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Title 21

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Editorial codification of the general and permanent rules published in the Federal Register.

Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter A General 1 – 99
Part 10 Administrative Practices and Procedures 10.1 – 10.206
Subpart B General Administrative Procedures 10.20 – 10.115
§ 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.