[Congressional Record Volume 162, Number 164 (Wednesday, November 16, 2016)]
[Senate]
[Pages S6416-S6417]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 5109. Mr. McCONNELL (for Ms. Ayotte) proposed an amendment to the
bill S. 1915, to direct the Secretary of Homeland Security to make
anthrax vaccines available to emergency response providers, and for
other purposes; as follows:
Strike all after the enacting clause and insert the
following:
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
[[Page S6417]]
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.
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