are listed in part 73
§ 74.1330 D&C Red No. 30. of this chapter as safe for use in color
additive mixtures for coloring exter-
(a) Identity. (1) The color additive nally applied drugs.
D&C Red No. 30 is principally 6-chloro- (b) Specifications. D&C Red No. 31
2-(6-chloro-4-methyl-3- shall conform to the following speci-
oxobenzo[b]thien-2(3H)-ylidene)-4- fications and shall be free from impuri-
methyl-benzo[b]thiophen-3(2H)-one ties, other than those named, to the ex-
(CAS Reg. No. 2379–74–0). tent that such other impurities may be
(2) Color additive mixtures for drug avoided by good manufacturing prac-
use made with D&C Red No. 30 may tice:
contain only those diluents that are
Sum of volatile matter (at 135 °C) and
suitable and that are listed in part 73
chlorides and sulfates (calculated as so-
of this chapter as safe for use in color dium salts), not more than 10 percent.
additive mixtures for coloring drugs. Aniline, not more than 0.2 percent.
(b) Specifications. D&C Red No. 30 3-Hydroxy-2-naphthoic acid, calcium salt,
shall conform to the following speci- not more than 0.4 percent.
fications and shall be free from impuri- Subsidiary colors, not more than 1 percent.
ties other than those named to the ex- Lead (as Pb), not more than 20 parts per mil-
lion.
tent that such impurities may be Arsenic (as As), not more than 3 parts per
avoided by current good manufacturing million.
practice: Mercury (as Hg), not more than 1 part per
million.
Volatile matter (at 135 °C), not more than 5
Total color, not less than 90 percent.
percent.
Chlorides and sulfates (calculated as sodium (c) Uses and restrictions. D&C Red No.
salts), not more than 3 percent. 31 may be safely used in externally ap-
Matter soluble in acetone, not more than 5 plied drugs in amounts consistent with
percent. good manufacturing practice.
Total color, not less than 90 percent.
(d) Labeling. The label of the color ad-
Lead (as Pb), not more than 20 parts per mil-
lion. ditive and any mixtures prepared
Arsenic (as As), not more than 3 parts per therefrom intended solely or in part for
million. coloring purposes shall conform to the
Mercury (as Hg), not more than 1 part per requirements of § 70.25 of this chapter.
million. (e) Certification. All batches of D&C
(c) Uses and restrictions. D&C Red No. Red No. 31 shall be certified in accord-
30 may be safely used for coloring ance with regulations in part 80 of this
drugs generally in amounts consistent chapter.
with current good manufacturing prac- § 74.1333 D&C Red No. 33.
tice.
(d) Labeling. The label of the color ad- (a) Identity. (1) The color additive
ditive and any mixtures prepared D&C Red No. 33 is principally the diso-
therefrom intended solely or in part for dium salt of 5-amino-4-hydroxy-3-
coloring purposes shall conform to the (phenylazo)-2,7-naphthalenedisulfonic
requirements of § 70.25 of this chapter. acid (CAS Reg. No. 3567–66–6). To manu-
(e) Certification. All batches of D&C facture the additive, the product ob-
Red No. 30 shall be certified in accord- tained from the nitrous acid
ance with regulations in part 80 of this diazotization of aniline is coupled with
chapter. 4-hydroxy-5-amino-2,7-
naphthalenedisulfonic acid in an alka-
[47 FR 22510, May 25, 1982] line aqueous medium. The color addi-
tive is isolated as the sodium salt.
§ 74.1331 D&C Red No. 31. (2) Color additive mixtures for drug
(a) Identity. (1) The color additive use made with D&C Red No. 33 may
D&C Red No. 31 is principally the cal- contain only those diluents that are

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Food and Drug Administration, HHS § 74.1336

suitable and that are listed in part 73 § 74.1334 D&C Red No. 34.
of this chapter as safe for use in color
(a) Identity. (1) The color additive
additive mixtures for coloring drugs.
D&C Red No. 34 is principally the cal-
(b) Specifications. D&C Red No. 33 cium salt of 3-hydroxy-4-[(1-sulfo-2-
shall conform to the following speci- naphthalenyl)azo]-2-naphthalene-car-
fications and shall be free from impuri- boxylic acid.
ties other than those named to the ex- (2) Color additive mixtures for drug
tent that such impurities may be use made with D&C Red No. 34 may
avoided by current good manufacturing contain only those diluents that are
practices: suitable and that are listed in part 73
Sum of volatile matter at 135 °C (275 °F) and of this chapter as safe for use in color
chlorides and sulfates (calculated as so- additive mixtures for coloring exter-
dium salts), not more than 18 percent. nally applied drugs.
Water-insoluble matter, not more than 0.3 (b) Specifications. D&C Red No. 34
percent. shall conform to the following speci-
4-Amino-5-hydroxy-2,7-naphthalenedisulfonic
fications and shall be free from impuri-
acid, disodium salt, not more than 0.3 per-
cent. ties, other than those named, to the ex-
4,5-Dihydroxy-3-(phenylazo)-2,7- tent that such other impurities may be
naphthalenedisulfonic acid, disodium salt, avoided by good manufacturing prac-
not more than 3.0 percent. tice:
Aniline, not more than 25 parts per million.
Sum of volatile matter (at 135 °C) and
4-Aminoazobenzene, not more than 100 parts
chlorides and sulfates (calculated at so-
per billion.
dium salts), not more than 15 percent.
1,3-Diphenyltriazene, not more than 125 parts
2-Amino-1-naphthalenesulfonic acid, calcium
per billion.
salt, not more than 0.2 percent.
4-Aminobiphenyl, not more than 275 parts
3-Hydroxy-2-naphthoic acid, not more than
per billion.
0.4 percent.
Azobenzene, not more than 1 part per mil- Subsidiary colors, not more than 4 percent.
lion. Lead (as Pb), not more than 20 parts per mil-
Benzidine, not more than 20 parts per billion. lion.
Lead (as Pb), not more than 20 parts per mil- Arsenic (as As), not more than 3 parts per
lion. million.
Arsenic (as As), not more than 3 parts per Mercury (as Hg), not more than 1 part per
million. million.
Mercury (as Hg), not more than 1 part per Total color not less than 85 percent.
million.
Total color, not less than 82 percent. (c) Uses and restrictions. The color ad-
ditive D&C Red No. 34 may be safely
(c) Uses and restrictions. The color ad- used for coloring externally applied
ditive D&C Red. No 33 may be safely drugs in amounts consistent with good
used for coloring ingested drugs, other manufacturing practice.
than mouthwashes and dentifrices, in (d) Labeling. The label of the color ad-
amounts not to exceed 0.75 milligram ditive and any mixtures prepared
per daily dose of the drug. D&C Red No. therefrom intended solely or in part for
33 may be safely used for coloring ex- coloring purposes shall conform to the
ternally applied drugs, mouthwashes, requirements of § 70.25 of this chapter.
and dentifrices in amounts consistent (e) Certification. All batches of D&C
with current good manufacturing prac- Red No. 34 shall be certified in accord-
tice. ance with regulations in part 80 of this
(d) Labeling requirements. The label of chapter.
the color additive and any mixtures
prepared therefrom intended solely or § 74.1336 D&C Red No. 36.
in part for coloring purposes shall con-
(a) Identity. (1) The color additive
form to the requirements of § 70.25 of
D&C Red No. 36 is 1-[(2-chloro-4-
this chapter.
nitrophenyl)azo]-2-naphthalenol (CAS
(e) Certification. All batches of D&C
Reg. No. 2814–77–9). The color additive
Red No. 33 shall be certified in accord-
is manufactured by diazotization of 2-
ance with regulations in part 80 of this
chloro-4-nitrobenzenamine in acid me-
chapter.
dium and coupling with 2-naphthalenol
[53 FR 33120, Aug. 30, 1988] in acid medium.

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§ 74.1339 21 CFR Ch. I (4–1–11 Edition)

(2) Color additive mixtures for drug ance with regulations in part 80 of this
use made with D&C Red No. 36 may chapter.
contain only those diluents that are [53 FR 29031, Aug. 2, 1988; 53 FR 35255, Sept.
suitable and that are listed in part 73 12, 1988, as amended at 53 FR 52130, Dec. 27,
of this chapter as safe for use in color 1988]
additive mixtures for coloring drugs.
(b) Specifications. D&C Red No. 36 § 74.1339 D&C Red No. 39.
shall conform to the following speci- (a) Identity. (1) The color additive
fications and shall be free from impuri- D&C Red No. 39 is o-[p(b,b′-dihydroxy-
ties other than those named to the ex- diethylamino)-phenylazo]-benzoic acid.
tent that such impurities may be (2) Color additive mixtures made
avoided by current good manufacturing with D&C Red No. 39 may contain the
practice: following diluents: Water, acetone, iso-
Volatile matter at 135 °C (275 °F), not more propyl alcohol, and specially denatured
than 1.5 percent. alcohols used in accordance with 26
Matter insoluble in toluene, not more than CFR part 212.
1.5 percent. (b) Specifications. D&C Red No. 39
2-Chloro-4-nitrobenzenamine, not more than
shall conform to the following speci-
0.3 percent.
2-Naphthalenol, not more than 1 percent. fications and shall be free from impuri-
2,4-Dinitrobenzenamine, not more than 0.02 ties other than those named to the ex-
percent. tent that such other impurities may be
1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, avoided by good manufacturing prac-
not more than 0.5 percent. tice:
4-[(2-Chloro-4-nitrophenyl)azo]-1-
naphthalenol, not more than 0.5 percent. Volatile matter (at 100 °C.), not more than
1-[(4-Nitrophenyl)azo]-2-naphthalenol, not 2.0 percent.
more than 0.3 percent. Matter insoluble in acetone, not more than
1-[(4-Chloro-2-nitrophenyl)azo]-2- 1.0 percent.
naphthalenol, not more than 0.3 percent. Anthranilic acid, not more than 0.2 percent.
Lead (as Pb), not more than 20 parts per mil- N,N-(b,b′-Dihydroxy-diethyl) aniline, not
lion. more than 0.2 percent.
Arsenic (as As), not more than 3 parts per Subsidiary colors, not more than 3.0 percent.
million. Lead (as Pb), not more than 20 parts per mil-
Mercury (as Hg), not more than 1 part per lion.
million. Arsenic (as As), not more than 3 parts per
Total color, not less than 95 percent. million.
Total color, not less than 95.0 percent.
(c) Uses and restrictions. The color ad-
ditive D&C Red No. 36 may be safely (c) Uses and restrictions. The color ad-
used for coloring ingested drugs, other ditive D&C Red No. 39 may be safely
than mouthwashes and dentifrices, in used for the coloring of quaternary am-
amounts not to exceed 1.7 milligrams monium type germicidal solutions in-
per daily dose of the drug for drugs tended for external application only,
that are taken continuously only for and subject to the further restriction
less than 1 year. For drugs taken con- that the quantity of the color additive
tinuously for longer than 1 year, the does not exceed 0.1 percent by weight
color additive shall not be used in of the finished drug product.
amounts to exceed 1.0 milligram per (d) Labeling. The label of the color ad-
daily dose of the drug. D&C Red No. 36 ditive and any mixtures prepared
may be safely used for coloring exter- therefrom and intended solely or in
nally applied drugs in amounts con- part for coloring purposes shall con-
sistent with current good manufac- form to the requirements of § 70.25 of
turing practice. this chapter.
(d) Labeling requirements. The label of (e) Certification. All batches of D&C
the color additive and any mixtures Red No. 39 shall be certified in accord-
prepared therefrom intended solely or ance with regulations promulgated
in part for coloring purposes shall con- under part 80 of this chapter.
form to the requirements of § 70.25 of
this chapter. § 74.1340 FD&C Red No. 40.
(e) Certification. All batches of D&C (a) Identity and specifications. (1) The
Red No. 36 shall be certified in accord- color additive FD&C Red No. 40 shall

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Food and Drug Administration, HHS § 74.1705

conform in identity and specifications (b) Specifications. D&C Violet No. 2


to the requirements of § 74.340(a)(1) and shall conform to the following speci-
(b). fications and shall be free from impuri-
(2) Color additive mixtures for drug ties, other than those named, to the ex-
use made with FD&C Red No. 40 may tent that such other impurities can be
contain only those diluents that are avoided by good manufacturing prac-
suitable and that are listed in part 73 tice:
of this chapter as safe for use in color
additive mixtures for coloring drugs. Volatile matter (at 135 °C.), not more than
2.0 percent.
(3) The listing of this color additive
Matter insoluble in both carbon tetra-
includes lakes prepared as described in chloride and water, not more than 0.5 per-
§§ 82.51 and 82.1051 of this chapter, ex- cent.
cept that the color additive used is p- Toluidine, not more than 0.2 percent.
FD&C Red No. 40 and the resultant 1-Hydroxy-9,10-anthracenedione, not more
lakes meet the specification and label- than 0.5 percent.
ing requirements prescribed by §§ 82.51 1,4-Dihydroxy-9,10-anthracenedione, not
or 82.1051 of this chapter.) more than 0.5 percent.
(b) Uses and restrictions. (1) FD&C Red Subsidiary colors, not more than 1.0 percent.
No. 40 and FD&C Red No. 40 Aluminum Lead (as Pb), not more than 20 parts per mil-
Lake may be safely used in coloring lion.
drugs, including those intended for use Arsenic (as As), not more than 3 parts per
in the area of the eye, subject to the million.
restrictions on the use of color addi- Total color, not less than 96.0 percent.
tives in § 70.5(b) and (c) of this chapter, (c) Uses and restrictions. The color ad-
in amounts consistent with current ditive D&C Violet No. 2 may be safely
good manufacturing practice. used for coloring externally applied
(2) Other lakes of FD&C Red No. 40 drugs in amounts consistent with good
may be safely used in coloring drugs, manufacturing practice.
subject to the restrictions on the use of (d) Labeling. The label of the color ad-
color additives in § 70.5 of this chapter,
ditive and any mixtures prepared
in amounts consistent with current
therefrom intended solely or in part for
good manufacturing practice.
coloring purposes shall conform to the
(c) Labeling. The label of the color ad-
requirements of § 70.25 of this chapter.
ditive and any lakes or mixtures pre-
pared therefrom intended solely or in (e) Certification. All batches of D&C
part for coloring purposes shall con- Violet No. 2 shall be certified in ac-
form to the requirements of § 70.25 of cordance with regulations in part 80 of
this chapter. this chapter.
(d) Certification. All batches of FD&C [42 FR 15654, Mar. 22, 1977, as amended at 45
Red No. 40 and lakes thereof shall be FR 62978, Sept. 23, 1980; 55 FR 18868, May 7,
certified in accordance with regula- 1990]
tions, in part 80 of this chapter.
§ 74.1705 FD&C Yellow No. 5.
[42 FR 15654, Mar. 22, 1977, as amended at 59
FR 7636, Feb. 16, 1994] (a) Identity and specifications. (1) The
color additive FD&C Yellow No. 5 shall
§ 74.1602 D&C Violet No. 2. conform in identity and specifications
(a) Identity. (1) The color additive to the requirements of § 74.705 (a)(1) and
D&C Violet No. 2 is principally 1-hy- (b).
droxy -4-[(4-methylphenyl)amino]-9,10- (2) FD&C Yellow No. 5 Aluminum
anthracenedione. Lake shall be prepared in accordance
(2) Color additive mixtures for use in with the requirements of § 82.51 of this
externally applied drugs made with chapter.
D&C Violet No. 2 may contain only (3) Color additive mixtures for drug
those diluents that are suitable and use made with FD&C Yellow No. 5 may
that are listed in part 73 of this chapter contain only those diluents that are
as safe for use in color additive mix- suitable and are listed in part 73 of this
tures for coloring externally applied chapter as safe for use in color additive
drugs. mixtures for coloring drugs.

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§ 74.1706 21 CFR Ch. I (4–1–11 Edition)

(b) Uses and restrictions. (1) FD&C Yel- (d) Certification. All batches of FD&C
low No. 5 may be safely used for color- Yellow No. 5 shall be certified in ac-
ing drugs generally, including drugs in- cordance with regulations in part 80 of
tended for use in the area of the eye, in this chapter.
amounts consistent with current good [42 FR 15654, Mar. 22, 1977, as amended at 44
manufacturing practice. FR 37220, June 26, 1979; 50 FR 35782, Sept. 4,
(2) FD&C Yellow No. 5 Aluminum 1985; 51 FR 24519, July 7, 1986; 59 FR 60897,
Lake may be safely used for coloring Nov. 29, 1994]
drugs intended for use in the area of
the eye, when prepared in accordance § 74.1706 FD&C Yellow No. 6.
with § 82.51 of this chapter. (a) Identity and specifications. (1) The
(c) Labeling requirements. (1) The label color additive FD&C Yellow No. 6 shall
of the color additive and any mixtures conform in identity and specifications
intended solely or in part for coloring to the requirements of § 74.706(a)(1) and
purposes prepared therefrom shall con- (b).
form to the requirements of § 70.25 of (2) Color additive mixtures for drug
this chapter. use made with FD&C Yellow No. 6 may
(2) The label of OTC and prescription contain only those diluents that are
drug products intended for human use suitable and that are listed in part 73
administered orally, nasally, rectally, of this chapter as safe for use in color
or vaginally, or for use in the area of additive mixtures for coloring drugs.
the eye, containing FD&C Yellow No. 5 (b) Uses and restrictions. FD&C Yellow
shall specifically declare the presence No. 6 may be safely used for coloring
of FD&C Yellow No. 5 by listing the drugs generally in amounts consistent
color additive using the names FD&C with current good manufacturing prac-
Yellow No. 5 and tartrazine. The label tice.
shall bear a statement such as ‘‘Con- (c) Labeling requirements. (1) The label
tains FD&C Yellow No. 5 (tartrazine) of the color additive and any mixtures
as a color additive’’ or ‘‘Contains color intended solely or in part for coloring
additives including FD&C Yellow No. 5 purposes prepared therefrom shall con-
(tartrazine).’’ The labels of certain drug form to the requirements of § 70.25 of
products subject to this labeling re- this chapter.
quirement that are also cosmetics, (2) [Reserved]
such as: antibacterial mouthwashes (d) Certification. All batches of FD&C
and fluoride toothpastes, need not com- Yellow No. 6 shall be certified in ac-
ply with this requirement provided cordance with regulations in part 80 of
they comply with the requirements of this chapter.
§ 701.3 of this chapter. [51 FR 41782, Nov. 19, 1986, as amended at 52
(3) For prescription drugs for human FR 21508, June 8, 1987; 53 FR 49138, Dec. 6,
use containing FD&C Yellow No. 5 that 1988]
are administered orally, nasally,
vaginally, or rectally, or for use in the § 74.1707 D&C Yellow No. 7.
area of the eye, the labeling required (a) Identity. (1) The color additive
by § 201.100(d) of this chapter shall, in D&C Yellow No. 7 is principally fluo-
addition to the label statement re- rescein.
quired under paragraph (c)(2) of this (2) Color additive mixtures for use in
section, bear the warning statement externally applied drugs made with
‘‘This product contains FD&C Yellow D&C Yellow No. 7 may contain only
No. 5 (tartrazine) which may cause al- those diluents that are suitable and
lergic-type reactions (including bron- that are listed in part 73 of this chapter
chial asthma) in certain susceptible for use in color additive mixtures for
persons. Although the overall incidence coloring externally applied drugs.
of FD&C Yellow No. 5 (tartrazine) sen- (b) Specifications. D&C Yellow No. 7
sitivity in the general population is shall conform to the following speci-
low, it is frequently seen in patients fications and shall be free from impuri-
who also have aspirin hyper- ties other than those named to the ex-
sensitivity.’’ This warning statement tent that such impurities may be
shall appear in the ‘‘Precautions’’ sec- avoided by good manufacturing prac-
tion of the labeling. tice:

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Food and Drug Administration, HHS § 74.1708
Sum of water and chlorides and sulfates (cal- Mercury (as Hg), not more than 1 part per
culated as sodium salts), not more than 6 million.
percent. Total color, not less than 85 percent.
Matter insoluble in alkaline water, not more
than 0.5 percent. (c) Uses and restrictions. Ext. D&C
Resorcinol, not more than 0.5 percent. Yellow No. 7 may be safely used in ex-
Phthalic acid, not more than 0.5 percent. ternally applied drugs in amounts con-
2-2,4-(Dihydroxybenzoyl) benzoic acid, not sistent with good manufacturing prac-
more than 0.5 percent. tice.
Lead (as Pb), not more than 20 parts per mil- (d) Labeling. The label of the color ad-
lion.
ditive and any mixtures prepared
Arsenic (as As), not more than 3 parts per
million. therefrom intended solely or in part for
Mercury (as Hg), not more than 1 part per coloring purposes shall conform to the
million. requirements of § 70.25 of this chapter.
Total color, not less than 94 percent. (e) Certification. All batches of Ext.
(c) Uses and restrictions. D&C Yellow D&C Yellow No. 7 shall be certified in
No. 7 may be safely used in externally accordance with regulations in part 80
applied drugs in amounts consistent of this chapter.
with good manufacturing practice. § 74.1708 D&C Yellow No. 8.
(d) Labeling. The label of the color ad-
ditive and any mixtures prepared (a) Identity. (1) The color additive
therefrom intended solely or in part for D&C Yellow No. 8 is principally the di-
coloring purposes shall conform to the sodium salt of fluorescein.
requirements of § 70.25 of this chapter. (2) Color additive mixtures for use in
(e) Certification. All batches of D&C externally applied drugs made with
Yellow No. 7 shall be certified in ac- D&C Yellow No. 8 may contain only
cordance with regulations in part 80 of those diluents that are suitable and
this chapter. that are listed in part 73 of this chapter
for use in color additive mixtures for
§ 74.1707a Ext. D&C Yellow No. 7. coloring externally applied drugs.
(a) Identity. (1) The color additive (b) Specifications. D&C Yellow No. 8
Ext. D&C Yellow No. 7 is principally shall be free from impurities other
the disodium salt of 8-hydroxy-5,7-di- than those named to the extent that
nitro-2-naphthalenesulfonic acid. such impurities may be avoided by
(2) Color additive mixtures for drug good manufacturing practice:
use made with Ext. D&C Yellow No. 7 Sum of water and chlorides and sulfates (cal-
may contain only those diluents that culated as sodium salts), not more than 15
are suitable and that are listed in part percent.
73 of this chapter as safe for use in Matter insoluble in alkaline water, not more
color additive mixtures for coloring ex- than 0.3 percent.
ternally applied drugs. Resorcinol, not more than 0.5 percent.
(b) Specifications. Ext. D&C Yellow Phthalic acid, not more than 1 percent.
2-(2,4-Dihydroxybenzoyl) benzoic acid, not
No. 7 shall conform to the following more than 0.5 percent.
specifications and shall be free from Lead (as Pb), not more than 20 parts per mil-
impurities, other than those named, to lion.
the extent that such other impurities Arsenic (as As), not more than 3 parts per
may be avoided by good manufacturing million.
practice: Mercury (as Hg), not more than 1 part per
million.
Sum of volatile matter (at 135 °C) and Total color, not less than 85 percent.
chlorides and sulfates (calculated as so-
dium salts), not more than 15 percent. (c) Uses and restrictions. D&C Yellow
Water-insoluble matter, not more than 0.2 No. 8 may be safely used in externally
percent. applied drugs in amounts consistent
1-Naphthol, not more than 0.2 percent. with good manufacturing practice.
2,4-Dinitro-1-naphthol, not more than 0.03
(d) Labeling. The label of the color ad-
percent.
Lead (as Pb), not more than 20 parts per mil- ditive and any mixtures prepared
lion. therefrom intended solely or in part for
Arsenic (as As), not more than 3 parts per coloring purposes shall conform to the
million. requirements of § 70.25 of this chapter.

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§ 74.1710 21 CFR Ch. I (4–1–11 Edition)

(e) Certification. All batches of D&C lion, using added 2-(2-quinolinyl)-1H-in-


Yellow No. 8 shall be certified in ac- dene-1,3 (2H)-dione for calibration.
cordance with regulations in part 80 of Lead (as Pb), not more than 20 parts per mil-
this chapter. lion.
Arsenic (as As), not more than 3 parts per
million.
§ 74.1710 D&C Yellow No. 10.
Mercury (as Hg), not more than 1 part per
(a) Identity. (1) The color additive million.
D&C Yellow No. 10 is a mixture of the Total color, not less than 85 percent.
sodium salts of the mono- and
(c) Uses and restrictions. The color ad-
disulfonic acids of 2-(2-quinolinyl)-1H-
ditive D&C Yellow No. 10 may be safely
indene-1,3 (2H)-dione consisting prin-
used for coloring drugs generally in
cipally of the sodium salts of 2-(2,3-
amounts consistent with current good
dihydro-1,3-dioxo-1H-indene-2-yl)-6-
manufacturing practice.
quinolinesulfonic acid and 2-(2,3-
(d) Labeling. The label of the color ad-
dihydro-1,3-dioxo-1H-indene-2-yl)-8-
ditive and any mixtures prepared
quinolinesulfonic acid with lesser
therefrom and intended solely or in
amounts of the disodium salts of the
part for coloring purposes shall con-
disulfonic acids of 2-(2-quinolinyl)-1H-
form to the requirements of § 70.25 of
indene-1,3(2H)-dione (CAS Reg. No.
this chapter.
8004–92–0). D&C Yellow No. 10 is manu-
factured by condensing quinaldine with (e) Certification. All batches of D&C
phthalic anhydride to give the Yellow No. 10 shall be certified in ac-
unsulfonated dye, which is then sulfo- cordance with regulations in part 80 of
nated with oleum. this chapter.
(2) Color additive mixtures made [48 FR 39219, Aug. 30, 1983, as amended at 49
with D&C Yellow No. 10 for drug use FR 8432, Mar. 7, 1984]
may contain only those diluents that
are suitable and that are listed in part § 74.1711 D&C Yellow No. 11.
73 of this chapter as safe for use in (a) Identity. (1) The color additive
color additive mixtures for coloring D&C Yellow No. 11 is principally 2-(2-
drugs. quinolyl)-1,3-indandione.
(b) Specifications. The color additive (2) Color additive mixtures, for drug
D&C Yellow No. 10 shall conform to the use made with D&C Yellow No. 11 may
following specifications and shall be contain only those diluents that are
free from impurities other than those suitable and that are listed in part 73
named to the extent that such other of this chapter as safe for use in color
impurities may be avoided by current additive mixtures for coloring exter-
good manufacturing practice: nally applied drugs.
Sum of volatile matter at 135 °C (275 °F) and (b) Specifications. D&C Yellow No. 11
chlorides and sulfates (calculated as so- shall conform to the following speci-
dium salts), not more than 15 percent. fications and shall be free from impuri-
Matter insoluble in both water and chloro- ties, other than those named, to the ex-
form, not more than 0.2 percent. tent that such other impurities may be
Total sulfonated quinaldines, sodium salts, avoided by good manufacturing prac-
not more than 0.2 percent. tice:
Total sulfonated phthalic acids, sodium
salts, not more than 0.2 percent. Volatile matter (at 135 °C), not more than 1
2-(2-Quinolinyl)-1H-indene-1,3 (2H)-dione, not percent.
more than 4 parts per million. Ethyl alcohol-insoluble matter, not more
Sum of sodium salts of the monosulfonates than 0.4 percent.
of 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione, Phthalic acid, not more than 0.3 percent.
not less than 75 percent. Quinaldine, not more than 0.2 percent.
Sum of sodium salts of the disulfonates of 2- Subsidiary colors, not more than 5 percent.
(2-quinolinyl)-1H-indene-1,3 (2H)-dione, not Lead (as Pb), not more than 20 parts per mil-
more than 15 percent. lion.
2-(2,3-Dihydro-1,3-dioxo-1H-indene-2-yl)-6, 8- Arsenic (as As), not more than 3 parts per
quinolinedisulfonic acid, disodium salt, not million.
more than 3 percent. Mercury (as Hg), not more than 1 part per
Diethyl ether soluble matter other than that million.
specified, not more than 2 parts per mil- Total color, not less than 96 percent.

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Food and Drug Administration, HHS § 74.2053

(c) Uses and restrictions. D&C Yellow (c) Uses and restrictions. D&C Black
No. 11 may be safely used in externally No. 2 may be safely used for coloring
applied drugs in amounts consistent the following cosmetics in amounts
with good manufacturing practice. consistent with current good manufac-
(d) Labeling. The label of the color ad- turing practice: Eyeliner, brush-on-
ditive and any mixtures prepared brow, eye shadow, mascara, lipstick,
therefrom intended solely or in part for blushers and rouge, makeup and foun-
coloring purposes shall conform to the dation, and nail enamel.
requirements of § 70.25 of this chapter. (d) Labeling. The label of the color ad-
(e) Certification. All batches of D&C ditive shall conform to the require-
Yellow No. 11 shall be certified in ac- ments of § 70.25 of this chapter.
cordance with regulations in part 80 of (e) Certification. All batches of D&C
this chapter. Black No. 2 shall be certified in accord-
ance with regulations in part 80 of this
Subpart C—Cosmetics chapter.
[69 FR 44930, July 28, 2004, as amended at 72
§ 74.2052 D&C Black No. 2. FR 10357]
(a) Identity. The color additive D&C
Black No. 2 is a high-purity carbon § 74.2053 D&C Black No. 3.
black prepared by the oil furnace proc- (a) Identity. The color additive D&C
ess. It is manufactured by the combus- Black No. 3 is a washed bone char pre-
tion of aromatic petroleum oil feed- pared from calcined cattle bones. The
stock and consists essentially of pure bones are twice heated in excess of 700
carbon, formed as aggregated fine par- °C for at least 6 hours.
ticles with a surface area range of 200 (b) Specifications. D&C Black No. 3
to 260 meters (m)2/gram. shall conform to the following speci-
(b) Specifications. D&C Black No. 2 fications and shall be free from impuri-
shall conform to the following speci- ties other than those named, to the ex-
fications and shall be free from impuri- tent that such other impurities may be
ties other than those named to the ex- avoided by current good manufacturing
tent that such other impurities may be practices:
avoided by good manufacturing prac- (1) Calcium hydroxyapatite (CaO and
tice: P2O5), not less than 75 percent and not
(1) Surface area by nitrogen BET more than 84 percent;
(Brunauer, Emmett, Teller) method, (2) Elemental carbon, not less than 7
200 to 260 m2/gram. percent;
(2) Weight loss on heating at 950 °C (3) Moisture, not more than 7 per-
for 7 minutes (predried for 1 hour at 125 cent;
°C), not more than 2 percent. (4) Silica (SiO2), not more than 5 per-
(3) Ash content, not more than 0.15 cent;
percent. (5) Arsenic, not more than 3 milli-
(4) Arsenic (total), not more than 3 grams (mg)/kilogram (kg) (3 parts per
milligrams per kilogram (mg/kg) (3 million (ppm));
parts per million). (6) Lead, not more than 10 mg/kg (10
(5) Lead (total), not more than 10 mg/ ppm); and
kg (10 parts per million). (7) Total polycyclic aromatic hydro-
(6) Mercury (total), not more than 1 carbons (PAHs), not more than 5 mg/kg
mg/kg (1 part per million). (5 ppm).
(7) Total sulfur, not more than 0.65 (c) Uses and restrictions. Cosmetics
percent. containing D&C Black No. 3 must com-
(8) Total PAHs, not more than 0.5 mg/ ply with § 700.27 of this chapter with re-
kg (500 parts per billion). spect to prohibited cattle materials in
(9) Benzo[a]pyrene, not more than cosmetic products. D&C Black No. 3
0.005 mg/kg (5 parts per billion). may be safely used for coloring the fol-
(10) Dibenz[a,h]anthracene, not more lowing cosmetics in amounts con-
than 0.005 mg/kg (5 parts per billion). sistent with current good manufac-
(11) Total color (as carbon), not less turing practice: Eyeliner, eye shadow,
than 95 percent. mascara, and face powder.

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§ 74.2101 21 CFR Ch. I (4–1–11 Edition)

(d) Labeling. The label of the color ad- ing cosmetics generally, including cos-
ditive shall conform to the require- metics intended for use in the area of
ments of § 70.25 of this chapter. the eye, in amounts consistent with
(e) Certification. All batches of D&C current good manufacturing practice.
Black No. 3 shall be certified in accord- (2) FD&C Blue No. 1 Aluminum Lake
ance with regulations in part 80 of this may be safely used for coloring cos-
chapter. metics intended for use in the area of
[72 FR 33666, June 19, 2007] the eye, in amounts consistent with
current good manufacturing practice.
§ 74.2101 FD&C Blue No. 1. (d) Labeling. The label of the color ad-
(a) Identity. The color additive FD&C ditive shall conform to the require-
Blue No. 1 is principally the disodium ments of § 70.25 of this chapter.
salt of ethyl[4-[p-[ethyl(m- (e) Certification. All batches of FD&C
sulfobenzyl)amino]-a-(o- Blue No. 1 shall be certified in accord-
sulfophenyl)benzylidene]-2,5- ance with regulations in part 80 of this
cyclohexadien-1-ylidene](m- chapter.
sulfobenzyl)ammonium hydroxide [47 FR 42565, Sept. 28, 1982, as amended at 58
inner salt with smaller amounts of the FR 17511, Apr. 5, 1993; 59 FR 7638, Feb. 16,
isomeric disodium salts of ethyl[4-[p- 1994]
[ethyl(p-sulfobenzyl)amino]-a-(o-
sulfophenyl)benzylidene]-2,5- § 74.2104 D&C Blue No. 4.
cyclohexadien-1-ylidene](p- (a) Identity and specifications. The
sulfobenzyl)ammonium hydroxide color additive D&C Blue No. 4 shall
inner salt and ethyl[4-[p-[ethyl(o- conform in identity and specifications
sulfobenzyl)amino]-a-(o- to the requirements of § 74.1104(a)(1)
sulfophenyl)benzylidene]-2,5- and (b).
cyclohexadien-1-ylidene](o- (b) Uses and restrictions. D&C Blue No.
sulfobenzyl)ammonium hydroxide 4 may be safely used for coloring exter-
inner salt. Additionally, FD&C Blue nally applied cosmetics in amounts
No. 1 is manufactured by the acid cata- consistent with good manufacturing
lyzed condensation of one mole of so-
practice.
dium 2-formylbenzenesulfonate with
(c) Labeling. The label of the color ad-
two moles from a mixture consisting
ditive shall conform to the require-
principally of 3-
ments of § 70.25 of this chapter.
[(ethylphenylamino)methyl]
benzenesulfonic acid, and smaller (d) Certification. All batches of D&C
amounts of 4- Blue No. 4 shall be certified in accord-
[(ethylphenylamino)methyl] ance with regulations in part 80 of this
benzenesulfonic acid and 2- chapter.
[(ethylphenylamino)methyl] § 74.2151 D&C Brown No. 1.
benzenesulfonic acid to form the leuco
base. The leuco base is then oxidized (a) Identity. The color additive D&C
with lead dioxide and acid, or with di- Brown No. 1 is a mixture of the sodium
chromate and acid, or with manganese salts of 4[[5-[(dialkylphenyl)- azo]-2,4-
dioxide and acid to form the dye. The dihydroxyphenyl]azo]-benzene sulfonic
intermediate sodium 2- acid. The alkyl group is principally the
formylbenzenesulfonate is prepared methyl group.
from 2-chlorobenzaldehyde and sodium (b) Specifications. D&C Brown No. 1
sulfite. shall conform to the following speci-
(b) Specifications. (1) The color addi- fications and shall be free from impuri-
tive FD&C Blue No. 1 shall conform in ties other than those named to the ex-
specifications to the requirements of tent that such other impurities may be
§ 74.101(b). avoided by good manufacturing prac-
(2) FD&C Blue No. 1 Aluminum Lake tice:
shall be prepared in accordance with Sum of volatile matter (at 135 °C) and
the requirements of § 82.51 of this chap- chlorides and sulfates (calculated as so-
ter. dium salts), not more than 16 percent.
(c) Uses and restrictions. (1) FD&C Water-insoluble matter, not more than 0.2
Blue No. 1 may be safely used for color- percent.

