1961 lines
280 KiB
XML
1961 lines
280 KiB
XML
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<?xml-stylesheet type="text/css" href="uslm.css"?><statuteCompilation xmlns="http://schemas.gpo.gov/xml/uslm" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:gpo="http://www.gpo.gov/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://schemas.gpo.gov/xml/uslm https://www.govinfo.gov/schemas/xml/uslm/uslm-2.0.9.xsd" xml:lang="en" style="-uslm-dtd:statute">
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<dc:title>Pandemic and All-Hazards Preparedness Reauthorization Act of 2013</dc:title>
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<citableAs>Public Law 113–5</citableAs>
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<citableAsShortTitle>Pandemic and All-Hazards Preparedness Reauthorization Act of 2013</citableAsShortTitle>
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<docNumber>5</docNumber>
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<currentThroughPublicLaw>113–5</currentThroughPublicLaw>
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<dc:type>Statute Compilation</dc:type>
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<dc:creator>United States House of Representatives</dc:creator>
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<dc:creator>Office of the Legislative Counsel</dc:creator>
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<dc:format>text/xml</dc:format>
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<dc:language>EN</dc:language>
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<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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<processedDate>2021-05-25</processedDate>
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<containsShortTitle>Pandemic and All-Hazards Preparedness Reauthorization Act of 2013</containsShortTitle>
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<property role="fileId">10510</property>
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<congress>113</congress>
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<approvedDate>2013-03-13</approvedDate>
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<preface style="-uslm-dtd:compilation-act-form">
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<property style="-uslm-dtd:comp-short-title" role="compShortTitle">Pandemic and All-Hazards Preparedness Reauthorization Act of 2013</property>
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<citationNote style="-uslm-dtd:public-law">[(<citableAs>Public Law 113–5</citableAs>)]</citationNote>
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<editionNote style="-uslm-dtd:updated-through-note">[This law has not been amended]</editionNote>
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<explanationNote style="-uslm-dtd:explanatory-note"><b>[</b>Currency: This publication is a compilation of the text of Public Law 113-5. It was last amended by the public law listed in the As Amended Through note above and below at the bottom of each page of the pdf version and reflects current law through the date of the enactment of the public law listed at https://www.govinfo.gov/app/collection/comps/<b>]</b></explanationNote>
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<explanationNote style="-uslm-dtd:explanatory-note"><b>[</b>Note: While this publication does not represent an official version of any Federal statute, substantial efforts have been made to ensure the accuracy of its contents. The official version of Federal law is found in the United States Statutes at Large and in the United States Code. The legal effect to be given to the Statutes at Large and the United States Code is established by statute (1 U.S.C. 112, 204).<b>]</b></explanationNote>
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</preface>
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<main style="-uslm-dtd:legis-body"><longTitle><docTitle style="-uslm-dtd:legis-type">AN ACT</docTitle><officialTitle style="-uslm-dtd:official-title">To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, and for other purposes.</officialTitle></longTitle><enactingFormula style="-uslm-dtd:enacting-clause">Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,</enactingFormula>
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<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/s1" styleType="OLC">
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<num style="-uslm-dtd:enum" value="1">SECTION 1. </num><heading style="-uslm-dtd:header">SHORT TITLE; TABLE OF CONTENTS. </heading>
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<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/s1/a" styleType="OLC">
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<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Short Title.—</heading><content style="-uslm-dtd:text">This Act may be cited as the “<shortTitle style="-uslm-dtd:quote"><inline style="-uslm-dtd:short-title">Pandemic and All-Hazards Preparedness Reauthorization Act of 2013</inline></shortTitle>”.</content>
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</subsection>
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<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/s1/b" styleType="OLC">
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<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Table of Contents.—</heading><content style="-uslm-dtd:text">The table of contents of this Act is as follows:<toc style="-uslm-dtd:toc">
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 1.</designator><label> Short title; table of contents.</label></referenceItem>
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<groupItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="title"><designator>TITLE I—</designator><label>STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC HEALTH EMERGENCIES</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 101.</designator><label> National Health Security Strategy.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 102.</designator><label> Assistant Secretary for Preparedness and Response.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 103.</designator><label> National Advisory Committee on Children and Disasters.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 104.</designator><label> Modernization of the National Disaster Medical System.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 105.</designator><label> Continuing the role of the Department of Veterans Affairs.</label></referenceItem>
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</groupItem>
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<groupItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="title"><designator>TITLE II—</designator><label>OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND RESPONSE</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 201.</designator><label> Temporary reassignment of State and local personnel during a public health emergency.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 202.</designator><label> Improving State and local public health security.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 203.</designator><label> Hospital preparedness and medical surge capacity.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 204.</designator><label> Enhancing situational awareness and biosurveillance.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 205.</designator><label> Eliminating duplicative Project Bioshield reports.</label></referenceItem>
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</groupItem>
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<groupItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="title"><designator>TITLE III—</designator><label>ENHANCING MEDICAL COUNTERMEASURE REVIEW</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 301.</designator><label> Special protocol assessment.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 302.</designator><label> Authorization for medical products for use in emergencies.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 303.</designator><label> Definitions.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 304.</designator><label> Enhancing medical countermeasure activities.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 305.</designator><label> Regulatory management plans.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 306.</designator><label> Report.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 307.</designator><label> Pediatric medical countermeasures.</label></referenceItem>
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</groupItem>
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<groupItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="title"><designator>TITLE IV—</designator><label>ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 401.</designator><label> BioShield.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 402.</designator><label> Biomedical Advanced Research and Development Authority.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 403.</designator><label> Strategic National Stockpile.</label></referenceItem>
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<referenceItem style="-uslm-dtd:toc-entry" role="section"><designator>Sec. 404.</designator><label> National Biodefense Science Board.</label></referenceItem>
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</groupItem></toc></content>
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</subsection>
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</section>
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<title style="-uslm-dtd:title" identifier="/us/sComp/113/5/tI" styleType="OLC">
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<num style="-uslm-dtd:enum" value="I">TITLE I—</num><heading style="-uslm-dtd:header">STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC HEALTH EMERGENCIES </heading>
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<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tI/s101" styleType="OLC">
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<num style="-uslm-dtd:enum" value="101">SEC. 101. </num><heading style="-uslm-dtd:header">NATIONAL HEALTH SECURITY STRATEGY. </heading>
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<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tI/s101/a" styleType="OLC">
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<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><chapeau style="-uslm-dtd:text">Section 2802 of the Public Health Service Act (42 U.S.C. 300hh-1) is amended—</chapeau>
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<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s101/a/1" styleType="OLC">
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<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subsection (a)(1), by striking “<quotedText style="-uslm-dtd:quote">2009</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">2014</quotedText>”; and</content>
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</paragraph>
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<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s101/a/2" styleType="OLC">
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<num style="-uslm-dtd:enum" value="2">(2) </num><chapeau style="-uslm-dtd:text">in subsection (b)—</chapeau>
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<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s101/a/2/A" styleType="OLC">
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<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (1)(A), by inserting “<quotedText style="-uslm-dtd:quote">, including drills and exercises to ensure medical surge capacity for events without notice</quotedText>” after “<quotedText style="-uslm-dtd:quote">exercises</quotedText>”; and</content>
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</subparagraph>
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<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s101/a/2/B" styleType="OLC">
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<num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">in paragraph (3)—</chapeau>
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<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tI/s101/a/2/B/i" styleType="OLC">
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<num style="-uslm-dtd:enum" value="i">(i) </num><chapeau style="-uslm-dtd:text">in the matter preceding subparagraph (A)—</chapeau>
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<subclause style="-uslm-dtd:subclause" identifier="/us/sComp/113/5/tI/s101/a/2/B/i/I" styleType="OLC">
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<num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">facilities), and trauma care</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">and ambulatory care facilities and which may include dental health facilities), and trauma care, critical care,</quotedText>”; and</content>
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</subclause>
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<subclause style="-uslm-dtd:subclause" identifier="/us/sComp/113/5/tI/s101/a/2/B/i/II" styleType="OLC">
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<num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">by inserting “<quotedText style="-uslm-dtd:quote">(including related availability, accessibility, and coordination)</quotedText>” after “<quotedText style="-uslm-dtd:quote">public health emergencies</quotedText>”;</content>
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</subclause>
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</clause>
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<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tI/s101/a/2/B/ii" styleType="OLC">
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<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">in subparagraph (A), by inserting “<quotedText style="-uslm-dtd:quote">and trauma</quotedText>” after “<quotedText style="-uslm-dtd:quote">medical</quotedText>”;</content>
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</clause>
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<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tI/s101/a/2/B/iii" styleType="OLC">
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<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">in subparagraph (B), by striking “<quotedText style="-uslm-dtd:quote">Medical evacuation and fatality management</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">Fatality management</quotedText>”;</content>
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</clause>
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<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tI/s101/a/2/B/iv" styleType="OLC">
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<num style="-uslm-dtd:enum" value="iv">(iv) </num><content style="-uslm-dtd:text">by redesignating subparagraphs (C), (D), and (E) as subparagraphs (D), (E), and (F), respectively;</content>
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</clause>
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<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tI/s101/a/2/B/v" styleType="OLC">
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<num style="-uslm-dtd:enum" value="v">(v) </num><content style="-uslm-dtd:text">by inserting after subparagraph (B), the following the new subparagraph:<quotedContent style="-uslm-dtd:quoted-block">
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<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">Coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care.”</content>
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</subparagraph></quotedContent>;</content>
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</clause>
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<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tI/s101/a/2/B/vi" styleType="OLC">
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<num style="-uslm-dtd:enum" value="vi">(vi) </num><content style="-uslm-dtd:text">in subparagraph (E), as redesignated by clause (iv), by inserting “<quotedText style="-uslm-dtd:quote">(which may include such dental health assets)</quotedText>” after “<quotedText style="-uslm-dtd:quote">medical assets</quotedText>”; and</content>
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</clause>
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<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tI/s101/a/2/B/vii" styleType="OLC">
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<num style="-uslm-dtd:enum" value="vii">(vii) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
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<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="G">“(G) </num><content style="-uslm-dtd:text">Optimizing a coordinated and flexible approach to the medical surge capacity of hospitals, other health care facilities, critical care, trauma care (which may include trauma centers), and emergency medical systems.”</content>
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</subparagraph></quotedContent>;</content>
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</clause>
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</subparagraph>
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<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s101/a/2/C" styleType="OLC">
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<num style="-uslm-dtd:enum" value="C">(C) </num><chapeau style="-uslm-dtd:text">in paragraph (4)—</chapeau>
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<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tI/s101/a/2/C/i" styleType="OLC">
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<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">in subparagraph (A), by inserting “<quotedText style="-uslm-dtd:quote">, including the unique needs and considerations of individuals with disabilities,</quotedText>” after “<quotedText style="-uslm-dtd:quote">medical needs of at-risk individuals</quotedText>”; and</content>
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</clause>
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<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tI/s101/a/2/C/ii" styleType="OLC">
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<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">in subparagraph (B), by inserting “<quotedText style="-uslm-dtd:quote">the</quotedText>” before “<quotedText style="-uslm-dtd:quote">purpose of this section</quotedText>”; and</content>
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</clause>
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</subparagraph>
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<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s101/a/2/D" styleType="OLC">
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<num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
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<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="7">“(7) </num><heading style="-uslm-dtd:header">Countermeasures. </heading>
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<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">Promoting strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate.</content>
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</subparagraph>
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<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">For purposes of this paragraph, the term ‘<quotedText style="-uslm-dtd:quote">countermeasures</quotedText>’ has the same meaning as the terms ‘<quotedText style="-uslm-dtd:quote">qualified countermeasures</quotedText>’ under section 319F-1, ‘<quotedText style="-uslm-dtd:quote">qualified pandemic and epidemic products</quotedText>’ under section 319F-3, and ‘<quotedText style="-uslm-dtd:quote">security countermeasures</quotedText>’ under section 319F-2.</content>
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</subparagraph>
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</paragraph>
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<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="8">“(8) </num><heading style="-uslm-dtd:header">Medical and public health community resiliency. </heading><chapeau style="-uslm-dtd:text">Strengthening the ability of States, local communities, and tribal communities to prepare for, respond to, and be resilient in the event of public health emergencies, whether naturally occurring, unintentional, or deliberate by—</chapeau>
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<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">optimizing alignment and integration of medical and public health preparedness and response planning and capabilities with and into routine daily activities; and</content>
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</subparagraph>
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<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">promoting familiarity with local medical and public health systems.”</content>
