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