First-Generation Guidelines for NCI-Supported Biorepositories, 32110-32111 [06-5059]

Download as PDF 32110 Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Notices jlentini on PROD1PC65 with NOTICES Name of Committee: Immunology Integrated Review Group, Vaccines Against Microbial Diseases. Date: June 29–30, 2006. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Jian Wang, MD, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4198, MSC 7812, Bethesda, MD 20892. (301) 435– 2778. wangjia@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Biophysical and Biochemical Sciences Fellowship Panel. Date: June 29–30, 2006. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Churchill Hotel, 1914 Connecticut Avenue, NW., Washington, DC 20009. Contact Person: James W. Mack, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (301) 435–1747. mackj2@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict-Behavioral Pharmacology. Date: June 29, 2006. Time: 1 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Maribeth Champoux, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3146, MSC 7759, Bethesda, MD 20892. (301) 594– 3163. champoum@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Technology Development. Date: June 29–30, 2006. Time: 6 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavillon, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Sally Ann Amero, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4190, MSC 7849, Bethesda, MD 20892. (301) 435– 1159. ameros@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396. 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: May 25, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–5067 Filed 6–1–06; 8:45 am] BILLING CODE 4140–01–M VerDate Aug<31>2005 18:05 Jun 01, 2006 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Human Monoclonal Antibodies, Their Fragments and Derivatives as Biotherapeutics for the Treatment of HIV Infections AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the inventions embodied in: U.S. Provisional Patent Application S/N 60/378,408, filed May 6, 2002 (E–144–2002/0–US–01), PCT Application, PCT/US03/14292, filed May 6, 2003, (E–144–2002/0–PCT–02), converted into 03736557.4 (E–144– 2002/0–EP–04) filed in Europe on December 3, 2004, and 2003237187 (E– 144–2002/0–AU–05) filed in Australia on November 3, 2004, 10/513,725 (E– 144–2002/0–US–03) filed in USA on November 5, 2004, as well as 2,484,930 (E–144–2002/0–CA–06) filed in Canada on November 5, 2004, entitled ‘‘Novel broadly cross-reactive HIV neutralizing human monoclonal antibodies selected from Fab phage display libraries using a novel strategy based on alternative antigen panning,’’ Inventors: Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC), to Profectus Biosciences, Inc., having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America. DATES: Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before August 1, 2006 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Sally Hu, Ph.D., M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; E-mail: hus@od.nih.gov; Telephone: (301) 435–5606; Facsimile: (301) 402– 0220. SUPPLEMENTARY INFORMATION: The subject invention (E–144–2002/0) identifies four antibodies, designed 4B1–4, 4B1–10, 4H4, and 5H22 (M12, M14, M16, and M18). These four antibodies were isolated from a human PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 Fab phage display library using alternating antigen panning (AAP). All four antibodies bind to recombinant HIV envelope glycoproteins (Env) gp12089.6, gp120JR–FL and gp120IIIB with high affinity. Moreover, 4B1–10 binding to gp 120 or gp 140 is significantly enhanced in the presence of the receptor CD4. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. The field of use may be limited to the development of human monoclonal antibodies for use as a therapeutic or preventative in HIV infection either alone or in combination with other compounds. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: May 25, 2006. David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–8628 Filed 6–1–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health First-Generation Guidelines for NCISupported Biorepositories AGENCY: National Institutes of Health (NIH), National Cancer Institute (NCI), HHS. ACTION: Notice. SUMMARY: The public comment period for the First Generation Guidelines for NCI-Supported Biorepositories (Federal Register, Vol. 71, Number 82, Page 25814, April 28, 2006) will be extended an additional 30 days beyond publication of this notice. DATES: Effective Date: July 3, 2006. FOR FURTHER INFORMATION CONTACT: Implementation assistance and inquiries should be directed to senior staff of the E:\FR\FM\02JNN1.SGM 02JNN1 Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Notices relevant NCI Extramural and Intramural Program offices. DEPARTMENT OF HEALTH AND HUMAN SERVICES Written comments should be sent to: First-Generation Guidelines, Office of Biorepositories and Biospecimen Research, Office of the Deputy Director for Advanced Technologies and Strategic