[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: 21CFR14.70]

[Page 148-149]
 
                        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).

[[Page 149]]

    (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.