21 CFR § 516.13 - Definitions.

---
identifier: "/us/cfr/t21/s516.13"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 516.13 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "516.13"
section_name: "Definitions."
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"
---


# 516.13 Definitions.

The following definitions of terms apply only in the context of subpart B of this part:

*Director* means the Director of the Office of Minor Use and Minor Species Animal Drug Development of the FDA Center for Veterinary Medicine.

*Intended use* means the intended treatment, control or prevention of a disease or condition, or the intention to affect the structure or function of the body of animals within an identified species, subpopulation of a species, or collection of species.

*MUMS-designated drug* means a new animal drug, as defined in section 201 of the act, intended for a minor use or for use in a minor species that has been designated under section 573 of the act.

*MUMS-drug exclusive marketing rights* or *exclusive marketing rights* means that, effective on the date of FDA conditional approval or approval as stated in the approval letter of an application for a MUMS-designated drug, no conditional approval or approval will be given to a subsequent application for the same drug, in the same dosage form, for the same intended use for 7 years, except as otherwise provided by law or in this subpart.