[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR13.10]

[Page 163-164]
 
                        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

[[Page 164]]

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.
    (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]