[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.29]

[Page 152-153]
 
                        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 B--Meeting Procedures
 
Sec. 14.29  Conduct of a hearing before an advisory committee.

    (a) For each meeting, the open portion for public participation, 
which constitutes a public hearing under Sec. 14.25(a), will be at least 
1 hour, unless public participation does not last that long, and may 
last for whatever longer time the committee chairman determines will 
facilitate the work of the committee. The Federal Register notice 
published under Sec. 14.20 will designate the time specifically reserved 
for the hearing, which is ordinarily the first portion of the meeting. 
Further public participation in any open portion of the meeting under 
Sec. 14.25(b) is solely at the discretion of the chairman.
    (b) An interested person who wishes to be assured of the right to 
make an oral presentation at a meeting shall inform the executive 
secretary or other designated agency employee, orally or in writing, 
before the meeting.
    (1) The person shall state the general nature of the presentation 
and the approximate time desired. Whenever possible, all written 
information to be discussed by that person at the meeting should be 
furnished in advance to the executive secretary or other designated 
agency employee. This material may be distributed or mailed by FDA to 
the committee members in advance of the meeting if time permits, and 
otherwise will be distributed to the members when they arrive for the 
meeting. The mailing or distribution may be undertaken only by FDA 
unless FDA grants permission to a person to mail or distribute the 
material
    (2) Before the meeting, the executive secretary or other designated 
agency employee shall determine the amount of time allocated to each 
person for oral presentation and the time that the presentation is to 
begin. Each person will be so informed in writing, if time permits, or 
by telephone. FDA may require persons with common interests to make 
joint presentations.
    (c) The chairman of the committee shall preside at the meeting in 
accordance with Sec. 14.30 and be accompanied by other committee 
members, who serve as a panel in conducting the hearing portion of the 
meeting.

[[Page 153]]

    (d) Each person may use the allotted time as desired, consistent 
with an orderly hearing. A person may be accompanied by additional 
persons, and may present any written information or views for inclusion 
in the record of the hearing, subject to the requirements of 
Sec. 14.35(c).
    (e) If a person is absent at the time specified for that person's 
presentation, the persons following will appear in order. An attempt 
will be made to hear the person at the conclusion of the hearing. 
Interested persons attending the hearing who did not request an 
opportunity to make an oral presentation may be given an opportunity to 
do so at the discretion of the chairman.
    (f) The chairman and other members may question a person concerning 
that person's presentation. No other person, however, may question the 
person. The chairman may allot additional time when it is in the public 
interest, but may not reduce the time allotted without consent of the 
person.
    (g) Participants may question a committee member only with that 
member's permission and only about matters before the committee.
    (h) 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 matters presented. No participant may interrrupt the 
presentation of another participant.