102 STAT. 90
PUBLIC LAW 100-290—APR. 18, 1988 Public Law 100-290 100th Congress An Act
Apr. 18, 1988 [H.R. 3459]
Orphan Drug
To amend the Federal Food, Drug, and Cosmetic Act to revise the provisions respecting orphan drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
Amendments of 1988. SECTION 1. SHORT TITLE. 21 USC 301 note. '^^^^ ^^^ ^^V ^^ cited as the " O r p h a n D r u g Amendments 19oo. SEC. 2. DESIGNATION AS AN ORPHAN DRUG.
of
(a) REQUEST.—Section 526(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb(a)(l)) is amended by adding after the first sentence the following: "A request for designation of a drug shall be made before the submission of an application under section 505(b) for the drug, the submission of an application for certification of the drug under section 507, or the submission of an application for licensing of the drug under section 351 of the Public Health Service Act". (b) DISCONTINUANCE.—Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) is amended by redesignating subsections (b) and (c) as subsections (c) and (d), respectively, and by adding after subsection (a) the following: "(b) A designation of a drug under subsection (a) shall be subject to the condition that— "(1) if an application was approved for the drug under section 505(b), a certificate was issued for the drug under section 507, or a license was issued for the drug under section 351 of the Public Health Service Act, the manufacturer of the drug will notify the Secretary of any discontinuance of the production of the drug at least one year before discontinuance, and "(2) if an application has not been approved for the drug under section 505(b), a certificate has not been issued for the drug under section 507, or a license has not been issued for the drug under section 351 of the Public Health Service Act and if preclinical investigations or investigations under section 505(i) are being conducted with the drug, the manufacturer or sponsor of the drug will notify the Secretary of any decision to discontinue active pursuit of approval of an application under section 505(b), approval of an application for certification under section 507, or approval of a license under section 351 of the Public Health Service Act.". SEC. 3. FINANCIAL ASSISTANCE. (a) MEDICAL DEVICES.—Section 5 of the Orphan Drug Act (21
U.S.C. 360ee) is amended— (1) in subsection (a), by inserting "(1)" after "assist in" and by inserting before the period a comma and "(2) defraying the costs
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