National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 4258 [2022-01549]
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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This guidance finalizes the draft
guidance entitled ‘‘Information Requests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comments received on the draft
guidance as the guidance was finalized.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.
lotter on DSK11XQN23PROD with NOTICES1
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).
VerDate Sep<11>2014
17:53 Jan 26, 2022
Jkt 256001
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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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)
PO 00000
Frm 00068
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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 Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Page 4258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01549]
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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 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, [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 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]
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