Government-Owned Inventions; Availability for Licensing, 929-930 [2024-00087]

Download as PDF Federal Register / Vol. 89, No. 5 / Monday, January 8, 2024 / Notices Contact Person: Anita Szajek, Ph.D., Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6701 Rockledge Drive, Room 2131D, Bethesda, MD 20892, anita.szajek@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) Dated: January 3, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. Dated: January 3, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. National Institutes of Health [FR Doc. 2024–00115 Filed 1–5–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings ddrumheller on DSK120RN23PROD with NOTICES1 Pursuant to section 1009 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: Biobehavioral and Behavioral Sciences Study Section. Date: March 19, 2024. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting). Contact Person: Chi-Tso Chiu, Ph.D., Scientific Review Branch (SRB), Eunice Kennedy Shriver National Institute of Child Health & Human Development, NIH, DHHS, 6710B Rockledge Drive, Rm. 2127B, Bethesda, MD 20817, (301) 435–7486, chiuc@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) VerDate Sep<11>2014 16:46 Jan 05, 2024 Jkt 262001 [FR Doc. 2024–00113 Filed 1–5–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. 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: Eunice Kennedy Shriver National Institute of Child Health and Human Development Initial Review Group; Obstetrics and Maternal-Fetal Biology Study Section. Date: March 22, 2024. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Room 2131B, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Luis E. Dettin, Ph.D., Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Room 2131B, Bethesda, MD 20892, (301) 827–8231, luis.dettin@nih.gov. Name of Committee: Eunice Kennedy Shriver National Institute of Child Health and Human Development Initial Review Group; Function, Integration, and Rehabilitation Sciences Study Section. Date: April 8–9, 2024. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Room 2125D, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Moushumi Paul, Ph.D., Scientific Review Officer, Scientific Review PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 929 Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Room 2125D, Bethesda, MD 20817, (301) 496–3596, moushumi.paul@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) Dated: January 3, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–00114 Filed 1–5–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. SUMMARY: The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Dr. Terrence Joyce at (240) 987–2347, or Terrence.joyce@NIH.gov. Licensing information may be obtained by communicating with the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852: tel. 301–496– 2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows: Vesicular Stomatitis Virus (VSV)-Based Vaccine Against Sudan Virus Description of Technology: There are five known Ebolavirus species: Ebola virus (Zaire ebolavirus); Sudan virus (Sudan ebolavirus or SUDV); Taı¨ Forest virus (Taı¨ Forest ebolavirus, formerly Cote d’Ivoire ebolavirus); Bundibugyo virus (Bundibugyo ebolavirus); and Reston virus (Reston ebolavirus). Last year an ebolavirus outbreak resulted in 164 cases and 55 deaths. While there is an E:\FR\FM\08JAN1.SGM 08JAN1 ddrumheller on DSK120RN23PROD with NOTICES1 930 Federal Register / Vol. 89, No. 5 / Monday, January 8, 2024 / Notices FDA-approved Ebola virus vaccine authorized for use against Ebola virus infections, ERVEBO, this vaccine is not effective against SUDV due to the significant variation between Ebola virus and SUDV. ERVEBO is a live recombinant viral vaccine consisting of a vesicular stomatitis virus (VSV) backbone deleted for the VSV envelope glycoprotein and substituted with the envelope glycoprotein of the Ebola virus (Kikwit 1995 strain). This invention provides a VSV-based vaccine expressing the SUDV-Gulu GP (VSV–SUDV). The VSV backbone of this vaccine appears to be very similar to the VSV backbone used in the ERVEBO vaccine discussed above. This could allow for a quicker and more efficient regulatory approval pathway through the FDA. Efficacy studies in non-human primates demonstrated that a single intramuscular vaccination protected animals from a lethal challenge dose of SUDV even when vaccination occurred only seven days prior to challenge. In addition, pre-exposure to the VSV vector did not inhibit a robust response to the SUDV GP component of the vaccine. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. Potential Commercial Applications: • Prophylactic usage against SUDV infections in normal or high-risk populations. • Therapeutic treatment, alone or in combination, in patients with SUDV infection. • Assay development for surveillance, diagnostic, and prevention measures. Competitive Advantages: • Uses a VSV-based system to express antigens thereby increasing safety of the vaccine. • Efficacious after single low dose vaccination in NHPs. • VSV-platform induces a strong & rapid immune response. Development Stage: Pre-clinical. Inventors: Andrea Marzi, Ph.D., and Heinz Feldmann, MD, Ph.D., both of NIAID. Publications: Marzi, A, et al., ‘‘Species-specific immunogenicity and protective efficacy of a vesicular stomatitis virus-based Sudan virus vaccine: a challenge study in macaques,’’ Lancet Microbe, 2023 Mar;4(3): e171-e178. doi: 10.1016/ S2666–5247(23)00001–0. Epub 2023 Feb 2. Intellectual Property: U.S. Provisional Application No. 63/419,637, filed VerDate Sep<11>2014 16:46 Jan 05, 2024 Jkt 262001 October 26, 2022, U.S. Provisional Application No. 63/517,246 filed August 02, 2023, and PCT application PCT/US2023/077444 filed on October 20, 2023. Licensing Contact: To license this technology, please contact Dr. Terrence Joyce at (240) 987–2347, or Terrence.joyce@NIH.gov, and reference E–002–2023. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. For collaboration opportunities, please contact Dr. Terrence Joyce at (240) 987– 2347, or Terrence.joyce@NIH.gov. Dated: January 2, 2024. Haiqing Li, Acting Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2024–00087 Filed 1–5–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. 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: Eunice Kennedy Shriver National Institute of Child Health and Human Development Initial Review Group; Reproduction, Andrology, and Gynecology Study Section. Date: February 15, 2024. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Room 2125D, Bethesda, MD 20892 (Virtual Meeting). PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Contact Person: Jagpreet Singh Nanda, Ph.D., Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Room 2125D, Bethesda, MD 20892, (301) 451–4454, jagpreet.nanda@nih.gov. Name of Committee: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Initial Review Group; Developmental Biology Study Section. Date: February 23, 2024. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Room 2131B, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jolanta Maria Topczewska, Ph.D., Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Room 2131B, Bethesda, MD 20892, (301) 451–0000, jolanta.topczewska@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) Dated: January 3, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–00112 Filed 1–5–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2023–0586] National Commercial Fishing Safety Advisory Committee; September 2023 Meetings United States Coast Guard, Department of Homeland Security. ACTION: Notice of availability of recommendations and request for comments. AGENCY: SUMMARY: The U. S. Coast Guard announces the availability of recommendations from the National Commercial Fishing Safety Advisory Committee (NCFSAC). The Committee met in September 2023 and sent eight recommendations to the Secretary of Homeland Security. The U.S. Coast Guard issues this Notice as the mechanism for receiving public comments and requests public comments on the recommendations. DATES: Comments must be submitted on or before April 8, 2024. E:\FR\FM\08JAN1.SGM 08JAN1

