Page:United States Statutes at Large Volume 116 Part 3.djvu/397

 PUBLIC LAW 107-280—NOV. 6, 2002 116 STAT. 1989 United States and more than 800 additional drugs are in the research pipeUne. (6) Despite the tremendous success of the Orphan Drug Act, rare diseases and disorders deserve greater emphasis in the national biomedical research enterprise. The Office of Rare Diseases at the National Institutes of Health was created in 1993, but lacks a statutory authorization. (7) The National Institutes of Health has received a substantial increase in research funding from Congress for the purpose of expanding the national investment of the United States in behavioral and biomedical research. (8) Notwithstanding such increases, funding for rare diseases and disorders at the National Institutes of Health has not increased appreciably. (9) To redress this oversight, the Department of Health and Human Services has proposed the establishment of a network of regional centers of excellence for research on rare diseases. (b) PURPOSES. — The purposes of this Act are to— (1) amend the Public Health Service Act to establish an Office of Rare Diseases at the National Institutes of Health; and (2) increase the national investment in the development of diagnostics and treatments for patients with rare diseases and disorders. SEC. 3. NIH OFFICE OF RARE DISEASES AT NATIONAL INSTITUTES OF HEALTH. Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.), as amended by Public Law 107-84, is amended by inserting after section 404E the following: "OFFICE OF RARE DISEASES "SEC. 404F. (a) ESTABLISHMENT.— T here is established within 42 USC 283h. the Office of the Director of NIH an office to be known as the Office of Rare Diseases (in this section referred to as the 'Office'), which shall be headed by a Director (in this section referred to as the 'Director'), appointed by the Director of NIH. "(b) DUTIES. — "(1) IN GENERAL.— The Director of the Office shall carry out the following: "(A) The Director shall recommend an agenda for conducting and supporting research on rare diseases through the national research institutes and centers. The agenda shall provide for a broad range of research and education activities, including scientific workshops and symposia to identify research opportunities for rare diseases. "(B) The Director shall, with respect to rare diseases, promote coordination and cooperation among the national research institutes and centers and entities whose research is supported by such institutes. "(C) The Director, in collaboration with the directors of the other relevant institutes and centers of the National Institutes of Health, may enter into cooperative agreements with and make grants for regional centers of excellence on rare diseases in accordance with section 404G.

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