<?xml version="1.0" encoding="UTF-8" standalone="no"?><?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" style="-uslm-dtd:statute" xml:lang="en" xsi:schemaLocation="http://schemas.gpo.gov/xml/uslm https://www.govinfo.gov/schemas/xml/uslm/uslm-2.0.13.xsd">
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        <dc:title>First Responder Anthrax Preparedness Act</dc:title>
        <citableAsShortTitle>First Responder Anthrax Preparedness Act</citableAsShortTitle>
        <docNumber/>
        <currentThroughPublicLaw>114–268</currentThroughPublicLaw>
        <dc:type>Statute Compilation</dc:type>
        <dc:creator>United States House of Representatives</dc:creator>
        <dc:creator>Office of the Legislative Counsel</dc:creator>
        <dc:format>text/xml</dc:format>
        <dc:language>EN</dc:language>
        <dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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        <processedDate>2026-09-25</processedDate>
        <containsShortTitle>First Responder Anthrax Preparedness Act</containsShortTitle>
        <property role="fileId">18442</property>
        <congress>114</congress>
        <approvedDate>2016-12-14</approvedDate>
    </meta>
    <preface style="-uslm-dtd:compilation-act-form">
        <property role="compShortTitle" style="-uslm-dtd:comp-short-title">First Responder Anthrax Preparedness Act</property>
        <citationNote style="-uslm-dtd:public-law">[(<citableAs>Public Law 114–268</citableAs>)]</citationNote>
        <editionNote style="-uslm-dtd:updated-through-note">[This law has not been amended]</editionNote>
        <explanationNote style="-uslm-dtd:explanatory-note"><b>[</b>Currency: This publication is a compilation of the text of Public Law 114–268. 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>
        <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>
    </preface>
    <main style="-uslm-dtd:legis-body"><longTitle><docTitle style="-uslm-dtd:legis-type">AN ACT</docTitle><officialTitle style="-uslm-dtd:official-title">To direct the Secretary of Homeland Security to make anthrax vaccines available to emergency response providers, 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>
        <section identifier="/us/sComp/114/268/s1" style="-uslm-dtd:section" styleType="OLC">
            <num style="-uslm-dtd:enum" value="1">SECTION 1. </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t42/s247d-6b">42 U.S.C. 247d-6b</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">SHORT TITLE. </heading>
            <content class="block" style="-uslm-dtd:text">This Act may be cited as the “<shortTitle style="-uslm-dtd:quote">First Responder Anthrax Preparedness Act</shortTitle>”.</content>
        </section>
        <section identifier="/us/sComp/114/268/s2" style="-uslm-dtd:section" styleType="OLC">
            <num style="-uslm-dtd:enum" value="2">SEC. 2. </num><heading style="-uslm-dtd:header">VOLUNTARY PRE-EVENT ANTHRAX VACCINATION PILOT PROGRAM FOR EMERGENCY RESPONSE PROVIDERS. </heading>
            <subsection identifier="/us/sComp/114/268/s2/a" style="-uslm-dtd:subsection" styleType="OLC">
                <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Pilot Program.—</heading>
                <paragraph identifier="/us/sComp/114/268/s2/a/1" style="-uslm-dtd:paragraph" styleType="OLC">
                    <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Establishment.—</heading><content style="-uslm-dtd:text">The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, shall carry out a pilot program to provide eligible anthrax vaccines from the Strategic National Stockpile under section 319F-2(a) of the Public Health Service Act (42 U.S.C. 247d-6b(a)) that will be nearing the end of their labeled dates of use at the time such vaccines are made available to States for administration to emergency response providers who would be at high risk of exposure to anthrax if such an attack should occur and who voluntarily consent to such administration.</content>
                </paragraph>
                <paragraph identifier="/us/sComp/114/268/s2/a/2" style="-uslm-dtd:paragraph" styleType="OLC">
                    <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Determination.—</heading><chapeau style="-uslm-dtd:text">The Secretary of Health and Human Services shall determine whether an anthrax vaccine is eligible to be provided to the Secretary of Homeland Security for the pilot program described in paragraph (1) based on—</chapeau>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/2/A" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">a determination that the vaccine is not otherwise allotted for other purposes;</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/2/B" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">a determination that the provision of the vaccine will not reduce, or otherwise adversely affect, the capability to meet projected requirements for this product during a public health emergency, including a significant reduction of available quantities of vaccine in the Strategic National Stockpile; and</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/2/C" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">such other considerations as determined appropriate by the Secretary of Health and Human Services.</content>
                    </subparagraph>
                </paragraph>
                <paragraph identifier="/us/sComp/114/268/s2/a/3" style="-uslm-dtd:paragraph" styleType="OLC">
                    <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Preliminary requirements.—</heading><chapeau style="-uslm-dtd:text">Before implementing the pilot program required under this subsection, the Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, shall—</chapeau>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/3/A" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">establish a communication platform for the pilot program;</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/3/B" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">develop and deliver education and training for the pilot program;</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/3/C" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">conduct economic analysis of the pilot program, including a preliminary estimate of total costs and expected benefits;</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/3/D" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">create a logistical platform for the anthrax vaccine request process under the pilot program;</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/3/E" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="E">(E) </num><content style="-uslm-dtd:text">establish goals and desired outcomes for the pilot program; and</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/3/F" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="F">(F) </num><chapeau style="-uslm-dtd:text">establish a mechanism to reimburse the Secretary of Health and Human Services for—</chapeau>
