You are on page 1of 3

11936 Federal Register / Vol. 73, No.

44 / Wednesday, March 5, 2008 / Notices

SUMMARY: This is notice, in accordance technology is A-dmDT390-bisFV Register on June 9, 1994 (59 FR 29908),
with 35 U.S.C. 209(c)(1) and 37 CFR (UCHT1). The immunotoxins are on September 30, 1997 (62 FR 51118),
part 404.7(a)(1)(i), that the National targeted via an antibody that is specific and on April 13, 2004 (69 FR 19644).
Institutes of Health, Department of to T cells, allowing the specific ablation A notice listing all currently certified
Health and Human Services, is of both malignant T cells and resting T laboratories is published in the Federal
contemplating the grant of an exclusive cells. The transient ablation of resting T Register during the first week of each
patent license to practice the inventions cells can ‘‘reset’’ the immune system by month. If any laboratory’s certification
embodied in U.S. Patent 5,167,956 accentuating tolerating responses to is suspended or revoked, the laboratory
entitled ‘‘Immunotoxin with in-vivo T– autoimmune diseases like Lupus. will be omitted from subsequent lists
Cell suppressant activity and Methods Additionally, the immunotoxins can be until such time as it is restored to full
of Use’’ [HHS Ref. E–012–1991/0–US– used to treat T cell related cancers such certification under the Mandatory
01], U.S. Patent Application 60/037,196 as non-Hodgkins’ lymphomas, including Guidelines.
entitled ‘‘Novel Vectors and Expression cutaneous T cell lymphoma (CTCL). If any laboratory has withdrawn from
Methods for Producing Mutant The prospective exclusive license will the HHS National Laboratory
Proteins’’ [HHS Ref. E–043–1997/0–US– be royalty bearing and will comply with Certification Program (NLCP) during the
01], U.S. Patent Application 60/039,987 the terms and conditions of 35 U.S.C. past month, it will be listed at the end,
entitled ‘‘Novel Immunotoxins and 209 and 37 CFR 404.7. The prospective and will be omitted from the monthly
Methods of Inducing Immune exclusive license may be granted unless listing thereafter.
Tolerance’’ [HHS Ref. E–044–1997/0– within sixty (60) days from the date of
US–01], U.S. Patent Application 09/ this published notice, the NIH receives This notice is also available on the
064,413 entitled ‘‘Use of Immunotoxins written evidence and argument that Internet at http://
to Induce Immune Tolerance to establishes that the grant of the license www.workplace.samhsa.gov and http://
Pancreatic Islet Transplantation’’ [HHS would not be consistent with the www.drugfreeworkplace.gov.
Ref. E–059–1998/0–US–01], U.S. Patent requirements of 35 U.S.C. 209 and 37 FOR FURTHER INFORMATION CONTACT: Mrs.
Application 09/291,712 entitled CFR 404.7. Giselle Hersh, Division of Workplace
‘‘Methods Related to the Combined Use Applications for a license in the field Programs, SAMHSA/CSAP, Room 2–
of Immunotoxins and Agents that of use filed in response to this notice 1042, One Choke Cherry Road,
Inhibit Dendritic Cell Maturation’’ [HHS will be treated as objections to the grant Rockville, Maryland 20857; 240–276–
Ref. E–168–1999/0–US–01], and all of the contemplated exclusive license. 2600 (voice), 240–276–2610 (fax).
continuing applications and foreign Comments and objections submitted to
counterparts, to CK Life Sciences this notice will not be made available SUPPLEMENTARY INFORMATION: The
International, Inc., which has offices in for public inspection and, to the extent Mandatory Guidelines were developed
Hong Kong. The patent rights in these permitted by law, will not be released in accordance with Executive Order
inventions have been assigned to and/or under the Freedom of Information Act, 12564 and section 503 of Public Law
exclusively licensed to the Government 5 U.S.C. 552. 100–71. Subpart C of the Mandatory
of the United States of America. Guidelines, ‘‘Certification of
Dated: February 27, 2008. Laboratories Engaged in Urine Drug
The prospective exclusive license Bonny Harbinger,
territory may be worldwide, and the Testing for Federal Agencies,’’ sets strict
Deputy Director, Office of Technology standards that laboratories must meet in
field of use may be limited to: The Transfer, National Institutes of Health.
production and use of the order to conduct drug and specimen
[FR Doc. E8–4198 Filed 3–4–08; 8:45 am] validity tests on urine specimens for
immunotoxins covered by the licensed
patent rights for the treatment of T-cell BILLING CODE 4140–01–P Federal agencies. To become certified,
mediated diseases, including but not an applicant laboratory must undergo
limited to T-cell lymphoma and three rounds of performance testing plus
DEPARTMENT OF HEALTH AND an on-site inspection. To maintain that
autoimmune diseases. HUMAN SERVICES certification, a laboratory must
DATES: Only written comments and/or
participate in a quarterly performance
applications for a license which are Substance Abuse and Mental Health testing program plus undergo periodic,
received by the NIH Office of Services Administration on-site inspections.
Technology Transfer on or before May 5,
2008 will be considered. Current List of Laboratories Which Laboratories which claim to be in the
ADDRESSES: Requests for copies of the Meet Minimum Standards To Engage in applicant stage of certification are not to
patent application, inquiries, comments, Urine Drug Testing for Federal be considered as meeting the minimum
and other materials relating to the Agencies requirements described in the HHS
contemplated exclusive license should Mandatory Guidelines. A laboratory
AGENCY: Substance Abuse and Mental must have its letter of certification from
be directed to: David A. Lambertson, Health Services Administration, HHS.
Ph.D., Technology Licensing Specialist, HHS/SAMHSA (formerly: HHS/NIDA)
ACTION: Notice. which attests that it has met minimum
Office of Technology Transfer, National
Institutes of Health, 6011 Executive standards.
SUMMARY: The Department of Health and
Boulevard, Suite 325, Rockville, MD Human Services (HHS) notifies Federal In accordance with Subpart C of the
20852–3804; Telephone: (301) 435– agencies of the laboratories currently Mandatory Guidelines dated April 13,
4632; Facsimile: (301) 402–0220; E-mail: certified to meet the standards of 2004 (69 FR 19644), the following
lambertsond@od.nih.gov. Subpart C of the Mandatory Guidelines laboratories meet the minimum
SUPPLEMENTARY INFORMATION: The for Federal Workplace Drug Testing standards to conduct drug and specimen
jlentini on PROD1PC65 with NOTICES

