Professional Documents
Culture Documents
meeting, the background material will FDA also announced the availability for
be made publicly available at the public comment of a proposed risk
location of the advisory committee management plan for animal clones and
meeting, and the background material their progeny and a draft guidance for
will be posted on FDA’s Web site after industry describing FDA’s
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15888 Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices
recommendations regarding the use of the requirement of special controls for receive any comments on the proposed
edible products from animal clones and class II devices. Elsewhere in this issue reclassification. FDA is now identifying
their progeny in human food or in of the Federal Register, FDA is the guidance document entitled ‘‘Class
animal feed. publishing a final rule reclassifying II Special Controls Guidance Document:
The agency has received requests for these devices from class III (premarket Herpes Simplex Virus Types 1 and 2
an extension of the comment period for approval) into class II (special controls). Serological Assays’’ as the guidance
the draft risk assessment, proposed risk DATES: Submit written or electronic document that will serve as the special
management plan, and draft guidance. comments on agency guidances at any control for these devices.
These requests conveyed concern that time. General comments on agency The guidance document provides a
the current 90-day comment period does guidance documents are welcome at any means by which herpes simplex virus
not allow sufficient time to develop a time. types 1 and 2 serological assays may
meaningful or thoughtful response to ADDRESSES: Submit written requests for
comply with the requirement of special
the cloning documents. single copies of the guidance document controls for class II devices. Following
FDA has considered the requests and the effective date of the final
entitled ‘‘Class II Special Controls
is extending the comment period for the reclassification rule, any firm
Guidance Document: Herpes Simplex
draft risk assessment, proposed risk submitting a premarket notification
Virus Types 1 and 2 Serological Assays’’
management plan, and draft guidance (510(k)) for herpes simplex virus type 1
to the Division of Small Manufacturers,
until May 3, 2007. The agency believes and 2 serological assays will need to
International, and Consumer Assistance
this extension allows adequate time for address the issues covered in the special
(HFZ–220), Center for Devices and
interested persons to submit comments. controls guidance document. However,
Radiological Health, Food and Drug
the firm need only show that its device
II. Request for Comments Administration, 1350 Piccard Dr.,
meets the recommendations of the
Interested persons may submit to the Rockville, MD 20850. Send one self-
guidance document or in some other
Division of Dockets Management (see addressed adhesive label to assist that
way provides equivalent assurances of
ADDRESSES) written or electronic office in processing your request, or fax safety and effectiveness.
comments on these documents. Submit your request to 240–276–3151. See the
a single copy of electronic comments or SUPPLEMENTARY INFORMATION section for II. Significance of Guidance
two paper copies of any mailed information on electronic access to the This guidance is being issued
comments, except that individuals may guidance. consistent with FDA’s good guidance
submit one paper copy. Comments are Submit written comments concerning practices regulation (21 CFR 10.115).
to be identified with the docket number this guidance to the Division of Dockets The guidance represents the agency’s
found in brackets in the heading of this Management (HFA–305), Food and Drug current thinking on herpes simplex
document. Received comments may be Administration, 5630 Fishers Lane, rm. virus types 1 and 2 serological assays.
seen in the Division of Dockets 1061, Rockville, MD 20852. Submit It does not create or confer any rights for
Management between 9 a.m. and 4 p.m., electronic comments to http:// or on any person and does not operate
Monday through Friday. www.fda.gov/dockets/ecomments. to bind FDA or the public. An
Identify comments with the docket alternative approach may be used if
Dated: March 27, 2007. number found in brackets in the
Jeffrey Shuren, such approach satisfies the
heading of this document. requirements of the applicable statute
Assistant Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: and regulations.
[FR Doc. E7–6170 Filed 4–2–07; 8:45 am] Sally Hojvat, Center for Devices and
BILLING CODE 4160–01–S Radiological Health (HFZ–440), Food III. Electronic Access
and Drug Administration, 9200 Persons interested in obtaining a copy
Corporate Blvd., Rockville, MD 20850, of the guidance may do so by using the
DEPARTMENT OF HEALTH AND 240–276–0496. Internet. To receive ‘‘Class II Special
HUMAN SERVICES Controls Guidance Document: Herpes
SUPPLEMENTARY INFORMATION:
Food and Drug Administration Simplex Virus Types 1 and 2
I. Background Serological Assays’’ you may either
Docket No. 2005D–0468 In the Federal Register of January 9, send an e-mail request to
2006 (71 FR 1399), FDA published a dsmica@fda.hhs.gov to receive an
Guidance for Industry and Food and proposed rule to reclassify herpes electronic copy of the document or send
Drug Administration Staff; Class II simplex virus types 1 and 2 serological a fax request to 240–276–3151 to receive
Special Controls Guidance Document: assays from class III (premarket a hard copy. Please use the document
Herpes Simplex Virus Types 1 and 2 approval) into class II (special controls). number 1305 to identify the guidance
Serological Assays; Availability In addition, FDA issued a draft class II you are requesting.
AGENCY: Food and Drug Administration, special controls guidance document CDRH maintains an entry on the
HHS. entitled ‘‘Class II Special Controls Internet for easy access to information
ACTION: Notice. Guidance Document: Herpes Simplex including text, graphics, and files that
Virus Types 1 and 2 Serological Assays’’ may be downloaded to a personal
SUMMARY: The Food and Drug to support the proposed reclassification. computer with Internet access. Updated
Administration (FDA) is announcing the Herpes simplex virus types 1 and 2 on a regular basis, the CDRH home page
availability of the guidance document serological assays are in vitro diagnostic includes device safety alerts, Federal
entitled ‘‘Class II Special Controls devices that test for specific antibodies. Register reprints, information on
Guidance Document: Herpes Simplex In conjunction with other clinical premarket submissions (including lists
ycherry on PROD1PC64 with NOTICES
Virus Types 1 and 2 Serological laboratory findings, the detection of of approved applications and
Assays.’’ This guidance document these HSV type 1 and/or 2 -specific manufacturers’ addresses), small
describes a means by which herpes antibodies aids in the clinical laboratory manufacturer’s assistance, information
simplex virus type 1 and 2 (HSV 1 and diagnosis of an acute or past infection on video conferencing and electronic
2) serological assays may comply with by HSV type 1 and/or 2. FDA did not submissions, Mammography Matters,
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