Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings, 930 [2024-00112]
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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
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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]
[Page 930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00112]
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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).
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, [email protected].
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, [email protected].
(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