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Food and Drug Administration, HHS § 74.2208
Sulfanilic acid, sodium salt, not more than in amounts consistent with current
0.2 percent. good manufacturing practice.
Resorcinol, not more than 0.2 percent. (c) Labeling. The label of the color ad-
Xylidines, not more than 0.2 percent.
Disodium salt of 4[[5-[(4-sulfophenyl)-azo]-
ditive shall conform to the require-
2,4-dihydroxyphenyl]azo] benzenesulfonic ments of § 70.25 of this chapter.
acid, not more than 3 percent. (d) Certification. All batches of FD&C
Monosodium salt of 4[[5-[(2,4-dimethyl- Green No. 3 shall be certified in accord-
phenyl)azo] -2,4-dihydroxyphenyl]azo] ance with regulations in part 80 of this
benzenesulfonic acid, not less than 29 per- chapter.
cent and not more than 39 percent.
Monosodium salt of 4[[5-[(2,5-dimethyl- [47 FR 52144, Nov. 19, 1982]
phenyl)azo] -2,4-dihydroxyphenyl]azo]
benzenesulfonic acid, not less than 12 per- § 74.2205 D&C Green No. 5.
cent and not more than 17 percent. (a) Identity and specifications. The
Monosodium salt of 4[[5-[(2,3-dimethyl- color additive D&C Green No. 5 shall
phenyl)azo] - 2,4-dihydroxyphenyl]azo]
benzenesulfonic acid, not less than 6 per- conform in identity and specifications
cent and not more than 13 percent. to the requirements of § 74.1205 (a)(1)
Monosodium salt of 4[[5-[(2-ethylphenyl)- and (b)(2).
azo]-2,4-dihydroxyphenyl]-azo] (b) Uses and restrictions. D&C Green
benzenesulfonic acid, not less than 5 per- No. 5 may be safely used for coloring
cent and not more than 12 percent. cosmetics generally, including cos-
Monosodium salt of 4[[5-[(3,4-dimethyl- metics intended for use in the area of
phenyl)azo] -2,4-dihydroxyphenyl]azo]
benzenesulfonic acid, not less than 3 per-
the eye, in amounts consistent with
cent and not more than 9 percent. current good manufacturing practice.
Monosodium salt of 4[[5-[(2,6-dimethyl- (c) Labeling requirements. The label of
phenyl)azo] -2,4-dihydroxyphenyl]azo] the color additive shall conform to the
benzenesulfonic acid, not less than 3 per- requirements of § 70.25 of this chapter.
cent and not more than 8 percent. (d) Certification. All batches of D&C
Monosodium salt of 4[[5-[(4-ethylphenyl) Green No. 5 shall be certified in accord-
azo]-2,4-dihydroxyphenyl]-azo]
benzenesulfonic acid, not less than 2 per-
ance with regulations in part 80 of this
cent and not more than 8 percent. chapter.
Lead (as Pb), not more than 20 parts per mil- [47 FR 24285, June 4, 1982, as amended at 59
lion. FR 40805, Aug. 10, 1994]
Arsenic (as As), not more than 3 parts per
million. § 74.2206 D&C Green No. 6.
Mercury (as Hg), not more than 1 part per
million. (a) Identity and specifications. The
Total color, not less than 84 percent. color additive D&C Green No. 6 shall
conform in identity and specifications
(c) Uses and restrictions. D&C Brown
No. 1 may be safely used for coloring to the requirements of § 74.1206 (a) and
externally applied cosmetics in (b).
amounts consistent with good manu- (b) Uses and restrictions. D&C Green
facturing practice. No. 6 may be safely used for coloring
(d) Labeling. The label of the color ad- externally applied cosmetics in
ditive shall conform to the require- amounts consistent with good manu-
ments of § 70.25 of this chapter. facturing practice.
(e) Certification. All batches of D&C (c) Labeling requirements. The label of
Brown No. 1 shall be certified in ac- the color additive shall conform to the
cordance with regulations in part 80 of requirements of § 70.25 of this chapter.
this chapter. (d) Certification. All batches of D&C
Green No. 6 shall be certified in accord-
§ 74.2203 FD&C Green No. 3. ance with regulations in part 80 of this
(a) Identity and specifications. The chapter.
color additive FD&C Green No. 3 shall [47 FR 14146, Apr. 4, 1982, as amended at 51
conform in identity and specifications FR 9784, Mar. 21, 1986]
to the requirements of § 74.203(a)(1) and
(b). § 74.2208 D&C Green No. 8.
(b) Uses and restrictions. The color ad- (a) Identity and specifications. The
ditive FD&C Green No. 3 may be safely color additive D&C Green No. 8 shall
used for coloring cosmetics generally conform in identity and specifications

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§ 74.2254 21 CFR Ch. I (4–1–11 Edition)

to the requirements of § 74.1208(a)(1) (c) Labeling. The label of the color ad-
and (b). ditive shall conform to the require-
(b) Uses and restrictions. D&C Green ments of § 70.25 of this chapter.
No. 8 may be safely used for coloring (d) Certification. All batches of D&C
externally applied cosmetics in Orange No. 5 shall be certified in ac-
amounts not exceeding 0.01 percent by cordance with regulations in part 80 of
weight of the finished cosmetic prod- this chapter.
uct. [47 FR 49635, Nov. 2, 1982, as amended at 49
(c) Labeling. The label of the color ad- FR 13342, Apr. 4, 1984]
ditive shall conform to the require-
ments of § 70.25 of this chapter. § 74.2260 D&C Orange No. 10.
(d) Certification. All batches of D&C (a) Identity and specifications. The
Green No. 8 shall be certified in accord- color additive D&C Orange No. 10 shall
ance with regulations in part 80 of this conform in identity and specifications
chapter. to the requirements of § 74.1260(a)(1)
and (b).
§ 74.2254 D&C Orange No. 4. (b) Uses and restrictions. D&C Orange
No. 10 may be safely used for coloring
(a) Identity and specifications. The
externally applied cosmetics in
color additive D&C Orange No. 4 shall
amounts consistent with good manu-
conform in identity and specifications
facturing practice.
to the requirements of § 74.1254 (a)(1) (c) Labeling requirements. The label of
and (b). the color additive shall conform to the
(b) Uses and restrictions. D&C Orange requirements of § 70.25 of this chapter.
No. 4 may be safely used for coloring (d) Certification. All batches of D&C
externally applied cosmetics in Orange No. 11 shall be certified in ac-
amounts consistent with good manu- cordance with regulations in part 80 of
facturing practice. this chapter.
(c) Labeling. The label of the color ad-
[46 FR 18954, Mar. 27, 1981]
ditive shall conform to the require-
ments of § 70.25 of this chapter. § 74.2261 D&C Orange No. 11.
(d) Certification. All batches of D&C
(a) Identity and specifications. The
Orange No. 4 shall be certified in ac-
color additive D&C Orange No. 11 shall
cordance with regulations in part 80 of
conform in identity and specifications
this chapter.
to the requirements of § 74.1261(a)(1)
[42 FR 52396, Sept. 30, 1977] and (b).
(b) Uses and restrictions. D&C Orange
§ 74.2255 D&C Orange No. 5. No. 11 may be safely used for coloring
(a) Identity and specifications. The externally applied cosmetics in
color additive D&C Orange No. 5 shall amounts consistent with good manu-
conform in identity and specifications facturing practice.
to the requirements of § 74.1255 (a)(1) (c) Labeling requirements. The label of
and (b). the color additive shall conform to the
requirements of § 70.25 of this chapter.
(b) Uses and restrictions. D&C Orange
(d) Certification. All batches of D&C
No. 5 may be safely used for coloring
Orange No. 11 shall be certified in ac-
mouthwashes and dentifrices that are
cordance with regulations in part 80 of
ingested cosmetics in amounts con-
this chapter.
sistent with current good manufac-
turing practice. D&C Orange No. 5 may [46 FR 18954, Mar. 27, 1981]
be safely used for coloring lipsticks
and other cosmetics intended to be ap- § 74.2304 FD&C Red No. 4.
plied to the lips in amounts not exceed- (a) Identity and specifications. The
ing 5.0 percent by weight of the fin- color additive FD&C Red No. 4 shall
ished cosmetic products. D&C Orange conform in identity and specifications
No. 5 may be safely used for coloring to the requirements of § 74.1304(a)(1)
externally applied cosmetics in and (b).
amounts consistent with current good (b) Uses and restrictions. FD&C Red
manufacturing practice. No. 4 may be safely used for coloring

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Food and Drug Administration, HHS § 74.2327

externally applied cosmetics in (b) Uses and restrictions. D&C Red No.
amounts consistent with good manu- 17 may be safely used for coloring ex-
facturing practice. ternally applied cosmetics in amounts
(c) Labeling. The label of the color ad- consistent with good manufacturing
ditive shall conform to the require- practice.
ments of § 70.25 of this chapter. (c) Labeling. The label of the color ad-
(d) Certification. All batches of FD&C ditive shall conform to the require-
Red No. 4 shall be certified in accord- ments of § 70.25 of this chapter.
ance with regulations in part 80 of this (d) Certification. All batches of D&C
chapter. Red No. 17 shall be certified in accord-
ance with regulations in part 80 of this
§ 74.2306 D&C Red No. 6. chapter.
(a) Identity and specifications.The
color additive D&C Red No. 6 shall con- § 74.2321 D&C Red No. 21.
form in identity and specifications to (a) Identity and specifications. The
the requirements of § 74.1306 (a)(1) and color additive D&C Red No. 21 shall
(b). conform in identity and specifications
(b) Uses and restrictions. The color ad- to the requirements of § 74.1321(a)(1)
ditive D&C Red No. 6 may be safely and (b).
used for coloring cosmetics generally (b) Uses and restrictions. The color ad-
in amounts consistent with current ditive D&C Red No. 21 may be safely
good manufacturing practice. used for coloring cosmetics generally
(c) Labeling requirements. The label of in amounts consistent with current
the color additive shall conform to the good manufacturing practice.
requirements of § 70.25 of this chapter. (c) Labeling requirements. The label of
(d) Certification. All batches of D&C the color additive shall conform to the
Red No. 6 shall be certified in accord- requirements of § 70.25 of this chapter.
ance with regulations in part 80 of this (d) Certification. All batches of D&C
chapter. Red No. 21 shall be certified in accord-
ance with regulations in part 80 of this
[47 FR 57688, Dec. 28, 1982]
chapter.
§ 74.2307 D&C Red No. 7 [47 FR 53846, Nov. 30, 1982]
(a) Identity and specifications. The
color additive D&C Red No. 7 shall con- § 74.2322 D&C Red No. 22.
form in identity and specifications to (a) Identity and specifications. The
the requirements of § 74.1307 (a)(1) and color additive D&C Red No. 22 shall
(b). conform in identity and specifications
(b) Uses and restrictions. The color ad- to the requirements of § 74.1322(a)(1)
ditive D&C Red No. 7 may be safely and (b).
used for coloring cosmetics generally (b) Uses and restrictions. The color ad-
in amounts consistent with current ditive D&C Red No. 22 may be safely
good manufacturing practice. used for coloring cosmetics generally
(c) Labeling requirements. The label of in amounts consistent with current
the color additive shall conform to the good manufacturing practice.
requirements of § 70.25 of this chapter. (c) Labeling requirements. The label of
(d) Certification. All batches of D&C the color additive shall conform to the
Red No. 7 shall be certified in accord- requirements of § 70.25 of this chapter.
ance with regulations in part 80 of this (d) Certification. All batches of D&C
chapter. Red No. 22 shall be certified in accord-
ance with regulations in part 80 of this
[47 FR 57688, Dec. 28, 1982]
chapter.
§ 74.2317 D&C Red No. 17. [47 FR 53846, Nov. 30, 1982]
(a) Identity and specifications. The
color additive D&C Red No. 17 shall § 74.2327 D&C Red No. 27.
conform in identity and specifications (a) Identity and specifications. The
to the requirements of § 74.1317(a)(1) color additive D&C Red No. 27 shall
and (b). conform in identity and specifications

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§ 74.2328 21 CFR Ch. I (4–1–11 Edition)

to the requirements of § 74.1327 (a)(1) § 74.2331 D&C Red No. 31.


and (b). (a) Identity and specifications. The
(b) Uses and restrictions. D&C Red No. color additive D&C Red No. 31 shall
27 may be safely used for coloring cos- conform in identity and specifications
metics generally in amounts consistent to the requirements of § 74.1331(a)(1)
with current good manufacturing prac- and (b).
tice. (b) Uses and restrictions. D&C Red No.
(c) Labeling requirements. The label of 31 may be safely used for coloring ex-
the color additive shall conform to the ternally applied cosmetics in amounts
requirements of § 70.25 of this chapter. consistent with good manufacturing
(d) Certification. All batches of D&C practice.
Red No. 27 shall be certified in accord- (c) Labeling. The label of the color ad-
ance with regulations in part 80 of this ditive shall conform to the require-
chapter. ments of § 70.25 of this chapter.
(d) Certification. All batches of D&C
[47 FR 42568, Sept. 28, 1982] Red No. 31 shall be certified in accord-
ance with regulations in part 80 of this
§ 74.2328 D&C Red No. 28. chapter.
(a) Identity and specifications. The
color additive D&C Red No. 28 shall § 74.2333 D&C Red No. 33.
conform in identity and specifications (a) Identity and specifications. The
to the requirements of § 74.1328 (a)(1) color additive D&C Red No. 33 shall
and (b). conform in identity and specifications
(b) Uses and restrictions. D&C Red No. to the requirements of § 74.1333(a) (1)
28 may be safely used for coloring cos- and (b).
metics generally in amounts consistent (b) Uses and restrictions. The color ad-
with current good manufacturing prac- ditive D&C Red No. 33 may be safely
tice. used for coloring cosmetic lip products
(c) Labeling requirements. The label of in amounts not to exceed 3 percent
the color additive shall conform to the total color by weight of the finished
cosmetic products. D&C Red No. 33
requirements of § 70.25 of this chapter.
may be safely used for coloring
(d) Certification. All batches of D&C
mouthwashes (including breath fresh-
Red No. 28 shall be certified in accord- eners), dentifrices, and externally ap-
ance with regulations in part 80 of this plied cosmetics in amounts consistent
chapter. with current good manufacturing prac-
[47 FR 42568, Sept. 28, 1982] tice.
(c) Labeling requirements. The label of
§ 74.2330 D&C Red No. 30. the color additive and any mixtures
(a) Identity and specifications. The prepared therefrom intended solely or
in part for coloring purposes shall con-
color additive D&C Red No. 30 shall
form to the requirements of § 70.25 of
conform in identity and specifications
this chapter.
to the requirements of § 74.1330 (a)(1)
(d) Certification. All batches of D&C
and (b).
Red No. 33 shall be certified in accord-
(b) Uses and restrictions. D&C Red No. ance with regulations in part 80 of this
30 may be safely used for coloring cos- chapter.
metics generally in amounts consistent
with current good manufacturing prac- [53 FR 33120, Aug. 30, 1988]
tice.
§ 74.2334 D&C Red No. 34.
(c) Labeling requirements. The label of
the color additive shall conform to the (a) Identity and specifications. The
requirements of § 70.25 of this chapter. color additive D&C Red No. 34 shall
(d) Certification. All batches of D&C conform in identity and specifications
Red No. 30 shall be certified in accord- to the requirements of § 74.1334(a)(1)
ance with regulations in part 80 of this and (b).
(b) Uses and restrictions. D&C Red No.
chapter.
34 may be safely used for coloring ex-
[47 FR 22511, May 25, 1982] ternally applied cosmetics in amounts

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Food and Drug Administration, HHS § 74.2602a

consistent with good manufacturing (1) The color additive may be used in
practice. amounts consistent with current good
(c) Labeling. The label of the color ad- manufacturing practice.
ditive shall conform to the require- (2) The color additive shall not be ex-
ments of § 70.25 of this chapter. posed to oxidizing or reducing agents
(d) Certification. All batches of D&C that may affect the integrity of the
Red No. 34 shall be certified in accord- color additives or any other condition
ance with regulations in part 80 of this that may affect their integrity.
chapter. (c) Labeling. The label of the color ad-
ditive shall conform to the require-
§ 74.2336 D&C Red No. 36. ments of § 70.25 of this chapter.
(d) Certification. All batches of FD&C
(a) Identity and specifications. The Red No. 40 shall be certified in accord-
color additive D&C Red No. 36 shall ance with regulations in part 80 of this
conform in identity and specifications chapter.
to the requirements of § 74.1336 (a)(1)
and (b). [42 FR 15654, Mar. 22, 1977, as amended at 59
(b) Uses and restrictions. The color ad- FR 7636, Feb. 16, 1994]
ditive D&C Red No. 36 may be safely § 74.2602 D&C Violet No. 2.
used for coloring cosmetic lip products
in amounts not to exceed 3 percent (a) Identity and specifications. The
total color by weight of the finished color additive D&C Violet No. 2 shall
cosmetic products. D&C Red No. 36 conform in identity and specifications
may be safely used for coloring exter- to the requirements of § 74.1602(a)(1)
nally applied cosmetics in amounts and (b).
consistent with current good manufac- (b) Uses and restrictions. The color ad-
turing practice. ditive D&C Violet No. 2 may be safely
used for coloring externally applied
(c) Labeling requirements. The label of
cosmetics in amounts consistent with
the color additive shall conform to the
good manufacturing practice.
requirements of § 70.25 of this chapter.
(c) Labeling. The label of the color ad-
(d) Certification. All batches of D&C ditive shall conform to the require-
Red No. 36 shall be certified in accord- ments of § 70.25 of this chapter.
ance with regulations in part 80 of this (d) Certification. All batches of D&C
chapter. Violet No. 2 shall be certified in ac-
[53 FR 29031, Aug. 2, 1988] cordance with regulations in part 80 of
this chapter.
§ 74.2340 FD&C Red No. 40.
§ 74.2602a Ext. D&C Violet No. 2.
(a) Identity and specifications. (1) The
color additive FD&C Red No. 40 shall (a) Identity. The color additive Ext.
conform in identity and specifications D&C Violet No. 2 is principally the
to the requirements of § 74.340(a)(1) and monosodium salt of 2-[(9,10-dihydro-4-
(b) of this chapter. hydroxy -9,10-dioxo-1-anthracenyl)
amino]-5-methyl-benzenesulfonic acid.
(2) The listing of this color additive
(b) Specifications. Ext. D&C Violet No.
includes lakes prepared as described in
2 shall conform to the following speci-
§§ 82.51 and 82.1051 of this chapter, ex-
fications and shall be free from impuri-
cept that the color additive used is
ties, other than those named, to the ex-
FD&C Red No. 40 and the resultant
tent that such other impurities may be
lakes meet the specification and label-
avoided by good manufacturing prac-
ing requirements prescribed by § 82.51
tice:
or § 82.1051 of this chapter.
(b) Uses and restrictions. FD&C Red Sum of volatile matter (at 135 °C) and
No. 40 may be safely used in coloring chlorides and sulfates (calculated as so-
cosmetics generally, except that only dium salts), not more than 18 percent.
Water-insoluble matter, not more than 0.4
FD&C Red No. 40 and FD&C Red No. 40
percent.
Aluminum Lake may be safely used in 1-Hydroxy-9,10-anthracenedione, not more
coloring cosmetics intended for use in than 0.2 percent.
the area of the eye. These uses are sub- 1,4-Dihydroxy-9,10-anthracenedione, not
ject to the following restrictions: more than 0.2 percent.

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§ 74.2705 21 CFR Ch. I (4–1–11 Edition)
p- Toluidine, not more than 0.1 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-
p- Toluidine sulfonic acids, sodium salts, not sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-
more than 0.2 percent. 1H-pyrazole-3-carboxylate, disodium salt,
Subsidiary colors, not more than 1 percent. not more than 1 percent.
Lead (as Pb), not more than 20 parts per mil- Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-
lion. sulfophenyl)azo]-1H-pyrazole-3-carboxylic
Arsenic (as As), not more than 3 parts per acid, disodium salt, and 4,5-dihydro-5-oxo-
million. 4-(phenylazo)-1-(4-sulfophenyl)-1H-pyr-
Mercury (as Hg), not more than 1 part per azole-3-carboxylic acid, disodium salt, not
million. more than 0.5 percent.
Total color, not less than 80 percent. 4-Aminobenzenesulfonic acid, sodium salt,
(c) Uses and restrictions. The color ad- not more than 0.2 percent.
ditive Ext. D&C Violet No. 2 may be 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr-
safely used for coloring externally ap- azole-3-carboxylic acid, disodium salt, not
plied cosmetics in amounts consistent more than 0.2 percent.
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-
with good manufacturing practice.
sulfophenyl)-1H-pyrazole-3-carboxylate, so-
(d) Labeling. The label of the color ad- dium salt, not more than 0.1 percent.
ditive shall conform to the require- 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic
ments of § 70.25 of this chapter. acid], disodium salt, not more than 0.05
(e) Certification. All batches of Ext. percent.
D&C Violet No. 2 shall be certified in 4-Aminoazobenzene, not more than 75 parts
accordance with regulations in part 80 per billion.
of this chapter. 4-Aminobiphenyl, not more than 5 parts per
billion.
§ 74.2705 FD&C Yellow No. 5. Aniline, not more than 100 parts per billion.
(a) Identity. The color additive FD&C Azobenzene, not more than 40 parts per bil-
Yellow No. 5 is principally the tri- lion.
sodium salt of 4,5-dihydro-5-oxo-(1-4- Benzidine, not more than 1 part per billion.
sulfophenyl)-4-[(4-sulfophenyl)azo]-1H- 1,3-Diphenyltriazene, not more than 40 parts
pyrazole-3-carboxylic acid (CAS Reg. per billion.
No. 1934–21–0). To manufacture the ad- Lead (as Pb), not more than 10 parts per mil-
lion.
ditive, 4-aminobenzenesulfonic acid is
Arsenic (as As), not more than 3 parts per
diazotized using hydrochloric acid and
million.
sodium nitrite. The diazo compound is
Mercury (as Hg), not more than 1 part per
coupled with 4,5-dihydro-5-oxo-1-(4- million.
sulfophenyl)-1H-pyrazole-3-carboxylic Total color, not less than 87 percent.
acid or with the methyl ester, the
ethyl ester, or a salt of this carboxylic (2) FD&C Yellow No. 5 Aluminum
acid. The resulting dye is purified and Lake shall be prepared in accordance
isolated as the sodium salt. with the requirements of § 82.51 of this
(b) Specifications. (1) FD&C Yellow chapter.
No. 5 shall conform to the following (c) Uses and restrictions. (1) FD&C Yel-
specifications and shall be free from low No. 5 may be safely used for color-
impurities other than those named to ing cosmetics generally, including cos-
the extent that such other impurities metics intended for use in the area of
may be avoided by good manufacturing the eye, in amounts consistent with
practice: current good manufacturing practice.
Sum of volatile matter at 135 °C (275 °F) and (2) FD&C Yellow No. 5 Aluminum
chlorides and sulfates (calculated as so- Lake may be safely used for coloring
dium salts), not more than 13 percent. cosmetics intended for use in the area
Water-insoluble matter, not more than 0.2 of the eye, subject to the restrictions
percent.
4,4′-[4,5-Dihydro-5-oxo-4-[(4-
on use of color additives in § 70.5(b) and
sulfophenyl)hydrazono]-1H-pyrazol-1,3- (c) of this chapter, in amounts con-
diyl]bis[benzenesulfonic acid], trisodium sistent with current good manufac-
salt, not more than 1 percent. turing practice.
4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]- (d) Labeling. The label of the color ad-
4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr- ditive shall conform to the require-
azole-3-carboxylic acid, tetrasodium salt,
not more than 1 percent. ments of § 70.25 of this chapter.

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Food and Drug Administration, HHS § 74.2711

(e) Certification. All batches of FD&C (c) Labeling. The label of the color ad-
Yellow No. 5 shall be certified in ac- ditive shall conform to the require-
cordance with regulations in part 80 of ments of § 70.25 of this chapter.
this chapter. (d) Certification. All batches of Ext.
D&C Yellow No. 7 shall be certified in
[50 FR 35782, Sept. 4, 1985, as amended at 51
FR 24524, July 7, 1986; 59 FR 60898, Nov. 29,
accordance with regulations in part 80
1994] of this chapter.

§ 74.2706 FD&C Yellow No. 6. § 74.2708 D&C Yellow No. 8.


(a) Identity and specifications. The (a) Identity and specifications. The
color additive FD&C Yellow No. 6 shall color additive D&C Yellow No. 8 shall
conform in identity and specifications conform in identity and specifications
to the requirements of § 74.706 (a)(1) and to the requirements of § 74.1708(a)(1)
(b). and (b).
(b) Uses and restrictions. FD&C Yellow (b) Uses and restrictions. D&C Yellow
No. 6 may be safely used for coloring No. 8 may be safely used for coloring
cosmetics generally in amounts con- externally applied cosmetics in
sistent with current good manufac- amounts consistent with good manu-
facturing practice.
turing practice.
(c) Labeling. The label of the color ad-
(c) Labeling. The label of the color ad-
ditive shall conform to the require-
ditive shall conform to the require-
ments of § 70.25 of this chapter.
ments of § 70.25 of this chapter.
(d) Certification. All batches of D&C
(d) Certification. All batches of FD&C
Yellow No. 8 shall be certified in ac-
Yellow No. 6 shall be certified in ac-
cordance with regulations in part 80 of
cordance with regulations in part 80 of
this chapter.
this chapter.
[51 FR 41782, Nov. 19, 1986] § 74.2710 D&C Yellow No. 10.
(a) Identity and specifications. The
§ 74.2707 D&C Yellow No. 7. color additive D&C Yellow No. 10 shall
(a) Identity and specifications. The conform in identity and specifications
color additive D&C Yellow No. 7 shall to the requirements of § 74.1710(a)(1)
conform in identity and specifications and (b).
to the requirements of § 74.1707(a)(1) (b) Uses and restrictions. The color ad-
and (b). ditive D&C Yellow No. 10 may be safely
(b) Uses and restrictions. D&C Yellow used for coloring cosmetics generally
No. 7 may be safely used for coloring in amounts consistent with current
externally applied cosmetics in good manufacturing practice.
amounts consistent with good manu- (c) Labeling. The label of the color ad-
facturing practice. ditive shall conform to the require-
(c) Labeling. The label of the color ad- ments of § 70.25 of this chapter.
ditive shall conform to the require- (d) Certification. All batches of D&C
ments of § 70.25 of this chapter. Yellow No. 10 shall be certified in ac-
(d) Certification. All batches of D&C cordance with regulations in part 80 of
Yellow No. 7 shall be certified in ac- this chapter.
cordance with regulations in part 80 of [48 FR 39220, Aug. 30, 1983, as amended at 49
this chapter. FR 8432, Mar. 7, 1984]

§ 74.2707a Ext. D&C Yellow No. 7. § 74.2711 D&C Yellow No. 11.
(a) Identity and specifications. The (a) Identity and specifications. The
color additive Ext. D&C Yellow No. 7 color additive D&C Yellow No. 11 shall
shall conform in identity and specifica- conform in identity and specifications
tions to the requirements of § 74.1707a to the requirements of § 74.1711(a)(1)
(a)(1) and (b). and (b).
(b) Uses and restrictions. Ext. D&C (b) Uses and restrictions. D&C Yellow
Yellow No. 7 may be safely used for No. 11 may be safely used for coloring
coloring externally applied cosmetics externally applied cosmetics in
in amounts consistent with good manu- amounts consistent with good manu-
facturing practice. facturing practice.

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§ 74.3045 21 CFR Ch. I (4–1–11 Edition)

(c) Labeling. The label of the color ad- haptics for intraocular lenses, subject
ditive shall conform to the require- to the following restrictions:
ments of § 70.25 of this chapter. (i) The quantity of the color additive
(d) Certification. All batches of D&C does not exceed 0.5 percent by weight
Yellow No. 11 shall be certified in ac- of the suture or haptic material.
cordance with regulations in part 80 of (ii) The dyed suture shall conform in
this chapter. all respects to the requirements of the
U.S. Pharmacopeia.
Subpart D—Medical Devices (2) The color additive
[phthalocyaninato(2-)] copper may be
§ 74.3045 [Phthalocyaninato(2-)] cop- safely used for coloring contact lenses
per. in amounts not to exceed the minimum
(a) Identity. The color additive is reasonably required to accomplish the
[phthalocyaninato(2-)] copper (CAS intended coloring effect.
(3) Authorization for these uses shall
Reg. No. 147–14–8) having the structure
not be construed as waiving any of the
shown in Colour Index No. 74160.
requirements of section 510(k), 515, or
(b) Specifications. The color additive
520(g) the Federal Food, Drug, and Cos-
[phthalocyaninato(2-)] copper shall
metic Act with respect to the medical
conform to the following specifications
device in which [phthalocyaninato(2-)]
and shall be free from impurities other
copper is used.
than those named to the extent that
(d) Labeling. The label of the color ad-
such impurities may be avoided by cur-
ditive shall conform to the require-
rent good manufacturing practice:
ments of § 70.25 of this chapter.
Volatile matter 135 °C (275 °F), not more than (e) Certification. All batches of
0.3 percent. [phthalocyaninato (2-)] copper shall be
Salt content (as NaC1), not more than 0.3 certified in accordance with regula-
percent. tions in part 80 of this chapter.
Alcohol soluble matter, not more than 0.5
percent. [48 FR 34947, Aug. 2, 1983, as amended at 50
Organic chlorine, not more than 0.5 percent. FR 16228, Apr. 25, 1985; 51 FR 22929, June 24,
Aromatic amines, not more than 0.05 per- 1986; 51 FR 28930, Aug. 13, 1986; 51 FR 39371,
cent. Oct. 28, 1986; 52 FR 15945, May 1, 1987; 55 FR
Lead (as Pb), not more than 40 parts per mil- 19620, May 10, 1990; 64 FR 23186, Apr. 30, 1999]
lion.
Arsenic (as As), not more than 3 parts per § 74.3102 FD&C Blue No. 2.
million. (a) Identity. The color additive FD&C
Mercury (as Hg), not more than 1 part per Blue No. 2 shall conform in identity to
million.
the requirements of § 74.102(a)(1).
Total color, not less than 98.5 percent.
(b) Specifications. (1) The color addi-
(c) Uses and restrictions. (1) The color tive FD&C Blue No. 2 for use in color-
additive [phthalocyaninato(2-)] copper ing surgical sutures shall conform to
may be safely used to color poly- the following specifications and shall
propylene sutures, polybutester (the be free from impurities other than
generic designation for the suture fab- those named to the extent that such
ricated from 1,4-benzenedicarboxylic impurities may be avoided by current
acid, polymer with 1,4-butanediol and good manufacturing practice:
alpha-hydro-omega- hydroxypoly(oxy- Sum of volatile matter at 135 °C (275 °F) and
1,4-butanediyl), CAS Reg. No. 37282–12– chlorides and sulfates (calculated as so-
5) nonabsorbable sutures for use in gen- dium salts), not more than 15 percent.
eral and ophthalmic surgery, Water insoluble matter, not more than 0.4
polybutylene terephthalate nonabsorb- percent.
able monofilament sutures for general Isatin-5-sulfonic acid, not more than 0.4 per-
and ophthalmic surgery, nonabsorbable cent.
sutures made from poly(vinylidene flu- Isomeric colors, not more than 18 percent.
Lower sulfonated subsidiary colors, not more
oride) and poly(vinylidene fluoride-co-
than 5 percent.
hexafluoropropylene) for general and Lead (as Pb), not more than 10 parts per mil-
ophthalmic surgery, and lion.
polymethylmethacrylate Arsenic (as As), not more than 3 parts per
monofilament used as supporting million.