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</subparagraph>
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</paragraph></quotedContent>.</content>
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</subparagraph>
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</paragraph>
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</subsection>
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<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tI/s101/b" styleType="OLC">
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<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">At-Risk Individuals.—</heading><chapeau style="-uslm-dtd:text">Section 2814 of the Public Health Service Act (42 U.S.C. 300hh-16) is amended—</chapeau>
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<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s101/b/1" styleType="OLC">
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<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">by striking paragraphs (5), (7), and (8);</content>
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</paragraph>
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<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s101/b/2" styleType="OLC">
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<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in paragraph (4), by striking “<quotedText style="-uslm-dtd:quote">2811(b)(3)(B)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">2802(b)(4)(B)</quotedText>”;</content>
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</paragraph>
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<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s101/b/3" styleType="OLC">
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<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">by redesignating paragraphs (1) through (4) as paragraphs (2) through (5), respectively;</content>
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</paragraph>
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<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s101/b/4" styleType="OLC">
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<num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">by inserting before paragraph (2) (as so redesignated), the following:<quotedContent style="-uslm-dtd:quoted-block">
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<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">monitor emerging issues and concerns as they relate to medical and public health preparedness and response for at-risk individuals in the event of a public health emergency declared by the Secretary under section 319;”</content>
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</paragraph></quotedContent>;</content>
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</paragraph>
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<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s101/b/5" styleType="OLC">
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<num style="-uslm-dtd:enum" value="5">(5) </num><content style="-uslm-dtd:text">by amending paragraph (2) (as so redesignated) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
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<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
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<num style="-uslm-dtd:enum" value="2">“(2) </num><content style="-uslm-dtd:text">oversee the implementation of the preparedness goals described in section 2802(b) with respect to the public health and medical needs of at-risk individuals in the event of a public health emergency, as described in section 2802(b)(4);”</content>
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</paragraph></quotedContent>; and</content>
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</paragraph>
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<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s101/b/6" styleType="OLC">
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<num style="-uslm-dtd:enum" value="6">(6) </num><content style="-uslm-dtd:text">by inserting after paragraph (6), the following:<quotedContent style="-uslm-dtd:quoted-block">
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<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="7">“(7) </num><content style="-uslm-dtd:text">disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies in as timely a manner as is practicable, including from the time a public health threat is identified; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="8">“(8) </num><content style="-uslm-dtd:text">ensure that public health and medical information distributed by the Department of Health and Human Services during a public health emergency is delivered in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals.”</content>
|
||
</paragraph></quotedContent>.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tI/s102" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="102">SEC. 102. </num><heading style="-uslm-dtd:header">ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE. </heading>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tI/s102/a" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><chapeau style="-uslm-dtd:text">Section 2811 of the Public Health Service Act (42 U.S.C. 300hh-10) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s102/a/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">in subsection (b)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s102/a/1/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (3), by inserting “<quotedText style="-uslm-dtd:quote">, security countermeasures (as defined in section 319F-2),</quotedText>” after “<quotedText style="-uslm-dtd:quote">qualified countermeasures (as defined in section 319F-1)</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s102/a/1/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (4), by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><heading style="-uslm-dtd:header">Policy coordination and strategic direction. </heading><content style="-uslm-dtd:text">Provide integrated policy coordination and strategic direction with respect to all matters related to Federal public health and medical preparedness and execution and deployment of the Federal response for public health emergencies and incidents covered by the National Response Plan developed pursuant to section 504(6) of the Homeland Security Act of 2002, or any successor plan, before, during, and following public health emergencies.</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="E">“(E) </num><heading style="-uslm-dtd:header">Identification of inefficiencies. </heading><content style="-uslm-dtd:text">Identify and minimize gaps, duplication, and other inefficiencies in medical and public health preparedness and response activities and the actions necessary to overcome these obstacles.</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="F">“(F) </num><heading style="-uslm-dtd:header">Coordination of grants and agreements. </heading><chapeau style="-uslm-dtd:text">Align and coordinate medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this Act, to the extent possible, including program requirements, timelines, and measurable goals, and in consultation with the Secretary of Homeland Security, to—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">optimize and streamline medical and public health preparedness and response capabilities and the ability of local communities to respond to public health emergencies; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">gather and disseminate best practices among grant and cooperative agreement recipients, as appropriate.</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="G">“(G) </num><heading style="-uslm-dtd:header">Drill and operational exercises. </heading><chapeau style="-uslm-dtd:text">Carry out drills and operational exercises, in consultation with the Department of Homeland Security, the Department of Defense, the Department of Veterans Affairs, and other applicable Federal departments and agencies, as necessary and appropriate, to identify, inform, and address gaps in and policies related to all-hazards medical and public health preparedness and response, including exercises based on—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">identified threats for which countermeasures are available and for which no countermeasures are available; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">unknown threats for which no countermeasures are available.</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="H">“(H) </num><heading style="-uslm-dtd:header">National security priority. </heading><content style="-uslm-dtd:text">On a periodic basis consult with, as applicable and appropriate, the Assistant to the President for National Security Affairs, to provide an update on, and discuss, medical and public health preparedness and response activities pursuant to this Act and the Federal Food, Drug, and Cosmetic Act, including progress on the development, approval, clearance, and licensure of medical countermeasures.”</content>
|
||
</subparagraph></quotedContent>; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s102/a/1/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="7">“(7) </num><heading style="-uslm-dtd:header">Countermeasures budget plan. </heading><chapeau style="-uslm-dtd:text">Develop, and update on an annual basis, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d). Each such plan shall—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><chapeau style="-uslm-dtd:text">include consideration of the entire medical countermeasures enterprise, including—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">basic research and advanced research and development;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">approval, clearance, licensure, and authorized uses of products; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">procurement, stockpiling, maintenance, and replenishment of all products in the Strategic National Stockpile;</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">inform prioritization of resources and include measurable outputs and outcomes to allow for the tracking of the progress made toward identified priorities;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs within the continuum of the medical countermeasure enterprise consistent with section 319F-2; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">be made available to the appropriate committees of Congress upon request.”</content>
|
||
</subparagraph>
|
||
</paragraph></quotedContent>;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s102/a/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">by striking subsection (c) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">“(c) </num><heading style="-uslm-dtd:header">Functions. </heading><chapeau style="-uslm-dtd:text">The Assistant Secretary for Preparedness and Response shall—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">have lead responsibility within the Department of Health and Human Services for emergency preparedness and response policy coordination and strategic direction;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><chapeau style="-uslm-dtd:text">have authority over and responsibility for—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">the National Disaster Medical System pursuant to section 2812;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the Hospital Preparedness Cooperative Agreement Program pursuant to section 319C-2;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">the Biomedical Advanced Research and Development Authority pursuant to section 319L;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">the Medical Reserve Corps pursuant to section 2813;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="E">“(E) </num><content style="-uslm-dtd:text">the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 319I; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="F">“(F) </num><content style="-uslm-dtd:text">administering grants and related authorities related to trauma care under parts A through C of title XII, such authority to be transferred by the Secretary from the Administrator of the Health Resources and Services Administration to such Assistant Secretary;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><chapeau style="-uslm-dtd:text">exercise the responsibilities and authorities of the Secretary with respect to the coordination of—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">the Public Health Emergency Preparedness Cooperative Agreement Program pursuant to section 319C-1;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the Strategic National Stockpile pursuant to section 319F-2; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">the Cities Readiness Initiative; and</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><content style="-uslm-dtd:text">assume other duties as determined appropriate by the Secretary.”</content>
|
||
</paragraph>
|
||
</subsection></quotedContent>; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s102/a/3" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="d">“(d) </num><heading style="-uslm-dtd:header">Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">Not later than 180 days after the date of enactment of this subsection, and every year thereafter, the Assistant Secretary for Preparedness and Response shall develop and submit to the appropriate committees of Congress a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. In developing such a plan, the Assistant Secretary for Preparedness and Response shall consult with the Director of the Biomedical Advanced Research and Development Authority, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs. Such strategy and plan shall be known as the ‘<quotedText style="-uslm-dtd:quote">Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan</quotedText>’.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Requirements. </heading><chapeau style="-uslm-dtd:text">The plan under paragraph (1) shall—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">describe the chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation and the corresponding efforts to develop qualified countermeasures (as defined in section 319F-1), security countermeasures (as defined in section 319F-2), or qualified pandemic or epidemic products (as defined in section 319F-3) for each threat;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">evaluate the progress of all activities with respect to such countermeasures or products, including research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">identify and prioritize near-, mid-, and long-term needs with respect to such countermeasures or products to address a chemical, biological, radiological, and nuclear threat or threats;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><chapeau style="-uslm-dtd:text">identify, with respect to each category of threat, a summary of all awards and contracts, including advanced research and development and procurement, that includes—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">the time elapsed from the issuance of the initial solicitation or request for a proposal to the adjudication (such as the award, denial of award, or solicitation termination); and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">an identification of projected timelines, anticipated funding allocations, benchmarks, and milestones for each medical countermeasure priority under subparagraph (C), including projected needs with regard to replenishment of the Strategic National Stockpile;</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="E">“(E) </num><content style="-uslm-dtd:text">be informed by the recommendations of the National Biodefense Science Board pursuant to section 319M;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="F">“(F) </num><content style="-uslm-dtd:text">evaluate progress made in meeting timelines, allocations, benchmarks, and milestones identified under subparagraph (D)(ii);</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="G">“(G) </num><content style="-uslm-dtd:text">report on the amount of funds available for procurement in the special reserve fund as defined in section 319F-2(h) and the impact this funding will have on meeting the requirements under section 319F-2;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="H">“(H) </num><content style="-uslm-dtd:text">incorporate input from Federal, State, local, and tribal stakeholders;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="I">“(I) </num><chapeau style="-uslm-dtd:text">identify the progress made in meeting the medical countermeasure priorities for at-risk individuals (as defined in 2802(b)(4)(B)), as applicable under subparagraph (C), including with regard to the projected needs for related stockpiling and replenishment of the Strategic National Stockpile, including by addressing the needs of pediatric populations with respect to such countermeasures and products in the Strategic National Stockpile, including—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">a list of such countermeasures and products necessary to address the needs of pediatric populations;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">a description of measures taken to coordinate with the Office of Pediatric Therapeutics of the Food and Drug Administration to maximize the labeling, dosages, and formulations of such countermeasures and products for pediatric populations;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">a description of existing gaps in the Strategic National Stockpile and the development of such countermeasures and products to address the needs of pediatric populations; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iv">“(iv) </num><content style="-uslm-dtd:text">an evaluation of the progress made in addressing priorities identified pursuant to subparagraph (C);</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="J">“(J) </num><chapeau style="-uslm-dtd:text">identify the use of authority and activities undertaken pursuant to sections 319F-1(b)(1), 319F-1(b)(2), 319F-1(b)(3), 319F-1(c), 319F-1(d), 319F-1(e), 319F-2(c)(7)(C)(iii), 319F-2(c)(7)(C)(iv), and 319F-2(c)(7)(C)(v) of this Act, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act, by summarizing—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iv">“(iv) </num><content style="-uslm-dtd:text">whether, with respect to each procurement that is approved by the President under section 319F-2(c)(6), a contract was entered into within one year after such approval by the President; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="v">“(v) </num><content style="-uslm-dtd:text">with respect to section 319F-1(d), for the one-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="K">“(K) </num><content style="-uslm-dtd:text">be made publicly available.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">GAO report. </heading>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">Not later than 1 year after the date of the submission to the Congress of the first Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of Congress a report, concerning such Strategy and Implementation Plan.</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Content. </heading><chapeau style="-uslm-dtd:text">The report described in subparagraph (A) shall review and assess—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of the Federal Government pursuant to paragraph (2)(C);</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">the activities of the Department of Health and Human Services with respect to advanced research and development pursuant to section 319L; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">the progress made toward meeting the timelines, allocations, benchmarks, and milestones identified in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan under this subsection.</content>
|
||
</clause>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="e">“(e) </num><heading style="-uslm-dtd:header">Protection of National Security. </heading><content style="-uslm-dtd:text">In carrying out subsections (b)(7) and (d), the Secretary shall ensure that information and items that could compromise national security, contain confidential commercial information, or contain proprietary information are not disclosed.”</content>
|
||
