21 CFR § 516.23 - Timing of requests for MUMS-drug designation.

---
identifier: "/us/cfr/t21/s516.23"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 516.23 - Timing of requests for MUMS-drug designation."
title_number: 21
title_name: "Food and Drugs"
section_number: "516.23"
section_name: "Timing of requests for MUMS-drug designation."
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"
---


# 516.23 Timing of requests for MUMS-drug designation.

A sponsor may request MUMS-drug designation at any time in the drug development process prior to the submission of an application for either conditional approval or approval of the MUMS drug for which designation is being requested.