[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.75]

[Page 149]
 
                        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 D_Records of Meetings and Hearings Before Advisory Committees
 
Sec.  14.75  Examination of administrative record and other advisory committee records.

    (a) The administrative record and other committee records are 
available for public disclosure under part 20, except as provided in 
paragraph (b) of this section, at the following times:
    (1) The written information for consideration by the committee at 
any meeting: at the same time it is made available to the committee.
    (2) The transcript or recording of any open portion of a meeting: as 
soon as it is available.
    (3) The minutes of any open portion of a meeting: after they have 
been approved by the committee and certified by the chairman.
    (4) The brief summary of any closed portion of a meeting prepared 
under Sec.  14.60(c): as soon as it is available.
    (5) All written information or views submitted to the committee at 
an open portion of a meeting: as soon as they are submitted.
    (6) The minutes or portions thereof of a closed portion of a 
meeting--
    (i) For a matter not directed to be maintained as confidential under 
Sec.  14.22(i)(2): After they have been approved by the committee and 
certified by the chairman; and
    (ii) For a matter directed to be maintained as confidential under 
Sec.  14.22(i)(2): After the advice or report of the committee relevant 
to those minutes or portions thereof is acted upon by the Commissioner, 
or upon a determination by the Commissioner that such minutes or 
portions thereof may be made available for public disclosure without 
undue interference with agency or advisory committee operations.
    (7) Formal advice or a report of the committee: After it has been 
acted upon, i.e., approved, disapproved, or rejected as inadequate, by 
the Commissioner, or upon a determination by the Commissioner that such 
formal advice or report may be made available for public disclosure 
without undue interference with agency or committee operations. Such 
formal advice or report may be retained as confidential while it is 
under active advisement.
    (8) Any other committee records relating to the matter, except 
transcripts and recordings of closed portions of meetings: After the 
advice or report of the committee relevant to those records is acted 
upon by the Commissioner, or upon a determination by the Commissioner 
that the records may be made available for public disclosure without 
undue interference with agency or committee operations.
    (b) The following information contained in the administrative record 
is not available for public examination or copying except as provided in 
Sec.  12.32(g):
    (1) Material provided to the committee by FDA that is exempt from 
public disclosure under part 20 and the regulations referenced there.
    (2) Material provided to the advisory committee by a person making a 
presentation described in Sec.  14.25(c) and which is prohibited from 
public disclosure under part 20 and the regulations referenced there.
    (c) The Division of Dockets Management (HFA-305) will maintain a 
file for each committee containing the following principal records for 
ready access by the public:
    (1) The committee charter.
    (2) A list of committee members and their curricula vitae.
    (3) The minutes of committee meetings.
    (4) Any formal advice or report of the committee.

[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]

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