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. § 516.16

Eligibility to request designation

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The person requesting designation must be the sponsor and the real party in interest of the development and the intended or actual production and sales of the drug or the permanent-resident U.S. agent for such a sponsor.