I 

113TH CONGRESS 

1ST SESSION H. R. 225 

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. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 14, 2013 

Mrs. CAPPS (for herself, Mrs. MCMORRIS RODGERS, Ms. DEGETTE, Mr. HARPER, Ms. MATSUI, and Mr. KING of New York) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Pediatric Re5 search Network Act of 2013’’. 


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1 SEC. 2. NATIONAL PEDIATRIC RESEARCH NETWORK. 

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

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

4 is amended— 

5 (1) by redesignating subsection (d) as sub6 section (f); and 

7 (2) by inserting after subsection (c) the fol8 lowing: 

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

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

11 the Director of NIH, acting through the Director of 

12 the Eunice Kennedy Shriver National Institute of 

13 Child Health and Human Development and in col14 laboration with other appropriate national research 

15 institutes and national centers that carry out activi16 ties involving pediatric research, may provide for the 

17 establishment of a National Pediatric Research Net18 work consisting of the pediatric research consortia 

19 receiving awards under paragraph (2). 

20 ‘‘(2) PEDIATRIC RESEARCH CONSORTIA.— 

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

22 Institute may award funding, including through 

23 grants, contracts, or other mechanisms, to pub24 lic or private nonprofit entities— 


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

2 strengthening pediatric research consortia; 

3 and 

4 ‘‘(ii) for providing basic operating 

5 support for such consortia, including with 

6 respect to— 

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

8 translational research to meet unmet 

9 needs for pediatric research; and 

10 ‘‘(II) training researchers in pe11 diatric research techniques in order to 

12 address unmet pediatric research 

13 needs. 

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

15 shall ensure that— 

16 ‘‘(i) each consortium receiving an 

17 award under subparagraph (A) conducts or 

18 supports at least one category of research 

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

20 collectively such consortia conduct or sup21 port all such categories of research; and 

22 ‘‘(ii) one or more such consortia pro23 vide training described in subparagraph 

24 (A)(ii)(II). 


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1 ‘‘(C) NUMBER OF CONSORTIA.—The Direc2 tor of NIH may make awards under this para3 graph for not more than 20 pediatric research 

4 consortia. 

5 ‘‘(D) ORGANIZATION OF CONSORTIUM.— 

6 Each consortium receiving an award under sub7 paragraph (A) shall— 

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

9 cooperating institutions; 

10 ‘‘(ii) be coordinated by a lead institu11 tion; 

12 ‘‘(iii) agree to disseminate scientific 

13 findings, including from clinical trials, rap14 idly and efficiently; and 

15 ‘‘(iv) meet such requirements as may 

16 be prescribed by the Director of NIH. 

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

18 support received by a consortium under sub19 paragraph (A) shall be used to supplement, and 

20 not supplant, other public or private support for 

21 activities authorized to be supported under this 

22 paragraph. 

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

24 a consortium under subparagraph (A) may be 

25 for a period of not to exceed 5 years. Such peVerDate Mar 15 2010 04:35 Jan 15, 2013 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H225.IH H225

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1 riod may be extended at the discretion of the 

2 Director of NIH. 

3 ‘‘(3) COORDINATION OF CONSORTIA ACTIVI4 TIES.—The Director of NIH shall— 

5 ‘‘(A) as appropriate, provide for the coordi6 nation of activities (including the exchange of 

7 information and regular communication) among 

8 the consortia established pursuant to paragraph 

9 (2); and 

10 ‘‘(B) require the periodic preparation and 

11 submission to the Director of reports on the ac12 tivities of each such consortium. 

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

14 consortium receiving an award under paragraph 

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

16 Disease Control and Prevention in the establishment 

17 or expansion of patient registries and other surveil18 lance systems as appropriate and upon request by 

19 the Director of the Centers. 

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

21 CONDITIONS.— 

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

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

24 the Director of NIH shall ensure that an approVerDate Mar 15 2010 04:35 Jan 15, 2013 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H225.IH H225

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1 priate number of such awards are awarded to such 

2 consortia that agree to— 

3 ‘‘(A) focus primarily on pediatric rare dis4 eases or conditions (including any such diseases 

5 or conditions that are genetic disorders (such as 

6 spinal muscular atrophy and Duchenne mus7 cular dystrophy) or are related to birth defects 

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

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

10 multisite clinical trials of therapies for, or ap11 proaches to, the prevention, diagnosis, or treat12 ment of one or more pediatric rare diseases or 

13 conditions. 

14 ‘‘(2) DATA COORDINATING CENTER.— 

15 ‘‘(A) ESTABLISHMENT.—In connection 

16 with support of consortia described in para17 graph (1), the Director of NIH shall establish 

18 a data coordinating center for the following 

19 purposes: 

20 ‘‘(i) To distribute the scientific find21 ings referred to in paragraph (1)(C). 

22 ‘‘(ii) To provide assistance in the de23 sign and conduct of collaborative research 

24 projects and the management, analysis, 


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1 and storage of data associated with such 

2 projects. 

3 ‘‘(iii) To organize and conduct 

4 multisite monitoring activities. 

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

6 shall— 

7 ‘‘(i) require the data coordinating cen8 ter established under subparagraph (A) to 

9 provide regular reports to the Director of 

10 NIH and the Commissioner of Food and 

11 Drugs on research conducted by consortia 

12 described in paragraph (1), including infor13 mation on enrollment in clinical trials and 

14 the allocation of resources with respect to 

15 such research; and 

16 ‘‘(ii) as appropriate, incorporate infor17 mation reported under clause (i) into the 

18 Director’s biennial reports under section 

19 403.’’. 

Æ 


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