21 CFR § 16.95 - Administrative decision and record for decision.

---
identifier: "/us/cfr/t21/s16.95"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 16.95 - Administrative decision and record for decision."
title_number: 21
title_name: "Food and Drugs"
section_number: "16.95"
section_name: "Administrative decision and record for decision."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "16"
part_name: "REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364."
regulatory_source: "44 FR 22367, Apr. 13, 1979, unless otherwise noted."
cfr_part: "16"
---


# 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.