{"data":{"id":"us/21-cfr-16.95","jurisdiction":"us","citation":"21 CFR 16.95","heading":"Administrative decision and record for decision.","body":"(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.\n(b) With respect to a regulatory hearing required by the act or a regulation under § 16.1(b)—\n(1) The administrative record of the hearing specified in § 16.80(a) constitutes the exclusive record for decision;\n(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\n(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.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"eb06e77dafb141547d620b3791f2db6024a27ffae9b287dccc3c9400cb5e4b95","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-16.85","next":"us/21-cfr-16.119"},"notice":"GroundRules: Original legal text. Not legal advice."}