Part 316 — Orphan Drugs
Subpart A — General Provisions
Subpart B — Written Recommendations for Investigations of Orphan Drugs
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.