II 113th CONGRESS 1st Session S. 424 IN THE SENATE OF THE UNITED STATES February 28, 2013 Mr. Brown (for himself, Mr. Wicker , Mr. Blumenthal , Mr. Blunt , Ms. Collins , Mr. Portman , and Mr. Whitehouse ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend title IV of the Public Health Service Act to provide for a National Pediatric Research Network, including with respect to pediatric rare diseases or conditions.

1. Short title This Act may be cited as the National Pediatric Research Network Act of 2013 . 2. National Pediatric Research Network Section 409D of the Public Health Service Act ( 42 U.S.C. 284h ; relating to the Pediatric Research Initiative) is amended— (1) by redesignating subsection (d) as subsection (f); and (2) by inserting after subsection (c) the following: (d) National Pediatric Research Network (1) Network 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 consisting of the pediatric research consortia receiving awards under paragraph (2). (2) Pediatric research consortia (A) In general The Director of NIH may award funding, including through grants, contracts or other mechanisms, to public or private nonprofit entities— (i) for establishing or strengthening pediatric research consortia; and (ii) for providing support for such consortia, including with respect to— (I) basic, clinical, behavioral, or translational research to meet unmet pediatric research needs; and (II) training researchers in pediatric research techniques in order to address unmet pediatric research needs. (B) Research The Director of NIH may ensure that— (i) each consortium receiving an award under subparagraph (A) conducts or supports at least one category of research described in subparagraph (A)(ii)(I) and collectively such consortia conduct or support all such categories of research; and (ii) one or more such consortia provide training described in subparagraph (A)(ii)(II). (C) Number of consortia The Director of NIH may make awards under this paragraph for not more than 8 pediatric research consortia, with a minimum of one pediatric research consortium that prioritizes collaboration with institutions serving rural areas. (D) Organization of consortium Each consortium receiving an award under subparagraph (A) shall— (i) be formed from a collaboration of cooperating institutions; (ii) be coordinated by a lead institution; and (iii) meet such requirements as may be prescribed by the Director of NIH. (E) Supplement, not supplant 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. (F) Duration of consortium support 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. (3) Coordination of consortia activities The Director of NIH shall— (A) 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 (B) as appropriate, require the periodic preparation and submission to the Director of reports on the activities of each such consortium. (e) Research on pediatric rare diseases or conditions (1) In general In making awards under subsection (d)(2) for pediatric research consortia, the Director of NIH may ensure that an appropriate number of such awards are awarded to such consortia that agree to— (A) focus primarily on pediatric rare diseases or conditions (including any such diseases or conditions that are genetic disorders or are related to birth defects); and (B) 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. .