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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 Mar 22, 2024.

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 E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
 
PART 514NEW ANIMAL DRUG APPLICATIONS
 

Subpart A - General Provisions
   § 514.1 - Applications.
   § 514.3 - Definitions.
   § 514.4 - Substantial evidence.
   § 514.5 - Presubmission conferences.
   § 514.6 - Amended applications.
   § 514.7 - Withdrawal of applications without prejudice.
   § 514.8 - Supplements and other changes to an approved application.
   § 514.11 - Confidentiality of data and information in a new animal drug application file.
   § 514.12 - Confidentiality of data and information in an investigational new animal drug notice.
   § 514.15 - Untrue statements in applications.

Subpart B - Administrative Actions on Applications
   § 514.80 - Records and reports concerning experience with approved new animal drugs.
   § 514.87 - Annual reports for antimicrobial animal drug sales and distribution.
   § 514.100 - Evaluation and comment on applications.
   § 514.105 - Approval of applications.
   § 514.106 - Approval of supplemental applications.
   § 514.110 - Reasons for refusing to file applications.
   § 514.111 - Refusal to approve an application.
   § 514.115 - Withdrawal of approval of applications.
   § 514.116 - Notice of withdrawal of approval of application.
   § 514.117 - Adequate and well-controlled studies.
   § 514.120 - Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.
   § 514.121 - Service of notices and orders.

Subpart C - Hearing Procedures
   § 514.200 - Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.
   § 514.201 - Procedures for hearings.

Subparts D-E [Reserved]

Subpart F - Judicial Review
   § 514.235 - Judicial review.

Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 371, 379e, 381.
Source: 40 FR 13825, Mar. 27, 1975, unless otherwise noted.

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