Advisory Committee; Nonprescription Drugs Advisory Committee; Renewal
| Citation | 86 FR 47646 |
| Record Number | 2021-18396 |
| Published date | 26 August 2021 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 86 Issue 163 (Thursday, August 26, 2021)
[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47646-47647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18396]
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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 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 https://www.fda.gov/advisory-committees/human-drug-advisory-committees/nonprescription-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. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/advisory-committees.
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
