II 

Calendar No. 458 

114TH CONGRESS 

2D SESSION S. 1915 

[Report No. 114–251] 

To direct the Secretary of Homeland Security to make anthrax vaccines 

and antimicrobials available to emergency response providers, and for 

other purposes. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

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

4 SEC. 2. PRE-EVENT ANTHRAX VACCINATION PROGRAM FOR 

5 EMERGENCY RESPONSE PROVIDERS. 

6 (a) ANTHRAX PREPAREDNESS.— 

7 (1) IN GENERAL.—Title V of the Homeland Se8 curity Act of 2002 (6 U.S.C. 311 et seq.) is amend9 ed by adding at the end the following new section: 

10 ‘‘SEC. 526. ANTHRAX PREPAREDNESS. 

11 ‘‘(a) PRE-EVENT ANTHRAX VACCINATION PROGRAM

12 FOR EMERGENCY RESPONSE PROVIDERS.—For the pur13 pose of domestic preparedness for and collective response 

14 to terrorism, the Secretary, in coordination with the Sec15 retary of Health and Human Services, shall— 

16 ‘‘(1) establish a program to provide anthrax 

17 vaccines from the strategic national stockpile under 

18 section 319F–2(a) of the Public Health Service Act 

19 (42 U.S.C. 247d–6b(a)) that will be nearing the end 

20 of their labeled dates of use at the time such vac21 cines are to be administered to emergency response 

22 providers who are at high risk of exposure to an23 thrax and who voluntarily consent to such adminis24 tration; 


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1 ‘‘(2) establish any necessary logistical and 

2 tracking systems to facilitate making the vaccines 

3 described in paragraph (1) so available; 

4 ‘‘(3) distribute disclosures regarding associated 

5 benefits and risks to end users; and 

6 ‘‘(4) conduct outreach to educate emergency re7 sponse providers about the voluntary program. 

8 ‘‘(b) THREAT ASSESSMENT.—The Secretary shall— 

9 ‘‘(1) support homeland security-focused risk 

10 analysis and risk assessments of the threats posed 

11 by anthrax from an act of terror; 

12 ‘‘(2) leverage existing and emerging homeland 

13 security intelligence capabilities and structures to 

14 enhance prevention, protection, response, and recov15 ery efforts with respect to an anthrax terror attack; 

16 and 

17 ‘‘(3) share information and provide tailored an18 alytical support on threats posed by anthrax to 

19 State, local, and tribal authorities, as well as other 

20 national biosecurity and biodefense stakeholders.’’. 

21 (2) CLERICAL AMENDMENT.—The table of con22 tents in section 1(b) of such Act is amended by in23 serting at the end of the items relating to title V the 

24 following new item: 

‘‘Sec. 526. Anthrax preparedness.’’. 

25 (b) PILOT PROGRAM.— 


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1 (1) IN GENERAL.—In carrying out the pre2 event vaccination program authorized under section 

3 526(a) of the Homeland Security Act of 2002, as 

4 added by subsection (a), the Secretary of Homeland 

5 Security, in coordination with the Secretary of 

6 Health and Human Services, shall carry out a pilot 

7 program to provide anthrax vaccines to emergency 

8 response providers as so authorized. The duration of 

9 the pilot program shall be 24 months from the date 

10 the initial vaccines are administered to participants. 

11 (2) PRELIMINARY REQUIREMENTS.—Prior to 

12 implementing the pilot program under paragraph 

13 (1), the Secretary of Homeland Security shall— 

14 (A) establish a communication platform for 

15 the pilot program; 

16 (B) establish education and training mod17 ules for the pilot program; 

18 (C) conduct economic analysis of the pilot 

19 program; and 

20 (D) create a logistical platform for the an21 thrax vaccine request process under the pilot 

22 program. 

23 (3) LOCATION.—In carrying out the pilot pro24 gram under this subsection, the Secretary of Home25 land Security shall select emergency response proVerDate Sep 11 2014 22:53 May 09, 2016 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6401 E:\BILLS\S1915.RS S1915

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1 viders based in not less than 2 States for participa2 tion in the pilot program. 

3 (4) DISTRIBUTION OF INFORMATION.—The 

4 Secretary of Homeland Security shall provide to 

5 each emergency response provider who participates 

6 in the pilot program under this subsection disclo7 sures and educational materials regarding the asso8 ciated benefits and risks of any vaccine provided 

9 under the pilot program and of exposure to anthrax. 

10 (5) REPORT.— 

11 (A) IN GENERAL.—Not later than 1 year 

12 after the date of enactment of this Act, and an13 nually thereafter until 1 year after the comple14 tion of the pilot program, the Secretary of 

15 Homeland Security shall submit to the Com16 mittee on Homeland Security and the Com17 mittee on Energy and Commerce of the House 

18 of Representatives and the Committee on 

19 Homeland Security and Governmental Affairs 

20 of the Senate a report on the progress and re21 sults of the pilot program, including— 

22 (i) the percentage of eligible emer23 gency response providers, as determined by 

24 each pilot location, that volunteer to par25 ticipate; 


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1 (ii) the degree to which participants 

2 obtain necessary vaccinations, as appro3 priate; and 

4 (iii) recommendations to improve ini5 tial and recurrent participation in the pilot 

6 program. 

