[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: 21CFR10.1]

[Page 107-108]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10_ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 10.1  Scope.




                      Subpart A_General Provisions

Sec.
10.1 Scope.
10.3 Definitions.
10.10 Summaries of administrative practices and procedures.
10.19 Waiver, suspension, or modification of procedural requirements.

               Subpart B_General Administrative Procedures

10.20 Submission of documents to Division of Dockets Management; 
          computation of time; availability for public disclosure.
10.25 Initiation of administrative proceedings.
10.30 Citizen petition.
10.33 Administrative reconsideration of action.
10.35 Administrative stay of action.
10.40 Promulgation of regulations for the efficient enforcement of the 
          law.
10.45 Court review of final administrative action; exhaustion of 
          administrative remedies.
10.50 Promulgation of regulations and orders after an opportunity for a 
          formal evidentiary public hearing.
10.55 Separation of functions; ex parte communications.
10.60 Referral by court.
10.65 Meetings and correspondence.
10.70 Documentation of significant decisions in administrative file.
10.75 Internal agency review of decisions.
10.80 Dissemination of draft Federal Register notices and regulations.
10.85 Advisory opinions.
10.90 Food and Drug Administration regulations, recommendations, and 
          agreements.
10.95 Participation in outside standard-setting activities.
10.100 Public calendar.
10.105 Representation by an organization.
10.110 Settlement proposals.

[[Page 108]]

10.115 Good guidance practices.

      Subpart C_Electronic Media Coverage of Public Administrative 
             Proceedings; Guideline on Policy and Procedures

10.200 Scope.
10.203 Definitions.
10.204 General.
10.205 Electronic media coverage of public administrative proceedings.
10.206 Procedures for electronic media coverage of agency public 
          administrative proceedings.

    Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 
141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 
262, 263b, 264.

    Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 10 appear at 68 FR 
24879, May 9, 2003.



    (a) Part 10 governs practices and procedures for petitions, 
hearings, and other administrative proceedings and activities conducted 
by the Food and Drug Administration under the Federal Food, Drug, and 
Cosmetic Act, the Public Health Service Act, and other laws that the 
Commissioner of Food and Drugs administers under Sec. 5.10.
    (b) If a requirement in another part of title 21 differs from a 
requirement in this part, the requirements of this part apply to the 
extent that they do not conflict with the other requirements.
    (c) References in this part and parts 12, 13, 14, 15, and 16 to 
regulatory sections of the Code of Federal Regulations are to chapter I 
of title 21 unless otherwise noted.
    (d) References in this part and parts 12, 13, 14, 15, and 16 to 
publication, or to the day or date of publication, or use of the phrase 
to publish, refer to publication in the Federal Register unless 
otherwise noted.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989]