21 CFR Part 514
PART 514—NEW ANIMAL DRUG APPLICATIONS
- PART 514—NEW ANIMAL DRUG APPLICATIONS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter E—Animal Drugs, Feeds, and Related Products
- 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.
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