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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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Title 21
Chapter I
Part 316
Subpart C - 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.
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