Partnerships, National Cancer Institute, National Institutes of Health, 31 Center Drive, Room 10A03, Bethesda, MD 20892. Comments submitted via e-mail should use biospecimen@mail.nih.gov and enter ‘‘First-Generation Guidelines Comment’’ in the subject line. Substance Abuse and Mental Health Services Administration ADDRESSES: In order to have adequate time to review and comment on these Guidelines, several individuals and organizations have requested an extension of the 30-day public comment period, scheduled to end May 30, 2006. The NCI agrees that, due to the amount of time that it will take for many organizations to review the Guidelines and draft through responses, an extension of the 30-day comment period is warranted. Therefore the public comment period will be extended an additional 30 days beyond the publication date of this notice. After the comment period has closed, any comments received will be considered in a timely manner by the NCI Office of Biorepositories and Biospecimen Research and appropriate changes will be made and the final guidelines will be published and voluntarily in effect. After the effective date of publication of the final guidelines, written comments will continue to be accepted for the first year of implementation and can be sent to: First-Generation Guidelines, Office of Biorepositories and Biospecimen Research, Office of the Deputy Director for Advanced Technologies and Strategic Partnerships, National Cancer Institute, National Institutes of Health, 31 Center Drive, Room 10A03, Bethesda, MD 20892. Comments submitted via email should use biospecimen@mail.nih.gov and enter ‘‘First-Generation Guidelines Comment’’ in the subject line. During the first year of implementation, the NCI will review any additional comments and experience with the guidelines to evaluate a possible need for future guidelines modification. jlentini on PROD1PC65 with NOTICES SUPPLEMENTARY INFORMATION: Dated: May 25, 2006. John Niederhuber, Deputy Director, National Center Institute, Deputy Director for Translational & Clinical Sciences. [FR Doc. 06–5059 Filed 6–1–06; 8:45 am] BILLING CODE 4140–01–M VerDate Aug<31>2005 18:05 Jun 01, 2006 Jkt 208001 Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. SUMMARY: The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory’s certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https://workplace.samhsa.gov and https://www.drugfreeworkplace.gov. FOR FURTHER INFORMATION CONTACT: Mrs. Giselle Hersh or Dr. Walter Vogl, Division of Workplace Programs, SAMHSA/CSAP, Room 2–1035, 1 Choke Cherry Road, Rockville, Maryland 20857; 240–276–2600 (voice), 240–276– 2610 (fax). SUPPLEMENTARY INFORMATION: The Mandatory Guidelines were developed in accordance with Executive Order 12564 and section 503 of Pub. L. 100– 71. Subpart C of the Mandatory Guidelines, ‘‘Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,’’ sets strict standards that laboratories must meet in order to conduct drug and specimen validity tests on urine specimens for Federal agencies. To become certified, an applicant laboratory must undergo three rounds of performance testing plus an on-site inspection. To maintain that PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 32111 certification, a laboratory must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories which claim to be in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A laboratory must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA) which attests that it has met minimum standards. In accordance with Subpart C of the Mandatory Guidelines dated April 13, 2004 (69 FR 19644), the following laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens: ACL Laboratories, 8901 W. Lincoln Ave., West Allis, WI 53227, 414–328– 7840/800–877–7016, (Formerly: Bayshore Clinical Laboratory) ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 585–429–2264 Advanced Toxicology Network, 3560 Air Center Cove, Suite 101, Memphis, TN 38118, 901–794–5770/888–290– 1150 Aegis Analytical Laboratories, Inc., 345 Hill Ave., Nashville, TN 37210, 615– 255–2400 Baptist Medical Center-Toxicology Laboratory, 9601 I–630, Exit 7, Little Rock, AR 72205–7299, 501–202–2783, (Formerly: Forensic Toxicology Laboratory Baptist Medical Center) Clinical Reference Lab, 8433 Quivira Road, Lenexa, KS 66215–2802, 800– 445–6917 Diagnostic Services, Inc., dba DSI, 12700 Westlinks Drive, Fort Myers, FL 33913, 239–561–8200/800–735– 5416 Doctors Laboratory, Inc., 2906 Julia Drive, Valdosta, GA 31602, 229–671– 2281 DrugScan, Inc., P.O. Box 2969, 1119 Mearns Road, Warminster, PA 18974, 215–674–9310 Dynacare Kasper Medical Laboratories*, 10150–102 St., Suite 200, Edmonton, Alberta, Canada T5J 5E2, 780–451– 3702/800–661–9876 ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662– 236–2609 Express Analytical Labs, 3405 7th Ave., Suite 106, Marion, IA 52302, 319– 377–0500 Gamma-Dynacare Medical Laboratories,* A Division of the Gamma-Dynacare Laboratory Partnership, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519– 679–1630 E:\FR\FM\02JNN1.SGM 02JNN1

