First Responder Anthrax Preparedness Act

Summary: (This measure has not been amended since it was passed by the Senate on November 16, 2016.  First Responder Anthrax Preparedness Act (Sec. 2) This bill requires the Department of Homeland Security (DHS), in coordination with the Department of Health and Human Services (HHS), to carry out a pilot program to provide eligible anthrax vaccines nearing the end of their labeled dates of use from the strategic national stockpile to emergency response providers who would be at high risk of exposure to anthrax if an attack should occur and who voluntarily consent.  HHS shall determine whether an anthrax vaccine is eligible to be provided to DHS for the program based on determinations that: (1) the vaccine is not otherwise allotted for other purposes; and (2) the provision of the vaccine will not reduce or otherwise adversely affect the capability to meet projected requirements for such product during a public health emergency. DHS shall establish a communication platform, develop and deliver education and training, conduct an economic analysis, create a logistical platform, establish goals and desired outcomes for the program, and establish a mechanism to reimburse HHS for the costs of shipment and transportation of such vaccines provided to DHS under such program and the amount by which the warehousing costs of the stockpile are increased in order to operate such program. DHS must: (1) select between two and five states for voluntary participation in the program; (2) provide guidance to participating states and local governments on identifying providers who are at high risk of exposure; and (3) require each participating state to submit a written certification that each participating emergency response provider is provided with disclosures and educational materials regarding the associated benefits and risks of any vaccine provided and of exposure to anthrax, additional material consistent with the Centers for Disease Control and Prevention's clinical guidance, and notice that the federal government is not obligated to continue providing anthrax vaccine after the program ends. Each state that participates in the program shall ensure that such participation is consistent with the state's All-Hazards Public Health Emergency Preparedness and Response Plan. DHS shall enter into a memorandum of understanding with HHS to: (1) define each department's roles and responsibilities, and (2) establish appropriate performance metrics and policies for the program. DHS must submit annual reports on program progress and results, which shall include the costs to administer the program, the number and percentage of eligible providers that volunteer to participate, the degree to which participants complete the vaccine regimen, the total number of doses of vaccine administered, and recommendations to improve participation.  The final report shall consider whether the program should continue beyond five years after enactment of this bill and shall include: (1) an analysis of the costs and benefits of continuing the program; (2) an explanation of the economic, health, and other risks and benefits of administering vaccines through the program rather than post-event treatment; and (3) a plan under which the program could be continued.

SECTION 1. SHORT TITLE.
    This Act may be cited as the ``First Responder Anthrax Preparedness 
Act''.
SEC. 2. VOLUNTARY PRE-EVENT ANTHRAX VACCINATION PILOT PROGRAM FOR 
EMERGENCY RESPONSE PROVIDERS.
    (a) Pilot Program.--
        (1) Establishment.--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.
        (2) Determination.--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--
            (A) a determination that the vaccine is not otherwise 
        allotted for other purposes;
            (B) 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
            (C) such other considerations as determined appropriate by 
        the Secretary of Health and Human Services.
        (3) Preliminary requirements.--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--
            (A) establish a communication platform for the pilot 
        program;
            (B) develop and deliver education and training for the 
        pilot program;
            (C) conduct economic analysis of the pilot program, 
        including a preliminary estimate of total costs and expected 
        benefits;
            (D) create a logistical platform for the anthrax vaccine 
        request process under the pilot program;
            (E) establish goals and desired outcomes for the pilot 
        program; and
            (F) establish a mechanism to reimburse the Secretary of 
        Health and Human Services for--
                (i) 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
                (ii) the amount, if any, by which the warehousing costs 
            of the Strategic National Stockpile are increased in order 
            to operate such pilot program.
        (4) Location.--
            (A) In general.--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.
            (B) Requirement.--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).
        (5) Guidance for selection.--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.
        (6) Distribution of information.--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--
            (A) materials regarding the associated benefits and risks 
        of any vaccine provided under the pilot program, and of 
        exposure to anthrax;
            (B) additional material consistent with the Centers for 
        Disease Control and Prevention's clinical guidance; and
            (C) notice that the Federal Government is not obligated to 
        continue providing anthrax vaccine after the date on which the 
        pilot program ends.
        (7) Memorandum of understanding.--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--
            (A) define the roles and responsibilities of each 
        Department for the pilot program; and
            (B) establish other performance metrics and policies for 
        the pilot program, as appropriate.
        (8) Report.--
            (A) In general.--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--
                (i) a detailed tabulation of the costs to administer 
            the program, including--

                    (I) total costs for management and administration;
                    (II) total costs to ship vaccines;
                    (III) total number of full-time equivalents 
                allocated to the program; and
                    (IV) total costs to the Strategic National 
                Stockpile;

                (ii) the number and percentage of eligible emergency 
            response providers, as determined by each pilot location, 
            that volunteer to participate;
                (iii) the degree to which participants complete the 
            vaccine regimen;
                (iv) the total number of doses of vaccine administered; 
            and
                (v) recommendations to improve initial and recurrent 
            participation in the pilot program.
            (B) Final report.--The final report required under 
        subparagraph (A) shall--
                (i) consider whether the pilot program required under 
            this subsection should continue after the date described in 
            subsection (c); and
                (ii) include--

                    (I) an analysis of the costs and benefits of 
                continuing the program to provide anthrax vaccines to 
                emergency response providers;
                    (II) an explanation of the economic, health, and 
                other risks and benefits of administering vaccines 
                through the pilot program rather than post-event 
                treatment; and
                    (III) 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.

    (b) Deadline for Implementation.--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.
    (c) Sunset.--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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.