Page:United States Statutes at Large Volume 116 Part 3.djvu/401

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PUBLIC LAW 107-281—NOV. 6, 2002 116 STAT. 1993 United States and more than 800 additional drugs are in the research pipehne. (6) Despite the tremendous success of the Orphan Drug Act, rare diseases and disorders deserve greater emphasis in the national biomedical research enterprise. (7) The Food and Drug Administration supports small clinical trials through Orphan Products Research Grants. Such grants embody successful partnerships of government and industry, and have led to the development of at least 23 drugs and four medical devices for rare diseases and disorders. Yet the appropriations in fiscal year 2001 for such grants were less than in fiscal year 1995. (b) PURPOSES.— The purpose of this Act is to increase the national investment in the development of diagnostics and treatments for patients with rare diseases and disorders. SEC. 3. FOOD AND DRUG ADMINISTRATION; GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN DRUGS. Subsection (c) of section 5 of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows: "(c) For grants and contracts under subsection (a), there are Appropriation authorized to be appropriated such sums as already have been authorization. appropriated for fiscal year 2002, and $25,000,000 for each of the fiscal years 2003 through 2006.". SEC. 4. TECHNICAL AMENDMENT. Section 527(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(a)) is amended in the matter following paragraph (2)— (1) by striking ", of such certification,"; and (2) by striking ", the issuance of the certification,". Approved November 6, 2002. LEGISLATIVE HISTORY—H.R. 4014: HOUSE REPORTS: No. 107-702 (Comm. on Energy and Commerce). CONGRESSIONAL RECORD, Vol. 148 (2002): Oct. 1, considered and passed House. Oct. 17, considered and passed Senate.