Sec. 202. National Pediatric Research Network
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Section 409D of the Public Health Service Act ( 42 U.S.C. 284h ; relating to the Pediatric Research Initiative) is amended— by redesignating subsection
(d)as subsection (f); and by inserting after subsection
(c)the following: In carrying out the Initiative, the Director of NIH, in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research, may provide for the establishment of a National Pediatric Research Network in order to more effectively support pediatric research and optimize the use of Federal resources. Such National Pediatric Research Network may be comprised of, as appropriate— the pediatric research consortia receiving awards under paragraph (2); or other consortia, centers, or networks focused on pediatric research that are recognized by the Director of NIH and established pursuant to the authorities vested in the National Institutes of Health by other sections of this Act. The Director of NIH may award funding, including through grants, contracts, or other mechanisms, to public or private nonprofit entities for providing support for pediatric research consortia, including with respect to— basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research; and training researchers in pediatric research techniques in order to address unmet pediatric research needs. The Director of NIH shall, as appropriate, ensure that— each consortium receiving an award under subparagraph
(A)conducts or supports at least one category of research described in subparagraph (A)(i) and collectively such consortia conduct or support such categories of research; and one or more such consortia provide training described in subparagraph (A)(ii). Each consortium receiving an award under subparagraph
(A)shall— be formed from a collaboration of cooperating institutions; be coordinated by a lead institution or institutions; agree to disseminate scientific findings, including from clinical trials, rapidly and efficiently, as appropriate, to— other consortia; the National Institutes of Health; the Food and Drug Administration; and other relevant agencies; and meet such requirements as may be prescribed by the Director of NIH. Any support received by a consortium under subparagraph
(A)shall be used to supplement, and not supplant, other public or private support for activities authorized to be supported under this paragraph. Support of a consortium under subparagraph
(A)may be for a period of not to exceed 5 years. Such period may be extended at the discretion of the Director of NIH. The Director of NIH shall, as appropriate— provide for the coordination of activities (including the exchange of information and regular communication) among the consortia established pursuant to paragraph (2); and require the periodic preparation and submission to the Director of reports on the activities of each such consortium. Each consortium receiving an award under paragraph (2)(A) may provide assistance, as appropriate, to the Centers for Disease Control and Prevention for activities related to patient registries and other surveillance systems upon request by the Director of the Centers for Disease Control and Prevention. In making awards under subsection (d)(2) for pediatric research consortia, the Director of NIH shall ensure that an appropriate number of such awards are awarded to such consortia that agree to— consider pediatric rare diseases or conditions, or those related to birth defects; and conduct or coordinate one or more multisite clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of one or more pediatric rare diseases or conditions. .
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Sec. 202
National Pediatric Research Network
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