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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
 
PART 316ORPHAN DRUGS
 

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 - 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.

Authority: 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
Source: 57 FR 62085, Dec. 29, 1992, unless otherwise noted.

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