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Food and Drug Administration, HHS § 74.3106
Total color, not less than 85 percent. ties other than those named to the ex-
(2) The color additive FD&C Blue No. tent that such impurities may be
2–Aluminum Lake on alumina for use avoided by good manufacturing prac-
in bone cement shall be prepared in ac- tice:
cordance with the requirements of Volatile matter at 135 °C (275 °F), not more
§ 82.51 of this chapter. than 3 percent.
(c) Uses and restrictions. (1) The color Matter insoluble in N,N-
additive FD&C Blue No. 2 may be safe- dimethylformamide, not more than 1 per-
cent.
ly used for coloring nylon (the copoly- Isatin, not more than 0.3 percent.
mer of adipic acid and hexamethylene Anthranilic acid, not more than 0.3 percent.
diamine) surgical sutures for use in Indirubin, not more than 1 percent.
general surgery subject to the fol- Lead (as Pb), not more than 10 parts per mil-
lowing restrictions: lion.
(i) The quantity of color additive Arsenic (as As), not more than 3 parts per
does not exceed 1 percent by weight of million.
Mercury (as Hg), not more than 1 part per
the suture; million.
(ii) The dyed suture shall conform in Total color, not less than 95 percent.
all respects to the requirements of the
United States Pharmacopeia XX (1980); (c) Uses and restrictions. (1) D&C Blue
and No. 6 may be safely used at a level—
(iii) When the sutures are used for (i) Not to exceed 0.2 percent by
the purposes specified in their labeling, weight of the suture material for color-
the color additive does not migrate to ing polyethylene terephthalate sur-
the surrounding tissues. gical sutures for general surgical use;
(ii) Not to exceed 0.25 percent by
(2) The color additive FD&C Blue No.
weight of the suture material for color-
2–Aluminum Lake on alumina may be
ing plain or chromic collagen absorb-
safely used for coloring bone cement at
able sutures for general surgical use;
a level not to exceed 0.1 percent by
(iii) Not to exceed 0.5 percent by
weight of the bone cement.
weight of the suture material for color-
(3) Authorization and compliance
ing plain or chromic collagen absorb-
with these uses shall not be construed
able sutures for ophthalmic surgical
as waiving any of the requirements of
use;
sections 510(k), 515, and 520(g) of the
(iv) Not to exceed 0.5 percent by
Federal Food, Drug, and Cosmetic Act
weight of the suture material for color-
with respect to the medical device in
ing polypropylene surgical sutures for
which the color additive FD&C Blue
general surgical use; and
No. 2 and the color additive FD&C Blue
(v) Not to exceed 0.5 percent by
No. 2–Aluminum Lake on alumina are
weight of the suture material for color-
used.
ing polydioxanone synthetic absorbable
(d) Labeling. The labels of the color
sutures for ophthalmic and general sur-
additive FD&C Blue No. 2 and the color
gical use.
additive FD&C Blue No. 2–Aluminum (2) Authorization for these uses shall
Lake on alumina shall conform to the not be construed as waiving any of the
requirements of § 70.25 of this chapter. requirements of sections 510(k), 515,
(e) Certification. All batches of FD&C and 520(g) of the Federal Food, Drug,
Blue No. 2 and its lake shall be cer- and Cosmetic Act with respect to the
tified in accordance with regulations in medical device in which the color addi-
part 80 of this chapter. tive is used.
[64 FR 48290, Sept. 3, 1999] (d) Labeling. The label of the color ad-
ditive shall conform to the require-
§ 74.3106 D&C Blue No. 6. ments of § 70.25 of this chapter.
(a) Identity. The color additive D&C (e) Certification. All batches of D&C
Blue No. 6 is principally [Δ2,2′- Blue No. 6 shall be certified in accord-
biindoline]-3,3′ dione (CAS Reg. No. ance with regulations in part 80 of this
482–89–3). chapter.
(b) Specifications. D&C Blue No. 6 [49 FR 29956, July 25, 1984; 49 FR 34447, Aug.
shall conform to the following speci- 31, 1984, as amended at 50 FR 30698, July 29,
fications and shall be free from impuri- 1985]

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§ 74.3206 21 CFR Ch. I (4–1–11 Edition)

§ 74.3206 D&C Green No. 6. § 74.3230 D&C Red No. 17.


(a) Identity. The color additive D&C (a) Identity and specifications. The
Green No. 6 shall conform in identity color additive D&C Red No. 17 shall
to the requirements of § 74.1206(a). conform in identity and specifications
(b) Specifications. The color additive to the requirements of § 74.1317(a)(1)
D&C Green No. 6 for use in medical de- and (b).
vices shall conform to the specifica- (b) Uses and restrictions. (1) The sub-
tions of § 74.1206(b). stance listed in paragraph (a) of this
(c) Uses and restrictions. (1) The color section may be used as a color additive
additive D&C Green No. 6 may be safe- in contact lens in amounts not to ex-
ly used at a level ceed the minimum reasonably required
(i) Not to exceed 0.03 percent by to accomplish the intended coloring ef-
weight of the lens material for coloring fect.
contact lenses; (2) Authorization for this use shall
(ii) Not to exceed 0.75 percent by not be construed as waiving any of the
weight of the suture material for color- requirements of section 510(k), 515, and
ing polyethylene terephthalate sur- 520(g) of the Federal Food, Drug, and
gical sutures, including sutures for Cosmetic Act with respect to the con-
ophthalmic use; tact lens in which the color additive is
(iii) Not to exceed 0.1 percent by used.
weight of the suture material for color- (c) Labeling. The label of the color ad-
ing polyglycolic acid surgical sutures ditive shall conform to the require-
with diameter greater than U.S.P. size ments of § 70.25 of this chapter.
8–0, including sutures for ophthalmic (d) Certification. All batches of D&C
use; Red No. 17 shall be certified in accord-
(iv) Not to exceed 0.5 percent by ance with regulations in part 80 of this
weight of the suture material for color- chapter.
ing polyglycolic acid surgical sutures
with diameter not greater than U.S.P. [55 FR 22898, June 5, 1990]
size 8–0, including sutures for oph-
thalmic use; § 74.3602 D&C Violet No. 2.
(v) Not to exceed 0.21 percent by (a) Identity and specifications. The
weight of the suture material for color- color additive D&C Violet No. 2 shall
ing poly(glycolic acid-co-trimethylene conform in identity and specifications
carbonate) sutures (also referred to as to the requirements of § 74.1602(a)(1)
1,4-dioxan-2,5-dione polymer with 1,3- and (b).
dioxan-2-one) for general surgical use; (b) Uses and restrictions. (1) The color
and additive, D&C Violet No. 2, may be
(vi) Not to exceed 0.10 percent by safely used for coloring contact lenses
weight of the haptic material for color- in amounts not to exceed the minimum
ing polymethylmethacrylate support reasonably required to accomplish the
haptics of intraocular lenses. intended coloring effect.
(2) Authorization for these uses shall (2) D&C Violet No. 2 may be safely
not be construed as waiving any of the used for coloring sutures for use in sur-
requirements of sections 510(k), 515, gery subject to the following condi-
and 520(g) of the Federal Food, Drug, tions:
and Cosmetic Act with respect to the (i) At a level not to exceed 0.2 percent
medical device in which D&C Green No. by weight of the suture material for
6 is used. coloring copolymers of 90 percent
(d) Labeling. The label of the color ad- glycolide and 10 percent L-lactide syn-
ditive shall conform to the require- thetic absorbable sutures for use in
ments of § 70.25 of this chapter. general and ophthalmic surgery; and
(e) Certification. All batches of D&C (ii) At a level not to exceed 0.3 per-
Green No. 6 shall be certified in accord- cent by weight of the suture material
ance with regulations in part 80 of this for coloring polydioxanone synthetic
chapter. absorbable sutures for use in general
[48 FR 13022, Mar. 29, 1983, as amended at 51 and ophthalmic surgery.
FR 9784, Mar. 21, 1986; 51 FR 37909, Oct. 27, (iii) At a level not to exceed 0.25 per-
1986; 58 FR 21542, Apr. 22, 1993] cent by weight of the suture material

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Food and Drug Administration, HHS Pt. 74, App. A

for coloring poliglecaprone 25 (e- lenses shall conform to the specifica-


caprolactone/glycolide copolymer) syn- tions of § 74.1710(b).
thetic absorbable sutures for use in (c) Uses and restrictions. (1) The color
general surgery. additive D&C Yellow No. 10 may be
(iv) At a level not to exceed 0.1 per- used for coloring contact lenses in
cent by weight of the suture material amounts not to exceed the minimum
for coloring poly(e-caprolactone) ab- reasonably required to accomplish the
sorbable sutures for use in general sur- intended coloring effect.
gery. (2) Authorization for this use shall
(v) At a level not to exceed 0.2 per- not be construed as waiving any of the
cent by weight of the suture material requirements of sections 510(k), 515,
for coloring glycolide/dioxanone/ and 520(g) of the Federal Food, Drug,
trimethylene carbonate tripolymer ab- and Cosmetic Act with respect to the
sorbable sutures for use in general sur- contact lens in which the color addi-
gery. tive is used.
(vi) At a level not to exceed 0.2 per- (d) Labeling. The label of the color ad-
cent by weight of the suture material ditive shall conform to the require-
for coloring absorbable sutures pre- ments of § 70.25 of this chapter.
pared from homopolymers of glycolide (e) Certification. All batches of D&C
for use in general surgery. Yellow No. 10 shall be certified in ac-
(3) The color additive, D&C Violet cordance with regulations in part 80 of
No. 2, may be safely used for coloring this chapter.
polymethylmethacrylate intraocular [52 FR 28690, Aug. 3, 1987]
lens haptics at a level not to exceed 0.2
percent by weight of the haptic mate- APPENDIX A TO PART 74—THE PROCE-
rial. DURE FOR DETERMINING ETHER
(4) The color additive, D&C Violet SOLUBLE MATERIAL IN D&C RED
No. 2, may be safely used for coloring NOS. 6 AND 7
absorbable meniscal tacks made from
The dye is dissolved in glacial acetic and 8
poly (L-lactic acid) at a level not to ex- N hydrochloric acids (1.33 : 1) and extracted
ceed 0.15 percent by weight of the tack with diethyl ether. Sulfonated moieties, in-
material. cluding the color additive, are discarded in
(5) Authorization for these uses shall subsequent aqueous extractions of the ether.
not be construed as waiving any of the Carboxylated moieties are removed from the
requirements of sections 510(k), 515, ether by extraction with 2% (w/w) NaOH. The
and 520(g) of the Federal Food, Drug, ether is evaporated to near dryness, ethanol
(95%) is added, and the solution is analyzed
and Cosmetic Act with respect to the
spectrophotometrically in the visible range.
medical devices in which the color ad- The absorbance at each wavelength must not
ditive is used. exceed 150% of the absorbance similarly ob-
(c) Labeling. The label of the color ad- tained for D&C Red No. 6 Lot AA5169.
ditive shall conform to the require-
ments of § 70.25 of this chapter. APPARATUS
(d) Certification. All batches of D&C (A) Spectrophotometer (Cary 118 or equiva-
Violet No. 2 shall be certified in ac- lent).
cordance with regulations in part 80 of (B) Separatory funnels—one 1000 mL and
one 500 mL.
this chapter.
[52 FR 19722, May 27, 1987, as amended at 55 REAGENTS
FR 18868, May 7, 1990; 58 FR 60109, Nov. 15, NOTE: Use distilled water when water is re-
1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098, quired.
Apr. 23, 1998; 64 FR 32805, June 18, 1999; 65 FR (A) Glacial Acetic Acid (ACS grade).
46344, July 28, 2000] (B) Diethyl ether (Anhydrous)—Note and
follow safety precautions on container.
§ 74.3710 D&C Yellow No. 10. (C) 8 N HCl—Pour 165 mL H2O into a 500 mL
(a) Identity. The color additive D&C graduate. Place the graduate in hood, then
add HCl conc. to bring to volume. Carefully
Yellow No. 10 shall conform to the pour this solution into a 500 mL Erlenmeyer
identity requirements of § 74.1710(a). flask, Stopper and shake. Label the flask.
(b) Specifications. The color additive (D) 2% (w/w) NaOH—Pour ca 190 mL H2O
D&C Yellow No. 10 for use in contact into a 250 mL mixing graduate. Add 8 g. (5.23

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Pt. 74, App. A 21 CFR Ch. I (4–1–11 Edition)
mL) of 50% (w/w) NaOH, bring to 200 mL vol- Remove the unsulfonated subsidiary color
ume with water, stopper and mix. Pour this from the ether by shaking the ether layer for
solution into a glass bottle, label and stopper one minute with 20 mL of 2% (w/w) NaOH.
with a polytetrafluoroethylene top. Appropriately label a 100 mL beaker. After the
(E) Ethanol (95%). layers separate, drain the aqueous alkaline
layer into the beaker and save for the deter-
PROCEDURE
mination of 3-hydroxy-4-[(4-methylphenyl)
Weigh a 250 mL beaker to tenths of a mg azo]-2-naphthalenecarboxylic acid, sodium
and add 100 mg of dye. Record weight to salt.
tenths of a mg. If there is any color left in the ether, shake
NOTE: The following work must be per- for one minute with another 20 mL portion
formed in the hood. of 2% (w/w) NaOH. After the layers have sep-
Add 75 mL of 8 N HCl and 100 mL of glacial arated, drain off the aqueous alkaline layer
acetic acid to the beaker and stir. into the 100 mL beaker.
Place the beaker on a hot plate and heat
If color remains in the ether layer, repeat
with stirring, until all of the dye is in solu-
the above step for a total of three washes of
tion.
Remove the beaker from the hot plate, the ether with 2% (w/w) NaOH. Note: Three
cover with a watch glass and allow to cool to washes is usually sufficient to remove the
room temperature (1–2 hrs). unsulfonated subsidiary.
When the dye solution is at room tempera- With the stopper removed, gently swirl the
ture, transfer the solution to a 1000 mL sepa- ether layer in the sep. funnel twice to sepa-
ratory funnel. rate the remaining aqueous base. Drain this
Rinse the beaker three times with 50 mL into the 100 mL beaker.
portions of H2O, transferring each rinse to Appropriately label a 250 mL beaker. Pour
the 1000 mL funnel. the ether layer into the beaker. Allow the
Add 150 mL of ether to the funnel, stopper ether to evaporate to near dryness. Cool to
and shake for 10 seconds, then invert funnel room temperature. Add ca 8 mL ethanol
and open stopcock to remove gas buildup. (95%). Swirl beaker to mix contents. Quan-
Shake the funnel for one minute, opening titatively transfer to a 25 mL graduate using
the stopcock a few times while the funnel is ethanol (95%) rinses. Add ethanol (95%) to
inverted to remove gas buildup. (Use this bring volume to 15 mL.
shake procedure throughout method.)
Allow the funnel to stand until the layers SPECTROPHOTOMETRIC ANALYSIS
have separated.
Transfer the bottom (aqueous) layer to a Spectrophotometer Parameters:
500 mL separatory funnel, add 100 mL of Scan Range: 400–700 nm
ether, stopper and shake for one minute. Scan: 50 nm/in; 5.0 nm/sec.
When the layers have separated, drain off Absorbance Range: 0–1 AUFS
the bottom layer into a waste beaker. Cell length: 1 cm (Note: Reference and Sam-
Pour the ether layer in the 500 mL sepa- ple cells)
ratory funnel into the 1000 mL separatory (1) Record the visible spectrum of a blank.
funnel. Fill the reference cell with distilled water
Rinse the 500 mL sep. funnel with 100 mL and the sample cell with ethanol (95%).
H2 O, then transfer it to the 1000 mL sep. fun-
(2) Rinse the sample cell with 2–3 mL of the
nel, stopper and shake for one minute.
When the layers have separated, drain off ether soluble material (in ethanol solution);
the bottom aqueous layer into the waste then fill the cell. Record the visible spec-
beaker. trum of the ether soluble material.
Rinse the 500 mL funnel at least three (3) Compare the spectra obtained to the
times (total) and repeat the 100 mL water spectra attached. The attached spectra rep-
washes until no color is present in the aque- resents 150% of the absorbance at each wave-
ous layer. Discard the bottom aqueous layer length for similarly analyzed D&C Red No. 6
to the waste beaker after each separation. Lot AA5169.
Shake the ether layer twice more with 100 The spectra of the current sample must
mL portions of H2 O, discarding the bottom not exceed the attached spectra at any wave-
aqueous layer after each separation. length in order to pass test.

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Food and Drug Administration, HHS Pt. 74, App. A

[47 FR 57688, Dec. 28, 1982; 48 FR 3946, Jan. 28, 1983; 48 FR 7438, Feb. 22, 1983; 48 FR 10811, Mar.
15, 1983]

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Pt. 80 21 CFR Ch. I (4–1–11 Edition)

PART 80—COLOR ADDITIVE the Food and Drug Administration,


CERTIFICATION collectable at par at Washington, DC.
All such deposits and fees shall be for-
Subpart A—General Provisions warded to the Center for Food Safety
and Applied Nutrition (HFS–100), Food
Sec. and Drug Administration, 5100 Paint
80.10 Fees for certification services. Branch Pkwy., College Park, MD 20740,
whereupon after making appropriate
Subpart B—Certification Procedures
records thereof, they will be trans-
80.21 Request for certification. mitted to the Treasurer of the United
80.22 Samples to accompany requests for States for deposit to the special ac-
certification. count ‘‘Salaries and Expenses, Certifi-
80.31 Certification.
cation, Inspection, and Other Services,
80.32 Limitations of certificates.
80.34 Authority to refuse certification serv- Food and Drug Administration.’’
ice. (e) Refunds from advance deposits.
80.35 Color additive mixtures; certification Whenever in the judgment of the Com-
and exemption from certification. missioner the ratio between fees col-
80.37 Treatment of batch pending certifi- lected (which are based upon experi-
cation. ence and the best estimate of costs and
80.38 Treatment of batch after certification.
80.39 Records of distribution. the best estimate of earnings) and the
costs of providing the service during an
AUTHORITY: 21 U.S.C. 371, 379e. elapsed period of time, in the light of
SOURCE: 42 FR 15662, Mar. 22, 1977, unless all circumstances and contingencies,
otherwise noted. warrants a refund from the fund col-
lected during such period, he shall
Subpart A—General Provisions make ratable refunds to those persons
to whom the services were rendered
§ 80.10 Fees for certification services. and charged, except that no refund
(a) Fees for straight colors including shall be made where the computed rat-
lakes. The fee for the services provided able amount for the elapsed period is
by the regulations in this part in the less than $5.00.
case of each request for certification [42 FR 15662, Mar. 22, 1977, as amended at 47
submitted in accordance with FR 24692, June 8, 1982; 54 FR 24890, June 12,
§ 80.21(j)(1) and (j)(2) shall be $0.35 per 1989; 59 FR 60899, Nov. 29, 1994; 61 FR 3572,
pound of the batch covered by such re- Feb. 1, 1996; 61 FR 14479, Apr. 2, 1996; 66 FR
quests, but no such fee shall be less 56035, Nov. 6, 2001; 70 FR 15756, Mar. 29, 2005;
than $224. 71 FR 70875, Dec. 7, 2006]
(b) Fees for repacks of certified color
additives and color additive mixtures. The Subpart B—Certification
fees for the services provided under the Procedures
regulations in this part in the case of
each request for certification sub- § 80.21 Request for certification.
mitted in accordance with § 80.21(j)(3)
A request for certification of a batch
and (j)(4) shall be:
(1) 100 pounds or less—$35. of color additive shall:
(2) Over 100 pounds but not over 1,000 (a) Be addressed to the Commissioner
pounds—$35 plus $0.06 for each pound of Food and Drugs.
over 100 pounds. (b) Be prepared in the manner set
(3) Over 1,000 pounds—$89 plus $0.02 forth in paragraph (j) of this section.
for each pound over 1,000 pounds. (c) Be submitted in duplicate.
(c) Advance deposits. Any person regu- (d) Be signed by a responsible officer
larly requesting certification services of the person requesting certification
may deposit funds in advance of re- of the batch. In the case of a foreign
quests as prepayment of fees required manufacturer, the request for certifi-
by this section. cation must be signed by a responsible
(d) Method of payment. All deposits officer of such firm, and, by his agent
and fees required by this section shall who resides in the United States.
be paid by money order, bank draft, or (e) Show the name and post office ad-
certified check, drawn to the order of dress of the actual manufacturer in

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Food and Drug Administration, HHS § 80.21

case such manufacturer is not the per- (1) Request for certification of a batch
son requesting certification of the of straight color additive.
batch. Date llll
(f) Be accompanied by the fee pre- Office of Cosmetics and Colors (HFS–100),
scribed in § 80.10 unless the person has Center for Food Safety and Applied Nutri-
established with the Food and Drug tion,
Administration an advanced deposit to Food and Drug Administration,
be used for prepayment of such fees. In 5100 Paint Branch Pkwy.,
no case shall the Commissioner con- College Park, MD 20740
In accordance with the regulations promul-
sider a request for certification of a gated under the Federal Food, Drug, and
batch of color additive if the fee ac- Cosmetic Act, we hereby make application
companying such request is less than for the certification of a batch of straight
that required by § 80.10 or if such fee ex- color additive.
ceeds the amount held in the advance Name of color llllllllllllllll
deposit account of the manufacturer (As listed in 21 CFR part 74)
submitting such request for certifi-
Batch number llllllllllllllll
cation.
(Manufacturer’s number)
(g) Be accompanied by the sample
prescribed in § 80.22 consisting of: Batch weighs ll pounds
(1) Four ounces in the case of Batch manufactured by llllll at
lllllllll (Name and address of ac-
straight colors and lakes.
tual manufacturer)
(2) Two ounces in the case of repacks
and mixtures. How stored pending certification llllll
llllllllllllllllllllllll
A sample accompanying a request for (State conditions of storage, with kind and
certification must be submitted under size of containers, location, etc.)
separate cover and should be addressed Certification requested of this color for use
to the Color Certification Branch. in lllllllllllllllllllll
(h) The name of a color additive shall llllllllllllllllllllllll
be given in the following manner: llllllllllllllllllllllll
(State proposed uses)
(1) The name of a straight color shall
be the name of the color as listed in Required fee, $ll (drawn to the order of
parts 74 and 81 of this chapter. Food and Drug Administration).
(2) The name of a lake shall be the The accompanying sample was taken after
the batch was mixed in accordance with 21
name derived in the manner described
CFR 80.22 and is accurately representative
in part 82 of this chapter. thereof.
(3) The name of a mixture shall be
the name given to such mixture by the (Signed) llllllllll
By llllllllll
person requesting certification. llllllllll
(4) The name of a repack shall be the (Title)
name described in paragraph (h)(1), (2),
or (3) of this section, whichever is ap- (2) Request for certification of a batch
plicable. of color additive lake.
(i) The information and samples enu- Date llll
merated in paragraphs (a) to (h), inclu-
Office of Cosmetics and Colors (HFS–100),
sive, of this section are the minimum Center for Food Safety and Applied Nutri-
required. Additional information and tion,
samples shall be submitted at the re- Food and Drug Administration,
quest of the Food and Drug Adminis- 5100 Paint Branch Pkwy.,
tration when such additional informa- College Park, MD 20740
tion and samples are necessary to de- In accordance with the regulations promul-
gated under the Federal Food, Drug, and
termine compliance with the require-
Cosmetic Act, we hereby make application
ments of § 80.31 for the issuance of a for the certification of a batch of color addi-
certificate. tive lake.
(j) The form for submission of the ap-
Name of color llllllllllllllll
plication shall be one of the following,
Batch number llllllllllllllll
depending upon whether the color addi- (Manufacturer’s number)
tive is a straight color, a lake, a repack
of a previously certified color additive, Batch weighs ll pounds
or a color additive mixture. Name of color used lllllllllllll

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§ 80.21 21 CFR Ch. I (4–1–11 Edition)
Quantity ll pounds The accompanying sample was taken after
the batch was mixed in accordance with 21
Lot number lllllllllllllllll
CFR 80.22 and is accurately representative
(When certification of the lake
for use in foods is requested) thereof.
Precipitant used llllllllllllll (Signed) lllllllll
Substratum used llllllllllllll By llllllllll
Quantity ll pounds llllllllll
Batch manufactured by lllll at (Title)
lllllll (Name and address of actual (4) Request for certification of a batch
manufacturer) of color additive mixture.
How stored pending certification llllll
llllllllllllllllllllllll Date lllll
(State conditions of storage, with kind and Office of Cosmetics and Colors (HFS–100),
size of containers, location, etc.) Center for Food Safety and Applied Nutri-
Certification requested of this color for use tion,
in lllllllllllllllllllll Food and Drug Administration,
llllllllllllllllllllllll 5100 Paint Branch Pkwy.,
llllllllllllllllllllllll College Park, MD 20740
(State proposed uses) In accordance with the regulations promul-
Required fee, $ll (drawn to the order of gated under the Federal Food, Drug, and
Food and Drug Administration). Cosmetic Act, we hereby make application
The accompanying sample was taken after for the certification of a batch of color addi-
the batch was mixed in accordance with 21 tive mixture.
CFR 80.22 and is accurately representative Name of mixture llllllllllllll
thereof. (Manufacturer’s trade name)
(Signed) llllllllll Batch number llllllllllllllll
By llllllllll (Manufacturer’s number)
llllllllll Weight of batch ll pounds
(Title) Volume of batch ll (If liquid) gallons
(3) Request for certification of a repack Batch manufactured by lllllllllll
of a batch of certified color additive.
Constituents of the mixture:
Date lllll 1. Color(s). (List separately each color and
Office of Cosmetics and Colors (HFS–100), each lot number.)
Center for Food Safety and Applied Nutri- Name of color
tion, as certified Lot number
Food and Drug Administration, llllllllllllllllllllllll
5100 Paint Branch Pkwy., llllllllllllllllllllllll
College Park, MD 20740 Quantity used
In accordance with the regulations promul- (in pounds) Obtained from
gated under the Federal Food, Drug, and llllllllllllllllllllllll
Cosmetic Act, we hereby make application llllllllllllllllllllllll
for the certification of a batch of color addi- 2. List of diluents. (List separately each dil-
tive repack. uent.)
Name of color llllllllllllllll
Name of diluent
(As listed in regulations and as certified; or
repacker’s name, if a mixture) llllllllllllllllllllllll
Original lot number lllllllllllll llllllllllllllllllllllll
Certified color content lllllllllll
This color obtained from llllllllll Quantity used
Batch number llllllllllllllll By volume
Batch weighs ll pounds By weight (if liquid)
llllllllllllllllllllllll
How stored pending certification llllll llllllllllllllllllllllll
llllllllllllllllllllllll Batch mixed as follows lllllllllll
(State conditions of storage, with kind and
(Describe in detail)
size of containers, location, etc.)
How stored pending certification llllll
Certification requested for use in llllll
llllllllllllllllllllllll
llllllllllllllllllllllll
(State conditions of storage, with kind and
llllllllllllllllllllllll
size of containers, location, etc.)
(State proposed uses)
Certification requested for use in llllll
Required fee, $ll (drawn to the order of llllllllllllllllllllllll
Food and Drug Administration). llllllllllllllllllllllll

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Food and Drug Administration, HHS § 80.32
(State proposed uses) (b) If the Commissioner determines,
Required fee, $ll (drawn to the order of after such investigation as he considers
Food and Drug Administration). to be necessary, that a request sub-
The accompanying sample was taken after mitted in accordance with § 80.21, or
the batch was mixed in accordance with 21 the batch of color additive covered by
CFR 80.22 and is accurately representative such request, does not comply with the
thereof. requirements prescribed by paragraph
(Signed) llllllllll (a) of this section for the issuance of a
By lllllllll certificate, the Commissioner shall
llllllllll refuse to certify such batch and shall
(Title) give notice thereof to the person who
[42 FR 15662, Mar. 22, 1977; 44 FR 17658, Mar. submitted such request, stating his
23, 1979; 44 FR 22053, Apr. 13, 1979, as amended reasons for refusal. Any person who
at 54 FR 24890, June 12, 1989; 61 FR 14479, Apr. contests such refusal shall have an op-
2, 1996; 66 FR 56035, Nov. 6, 2001] portunity for a regulatory hearing be-
fore the Food and Drug Administration
§ 80.22 Samples to accompany requests pursuant to part 16 of this chapter.
for certification.
A sample of a batch of color additive § 80.32 Limitations of certificates.
which is to accompany a request for (a) If a certificate is obtained
certification shall: through fraud or misrepresentation of
(a) Be taken only after such batch a material fact, such certificate shall
has been so thoroughly mixed as to be not be effective, and a color additive
of uniform composition throughout. from the batch on which such certifi-
(b) Held under the control of the per- cate was issued shall be considered to
son requesting certification until cer- be from a batch that has not been cer-
tified. tified in accordance with the regula-
(c) Be labeled to show: tions in this part. Whenever, the Com-
(1) The name of the color additive. missioner learns that any certificate
(2) The manufacturer’s batch num- has been obtained through fraud or ma-
ber. terial misrepresentation, he shall no-
(3) The quantity of such batch. tify the holder of the certificate that it
(4) The name and post-office address is of no effect.
of the person requesting certification (b) If between the time a sample of
of such batch. color additive accompanying a request
(5) Be accompanied by any label or for certification is taken and the time
labeling intended to be used. a certificate covering the batch of such
color additive is received by the person
§ 80.31 Certification. to whom it is issued, any such color ad-
(a) If the Commissioner determines, ditive becomes changed in composi-
after such investigations as he con- tion, such certificates shall not be ef-
siders to be necessary, that: fective with respect to such changed
(1) A request submitted in accordance color additive and such changed color
with § 80.21 appears to contain no un- additive shall be considered to be from
true statement of a material fact; a batch that has not been certified in
(2) Such color additive conforms to accordance with the regulations in this
the specifications and any other condi- part.
tions set forth therefor in parts 81 and (c) If at any time after a certificate
82 of this chapter. is received by the person to whom it is
(3) The batch covered by such request issued any color additive from the
otherwise appears to comply with the batch covered by such certificate be-
regulations in this chapter, the Com- comes changed in composition, such
missioner shall issue to the person who certificate shall expire with respect to
submitted such request a certificate such changed color additive. After such
showing the lot number assigned to expiration, such color additive shall be
such batch and that such batch, subject considered to be from a batch that has
to the terms, conditions, and restric- not been certified in accordance with
tions prescribed by part 74, 81, and 82 of this part; except that such color addi-
this chapter, is a certified batch. tive shall not be so considered when

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§ 80.32 21 CFR Ch. I (4–1–11 Edition)

used for coloring a food, drug, or cos- using color additive in accordance with
metic, or for the purpose of certifying § 80.38, or, such package has been
a batch of a mixture in which such opened by a duly authorized represent-
color additive was used as an ingre- ative of the Administration or Depart-
dient, or for use in preparing a batch of ment in the performance of his official
a mixture for which exemption from duties, and he has immediately re-
certification has been authorized, if sealed the package in conformance
such change resulted solely from such with § 70.20 of this chapter.
use. (g) A certificate shall not be effective
(d) A certificate shall expire with re- with respect to a package of color addi-
spect to any color additive covered
tive and such color additive shall be
thereby if the package in which such
considered to be from a batch that has
color additive was closed for shipment
or delivery is opened. After such expi- not been certified if such color additive
ration such color additive shall be con- is used in any manner other than that
sidered to be from a batch that has not for which it was certified.
been certified, except that such color (h) When the listing or the specifica-
additive shall not be so considered tions for a color additive are revoked
when the package is opened; or amended, the final order effecting
(1) and such color additive is used, the revocation or amendment may
subject to the restrictions prescribed specify, in addition to its own effective
by paragraphs (f), (g), and (h) of this date, a date on which all certificates
section, in coloring a food, drug, or cos- for existing batches and portions of
metic; batches of such a color additive there-
(2) for the purpose of certifying a tofore issued under such revoked or
batch made by repacking such color; amended regulations shall cease to be
(3) for the purpose of certifying a effective; and any such lots of the color
batch of a mixture in which such color additive shall be regarded as
is used as an ingredient; or uncertified after the date specified un-
(4) for the purpose of preparing a less a new certificate can be and is ob-
batch of a mixture for which exemption tained in conformance with the new
from certification has been authorized; regulations. When a certificate thus
or
ceases to be effective for a color addi-
(5) when the package is reopened
tive, any certificates previously issued
solely for repackaging by the person to
for a color additive mixture containing
whom such certificate was issued.
(e) A certificate shall not be effective that color additive shall cease to be ef-
with respect to a package of color addi- fective on the same date. Use of such
tive and such color additive shall be color additive or color additive mix-
considered to be from a batch that has ture after such specified date without
not been certified if such package is the new certificate in preparing foods,
shipped or delivered under a label drugs, or cosmetics will result in such
which does not bear all words, state- food, drugs, or cosmetics being adulter-
ments, and other information required ated. When a certified color additive
by § 70.25 of this chapter to appear has been used in food, drugs, or cos-
thereon. metics and the status of the color addi-
(f) A certificate shall not be effective tive is thereafter changed by amend-
with respect to a package of color addi- ment or revocation of its listing or
tive, and such color additive shall be specification regulations, such food,
considered to be from a batch that has drugs, and cosmetics will not be re-
not been certified if: garded as adulterated by reason of the
(1) Such package has not been sealed use of such color additive, unless the
in accordance with § 70.20 of this chap- hazard to health is such that existing
ter. stocks of the foods, drugs, or cosmetics
(2) Such package has been sealed in cannot be safely used, in which cases
accordance with § 70.20 of this chapter findings to that effect will be made and
and the seal has been broken, inten-
regulations appropriate for such spe-
tionally or accidentally, unless such
cial cases will be issued.
seal has been broken for the purpose of

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Food and Drug Administration, HHS § 80.38

