113 S 252 ENR: To reduce preterm labor and delivery and the risk of pregnancy-related deaths and complications due to pregnancy, and to reduce infant mortality caused by prematurity, and for other purposes.Senate Bill252113 S 252 ENR113s252enr113 S. 252 ENRUnited States SenateUnited States Government Publishing Officetext/xmlENPursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.ENRGPO Locator to USLM Converter 3.11.8;Stage2.202201272023-01-071131publicS.252One Hundred Thirteenth Congress of the United States of AmericaA T T H E F I R S T S E S S I O NBegun and held at the City of Washington on Thursday, the third day of January, two thousand and thirteenAn ActTo reduce preterm labor and delivery and the risk of pregnancy-related deaths and complications due to pregnancy, and to reduce infant mortality caused by prematurity, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,SECTION 1. TABLE OF CONTENTS. The table of contents for this Act is as follows:
Sec. 1. TITLE I—Sec. 101. Sec. 102. Sec. 103. Sec. 104. TITLE II—Sec. 201. Sec. 202. TITLE III—Sec. 301. Sec. 302. <num value="I">TITLE I—</num><heading>PREEMIE ACT REAUTHORIZATION</heading>
<section id="d167596e138" identifier="/us/bill/113/s/252/tI/s101" style="-uslm-lc:I650143"><num value="101">SEC. 101. </num><heading>SHORT TITLE.</heading><content style="-uslm-lc:I650120"> This title may be cited as the “<shortTitle role="title">Prematurity Research Expansion and Education for Mothers who deliver Infants Early Reauthorization Act</shortTitle>” or the “<shortTitle role="title">PREEMIE Reauthorization Act</shortTitle>”.</content></section>
<section id="d167596e151" identifier="/us/bill/113/s/252/tI/s102" style="-uslm-lc:I650143"><num value="102">SEC. 102. </num><heading>RESEARCH AND ACTIVITIES AT THE CENTERS FOR DISEASE CONTROL AND PREVENTION.</heading><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e155" identifier="/us/bill/113/s/252/tI/s102/a" role="instruction" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="a">(a) </num><heading><inline class="smallCaps">Epidemiological Studies</inline>.—</heading><content>Section 3 of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act (<ref href="/us/usc/t42/s247b–4f">42 U.S.C. 247b–4f</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> subsection (b) and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><subsection class="indentUp0 firstIndent1 fontsize10" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="b">“(b) </num><heading><inline class="smallCaps">Studies and Activities on Preterm Birth</inline>.—</heading><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">“(1) </num><heading><inline class="smallCaps">In general</inline>.—</heading><chapeau>The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, may, subject to the availability of appropriations—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">“(A) </num><content>conduct epidemiological studies on the clinical, biological, social, environmental, genetic, and behavioral factors relating to prematurity, as appropriate;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">“(B) </num><content>conduct activities to improve national data to facilitate tracking the burden of preterm birth; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">“(C) </num><content>continue efforts to prevent preterm birth, including late preterm birth, through the identification of opportunities for prevention and the assessment of the impact of such efforts.</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">“(2) </num><heading><inline class="smallCaps">Report</inline>.—</heading><content>Not later than 2 years after the date of enactment of the PREEMIE Reauthorization Act, and every 2 years thereafter, the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the appropriate committees of Congress reports concerning the progress and any results of studies conducted under paragraph (1).”</content></paragraph></subsection></quotedContent>.</content></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e213" identifier="/us/bill/113/s/252/tI/s102/b" role="instruction" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="b">(b) </num><heading><inline class="smallCaps">Reauthorization</inline>.—</heading><content>Section 3(e) of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act (<ref href="/us/usc/t42/s247b–4f/e">42 U.S.C. 247b–4f(e)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>$5,000,000</quotedText>” and all that follows through “<quotedText>2011.</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>$1,880,000 for each of fiscal years 2014 through 2018.</quotedText>”.</content></subsection></section>
