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Bill
Notes

S. 1915 — what changed

First Responder Anthrax Preparedness Act

From Reported in Senate to Engrossed in Senate. 1 section amended between Reported in Senate and Engrossed in Senate.

Sec. 2 Voluntary pre-event anthrax vaccination pilot program for emergency response providers

(a)
changed Anthrax preparedness—Pilot program—
(1)
changed In general—Establishment— Title V The Secretary of the Homeland Security Act Security, in coordination with the Secretary of 2002 (6 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. 311 et seq.) is amended by adding at 247d–6b(a)) that will be nearing the end of their labeled dates of use at the following new section: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.

removed “526. Anthrax preparedness

removed “(a) Pre-Event anthrax vaccination program for emergency response providers—For the purpose of domestic preparedness for and collective response to terrorism, the Secretary, in coordination with the Secretary of Health and Human Services, shall—

removed “(1) establish a program to provide 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 to be administered to emergency response providers who are at high risk of exposure to anthrax and who voluntarily consent to such administration;

removed “(2) establish any necessary logistical and tracking systems to facilitate making the vaccines described in paragraph (1) so available;

removed “(3) distribute disclosures regarding associated benefits and risks to end users; and

removed “(4) conduct outreach to educate emergency response providers about the voluntary program.

removed “(b) Threat assessment—The Secretary shall—

removed “(1) support homeland security-focused risk analysis and risk assessments of the threats posed by anthrax from an act of terror;

removed “(2) leverage existing and emerging homeland security intelligence capabilities and structures to enhance prevention, protection, response, and recovery efforts with respect to an anthrax terror attack; and

removed “(3) share information and provide tailored analytical support on threats posed by anthrax to State, local, and tribal authorities, as well as other national biosecurity and biodefense stakeholders.”

(2)
changed Clerical amendment—Determination— The table of contents in section 1(b) Secretary of such Act Health and Human Services shall determine whether an anthrax vaccine is amended by inserting at eligible to be provided to the end Secretary of the items relating to title V Homeland Security for the following new item:pilot program described in paragraph (1) based on—
(A)
added a determination that the vaccine is not otherwise allotted for other purposes;
(B)
added 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)
added such other considerations as determined appropriate by the Secretary of Health and Human Services.
(3)
added 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—
(b)
removed Pilot program—
(1)
removed In general— In carrying out the pre-event vaccination program authorized under section 526(a) of the Homeland Security Act of 2002, as added by subsection (a), the Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, shall carry out a pilot program to provide anthrax vaccines to emergency response providers as so authorized. The duration of the pilot program shall be 24 months from the date the initial vaccines are administered to participants.
(2)
removed Preliminary requirements— Prior to implementing the pilot program under paragraph (1), the Secretary of Homeland Security shall—
(A)
renumbered was (3)(3)(3) establish a communication platform for the pilot program;
(B)
added develop and deliver education and training for the pilot program;
(C)
added conduct economic analysis of the pilot program, including a preliminary estimate of total costs and expected benefits;
(D)
added create a logistical platform for the anthrax vaccine request process under the pilot program;
(E)
added establish goals and desired outcomes for the pilot program; and
(F)
added establish a mechanism to reimburse the Secretary of Health and Human Services for—
(i)
added 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)
added the amount, if any, by which the warehousing costs of the Strategic National Stockpile are increased in order to operate such pilot program.
(4)
added Location—
(A)
added 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)
added 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)
added 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)
added 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)
added materials regarding the associated benefits and risks of any vaccine provided under the pilot program, and of exposure to anthrax;
(B)
added additional material consistent with the Centers for Disease Control and Prevention’s clinical guidance; and
(C)
added notice that the Federal Government is not obligated to continue providing anthrax vaccine after the date on which the pilot program ends.
(7)
added 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)
added define the roles and responsibilities of each Department for the pilot program; and
(B)
added establish other performance metrics and policies for the pilot program, as appropriate.
(8)
added Report—
(A)
added 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)
added a detailed tabulation of the costs to administer the program, including—
(I)
added total costs for management and administration;
(II)
added total costs to ship vaccines;
(III)
added total number of full-time equivalents allocated to the program; and
(IV)
added total costs to the Strategic National Stockpile;
(ii)
added the number and percentage of eligible emergency response providers, as determined by each pilot location, that volunteer to participate;
(iii)
added the degree to which participants complete the vaccine regimen;
(iv)
added the total number of doses of vaccine administered; and
(B)
removed establish education and training modules for the pilot program;
(C)
removed conduct economic analysis of the pilot program; and
(D)
removed create a logistical platform for the anthrax vaccine request process under the pilot program.
(3)
removed Location— In carrying out the pilot program under this subsection, the Secretary of Homeland Security shall select emergency response providers based in not less than 2 States for participation in the pilot program.
(4)
removed Distribution of information— The Secretary of Homeland Security shall provide to each emergency response provider who participates in the pilot program under this subsection disclosures and educational materials regarding the associated benefits and risks of any vaccine provided under the pilot program and of exposure to anthrax.
(5)
removed Report—
(A)
removed In general— Not later than 1 year after the date of enactment of this Act, and annually thereafter until 1 year after the completion of the pilot program, the Secretary of Homeland Security 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 of the Senate a report on the progress and results of the pilot program, including—
(i)
removed the percentage of eligible emergency response providers, as determined by each pilot location, that volunteer to participate;
(ii)
removed the degree to which participants obtain necessary vaccinations, as appropriate; and
(v)
renumbered was (3)(6)(2)(5) recommendations to improve initial and recurrent participation in the pilot program.
(B)
added Final report— The final report required under subparagraph (A) shall—
(i)
added consider whether the pilot program required under this subsection should continue after the date described in subsection (c); and
(ii)
added include—
(I)
added an analysis of the costs and benefits of continuing the program to provide anthrax vaccines to emergency response providers;
(II)
added 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)
added 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)
added 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)
added 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.
(B)
removed Required plan— The report required under subparagraph (A) shall include a plan under which the Secretary plans to continue the program to provide vaccines to emergency response providers under section 526(a) of the Homeland Security Act of 2002, as added by subsection (a).
(6)
removed 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 subsection.