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, including with respect to pediatric rare diseases or conditions. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘National Pediatric Re3 search Network Act of 2013’’. 

4 SEC. 2. NATIONAL PEDIATRIC RESEARCH NETWORK. 

5 Section 409D of the Public Health Service Act (42 

6 U.S.C. 284h; relating to the Pediatric Research Initiative) 

7 is amended— 

8 (1) by redesignating subsection (d) as sub9 section (f); and 

10 (2) by inserting after subsection (c) the fol11 lowing: 

12 ‘‘(d) NATIONAL PEDIATRIC RESEARCH NETWORK.— 

13 ‘‘(1) NETWORK.—In carrying out the Initiative, 

14 the Director of NIH, acting through the Director of 

15 the Eunice Kennedy Shriver National Institute of 

16 Child Health and Human Development and in col17 laboration with other appropriate national research 

18 institutes and national centers that carry out activi19 ties involving pediatric research, may provide for the 

20 establishment of a National Pediatric Research Net21 work consisting of the pediatric research consortia 

22 receiving awards under paragraph (2). 

23 ‘‘(2) PEDIATRIC RESEARCH CONSORTIA.— 

24 ‘‘(A) IN GENERAL.—The Director of the 

25 Institute may award funding, including through 


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1 grants, contracts, or other mechanisms, to pub2 lic or private nonprofit entities— 

3 ‘‘(i) for planning, establishing, or 

4 strengthening pediatric research consortia; 

5 and 

6 ‘‘(ii) for providing basic operating 

7 support for such consortia, including with 

8 respect to— 

9 ‘‘(I) basic, clinical, behavioral, or 

10 translational research to meet unmet 

11 needs for pediatric research; and 

12 ‘‘(II) training researchers in pe13 diatric research techniques in order to 

14 address unmet pediatric research 

15 needs. 

16 ‘‘(B) RESEARCH.—The Director of NIH 

17 shall ensure that— 

18 ‘‘(i) each consortium receiving an 

19 award under subparagraph (A) conducts or 

20 supports at least one category of research 

21 described in subparagraph (A)(ii)(I) and 

22 collectively such consortia conduct or sup23 port all such categories of research; and 


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1 ‘‘(ii) one or more such consortia pro2 vide training described in subparagraph 

3 (A)(ii)(II). 

4 ‘‘(C) NUMBER OF CONSORTIA.—The Direc5 tor of NIH may make awards under this para6 graph for not more than 20 pediatric research 

7 consortia. 

8 ‘‘(D) ORGANIZATION OF CONSORTIUM.— 

9 Each consortium receiving an award under sub10 paragraph (A) shall— 

11 ‘‘(i) be formed from a collaboration of 

12 cooperating institutions; 

13 ‘‘(ii) be coordinated by a lead institu14 tion; 

15 ‘‘(iii) agree to disseminate scientific 

16 findings, including from clinical trials, rap17 idly and efficiently; and 

18 ‘‘(iv) meet such requirements as may 

19 be prescribed by the Director of NIH. 

20 ‘‘(E) SUPPLEMENT, NOT SUPPLANT.—Any 

21 support received by a consortium under sub22 paragraph (A) shall be used to supplement, and 

23 not supplant, other public or private support for 

24 activities authorized to be supported under this 

25 paragraph. 


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1 ‘‘(F) DURATION OF SUPPORT.—Support of 

2 a consortium under subparagraph (A) may be 

3 for a period of not to exceed 5 years. Such pe4 riod may be extended at the discretion of the 

5 Director of NIH. 

6 ‘‘(3) COORDINATION OF CONSORTIA ACTIVI7 TIES.—The Director of NIH shall— 

8 ‘‘(A) as appropriate, provide for the coordi9 nation of activities (including the exchange of 

10 information and regular communication) among 

11 the consortia established pursuant to paragraph 

12 (2); and 

13 ‘‘(B) require the periodic preparation and 

14 submission to the Director of reports on the ac15 tivities of each such consortium. 

16 ‘‘(4) ASSISTANCE WITH REGISTRIES.—Each 

17 consortium receiving an award under paragraph 

18 (2)(A) shall provide assistance to the Centers for 

19 Disease Control and Prevention in the establishment 

20 or expansion of patient registries and other surveil21 lance systems as appropriate and upon request by 

22 the Director of the Centers. 

23 ‘‘(e) RESEARCH ON PEDIATRIC RARE DISEASES OR

24 CONDITIONS.— 


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1 ‘‘(1) IN GENERAL.—In making awards under 

2 subsection (d)(2) for pediatric research consortia, 

3 the Director of NIH shall ensure that an appro4 priate number of such awards are awarded to such 

5 consortia that agree to— 

6 ‘‘(A) focus primarily on pediatric rare dis7 eases or conditions (including any such diseases 

8 or conditions that are genetic disorders (such as 

9 spinal muscular atrophy and Duchenne mus10 cular dystrophy) or are related to birth defects 

11 (such as Down syndrome and fragile X)); and 

12 ‘‘(B) conduct or coordinate one or more 

13 multisite clinical trials of therapies for, or ap14 proaches to, the prevention, diagnosis, or treat15 ment of one or more pediatric rare diseases or 

16 conditions. 

17 ‘‘(2) DATA COORDINATING CENTER.— 

18 ‘‘(A) ESTABLISHMENT.—In connection 

19 with support of consortia described in para20 graph (1), the Director of NIH shall establish 

21 a data coordinating center for the following 

22 purposes: 

23 ‘‘(i) To distribute the scientific find24 ings referred to in paragraph (1)(C). 


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1 ‘‘(ii) To provide assistance in the de2 sign and conduct of collaborative research 

3 projects and the management, analysis, 

4 and storage of data associated with such 

5 projects. 

6 ‘‘(iii) To organize and conduct 

7 multisite monitoring activities. 

8 ‘‘(B) REPORTING.—The Director of NIH 

9 shall— 

10 ‘‘(i) require the data coordinating cen11 ter established under subparagraph (A) to 

12 provide regular reports to the Director of 

13 NIH and the Commissioner of Food and 

14 Drugs on research conducted by consortia 

15 described in paragraph (1), including infor16 mation on enrollment in clinical trials and 

17 the allocation of resources with respect to 

18 such research; and 

19 ‘‘(ii) as appropriate, incorporate infor20 mation reported under clause (i) into the 


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1 Director’s biennial reports under section 

2 403.’’. 

Passed the House of Representatives February 4, 

2013. 

Attest: KAREN L. HAAS, 

Clerk. 


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