<section id="d167596e235" identifier="/us/bill/113/s/252/tI/s103" style="-uslm-lc:I650143"><num value="103">SEC. 103. </num><heading>ACTIVITIES AT THE HEALTH RESOURCES AND SERVICES ADMINISTRATION.</heading><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e239" identifier="/us/bill/113/s/252/tI/s103/a" role="instruction" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="a">(a) </num><heading><inline class="smallCaps">Telemedicine and High-Risk Pregnancies</inline>.—</heading><content>Section 330I(i)(1)(B) of the Public Health Service Act (<ref href="/us/usc/t42/s254c–14/i/1/B">42 U.S.C. 254c–14(i)(1)(B)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>or case management services</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>case management services, or prenatal care for high-risk pregnancies</quotedText>”;</content></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e260" identifier="/us/bill/113/s/252/tI/s103/b" role="instruction" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="b">(b) </num><heading><inline class="smallCaps">Public and Health Care Provider Education</inline>.—</heading><chapeau>Section 399Q of the Public Health Service Act (<ref href="/us/usc/t42/s280g–5">42 U.S.C. 280g–5</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e275" identifier="/us/bill/113/s/252/tI/s103/b/1" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in subsection (b)—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e279" identifier="/us/bill/113/s/252/tI/s103/b/1/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>in paragraph (1), by <amendingAction type="delete">striking</amendingAction> subparagraphs (A) through (F) and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><subparagraph class="indentUp2 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">“(A) </num><content>the core risk factors for preterm labor and delivery;</content></subparagraph><subparagraph class="indentUp2 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">“(B) </num><content>medically indicated deliveries before full term;</content></subparagraph><subparagraph class="indentUp2 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">“(C) </num><chapeau>the importance of preconception and prenatal care, including—</chapeau><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="i">“(i) </num><content>smoking cessation;</content></clause><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>weight maintenance and good nutrition, including folic acid;</content></clause><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>the screening for and the treatment of infections; and</content></clause><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="iv">“(iv) </num><content>stress management;</content></clause></subparagraph><subparagraph class="indentUp2 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="D">“(D) </num><content>treatments and outcomes for premature infants, including late preterm infants;</content></subparagraph><subparagraph class="indentUp2 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="E">“(E) </num><content>the informational needs of families during the stay of an infant in a neonatal intensive care unit; and</content></subparagraph><subparagraph class="indentUp2 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="F">“(F) </num><content>utilization of evidence-based strategies to prevent birth injuries;”</content></subparagraph></quotedContent>; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e332" identifier="/us/bill/113/s/252/tI/s103/b/1/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (2) and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">“(2) </num><content>programs to increase the availability, awareness, and use of pregnancy and post-term information services that provide evidence-based, clinical information through counselors, community outreach efforts, electronic or telephonic communication, or other appropriate means regarding causes associated with prematurity, birth defects, or health risks to a post-term infant;”</content></paragraph></quotedContent>; and</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e349" identifier="/us/bill/113/s/252/tI/s103/b/2" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">(2) </num><content>in subsection (c), by <amendingAction type="delete">striking</amendingAction> “<quotedText>$5,000,000</quotedText>” and all that follows through “<quotedText>2011.</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>$1,900,000 for each of fiscal years 2014 through 2018.</quotedText>”.</content></paragraph></subsection></section>
<section id="d167596e361" identifier="/us/bill/113/s/252/tI/s104" style="-uslm-lc:I650143"><num value="104">SEC. 104. </num><heading>OTHER ACTIVITIES.</heading><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e365" identifier="/us/bill/113/s/252/tI/s104/a" role="instruction" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="a">(a) </num><heading><inline class="smallCaps">Interagency Coordinating Council on Prematurity and Low Birthweight</inline>.—</heading><content>The Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> section 5 (<ref href="/us/usc/t42/s247b–4g">42 U.S.C. 247b–4g</ref>).</content></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e383" identifier="/us/bill/113/s/252/tI/s104/b" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="b">(b) </num><heading><inline class="smallCaps">Advisory Committee on Infant Mortality</inline>.—</heading><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e390" identifier="/us/bill/113/s/252/tI/s104/b/1" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">(1) </num><heading><inline class="smallCaps">Establishment</inline>.—</heading><content>The Secretary of Health and Human Services (referred to in this section as the “Secretary”) may establish an advisory committee known as the “Advisory Committee on Infant Mortality” (referred to in this section as the “Advisory Committee”).