121 STAT. 864
Reports.
PUBLIC LAW 110–85—SEPT. 27, 2007
(c) USE OF FUNDS.—A nonprofit consortium that receives a grant or contract under this section shall facilitate the development, production, and distribution of pediatric medical devices by— (1) encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers; (2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing; (3) connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology; (4) assessing the scientific and medical merit of proposed pediatric device projects; and (5) providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section. (d) COORDINATION.— (1) NATIONAL INSTITUTES OF HEALTH.—Each consortium that receives a grant or contract under this section shall— (A) coordinate with the National Institutes of Health’s pediatric device contact point or office, designated under section 402(b)(23) of the Public Health Service Act, as added by section 304(a) of this Act; and (B) provide to the National Institutes of Health any identified pediatric device needs that the consortium lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate manufacturer interest. (2) FOOD AND DRUG ADMINISTRATION.—Each consortium that receives a grant or contract under this section shall coordinate with the Commissioner of Food and Drugs and device companies to facilitate the application for approval or clearance of devices labeled for pediatric use. (3) EFFECTIVENESS AND OUTCOMES.—Each consortium that receives a grant or contract under this section shall annually report to the Secretary of Health and Human Services on the status of pediatric device development, production, and distribution that has been facilitated by the consortium. (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $6,000,000 for each of fiscal years 2008 through 2012. SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC ADVISORY COMMITTEE.
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(a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 6(b) of the Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is amended by inserting ‘‘, including increasing pediatric access to medical devices’’ after ‘‘pediatric issues’’.
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