Title 21

PART 10

Part 10 - Administrative Practices And Procedures

PART 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES 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.

21:1.0.1.1.7.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.7.1.63.1SECTION 10.1
   10.1 Scope.
21:1.0.1.1.7.1.63.2SECTION 10.3
   10.3 Definitions.
21:1.0.1.1.7.1.63.3SECTION 10.10
   10.10 Summaries of administrative practices and procedures.
21:1.0.1.1.7.1.63.4SECTION 10.19
   10.19 Waiver, suspension, or modification of procedural requirements.
21:1.0.1.1.7.2SUBPART B
Subpart B - General Administrative Procedures
21:1.0.1.1.7.2.63.1SECTION 10.20
   10.20 Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure.
21:1.0.1.1.7.2.63.2SECTION 10.25
   10.25 Initiation of administrative proceedings.
21:1.0.1.1.7.2.63.3SECTION 10.30
   10.30 Citizen petition.
21:1.0.1.1.7.2.63.4SECTION 10.31
   10.31 Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.
21:1.0.1.1.7.2.63.5SECTION 10.33
   10.33 Administrative reconsideration of action.
21:1.0.1.1.7.2.63.6SECTION 10.35
   10.35 Administrative stay of action.
21:1.0.1.1.7.2.63.7SECTION 10.40
   10.40 Promulgation of regulations for the efficient enforcement of the law.
21:1.0.1.1.7.2.63.8SECTION 10.45
   10.45 Court review of final administrative action; exhaustion of administrative remedies.
21:1.0.1.1.7.2.63.9SECTION 10.50
   10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
21:1.0.1.1.7.2.63.10SECTION 10.55
   10.55 Separation of functions; ex parte communications.
21:1.0.1.1.7.2.63.11SECTION 10.60
   10.60 Referral by court.
21:1.0.1.1.7.2.63.12SECTION 10.65
   10.65 Meetings and correspondence.
21:1.0.1.1.7.2.63.13SECTION 10.70
   10.70 Documentation of significant decisions in administrative file.
21:1.0.1.1.7.2.63.14SECTION 10.75
   10.75 Internal agency review of decisions.
21:1.0.1.1.7.2.63.15SECTION 10.80
   10.80 Dissemination of draft Federal Register notices and regulations.
21:1.0.1.1.7.2.63.16SECTION 10.85
   10.85 Advisory opinions.
21:1.0.1.1.7.2.63.17SECTION 10.90
   10.90 Food and Drug Administration regulations, recommendations, and agreements.
21:1.0.1.1.7.2.63.18SECTION 10.95
   10.95 Participation in outside standard-setting activities.
21:1.0.1.1.7.2.63.19SECTION 10.100
   10.100 Public calendar.
21:1.0.1.1.7.2.63.20SECTION 10.105
   10.105 Representation by an organization.
21:1.0.1.1.7.2.63.21SECTION 10.110
   10.110 Settlement proposals.
21:1.0.1.1.7.2.63.22SECTION 10.115
   10.115 Good guidance practices.
21:1.0.1.1.7.3SUBPART C
Subpart C - Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures
21:1.0.1.1.7.3.63.1SECTION 10.200
   10.200 Scope.
21:1.0.1.1.7.3.63.2SECTION 10.203
   10.203 Definitions.
21:1.0.1.1.7.3.63.3SECTION 10.204
   10.204 General.
21:1.0.1.1.7.3.63.4SECTION 10.205
   10.205 Electronic media coverage of public administrative proceedings.
21:1.0.1.1.7.3.63.5SECTION 10.206
   10.206 Procedures for electronic media coverage of agency public administrative proceedings.