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FEDERAL · 21 CFR

Part 10 — Administrative Practices and Procedures

31 sections · Title 21: Food and Drugs

§ 10.1Scope.
§ 10.3Definitions.
§ 10.10Summaries of administrative practices and procedures.
§ 10.19Waiver, suspension, or modification of procedural requirements.
§ 10.20Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
§ 10.25Initiation of administrative proceedings.
§ 10.30Citizen petition.
§ 10.31Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.
§ 10.33Administrative reconsideration of action.
§ 10.35Administrative stay of action.
§ 10.40Promulgation of regulations for the efficient enforcement of the law.
§ 10.45Court review of final administrative action; exhaustion of administrative remedies.
§ 10.50Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
§ 10.55Separation of functions; ex parte communications.
§ 10.60Referral by court.
§ 10.65Meetings and correspondence.
§ 10.70Documentation of significant decisions in administrative file.
§ 10.75Internal agency review of decisions.
§ 10.80Dissemination of draft Federal Register notices and regulations.
§ 10.85Advisory opinions.
§ 10.90Food and Drug Administration regulations, recommendations, and agreements.
§ 10.95Participation in outside standard-setting activities.
§ 10.100Public calendar.
§ 10.105Representation by an organization.
§ 10.110Settlement proposals.
§ 10.115Good guidance practices.
§ 10.200Scope.
§ 10.203Definitions.
§ 10.204General.
§ 10.205Electronic media coverage of public administrative proceedings.
§ 10.206Procedures for electronic media coverage of agency public administrative proceedings.