Text of the National Pediatric Research Network Act of 2013

This bill was introduced in a previous session of Congress and was passed by the House on February 4, 2013 but was never passed by the Senate. The text of the bill below is as of Feb 7, 2013 (Referred to Senate Committee).

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1st Session

H. R. 225


February 7, 2013

Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions


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.


Short title

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


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—


by redesignating subsection (d) as subsection (f); and


by inserting after subsection (c) the following:


National Pediatric Research 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).


Pediatric research consortia


In general

The Director of the Institute may award funding, including through grants, contracts, or other mechanisms, to public or private nonprofit entities—


for planning, establishing, or strengthening pediatric research consortia; and


for providing basic operating support for such 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 ensure that—


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


one or more such consortia provide training described in subparagraph (A)(ii)(II).


Number of consortia

The Director of NIH may make awards under this paragraph for not more than 20 pediatric research consortia.


Organization of consortium

Each consortium receiving an award under subparagraph (A) shall—


be formed from a collaboration of cooperating institutions;


be coordinated by a lead institution;


agree to disseminate scientific findings, including from clinical trials, rapidly and efficiently; and


meet such requirements as may be prescribed by the Director of NIH.


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.


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.


Coordination of consortia activities

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.


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.


Research on pediatric rare diseases or conditions


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—


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


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.


Data coordinating center



In connection with support of consortia described in paragraph (1), the Director of NIH shall establish a data coordinating center for the following purposes:


To distribute the scientific findings referred to in paragraph (1)(C).


To provide assistance in the design and conduct of collaborative research projects and the management, analysis, and storage of data associated with such projects.


To organize and conduct multisite monitoring activities.



The Director of NIH shall—


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


as appropriate, incorporate information reported under clause (i) into the

Director’s biennial reports under section 403.


Passed the House of Representatives February 4, 2013.

Karen L. Haas,