Subpart A - General Provisions

§ 514.1 - Applications.

§ 514.2 - Applications for animal feeds bearing or containing new animal drugs.

§ 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.

§ 514.9 - Supplemental applications for animal feeds bearing or containing new animal drugs.

§ 514.10 - Confidentiality of data and information in an investigational new animal drug notice and a new animal drug application file for an antibiotic drug.

§ 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 - XXX

Subpart F - Judicial Review

§ 514.235 - Judicial review.