<?xml version="1.0"?>
<?xml-stylesheet type="text/xsl" href="billres.xsl"?>
<!DOCTYPE bill PUBLIC "-//US Congress//DTDs/bill.dtd//EN" "bill.dtd">
<bill bill-type="olc" bill-stage="Introduced-in-Senate" dms-id="A1" public-private="public" slc-id="S1-BAI21287-GNH-72-K2W"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>117 S1357 IS: Pediatricians Accelerate Childhood Therapies Act of 2021</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2021-04-22</dc:date>
<dc:format>text/xml</dc:format>
<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>
</dublinCore>
</metadata>
<form>
<distribution-code display="yes">II</distribution-code><congress>117th CONGRESS</congress><session>1st Session</session><legis-num>S. 1357</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20210422">April 22, 2021</action-date><action-desc><sponsor name-id="S376">Ms. Ernst</sponsor> (for herself, <cosponsor name-id="S337">Mr. Coons</cosponsor>, <cosponsor name-id="S309">Mr. Casey</cosponsor>, <cosponsor name-id="S395">Mrs. Hyde-Smith</cosponsor>, <cosponsor name-id="S318">Mr. Wicker</cosponsor>, and <cosponsor name-id="S330">Mr. Bennet</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To amend the Public Health Service Act to authorize the Director of the National Institutes of Health to make awards to outstanding scientists, including physician-scientists, to support researchers focusing on pediatric research, including basic, clinical, translational, or pediatric pharmacological research, and for other purposes.</official-title></form><legis-body style="OLC" display-enacting-clause="yes-display-enacting-clause" id="HEB71018223B743CDBD000AD08CAA43F2"><section section-type="section-one" id="H790C04B0F4BA449896B025C1EDD79C70"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Pediatricians Accelerate Childhood Therapies Act of 2021</short-title></quote> or the <quote><short-title>PACT Act of 2021</short-title></quote>.</text></section><section id="H5489E1E9A248470CA4565E4BD4E8EBC6"><enum>2.</enum><header>Trans-NIH Awards for Early-Career Pediatric Researchers</header><text display-inline="no-display-inline">Part G of title IV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/288">42 U.S.C. 288</external-xref> et seq.) is amended by adding at the end the following new section:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H1DDEA137610D45C7B831ADB23B3A0151"><section id="HCE9BF46854DE4AA990957C682A76FE22"><enum>489A.</enum><header>Trans-NIH Awards for Early-Career Pediatric Researchers</header><subsection id="H9476D30DFC644C84ADBD06734F77C913"><enum>(a)</enum><header>In general</header><text>The Director of the NIH shall make awards to outstanding scientists, including physician-scientists, to support early-career researchers focusing on pediatric research, including basic, clinical, translational, or pediatric pharmacological research.</text></subsection><subsection id="id1B4C7DCE86BF4BF99F063336FFDC5954"><enum>(b)</enum><header>Priority research populations</header><text>In carrying out subsection (a), the Director of NIH may prioritize the issuance of awards to applicants who—</text><paragraph id="id8A1895E460624AAC95BD2ECE6B1D9C26"><enum>(1)</enum><text>are individual researchers presenting qualifying applications and representing populations that have been historically underrepresented in pediatric medical research, including women and underrepresented racial minorities; or</text></paragraph><paragraph id="id027858A775A544328239F4C1A526D56F"><enum>(2)</enum><text>are institutions of higher education that are eligible to receive funds under part A or B of title III of the Higher Education Act of 1965, part A or B of title V of such Act, or subpart 4 of part A of title VII of such Act, or research institutions partnering with such institutions of higher education to offer programs to support early-career pediatric researchers. </text></paragraph></subsection><subsection id="H2121C9611658464CBF9E98D871186CE2"><enum>(c)</enum><header>Priority research topic areas</header><text display-inline="yes-display-inline">In carrying out subsection (a), the Director of NIH, in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the directors of other national research institutes and national centers that participate within the Trans-NIH Pediatric Research Consortium, shall—</text><paragraph id="H83C9264F2B504DB0910D8BF1EA7F8E40"><enum>(1)</enum><text>establish priority research topic areas, informed by external stakeholders, including research institutions, research societies, patient organizations, and industry; and</text></paragraph><paragraph id="H1CCAEF3934EE430E8A114F148199293E"><enum>(2)</enum><text display-inline="yes-display-inline">consider opportunities to align such priority pediatric research topic areas with current and future priorities of the National Institutes of Health, including—</text><subparagraph id="HB5418BCAC8D9449186A7DEF2A304E83D"><enum>(A)</enum><text>pediatric and adolescent mental and behavioral health, including addiction medicine;</text></subparagraph><subparagraph id="id9BFBF87D665D4777A45CBECBC64CD6F2"><enum>(B)</enum><text>childhood cancer;</text></subparagraph><subparagraph id="H10B139504E8A44C9ADC6AF3E50BCB571"><enum>(C)</enum><text>precision medicine, genetics, and genomics;</text></subparagraph><subparagraph id="HDCBCE326C68742CABFEC05DED651592E"><enum>(D)</enum><text>rare diseases and disorders, such as sickle cell disease, and other diseases and disorders with significant unmet training needs; and</text></subparagraph><subparagraph id="H94A9FE0317134EB381F2E1D3FC2B43A2"><enum>(E)</enum><text>fetal, placental, and neonatal development.