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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
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 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Subpart A--GENERAL PROVISIONS
Subpart B--DESIGNATION OF A MINOR USE OR MINOR SPECIES NEW ANIMAL DRUG
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| Submission of requests for designation. |
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| Eligibility to request designation. |
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| Content and format of a request for MUMS-drug designation. |
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| Documentation of minor use status. |
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| Permanent-resident U.S. agent for foreign sponsor. |
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| Timing of requests for MUMS-drug designation. |
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| Granting MUMS-drug designation. |
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| Refusal to grant MUMS-drug designation. |
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| Amendment to MUMS-drug designation. |
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| Publication of MUMS-drug designations. |
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| Termination of MUMS-drug designation. |
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| Annual reports for a MUMS-designated drug. |
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| Scope of MUMS-drug exclusive marketing rights. |
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| FDA recognition of exclusive marketing rights. |
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| Insufficient quantities of MUMS-designated drugs. |
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| Availability for public disclosure of data and information in requests. |
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Subpart C--INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES
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| Submission of correspondence under this subpart. |
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| Permanent-resident U.S. agent for foreign requestors and holders. |
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| Informal conferences regarding agency administrative actions. |
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| Investigational use of minor species new animal drugs to support indexing. |
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| Content and format of a request for determination of eligibility for indexing. |
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| Refuse to file a request for determination of eligibility for indexing. |
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| Denying a request for determination of eligibility for indexing. |
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| Granting a request for determination of eligibility for indexing. |
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| Notification of decision regarding eligibility for indexing. |
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| Content and format of a request for addition to the index. |
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| Refuse to file a request for addition to the index. |
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| Denying a request for addition to the index. |
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| Granting a request for addition to the index. |
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| Notification of decision regarding index listing. |
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| Labeling of indexed drugs. |
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| Publication of the index and content of an index listing. |
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| Modifications to indexed drugs. |
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| Change in ownership of an index file. |
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| Confidentiality of data and information in an index file. |
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Subpart D--[RESERVED]
Subpart E--CONDITIONALLY APPROVED NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
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