[United States Statutes at Large, Volume 130, 114th Congress, 2nd Session]
[From the U.S. Government Publishing Office, www.gpo.gov]


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. <>

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;

[[Page 1388]]

(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--

[[Page 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) <>
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.

[[Page 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.