CFR /  Title 21  /  Part 516  /  Sec. 516.24 Granting MUMS-drug designation.

(a) FDA may grant the request for MUMS-drug designation if none of the reasons described in Sec. 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 Sec. 516.28.