SUBPART C—Designation of an Orphan Drug (§316.20 to §316.30)
- 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—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.