IIB 
113TH CONGRESS 
1ST SESSION 
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 
AN ACT 
To amend title IV of the Public Health Service Act to 
provide for a National Pediatric Research Network, in-
cluding with respect to pediatric rare diseases or condi-
tions. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘National Pediatric Re-
search 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 sub-
section (f); and 
(2) by inserting after subsection (c) the fol-
lowing: 
‘‘(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 col-
laboration with other appropriate national research 
institutes and national centers that carry out activi-
ties involving pediatric research, may provide for the 
establishment of a National Pediatric Research Net-
work 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 
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grants, contracts, or other mechanisms, to pub-
lic 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 pe-
diatric 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 sup-
port all such categories of research; and 
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‘‘(ii) one or more such consortia pro-
vide training described in subparagraph 
(A)(ii)(II). 
‘‘(C) NUMBER OF CONSORTIA.—The Direc-
tor of NIH may make awards under this para-
graph for not more than 20 pediatric research 
consortia. 
‘‘(D) ORGANIZATION
OF
CONSORTIUM.— 
Each consortium receiving an award under sub-
paragraph (A) shall— 
‘‘(i) be formed from a collaboration of 
cooperating institutions; 
‘‘(ii) be coordinated by a lead institu-
tion; 
‘‘(iii) agree to disseminate scientific 
findings, including from clinical trials, rap-
idly 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 sub-
paragraph (A) shall be used to supplement, and 
not supplant, other public or private support for 
activities authorized to be supported under this 
paragraph. 
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‘‘(F) DURATION OF SUPPORT.—Support of 
a consortium under subparagraph (A) may be 
for a period of not to exceed 5 years. Such pe-
riod may be extended at the discretion of the 
Director of NIH. 
‘‘(3) COORDINATION
OF
CONSORTIA
ACTIVI-
TIES.—The Director of NIH shall— 
‘‘(A) as appropriate, provide for the coordi-
nation 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 ac-
tivities 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 surveil-
lance systems as appropriate and upon request by 
the Director of the Centers. 
‘‘(e) RESEARCH ON PEDIATRIC RARE DISEASES OR 
CONDITIONS.— 
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‘‘(1) IN GENERAL.—In making awards under 
subsection (d)(2) for pediatric research consortia, 
the Director of NIH shall ensure that an appro-
priate number of such awards are awarded to such 
consortia that agree to— 
‘‘(A) focus primarily on pediatric rare dis-
eases or conditions (including any such diseases 
or conditions that are genetic disorders (such as 
spinal muscular atrophy and Duchenne mus-
cular 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 ap-
proaches to, the prevention, diagnosis, or treat-
ment of one or more pediatric rare diseases or 
conditions. 
‘‘(2) DATA COORDINATING CENTER.— 
‘‘(A) 
ESTABLISHMENT.—In 
connection 
with support of consortia described in para-
graph (1), the Director of NIH shall establish 
a data coordinating center for the following 
purposes: 
‘‘(i) To distribute the scientific find-
ings referred to in paragraph (1)(C). 
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‘‘(ii) To provide assistance in the de-
sign 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 cen-
ter 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 infor-
mation on enrollment in clinical trials and 
the allocation of resources with respect to 
such research; and 
‘‘(ii) as appropriate, incorporate infor-
mation reported under clause (i) into the 
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