21 CFR Part 316
PART 316—ORPHAN DRUGS
- PART 316—ORPHAN DRUGS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter D—Drugs for Human Use
- Subpart A—General Provisions
- § 316.1 Scope of this part.
- § 316.2 Purpose.
- § 316.3 Definitions.
- § 316.4 Address for submissions.
- Subpart B—Written Recommendations for Investigations of Orphan Drugs
- § 316.10 Content and format of a request for written recommendations.
- § 316.12 Providing written recommendations.
- § 316.14 Refusal to provide written recommendations.
- 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.
- Subpart D—Orphan-drug Exclusive Approval
- § 316.31 Scope of orphan-drug exclusive approval.
- § 316.34 FDA recognition of exclusive approval.
- § 316.36 Insufficient quantities of orphan drugs.
- Subpart E—Open Protocols for Investigations
- § 316.40 Treatment use of a designated orphan drug.
- Subpart F—Availability of Information
- § 316.50 Guidance documents.
- § 316.52 Availability for public disclosure of data and information in requests and applications.
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