</subsection></quotedContent>.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tI/s102/b" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Interagency Coordination Plan.—</heading><chapeau style="-uslm-dtd:text">In the first Public Health Emergency Countermeasures Enterprise Strategy and Implementation Plan submitted under subsection (d) of section 2811 of the Public Health Service Act (42 U.S.C. 300hh-10) (as added by subsection (a)(3)), the Secretary of Health and Human Services, in consultation with the Secretary of Defense, shall include a description of the manner in which the Department of Health and Human Services is coordinating with the Department of Defense regarding countermeasure activities to address chemical, biological, radiological, and nuclear threats. Such report shall include information with respect to—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s102/b/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">the research, advanced research, development, procurement, stockpiling, and distribution of countermeasures to meet identified needs; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s102/b/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">the coordination of efforts between the Department of Health and Human Services and the Department of Defense to address countermeasure needs for various segments of the population.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tI/s103" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="103">SEC. 103. </num><heading style="-uslm-dtd:header">NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS. </heading>
|
||
<content style="-uslm-dtd:text" class="block">Subtitle B of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh et seq.) is amended by inserting after section 2811 the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<section style="-uslm-dtd:section" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2811A">“SEC. 2811A. </num><heading style="-uslm-dtd:header">NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS </heading>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">“(a) </num><heading style="-uslm-dtd:header">Establishment. </heading><content style="-uslm-dtd:text">The Secretary, in consultation with the Secretary of Homeland Security, shall establish an advisory committee to be known as the ‘<quotedText style="-uslm-dtd:quote">National Advisory Committee on Children and Disasters</quotedText>’ (referred to in this section as the ‘<quotedText style="-uslm-dtd:quote">Advisory Committee</quotedText>’).</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">“(b) </num><heading style="-uslm-dtd:header">Duties. </heading><chapeau style="-uslm-dtd:text">The Advisory Committee shall—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">provide advice and consultation with respect to the activities carried out pursuant to section 2814, as applicable and appropriate;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><content style="-uslm-dtd:text">evaluate and provide input with respect to the medical and public health needs of children as they relate to preparation for, response to, and recovery from all-hazards emergencies; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><content style="-uslm-dtd:text">provide advice and consultation with respect to State emergency preparedness and response activities and children, including related drills and exercises pursuant to the preparedness goals under section 2802(b).</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">“(c) </num><heading style="-uslm-dtd:header">Additional Duties. </heading><content style="-uslm-dtd:text">The Advisory Committee may provide advice and recommendations to the Secretary with respect to children and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this title and title III.</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="d">“(d) </num><heading style="-uslm-dtd:header">Membership. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint not to exceed 15 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Required members. </heading><chapeau style="-uslm-dtd:text">The Secretary, in consultation with such other Secretaries as may be appropriate, may appoint to the Advisory Committee under paragraph (1) such individuals as may be appropriate to perform the duties described in subsections (b) and (c), which may include—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">the Assistant Secretary for Preparedness and Response;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the Director of the Biomedical Advanced Research and Development Authority;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">the Director of the Centers for Disease Control and Prevention;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">the Commissioner of Food and Drugs;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="E">“(E) </num><content style="-uslm-dtd:text">the Director of the National Institutes of Health;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="F">“(F) </num><content style="-uslm-dtd:text">the Assistant Secretary of the Administration for Children and Families;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="G">“(G) </num><content style="-uslm-dtd:text">the Administrator of the Federal Emergency Management Agency;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="H">“(H) </num><content style="-uslm-dtd:text">at least two non-Federal health care professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="I">“(I) </num><content style="-uslm-dtd:text">at least two representatives from State, local, territorial, or tribal agencies with expertise in pediatric disaster planning, preparedness, response, or recovery; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="J">“(J) </num><content style="-uslm-dtd:text">representatives from such Federal agencies (such as the Department of Education and the Department of Homeland Security) as determined necessary to fulfill the duties of the Advisory Committee, as established under subsections (b) and (c).</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="e">“(e) </num><heading style="-uslm-dtd:header">Meetings. </heading><content style="-uslm-dtd:text">The Advisory Committee shall meet not less than biannually.</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="f">“(f) </num><heading style="-uslm-dtd:header">Sunset. </heading><content style="-uslm-dtd:text">The Advisory Committee shall terminate on September 30, 2018.”</content>
|
||
</subsection>
|
||
</section></quotedContent>.</content>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tI/s104" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="104">SEC. 104. </num><heading style="-uslm-dtd:header">MODERNIZATION OF THE NATIONAL DISASTER MEDICAL SYSTEM. </heading>
|
||
<chapeau style="-uslm-dtd:text" class="block">Section 2812 of the Public Health Service Act (42 U.S.C. 300hh-11) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s104/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">in subsection (a)(3)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s104/1/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in subparagraph (A), in clause (i) by inserting “<quotedText style="-uslm-dtd:quote">, including at-risk individuals as applicable</quotedText>” after “<quotedText style="-uslm-dtd:quote">victims of a public health emergency</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s104/1/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by redesignating subparagraph (C) as subparagraph (E); and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tI/s104/1/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by inserting after subparagraph (B), the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><heading style="-uslm-dtd:header">Considerations for at-risk populations. </heading><content style="-uslm-dtd:text">The Secretary shall take steps to ensure that an appropriate specialized and focused range of public health and medical capabilities are represented in the National Disaster Medical System, which take into account the needs of at-risk individuals, in the event of a public health emergency.”</content>
|
||
</subparagraph></quotedContent>.<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><heading style="-uslm-dtd:header">Administration. </heading><content style="-uslm-dtd:text">The Secretary may determine and pay claims for reimbursement for services under subparagraph (A) directly or through contracts that provide for payment in advance or by way of reimbursement.”</content>
|
||
</subparagraph></quotedContent>; and</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tI/s104/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in subsection (g), by striking “<quotedText style="-uslm-dtd:quote">such sums as may be necessary for each of the fiscal years 2007 through 2011</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$52,700,000 for each of fiscal years 2014 through 2018</quotedText>”.</content>
|
||
</paragraph>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tI/s105" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="105">SEC. 105. </num><heading style="-uslm-dtd:header">CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS AFFAIRS. </heading>
|
||
<content style="-uslm-dtd:text" class="block">Section 8117(g) of title 38, United States Code, is amended by striking “<quotedText style="-uslm-dtd:quote">such sums as may be necessary to carry out this section for each of fiscal years 2007 through 2011</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$155,300,000 for each of fiscal years 2014 through 2018 to carry out this section</quotedText>”.</content>
|
||
</section>
|
||
</title>
|
||
<title style="-uslm-dtd:title" identifier="/us/sComp/113/5/tII" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="II">TITLE II—</num><heading style="-uslm-dtd:header">OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND RESPONSE </heading>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tII/s201" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="201">SEC. 201. </num><heading style="-uslm-dtd:header">TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A PUBLIC HEALTH EMERGENCY. </heading>
|
||
<content style="-uslm-dtd:text" class="block">Section 319 of the Public Health Service Act (42 U.S.C. 247d) is amended by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="e">“(e) </num><heading style="-uslm-dtd:header">Temporary Reassignment of State and Local Personnel During a Public Health Emergency. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">Emergency reassignment of federally funded personnel. </heading><content style="-uslm-dtd:text">Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such Governor or tribal organization’s designee, the Secretary may authorize the requesting State or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian tribe, State and local public health department or agency personnel funded in whole or in part through programs authorized under this Act, as appropriate.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Activation of emergency reassignment. </heading>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">Public health emergency. </heading><content style="-uslm-dtd:text">The Secretary may authorize a temporary reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a).</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Contents of request. </heading><chapeau style="-uslm-dtd:text">To seek authority for a temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following:</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">An assurance that the public health emergency in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available.</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1).</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 319C-1.</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iv">“(iv) </num><chapeau style="-uslm-dtd:text">An identification of—</chapeau>
|
||
<subclause style="-uslm-dtd:subclause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="I">“(I) </num><content style="-uslm-dtd:text">each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; and</content>
|
||
</subclause>
|
||
<subclause style="-uslm-dtd:subclause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="II">“(II) </num><content style="-uslm-dtd:text">the number of personnel who would be so reassigned from each such program.</content>
|
||
</subclause>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="v">“(v) </num><content style="-uslm-dtd:text">Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree.</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><heading style="-uslm-dtd:header">Consideration. </heading><content style="-uslm-dtd:text">In reviewing a request for temporary reassignment under paragraph (1), the Secretary shall consider the degree to which the program or programs funded in whole or in part by programs authorized under this Act would be adversely affected by the reassignment.</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><heading style="-uslm-dtd:header">Termination and extension. </heading>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><heading style="-uslm-dtd:header">Termination. </heading><chapeau style="-uslm-dtd:text">A State or Indian tribe’s temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following:</chapeau>
|
||
<subclause style="-uslm-dtd:subclause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="I">“(I) </num><content style="-uslm-dtd:text">The Secretary’s determination that the public health emergency no longer exists.</content>
|
||
</subclause>
|
||
<subclause style="-uslm-dtd:subclause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="II">“(II) </num><content style="-uslm-dtd:text">Subject to clause (ii), the expiration of the 30-day period following the date on which the Secretary approved the State or Indian tribe’s request for such reassignment flexibility.</content>
|
||
</subclause>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><heading style="-uslm-dtd:header">Extension of reassignment flexibility. </heading><chapeau style="-uslm-dtd:text">The Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if—</chapeau>
|
||
<subclause style="-uslm-dtd:subclause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="I">“(I) </num><content style="-uslm-dtd:text">the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and</content>
|
||
</subclause>
|
||
<subclause style="-uslm-dtd:subclause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="II">“(II) </num><content style="-uslm-dtd:text">the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph (B).</content>
|
||
</subclause>
|
||
</clause>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">Voluntary nature of temporary reassignment of state and local personnel. </heading>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">In general. </heading><chapeau style="-uslm-dtd:text">Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">shall have the opportunity to volunteer for temporary reassignment; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">shall not be required to agree to a temporary reassignment.</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Prohibition on conditioning federal awards. </heading><content style="-uslm-dtd:text">The Secretary may not condition the award of a grant, contract, or cooperative agreement under this Act on the requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><heading style="-uslm-dtd:header">Notice to congress. </heading><chapeau style="-uslm-dtd:text">The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">any initial request for temporary reassignment of personnel; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">any request for an extension of such temporary reassignment.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">“(5) </num><heading style="-uslm-dtd:header">Guidance. </heading><chapeau style="-uslm-dtd:text">The Secretary shall—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">not later than 6 months after the enactment of this subsection, issue proposed guidance on the temporary reassignment of personnel under this subsection; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">after providing notice and a 60-day period for public comment, finalize such guidance.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="6">“(6) </num><heading style="-uslm-dtd:header">Report to congress. </heading><chapeau style="-uslm-dtd:text">Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">a description of how, and under what circumstances, such temporary reassignment has been used by States and Indian tribes;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="E">“(E) </num><content style="-uslm-dtd:text">recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="7">“(7) </num><heading style="-uslm-dtd:header">Definitions. </heading><chapeau style="-uslm-dtd:text">In this subsection—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">the terms ‘<quotedText style="-uslm-dtd:quote">Indian tribe</quotedText>’ and ‘<quotedText style="-uslm-dtd:quote">tribal organization</quotedText>’ have the meanings given such terms in section 4 of the Indian Self-Determination and Education Assistance Act; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the term ‘<quotedText style="-uslm-dtd:quote">State</quotedText>’ includes, in addition to the entities listed in the definition of such term in section 2, the Freely Associated States.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="8">“(8) </num><heading style="-uslm-dtd:header">Sunset. </heading><content style="-uslm-dtd:text">This subsection shall terminate on September 30, 2018.”</content>
|
||
</paragraph>
|
||
</subsection></quotedContent>.</content>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tII/s202" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="202">SEC. 202. </num><heading style="-uslm-dtd:header">IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY. </heading>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tII/s202/a" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Cooperative Agreements.—</heading><chapeau style="-uslm-dtd:text">Section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/a/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subsection (b)(1)(C), by striking “<quotedText style="-uslm-dtd:quote">consortium of entities described in subparagraph (A)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">consortium of States</quotedText>”;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/a/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><chapeau style="-uslm-dtd:text">in subsection (b)(2)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/2/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">in subparagraph (A)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s202/a/2/A/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by striking clauses (i) and (ii) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">a description of the activities such entity will carry out under the agreement to meet the goals identified under section 2802, including with respect to chemical, biological, radiological, or nuclear threats, whether naturally occurring, unintentional, or deliberate;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">a description of the activities such entity will carry out with respect to pandemic influenza, as a component of the activities carried out under clause (i), and consistent with the requirements of paragraphs (2) and (5) of subsection (g);”</content>
|
||
</clause></quotedContent>;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s202/a/2/A/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">in clause (iv), by striking “<quotedText style="-uslm-dtd:quote">and</quotedText>” at the end; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s202/a/2/A/iii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="vi">“(vi) </num><content style="-uslm-dtd:text">a description of how, as appropriate, the entity may partner with relevant public and private stakeholders in public health emergency preparedness and response;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="vii">“(vii) </num><content style="-uslm-dtd:text">a description of how the entity, as applicable and appropriate, will coordinate with State emergency preparedness and response plans in public health emergency preparedness, including State educational agencies (as defined in section 9101(41) of the Elementary and Secondary Education Act of 1965) and State child care lead agencies (designated under section 658D of the Child Care and Development Block Grant Act of 1990);</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="viii">“(viii) </num><content style="-uslm-dtd:text">in the case of entities that operate on the United States-Mexico border or the United States-Canada border, a description of the activities such entity will carry out under the agreement that are specific to the border area including disease detection, identification, investigation, and preparedness and response activities related to emerging diseases and infectious disease outbreaks whether naturally occurring or due to bioterrorism, consistent with the requirements of this section; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ix">“(ix) </num><content style="-uslm-dtd:text">a description of any activities that such entity will use to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance, including any utilization of poison control centers;”</content>
|
||
