[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: 21CFR14.80]
[Page 150-151]
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 E Members of Advisory Committees
Sec. 14.80 Qualifications for members of standing policy and technical
advisory committees.
(a) Members of a policy advisory committee--
(1) Shall have diverse interests, education, training, and
experience; specific technical expertise is not a requirement;
(2) Are subject to the conflict of interest laws and regulations
either as special Government employees or as members of the uniformed
services, including the Commissioned Corps of the Public Health Service
(the Commissioner has determined that, because members representing
particular interests, e.g., a representative of labor, industry,
consumers, or agriculture, are included on advisory committees
specifically for the purpose of representing these interests, any
financial interest covered by 18 U.S.C. 208(a) in the class which the
member represents is irrelevant to the services which the Government
expects from them and thus is hereby exempted under 18 U.S.C. 208(b) as
too remote and inconsequential to affect the integrity of their
services); and
(3) Shall be voting members.
(b) Technical advisory committee.(1) Voting members of technical
advisory committees--
(i) Shall have expertise in the subject matter with which the
committee is concerned and have diverse professional education,
training, and experience so that the committee will reflect a balanced
composition of sufficient scientific expertise to handle the problems
that come before it; and
(ii) Except for members of the Technical Electronic Product
Radiation Safety Standards Committee (TEPRSSC), are subject to the
conflict of interest laws and regulations either as special Government
employees or as members of the uniformed services, including the
Commissioned Corps of the Public Health Service.
(2) The Commissioner shall, when required by statute, and may when
not required by statute, provide for nonvoting members of a technical
advisory committee to serve as representatives of and liaison with
interested organizations. Nonvoting members--
(i) Shall be selected by the interested organizations, as provided
in Sec. 14.84; technical expertise in the subject matter with which the
committee is involved is not a requirement; and
(ii) May be special Government employees subject to the conflict of
interest laws and regulations, except as provided in Sec. 14.84(e).
(c) A person may serve as a voting or nonvoting member on only one
FDA advisory committee unless the Commissioner determines in writing
that dual membership will aid the work of the committees involved and is
in the public interest.
(d) Members of FDA advisory committees, and the chairman, are
appointed from among those nominated under Sec. Sec. 14.82 and 14.84
and from any other sources by the Secretary, or, by delegation of
authority, by the Assistant Secretary for Health, or the Commissioner.
(e) Members appointed to an advisory committee serve for the
duration of the committee, or until their terms of appointment expire,
they resign, or they are removed from membership by the Commissioner.
(f) A committee member may be removed from membership for good
cause. Good cause includes excessive absenteeism from committee
meetings, a demonstrated bias that interferes with the ability to render
objective advice, failure to abide by the procedures established in this
subpart, or violation of other applicable rules and regulations, e.g.,
for nonvoting members, the provisions of Sec. 14.86(c).
[[Page 151]]
(g) Consultants appointed under Sec. 14.31(e) are not members of
advisory committees.
[44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988;
54 FR 9035, Mar. 3, 1989]
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