Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal, 63207 [2024-17089]
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Federal Register / Vol. 89, No. 149 / Friday, August 2, 2024 / Notices
Dated: July 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17103 Filed 8–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0008]
Advisory Committee;
Psychopharmacologic Drugs Advisory
Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the
Psychopharmacologic Drugs Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Psychopharmacologic Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
June 4, 2026, expiration date.
DATES: Authority for the
Psychopharmacologic Drugs Advisory
Committee will expire on June 4, 2026,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Joyce Frimpong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–7973, email: PDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Psychopharmacologic
Drugs Advisory Committee (the
Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:22 Aug 01, 2024
Jkt 262001
investigational human drug products for
use in the practice of psychiatry and
related fields and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
Pursuant to its Charter, the Committee
shall consist of a core of nine voting
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of psychopharmacology, psychiatry,
epidemiology or statistics, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Non-Federal members of this
committee will serve as Special
Government Employees or
representatives. Federal members will
serve as Regular Government Employees
or Ex-Officios. The core of voting
members may include one technically
qualified member, selected by the
Commissioner or designee, who is
identified with consumer interests and
is recommended by either a consortium
of consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
PO 00000
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63207
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
psychopharmacologic-drugs-advisorycommittee or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). For general
information related to FDA advisory
committees, please visit us at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
Dated: July 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17089 Filed 8–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Scientific Advisory Committee on
Alternative Toxicological Methods;
Notice of Public Meeting; Request for
Public Input
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This notice announces the
next meeting of the Scientific Advisory
Committee on Alternative Toxicological
Methods (SACATM). SACATM is a
federally chartered external advisory
group of scientists from the public and
private sectors, including
representatives of regulated industry
and national animal protection
organizations. SACATM advises the
Interagency Coordinating Committee on
the Validation of Alternative Methods
(ICCVAM), the National Toxicology
Program (NTP) Interagency Center for
the Evaluation of Alternative
Toxicological Methods (NICEATM), and
the Director of the National Institute of
Environmental Health Sciences (NIEHS)
and NTP regarding statutorily mandated
duties of ICCVAM and activities of
NICEATM.
SUMMARY:
DATES:
Meeting: September 17, 2024, 10 a.m.
to approximately 4 p.m. EDT;
September 18, 2024, 9:30 a.m. to
approximately 4 p.m. EDT.
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 89, Number 149 (Friday, August 2, 2024)]
[Notices]
[Page 63207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17089]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Advisory Committee; Psychopharmacologic Drugs Advisory Committee;
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Psychopharmacologic Drugs Advisory
Committee by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Psychopharmacologic Drugs Advisory Committee for an additional 2
years beyond the charter expiration date. The new charter will be in
effect until the June 4, 2026, expiration date.
DATES: Authority for the Psychopharmacologic Drugs Advisory Committee
will expire on June 4, 2026, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Joyce Frimpong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7973, email: [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the
Psychopharmacologic Drugs Advisory Committee (the Committee). The
Committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Committee advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective drugs for human use and, as
required, any other product for which FDA has regulatory
responsibility.
The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the practice of psychiatry and related fields and makes
appropriate recommendations to the Commissioner of Food and Drugs.
Pursuant to its Charter, the Committee shall consist of a core of
nine voting members including the Chair. Members and the Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of psychopharmacology, psychiatry,
epidemiology or statistics, and related specialties. Members will be
invited to serve for overlapping terms of up to 4 years. Non-Federal
members of this committee will serve as Special Government Employees or
representatives. Federal members will serve as Regular Government
Employees or Ex-Officios. The core of voting members may include one
technically qualified member, selected by the Commissioner or designee,
who is identified with consumer interests and is recommended by either
a consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting representative member who is identified with industry
interests. There may also be an alternate industry representative.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
If functioning as a medical device panel, an additional non-voting
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/human-drug-advisory-committees/psychopharmacologic-drugs-advisory-committee or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that no change has
been made to the committee name or description of duties, no amendment
will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: July 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17089 Filed 8-1-24; 8:45 am]
BILLING CODE 4164-01-P
