Subpart C - DESIGNATION OF AN ORPHAN DRUG
- Section 316.20 - Content and format of a request for orphan-drug designation
- Section 316.21 - Verification of orphan-drug status
- Section 316.22 - Permanent-resident agent for foreign sponsor
- Section 316.23 - Timing of requests for orphan-drug designation; designation of already approved drugs
- Section 316.24 - Deficiency letters and granting orphan-drug designation
- Section 316.25 - Refusal to grant orphan-drug designation
- Section 316.26 - Amendment to orphan-drug designation
- Section 316.27 - Change in ownership of orphan-drug designation
- Section 316.28 - Publication of orphan-drug designations
- Section 316.29 - Revocation of orphan-drug designation
- Section 316.30 - Annual reports of holder of orphan-drug designation