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Electronic Code of Federal Regulations

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter EPart 514


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 514—NEW ANIMAL DRUG APPLICATIONS

rule

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.
rule

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.
rule

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.
rule

Subparts D-E [Reserved]

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Subpart F—JUDICIAL REVIEW

§514.235
Judicial review.

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