114TH CONGRESS 

2D SESSION S. 1915 

AN ACT 

To direct the Secretary of Homeland Security to make anthrax vaccines available to emergency response providers, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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†S 1915 ES

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘First Responder An3 thrax Preparedness Act’’. 

4 SEC. 2. VOLUNTARY PRE-EVENT ANTHRAX VACCINATION 

5 PILOT PROGRAM FOR EMERGENCY RE6 SPONSE PROVIDERS. 

7 (a) PILOT PROGRAM.— 

8 (1) ESTABLISHMENT.—The Secretary of Home9 land Security, in coordination with the Secretary of 

10 Health and Human Services, shall carry out a pilot 

11 program to provide eligible anthrax vaccines from 

12 the Strategic National Stockpile under section 

13 319F–2(a) of the Public Health Service Act (42 

14 U.S.C. 247d–6b(a)) that will be nearing the end of 

15 their labeled dates of use at the time such vaccines 

16 are made available to States for administration to 

17 emergency response providers who would be at high 

18 risk of exposure to anthrax if such an attack should 

19 occur and who voluntarily consent to such adminis20 tration. 

21 (2) DETERMINATION.—The Secretary of Health 

22 and Human Services shall determine whether an an23 thrax vaccine is eligible to be provided to the Sec24 retary of Homeland Security for the pilot program 

25 described in paragraph (1) based on— 
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1 (A) a determination that the vaccine is not 

2 otherwise allotted for other purposes; 

3 (B) a determination that the provision of 

4 the vaccine will not reduce, or otherwise ad5 versely affect, the capability to meet projected 

6 requirements for this product during a public 

7 health emergency, including a significant reduc8 tion of available quantities of vaccine in the 

9 Strategic National Stockpile; and 

10 (C) such other considerations as deter11 mined appropriate by the Secretary of Health 

12 and Human Services. 

13 (3) PRELIMINARY REQUIREMENTS.—Before im14 plementing the pilot program required under this 

15 subsection, the Secretary of Homeland Security, in 

16 coordination with the Secretary of Health and 

17 Human Services, shall— 

18 (A) establish a communication platform for 

19 the pilot program; 

20 (B) develop and deliver education and 

21 training for the pilot program; 

22 (C) conduct economic analysis of the pilot 

23 program, including a preliminary estimate of 

24 total costs and expected benefits; 
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1 (D) create a logistical platform for the an2 thrax vaccine request process under the pilot 

3 program; 

4 (E) establish goals and desired outcomes 

5 for the pilot program; and 

6 (F) establish a mechanism to reimburse 

7 the Secretary of Health and Human Services 

8 for— 

9 (i) the costs of shipment and trans10 portation of such vaccines provided to the 

11 Secretary of Homeland Security from the 

12 Strategic National Stockpile under such 

13 pilot program, including staff time directly 

14 supporting such shipment and transpor15 tation; and 

16 (ii) the amount, if any, by which the 

17 warehousing costs of the Strategic Na18 tional Stockpile are increased in order to 

19 operate such pilot program. 

20 (4) LOCATION.— 

21 (A) IN GENERAL.—In carrying out the 

22 pilot program required under this subsection, 

23 the Secretary of Homeland Security shall select 

24 not fewer than 2 nor more than 5 States for 

25 voluntary participation in the pilot program. 
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1 (B) REQUIREMENT.—Each State that par2 ticipates in the pilot program under this sub3 section shall ensure that such participation is 

4 consistent with the All-Hazards Public Health 

5 Emergency Preparedness and Response Plan of 

6 the State developed under section 319C–1 of 

7 the Public Health Service Act (42 U.S.C. 

8 247d–3a). 

9 (5) GUIDANCE FOR SELECTION.—To ensure 

10 that participation in the pilot program under this 

11 subsection strategically increases State and local re12 sponse readiness in the event of an anthrax release, 

13 the Secretary of Homeland Security, in coordination 

14 with the Secretary of Health and Human Services, 

15 shall provide guidance to participating States and 

16 units of local government on identifying emergency 

17 response providers who are at high risk of exposure 

18 to anthrax. 

