[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: 21CFR14.84]
[Page 151-152]
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. 14.84 Nominations and selection of nonvoting members of standing
technical advisory committees.
(a) This section applies when the Commissioner concludes that a
technical advisory committee should include nonvoting members to
represent and serve as a liaison with interested individuals and
organizations.
(b) Except when the Commissioner concludes otherwise, nonvoting
members of a technical advisory committee are selected in accordance
with paragraphs (c) and (d) of this section and are normally limited to
one person selected by consumer groups and organizations and one person
selected by industry groups and organizations.
(c) To select a nonvoting member to represent consumer interests,
except as provided in paragraph (c)(5) of this section, the Commissioner
publishes a notice in the Federal Register requesting nominations for
each specific committee, or subcommittee, for which nonvoting members
are to be appointed.
(1) A period of 30 days will be permitted for submission of
nominations for that committee or subcommittee. Interested persons may
nominate one or more qualified persons to represent consumer interests.
Although nominations from individuals will be accepted, individuals are
encouraged to submit their nominations through consumer organizations as
defined in paragraph (c)(3) of this section. Nominations of qualified
persons for general consideration as nonvoting members of unspecified
advisory committees or subcommittees may be made at any time. All
nominations are to be submitted in writing to the Office of Consumer
Affairs (HFE-40), Food and Drug Administration, Rm. 16-85, 5600 Fishers
Lane, Rockville, MD 20857.
(2) A complete curriculum vitae of any nominee is to be included.
Nominations must state that the nominee is aware of the nomination, is
willing to serve as a member of an advisory committee, and appears to
have no conflict of interest. The nomination must state whether a
nominee is interested only in a particular advisory committee or
subcommittee, or whether the nominee is interested in becoming a member
of any advisory committee or subcommittee. Nominations that do not
comply with the requirements of this paragraph will not be considered.
(3) The Office of Consumer Affairs will compile a list of
organizations whose objectives are to promote, encourage, and contribute
to the advancement of consumer education and to the resolution of
consumer problems. All organizations listed are entitled to vote upon
the nominees. The list will include organizations representing the
public interest, consumer advocacy groups, and consumer/health branches
of Federal, State, and local governments. Any organization that meets
the criteria may be included on such list on request.
[[Page 152]]
(4) The executive secretary, or other designated agency employee,
will review the list of nominees and select three to five qualified
nominees to be placed on a ballot. Names not selected will remain on a
list of eligible nominees and be reviewed periodically by the Office of
Consumer Affairs to determine continued interest. Upon selection of the
nominees to be placed on the ballot, the curriculum vitae for each of
the nominees will be sent to each of the organizations on the list
complied under paragraph (c)(3) of this section, together with a ballot
to be filled out and returned within 30 days. After the time for return
of the ballots has expired, the ballots will be counted and the nominee
who has received the highest number of votes will be selected as the
nonvoting member representing consumer interests for that particular
advisory committee or subcommittee. In the event of a tie, the
Commissioner will select the winner by lot from among those tied for the
highest number of votes.
(5) If a member representing consumer interests resigns or is
removed before termination of the committee on which the member is
serving, the following procedures will be used to appoint a replacement
to serve out the term of the former member:
(i) The Commissioner will appoint the runner-up, in order of number
of ballots received, on the original ballot submitted under paragraph
(c)(4) of this section to fill the vacancy. If the runner-up is no
longer willing to serve as a member, then the next runner-up will be
appointed.
(ii) If none of the nominees on the original ballot is willing to
serve, or if there was only one nominee on the original ballot, the
Office of Consumer Affairs will contact by telephone eligible
individuals whose names have been submitted in the past as candidates
for membership as representatives of consumer interests. A list of
persons who are interested in serving on an advisory committee will then
be prepared. The curricula vitae of these persons, together with a
ballot, will be sent to a representative number of consumer
organizations that have been determined to be eligible to vote for
consumer representatives in accordance with paragraph (c)(3) of this
section. After 4 days have elapsed, the Office of Consumer Affairs will
contact the consumer organizations by telephone and elicit their votes.
The candidate who has received the highest number of votes will be
selected. In the event of a tie, the Commissioner will select the winner
by lot from among those tied for the highest number of votes.
(d) To select a nonvoting member to represent industry interests,
the Commissioner will publish, for each committee for which the
Commissioner has determined to appoint a nonvoting member, a notice
requesting that, within 30 days, any industry organization interested in
participating in the selection of an appropriate nonvoting member to
represent industry interests send a letter stating that interest to the
FDA employee designated in the notice. After 30 days, a letter will be
sent to each organization that has expressed an interest, attaching a
complete list of all such organizations, and stating that it is their
responsibility to consult with each other in selecting, within 60 days
after receipt of the letter, a single nonvoting member to represent
industry interests for that committee. If no individual is selected
within 60 days, the Commissioner will select the nonvoting member
representing industry interests.
(e) The Commissioner has determined that, because nonvoting members
representing consumer and industry interests are included on advisory
committees specifically for the purpose of representing such interests
and have no vote, any financial interest covered by 18 U.S.C. 208(a) in
the class which the member represents is irrelevant to the services 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.
[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
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