2-4-13, House Passed Bill 375-27
H. R. 225
IN THE SENATE OF THE UNITED STATES
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.
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
`(i) for planning, establishing, or strengthening pediatric research
`(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
`(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
`(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
`(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
`(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.'.
Passed the House of Representatives February 4, 2013.
KAREN L. HAAS,