invention concerns immunotoxins and Programs (Mandatory Guidelines). The validity tests on urine specimens:
methods of using the immunotoxins for Mandatory Guidelines were first ACL Laboratories, 8901 W. Lincoln
the treatment of autoimmune diseases published in the Federal Register on Ave., West Allis, WI 53227, 414–328–
and T cell malignancies. A specific April 11, 1988 (53 FR 11970), and 7840/800–877–7016, (Formerly:
immunotoxin covered by this subsequently revised in the Federal Bayshore Clinical Laboratory).

VerDate Aug<31>2005 18:03 Mar 04, 2008 Jkt 214001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1
Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Notices 11937

ACM Medical Laboratory, Inc., 160 Roche Biomedical Laboratory; Roche Phamatech, Inc., 10151 Barnes Canyon
Elmgrove Park, Rochester, NY 14624, CompuChem Laboratories, Inc., A Road, San Diego, CA 92121, 858–643–
585–429–2264. Member of the Roche Group). 5555.
Advanced Toxicology Network, 3560 Laboratory Corporation of America Quest Diagnostics Incorporated, 3175
Air Center Cove, Suite 101, Memphis, Holdings, 13112 Evening Creek Drive, Presidential Dr., Atlanta, GA 30340,
TN 38118, 901–794–5770/888–290– Suite 100, San Diego, CA 92128, 858– 770–452–1590/800–729–6432,
1150. 668–3710/800–882–7272, (Formerly: (Formerly: SmithKline Beecham
Aegis Sciences Corporation, 345 Hill Poisonlab, Inc.). Clinical Laboratories; SmithKline Bio-
Ave., Nashville, TN 37210, 615–255– Laboratory Corporation of America Science Laboratories).
2400, (Formerly: Aegis Analytical Holdings, 550 17th Ave., Suite 300, Quest Diagnostics Incorporated, 400
Laboratories, Inc.). Seattle, WA 98122, 206–923–7020/ Egypt Road, Norristown, PA 19403,
Baptist Medical Center-Toxicology 800–898–0180, (Formerly: DrugProof, 610–631–4600/877–642–2216,
Laboratory, 9601 I–630, Exit 7, Little Division of Dynacare/Laboratory of (Formerly: SmithKline Beecham
Rock, AR 72205–7299, 501–202–2783, Pathology, LLC; Laboratory of Clinical Laboratories; SmithKline Bio-
(Formerly: Forensic Toxicology Pathology of Seattle, Inc.; DrugProof, Science Laboratories).
Laboratory Baptist Medical Center). Division of Laboratory of Pathology of Quest Diagnostics Incorporated, 7600
Clinical Reference Lab, 8433 Quivira Seattle, Inc.) Tyrone Ave., Van Nuys, CA 91405,
Road, Lenexa, KS 66215–2802, 800– Laboratory Corporation of America 866–370–6699/818–989–2521,
445–6917. (Formerly: SmithKline Beecham
Holdings, 1120 Main Street,
Diagnostic Services, Inc., dba DSI, Clinical Laboratories).
Southaven, MS 38671, 866–827–8042/
12700 Westlinks Drive, Fort Myers, S.E.D. Medical Laboratories, 5601 Office
800–233–6339, (Formerly: LabCorp Blvd., Albuquerque, NM 87109, 505–
FL 33913, 239–561–8200/800–735– Occupational Testing Services, Inc.;
5416. 727–6300/800–999–5227.
MedExpress/National Laboratory South Bend Medical Foundation, Inc.,
Doctors Laboratory, Inc., 2906 Julia Center).
Drive, Valdosta, GA 31602, 229–671– 530 N. Lafayette Blvd., South Bend,
LabOne, Inc. d/b/a Quest Diagnostics, IN 46601, 574–234–4176 x276.
2281. 10101 Renner Blvd., Lenexa, KS
DrugScan, Inc., P.O. Box 2969, 1119 Southwest Laboratories, 4645 E. Cotton
66219, 913–888–3927/800–873–8845, Center Boulevard, Suite 177, Phoenix,
Mearns Road, Warminster, PA 18974,
(Formerly: Quest Diagnostics AZ 85040, 602–438–8507/800–279–
215–674–9310.
Incorporated; LabOne, Inc.; Center for 0027.
Dynacare Kasper Medical Laboratories,*
