Page:United States Statutes at Large Volume 102 Part 4.djvu/98

 102 STAT. 3068

PUBLIC LAW 100-607—NOV. 4, 1988

42 USC

"SEC. 2313. COMMUNITY-BASED THERAPIES.

Grants. Contracts.

"(a) IN GENERAL.—After consultation with the Commissioner of Food and Drugs, the Director of the National Institutes of Health, acting through the National Institute of Allergy and Infectious Diseases, may make grants to public entities and nonprofit private entities concerned with acquired immune deficiency syndrome, and may enter into contracts with public and private such entities, for the purpose of planning and conducting, in the community involved, clinical trials of experimental treatments for infection with the etiologic agent for such syndrome that are approved by the Commissioner of Food and Drugs for investigational use under regulations issued under section 505 of the Federal Food, Drug, and Cosmetic Act.

300CC-13.

EVALUATIONS

OF

EXPERIMENTAL

"(b) REQUIREMENT OF CERTAIN PROJECTS.—

Health care professionals. Minorities. Women. Children and youth.

"(1) Financial assistance under subsection (a) shall include such assistance to community-bgised organizations and community health centers for the purpose of— "(A) retaining appropriate medical supervision; "(B) assisting with administration, data collection and record management; and "(C) conducting training of community physicians, nurse practitioners, physicians' assistants and other health professionals for the purpose of conducting clinical trials. "(2)(A) Financial assistance under subsection (a) shall include such assistance for demonstration projects designed to implement and conduct community-based clinical trials in order to provide access to the entire scope of communities affected by infections with the etiologic agent for acquired immune deficiency S3nidrome, including minorities, hemophiliacs and transfusion-exposed individuals, women, children, users of intravenous drugs, and individuals who are asymptomatic with respect to such infection. "(B) The Director of the National Institutes of Health may not provide financial assistance under this paragraph unless the application for such assistance is approved— "(i) by the Commissioner of Food and Drugs;. "(ii) by a duly constituted Institutional Review Board that meets the requirements of part 56 of title 21, Code of Federed Regulations; and "(iii) by the Director of the National Institute of Allergy and Infectious Diseases. "(c) PARTICIPATION OF PRIVATE INDUSTRY AND SCHOOI^ OF MEDI-

CINE.—Programs carried out with financial assistance provided under subsection (a) shall be designed to encourage private industry and schools of medicine to participate in, and to support, the clinical trials conducted pursuant to the programs. "(d) REQUIREMENT OF APPLICATION.—The Secretary may not provide financial assistance under subsection (a) unless— "(1) an application for the assistance is submitted to the Secretary; "(2) with respect to carrying out the purpose for which the assistance is to be made, the ^plication provides assurances of compliance satisfactory to the Secretary; and "(3) the application otherwise is in such form, is made in such manner, and contains such agreements, assurances, and

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