Subpart B - GENERAL ADMINISTRATIVE PROCEDURES
- Section 10.20 - Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure
- Section 10.25 - Initiation of administrative proceedings
- Section 10.30 - Citizen petition
- Section 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
- Section 10.33 - Administrative reconsideration of action
- Section 10.35 - Administrative stay of action
- Section 10.40 - Promulgation of regulations for the efficient enforcement of the law
- Section 10.45 - Court review of final administrative action; exhaustion of administrative remedies
- Section 10.50 - Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing
- Section 10.55 - Separation of functions; ex parte communications
- Section 10.60 - Referral by court
- Section 10.65 - Meetings and correspondence
- Section 10.70 - Documentation of significant decisions in administrative file
- Section 10.75 - Internal agency review of decisions
- Section 10.80 - Dissemination of draft Federal Register notices and regulations
- Section 10.85 - Advisory opinions
- Section 10.90 - Food and Drug Administration regulations, recommendations, and agreements
- Section 10.95 - Participation in outside standard-setting activities
- Section 10.100 - Public calendar
- Section 10.105 - Representation by an organization
- Section 10.110 - Settlement proposals
- Section 10.115 - Good guidance practices