Subpart C. Designation of an Orphan Drug

• § 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.