Agencies

[Federal Register Volume 89, Number 5 (Monday, January 8, 2024)]
[Notices]
[Pages 929-930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00087]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Dr. Terrence Joyce at (240) 987-2347, 
or [email protected]. Licensing information may be obtained by 
communicating with the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases, 5601 
Fishers Lane, Rockville, MD 20852: tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Vesicular Stomatitis Virus (VSV)-Based Vaccine Against Sudan Virus

    Description of Technology:
    There are five known Ebolavirus species: Ebola virus (Zaire 
ebolavirus); Sudan virus (Sudan ebolavirus or SUDV); Ta[iuml] Forest 
virus (Ta[iuml] Forest ebolavirus, formerly Cote d'Ivoire ebolavirus); 
Bundibugyo virus (Bundibugyo ebolavirus); and Reston virus (Reston 
ebolavirus). Last year an ebolavirus outbreak resulted in 164 cases and 
55 deaths. While there is an

[[Page 930]]

FDA-approved Ebola virus vaccine authorized for use against Ebola virus 
infections, ERVEBO, this vaccine is not effective against SUDV due to 
the significant variation between Ebola virus and SUDV. ERVEBO is a 
live recombinant viral vaccine consisting of a vesicular stomatitis 
virus (VSV) backbone deleted for the VSV envelope glycoprotein and 
substituted with the envelope glycoprotein of the Ebola virus (Kikwit 
1995 strain).
    This invention provides a VSV-based vaccine expressing the SUDV-
Gulu GP (VSV-SUDV). The VSV backbone of this vaccine appears to be very 
similar to the VSV backbone used in the ERVEBO vaccine discussed above. 
This could allow for a quicker and more efficient regulatory approval 
pathway through the FDA. Efficacy studies in non-human primates 
demonstrated that a single intramuscular vaccination protected animals 
from a lethal challenge dose of SUDV even when vaccination occurred 
only seven days prior to challenge. In addition, pre-exposure to the 
VSV vector did not inhibit a robust response to the SUDV GP component 
of the vaccine.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.
    Potential Commercial Applications:
     Prophylactic usage against SUDV infections in normal or 
high-risk populations.
     Therapeutic treatment, alone or in combination, in 
patients with SUDV infection.
     Assay development for surveillance, diagnostic, and 
prevention measures.
    Competitive Advantages:
     Uses a VSV-based system to express antigens thereby 
increasing safety of the vaccine.
     Efficacious after single low dose vaccination in NHPs.
     VSV-platform induces a strong & rapid immune response.
    Development Stage: Pre-clinical.
    Inventors: Andrea Marzi, Ph.D., and Heinz Feldmann, MD, Ph.D., both 
of NIAID.
    Publications: Marzi, A, et al., ``Species-specific immunogenicity 
and protective efficacy of a vesicular stomatitis virus-based Sudan 
virus vaccine: a challenge study in macaques,'' Lancet Microbe, 2023 
Mar;4(3): e171-e178. doi: 10.1016/S2666-5247(23)00001-0. Epub 2023 Feb 
2.
    Intellectual Property: U.S. Provisional Application No. 63/419,637, 
filed October 26, 2022, U.S. Provisional Application No. 63/517,246 
filed August 02, 2023, and PCT application PCT/US2023/077444 filed on 
October 20, 2023.
    Licensing Contact: To license this technology, please contact Dr. 
Terrence Joyce at (240) 987-2347, or [email protected], and 
reference E-002-2023.
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize this technology. For collaboration 
opportunities, please contact Dr. Terrence Joyce at (240) 987-2347, or 
[email protected].

    Dated: January 2, 2024.
Haiqing Li,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-00087 Filed 1-5-24; 8:45 am]
BILLING CODE 4140-01-P
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