Gabriella Miller Kids First Research Act 2.0

Bill: 118-s-1624
Sponsor: full_name: Sen. Kaine, Tim [D-VA]
Introduced: 2023-05-16
Policy area: Health
Subjects: Cancer

Child health

Congressional oversight

Government trust funds

Medical research

National Institutes of Health (NIH)

Research administration and funding
Latest action: action_date: 2023-10-04
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 224.

Summaries:
action_date: 2023-05-16
action_desc: Introduced in Senate
text: <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>

tv_txt: II Calendar No. 224 118th CONGRESS 1st Session S. 1624 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 , Mr. Van Hollen , Ms. Murkowski , Mr. Casey , Mr. Luján , and Mr. Marshall ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions October 4, 2023 Reported by Mr. Sanders , with an amendment and an amendment to the title Strike out all after the enacting clause and insert the part printed in italic 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— (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 . 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) ).

1. Short title This Act may be cited as the Gabriella Miller Kids First Research Act 2.0 . 2. 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 striking this section, $12,600,000 for each of fiscal years 2014 through 2023. and inserting “this section— (A) $12,600,000 for fiscal year 2024; (B) $15,100,000 for each of fiscal years 2025 and 2026; (C) $17,600,000 for each of fiscal years 2027 and 2028; (D) $20,100,000 for each of fiscal years 2029 and 2030; (E) $22,600,000 for each of fiscal years 2031 and 2032; and (F) $25,000,000 for fiscal year 2033. . (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 . 3. 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 . 4. 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) ).

Amend the title so as to read: A bill to reauthorize the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health, and for other purposes. .

October 4, 2023 Reported with an amendment and an amendment to the title

tv_txt: II 118th CONGRESS 1st Session S. 1624 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.

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— (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 . 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) ).