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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 27, 2025
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Title 21
Chapter I
Part 316 - PART 316—ORPHAN DRUGS
Subpart A [§ 316.1 - § 316.4] - Subpart A—General Provisions
Subpart B [§ 316.10 - § 316.14] - Subpart B—Written Recommendations for Investigations of Orphan Drugs
Subpart C [§ 316.20 - § 316.30] - Subpart C—Designation of an Orphan Drug
Subpart D [§ 316.31 - § 316.36] - Subpart D—Orphan-drug Exclusive Approval
Subpart E [§ 316.40 - § 316.40] - Subpart E—Open Protocols for Investigations
Subpart F [§ 316.50 - § 316.52] - Subpart F—Availability of Information
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