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 Gastrointestinal 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 gastrointestinal diseases 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
gastroenterology, endocrinology, surgery, clinical
pharmacology, physiology, pathology, liver function,
motility, esophagitis, andstatistics. The core of voting
members may include one technically qualified member,
selected by the Commissioner or designee, who is identified
with consumer interest 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 interest.
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 4-year terms. Terms of more than 2 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 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 $46,159. The estimated personyears of staff support required is 0.73, at an estimated annual cost of $67,224.27.
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 Gastrointestinal Drugs Advisory
Committee will terminate on March 3, 2010.
Approved:
_____2/27/06_____________
_______//S//________________________
Date
Jason D. Brodsky
Acting Associate
Commissioner
for
External Relations, FDA
NOTICE OF RENEWAL OF THE
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
I determine that renewal of the
Gastrointestinal Drugs Advisory Committee beyond March 3,
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 3,
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.
_______2/27/06 ____
_______//S//_________________________
Date
Jason D. Brodsky
Acting Associate
Commissioner
for
External Relations