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Orphan Products Laws and Regulations

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 Drugs:

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

Humanitarian Use Devices and Humanitiarian Device Exemption:

Safe Medical Devices Act of 1990

Food and Drug Administration Modernization Act of 1997

Current HUD/HDE Regulations (21 CFR 814 Subpart H)

Federal Register Final Rule- Nov 3, 1998

Federal Register Final Rule- June 26, 1996

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