Part 316 — Orphan Drugs
Current through Sep 8, 2026
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.
Sections
- § 316.1 Scope of this part.
- § 316.2 Purpose.
- § 316.3 Definitions.
- § 316.4 Address for submissions.
- § 316.10 Content and format of a request for written recommendations.
- § 316.12 Providing written recommendations.
- § 316.14 Refusal to provide written recommendations.
- § 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.
- § 316.31 Scope of orphan-drug exclusive approval.
- § 316.34 FDA recognition of exclusive approval.
- § 316.36 Insufficient quantities of orphan drugs.
- § 316.40 Treatment use of a designated orphan drug.
- § 316.50 Guidance documents.
- § 316.52 Availability for public disclosure of data and information in requests and applications.