21 CFR Part 12
PART 12—FORMAL EVIDENTIARY PUBLIC HEARING
- PART 12—FORMAL EVIDENTIARY PUBLIC HEARING
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- Subpart A—General Provisions
- § 12.1 Scope.
- Subpart B—Initiation of Proceedings
- § 12.20 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.
- § 12.21 Initiation of a hearing involving the issuance, amendment, or revocation of an order.
- § 12.22 Filing objections and requests for a hearing on a regulation or order.
- § 12.23 Notice of filing of objections.
- § 12.24 Ruling on objections and requests for hearing.
- § 12.26 Modification or revocation of regulation or order.
- § 12.28 Denial of hearing in whole or in part.
- § 12.30 Judicial review after waiver of hearing on a regulation.
- § 12.32 Request for alternative form of hearing.
- § 12.35 Notice of hearing; stay of action.
- § 12.37 Effective date of a regulation.
- § 12.38 Effective date of an order.
- Subpart C—Appearance and Participation
- § 12.40 Appearance.
- § 12.45 Notice of participation.
- § 12.50 Advice on public participation in hearings.
- Subpart D—Presiding Officer
- § 12.60 Presiding officer.
- § 12.62 Commencement of functions.
- § 12.70 Authority of presiding officer.
- § 12.75 Disqualification of presiding officer.
- § 12.78 Unavailability of presiding officer.
- Subpart E—Hearing Procedures
- § 12.80 Filing and service of submissions.
- § 12.82 Petition to participate in forma pauperis.
- § 12.83 Advisory opinions.
- § 12.85 Disclosure of data and information by the participants.
- § 12.87 Purpose; oral and written testimony; burden of proof.
- § 12.89 Participation of nonparties.
- § 12.90 Conduct at oral hearings or conferences.
- § 12.91 Time and place of prehearing conference.
- § 12.92 Prehearing conference procedure.
- § 12.93 Summary decisions.
- § 12.94 Receipt of evidence.
- § 12.95 Official notice.
- § 12.96 Briefs and arguments.
- § 12.97 Interlocutory appeal from ruling of presiding officer.
- § 12.98 Official transcript.
- § 12.99 Motions.
- Subpart F—Administrative Record
- § 12.100 Administrative record of a hearing.
- § 12.105 Examination of record.
- Subpart G—Initial and Final Decisions
- § 12.120 Initial decision.
- § 12.125 Appeal from or review of initial decision.
- § 12.130 Decision by Commissioner on appeal or review of initial decision.
- § 12.139 Reconsideration and stay of action.
- Subpart H—Judicial Review
- § 12.140 Review by the courts.
- § 12.159 Copies of petitions for judicial review.
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