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The supporting laws and regulations that comprise the mission and scope of the Office of Orphan Products can be found in the following documents:
Orphan Drug Act of 1983
Orphan Drug Regulations (21 CFR 316)
Federal Register Final Rule (December 29, 1992)
Tax Credit (Section 45C of the Internal Revenue Code)
User Fee Waiver
Safe Medical Devices Act of 1990
Food and Drug Administration Modernization Act of 1997
Current HUD/HDE Regulations (21 CFR 814 Subpart H)