[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63662-63663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2649]


Advisory Committee; Nonprescription Drugs Advisory Committee, 
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of 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 August 27, 2021.

[[Page 63663]]


DATES: Authority for the Nonprescription Drugs Advisory Committee will 
expire on August 27, 2021, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Moon Hee V. 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: NDAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3, 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 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 review of agency sponsored intramural and extramural scientific 
biomedical programs in support of FDA's mission and regulatory 
responsibilities.
    Pursuant to its charter, the Committee consists of a core 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 are invited to serve for overlapping terms of up to 4 years. 
Almost all non-Federal members of this committee serve as Special 
Government Employees. 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 member who is identified with industry interests.
    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 document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: November 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24917 Filed 11-15-19; 8:45 am]
 BILLING CODE 4164-01-P