Laboratory Services, a Division of Sparrow Health System, Toxicology
10150–102 St., Suite 200, Edmonton,
LabOne, Inc.). Testing Center, St. Lawrence Campus,
Alberta, Canada T5J 5E2, 780–451–
MAXXAM Analytics Inc.,* 6740 1210 W. Saginaw, Lansing, MI 48915,
3702/800–661–9876.
ElSohly Laboratories, Inc., 5 Industrial Campobello Road, Mississauga, ON, 517–364–7400, (Formerly: St.
Park Drive, Oxford, MS 38655, 662– Canada L5N 2L8, 905–817–5700, Lawrence Hospital & Healthcare
236–2609. (Formerly: NOVAMANN (Ontario), System).
Gamma-Dynacare Medical Inc.). St. Anthony Hospital Toxicology
Laboratories*, A Division of the MedTox Laboratories, Inc., 402 W. Laboratory, 1000 N. Lee St.,
Gamma-Dynacare Laboratory County Road D, St. Paul, MN 55112, Oklahoma City, OK 73101, 405–272–
Partnership, 245 Pall Mall Street, 651–636–7466/800–832–3244. 7052.
MetroLab-Legacy Laboratory Services, Toxicology & Drug Monitoring
London, ONT, Canada N6A 1P4, 519–
1225 NE 2nd Ave., Portland, OR Laboratory, University of Missouri
679–1630.
97232, 503–413–5295/800–950–5295. Hospital & Clinics, 301 Business Loop
Kroll Laboratory Specialists, Inc., 1111
Minneapolis Veterans Affairs Medical 70 West, Suite 208, Columbia, MO
Newton St., Gretna, LA 70053, 504–
Center, Forensic Toxicology 65203, 573–882–1273.
361–8989/800–433–3823, (Formerly: Toxicology Testing Service, Inc., 5426
Laboratory Specialists, Inc.). Laboratory, 1 Veterans Drive,
Minneapolis, MN 55417, 612–725– NW. 79th Ave., Miami, FL 33166,
Kroll Laboratory Specialists, Inc., 450
2088. 305–593–2260.
Southlake Blvd., Richmond, VA US Army Forensic Toxicology Drug
23236, 804–378–9130, (Formerly: National Toxicology Laboratories, Inc.,
1100 California Ave., Bakersfield, CA Testing Laboratory, 2490 Wilson St.,
Scientific Testing Laboratories, Inc.; Fort George G. Meade, MD 20755–
Kroll Scientific Testing Laboratories, 93304, 661–322–4250/800–350–3515.
One Source Toxicology Laboratory, Inc., 5235, 301–677–7085.
Inc.). Upon finding a Canadian laboratory to
Laboratory Corporation of America 1213 Genoa-Red Bluff, Pasadena, TX
be qualified, HHS will recommend that
Holdings, 7207 N. Gessner Road, 77504, 888–747–3774, (Formerly:
Houston, TX 77040, 713–856–8288/ University of Texas Medical Branch, * The Standards Council of Canada (SCC) voted
800–800–2387. Clinical Chemistry Division; UTMB to end its Laboratory Accreditation Program for
Laboratory Corporation of America Pathology-Toxicology Laboratory). Substance Abuse (LAPSA) effective May 12, 1998.
Holdings, 69 First Ave., Raritan, NJ Oregon Medical Laboratories, 123 Laboratories certified through that program were
accredited to conduct forensic urine drug testing as
08869, 908–526–2400/800–437–4986, International Way, Springfield, OR required by U.S. Department of Transportation
(Formerly: Roche Biomedical 97477, 541–341–8092. (DOT) regulations. As of that date, the certification
Laboratories, Inc.). Pacific Toxicology Laboratories, 9348 of those accredited Canadian laboratories will
Laboratory Corporation of America DeSoto Ave., Chatsworth, CA 91311, continue under DOT authority. The responsibility
for conducting quarterly performance testing plus
Holdings, 1904 Alexander Drive, 800–328–6942, (Formerly: Centinela periodic on-site inspections of those LAPSA-
Research Triangle Park, NC 27709, Hospital Airport Toxicology accredited laboratories was transferred to the U.S.
jlentini on PROD1PC65 with NOTICES