§ 80.34 Authority to refuse certifi- for exempt mixtures. The label of such
cation service. color additive mixtures shall not bear
(a) When it appears to the Commis- the lot number assigned by the Food
sioner that a person has: and Drug Administration to the cer-
(1) Obtained, or attempted to obtain, tified straight color components, but
a certificate through fraud or misrepre- shall bear the manufacturer’s control
sentation of a material fact. number through which the history of
(2) Falsified the records required to the straight color can be determined.
be kept by § 80.39; or (c) Additions to the list of diluents. A
(3) Failed to keep such records, or to person requesting additions to the list
make them available, or to accord full of diluents authorized for the purposes
opportunity to make inventory of described in paragraphs (a) and (b) of
stocks on hand or otherwise to check this section shall submit a petition in
the correctness of such records, as re- accordance with the provisions of § 71.1
quired by § 80.39; or of this chapter. Each such petition
(4) Refused to permit duly authorized shall be accompanied by the fee pre-
employees of the Food and Drug Ad- scribed in § 70.19 of this chapter, unless
ministration free access to all manu- there is an advance deposit to be used
facturing facilities, processes, and for- for prepayment of such fees.
mulae involved in the manufacture of
NOTE: The provisions of § 80.35 with respect
color additives and intermediates from
only to diluents for use in cosmetic color ad-
which such color additives are derived; ditive mixtures were stayed, until a regula-
he may immediately suspend certifi- tion is effected listing safe diluents for cos-
cation service to such person and may metic use, including cosmetics which color
continue such suspension until ade- the human body, 29 FR 18495, Dec. 29, 1964.
quate corrective action has been taken.
(b) Any person who contests suspen- § 80.37 Treatment of batch pending
sion of service shall have an oppor- certification.
tunity for a regulatory hearing before Immediately after the sample that is
the Food and Drug Administration pur- to accompany a request for certifi-
suant to part 16 of this chapter. cation of a batch of color additive is
taken, the batch shall be:
§ 80.35 Color additive mixtures; certifi-
cation and exemption from certifi- (a) Stored in containers of such kind
cation. as to prevent change in composition.
(a) Color additive mixtures to be cer- (b) Held under the control of the per-
tified. Any color additive mixture that son requesting certification until cer-
contains one or more straight colors tified.
listed in part 74 of this chapter, to- (c) Marked, by labeling or otherwise,
gether with any diluents listed in such in a manner such that there can be no
subparts for use with such straight col- question as to the identity of the batch
ors, shall be certified if intended for and no question that it is not to be
use in foods, drugs, or cosmetics, or in used until the requested certificate has
coloring the human body, as the case been issued.
may be, subject to any restriction pre-
scribed in parts 70 and 71 of this chap- § 80.38 Treatment of batch after cer-
tification.
ter.
(b) Color additive mixtures exempted (a) Immediately upon notification
from certification. A color additive mix- that a batch of color additive has been
ture prepared from a previously cer- certified, the person requesting certifi-
tified batch of one or more straight cation thereof shall identify such
colors, with or without any diluent batch, by labeling, with the certified
that has been listed in part 73 of this lot number.
chapter for use in mixtures, shall be (b) The person requesting certifi-
exempt from batch certification if the cation shall maintain storage in such
straight color used has not changed in manner as to prevent change in com-
composition in any manner whatsoever position until such batch has been
since its certification and if it is sim- packaged and labeled as required by
ply mixed with the approved diluents §§ 70.20 and 70.25 of this chapter, except

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§ 80.39 21 CFR Ch. I (4–1–11 Edition)

that the person requesting certifi- section 203(b) of the Color Additive
cation may use such color additive for Amendments of 1960 (sec. 203(b), 74
the purpose of coloring a food, drug, or Stat. 405 (21 U.S.C. 379e note)). Except
cosmetic. for color additives for which petitions
have been filed, progress reports are re-
§ 80.39 Records of distribution. quired by January 1, 1968, and at 6-
(a) The person to whom a certificate month intervals thereafter. Specifica-
is issued shall keep complete records tions for color additives listed in para-
showing the disposal of all the color graphs (a), (b), and (c) of this section
additive from the batch covered by appear in the respective designated
such certificate. Upon the request of sections. The listing of color additives
any officer or employee of the Food in this section is not to be construed as
and Drug Administration or of any a listing for surgical suture use unless
other officer or employee acting on be- color additive petitions have been sub-
half of the Secretary of Health and mitted for such use or the Commis-
Human Services, such person, at all sioner has been notified of studies un-
reasonable hours until at least 2 years derway to establish the safety of the
after disposal of all such color additive, color additive for such use. The color
shall make such records available to additives listed in paragraphs (a), (b),
any such officer or employee, and shall and (c) of this section may not be used
accord to such officer or employee full in products which are intended to be
opportunity to make inventory of used in the area of the eye. The color
stocks of such color additive on hand additives listed in paragraphs (a), (b),
and otherwise to check the correctness and (c) of this section are provisionally
of such records. listed until the closing dates set forth
(b) The records required to be kept by therein.
paragraph (a) of this section shall (a) Color additives previously and pres-
show: ently subject to certification and provi-
(1) Each quantity used by such person sionally listed for food, drug, and cosmetic
from such batch and the date and kind use.
of such use.
(2) The date and quantity of each Closing date
shipment or delivery from such batch, Color additive Drug and Restrictions
and the name and post-office address of Food use cosmetic
use
the person to whom such shipment or
delivery was made. Lakes (FD&C)
(c) The records required to be kept by (sec. 82.51 of
this chapter).
paragraph (a) of this section shall be
kept separately from all other records. (b) Color additives previously and pres-
ently subject to certification and provi-
PART 81—GENERAL SPECIFICA- sionally listed for drug and cosmetic use.
TIONS AND GENERAL RESTRIC-
Closing date Restrictions
TIONS FOR PROVISIONAL COLOR
ADDITIVES FOR USE IN FOODS, Lakes (D&C) (Sec.
82.2051 of this chapter).
DRUGS, AND COSMETICS
(c) Color additives previously and pres-
Sec.
81.1 Provisional lists of color additives. ently subject to certification and provi-
81.10 Termination of provisional listings of sionally listed for use in externally ap-
color additives. plied drugs and cosmetics.
81.30 Cancellation of certificates.
81.32 Limitation of certificates. Closing date Restrictions

AUTHORITY: 21 U.S.C. 371, 379e, 379e note. Lakes (Ext. D&C) (sec.
82.105(1) of this chap-
ter)
§ 81.1 Provisional lists of color addi-
tives.
The Commissioner of Food and Drugs [42 FR 15665, Mar. 22, 1977]
finds that the following lists of color EDITORIAL NOTE: For FEDERAL REGISTER ci-
additives are provisionally listed under tations affecting § 81.1, see the List of CFR

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Food and Drug Administration, HHS § 81.10
Sections Affected, which appears in the the other is living. Three of the dogs on
Finding Aids section of the printed volume the 1 percent dosage level died or were
and at www.fdsys.gov. sacrificed within 13 months. All de-
§ 81.10 Termination of provisional list- ceased or sacrificed dogs have shown
ings of color additives. liver damage grossly and/or micro-
scopically. Deceased dogs on the 1 per-
(a) Ext. D&C Yellow Nos. 9 and 10. cent and 2 percent dosage level showed
These colors cannot be produced with poor physical condition.
any assurance that they do not contain
b-naphthylamine as an impurity. While The Commissioner of Food and Drugs
it has been asserted that the two colors having concluded that ingestion of this
can be produced without the impurity color additive over a long period of
named, no method of analysis has been time would be unsafe, and in order to
suggested to establish the fact. b-Naph- protect the public health, hereby ter-
thylamine is a known carcinogen; minates the provisional listing of
therefore, there is no scientific evi- FD&C Red No. 1 for use in foods, drugs,
dence that will support a safe tolerance and cosmetics.
for these colors in products to be used (d) FD&C Red No. 4. Feeding tests of
in contact with the skin. The Commis- this color additive have been conducted
sioner of Food and Drugs, having con- with three species:
cluded that such action is necessary to (1) Rats of the Osborne-Mendel and
protect the public health, hereby ter- Sprague-Dawley strains were fed FD&C
minated the provisional listing of Ext. Red No. 4 for 2 years at levels of 5 per-
D&C Yellow No. 9 and Ext. D&C Yellow cent, 2 percent, 1 percent, and 0.5 per-
No. 10. cent of the diet. No effect was found.
(b) [Reserved] (2) Mice of the C3Hf and C57BL
(c) FD&C Red No. 1. Results of recent strains were fed FD&C Red No. 4 for 2
feeding tests of this color additive have years at levels of 2 percent and 1 per-
demonstrated it to be toxic upon inges- cent of the diet. No effect was found.
tion: (3) Dogs were fed FD&C Red No. 4 at
(1) Groups of 50 rats are being fed levels of 2 percent and 1 percent of the
diets containing FD&C Red No. 1 at diet. Adverse effects were found at both
levels of 5 percent, 2 percent, 1 percent, levels in the urinary bladder and in the
0.5 percent, and 0 percent. At this stage adrenals. Three dogs of five fed on the
of the tests, which have now been in 2-percent level died after 6 months, 9
progress for from 15 months to 18
months, and 51⁄2 years on the test. Two
months, 116 animals from the 250 being
of the dogs on the 2-percent level and
fed FD&C Red No. 1 at various levels
all five of the dogs on the 1-percent
and 27 of the 100 controls have died. Of
level survived to the completion of the
these, 11 being fed at the 5 percent
7 year study.
level, 16 being fed at the 2 percent
level, 11 being fed at the 1 percent The Commissioner of Food and Drugs
level, and 2 being fed at the 0.5 percent has concluded that available data do
level, have shown liver damage. None not permit the establishment of a safe
of the controls that have died have level of use of this color additive in
shown liver damage. food, ingested drugs and ingested cos-
(2) Groups of 100 mice are being fed metics. In order to protect the public
diets containing 2 percent, 1 percent, health, the Commissioner hereby ter-
0.5 percent, and 0.1 percent FD&C Red minates the provisional listing of
No. 1, with 400 mice as controls. All FD&C Red No. 4 for use in food and in-
mice on dosage levels of 2 percent and gested drugs. The Commissioner has
1 percent died before the seventieth previously terminated the provisional
week. Gross liver damage has been ob- listing of FD&C Red No. 4 for use in in-
served in all groups fed at the 0.5 per- gested cosmetics. FD&C Red No. 4 is
cent diet and above. listed for use in externally applied
(3) Groups of 4 dogs are being fed drugs and cosmetics by §§ 74.1304 and
diets containing 2 percent, 1 percent, 74.2304 of this chapter, respectively.
0.25 percent, and 0 percent FD&C Red Section 82.304 of this chapter is re-
No. 1. Three of the dogs on the 2 per- tained in part 82 of this chapter to per-
cent dosage level died before 32 weeks; mit the use of lakes of FD&C Red No.

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§ 81.10 21 CFR Ch. I (4–1–11 Edition)

4 in externally applied drugs and cos- of a subsidiary reaction product that


metics. might be present in the color. 4-
(e) FD&C Violet No. 1. The Commis- Aminobiphenyl and benzidine are
sioner of Food and Drugs, in order to known carcinogens; therefore, there is
protect the public health, hereby ter- no scientific evidence that will support
minates the provisional listing of a safe tolerance for these colors in
FD&C Violet No. 1 for use in foods, drugs or cosmetics. In addition, insuffi-
drugs, and cosmetics. cient data have been submitted to per-
(f) FD&C Red No. 2. The Commis- mit establishment of appropriate speci-
sioner of Food and Drugs, in order to fications for the batch certification of
protect the public health, hereby ter- the color. The Commissioner of Food
minates the provisional listing of and Drugs, in order to protect the pub-
FD&C Red No. 2 for use in food, drugs, lic health, hereby terminates the provi-
and cosmetics. sional listing of Ext. D&C Yellow No. 1
(g) Carbon black (prepared by the ‘‘im- for use in externally applied drugs and
pingement’’ or ‘‘channel’’ process). The cosmetics, effective December 13, 1977.
Commissioner of Food and Drugs, in (j) Graphite. Data have been devel-
order to protect the public health, oped that show the contamination of
hereby terminates the provisional list- graphite with polynuclear aromatic hy-
ing of carbon black (prepared by the drocarbons (PNA’s). There is no reason-
impingement or channel process) for use able assurance this color can be pro-
in food, drugs, and cosmetics. duced so that it will not contain PNA’s
(h) D&C Red Nos. 10, 11, 12, and 13. as an impurity. The presence of certain
The petition for these color additives PNA’s in graphite would indicate that
was withdrawn so that there no longer PNA’s known to be carcinogenic to ani-
exists a basis for their continued provi- mals and humans may also be present.
sional listing. In addition, the Commis- Therefore, there is no scientific evi-
sioner has learned of the possible con- dence that will support a safe tolerance
tamination of D&C Red No. 10, D&C for this color in drugs or cosmetics.
Red No. 11, D&C Red No. 12, and D&C The Commissioner of Food and Drugs,
Red No. 13 with b-naphthyl-amine. The in order to protect the public health,
Commissioner concludes that these hereby terminates the provisional list-
colors cannot be produced with any ing of graphite for use in externally ap-
reasonable assurance that they will not plied cosmetics, effective November 29,
contain b-naphthylamine as an impu- 1977.
rity or not yield b-naphthylamine from (k) Ext. D&C Green No. 1. The Com-
the metabolism of subsidiary colors missioner concludes that there are in-
present in them. b-Naphthylamine is a adequate analytical methods to permit
known carcinogen; therefore, there is certification of the color additive Ext.
no scientific evidence that will support D&C Green No. 1. In addition, the Com-
a safe tolerance for these colors in missioner has found that there was a
drugs or cosmetics. The Commissioner failure to comply with the conditions
of Food and Drugs, upon withdrawal of attached to the postponement of the
the petition for their use and in order closing date in accordance with section
to protect the public health, hereby 203(a)(2) of the transitional provisions
terminates the provisional listing of of the Color Additive Amendments of
D&C Red No. 10, D&C Red No. 11, D&C 1960. The Commissioner of Food and
Red No. 12, and D&C Red No. 13 for use Drugs hereby terminates the provi-
in drugs and cosmetics, effective De- sional listing of Ext. D&C Green No. 1
cember 13, 1977. for use in externally applied drugs and
(i) Ext. D&C Yellow No. 1. The Com- cosmetics, effective November 29, 1977.
missioner has learned of the contami- (l) [Reserved]
nation of Ext. D&C Yellow No. 1 with 4- (m) D&C Orange Nos. 10 and 11. In the
aminobiphenyl. The Commissioner con- absense of a petition to list D&C Or-
cludes that this color cannot be pro- ange No. 10 and D&C Orange No. 11 for
duced with any reasonable assurance use in ingested drugs and cosmetics,
that it will not contain 4- there no longer exists a basis for provi-
aminobiphenyl as an impurity or not sional listing for such uses. Therefore,
yield benzidine from the decomposition FDA is terminating the provisional

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Food and Drug Administration, HHS § 81.30

listing of D&C Orange No. 10 and D&C D&C Red No. 9 for use in mouthwash,
Orange No. 11 for use in ingested drugs dentifrices, and ingested drugs, except
and cosmetics, effective April 28, 1981. ingested drug lip products, effective
(n) D&C Blue No. 6. The Commis- January 6, 1987.
sioner of Food and Drugs, having con- (u) FD&C Red No. 3. Having concluded
cluded that unresolved questions re- that FD&C Red No. 3 causes cancer in
main concerning the chemistry of un- rats, the agency hereby terminates the
identified minor components, hereby provisional listing of FD&C Red No. 3
terminates the provisional listing of for use in cosmetics and externally ap-
D&C Blue No. 6 for use in drugs and plied drugs and the provisional listing
cosmetics. of the lakes of FD&C Red No. 3 for use
(o) D&C Green No. 6. In the absence of in food, drug, and cosmetic products,
a petition to list D&C Green No. 6 for effective January 29, 1990.
use in ingested drugs and cosmetics,
[42 FR 15665, Mar. 22, 1977]
there no longer exists a basis for provi-
sional listing for such uses. Accord- EDITORIAL NOTE: For FEDERAL REGISTER ci-
ingly, the Commissioner of Food and tations affecting § 81.10, see the List of CFR
Drugs hereby terminates the provi- Sections Affected, which appears in the
sional listing of D&C Green No. 6 for Finding Aids section of the printed volume
and at www.fdsys.gov.
use in ingested drugs and cosmetics, ef-
fective March 27, 1981. § 81.30 Cancellation of certificates.
(p) [Reserved]
(q)(1) D&C Red No. 19 and D&C Red (a) Certificates issued heretofore for
No. 37. Having concluded that, when in- colors being removed from the provi-
gested, D&C Red No. 19 causes cancer sional list (§ 81.10(a)) are cancelled and
in rats and mice, the agency hereby of no effect after December 1, 1960, and
terminates the provisional listings of use of such color additives in drugs or
D&C Red No. 19 and chemically related cosmetics after that date will result in
D&C Red No. 37 for use in ingested adulteration.
drugs and ingested cosmetics, effective (b)(1) Certificates issued heretofore
February 4, 1983. for the color additive designated FD&C
(2) D&C Red No. 37. In the absence of Red No. 1 are cancelled as of the date
a petition to list D&C Red No. 37 for of the publication of this Order, and
external uses, there no longer exists a use of this color additive in the manu-
basis for provisional listing for such facture of foods, drugs, or cosmetics
uses. Accordingly, the Commissioner of after that date will result in adultera-
Food and Drugs hereby terminates the tion.
provisional listings of D&C Red No. 37 (2) The Commissioner finds that no
for use in externally applied drugs and action needs to be taken to remove
cosmetics, effective June 6, 1986. foods, drugs, and cosmetics containing
(r) [Reserved] this color additive from the market on
(s) D&C Orange No. 17. Having con- the basis of the scientific evidence be-
cluded that, when ingested, D&C Or- fore him, taking into account that the
ange No. 17 causes cancer in rats and additive is not an acute toxic sub-
mice, the agency has terminated the stance and that it is only used in small
provisional listing of D&C Orange No. amounts in foods, drugs, and cos-
17 for use in ingested drugs and in- metics.
gested cosmetics, effective March 31, (c) Certificates issued for FD&C Red
1983. No. 4 and all mixtures containing this
(t) D&C Red No. 8 and D&C Red No. 9. color additive are cancelled and have
In the absence of a petition to list D&C no effect after September 23, 1976 inso-
Red No. 8 and D&C Red No. 9 for far as food, ingested drugs, and in-
mouthwash, dentifrices, and ingested gested cosmetics are concerned, and
drugs, except ingested drug lip prod- use of this color additive in the manu-
ucts, there no longer exists a basis for facture of food, ingested drugs, and in-
provisional listing for such uses. Ac- gested cosmetics after this date will re-
cordingly, the Commissioner of Food sult in adulteration. The certificates
and Drugs hereby terminates the provi- shall continue in effect for the use of
sional listings of D&C Red No. 8 and FD&C Red No. 4 in externally applied

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§ 81.30 21 CFR Ch. I (4–1–11 Edition)

drugs and cosmetics. The Commis- gested use is concerned. Use of this
sioner finds, on the basis of the sci- color additive in the manufacture of
entific evidence before him that no ac- ingested drugs or cosmetics subject to
tion has to be taken to remove from ingestion after that date will result in
the market food, ingested drugs and in- adulteration.
gested cosmetics containing the color (g) Certificates issued for D&C Red
additive. No. 17, D&C Red No. 31, D&C Red No.
(d) Certificates issued for the fol- 34, D&C Orange No. 4, and D&C Violet
lowing color additives and all mixtures No. 2, and all mixtures containing
containing these color additives are these color additives, are canceled and
canceled and have no effect after Octo- have no effect after December 31, 1968,
ber 4, 1966, and use of such color addi- insofar as ingested use is concerned.
tives in the manufacture of foods, Use of these color additives in the man-
drugs, or cosmetics after that date will ufacture of ingested drugs or cosmetics
result in adulteration: subject to ingestion after that date will
FD&C Green No. 1. result in adulteration.
FD&C Green No. 2. (h)(1) Certificates issued for FD&C
D&C Green No. 7. Violet No. 1 and all mixtures con-
D&C Red No. 5. taining this color additive are canceled
D&C Red No. 14.
and have no effect after April 10, 1973,
D&C Red No. 18.
D&C Red No. 24. and use of such color additive in the
D&C Red No. 29. manufacture of foods, drugs, or cos-
D&C Red No. 35. metics after that date will result in
D&C Red No. 38. adulteration.
D&C Orange No. 3. (2) The Commissioner finds that no
D&C Orange No. 8.
action needs to be taken to remove
D&C Orange No. 14.
D&C Orange No. 15. foods, drugs, and cosmetics containing
D&C Orange No. 16. this color additive from the market on
D&C Blue No. 7. the basis of the scientific evidence be-
D&C Black No. 1. fore him.
Ext. D&C Yellow No. 5. (i) Certificates issued prior to July 1,
Ext. D&C Yellow No. 6.
1968, for D&C Brown No. 1 and Ext.
Ext. D&C Red No. 1.
Ext. D&C Red No. 2. D&C Violet No. 2 and all mixtures con-
Ext. D&C Red No. 3. taining these colors are canceled and
Ext. D&C Red No. 10. have no effect. This cancellation does
Ext. D&C Red No. 11. not apply to certificates issued after
Ext. D&C Red No. 13. March 15, 1973, for D&C Brown No. 1
Ext. D&C Red No. 14. and Ext. D&C Violet No. 2, which are
Ext. D&C Red No. 15.
provisionally listed in § 81.1(b) and (c)
Ext. D&C Blue No. 1.
Ext. D&C Blue No. 4. respectively for coloring externally ap-
Ext. D&C Orange No. 1. plied cosmetics.
Ext. D&C Orange No. 4. (j)(1) Certificates issued for FD&C
Red No. 2 and all mixtures containing
(e) Certificates issued for the fol-
this color additive are canceled and
lowing color additives and all mixtures
have no effect after January 28, 1976,
containing these color additives are
and use of this color additive in the
canceled and have no effect after July
manufacture of food, drugs, or cos-
1, 1968, and use of such color additives
metics after this date will result in
in the manufacture of drugs or cos-
adulteration.
metics after that date will result in
adulteration: (2) The Commissioner finds, on the
basis of the scientific evidence before
Ext. D&C Yellow No. 3. him, that no action has to be taken to
Ext. D&C Red No. 8 remove from the market food, drugs,
Ext. D&C Orange No. 3. and cosmetics containing the color ad-
(f) Certificates issued for D&C Yellow ditive.
No. 11 and all mixtures containing this (k)(1) Certificates issued for D&C Red
color additive are canceled and have no No. 10, D&C Red No. 11, D&C Red No.
effect after April 30, 1968, insofar as in- 12, and D&C Red No. 13, their lakes and

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Food and Drug Administration, HHS § 81.30

all mixtures containing these color ad- concerned and have no effect after De-
ditives or their lakes are cancelled and cember 13, 1977, and use of the color ad-
have no effect after December 13, 1977, ditive in the manufacture of drugs or
and use of these color additivies in the cosmetics after this date will result in
manufacture of drugs or cosmetics adulteration. The color will continue
after this date will result in adultera- to be certified for use in the coloring of
tion. surgical sutures.
(2) The Commissioner finds, on the (2) The Commissioner finds, on the
basis of the scientific evidence before basis of the scientific evidence before
him, that no action has to be taken to him, that no action has to be taken to
remove from the market, drug and cos- remove from the market drugs and cos-
metic products containing the color ad- metics containing the color additive.
ditives.
(p)(1) Certificates issued for D&C
(l)(1) Certificates issued for Ext. D&C
Green No. 6, its lakes and all mixtures
Yellow No. 1 and all mixtures con-
taining this color additive are can- containing this color additive are can-
celled and have no effect after Decem- celled and have no effect as pertains to
ber 13, 1977, and use of this color addi- their use in ingested drugs and cos-
tive in the manufacture of drugs or metics after May 4, 1982 and use of the
cosmetics after this date will result in color additive in the manufacture of
adulteration. ingested drugs or cosmetics after this
(2) The Commissioner finds, on the date will result in adulteration.
basis of the scientific evidence before (2) The agency finds, on the basis of
him, that no action has to be taken to the scientific evidence before it, that
remove from the market drugs and cos- no action has to be taken to remove
metics containing the color additive. from the market ingested drugs and
(m)(1) Certificates issued for Ext. cosmetics containing the color addi-
D&C Green No. 1 and all mixtures con- tive.
taining this color additive are can- (q) [Reserved]
celled and have no effect after Novem- (r)(1) Certificates issued for D&C Red
ber 29, 1977, and use of the color addi- No. 19 and D&C Red No. 37, their lakes,
tive in the manufacture of drugs or and all mixtures containing these color
cosmetics after this date will result in additives are cancelled and have no ef-
adulteration. fect as pertains to their use in ingested
(2) The Commissioner finds, on the drugs and cosmetics after February 4,
basis of the scientific evidence before 1983, and use of these color additives in
him, that no action has to be taken to the manufacture of ingested drugs or
remove from the market drugs and cos- cosmetics after this date will result in
metics containing the color additive.
adulteration.
(n)(1) Certificates issued for D&C Or-
(2) The agency finds, on the scientific
ange No. 10, D&C Orange No. 11, their
lakes, and all mixtures containing evidence before it, that no action has
these color additives are cancelled and to be taken to remove from the market
have no effect as pertains to their use ingested drugs and cosmetics to which
in ingested drugs and cosmetics after D&C Red No. 19 and D&C Red No. 37
April 28, 1981 and use of these color ad- were added on or before February 4,
ditives in the manufacture of ingested 1983, or externally applied drugs and
drugs or cosmetics after this date will cosmetics to which D&C Red No. 37 was
result in adulteration. added on or before June 6, 1986.
(2) The agency finds, on the basis of (3) Certificates issued for D&C Red
the scientific evidence before it, that No. 37, its lakes, and all mixtures con-
no action has to be taken to remove taining this color additive are can-
from the market drugs and cosmetics celled and have no effect as pertains to
to which the color additives were added its use in externally applied drugs and
on or before April 28, 1981. cosmetics after June 6, 1986, and use of
(o)(1) Certificates issued for D&C this color additive in the manufacture
Blue No. 6 and all mixtures containing of externally applied drugs or cos-
this color additive are cancelled inso- metics after this date will result in
far as its use in drugs and cosmetics is adulteration.

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§ 81.30 21 CFR Ch. I (4–1–11 Edition)

(4) Certificates issued for D&C Red containing this color additive are can-
No. 19, its lakes, and all mixtures con- celled and have no effect as pertains to
taining this color additive are can- its use in ingested drugs and ingested
celled and have no effect as pertains to cosmetics after March 31, 1983 and use
its use in externally applied drugs and of this color additive in the manufac-
cosmetics after July 15, 1988, and use of ture of ingested drugs or ingested cos-
this color in the manufacture of exter- metics after this date will result in
nally applied drugs or cosmetics after adulteration.
this date will result in adulteration. (2) The agency finds, on the scientific
(5) The agency finds, on the scientific evidence before it, that no action has
evidence before it, that no action has to be taken to remove from the market
to be taken to remove from the market drugs and cosmetics to which the color
externally applied drugs and cosmetics additive was added on or before March
to which D&C Red No. 19 was added on 31, 1983.
or before July 15, 1988. (3) Certificates issued for D&C Or-
(s)(1) Certificates issued for D&C Red ange No. 17, its lakes and all mixtures
No. 8 and D&C Red No. 9, their lakes, containing this color additive are can-
and all mixtures containing these color celled and have no effect as pertains to
additives are canceled and have no ef- its use in externally applied drugs and
fect as pertains to their use in mouth- cosmetics after July 15, 1988, and use of
wash, dentifrices, and ingested drugs, this color in the manufacture of exter-
except ingested drug lip products, after nally applied drugs or cosmetics after
January 6, 1987, and use of these color this date will result in adulteration.
additives in the manufacture of mouth- (4) The agency finds, on the scientific
wash, dentifrices, and ingested drugs, evidence before it, that no action has
except ingested drug lip products, after to be taken to remove from the market
this date will result in adulteration. externally applied drugs and cosmetics
(2) The agency finds, on the basis of to which D&C Orange No. 17 was added
the scientific evidence before it, that on or before July 15, 1988.
no action has to be taken to remove (u)(1) Certificates issued for FD&C
from the market mouthwash, Red No. 3 and all mixtures containing
dentifrices, and ingested drugs to this color additive are cancelled and
which the color additives were added have no effect as pertains to their use
on or before January 6, 1987. Ingested in cosmetics and externally applied
drug lip products, however, are regu- drugs after January 29, 1990. Certifi-
lated for use in §§ 74.1308 and 74.1309. cates issued for FD&C Red No. 3 lakes
(3) Certificates issued for D&C Red and all mixtures containing these lakes
No. 8, and D&C Red No. 9, their lakes, are cancelled and have no effect as per-
and all mixtures containing these color tains to their use in food, drugs, and
additives are cancelled and have no ef- cosmetics after January 29, 1990. Cer-
fect as pertains to their use in ingested tificates issued for D&C Red No. 3 lakes
drug and cosmetic lip products and in and all mixtures containing those
externally applied drugs and cosmetics lakes are cancelled and have no effect
after July 15, 1988, and use of these as pertains to their use in drugs and
color additives in the manufacture of cosmetics after January 29, 1990. Use of
ingested drugs and cosmetic lip prod- this color additve in the manufacture
ucts and in externally applied drugs of cosmetics and of externally applied
and cosmetics after this date will re- drugs and any use of the lakes of FD&C
sult in adulteration. Red No. 3 (including the lakes of D&C
(4) The agency finds, on the basis of Red No. 3) after this date will result in
the scientific evidence before it, that adulteration.
no action has to be taken to remove (2) The agency finds, on the scientific
from the market ingested drug and cos- evidence before it, that no action must
metic lip products and externally ap- be taken to remove from the market
plied drugs and cosmetics to which the food, drugs, and cosmetics to which the
color additives were added on or before provisionally listed color additive or
July 15, 1988. its lakes were added on or before Janu-
(t)(1) Certificates issued for D&C Or- ary 29, 1990.
ange No. 17, its lakes, and all mixtures [42 FR 15665, Mar. 22, 1977]

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Food and Drug Administration, HHS § 82.5
EDITORIAL NOTE: For FEDERAL REGISTER ci- 82.1336 D&C Red No. 36.
tations affecting § 81.30, see the List of CFR 82.1602 D&C Violet No. 2.
Sections Affected, which appears in the 82.1707 D&C Yellow No. 7.
Finding Aids section of the printed volume 82.1708 D&C Yellow No. 8.
and at www.fdsys.gov. 82.1710 D&C Yellow No. 10.

§ 81.32 Limitation of certificates. Subpart D—Externally Applied Drugs and


Certificates issued for the color addi- Cosmetics
tives listed in § 81.25 and for all mix- 82.2050 General.
tures containing these color additives 82.2051 Lakes (Ext. D&C).
are limited to the conditions stated in 82.2707a Ext. D&C Yellow No. 7.
§ 81.25. The use of these color additives AUTHORITY: 21 U.S.C. 371, 379e, 379e note.
in drugs and cosmetics in any other
SOURCE: 42 FR 15669, Mar. 22, 1977, unless
manner will result in adulteration. otherwise noted.
Each of these color additives shall bear
a label statement of the tolerance and
use limitations applicable to it. Subpart A—General Provisions
[44 FR 48966, Aug. 21, 1979] § 82.3 Definitions.
For the purposes of this part:
PART 82—LISTING OF CERTIFIED (a)–(f) [Reserved]
PROVISIONALLY LISTED COLORS (g) The term alumina means a suspen-
AND SPECIFICATIONS sion in water of precipitated aluminum
hydroxide.
Subpart A—General Provisions (h) The term blanc fixe means a sus-
pension in water of precipitated barium
Sec. sulfate.
82.3 Definitions. (i) The term gloss white means a sus-
82.5 General specifications for straight col-
pension in water of co-precipitated alu-
ors.
82.6 Certifiable mixtures. minum hydroxide and barium sulfate.
(j) The term mixed oxides means the
Subpart B—Foods, Drugs, and Cosmetics sum of the quantities of aluminum,
iron, calcium, and magnesium (in
82.50 General. whatever combination they may exist
82.51 Lakes (FD&C).
in a coal-tar color) calculated as alu-
82.101 FD&C Blue No. 1.
82.102 FD&C Blue No. 2. minum trioxide, ferric oxide, calcium
82.203 FD&C Green No. 3. oxide, and magnesium oxide.
82.304 FD&C Red No. 4. (k)–(m) [Reserved]
82.705 FD&C Yellow No. 5. (n) The term externally applied drugs
82.706 FD&C Yellow No. 6. and cosmetics means drugs and cos-
metics which are applied only to exter-
Subpart C—Drugs and Cosmetics nal parts of the body and not to the
82.1050 General. lips or any body surface covered by mu-
82.1051 Lakes (D&C). cous membrane.
82.1104 D&C Blue No. 4. (o)–(p) [Reserved]
82.1205 D&C Green No. 5. (q) The definitions and interpreta-
82.1206 D&C Green No. 6. tions of terms contained in section 201
82.1254 D&C Orange No. 4.
of the Federal Food, Drug, and Cos-
82.1255 D&C Orange No. 5.
82.1260 D&C Orange No. 10. metic Act shall be applicable also to
82.1261 D&C Orange No. 11. such terms when used in this part.
82.1306 D&C Red No. 6.
82.1307 D&C Red No. 7. § 82.5 General specifications for
82.1317 D&C Red No. 17. straight colors.
82.1321 D&C Red No. 21. No batch of a straight color listed in
82.1322 D&C Red No. 22. subpart B, C, or D shall be certified
82.1327 D&C Red No. 27.
82.1328 D&C Red No. 28.
under this part unless:
82.1330 D&C Red No. 30. (a) It is free from all impurities
82.1331 D&C Red No. 31. (other than those named in paragraph
82.1333 D&C Red No. 33. (b) of this section or in the specifica-
82.1334 D&C Red No. 34. tions set forth in such paragraph for

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§ 82.6 21 CFR Ch. I (4–1–11 Edition)

such color) to the extent that such im- (b) A batch of a mixture which con-
purities can be avoided by good manu- tains no straight color listed in subpart
facturing practice. D, or which contains a diluent not per-
(b) It conforms to the following spec- mitted by paragraph (a)(3) of this sec-
ifications: tion, may be certified in accordance
(1) In the case of a straight color list- with the provisions of this part, for use
ed in subpart B: only in drugs and cosmetics, if:
(i) Lead (as Pb), not more than 0.001 (1) Each coal-tar color used as an in-
percent. gredient in mixing such batch is from a
(ii) Arsenic (as As2O3), not more than previously certified batch and such
0.00014 percent. color has not changed in composition
(iii) Heavy metals (except Pb and As) in any manner whatever since such
(by precipitation as sulfides), not more previous certification, except by mix-
than trace. ing into such batch of mixture.
(2) In the case of a straight color list- (2) Each diluent in such batch of mix-
ed in subpart C or D: ture is harmless and suitable for use
(i) Lead (as Pb), not more than 0.002 therein.
percent. (c) A batch of a mixture which con-
(ii) Arsenic (as As2O3), not more than tains a straight color listed in subpart
0.0002 percent. D may be certified in accordance with
(iii) Heavy metals (except Pb and As) the provisions of this part, for use only
(by precipitation as sulfides), not more in externally applied drugs and cos-
than 0.003 percent. metics, if:
(3) In the case of a straight color (1) Each coal-tar color used as an in-
which contains a barium salt listed in gredient in mixing such batch is from a
subpart C or D—soluble barium (in di- previously certified batch and such
lute HCl) (as BaCl2), not more than 0.05 color has not changed in composition
percent. in any manner whatever since such
previous certification, except by mix-
§ 82.6 Certifiable mixtures.
ing into such batch of mixture; and
(a) A batch of a mixture which con- (2) Each diluent in such batch of mix-
tains no straight color listed in subpart ture is harmless and suitable for use
C or D may be certified for use in food, therein.
drugs and cosmetics, if:
(1) Each coal-tar color used as an in-
gredient in mixing such batch is from a
Subpart B—Foods, Drugs, and
previously certified batch and such Cosmetics
color has not changed in composition § 82.50 General.
in any manner whatever since such
previous certification, except by mix- A batch of a straight color listed in
ing into such batch of mixture; this subpart may be certified, in ac-
(2) Each diluent in such batch of mix- cordance with the provisions of the
ture is harmless and suitable for use regulations in this part, for use in food,
therein; and drugs, and cosmetics, if such batch
(3) No diluent (except resins, natural conforms to the requirements of § 82.5
gum, pectin and, in the case of mix- and to the specifications in this sub-
tures which are aqueous solutions or part set forth for such color.
aqueous pastes, sodium benzoate in a
quantity of not more than 1⁄10 of 1 per- § 82.51 Lakes (FD&C).
cent) in such mixture is a nonnutritive (a)(1) General. Any lake made by ex-
substance, unless such mixture is for tending on a substratum of alumina, a
external application to shell eggs, or salt prepared from one of the certified
for use in coloring a food specified in water-soluble straight colors herein-
the requests for certification of such before listed in this subpart by com-
batch submitted in accordance with bining such color with the basic radical
§ 80.21 of this chapter, and such diluent, aluminum or calcium.
in the usual process of manufacturing (2) Specifications. Prepared from pre-
such food, is removed and does not be- viously certified colors listed in this
come a component of such food. subpart.

