21 CFR Part 514 — New 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.