21 C.F.R. § 516.1 – 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. (1) Subpart A—General Provisions.
2. (2) Subpart B—Designation of a Minor Use or Minor Species New Animal Drug.
3. (3) Subpart C [Reserved]
4. (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.