II Calendar No. 458 114th CONGRESS 2d Session S. 1915 [Report No. 114–251] IN THE SENATE OF THE UNITED STATES August 3, 2015 Ms. Ayotte (for herself, Mr. Booker , Mr. Coons , Mrs. Feinstein , Mr. Hoeven , Mr. Wicker , Mr. Rounds , Ms. Baldwin , Mr. Cochran , Mrs. Capito , Mr. Peters , Mr. Casey , Mr. Cardin , Mr. Gardner , Mr. Barrasso , Mr. Donnelly , Mr. Daines , and Mr. Kirk ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs May 9, 2016 Reported by Mr. Johnson , with an amendment and an amendment to the title Strike out all after the enacting clause and insert the part printed in italic A BILL To direct the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers, and for other purposes.

1. Short title This Act may be cited as the First Responder Anthrax Preparedness Act . 2. Pre-event anthrax vaccination program for emergency response providers (a) Anthrax preparedness (1) In general Title V of the Homeland Security Act of 2002 ( 6 U.S.C. 311 et seq. ) is amended by adding at the end the following new section: 526. Anthrax preparedness (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— (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; (2) establish any necessary logistical and tracking systems to facilitate making the vaccines described in paragraph (1) so available; (3) distribute disclosures regarding associated benefits and risks to end users; and (4) conduct outreach to educate emergency response providers about the voluntary program. (b) Threat assessment The Secretary shall— (1) support homeland security-focused risk analysis and risk assessments of the threats posed by anthrax from an act of terror; (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 (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) Clerical amendment The table of contents in section 1(b) of such Act is amended by inserting at the end of the items relating to title V the following new item: Sec. 526. Anthrax preparedness. . (b) Pilot program (1) 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) Preliminary requirements Prior to implementing the pilot program under paragraph (1), the Secretary of Homeland Security shall— (A) establish a communication platform for the pilot program; (B) establish education and training modules for the pilot program; (C) conduct economic analysis of the pilot program; and (D) create a logistical platform for the anthrax vaccine request process under the pilot program. (3) 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) 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) Report (A) 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) the percentage of eligible emergency response providers, as determined by each pilot location, that volunteer to participate; (ii) the degree to which participants obtain necessary vaccinations, as appropriate; and (iii) recommendations to improve initial and recurrent participation in the pilot program. (B) 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) 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.

1. Short title This Act may be cited as the First Responder Anthrax Preparedness Act . 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 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. (2) Duration The duration of the pilot program required under paragraph (1) shall be 36 months beginning on the date on which the initial vaccines are administered. (3) Preliminary requirements Before implementing the pilot program under paragraph (1), 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 an 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; and (E) establish goals and desired outcomes for the pilot program. (4) 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 nor more than 5 States for participation in the pilot program. (5) Guidance for selection To ensure that participation in the pilot program strategically increases State and local response readiness for 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 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, consistent with Centers for Disease Control and Prevention clinical guidance, and of exposure to anthrax, including notice that the Federal Government is not obligated to continue providing anthrax vaccines after the pilot program has ended. (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 or policies, as appropriate. (8) Report (A) In general 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, 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; and (III) the total number of full-time equivalents allocated to the program; (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 obtain the necessary vaccinations; (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 include an analysis of the costs and benefits of continuing the program to provide anthrax vaccines to emergency response providers, an explanation of the economic, health, and other benefits of administering vaccines through the pilot program rather than post-event treatment, and a plan under which the 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.

Amend the title so as to read: A bill to direct the Secretary of Homeland Security to make anthrax vaccines available to emergency response providers, and for other purposes. .

May 9, 2016 Reported with an amendment and an amendment to the title