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<dc:title>118 S1624 RS: Gabriella Miller Kids First Research Act 2.0</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2023-10-04</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">II</distribution-code><calendar>Calendar No. 224</calendar><congress>118th CONGRESS</congress><session>1st Session</session><legis-num>S. 1624</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20230516">May 16, 2023</action-date><action-desc><sponsor name-id="S362">Mr. Kaine</sponsor> (for himself, <cosponsor name-id="S347">Mr. Moran</cosponsor>, <cosponsor name-id="S359">Mr. Heinrich</cosponsor>, <cosponsor name-id="S350">Mr. Rubio</cosponsor>, <cosponsor name-id="S394">Ms. Smith</cosponsor>, <cosponsor name-id="S375">Mr. Daines</cosponsor>, <cosponsor name-id="S422">Mr. Welch</cosponsor>, <cosponsor name-id="S372">Mrs. Capito</cosponsor>, <cosponsor name-id="S417">Mr. Budd</cosponsor>, <cosponsor name-id="S327">Mr. Warner</cosponsor>, <cosponsor name-id="S390">Mr. Van Hollen</cosponsor>, <cosponsor name-id="S288">Ms. Murkowski</cosponsor>, <cosponsor name-id="S309">Mr. Casey</cosponsor>, <cosponsor name-id="S409">Mr. Luján</cosponsor>, and <cosponsor name-id="S411">Mr. Marshall</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00" added-display-style="italic" deleted-display-style="strikethrough">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><action stage="Reported-in-Senate"><action-date date="20231004">October 4, 2023</action-date><action-desc>Reported by <sponsor name-id="S313">Mr. Sanders</sponsor>, with an amendment and an amendment to the title</action-desc><action-instruction>Strike out all after the enacting clause and insert the part printed in italic</action-instruction></action><legis-type>A BILL</legis-type><official-title>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.</official-title></form><legis-body style="OLC" display-enacting-clause="yes-display-enacting-clause" id="H5AFEF10CFE0849DDA0B729157F068269"><section section-type="section-one" id="H5E368C0A12C646848D4E97716763220C" changed="deleted" reported-display-style="strikethrough" committee-id="SSHR00"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Gabriella Miller Kids First Research Act 2.0</short-title></quote>. </text></section><section id="H5A42AE1AC9864BA2A509E8ED63156497" changed="deleted" reported-display-style="strikethrough" committee-id="SSHR00"><enum>2.</enum><header>Transfer of funds to the Pediatric Research Initiative</header><text display-inline="no-display-inline">Section 30A of the Securities Exchange Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/15/78dd-1">15 U.S.C. 78dd–1</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H769EA5E6A3C54BD89C9D06DAD927D7A9" changed="deleted" reported-display-style="strikethrough" committee-id="SSHR00"><subsection id="H3F17360E7E9C41A291D3E861B68B4F55"><enum>(h)</enum><header>Transfer of amounts</header><paragraph id="HC5452200277D42D69816003AB00D5C14"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided under section 21F, the Secretary of the Treasury shall transfer to the Pediatric Research Initiative Fund described in <external-xref legal-doc="usc" parsable-cite="usc/26/9008">section 9008(i)(2)</external-xref> of the Internal Revenue Code of 1986 (referred to in this subsection as the <quote>Fund</quote>), 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—</text><subparagraph id="HDAB9CD45A9CC4D60AD1A52B2932D6A08"><enum>(A)</enum><text>registered under subsection (b)(1) or (i)(1)(A)(i) of section 510 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360</external-xref>);</text></subparagraph><subparagraph id="id0DDA83A2097D43458836D2DA59F4FEB1"><enum>(B)</enum><text>registered under subsection (b)(2) or (i)(1)(A)(ii) of section 510 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360</external-xref>);</text></subparagraph><subparagraph id="H177B75E3E10D418DA3C045AEFAE524BD"><enum>(C)</enum><text display-inline="yes-display-inline">that produce, manufacture, sell, transport, or distribute dietary supplements (as defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321(ff)</external-xref>)); or</text></subparagraph><subparagraph id="HC687FC72266245DE9890840FCABF4DF8"><enum>(D)</enum><text>that produce, manufacture, sell, transport, or distribute cosmetics (as defined in section 201(i) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321(i)</external-xref>)).</text></subparagraph></paragraph><paragraph id="HE4B1D6CA0FBC4A8D91E84C46E9094518"><enum>(2)</enum><header>Exception for funds to be paid to harmed investors</header><text display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/15/7246">15 U.S.C. 7246</external-xref>).</text></paragraph><paragraph id="H9F80B269615D489DAD21651511CE7551"><enum>(3)</enum><header>Application</header><text display-inline="yes-display-inline">Amounts transferred to the Fund under this subsection shall be—</text><subparagraph id="H478489EC1DA24505A048923B68E1C58A"><enum>(A)</enum><text>transferred in the manner described in <external-xref legal-doc="usc" parsable-cite="usc/26/9601">section 9601</external-xref> of the Internal Revenue Code of 1986; and</text></subparagraph><subparagraph id="HA945691F28834CC6BCE800E51DA5C76B"><enum>(B)</enum><text>available as described in section 9008(i)(2) of such Code.