[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: 21CFR14.29]
[Page 143-144]
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.
[[Page 144]]
(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.
(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.
Back to Top
© 2007 Betterchem Corp.
|
