Page:United States Statutes at Large Volume 123.djvu/197

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123STA T . 1 7 7 PUBLIC LA W 111 –5—FE B. 17 , 2 0 0 910 1 3oftheM e dicar e P re s cri p tio nD r ug,Im pro v ement, and Mod - erni z ation A ct of 2 003, $7 00,000,000 for comparative effectiveness research

Provide

d, T hat of the amount appropriated in this para- graph, $ 4 00,000,000 sha l l b e transferred to the O ffice of the Director of the N ational Institutes of H ealth (‘ ‘Office of the Director ’ ’ ) to conduct or support comparative effectiveness research under section 301 and title I V of the Public Health S ervice Act: Provided fu r th er, That funds transferred to the Office of the Director ma y be trans- ferred to the Institutes and C enters of the National Institutes of Health and to the Common F und established under section 402A(c)(1) of the Public Health Service Act: Provided further, That this transfer authority is in addition to any other transfer authority available to the National Institutes of Health: Provided further, That w ithin the amount available in this paragraph for the Agency for Healthcare R esearch and Q uality, not more than 1 percent shall be made available for additional full-time e q uivalents . In addition, $400,000,000 shall be available for comparative effectiveness research to be allocated at the discretion of the Sec- retary of Health and Human Services (‘‘Secretary’’): Provided, That the funding appropriated in this paragraph shall be used to accel- erate the development and dissemination of research assessing the comparative effectiveness of health care treatments and strate- gies, through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions

and (2) encourage the development and use of clinical registries, clinical data networ k s, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1, 5 00,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than J une 30, 200 9 , that includes recommendations on the national priorities for comparative effectiveness research to be conducted or supported with the funds provided in this para- graph and that considers input from stakeholders: Provided further, That the Secretary shall consider any recommendations of the Fed- eral Coordinating Council for Comparative E ffectiveness Research established by section 8 04 of this Act and any recommendations included in the Institute of Medicine report pursuant to the pre- ceding proviso in designating activities to receive funds provided in this paragraph and may make grants and contracts with appro- priate entities, which may include agencies within the Department of Health and Human Services and other governmental agencies, as well as private sector entities, that have demonstrated e x perience and capacity to achieve the goals of comparative effectiveness research: Provided further, That the Secretary shall publish information on grants and contracts awarded with the funds pro- vided under this heading within a reasonable time of the obligation of funds for such grants and contracts and shall disseminate research findings from such grants and contracts to clinicians, patients, and the general public, as appropriate: Provided further, That, to the extent feasible, the Secretary shall ensure that the recipients of the funds provided by this paragraph offer an oppor- tunity for public comment on the research: Provided further, That research conducted with funds appropriated under this paragraph Res e arch a nd de v e lopm en t.Pub l i c comment. Publication. C ontracts. Reports. D eadline.