Subpart B. Subpart B—General Administrative Procedures
- § 10.20 - Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
- § 10.25 -
- § 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.