Nonprescription Drugs Advisory Committee Charter
Purpose
The Secretary and, by delegation, the
Assistant Secretary for Health and the Commissioner of Food
and Drugs are charged with the administration of the Federal
Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling
Act, and various provisions of the Public Health Service Act.
The Nonprescription Drugs Advisory 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 the Food and Drug Administration has
regulatory responsibility.
Authority
15 USC 1451 et seq.; 21 USC 321, 341, 342,
343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352,
353(f), 355, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393,
394, 881(b); 42 USC 217a, 241, 242, 242a, 262, 264; 21 CFR
Part 14, 330.10 (a); the Committee is governed by the
provisions of Public Law 92-463, as amended (5 USC App. 2),
which sets forth standards for the formation and use of
advisory committees.
Function
The Committee shall review and evaluate
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 advise 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 will serve 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.
Structure
The Committee shall consist of a core of 14
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. 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.
The Commissioner or designee shall have the
authority to select members of other scientific and technical
FDA advisory committees (normally not to exceed 10 members) to
serve temporarily as voting members and to designate
consultants to serve temporarily as voting members when: (1)
expertise is required that is not available among current
voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed
expertise, a quorum will be based on the combined total of
regular and added members), or (2) to comprise a quorum when,
because of unforeseen circumstances, a quorum is or will be
lacking.
If functioning as a medical device panel, a
nonvoting representative of consumer interests and a nonvoting
representative of industry interests will be included in
addition to the voting members.
Members shall be invited to serve for
overlapping 4-year terms. Terms of more than 2 years are
contingent upon the renewal of the Committee by appropriate
action prior to its expiration. A member may serve after the
expiration of the member's term until a successor has taken
office.
Temporary subcommittees consisting of two or
more committee members, may be established by the Commissioner
or designee as needed to
address specific issues within their respective areas of
expertise.
Subcommittees make preliminary recommendations
regarding specific issues for subsequent action by the full
Committee. The Department Committee Management Officer shall
be notified upon establishment of each subcommittee, and shall
be provided information on its name, membership, function, and estimated frequency of meetings.
Management and support services shall be
provided by the Center for Drug Evaluation and Research, Food
and Drug Administration.
Meetings
Meetings shall be held approximately four
times a year at the call of the Chair and with the advance
approval of a Government official, who shall also approve the
agenda. A Government official shall be present at all
meetings.
Because of the size of the Committee and the
variety in the types of issues it will consider, FDA may, in
connection with a particular committee meeting, specify a
quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR ยง 14.22 (d))
authorize a committee charter to specify quorum requirements.
Meetings shall be open to the public except as
determined otherwise by the Commissioner or designee. Notice
of all meetings shall be given to the public.
Meetings shall be conducted and records of the
proceedings kept as required by applicable laws and
Departmental regulations.
Compensation
Members who are not full-time Federal
employees shall be paid at the rate of the General Schedule
15, step 10, per day for time spent at meetings, plus per diem
and travel expenses in accordance with Standard Government
Travel Regulations.
Annual Cost Estimate
The estimated annual cost for operating the
Committee, including compensation and travel expenses for
members but excluding staff support, is $137,966. The
estimated personyears of staff support required is 1.03, at an
estimated annual cost of $88,647.
Reports
In the event that the Commissioner or designee
determines that a portion of a meeting is
closed to the public, in accordance with the Government in the
Sunshine Act (5 U.S.C. 552b (c)) and the Federal Advisory
Committee Act, a report shall be prepared not later
than November 1 of each year which contains as a minimum the
function of the Committee, a list of members and their
business addresses, the dates and places of meetings, and a
summary of the Committee's activities and recommendations
during the preceding year. A copy of the report shall be
provided to the Department Committee Management Officer.
Termination Date
Unless renewed by appropriate action prior to
its expiration, the Nonprescription Drugs Advisory Committee
will terminate on August 27, 2009.
Date: 7/24/2007
Approved: Randall W. Lutter,
Ph.D.
Associate Deputy Commissioner for
Policy, FDA
NOTICE OF RENEWAL OF THE NONPRESCRIPTION
DRUGS ADVISORY COMMITTEE
I determine that renewal of the
Nonprescription Drugs Advisory Committee beyond August 27,
2007, is in the public interest in connection with the
performance of duties imposed on the Food and Drug
Administration by law, and that such duties can best be
performed through the advice and counsel of such a group.
Therefore, the Committee is continued until August 27, 2009.
I deem that it is not feasible for the Food
and Drug Administration or any of its existing committees to
perform these duties, and that a satisfactory plan for
appropriate balance of the Committee membership has been
submitted.
Date: 7/24/2007
Approved: Randall W. Lutter, Ph.D.
Associate Deputy Commissioner for Policy, FDA
Last Updated: August 3, 2007
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