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Title 21: Food and Drugs
Subpart C - Records of a Hearing Before a Board
§ 13.40 Administrative record of a Board.

(a) The administrative record of a hearing before a Board consists of the following:

(1) All relevant Federal Register notices.

(2) All written submissions under § 13.20.

(3) The transcripts of all hearings of the Board.

(4) The initial decision of the Board.

(b) The record of the administrative proceeding is closed -

(1) Relevant to receiving information and data, at the time specified in § 13.30(i); and

(2) Relevant to pleadings, at the time specified in § 13.30(i) for filing a written statement of position with proposed findings and conclusions.

(c) The Board may, in its discretion, reopen the record to receive further evidence at any time before filing an initial decision.

§ 13.45 Examination of administrative record.

(a) The availability for public examination and copying of each document which is a part of the administrative record of the hearing is governed by § 10.20(j). Each document available for public examination or copying is placed on public display in the office of the Division of Dockets Management promptly upon receipt in that office.

(b) Lists of nominees and comments submitted on them under § 13.10(b)(3) are not subject to disclosure unless they become an issue in a court proceeding.

§ 13.50 Record for administrative decision.

The administrative record of the hearing specified in § 13.40(a) constitutes the exclusive record for decision.

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