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H28E58412462A46BAA078A85EA9CA68FD" changed="deleted" reported-display-style="strikethrough" committee-id="SSHR00"><enum>3.</enum><header>Funding for the Pediatric Research Initiative</header><subsection id="H834FD9A4C063433989F2F87A62131690"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 402A(a)(2) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282a">42 U.S.C. 282a(a)(2)</external-xref>) is amended—</text><paragraph id="HBC9A8ED4AEE944FF80E6FE6AC791CE42"><enum>(1)</enum><text>in the paragraph heading, by striking <quote><header-in-text level="paragraph" style="OLC">10-year</header-in-text></quote>; </text></paragraph><paragraph id="H9EA58D7C2970488DB82173D6FC1774E7"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>the Common Fund</quote> and inserting <quote>the Division of Program Coordination, Planning, and Strategic Initiatives</quote>;</text></paragraph><paragraph id="HD5D61979EB6943EFA4A6F943B1850B84"><enum>(3)</enum><text>by striking <quote>10-Year</quote>; and</text></paragraph><paragraph id="HE5A6BF320FBB48C0996151344B359425"><enum>(4)</enum><text>by inserting before the period the following: <quote>, and amounts transferred into the Pediatric Research Initiative Fund under subsection (h) of section 30A of the Securities Exchange Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/15/78dd-1">15 U.S.C. 78dd–1</external-xref>)</quote>.</text></paragraph></subsection><subsection id="HD1F54A0F173A4351AA3FB8952D3A6467"><enum>(b)</enum><header>NIH Director</header><text display-inline="yes-display-inline">Section 402(b)(7)(B)(ii) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282(b)(7)(B)(ii)</external-xref>) is amended by striking <quote>the Common Fund</quote> and inserting <quote>the Division of Program Coordination, Planning, and Strategic Initiatives</quote>.</text></subsection><subsection id="HE7A3FAFA3D5948D797C22EEE598C33F3"><enum>(c)</enum><header>Use of amounts for initiative</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/9008">Section 9008(i)(2)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>10-year</quote>.</text></subsection></section><section id="H5791F6AD8E1F44D7ACD337F731E2B546" changed="deleted" reported-display-style="strikethrough" committee-id="SSHR00"><enum>4.</enum><header>Coordination of NIH funding for pediatric research</header><subsection id="HD023DA39EE1942C2BC960F60E0DAEC72"><enum>(a)</enum><header>Sense of Congress</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="HB7417B38246948588D9B5AB106438AE8"><enum>(b)</enum><header>Avoiding duplication</header><text display-inline="yes-display-inline">Section 402(b)(7)(B)(ii) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282(b)(7)(B)(ii)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id6f2a82a2e7b341f2b4e78877268deb7c"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>grants</quote> and inserting <quote>awards</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4374d2ec1a934986b7f9804df3b86308"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting <quote>and shall prioritize such pediatric research that does not duplicate existing research activities of the National Institutes of Health</quote> before <quote>; and</quote>.</text></paragraph></subsection></section><section id="id0268ea9ce711438a878aa49744b9c6fc" changed="deleted" reported-display-style="strikethrough" committee-id="SSHR00"><enum>5.</enum><header>Report on progress and investments in pediatric research</header><text display-inline="no-display-inline">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—</text><paragraph id="id727b4fe25e124d37af9b6cabb1d273ca"><enum>(1)</enum><text>details pediatric research projects and initiatives receiving funds allocated pursuant to section 402(b)(7)(B)(ii) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282(b)(7)(B)(ii)</external-xref>); and</text></paragraph><paragraph id="id6a3ac7ec00f14e4e94e39637491477dd"><enum>(2)</enum><text>summarizes advancements made in pediatric research with funds allocated pursuant to section 402(b)(7)(B)(ii) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282(b)(7)(B)(ii)</external-xref>). </text></paragraph></section></legis-body><legis-body style="OLC" display-enacting-clause="no-display-enacting-clause"><section section-type="section-one" id="id5a4b8d4c-98e6-4d24-abbd-784dfca98183" changed="added" reported-display-style="italic" committee-id="SSHR00"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Gabriella Miller Kids First Research Act 2.0</short-title></quote>. </text></section><section id="id0c40e8c0-7e07-4d48-a2d7-a6543f628be1" changed="added" reported-display-style="italic" committee-id="SSHR00"><enum>2.