</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e398" identifier="/us/bill/113/s/252/tI/s104/b/2" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">(2) </num><heading><inline class="smallCaps">Duties</inline>.—</heading><chapeau>The Advisory Committee shall provide advice and recommendations to the Secretary concerning the following activities:</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e406" identifier="/us/bill/113/s/252/tI/s104/b/2/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>Programs of the Department of Health and Human Services that are directed at reducing infant mortality and improving the health status of pregnant women and infants.</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e410" identifier="/us/bill/113/s/252/tI/s104/b/2/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>Strategies to coordinate the various Federal programs and activities with State, local, and private programs and efforts that address factors that affect infant mortality.</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e414" identifier="/us/bill/113/s/252/tI/s104/b/2/C" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">(C) </num><content>Implementation of the Healthy Start program under section 330H of the Public Health Service Act (<ref href="/us/usc/t42/s254c–8">42 U.S.C. 254c–8</ref>) and Healthy People 2020 infant mortality objectives.</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e422" identifier="/us/bill/113/s/252/tI/s104/b/2/D" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="D">(D) </num><content>Strategies to reduce preterm birth rates through research, programs, and education.</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e426" identifier="/us/bill/113/s/252/tI/s104/b/3" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="3">(3) </num><heading><inline class="smallCaps">Plan for hhs preterm birth activities</inline>.—</heading><chapeau>Not later than 1 year after the date of enactment of this section, the Advisory Committee (or an advisory committee in existence as of the date of enactment of this Act and designated by the Secretary) shall develop a plan for conducting and supporting research, education, and programs on preterm birth through the Department of Health and Human Services and shall periodically review and revise the plan, as appropriate. The plan shall—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e434" identifier="/us/bill/113/s/252/tI/s104/b/3/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>examine research and educational activities that receive Federal funding in order to enable the plan to provide informed recommendations to reduce preterm birth and address racial and ethnic disparities in preterm birth rates;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e438" identifier="/us/bill/113/s/252/tI/s104/b/3/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>identify research gaps and opportunities to implement evidence-based strategies to reduce preterm birth rates among the programs and activities of the Department of Health and Human Services regarding preterm birth, including opportunities to minimize duplication; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e442" identifier="/us/bill/113/s/252/tI/s104/b/3/C" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">(C) </num><content>reflect input from a broad range of scientists, patients, and advocacy groups, as appropriate.</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e446" identifier="/us/bill/113/s/252/tI/s104/b/4" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="4">(4) </num><heading><inline class="smallCaps">Membership</inline>.—</heading><chapeau>The Secretary shall ensure that the membership of the Advisory Committee includes the following:</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e454" identifier="/us/bill/113/s/252/tI/s104/b/4/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>Representatives provided for in the original charter of the Advisory Committee.</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e458" identifier="/us/bill/113/s/252/tI/s104/b/4/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>A representative of the National Center for Health Statistics.</content></subparagraph></paragraph></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e462" identifier="/us/bill/113/s/252/tI/s104/c" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="c">(c) </num><heading><inline class="smallCaps">Patient Safety Studies and Report</inline>.—</heading><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e469" identifier="/us/bill/113/s/252/tI/s104/c/1" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">(1) </num><heading><inline class="smallCaps">In general</inline>.—</heading><content>The Secretary shall designate an appropriate agency within the Department of Health and Human Services to coordinate existing studies on hospital readmissions of preterm infants.</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e477" identifier="/us/bill/113/s/252/tI/s104/c/2" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">(2) </num><heading><inline class="smallCaps">Report to secretary and congress</inline>.—</heading><content>Not later than 1 year after the date of the enactment of this Act, the agency designated under paragraph (1) shall submit to the Secretary and to Congress a report containing the findings and recommendations resulting from the studies coordinated under such paragraph, including recommendations for hospital discharge and followup procedures designed to reduce rates of preventable hospital readmissions for preterm infants.</content></paragraph></subsection></section>
