21 CFR 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 § 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 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 Science Advisory Board of the National Center for Toxicological Research will generally hold meetings in the Little Rock, AR, vicinity.
(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 § 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 §§ 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 Chairperson only when matters are to be discussed which the Commissioner has determined may be considered in closed session under § 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 § 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.
Title 21 published on 13-Apr-2017 03:05
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 14 after this date.