Title 21

PART 316 SUBPART C

Subpart C - Designation of an Orphan Drug

• 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
• 57 FR 62085, Dec. 29, 1992, unless otherwise noted.

21:5.0.1.1.6.3.1.1	SECTION 316.20	316.20 Content and format of a request for orphan-drug designation.
21:5.0.1.1.6.3.1.2	SECTION 316.21	316.21 Verification of orphan-drug status.
21:5.0.1.1.6.3.1.3	SECTION 316.22	316.22 Permanent-resident agent for foreign sponsor.
21:5.0.1.1.6.3.1.4	SECTION 316.23	316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
21:5.0.1.1.6.3.1.5	SECTION 316.24	316.24 Deficiency letters and granting orphan-drug designation.
21:5.0.1.1.6.3.1.6	SECTION 316.25	316.25 Refusal to grant orphan-drug designation.
21:5.0.1.1.6.3.1.7	SECTION 316.26	316.26 Amendment to orphan-drug designation.
21:5.0.1.1.6.3.1.8	SECTION 316.27	316.27 Change in ownership of orphan-drug designation.
21:5.0.1.1.6.3.1.9	SECTION 316.28	316.28 Publication of orphan-drug designations.
21:5.0.1.1.6.3.1.10	SECTION 316.29	316.29 Revocation of orphan-drug designation.
21:5.0.1.1.6.3.1.11	SECTION 316.30	316.30 Annual reports of holder of orphan-drug designation.

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