Gabriella Miller Kids First Research Act 2.0

Subjects: Health

Summary:  <p><b>Gabriella Miller Kids First Research Act 2.0</b></p> <p>This bill modifies funding for, and requires reporting about, a pediatric disease research initiative within the National Institutes of Health (NIH).</p> <p>Currently, this initiative receives funding through FY2023 from the 10-Year Pediatric Research Initiative Fund.</p> <p>This bill directs certain penalties assessed by the Securities and Exchange Commission against pharmaceutical companies for specified violations to that fund. Additionally, the NIH must prioritize pediatric research that does not duplicate existing research activities when making allocations from the fund.</p> <p>The bill also requires the Department of Health and Human Services to report to Congress about the research projects funded through the initiative.</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1624 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                S. 1624

To require certain civil penalties to be transferred to a fund through 
 which amounts are made available for the Gabriella Miller Kids First 
 Pediatric Research Program at the National Institutes of Health, and 
                          for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 16, 2023

Mr. Kaine (for himself, Mr. Moran, Mr. Heinrich, Mr. Rubio, Ms. Smith, 
 Mr. Daines, Mr. Welch, Mrs. Capito, Mr. Budd, Mr. Warner, and Mr. Van 
    Hollen) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To require certain civil penalties to be transferred to a fund through 
 which amounts are made available for the Gabriella Miller Kids First 
 Pediatric Research Program at the National Institutes of Health, and 
                          for other purposes.

    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 ``Gabriella Miller Kids First Research 
Act 2.0''.

SEC. 2. TRANSFER OF FUNDS TO THE PEDIATRIC RESEARCH INITIATIVE.

    Section 30A of the Securities Exchange Act of 1934 (15 U.S.C. 78dd-
1) is amended by adding at the end the following:
    ``(h) Transfer of Amounts.--
            ``(1) In general.--Except as provided under section 21F, 
        the Secretary of the Treasury shall transfer to the Pediatric 
        Research Initiative Fund described in section 9008(i)(2) of the 
        Internal Revenue Code of 1986 (referred to in this subsection 
        as the `Fund'), an amount equal to the sum of all civil 
        monetary sanctions, including penalties, disgorgement, and 
        interest, recovered with respect to violations of this section 
        and section 13(b)(2) from persons--
                    ``(A) registered under subsection (b)(1) or 
                (i)(1)(A)(i) of section 510 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360);
                    ``(B) registered under subsection (b)(2) or 
                (i)(1)(A)(ii) of section 510 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360);
                    ``(C) that produce, manufacture, sell, transport, 
                or distribute dietary supplements (as defined in 
                section 201(ff) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 321(ff))); or
                    ``(D) that produce, manufacture, sell, transport, 
                or distribute cosmetics (as defined in section 201(i) 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                321(i))).
            ``(2) Exception for funds to be paid to harmed investors.--
        Paragraph (1) shall not apply to any monetary sanction 
        collected by the Commission in any judicial or administrative 
        action brought by the Commission under the securities laws that 
        is added to a disgorgement fund or other fund under section 308 
        of the Sarbanes-Oxley Act of 2002 (15 U.S.C. 7246).
            ``(3) Application.--Amounts transferred to the Fund under 
        this subsection shall be--
                    ``(A) transferred in the manner described in 
                section 9601 of the Internal Revenue Code of 1986; and
                    ``(B) available as described in section 9008(i)(2) 
                of such Code.''.

SEC. 3. FUNDING FOR THE PEDIATRIC RESEARCH INITIATIVE.

    (a) In General.--Section 402A(a)(2) of the Public Health Service 
Act (42 U.S.C. 282a(a)(2)) is amended--
            (1) in the paragraph heading, by striking ``10-year'';
            (2) by striking ``the Common Fund'' and inserting ``the 
        Division of Program Coordination, Planning, and Strategic 
        Initiatives'';
            (3) by striking ``10-Year''; and
            (4) by inserting before the period the following: ``, and 
        amounts transferred into the Pediatric Research Initiative Fund 
        under subsection (h) of section 30A of the Securities Exchange 
        Act of 1934 (15 U.S.C. 78dd-1)''.
    (b) NIH Director.--Section 402(b)(7)(B)(ii) of the Public Health 
Service Act (42 U.S.C. 282(b)(7)(B)(ii)) is amended by striking ``the 
Common Fund'' and inserting ``the Division of Program Coordination, 
Planning, and Strategic Initiatives''.
    (c) Use of Amounts for Initiative.--Section 9008(i)(2) of the 
Internal Revenue Code of 1986 is amended by striking ``10-year''.

SEC. 4. COORDINATION OF NIH FUNDING FOR PEDIATRIC RESEARCH.

    (a) Sense of Congress.--It is the sense of Congress that the 
Director of the National Institutes of Health should oversee and 
coordinate research that is conducted or supported by the National 
Institutes of Health for research on pediatric cancer and other 
pediatric diseases and conditions, including through the Pediatric 
Research Initiative Fund.
    (b) Avoiding Duplication.--Section 402(b)(7)(B)(ii) of the Public 
Health Service Act (42 U.S.C. 282(b)(7)(B)(ii)) is amended--
            (1) by striking ``grants'' and inserting ``awards''; and
            (2) by inserting ``and shall prioritize such pediatric 
        research that does not duplicate existing research activities 
        of the National Institutes of Health'' before ``; and''.

SEC. 5. REPORT ON PROGRESS AND INVESTMENTS IN PEDIATRIC RESEARCH.

    Not later than 4 years after the date of the enactment of this Act, 
the Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report that--
            (1) details pediatric research projects and initiatives 
        receiving funds allocated pursuant to section 402(b)(7)(B)(ii) 
        of the Public Health Service Act (42 U.S.C. 282(b)(7)(B)(ii)); 
        and
            (2) summarizes advancements made in pediatric research with 
        funds allocated pursuant to section 402(b)(7)(B)(ii) of the 
        Public Health Service Act (42 U.S.C. 282(b)(7)(B)(ii)).
                                 &lt;all&gt;
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