Gabriella Miller Kids First Research Act 2.0

II Calendar No. 224 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, Mr. VAN HOLLEN, Ms. MURKOWSKI, Mr. CASEY, Mr. LUJA´N, and Mr. MAR- SHALL) 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 pur- poses. VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 •S 1624 RS Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Gabriella Miller Kids 4 First Research Act 2.0’’. 5 SEC. 2. TRANSFER OF FUNDS TO THE PEDIATRIC RE- 6 SEARCH INITIATIVE. 7 Section 30A of the Securities Exchange Act of 1934 8 (15 U.S.C. 78dd–1) is amended by adding at the end the 9 following: 10 ‘‘(h) TRANSFER OF AMOUNTS.— 11 ‘‘(1) IN GENERAL.—Except as provided under 12 section 21F, the Secretary of the Treasury shall 13 transfer to the Pediatric Research Initiative Fund 14 described in section 9008(i)(2) of the Internal Rev- 15 enue Code of 1986 (referred to in this subsection as 16 the ‘Fund’), an amount equal to the sum of all civil 17 monetary sanctions, including penalties, 18 disgorgement, and interest, recovered with respect to 19 violations of this section and section 13(b)(2) from 20 persons— 21 ‘‘(A) registered under subsection (b)(1) or 22 (i)(1)(A)(i) of section 510 of the Federal Food, 23 Drug, and Cosmetic Act (21 U.S.C. 360); 24 VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6401 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 •S 1624 RS ‘‘(B) registered under subsection (b)(2) or 1 (i)(1)(A)(ii) of section 510 of the Federal Food, 2 Drug, and Cosmetic Act (21 U.S.C. 360); 3 ‘‘(C) that produce, manufacture, sell, 4 transport, or distribute dietary supplements (as 5 defined in section 201(ff) of the Federal Food, 6 Drug, and Cosmetic Act (21 U.S.C. 321(ff))); 7 or 8 ‘‘(D) that produce, manufacture, sell, 9 transport, or distribute cosmetics (as defined in 10 section 201(i) of the Federal Food, Drug, and 11 Cosmetic Act (21 U.S.C. 321(i))). 12 ‘‘(2) EXCEPTION FOR FUNDS TO BE PAID TO 13 HARMED INVESTORS.—Paragraph (1) shall not 14 apply to any monetary sanction collected by the 15 Commission in any judicial or administrative action 16 brought by the Commission under the securities laws 17 that is added to a disgorgement fund or other fund 18 under section 308 of the Sarbanes-Oxley Act of 19 2002 (15 U.S.C. 7246). 20 ‘‘(3) APPLICATION.—Amounts transferred to 21 the Fund under this subsection shall be— 22 ‘‘(A) transferred in the manner described 23 in section 9601 of the Internal Revenue Code of 24 1986; and 25 VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 •S 1624 RS ‘‘(B) available as described in section 1 9008(i)(2) of such Code.’’. 2 SEC. 3. FUNDING FOR THE PEDIATRIC RESEARCH INITIA- 3 TIVE. 4 (a) IN GENERAL.—Section 402A(a)(2) of the Public 5 Health Service Act (42 U.S.C. 282a(a)(2)) is amended— 6 (1) in the paragraph heading, by striking ‘‘10- 7 YEAR’’; 8 (2) by striking ‘‘the Common Fund’’ and insert- 9 ing ‘‘the Division of Program Coordination, Plan- 10 ning, and Strategic Initiatives’’; 11 (3) by striking ‘‘10-Year’’; and 12 (4) by inserting before the period the following: 13 ‘‘, and amounts transferred into the Pediatric Re- 14 search Initiative Fund under subsection (h) of sec- 15 tion 30A of the Securities Exchange Act of 1934 (15 16 U.S.C. 78dd–1)’’. 17 (b) NIH DIRECTOR.—Section 402(b)(7)(B)(ii) of the 18 Public Health Service Act (42 U.S.C. 282(b)(7)(B)(ii)) is 19 amended by striking ‘‘the Common Fund’’ and inserting 20 ‘‘the Division of Program Coordination, Planning, and 21 Strategic Initiatives’’. 22 (c) USE OF AMOUNTS FOR INITIATIVE.—Section 23 9008(i)(2) of the Internal Revenue Code of 1986 is 24 amended by striking ‘‘10-year’’. 25 VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6401 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB 5 •S 1624 RS SEC. 4. COORDINATION OF NIH FUNDING FOR PEDIATRIC 1 RESEARCH. 2 (a) SENSE OF CONGRESS.—It is the sense of Con- 3 gress that the Director of the National Institutes of 4 Health should oversee and coordinate research that is con- 5 ducted or supported by the National Institutes of Health 6 for research on pediatric cancer and other pediatric dis- 7 eases and conditions, including through the Pediatric Re- 8 search Initiative Fund. 9 (b) AVOIDING DUPLICATION.—Section 10 402(b)(7)(B)(ii) of the Public Health Service Act (42 11 U.S.C. 282(b)(7)(B)(ii)) is amended— 12 (1) by striking ‘‘grants’’ and inserting 13 ‘‘awards’’; and 14 (2) by inserting ‘‘and shall prioritize such pedi- 15 atric research that does not duplicate existing re- 16 search activities of the National Institutes of 17 Health’’ before ‘‘; and’’. 18 SEC. 5. REPORT ON PROGRESS AND INVESTMENTS IN PEDI- 19 ATRIC RESEARCH. 