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.

21:5.0.1.1.6.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.6.1.1.1SECTION 316.1
   316.1 Scope of this part.
21:5.0.1.1.6.1.1.2SECTION 316.2
   316.2 Purpose.
21:5.0.1.1.6.1.1.3SECTION 316.3
   316.3 Definitions.
21:5.0.1.1.6.1.1.4SECTION 316.4
   316.4 Address for submissions.
21:5.0.1.1.6.2SUBPART B
Subpart B - Written Recommendations for Investigations of Orphan Drugs
21:5.0.1.1.6.2.1.1SECTION 316.10
   316.10 Content and format of a request for written recommendations.
21:5.0.1.1.6.2.1.2SECTION 316.12
   316.12 Providing written recommendations.
21:5.0.1.1.6.2.1.3SECTION 316.14
   316.14 Refusal to provide written recommendations.
21:5.0.1.1.6.3SUBPART C
Subpart C - Designation of an Orphan Drug
21:5.0.1.1.6.3.1.1SECTION 316.20
   316.20 Content and format of a request for orphan-drug designation.
21:5.0.1.1.6.3.1.2SECTION 316.21
   316.21 Verification of orphan-drug status.
21:5.0.1.1.6.3.1.3SECTION 316.22
   316.22 Permanent-resident agent for foreign sponsor.
21:5.0.1.1.6.3.1.4SECTION 316.23
   316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
21:5.0.1.1.6.3.1.5SECTION 316.24
   316.24 Deficiency letters and granting orphan-drug designation.
21:5.0.1.1.6.3.1.6SECTION 316.25
   316.25 Refusal to grant orphan-drug designation.
21:5.0.1.1.6.3.1.7SECTION 316.26
   316.26 Amendment to orphan-drug designation.
21:5.0.1.1.6.3.1.8SECTION 316.27
   316.27 Change in ownership of orphan-drug designation.
21:5.0.1.1.6.3.1.9SECTION 316.28
   316.28 Publication of orphan-drug designations.
21:5.0.1.1.6.3.1.10SECTION 316.29
   316.29 Revocation of orphan-drug designation.
21:5.0.1.1.6.3.1.11SECTION 316.30
   316.30 Annual reports of holder of orphan-drug designation.
21:5.0.1.1.6.4SUBPART D
Subpart D - Orphan-drug Exclusive Approval
21:5.0.1.1.6.4.1.1SECTION 316.31
   316.31 Scope of orphan-drug exclusive approval.
21:5.0.1.1.6.4.1.2SECTION 316.34
   316.34 FDA recognition of exclusive approval.
21:5.0.1.1.6.4.1.3SECTION 316.36
   316.36 Insufficient quantities of orphan drugs.
21:5.0.1.1.6.5SUBPART E
Subpart E - Open Protocols for Investigations
21:5.0.1.1.6.5.1.1SECTION 316.40
   316.40 Treatment use of a designated orphan drug.
21:5.0.1.1.6.6SUBPART F
Subpart F - Availability of Information
21:5.0.1.1.6.6.1.1SECTION 316.50
   316.50 Guidance documents.
21:5.0.1.1.6.6.1.2SECTION 316.52
   316.52 Availability for public disclosure of data and information in requests and applications.