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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL
 
PART 10ADMINISTRATIVE 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.

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.

Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.
Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.

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