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 Peripheral and Central
Nervous System 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 neurologic 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 neurology, neuropharmacology, neuropathology,
otolaryngology, 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 $171,262.92. The estimated personyears
of staff support required is 1.10, at an estimated annual cost
of $86,607.75.
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 Peripheral and Central Nervous System Drugs
Advisory Committee will terminate on June 4, 2010.
Approved:
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Date:
5/25/06 |
Randall Lutter, Ph.D.
Associate Commissioner for
Policy and Planning, FDA |
NOTICE OF RENEWAL OF THE
PERIPHERAL AND CENTRAL NERVOUS SYSTEM
DRUGS ADVISORY COMMITTEE
I determine that renewal of the Peripheral and Central
Nervous System Drugs Advisory Committee beyond June 4, 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 June 4, 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.
______________________
________________________________
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Date
5/25/06 |
Randall Lutter, Ph.D.
Associate Commissioner for
Policy and Planning, FDA |