21 CFR Part 10 — Administrative Practices and Procedures
Subpart A — General Provisions
Subpart B — General Administrative Procedures
- § 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.