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FEDERAL · 21 CFR

Part 1316 — Administrative Functions, Practices, and Procedures

49 sections · Title 21: Food and Drugs

§ 1316.01Scope of subpart A.
§ 1316.02Definitions.
§ 1316.03Authority to make inspections.
§ 1316.04Exclusion from inspection.
§ 1316.05Entry.
§ 1316.06Notice of inspection.
§ 1316.07Requirement for administrative inspection warrant; exceptions.
§ 1316.08Consent to inspection.
§ 1316.09Application for administrative inspection warrant.
§ 1316.10Administrative probable cause.
§ 1316.11Execution of warrants.
§ 1316.12Refusal to allow inspection with an administrative warrant.
§ 1316.13Frequency of administrative inspections.
§ 1316.21Definitions.
§ 1316.22Exemption.
§ 1316.23Confidentiality of identity of research subjects.
§ 1316.24Exemption from prosecution for researchers.
§ 1316.31Authority for enforcement proceeding.
§ 1316.32Notice of proceeding; time and place.
§ 1316.33Conduct of proceeding.
§ 1316.34Records of proceeding.
§ 1316.41Scope of subpart D.
§ 1316.42Definitions.
§ 1316.43Information; special instructions.
§ 1316.44Waiver or modification of rules.
§ 1316.45Filings; address; hours.
§ 1316.46Inspection of record.
§ 1316.47Request for hearing; answer.
§ 1316.48Notice of appearance.
§ 1316.49Waiver of hearing.
§ 1316.50Appearance; representation; authorization.
§ 1316.51Conduct of hearing and parties; ex parte communications.
§ 1316.52Presiding officer.
§ 1316.53Time and place of hearing.
§ 1316.54Prehearing conference.
§ 1316.55Prehearing ruling.
§ 1316.56Burden of proof.
§ 1316.57Submission of documentary evidence and affidavits and identification of witnesses subsequent to prehearing conference.
§ 1316.58Summary of testimony; affidavits.
§ 1316.59Submission and receipt of evidence.
§ 1316.60Objections; offer of proof.
§ 1316.61Exceptions to rulings.
§ 1316.62Interlocutory appeals from rulings of the presiding officer.
§ 1316.63Official transcript; index; corrections.
§ 1316.64Proposed findings of fact and conclusions of law.
§ 1316.65Report and record.
§ 1316.66Exceptions.
§ 1316.67Final order.
§ 1316.68Copies of petitions for judicial review.