Part 10 — Administrative Practices and Procedures
Current through Sep 8, 2026
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, and at 88 FR 45064, July 14, 2023.
Sections
- § 10.1 Scope.
- § 10.3 Definitions.
- § 10.10 Summaries of administrative practices and procedures.
- § 10.19 Waiver, suspension, or modification of procedural requirements.
- § 10.20 Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
- § 10.25 Initiation of administrative proceedings.
- § 10.30 Citizen petition.
- § 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.
- § 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.
- § 10.115 Good guidance practices.
- § 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.