National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 1175 [2025-00099]
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
research uses, they should not be
required and instead should be optional.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
and OHRP on ‘‘Considerations for
Including Tissue Biopsies in Clinical
Trials.’’ It does not establish any rights
for any person and is not binding on
FDA, OHRP, or the public. You can use
an alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
II. Paperwork Reduction Act of 1995
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information related to the protection of
human subjects under 21 CFR part 50
and the IRB under 21 CFR part 56 have
been approved under OMB control
number 0910–0130; the collection of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; the collections of
information in 21 CFR part 312,
including Form FDA 1572, have been
approved under OMB control number
0910–0014 and the collections of
information in the guidance document,
‘‘Requests for Feedback and Meetings
for Medical Device Submissions: The QSubmission Program’’ have been
approved under OMB control number
0910–0756. The collections of
information in 21 CFR part 11 have been
approved under OMB control number
0910–0303. The collections of
information in 45 CFR part 46 and the
final rule entitled, ‘‘Federal Policy for
the Protection of Human Subjects’’
(known as the Common Rule), have
been approved under OMB control
number 0990–0260.
ddrumheller on DSK120RN23PROD with NOTICES1
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
[FR Doc. 2024–31536 Filed 1–6–25; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; A Solicitation of the
National Institutes of Health (NIH) and the
Centers for Disease Control and Prevention
(CDC) for Small Business Innovation
Research (SBIR) Contract Proposals (PHS
2025–1), NIH/NIAID 142—Adjuvant
Development for Vaccines.
Date: January 30–31, 2025.
Time: 9:00 a.m. to 6:00 p.m.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22,
Rockville, MD 20892 (Video Assisted
Meeting).
Agenda: To review and evaluate contract
proposals.
Contact Person: Michael M. Opata, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G22, Rockville, MD
20892, 240–627–3319, michael.opata@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC–SBIR PHS
2025–1 Phase I and Fast Track: Devices and
Materials-Based Platforms for the Delivery of
Broadly Neutralizing Antibodies (Topic 138).
Date: January 24, 2025.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E71,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Samita S. Andreansky,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E71,
Rockville, MD 20892, 240–669–2915,
samita.andreansky@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: January 2, 2025.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2025–00101 Filed 1–6–25; 8:45 am]
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Dated: January 2, 2025.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2025–00099 Filed 1–6–25; 8:45 am]
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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Page 1175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00099]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; A Solicitation of the National
Institutes of Health (NIH) and the Centers for Disease Control and
Prevention (CDC) for Small Business Innovation Research (SBIR)
Contract Proposals (PHS 2025-1), NIH/NIAID 142--Adjuvant Development
for Vaccines.
Date: January 30-31, 2025.
Time: 9:00 a.m. to 6:00 p.m.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G22,
Rockville, MD 20892 (Video Assisted Meeting).
Agenda: To review and evaluate contract proposals.
Contact Person: Michael M. Opata, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G22,
Rockville, MD 20892, 240-627-3319, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: January 2, 2025.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2025-00099 Filed 1-6-25; 8:45 am]
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