21 CFR § 516.1 - Scope.

---
identifier: "/us/cfr/t21/s516.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 516.1 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "516.1"
section_name: "Scope."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "516"
part_name: "NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360ccc-1, 360ccc-2, 371."
regulatory_source: "72 FR 41017, July 26, 2007, unless otherwise noted."
cfr_part: "516"
---


# 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) 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.