Prospective Grant of Exclusive License: Development of FDA Approved HIV Resistance Diagnosis Kit, 67743 [E7-23191]

Download as PDF Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 26, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–5882 Filed 11–29–07; 8:45 am] National Institutes of Health BILLING CODE 4140–01–M National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. rwilkins on PROD1PC63 with NOTICES Name of Committee: Center for Scientific Review Special Emphasis Panel, ZRG RUS F 51 Nephrology Applications. Date: December 10–11, 2007. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ryan G. Morris, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4205, MSC 7814, Bethesda, MD 20892, 301–435– 1501, morrisr@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (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: November 19, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–5877 Filed 11–29–07; 8:45 am] BILLING CODE 4140–01–M VerDate Aug<31>2005 16:27 Nov 29, 2007 Prospective Grant of Exclusive License: Development of FDA Approved HIV Resistance Diagnosis Kit Jkt 214001 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, is contemplating the grant of an exclusive license to practice the invention embodied in U.S. Patent No. 5,714,313, issued February 03, 1998, entitled ‘‘Simple Method For Detecting Inhibitors Of Retroviral Replication’’ (HHS Ref. E–054–1991/1–US–01) (Inventors: David Garfinkel, Joan Curcio, Dwight Nissley and Jeffrey Strathern) (NCI), to AmiKana.BioLogics (Hereafter AmiKana), having a place of business in France. 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 January 29, 2008 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 technology discloses a DNA vector comprised of a selectable marker gene inserted into a retrotransposon for use in identifying and selecting cells in which retrotransposition has occurred. This novel method uses a retrotransposon comprised of a retroviral reverse transcriptase/RNAse H gene domain, which creates a unique restriction enzyme site wherever reverse transcription occurs. This novel system offers a means of identifying compounds or agents that can inhibit retrotransposition or retroviral replication. Previous methods developed to detect retrotransposition have not been able to accurately identify DNA in which reverse transcription has occurred. Certain types of PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 67743 retrotransposition are similar to retroviral replication. Thus, this method is applicable to identifying antiretroviral compounds as well as inhibitors of retrotransposition. The field of use may be limited to the development of FDA approved HIV resistance diagnosis kit through the combination of the subject technology and AmiKana’s proprietary yeast based HIV protease phenotyping procedure (Patent Publication No. WO2006000693). 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. 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: November 19, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–23191 Filed 11–29–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket No. FEMA–2007–0013] National Advisory Council Federal Emergency Management Agency, DHS. ACTION: Notice of teleconference meeting. AGENCY: SUMMARY: The National Advisory Council (NAC) will be holding a teleconference meeting for purposes of discussing governance and standard operating procedures. The teleconference meeting will be open to the public. DATES: Meeting Date: Tuesday, December 18, 2007, 1 p.m.–2 p.m. e.s.t. Comment Date: Written comments must be received by December 14, 2007. E:\FR\FM\30NON1.SGM 30NON1

Agencies

[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Page 67743]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23191]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of FDA 
Approved HIV Resistance Diagnosis Kit

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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, is contemplating the grant of 
an exclusive license to practice the invention embodied in U.S. Patent 
No. 5,714,313, issued February 03, 1998, entitled ``Simple Method For 
Detecting Inhibitors Of Retroviral Replication'' (HHS Ref. E-054-1991/
1-US-01) (Inventors: David Garfinkel, Joan Curcio, Dwight Nissley and 
Jeffrey Strathern) (NCI), to AmiKana.BioLogics (Hereafter AmiKana), 
having a place of business in France. 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 
January 29, 2008 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 technology discloses a DNA 
vector comprised of a selectable marker gene inserted into a 
retrotransposon for use in identifying and selecting cells in which 
retrotransposition has occurred. This novel method uses a 
retrotransposon comprised of a retroviral reverse transcriptase/RNAse H 
gene domain, which creates a unique restriction enzyme site wherever 
reverse transcription occurs. This novel system offers a means of 
identifying compounds or agents that can inhibit retrotransposition or 
retroviral replication. Previous methods developed to detect 
retrotransposition have not been able to accurately identify DNA in 
which reverse transcription has occurred. Certain types of 
retrotransposition are similar to retroviral replication. Thus, this 
method is applicable to identifying antiretroviral compounds as well as 
inhibitors of retrotransposition.
    The field of use may be limited to the development of FDA approved 
HIV resistance diagnosis kit through the combination of the subject 
technology and AmiKana's proprietary yeast based HIV protease 
phenotyping procedure (Patent Publication No. WO2006000693).
    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.
    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: November 19, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-23191 Filed 11-29-07; 8:45 am]
BILLING CODE 4140-01-P

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