Page:United States Statutes at Large Volume 92 Part 3.djvu/816

 92 STAT. 3448

Grants and contracts.

42 USC 242m. Limitations.

Requirements.

Review requirements for certain grants and contracts.

PUBLIC LAW 95-623—NOV. 9, 1978 " (3) The Secretary, acting through the Center, shall encourage and support (by grant or contract) research, evaluations, and demonstrations respecting the safety and efficacy of particular health care technologies. "(4) The Secretary, acting through the Center and in consultation with the National Council on Health Care Technology, shall establish priorities for the activities prescribed by paragraphs (1), (2), and (3). In determining if an activity respecting a particular health care technology should be given priority, emphasis shall be placed on— "(A) the actual or potential risks and the actual or potential benefits to patients associated with the use of the technology, "(B) the actual or potential cost of the technology, "(C) the actual or potential rate of its use, and "(D) the stage of development of the technology. "(5) The Center may make recommendations to the Secretary respecting health care technology issues in the administration of the laws under the Secretary's jurisdiction, including recommendations with respect to reimbursement policy. "(c)(1) The Secretary, acting through the Center, shall, by grant or contract, assist public and private nonprofit entities in meeting the costs of planning and establishing new centers, and operating existing and new centers, for assessments, multidisciplinary research, evaluations, and demonstrations respecting the matters referred to in paragraphs (1) and (2) of subsection (b). To the extent practicable, the Secretary shall take such actions, in accordance with the requirements of this subsection and section 308, to assure that three such centers shall be operational by September 1, 1981. "(2)(A) No grant or contract may be made under this subsection for planning and establishing a center unless the Secretary, acting through the Center, determines that when it is operational it will meet the requirements listed in subparagraph (B), and no payment shall be made under a grant or contract for operation of a center unless the center meets such requirements. "(B) Each center shall meet the following requirements: "(i) There shall be a full-time director of the center who possesses a demonstrated capacity for sustained productivity and leadership in assessments, research, demonstrations, and evaluations respecting the matters referred to in paragraphs (1) and (2) of subsection (D), and there shall be such additional professional staff as may be appropriate. "(ii) The staff of the center shall have expertise in the various disciplines needed to conduct assessments, multidisciplinary research, evaluations and demonstrations respecting the matters referred to in paragraphs (1) and (2) of subsection (b). " (iii) The center shall be located within an established academic or research institution with departments and resources appropriate to the programs of the center. "(iv) Each center shall meet such additional requirements as the Secretary may by regulation prescribe. "(d) Any grant or contract under subsection (b) or (c), the direct cost of which will exceed $35,000, may be made or entered into only after appropriate review for scientific merit by peer review groups composed of experts in the relevant fields and only after the National Council on Health Care Technology has had an opportunity to review

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