</clause></quotedContent>; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/2/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in subparagraph (C), by inserting “<quotedText style="-uslm-dtd:quote">, including addressing the needs of at-risk individuals,</quotedText>” after “<quotedText style="-uslm-dtd:quote">capabilities of such entity</quotedText>”;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/a/3" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">(3) </num><chapeau style="-uslm-dtd:text">in subsection (f)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/3/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (2), by adding “<quotedText style="-uslm-dtd:quote">and</quotedText>” at the end;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/3/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (3), by striking “<quotedText style="-uslm-dtd:quote">; and</quotedText>” and inserting a period; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/3/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by striking paragraph (4);</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/a/4" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">(4) </num><chapeau style="-uslm-dtd:text">in subsection (g)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/4/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (1), by striking subparagraph (A) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">include outcome goals representing operational achievements of the National Preparedness Goals developed under section 2802(b) with respect to all-hazards, including chemical, biological, radiological, or nuclear threats; and”</content>
|
||
</subparagraph></quotedContent>; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/4/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (2)(A), by adding at the end the following: “<quotedText style="-uslm-dtd:quote">The Secretary shall periodically update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration of such criteria into the benchmarks and standards described in paragraph (1).</quotedText>”;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/a/5" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">(5) </num><content style="-uslm-dtd:text">by striking subsection (h);</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/a/6" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="6">(6) </num><content style="-uslm-dtd:text">by redesignating subsections (i), (j), and (k) as subsections (h), (i), and (j), respectively;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/a/7" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="7">(7) </num><chapeau style="-uslm-dtd:text">in subsection (h), as so redesignated—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/7/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">in paragraph (1)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s202/a/7/A/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><chapeau style="-uslm-dtd:text">in subparagraph (A)—</chapeau>
|
||
<subclause style="-uslm-dtd:subclause" identifier="/us/sComp/113/5/tII/s202/a/7/A/i/I" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">$824,000,000 for fiscal year 2007, of which $35,000,000 shall be used to carry out subsection (h),</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$641,900,000 for fiscal year 2014</quotedText>”; and</content>
|
||
</subclause>
|
||
<subclause style="-uslm-dtd:subclause" identifier="/us/sComp/113/5/tII/s202/a/7/A/i/II" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">such sums as may be necessary for each of fiscal years 2008 through 2011</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$641,900,000 for each of fiscal years 2015 through 2018</quotedText>”;</content>
|
||
</subclause>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s202/a/7/A/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking subparagraph (B);</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s202/a/7/A/iii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">by redesignating subparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s202/a/7/A/iv" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iv">(iv) </num><content style="-uslm-dtd:text">in subparagraph (C), as so redesignated, by striking “<quotedText style="-uslm-dtd:quote">subparagraph (C)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">subparagraph (B)</quotedText>”;</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/7/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in subparagraphs (C) and (D) of paragraph (3), by striking “<quotedText style="-uslm-dtd:quote">(1)(A)(i)(I)</quotedText>” each place it appears and inserting “<quotedText style="-uslm-dtd:quote">(1)(A)</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/7/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">in paragraph (4)(B), by striking “<quotedText style="-uslm-dtd:quote">subsection (c)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">subsection (b)</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/7/D" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="7">“(7) </num><heading style="-uslm-dtd:header">Availability of cooperative agreement funds. </heading>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">Amounts provided to an eligible entity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided.</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Funds contingent on achieving benchmarks. </heading><content style="-uslm-dtd:text">The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as described in subsection (g).”</content>
|
||
</subparagraph>
|
||
</paragraph></quotedContent>; and</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/a/8" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="8">(8) </num><chapeau style="-uslm-dtd:text">in subsection (i), as so redesignated—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/8/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (1)(E), by striking “<quotedText style="-uslm-dtd:quote">subsection (k)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">subsection (j)</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/a/8/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by striking paragraph (3).</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tII/s202/b" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Vaccine Tracking and Distribution.—</heading><content style="-uslm-dtd:text">Section 319A(e) of the Public Health Service Act (42 U.S.C. 247d-1(e)) is amended by striking “<quotedText style="-uslm-dtd:quote">such sums for each of fiscal years 2007 through 2011</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$30,800,000 for each of fiscal years 2014 through 2018</quotedText>”.</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tII/s202/c" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Technical and Conforming Amendments.—</heading>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/c/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">Section 319C-1(b)(1)(B) of the Public Health Service Act (42 U.S.C. 247d-3a(b)(1)(B)) is amended by striking “<quotedText style="-uslm-dtd:quote">subsection (i)(4)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">subsection (h)(4)</quotedText>”.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s202/c/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><chapeau style="-uslm-dtd:text">Section 319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b) is amended—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/c/2/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in subsection (i), by striking “<quotedText style="-uslm-dtd:quote">(j), and (k)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">(i), and (j)</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s202/c/2/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in subsection (j)(3), by striking “<quotedText style="-uslm-dtd:quote">319C-1(i)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">319C-1(h)</quotedText>”.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tII/s203" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="203">SEC. 203. </num><heading style="-uslm-dtd:header">HOSPITAL PREPAREDNESS AND MEDICAL SURGE CAPACITY. </heading>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tII/s203/a" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">All-Hazards Public Health and Medical Response Curricula and Training.—</heading><content style="-uslm-dtd:text">Section 319F(a)(5)(B) of the Public Health Service Act (42 U.S.C. 247d-6(a)(5)(B)) is amended by striking “<quotedText style="-uslm-dtd:quote">public health or medical</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">public health, medical, or dental</quotedText>”.</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tII/s203/b" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Encouraging Health Professional Volunteers.—</heading>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s203/b/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Emergency system for advance registration of volunteer health professionals.—</heading><content style="-uslm-dtd:text">Section 319I(k) of the Public Health Service Act (42 U.S.C. 247d-7b(k)) is amended by striking “<quotedText style="-uslm-dtd:quote">$2,000,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2011</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$5,000,000 for each of fiscal years 2014 through 2018</quotedText>”.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s203/b/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Volunteers.—</heading><chapeau style="-uslm-dtd:text">Section 2813 of the Public Health Service Act (42 U.S.C. 300hh-15) is amended—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s203/b/2/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in subsection (d)(2), by adding at the end the following: “<quotedText style="-uslm-dtd:quote">Such training exercises shall, as appropriate and applicable, incorporate the needs of at-risk individuals in the event of a public health emergency.</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s203/b/2/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in subsection (i), by striking “<quotedText style="-uslm-dtd:quote">$22,000,000 for fiscal year 2007, and such sums as may be necessary for each of fiscal years 2008 through 2011</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$11,200,000 for each of fiscal years 2014 through 2018</quotedText>”.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tII/s203/c" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Partnerships for State and Regional Preparedness To Improve Surge Capacity.—</heading><chapeau style="-uslm-dtd:text">Section 319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s203/c/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subsection (a), by inserting “<quotedText style="-uslm-dtd:quote">, including, as appropriate, capacity and preparedness to address the needs of children and other at-risk individuals</quotedText>” before the period at the end;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s203/c/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in subsection (b)(1)(A)(ii), by striking “<quotedText style="-uslm-dtd:quote">centers, primary</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">centers, community health centers, primary</quotedText>”;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s203/c/3" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">by striking subsection (c) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">“(c) </num><heading style="-uslm-dtd:header">Use of Funds. </heading><content style="-uslm-dtd:text">An award under subsection (a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with respect to all-hazards, including chemical, biological, radiological, or nuclear threats.”</content>
|
||
</subsection></quotedContent>;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s203/c/4" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">by striking subsection (g) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="g">“(g) </num><heading style="-uslm-dtd:header">Coordination. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">Local response capabilities. </heading><content style="-uslm-dtd:text">An eligible entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities of relevant local Metropolitan Medical Response Systems, local Medical Reserve Corps, the local Cities Readiness Initiative, and local emergency plans.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">National collaboration. </heading><content style="-uslm-dtd:text">Partnerships consisting of one or more eligible entities under this section may, to the extent practicable, collaborate with other partnerships consisting of one or more eligible entities under this section for purposes of national coordination and collaboration with respect to activities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b).”</content>
|
||
</paragraph>
|
||
</subsection></quotedContent>;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s203/c/5" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">(5) </num><chapeau style="-uslm-dtd:text">in subsection (i)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s203/c/5/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">The requirements of</quotedText>” and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">The requirements of”</content>
|
||
</paragraph></quotedContent>; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s203/c/5/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Meeting goals of national health security strategy. </heading><content style="-uslm-dtd:text">The Secretary shall implement objective, evidence-based metrics to ensure that entities receiving awards under this section are meeting, to the extent practicable, the applicable goals of the National Health Security Strategy under section 2802.”</content>
|
||
</paragraph></quotedContent>; and</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s203/c/6" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="6">(6) </num><chapeau style="-uslm-dtd:text">in subsection (j)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s203/c/6/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">by amending paragraph (1) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">For purposes of carrying out this section, there is authorized to be appropriated $374,700,000 for each of fiscal years 2014 through 2018.”</content>
|
||
</paragraph></quotedContent>; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s203/c/6/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><heading style="-uslm-dtd:header">Availability of cooperative agreement funds. </heading>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">Amounts provided to an eligible entity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided.</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Funds contingent on achieving benchmarks. </heading><content style="-uslm-dtd:text">The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as required under subsection (i).”</content>
|
||
</subparagraph>
|
||
</paragraph></quotedContent>.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tII/s204" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="204">SEC. 204. </num><heading style="-uslm-dtd:header">ENHANCING SITUATIONAL AWARENESS AND BIOSURVEILLANCE. </heading>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tII/s204/a" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><chapeau style="-uslm-dtd:text">Section 319D of the Public Health Service Act (42 U.S.C. 247d-4) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s204/a/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">in subsection (b)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/1/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (1)(B), by inserting “<quotedText style="-uslm-dtd:quote">poison control centers,</quotedText>” after “<quotedText style="-uslm-dtd:quote">hospitals,</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/1/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (2), by inserting before the period at the end the following: “<quotedText style="-uslm-dtd:quote">, allowing for coordination to maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/1/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">in paragraph (3), by inserting before the period at the end the following: “<quotedText style="-uslm-dtd:quote">and update such standards as necessary</quotedText>”;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s204/a/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">by striking subsection (c);</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s204/a/3" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">by redesignating subsections (d) through (g) as subsections (c) through (f), respectively;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s204/a/4" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">(4) </num><chapeau style="-uslm-dtd:text">in subsection (c), as so redesignated—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/4/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in the subsection heading, by striking “<quotedText style="-uslm-dtd:quote">Public Health Situational Awareness</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">Modernizing Public Health Situational Awareness and Biosurveillance</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/4/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">in paragraph (1)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s204/a/4/B/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">Pandemic and All-Hazards Preparedness Act</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">Pandemic and All-Hazards Preparedness Reauthorization Act of 2013</quotedText>”; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s204/a/4/B/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by inserting “<quotedText style="-uslm-dtd:quote">, novel emerging threats,</quotedText>” after “<quotedText style="-uslm-dtd:quote">disease outbreaks</quotedText>”;</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/4/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by striking paragraph (2) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Strategy and implementation plan. </heading><chapeau style="-uslm-dtd:text">Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Secretary shall submit to the appropriate committees of Congress a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the measurable steps the Secretary will carry out to—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">develop, implement, and evaluate the network described in paragraph (1), utilizing the elements described in paragraph (3);</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">modernize and enhance biosurveillance activities; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services.”</content>
|
||
</subparagraph>
|
||
</paragraph></quotedContent>;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/4/D" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">in paragraph (3)(D), by inserting “<quotedText style="-uslm-dtd:quote">community health centers, health centers</quotedText>” after “<quotedText style="-uslm-dtd:quote">poison control,</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/4/E" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="E">(E) </num><content style="-uslm-dtd:text">in paragraph (5), by striking subparagraph (A) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">utilize applicable interoperability standards as determined by the Secretary, and in consultation with the Office of the National Coordinator for Health Information Technology, through a joint public and private sector process;”</content>
|
||
</subparagraph></quotedContent>; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/4/F" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="F">(F) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="6">“(6) </num><heading style="-uslm-dtd:header">Consultation with the national biodefense science board. </heading><chapeau style="-uslm-dtd:text">In carrying out this section and consistent with section 319M, the National Biodefense Science Board shall provide expert advice and guidance, including recommendations, regarding the measurable steps the Secretary should take to modernize and enhance biosurveillance activities pursuant to the efforts of the Department of Health and Human Services to ensure comprehensive, real-time, all-hazards biosurveillance capabilities. In complying with the preceding sentence, the National Biodefense Science Board shall—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">identify the steps necessary to achieve a national biosurveillance system for human health, with international connectivity, where appropriate, that is predicated on State, regional, and community level capabilities and creates a networked system to allow for two-way information flow between and among Federal, State, and local government public health authorities and clinical health care providers;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">identify any duplicative surveillance programs under the authority of the Secretary, or changes that are necessary to existing programs, in order to enhance and modernize such activities, minimize duplication, strengthen and streamline such activities under the authority of the Secretary, and achieve real-time and appropriate data that relate to disease activity, both human and zoonotic; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">coordinate with applicable existing advisory committees of the Director of the Centers for Disease Control and Prevention, including such advisory committees consisting of representatives from State, local, and tribal public health authorities and appropriate public and private sector health care entities and academic institutions, in order to provide guidance on public health surveillance activities.”</content>
