Code of Federal Regulations · Subpart

Subpart C — Designation Of An Orphan Drug

21 C.F.R. pt. 316, subpt. C

• § 316.20 Content And Format Of A Request For Orphan-drug Designation
• § 316.21 Verification Of Orphan-drug Status
• § 316.22 Permanent-resident Agent For Foreign Sponsor
• § 316.23 Timing Of Requests For Orphan-drug Designation; Designation Of Already Approved Drugs
• § 316.24 Deficiency Letters And Granting Orphan-drug Designation
• § 316.25 Refusal To Grant Orphan-drug Designation
• § 316.26 Amendment To Orphan-drug Designation
• § 316.27 Change In Ownership Of Orphan-drug Designation
• § 316.28 Publication Of Orphan-drug Designations
• § 316.29 Revocation Of Orphan-drug Designation
• § 316.30 Annual Reports Of Holder Of Orphan-drug Designation