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Title 21 - Title 21
Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES
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GENERAL - ADMINISTRATIVE PRACTICES AND PROCEDURES
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31 sections
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§10.1 - Scope.
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§10.10 - Summaries of administrative practices and procedures.
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§10.100 - Public calendar.
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§10.105 - Representation by an organization.
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§10.110 - Settlement proposals.
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§10.115 - Good guidance practices.
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§10.19 - Waiver, suspension, or modification of procedural requirements.
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§10.20 - Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure.
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§10.200 - Scope.
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§10.203 - Definitions.
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§10.204 - General.
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§10.205 - Electronic media coverage of public administrative proceedings.
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§10.206 - Procedures for electronic media coverage of agency public administrative proceedings.
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§10.25 - Initiation of administrative proceedings.
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§10.3 - Definitions.
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§10.30 - Citizen petition.
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§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.
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§10.33 - Administrative reconsideration of action.
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§10.35 - Administrative stay of action.
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§10.40 - Promulgation of regulations for the efficient enforcement of the law.
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§10.45 - Court review of final administrative action; exhaustion of administrative remedies.
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§10.50 - Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
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§10.55 - Separation of functions; ex parte communications.
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§10.60 - Referral by court.
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§10.65 - Meetings and correspondence.
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§10.70 - Documentation of significant decisions in administrative file.
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§10.75 - Internal agency review of decisions.
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§10.80 - Dissemination of draft Federal Register notices and regulations.
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§10.85 - Advisory opinions.
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§10.90 - Food and Drug Administration regulations, recommendations, and agreements.
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§10.95 - Participation in outside standard-setting activities.
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