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. § 516.12

Purpose

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This subpart establishes standards and procedures for determining eligibility for designation and the associated incentives and benefits described in section 573 of the act, including a 7-year period of exclusive marketing rights.