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
Endocrinologic and Metabolic 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 data concerning the safety and
effectiveness of marketed and investigational human drug
products for use in the treatment of endocrine and metabolic
disorders, and makes appropriate recommendations to the
Commissioner of Food and Drugs.
Structure
The
Committee shall consist of a core of 11 voting members
including the Chair. Members
and the Chair are selected by the Commissioner or designee
from among authorities knowledgeable in the fields of
endocrinology, metabolism, 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 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.
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 $155,209.53.
The estimated personyears of staff support required is
1.20, at an estimated annual cost of $144,144.01.
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
Endocrinologic and Metabolic Drugs Advisory Committee will
terminate on
August 27, 2010.
Approved
Date: 8/17/06 |
Randall Lutter,
Ph.D.
Associate
Commissioner for
Policy and Planning, FDA |