21 CFR Subpart B
General Administrative Procedures
June 25, 2020
§
10.110
Settlement proposals
§
10.115
Good guidance practices
§
10.20
Submission of documents to Division of Dockets Management; 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
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