                        <clause identifier="/us/sComp/114/268/s2/a/3/F/i" style="-uslm-dtd:clause" styleType="OLC">
                            <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">the costs of shipment and transportation of such vaccines provided to the Secretary of Homeland Security from the Strategic National Stockpile under such pilot program, including staff time directly supporting such shipment and transportation; and</content>
                        </clause>
                        <clause identifier="/us/sComp/114/268/s2/a/3/F/ii" style="-uslm-dtd:clause" styleType="OLC">
                            <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">the amount, if any, by which the warehousing costs of the Strategic National Stockpile are increased in order to operate such pilot program.</content>
                        </clause>
                    </subparagraph>
                </paragraph>
                <paragraph identifier="/us/sComp/114/268/s2/a/4" style="-uslm-dtd:paragraph" styleType="OLC">
                    <num style="-uslm-dtd:enum" value="4">(4) </num><heading style="-uslm-dtd:header">Location.—</heading>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/4/A" 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">In carrying out the pilot program required under this subsection, the Secretary of Homeland Security shall select not fewer than 2 nor more than 5 States for voluntary participation in the pilot program.</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/4/B" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Requirement.—</heading><content style="-uslm-dtd:text">Each State that participates in the pilot program under this subsection shall ensure that such participation is consistent with the All-Hazards Public Health Emergency Preparedness and Response Plan of the State developed under section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a).</content>
                    </subparagraph>
                </paragraph>
                <paragraph identifier="/us/sComp/114/268/s2/a/5" style="-uslm-dtd:paragraph" styleType="OLC">
                    <num style="-uslm-dtd:enum" value="5">(5) </num><heading style="-uslm-dtd:header">Guidance for selection.—</heading><content style="-uslm-dtd:text">To ensure that participation in the pilot program under this subsection strategically increases State and local response readiness in the event of an anthrax release, the Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, shall provide guidance to participating States and units of local government on identifying emergency response providers who are at high risk of exposure to anthrax.</content>
                </paragraph>
                <paragraph identifier="/us/sComp/114/268/s2/a/6" style="-uslm-dtd:paragraph" styleType="OLC">
                    <num style="-uslm-dtd:enum" value="6">(6) </num><heading style="-uslm-dtd:header">Distribution of information.—</heading><chapeau style="-uslm-dtd:text">The Secretary of Homeland Security shall require that each State that participates in the pilot program under this subsection submit a written certification to the Secretary of Homeland Security stating that each emergency response provider within the State that participates in the pilot program is provided with disclosures and educational materials designated by the Secretary of Health and Human Services, which may include—</chapeau>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/6/A" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">materials regarding the associated benefits and risks of any vaccine provided under the pilot program, and of exposure to anthrax;</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/6/B" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">additional material consistent with the Centers for Disease Control and Prevention’s clinical guidance; and</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/6/C" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">notice that the Federal Government is not obligated to continue providing anthrax vaccine after the date on which the pilot program ends.</content>
                    </subparagraph>
                </paragraph>
                <paragraph identifier="/us/sComp/114/268/s2/a/7" style="-uslm-dtd:paragraph" styleType="OLC">
                    <num style="-uslm-dtd:enum" value="7">(7) </num><heading style="-uslm-dtd:header">Memorandum of understanding.—</heading><chapeau style="-uslm-dtd:text">Before implementing the pilot program under this subsection, the Secretary of Homeland Security shall enter into a memorandum of understanding with the Secretary of Health and Human Services to—</chapeau>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/7/A" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">define the roles and responsibilities of each Department for the pilot program; and</content>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/7/B" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">establish other performance metrics and policies for the pilot program, as appropriate.</content>
                    </subparagraph>
                </paragraph>
                <paragraph identifier="/us/sComp/114/268/s2/a/8" style="-uslm-dtd:paragraph" styleType="OLC">
                    <num style="-uslm-dtd:enum" value="8">(8) </num><heading style="-uslm-dtd:header">Report.—</heading>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/8/A" 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">Notwithstanding subsection (c), not later than 1 year after the date on which the initial vaccines are administered under this section, and annually thereafter until 1 year after the completion of the pilot program under this section, the Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, shall submit to the Committee on Homeland Security and the Committee on Energy and Commerce of the House of Representatives and the Committee on Homeland Security and Governmental Affairs and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the progress and results of the pilot program, including—</chapeau>
