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 Drug Safety and Risk
Management 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 advises the Commissioner of Food and Drugs on risk
management, risk communication, and quantitative evaluation of spontaneous
reports for drugs for human use and for any other product for which the
Food and Drug Administration has regulatory responsibility. The Committee
also advises the Commissioner of Food and Drugs regarding the scientific
and medical evaluation of all information gathered by the Department of
Health and Human Services and the Department of Justice with regard to
safety, efficacy, and abuse potential of drugs or other substances, and
recommends actions to be taken by the Department of Health and Human
Services with regard to the marketing, investigation, and control of such
drugs or other substances.
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 risk communication, risk
management, drug safety, medical, behavioral, and biological sciences as
they apply to risk management, and drug abuse. 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
$192,101.10. The estimated personyears of staff support required is 1.27,
at an estimated annual cost of $147,069.49.
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 Drug
Safety and Risk Management Advisory Committee will terminate on May 31,
2010.
Approved:
|
|
Date:
5/19/06 |
Jason D. Brodsky
Acting
Associate Commissioner
for External Relations, FDA |
I determine that renewal of the Drug
Safety and Risk Management Advisory Committee beyond May 31, 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 31, 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.