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Food and Drug Administration, HHS § 82.1051
Soluble chlorides and sulfates (as sodium § 82.706 FD&C Yellow No. 6.
salts), not more than 2.0 percent.
Inorganic matter, insoluble HCl, not more (a) The color additive FD&C Yellow
than 0.5 percent. No. 6 shall conform in identity and
specifications to the requirements of
(b) Each lake made as prescribed in § 74.706 (a)(1) and (b) of this chapter.
paragraph (a) of this section shall be (b) All lakes including current D&C
considered to be a straight color and to external and D&C lakes of FD&C Yel-
be listed therein under the name which low No. 6 shall be manufactured from
is formed as follows: previously certified batches of the
(1) The listed name of the color from straight color additive.
which the lake is prepared; [52 FR 21509, June 8, 1987]
(2) The name of the basic radical
combined in such color; and
Subpart C—Drugs and Cosmetics
(3) The word ‘‘Lake’’.
(For example, the name of a lake pre- § 82.1050 General.
pared by extending the aluminum salt A batch of a straight color listed in
prepared from FD&C Blue No. 1 upon this subpart may be certified, in ac-
the substratum would be FD&C Blue cordance with the provisions of this
No. 1—Aluminum Lake.) part, for use only in drugs and cos-
metics, if such batch conforms to the
§ 82.101 FD&C Blue No. 1. requirements of § 82.5 and to the speci-
The color additive FD&C Blue No. 1 fications set forth in this subpart for
shall conform in identity and specifica- such color.
tions to the requirements of § 82.1051 Lakes (D&C).
§ 74.101(a)(1) and (b) of this chapter.
(a)(1) General. Any lake, other than
§ 82.102 FD&C Blue No. 2. those listed in subpart B, made by ex-
tending on a substratum of alumina,
The color additive FD&C Blue No. 2 blanc fixe, gloss white, clay, titanium
shall conform in identity and specifica- dioxide, zinc oxide, talc, rosin, alu-
tions to the requirements of minum benzoate, calcium carbonate, or
§ 74.102(a)(1) and (b) of this chapter. any combination of two or more of
[48 FR 5261, Feb. 4, 1983] these, (i) one of the straight colors (ex-
cept lakes) listed in subpart B or here-
§ 82.203 FD&C Green No. 3. inbefore listed in this subpart, which
color is a salt in which is combined the
The color additive FD&C Green No. 3 basic radical sodium, potassium, alu-
shall conform in identity and specifica- minum, barium, calcium, strontium, or
tions to the requirements of zirconium; or (ii) a salt prepared from
§ 74.203(a)(1) and (b) of this chapter. one of the straight colors (except
[47 FR 52144, Nov. 19, 1982] lakes) listed in subpart B, or herein-
before listed in this subpart, by com-
§ 82.304 FD&C Red No. 4. bining such color with the basic radical
sodium, potassium, aluminum, barium,
The color additive FD&C Red No. 4
calcium, strontium, or zirconium.
shall conform in identity and specifica-
(2) Specifications.
tions to the requirements of
§ 74.1304(a)(1) and (b) of this chapter. Ether extracts, not more than 0.5 percent.
FD&C Red No. 4 is restricted to use in Soluble chlorides and sulfates (as sodium
salts), not more than 3.0 percent.
externally applied drugs and cosmetics.
Intermediates, not more than 0.2 percent.
§ 82.705 FD&C Yellow No. 5. (b) Each lake made as prescribed in
The color additive FD&C Yellow No. paragraph (a) of this section shall be
5 shall conform in identity and speci- considered to be a straight color and to
fications to the requirements of § 74.705 be listed therein under the name which
is formed as follows:
(a)(1) and (b) of this chapter.
(1) The listed name of the color from
[51 FR 24519, July 7, 1986] which the lake is prepared, except that

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§ 82.1104 21 CFR Ch. I (4–1–11 Edition)

if such name contains the symbol (b) The color additive D&C Orange
‘‘FD&C’’ such symbol shall be changed No. 5. may be safely used for coloring
to ‘‘D&C’’; externally applied drugs in amounts
(2) The name of the basic radical not exceeding 5 milligrams per daily
combined in such color; and dose of the drug. The color additive
(3) The word ‘‘Lake.’’ D&C Orange No. 5 may be safely used
(For example, the name of a lake pre- for coloring lipsticks and other cos-
pared by extending the color D&C Red metics intended to be applied to the
No. 9 upon a substratum is ‘‘D&C Red lips in amounts not exceeding 5.0 per-
No. 9—Barium Lake’’, and a lake pre- cent by weight of the finished cosmetic
pared by extending the aluminum salt products, and for coloring
prepared from FD&C Green No. 1 upon mouthwashes, dentifrices, and exter-
a substratum other than alumina is nally applied cosmetics in amounts
‘‘D&C Green No. 1—Aluminum Lake’’.) consistent with current good manufac-
turing practice.
§ 82.1104 D&C Blue No. 4. [49 FR 13343, Apr. 4, 1984]
The color additive D&C Blue No. 4
shall conform in identity and specifica- § 82.1260 D&C Orange No. 10.
tions to the requirements of The color additive D&C Orange No. 10
§ 74.1104(a)(1) and (b) of this chapter. shall conform in identity and specifica-
D&C Blue No. 4 is restricted to use in tions to the requirements to
externally applied drugs and cosmetics. § 74.1260(a)(1) and (b) of this chapter.
D&C Orange No. 10 is restricted to use
§ 82.1205 D&C Green No. 5. in externally applied drugs and cos-
The color additive D&C Green No. 5 metics.
shall conform in identity and specifica-
[46 FR 18954, Mar. 27, 1981]
tions to the requirements of
§ 74.1205(a)(1) and (b)(2) of this chapter. § 82.1261 D&C Orange No. 11.
[47 FR 24285, June 4, 1982] The color additive D&C Orange No. 11
shall conform in identity and specifica-
§ 82.1206 D&C Green No. 6. tions to the requirements of
The color additive D&C Green No. 6 § 74.1261(a)(1) and (b) of this chapter.
shall conform in identity and specifica- D&C Orange No. 11 is restricted to use
tions to the requirements of § 74.1206 (a) in externally applied drugs and cos-
and (b) of this chapter. D&C Green No. metics.
6 is restricted to use in externally ap- [46 FR 18954, Mar. 27, 1981]
plied drugs and cosmetics.
[47 FR 14147, Apr. 2, 1982, as amended at 51 § 82.1306 D&C Red No. 6.
FR 9785, Mar. 21, 1986] (a) The color additive D&C Red No. 6
shall conform in identity and specifica-
§ 82.1254 D&C Orange No. 4. tions to the requirements of § 74.1306
The color additive D&C Orange No. 4 (a)(1) and (b) of this chapter.
shall conform in identity and specifica- (b) The color additive D&C Red No. 6
tions to the requirements of may be safely used for coloring drugs
§ 74.1254(a)(1) and (b) of this chapter. such that the combined total of D&C
D&C Orange No. 4 is restricted to use Red No. 6 and D&C Red No. 7 does not
in externally applied drugs and cos- exceed 5 milligrams per daily dose of
metics. the drug.
[42 FR 52396, Sept. 30, 1977] [47 FR 57691, Dec. 28, 1982]

§ 82.1255 D&C Orange No. 5. § 82.1307 D&C Red No. 7.


(a) The color additive D&C Orange (a) The color additive D&C Red No. 7
No. 5 shall conform in identity and shall conform in identity and specifica-
specifications to the requirements of tions to the requirements of § 74.1307
§ 74.1255(a)(1) and (b) of this chapter. (a)(1) and (b) of this chapter.
D&C Orange No. 5 is restricted to the (b) The color additive D&C Red No. 7
uses described in this section. may be safely used for coloring drugs

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Food and Drug Administration, HHS § 82.1708

such that the combined total of D&C § 82.1333 D&C Red No. 33.
Red No. 6 and D&C Red No. 7 does not
(a) The color additive D&C Red. No.
exceed 5 milligrams per daily dose of
33 shall conform in identity and speci-
the drug.
fications to the requirements of
[47 FR 57691, Dec. 28, 1982] § 74.1333(a) (1) and (b) of this chapter.
(b) All lakes of D&C Red. No. 33 shall
§ 82.1317 D&C Red No. 17. be manufactured from previously cer-
The color additive D&C Red No. 17 tified batches of the straight color ad-
shall conform in identity and specifica- ditive.
tions to the requirements of § 74.1317 [53 FR 33121, Aug. 30, 1988]
(a)(1) and (b) of this chapter. D&C Red
No. 17 is restricted to use in externally § 82.1334 D&C Red No. 34.
applied drugs and cosmetics.
Calcium salt of 3-hydroxy-4-[(1-sulfo-
§ 82.1321 D&C Red No. 21. 2 -naphthalenyl)azol-2-
naphthalenecarboxylic acid.
The color additive D&C Red No. 21
shall conform in identity and specifica- Sum of volatile matter (at 135 °C) and
tions to the requirements of § 74.1321 chlorides and sulfates (calculated as so-
(a)(1) and (b) of this chapter. dium salts), not more than 15 percent.
2-Amino-1-naphthalenesulfonic acid, calcium
[47 FR 53847, Nov. 30, 1982] salt, not more than 0.2 percent.
3-Hydroxy-2-naphthoic acid, not more than
§ 82.1322 D&C Red No. 22. 0.4 percent.
The color additive D&C Red No. 22 Subsidiary colors, not more than 4 percent.
shall conform in identity and specifica- Total color not less than 85 percent.
tions to the requirements of § 74.1322
(a)(1) and (b) of this chapter. § 82.1336 D&C Red No. 36.
[47 FR 53847, Nov. 30, 1982] (a) The color additive D&C Red No. 36
shall conform in identity and specifica-
§ 82.1327 D&C Red No. 27. tions to the requirements of § 74.1336
The color additive D&C Red No. 27 (a)(1) and (b) of this chapter.
shall conform in identity and specifica- (b) All lakes of D&C Red No. 36 shall
tions to the requirements of § 74.1327 be manufactured from previously cer-
(a)(1) and (b) of this chapter. tified batches of the straight color ad-
ditive.
[47 FR 42568, Sept. 28, 1982]
[53 FR 29031, Aug. 2, 1988]
§ 82.1328 D&C Red No. 28.
§ 82.1602 D&C Violet No. 2.
The color additive D&C Red No. 28
shall conform in identity and specifica- The color additive D&C Violet No. 2
tions to the requirements of § 74.1328 shall conform in identity and specifica-
(a)(1) and (b) of this chapter. tions to the requirements of
§ 74.1602(a)(1) and (b) of this chapter.
[47 FR 42568, Sept. 28, 1982]
§ 82.1707 D&C Yellow No. 7.
§ 82.1330 D&C Red No. 30.
The color additive D&C Yellow No. 7
The color additive D&C Red No. 30 shall conform in identity and specifica-
shall conform in identity and specifica- tions to the requirements of
tions to the requirements of § 74.1330 § 74.1707(a)(1) and (b) of this chapter.
(a)(1) and (b) of this chapter. D&C Yellow No. 7 is restricted to use in
[47 FR 22511, May 25, 1982] externally applied drugs and cosmetics.

§ 82.1331 D&C Red No. 31. § 82.1708 D&C Yellow No. 8.


The color additive D&C Red No. 31 The color additive D&C Yellow No. 8
shall conform in identity and specifica- shall conform in identity and specifica-
tions to the requirements of tions to the requirements of
§ 74.1331(a)(1) and (b) of this chapter. § 74.1707(a)(1) and (b) of this chapter.
D&C Red No. 31 is restricted to use in D&C Yellow No. 8 is restricted to use in
externally applied drugs and cosmetics. externally applied drugs and cosmetics.

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§ 82.1710 21 CFR Ch. I (4–1–11 Edition)

§ 82.1710 D&C Yellow No. 10. pared by extending the barium salt pre-
pared from Ext. D&C Red No. 2 upon
The color additive D&C Yellow No. 10
the substratum is ‘‘Ext. D&C Red No.
shall conform in identity and specifica-
2—Barium Lake.’’)
tions to the requirements of
§ 74.1710(a)(1) and (b) of this chapter. § 82.2707a Ext. D&C Yellow No. 7.
[48 FR 39220, Aug. 30, 1983] The color additive Ext. D&C Yellow
No. 7 shall conform in identity with
Subpart D—Externally Applied specifications to the requirements of
Drugs and Cosmetics § 74.1707a(a)(1) and (b) of this chapter.
Ext. D&C Yellow No. 7 is restricted to
§ 82.2050 General. use in externally applied drugs and cos-
A batch of a straight color listed in metics.
this subpart may be certified, in ac-
cordance with the provisions of this PARTS 83–98 [RESERVED]
part, for use in externally applied
drugs and cosmetics, if such batch con- PART 99—DISSEMINATION OF IN-
forms to the requirements of § 82.5 and FORMATION ON UNAPPROVED/
to the specifications set forth in this
subpart for such color.
NEW USES FOR MARKETED
DRUGS, BIOLOGICS, AND DE-
§ 82.2051 Lakes (Ext. D&C). VICES
(a)(1) General. Any lake made by ex-
tending on a substratum of alumina, Subpart A—General Information
blanc fixe, gloss white, clay, titanium Sec.
dioxide, zinc oxide, talc, rosin, alu- 99.1 Scope.
minum benzoate, calcium carbonate, or 99.3 Definitions.
on any combination of two or more of
these (i) one of the straight colors Subpart B—Information To Be Disseminated
hereinbefore listed in this subpart, 99.101 Information that may be dissemi-
which color is a salt in which is com- nated.
bined the basic radical sodium, potas- 99.103 Mandatory statements and informa-
sium, barium, or calcium; or (ii) a salt tion.
prepared from one of the straight col- 99.105 Recipients of information.
ors hereinbefore listed in this subpart
by combining such color with the basic Subpart C—Manufacturer’s Submissions,
radical sodium, potassium, aluminum, Requests, and Applications
barium, calcium, strontium, or zir- 99.201 Manufacturer’s submission to the
conium. agency.
(2) Specifications. 99.203 Request to extend the time for com-
pleting planned studies.
Ether extracts, not more than 0.5 percent.
99.205 Application for exemption from the
Soluble chlorides and sulfates (as sodium
requirement to file a supplemental appli-
salts), not more than 3.0 percent.
cation.
Intermediates, not more than 0.2 percent.
(b) Each lake made as prescribed in Subpart D—FDA Action on Submissions,
paragraph (a) of this section shall be Requests, and Applications
considered to be a straight color and to 99.301 Agency action on a submission.
be listed therein under the name which 99.303 Extension of time for completing
is formed as follows: planned studies.
(1) The listed name of the color from 99.305 Exemption from the requirement to
which the lake is prepared; file a supplemental application.
(2) The name of the basic radical
combined in such color; and Subpart E—Corrective Actions and
(3) The word ‘‘Lake.’’ (For example, Cessation of Dissemination
the name of a lake prepared by extend- 99.401 Corrective actions and cessation of
ing the color Ext. D&C Yellow No. 2 dissemination of information.
upon a substratum is ‘‘Ext. D&C Yellow 99.403 Termination of approvals of applica-
No. 2—Calcium Lake,’’ and a lake pre- tions for exemption.

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Food and Drug Administration, HHS § 99.3
99.405 Applicability of labeling, adultera- (1) Amounts paid for the diagnosis,
tion, and misbranding authority. cure, mitigation, treatment, or preven-
tion of disease, or amounts paid for the
Subpart F—Recordkeeping and Reports
purpose of affecting any structure or
99.501 Recordkeeping and reports. function of the body;
AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 355, (2) Amounts paid for transportation
360, 360c, 360e, 360aa–360aaa–6, 371, and 374; 42 primarily for and essential to medical
U.S.C. 262. care referred to in paragraph (c)(1) of
SOURCE: 63 FR 64581, Nov. 20, 1998, unless this section; and
otherwise noted. (3) Amounts paid for insurance cov-
ering medical care referred to in para-
Subpart A—General Information graphs (c)(1) and (c)(2) of this section.
(d) Health care practitioner means a
§ 99.1 Scope. physician or other individual who is a
(a) This part applies to the dissemi- health care provider and licensed under
nation of information on human drugs, State law to prescribe drugs or devices.
including biologics, and devices where (e) Health insurance issuer means an
the information to be disseminated: insurance company, insurance service,
(1) Concerns the safety, effectiveness, or insurance organization (including a
or benefit of a use that is not included health maintenance organization, as
in the approved labeling for a drug or defined in paragraph (e)(2) of this sec-
device approved by the Food and Drug tion) which is licensed to engage in the
Administration for marketing or in the business of insurance in a State and
statement of intended use for a device which is subject to State law which
cleared by the Food and Drug Adminis- regulates insurance (within the mean-
tration for marketing; and ing of section 514(b)(2) of the Employee
(2) Will be disseminated to a health Retirement Income Security Act of
care practitioner, pharmacy benefit 1974 (29 U.S.C. 1144(b)(2))).
manager, health insurance issuer, (1) Such term does not include a
group health plan, or Federal or State group health plan.
Government agency. (2) For purposes of this part, the
(b) This part does not apply to a term health maintenance organization
manufacturer’s dissemination of infor- means:
mation that responds to a health care (i) A Federally qualified health main-
practitioner’s unsolicited request. tenance organization (as defined in sec-
§ 99.3 Definitions. tion 1301(a) of the Public Health Serv-
ice Act (42 U.S.C. 300e(a)));
(a) Agency or FDA means the Food (ii) An organization recognized under
and Drug Administration. State law as a health maintenance or-
(b) For purposes of this part, a clin- ganization; or
ical investigation is an investigation in
(iii) A similar organization regulated
humans that tests a specific clinical
under State law for solvency in the
hypothesis.
same manner and to the same extent as
(c) Group health plan means an em-
ployee welfare benefit plan (as defined such a health maintenance organiza-
in section 3(1) of the Employee Retire- tion.
ment Income Security Act of 1974 (29 (f) Manufacturer means a person who
U.S.C. 1002(1))) to the extent that the manufactures a drug or device or who
plan provides medical care (as defined is licensed by such person to distribute
in paragraphs (c)(1) through (c)(3) of or market the drug or device. For pur-
this section and including items and poses of this part, the term may also
services paid for as medical care) to include the sponsor of the approved, li-
employees or their dependents (as de- censed, or cleared drug or device.
fined under the terms of the plan) di- (g) New use means a use that is not
rectly or through insurance, reim- included in the approved labeling of an
bursement, or otherwise. For purposes approved drug or device, or a use that
of this part, the term medical care is not included in the statement of in-
means: tended use for a cleared device.

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§ 99.101 21 CFR Ch. I (4–1–11 Edition)

(h) Pharmacy benefit manager means a (k) Supplemental application means:


person or entity that has, as its prin- (1) For drugs, a supplement to sup-
cipal focus, the implementation of one port a new use to an approved new drug
or more device and/or prescription drug application;
benefit programs. (2) For biologics, a supplement to an
(i) A reference publication is a publica- approved license application;
tion that: (3) For devices that are the subject of
(1) Has not been written, edited, ex- a cleared 510(k) submission and devices
cerpted, or published specifically for, that are exempt from the 510(k) proc-
or at the request of, a drug or device ess, a new 510(k) submission to support
manufacturer; a new use or, for devices that are the
(2) Has not been edited or signifi- subject of an approved premarket ap-
cantly influenced by such a manufac- proval application, a supplement to
turer; support a new use to an approved pre-
(3) Is not solely distributed through market approval application.
such a manufacturer, but is generally
available in bookstores or other dis-
tribution channels where medical text-
Subpart B—Information To Be
books are sold; Disseminated
(4) Does not focus on any particular § 99.101 Information that may be dis-
drug or device of a manufacturer that seminated.
disseminates information under this
part and does not have a primary focus (a) A manufacturer may disseminate
on new uses of drugs or devices that written information concerning the
are marketed or are under investiga- safety, effectiveness, or benefit of a use
tion by a manufacturer supporting the not described in the approved labeling
dissemination of information; and for an approved drug or device or in the
(5) Does not present materials that statement of intended use for a cleared
are false or misleading. device, provided that the manufacturer
(j) Scientific or medical journal means complies with all other relevant re-
a scientific or medical publication: quirements under this part. Such infor-
(1) That is published by an organiza- mation shall:
tion that has an editorial board, that (1) Be about a drug or device that has
uses experts who have demonstrated been approved, licensed, or cleared for
expertise in the subject of an article marketing by FDA;
under review by the organization and (2) Be in the form of:
who are independent of the organiza- (i) An unabridged reprint or copy of
tion, to review and objectively select, an article, peer-reviewed by experts
reject, or provide comments about pro- qualified by scientific training or expe-
posed articles, and that has a publicly rience to evaluate the safety or effec-
stated policy, to which the organiza- tiveness of the drug or device involved,
tion adheres, of full disclosure of any which was published in a scientific or
conflict of interest or biases for all au- medical journal. In addition, the arti-
thors or contributors involved with the cle must be about a clinical investiga-
journal or organization; tion with respect to the drug or device
(2) Whose articles are peer-reviewed and must be considered to be scientif-
and published in accordance with the ically sound by the experts described in
regular peer-review procedures of the this paragraph; or
organization; (ii) An unabridged reference publica-
(3) That is generally recognized to be tion that includes information about a
of national scope and reputation; clinical investigation with respect to
(4) That is indexed in the Index the drug or device, which experts quali-
Medicus of the National Library of fied by scientific training or experience
Medicine of the National Institutes of to evaluate the safety or effectiveness
Health; and of the drug or device that is the subject
(5) That is not in the form of a spe- of the clinical investigation would con-
cial supplement that has been funded sider to be scientifically sound;
in whole or in part by one or more (3) Not pose a significant risk to the
manufacturers. public health;

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Food and Drug Administration, HHS § 99.103

(4) Not be false or misleading. FDA (i) For a drug, ‘‘This information con-
may consider information dissemi- cerns a use that has not been approved
nated under this part to be false or by the Food and Drug Administration.’’
misleading if, among other things, the For devices, the statement shall read,
information includes only favorable ‘‘This information concerns a use that
publications when unfavorable publica- has not been approved or cleared by the
tions exist or excludes articles, ref- Food and Drug Administration.’’ If the
erence publications, or other informa- information to be disseminated in-
tion required under § 99.103(a)(4) or the cludes both an approved and unap-
information presents conclusions that proved use or uses or a cleared and
clearly cannot be supported by the re- uncleared use or uses, the manufac-
sults of the study; and turer shall modify the statement to
(5) Not be derived from clinical re- identify the unapproved or uncleared
search conducted by another manufac- new use or uses. The manufacturer
turer unless the manufacturer dissemi- shall permanently affix the statement
nating the information has the permis- to the front of each reprint or copy of
sion of such other manufacturer to an article from a scientific or medical
make the dissemination. journal and to the front of each ref-
(b) For purposes of this part: erence publication disseminated under
(1) FDA will find that all journal ar- this part;
ticles and reference publications (as (ii) If applicable, the information is
those terms are defined in § 99.3) are being disseminated at the expense of
scientifically sound except: the manufacturer;
(i) Letters to the editor; (iii) If applicable, the names of any
(ii) Abstracts of a publication; authors of the information who were
(iii) Those regarding Phase 1 trials in employees of, or consultants to, or re-
healthy people; ceived compensation from the manu-
(iv) Flagged reference publications facturer, or who had a significant fi-
that contain little or no substantive nancial interest in the manufacturer
discussion of the relevant clinical in- during the time that the study that is
vestigation; and the subject of the dissemination was
(v) Those regarding observations in conducted up through 1 year after the
four or fewer people that do not reflect time the article/reference publication
any systematic attempt to collect was written and published;
data, unless the manufacturer dem- (iv) If applicable, a statement that
onstrates to FDA that such reports there are products or treatments that
could help guide a physician in his/her have been approved or cleared for the
medical practice. use that is the subject of the informa-
(2) A reprint or copy of an article or tion being disseminated; and
reference publication is ‘‘unabridged’’ (v) The identification of any person
only if it retains the same appearance, that has provided funding for the con-
form, format, content, or configuration duct of a study relating to the new use
as the original article or publication. of a drug or device for which such in-
Such reprint, copy of an article, or ref- formation is being disseminated; and
erence publication shall not be dis- (2) The official labeling for the drug
seminated with any information that is or device;
promotional in nature. A manufacturer (3) A bibliography of other articles
may cite a particular discussion about (that concern reports of clinical inves-
a new use in a reference publication in tigations both supporting and not sup-
the explanatory or other information porting the new use) from a scientific
attached to or otherwise accompanying reference publication or scientific or
the reference publication under § 99.103. medical journal that have been pre-
viously published about the new use of
§ 99.103 Mandatory statements and in- the drug or device covered by the infor-
formation. mation that is being disseminated, un-
(a) Any information disseminated less the disseminated information al-
under this part shall include: ready includes such a bibliography; and
(1) A prominently displayed state- (4) Any additional information re-
ment disclosing: quired by FDA under § 99.301(a)(2). Such

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§ 99.105 21 CFR Ch. I (4–1–11 Edition)

information shall be attached to the Subpart C—Manufacturer’s Sub-


front of the disseminated information missions, Requests, and Appli-
or, if attached to the back of the dis- cations
seminated information, its presence
shall be made known to the reader by § 99.201 Manufacturer’s submission to
a sticker or notation on the front of the agency.
the disseminated information and may (a) Sixty days before disseminating
consist of: any written information concerning
(i) Objective and scientifically sound the safety, effectiveness, or benefit of a
information pertaining to the safety or new use for a drug or device, a manu-
effectiveness of the new use of the drug facturer shall submit to the agency:
or device and which FDA determines is (1) An identical copy of the informa-
necessary to provide objectivity and tion to be disseminated, including any
balance. This may include information information (e.g., the bibliography) and
that the manufacturer has submitted statements required under § 99.103;
to FDA or, where appropriate, a sum- (2) Any other clinical trial informa-
mary of such information and any tion which the manufacturer has relat-
other information that can be made ing to the effectiveness of the new use,
publicly available; and any other clinical trial information
(ii) An objective statement prepared that the manufacturer has relating to
by FDA, based on data or other sci- the safety of the new use, any reports
entifically sound information, bearing of clinical experience pertinent to the
on the safety or effectiveness of the safety of the new use, and a summary
new use of the drug or device. of such information. For purposes of
(b) Except as provided in paragraphs this part, clinical trial information in-
cludes, but is not limited to, published
(a)(1)(i) and (a)(4) of this section, the
papers and abstracts, even if not in-
statements, bibliography, and other in-
tended for dissemination, and unpub-
formation required by this section lished manuscripts, abstracts, and data
shall be attached to such disseminated analyses from completed or ongoing in-
information. vestigations. The reports of clinical ex-
(c) For purposes of this section, fac- perience required under this paragraph
tors to be considered in determining shall include case studies, retrospec-
whether a statement is ‘‘prominently tive reviews, epidemiological studies,
displayed’’ may include, but are not adverse event reports, and any other
limited to, type size, font, layout, con- material concerning adverse effects or
trast, graphic design, headlines, spac- risks reported for or associated with
ing, and any other technique to achieve the new use. If the manufacturer has
emphasis or notice. The required state- no knowledge of clinical trial informa-
ments shall be outlined, boxed, high- tion relating to the safety or effective-
lighted, or otherwise graphically de- ness of the new use or reports of clin-
signed and presented in a manner that ical experience pertaining to the safety
achieves emphasis or notice and is dis- of the new use, the manufacturer shall
tinct from the other information being provide a statement to that effect;
disseminated. (3) An explanation of the manufac-
turer’s method of selecting the articles
§ 99.105 Recipients of information. for the bibliography (e.g., the data-
bases or sources and criteria (i.e., sub-
A manufacturer disseminating infor-
ject headings/keywords) used to gen-
mation on a new use under this part erate the bibliography and the time pe-
may only disseminate that information riod covered by the bibliography); and
to a health care practitioner, a phar- (4) If the manufacturer has not sub-
macy benefit manager, a health insur- mitted a supplemental application for
ance issuer, a group health plan, or a the new use, one of the following:
Federal or State Government agency. (i) If the manufacturer has completed
studies needed for the submission of a
supplemental application for the new
use:

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Food and Drug Administration, HHS § 99.201

(A) A copy of the protocol for each an extension granted under § 99.303(a)];’’
completed study or, if such protocol or
was submitted to an investigational (iii) An application for exemption
new drug application or an investiga- from the requirement of a supple-
tional device exemption, the number(s) mental application; or
for the investigational new drug appli- (5) If the manufacturer has submitted
cation or investigational device exemp- a supplemental application for the new
tion covering the new use, the date of use, a cross-reference to that supple-
submission of the protocol(s), the pro- mental application.
tocol number(s), and the date of any (b) The manufacturer’s attorney,
amendments to the protocol(s); and agent, or other authorized official shall
(B) A certification stating that, ‘‘On sign the submission and certification
behalf of [insert manufacturer’s name], statement or application for exemp-
I certify that [insert manufacturer’s tion. If the manufacturer does not have
name] has completed the studies need- a place of business in the United
ed for the submission of a supplemental States, the submission and certifi-
application for [insert new use] and cation statement or application for ex-
will submit a supplemental application emption shall contain the signature,
for such new use to the Food and Drug name, and address of the manufactur-
Administration no later than [insert er’s attorney, agent, or other author-
date no later than 6 months from date ized official who resides or maintains a
that dissemination of information place of business in the United States.
under this part can begin]’’; or (c) The manufacturer shall send three
copies of the submission and certifi-
(ii) If the manufacturer has planned
cation statement or application for ex-
studies that will be needed for the sub-
emption to FDA. The outside of the
mission of a supplemental application
shipping container shall be marked as
for the new use:
‘‘Submission for the Dissemination of
(A) The proposed protocols and Information on an Unapproved/New
schedule for conducting the studies Use.’’ The manufacturer shall send the
needed for the submission of a supple- submission and certification statement
mental application for the new use. or application for exemption to the ap-
The protocols shall comply with all ap- propriate FDA component listed in
plicable requirements in parts 312 of paragraphs (c)(1) through (c)(3) of this
this chapter (investigational new drug section.
applications) and 812 of this chapter (1) For biological products and de-
(investigational device exemptions). vices regulated by the Center for Bio-
The schedule shall include the pro- logics Evaluation and Research, the
jected dates on which the manufac- Advertising and Promotional Labeling
turer expects the principal study Staff (HFM–602), Center for Biologics
events to occur (e.g., initiation and Evaluation and Research, Food and
completion of patient enrollment, com- Drug Administration, 1401 Rockville
pletion of data collection, completion Pike, suite 200N, Rockville, MD 20852–
of data analysis, and submission of the 1448;
supplemental application); and (2) For human drug products, biologi-
(B) A certification stating that, ‘‘On cal products, and devices regulated by
behalf of [insert manufacturer’s name], the Center for Drug Evaluation and Re-
I certify that [insert manufacturer’s search, the Division of Drug Mar-
name] will exercise due diligence to keting, Advertising, and Communica-
complete the clinical studies necessary tions (HFD–42), Center for Drug Eval-
to submit a supplemental application uation and Research, Food and Drug
for [insert new use] and will submit a Administration, 5600 Fishers Lane,
supplemental application for such new Rockville, MD 20857; or
use to the Food and Drug Administra- (3) For medical devices, the Pro-
tion no later than [insert date no later motion and Advertising Policy Staff
than 36 months from date that dissemi- (HFZ–302), Office of Compliance, Center
nation of information under this part for Devices and Radiological Health,
can begin or no later than such time Food and Drug Administration, 2098
period as FDA may specify pursuant to Gaither Rd., Rockville, MD 20850.

