part_subject: "REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION"
subpart_code: "E"
subpart_subject: "Administrative Record and Decision"
section_number: "16.95"
section_subject: "Administrative decision and record for decision."
cfr_reference: "21 CFR 16.95"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.