Anesthetic 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
Anesthetic and Life Support 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 anesthesiology and surgery 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 anesthesiology, surgery, 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 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 $47,504.
The estimated personyears of staff support required is .78,
at an estimated annual cost of $60,260.
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 Anesthetic and Life Support Drugs Advisory Committee
will terminate on May
1, 2008.
Approved:
Date 4/17/06 |
Jason D. Brodsky
Acting
Associate Commissioner
for External Relations, FDA |
NOTICE
OF RENEWAL OF THE
ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE
I determine that renewal of the Anesthetic and Life
Support Drugs Advisory Committee beyond May 1, 2006, 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 May 1, 2008
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
4/17/06 |
Jason D. Brodsky
Acting
Associate Commissioner
for External Relations, FDA |
Last Updated: July 18, 2006
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