Title 21

PART 514

Part 514 - New Animal Drug Applications

PART 514 - NEW ANIMAL DRUG APPLICATIONS Authority:21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 371, 379e, 381. Source:40 FR 13825, Mar. 27, 1975, unless otherwise noted.

21:6.0.1.1.8.1SUBPART A
Subpart A - General Provisions
21:6.0.1.1.8.1.1.1SECTION 514.1
   514.1 Applications.
21:6.0.1.1.8.1.1.2SECTION 514.3
   514.3 Definitions.
21:6.0.1.1.8.1.1.3SECTION 514.4
   514.4 Substantial evidence.
21:6.0.1.1.8.1.1.4SECTION 514.5
   514.5 Presubmission conferences.
21:6.0.1.1.8.1.1.5SECTION 514.6
   514.6 Amended applications.
21:6.0.1.1.8.1.1.6SECTION 514.7
   514.7 Withdrawal of applications without prejudice.
21:6.0.1.1.8.1.1.7SECTION 514.8
   514.8 Supplements and other changes to an approved application.
21:6.0.1.1.8.1.1.8SECTION 514.11
   514.11 Confidentiality of data and information in a new animal drug application file.
21:6.0.1.1.8.1.1.9SECTION 514.12
   514.12 Confidentiality of data and information in an investigational new animal drug notice.
21:6.0.1.1.8.1.1.10SECTION 514.15
   514.15 Untrue statements in applications.
21:6.0.1.1.8.2SUBPART B
Subpart B - Administrative Actions on Applications
21:6.0.1.1.8.2.1.1SECTION 514.80
   514.80 Records and reports concerning experience with approved new animal drugs.
21:6.0.1.1.8.2.1.2SECTION 514.87
   514.87 Annual reports for antimicrobial animal drug sales and distribution.
21:6.0.1.1.8.2.1.3SECTION 514.100
   514.100 Evaluation and comment on applications.
21:6.0.1.1.8.2.1.4SECTION 514.105
   514.105 Approval of applications.
21:6.0.1.1.8.2.1.5SECTION 514.106
   514.106 Approval of supplemental applications.
21:6.0.1.1.8.2.1.6SECTION 514.110
   514.110 Reasons for refusing to file applications.
21:6.0.1.1.8.2.1.7SECTION 514.111
   514.111 Refusal to approve an application.
21:6.0.1.1.8.2.1.8SECTION 514.115
   514.115 Withdrawal of approval of applications.
21:6.0.1.1.8.2.1.9SECTION 514.116
   514.116 Notice of withdrawal of approval of application.
21:6.0.1.1.8.2.1.10SECTION 514.117
   514.117 Adequate and well-controlled studies.
21:6.0.1.1.8.2.1.11SECTION 514.120
   514.120 Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.
21:6.0.1.1.8.2.1.12SECTION 514.121
   514.121 Service of notices and orders.
21:6.0.1.1.8.3SUBPART C
Subpart C - Hearing Procedures
21:6.0.1.1.8.3.1.1SECTION 514.200
   514.200 Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.
21:6.0.1.1.8.3.1.2SECTION 514.201
   514.201 Procedures for hearings.
21:6.0.1.1.8.4SUBPART D
Subparts D-E [Reserved]
21:6.0.1.1.8.5SUBPART F
Subpart F - Judicial Review
21:6.0.1.1.8.5.1.1SECTION 514.235
   514.235 Judicial review.