919–572–6900/800–833–3984, Laboratory). HHS, with the HHS’ NLCP contractor continuing to


(Formerly: LabCorp Occupational Pathology Associates Medical have an active role in the performance testing and
laboratory inspection processes. Other Canadian
Testing Services, Inc., CompuChem Laboratories, 110 West Cliff Dr., laboratories wishing to be considered for the NLCP
Laboratories, Inc.; CompuChem Spokane, WA 99204, 509–755–8991/ may apply directly to the NLCP contractor just as
Laboratories, Inc., A Subsidiary of 800–541–7891x7. U.S. laboratories do.

VerDate Aug<31>2005 18:03 Mar 04, 2008 Jkt 214001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1
11938 Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Notices

DOT certify the laboratory (Federal System: Secure Border Initiative-net. member) data for commercial aircraft
Register, July 16, 1996) as meeting the Component: Customs and Border overflying the United States. CBP
minimum standards of the Mandatory Protection. published a PIA and an associated
Guidelines published in the Federal Date of approval: July 20, 2007. SORN and NPRM for Privacy Act
Register on April 13, 2004 (69 FR The Secure Border Initiative-net exemptions for APIS.
19644). After receiving DOT (SBInet) is a DHS Customs and Border System: Secure Flight Program.
certification, the laboratory will be Protection (CBP) system designed to Component: Transportation Security
included in the monthly list of HHS- detect, identify, apprehend, and remove Administration.
certified laboratories and participate in illegal entrants to the U.S. on and Date of approval: August 9, 2007.
the NLCP certification maintenance between the Ports of Entry (POE). This The Secure Flight Program is
program. PIA addresses Project 28, which is a intended to match identifying
concept demonstration prototype for the information of aviation passengers and
Elaine Parry, SBInet program. Project 28 focuses on a certain non-travelers against the
Acting Director, Office of Program Services, 28 mile border segment surrounding the
SAMHSA.
consolidated and integrated terrorist
Sasabe, Arizona POE. This PIA has been watch list maintained by the Federal
[FR Doc. E8–4213 Filed 3–4–08; 8:45 am] conducted because SBInet collects and Government in a consistent and
BILLING CODE 4160–20–P processes personally identifiable accurate manner, while minimizing
information (PII). false matches and protecting personally
System: Arrival and Departure identifiable information. The program,
DEPARTMENT OF HOMELAND Information System. this PIA, the associated SORN, and the
SECURITY Component: U.S. VISIT. NPRM are expected to change in
Date of approval: August 1, 2007. response to public comment. A revised
Office of the Secretary The PIA for the Arrival and Departure PIA and if necessary a revised SORN
Information System (ADIS) describes will be issued in conjunction with the
Published Privacy Impact changes to ADIS corresponding to the
Assessments on the Web Final Rule for Secure Flight.
publication of a new ADIS System of System: Western Hemisphere Travel
AGENCY: Privacy Office, Office of the Records Notice (SORN). As now Initiative (WHTI) Land and Sea Rule.
Secretary, Department of Homeland proposed, ADIS will be a DHS-wide Component: Customs and Border
Security. system to serve certain programs, Protection.
ACTION: Notice of Publication of Privacy including those of the intelligence Date of approval: August 10, 2007.
Impact Assessments. community, that require information, in CBP, in conjunction with the Bureau
support of the DHS mission, on of Consular Affairs at the Department of
SUMMARY: The Privacy Office of the individuals who seek to enter or who State, published a notice of proposed
