[114th Congress Public Law 268]
[From the U.S. Government Publishing Office]



[[Page 130 STAT. 1387]]

Public Law 114-268
114th Congress

                                 An Act


 
 To direct the Secretary of Homeland Security to make anthrax vaccines 
        available to emergency response providers, and for other 
             purposes. <<NOTE: Dec. 14, 2016 -  [S. 1915]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: First Responder 
Anthrax Preparedness Act. 42 USC 247d-6b.>> 
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) <<NOTE: Coordination.>>  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) <<NOTE: Coordination.>>  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;

[[Page 130 STAT. 1388]]

                    (C) <<NOTE: Analysis.>>  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) <<NOTE: Reimbursement.>>  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) <<NOTE: State and local governments.>>  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) <<NOTE: Coordination.>>  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--

[[Page 130 STAT. 1389]]

                    (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) <<NOTE: Recommenda- tions.>>  
                      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) <<NOTE: Analysis.>>  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.

[[Page 130 STAT. 1390]]

    (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.

    Approved December 14, 2016.

LEGISLATIVE HISTORY--S. 1915 (H.R. 1300):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 114-222, Pt. 1 (Comm. on Homeland Security) 
accompanying H.R. 1300.
SENATE REPORTS: No. 114-251 (Comm. on Homeland Security and Governmental 
Affairs).
CONGRESSIONAL RECORD, Vol. 162 (2016):
            Nov. 16, considered and passed Senate.
            Nov. 29, considered and passed House.

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