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 Pharmaceutical Science and Clinical Pharmacology advises the Commissioner or
designee in discharging responsibilities as they relate to helping
to ensure safe and effective drugs for human use and, that such
drugs for human use meet, 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 shall provide advice on scientific and technical
issues concerning the safety, and effectiveness of drug products for use in the treatment of a broad spectrum of
human diseases, and as required, the quality characteristics which
such drugs purport or are represented to have, and as required, any other product for which the
Food and Drug Administration has regulatory responsibility, and
make appropriate recommendations to the Commissioner of Food and
Drugs. The Committee may also review Agency sponsored intramural
and extramural biomedical research programs in support of FDA’s
drug regulatory responsibilities and its critical path initiatives
related to improving the efficacy and safety of drugs and
improving the efficiency of drug development..
Structure
The Committee shall
consist of a core of 26 voting members including the Chair.
Members and the Chair are selected by the Commissioner or designee
from among authorities knowledgeable in the fields of
pharmaceutical sciences (pharmaceutical manufacturing,
bioequivalence research, laboratory analytical
techniques, pharmaceutical chemistry, physiochemistry,
biochemistry, molecular biology, immunology, microbiology) and
clinical pharmacology (dose-response,
pharmacokinetics-pharmacodynamics, modeling and simulation,
pharmacogenomics, clinical trial design, pediatrics and special
populations and innovative methods in drug development), biostatistics and related biomedical and
pharmacological specialties, current good manufacturing practices,
and quality systems implementation.. The core of voting members may
include two technically qualified members, 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 up to
four non-voting members who are 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 Designated Federal officer,
who shall also approve the agenda. A Designated Federal
officer 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 § 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 in accordance with the
Government in the Sunshine Act (5 U.S.C. 552b (c)) and the Federal
Advisory Committee Act. 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 $212,542. The estimated personyears
of staff support required is 1.25, at an estimated annual cost of
$112,367.
Reports
In
the event that the Commissioner or designee determines that a portion of a meeting is closed to the public
in accordance with the Government and the Sunshine Act (5 U.S.C.
552b (c)) and the Federal Advisory Committee Act, 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.
.
Approved:
Date: February 8, 2007 |
__________//S//_____________________
Randall Lutter, Ph.D.
Associate
Commissioner
for Policy and Planning, FDA |