Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter A - General |
Part 16 - Regulatory Hearing Before the Food and Drug Administration |
Subpart E - Administrative Record and Decision |
§ 16.95 - Administrative decision and record for decision.
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§ 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.