National Institute on Aging; Notice of Closed Meetings, 4258-4259 [2022-01597]
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4258
Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices
This guidance explains how FDA will
issue and use an IR and a DRL during
the assessment of an original ANDA
under section 505(j) of the FD&C Act (21
U.S.C. 355(j)), as contemplated under
GDUFA II. This guidance does not apply
to an amendment made in response to
a Complete Response Letter, a
supplement, or an amendment to a
supplement.
This guidance identifies the timing of
FDA’s issuance of an IR or a DRL and
the effect FDA’s issuance of an IR or a
DRL will have on the assessment clock
for a given assessment cycle.
This guidance finalizes the draft
guidance entitled ‘‘Information Requests
and Discipline Review Letters Under
GDUFA’’ issued on December 18, 2017
(82 FR 60018). FDA considered
comments received on the draft
guidance as the guidance was finalized.
Minor changes were made from the draft
to the final guidance, primarily to reflect
current terminology.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Information
Requests and Discipline Review Letters
Under GDUFA.’’ 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 314 for approval
of abbreviated new drug applications
have been approved under OMB control
number 0910–0001. The collections of
information that support FDA’s
guidance for industry on controlled
correspondence related to generic drug
development have been approved under
OMB control number 0910–0797.
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III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
Reauthorization Performance Goals and Program
Enhancements Fiscal Years 2018–2022 (GDUFA II
Commitment Letter).
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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: January 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01605 Filed 1–26–22; 8:45 am]
Dated: January 21, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–01549 Filed 1–26–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
BILLING CODE 4164–01–P
National Institute on Aging; Notice of
Closed Meetings
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) 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.
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) 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: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
B Research Study Section.
Date: February 28–March 2, 2022.
Time: 11:00 a.m. to 5:30 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 3F30,
Rockville, MD 20892 (Virtual Meeting).
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)
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Name of Committee: National Institute on
Aging Special Emphasis Panel; NIA Multisite Clinical Trial Implementation.
Date: February 22, 2022.
Time: 2:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Isis S. Mikhail, MD, MPH,
DrPH, National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7704,
MIKHAILI@MAIL.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Improving
skin wounds’ healing in aging.
Date: February 24, 2022.
Time: 9:30 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Maurizio Grimaldi, MD,
Ph.D., Scientific Review Officer, National
Institute on Aging, National Institutes of
Health, 7201 Wisconsin Avenue, Room
2C218, Bethesda, MD 20892, 301–496–9374,
grimaldim2@mail.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; ADNI 4.
Date: February 25, 2022.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Virtual Meeting).
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Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices
Contact Person: Maurizio Grimaldi, MD,
Ph.D., Scientific Review Officer, National
Institute on Aging, National Institutes of
Health, 7201 Wisconsin Avenue, Room
2C218, Bethesda, MD 20892, 301–496–9374,
grimaldim2@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: January 21, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–01597 Filed 1–26–22; 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
lotter on DSK11XQN23PROD with NOTICES1
Pursuant to section 10(d) 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: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
Research Study Section MID Research Study
Section.
Date: February 15–16, 2022.
Time: 10:00 a.m. to 6:00 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 3F40A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Robert C. Unfer, 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 3F40A, Rockville, MD
20852, (240) 669–5035, robert.unfer@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)
VerDate Sep<11>2014
17:53 Jan 26, 2022
Jkt 256001
Dated: January 21, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–01551 Filed 1–26–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) 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/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 the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Exploiting Genome or Epigenome Editing to
Functionally Validate Genes or Variants
Involved in Substance Use Disorders (R21/
R33 Clinical Trial Not Allowed).
Date: February 14, 2022.
Time: 11:00 a.m. to 1:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute on Drug Abuse/
NIH, National Institute on Drug Abuse, 301
North Stonestreet Avenue, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, 301 North Stonestreet
Avenue, MSC 6021, Bethesda, MD 20892,
(301) 827–4471, ramadanir@mail.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Avenir
Award Program for Genetics or Epigenetics of
Substance Use Disorders (DP1 Clinical Trial
Optional).
Date: February 23–24, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
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4259
Drug Abuse, NIH, 301 North Stonestreet
Avenue, MSC 6021, Bethesda, MD 20892,
(301) 827–4471, ramadanir@mail.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; DeviceBased Treatments for Substance Use
Disorders (UG3/UH3, Clinical Trial
Optional).
Date: March 2, 2022.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Preethy Nayar, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Drug Abuse,
NIH, 301 North Stonestreet Avenue, MSC
6021, Bethesda, MD 20892, 301–443–4577,
nayarp2@csr.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; NIDA
Centers Review.
Date: March 3, 2022.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Trinh T. Tran, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, 301 North Stonestreet
Avenue, MSC 6021, Bethesda, MD 20892,
(301) 827–5843, trinh.tran@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; PrEP for
HIV Prevention among Substance Using
Populations (R01—Clinical Trial Optional).
Date: March 7, 2022.
Time: 10:00 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Rebekah Feng, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Drug Abuse,
NIH, 301 North Stonestreet Avenue, MSC
6021, Bethesda, MD 20892, (301) 827–7245,
rebekah.feng@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; HEAL
Initiative: Novel Targets for Opioid Use
Disorders and Opioid Overdose.
Date: March 8–9, 2022.
Time: 10:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, 301 North Stonestreet
E:\FR\FM\27JAN1.SGM
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[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4258-4259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01597]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Pursuant to section 10(d) 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: National Institute on Aging Special Emphasis
Panel; NIA Multi-site Clinical Trial Implementation.
Date: February 22, 2022.
Time: 2:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Isis S. Mikhail, MD, MPH, DrPH, National
Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301-402-7704, [email protected].
Name of Committee: National Institute on Aging Special Emphasis
Panel; Improving skin wounds' healing in aging.
Date: February 24, 2022.
Time: 9:30 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Maurizio Grimaldi, MD, Ph.D., Scientific Review
Officer, National Institute on Aging, National Institutes of Health,
7201 Wisconsin Avenue, Room 2C218, Bethesda, MD 20892, 301-496-9374,
[email protected].
Name of Committee: National Institute on Aging Special Emphasis
Panel; ADNI 4.
Date: February 25, 2022.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting).
[[Page 4259]]
Contact Person: Maurizio Grimaldi, MD, Ph.D., Scientific Review
Officer, National Institute on Aging, National Institutes of Health,
7201 Wisconsin Avenue, Room 2C218, Bethesda, MD 20892, 301-496-9374,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: January 21, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-01597 Filed 1-26-22; 8:45 am]
BILLING CODE 4140-01-P
