[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.40]

[Page 157]
 
                        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 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]