|
||
</subparagraph>
|
||
</paragraph></quotedContent>;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s204/a/5" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">(5) </num><chapeau style="-uslm-dtd:text">in subsection (d), as so redesignated—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/5/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (1), by striking “<quotedText style="-uslm-dtd:quote">subsection (d)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">subsection (c)</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/5/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (4)(B), by striking “<quotedText style="-uslm-dtd:quote">subsection (d)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">subsection (c)</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tII/s204/a/5/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><chapeau style="-uslm-dtd:text">in paragraph (5)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s204/a/5/C/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">4 years after the date of enactment of the Pandemic and All-Hazards Preparedness Act</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">3 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013</quotedText>”; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tII/s204/a/5/C/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">subsection (d)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">subsection (c)</quotedText>”;</content>
|
||
</clause>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s204/a/6" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="6">(6) </num><content style="-uslm-dtd:text">in subsection (f), as so redesignated, by striking “<quotedText style="-uslm-dtd:quote">such sums as may be necessary in each of fiscal years 2007 through 2011</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$138,300,000 for each of fiscal years 2014 through 2018</quotedText>”; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tII/s204/a/7" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="7">(7) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="g">“(g) </num><heading style="-uslm-dtd:header">Definition. </heading><content style="-uslm-dtd:text">For purposes of this section the term ‘<quotedText style="-uslm-dtd:quote">biosurveillance</quotedText>’ means the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity.”</content>
|
||
</subsection></quotedContent>.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tII/s204/b" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Technical and Conforming Amendment.—</heading><content style="-uslm-dtd:text">Section 319C-1(b)(2)(D) of the Public Health Service Act (42 U.S.C. 247d-3a(b)(2)(D)) is amended by striking “<quotedText style="-uslm-dtd:quote">section 319D(d)(3)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">section 319D(c)(3)</quotedText>”.</content>
|
||
</subsection>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tII/s205" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="205">SEC. 205. </num><heading style="-uslm-dtd:header">ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS. </heading>
|
||
<content style="-uslm-dtd:text" class="block">Section 5 of the Project Bioshield Act of 2004 (42 U.S.C. 247d-6c) is repealed.</content>
|
||
</section>
|
||
</title>
|
||
<title style="-uslm-dtd:title" identifier="/us/sComp/113/5/tIII" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="III">TITLE III—</num><heading style="-uslm-dtd:header">ENHANCING MEDICAL COUNTERMEASURE REVIEW </heading>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIII/s301" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="301">SEC. 301. </num><heading style="-uslm-dtd:header">SPECIAL PROTOCOL ASSESSMENT. </heading>
|
||
<content style="-uslm-dtd:text" class="block">Section 505(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by striking “<quotedText style="-uslm-dtd:quote">size of clinical trials intended</quotedText>” and all that follows through “<quotedText style="-uslm-dtd:quote">. The sponsor or applicant</quotedText>” and inserting the following:<quotedContent style="-uslm-dtd:quoted-block" class="inline"><chapeau style="-uslm-dtd:text">“size—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC" class="leftIndentDecrease2">
|
||
<num style="-uslm-dtd:enum" value="i">“(i)</num><subclause style="-uslm-dtd:subclause" styleType="OLC" class="inline"><num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">of clinical trials intended to form the primary basis of an effectiveness claim; or</content></subclause>
|
||
<subclause style="-uslm-dtd:subclause" styleType="OLC" class="leftIndentDecrease1">
|
||
<num style="-uslm-dtd:enum" value="II">“(II) </num><content style="-uslm-dtd:text">in the case where human efficacy studies are not ethical or feasible, of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim; or</content>
|
||
</subclause>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC" class="leftIndentDecrease2">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">with respect to an application for approval of a biological product under section 351(k) of the Public Health Service Act, of any necessary clinical study or studies.</content>
|
||
</clause><continuation style="-uslm-dtd:continuation-text" role="section">The sponsor or applicant”</continuation></quotedContent>.</content>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIII/s302" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="302">SEC. 302. </num><heading style="-uslm-dtd:header">AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES. </heading>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIII/s302/a" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><chapeau style="-uslm-dtd:text">Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/a/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">in subsection (a)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/1/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (1), by striking “<quotedText style="-uslm-dtd:quote">sections 505, 510(k), and 515 of this Act</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">any provision of this Act</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/1/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (2)(A), by striking “<quotedText style="-uslm-dtd:quote">under a provision of law referred to in such paragraph</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/1/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">in paragraph (3), by striking “<quotedText style="-uslm-dtd:quote">a provision of law referred to in such paragraph</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">a section of this Act or the Public Health Service Act referred to in paragraph (2)(A)</quotedText>”;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/a/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><chapeau style="-uslm-dtd:text">in subsection (b)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/2/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in the subsection heading, by striking “<quotedText style="-uslm-dtd:quote">Emergency</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">Emergency or Threat Justifying Emergency Authorized Use</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/2/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">in paragraph (1)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/2/B/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">in the matter preceding subparagraph (A), by striking “<quotedText style="-uslm-dtd:quote">may declare an emergency</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">may make a declaration that the circumstances exist</quotedText>”;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/2/B/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">in subparagraph (A), by striking “<quotedText style="-uslm-dtd:quote">specified</quotedText>”;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/2/B/iii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">(iii) </num><chapeau style="-uslm-dtd:text">in subparagraph (B)—</chapeau>
|
||
<subclause style="-uslm-dtd:subclause" identifier="/us/sComp/113/5/tIII/s302/a/2/B/iii/I" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">specified</quotedText>”; and</content>
|
||
</subclause>
|
||
<subclause style="-uslm-dtd:subclause" identifier="/us/sComp/113/5/tIII/s302/a/2/B/iii/II" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">; or</quotedText>” and inserting a semicolon;</content>
|
||
</subclause>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/2/B/iv" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iv">(iv) </num><content style="-uslm-dtd:text">by amending subparagraph (C) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or”</content>
|
||
</subparagraph></quotedContent>; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/2/B/v" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="v">(v) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">the identification of a material threat pursuant to section 319F-2 of the Public Health Service Act sufficient to affect national security or the health and security of United States citizens living abroad.”</content>
|
||
</subparagraph></quotedContent>;</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/2/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><chapeau style="-uslm-dtd:text">in paragraph (2)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/2/C/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">in subparagraph (A), by amending clause (ii) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">a change in the approval status of the product such that the circumstances described in subsection (a)(2) have ceased to exist.”</content>
|
||
</clause></quotedContent>;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/2/C/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking subparagraph (B); and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/2/C/iii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">by redesignating subparagraph (C) as subparagraph (B);</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/2/D" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">in paragraph (4), by striking “<quotedText style="-uslm-dtd:quote">advance notice of termination, and renewal under this subsection.</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">, and advance notice of termination under this subsection.</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/2/E" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="E">(E) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">“(5) </num><heading style="-uslm-dtd:header">Explanation by secretary. </heading><content style="-uslm-dtd:text">If an authorization under this section with respect to an unapproved product or an unapproved use of an approved product has been in effect for more than 1 year, the Secretary shall provide in writing to the sponsor of such product an explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be taken by the Secretary and the sponsor to overcome such obstacles.”</content>
|
||
</paragraph></quotedContent>;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/a/3" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">(3) </num><chapeau style="-uslm-dtd:text">in subsection (c)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/3/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">in the matter preceding paragraph (1)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/3/A/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by inserting “<quotedText style="-uslm-dtd:quote">the Assistant Secretary for Preparedness and Response,</quotedText>” after “<quotedText style="-uslm-dtd:quote">consultation with</quotedText>”;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/3/A/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">Health and</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">Health, and</quotedText>”; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/3/A/iii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">circumstances of the emergency involved</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">applicable circumstances described in subsection (b)(1)</quotedText>”;</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/3/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (1), by striking “<quotedText style="-uslm-dtd:quote">specified</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">referred to</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/3/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">in paragraph (2)(B), by inserting “<quotedText style="-uslm-dtd:quote">, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable</quotedText>” after “<quotedText style="-uslm-dtd:quote">risks of the product</quotedText>”;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/a/4" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">in subsection (d)(3), by inserting “<quotedText style="-uslm-dtd:quote">, to the extent practicable given the circumstances of the emergency,</quotedText>” after “<quotedText style="-uslm-dtd:quote">including</quotedText>”;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/a/5" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">(5) </num><chapeau style="-uslm-dtd:text">in subsection (e)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/5/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (1)(A), by striking “<quotedText style="-uslm-dtd:quote">circumstances of the emergency</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">applicable circumstances described in subsection (b)(1)</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/5/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (1)(B), by amending clause (iii) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">Appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period.”</content>
|
||
</clause></quotedContent>;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/5/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><chapeau style="-uslm-dtd:text">in paragraph (2)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/5/C/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><chapeau style="-uslm-dtd:text">in subparagraph (A)—</chapeau>
|
||
<subclause style="-uslm-dtd:subclause" identifier="/us/sComp/113/5/tIII/s302/a/5/C/i/I" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">manufacturer of the product</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">person</quotedText>”;</content>
|
||
</subclause>
|
||
<subclause style="-uslm-dtd:subclause" identifier="/us/sComp/113/5/tIII/s302/a/5/C/i/II" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">circumstances of the emergency</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">applicable circumstances described in subsection (b)(1)</quotedText>”; and</content>
|
||
</subclause>
|
||
<subclause style="-uslm-dtd:subclause" identifier="/us/sComp/113/5/tIII/s302/a/5/C/i/III" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="III">(III) </num><content style="-uslm-dtd:text">by inserting at the end before the period “<quotedText style="-uslm-dtd:quote">or in paragraph (1)(B)</quotedText>”;</content>
|
||
</subclause>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/5/C/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">in subparagraph (B)(i), by inserting before the period at the end “<quotedText style="-uslm-dtd:quote">, except as provided in section 564A with respect to authorized changes to the product expiration date</quotedText>”; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIII/s302/a/5/C/iii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">by amending subparagraph (C) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">In establishing conditions under this paragraph with respect to the distribution and administration of the product for the unapproved use, the Secretary shall not impose conditions that would restrict distribution or administration of the product when distributed or administered for the approved use.”</content>
|
||
</subparagraph></quotedContent>; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/5/D" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">by amending paragraph (3) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">Good manufacturing practice; prescription. </heading><chapeau style="-uslm-dtd:text">With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the applicable circumstances described in subsection (b)(1)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including such requirements established under section 501 or 520(f)(1), and including relevant conditions prescribed with respect to the product by an order under section 520(f)(2);</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">requirements established under section 503(b); and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">requirements established under section 520(e).”</content>
|
||
</subparagraph>
|
||
</paragraph></quotedContent>;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/a/6" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="6">(6) </num><chapeau style="-uslm-dtd:text">in subsection (g)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/6/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in the subsection heading, by inserting “<quotedText style="-uslm-dtd:quote">Review and</quotedText>” before “<quotedText style="-uslm-dtd:quote">Revocation</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/6/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (1), by inserting after the period at the end the following:<quotedContent style="-uslm-dtd:quoted-block" class="inline"><chapeau style="-uslm-dtd:text">“As part of such review, the Secretary shall regularly review the progress made with respect to the approval, licensure, or clearance of—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">an unapproved product for which an authorization was issued under this section; or</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">an unapproved use of an approved product for which an authorization was issued under this section.”</content>
|
||
</subparagraph></quotedContent>; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIII/s302/a/6/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by amending paragraph (2) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Revision and revocation. </heading><chapeau style="-uslm-dtd:text">The Secretary may revise or revoke an authorization under this section if—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">the circumstances described under subsection (b)(1) no longer exist;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the criteria under subsection (c) for issuance of such authorization are no longer met; or</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">other circumstances make such revision or revocation appropriate to protect the public health or safety.”</content>
|
||
</subparagraph>
|
||
</paragraph></quotedContent>;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/a/7" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="7">(7) </num><content style="-uslm-dtd:text">in subsection (h)(1), by adding after the period at the end the following: “<quotedText style="-uslm-dtd:quote">The Secretary shall make any revisions to an authorization under this section available on the Internet Web site of the Food and Drug Administration.</quotedText>”;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/a/8" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="8">(8) </num><content style="-uslm-dtd:text">by adding at the end of subsection (j) the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><content style="-uslm-dtd:text">Nothing in this section shall be construed as authorizing a delay in the review or other consideration by the Secretary of any application or submission pending before the Food and Drug Administration for a product for which an authorization under this section is issued.”</content>
|
||
