[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.1]

[Page 145-146]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 12_FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 12.1  Scope.




                      Subpart A_General Provisions

Sec.
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 argument.
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.

[[Page 146]]

                  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.



    The procedures in this part apply when--
    (a) A person has a right to an opportunity for a hearing under the 
laws specified in Sec. 10.50; or
    (b) The Commissioner concludes that it is in the public interest to 
hold a formal evidentiary public hearing on any matter before FDA.