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Title 21

Displaying title 21, up to date as of 9/23/2021. Title 21 was last amended 9/21/2021.
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Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter D Drugs for Human Use 300 – 499
Part 316 Orphan Drugs 316.1 – 316.52
Subpart A General Provisions 316.1 – 316.4
§ 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 – 316.14
§ 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 – 316.30
Subpart D Orphan-drug Exclusive Approval 316.31 – 316.36
§ 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
§ 316.40 Treatment use of a designated orphan drug.
Subpart F Availability of Information 316.50 – 316.52
§ 316.50 Guidance documents.
§ 316.52 Availability for public disclosure of data and information in requests and applications.