</paragraph></quotedContent>; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/a/9" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="9">(9) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="m">“(m) </num><heading style="-uslm-dtd:header">Categorization of Laboratory Tests Associated With Devices Subject to Authorization. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><chapeau style="-uslm-dtd:text">In issuing an authorization under this section with respect to a device, the Secretary may, subject to the provisions of this section, determine that a laboratory examination or procedure associated with such device shall be deemed, for purposes of section 353 of the Public Health Service Act, to be in a particular category of examinations and procedures (including the category described by subsection (d)(3) of such section) if, based on the totality of scientific evidence available to the Secretary—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">such categorization would be beneficial to protecting the public health; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Conditions of determination. </heading><content style="-uslm-dtd:text">The Secretary may establish appropriate conditions on the performance of the examination or procedure pursuant to such determination.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">Effective period. </heading><content style="-uslm-dtd:text">A determination under this subsection shall be effective for purposes of section 353 of the Public Health Service Act notwithstanding any other provision of that section during the effective period of the relevant declaration under subsection (b).”</content>
|
||
</paragraph>
|
||
</subsection></quotedContent>.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIII/s302/b" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Emergency Use of Medical Products.—</heading><content style="-uslm-dtd:text">Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 564 the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<section style="-uslm-dtd:section" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="564A">“SEC. 564A. </num><heading style="-uslm-dtd:header">EMERGENCY USE OF MEDICAL PRODUCTS </heading>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">“(a) </num><heading style="-uslm-dtd:header">Definitions. </heading><chapeau style="-uslm-dtd:text">In this section:</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">Eligible product. </heading><chapeau style="-uslm-dtd:text">The term ‘<quotedText style="-uslm-dtd:quote">eligible product</quotedText>’ means a product that—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">is approved or cleared under this chapter or licensed under section 351 of the Public Health Service Act;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B)</num><clause style="-uslm-dtd:clause" styleType="OLC" class="inline"><num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">is intended for use to prevent, diagnose, or treat a disease or condition involving a biological, chemical, radiological, or nuclear agent or agents; or</content></clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC" class="leftIndentDecrease1">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">is intended for use to prevent, diagnose, or treat a serious or life-threatening disease or condition caused by a product described in clause (i); and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><chapeau style="-uslm-dtd:text">is intended for use during the circumstances under which—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">a determination described in subparagraph (A), (B), or (C) of section 564(b)(1) has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">the identification of a material threat described in subparagraph (D) of section 564(b)(1) has been made pursuant to section 319F-2 of the Public Health Service Act.</content>
|
||
</clause>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Product. </heading><content style="-uslm-dtd:text">The term ‘<quotedText style="-uslm-dtd:quote">product</quotedText>’ means a drug, device, or biological product.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">“(b) </num><heading style="-uslm-dtd:header">Expiration Dating. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><chapeau style="-uslm-dtd:text">The Secretary may extend the expiration date and authorize the introduction or delivery for introduction into interstate commerce of an eligible product after the expiration date provided by the manufacturer if—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><chapeau style="-uslm-dtd:text">the expiration date extension is intended to support the United States ability to protect—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">the public health; or</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">military preparedness and effectiveness; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the Secretary.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Requirements and conditions. </heading><chapeau style="-uslm-dtd:text">Any extension of an expiration date under paragraph (1) shall, as part of the extension, identify—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">each specific lot, batch, or other unit of the product for which extended expiration is authorized;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the duration of the extension; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">any other requirements or conditions as the Secretary may deem appropriate for the protection of the public health, which may include requirements for, or conditions on, product sampling, storage, packaging or repackaging, transport, labeling, notice to product recipients, recordkeeping, periodic testing or retesting, or product disposition.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">Effect. </heading><content style="-uslm-dtd:text">Notwithstanding any other provision of this Act or the Public Health Service Act, an eligible product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product, the Secretary has, under paragraph (1), extended the expiration date and authorized the introduction or delivery for introduction into interstate commerce of such product after the expiration date provided by the manufacturer.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><heading style="-uslm-dtd:header">Expiration date. </heading><content style="-uslm-dtd:text">For purposes of this subsection, the term ‘<quotedText style="-uslm-dtd:quote">expiration date</quotedText>’ means the date established through appropriate stability testing required by the regulations issued by the Secretary to ensure that the product meets applicable standards of identity, strength, quality, and purity at the time of use.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">“(c) </num><heading style="-uslm-dtd:header">Current Good Manufacturing Practice. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">The Secretary may, when the circumstances of a domestic, military, or public health emergency or material threat described in subsection (a)(1)(C) so warrant, authorize, with respect to an eligible product, deviations from current good manufacturing practice requirements otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including requirements under section 501 or 520(f)(1) or applicable conditions prescribed with respect to the eligible product by an order under section 520(f)(2).</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Effect. </heading><content style="-uslm-dtd:text">Notwithstanding any other provision of this Act or the Public Health Service Act, an eligible product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1).</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="d">“(d) </num><heading style="-uslm-dtd:header">Emergency Dispensing. </heading><chapeau style="-uslm-dtd:text">The requirements of sections 503(b) and 520(e) shall not apply to an eligible product, and the product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because it is dispensed without an individual prescription, if—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">the product is dispensed during the circumstances described in subsection (a)(1)(C); and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><chapeau style="-uslm-dtd:text">such dispensing without an individual prescription occurs—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">as permitted under the law of the State in which the product is dispensed; or</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances described in subsection (a)(1)(C).</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="e">“(e) </num><heading style="-uslm-dtd:header">Emergency Use Instructions. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">The Secretary, acting through an appropriate official within the Department of Health and Human Services, may create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning such product’s approved, licensed, or cleared conditions of use.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Effect. </heading><chapeau style="-uslm-dtd:text">Notwithstanding any other provisions of this Act or the Public Health Service Act, a product shall not be considered an unapproved product and shall not be deemed adulterated or misbranded under this Act because of the issuance of emergency use instructions under paragraph (1) with respect to such product or the introduction or delivery for introduction of such product into interstate commerce accompanied by such instructions—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">during an emergency response to an actual emergency that is the basis for a determination described in subsection (a)(1)(C)(i); or</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">by a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, in preparation for an emergency response.”</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
</section></quotedContent>.</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIII/s302/c" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Risk Evaluation and Mitigation Strategies.—</heading><chapeau style="-uslm-dtd:text">Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/c/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subsection (f), by striking paragraph (7); and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s302/c/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="k">“(k) </num><heading style="-uslm-dtd:header">Waiver in Public Health Emergencies. </heading><chapeau style="-uslm-dtd:text">The Secretary may waive any requirement of this section with respect to a qualified countermeasure (as defined in section 319F-1(a)(2) of the Public Health Service Act) to which a requirement under this section has been applied, if the Secretary determines that such waiver is required to mitigate the effects of, or reduce the severity of, the circumstances under which—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">a determination described in subparagraph (A), (B), or (C) of section 564(b)(1) has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><content style="-uslm-dtd:text">the identification of a material threat described in subparagraph (D) of section 564(b)(1) has been made pursuant to section 319F-2 of the Public Health Service Act.”</content>
|
||
</paragraph>
|
||
</subsection></quotedContent>.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIII/s302/d" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Products Held for Emergency Use.—</heading><content style="-uslm-dtd:text">The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after section 564A, as added by subsection (b), the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<section style="-uslm-dtd:section" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="564B">“SEC. 564B. </num><heading style="-uslm-dtd:header">PRODUCTS HELD FOR EMERGENCY USE </heading>
|
||
<chapeau style="-uslm-dtd:text" class="block">“It is not a violation of any section of this Act or of the Public Health Service Act for a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, to introduce into interstate commerce a product (as defined in section 564(a)(4)) intended for emergency use, if that product—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">is intended to be held and not used; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><chapeau style="-uslm-dtd:text">is held and not used, unless and until that product—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">is approved, cleared, or licensed under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">is authorized for investigational use under section 505 or 520 of this Act or section 351 of the Public Health Service Act; or</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">is authorized for use under section 564.”</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</section></quotedContent>.</content>
|
||
</subsection>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIII/s303" styleType="OLC" role="definitions">
|
||
<num style="-uslm-dtd:enum" value="303">SEC. 303. </num><heading style="-uslm-dtd:header">DEFINITIONS. </heading>
|
||
<content style="-uslm-dtd:text" class="block">Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4) is amended by striking “<term style="-uslm-dtd:quote">The Secretary, in consultation</term>” and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">“(a) </num><heading style="-uslm-dtd:header">Definitions. </heading><chapeau style="-uslm-dtd:text">In this section—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">the term ‘<term style="-uslm-dtd:quote">countermeasure</term>’ means a qualified countermeasure, a security countermeasure, and a qualified pandemic or epidemic product;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><content style="-uslm-dtd:text">the term ‘<term style="-uslm-dtd:quote">qualified countermeasure</term>’ has the meaning given such term in section 319F-1 of the Public Health Service Act;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><content style="-uslm-dtd:text">the term ‘<term style="-uslm-dtd:quote">security countermeasure</term>’ has the meaning given such term in section 319F-2 of such Act; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><chapeau style="-uslm-dtd:text">the term ‘<term style="-uslm-dtd:quote">qualified pandemic or epidemic product</term>’ means a product that meets the definition given such term in section 319F-3 of the Public Health Service Act and—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">that has been identified by the Department of Health and Human Services or the Department of Defense as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including pandemic influenza; or</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">is included under this paragraph pursuant to a determination by the Secretary.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">“(b) </num><heading style="-uslm-dtd:header">General Duties. </heading><content style="-uslm-dtd:text">The Secretary, in consultation”</content>
|
||
</subsection></quotedContent>.</content>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIII/s304" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="304">SEC. 304. </num><heading style="-uslm-dtd:header">ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES. </heading>
|
||
<chapeau style="-uslm-dtd:text" class="block">Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4), as amended by section 303, is further amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s304/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in the section heading, by striking “<quotedText style="-uslm-dtd:quote"><headingText style="-uslm-dtd:header-in-text">technical assistance</headingText></quotedText>” and inserting “<quotedText style="-uslm-dtd:quote"><headingText style="-uslm-dtd:header-in-text">countermeasure development, review, and technical assistance</headingText></quotedText>”;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s304/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in subsection (b), by striking the subsection enumerator and all that follows through “<quotedText style="-uslm-dtd:quote">shall establish</quotedText>” and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">“(b) </num><heading style="-uslm-dtd:header">General Duties. </heading><chapeau style="-uslm-dtd:text">In order to accelerate the development, stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant Secretary for Preparedness and Response, shall—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">ensure the appropriate involvement of Food and Drug Administration personnel in interagency activities related to countermeasure advanced research and development, consistent with sections 319F, 319F-1, 319F-2, 319F-3, 319L, and 2811 of the Public Health Service Act;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><content style="-uslm-dtd:text">ensure the appropriate involvement and consultation of Food and Drug Administration personnel in any flexible manufacturing activities carried out under section 319L of the Public Health Service Act, including with respect to meeting regulatory requirements set forth in this Act;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><chapeau style="-uslm-dtd:text">promote countermeasure expertise within the Food and Drug Administration by—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">ensuring that Food and Drug Administration personnel involved in reviewing countermeasures for approval, licensure, or clearance are informed by the Assistant Secretary for Preparedness and Response on the material threat assessment conducted under section 319F-2 of the Public Health Service Act for the agent or agents for which the countermeasure under review is intended;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">training Food and Drug Administration personnel regarding review of countermeasures for approval, licensure, or clearance;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">holding public meetings at least twice annually to encourage the exchange of scientific ideas; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">establishing protocols to ensure that countermeasure reviewers have sufficient training or experience with countermeasures;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><chapeau style="-uslm-dtd:text">maintain teams, composed of Food and Drug Administration personnel with expertise on countermeasures, including specific countermeasures, populations with special clinical needs (including children and pregnant women that may use countermeasures, as applicable and appropriate), classes or groups of countermeasures, or other countermeasure-related technologies and capabilities, that shall—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">consult with countermeasure experts, including countermeasure sponsors and applicants, to identify and help resolve scientific issues related to the approval, licensure, or clearance of countermeasures, through workshops or public meetings; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><chapeau style="-uslm-dtd:text">improve and advance the science relating to the development of new tools, standards, and approaches to assessing and evaluating countermeasures—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">in order to inform the process for countermeasure approval, clearance, and licensure; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">with respect to the development of countermeasures for populations with special clinical needs, including children and pregnant women, in order to meet the needs of such populations, as necessary and appropriate; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">“(5) </num><content style="-uslm-dtd:text">establish”</content>
|
||
</paragraph>
|
||
</subsection></quotedContent>; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s304/3" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">“(c) </num><heading style="-uslm-dtd:header">Final Guidance on Development of Animal Models. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Secretary shall provide final guidance to industry regarding the development of animal models to support approval, clearance, or licensure of countermeasures referred to in subsection (a) when human efficacy studies are not ethical or feasible.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Authority to extend deadline. </heading><content style="-uslm-dtd:text">The Secretary may extend the deadline for providing final guidance under paragraph (1) by not more than 6 months upon submission by the Secretary of a report on the status of such guidance to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="d">“(d) </num><heading style="-uslm-dtd:header">Development and Animal Modeling Procedures. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">Availability of animal model meetings. </heading><chapeau style="-uslm-dtd:text">To facilitate the timely development of animal models and support the development, stockpiling, licensure, approval, and clearance of countermeasures, the Secretary shall, not later than 180 days after the enactment of this subsection, establish a procedure by which a sponsor or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and receive—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">a meeting to discuss proposed animal model development activities; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">a meeting prior to initiating pivotal animal studies.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Pediatric models. </heading><content style="-uslm-dtd:text">To facilitate the development and selection of animal models that could translate to pediatric studies, any meeting conducted under paragraph (1) shall include discussion of animal models for pediatric populations, as appropriate.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="e">“(e) </num><heading style="-uslm-dtd:header">Review and Approval of Countermeasures. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">Material threat. </heading><content style="-uslm-dtd:text">When evaluating an application or submission for approval, licensure, or clearance of a countermeasure, the Secretary shall take into account the material threat posed by the chemical, biological, radiological, or nuclear agent or agents identified under section 319F-2 of the Public Health Service Act for which the countermeasure under review is intended.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Review expertise. </heading><content style="-uslm-dtd:text">When practicable and appropriate, teams of Food and Drug Administration personnel reviewing applications or submissions described under paragraph (1) shall include a reviewer with sufficient training or experience with countermeasures pursuant to the protocols established under subsection (b)(3)(D).”</content>
