[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: 21CFR13.10]
[Page 132.133]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY--Table of Contents
Subpart A General Provisions
Sec. 13.10 Members of a Board.
(a) All members of a Board are to have medical, technical,
scientific, or other qualifications relevant to the issues to be
considered, are subject to the conflict of interest rules applicable to
special Government employees, and are to be free from bias or prejudice
concerning the issues involved. A member of a Board may be a full-time
or part-time Federal Government employee or may serve on an FDA advisory
committee but, except with the agreement of all parties, may not
currently be a full-time or part-time employee of FDA or otherwise act
as a special Government employee of FDA.
(b) Within 30 days of publication of the notice of hearing, the
director of the center of FDA responsible for a matter before a Board,
the other parties to the proceeding, and any person whose petition was
granted and is the subject of the hearing, shall each submit to the
Division of Dockets Management the names and full curricula vitae of
five nominees for members of the Board. Nominations are to state that
the nominee is aware of the nomination, is interested in becoming a
member of the Board, and appears to have no conflict of interest.
(1) Any two or more persons entitled to nominate members may agree
upon a joint list of five qualified nominees.
(2) The lists of nominees must be submitted to the persons entitled
to submit a list of nominees under this paragraph but not to all
participants. Within 10 days of receipt of the lists of nominees, such
persons may submit comments to the Division of Dockets Management on
whether the nominees of the other persons meet the criteria established
in paragraph (a) of this section. A person submitting comments to the
Division of Dockets Management shall submit them to all persons entitled
to submit a list of nominees.
(3) The lists of nominees and comments on them are to be held in
confidence by the Division of Dockets Management as part of the
administrative record of the proceeding and are not to be made available
for public disclosure, and all persons who submit or receive them shall
similarly hold them in confidence. This portion of the administrative
record remains confidential but is available for judicial review in the
event that it becomes relevant to any issue before a court.
(c) After reviewing the lists of nominees and any comments, the
Commissioner will choose three qualified persons as members of a Board.
One member will be from the lists of nominees submitted by the director
of the center and by any person whose petition was granted and is the
subject of the hearing. The second will be from the lists of nominees
submitted by the other parties. The Commissioner may choose the third
member from any source. That member is the Chairman of the Board.
(1) If the Commissioner is unable to find a qualified person with no
conflict of interest from among a list of nominees or if additional
information is needed, the Commissioner will request the submission of
the required additional nominees or information.
[[Page 133]]
(2) If a person fails to submit a list of nominees as required by
paragraph (b) of this section, the Commissioner may choose a qualified
member without further consultation with that person.
(3) The Commissioner will announce the members of a Board by filing
a memorandum in the record of the proceeding and sending a copy to all
participants.
(d) Instead of using the selection method in paragraphs (b) and (c)
of this section, the director of the center, the other parties to the
proceeding, and any person whose petition was granted and is the subject
of the hearing, may, with the approval of the Commissioner, agree that a
standing advisory committee listed in Sec. 14.80 constitutes the Board
for a particular proceeding, or that another procedure is to be used for
selection of the members of the Board, or that the Board consists of a
larger number of members.
(e) The members of a Board serve as consultants to the Commissioner
and are special Government employees or Government employees. A Board
functions as an administrative law tribunal in the proceeding and is not
an advisory committee subject to the requirements of the Federal
Advisory Committee Act or part 14.
(f) The Chairman of the Board has the authority of a presiding
officer set out in Sec. 12.70.
[44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985]
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