[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.61]

[Page 179-180]
 
                        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. 14.61  Transcripts of advisory committee meetings.

    (a) The agency will arrange for a transcript or recording to be made 
for each portion of a meeting.
    (b) A transcript or recording of an open portion of a meeting made 
by FDA is to be included in the record of the committee proceedings.
    (c) A transcript or recording of any closed portion of a meeting 
made by FDA will not be included in the administrative record of the 
committee proceedings. The transcript or recording will be retained as 
confidential by

[[Page 180]]

FDA, and will not be discarded or erased.
    (d) Any transcript or recording of a meeting or portion thereof 
which is publicly available under this section will be available at 
actual cost of duplication, which will be, where applicable, the fees 
established in Sec. 20.45. FDA may furnish the requested transcript or 
recording for copying to a private contractor who shall charge directly 
for the cost of copying under Sec. 20.53.
    (e) A person attending any open portion of a meeting may, consistent 
with the orderly conduct of the meeting, record or otherwise take a 
transcript of the meeting. This transcription will not be part of the 
administrative record.
    (f) Only FDA may make a transcript or recording of a closed portion 
of a meeting.

[44 FR 22351, Apr. 13, 1979, as amended at 68 FR 25285, May 12, 2003]