CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL (parts 1 to 99) > PART 16—REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION > SUBPART E—Administrative Record and Decision (§16.80 to §16.95) > 16.95—Administrative decision and record for decision.

16.95—Administrative decision and record for decision.

(a) With respect to a regulatory hearing at the Commissioner's initiative under § 16.1(a), the Commissioner shall consider the administrative record of the hearing specified in § 16.80(a) together with all other relevant information and views available to FDA in determining whether regulatory action should be taken and, if so, in what form.
(b) With respect to a regulatory hearing required by the act or a regulation under § 16.1(b) —
(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.