Department of Homeland Security is have arrived in or departed from the rulemaking to notify the public of how
making available nine (9) Privacy United States. US-VISIT conducted this they intend to implement the WHTI for
Impact Assessments on various PIA update based on these proposed sea and land ports of entry. The
programs and systems in the changes. proposed rule, would remove the
Department. These assessments were
System: Automated Targeting System. current regulatory exceptions to the
approved and published on the Privacy
Component: Customs and Border passport requirement provided under
Office’s Web site between July 1, 2007
Protection. sections 212(d)(4)(B) and 215(b) of the
and September 30, 2007. Date of approval: August 3, 2007. Immigration and Nationality Act (INA).
DATES: The Privacy Impact Assessments CBP has developed the Automated The PIA discusses the privacy impact of
will be available on the DHS Web site Targeting System (ATS). ATS is one of the program.
until May 5, 2008, after which they may the most advanced targeting systems in System: Verification Information
be obtained by contacting the DHS the world. Using a common approach System Update.
Privacy Office (contact information for data management, analysis, rules- Component: U.S. Citizenship and
below). based risk management, and user Immigration Services.
FOR FURTHER INFORMATION CONTACT: interfaces, ATS supports all CBP Date of approval: September 5, 2007.
Hugo Teufel III, Chief Privacy Officer, mission areas and the data and rules United States Citizenship and
Department of Homeland Security, Mail specific to those areas. CBP updated and Immigration Services (USCIS) provides
Stop 0550, Washington, DC 20528, or e- republished the PIA in conjunction with immigration status verification services
mail: pia@dhs.gov. the SORN and the Notice of Proposed for benefit determinations and
SUPPLEMENTARY INFORMATION: July 1, Rulemaking (NPRM) for Privacy Act employment authorization through its
2007 and September 30, 2007, the Chief exemptions that was published on Verification Division. Presently, two
Privacy Officer of the Department of August 6, 2007 in the Federal Register. programs exist to implement this
Homeland Security (DHS) approved and System: Advanced Passenger mandate: the Systematic Alien
published nine (9) Privacy Impact Information System Update for Final Verification for Entitlements (SAVE)
Assessments (PIAs) on the DHS Privacy Rule. program for government benefits and
Office Web site, http://www.dhs.gov/ Component: Customs and Border the Employment Eligibility Verification/
privacy, under the link for ‘‘Privacy Protection. Basic Pilot Program, recently renamed
Impact Assessments.’’ Below is a short Date of approval: August 9, 2007. ‘‘E-Verify,’’ for employment
summary of each of those systems, CBP issued a Final Rule to amend authorization for all newly hired
including the DHS component regulations governing the submission of employees. The Verification Information
jlentini on PROD1PC65 with NOTICES

responsible for the system, the name of Advanced Passenger Information System (VIS) is a composite information
the system, and the date on which the System (APIS) data by commercial system incorporating data from various
PIA was approved. Additional aircraft and vessels prior to departing Department of Homeland Security
information can be found on the Web for or from the United States and for databases and functions as the
site or by contacting the Privacy Office. crew member (and certain non crew- underlying information technology that

VerDate Aug<31>2005 18:03 Mar 04, 2008 Jkt 214001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1

You might also like