National Institute on Aging; Notice of Closed Meeting, 64446 [2023-20239]
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Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices
Biological Products’’ issued on
December 20, 2019 (84 FR 70196) and
the 1998 guidance entitled ‘‘Providing
Clinical Evidence of Effectiveness for
Human Drug and Biological Products’’
issued on May 15, 1998 (63 FR 27093).
In 1962, Congress required for the first
time that new drugs be shown to be
effective as well as safe. A new drug’s
effectiveness must be established by
substantial evidence. FDA has
interpreted this substantial evidence
requirement as generally requiring two
adequate and well-controlled clinical
investigations, each convincing on its
own, to establish effectiveness.
In 1997, Congress amended section
505(d) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(d)) to make clear that FDA may
consider data from one adequate and
well-controlled investigation and
confirmatory evidence to constitute
substantial evidence if FDA determines
that such data are sufficient to establish
effectiveness. FDA issued the 1998
Effectiveness guidance in response to
this legislative change. In 2019, the
Agency concluded that more guidance
was needed on the flexibility in the
amount and type of evidence needed to
meet the substantial evidence standard
and issued the 2019 Effectiveness draft
guidance, which discussed a number of
approaches that can yield evidence that
meets the statutory standard for
substantial evidence.
Although both the 1998 Effectiveness
guidance and the 2019 Effectiveness
draft guidance provide examples of how
a single adequate and well-controlled
clinical investigation and confirmatory
evidence can be used to support a
marketing application, these guidances
are not intended to provide a
comprehensive discussion of meeting
the substantial evidence standard based
on one adequate and well-controlled
clinical investigation and confirmatory
evidence. Thus, there is a need for more
Agency guidance to describe how one
adequate and well-controlled clinical
investigation and confirmatory evidence
can be used to meet the substantial
evidence requirement.
When one adequate and wellcontrolled clinical investigation and
confirmatory evidence are considered
together to assess effectiveness, the
quality and quantity of the confirmatory
evidence are also important
considerations. Confirmatory evidence
should be evidence generated from
quality data derived from an appropriate
source. The quantity of confirmatory
evidence needed in a development
program will be impacted by the
features of, and results from, the single
adequate and well-controlled clinical
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investigation that the confirmatory
evidence is intended to substantiate.
This draft guidance describes these
considerations in greater detail. It also
provides examples of the types of
evidence that could be considered
confirmatory evidence that can be used
with one adequate and well-controlled
clinical investigation to demonstrate
substantial evidence of effectiveness.
Finally, the draft guidance includes
recommendations for early engagement
with the Agency for sponsors who
intend to establish substantial evidence
of effectiveness with one adequate and
well-controlled clinical investigation
and confirmatory evidence.
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 ‘‘Demonstrating Substantial Evidence
of Effectiveness Based on One Adequate
and Well-Controlled Clinical
Investigation and Confirmatory
Evidence.’’ 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 new
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 in 21 CFR parts 58, 312,
314, and 601 have been approved under
OMB control numbers 0910–0119,
0910–0014, 0910–0001, and 0910–0338,
respectively. In addition, the collections
of information pertaining to FDA’s
guidance entitled ‘‘Formal Meetings
Between the FDA and Sponsors or
Applicants of PDUFA Products’’ have
been approved under OMB control
number 0910–0001.
III. Electronic Access
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[FR Doc. 2023–20228 Filed 9–18–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on
Aging Special Emphasis Panel; Interorgan
signal.
Date: October 19–20, 2023.
Time: 10:00 a.m. to 6:00 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: Nijaguna Prasad, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institutes of Health,
National Institute on Aging, 7201 Wisconsin
Avenue, Gateway Building, Suite 2W200,
Bethesda, MD 20892, (301) 496–9667,
prasadnb@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: September 14, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–20239 Filed 9–18–23; 8:45 am]
BILLING CODE 4140–01–P
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, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
PO 00000
Dated: September 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Digestive Diseases
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[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Page 64446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20239]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on Aging Special Emphasis
Panel; Interorgan signal.
Date: October 19-20, 2023.
Time: 10:00 a.m. to 6:00 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: Nijaguna Prasad, Ph.D., Scientific Review
Officer, Scientific Review Branch, National Institutes of Health,
National Institute on Aging, 7201 Wisconsin Avenue, Gateway
Building, Suite 2W200, Bethesda, MD 20892, (301) 496-9667,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: September 14, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-20239 Filed 9-18-23; 8:45 am]
BILLING CODE 4140-01-P
