21 CFR 16.95
§ 16.95 Administrative decision and record for decision.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 16.95, § 16.95 Administrative decision and record for decision, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83243
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.