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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 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
 

Subpart A - General Provisions
   § 16.1 - Scope.
   § 16.5 - Inapplicability and limited applicability.

Subpart B - Initiation of Proceedings
   § 16.22 - Initiation of regulatory hearing.
   § 16.24 - Regulatory hearing required by the act or a regulation.
   § 16.26 - Denial of hearing and summary decision.

Subpart C - Commissioner and Presiding Officer
   § 16.40 - Commissioner.
   § 16.42 - Presiding officer.
   § 16.44 - Communication to presiding officer and Commissioner.

Subpart D - Procedures for Regulatory Hearing
   § 16.60 - Hearing procedure.
   § 16.62 - Right to counsel.

Subpart E - Administrative Record and Decision
   § 16.80 - Administrative record of a regulatory hearing.
   § 16.85 - Examination of administrative record.
   § 16.95 - Administrative decision and record for decision.

Subpart F - Reconsideration and Stay
   § 16.119 - Reconsideration and stay of action.

Subpart G - Judicial Review
   § 16.120 - Judicial review.

Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
Source: 44 FR 22367, Apr. 13, 1979, unless otherwise noted.

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