Code of Federal Regulations Title 21. Food and Drugs § 21.16.95 Administrative decision and record for decision

(1) The administrative record of the hearing specified in § 16.80(a) constitutes the exclusive record for decision;

(2) On the basis of the administrative record of the hearing, the Commissioner shall issue a written decision stating the reasons for the Commissioner's administrative action and the basis in the record;  and

(3) For purposes of judicial review under § 10.45, the record of the administrative proceeding consists of the record of the hearing and the Commissioner's decision.