Title 21

PART 316 Part 316 - Orphan Drugs

PART 316 - ORPHAN DRUGS Authority:21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371. Source:57 FR 62085, Dec. 29, 1992, unless otherwise noted. Editorial Note:Nomenclature changes to part 316 appear at 69 FR 13717, Mar. 24, 2004.

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

21:5.0.1.1.6.1	SUBPART A	Subpart A - General Provisions
21:5.0.1.1.6.1.1.1	SECTION 316.1	316.1 Scope of this part.
21:5.0.1.1.6.1.1.2	SECTION 316.2	316.2 Purpose.
21:5.0.1.1.6.1.1.3	SECTION 316.3	316.3 Definitions.
21:5.0.1.1.6.1.1.4	SECTION 316.4	316.4 Address for submissions.
21:5.0.1.1.6.2	SUBPART B	Subpart B - Written Recommendations for Investigations of Orphan Drugs
21:5.0.1.1.6.2.1.1	SECTION 316.10	316.10 Content and format of a request for written recommendations.
21:5.0.1.1.6.2.1.2	SECTION 316.12	316.12 Providing written recommendations.
21:5.0.1.1.6.2.1.3	SECTION 316.14	316.14 Refusal to provide written recommendations.
21:5.0.1.1.6.3	SUBPART C	Subpart C - Designation of an Orphan Drug
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.
21:5.0.1.1.6.4	SUBPART D	Subpart D - Orphan-drug Exclusive Approval
21:5.0.1.1.6.4.1.1	SECTION 316.31	316.31 Scope of orphan-drug exclusive approval.
21:5.0.1.1.6.4.1.2	SECTION 316.34	316.34 FDA recognition of exclusive approval.
21:5.0.1.1.6.4.1.3	SECTION 316.36	316.36 Insufficient quantities of orphan drugs.
21:5.0.1.1.6.5	SUBPART E	Subpart E - Open Protocols for Investigations
21:5.0.1.1.6.5.1.1	SECTION 316.40	316.40 Treatment use of a designated orphan drug.
21:5.0.1.1.6.6	SUBPART F	Subpart F - Availability of Information
21:5.0.1.1.6.6.1.1	SECTION 316.50	316.50 Guidance documents.
21:5.0.1.1.6.6.1.2	SECTION 316.52	316.52 Availability for public disclosure of data and information in requests and applications.