[Congressional Record (Bound Edition), Volume 162 (2016), Part 11]
[House]
[Pages 14710-14711]
[From the U.S. Government Publishing Office, www.gpo.gov]




                FIRST RESPONDER ANTHRAX PREPAREDNESS ACT

  Mr. KING of New York. Mr. Speaker, I ask unanimous consent to take 
from the Speaker's table the bill (S. 1915) to direct the Secretary of 
Homeland Security to make anthrax vaccines available to emergency 
response providers, and for other purposes, and ask for its immediate 
consideration in the House.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New York?
  There was no objection.
  The text of the bill is as follows:

                                S. 1915

       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;

[[Page 14711]]

       (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.

  The bill was ordered to be read a third time, was read the third 
time, and passed, and a motion to reconsider was laid on the table.

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