```

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1915 Engrossed in Senate (ES)]

<DOC>
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
114th CONGRESS
  2d Session
                                S. 1915

_______________________________________________________________________

                                 AN ACT

 
 To direct the Secretary of Homeland Security to make anthrax vaccines 
   available to emergency response providers, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. 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.

            Passed the Senate November 16, 2016.

            Attest:

                                                             Secretary.
114th CONGRESS

  2d Session

                                S. 1915

_______________________________________________________________________

                                 AN ACT

 To direct the Secretary of Homeland Security to make anthrax vaccines 
   available to emergency response providers, and for other purposes.
```