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General Administrative Procedures | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter A
Part 10
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.