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Part 514
FEDERAL · 21 CFR
Part 514 — New Animal Drug Applications
25 sections · Title 21: Food and Drugs
§ 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.
§ 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.
§ 514.200
Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.
§ 514.201
Procedures for hearings.
§ 514.235
Judicial review.