|
||
</paragraph>
|
||
</subsection></quotedContent>.</content>
|
||
</paragraph>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIII/s305" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="305">SEC. 305. </num><heading style="-uslm-dtd:header">REGULATORY MANAGEMENT PLANS. </heading>
|
||
<content style="-uslm-dtd:text" class="block">Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4), as amended by section 304, is further amended by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="f">“(f) </num><heading style="-uslm-dtd:header">Regulatory Management Plan. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">Definition. </heading><chapeau style="-uslm-dtd:text">In this subsection, the term ‘<quotedText style="-uslm-dtd:quote">eligible countermeasure</quotedText>’ means—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">a security countermeasure with respect to which the Secretary has entered into a procurement contract under section 319F-2(c) of the Public Health Service Act; or</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">a countermeasure with respect to which the Biomedical Advanced Research and Development Authority has provided funding under section 319L of the Public Health Service Act for advanced research and development.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Regulatory management plan process. </heading><content style="-uslm-dtd:text">The Secretary, in consultation with the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority, shall establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans in accordance with this subsection.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">Submission of request and proposed plan by sponsor or applicant. </heading>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">A sponsor or applicant of an eligible countermeasure may initiate the process described under paragraph (2) upon submission of a written request to the Secretary. Such request shall include a proposed regulatory management plan.</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Timing of submission. </heading><content style="-uslm-dtd:text">A sponsor or applicant may submit a written request under subparagraph (A) after the eligible countermeasure has an investigational new drug or investigational device exemption in effect.</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><heading style="-uslm-dtd:header">Response by secretary. </heading><content style="-uslm-dtd:text">The Secretary shall direct the Food and Drug Administration, upon submission of a written request by a sponsor or applicant under subparagraph (A), to work with the sponsor or applicant to agree on a regulatory management plan within a reasonable time not to exceed 90 days. If the Secretary determines that no plan can be agreed upon, the Secretary shall provide to the sponsor or applicant, in writing, the scientific or regulatory rationale why such agreement cannot be reached.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><heading style="-uslm-dtd:header">Plan. </heading><chapeau style="-uslm-dtd:text">The content of a regulatory management plan agreed to by the Secretary and a sponsor or applicant shall include—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">an agreement between the Secretary and the sponsor or applicant regarding developmental milestones that will trigger responses by the Secretary as described in subparagraph (B);</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">performance targets and goals for timely and appropriate responses by the Secretary to the triggers described under subparagraph (A), including meetings between the Secretary and the sponsor or applicant, written feedback, decisions by the Secretary, and other activities carried out as part of the development and review process; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">an agreement on how the plan shall be modified, if needed.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">“(5) </num><heading style="-uslm-dtd:header">Milestones and performance targets. </heading><chapeau style="-uslm-dtd:text">The developmental milestones described in paragraph (4)(A) and the performance targets and goals described in paragraph (4)(B) shall include—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">feedback from the Secretary regarding the data required to support the approval, clearance, or licensure of the eligible countermeasure involved;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">feedback from the Secretary regarding the data necessary to inform any authorization under section 564;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">feedback from the Secretary regarding the data necessary to support the positioning and delivery of the eligible countermeasure, including to the Strategic National Stockpile;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">feedback from the Secretary regarding the data necessary to support the submission of protocols for review under section 505(b)(5)(B);</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="E">“(E) </num><content style="-uslm-dtd:text">feedback from the Secretary regarding any gaps in scientific knowledge that will need resolution prior to approval, licensure, or clearance of the eligible countermeasure and plans for conducting the necessary scientific research;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="F">“(F) </num><content style="-uslm-dtd:text">identification of the population for which the countermeasure sponsor or applicant seeks approval, licensure, or clearance and the population for which desired labeling would not be appropriate, if known; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="G">“(G) </num><content style="-uslm-dtd:text">as necessary and appropriate, and to the extent practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric dosing, formulation, and administration with respect to the eligible countermeasure, provided that such plan would not delay authorization under section 564, approval, licensure, or clearance for adults.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="6">“(6) </num><heading style="-uslm-dtd:header">Prioritization. </heading>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">Plans for security countermeasures. </heading><content style="-uslm-dtd:text">The Secretary shall establish regulatory management plans for all security countermeasures for which a request is submitted under paragraph (3)(A).</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Plans for other eligible countermeasures. </heading><content style="-uslm-dtd:text">The Secretary shall determine whether resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures. If resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures, and if resources are not available to establish regulatory management plans for all eligible countermeasures for which requests have been submitted, the Director of the Biomedical Advanced Research and Development Authority, in consultation with the Commissioner, shall prioritize which eligible countermeasures may receive regulatory management plans.”</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection></quotedContent>.</content>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIII/s306" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="306">SEC. 306. </num><heading style="-uslm-dtd:header">REPORT. </heading>
|
||
<content style="-uslm-dtd:text" class="block">Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4), as amended by section 305, is further amended by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="g">“(g) </num><heading style="-uslm-dtd:header">Annual Report. </heading><chapeau style="-uslm-dtd:text">Not later than 180 days after the date of enactment of this subsection, and annually thereafter, the Secretary shall make publicly available on the Web site of the Food and Drug Administration a report that details the countermeasure development and review activities of the Food and Drug Administration, including—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><chapeau style="-uslm-dtd:text">with respect to the development of new tools, standards, and approaches to assess and evaluate countermeasures—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">the identification of the priorities of the Food and Drug Administration and the progress made on such priorities; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the identification of scientific gaps that impede the development, approval, licensure, or clearance of countermeasures for populations with special clinical needs, including children and pregnant women, and the progress made on resolving these challenges;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><chapeau style="-uslm-dtd:text">with respect to countermeasures for which a regulatory management plan has been agreed upon under subsection (f), the extent to which the performance targets and goals set forth in subsection (f)(4)(B) and the regulatory management plan have been met, including, for each such countermeasure—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">whether the regulatory management plan was completed within the required timeframe, and the length of time taken to complete such plan;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">whether the Secretary adhered to the timely and appropriate response times set forth in such plan; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">explanations for any failure to meet such performance targets and goals;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><content style="-uslm-dtd:text">the number of regulatory teams established pursuant to subsection (b)(4), the number of products, classes of products, or technologies assigned to each such team, and the number of, type of, and any progress made as a result of consultations carried out under subsection (b)(4)(A);</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><chapeau style="-uslm-dtd:text">an estimate of resources obligated to countermeasure development and regulatory assessment, including—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">Center-specific objectives and accomplishments; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the number of full-time equivalent employees of the Food and Drug Administration who directly support the review of countermeasures;</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">“(5) </num><content style="-uslm-dtd:text">the number of countermeasure applications and submissions submitted, the number of countermeasures approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each type of authorization issued pursuant to section 564;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="6">“(6) </num><content style="-uslm-dtd:text">the number of written requests for a regulatory management plan submitted under subsection (f)(3)(A), the number of regulatory management plans developed, and the number of such plans developed for security countermeasures; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="7">“(7) </num><chapeau style="-uslm-dtd:text">the number, type, and frequency of meetings between the Food and Drug Administration and—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">sponsors of a countermeasure as defined in subsection (a); or</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">another agency engaged in development or management of portfolios for such countermeasures, including the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the National Institutes of Health, and the appropriate agencies of the Department of Defense.”</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection></quotedContent>.</content>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIII/s307" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="307">SEC. 307. </num><heading style="-uslm-dtd:header">PEDIATRIC MEDICAL COUNTERMEASURES. </heading>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIII/s307/a" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Pediatric Studies of Drugs.—</heading><chapeau style="-uslm-dtd:text">Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s307/a/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subsection (d), by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">“(5) </num><heading style="-uslm-dtd:header">Consultation. </heading><content style="-uslm-dtd:text">With respect to a drug that is a qualified countermeasure (as defined in section 319F-1 of the Public Health Service Act), a security countermeasure (as defined in section 319F-2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F-3 of the Public Health Service Act), the Secretary shall solicit input from the Assistant Secretary for Preparedness and Response regarding the need for and, from the Director of the Biomedical Advanced Research and Development Authority regarding the conduct of, pediatric studies under this section.”</content>
|
||
</paragraph></quotedContent>; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s307/a/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in subsection (n)(1), by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">For a drug that is a qualified countermeasure (as defined in section 319F-1 of the Public Health Service Act), a security countermeasure (as defined in section 319F-2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F-3 of such Act), in addition to any action with respect to such drug under subparagraph (A) or (B), the Secretary shall notify the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority of all pediatric studies in the written request issued by the Commissioner of Food and Drugs.”</content>
|
||
</subparagraph></quotedContent>.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIII/s307/b" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Addition to Priority List Considerations.—</heading><chapeau style="-uslm-dtd:text">Section 409I of the Public Health Service Act (42 U.S.C. 284m) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s307/b/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">by striking subsection (a)(2) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Consideration of available information. </heading><chapeau style="-uslm-dtd:text">In developing and prioritizing the list under paragraph (1), the Secretary—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><chapeau style="-uslm-dtd:text">shall consider—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">may consider the availability of qualified countermeasures (as defined in section 319F-1), security countermeasures (as defined in section 319F-2), and qualified pandemic or epidemic products (as defined in section 319F-3) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.”</content>
|
||
</subparagraph>
|
||
</paragraph></quotedContent>; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s307/b/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in subsection (b), by striking “<quotedText style="-uslm-dtd:quote">subsection (a)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">paragraphs (1) and (2)(A) of subsection (a)</quotedText>”.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIII/s307/c" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">(c) </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t42/s284m-1">42 U.S.C. 284m-1</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">Advice and Recommendations of the Pediatric Advisory Committee Regarding Countermeasures for Pediatric Populations.—</heading><chapeau style="-uslm-dtd:text">Subsection (b)(2) of section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s307/c/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subparagraph (C), by striking the period and inserting “<quotedText style="-uslm-dtd:quote">; and</quotedText>”; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIII/s307/c/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">the development of countermeasures (as defined in section 565(a) of the Federal Food, Drug, and Cosmetic Act) for pediatric populations.”</content>
|
||
</subparagraph></quotedContent>.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
</section>
|
||
</title>
|
||
<title style="-uslm-dtd:title" identifier="/us/sComp/113/5/tIV" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="IV">TITLE IV—</num><heading style="-uslm-dtd:header">ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT </heading>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIV/s401" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="401">SEC. 401. </num><heading style="-uslm-dtd:header">BIOSHIELD. </heading>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIV/s401/a" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Procurement of Countermeasures.—</heading><chapeau style="-uslm-dtd:text">Section 319F-2(c) of the Public Health Service Act (42 U.S.C. 247d-6b(c)) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s401/a/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in paragraph (1)(B)(i)(III)(bb), by striking “<quotedText style="-uslm-dtd:quote">eight years</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">10 years</quotedText>”;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s401/a/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in paragraph (2)(C), by striking “<quotedText style="-uslm-dtd:quote">the designated congressional committees (as defined in paragraph (10))</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">the appropriate committees of Congress</quotedText>”;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s401/a/3" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">in paragraph (5)(B)(ii), by striking “<quotedText style="-uslm-dtd:quote">eight years</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">10 years</quotedText>”;</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s401/a/4" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">(4) </num><chapeau style="-uslm-dtd:text">in subparagraph (C) of paragraph (6)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s401/a/4/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in the subparagraph heading, by striking “<quotedText style="-uslm-dtd:quote">designated congressional committees</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">appropriate congressional committees</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s401/a/4/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">the designated congressional committees</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">the appropriate congressional committees</quotedText>”; and</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s401/a/5" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="5">(5) </num><chapeau style="-uslm-dtd:text">in paragraph (7)(C)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s401/a/5/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in clause (i)(I), by inserting “<quotedText style="-uslm-dtd:quote">including advanced research and development,</quotedText>” after “<quotedText style="-uslm-dtd:quote">as may reasonably be required,</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s401/a/5/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">in clause (ii)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s401/a/5/B/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">in subclause (III), by striking “<quotedText style="-uslm-dtd:quote">eight years</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">10 years</quotedText>”; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s401/a/5/B/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking subclause (IX) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subclause style="-uslm-dtd:subclause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="IX">“(IX) </num><heading style="-uslm-dtd:header">Contract terms. </heading><chapeau style="-uslm-dtd:text">The Secretary, in any contract for procurement under this section—</chapeau>
|
||
<item style="-uslm-dtd:item" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="aa">“(aa) </num><chapeau style="-uslm-dtd:text">may specify—</chapeau>
