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 Pedi-
atric Research Site Network. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pediatric Network 
Support Act’’. 
SEC. 2. PEDIATRIC RESEARCH SITE NETWORK. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
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‘‘SEC. 524C. PEDIATRIC RESEARCH SITE NETWORK. 
‘‘(a) ESTABLISHMENT.—The Secretary shall provide 
for the establishment and maintenance of a Pediatric Re-
search Site Network in which— 
‘‘(1) the Secretary awards grants to eligible en-
tities; and 
‘‘(2) through such grants, the eligible entities 
collaborate on— 
‘‘(A) the development and dissemination of 
guidance and educational materials for the pur-
poses of— 
‘‘(i) enhancing pediatric clinical trials, 
including with respect to pediatric study 
design and feasibility; 
‘‘(ii) identifying and mitigating chal-
lenges in pediatric research that delay pe-
diatric clinical trials; 
‘‘(iii) best practices in the conduct of 
pediatric clinical trials; 
‘‘(iv) improving the process for the de-
velopment of medical products; 
‘‘(v) labeling innovative medical prod-
ucts; 
‘‘(vi) accelerating medical product de-
velopment; and 
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‘‘(vii) enhancing medical product safe-
ty; and 
‘‘(B) such other activities as may be deter-
mined by the Secretary for purposes of enhanc-
ing pediatric clinical trials. 
‘‘(b) ELIGIBLE ENTITY.—To be eligible to receive a 
grant under this section, an entity shall meet each of the 
following: 
‘‘(1) The entity is— 
‘‘(A) an institution of higher education as 
defined in subsection (a) or (b) of section 101 
of the Higher Education Act of 1965; or 
‘‘(B) an organization described in section 
501(c)(3) of the Internal Revenue Code of 1986 
and exempt from tax under section 501(a) of 
such Code. 
‘‘(2) The entity has experienced personnel, and 
clinical and other technical expertise, in the bio-
medical sciences. 
‘‘(3) The entity demonstrates to the Secretary’s 
satisfaction that the entity is capable of carrying out 
the activities described in subsection (a)(2). 
‘‘(c) ANNUAL REPORT.—Not later than 18 months 
after the date of enactment of this section, and annually 
thereafter, the Secretary, in collaboration with the grant-
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ees under this section, shall submit a report to the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of 
the House of Representatives— 
‘‘(1) reviewing the operations and activities of 
the Pediatric Research Site Network in the previous 
year; and 
‘‘(2) addressing such other issues relating to 
this section as the Secretary determines to be appro-
priate. 
‘‘(d) DEFINITION.—In this section, the term ‘medical 
product’ means a drug (including a biological product), a 
device (including a diagnostic test), and any combination 
product described in section 503(g). 
‘‘(e) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $2,000,000 for each of fiscal years 2024 through 
2029.’’. 
Æ 
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