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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5269 Introduced in House (IH)]

<DOC>

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.

    Be it enacted by the Senate and House of Representatives 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 amended by adding at the end the 
following:

``SEC. 524C. PEDIATRIC RESEARCH SITE NETWORK.

    ``(a) Establishment.--The Secretary shall provide for the 
establishment and maintenance of a Pediatric Research Site Network in 
which--
            ``(1) the Secretary awards grants to eligible entities; and
            ``(2) through such grants, the eligible entities 
        collaborate on--
                    ``(A) the development and dissemination of guidance 
                and educational materials for the purposes of--
                            ``(i) enhancing pediatric clinical trials, 
                        including with respect to pediatric study 
                        design and feasibility;
                            ``(ii) identifying and mitigating 
                        challenges in pediatric research that delay 
                        pediatric clinical trials;
                            ``(iii) best practices in the conduct of 
                        pediatric clinical trials;
                            ``(iv) improving the process for the 
                        development of medical products;
                            ``(v) labeling innovative medical products;
                            ``(vi) accelerating medical product 
                        development; and
                            ``(vii) enhancing medical product safety; 
                        and
                    ``(B) such other activities as may be determined by 
                the Secretary for purposes of enhancing 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 biomedical 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 grantees under this section, shall submit a 
report to the Committee 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 appropriate.
    ``(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 appropriated $2,000,000 for each of fiscal 
years 2024 through 2029.''.
                                 <all>
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