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Antiviral 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 Antiviral
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 acquired immune deficiency syndrome, human
immunodeficiency virus related illnesses, and other viral,
fungal and mycobacterial infections, and makes 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 clinical
pharmacology, internal medicine, infectious diseases,
microbiology, virology, psychiatry, statistics, epidemiology,
ophthalmology, immunology, pediatrics, hematology, 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 ยง14.22(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 in accordance with the Government in the Sunshine
Act. 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 $152,415. The
estimated personyears of staff support required is 1.20, at an
estimated annual cost of $79,420.
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 Antiviral Drugs Advisory
Committee will terminate on February 15, 2009.
Approved:
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__________//S//_________ |
Date: 2/820/07 |
Randall Lutter, Ph.D.
Associate Commissioner
for Policy and Planning, FDA |
NOTICE
OF RENEWAL OF THE
ANTIVIRAL DRUGS ADVISORY COMMITTEE
I determine that renewal of the Antiviral Drugs Advisory Committee
beyond February 15, 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 February 15, 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: 2/8/2007
Approved: Randall Lutter, Ph.D.
Associate Commissioner for Policy and Planning, FDA
Last Updated: February 11, 2008
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