Title 21

SECTION 14.70

14.70 Administrative record of a public hearing before an advisory committee.

§ 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 § 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 § 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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