[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: 21CFR14.70]
[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. 14.70 Administrative record of a public hearing before an advisory committee.
(a) Advice or recommendations of an advisory committee may be given
only on matters covered in the administrative record of the committee's
proceedings. Except as specified in other FDA regulations, the
administrative record consists of all the following items relating to
the matter:
(1) Any transcript or recording of an open portion of a meeting.
(2) The minutes of all portions of all meetings, after any deletions
under Sec. 14.60(b)(4).
(3) All written submissions to and information considered by the
committee.
(4) All reports made by the committee.
(5) Any reports prepared by a consultant under Sec. 14.31(e).
(b) The record of the proceeding is closed at the time the advisory
committee renders its advice or recommendations or at any earlier time
specified by the committee or in other sections in this chapter.
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