Agencies

[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Notices]
[Pages 32110-32111]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


First-Generation Guidelines for NCI-Supported Biorepositories

AGENCY: National Institutes of Health (NIH), National Cancer Institute 
(NCI), HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The public comment period for the First Generation Guidelines 
for NCI-Supported Biorepositories (Federal Register, Vol. 71, Number 
82, Page 25814, April 28, 2006) will be extended an additional 30 days 
beyond publication of this notice.

DATES: Effective Date: July 3, 2006.

FOR FURTHER INFORMATION CONTACT: Implementation assistance and 
inquiries should be directed to senior staff of the

[[Page 32111]]

relevant NCI Extramural and Intramural Program offices.

ADDRESSES: Written comments should be sent to: First-Generation 
Guidelines, Office of Biorepositories and Biospecimen Research, Office 
of the Deputy Director for Advanced Technologies and Strategic 
Partnerships, National Cancer Institute, National Institutes of Health, 
31 Center Drive, Room 10A03, Bethesda, MD 20892. Comments submitted via 
e-mail should use biospecimen@mail.nih.gov and enter ``First-Generation 
Guidelines Comment'' in the subject line.

SUPPLEMENTARY INFORMATION: In order to have adequate time to review and 
comment on these Guidelines, several individuals and organizations have 
requested an extension of the 30-day public comment period, scheduled 
to end May 30, 2006. The NCI agrees that, due to the amount of time 
that it will take for many organizations to review the Guidelines and 
draft through responses, an extension of the 30-day comment period is 
warranted. Therefore the public comment period will be extended an 
additional 30 days beyond the publication date of this notice. After 
the comment period has closed, any comments received will be considered 
in a timely manner by the NCI Office of Biorepositories and Biospecimen 
Research and appropriate changes will be made and the final guidelines 
will be published and voluntarily in effect. After the effective date 
of publication of the final guidelines, written comments will continue 
to be accepted for the first year of implementation and can be sent to: 
First-Generation Guidelines, Office of Biorepositories and Biospecimen 
Research, Office of the Deputy Director for Advanced Technologies and 
Strategic Partnerships, National Cancer Institute, National Institutes 
of Health, 31 Center Drive, Room 10A03, Bethesda, MD 20892. Comments 
submitted via e-mail should use biospecimen@mail.nih.gov and enter 
``First-Generation Guidelines Comment'' in the subject line. During the 
first year of implementation, the NCI will review any additional 
comments and experience with the guidelines to evaluate a possible need 
for future guidelines modification.

    Dated: May 25, 2006.
John Niederhuber,
Deputy Director, National Center Institute, Deputy Director for 
Translational & Clinical Sciences.
[FR Doc. 06-5059 Filed 6-1-06; 8:45 am]
BILLING CODE 4140-01-M

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