21 CFR 316.24 - Granting orphan-drug designation.
(a) FDA will grant the request for orphan-drug designation if none of the reasons described in § 316.25 for requiring or permitting refusal to grant such a request applies.
(b) When a request for orphan-drug designation is granted, FDA will notify the sponsor in writing and will publicize the orphan-drug designation in accordance with § 316.28.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.