[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: 21CFR14.27]
[Page 142-143]
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. 14.27 Determination to close portions of advisory committee meetings.
(a) No committee meeting may be entirely closed. A portion of a
meeting may be closed only in accordance with a written determination by
the Commissioner under this section.
(b) The executive secretary or other designated agency employee
shall prepare the initial request for a determination to close a portion
of a meeting, specifying the matter(s) to be discussed during the closed
portion and the reasons why the portion should be closed. The
Commissioner, based upon this request and with the concurrence of the
Chief Counsel, will determine whether to close a portion of a meeting.
The reasons for closing a portion of a meeting will be announced in the
Federal Register notice of the meeting under Sec. 14.20 in accordance
with the following rules:
(1) Any determination to close a portion of a meeting restricts the
closing to the shortest possible time consistent with the policy in this
section.
(2) A portion of a meeting may be closed only if the Commissioner
determines that the closing is permitted under 5 U.S.C. 552b(c), and
that the closing is necessary.
(3) Portions of meetings may ordinarily be closed if they concern
the review, discussion, and evaluation of drafts or regulations,
guidance documents or similar preexisting internal agency documents, but
only if their premature disclosure would significantly impede proposed
agency action; review of trade secrets and confidential commercial or
financial information; consideration of matters involving investigatory
files compiled for law enforcement purposes; and review of matters, the
disclosure of which would constitute a clearly unwarranted invasion of
personal privacy.
(4) Portions of meetings ordinarily may not be closed if they
concern review, discussion, and evaluation of general preclinical and
clinical test protocols and procedures for a class of drugs or devices;
consideration of labeling requirements for a class of marketed drugs and
devices; review of information on specific investigational or marketed
drugs and devices that have previously been made public; presentation of
any other information not exempt from public disclosure under 5 U.S.C.
552b(c); the formulation of advice and recommendations to FDA on matters
that do not independently justify closing.
(5) No portion of a meeting devoted to matters other than those
designated in paragraph (b) (1) through (3) of this section may be
closed.
[[Page 143]]
(6) A matter which is properly considered in an open portion of a
meeting may instead be considered in a closed portion only if it is so
inextricably intertwined with matters to be discussed in a closed
portion that it is not feasible to separate them or discussion of the
matter in an open portion would compromise the matters to be discussed
in the closed portion.
(c) Attendance at a closed portion of a meeting is governed by the
following rules:
(1) A portion of a meeting closed for the presentation or discussion
of information that constitutes a trade secret or confidential
commercial or financial information as defined in Sec. 20.61 may be
attended only by voting advisory committee members, nonvoting members
representing consumer interests who are also special government
employees as provided in Sec. 14.80(b), the executive secretary of the
advisory committee, a transcriber, consultants, and such other regular
employees of FDA (including members of the Office of the Chief Counsel)
as the chairman of the advisory committee may invite, and by those
persons authorized to be present under Sec. 14.25(c), for presentation
of information prohibited from public disclosure. A person making a
presentation described in Sec. 14.25(c) may be accompanied by a
reasonable number of employees, consultants, or other persons in a
commercial arrangement within the meaning of Sec. 20.81(a).
(2) A portion of a meeting that has been closed for consideration of
existing internal agency documents falling within Sec. 20.62 where
premature disclosure is likely to significantly impede proposed agency
action; personnel, medical, and similar files, disclosure of which would
be a clearly unwarranted invasion of personal privacy within the meaning
of Sec. 20.63; or investigatory records compiled for law enforcement
purposes as defined in Sec. 20.64 may be attended only by committee
members (voting and nonvoting), the executive secretary of the
committee, a transcriber, and other regular employees of FDA (including
members of the Office of the Chief Counsel) whom the chairman of the
committee may invite. Consultants, individuals performing personal
service contracts, employees of other Federal agencies, and the general
public may not attend such portions.
(3) If a person other than a person permitted to attend in
accordance with paragraph (c) (1) and (2) of this section attempts to
attend a closed portion of a meeting without the approval of the
executive secretary and the chairman, and the matter is brought to their
attention, the person will be required to leave the meeting immediately.
This inadvertent and unauthorized attendance does not enable other
unauthorized persons to attend, nor does it, of itself, constitute
grounds for release of transcripts of closed portions or any other
documents otherwise exempt from disclosure under Sec. 14.75 and part
20.
(4) If a person other than a person permitted to attend in
accordance with paragraphs (c) (1) and (2) of this section is allowed by
the executive secretary and the chairman to attend a closed portion of a
meeting, that portion is open to attendance by any interested person.
[44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000]
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