|
||
<subitem style="-uslm-dtd:subitem" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="AA">“(AA) </num><content style="-uslm-dtd:text">the dosing and administration requirements for the countermeasure to be developed and procured;</content>
|
||
</subitem>
|
||
<subitem style="-uslm-dtd:subitem" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="BB">“(BB) </num><content style="-uslm-dtd:text">the amount of funding that will be dedicated by the Secretary for advanced research, development, and procurement of the countermeasure; and</content>
|
||
</subitem>
|
||
<subitem style="-uslm-dtd:subitem" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="CC">“(CC) </num><content style="-uslm-dtd:text">the specifications the countermeasure must meet to qualify for procurement under a contract under this section; and</content>
|
||
</subitem>
|
||
</item>
|
||
<item style="-uslm-dtd:item" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="bb">“(bb) </num><content style="-uslm-dtd:text">shall provide a clear statement of defined Government purpose limited to uses related to a security countermeasure, as defined in paragraph (1)(B).”</content>
|
||
</item>
|
||
</subclause></quotedContent>; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s401/a/5/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="viii">“(viii) </num><heading style="-uslm-dtd:header">Flexibility. </heading><content style="-uslm-dtd:text">In carrying out this section, the Secretary may, consistent with the applicable provisions of this section, enter into contracts and other agreements that are in the best interest of the Government in meeting identified security countermeasure needs, including with respect to reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved.”</content>
|
||
</clause></quotedContent>.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIV/s401/b" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Reauthorization of the Special Reserve Fund.—</heading><chapeau style="-uslm-dtd:text">Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s401/b/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">in subsection (c)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s401/b/1/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">special reserve fund under paragraph (10)</quotedText>” each place it appears and inserting “<quotedText style="-uslm-dtd:quote">special reserve fund as defined in subsection (h)</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s401/b/1/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by striking paragraphs (9) and (10); and</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s401/b/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="g">“(g) </num><heading style="-uslm-dtd:header">Special Reserve Fund. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">Authorization of appropriations. </heading><content style="-uslm-dtd:text">In addition to amounts appropriated to the special reserve fund prior to the date of the enactment of this subsection, there is authorized to be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section 319L (relating to the Biomedical Advanced Research and Development Authority), $2,800,000,000 for the period of fiscal years 2014 through 2018. Amounts appropriated pursuant to the preceding sentence are authorized to remain available until September 30, 2019.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Use of special reserve fund for advanced research and development. </heading><content style="-uslm-dtd:text">The Secretary may utilize not more than 50 percent of the amounts authorized to be appropriated under paragraph (1) to carry out section 319L (related to the Biomedical Advanced Research and Development Authority). Amounts authorized to be appropriated under this subsection to carry out section 319L are in addition to amounts otherwise authorized to be appropriated to carry out such section.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">Restrictions on use of funds. </heading><content style="-uslm-dtd:text">Amounts in the special reserve fund shall not be used to pay costs other than payments made by the Secretary to a vendor for advanced development (under section 319L) or for procurement of a security countermeasure under subsection (c)(7).</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="4">“(4) </num><heading style="-uslm-dtd:header">Report. </heading><chapeau style="-uslm-dtd:text">Not later than 30 days after any date on which the Secretary determines that the amount of funds in the special reserve fund available for procurement is less than $1,500,000,000, the Secretary shall submit to the appropriate committees of Congress a report detailing the amount of such funds available for procurement and the impact such reduction in funding will have—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">in meeting the security countermeasure needs identified under this section; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to section 2811(d)).</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="h">“(h) </num><heading style="-uslm-dtd:header">Definitions. </heading><chapeau style="-uslm-dtd:text">In this section:</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">The term ‘<quotedText style="-uslm-dtd:quote">advanced research and development</quotedText>’ has the meaning given such term in section 319L(a).</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><content style="-uslm-dtd:text">The term ‘<quotedText style="-uslm-dtd:quote">special reserve fund</quotedText>’ means the ‘<quotedText style="-uslm-dtd:quote">Biodefense Countermeasures</quotedText>’ appropriations account, any appropriation made available pursuant to section 521(a) of the Homeland Security Act of 2002, and any appropriation made available pursuant to subsection (g)(1).”</content>
|
||
</paragraph>
|
||
</subsection></quotedContent>.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIV/s402" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="402">SEC. 402. </num><heading style="-uslm-dtd:header">BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY. </heading>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIV/s402/a" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Duties.—</heading><chapeau style="-uslm-dtd:text">Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d-7e(c)(4)) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s402/a/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subparagraph (B)(iii), by inserting “<quotedText style="-uslm-dtd:quote">(which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act)</quotedText>” after “<quotedText style="-uslm-dtd:quote">development</quotedText>”; and</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s402/a/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in subparagraph (D)(iii), by striking “<quotedText style="-uslm-dtd:quote">and vaccine manufacturing technologies</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, and platform technologies</quotedText>”.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIV/s402/b" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Transaction Authorities.—</heading><content style="-uslm-dtd:text">Section 319L(c)(5) of the Public Health Service Act (42 U.S.C. 247d-7e(c)(5)) is amended by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="G">“(G) </num><heading style="-uslm-dtd:header">Government purpose. </heading><content style="-uslm-dtd:text">In awarding contracts, grants, and cooperative agreements under this section, the Secretary shall provide a clear statement of defined Government purpose related to activities included in subsection (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.”</content>
|
||
</subparagraph></quotedContent>.</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIV/s402/c" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Fund.—</heading><content style="-uslm-dtd:text">Paragraph (2) of section 319L(d) of the Public Health Service Act (42 U.S.C. 247d-7e(d)(2)) is amended to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Funding. </heading><content style="-uslm-dtd:text">To carry out the purposes of this section, there is authorized to be appropriated to the Fund $415,000,000 for each of fiscal years 2014 through 2018, such amounts to remain available until expended.”</content>
|
||
</paragraph></quotedContent>.</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIV/s402/d" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Continued Inapplicability of Certain Provisions.—</heading><content style="-uslm-dtd:text">Section 319L(e)(1)(C) of the Public Health Service Act (42 U.S.C. 247d-7e(e)(1)(C)) is amended by striking “<quotedText style="-uslm-dtd:quote">7 years</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">12 years</quotedText>”.</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIV/s402/e" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="e">(e) </num><heading style="-uslm-dtd:header">Extension of Limited Antitrust Exemption.—</heading>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s402/e/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">Section 405(b) of the Pandemic and All-Hazards Preparedness Act (42 U.S.C. 247d-6a note) is amended by striking “<quotedText style="-uslm-dtd:quote">6-year</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">12-year</quotedText>”.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s402/e/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t42/s247d-6a">42 U.S.C. 247d-6a note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">Effective date.—</heading><content style="-uslm-dtd:text">This subsection shall take effect as if enacted on December 17, 2012.</content>
|
||
</paragraph>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIV/s402/f" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="f">(f) </num><heading style="-uslm-dtd:header">Independent Evaluation.—</heading><content style="-uslm-dtd:text">Section 319L of the Public Health Service Act (42 U.S.C. 247d-7e) is amended by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subsection style="-uslm-dtd:subsection" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="f">“(f) </num><heading style="-uslm-dtd:header">Independent Evaluation. </heading>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general. </heading><content style="-uslm-dtd:text">Not later than 180 days after the date of enactment of this subsection, the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out to facilitate flexible manufacturing capacity pursuant to this section.</content>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Report. </heading><chapeau style="-uslm-dtd:text">Not later than 1 year after the date of enactment of this subsection, the Comptroller General of the United States shall submit to the appropriate committees of Congress a report concerning the results of the evaluation conducted under paragraph (1). Such report shall review and assess—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">the extent to which flexible manufacturing capacity under this section is dedicated to chemical, biological, radiological, and nuclear threats;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">the activities supported by flexible manufacturing initiatives; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">“(C) </num><chapeau style="-uslm-dtd:text">the ability of flexible manufacturing activities carried out under this section to—</chapeau>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">secure and leverage leading technical expertise with respect to countermeasure advanced research, development, and manufacturing processes; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">meet the surge manufacturing capacity needs presented by novel and emerging threats, including chemical, biological, radiological, and nuclear agents.”</content>
|
||
</clause>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection></quotedContent>.</content>
|
||
</subsection>
|
||
<subsection style="-uslm-dtd:subsection" identifier="/us/sComp/113/5/tIV/s402/g" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="g">(g) </num><heading style="-uslm-dtd:header">Definitions.—</heading>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s402/g/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Qualified countermeasure.—</heading><chapeau style="-uslm-dtd:text">Section 319F-1(a)(2)(A) of the Public Health Service Act (42 U.S.C. 247d-6a(a)(2)(A)) is amended—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s402/g/1/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in the matter preceding clause (i), by striking “<quotedText style="-uslm-dtd:quote">to—</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">—</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s402/g/1/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">in clause (i)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s402/g/1/B/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">diagnose</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">to diagnose</quotedText>”; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s402/g/1/B/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">; or</quotedText>” and inserting a semicolon;</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s402/g/1/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><chapeau style="-uslm-dtd:text">in clause (ii)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s402/g/1/C/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">diagnose</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">to diagnose</quotedText>”; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s402/g/1/C/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking the period at the end and inserting “<quotedText style="-uslm-dtd:quote">; or</quotedText>”; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s402/g/1/D" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).”</content>
|
||
</clause></quotedContent>.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s402/g/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Qualified pandemic or epidemic product.—</heading><chapeau style="-uslm-dtd:text">Section 319F-3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d-6d(i)(7)(A)) is amended—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s402/g/2/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in clause (i)(II), by striking “<quotedText style="-uslm-dtd:quote">; or</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">;</quotedText>”;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s402/g/2/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in clause (ii), by striking “<quotedText style="-uslm-dtd:quote">; and</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">; or</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s402/g/2/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and”</content>
|
||
</clause></quotedContent>.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s402/g/3" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Technical amendments.—</heading><chapeau style="-uslm-dtd:text">Section 319F-3(i) of the Public Health Service Act (42 U.S.C. 247d-6d(i)) is amended—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s402/g/3/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (1)(C), by inserting “<quotedText style="-uslm-dtd:quote">, 564A, or 564B</quotedText>” after “<quotedText style="-uslm-dtd:quote">564</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s402/g/3/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (7)(B)(iii), by inserting “<quotedText style="-uslm-dtd:quote">, 564A, or 564B</quotedText>” after “<quotedText style="-uslm-dtd:quote">564</quotedText>”.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</subsection>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIV/s403" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="403">SEC. 403. </num><heading style="-uslm-dtd:header">STRATEGIC NATIONAL STOCKPILE. </heading>
|
||
<chapeau style="-uslm-dtd:text" class="block">Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s403/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">in subsection (a)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s403/1/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">in paragraph (1)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s403/1/A/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by inserting “<quotedText style="-uslm-dtd:quote">consistent with section 2811</quotedText>” before “<quotedText style="-uslm-dtd:quote">by the Secretary to be appropriate</quotedText>”; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s403/1/A/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by inserting before the period at the end of the second sentence the following: “<quotedText style="-uslm-dtd:quote">and shall submit such review annually to the appropriate congressional committees of jurisdiction to the extent that disclosure of such information does not compromise national security</quotedText>”; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s403/1/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in paragraph (2)(D), by inserting before the semicolon at the end the following: “<quotedText style="-uslm-dtd:quote">and that the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment</quotedText>”; and</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s403/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in subsection (f)(1), by striking “<quotedText style="-uslm-dtd:quote">$640,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (c)(10)(A).</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$533,800,000 for each of fiscal years 2014 through 2018. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (h).</quotedText>”.</content>
|
||
</paragraph>
|
||
</section>
|
||
<section style="-uslm-dtd:section" identifier="/us/sComp/113/5/tIV/s404" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="404">SEC. 404. </num><heading style="-uslm-dtd:header">NATIONAL BIODEFENSE SCIENCE BOARD. </heading>
|
||
<chapeau style="-uslm-dtd:text" class="block">Section 319M(a) of the Public Health Service Act (42 U.S.C. 247d-f(a)) is amended—</chapeau>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s404/1" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">in paragraph (2)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s404/1/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">in subparagraph (D)—</chapeau>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s404/1/A/i" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">in clause (i), by striking “<quotedText style="-uslm-dtd:quote">and</quotedText>” at the end;</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s404/1/A/ii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">in clause (ii), by striking the period and inserting a semicolon; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" identifier="/us/sComp/113/5/tIV/s404/1/A/iii" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">one such member shall be an individual with pediatric subject matter expertise; and</content>
|
||
</clause>
|
||
<clause style="-uslm-dtd:clause" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="iv">“(iv) </num><content style="-uslm-dtd:text">one such member shall be a State, tribal, territorial, or local public health official.”</content>
|
||
</clause></quotedContent>; and</content>
|
||
</clause>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s404/1/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by adding at the end the following flush sentence:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<content style="-uslm-dtd:text" class="block">“Nothing in this paragraph shall preclude a member of the Board from satisfying two or more of the requirements described in subparagraph (D).”</content></quotedContent>; and</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
<paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/113/5/tIV/s404/2" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="2">(2) </num><chapeau style="-uslm-dtd:text">in paragraph (5)—</chapeau>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s404/2/A" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in subparagraph (B), by striking “<quotedText style="-uslm-dtd:quote">and</quotedText>” at the end;</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s404/2/B" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">in subparagraph (C), by striking the period and inserting “<quotedText style="-uslm-dtd:quote">; and</quotedText>”; and</content>
|
||
</subparagraph>
|
||
<subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/113/5/tIV/s404/2/C" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
|
||
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
|
||
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">provide any recommendation, finding, or report provided to the Secretary under this paragraph to the appropriate committees of Congress.”</content>
|
||
</subparagraph></quotedContent>.</content>
|
||
</subparagraph>
|
||
</paragraph>
|
||
</section>
|
||
</title>
|
||
</main>
|
||
</statuteCompilation>
|