<num value="II">TITLE II—</num><heading>NATIONAL PEDIATRIC RESEARCH NETWORK</heading>
<section id="d167596e492" identifier="/us/bill/113/s/252/tII/s201" style="-uslm-lc:I650143"><num value="201">SEC. 201. </num><heading>SHORT TITLE.</heading><content style="-uslm-lc:I650120"> This title may be cited as the “<shortTitle role="title">National Pediatric Research Network Act of 2013</shortTitle>”.</content></section>
<section id="d167596e502" identifier="/us/bill/113/s/252/tII/s202" role="instruction" style="-uslm-lc:I650143"><num value="202">SEC. 202. </num><heading>NATIONAL PEDIATRIC RESEARCH NETWORK.</heading><chapeau class="indentUp0 firstIndent1 fontsize10" style="-uslm-lc:I650120"> Section 409D of the Public Health Service Act (<ref href="/us/usc/t42/s284h">42 U.S.C. 284h</ref>; relating to the Pediatric Research Initiative) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e514" identifier="/us/bill/113/s/252/tII/s202/1" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subsection (d) as subsection (f); and</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e522" identifier="/us/bill/113/s/252/tII/s202/2" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="insert">inserting</amendingAction> after subsection (c) the following:<quotedContent><subsection class="indentUp0 firstIndent1 fontsize10" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="d">“(d) </num><heading><inline class="smallCaps">National Pediatric Research Network</inline>.—</heading><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">“(1) </num><heading><inline class="smallCaps">Network</inline>.—</heading><chapeau>In carrying out the Initiative, the Director of NIH, in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research, may provide for the establishment of a National Pediatric Research Network in order to more effectively support pediatric research and optimize the use of Federal resources. Such National Pediatric Research Network may be comprised of, as appropriate—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">“(A) </num><content>the pediatric research consortia receiving awards under paragraph (2); or</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">“(B) </num><content>other consortia, centers, or networks focused on pediatric research that are recognized by the Director of NIH and established pursuant to the authorities vested in the National Institutes of Health by other sections of this Act.</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">“(2) </num><heading><inline class="smallCaps">Pediatric research consortia</inline>.—</heading><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">“(A) </num><heading><inline class="smallCaps">In general</inline>.—</heading><chapeau>The Director of NIH may award funding, including through grants, contracts, or other mechanisms, to public or private nonprofit entities for providing support for pediatric research consortia, including with respect to—</chapeau><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="i">“(i) </num><content>basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research; and</content></clause><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>training researchers in pediatric research techniques in order to address unmet pediatric research needs.</content></clause></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">“(B) </num><heading><inline class="smallCaps">Research</inline>.—</heading><chapeau>The Director of NIH shall, as appropriate, ensure that—</chapeau><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="i">“(i) </num><content>each consortium receiving an award under subparagraph (A) conducts or supports at least one category of research described in subparagraph (A)(i) and collectively such consortia conduct or support such categories of research; and</content></clause><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>one or more such consortia provide training described in subparagraph (A)(ii).</content></clause></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">“(C) </num><heading><inline class="smallCaps">Organization of consortium</inline>.—</heading><chapeau>Each consortium receiving an award under subparagraph (A) shall—</chapeau><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="i">“(i) </num><content>be formed from a collaboration of cooperating institutions;</content></clause><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>be coordinated by a lead institution or institutions;</content></clause><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="iii">“(iii) </num><chapeau>agree to disseminate scientific findings, including from clinical trials, rapidly and efficiently, as appropriate, to—</chapeau><subclause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650128"><num style="-uslm-lc:emspace2" value="I">“(I) </num><content>other consortia;</content></subclause><subclause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650128"><num style="-uslm-lc:emspace2" value="II">“(II) </num><content>the National Institutes of Health;</content></subclause><subclause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650128"><num style="-uslm-lc:emspace2" value="III">“(III) </num><content>the Food and Drug Administration;</content></subclause><subclause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650128"><num style="-uslm-lc:emspace2" value="IV">“(IV) </num><content>and other relevant agencies; and</content></subclause></clause><clause class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650126"><num style="-uslm-lc:emspace2" value="iv">“(iv) </num><content>meet such requirements as may be prescribed by the Director of NIH.