National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 73603-73604 [2023-23626]
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Federal Register / Vol. 88, No. 206 / Thursday, October 26, 2023 / Notices
monitoring program; and (3)
outsourcing facilities registered under
section 503B (21 U.S.C. 356b) of the
FD&C Act. FDA may consider the use of
a remote interactive evaluation for any
of the inspection program areas
described in the draft guidance.
During the Coronavirus Disease 2019
(COVID–19) pandemic, FDA expanded
our use of alternative tools for
evaluating drug manufacturing facilities
to support regulatory decision-making.
When an inspection was not feasible or
practical because of the public health
emergency (PHE), FDA used other
available tools and information to
support regulatory decisions and
oversight of facilities. FDA announced
its policy for using these alternative
tools in a guidance entitled ‘‘Remote
Interactive Evaluations of Drug
Manufacturing and Bioresearch
Monitoring Facilities During the
COVID–19 Public Health Emergency’’
posted in April 2021 and announced in
the Federal Register on May 27, 2021
(86 FR 28627) (‘‘2021 COVID–19 Remote
Interactive Evaluations Guidance’’).
FDA issued the guidance to
communicate its policy for the duration
of the COVID–19 PHE declared by the
Secretary of Health and Human Services
(HHS) on January 31, 2020, including
any renewals made by the HHS
Secretary in accordance with section
319(a)(2) of the Public Health Service
Act (42 U.S.C. 247d(a)(2)). Furthermore,
in the Federal Register of March 13,
2023 (88 FR 15417) FDA listed the: (1)
guidances that will no longer be
effective with the expiration of the PHE
declaration, (2) guidances that FDA was
revising to continue in effect for 180
days after the expiration of the PHE
declaration to provide a period for
stakeholder transition and then would
no longer be in effect, and (3) guidances
that FDA was revising to continue in
effect for 180 days after the expiration
of the PHE declaration during which
time FDA planned to further revise the
guidances. The 2021 COVID–19 Remote
Interactive Evaluations Guidance is
included in the latter category and was
revised to remain in effect for 180 days
post expiration of the PHE declaration.
Although the HHS Secretary of has
announced that the COVID–19 public
health emergency declaration has ended
and FDA has largely resumed
inspections, FDA has determined that
continued use of alternative tools,
including remote interactive
evaluations, based on risk and program
needs, will enhance our ability to assess
facilities.
This draft guidance describes the
various remote interactive tools we may
request to use to conduct an evaluation.
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In this draft guidance, we refer to our
use of any combination of these
interactive tools as a remote interactive
evaluation. FDA may request to conduct
a remote interactive evaluation prior to
or following other types of regulatory
oversight activities (e.g., an inspection
or a request for records or other
information). In preparing this draft
guidance, FDA considered comments
received on the 2021 COVID–19 Remote
Interactive Evaluations Guidance.
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 ‘‘Remote Interactive Evaluations of
Drug Manufacturing and Bioresearch
Monitoring Facilities.’’ 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.
FDA also is announcing that the 2021
COVID–19 Remote Interactive
Evaluations Guidance will be
withdrawn upon publication of this
draft guidance. FDA has determined
that the 2021 COVID–19 Remote
Interactive Evaluations Guidance is no
longer needed because this new draft
guidance is available and its
recommendations, when finalized, will
be applicable outside the context of the
COVID–19 public health emergency.
II. Paperwork Reduction Act of 1995
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). The
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014. The
collections of information in 21 CFR
part 314 have been approved under
OMB control number 0910–0001. The
collections of information in 21 CFR
part 58 pertaining to good laboratory
practices have been approved under
OMB control number 0910–0119. The
collection of information pertaining to
current good manufacturing practices
have been approved under OMB control
number 0910–0139. The collections of
information relating to the registration
of human drug compounding
outsourcing facilities under section
503B of the FD&C Act and associated
fees under section 744K of the FD&C
Act (21 U.S.C. 379j–62) have been
approved under OMB control number
0910–0776. The collections of
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73603
information pertaining to human drug
compounding under sections 503A (21
U.S.C. 356a) and 503B of the FD&C Act
have been approved under OMB control
number 0910–0800. The collections of
information in 21 CFR part 11 have been
approved under OMB control number
0910–0303. The collections of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130.
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/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: October 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–23677 Filed 10–25–23; 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
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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01 Clinical
Trial Not Allowed).
