General Administrative Procedures

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. General
  6. Administrative Practices and Procedures
  7. General Administrative Procedures

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Section
10.20

Submission of documents to Division of Dockets Management; 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.