</content></clause></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="D">“(D) </num><heading><inline class="smallCaps">Supplement, not supplant</inline>.—</heading><content>Any support received by a consortium under subparagraph (A) shall be used to supplement, and not supplant, other public or private support for activities authorized to be supported under this paragraph.</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="E">“(E) </num><heading><inline class="smallCaps">Duration of support</inline>.—</heading><content>Support of a consortium under subparagraph (A) may be for a period of not to exceed 5 years. Such period may be extended at the discretion of the Director of NIH.</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="3">“(3) </num><heading><inline class="smallCaps">Coordination of consortia activities</inline>.—</heading><chapeau>The Director of NIH shall, as appropriate—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">“(A) </num><content>provide for the coordination of activities (including the exchange of information and regular communication) among the consortia established pursuant to paragraph (2); and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">“(B) </num><content>require the periodic preparation and submission to the Director of reports on the activities of each such consortium.</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="4">“(4) </num><heading><inline class="smallCaps">Assistance with registries</inline>.—</heading><content>Each consortium receiving an award under paragraph (2)(A) may provide assistance, as appropriate, to the Centers for Disease Control and Prevention for activities related to patient registries and other surveillance systems upon request by the Director of the Centers for Disease Control and Prevention.</content></paragraph></subsection><subsection class="indentUp0 firstIndent1 fontsize10" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="e">“(e) </num><heading><inline class="smallCaps">Research on Pediatric Rare Diseases or Conditions</inline>.—</heading><chapeau>In making awards under subsection (d)(2) for pediatric research consortia, the Director of NIH shall ensure that an appropriate number of such awards are awarded to such consortia that agree to—</chapeau><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">“(1) </num><content>consider pediatric rare diseases or conditions, or those related to birth defects; and</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">“(2) </num><content>conduct or coordinate one or more multisite clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of one or more pediatric rare diseases or conditions.”</content></paragraph></subsection></quotedContent>.</content></paragraph></section>
<num value="III">TITLE III—</num><heading>CHIMP ACT AMENDMENTS</heading>
<section id="d167596e698" identifier="/us/bill/113/s/252/tIII/s301" style="-uslm-lc:I650143"><num value="301">SEC. 301. </num><heading>SHORT TITLE.</heading><content style="-uslm-lc:I650120"> This title may be cited as the “<shortTitle role="title">CHIMP Act Amendments of 2013</shortTitle>”.</content></section>
<section id="d167596e708" identifier="/us/bill/113/s/252/tIII/s302" style="-uslm-lc:I650143"><num value="302">SEC. 302. </num><heading>CARE FOR NIH CHIMPANZEES.</heading><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e712" identifier="/us/bill/113/s/252/tIII/s302/a" role="instruction" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="a">(a) </num><heading><inline class="smallCaps">In General</inline>.—</heading><chapeau>Section 404K(g) of the Public Health Service Act (<ref href="/us/usc/t42/s283m/g">42 U.S.C. 283m(g)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e727" identifier="/us/bill/113/s/252/tIII/s302/a/1" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="amend">amending</amendingAction> paragraph (1) to read as follows:<quotedContent><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">“(1) </num><heading><inline class="smallCaps">In general</inline>.—</heading><chapeau>Of the amount appropriated for the National Institutes of Health, there are authorized to be appropriated to carry out this section and for the care, maintenance, and transportation of all chimpanzees otherwise under the ownership or control of the National Institutes of Health, and to enable the National Institutes of Health to operate more efficiently and economically by decreasing the overall Federal cost of providing for the care, maintenance, and transportation of chimpanzees—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">“(A) </num><content>for fiscal year 2014, $12,400,000;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">“(B) </num><content>for fiscal year 2015, $11,650,000;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">“(C) </num><content>for fiscal year 2016, $10,900,000;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="D">“(D) </num><content>for fiscal year 2017, $10,150,000; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="E">“(E) </num><content>for fiscal year 2018, $9,400,000.”