[Federal Register Volume 89, Number 156 (Tuesday, August 13, 2024)]
[Notices]
[Pages 65916-65917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18004]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 
[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 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 https://www.fda.gov/advisory-committees/human-drug-advisory-committees/Peripheral-and-Central-Nervous-System-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.) and 21 CFR part 14, relating to advisory 
committees. For general information related to FDA advisory committees, 
please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    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