[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.40]
[Page 146.147]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
Subpart C Establishment of Advisory Committees
Sec. 14.40 Establishment and renewal of advisory committees.
(a) An advisory committee may be established or renewed whenever it
is necessary or appropriate for the committee to hold a public hearing
and to review and make recommendations on any matter pending before FDA.
Except for committees established by statute, before a committee is
established or renewed it must first be approved by the Department
pursuant to 45 CFR part 11 and by the General Services Administration.
(b) When an advisory committee is established or renewed, the
Commissioner will issue a Federal Register notice certifying that the
establishment or renewal is in the public interest and stating the
structure, function, and purposes of the committee and, if it is a
standing advisory committee, shall amend Sec. 14.100 to add it to the
list of standing advisory committees. A notice of establishment will be
published at least 15 days before the filing of the advisory committee
charter under paragraph (c) of this section. A notice of renewal does
not require the 15-day notice.
(c) No committee may meet or take action until its charter is
prepared and filed as required by section 9(c) of the Federal Advisory
Committee Act. This requirement is to be met by an advisory committee
utilized by FDA, even though it is not established by the agency, prior
to utilization.
(d) The regulations of the Department cited in paragraph (a) of this
section provide that the charter of a parent committee may incorporate
information concerning activities of a subgroup. In such instances, a
subgroup will not be established as a committee distinct from the parent
committee. However, a subgroup will be established as a separate
committee when the charter of the parent committee does not incorporate
the activities of the subgroup, or when the subgroup includes members
who are not all drawn from the parent committee.
(e) An advisory committee not required to be established by law will
be established or utilized only if it is in
[[Page 147]]
the public interest and only if its functions cannot reasonably be
performed by other existing advisory committees or by FDA.
(f) An advisory committee must meet the following standards:
(1) Its purpose is clearly defined.
(2) Its membership is balanced fairly in terms of the points of view
represented in light of the functions to be performed. Although
proportional representation is not required, advisory committee members
are selected without regard to race, color, national origin, religion,
age, or sex.
(3) It is constituted and utilizes procedures designed to assure
that its advice and recommendations are the result of the advisory
committee's independent judgment.
(4) Its staff is adequate. The Commissioner designates an executive
secretary and alternate for every advisory committee, who are employees
of FDA. The executive secretary is responsible for all staff support
unless other agency employees are designated for this function.
(5) Whenever feasible, or required by statute, it includes
representatives of the public interest.
[44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990]
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