[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 225 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 225

  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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 14, 2013

   Mrs. Capps (for herself, Mrs. McMorris Rodgers, Ms. DeGette, Mr. 
Harper, Ms. Matsui, and Mr. King of New York) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Pediatric Research Network 
Act of 2013''.

SEC. 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, acting through 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 the Institute 
                may award funding, including through grants, contracts, 
                or other mechanisms, to public or private nonprofit 
                entities--
                            ``(i) for planning, establishing, or 
                        strengthening pediatric research consortia; and
                            ``(ii) for providing basic operating 
                        support for such consortia, including with 
                        respect to--
                                    ``(I) basic, clinical, behavioral, 
                                or translational research to meet unmet 
                                needs for pediatric research; and
                                    ``(II) training researchers in 
                                pediatric research techniques in order 
                                to address unmet pediatric research 
                                needs.
                    ``(B) Research.--The Director of NIH shall 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 20 
                pediatric research consortia.
                    ``(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;
                            ``(iii) agree to disseminate scientific 
                        findings, including from clinical trials, 
                        rapidly and efficiently; and
                            ``(iv) 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 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) require the periodic preparation and 
                submission to the Director of reports on the activities 
                of each such consortium.
            ``(4) Assistance with registries.--Each consortium 
        receiving an award under paragraph (2)(A) shall provide 
        assistance to the Centers for Disease Control and Prevention in 
        the establishment or expansion of patient registries and other 
        surveillance systems as appropriate and upon request by the 
        Director of the Centers.
    ``(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 shall 
        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 (such as spinal muscular 
                atrophy and Duchenne muscular dystrophy) or are related 
                to birth defects (such as Down syndrome and fragile 
                X)); 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.
            ``(2) Data coordinating center.--
                    ``(A) Establishment.--In connection with support of 
                consortia described in paragraph (1), the Director of 
                NIH shall establish a data coordinating center for the 
                following purposes:
                            ``(i) To distribute the scientific findings 
                        referred to in paragraph (1)(C).
                            ``(ii) To provide assistance in the design 
                        and conduct of collaborative research projects 
                        and the management, analysis, and storage of 
                        data associated with such projects.
                            ``(iii) To organize and conduct multisite 
                        monitoring activities.
                    ``(B) Reporting.--The Director of NIH shall--
                            ``(i) require the data coordinating center 
                        established under subparagraph (A) to provide 
                        regular reports to the Director of NIH and the 
                        Commissioner of Food and Drugs on research 
                        conducted by consortia described in paragraph 
                        (1), including information on enrollment in 
                        clinical trials and the allocation of resources 
                        with respect to such research; and
                            ``(ii) as appropriate, incorporate 
                        information reported under clause (i) into the 
                        Director's biennial reports under section 
                        403.''.
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