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§ 99.203 21 CFR Ch. I (4–1–11 Edition)

(d) The 60-day period shall begin tion of Information on an Unapproved


when FDA receives a manufacturer’s Use.’’
submission, including, where applica-
ble, a certification statement or an ap- § 99.205 Application for exemption
plication for an exemption. from the requirement to file a sup-
plemental application.
[63 FR 64581, Nov. 20, 1998, as amended at 70
FR 14980, Mar. 24, 2005] (a) In certain circumstances, de-
scribed in paragraph (b) of this section,
§ 99.203 Request to extend the time for a manufacturer may submit an applica-
completing planned studies. tion for an exemption from the require-
(a) A manufacturer may request, ment to submit a supplemental appli-
prior to or at the time of making a sub- cation for a new use for purposes of dis-
mission to FDA under § 99.201, that seminating information on that use.
FDA extend the 36-month time period (b) The manufacturer’s application
for completing the studies and submit- for an exemption shall identify the
ting a supplemental application for the basis for the proposed exemption and
new use that is the subject of the infor- shall include materials demonstrating
mation to be disseminated. Such re- that it would be economically prohibi-
quest must set forth the reasons that tive or that it would be unethical to
such studies cannot be completed and conduct the studies necessary to sub-
submitted in a supplemental applica- mit a supplemental application for the
tion within 36 months. new use.
(b) A manufacturer who has certified (1) If the basis for the manufacturer’s
that it will complete the studies nec- application for exemption is that it
essary to submit a supplemental appli- would be economically prohibitive to
cation for a new use within a specified incur the costs necessary to submit a
period of time from the date that dis- supplemental application for a new use,
semination of information under this the manufacturer shall, at a minimum,
part can begin under § 99.201(a)(4)(ii), provide:
but later finds that it will be unable to
(i) Evidence explaining why existing
complete such studies and submit a
data characterizing the safety and ef-
supplemental application within that
fectiveness of the drug or device, in-
time period may request an extension
cluding data from the study described
of time from FDA. The manufacturer,
in the information to be disseminated,
in its request for extension, shall iden-
are not adequate to support the sub-
tify the product, the new use, and
shall: mission of a supplemental application
(1) Describe the study or studies that for the new use. Such evidence shall in-
cannot be completed on time and ex- clude an analysis of all data relevant
plain why the study or studies cannot to the safety and effectiveness of the
be completed on time; use, a summary of those data, and any
(2) Describe the current status of the documentation resulting from prior
incomplete study or studies and sum- discussions with the agency concerning
marize the work conducted, including the adequacy of the existing data; and
the dates on which principal events (ii) Evidence demonstrating that the
concerning the study or studies oc- cost of the study or studies for the new
curred; and use reasonably exceeds the expected
(3) Estimate the additional time revenue from the new use minus the
needed to complete the studies and costs of goods sold and marketing and
submit a supplemental application. administrative expenses attributable
The requested extension shall not ex- to the new use of the product. Such
ceed an additional 24 months. evidence shall include:
(c) The manufacturer shall send three (A) A description of the additional
copies of the request for extension to studies that the manufacturer believes
the same FDA office that received the are necessary to support the submis-
manufacturer’s initial submission and sion of a supplemental application for
certification statement. The outside of the new use, including documentation
the envelope shall be marked as ‘‘Re- from prior discussions, if any, with the
quest for Time Extension—Dissemina- agency concerning the studies that

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Food and Drug Administration, HHS § 99.301

would be needed, and an estimate of support the submission of a supple-


the projected costs for such studies; mental application for the new use, the
(B) The expected patient population data are persuasive to the extent that
for the new use; withholding the drug or device in a
(C) The expected revenue for the new controlled study (e.g., by providing no
use, including an explanation of the therapy, a placebo, an alternative ther-
price at which the drug or device will apy, or an alternative dose) would pose
be sold; an unreasonable risk of harm to human
(D) Any exclusivity for the drug or subjects. In assessing the appropriate-
device for the new use; and ness of conducting studies to support
(E) Any other information that the the new use, the manufacturer may
manufacturer has showing that con- provide evidence showing that the new
ducting the studies on the new use use is broadly accepted as current
would be economically prohibitive; and standard medical treatment or ther-
(iii) An attestation by a responsible apy. The manufacturer shall also ad-
individual of the manufacturer or an dress the possibility of conducting
individual acting on the manufactur- studies in different populations or of
er’s behalf verifying that the estimates modified design (e.g., adding the new
included with the submission are accu- therapy to existing treatments or
rate and were prepared in accordance using an alternative dose if
with generally accepted accounting monotherapy studies could not be con-
procedures. The data underlying and ducted).
supporting the estimates shall be made
available to FDA upon request. Alter- Subpart D—FDA Action on Sub-
natively, a manufacturer may submit a missions, Requests, and Appli-
report of an independent certified pub-
lic accountant in accordance with the
cations
Statement of Standards for Attesta- § 99.301 Agency action on a submis-
tion established by the American Insti- sion.
tute of Certified Public Accountants
and agreed upon procedures performed (a) Submissions. Within 60 days after
with respect to the estimates sub- receiving a submission under this part,
mitted under this section. FDA may:
(2) If the basis for the manufacturer’s (1) Determine that the manufacturer
application for exemption is that it does not comply with the requirements
would be unethical to conduct the under this part and that, as a result,
studies necessary for the supplemental the manufacturer shall not disseminate
application for a new use, the manufac- any information under this part;
turer shall provide evidence: (2) After providing the manufacturer
(i) Explaining why existing data notice and an opportunity for a meet-
characterizing the safety and effective- ing, determine that the information
ness of the drug or device, including submitted regarding a new use fails to
data from the study described in the provide data, analyses, or other writ-
information to be disseminated, are ten matter that is objective and bal-
not adequate to support the submission anced and:
of a supplemental application for the (i) Require the manufacturer to dis-
new use. Such evidence shall include an seminate additional information, in-
analysis of all data relevant to the cluding information that the manufac-
safety and effectiveness of the new use, turer has submitted to FDA or, where
a summary of those data, and any doc- appropriate, a summary of such infor-
umentation resulting from prior dis- mation or any other information that
cussions with the agency concerning can be made publicly available, which,
the adequacy of the existing data; and in the agency’s opinion:
(ii) Explaining why it would be un- (A) Is objective and scientifically
ethical to conduct the further studies sound;
that would be necessary for the ap- (B) Pertains to the safety or effec-
proval of the new use. Such evidence tiveness of the new use; and
shall establish that, notwithstanding (C) Is necessary to provide objec-
the insufficiency of available data to tivity and balance; and

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§ 99.303 21 CFR Ch. I (4–1–11 Edition)

(ii) Require the manufacturer to dis- (b) The manufacturer may, after be-
seminate an objective statement pre- ginning the studies needed for the sub-
pared by FDA that is based on data or mission of a supplemental application
other scientifically sound information for a new use, request in writing that
available to the agency and bears on FDA extend the time period for con-
the safety or effectiveness of the drug ducting studies needed for the submis-
or device for the new use; and sion of a supplemental application for
(3) Require the manufacturer to a new use and submitting a supple-
maintain records that will identify in- mental application to FDA. FDA may
dividual recipients of the information grant or deny the request or, after con-
that is to be disseminated when such sulting the manufacturer, grant an ex-
individual records are warranted due to tension different from that requested
special safety considerations associ- by the manufacturer. FDA may grant a
ated with the new use. manufacturer’s request for an exten-
(b) Protocols/Studies. Within 60 days sion if FDA determines that the manu-
after receiving a submission under this facturer has acted with due diligence
part, FDA shall: to conduct the studies needed for the
(1) If the manufacturer has planned submission of a supplemental applica-
studies that will be needed for the sub- tion for a new use and to submit such
mission of a supplemental application a supplemental application to FDA in a
timely manner and that, despite such
for the new use, review the manufac-
actions, the manufacturer needs addi-
turer’s proposed protocols and schedule
tional time to complete the studies and
for completing such studies and deter-
submit the supplemental application.
mine whether the proposed protocols
Extensions under this paragraph shall
are adequate and whether the proposed
not exceed 24 months.
schedule for completing the studies is
(c) If FDA extends the time period for
reasonable. FDA shall notify the manu-
completing the studies and submitting
facturer of its determination; or
a supplemental application under para-
(2) If the manufacturer has completed graph (a) of this section after the man-
studies that the manufacturer believes ufacturer has submitted a certification
would be an adequate basis for the sub- under § 99.201(a)(4)(ii)(B), or if FDA
mission of a supplemental application grants a manufacturer’s request for an
for the new use, conduct a review of extension under paragraph (b) of this
the protocols submitted for such stud- section, the manufacturer shall submit
ies to determine whether they are ade- a new certification under
quate. FDA shall notify the manufac- § 99.201(a)(4)(ii)(B) that sets forth the
turer of its determination. timeframe within which clinical stud-
ies will be completed and a supple-
§ 99.303 Extension of time for com-
mental application will be submitted
pleting planned studies.
to FDA.
(a) Upon review of a drug or device
manufacturer’s proposed protocols and § 99.305 Exemption from the require-
schedules for conducting studies need- ment to file a supplemental applica-
ed for the submission of a supplemental tion.
application for a new use, FDA may, (a) Within 60 days after receipt of an
with or without a request for an exten- application for an exemption from the
sion from the manufacturer, determine requirement of a supplemental applica-
that such studies cannot be completed tion, FDA shall approve or deny the ap-
and submitted within 36 months. The plication.
agency may exercise its discretion in (1) If FDA does not act on the appli-
extending the time period for com- cation for an exemption within the 60-
pleting the studies and submitting a day period, the application for an ex-
supplemental application. Extensions emption shall be deemed to be ap-
under this paragraph are not subject to proved.
any time limit, but shall be made be- (2) If an application for an exemption
fore the manufacturer begins the stud- is deemed to be approved, FDA may, at
ies needed for the submission of a sup- any time, terminate such approval if it
plemental application for the new use. determines that the requirements for

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Food and Drug Administration, HHS § 99.401

granting an exemption have not been the new use of the drug or device is
met. FDA shall notify the manufac- broadly accepted as current standard
turer if the approval is terminated. medical treatment or therapy.
(b) In reviewing an application for an
exemption, FDA shall consider the ma- Subpart E—Corrective Actions
terials submitted by the manufacturer
and may consider any other appro-
and Cessation of Dissemination
priate information, including, but not § 99.401 Corrective actions and ces-
limited to, any pending or previously sation of dissemination of informa-
approved applications for exemption tion.
submitted by the manufacturer.
(c) FDA may grant an application for (a) FDA actions based on post dissemi-
an exemption if FDA determines that: nation data. If FDA receives data after
(1) It would be economically prohibi- a manufacturer has begun dissemi-
tive for the manufacturer to incur the nating information on a new use and,
costs necessary to submit a supple- based on that data, determines that
mental application for a new use, the new use that is the subject of infor-
which at a minimum requires: mation disseminated under this part
(i) That existing data characterizing may not be effective or may present a
the safety and effectiveness of the drug significant risk to public health, FDA
or device, including data from the shall consult the manufacturer and,
study described in the information to after such consultation, take appro-
be disseminated are not adequate to priate action to protect the public
support the submission of a supple- health. Such action may include order-
mental application for the new use; and ing the manufacturer to cease dissemi-
(ii) That the cost of the study or nating information on the new use and
studies for the new use reasonably ex- to take appropriate corrective action.
ceeds the expected revenue from the (b) FDA actions based on information
new use minus the cost of goods sold disseminated by a manufacturer. If FDA
and marketing and administrative ex- determines that a manufacturer is dis-
penses attributable to the new use of seminating information that does not
the product, and there are not less ex- comply with the requirements under
pensive ways to obtain the needed in- this part, FDA may:
formation; or (1) Provide to the manufacturer an
(2) It would be unethical to conduct opportunity to bring itself into compli-
clinical studies needed to support the ance with the requirements under this
submission of a supplemental applica- part if the manufacturer’s noncompli-
tion for the new use because: ance constitutes a minor violation of
(i) Existing data characterizing the these requirements; or
safety and effectiveness of the drug or (2) Order the manufacturer to cease
device, including data from the study dissemination of information and to
described in the information to be dis-
take corrective action. FDA shall issue
seminated are not adequate to support
such an order only after it has:
the submission of a supplemental ap-
plication for the new use; and (i) Provided notice to the manufac-
(ii) Although available evidence turer regarding FDA’s intent to issue
would not support the submission of a an order to cease dissemination; and
supplemental application for the new (ii) Provided to the manufacturer an
use, the data are persuasive to the ex- opportunity for a meeting. FDA need
tent that withholding the drug or de- not provide an opportunity for a meet-
vice in a controlled study would pose ing if the manufacturer certified that
an unreasonable risk of harm to human it will submit a supplemental applica-
subjects and no studies in different tion for the new use within 6 months of
populations or of modified design can the date that dissemination can begin
be utilized. In determining whether it and the noncompliance involves a fail-
would be unethical to conduct clinical ure to submit such supplemental appli-
studies, the agency shall consider, in cation.
addition to the persuasiveness of avail- (c) FDA actions based on a manufactur-
able evidence of effectiveness, whether er’s supplemental application. FDA may

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§ 99.403 21 CFR Ch. I (4–1–11 Edition)

order a manufacturer to cease dissemi- turer shall notify FDA immediately if


nating information under this part and it ceases dissemination under this
to take corrective action if: paragraph.
(1) In the case of a manufacturer that
has submitted a supplemental applica- § 99.403 Termination of approvals of
tion for the new use, FDA determines applications for exemption.
that the supplemental application does (a) FDA may, at any time, terminate
not contain adequate information for the approval of an application for an
approval of the new use; exemption from the requirement to file
(2) In the case of a manufacturer that a supplemental application if:
has certified that it will submit a sup- (1) The application for an exemption
plemental application for the new use had been deemed to be approved be-
within 6 months, the manufacturer has cause the agency had not acted on the
not, within the 6-month period, sub- application within 60 days after its re-
mitted a supplemental application for ceipt by FDA;
the new use; (2) The manufacturer is dissemi-
(3) In the case of a manufacturer that nating written information on the new
has certified that it will submit a sup- use; and
plemental application for the new use (3) FDA determines that it would be
within 36 months or within such time economically and ethically possible for
as FDA has determined to be appro- the manufacturer to conduct the clin-
priate under § 99.303(a) or (b), such man- ical studies needed to submit a supple-
ufacturer has not submitted the sup- mental application for the new use.
plemental application within the cer- (b) If FDA terminates a deemed ap-
tified time, or FDA, after an informal proval of an application for an exemp-
hearing, has determined that the man- tion under paragraph (a) of this sec-
ufacturer is not acting with due dili- tion, FDA also may:
gence to initiate or complete the stud- (1) Order the manufacturer to cease
ies necessary to support a supple- disseminating information; and
mental application for the new use; or (2) Order the manufacturer to take
(4) In the case of a manufacturer that action to correct the information that
has certified that it will submit a sup- has been disseminated if FDA deter-
plemental application for the new use mines that the new use described in the
within 36 months or within such time disseminated information would pose a
as FDA has determined to be appro- significant risk to public health.
priate under § 99.303(a) or (b), the manu- (c) FDA shall notify the manufac-
facturer has discontinued or termi- turer if it terminates the deemed ap-
nated the clinical studies that would be proval of an application for an exemp-
necessary to support a supplemental tion under paragraph (a) of this sec-
application for a new use. tion. If FDA also issues an order to
(d) Effective date of orders to cease dis- cease dissemination of information,
semination. An order to cease dissemi- the manufacturer shall comply with
nation of information shall be effective the order no later than 60 days after its
upon date of receipt by the manufac- receipt.
turer, unless otherwise stated in such (d) FDA may, at any time, terminate
order. the approval of an application for an
(e) Cessation of dissemination by a non- exemption from the requirement to file
complying manufacturer. A manufac- a supplemental application for a new
turer that begins to disseminate infor- use if, after consulting with the manu-
mation in compliance with this part, facturer that was granted such exemp-
but subsequently fails to comply with tion, FDA determines that the manu-
this part, shall immediately cease dis- facturer no longer meets the require-
seminating information under this ments for an exemption on the basis
part. A manufacturer that discon- that it is economically prohibitive or
tinues, terminates, or fails to conduct unethical to conduct the studies need-
with due diligence clinical studies that ed to submit a supplemental applica-
it certified it would complete under tion for the new use.
§ 99.201(a)(4)(ii) shall be deemed not in (e) If FDA terminates an approval of
compliance with this part. A manufac- an application for an exemption under

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Food and Drug Administration, HHS § 99.501

paragraph (d) of this section, the man- recipients of the disseminated informa-
ufacturer must, within 60 days of being tion. Manufacturers whose records
notified by FDA that its exemption ap- identify recipients by category only
proval has been terminated, file a sup- shall:
plemental application for the new use (A) Identify subcategories of recipi-
that is the subject of the information ents where appropriate (e.g.,
being disseminated under the exemp- oncologists, pediatricians, obstetri-
tion, certify, under § 99.201(a)(4)(i) or cians, etc.); and
(a)(4)(ii) that it will file a supplemental (B) Ensure that any corrective action
application for the new use, or cease to be taken will be sufficiently con-
disseminating the information on the spicuous to individuals within that cat-
new use. FDA may require a manufac- egory of recipients;
turer that ceases dissemination of in- (2) Maintain an identical copy of the
formation on the new use to undertake information disseminated under this
corrective action. part; and
(3) Upon the submission of a supple-
§ 99.405 Applicability of labeling, adul- mental application to FDA, notify the
teration, and misbranding author-
ity. appropriate office identified in
§ 99.201(c) of this part.
The dissemination of information re- (b) A manufacturer disseminating in-
lating to a new use for a drug or device formation on a new use for a drug or
may constitute labeling, evidence of a device shall, on a semiannual basis,
new intended use, adulteration, or mis- submit to the FDA office identified in
branding of the drug or device if such § 99.201(c) of this part:
dissemination fails to comply with sec- (1) A list containing the titles of arti-
tion 551 of the Federal Food, Drug, and cles and reference publications relating
Cosmetic Act (the act) (21 U.S.C. to the new use of drugs or devices that
360aaa) and the requirements of this the manufacturer disseminated to a
part. A manufacturer’s failure to exer- health care practitioner, pharmacy
cise due diligence in submitting the benefit manager, health insurance
clinical studies that are necessary for issuer, group health plan, or Federal or
the approval of a new use that is the State Government agency. The list
subject of information disseminated shall cover articles and reference publi-
under this part or in beginning or com- cations disseminated in the 6-month
pleting such clinical studies shall be period preceding the date on which the
deemed a failure to comply with sec- manufacturer provides the list to FDA;
tion 551 of the act and the require- (2) A list identifying the categories of
ments of this part. health care practitioners, pharmacy
benefit managers, health insurance
Subpart F—Recordkeeping and issuers, group health plans, or Federal
Reports or State Government agencies that re-
ceived the articles and reference publi-
§ 99.501 Recordkeeping and reports. cations in the 6-month period described
(a) A manufacturer disseminating in- in paragraph (b)(1) of this section. The
formation under this part shall: list shall also identify which category
(1) Maintain records sufficient to of recipients received a particular arti-
allow the manufacturer to take correc- cle or reference publication;
tive action as required by FDA. The (3) A notice and summary of any ad-
manufacturer shall make such records ditional clinical research or other data
available to FDA, upon request, for in- relating to the safety or effectiveness
spection and copying. Such records of the new use, and, if the manufac-
shall either: turer possesses such clinical research
(i) Identify, by name, those persons or other data, a copy of the research or
receiving the disseminated informa- data. Such other data may include, but
tion; or is not limited to, new articles pub-
(ii) Identify, by category, the recipi- lished in scientific or medical journals,
ents of the disseminated information, reference publications, and summaries
unless FDA requires the manufacturer of adverse effects that are or may be
to retain records identifying individual associated with the new use;

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§ 99.501 21 CFR Ch. I (4–1–11 Edition)

(4) If the manufacturer is conducting manufacturer continues to meet the re-


studies necessary for the submission of quirements for such exemption. This
a supplemental application, the manu- information may include, but is not
facturer shall submit periodic progress limited to, new or additional informa-
reports on these studies to FDA. Such tion regarding revenues from the prod-
reports shall describe the studies’ cur- uct that is the subject of the dissemi-
rent status (i.e., progress on patient nation and new or additional informa-
enrollment, any significant problems tion regarding the persuasiveness of
that could affect the manufacturer’s the data on the new use, including in-
ability to complete the studies, and ex-
formation regarding whether the new
pected completion dates). If the manu-
use is broadly accepted as current
facturer discontinues or terminates a
study before completing it, the manu- standard medical treatment or ther-
facturer shall, as part of the next peri- apy.
odic progress report, state the reasons (c) A manufacturer shall maintain a
for such discontinuation or termi- copy of all information, lists, records,
nation; and and reports required or disseminated
(5) If the manufacturer was granted under this part for 3 years after it has
an exemption from the requirements to ceased dissemination of such informa-
submit a supplemental application for tion and make such documents avail-
the new use, any new or additional in- able to FDA for inspection and copy-
formation that relates to whether the ing.

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FINDING AIDS

A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabet-
ical list of agencies publishing in the CFR are included in the CFR Index and
Finding Aids volume to the Code of Federal Regulations which is published sepa-
rately and revised annually.
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected

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Table of CFR Titles and Chapters
(Revised as of April 1, 2011)

Title 1—General Provisions

I Administrative Committee of the Federal Register (Parts 1—49)


II Office of the Federal Register (Parts 50—299)
III Administrative Conference of the United States (Parts 300—399)
IV Miscellaneous Agencies (Parts 400—500)

Title 2—Grants and Agreements

SUBTITLE A—OFFICE OF MANAGEMENT AND BUDGET GUIDANCE FOR


GRANTS AND AGREEMENTS
I Office of Management and Budget Governmentwide Guidance for
Grants and Agreements (Parts 100—199)
II Office of Management and Budget Circulars and Guidance (200—
299)
SUBTITLE B—FEDERAL AGENCY REGULATIONS FOR GRANTS AND
AGREEMENTS
III Department of Health and Human Services (Parts 300— 399)
IV Department of Agriculture (Parts 400—499)
VI Department of State (Parts 600—699)
VIII Department of Veterans Affairs (Parts 800—899)
IX Department of Energy (Parts 900—999)
XI Department of Defense (Parts 1100—1199)
XII Department of Transportation (Parts 1200—1299)
XIII Department of Commerce (Parts 1300—1399)
XIV Department of the Interior (Parts 1400—1499)
XV Environmental Protection Agency (Parts 1500—1599)
XVIII National Aeronautics and Space Administration (Parts 1880—
1899)
XX United States Nuclear Regulatory Commission (Parts 2000—2099)
XXII Corporation for National and Community Service (Parts 2200—
2299)
XXIII Social Security Administration (Parts 2300—2399)
XXIV Housing and Urban Development (Parts 2400—2499)
XXV National Science Foundation (Parts 2500—2599)
XXVI National Archives and Records Administration (Parts 2600—2699)
XXVII Small Business Administration (Parts 2700—2799)
XXVIII Department of Justice (Parts 2800—2899)
XXX Department of Homeland Security (Parts 3000—3099)

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Title 2—Grants and Agreements—Continued
Chap.

XXXI Institute of Museum and Library Services (Parts 3100—3199)


XXXII National Endowment for the Arts (Parts 3200—3299)
XXXIII National Endowment for the Humanities (Parts 3300—3399)
XXXV Export-Import Bank of the United States (Parts 3500—3599)
XXXVII Peace Corps (Parts 3700—3799)
LVIII Election Assistance Commission (Parts 5800—5899)

Title 3—The President

I Executive Office of the President (Parts 100—199)

Title 4—Accounts

I Government Accountability Office (Parts 1—99)


II Recovery Accountability and Transparency Board (Parts 200—
299)

Title 5—Administrative Personnel

I Office of Personnel Management (Parts 1—1199)


II Merit Systems Protection Board (Parts 1200—1299)
III Office of Management and Budget (Parts 1300—1399)
V The International Organizations Employees Loyalty Board
(Parts 1500—1599)
VI Federal Retirement Thrift Investment Board (Parts 1600—1699)
VIII Office of Special Counsel (Parts 1800—1899)
IX Appalachian Regional Commission (Parts 1900—1999)
XI Armed Forces Retirement Home (Parts 2100—2199)
XIV Federal Labor Relations Authority, General Counsel of the Fed-
eral Labor Relations Authority and Federal Service Impasses
Panel (Parts 2400—2499)
XV Office of Administration, Executive Office of the President
(Parts 2500—2599)
XVI Office of Government Ethics (Parts 2600—2699)
XXI Department of the Treasury (Parts 3100—3199)
XXII Federal Deposit Insurance Corporation (Parts 3200—3299)
XXIII Department of Energy (Parts 3300—3399)
XXIV Federal Energy Regulatory Commission (Parts 3400—3499)
XXV Department of the Interior (Parts 3500—3599)
XXVI Department of Defense (Parts 3600— 3699)
XXVIII Department of Justice (Parts 3800—3899)
XXIX Federal Communications Commission (Parts 3900—3999)
XXX Farm Credit System Insurance Corporation (Parts 4000—4099)
XXXI Farm Credit Administration (Parts 4100—4199)
XXXIII Overseas Private Investment Corporation (Parts 4300—4399)
XXXIV Securities and Exchange Commission (Parts 4400—4499)

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Title 5—Administrative Personnel—Continued
Chap.

XXXV Office of Personnel Management (Parts 4500—4599)


XL Interstate Commerce Commission (Parts 5000—5099)
XLI Commodity Futures Trading Commission (Parts 5100—5199)
XLII Department of Labor (Parts 5200—5299)
XLIII National Science Foundation (Parts 5300—5399)
XLV Department of Health and Human Services (Parts 5500—5599)
XLVI Postal Rate Commission (Parts 5600—5699)
XLVII Federal Trade Commission (Parts 5700—5799)
XLVIII Nuclear Regulatory Commission (Parts 5800—5899)
XLIX Federal Labor Relations Authority (Parts 5900—5999)
L Department of Transportation (Parts 6000—6099)
LII Export-Import Bank of the United States (Parts 6200—6299)
LIII Department of Education (Parts 6300—6399)
LIV Environmental Protection Agency (Parts 6400—6499)
LV National Endowment for the Arts (Parts 6500—6599)
LVI National Endowment for the Humanities (Parts 6600—6699)
LVII General Services Administration (Parts 6700—6799)
LVIII Board of Governors of the Federal Reserve System (Parts 6800—
6899)
LIX National Aeronautics and Space Administration (Parts 6900—
6999)
LX United States Postal Service (Parts 7000—7099)
LXI National Labor Relations Board (Parts 7100—7199)
LXII Equal Employment Opportunity Commission (Parts 7200—7299)
LXIII Inter-American Foundation (Parts 7300—7399)
LXIV Merit Systems Protection Board (Parts 7400—7499)
LXV Department of Housing and Urban Development (Parts 7500—
7599)
LXVI National Archives and Records Administration (Parts 7600—7699)
LXVII Institute of Museum and Library Services (Parts 7700—7799)
LXVIII Commission on Civil Rights (Parts 7800—7899)
LXIX Tennessee Valley Authority (Parts 7900—7999)
LXXI Consumer Product Safety Commission (Parts 8100—8199)
LXXII Special Inspector General for Iraq Reconstruction (Parts 8200—
8299)
LXXIII Department of Agriculture (Parts 8300—8399)
LXXIV Federal Mine Safety and Health Review Commission (Parts
8400—8499)
LXXVI Federal Retirement Thrift Investment Board (Parts 8600—8699)
LXXVII Office of Management and Budget (Parts 8700—8799)
LXXX Federal Housing Finance Agency (Parts 8700—8799)
LXXXII Special Inspector General for Iraq Reconstruction (Parts 9200—
9299)
XCVII Department of Homeland Security Human Resources Manage-
ment System (Department of Homeland Security—Office of
Personnel Management) (Parts 9700—9799)

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Title 5—Administrative Personnel—Continued
Chap.

XCIX Department of Defense Human Resources Management and


Labor Relations Systems (Department of Defense—Office of
Personnel Management) (Parts 9900—9999)

Title 6—Domestic Security

I Department of Homeland Security, Office of the Secretary


(Parts 0—99)

Title 7—Agriculture

SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS


0—26)
SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE
I Agricultural Marketing Service (Standards, Inspections, Mar-
keting Practices), Department of Agriculture (Parts 27—209)
II Food and Nutrition Service, Department of Agriculture (Parts
210—299)
III Animal and Plant Health Inspection Service, Department of Ag-
riculture (Parts 300—399)
IV Federal Crop Insurance Corporation, Department of Agriculture
(Parts 400—499)
V Agricultural Research Service, Department of Agriculture
(Parts 500—599)
VI Natural Resources Conservation Service, Department of Agri-
culture (Parts 600—699)
VII Farm Service Agency, Department of Agriculture (Parts 700—
799)
VIII Grain Inspection, Packers and Stockyards Administration (Fed-
eral Grain Inspection Service), Department of Agriculture
(Parts 800—899)
IX Agricultural Marketing Service (Marketing Agreements and Or-
ders; Fruits, Vegetables, Nuts), Department of Agriculture
(Parts 900—999)
X Agricultural Marketing Service (Marketing Agreements and Or-
ders; Milk), Department of Agriculture (Parts 1000—1199)
XI Agricultural Marketing Service (Marketing Agreements and Or-
ders; Miscellaneous Commodities), Department of Agriculture
(Parts 1200—1299)
XIV Commodity Credit Corporation, Department of Agriculture
(Parts 1400—1499)
XV Foreign Agricultural Service, Department of Agriculture (Parts
1500—1599)
XVI Rural Telephone Bank, Department of Agriculture (Parts 1600—
1699)
XVII Rural Utilities Service, Department of Agriculture (Parts 1700—
1799)
XVIII Rural Housing Service, Rural Business-Cooperative Service,
Rural Utilities Service, and Farm Service Agency, Depart-
ment of Agriculture (Parts 1800—2099)
XX Local Television Loan Guarantee Board (Parts 2200—2299)

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Title 7—Agriculture—Continued
Chap.

XXVI Office of Inspector General, Department of Agriculture (Parts


2600—2699)
XXVII Office of Information Resources Management, Department of
Agriculture (Parts 2700—2799)
XXVIII Office of Operations, Department of Agriculture (Parts 2800—
2899)
XXIX Office of Energy Policy and New Uses, Department of Agri-
culture (Parts 2900—2999)
XXX Office of the Chief Financial Officer, Department of Agriculture
(Parts 3000—3099)
XXXI Office of Environmental Quality, Department of Agriculture
(Parts 3100—3199)
XXXII Office of Procurement and Property Management, Department
of Agriculture (Parts 3200—3299)
XXXIII Office of Transportation, Department of Agriculture (Parts
3300—3399)
XXXIV National Institute of Food and Agriculture (Parts 3400—3499)
XXXV Rural Housing Service, Department of Agriculture (Parts 3500—
3599)
XXXVI National Agricultural Statistics Service, Department of Agri-
culture (Parts 3600—3699)
XXXVII Economic Research Service, Department of Agriculture (Parts
3700—3799)
XXXVIII World Agricultural Outlook Board, Department of Agriculture
(Parts 3800—3899)
XLI [Reserved]
XLII Rural Business-Cooperative Service and Rural Utilities Service,
Department of Agriculture (Parts 4200—4299)
L Rural Business-Cooperative Service, Rurual Housing Service,
and Rural Utilities Service, Department of Agriculture (Parts
5000—5099)

Title 8—Aliens and Nationality

I Department of Homeland Security (Immigration and Naturaliza-


tion) (Parts 1—499)
V Executive Office for Immigration Review, Department of Justice
(Parts 1000—1399)

Title 9—Animals and Animal Products

I Animal and Plant Health Inspection Service, Department of Ag-


riculture (Parts 1—199)
II Grain Inspection, Packers and Stockyards Administration
(Packers and Stockyards Programs), Department of Agri-
culture (Parts 200—299)
III Food Safety and Inspection Service, Department of Agriculture
(Parts 300—599)

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Title 10—Energy
Chap.

I Nuclear Regulatory Commission (Parts 0—199)


II Department of Energy (Parts 200—699)
III Department of Energy (Parts 700—999)
X Department of Energy (General Provisions) (Parts 1000—1099)
XIII Nuclear Waste Technical Review Board (Parts 1303—1399)
XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799)
XVIII Northeast Interstate Low-Level Radioactive Waste Commission
(Parts 1800—1899)

Title 11—Federal Elections

I Federal Election Commission (Parts 1—9099)


II Election Assistance Commission (Parts 9400—9499)

Title 12—Banks and Banking

I Comptroller of the Currency, Department of the Treasury (Parts


1—199)
II Federal Reserve System (Parts 200—299)
III Federal Deposit Insurance Corporation (Parts 300—399)
IV Export-Import Bank of the United States (Parts 400—499)
V Office of Thrift Supervision, Department of the Treasury (Parts
500—599)
VI Farm Credit Administration (Parts 600—699)
VII National Credit Union Administration (Parts 700—799)
VIII Federal Financing Bank (Parts 800—899)
IX Federal Housing Finance Board (Parts 900—999)
XI Federal Financial Institutions Examination Council (Parts
1100—1199)
XII Federal Housing Finance Agency (Parts 1200—1299)
XIV Farm Credit System Insurance Corporation (Parts 1400—1499)
XV Department of the Treasury (Parts 1500—1599)
XVII Office of Federal Housing Enterprise Oversight, Department of
Housing and Urban Development (Parts 1700—1799)
XVIII Community Development Financial Institutions Fund, Depart-
ment of the Treasury (Parts 1800—1899)

Title 13—Business Credit and Assistance

I Small Business Administration (Parts 1—199)


III Economic Development Administration, Department of Com-
merce (Parts 300—399)
IV Emergency Steel Guarantee Loan Board (Parts 400—499)
V Emergency Oil and Gas Guaranteed Loan Board (Parts 500—599)

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Title 14—Aeronautics and Space
Chap.

I Federal Aviation Administration, Department of Transportation


(Parts 1—199)
II Office of the Secretary, Department of Transportation (Aviation
Proceedings) (Parts 200—399)
III Commercial Space Transportation, Federal Aviation Adminis-
tration, Department of Transportation (Parts 400—499)
V National Aeronautics and Space Administration (Parts 1200—
1299)
VI Air Transportation System Stabilization (Parts 1300—1399)

Title 15—Commerce and Foreign Trade

SUBTITLE A—OFFICE OF THE SECRETARY OF COMMERCE (PARTS 0—


29)
SUBTITLE B—REGULATIONS RELATING TO COMMERCE AND FOREIGN
TRADE
I Bureau of the Census, Department of Commerce (Parts 30—199)
II National Institute of Standards and Technology, Department of
Commerce (Parts 200—299)
III International Trade Administration, Department of Commerce
(Parts 300—399)
IV Foreign-Trade Zones Board, Department of Commerce (Parts
400—499)
VII Bureau of Industry and Security, Department of Commerce
(Parts 700—799)
VIII Bureau of Economic Analysis, Department of Commerce (Parts
800—899)
IX National Oceanic and Atmospheric Administration, Department
of Commerce (Parts 900—999)
XI Technology Administration, Department of Commerce (Parts
1100—1199)
XIII East-West Foreign Trade Board (Parts 1300—1399)
XIV Minority Business Development Agency (Parts 1400—1499)
SUBTITLE C—REGULATIONS RELATING TO FOREIGN TRADE AGREE-
MENTS
XX Office of the United States Trade Representative (Parts 2000—
2099)
SUBTITLE D—REGULATIONS RELATING TO TELECOMMUNICATIONS
AND INFORMATION
XXIII National Telecommunications and Information Administration,
Department of Commerce (Parts 2300—2399)

Title 16—Commercial Practices

I Federal Trade Commission (Parts 0—999)


II Consumer Product Safety Commission (Parts 1000—1799)

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Title 17—Commodity and Securities Exchanges
Chap.

