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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
 
PART 12FORMAL 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.

Authority: 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112.
Source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.

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