HHS - 21 CFR PART 516
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
active, Most Current
| Organization: | HHS |
| Publication Date: | 1 April 2016 |
| 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.
Document History
April 1, 2023
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...
April 1, 2022
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...
April 1, 2021
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...
April 1, 2020
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...
April 1, 2019
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...
April 1, 2018
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...
April 1, 2017
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...
21 CFR PART 516
April 1, 2016
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...
April 1, 2015
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...
April 1, 2014
NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
(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...