I Commodity Futures Trading Commission (Parts 1—199)


II Securities and Exchange Commission (Parts 200—399)
IV Department of the Treasury (Parts 400—499)

Title 18—Conservation of Power and Water Resources

I Federal Energy Regulatory Commission, Department of Energy


(Parts 1—399)
III Delaware River Basin Commission (Parts 400—499)
VI Water Resources Council (Parts 700—799)
VIII Susquehanna River Basin Commission (Parts 800—899)
XIII Tennessee Valley Authority (Parts 1300—1399)

Title 19—Customs Duties

I U.S. Customs and Border Protection, Department of Homeland


Security; Department of the Treasury (Parts 0—199)
II United States International Trade Commission (Parts 200—299)
III International Trade Administration, Department of Commerce
(Parts 300—399)
IV U.S. Immigration and Customs Enforcement, Department of
Homeland Security (Parts 400—599)

Title 20—Employees’ Benefits

I Office of Workers’ Compensation Programs, Department of


Labor (Parts 1—199)
II Railroad Retirement Board (Parts 200—399)
III Social Security Administration (Parts 400—499)
IV Employees Compensation Appeals Board, Department of Labor
(Parts 500—599)
V Employment and Training Administration, Department of Labor
(Parts 600—699)
VI Office of Workers’ Compensation Programs, Department of
Labor (Parts 700—799)
VII Benefits Review Board, Department of Labor (Parts 800—899)
VIII Joint Board for the Enrollment of Actuaries (Parts 900—999)
IX Office of the Assistant Secretary for Veterans’ Employment and
Training Service, Department of Labor (Parts 1000—1099)

Title 21—Food and Drugs

I Food and Drug Administration, Department of Health and


Human Services (Parts 1—1299)
II Drug Enforcement Administration, Department of Justice (Parts
1300—1399)
III Office of National Drug Control Policy (Parts 1400—1499)

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Title 22—Foreign Relations
Chap.

I Department of State (Parts 1—199)


II Agency for International Development (Parts 200—299)
III Peace Corps (Parts 300—399)
IV International Joint Commission, United States and Canada
(Parts 400—499)
V Broadcasting Board of Governors (Parts 500—599)
VII Overseas Private Investment Corporation (Parts 700—799)
IX Foreign Service Grievance Board (Parts 900—999)
X Inter-American Foundation (Parts 1000—1099)
XI International Boundary and Water Commission, United States
and Mexico, United States Section (Parts 1100—1199)
XII United States International Development Cooperation Agency
(Parts 1200—1299)
XIII Millenium Challenge Corporation (Parts 1300—1399)
XIV Foreign Service Labor Relations Board; Federal Labor Relations
Authority; General Counsel of the Federal Labor Relations
Authority; and the Foreign Service Impasse Disputes Panel
(Parts 1400—1499)
XV African Development Foundation (Parts 1500—1599)
XVI Japan-United States Friendship Commission (Parts 1600—1699)
XVII United States Institute of Peace (Parts 1700—1799)

Title 23—Highways

I Federal Highway Administration, Department of Transportation


(Parts 1—999)
II National Highway Traffic Safety Administration and Federal
Highway Administration, Department of Transportation
(Parts 1200—1299)
III National Highway Traffic Safety Administration, Department of
Transportation (Parts 1300—1399)

Title 24—Housing and Urban Development

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING


AND URBAN DEVELOPMENT (PARTS 0—99)
SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE-
VELOPMENT
I Office of Assistant Secretary for Equal Opportunity, Department
of Housing and Urban Development (Parts 100—199)
II Office of Assistant Secretary for Housing-Federal
HousingCommissioner, Department of Housing and Urban De-
velopment (Parts 200—299)
III Government National Mortgage Association, Department of
Housing and Urban Development (Parts 300—399)
IV Office of Housing and Office of Multifamily Housing Assistance
Restructuring, Department of Housing and Urban Develop-
ment (Parts 400—499)

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Title 24—Housing and Urban Development—Continued
Chap.

V Office of Assistant Secretary for Community Planning and De-


velopment, Department of Housing and Urban Development
(Parts 500—599)
VI Office of Assistant Secretary for Community Planning and De-
velopment, Department of Housing and Urban Development
(Parts 600—699) [Reserved]
VII Office of the Secretary, Department of Housing and Urban Devel-
opment (Housing Assistance Programs and Public and Indian
Housing Programs) (Parts 700—799)
VIII Office of the Assistant Secretary for Housing—Federal Housing
Commissioner, Department of Housing and Urban Develop-
ment (Section 8 Housing Assistance Programs, Section 202 Di-
rect Loan Program, Section 202 Supportive Housing for the El-
derly Program and Section 811 Supportive Housing for Persons
With Disabilities Program) (Parts 800—899)
IX Office of Assistant Secretary for Public and Indian Housing, De-
partment of Housing and Urban Development (Parts 900—1699)
X Office of Assistant Secretary for Housing—Federal Housing
Commissioner, Department of Housing and Urban Develop-
ment (Interstate Land Sales Registration Program) (Parts
1700—1799)
XII Office of Inspector General, Department of Housing and Urban
Development (Parts 2000—2099)
XV Emergency Mortgage Insurance and Loan Programs, Depart-
ment of Housing and Urban Development (Parts 2700—2799)
XX Office of Assistant Secretary for Housing—Federal Housing
Commissioner, Department of Housing and Urban Develop-
ment (Parts 3200—3899)
XXIV Board of Directors of the HOPE for Homeowners Program (Parts
4000—4099)
XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)

Title 25—Indians

I Bureau of Indian Affairs, Department of the Interior (Parts 1—


299)
II Indian Arts and Crafts Board, Department of the Interior (Parts
300—399)
III National Indian Gaming Commission, Department of the Inte-
rior (Parts 500—599)
IV Office of Navajo and Hopi Indian Relocation (Parts 700—799)
V Bureau of Indian Affairs, Department of the Interior, and Indian
Health Service, Department of Health and Human Services
(Part 900)
VI Office of the Assistant Secretary-Indian Affairs, Department of
the Interior (Parts 1000—1199)
VII Office of the Special Trustee for American Indians, Department
of the Interior (Parts 1200—1299)

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Title 26—Internal Revenue
Chap.

I Internal Revenue Service, Department of the Treasury (Parts 1—


899)

Title 27—Alcohol, Tobacco Products and Firearms

I Alcohol and Tobacco Tax and Trade Bureau, Department of the


Treasury (Parts 1—399)
II Bureau of Alcohol, Tobacco, Firearms, and Explosives, Depart-
ment of Justice (Parts 400—699)

Title 28—Judicial Administration

I Department of Justice (Parts 0—299)


III Federal Prison Industries, Inc., Department of Justice (Parts
300—399)
V Bureau of Prisons, Department of Justice (Parts 500—599)
VI Offices of Independent Counsel, Department of Justice (Parts
600—699)
VII Office of Independent Counsel (Parts 700—799)
VIII Court Services and Offender Supervision Agency for the District
of Columbia (Parts 800—899)
IX National Crime Prevention and Privacy Compact Council (Parts
900—999)
XI Department of Justice and Department of State (Parts 1100—
1199)

Title 29—Labor

SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99)


SUBTITLE B—REGULATIONS RELATING TO LABOR
I National Labor Relations Board (Parts 100—199)
II Office of Labor-Management Standards, Department of Labor
(Parts 200—299)
III National Railroad Adjustment Board (Parts 300—399)
IV Office of Labor-Management Standards, Department of Labor
(Parts 400—499)
V Wage and Hour Division, Department of Labor (Parts 500—899)
IX Construction Industry Collective Bargaining Commission (Parts
900—999)
X National Mediation Board (Parts 1200—1299)
XII Federal Mediation and Conciliation Service (Parts 1400—1499)
XIV Equal Employment Opportunity Commission (Parts 1600—1699)
XVII Occupational Safety and Health Administration, Department of
Labor (Parts 1900—1999)
XX Occupational Safety and Health Review Commission (Parts
2200—2499)
XXV Employee Benefits Security Administration, Department of
Labor (Parts 2500—2599)

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Title 29—Labor—Continued
Chap.

XXVII Federal Mine Safety and Health Review Commission (Parts


2700—2799)
XL Pension Benefit Guaranty Corporation (Parts 4000—4999)

Title 30—Mineral Resources

I Mine Safety and Health Administration, Department of Labor


(Parts 1—199)
II Bureau of Ocean Energy Management, Regulation, and Enforce-
ment, Department of the Interior (Parts 200—299)
IV Geological Survey, Department of the Interior (Parts 400—499)
VII Office of Surface Mining Reclamation and Enforcement, Depart-
ment of the Interior (Parts 700—999)
XII Office of Natural Resources Revenue, Department of the Interior
(Parts 1200—1299)

Title 31—Money and Finance: Treasury

SUBTITLE A—OFFICE OF THE SECRETARY OF THE TREASURY (PARTS


0—50)
SUBTITLE B—REGULATIONS RELATING TO MONEY AND FINANCE
I Monetary Offices, Department of the Treasury (Parts 51—199)
II Fiscal Service, Department of the Treasury (Parts 200—399)
IV Secret Service, Department of the Treasury (Parts 400—499)
V Office of Foreign Assets Control, Department of the Treasury
(Parts 500—599)
VI Bureau of Engraving and Printing, Department of the Treasury
(Parts 600—699)
VII Federal Law Enforcement Training Center, Department of the
Treasury (Parts 700—799)
VIII Office of International Investment, Department of the Treasury
(Parts 800—899)
IX Federal Claims Collection Standards (Department of the Treas-
ury—Department of Justice) (Parts 900—999)
X Financial Crimes Enforcement Network, Departmnent of the
Treasury (Parts 1000—1099)

Title 32—National Defense

SUBTITLE A—DEPARTMENT OF DEFENSE


I Office of the Secretary of Defense (Parts 1—399)
V Department of the Army (Parts 400—699)
VI Department of the Navy (Parts 700—799)
VII Department of the Air Force (Parts 800—1099)
SUBTITLE B—OTHER REGULATIONS RELATING TO NATIONAL DE-
FENSE
XII Defense Logistics Agency (Parts 1200—1299)
XVI Selective Service System (Parts 1600—1699)

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Title 32—National Defense—Continued
Chap.

XVII Office of the Director of National Intelligence (Parts 1700—1799)


XVIII National Counterintelligence Center (Parts 1800—1899)
XIX Central Intelligence Agency (Parts 1900—1999)
XX Information Security Oversight Office, National Archives and
Records Administration (Parts 2000—2099)
XXI National Security Council (Parts 2100—2199)
XXIV Office of Science and Technology Policy (Parts 2400—2499)
XXVII Office for Micronesian Status Negotiations (Parts 2700—2799)
XXVIII Office of the Vice President of the United States (Parts 2800—
2899)

Title 33—Navigation and Navigable Waters

I Coast Guard, Department of Homeland Security (Parts 1—199)


II Corps of Engineers, Department of the Army (Parts 200—399)
IV Saint Lawrence Seaway Development Corporation, Department
of Transportation (Parts 400—499)

Title 34—Education

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDU-


CATION (PARTS 1—99)
SUBTITLE B—REGULATIONS OF THE OFFICES OF THE DEPARTMENT
OF EDUCATION
I Office for Civil Rights, Department of Education (Parts 100—199)
II Office of Elementary and Secondary Education, Department of
Education (Parts 200—299)
III Office of Special Education and Rehabilitative Services, Depart-
ment of Education (Parts 300—399)
IV Office of Vocational and Adult Education, Department of Edu-
cation (Parts 400—499)
V Office of Bilingual Education and Minority Languages Affairs,
Department of Education (Parts 500—599)
VI Office of Postsecondary Education, Department of Education
(Parts 600—699)
VII Office of Educational Research and Improvmeent, Department of
Education [Reserved]
XI National Institute for Literacy (Parts 1100—1199)
SUBTITLE C—REGULATIONS RELATING TO EDUCATION
XII National Council on Disability (Parts 1200—1299)

Title 35 [Reserved]

Title 36—Parks, Forests, and Public Property

I National Park Service, Department of the Interior (Parts 1—199)


II Forest Service, Department of Agriculture (Parts 200—299)
III Corps of Engineers, Department of the Army (Parts 300—399)

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Title 36—Parks, Forests, and Public Property—Continued
Chap.

IV American Battle Monuments Commission (Parts 400—499)


V Smithsonian Institution (Parts 500—599)
VI [Reserved]
VII Library of Congress (Parts 700—799)
VIII Advisory Council on Historic Preservation (Parts 800—899)
IX Pennsylvania Avenue Development Corporation (Parts 900—999)
X Presidio Trust (Parts 1000—1099)
XI Architectural and Transportation Barriers Compliance Board
(Parts 1100—1199)
XII National Archives and Records Administration (Parts 1200—1299)
XV Oklahoma City National Memorial Trust (Parts 1500—1599)
XVI Morris K. Udall Scholarship and Excellence in National Environ-
mental Policy Foundation (Parts 1600—1699)

Title 37—Patents, Trademarks, and Copyrights

I United States Patent and Trademark Office, Department of


Commerce (Parts 1—199)
II Copyright Office, Library of Congress (Parts 200—299)
III Copyright Royalty Board, Library of Congress (Parts 301—399)
IV Assistant Secretary for Technology Policy, Department of Com-
merce (Parts 400—499)
V Under Secretary for Technology, Department of Commerce
(Parts 500—599)

Title 38—Pensions, Bonuses, and Veterans’ Relief

I Department of Veterans Affairs (Parts 0—99)


II Armed Forces Retirement Home

Title 39—Postal Service

I United States Postal Service (Parts 1—999)


III Postal Regulatory Commission (Parts 3000—3099)

Title 40—Protection of Environment

I Environmental Protection Agency (Parts 1—1099)


IV Environmental Protection Agency and Department of Justice
(Parts 1400—1499)
V Council on Environmental Quality (Parts 1500—1599)
VI Chemical Safety and Hazard Investigation Board (Parts 1600—
1699)
VII Environmental Protection Agency and Department of Defense;
Uniform National Discharge Standards for Vessels of the
Armed Forces (Parts 1700—1799)

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Title 41—Public Contracts and Property Management
Chap.

SUBTITLE B—OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS


50 Public Contracts, Department of Labor (Parts 50–1—50–999)
51 Committee for Purchase From People Who Are Blind or Severely
Disabled (Parts 51–1—51–99)
60 Office of Federal Contract Compliance Programs, Equal Employ-
ment Opportunity, Department of Labor (Parts 60–1—60–999)
61 Office of the Assistant Secretary for Veterans’ Employment and
Training Service, Department of Labor (Parts 61–1—61–999)
62—100 [Reserved]
SUBTITLE C—FEDERAL PROPERTY MANAGEMENT REGULATIONS
SYSTEM
101 Federal Property Management Regulations (Parts 101–1—101–99)
102 Federal Management Regulation (Parts 102–1—102–299)
103—104 [Reserved]
105 General Services Administration (Parts 105–1—105–999)
109 Department of Energy Property Management Regulations (Parts
109–1—109–99)
114 Department of the Interior (Parts 114–1—114–99)
115 Environmental Protection Agency (Parts 115–1—115–99)
128 Department of Justice (Parts 128–1—128–99)
129—200 [Reserved]
SUBTITLE D—OTHER PROVISIONS RELATING TO PROPERTY MANAGE-
MENT [RESERVED]
SUBTITLE E—FEDERAL INFORMATION RESOURCES MANAGEMENT
REGULATIONS SYSTEM [RESERVED]
SUBTITLE F—FEDERAL TRAVEL REGULATION SYSTEM
300 General (Parts 300–1—300–99)
301 Temporary Duty (TDY) Travel Allowances (Parts 301–1—301–99)
302 Relocation Allowances (Parts 302–1—302–99)
303 Payment of Expenses Connected with the Death of Certain Em-
ployees (Part 303–1—303–99)
304 Payment of Travel Expenses from a Non-Federal Source (Parts
304–1—304–99)

Title 42—Public Health

I Public Health Service, Department of Health and Human Serv-


ices (Parts 1—199)
IV Centers for Medicare & Medicaid Services, Department of Health
and Human Services (Parts 400—499)
V Office of Inspector General-Health Care, Department of Health
and Human Services (Parts 1000—1999)

Title 43—Public Lands: Interior

SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS


1—199)
SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS

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Title 43—Public Lands: Interior—Continued
Chap.

I Bureau of Reclamation, Department of the Interior (Parts 200—


499)
II Bureau of Land Management, Department of the Interior (Parts
1000—9999)
III Utah Reclamation Mitigation and Conservation Commission
(Parts 10000—10099)

Title 44—Emergency Management and Assistance

I Federal Emergency Management Agency, Department of Home-


land Security (Parts 0—399)
IV Department of Commerce and Department of Transportation
(Parts 400—499)

Title 45—Public Welfare

SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES


(PARTS 1—199)
SUBTITLE B—REGULATIONS RELATING TO PUBLIC WELFARE
II Office of Family Assistance (Assistance Programs), Administra-
tion for Children and Families, Department of Health and
Human Services (Parts 200—299)
III Office of Child Support Enforcement (Child Support Enforce-
ment Program), Administration for Children and Families,
Department of Health and Human Services (Parts 300—399)
IV Office of Refugee Resettlement, Administration for Children and
Families, Department of Health and Human Services (Parts
400—499)
V Foreign Claims Settlement Commission of the United States,
Department of Justice (Parts 500—599)
VI National Science Foundation (Parts 600—699)
VII Commission on Civil Rights (Parts 700—799)
VIII Office of Personnel Management (Parts 800—899) [Reserved]
X Office of Community Services, Administration for Children and
Families, Department of Health and Human Services (Parts
1000—1099)
XI National Foundation on the Arts and the Humanities (Parts
1100—1199)
XII Corporation for National and Community Service (Parts 1200—
1299)
XIII Office of Human Development Services, Department of Health
and Human Services (Parts 1300—1399)
XVI Legal Services Corporation (Parts 1600—1699)
XVII National Commission on Libraries and Information Science
(Parts 1700—1799)
XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899)
XXI Commission on Fine Arts (Parts 2100—2199)
XXIII Arctic Research Commission (Part 2301)
XXIV James Madison Memorial Fellowship Foundation (Parts 2400—
2499)

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Title 45—Public Welfare—Continued
Chap.

XXV Corporation for National and Community Service (Parts 2500—


2599)

Title 46—Shipping

I Coast Guard, Department of Homeland Security (Parts 1—199)


II Maritime Administration, Department of Transportation (Parts
200—399)
III Coast Guard (Great Lakes Pilotage), Department of Homeland
Security (Parts 400—499)
IV Federal Maritime Commission (Parts 500—599)

Title 47—Telecommunication

I Federal Communications Commission (Parts 0—199)


II Office of Science and Technology Policy and National Security
Council (Parts 200—299)
III National Telecommunications and Information Administration,
Department of Commerce (Parts 300—399)
IV National Telecommunications and Information Administration,
Department of Commerce, and National Highway Traffic Safe-
ty Administration, Department of Transportation (Parts 400—
499)

Title 48—Federal Acquisition Regulations System

1 Federal Acquisition Regulation (Parts 1—99)


2 Defense Acquisition Regulations System, Department of Defense
(Parts 200—299)
3 Health and Human Services (Parts 300—399)
4 Department of Agriculture (Parts 400—499)
5 General Services Administration (Parts 500—599)
6 Department of State (Parts 600—699)
7 Agency for International Development (Parts 700—799)
8 Department of Veterans Affairs (Parts 800—899)
9 Department of Energy (Parts 900—999)
10 Department of the Treasury (Parts 1000—1099)
12 Department of Transportation (Parts 1200—1299)
13 Department of Commerce (Parts 1300—1399)
14 Department of the Interior (Parts 1400—1499)
15 Environmental Protection Agency (Parts 1500—1599)
16 Office of Personnel Management, Federal Employees Health
Benefits Acquisition Regulation (Parts 1600—1699)
17 Office of Personnel Management (Parts 1700—1799)
18 National Aeronautics and Space Administration (Parts 1800—
1899)
19 Broadcasting Board of Governors (Parts 1900—1999)
20 Nuclear Regulatory Commission (Parts 2000—2099)

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Title 48—Federal Acquisition Regulations System—Continued
Chap.

21 Office of Personnel Management, Federal Employees Group Life


Insurance Federal Acquisition Regulation (Parts 2100—2199)
23 Social Security Administration (Parts 2300—2399)
24 Department of Housing and Urban Development (Parts 2400—
2499)
25 National Science Foundation (Parts 2500—2599)
28 Department of Justice (Parts 2800—2899)
29 Department of Labor (Parts 2900—2999)
30 Department of Homeland Security, Homeland Security Acquisi-
tion Regulation (HSAR) (Parts 3000—3099)
34 Department of Education Acquisition Regulation (Parts 3400—
3499)
51 Department of the Army Acquisition Regulations (Parts 5100—
5199)
52 Department of the Navy Acquisition Regulations (Parts 5200—
5299)
53 Department of the Air Force Federal Acquisition Regulation
Supplement [Reserved]
54 Defense Logistics Agency, Department of Defense (Parts 5400—
5499)
57 African Development Foundation (Parts 5700—5799)
61 Civilian Board of Contract Appeals, General Services Adminis-
tration (Parts 6100—6199)
63 Department of Transportation Board of Contract Appeals (Parts
6300—6399)
99 Cost Accounting Standards Board, Office of Federal Procure-
ment Policy, Office of Management and Budget (Parts 9900—
9999)

Title 49—Transportation

SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION


(PARTS 1—99)
SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION
I Pipeline and Hazardous Materials Safety Administration, De-
partment of Transportation (Parts 100—199)
II Federal Railroad Administration, Department of Transportation
(Parts 200—299)
III Federal Motor Carrier Safety Administration, Department of
Transportation (Parts 300—399)
IV Coast Guard, Department of Homeland Security (Parts 400—499)
V National Highway Traffic Safety Administration, Department of
Transportation (Parts 500—599)
VI Federal Transit Administration, Department of Transportation
(Parts 600—699)
VII National Railroad Passenger Corporation (AMTRAK) (Parts
700—799)
VIII National Transportation Safety Board (Parts 800—999)

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Title 49—Transportation—Continued
Chap.

X Surface Transportation Board, Department of Transportation


(Parts 1000—1399)
XI Research and Innovative Technology Administration, Depart-
ment of Transportation [Reserved]
XII Transportation Security Administration, Department of Home-
land Security (Parts 1500—1699)

Title 50—Wildlife and Fisheries

I United States Fish and Wildlife Service, Department of the Inte-


rior (Parts 1—199)
II National Marine Fisheries Service, National Oceanic and Atmos-
pheric Administration, Department of Commerce (Parts 200—
299)
III International Fishing and Related Activities (Parts 300—399)
IV Joint Regulations (United States Fish and Wildlife Service, De-
partment of the Interior and National Marine Fisheries Serv-
ice, National Oceanic and Atmospheric Administration, De-
partment of Commerce); Endangered Species Committee Reg-
ulations (Parts 400—499)
V Marine Mammal Commission (Parts 500—599)
VI Fishery Conservation and Management, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts
600—699)

CFR Index and Finding Aids

Subject/Agency Index
List of Agency Prepared Indexes
Parallel Tables of Statutory Authorities and Rules
List of CFR Titles, Chapters, Subchapters, and Parts
Alphabetical List of Agencies Appearing in the CFR

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Alphabetical List of Agencies Appearing in the CFR
(Revised as of April 1, 2011)

CFR Title, Subtitle or


Agency Chapter
Administrative Committee of the Federal Register 1, I
Administrative Conference of the United States 1, III
Advanced Research Projects Agency 32, I
Advisory Council on Historic Preservation 36, VIII
African Development Foundation 22, XV
Federal Acquisition Regulation 48, 57
Agency for International Development 22, II
Federal Acquisition Regulation 48, 7
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agriculture Department 2, IV; 5, LXXIII
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Animal and Plant Health Inspection Service 7, III; 9, I
Chief Financial Officer, Office of 7, XXX
Commodity Credit Corporation 7, XIV
Economic Research Service 7, XXXVII
Energy Policy and New Uses, Office of 2, IX; 7, XXIX
Environmental Quality, Office of 7, XXXI
Farm Service Agency 7, VII, XVIII
Federal Acquisition Regulation 48, 4
Federal Crop Insurance Corporation 7, IV
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Forest Service 36, II
Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II
Information Resources Management, Office of 7, XXVII
Inspector General, Office of 7, XXVI
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National Institute of Food and Agriculture. 7, XXXIV
Natural Resources Conservation Service 7, VI
Operations, Office of 7, XXVIII
Procurement and Property Management, Office of 7, XXXII
Rural Business-Cooperative Service 7, XVIII, XLII, L
Rural Development Administration 7, XLII
Rural Housing Service 7, XVIII, XXXV, L
Rural Telephone Bank 7, XVI
Rural Utilities Service 7, XVII, XVIII, XLII, L
Secretary of Agriculture, Office of 7, Subtitle A
Transportation, Office of 7, XXXIII
World Agricultural Outlook Board 7, XXXVIII
Air Force Department 32, VII
Federal Acquisition Regulation Supplement 48, 53
Air Transportation Stabilization Board 14, VI
Alcohol and Tobacco Tax and Trade Bureau 27, I
Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II
AMTRAK 49, VII
American Battle Monuments Commission 36, IV
American Indians, Office of the Special Trustee 25, VII
Animal and Plant Health Inspection Service 7, III; 9, I
Appalachian Regional Commission 5, IX

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CFR Title, Subtitle or
Agency Chapter
Architectural and Transportation Barriers Compliance Board 36, XI
Arctic Research Commission 45, XXIII
Armed Forces Retirement Home 5, XI
Army Department 32, V
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 51
Bilingual Education and Minority Languages Affairs, Office of 34, V
Blind or Severely Disabled, Committee for Purchase From 41, 51
People Who Are
Broadcasting Board of Governors 22, V
Federal Acquisition Regulation 48, 19
Bureau of Ocean Energy Management, Regulation, and 30, II
Enforcement
Census Bureau 15, I
Centers for Medicare & Medicaid Services 42, IV
Central Intelligence Agency 32, XIX
Chief Financial Officer, Office of 7, XXX
Child Support Enforcement, Office of 45, III
Children and Families, Administration for 45, II, III, IV, X
Civil Rights, Commission on 5, LXVIII; 45, VII
Civil Rights, Office for 34, I
Coast Guard 33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage) 46, III
Commerce Department 44, IV; 50, VI
Census Bureau 15, I
Economic Affairs, Under Secretary 37, V
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Emergency Management and Assistance 44, IV
Federal Acquisition Regulation 48, 13
Fishery Conservation and Management 50, VI
Foreign-Trade Zones Board 15, IV
Industry and Security, Bureau of 15, VII
International Trade Administration 15, III; 19, III
National Institute of Standards and Technology 15, II
National Marine Fisheries Service 50, II, IV
National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI
National Telecommunications and Information 15, XXIII; 47, III, IV
Administration
National Weather Service 15, IX
Patent and Trademark Office, United States 37, I
Productivity, Technology and Innovation, Assistant 37, IV
Secretary for
Secretary of Commerce, Office of 15, Subtitle A
Technology, Under Secretary for 37, V
Technology Administration 15, XI
Technology Policy, Assistant Secretary for 37, IV
Commercial Space Transportation 14, III
Commodity Credit Corporation 7, XIV
Commodity Futures Trading Commission 5, XLI; 17, I
Community Planning and Development, Office of Assistant 24, V, VI
Secretary for
Community Services, Office of 45, X
Comptroller of the Currency 12, I
Construction Industry Collective Bargaining Commission 29, IX
Consumer Product Safety Commission 5, LXXI; 16, II
Copyright Office 37, II
Copyright Royalty Board 37, III
Corporation for National and Community Service 2, XXII; 45, XII, XXV
Cost Accounting Standards Board 48, 99
Council on Environmental Quality 40, V
Court Services and Offender Supervision Agency for the 28, VIII
District of Columbia
Customs and Border Protection Bureau 19, I
Defense Contract Audit Agency 32, I
Defense Department 5, XXVI; 32, Subtitle A;
40, VII

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CFR Title, Subtitle or
Agency Chapter
Advanced Research Projects Agency 32, I
Air Force Department 32, VII
Army Department 32, V; 33, II; 36, III, 48,
51
Defense Acquisition Regulations System 48, 2
Defense Intelligence Agency 32, I
Defense Logistics Agency 32, I, XII; 48, 54
Engineers, Corps of 33, II; 36, III
Human Resources Management and Labor Relations 5, XCIX
Systems
National Imagery and Mapping Agency 32, I
Navy Department 32, VI; 48, 52
Secretary of Defense, Office of 2, XI; 32, I
Defense Contract Audit Agency 32, I
Defense Intelligence Agency 32, I
Defense Logistics Agency 32, XII; 48, 54
Defense Nuclear Facilities Safety Board 10, XVII
Delaware River Basin Commission 18, III
District of Columbia, Court Services and Offender Supervision 28, VIII
Agency for the
Drug Enforcement Administration 21, II
East-West Foreign Trade Board 15, XIII
Economic Affairs, Under Secretary 37, V
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Economic Research Service 7, XXXVII
Education, Department of 5, LIII
Bilingual Education and Minority Languages Affairs, Office 34, V
of
Civil Rights, Office for 34, I
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Federal Acquisition Regulation 48, 34
Postsecondary Education, Office of 34, VI
Secretary of Education, Office of 34, Subtitle A
Special Education and Rehabilitative Services, Office of 34, III
Vocational and Adult Education, Office of 34, IV
Educational Research and Improvement, Office of 34, VII
Election Assistance Commission 2, LVIII; 11, II
Elementary and Secondary Education, Office of 34, II
Emergency Oil and Gas Guaranteed Loan Board 13, V
Emergency Steel Guarantee Loan Board 13, IV
Employee Benefits Security Administration 29, XXV
Employees’ Compensation Appeals Board 20, IV
Employees Loyalty Board 5, V
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Endangered Species Committee 50, IV
Energy, Department of 5, XXIII; 10, II, III, X
Federal Acquisition Regulation 48, 9, 34
Federal Energy Regulatory Commission 5, XXIV; 18, I
Property Management Regulations 41, 109
Energy, Office of 7, XXIX
Engineers, Corps of 33, II; 36, III
Engraving and Printing, Bureau of 31, VI
Environmental Protection Agency 2, XV; 5, LIV; 40, I, IV,
VII
Federal Acquisition Regulation 48, 15
Property Management Regulations 41, 115
Environmental Quality, Office of 7, XXXI
Equal Employment Opportunity Commission 5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary for 24, I
Executive Office of the President 3, I
Administration, Office of 5, XV
Environmental Quality, Council on 40, V
Management and Budget, Office of 5, III, LXXVII; 14, VI;
48, 99

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CFR Title, Subtitle or
Agency Chapter
National Drug Control Policy, Office of 21, III
National Security Council 32, XXI; 47, 2
Presidential Documents 3
Science and Technology Policy, Office of 32, XXIV; 47, II
Trade Representative, Office of the United States 15, XX
Export-Import Bank of the United States 2, XXXV; 5, LII; 12, IV
Family Assistance, Office of 45, II
Farm Credit Administration 5, XXXI; 12, VI
Farm Credit System Insurance Corporation 5, XXX; 12, XIV
Farm Service Agency 7, VII, XVIII
Federal Acquisition Regulation 48, 1
Federal Aviation Administration 14, I
Commercial Space Transportation 14, III
Federal Claims Collection Standards 31, IX
Federal Communications Commission 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of 41, 60
Federal Crop Insurance Corporation 7, IV
Federal Deposit Insurance Corporation 5, XXII; 12, III
Federal Election Commission 11, I
Federal Emergency Management Agency 44, I
Federal Employees Group Life Insurance Federal Acquisition 48, 21
Regulation
Federal Employees Health Benefits Acquisition Regulation 48, 16
Federal Energy Regulatory Commission 5, XXIV; 18, I
Federal Financial Institutions Examination Council 12, XI
Federal Financing Bank 12, VIII
Federal Highway Administration 23, I, II
Federal Home Loan Mortgage Corporation 1, IV
Federal Housing Enterprise Oversight Office 12, XVII
Federal Housing Finance Agency 5, LXXX; 12, XII
Federal Housing Finance Board 12, IX
Federal Labor Relations Authority 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center 31, VII
Federal Management Regulation 41, 102
Federal Maritime Commission 46, IV
Federal Mediation and Conciliation Service 29, XII
Federal Mine Safety and Health Review Commission 5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration 49, III
Federal Prison Industries, Inc. 28, III
Federal Procurement Policy Office 48, 99
Federal Property Management Regulations 41, 101
Federal Railroad Administration 49, II
Federal Register, Administrative Committee of 1, I
Federal Register, Office of 1, II
Federal Reserve System 12, II
Board of Governors 5, LVIII
Federal Retirement Thrift Investment Board 5, VI, LXXVI
Federal Service Impasses Panel 5, XIV
Federal Trade Commission 5, XLVII; 16, I
Federal Transit Administration 49, VI
Federal Travel Regulation System 41, Subtitle F
Financial Crimes Enforcement Network 31, X
Fine Arts, Commission on 45, XXI
Fiscal Service 31, II
Fish and Wildlife Service, United States 50, I, IV
Fishery Conservation and Management 50, VI
Food and Drug Administration 21, I
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Assets Control, Office of 31, V
Foreign Claims Settlement Commission of the United States 45, V
Foreign Service Grievance Board 22, IX
Foreign Service Impasse Disputes Panel 22, XIV
Foreign Service Labor Relations Board 22, XIV
Foreign-Trade Zones Board 15, IV
Forest Service 36, II

