{"data":{"id":"us/21-cfr-12.100","jurisdiction":"us","citation":"21 CFR 12.100","heading":"Administrative record of a hearing.","body":"(a) The record of a hearing consists of—\n(1) The order or regulation or notice of opportunity for hearing that gave rise to the hearing;\n(2) All objections and requests for hearing filed by the Dockets Management Staff under §§ 12.20 through 12.22;\n(3) The notice of hearing published under § 12.35;\n(4) All notices of participation filed under § 12.45;\n(5) All Federal Register notices pertinent to the proceeding;\n(6) All submissions filed under § 12.82, e.g., the submissions required by § 12.85, all other documentary evidence and written testimony, pleadings, statements of position, briefs, and other similar documents;\n(7) The transcript, written order, and all other documents relating to the prehearing conference, prepared under § 12.92;\n(8) All documents relating to any motion for summary decision under § 12.93;\n(9) All documents of which official notice is taken under § 12.95;\n(10) All pleadings filed under § 12.96;\n(11) All documents relating to any interlocutory appeal under § 12.97;\n(12) All transcripts prepared under § 12.98; and\n(13) Any other document relating to the hearing and filed with the Dockets Management Staff by the presiding officer or any participant;\n(b) The record of the administrative proceeding is closed—\n(1) With respect to the taking of evidence, when specified by the presiding officer; and\n(2) With respect to pleadings, at the time specified in § 12.96(a) for the filing of briefs.\n(c) The presiding officer may reopen the record to receive further evidence at any time before the filing of the initial decision.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 12—FORMAL EVIDENTIARY PUBLIC HEARING","Subpart F—Administrative Record"],"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":"1c63d907bb80a9c09fe337f8f917d9bfa3c77264e34e44c35b6ba128ea00dc12","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-12.99","next":"us/21-cfr-12.105"},"notice":"GroundRules: Original legal text. Not legal advice."}