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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 12 - Formal Evidentiary Public Hearing |
| 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. |