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.

• 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.

21:1.0.1.1.8.1	SUBPART A	Subpart A - General Provisions
21:1.0.1.1.8.1.63.1	SECTION 10.1	10.1 Scope.
21:1.0.1.1.8.1.63.2	SECTION 10.3	10.3 Definitions.
21:1.0.1.1.8.1.63.3	SECTION 10.10	10.10 Summaries of administrative practices and procedures.
21:1.0.1.1.8.1.63.4	SECTION 10.19	10.19 Waiver, suspension, or modification of procedural requirements.
21:1.0.1.1.8.2	SUBPART B	Subpart B - General Administrative Procedures
21:1.0.1.1.8.2.63.1	SECTION 10.20	10.20 Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure.
21:1.0.1.1.8.2.63.2	SECTION 10.25	10.25 Initiation of administrative proceedings.
21:1.0.1.1.8.2.63.3	SECTION 10.30	10.30 Citizen petition.
21:1.0.1.1.8.2.63.4	SECTION 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.
21:1.0.1.1.8.2.63.5	SECTION 10.33	10.33 Administrative reconsideration of action.
21:1.0.1.1.8.2.63.6	SECTION 10.35	10.35 Administrative stay of action.
21:1.0.1.1.8.2.63.7	SECTION 10.40	10.40 Promulgation of regulations for the efficient enforcement of the law.
21:1.0.1.1.8.2.63.8	SECTION 10.45	10.45 Court review of final administrative action; exhaustion of administrative remedies.
21:1.0.1.1.8.2.63.9	SECTION 10.50	10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
21:1.0.1.1.8.2.63.10	SECTION 10.55	10.55 Separation of functions; ex parte communications.
21:1.0.1.1.8.2.63.11	SECTION 10.60	10.60 Referral by court.
21:1.0.1.1.8.2.63.12	SECTION 10.65	10.65 Meetings and correspondence.
21:1.0.1.1.8.2.63.13	SECTION 10.70	10.70 Documentation of significant decisions in administrative file.
21:1.0.1.1.8.2.63.14	SECTION 10.75	10.75 Internal agency review of decisions.
21:1.0.1.1.8.2.63.15	SECTION 10.80	10.80 Dissemination of draft Federal Register notices and regulations.
21:1.0.1.1.8.2.63.16	SECTION 10.85	10.85 Advisory opinions.
21:1.0.1.1.8.2.63.17	SECTION 10.90	10.90 Food and Drug Administration regulations, recommendations, and agreements.
21:1.0.1.1.8.2.63.18	SECTION 10.95	10.95 Participation in outside standard-setting activities.
21:1.0.1.1.8.2.63.19	SECTION 10.100	10.100 Public calendar.
21:1.0.1.1.8.2.63.20	SECTION 10.105	10.105 Representation by an organization.
21:1.0.1.1.8.2.63.21	SECTION 10.110	10.110 Settlement proposals.
21:1.0.1.1.8.2.63.22	SECTION 10.115	10.115 Good guidance practices.
21:1.0.1.1.8.3	SUBPART C	Subpart C - Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures
21:1.0.1.1.8.3.63.1	SECTION 10.200	10.200 Scope.
21:1.0.1.1.8.3.63.2	SECTION 10.203	10.203 Definitions.
21:1.0.1.1.8.3.63.3	SECTION 10.204	10.204 General.
21:1.0.1.1.8.3.63.4	SECTION 10.205	10.205 Electronic media coverage of public administrative proceedings.
21:1.0.1.1.8.3.63.5	SECTION 10.206	10.206 Procedures for electronic media coverage of agency public administrative proceedings.

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