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21 C.F.R. PART 12--FORMAL EVIDENTIARY PUBLIC HEARING

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 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.