Prospective Grant of Exclusive License: Use of HIV-Dependent Expression Constructs and Uses Therefor for the Development of FDA-Approvable HIV Diagnostic Kits, 42356-42357 [05-14502]

Download as PDF 42356 Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Notices Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5204, MSC 7850, Bethesda, MD 20892, (301) 435– 1178, fujiij@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. Name of Committee: Center for Scientific Review Special Emphasis Panel, Technology for DNA Analysis. Date: August 3, 2005. Time: 2 p.m. to 3 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: 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. 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. Name of Committee: Center for Scientific Review Special Emphasis Panel, Neurogenesis Special Interest Panel. Date: August 4, 2005. Time: 12 p.m. to 3 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: Michael A. Lang, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4140, MSC 7850, Bethesda, MD 20892, (301) 435– 1265, langm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Genetic Basis for Psychiatric Diseases. Date: August 8, 2005. Time: 2 p.m. to 4 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: David J. Remondini, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2210, MSC 7890, Bethesda, MD 20892, (301) 435– 1038, remondid@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Pain Studies. Date: August 8, 2005. Time: 2 p.m. to 3 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: J. Terrell Hoffeld, PhD, DDS, Dental Officer, USPHS, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4116, MSC 7816, Bethesda, MD 20892, (301) 435– 1781, hoffeldt@csr.nih.gov. VerDate jul<14>2003 19:28 Jul 21, 2005 Jkt 205001 Name of Committee: Center for Scientific Review Special Emphasis Panel, Neuronal Calcium Signaling. Date: August 11, 2005. Time: 1 p.m. to 3 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: Peter B. Guthrie, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4142, MSC 7850, Bethesda, MD 20892, (301) 435– 1239, guthriep@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Molecular Mechanisms of Neurodegeneration. Date: August 15, 2005. Time: 4 p.m. to 5:30 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: Toby Behar, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4136, MSC 7850, Bethesda, MD 20892, (301) 435– 4433, behart@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clincial 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: July 15, 2005. Anthony M. Coelho, Jr., Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–14494 Filed 7–21–05; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Use of HIV-Dependent Expression Constructs and Uses Therefor for the Development of FDAApprovable HIV Diagnostic Kits National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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 PCT/US04/31967 filed September 28, 2004 from U.S. provisional application 60/507,034 (E– 276–2003/0–US–01), entitled ‘‘HIVDependent Expression Constructs and PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Uses Therefor’’ (E–276–2003/0–PCT– 02), (Inventors: Yuntao Wu and Jon Marsh), to Revix Technology LLC (hereafter Revix), having a place of business in Manassas, Virginia. 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 September 20, 2005 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@mail.nih.gov; Telephone: (301) 435–5606; Facsimile: (301) 402– 0220. SUPPLEMENTARY INFORMATION: E–276– 2003/0–PCT–02 provides nucleic acid molecules comprising expressible sequences, which could be reporter or therapeutic genes, whose expression depends on the presence of HIV Tat and Rev proteins. This invention could be used for detection of HIV infection, in screening assays to identify compounds that inhibit HIV infection, and potentially as a therapeutic to kill HIVinfected cells and treat HIV-infected subjects. 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 FDA-approvable HIV clinical diagnostic kit. It has to be noted that the nonexclusive license opportunities in the field(s) of use of the development of HIV detection kit/reagent for research use and/or cellular screening method for research use, as well as the exclusive license opportunity in the field of use of the development of a novel therapeutic against HIV infections are still available for subject invention. 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 E:\FR\FM\22JYN1.SGM 22JYN1 Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Notices permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: July 12, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–14502 Filed 7–21–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Proposed Collection; Comment Request Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, U.S. Department of Homeland Security. ACTION: Notice and request for comments. AGENCY: SUMMARY: The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed continuing information collections. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)), this notice seeks comments concerning renewal of the Standard Flood Hazard Determination Form (FEMA Form 81– 93). SUPPLEMENTARY INFORMATION: FEMA is seeking to extend the use of the Standard Flood Hazard Determination Form, required by Title V, Section 528 of the National Flood Insurance Reform Act of 1994 (NFIRA). The form records the determination of whether a structure is located within an identified Special Flood Hazard Area and whether flood insurance is available. Federallyregulated lender institutions, are mandated to complete this form for any loan made, increased, extended, renewed, or purchased. Collection of Information Title: Standard Flood Hazard Determination Form. Type of Information Collection: Extension of a currently approved collection. OMB Number: 1660–0040. Form Numbers: FEMA 81–93 Standard Flood Hazard Determination Form. Abstract: On September 23, 1994, the President signed the Riegle Community Development and Regulatory Improvement Act of 1994. Title V of this Act is the National Flood Insurance Reform Act (NFIRA). Section 528 of the No. of respondents (A) FEMA forms 42357 NFIRA requires that FEMA develop a standard hazard determination form for recording the determination of whether a structure is located within an identified Special Flood Hazard Area and whether flood insurance is available. Section 528 of the NFIRA also requires the use of this form by regulated lending institutions, Federal agency lenders, the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation, and the Government National Mortgage Association for any loan made, increased, extended, renewed or purchased by these entities. The form developed to comply with the above requirements is the Standard Flood Hazard Determination form (FEMA Form 83–93, dated October 2002). This form will be completed by federally regulated lending institutions when making, increasing, extending, renewing or purchasing each loan for the purpose of documenting the factors considered as to whether flood insurance is required and available. An estimated 33,000,000 such uses are made each year. This number is entirely driven by the volume of mortgage transactions, of which fluctuations in interest rates is a principal factor. Affected Public: Business or other forprofit, Federal Government. Estimated Total Annual Burden Hours: 10,890,000 hours. Frequency of response (B) Burden hours per response (C) Annual burden hours (A x B x C) 81–93 .......................................................................................................... 33,000,000 1 0.33 (20 minutes) 10,890,000 Total ..................................................................................................... 33,000,000 (1) 0.33 .................... 10,890,000 Estimated Cost: The total cost to federally-regulated lenders for completing FEMA Form 81–93 totals $295,119,000, representing an average cost of $8.00 per loan transaction (respondent). Comments: Written comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, VerDate jul<14>2003 19:28 Jul 21, 2005 Jkt 205001 electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Comments should be received within 60 days of the date of this notice. ADDRESSES: Interested persons should submit written comments to Chief, Records Management Section, Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security, 500 C Street, SW., Room 316, Washington, DC 20472. FOR FURTHER INFORMATION CONTACT: Contact Cecelia Lynch, Program Specialist, Mitigation Division at (202) 646–7045 for additional information. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 You may contact the Records Management Section at (202) 646–3347 or e-mail address: FEMA-InformationCollections@dhs.gov. Dated: July 13, 2005. George S. Trotter, Acting Branch Chief, Information Resources Management Branch, Information Technology Services Division. [FR Doc. 05–14480 Filed 7–21–05; 8:45 am] BILLING CODE 9110–11–P E:\FR\FM\22JYN1.SGM 22JYN1

