Document ID: FDA-2021-N-0806-0002
Agency: fda
Document Type: Notice
Title: Advisory Committee; Nonprescription Drugs Advisory Committee; Renewal
Posted Date: 2023-11-15T05:00Z

[Federal Register Volume 88, Number 219 (Wednesday, November 15, 2023)]
[Notices]
[Pages 78371-78372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25100]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0806]

Advisory Committee; Nonprescription 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) is announcing the 
renewal of the Nonprescription 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 
Nonprescription Drugs Advisory Committee for an additional 2 years 
beyond the charter expiration date. The new charter will be in effect 
until the August 27, 2025, expiration date.

DATES: Authority for the Nonprescription Drugs Advisory Committee will 
expire on August 27, 2025, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Moon Hee Choi, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, [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 Nonprescription 
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 available data concerning the 
safety and effectiveness of over-the-counter (nonprescription) human 
drug products, or any other FDA-regulated product, for use in the 
treatment of a broad spectrum of human symptoms and diseases and 
advises the Commissioner either on the promulgation of monographs 
establishing conditions under which these drugs are generally 
recognized as safe and effective and not misbranded or on the approval 
of new drug applications for such drugs. The Committee serves as a 
forum for the exchange of views regarding the prescription and 
nonprescription status, including switches from one status to another, 
of these various drug products and combinations thereof. The Committee 
may also conduct peer

[[Page 78372]]

review of agency sponsored intramural and extramural scientific 
biomedical programs in support of FDA's mission and regulatory 
responsibilities.
    The Committee shall consist of 10 voting members including the 
Chair. Members and the Chair are selected by the Commissioner or 
designee from among authorities knowledgeable in the fields of internal 
medicine, family practice, clinical toxicology, clinical pharmacology, 
pharmacy, dentistry, 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, 
representatives, or Ex-Officio members. 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.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/advisory-committees/nonprescription-drugs-advisory-committee/nonprescription-drugs-advisory-committee-charter 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. app.). For general information related to FDA advisory 
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: November 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25100 Filed 11-14-23; 8:45 am]
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