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Title 21 - Food and Drugs
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CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590)
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PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
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SUBPART B—Designation of a Minor Use or Minor Species New Animal Drug (§516.11 to §516.52)
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SUBPART B—Designation of a Minor Use or Minor Species New Animal Drug (§516.11 to §516.52)
516.11—Scope of this subpart.
516.12—Purpose.
516.13—Definitions.
516.14—Submission of requests for designation.
516.16—Eligibility to request designation.
516.20—Content and format of a request for MUMS-drug designation.
516.21—Documentation of minor use status.
516.22—Permanent-resident U.S. agent for foreign sponsor.
516.23—Timing of requests for MUMS-drug designation.
516.24—Granting MUMS-drug designation.
516.25—Refusal to grant MUMS-drug designation.
516.26—Amendment to MUMS-drug designation.
516.27—Change in sponsorship.
516.28—Publication of MUMS-drug designations.
516.29—Termination of MUMS-drug designation.
516.30—Annual reports for a MUMS-designated drug.
516.31—Scope of MUMS-drug exclusive marketing rights.
516.34—FDA recognition of exclusive marketing rights.
516.36—Insufficient quantities of MUMS-designated drugs.
516.52—Availability for public disclosure of data and information in requests.
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