Notice2024-18004
Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Renewal
Primary source
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Published
August 13, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Peripheral and Central Nervous System 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 Peripheral and Central Nervous System 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.
Full Text
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<title>Federal Register, Volume 89 Issue 156 (Tuesday, August 13, 2024)</title>
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[Federal Register Volume 89, Number 156 (Tuesday, August 13, 2024)]
[Notices]
[Pages 65916-65917]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-18004]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0691]
Advisory Committee; Peripheral and Central Nervous System Drugs
Advisory Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Peripheral and Central Nervous System
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 Peripheral and Central Nervous System 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 Peripheral and Central Nervous System 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: Jessica Seo, Center for Drug
Evaluation Research, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001,
<a href="/cdn-cgi/l/email-protection#c595868b9685a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="6c3c2f223f2c0a080d4204041f420b031a">[email protected]</span></a>.
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 Peripheral and
Central Nervous System 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 treatment of neurologic diseases, and makes appropriate
recommendations to the Commissioner of Food and Drugs.
Pursuant to its Charter, the Committee shall consist of a core of
12 voting members including two Chairpersons. Members and the
Chairpersons are selected by the Commissioner or designee from among
authorities knowledgeable in the fields of neurology, pediatric
neurology, epidemiology, 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.
[[Page 65917]]
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 <a href="https://www.fda.gov/advisory-committees/human-drug-advisory-committees/Peripheral-and-Central-Nervous-System-Drugs-advisory-committee">https://www.fda.gov/advisory-committees/human-drug-advisory-committees/Peripheral-and-Central-Nervous-System-Drugs-advisory-committee</a> 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.) and 21 CFR part 14, relating to advisory
committees. For general information related to FDA advisory committees,
please visit us at <a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: August 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18004 Filed 8-12-24; 8:45 am]
BILLING CODE 4164-01-P
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