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Table of Contents

Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

Subchapter A: General


Part 15: Public hearing before the commissioner


Subpart B: Procedures for public hearing before the commissioner


21 CFR 15.25 - Written submissions.

21 CFR 15.30 - Conduct of a public hearing before the Commissioner.

Subpart C: Records of a public hearing before the commissioner


21 CFR 15.40 - Administrative record.

21 CFR 15.45 - Examination of administrative record.

Part 16: Regulatory hearing before the food and drug administration


Subpart A: General provisions


21 CFR 16.1 - Scope.

21 CFR 16.5 - Inapplicability and limited applicability.

Subpart B: Initiation of proceedings


21 CFR 16.22 - Initiation of regulatory hearing.

21 CFR 16.24 - Regulatory hearing required by the act or a regulation.

21 CFR 16.26 - Denial of hearing and summary decision.

Subpart E: Administrative record and decision


21 CFR 16.80 - Administrative record of a regulatory hearing.

21 CFR 16.85 - Examination of administrative record.

21 CFR 16.95 - Administrative decision and record for decision.

Subpart C: Commissioner and presiding officer


21 CFR 16.40 - Commissioner.

21 CFR 16.42 - Presiding officer.

21 CFR 16.44 - Communication to presiding officer and Commissioner.

Subpart D: Procedures for regulatory hearing


21 CFR 16.60 - Hearing procedure.

21 CFR 16.62 - Right to counsel.

Subpart F: Reconsideration and stay


21 CFR 16.119 - Reconsideration and stay of action.

Subpart G: Judicial review


21 CFR 16.120 - Judicial review.

Part 17: Civil money penalties hearings


21 CFR 17.1 - Scope.

21 CFR 17.11 - Default upon failure to file an answer.

21 CFR 17.13 - Notice of hearing.

21 CFR 17.15 - Parties to the hearing.

21 CFR 17.17 - Summary decisions.

21 CFR 17.18 - Interlocutory appeal from ruling of presiding officer.

21 CFR 17.19 - Authority of the presiding officer.

21 CFR 17.2 - Maximum penalty amounts.

21 CFR 17.20 - Ex parte contacts.

21 CFR 17.21 - Prehearing conferences.

21 CFR 17.23 - Discovery.