[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: 21CFR14.22]
[Page 140.142]
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. 14.22 Meetings of an advisory committee.
(a) No advisory committee may conduct a meeting except at the call
or with the advance approval of, and with an agenda approved by, the
designated Federal employee or alternate. No meeting may be held in the
absence of the designated Federal employee.
(1) If any matter is added to the agenda after its publication in
the Federal Register under Sec. 14.20(b)(4), an attempt is to be made
to inform persons known to be interested in the matter, and the change
is to be announced at the beginning of the open portion of the meeting.
(2) The advisory committee meeting is to be conducted in accordance
with the approved final agenda insofar as practical.
(b) Advisory committee meetings will be held at places that are
reasonably accessible to the public. All advisory committee meetings
will be held in Washington, DC, or Rockville, MD, or the immediate
vicinity, unless the
[[Page 141]]
Commissioner receives and approves a written request from the advisory
committee for a different location. A different location may be approved
when one or more of the following applies:
(1) The total cost of the meeting to the Government will be reduced.
(2) A substantial number of the committee members will be at the
location at no expense to FDA for other reasons, e.g., for a meeting of
a professional association.
(3) It is a central location more readily accessible to committee
members.
(4) There is a need for increased participation available at that
location.
(5) The committee wishes to review work or facilities in a specific
location.
(6) The committee is concerned with matters that functionally or
historically occur in some other location, e.g., the Board of Tea
Experts and the Science Advisory Board of the National Center for
Toxicological Research will generally hold meetings in Brooklyn, NY, and
in the Little Rock, AR, vicinity, respectively.
(c) Advisory committee members may, with the approval of FDA,
conduct onsite visits relevant to their work.
(d) Unless the committee charter provides otherwise, a quorum for an
advisory committee is a majority of the current voting members of the
committee, except as provided in Sec. 14.125(c) for TEPRSSC. Any matter
before the advisory committee is to be decided by a majority vote of the
voting members present at the time, except that the designated Federal
official may require that any final report be voted upon by all current
voting members of the committee. Any current voting member of the
committee may file a separate report with additional or minority views.
(e) If space is available, any interested person may attend any
portion of any advisory committee meeting which is not closed.
(f) Whenever feasible, meetings are to be held in government
facilities or other facilities involving the least expense to the
public. The size of the meeting room is to be reasonable, considering
such factors as the size of the committee, the number of persons
expected to attend a meeting, and the resources and facilities
available.
(g) The Commissioner may authorize a meeting to be held by
conference telephone call. For these meetings, a speaker phone will be
provided in a conference room located in Washington, DC, or Rockville,
MD, or the immediate vicinity, to permit public participation in open
portions of the meetings, as provided in Sec. Sec. 14.25 and 14.29.
These meetings generally will be brief, and authorized--
(1) For the purpose of taking final votes or otherwise confirming
actions taken by the committee at other meetings; or
(2) Where time does not permit a meeting to be held at a central
location.
(h) Any portion of a meeting will be closed by the committee
chairman only when matters are to be discussed which the Commissioner
has determined may be considered in closed session under Sec. 14.27(b).
If a portion of the meeting is closed, the closed portion will be held
after the conclusion of the open portion whenever practicable.
(i) Any committee member may take notes during meetings and report
and discuss committee deliberations after a meeting is completed and
before official minutes or a report are available, within the rules and
regulations adopted by FDA and by the advisory committee with the
concurrence of FDA, including all of the following:
(1) There may be no attribution of individual views expressed in a
closed session or revealing of numerical votes.
(2) There may be no reporting or discussion of any particular matter
if the committee or FDA specifically so directs, e.g., where
deliberations are incomplete or involve a sensitive regulatory decision
that requires preparation or implementation.
(3) There may be no reporting or discussion of information
prohibited from public disclosure under Sec. 14.75.
(4) Notes or minutes kept or reports prepared by a committee member
have no status or effect unless adopted into the official minutes or
report by the committee. It is the responsibility of each committee
member to make certain that the official minutes and reports are
complete and accurate and fully reflect what happened at any
[[Page 142]]
meeting the committee member attended.
[44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept. 12, 1983, as amended at
54 FR 9035, Mar. 3, 1989]
Back to Top
© 2007 Betterchem Corp.
|
