Title 21
SECTION 516.24
516.24 Granting MUMS-drug designation.
§ 516.24 Granting MUMS-drug designation.(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.