Federal (United States) · Regulations
Subpart B — General Administrative Procedures
22 sections
22 sections
- 21 C.F.R. § 10.20Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
- 21 C.F.R. § 10.25Initiation of administrative proceedings.
- 21 C.F.R. § 10.30Citizen petition.
- 21 C.F.R. § 10.31Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.
- 21 C.F.R. § 10.33Administrative reconsideration of action.
- 21 C.F.R. § 10.35Administrative stay of action.
- 21 C.F.R. § 10.40Promulgation of regulations for the efficient enforcement of the law.
- 21 C.F.R. § 10.45Court review of final administrative action; exhaustion of administrative remedies.
- 21 C.F.R. § 10.50Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
- 21 C.F.R. § 10.55Separation of functions; ex parte communications.
- 21 C.F.R. § 10.60Referral by court.
- 21 C.F.R. § 10.65Meetings and correspondence.
- 21 C.F.R. § 10.70Documentation of significant decisions in administrative file.
- 21 C.F.R. § 10.75Internal agency review of decisions.
- 21 C.F.R. § 10.80Dissemination of draft Federal Register notices and regulations.
- 21 C.F.R. § 10.85Advisory opinions.
- 21 C.F.R. § 10.90Food and Drug Administration regulations, recommendations, and agreements.
- 21 C.F.R. § 10.95Participation in outside standard-setting activities.
- 21 C.F.R. § 10.100Public calendar.
- 21 C.F.R. § 10.105Representation by an organization.
- 21 C.F.R. § 10.110Settlement proposals.
- 21 C.F.R. § 10.115Good guidance practices.