Prospective Grant of an Exclusive Patent License: Development of a Bispecific T Cell Engager for the Treatment and Cure of HIV-1, 53334-53335 [2021-20908]

Download as PDF 53334 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices and Research Support Awards., National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: September 22, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–20885 Filed 9–24–21; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health Prospective Grant of an Exclusive Patent License: Development of a Bispecific T Cell Engager for the Treatment and Cure of HIV–1 AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: National Center for Complementary & Integrative Health; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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. lotter on DSK11XQN23PROD with NOTICES1 Name of Committee: National Center for Complementary and Integrative Health Special Emphasis Panel; Neural Mechanisms of Force-Based Manipulations: High Priority Research Networks. Date: October 29, 2021. Time: 10:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Center for Complementary and Integrative Health, Democracy II, 6707 Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sonia Elena Nanescu, Ph.D., Scientific Review Officer, Office of Scientific Review, Division of Extramural Activities, NCCIH/NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20892– 5475, sonia.nanescu@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS) Dated: September 22, 2021. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–20879 Filed 9–24–21; 8:45 am] BILLING CODE 4140–01–P 18:08 Sep 24, 2021 Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Gilead Sciences, Inc. (‘‘Gilead’’) located in Foster City, CA. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before October 12, 2021 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Rose M. Freel, Ph.D., Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 8490 Progress Drive, Suite 400, Frederick, MD 21701 (for business mail), Telephone: (301)624–8775; Email: rose.freel@ nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: National Institutes of Health VerDate Sep<11>2014 National Institutes of Health, HHS. Jkt 253001 Intellectual Property United States Provisional Patent Application No. 61/347,088, filed May 21, 2010 and entitled ‘‘High-affinity fully functional soluble single-domain human CD4, antibodies, and related fusion proteins’’ [HHS Reference No. E– 103–2010/0–US–01]; PCT Patent Application PCT/US2011/ 037439, filed May 20, 2011 and entitled ‘‘High-affinity fully functional soluble single-domain human CD4, antibodies, and related fusion proteins’’ [HHS Reference No. E–103–2010/0–PCT–02]; United States Patent No. 8,911,728, granted December 16, 2014, corresponding to U.S. Application No. 13/699,535, filed January 11, 2013, entitled ‘‘High-affinity fully functional soluble single-domain human CD4, antibodies, and related fusion proteins’’ [ HHS Reference No. E–103–2010–1– US–03]; and European Patent Application No. 21185510.1, filed July 14, 2021, entitled PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 ‘‘High-affinity fully functional soluble single-domain human CD4, antibodies, and related fusion proteins’’ [HHS Reference No. E–103–2010–1–EP–04]. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights for the following: ‘‘For use in an HIV Bispecific T cell engager construct comprising the CD4 mD1 which will be utilized in therapeutic regimens to treat and cure people living with HIV.’’ This technology discloses highly soluble and stable single-domain sCD4 proteins that have therapeutic potential for inhibition of HIV–1 viral entry into cells. CD4 is a glycoprotein present on the surface of mature CD4+ T cells and is the primary receptor allowing the entry of HIV–1 into cells. The interaction between the CD4 protein on the cell surface and the viral envelope glycoprotein is key for infecting a cell. As a result, the single-domain sCD4 proteins described in this invention have potential uses in a variety of therapeutic strategies attempting to prevent the interaction between cellular CD4 and the viral envelope and therefore, inhibition of viral entry. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute 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 part 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. E:\FR\FM\27SEN1.SGM 27SEN1 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices Dated: September 21, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2021–20908 Filed 9–24–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Nursing Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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. Name of Committee: National Institute of Nursing Research Initial Review Group. Date: October 21–22, 2021. Time: 9:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Nursing Research, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Cheryl Nordstrom, Ph.D., Scientific Review Officer, National Institute of Nursing Research, National Institutes of Health, 6701 Democracy Blvd., Suite 703H, Bethesda, MD 20892, (301) 827–1499, cheryl.nordstrom@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.361, Nursing Research, National Institutes of Health, HHS) Dated: September 22, 2021. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–20884 Filed 9–24–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES lotter on DSK11XQN23PROD with NOTICES1 National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 The meetings 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. Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Skeletal Muscle and Exercise Physiology Study Section. Date: October 19–20, 2021. Time: 9:00 a.m. to 9:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Richard Ingraham, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD 20892, (301) 496– 8551, ingrahamrh@mail.nih.gov. Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Molecular Genetics B Study Section. Date: October 25–26, 2021. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Michael L. Bloom, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7804, Bethesda, MD 20892, 301–451– 0132, bloomm2@mail.nih.gov. Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Arthritis, Connective Tissue and Skin Study Section. Date: October 26–27, 2021. Time: 9:30 a.m. to 9:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Robert Gersch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20817, (301) 867–5309, robert.gersch@ nih.gov. Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Imaging Technology Development Study Section. Date: October 28–29, 2021. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 53335 Contact Person: Bernard Joseph Dardzinski, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 827–3082, bernard.dardzinski@nih.gov. Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group; Healthcare and Health Disparities Study Section. Date: October 28–29, 2021. Time: 9:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jessica Bellinger, Ph.D., Scientific Review Officer, Center for Scientific of Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, Bethesda, MD 20892, 301–827–4446, bellingerjd@csr.nih.gov. Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Cancer, Heart, and Sleep Epidemiology: A Study Section. Date: October 28–29, 2021. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Denise Wiesch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3138, MSC 7770, Bethesda, MD 20892, (301) 437– 3478, wieschd@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: September 21, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–20881 Filed 9–24–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Quarterly IRS Interest Rates Used in Calculating Interest on Overdue Accounts and Refunds on Customs Duties U.S. Customs and Border Protection, Department of Homeland Security. ACTION: General notice. AGENCY: This notice advises the public that the quarterly Internal Revenue Service interest rates used to calculate interest on overdue accounts SUMMARY: E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53334-53335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20908]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development of 
a Bispecific T Cell Engager for the Treatment and Cure of HIV-1

