21 CFR § 516.24 New Animal Drugs for Minor Use and Minor Species

§ 516.24 Granting MUMS-drug designation.

Current through Sep 8, 2026 · Read all of Part 516

(a) FDA may grant the request for MUMS-drug designation if none of the reasons described in § 516.25 for refusal to grant such a request apply.

(b) When a request for MUMS-drug designation is granted, FDA will notify the sponsor in writing and will give public notice of the MUMS-drug designation in accordance with § 516.28.

← § 516.23 Timing of requests for MUMS-drug designation.§ 516.25 Refusal to grant MUMS-drug designation. →