</enum><header>Funding for the Pediatric Research Initiative</header><subsection id="id6707013b-3d8c-4e13-9b10-fd4a097cbcdf"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 402A(a)(2) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282a">42 U.S.C. 282a(a)(2)</external-xref>) is amended—</text><paragraph id="iddaacfb16-48dc-40d4-afeb-93bed952e3aa"><enum>(1)</enum><text>in the paragraph heading, by striking <quote><header-in-text level="paragraph" style="OLC">10-year</header-in-text></quote>; </text></paragraph><paragraph id="id67d5ba57-50f6-42a5-94ac-817a5371c1ca"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>the Common Fund</quote> and inserting <quote>the Division of Program Coordination, Planning, and Strategic Initiatives</quote>;</text></paragraph><paragraph id="id129d9676-49d4-4b38-b61d-d5ad793462e2"><enum>(3)</enum><text>by striking <quote>10-Year</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id52fbbcde46ce4664b6716da20c813917"><enum>(4)</enum><text display-inline="yes-display-inline">by striking <quote>this section, $12,600,000 for each of fiscal years 2014 through 2023.</quote> and inserting “this section—</text><quoted-block style="OLC" display-inline="no-display-inline" id="id221F5090113B42D1A157EA7D48B53804" changed="added" reported-display-style="italic" committee-id="SSHR00"><subparagraph commented="no" display-inline="no-display-inline" id="idfc833e6bb7db4f218afdf84d17d8f03d"><enum>(A)</enum><text display-inline="yes-display-inline">$12,600,000 for fiscal year 2024;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id31165022a93a4dd09951d628d878ecbf"><enum>(B)</enum><text display-inline="yes-display-inline">$15,100,000 for each of fiscal years 2025 and 2026;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="iddf6a5ddc1c704ac8b6ace1f124bdd98c"><enum>(C)</enum><text display-inline="yes-display-inline">$17,600,000 for each of fiscal years 2027 and 2028;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd59bc949950d464599ea0fc26f72bd73"><enum>(D)</enum><text display-inline="yes-display-inline">$20,100,000 for each of fiscal years 2029 and 2030;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id786f32549f2d499e8cfb27ab7c73a088"><enum>(E)</enum><text display-inline="yes-display-inline">$22,600,000 for each of fiscal years 2031 and 2032; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc7e55336030948c4bf277b7ec49864e3"><enum>(F)</enum><text display-inline="yes-display-inline">$25,000,000 for fiscal year 2033.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="id579b7d8c-97ae-476e-bd47-1870a769ce36"><enum>(b)</enum><header>NIH Director</header><text display-inline="yes-display-inline">Section 402(b)(7)(B)(ii) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282(b)(7)(B)(ii)</external-xref>) is amended by striking <quote>the Common Fund</quote> and inserting <quote>the Division of Program Coordination, Planning, and Strategic Initiatives</quote>.</text></subsection><subsection id="id4f484e82-04ba-46a1-9171-1d3ae68fb928"><enum>(c)</enum><header>Use of amounts for initiative</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/9008">Section 9008(i)(2)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>10-year</quote>.</text></subsection></section><section id="id71205191-f38f-4b16-a4f6-015b45e597db" changed="added" reported-display-style="italic" committee-id="SSHR00"><enum>3.</enum><header>Coordination of NIH funding for pediatric research</header><subsection id="idec96f964-d740-44cb-9d2b-2ac793b074b7"><enum>(a)</enum><header>Sense of Congress</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="idb87cca59-85f3-4586-8932-a871931d5327"><enum>(b)</enum><header>Avoiding duplication</header><text display-inline="yes-display-inline">Section 402(b)(7)(B)(ii) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282(b)(7)(B)(ii)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="idee921298-ae1f-4ffc-a9b4-c5761482760d"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>grants</quote> and inserting <quote>awards</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1bc24fdd-af81-496e-8002-208ab8b1f81f"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting <quote>and shall prioritize such pediatric research that does not duplicate existing research activities of the National Institutes of Health</quote> before <quote>; and</quote>.</text></paragraph></subsection></section><section id="id74a0c19a-0187-4e27-a0bd-731fb0f4a0b1" changed="added" reported-display-style="italic" committee-id="SSHR00"><enum>4.</enum><header>Report on progress and investments in pediatric research</header><text display-inline="no-display-inline">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—</text><paragraph id="idc01b661a-f1bb-4b2d-b4cb-ca888f62b51b"><enum>(1)</enum><text>details pediatric research projects and initiatives receiving funds allocated pursuant to section 402(b)(7)(B)(ii) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282(b)(7)(B)(ii)</external-xref>); and</text></paragraph><paragraph id="id62b1c036-e996-40dd-9e3e-ba5acf549690"><enum>(2)</enum><text>summarizes advancements made in pediatric research with funds allocated pursuant to section 402(b)(7)(B)(ii) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282(b)(7)(B)(ii)</external-xref>). </text></paragraph></section></legis-body><official-title-amendment>Amend the title so as to read: <quote>A bill to reauthorize the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health, and for other purposes.</quote>.</official-title-amendment><endorsement><action-date date="20231004">October 4, 2023</action-date><action-desc>Reported with an amendment and an amendment to the title</action-desc></endorsement></bill> 