Date: November 15, 2023.
Time: 10:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F58,
Rockville, MD 20892 (Virtual Meeting).
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Federal Register / Vol. 88, No. 206 / Thursday, October 26, 2023 / Notices
Contact Person: Mario Cerritelli, 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 3F58, Rockville, MD
20852, 240–669–5199, cerritem@
mail.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: October 20, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2023–23626 Filed 10–25–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
National Institute on Drug Abuse;
Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council on Drug Abuse.
The meeting will be held as a virtual
meeting and is open to the public, as
indicated below. Individuals who plan
to view the virtual meeting and need
special assistance such as sign language
interpretation or other reasonable
accommodations to view the meeting,
should notify Dr. Jeanette Marketon via
email at jeanette.marketon@nih.gov five
days in advance of the meeting. The
open session will be videocast and can
be accessed from the NIH Videocasting
and Podcasting website (https://
videocast.nih.gov/).
A portion of 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 intramural programs
and projects as well as the grant
applications and/or contract proposals
and the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with intramural
programs and projects as well as the
grant applications and/or contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council on Drug Abuse.
Date: February 6, 2024.
Closed: 10:30 a.m. to 11:45 a.m. Agenda:
To review and evaluate grant applications.
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Closed: 11:45 a.m. to 12:15 p.m. Agenda:
Report to Council from the NIDA Board of
Scientific Counselors (BSC).
Open: 12:45 p.m. to 5:00 p.m. Agenda:
Presentations and other business of the
Council.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Susan R.B. Weiss, Ph.D.,
Director, Division of Extramural Research,
Office of the Director, National Institute on
Drug Abuse, NIH, Three White Flint North,
RM 09D08, 11601 Landsdown Street,
Bethesda, MD 20852 301–443–6480 sweiss@
nida.nih.gov.
Contact Person: Jeanette Marketon, Ph.D.,
Director, Office of Extramural Policy,
Division of Extramural Research Office of
Extramural Policy, National Institute on Drug
Abuse, NIH, Three White Flint North, RM
09C68, 11601 Landsdown Street, Bethesda,
MD 20852, 301–443–5239
jeanette.marketon@nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to Dr. Jeanette Marketon at
jeanette.marketon@nih.gov. The statement
should include the name, address, telephone
number and when applicable, the business or
professional affiliation of the interested
person.
Information is also available on the
Institute’s/Center’s home page:
www.drugabuse.gov/NACDA/
NACDAHome.html, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.277, Drug Abuse Scientist
Development Award for Clinicians, Scientist
Development Awards, and Research Scientist
Awards; 93.278, Drug Abuse National
Research Service Awards for Research
Training; 93.279, Drug Abuse and Addiction
Research Programs, National Institutes of
Health, HHS)
Dated: October 20, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2023–23628 Filed 10–25–23; 8:45 am]
BILLING CODE 4140–01–P
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.,
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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
Allergy and Infectious Diseases, Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01 Clinical
Trial Not Allowed).
Date: November 20, 2023.
Time: 9:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 903 South 4th Street, Room RML 31/
3118, Hamilton, MT 59840 (Virtual Meeting).
Contact Person: Kristin L. McNally, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 903
South 4th Street, Room RML 31/3118,
Hamilton, MT 59840, mcnallyk@
niaid.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: October 20, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2023–23627 Filed 10–25–23; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA—2023–0029; OMB No.
1660–0016]
Agency Information Collection
Activities: Proposed Collection,
Comment Request; Revision to
National Flood Insurance Program
Maps: Application Forms and
Instructions for LOMRs and CLOMRs
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: 60-Day notice of renewal and
request for comments.
AGENCY:
The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public to take this
opportunity to comment on a renewal of
SUMMARY:
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[Federal Register Volume 88, Number 206 (Thursday, October 26, 2023)]
[Notices]
[Pages 73603-73604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23626]
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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 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 Allergy and Infectious
Diseases Special Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01 Clinical Trial Not Allowed).
Date: November 15, 2023.
Time: 10:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3F58,
Rockville, MD 20892 (Virtual Meeting).
[[Page 73604]]
Contact Person: Mario Cerritelli, 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 3F58,
Rockville, MD 20852, 240-669-5199, [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: October 20, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee
Policy.
[FR Doc. 2023-23626 Filed 10-25-23; 8:45 am]
BILLING CODE 4140-01-P
