I 

118TH CONGRESS 

1ST SESSION H. R. 5269 

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 

establishment and maintenance of a Pediatric Research Site Network. 

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 25, 2023 

Mr. CURTIS (for himself and Mr. TONKO) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

provide for the establishment and maintenance of a Pediatric Research Site Network. 

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 ‘‘Pediatric Network 

5 Support Act’’. 

6 SEC. 2. PEDIATRIC RESEARCH SITE NETWORK. 

7 Subchapter A of chapter V of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend9 ed by adding at the end the following: 


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1 ‘‘SEC. 524C. PEDIATRIC RESEARCH SITE NETWORK. 

2 ‘‘(a) ESTABLISHMENT.—The Secretary shall provide 

3 for the establishment and maintenance of a Pediatric Re4 search Site Network in which— 

5 ‘‘(1) the Secretary awards grants to eligible en6 tities; and 

7 ‘‘(2) through such grants, the eligible entities 

8 collaborate on— 

9 ‘‘(A) the development and dissemination of 

10 guidance and educational materials for the pur11 poses of— 

12 ‘‘(i) enhancing pediatric clinical trials, 

13 including with respect to pediatric study 

14 design and feasibility; 

15 ‘‘(ii) identifying and mitigating chal16 lenges in pediatric research that delay pe17 diatric clinical trials; 

18 ‘‘(iii) best practices in the conduct of 

19 pediatric clinical trials; 

20 ‘‘(iv) improving the process for the de21 velopment of medical products; 

22 ‘‘(v) labeling innovative medical prod23 ucts; 

24 ‘‘(vi) accelerating medical product de25 velopment; and 


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1 ‘‘(vii) enhancing medical product safe2 ty; and 

3 ‘‘(B) such other activities as may be deter4 mined by the Secretary for purposes of enhanc5 ing pediatric clinical trials. 

6 ‘‘(b) ELIGIBLE ENTITY.—To be eligible to receive a 

7 grant under this section, an entity shall meet each of the 

8 following: 

9 ‘‘(1) The entity is— 

10 ‘‘(A) an institution of higher education as 

11 defined in subsection (a) or (b) of section 101 

12 of the Higher Education Act of 1965; or 

13 ‘‘(B) an organization described in section 

14 501(c)(3) of the Internal Revenue Code of 1986 

15 and exempt from tax under section 501(a) of 

16 such Code. 

17 ‘‘(2) The entity has experienced personnel, and 

18 clinical and other technical expertise, in the bio19 medical sciences. 

20 ‘‘(3) The entity demonstrates to the Secretary’s 

21 satisfaction that the entity is capable of carrying out 

22 the activities described in subsection (a)(2). 

23 ‘‘(c) ANNUAL REPORT.—Not later than 18 months 

24 after the date of enactment of this section, and annually 

25 thereafter, the Secretary, in collaboration with the grantVerDate Sep 11 2014 00:58 Aug 26, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5269.IH H5269

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1 ees under this section, shall submit a report to the Com2 mittee on Health, Education, Labor, and Pensions of the 

3 Senate and the Committee on Energy and Commerce of 

4 the House of Representatives— 

5 ‘‘(1) reviewing the operations and activities of 

6 the Pediatric Research Site Network in the previous 

7 year; and 

8 ‘‘(2) addressing such other issues relating to 

9 this section as the Secretary determines to be appro10 priate. 

11 ‘‘(d) DEFINITION.—In this section, the term ‘medical 

12 product’ means a drug (including a biological product), a 

13 device (including a diagnostic test), and any combination 

14 product described in section 503(g). 

15 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

16 carry out this section, there is authorized to be appro17 priated $2,000,000 for each of fiscal years 2024 through 

18 2029.’’. 

Æ 


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