II 

112TH CONGRESS 

2D SESSION S. 3461 

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 SENATE OF THE UNITED STATES 

JULY 31, 2012 

Mr. BROWN of Ohio (for himself, Mr. WICKER, Mr. KERRY, Mr. 

BLUMENTHAL, Mr. WHITEHOUSE, and Mr. BEGICH) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

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 2012’’. 


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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 cooperative agreements 

23 and grants to public or private nonprofit enti24 ties— 


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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. 

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

13 shall ensure that— 

14 ‘‘(i) each consortium receiving an 

15 award under subparagraph (A) conducts or 

16 supports at least one category of research 

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

18 collectively such consortia conduct or sup19 port all such categories of research; and 

20 ‘‘(ii) one or more such consortia pro21 vides training described in subparagraph 

22 (A)(ii)(II). 

23 ‘‘(C) NUMBER OF CONSORTIA.—The Direc24 tor of NIH may make awards under this paraVerDate Mar 15 2010 00:01 Aug 02, 2012 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3461.IS S3461

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1 graph for not more than 20 pediatric research 

2 consortia. 

3 ‘‘(D) ORGANIZATION OF CONSORTIUM.— 

4 Each consortium receiving an award under sub5 paragraph (A) shall— 

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

7 cooperating institutions; 

8 ‘‘(ii) be coordinated by a lead institu9 tion; and 

10 ‘‘(iii) meet such requirements as may 

11 be prescribed by the Director of NIH. 

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

13 support received by a consortium under sub14 paragraph (A) shall be used to supplement, and 

15 not supplant, other public or private support for 

16 activities authorized to be supported under this 

17 paragraph. 

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

19 a consortium under subparagraph (A) may be 

20 for a period of not to exceed 5 years. Such pe21 riod may be extended by the Director of NIH 

22 for additional periods of not more than 5 years. 

23 ‘‘(3) COORDINATION OF CONSORTIA ACTIVI24 TIES.—The Director of NIH shall— 


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1 ‘‘(A) as appropriate, provide for the coordi2 nation of activities (including the exchange of 

3 information and regular communication) among 

4 the consortia established pursuant to paragraph 

5 (2); and 

6 ‘‘(B) require the periodic preparation and 

7 submission to the Director of reports on the ac8 tivities of each such consortium. 

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

10 CONDITIONS.— 

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

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

13 the Director of NIH shall ensure that an appro14 priate number of such awards are awarded to such 

15 consortia that agree to— 

16 ‘‘(A) focus primarily on pediatric rare dis17 eases or conditions (including any such diseases 

18 or conditions that are genetic disorders (such as 

19 spinal muscular atrophy and Duchenne mus20 cular dystrophy) or are related to birth defects 

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

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

23 multisite clinical trials of therapies for, or ap24 proaches to, the prevention, diagnosis, or treatVerDate Mar 15 2010 00:01 Aug 02, 2012 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3461.IS S3461

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1 ment of one or more pediatric rare diseases or 

2 conditions; and 

3 ‘‘(C) rapidly and efficiently disseminate 

4 scientific findings resulting from such trials. 

5 ‘‘(2) DATA COORDINATING CENTER.— 

6 ‘‘(A) ESTABLISHMENT.—In connection 

7 with support of consortia described in para8 graph (1), the Director of NIH shall establish 

9 a data coordinating center for the following 

10 purposes: 

11 ‘‘(i) To distribute the scientific find12 ings referred to in paragraph (1)(C). 

13 ‘‘(ii) To provide assistance in the de14 sign and conduct of collaborative research 

15 projects and the management, analysis, 

16 and storage of data associated with such 

17 projects. 

18 ‘‘(iii) To organize and conduct 

19 multisite monitoring activities. 

20 ‘‘(iv) To provide assistance to the 

21 Centers for Disease Control and Preven22 tion in the establishment of patient reg23 istries. 

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

25 shall— 


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1 ‘‘(i) require the data coordinating cen2 ter established under subparagraph (A) to 

3 provide regular reports to the Director of 

4 NIH and the Commissioner of Food and 

5 Drugs on research conducted by consortia 

6 described in paragraph (1), including infor7 mation on enrollment in clinical trials and 

8 the allocation of resources with respect to 

9 such research; and 

10 ‘‘(ii) as appropriate, incorporate infor11 mation reported under clause (i) into the 

12 Director’s biennial reports under section 

13 403. 

14 ‘‘(3) DEFINITION.—In this subsection, the term 

15 ‘pediatric rare disease or condition’ means a rare 

16 disease or condition (as defined in section 526(a)(2) 

17 of the Federal Food, Drug, and Cosmetic Act) that 

18 affects pediatric populations.’’. 

Æ 


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