21 CFR § 516.24
Granting MUMS-drug designation
June 25, 2020
(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.