C.F.R. » Title 21 » 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 B—Designation of a Minor Use or Minor Species New Animal Drug

21 C.F.R. § 516.24

Granting MUMS-drug designation

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(a) FDA may grant the request for MUMS-drug designation if none of the reasons described in § 516.25 for refusal to grant such a request apply.

(b) When a request for MUMS-drug designation is granted, FDA will notify the sponsor in writing and will give public notice of the MUMS-drug designation in accordance with § 516.28.