Document ID: FDA-2015-N-3137-0001
Agency: fda
Document Type: Notice
Title: Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal
Posted Date: 2015-09-03T04:00Z

[Federal Register Volume 80, Number 171 (Thursday, September 3, 2015)]
[Notices]
[Pages 53311-53312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21914]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3137]

Advisory Committee; Nonprescription Drugs Advisory Committee, 
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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

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, 2015, expiration date.

DATES: Authority for the Nonprescription Drugs Advisory Committee will 
expire on August 27, 2017, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Division of Advisory 
Committee and Consultant Management, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-
0002, 301-796-9001, NDAC@fda.hhs.gov.

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 
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, effective, not misbranded, and on the approval of 
new drug applications. The Committee serves as a forum for the exchange 
of views regarding the prescription and nonprescription status, 
including switches from one status to another. 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 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 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. The core of

[[Page 53312]]

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 http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/default.htm 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 visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: August 28, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-21914 Filed 9-2-15; 8:45 am]
BILLING CODE 4164-01-P