Title 21, Part 316 — Orphan Drugs

Scope of this part.

Purpose.

Definitions.

Address for submissions.

Content and format of a request for written recommendations.

Providing written recommendations.

Refusal to provide written recommendations.

Content and format of a request for orphan-drug designation.

Verification of orphan-drug status.

Permanent-resident agent for foreign sponsor.

Timing of requests for orphan-drug designation; designation of already approved drugs.

Deficiency letters and granting orphan-drug designation.

Refusal to grant orphan-drug designation.

Amendment to orphan-drug designation.

Change in ownership of orphan-drug designation.

Publication of orphan-drug designations.

Revocation of orphan-drug designation.

Annual reports of holder of orphan-drug designation.

Scope of orphan-drug exclusive approval.

FDA recognition of exclusive approval.

Insufficient quantities of orphan drugs.

Treatment use of a designated orphan drug.

Guidance documents.

Availability for public disclosure of data and information in requests and applications.