TITLE 21--FOOD AND 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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