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Electronic Code of Federal Regulations

e-CFR data is current as of February 21, 2020

Title 21Chapter ISubchapter APart 12


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

rule

Subpart A—GENERAL PROVISIONS

§12.1
Scope.
rule

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.
rule

Subpart C—APPEARANCE AND PARTICIPATION

§12.40
Appearance.
§12.45
Notice of participation.
§12.50
Advice on public participation in hearings.
rule

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.
rule

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.
rule

Subpart F—ADMINISTRATIVE RECORD

§12.100
Administrative record of a hearing.
§12.105
Examination of record.
rule

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.
rule

Subpart H—JUDICIAL REVIEW

§12.140
Review by the courts.
§12.159
Copies of petitions for judicial review.

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