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CFR Title, Subtitle or
Agency Chapter
General Services Administration 5, LVII; 41, 105
Contract Appeals, Board of 48, 61
Federal Acquisition Regulation 48, 5
Federal Management Regulation 41, 102
Federal Property Management Regulations 41, 101
Federal Travel Regulation System 41, Subtitle F
General 41, 300
Payment From a Non-Federal Source for Travel Expenses 41, 304
Payment of Expenses Connected With the Death of Certain 41, 303
Employees
Relocation Allowances 41, 302
Temporary Duty (TDY) Travel Allowances 41, 301
Geological Survey 30, IV
Government Accountability Office 4, I
Government Ethics, Office of 5, XVI
Government National Mortgage Association 24, III
Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II
Harry S. Truman Scholarship Foundation 45, XVIII
Health and Human Services, Department of 2, III; 5, XLV; 45,
Subtitle A,
Centers for Medicare & Medicaid Services 42, IV
Child Support Enforcement, Office of 45, III
Children and Families, Administration for 45, II, III, IV, X
Community Services, Office of 45, X
Family Assistance, Office of 45, II
Federal Acquisition Regulation 48, 3
Food and Drug Administration 21, I
Human Development Services, Office of 45, XIII
Indian Health Service 25, V
Inspector General (Health Care), Office of 42, V
Public Health Service 42, I
Refugee Resettlement, Office of 45, IV
Homeland Security, Department of 2, XXX; 6, I
Coast Guard 33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage) 46, III
Customs and Border Protection Bureau 19, I
Federal Emergency Management Agency 44, I
Human Resources Management and Labor Relations 5, XCVII
Systems
Immigration and Customs Enforcement Bureau 19, IV
Immigration and Naturalization 8, I
Transportation Security Administration 49, XII
HOPE for Homeowners Program, Board of Directors of 24, XXIV
Housing and Urban Development, Department of 2, XXIV; 5, LXV; 24,
Subtitle B
Community Planning and Development, Office of Assistant 24, V, VI
Secretary for
Equal Opportunity, Office of Assistant Secretary for 24, I
Federal Acquisition Regulation 48, 24
Federal Housing Enterprise Oversight, Office of 12, XVII
Government National Mortgage Association 24, III
Housing—Federal Housing Commissioner, Office of 24, II, VIII, X, XX
Assistant Secretary for
Housing, Office of, and Multifamily Housing Assistance 24, IV
Restructuring, Office of
Inspector General, Office of 24, XII
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Secretary, Office of 24, Subtitle A, VII
Housing—Federal Housing Commissioner, Office of Assistant 24, II, VIII, X, XX
Secretary for
Housing, Office of, and Multifamily Housing Assistance 24, IV
Restructuring, Office of
Human Development Services, Office of 45, XIII
Immigration and Customs Enforcement Bureau 19, IV
Immigration and Naturalization 8, I
Immigration Review, Executive Office for 8, V
Independent Counsel, Office of 28, VII

491

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CFR Title, Subtitle or
Agency Chapter
Indian Affairs, Bureau of 25, I, V
Indian Affairs, Office of the Assistant Secretary 25, VI
Indian Arts and Crafts Board 25, II
Indian Health Service 25, V
Industry and Security, Bureau of 15, VII
Information Resources Management, Office of 7, XXVII
Information Security Oversight Office, National Archives and 32, XX
Records Administration
Inspector General
Agriculture Department 7, XXVI
Health and Human Services Department 42, V
Housing and Urban Development Department 24, XII
Institute of Peace, United States 22, XVII
Inter-American Foundation 5, LXIII; 22, X
Interior Department
American Indians, Office of the Special Trustee 25, VII
MBureau of Ocean Energy Management, Regulation, and 30, II
Enforcement
Endangered Species Committee 50, IV
Federal Acquisition Regulation 48, 14
Federal Property Management Regulations System 41, 114
Fish and Wildlife Service, United States 50, I, IV
Geological Survey 30, IV
Indian Affairs, Bureau of 25, I, V
Indian Affairs, Office of the Assistant Secretary 25, VI
Indian Arts and Crafts Board 25, II
Land Management, Bureau of 43, II
National Indian Gaming Commission 25, III
National Park Service 36, I
Natural Resource Revenue, Office of 30, XII
Reclamation, Bureau of 43, I
Secretary of the Interior, Office of 2, XIV; 43, Subtitle A
Surface Mining Reclamation and Enforcement, Office of 30, VII
Internal Revenue Service 26, I
International Boundary and Water Commission, United States 22, XI
and Mexico, United States Section
International Development, United States Agency for 22, II
Federal Acquisition Regulation 48, 7
International Development Cooperation Agency, United 22, XII
States
International Fishing and Related Activities 50, III
International Joint Commission, United States and Canada 22, IV
International Organizations Employees Loyalty Board 5, V
International Trade Administration 15, III; 19, III
International Trade Commission, United States 19, II
Interstate Commerce Commission 5, XL
Investment Security, Office of 31, VIII
James Madison Memorial Fellowship Foundation 45, XXIV
Japan–United States Friendship Commission 22, XVI
Joint Board for the Enrollment of Actuaries 20, VIII
Justice Department 2, XXVII; 5, XXVIII; 28,
I, XI; 40, IV
Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II
Drug Enforcement Administration 21, II
Federal Acquisition Regulation 48, 28
Federal Claims Collection Standards 31, IX
Federal Prison Industries, Inc. 28, III
Foreign Claims Settlement Commission of the United 45, V
States
Immigration Review, Executive Office for 8, V
Offices of Independent Counsel 28, VI
Prisons, Bureau of 28, V
Property Management Regulations 41, 128
Labor Department 5, XLII
Employee Benefits Security Administration 29, XXV
Employees’ Compensation Appeals Board 20, IV
Employment and Training Administration 20, V

492

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CFR Title, Subtitle or
Agency Chapter
Employment Standards Administration 20, VI
Federal Acquisition Regulation 48, 29
Federal Contract Compliance Programs, Office of 41, 60
Federal Procurement Regulations System 41, 50
Labor-Management Standards, Office of 29, II, IV
Mine Safety and Health Administration 30, I
Occupational Safety and Health Administration 29, XVII
Office of Workers’ Compensation Programs 20, VII
Public Contracts 41, 50
Secretary of Labor, Office of 29, Subtitle A
Veterans’ Employment and Training Service, Office of the 41, 61; 20, IX
Assistant Secretary for
Wage and Hour Division 29, V
Workers’ Compensation Programs, Office of 20, I
Labor-Management Standards, Office of 29, II, IV
Land Management, Bureau of 43, II
Legal Services Corporation 45, XVI
Library of Congress 36, VII
Copyright Office 37, II
Copyright Royalty Board 37, III
Local Television Loan Guarantee Board 7, XX
Management and Budget, Office of 5, III, LXXVII; 14, VI;
48, 99
Marine Mammal Commission 50, V
Maritime Administration 46, II
Merit Systems Protection Board 5, II, LXIV
Micronesian Status Negotiations, Office for 32, XXVII
Millenium Challenge Corporation 22, XIII
Mine Safety and Health Administration 30, I
Minority Business Development Agency 15, XIV
Miscellaneous Agencies 1, IV
Monetary Offices 31, I
Morris K. Udall Scholarship and Excellence in National 36, XVI
Environmental Policy Foundation
Museum and Library Services, Institute of 2, XXXI
National Aeronautics and Space Administration 2, XVIII; 5, LIX; 14, V
Federal Acquisition Regulation 48, 18
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National and Community Service, Corporation for 45, XII, XXV
National Archives and Records Administration 2, XXVI; 5, LXVI; 36,
XII
Information Security Oversight Office 32, XX
National Capital Planning Commission 1, IV
National Commission for Employment Policy 1, IV
National Commission on Libraries and Information Science 45, XVII
National Council on Disability 34, XII
National Counterintelligence Center 32, XVIII
National Credit Union Administration 12, VII
National Crime Prevention and Privacy Compact Council 28, IX
National Drug Control Policy, Office of 21, III
National Endowment for the Arts 2, XXXII
National Endowment for the Humanities 2, XXXIII
National Foundation on the Arts and the Humanities 45, XI
National Highway Traffic Safety Administration 23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency 32, I
National Indian Gaming Commission 25, III
National Institute for Literacy 34, XI
National Institute of Food and Agriculture. 7, XXXIV
National Institute of Standards and Technology 15, II
National Intelligence, Office of Director of 32, XVII
National Labor Relations Board 5, LXI; 29, I
National Marine Fisheries Service 50, II, IV
National Mediation Board 29, X
National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI
National Park Service 36, I
National Railroad Adjustment Board 29, III

493

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CFR Title, Subtitle or
Agency Chapter
National Railroad Passenger Corporation (AMTRAK) 49, VII
National Science Foundation 2, XXV; 5, XLIII; 45, VI
Federal Acquisition Regulation 48, 25
National Security Council 32, XXI
National Security Council and Office of Science and 47, II
Technology Policy
National Telecommunications and Information 15, XXIII; 47, III, IV
Administration
National Transportation Safety Board 49, VIII
Natural Resources Conservation Service 7, VI
Natural Resource Revenue, Office of 30, XII
Navajo and Hopi Indian Relocation, Office of 25, IV
Navy Department 32, VI
Federal Acquisition Regulation 48, 52
Neighborhood Reinvestment Corporation 24, XXV
Northeast Interstate Low-Level Radioactive Waste 10, XVIII
Commission
Nuclear Regulatory Commission 2, XX; 5, XLVIII; 10, I
Federal Acquisition Regulation 48, 20
Occupational Safety and Health Administration 29, XVII
Occupational Safety and Health Review Commission 29, XX
Offices of Independent Counsel 28, VI
Office of Workers’ Compensation Programs 20, VII
Oklahoma City National Memorial Trust 36, XV
Operations Office 7, XXVIII
Overseas Private Investment Corporation 5, XXXIII; 22, VII
Patent and Trademark Office, United States 37, I
Payment From a Non-Federal Source for Travel Expenses 41, 304
Payment of Expenses Connected With the Death of Certain 41, 303
Employees
Peace Corps 22, III
Pennsylvania Avenue Development Corporation 36, IX
Pension Benefit Guaranty Corporation 29, XL
Personnel Management, Office of 5, I, XXXV; 45, VIII
Human Resources Management and Labor Relations 5, XCIX
Systems, Department of Defense
Human Resources Management and Labor Relations 5, XCVII
Systems, Department of Homeland Security
Federal Acquisition Regulation 48, 17
Federal Employees Group Life Insurance Federal 48, 21
Acquisition Regulation
Federal Employees Health Benefits Acquisition Regulation 48, 16
Pipeline and Hazardous Materials Safety Administration 49, I
Postal Regulatory Commission 5, XLVI; 39, III
Postal Service, United States 5, LX; 39, I
Postsecondary Education, Office of 34, VI
President’s Commission on White House Fellowships 1, IV
Presidential Documents 3
Presidio Trust 36, X
Prisons, Bureau of 28, V
Procurement and Property Management, Office of 7, XXXII
Productivity, Technology and Innovation, Assistant 37, IV
Secretary
Public Contracts, Department of Labor 41, 50
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Public Health Service 42, I
Railroad Retirement Board 20, II
Reclamation, Bureau of 43, I
Recovery Accountability and Transparency Board 4, II
Refugee Resettlement, Office of 45, IV
Relocation Allowances 41, 302
Research and Innovative Technology Administration 49, XI
Rural Business-Cooperative Service 7, XVIII, XLII, L
Rural Development Administration 7, XLII
Rural Housing Service 7, XVIII, XXXV, L
Rural Telephone Bank 7, XVI
Rural Utilities Service 7, XVII, XVIII, XLII, L

494

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CFR Title, Subtitle or
Agency Chapter
Saint Lawrence Seaway Development Corporation 33, IV
Science and Technology Policy, Office of 32, XXIV
Science and Technology Policy, Office of, and National 47, II
Security Council
Secret Service 31, IV
Securities and Exchange Commission 5, XXXIV; 17, II
Selective Service System 32, XVI
Small Business Administration 2, XXVII; 13, I
Smithsonian Institution 36, V
Social Security Administration 2, XXIII; 20, III; 48, 23
Soldiers’ and Airmen’s Home, United States 5, XI
Special Counsel, Office of 5, VIII
Special Education and Rehabilitative Services, Office of 34, III
Special Inspector General for Iraq Reconstruction 5, LXXXVII
State Department 2, VI; 22, I; 28, XI
Federal Acquisition Regulation 48, 6
Surface Mining Reclamation and Enforcement, Office of 30, VII
Surface Transportation Board 49, X
Susquehanna River Basin Commission 18, VIII
Technology Administration 15, XI
Technology Policy, Assistant Secretary for 37, IV
Technology, Under Secretary for 37, V
Tennessee Valley Authority 5, LXIX; 18, XIII
Thrift Supervision Office, Department of the Treasury 12, V
Trade Representative, United States, Office of 15, XX
Transportation, Department of 2, XII; 5, L
Commercial Space Transportation 14, III
Contract Appeals, Board of 48, 63
Emergency Management and Assistance 44, IV
Federal Acquisition Regulation 48, 12
Federal Aviation Administration 14, I
Federal Highway Administration 23, I, II
Federal Motor Carrier Safety Administration 49, III
Federal Railroad Administration 49, II
Federal Transit Administration 49, VI
Maritime Administration 46, II
National Highway Traffic Safety Administration 23, II, III; 47, IV; 49, V
Pipeline and Hazardous Materials Safety Administration 49, I
Saint Lawrence Seaway Development Corporation 33, IV
Secretary of Transportation, Office of 14, II; 49, Subtitle A
Surface Transportation Board 49, X
Transportation Statistics Bureau 49, XI
Transportation, Office of 7, XXXIII
Transportation Security Administration 49, XII
Transportation Statistics Bureau 49, XI
Travel Allowances, Temporary Duty (TDY) 41, 301
Treasury Department 5, XXI; 12, XV; 17, IV;
31, IX
Alcohol and Tobacco Tax and Trade Bureau 27, I
Community Development Financial Institutions Fund 12, XVIII
Comptroller of the Currency 12, I
Customs and Border Protection Bureau 19, I
Engraving and Printing, Bureau of 31, VI
Federal Acquisition Regulation 48, 10
Federal Claims Collection Standards 31, IX
Federal Law Enforcement Training Center 31, VII
Financial Crimes Enforcement Network 31, X
Fiscal Service 31, II
Foreign Assets Control, Office of 31, V
Internal Revenue Service 26, I
Investment Security, Office of 31, VIII
Monetary Offices 31, I
Secret Service 31, IV
Secretary of the Treasury, Office of 31, Subtitle A
Thrift Supervision, Office of 12, V
Truman, Harry S. Scholarship Foundation 45, XVIII
United States and Canada, International Joint Commission 22, IV

495

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CFR Title, Subtitle or
Agency Chapter
United States and Mexico, International Boundary and Water 22, XI
Commission, United States Section
Utah Reclamation Mitigation and Conservation Commission 43, III
Veterans Affairs Department 2, VIII; 38, I
Federal Acquisition Regulation 48, 8
Veterans’ Employment and Training Service, Office of the 41, 61; 20, IX
Assistant Secretary for
Vice President of the United States, Office of 32, XXVIII
Vocational and Adult Education, Office of 34, IV
Wage and Hour Division 29, V
Water Resources Council 18, VI
Workers’ Compensation Programs, Office of 20, I
World Agricultural Outlook Board 7, XXXVIII

496

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List of CFR Sections Affected
All changes in this volume of the Code of Federal Regulations that
were made by documents published in the FEDERAL REGISTER since Jan-
uary 1, 2001, are enumerated in the following list. Entries indicate the
nature of the changes effected. Page numbers refer to FEDERAL REGISTER
pages. The user should consult the entries for chapters and parts as well
as sections for revisions.
For the period before January 1, 2001, see the ‘‘List of CFR Sections Af-
fected, 1949–1963, 1964–1972, 1973–1985, and 1986–2000’’ published in 11 sepa-
rate volumes.

2001 21 CFR—Continued 66 FR
Page
21 CFR 66 FR Chapter I—Continued
Page
(a)(3) added; eff. 1–22–01 to 4–22–01
Chapter I ................................................. 12848
1 Nomenclature change ................ 56034 50 Authority citation revised........ 20597
Authority citation revised ...........65447 50.1 (a) amended; interim .............. 20597
1.101 Added ................................... 65447 50.3 (b)(23), (24), (25) and (n)
5 Revised ...................................... 30993 through (s) added; interim ........ 20597
Nomenclature change ..................56034 50.50—50.56 (Subpart D) Added;
10 Nomenclature change............... 56034 interim..................................... 20598
10.20 (f) amended........................... 66742 56 Authority citation revised........ 20599
10.30 (i)(6) amended ........................ 6467 56.101 (a) amended; interim ........... 20599
(i)(6) amended; eff. 1–22–01 to 4– 56.102 (b)(21), (22) and (23) added;
22–01..........................................12848 interim..................................... 20599
10.33 (k)(6) amended ....................... 6467 56.109 (h) added; interim................ 20599
(k)(6) amended; eff. 1–22–01 to 4– 56.111 (c) added; interim ................ 20599
22–01..........................................12848 70 Nomenclature change............... 56034
10.35 (h)(6) amended ....................... 6468 71 Nomenclature change............... 56034
(h)(6) amended; eff. 1–22–01 to 4– 73 Nomenclature change...... 56034, 66742
22–01..........................................12848 80 Nomenclature change............... 56034
10.40 (g)(7) amended........................ 6468
(g)(7) amended; eff. 1–22–01 to 4– 2002
22–01..........................................12848
10.65 Revised .................................. 6468 21 CFR 67 FR
Page
Stayed; eff. to 4–22–01....................12848
10.65a Added; eff. to 4–22–01............ 12848 Chapter I
10.100 Revised ................................ 6468 1.101 Regulation at 66 FR 65447 eff.
Stayed; eff. to 4–22–01....................12848 date stayed ............................... 34387
10.100a Added; eff. to 4–22–01 .......... 12848 2 Authority citation revised ......... 48384
14 Authority citation revised; eff. Technical correction ..........49396, 58678
5–23–01........................................ 1259 2.125 Revised; eff. 1–20–03 ............... 48384
14.20 (e) removed ............................ 6469 5.28 (c)(1) revised; (c)(10) redesig-
(e) added; eff. 1–22–01 to 4–22–01 nated as (c)(11); new (c)(10)
................................................. 12848 added........................................ 53306
14.75 (a)(1) revised; eff. 5–23–01......... 1259 Regulation at 67 FR 53306 eff.
Regulation at 66 FR 1259 with- date confirmed..........................71461
drawn .......................................20401 10.50 (c)(7) removed; eff. 4–2–
16.60 (a)(3) removed ........................ 6469 02 ............................................... 4906

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21 CFR (4–1–11 Edition)

21 CFR—Continued 67 FR 21 CFR—Continued 68 FR
Page Page
Chapter I—Continued Chapter I—Continued
14.100 (c)(7) heading and (ii) re- 20.20 (e) added ............................... 25285
vised......................................... 45900 20.22 Existing text designated as
16.1 (b)(2) amended; eff. 5–7–02....... 5467 (a); (b) added ............................. 25285
16.42 (a) revised............................. 53306 20.26 (a)(4) added; (b) revised.......... 25285
Regulation at 67 FR 53306 eff. 20.27 Amended .............................. 25285
date confirmed..........................71461 20.28 Amended .............................. 25285
20.100 (c)(30) removed; (c)(31) 20.29 Amended .............................. 25285
through (41) redesignated as 20.33 Added ................................... 25285
(c)(30) through (40) .................... 13717 20.34 Added ................................... 25285
(c)(41) added .................................35729 20.40 (a) revised............................. 25285
56.108 OMB number ........................ 9585 20.41 (b) introductory text and (3)
56.115 OMB number ........................ 9585 revised; (b)(2) amended; (c)
58.3 (e)(23) added ........................... 35729 added........................................ 25285
58.35 OMB number .......................... 9585 20.42 Redesignated as 20.45; new
58.63 OMB number .......................... 9585 20.42 added ................................ 25286
58.90 OMB number .......................... 9585 20.43 Redesignated as 20.46; new
58.105 OMB number ........................ 9585 20.43 added ................................ 25286
58.120 OMB number ........................ 9585 20.44 Revised ................................ 25286
58.130 OMB number ........................ 9585 20.45 Redesignated as 20.47; new
58.190 OMB number ........................ 9585 20.45 redesignated from 20.42;
60.24 OMB number .......................... 9585 (a) introductory text and (c)(1)
60.30 OMB number .......................... 9585 amended; (c) introductory text
60.40 OMB number .......................... 9585 and (6) revised ........................... 25286
73.125 Added ................................. 35431 20.46 Redesignated as 20.48; new
Regulation at 67 FR 35431 con- 20.46 redesignated from
firmed.......................................49567 20.43.......................................... 25286
73.3128 Added ................................ 65312 (a) introductory text revised ........25287
20.47 Redesignated as 20.49; new
2003 20.47 redesignated from
21 CFR 68 FR 20.45.......................................... 25286
Page 20.48 Redesignated as 20.50; new
Chapter I 20.48 redesignated from
1 Authority citation revised ......... 58960 20.46.......................................... 25286
Meeting .......................................61340 Amended .....................................25287
Technical correction ...................63017 20.49 Redesignated as 20.51; new
Policy statement .........................69957 20.49 redesignated from
1.225—1.243 (Subpart H) Added; 20.47.......................................... 25286
interim..................................... 58960 (a) and (c) revised .........................25287
1.276—1.285 (Subpart I) Added; in- 20.50 Redesignated as 20.52; new
terim........................................ 59070 20.50 redesignated from
3 Nomenclature change ................ 24879 20.48.......................................... 25286
3.1 Amended ................................. 37077 20.51 Redesignated as 20.53; new
3.2 (b) revised................................ 37077 20.51 redesignated from
3.6 Revised ................................... 37077 20.49.......................................... 25286
3.7 (d) amended ............................. 37077 20.52 Redesignated as 20.54; new
3.9 (b) amended ............................. 37077 20.52 redesignated from
7 Nomenclature change ................ 24879 20.50.......................................... 25286
10 Nomenclature change............... 24879 20.53 Redesignated as 20.55; new
10.20 (c)(6) and (j)(2)(ii) amend- 20.53 redesignated from
ed ............................................. 25285 20.51.......................................... 25286
12 Nomenclature change............... 24879 Amended .....................................25287
14.61 (d) amended .......................... 25285 20.54 Redesignated from 20.52 ........ 25286
16.1 (b)(2) amended; interim .......... 62368 20.55 Redesignated from 20.53 ........ 25286
17 Nomenclature change............... 24879 20.81 (b) removed; (c) redesig-
20 Meeting.................................... 61340 nated as new (b)......................... 25287
Technical correction ...................63017 20.83 (a) amended .......................... 25287

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List of CFR Sections Affected

21 CFR—Continued 68 FR 21 CFR—Continued 69 FR
Page Page
Chapter I—Continued Chapter I—Continued
20.100 (c)(42) added; interim........... 58965 10.45 (d) introductory text re-
20.107 (a) revised ........................... 25287 vised......................................... 31705
20.111 (b) and (c)(4) amended .......... 25287 10.50 (c)(11) removed; CFR correc-
20.120 Added ................................. 25287 tion .......................................... 74418
(a) corrected ................................65392 11.1 (f) added ................................. 71655
25 Nomenclature change............... 24879 12 Nomenclature change............... 13717
58.3 (e)(9) correctly removed; CFR 13 Nomenclature change............... 13717
correction.................................. 6609 14 Nomenclature change............... 13717
60 Nomenclature change............... 24879 Authority citation revised ...........46099
73.3128 Regulation at 67 FR 65312 14.100 (a)(3) added.......................... 46099
eff. date confirmed ..................... 7416 (b)(2) heading and (ii) revised ........62810
15 Nomenclature change............... 13717
2004 16.1 (b)(1) amended........................ 31705
(b)(2) amended; eff. 5-25-05.............68680
21 CFR 69 FR 16.26 (a) revised............................. 17290
Page
16.40 Revised ................................ 17290
Title 21 Nomenclature change ...... 18803
17 Nomenclature change............... 13717
Chapter I 17.1 (d), (e) and (f) redesignated as
1 Policy statement ................. 1675, 7347 (e), (f) and (g); introductory
Comment period reopened...19763, 19766 text, (a), (b), new (e), (f) and (g)
Policy statement .......19765, 24070, 47765 revised; new (d) added ............... 43301
Meetings......................................71655 17.2 Added .................................... 43301
1.101 (d)(2)(ii) revised .................... 48774 Table corrected............................49807
1.231 (b)(1) revised; interim ........... 29428 20 Nomenclature change............... 13717
1.232 (d) and (g) revised; in- Comment period reopened............19766
terim........................................ 29428 20.65 Added ................................... 53616
1.276 (b)(3) corrected....................... 4851 20.66 Added ................................... 53616
1.276–1.285 (Subpart I) Regulation 20.67 Added ................................... 53616
at 68 FR 59070 comment period 21.43 (a)(2) revised ......................... 17290
extended................................... 28060 25 Nomenclature change............... 13717
1.279 (f) corrected ........................... 4851 25.5 (b)(5) revised .......................... 17291
1.280 (a), (c) and (d) corrected .......... 4851 25.40 (e) revised ............................. 17291
(d) corrected ..................................8330 25.45 (a) revised............................. 17291
1.281 (a)(6), (7), (9), (12), (13), (b) in- 26.1—26.21 (Subpart A) Appendix
troductory text, (6), (c) intro- E amended ................................ 48775
ductory text, (7) and (13) cor- 60 Nomenclature change............... 13717
rected ........................................ 4851 73.1 (b)(2) amended........................ 24511
1.283 (a)(1)(ii), (3) and (6) cor- 73.3125 (a) amended ....................... 24511
rected ........................................ 4851 74 Technical correction ................ 52169
(b), (c), (d) introductory text, (1) 74.2052 Added ................................ 44930
and (e) corrected .........................4852 Regulation at 69 FR 44930 con-
1.284 (b)(1) corrected....................... 4852 firmed.......................................60307
1.285 (b), (d), (f), (g), (i)(1), (j)(1),
(3), (l)(1) and (2) corrected ........... 4852
1.326—1.368 (Subpart J) Added ....... 71651
2005
1.377—1.406 (Subpart K) Added ...... 31701 21 CFR 70 FR
3 Nomenclature change ................ 13717 Page
5 Nomenclature change ................ 13717 Chapter I
Revised ........................................17286 1 Meetings.................................... 25461
5.1100 Amended.................... 48775, 52600 Policy statement ................53728, 70488
7 Nomenclature change ................ 13717 1.101 (d)(2)(i) and (ii) revised .......... 14980
7.45 (a) introductory text re- 1.225—1.243 (Subpart H) Regula-
vised......................................... 17290 tion at 68 FR 58960 con-
10 Nomenclature change............... 13717 firmed ...................................... 57509
10.1 (a) revised .............................. 17290 1.231 Regulation at 69 FR 29428
10.3 (a) amended............................ 17290 confirmed................................. 57509

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21 CFR (4–1–11 Edition)

21 CFR—Continued 70 FR 21 CFR—Continued 71 FR
Page Page
Chapter I—Continued Chapter I—Continued
1.232 Regulation at 69 FR 29428 73.1128 Stay removed .................... 41125
confirmed................................. 57509 80.10 (b)(2) revised; interim ........... 70875
1.363 (b) revised .............................. 8726
1.368 (a) revised .............................. 8727
2 Nomenclature change ....... 40880, 67651 2007
2.19 Amended................................ 40880 21 CFR 72 FR
2.125 (e)(2)(1) removed; eff. 12-31- Page
08.............................................. 17192 2.125 Regulation at 71 FR 70873
3 Authority citation revised ......... 49861 confirmed................................. 20942
3.2 (k) through (m) redesignated 14.100 (c)(16) heading and (ii) re-
as (l), (n), (o) and (p); new (k) vised .......................................... 9675
and (m) added............................ 49861
(a)(4) added ..................................41221
3.4 (b) redesignated as (c); new (b)
added........................................ 49861 16.1 Regulation at 68 FR 62368
3.7 (c)(2)(ix) and (3) revised ............ 49861 comment period reopened in
10 Nomenclature change............... 67651 part ........................................... 7825
10.95 (d)(8)(v) amended .................. 40880 20.100 (c)(43) added ........................ 41017
11 Policy statement...................... 70488 (c)(44) added .................................69118
20.65 Regulation at 69 FR 53616 25.20 (m) revised............................ 69118
withdrawn ................................. 2799 25.33 (a) introductory text, (c), (d)
Added ..........................................41958 introductory text and (g) re-
20.66 Regulation at 69 FR 53616 vised......................................... 69119
withdrawn ................................. 2799 71.1 Regulation at 65 FR 51762 con-
Added ..........................................41958
firmed........................................ 8111
20.67 Regulation at 69 FR 53616
withdrawn ................................. 2799 (c) amended..................................10357
Added ..........................................41958 73.1128 Redesignated as 73.1350 ...... 10357
20.82 (b)(3) revised ......................... 41958 73.1350 Redesignated from
20.100 Regulation at 68 FR 58965 73.1128....................................... 10357
confirmed................................. 57509 73.2396 (d)(1) amended ................... 10357
25.31 (f) amended........................... 14980 74.2052 (b)(9) amended ................... 10357
25.34 (b) revised; (i) added .............. 69277 74.2053 Added ................................ 33666
26.4 (b) amended............................ 14980 Regulation at 72 FR 33666 con-
73.585 Added ................................. 43045 firmed.......................................45328
73.1128 Added ................................ 42273
80.10 (a) and (b) revised; eff. 4–28–
05; interim ................................ 15756 2008
99.201 (c)(1) and (2) revised ............. 14980 21 CFR 73 FR
Page
2006 Chapter I
21 CFR 71 FR 1.231 (b)(2) revised ......................... 15883
Page
1.234 (d)(2) revised ......................... 15883
Chapter I 1.235 (d)(2) revised ......................... 15883
1 Policy statement .............. 36986, 56006 1.276—1.285 (Subpart I) Revised;
2.125 (e)(1)(i), (ii), (iv), (2)(ii), eff. 5–6–09 .................................. 66402
(4)(i), (ii) and (v) removed; eff. 2.125 (e)(2)(v) removed................... 69552
in part 4–27–07 and 8–1–07............ 70873
16 Technical correction ................ 54314
3.6 Amended ................................. 16033
11 Policy statement............. 36986, 56006 16.1 (b)(2) amended............... 49942, 51919
17.47 (a) amended............................ 5979 17.1 (c) through (g) redesignated
25.33 (a)(4) amended ...................... 74782 as (e) through (i); new (c) and
50.23 (e) added; interim ................. 32833 (d) added ................................... 66752
73.350 Added ................................. 31929 17.2 Introductory text revised ....... 15884
Regulation at 71 FR 31929 con- Revised ........................................66752
firmed.......................................54411
73.585 Stay removed ....................... 9448

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List of CFR Sections Affected

2009 21 CFR—Continued 75 FR
Page
21 CFR 74 FR Chapter I—Continued
Page 2.125 (e)(1)(iii), (v), (2)(iii), (iv),
Chapter I (4)(iv), (vii) and (viii) removed;
1.101 (d)(2)(ii) amended ................. 13112 eff. in part 6–30–11 and 12–31–
2.125 (e)(2)(v) correctly rein- 13.............................................. 19241
stated; CFR correction ............. 40069 3.6 Amended; eff. 4–19–10................ 13678
5 Revised ............................. 14721, 14721 5 Revised ...................................... 16354
10.90 (a) and (c) revised .................. 16346
14.100 (a)(4)(i) and (ii) revised ........ 35801
14.55 (f) added; eff. 4–14–11 .............. 73953
(a)(5) added ..................................43043 14.84 (c)(1), (3), (4) and (5)(ii) re-
16 Meetings .................................. 44750 vised......................................... 15342
16.5 (a)(5) added............................. 33095 17.1 (j) added; eff. 4–14–11 ............... 73953
17.1 Regulation at 73 FR 66752 con- 17.2 Revised; eff. 4–14–11 ................ 73954
firmed........................................ 8200 73.37 Regulation at 74 FR 57251
17.2 Regulation at 73 FR 66752 con- confirmed .................................. 5887
firmed........................................ 8200 73.352 Regulation at 74 FR 58845
26.1—26.21 (Subpart A) Appendix confirmed .................................. 5887
E amended ................................ 13112 73.2110 (c)(1) revised; eff. 4–27–
56.102 (b)(12) amended; eff. 7–14– 10.............................................. 14493
09 ............................................... 2368 Regulation at 75 FR 14493 con-
56.106 Added; eff, 7–14–09 ................. 2368 firmed.......................................34361
73.37 Added ................................... 57251
73.100 (d) revised; eff. 1–5–11 .............. 216 2011
Regulation at 74 FR 216 con- (Regulations published from January 1,
firmed.......................................10483 2011, through April 1, 2011)
73.352 Added ................................. 58845
73.2087 (c) revised; eff. 1–5–11............. 216
21 CFR 76 FR
Page
Regulation at 74 FR 216 con-
Chapter I
firmed.......................................10483
1 Regulation at 75 FR 73953 con-
firmed ...................................... 12563
2010 1.1 Regulation at 75 FR 73953 con-
21 CFR 75 FR firmed ...................................... 12563
Page 1.20 Regulation at 75 FR 73953 con-
firmed ...................................... 12563
Chapter I
14.55 Regulation at 75 FR 73953
1 Authority citation revised ......... 73953 confirmed................................. 12563
1.1 (b) revised; (c) amended; eff. 4– 17.1 Regulation at 75 FR 73953 con-
14–11 ......................................... 73953 firmed ...................................... 12563
1.20 Introductory text revised; 17.2 Regulation at 75 FR 73954 con-
eff. 4–14–11................................. 73953 firmed ...................................... 12563
1.101 (d)(2)(iii) revised ................... 20914 50.25 (c) and (d) redesignated as
2 Technical correction.................. 56858 (d) and (e); new (c) added ............... 270

501

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