Advisory Committee; Nonprescription Drugs Advisory Committee; Renewal

CourtFood And Drug Administration
Citation86 FR 47646
Record Number2021-18396
Publication Date26 Aug 2021
Federal Register, Volume 86 Issue 163 (Thursday, August 26, 2021)
[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
                [Pages 47646-47647]
                From the Federal Register Online via the Government Publishing Office []
                [FR Doc No: 2021-18396]
                Food and Drug Administration
                [Docket No. FDA-2021-N-0806]
                Advisory Committee; Nonprescription Drugs Advisory Committee;
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notice; renewal of federal advisory committee.
                SUMMARY: The Food and Drug Administration (FDA or Agency) 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, 2023, expiration date.
                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
                837-7126, [email protected].
                SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
                the Department of Health and Human Services pursuant to 45 CFR part 11
                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
                [[Page 47647]]
                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 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. Almost all non-Federal
                members of this committee serve as Special Government Employees.
                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
                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
                 Dated: August 20, 2021.
                Lauren K. Roth,
                Acting Principal Associate Commissioner for Policy.
                [FR Doc. 2021-18396 Filed 8-25-21; 8:45 am]
                BILLING CODE 4164-01-P

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