Agencies

[Federal Register Volume 70, Number 140 (Friday, July 22, 2005)]
[Notices]
[Pages 42356-42357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14502]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of HIV-Dependent 
Expression Constructs and Uses Therefor for the Development of FDA-
Approvable HIV Diagnostic Kits

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, is contemplating the grant of 
an exclusive license to practice the invention embodied in PCT/US04/
31967 filed September 28, 2004 from U.S. provisional application 60/
507,034 (E-276-2003/0-US-01), entitled ``HIV-Dependent Expression 
Constructs and Uses Therefor'' (E-276-2003/0-PCT-02), (Inventors: 
Yuntao Wu and Jon Marsh), to Revix Technology LLC (hereafter Revix), 
having a place of business in Manassas, Virginia. 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 
September 20, 2005 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@mail.nih.gov; 
Telephone: (301) 435-5606; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: E-276-2003/0-PCT-02 provides nucleic acid 
molecules comprising expressible sequences, which could be reporter or 
therapeutic genes, whose expression depends on the presence of HIV Tat 
and Rev proteins. This invention could be used for detection of HIV 
infection, in screening assays to identify compounds that inhibit HIV 
infection, and potentially as a therapeutic to kill HIV-infected cells 
and treat HIV-infected subjects.
    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 FDA-
approvable HIV clinical diagnostic kit.
    It has to be noted that the non-exclusive license opportunities in 
the field(s) of use of the development of HIV detection kit/reagent for 
research use and/or cellular screening method for research use, as well 
as the exclusive license opportunity in the field of use of the 
development of a novel therapeutic against HIV infections are still 
available for subject invention.
    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

[[Page 42357]]

permitted by law, will not be released under the Freedom of Information 
Act, 5 U.S.C. 552.

    Dated: July 12, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-14502 Filed 7-21-05; 8:45 am]
BILLING CODE 4140-01-P

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