20 Not later than 4 years after the date of the enact- 21 ment of this Act, the Secretary of Health and Human 22 Services shall submit to the Committee on Health, Edu- 23 cation, Labor, and Pensions of the Senate and the Com- 24 mittee on Energy and Commerce of the House of Rep- 25 resentatives a report that— 26 VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6401 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB 6 •S 1624 RS (1) details pediatric research projects and ini- 1 tiatives receiving funds allocated pursuant to section 2 402(b)(7)(B)(ii) of the Public Health Service Act 3 (42 U.S.C. 282(b)(7)(B)(ii)); and 4 (2) summarizes advancements made in pediatric 5 research with funds allocated pursuant to section 6 402(b)(7)(B)(ii) of the Public Health Service Act 7 (42 U.S.C. 282(b)(7)(B)(ii)). 8 SECTION 1. SHORT TITLE. 9 This Act may be cited as the ‘‘Gabriella Miller Kids 10 First Research Act 2.0’’. 11 SEC. 2. FUNDING FOR THE PEDIATRIC RESEARCH INITIA- 12 TIVE. 13 (a) IN GENERAL.—Section 402A(a)(2) of the Public 14 Health Service Act (42 U.S.C. 282a(a)(2)) is amended— 15 (1) in the paragraph heading, by striking ‘‘10- 16 YEAR’’; 17 (2) by striking ‘‘the Common Fund’’ and insert- 18 ing ‘‘the Division of Program Coordination, Plan- 19 ning, and Strategic Initiatives’’; 20 (3) by striking ‘‘10-Year’’; and 21 (4) by striking ‘‘this section, $12,600,000 for 22 each of fiscal years 2014 through 2023.’’ and insert- 23 ing ‘‘this section— 24 ‘‘(A) $12,600,000 for fiscal year 2024; 25 VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6203 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB 7 •S 1624 RS ‘‘(B) $15,100,000 for each of fiscal years 1 2025 and 2026; 2 ‘‘(C) $17,600,000 for each of fiscal years 3 2027 and 2028; 4 ‘‘(D) $20,100,000 for each of fiscal years 5 2029 and 2030; 6 ‘‘(E) $22,600,000 for each of fiscal years 7 2031 and 2032; and 8 ‘‘(F) $25,000,000 for fiscal year 2033.’’. 9 (b) NIH DIRECTOR.—Section 402(b)(7)(B)(ii) of the 10 Public Health Service Act (42 U.S.C. 282(b)(7)(B)(ii)) is 11 amended by striking ‘‘the Common Fund’’ and inserting 12 ‘‘the Division of Program Coordination, Planning, and 13 Strategic Initiatives’’. 14 (c) USE OF AMOUNTS FOR INITIATIVE.—Section 15 9008(i)(2) of the Internal Revenue Code of 1986 is amended 16 by striking ‘‘10-year’’. 17 SEC. 3. COORDINATION OF NIH FUNDING FOR PEDIATRIC 18 RESEARCH. 19 (a) SENSE OF CONGRESS.—It is the sense of Congress 20 that the Director of the National Institutes of Health should 21 oversee and coordinate research that is conducted or sup- 22 ported by the National Institutes of Health for research on 23 pediatric cancer and other pediatric diseases and condi- 24 VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB 8 •S 1624 RS tions, including through the Pediatric Research Initiative 1 Fund. 2 (b) AVOIDING DUPLICATION.—Section 402(b)(7)(B)(ii) 3 of the Public Health Service Act (42 U.S.C. 4 282(b)(7)(B)(ii)) is amended— 5 (1) by striking ‘‘grants’’ and inserting ‘‘awards’’; 6 and 7 (2) by inserting ‘‘and shall prioritize such pedi- 8 atric research that does not duplicate existing re- 9 search activities of the National Institutes of Health’’ 10 before ‘‘; and’’. 11 SEC. 4. REPORT ON PROGRESS AND INVESTMENTS IN PEDI- 12 ATRIC RESEARCH. 13 Not later than 4 years after the date of the enactment 14 of this Act, the Secretary of Health and Human Services 15 shall submit to the Committee on Health, Education, Labor, 16 and Pensions of the Senate and the Committee on Energy 17 and Commerce of the House of Representatives a report 18 that— 19 (1) details pediatric research projects and initia- 20 tives receiving funds allocated pursuant to section 21 402(b)(7)(B)(ii) of the Public Health Service Act (42 22 U.S.C. 282(b)(7)(B)(ii)); and 23 (2) summarizes advancements made in pediatric 24 research with funds allocated pursuant to section 25 VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6203 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB 9 •S 1624 RS 402(b)(7)(B)(ii) of the Public Health Service Act (42 1 U.S.C. 282(b)(7)(B)(ii)). 2 Amend the title so as to read: ‘‘A bill to reauthorize the Gabriella Miller Kids First Pediatric Research Pro- gram at the National Institutes of Health, and for other purposes.’’. VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB Calendar No. 224 118TH CONGRESS 1ST SESSION S. 1624 A BILL To require certain civil penalties to be transferred to a fund through which amounts are made avail- able for the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health, and for other purposes. OCTOBER 4, 2023 Reported with an amendment and an amendment to the title VerDate Sep 11 2014 01:09 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00010 Fmt 6651 Sfmt 6651 E:\BILLS\S1624.RS S1624 kjohnson on DSK7ZCZBW3PROD with $$_JOB