</text></subparagraph></paragraph></subsection><subsection id="H3B4AFEC1CA034234B78519F25F5B8C31"><enum>(d)</enum><header>Requirements</header><text>The Director of NIH—</text><paragraph id="H0A3F6AE795F04A50ADF2A7B414272AA2"><enum>(1)</enum><text>shall require recipients of awards under this section to use such awards to support pediatric research activities, including costs associated with laboratory staff and other costs associated with the conduct of research; and</text></paragraph><paragraph id="HAC366B5EAC1940FE881E2F6779FD2BF6"><enum>(2)</enum><text display-inline="yes-display-inline">may allow recipients of awards under this section to use such awards for costs associated with receiving guidance and training from senior researchers and mentors, as necessary to help such recipients reach a state of research independence, including conferences and other meeting participation.</text></paragraph></subsection><subsection id="HC19E4E79C03C4710AA3E9175625E5DCD"><enum>(e)</enum><header>Supplement, not supplant</header><text display-inline="yes-display-inline">Awards made under this section shall be used to supplement, and not supplant, other funding for pediatric research and career development awards.</text></subsection></section><after-quoted-block>. </after-quoted-block></quoted-block></section><section id="HD3E5D401FC3E4EC2A3FDF69FC08CF7C4"><enum>3.</enum><header>Trans-NIH Pediatric Consortium</header><text display-inline="no-display-inline">Title IV of the Public Health Service is amended by inserting after section 409D (<external-xref legal-doc="usc" parsable-cite="usc/42/284h">42 U.S.C. 284h</external-xref>) the following new section:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H2FA25E0F69854CFD8B6E6C4A99DCF583"><section id="HB680AD8D5CC54F6E83E4199AB8A1E14D"><enum>409D–1.</enum><header>Trans-NIH Pediatric Consortium</header><subsection id="HD3497B9D774245319FB06E4050A7BCE1"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">The Director of NIH shall establish and maintain a consortium to be known as the Trans-NIH Pediatric Research Consortium (in this sections referred to as the <quote>Consortium</quote>) to coordinate pediatric research programs across the National Institutes of Health.</text></subsection><subsection id="HE66FFF2E97A440B0AA5EA12A23E92F07"><enum>(b)</enum><header>Membership</header><text display-inline="yes-display-inline">The members of the Consortium shall consist of representatives of multiple national research institutes and national centers.</text></subsection><subsection id="H5221DD0D6AA04989BB430FC5184F33A8"><enum>(c)</enum><header>Chair</header><text>The Chair of the Consortium shall be the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (or the Director’s designee).</text></subsection><subsection id="HEBE625A6166546AD9C851A1B07E9292B"><enum>(d)</enum><header>Duties</header><text display-inline="yes-display-inline">In coordinating pediatric research programs across the National Institutes of Health, the Consortium shall—</text><paragraph id="HDAE499291C0D4BB998DBED93FC5B0B57"><enum>(1)</enum><text>establish pediatric research priorities;</text></paragraph><paragraph id="HE9270E61C2E142FCA96B232D01CE0C07"><enum>(2)</enum><text>identify gaps and opportunities for research collaborations involving multiple national research institutes and national centers; and</text></paragraph><paragraph id="H7115E9760B4C419782E0A021348610FD"><enum>(3)</enum><text>identify opportunities to develop the next generation of pediatric researchers.</text></paragraph></subsection><subsection id="H5D227EE7220241B2B86720BA1BF9ED07"><enum>(e)</enum><header>Consultation</header><text>The Consortium shall consult regularly with external experts in the field of pediatric research, including children’s hospitals, children’s research institutions, patient organizations, and other stakeholders. </text></subsection><subsection id="id86b7de500a7246828a1de003fd631e37"><enum>(f)</enum><header>Reporting</header><text>Beginning one year after the date of enactment of the <short-title>Pediatricians Accelerate Childhood Therapies Act of 2021</short-title> and every 2 years thereafter, the Consortium shall submit to Congress, and make publicly available on the website of the National Institutes of Health, a report on—</text><paragraph id="id31fc801c52954fbb97493e36019fcb7e"><enum>(1)</enum><text>any research project involving pediatrics and involving more than one Institute or Center that was supported during the review period;</text></paragraph><paragraph id="id870968d1cdf3455ea0178f20dbec450c"><enum>(2)</enum><text>any strategic initiatives that include a significant pediatric component;</text></paragraph><paragraph id="id42eb5168cbc24ea1bf6d222a50406e03"><enum>(3)</enum><text>career development awards for early-career researchers focused in pediatrics, including specific numbers of awards and amount of funding, made during the review period;</text></paragraph><paragraph id="id603e8b7caf36456ab329668e4cfb862e"><enum>(4)</enum><text>details on the composition of awards for early-career researchers, including demographic details indicating the proportion of recipients from populations that have been underrepresented in pediatric medical research; and</text></paragraph><paragraph id="idff5b2271ade244e9a0e8c63410c133cc"><enum>(5)</enum><text>such other information as the Director of NIH determines appropriate.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></legis-body></bill> 

