II 

113TH CONGRESS 

1ST SESSION S. 424 

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 

FEBRUARY 28, 2013 

Mr. BROWN (for himself, Mr. WICKER, Mr. BLUMENTHAL, Mr. BLUNT, Ms. 

COLLINS, Mr. PORTMAN, and Mr. WHITEHOUSE) 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 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, in consultation with the Direc12 tor of the Eunice Kennedy Shriver National Insti13 tute of Child Health and Human Development and 

14 in collaboration with other appropriate national re15 search institutes and national centers that carry out 

16 activities involving pediatric research, may provide 

17 for the establishment of a National Pediatric Re18 search Network consisting of the pediatric research 

19 consortia receiving awards under paragraph (2). 

20 ‘‘(2) PEDIATRIC RESEARCH CONSORTIA.— 

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

22 may award funding, including through grants, 

23 contracts or other mechanisms, to public or pri24 vate nonprofit entities— 

25 ‘‘(i) for establishing or strengthening 

26 pediatric research consortia; and 


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1 ‘‘(ii) for providing support for such 

2 consortia, including with respect to— 

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

4 translational research to meet unmet 

5 pediatric research needs; and 

6 ‘‘(II) training researchers in pe7 diatric research techniques in order to 

8 address unmet pediatric research 

9 needs. 

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

11 may ensure that— 

12 ‘‘(i) each consortium receiving an 

13 award under subparagraph (A) conducts or 

14 supports at least one category of research 

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

16 collectively such consortia conduct or sup17 port all such categories of research; and 

18 ‘‘(ii) one or more such consortia pro19 vide training described in subparagraph 

20 (A)(ii)(II). 

21 ‘‘(C) NUMBER OF CONSORTIA.—The Direc22 tor of NIH may make awards under this para23 graph for not more than 8 pediatric research 

24 consortia, with a minimum of one pediatric reVerDate Mar 15 2010 22:41 Mar 01, 2013 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S424.IS S424

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1 search consortium that prioritizes collaboration 

2 with institutions serving rural areas. 

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 CONSORTIUM SUP19 PORT.—Support of a consortium under sub20 paragraph (A) may be for a period of not to ex21 ceed 5 years. Such period may be extended at 

22 the discretion of the Director of NIH. 

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) as appropriate, require the periodic 

7 preparation and submission to the Director of 

8 reports on the activities of each such consor9 tium. 

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

11 CONDITIONS.— 

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

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

14 the Director of NIH may ensure that an appropriate 

15 number of such awards are awarded to such con16 sortia that agree to— 

17 ‘‘(A) focus primarily on pediatric rare dis18 eases or conditions (including any such diseases 

19 or conditions that are genetic disorders or are 

20 related to birth defects); and 

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

22 multisite clinical trials of therapies for, or ap23 proaches to, the prevention, diagnosis, or treatVerDate Mar 15 2010 22:41 Mar 01, 2013 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S424.IS S424

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1 ment of one or more pediatric rare diseases or 

2 conditions.’’. 

Æ 


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