                        <clause identifier="/us/sComp/114/268/s2/a/8/A/i" style="-uslm-dtd:clause" styleType="OLC">
                            <num style="-uslm-dtd:enum" value="i">(i) </num><chapeau style="-uslm-dtd:text">a detailed tabulation of the costs to administer the program, including—</chapeau>
                            <subclause identifier="/us/sComp/114/268/s2/a/8/A/i/I" style="-uslm-dtd:subclause" styleType="OLC">
                                <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">total costs for management and administration;</content>
                            </subclause>
                            <subclause identifier="/us/sComp/114/268/s2/a/8/A/i/II" style="-uslm-dtd:subclause" styleType="OLC">
                                <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">total costs to ship vaccines;</content>
                            </subclause>
                            <subclause identifier="/us/sComp/114/268/s2/a/8/A/i/III" style="-uslm-dtd:subclause" styleType="OLC">
                                <num style="-uslm-dtd:enum" value="III">(III) </num><content style="-uslm-dtd:text">total number of full-time equivalents allocated to the program; and</content>
                            </subclause>
                            <subclause identifier="/us/sComp/114/268/s2/a/8/A/i/IV" style="-uslm-dtd:subclause" styleType="OLC">
                                <num style="-uslm-dtd:enum" value="IV">(IV) </num><content style="-uslm-dtd:text">total costs to the Strategic National Stockpile;</content>
                            </subclause>
                        </clause>
                        <clause identifier="/us/sComp/114/268/s2/a/8/A/ii" style="-uslm-dtd:clause" styleType="OLC">
                            <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">the number and percentage of eligible emergency response providers, as determined by each pilot location, that volunteer to participate;</content>
                        </clause>
                        <clause identifier="/us/sComp/114/268/s2/a/8/A/iii" style="-uslm-dtd:clause" styleType="OLC">
                            <num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">the degree to which participants complete the vaccine regimen;</content>
                        </clause>
                        <clause identifier="/us/sComp/114/268/s2/a/8/A/iv" style="-uslm-dtd:clause" styleType="OLC">
                            <num style="-uslm-dtd:enum" value="iv">(iv) </num><content style="-uslm-dtd:text">the total number of doses of vaccine administered; and</content>
                        </clause>
                        <clause identifier="/us/sComp/114/268/s2/a/8/A/v" style="-uslm-dtd:clause" styleType="OLC">
                            <num style="-uslm-dtd:enum" value="v">(v) </num><content style="-uslm-dtd:text">recommendations to improve initial and recurrent participation in the pilot program.</content>
                        </clause>
                    </subparagraph>
                    <subparagraph identifier="/us/sComp/114/268/s2/a/8/B" style="-uslm-dtd:subparagraph" styleType="OLC">
                        <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Final report.—</heading><chapeau style="-uslm-dtd:text">The final report required under subparagraph (A) shall—</chapeau>
                        <clause identifier="/us/sComp/114/268/s2/a/8/B/i" style="-uslm-dtd:clause" styleType="OLC">
                            <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">consider whether the pilot program required under this subsection should continue after the date described in subsection (c); and</content>
                        </clause>
                        <clause identifier="/us/sComp/114/268/s2/a/8/B/ii" style="-uslm-dtd:clause" styleType="OLC">
                            <num style="-uslm-dtd:enum" value="ii">(ii) </num><chapeau style="-uslm-dtd:text">include—</chapeau>
                            <subclause identifier="/us/sComp/114/268/s2/a/8/B/ii/I" style="-uslm-dtd:subclause" styleType="OLC">
                                <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">an analysis of the costs and benefits of continuing the program to provide anthrax vaccines to emergency response providers;</content>
                            </subclause>
                            <subclause identifier="/us/sComp/114/268/s2/a/8/B/ii/II" style="-uslm-dtd:subclause" styleType="OLC">
                                <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">an explanation of the economic, health, and other risks and benefits of administering vaccines through the pilot program rather than post-event treatment; and</content>
                            </subclause>
                            <subclause identifier="/us/sComp/114/268/s2/a/8/B/ii/III" style="-uslm-dtd:subclause" styleType="OLC">
                                <num style="-uslm-dtd:enum" value="III">(III) </num><content style="-uslm-dtd:text">in the case of a recommendation under clause (i) to continue the pilot program after the date described in subsection (c), a plan under which the pilot program could be continued.</content>
                            </subclause>
                        </clause>
                    </subparagraph>
                </paragraph>
            </subsection>
            <subsection identifier="/us/sComp/114/268/s2/b" style="-uslm-dtd:subsection" styleType="OLC">
                <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Deadline for Implementation.—</heading><content style="-uslm-dtd:text">Not later than 1 year after the date of enactment of this Act, the Secretary of Homeland Security shall begin implementing the pilot program under this section.</content>
            </subsection>
            <subsection identifier="/us/sComp/114/268/s2/c" style="-uslm-dtd:subsection" styleType="OLC">
                <num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Sunset.—</heading><content style="-uslm-dtd:text">The authority to carry out the pilot program under this section shall expire on the date that is 5 years after the date of enactment of this Act.</content>
            </subsection>
        </section>
    </main>
</statuteCompilation>