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- 21 CFR 12.125 · Appeal from or review of initial decision.
- 21 CFR 12.130 · Decision by Commissioner on appeal or review of initial decision.
- 21 CFR 12.139 · Reconsideration and stay of action.
- 21 CFR 12.140 · Review by the courts.
- 21 CFR 12.159 · Copies of petitions for judicial review.
- 21 CFR 13.1 · Scope.
- 21 CFR 13.5 · Notice of a hearing before a Board.
- 21 CFR 13.10 · Members of a Board.
- 21 CFR 13.15 · Separation of functions; ex parte communications; administrative support.
- 21 CFR 13.20 · Submissions to a Board.
- 21 CFR 13.25 · Disclosure of data and information by the participants.
- 21 CFR 13.30 · Proceedings of a Board.
- 21 CFR 13.40 · Administrative record of a Board.
- 21 CFR 13.45 · Examination of administrative record.
- 21 CFR 13.50 · Record for administrative decision.
- 21 CFR 14.1 · Scope.
- 21 CFR 14.5 · Purpose of proceedings before an advisory committee.
- 21 CFR 14.7 · Administrative remedies.
- 21 CFR 14.10 · Applicability to Congress.
- 21 CFR 14.15 · Committees working under a contract with FDA.
- 21 CFR 14.20 · Notice of hearing before an advisory committee.
- 21 CFR 14.22 · Meetings of an advisory committee.
- 21 CFR 14.25 · Portions of advisory committee meetings.
- 21 CFR 14.27 · Determination to close portions of advisory committee meetings.
- 21 CFR 14.29 · Conduct of a hearing before an advisory committee.
- 21 CFR 14.30 · Chairperson of an advisory committee.
- 21 CFR 14.31 · Consultation by an advisory committee with other persons.
- 21 CFR 14.33 · Compilation of materials for members of an advisory committee.
- 21 CFR 14.35 · Written submissions to an advisory committee.
- 21 CFR 14.39 · Additional rules for a particular advisory committee.
- 21 CFR 14.40 · Establishment and renewal of advisory committees.
- 21 CFR 14.55 · Termination of advisory committees.
- 21 CFR 14.60 · Minutes and reports of advisory committee meetings.
- 21 CFR 14.61 · Transcripts of advisory committee meetings.
- 21 CFR 14.65 · Public inquiries and requests for advisory committee records.
- 21 CFR 14.70 · Administrative record of a public hearing before an advisory committee.
- 21 CFR 14.75 · Examination of administrative record and other advisory committee records.
- 21 CFR 14.80 · Qualifications for members of standing policy and technical advisory committees.
- 21 CFR 14.82 · Nominations of voting members of standing advisory committees.
- 21 CFR 14.84 · Nominations and selection of nonvoting members of standing technical advisory committees.
- 21 CFR 14.86 · Rights and responsibilities of nonvoting members of advisory committees.
- 21 CFR 14.90 · Ad hoc advisory committee members.
- 21 CFR 14.95 · Compensation of advisory committee members.
- 21 CFR 14.100 · List of standing advisory committees.
- 21 CFR 14.120 · Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).
- 21 CFR 14.122 · Functions of TEPRSSC.
- 21 CFR 14.125 · Procedures of TEPRSSC.
- 21 CFR 14.127 · Membership of TEPRSSC.
- 21 CFR 14.130 · Conduct of TEPRSSC meeting; availability of TEPRSSC records.
- 21 CFR 14.140 · Establishment of a color additive advisory committee.
- 21 CFR 14.142 · Functions of a color additive advisory committee.
- 21 CFR 14.145 · Procedures of a color additive advisory committee.
- 21 CFR 14.147 · Membership of a color additive advisory committee.
- 21 CFR 14.155 · Fees and compensation pertaining to a color additive advisory committee.
- 21 CFR 14.160 · Establishment of standing technical advisory committees for human prescription drugs.
- 21 CFR 14.171 · Utilization of an advisory committee on the initiative of FDA.
- 21 CFR 14.172 · Utilization of an advisory committee at the request of an interested person.
- 21 CFR 14.174 · Advice and recommendations in writing.
- 21 CFR 15.1 · Scope.
- 21 CFR 15.20 · Notice of a public hearing before the Commissioner.
- 21 CFR 15.21 · Notice of participation; schedule for hearing.
- 21 CFR 15.25 · Written submissions.
- 21 CFR 15.30 · Conduct of a public hearing before the Commissioner.
- 21 CFR 15.40 · Administrative record.
- 21 CFR 15.45 · Examination of administrative record.
- 21 CFR 16.1 · Scope.
- 21 CFR 16.5 · Inapplicability and limited applicability.
- 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.
- 21 CFR 16.40 · Commissioner.
- 21 CFR 16.42 · Presiding officer.
- 21 CFR 16.44 · Communication to presiding officer and Commissioner.
- 21 CFR 16.60 · Hearing procedure.
- 21 CFR 16.62 · Right to counsel.
- 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.
- 21 CFR 16.119 · Reconsideration and stay of action.
- 21 CFR 16.120 · Judicial review.
- 21 CFR 17.1 · Scope.
- 21 CFR 17.2 · Maximum penalty amounts.
- 21 CFR 17.3 · Definitions.
- 21 CFR 17.5 · Complaint.
- 21 CFR 17.7 · Service of complaint.
- 21 CFR 17.9 · Answer.
- 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 17.20 · Ex parte contacts.
- 21 CFR 17.21 · Prehearing conferences.
- 21 CFR 17.23 · Discovery.
- 21 CFR 17.25 · Exchange of witness lists, witness statements, and exhibits.
- 21 CFR 17.27 · Hearing subpoenas.
- 21 CFR 17.28 · Protective order.
- 21 CFR 17.29 · Fees.
- 21 CFR 17.30 · Computation of time.