HHS - 21 CFR PART 516
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Organization: | HHS |
Publication Date: | 1 April 2018 |
Status: | active |
Page Count: | 26 |
scope:
(a) This part implements section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and contains the following subparts:
(1) Subpart A-General Provisions.
(2) Subpart B-Designation of a Minor Use or Minor Species New Animal Drug.
(3) Subpart C [Reserved]
(4) Subpart D [Reserved]
(b) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted. §
Purpose.
This part establishes standards and procedures for implementing section 573 of the act, including designation of minor use or minor species new animal drugs and associated exclusive marketing rights.