Sections
Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Subchapter A: General
Part 10: Administrative practices and procedures
Subpart B: General administrative procedures
21 CFR 10.80 - Dissemination of draft Federal Register notices and regulations.
21 CFR 10.85 - Advisory opinions.
21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.
21 CFR 10.95 - Participation in outside standard-setting activities.
Subpart C: Electronic media coverage of public administrative proceedings; guideline on policy and procedures
21 CFR 10.205 - Electronic media coverage of public administrative proceedings.
Part 11: Electronic records; electronic signatures
Subpart A: General provisions
Subpart B: Electronic records
21 CFR 11.10 - Controls for closed systems.
21 CFR 11.30 - Controls for open systems.
21 CFR 11.50 - Signature manifestations.
21 CFR 11.70 - Signature/record linking.
Subpart C: Electronic signatures
21 CFR 11.100 - General requirements.
21 CFR 11.200 - Electronic signature components and controls.
21 CFR 11.300 - Controls for identification codes/passwords.
Part 12: Formal evidentiary public hearing
Subpart A: General provisions
Subpart B: Initiation of proceedings
21 CFR 12.21 - Initiation of a hearing involving the issuance, amendment, or revocation of an order.
21 CFR 12.22 - Filing objections and requests for a hearing on a regulation or order.
21 CFR 12.23 - Notice of filing of objections.
21 CFR 12.24 - Ruling on objections and requests for hearing.
21 CFR 12.26 - Modification or revocation of regulation or order.
21 CFR 12.28 - Denial of hearing in whole or in part.
21 CFR 12.30 - Judicial review after waiver of hearing on a regulation.