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this notice to Gilead 
Sciences, Inc. (``Gilead'') located in Foster City, CA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before October 12, 2021 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Rose M. Freel, Ph.D., Senior Licensing and 
Patenting Manager, NCI Technology Transfer Center, 8490 Progress Drive, 
Suite 400, Frederick, MD 21701 (for business mail), Telephone: 
(301)624-8775; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    United States Provisional Patent Application No. 61/347,088, filed 
May 21, 2010 and entitled ``High-affinity fully functional soluble 
single-domain human CD4, antibodies, and related fusion proteins'' [HHS 
Reference No. E-103-2010/0-US-01];
    PCT Patent Application PCT/US2011/037439, filed May 20, 2011 and 
entitled ``High-affinity fully functional soluble single-domain human 
CD4, antibodies, and related fusion proteins'' [HHS Reference No. E-
103-2010/0-PCT-02];
    United States Patent No. 8,911,728, granted December 16, 2014, 
corresponding to U.S. Application No. 13/699,535, filed January 11, 
2013, entitled ``High-affinity fully functional soluble single-domain 
human CD4, antibodies, and related fusion proteins'' [ HHS Reference 
No. E-103-2010-1-US-03]; and
    European Patent Application No. 21185510.1, filed July 14, 2021, 
entitled ``High-affinity fully functional soluble single-domain human 
CD4, antibodies, and related fusion proteins'' [HHS Reference No. E-
103-2010-1-EP-04].
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of the Licensed Patent 
Rights for the following: ``For use in an HIV Bispecific T cell engager 
construct comprising the CD4 mD1 which will be utilized in therapeutic 
regimens to treat and cure people living with HIV.''
    This technology discloses highly soluble and stable single-domain 
sCD4 proteins that have therapeutic potential for inhibition of HIV-1 
viral entry into cells. CD4 is a glycoprotein present on the surface of 
mature CD4+ T cells and is the primary receptor allowing the entry of 
HIV-1 into cells. The interaction between the CD4 protein on the cell 
surface and the viral envelope glycoprotein is key for infecting a 
cell. As a result, the single-domain sCD4 proteins described in this 
invention have potential uses in a variety of therapeutic strategies 
attempting to prevent the interaction between cellular CD4 and the 
viral envelope and therefore, inhibition of viral entry.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute 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 part 404.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.


[[Page 53335]]


    Dated: September 21, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-20908 Filed 9-24-21; 8:45 am]
BILLING CODE 4140-01-P
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