IIB 
112TH CONGRESS 
2D SESSION 
H. R. 6163 
IN THE SENATE OF THE UNITED STATES 
SEPTEMBER 20, 2012 
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 2012’’. 
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 and contracts, to public or private non-
profit 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. 
‘‘(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 
‘‘(ii) one or more such consortia pro-
vide training described in subparagraph 
(A)(ii)(II). 
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‘‘(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; 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 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. 
‘‘(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 by the Director of NIH 
for additional periods of not more than 5 years. 
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‘‘(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. 
‘‘(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 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)); 
‘‘(B) conduct or coordinate one or more 
multisite clinical trials of therapies for, or ap-
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proaches to, the prevention, diagnosis, or treat-
ment of one or more pediatric rare diseases or 
conditions; and 
‘‘(C) rapidly and efficiently disseminate 
scientific findings resulting from such trials. 
‘‘(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). 
‘‘(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. 
‘‘(iv) To provide assistance to the 
Centers for Disease Control and Preven-
tion in the establishment or expansion of 
patient registries and other surveillance 
systems. 
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‘‘(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 
Director’s biennial reports under section 
403.’’. 
Passed the House of Representatives September 19, 
2012. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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