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Anti-Infective Drugs Advisory Committee Charter
Purpose
The Secretary and,
by delegation, the Assistant Secretary for the Office of Public
Health and Science, 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 Anti-Infective
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
reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products
for use in the treatment of infectious diseases and disorders and
make appropriate recommendations to the Commissioner of Food and
Drugs.
Structure
The Committee
shall consist of a core of 13 voting members including the Chair.
Members and the Chair are selected by the Commissioner or designee
from among authorities knowledgeable in the fields of infectious
disease, internal medicine, microbiology, pediatrics, epidemiology
or statistics, 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 non-voting representative of consumer
interests and a non-voting representative of industry interests will
be included in addition to the voting members.
Members shall be
invited to serve for overlapping four-year terms. Terms of more
than two years are contingent upon the renewal of the Committee by
appropriate action prior to its expiration.
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 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 that 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
$203,108.27. The estimated personyears of staff support required is
1.20, at an estimated annual cost of $141,941.88.
Reports
In the event that
a portion of a meeting is closed to the public, 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 Anti-Infective Drugs
Advisory Committee will terminate on October 7, 2010.
Approved:
Date: September 28, 2006 |
Randall Lutter, Ph.D.
Associate Commissioner for
Policy and Planning, FDA |
NOTICE OF
RENEWAL OF THE
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
I
determine that renewal of the Anti-Infective Drugs Advisory
Committee beyond October 7, 2008, 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 October 7, 2010.
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: September 28, 2006 |
Randall Lutter, Ph.D.
Associate Commissioner for
Policy and Planning, FDA |
Last Updated: October 1, 2008
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