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Title 21

Displaying title 21, up to date as of 7/20/2026. Title 21 was last amended 7/20/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter EAnimal Drugs, Feeds, and Related Products500 – 599
Part 514New Animal Drug Applications514.1 – 514.235
Subpart AGeneral Provisions514.1 – 514.15
§ 514.1Applications.
§ 514.3Definitions.
§ 514.4Substantial evidence.
§ 514.5Presubmission conferences.
§ 514.6Amended applications.
§ 514.7Withdrawal of applications without prejudice.
§ 514.8Supplements and other changes to an approved application.
§ 514.11Confidentiality of data and information in a new animal drug application file.
§ 514.12Confidentiality of data and information in an investigational new animal drug notice.
§ 514.15Untrue statements in applications.
Subpart BAdministrative Actions on Applications514.80 – 514.121
Subpart CHearing Procedures514.200 – 514.201
§ 514.200Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.
§ 514.201Procedures for hearings.
Subparts D-E [Reserved]
Subpart FJudicial Review514.235
§ 514.235Judicial review.