Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 41408 [2023-13475]
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41408
Federal Register / Vol. 88, No. 121 / Monday, June 26, 2023 / Notices
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Kofi
Ansah, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4380, Silver Spring,
MD 20993–0002, 301–796–4158.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Psychedelic Drugs: Considerations for
Clinical Investigations.’’ This draft
guidance outlines general
considerations for drug development
programs considering the therapeutic
potential of psychedelic drugs for
treatment of medical conditions (e.g.,
psychiatric disorders, substance use
disorders).
This draft guidance is being issued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The draft guidance, when finalized, will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
on ‘‘Psychedelic Drugs: Considerations
for Clinical Investigations.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 relating
to the submission of investigational new
drug applications have been approved
under OMB control number 0910–0014.
The collections of information in 21
CFR part 314 relating to the submission
of new drug applications have been
approved under OMB control number
0910–0001. The collections of
information in 21 CFR parts 210 and
211 relating to current good
manufacturing practice requirements
have been approved under OMB control
number 0910–0139. The collections of
information relating to the protection of
human subjects and institutional review
boards in 21 CFR parts 50 and 56 have
been approved under OMB control
number 0910–0130.
VerDate Sep<11>2014
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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.
Dated: June 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13428 Filed 6–23–23; 8:45 am]
BILLING CODE 4164–01–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
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: Eunice Kennedy
Shriver National Institute of Child Health
and Human Development Special Emphasis
Panel; Chemical Screening and Optimization
Facility.
Date: July 20, 2023.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2131D, Bethesda, MD
20892 (Virtual Meeting).
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,
6710B Rockledge Drive, Room 2131D,
Bethesda, MD 20892, (301) 943–5604,
anita.szajek@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.865, Research for Mothers
and Children, National Institutes of Health,
HHS)
PO 00000
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Dated: June 20, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–13475 Filed 6–23–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Maximizing Investigators’
Research Award—E Study Section.
Date: July 6–7, 2023.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency, Bethesda, One Metro
Center, 7400 W Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Vandana Kumari, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, (301) 496–3290,
vandana.kumari@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Small Business Innovation
Research/Small Business Technology
Transfer.
Date: July 6–7, 2023.
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 (Hybrid Meeting).
Contact Person: Jennifer Di Noia, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000E,
Bethesda, MD 20892, (301) 594–0288,
dinoiaj2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topics: Cellular, Molecular, Bioanalytical
and Imaging Technologies.
Date: July 6, 2023.
Time: 9:30 a.m. to 8:00 p.m.
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[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Notices]
[Page 41408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13475]
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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 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: Eunice Kennedy Shriver National Institute of
Child Health and Human Development Special Emphasis Panel; Chemical
Screening and Optimization Facility.
Date: July 20, 2023.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, 6710B
Rockledge Drive, Room 2131D, Bethesda, MD 20892 (Virtual Meeting).
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, 6710B Rockledge Drive, Room 2131D, Bethesda, MD 20892, (301)
943-5604, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.865,
Research for Mothers and Children, National Institutes of Health,
HHS)
Dated: June 20, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-13475 Filed 6-23-23; 8:45 am]
BILLING CODE 4140-01-P