19 (6) DISTRIBUTION OF INFORMATION.—The 

20 Secretary of Homeland Security shall require that 

21 each State that participates in the pilot program 

22 under this subsection submit a written certification 

23 to the Secretary of Homeland Security stating that 

24 each emergency response provider within the State 

25 that participates in the pilot program is provided 
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1 with disclosures and educational materials des2 ignated by the Secretary of Health and Human 

3 Services, which may include— 

4 (A) materials regarding the associated ben5 efits and risks of any vaccine provided under 

6 the pilot program, and of exposure to anthrax; 

7 (B) additional material consistent with the 

8 Centers for Disease Control and Prevention’s 

9 clinical guidance; and 

10 (C) notice that the Federal Government is 

11 not obligated to continue providing anthrax vac12 cine after the date on which the pilot program 

13 ends. 

14 (7) MEMORANDUM OF UNDERSTANDING.—Be15 fore implementing the pilot program under this sub16 section, the Secretary of Homeland Security shall 

17 enter into a memorandum of understanding with the 

18 Secretary of Health and Human Services to— 

19 (A) define the roles and responsibilities of 

20 each Department for the pilot program; and 

21 (B) establish other performance metrics 

22 and policies for the pilot program, as appro23 priate. 

24 (8) REPORT.— 
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1 (A) IN GENERAL.—Notwithstanding sub2 section (c), not later than 1 year after the date 

3 on which the initial vaccines are administered 

4 under this section, and annually thereafter until 

5 1 year after the completion of the pilot program 

6 under this section, the Secretary of Homeland 

7 Security, in coordination with the Secretary of 

8 Health and Human Services, shall submit to 

9 the Committee on Homeland Security and the 

10 Committee on Energy and Commerce of the 

11 House of Representatives and the Committee 

12 on Homeland Security and Governmental Af13 fairs and the Committee on Health, Education, 

14 Labor, and Pensions of the Senate a report on 

15 the progress and results of the pilot program, 

16 including— 

17 (i) a detailed tabulation of the costs to 

18 administer the program, including— 

19 (I) total costs for management 

20 and administration; 

21 (II) total costs to ship vaccines; 

22 (III) total number of full-time 

23 equivalents allocated to the program; 

24 and 
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1 (IV) total costs to the Strategic 

2 National Stockpile; 

3 (ii) the number and percentage of eli4 gible emergency response providers, as de5 termined by each pilot location, that volun6 teer to participate; 

7 (iii) the degree to which participants 

8 complete the vaccine regimen; 

9 (iv) the total number of doses of vac10 cine administered; and 

11 (v) recommendations to improve ini12 tial and recurrent participation in the pilot 

13 program. 

14 (B) FINAL REPORT.—The final report re15 quired under subparagraph (A) shall— 

16 (i) consider whether the pilot program 

17 required under this subsection should con18 tinue after the date described in subsection 

19 (c); and 

20 (ii) include— 

21 (I) an analysis of the costs and 

22 benefits of continuing the program to 

23 provide anthrax vaccines to emergency 

24 response providers; 
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1 (II) an explanation of the eco2 nomic, health, and other risks and 

3 benefits of administering vaccines 

4 through the pilot program rather than 

5 post-event treatment; and 

6 (III) in the case of a rec7 ommendation under clause (i) to con8 tinue the pilot program after the date 

9 described in subsection (c), a plan 

10 under which the pilot program could 

11 be continued. 

12 (b) DEADLINE FOR IMPLEMENTATION.—Not later 

13 than 1 year after the date of enactment of this Act, the 

14 Secretary of Homeland Security shall begin implementing 

15 the pilot program under this section. 

16 (c) SUNSET.—The authority to carry out the pilot 

17 program under this section shall expire on the date that 

18 is 5 years after the date of enactment of this Act. 

Passed the Senate November 16, 2016. 

Attest: 

Secretary. 
114TH CONGRESS 

2D SESSION S. 1915 

AN ACT 

To direct the Secretary of Homeland Security to 

sponse providers, and for other purposes. make anthrax vaccines available to emergency re-