</content></subparagraph></paragraph></quotedContent>;</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e765" identifier="/us/bill/113/s/252/tIII/s302/a/2" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (2);</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e773" identifier="/us/bill/113/s/252/tIII/s302/a/3" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraph (3) as paragraph (2); and</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e781" identifier="/us/bill/113/s/252/tIII/s302/a/4" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="4">(4) </num><chapeau>in paragraph (2), as so redesignated—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e785" identifier="/us/bill/113/s/252/tIII/s302/a/4/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>With respect to amounts reserved under paragraph (1)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>With respect to amounts authorized to be appropriated by paragraph (1)</quotedText>”; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e796" identifier="/us/bill/113/s/252/tIII/s302/a/4/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>board of directors</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>Secretary in consultation with the board of directors</quotedText>”.</content></subparagraph></paragraph></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e807" identifier="/us/bill/113/s/252/tIII/s302/b" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="b">(b) </num><heading><inline class="smallCaps">GAO Study</inline>.—</heading><chapeau>Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of Congress a report, regarding chimpanzees under the ownership or control the National Institutes of Health. Such report shall review and assess—</chapeau><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e815" identifier="/us/bill/113/s/252/tIII/s302/b/1" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">(1) </num><content>the research status of such chimpanzees;</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e819" identifier="/us/bill/113/s/252/tIII/s302/b/2" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>the cost for the care, maintenance, and transportation of such chimpanzees, including the cost broken down by—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e823" identifier="/us/bill/113/s/252/tIII/s302/b/2/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>research or retirement status;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e827" identifier="/us/bill/113/s/252/tIII/s302/b/2/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>services included in the care, maintenance, and transportation; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d167596e831" identifier="/us/bill/113/s/252/tIII/s302/b/2/C" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">(C) </num><content>location;</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e835" identifier="/us/bill/113/s/252/tIII/s302/b/3" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="3">(3) </num><content>the extent to which matching requirements have been met pursuant to section 404K(e)(4) of the Public Health Service Act (<ref href="/us/usc/t42/s283m/e/4">42 U.S.C. 283m(e)(4)</ref>); and</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d167596e843" identifier="/us/bill/113/s/252/tIII/s302/b/4" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="4">(4) </num><content>any options for cost savings for the support and maintenance of such chimpanzees.</content></paragraph></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d167596e847" identifier="/us/bill/113/s/252/tIII/s302/c" role="instruction" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="c">(c) </num><heading><inline class="smallCaps">Biennial Report</inline>.—</heading><content>Section 404K(g) of the Public Health Service Act (<ref href="/us/usc/t42/s283m/g">42 U.S.C. 283m(g)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="3">“(3) </num><heading><inline class="smallCaps">Biennial report</inline>.—</heading><chapeau>Not later than 180 days after the date enactment of this Act, the Director of the National Institutes of Health shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations in the House of Representatives a report, to be updated biennially, regarding—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">“(A) </num><content>the care, maintenance, and transportation of the chimpanzees under the ownership or control of the National Institutes of Health;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">“(B) </num><content>costs related to such care, maintenance, and transportation, and any other related costs; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">“(C) </num><content>the research status of such chimpanzees.”</content></subparagraph></paragraph></quotedContent>.</content></subsection></section>
Speaker of the House of Representatives.Vice President of the United States and President of the Senate.