S. 1521Senate117th Congress (2021-2023)In Committee

Gabriella Miller Kids First Research Act 2.0

Sponsored by Tim KaineSen. Tim Kaine (D-VA)
Introduced April 29, 2021

AI-Generated Summary

Updated February 8, 2026 at 2:26 AM UTC

The bill directs civil monetary penalties collected from violations involving FDA‑registered drugs, devices, dietary supplements, and cosmetics to be transferred to the Gabriella Miller Kids First Pediatric Research Fund at the NIH. It also updates related health and tax statutes to reference this fund and includes a congressional sense that the NIH Director should coordinate pediatric research and avoid duplication of effort.

Key Provisions

  • Treasury must transfer civil penalties, disgorgement, and interest from specified FDA‑related violations to the Pediatric Research Initiative Fund, except amounts earmarked for harmed investors under Sarbanes‑Oxley provisions.
  • Amends the Public Health Service Act to replace references to the “Common Fund” with the Division of Program Coordination, Planning, and Strategic Initiatives and to include the transferred amounts in the pediatric research fund.
  • Updates the Internal Revenue Code language concerning the fund’s use, removing a ten‑year limitation.
  • Expresses the sense of Congress that the NIH Director should oversee and coordinate pediatric research, prioritizing projects that do not duplicate existing NIH work.

Legislative Activity

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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2365)

April 29, 2021

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SenateIntro Referral

Introduced in Senate

April 29, 2021

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2365)

April 29, 2021

Floor Debate

8 members

What members said about S. 1521 on the floor

2 Republicans6 Democrats
John Thune
Sen. John ThuneR-SD · Apr 29, 2021

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record. Mr. President, along with my livestock producer protection bill, I am also introducing legislation today to…

Tim Kaine
Sen. Tim KaineD-VA · Apr 29, 2021

Mr. President. A vibrant and independent media and public access to accurate information are critical to the functioning of any democracy. A free press is so important that our Founding Fathers…

Susan M. Collins
Sen. Susan M. CollinsR-ME · Apr 29, 2021

Mr. President, today I am pleased to be joined by my friend and colleague from Delaware, Senator Chris Coons, to reintroduce the Reach Every Mother and Child Act of 2021. Our legislation would make…

Alex Padilla
Sen. Alex PadillaD-CA · Apr 29, 2021

Mr. President, I rise to introduce the ``Protecting Unique and Beautiful Landscapes by Investing in California (PUBLIC) Lands Act.'' This measure would increase protections for over 1 million acres…

Dianne Feinstein
Sen. Dianne FeinsteinD-CA · Apr 29, 2021

Mr. President, I rise today to reintroduce bipartisan legislation that would better align the Department of Housing and Urban Development's (HUD) homeless assistance programs with other federal…

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Jack Reed
Sen. Jack ReedD-RI · Apr 29, 2021

Today, I am joined by Senators Warren, Brown, Van Hollen, and Gillibrand to introduce legislation to ensure that at least one Federal Reserve Governor has demonstrated primary experience in…

Tim Kaine
Sen. Tim KaineD-VA · Apr 29, 2021

Mr. President. While cancer is the leading cause of death by disease among children past infancy, childhood cancer and other rare pediatric diseases remain poorly understood. According to the…

Ron Wyden
Sen. Ron WydenD-OR · Apr 29, 2021

Madam President, today I have introduced the Retirement Parity for Student Loans Act. This legislation would permit employers to make matching contributions to workers under 401(k) and similar types…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Apr 29, 2021

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Bill Text

Latest available legislative text

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Introduced in SenateIssued April 29, 2021

II

117th CONGRESS

1st Session

S. 1521

IN THE SENATE OF THE UNITED STATES

April 29, 2021

Mr. Kaine (for himself, Mr. Moran, Mr. Warner, Mr. Cassidy, Mr. Casey, Mr. Rubio, and Mr. Manchin) 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.

1.

Short title

This Act may be cited as the Gabriella Miller Kids First Research Act 2.0.

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.

.

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.

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 by inserting and shall prioritize such pediatric research that does not duplicate existing research activities of the National Institutes of Health before ; and.