|
Advisory Committee for Reproductive Health 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 Advisory
Committee for Reproductive Health Drugs 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 on the safety and effectiveness of
marketed and investigational human drugs for use in the
practice of obstetrics, gynecology, and related specialties,
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 obstetrics, gynecology, endocrinology,
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 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 connectionwith 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 $137,009. The estimated personyears of
staff support required is 1.08, at an estimated annual cost of
$96,332.
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 Advisory
Committee for Reproductive Health Drugs will terminate on
March 23, 2008.
Approved
3/14/06_______________
___________//S//________________
Date Jason
D. Brodsky
Acting Associate Commissioner
for External Relations, FDA
NOTICE OF
RENEWAL OF THE
ADVISORY COMMITTEE FOR REPRODUCTIVE HEALTH DRUGS
I determine that
renewal of the Advisory Committee for Reproductive Health
Drugs beyond March 23, 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 March 23, 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.
3/14/06
Date |
//S//
Jason D. Brodsky
Acting
Associate Commissioner
for External Relations, FDA |
Last Updated: July 18, 2006
Back
to Top
Back
to Reproductive Health Advisory Committee Info
Back to Human Drug Advisory Committee
Information
|
|