21 C.F.R. PART 514--NEW ANIMAL DRUG APPLICATIONS
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 514--NEW ANIMAL DRUG APPLICATIONS
Subpart A--GENERAL PROVISIONS
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| Presubmission conferences.
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| Withdrawal of applications without prejudice.
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| Supplemental new animal drug applications.
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| Confidentiality of data and information in a new animal drug application file.
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| Confidentiality of data and information in an investigational new animal drug notice.
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| Untrue statements in applications.
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Subpart B--ADMINISTRATIVE ACTIONS ON APPLICATIONS
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| Records and reports concerning experience with approved new animal drugs.
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| Evaluation and comment on applications.
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| Approval of applications.
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| Approval of supplemental applications.
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| Reasons for refusing to file applications.
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| Refusal to approve an application.
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| Withdrawal of approval of applications.
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| Notice of withdrawal of approval of application.
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| Adequate and well-controlled studies.
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| Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.
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| Service of notices and orders.
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Subpart C--HEARING PROCEDURES
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| Contents of notice of opportunity for a hearing.
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Subparts D-E--[RESERVED]
Subpart F--JUDICIAL REVIEW
