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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 10 - Administrative Practices and Procedures |
| Subpart A - General Provisions |
| § 10.1 - Scope. |
| § 10.3 - Definitions. |
| § 10.10 - Summaries of administrative practices and procedures. |
| § 10.19 - Waiver, suspension, or modification of procedural requirements. |
| Subpart B - General Administrative Procedures |
| § 10.20 - Submission of documents to Dockets Management Staff; 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. |
| § 10.100a - Public calendars. |
| § 10.65a - Meetings and correspondence. |
| Subpart C - Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures |
| § 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. |