[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: 21CFR13.30]

[Page 145-146]
 
                        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 B--Hearing Procedures
 
Sec. 13.30  Proceedings of a Board.

    (a) The purpose of a Board is to review medical, scientific, and 
technical issues fairly and expeditiously. The proceedings of a Board 
are conducted as a scientific inquiry rather than a legal trial.
    (b) A Board may not hold its first hearing until after all 
participants have submitted the information required by Sec. 13.25.
    (c) The Chairman calls the first hearing of the Board. Notice of the 
time and location of the first hearing is to be published at least 15 
days in advance and the hearing will be open to the public. All 
participants will have an opportunity at the first hearing to make an 
oral presentation of the information and views which in their opinion 
are pertinent to the resolution of the issues being considered by a 
Board. A participant's presentation may be made by more than one person. 
The Chairman determines the order of the presentation. Participants may 
not interrupt a presentation, but members of the Board may ask 
questions. At the conclusion of a presentation, each of the other 
participants may briefly comment on the presentation and may request 
that the Board conduct further questioning on specified matters. Members 
of the Board may then ask further questions. Any other participant may 
be permitted to ask questions if the Chairman determines that it will 
help resolve the issues.
    (d) The hearing is informal and the rules of evidence do not apply. 
No motions or objections relating to the admissibility of information 
and views may be made or considered, but other participants may comment 
upon or rebut all such information and views. No participant may 
interrupt the presentation of another participant for any reason.
    (e) Within the time specified by the Board after its first hearing, 
participants may submit written rebuttal information and views in 
accordance with Sec. 13.20. The Chariman will then schedule a second 
hearing, if requested and justified by a participant. A second hearing, 
and any subsequent hearing, will be called only if the Chairman 
concludes that it is needed to fully and fairly present information that 
cannot otherwise adequately be considered and to properly resolve the 
issues. Notice of the time and location of any hearing is to be 
published at least 15 days in advance. The hearing is open to the 
public.
    (f) A Board may consult with any person who it concludes may have 
information or views relevant to the issues.
    (1) The consultation may occur only at an announced hearing of a 
Board. Participants have the right to suggest or, with the permission of 
the Chairman, ask questions of the consultant and present rebuttal 
information and views, as provided in paragraphs (c) and (d) of this 
section except that written statements may be submitted to the Board 
with the consent of all participants.
    (2) A participant may submit a request that the Board consult with a 
specific person who may have information or views relevant to the 
issues. The request will state why the person should be consulted and 
why the person's views cannot be furnished to the Board by means other 
than having FDA arrange for the person's appearance. The Board may, in 
its discretion, grant or deny the request.
    (g) All hearings are to be transcribed. All hearings are open to the 
public, except that a hearing under Sec. 10.20(j)(3) is closed to all 
persons except those persons making and participating in the 
presentation and Federal Government executive branch employees and 
special Government employees. At least a majority of Board members are 
to be present at every hearing. The executive sessions of a Board, 
during which a Board deliberates on the issues, are to be closed and are 
not transcribed. All members of the Board shall vote on the report of 
the Board.

[[Page 146]]

    (h) All legal questions are to be referred to the Chief counsel for 
FDA for resolution. The Chief Counsel's advice on any matter of 
procedure or legal authority is to be transmitted in writing and made a 
part of the record or presented in open session and transcribed.
    (i) At the conclusion of all public hearings the Board will announce 
that the record is closed to receiving information. The Board will 
provide an opportunity for participants to submit written statements of 
their positions, with proposed findings and conclusions, and may in its 
discretion, provide an opportunity for participants to summarize their 
positions orally.
    (j) The Board will prepare a decision on all issues. The decision is 
to include specific findings and references supporting and explaining 
the Board's conclusions, and a detailed statement of the reasoning on 
which the conclusions are based. Any member of the Board may file a 
separate report stating additional or dissenting views.