7 (B) REQUIRED PLAN.—The report re8 quired under subparagraph (A) shall include a 

9 plan under which the Secretary plans to con10 tinue the program to provide vaccines to emer11 gency response providers under section 526(a) 

12 of the Homeland Security Act of 2002, as 

13 added by subsection (a). 

14 (6) DEADLINE FOR IMPLEMENTATION.—Not 

15 later than 1 year after the date of enactment of this 

16 Act, the Secretary of Homeland Security shall begin 

17 implementing the pilot program under this sub18 section. 

19 SECTION 1. SHORT TITLE. 

20 This Act may be cited as the ‘‘First Responder Anthrax 

21 Preparedness Act’’. 

22 SEC. 2. VOLUNTARY PRE-EVENT ANTHRAX VACCINATION 

23 PILOT PROGRAM FOR EMERGENCY RESPONSE 

24 PROVIDERS. 

25 (a) PILOT PROGRAM.— 


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1 (1) ESTABLISHMENT.—The Secretary of Home2 land Security, in coordination with the Secretary of 

3 Health and Human Services, shall carry out a pilot 

4 program to provide anthrax vaccines from the stra5 tegic national stockpile under section 319F–2(a) of 

6 the Public Health Service Act (42 U.S.C. 247d–6b(a)) 

7 that will be nearing the end of their labeled dates of 

8 use at the time such vaccines are to be administered 

9 to emergency response providers who are at high risk 

10 of exposure to anthrax and who voluntarily consent 

11 to such administration. 

12 (2) DURATION.—The duration of the pilot pro13 gram required under paragraph (1) shall be 36 

14 months beginning on the date on which the initial 

15 vaccines are administered. 

16 (3) PRELIMINARY REQUIREMENTS.—Before im17 plementing the pilot program under paragraph (1), 

18 the Secretary of Homeland Security, in coordination 

19 with the Secretary of Health and Human Services, 

20 shall— 

21 (A) establish a communication platform for 

22 the pilot program; 

23 (B) develop and deliver education and 

24 training for the pilot program; 


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1 (C) conduct an economic analysis of the 

2 pilot program, including a preliminary estimate 

3 of total costs and expected benefits; 

4 (D) create a logistical platform for the an5 thrax vaccine request process under the pilot pro6 gram; and 

7 (E) establish goals and desired outcomes for 

8 the pilot program. 

9 (4) LOCATION.—In carrying out the pilot pro10 gram under this subsection, the Secretary of Home11 land Security shall select emergency response pro12 viders based in not less than 2 nor more than 5 

13 States for participation in the pilot program. 

14 (5) GUIDANCE FOR SELECTION.—To ensure that 

15 participation in the pilot program strategically in16 creases State and local response readiness for an an17 thrax release, the Secretary of Homeland Security, in 

18 coordination with the Secretary of Health and 

19 Human Services, shall provide guidance to partici20 pating States and units of local government on iden21 tifying emergency response providers who are at high 

22 risk of exposure to anthrax. 

23 (6) DISTRIBUTION OF INFORMATION.—The Sec24 retary of Homeland Security shall provide to each 

25 emergency response provider who participates in the 


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1 pilot program under this subsection disclosures and 

2 educational materials regarding the associated bene3 fits and risks of any vaccine provided under the pilot 

4 program, consistent with Centers for Disease Control 

5 and Prevention clinical guidance, and of exposure to 

6 anthrax, including notice that the Federal Govern7 ment is not obligated to continue providing anthrax 

8 vaccines after the pilot program has ended. 

9 (7) MEMORANDUM OF UNDERSTANDING.—Before 

10 implementing the pilot program under this sub11 section, the Secretary of Homeland Security shall 

12 enter into a memorandum of understanding with the 

13 Secretary of Health and Human Services to— 

14 (A) define the roles and responsibilities of 

15 each Department for the pilot program; and 

16 (B) establish other performance metrics or 

17 policies, as appropriate. 

18 (8) REPORT.— 

19 (A) IN GENERAL.—Not later than 1 year 

20 after the date on which the initial vaccines are 

21 administered under this section, and annually 

22 thereafter until 1 year after the completion of the 

23 pilot program, the Secretary of Homeland Secu24 rity, in coordination with the Secretary of 

25 Health and Human Services, shall submit to the 


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1 Committee on Homeland Security and the Com2 mittee on Energy and Commerce of the House of 

3 Representatives and the Committee on Homeland 

4 Security and Governmental Affairs and the 

5 Committee on Health, Education, Labor, and 

6 Pensions of the Senate a report on the progress 

7 and results of the pilot program, including— 

8 (i) a detailed tabulation of the costs to 

9 administer the program, including— 

10 (I) total costs for management 

11 and administration; 

12 (II) total costs to ship vaccines; 

13 and 

14 (III) the total number of full-time 

15 equivalents allocated to the program; 

16 (ii) the number and percentage of eligi17 ble emergency response providers, as deter18 mined by each pilot location, that volunteer 

19 to participate; 

20 (iii) the degree to which participants 

21 obtain the necessary vaccinations; 

22 (iv) the total number of doses of vac23 cine administered; and 


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1 (v) recommendations to improve initial 

2 and recurrent participation in the pilot 

3 program. 

4 (B) FINAL REPORT.—The final report re5 quired under subparagraph (A) shall include an 

6 analysis of the costs and benefits of continuing 

7 the program to provide anthrax vaccines to 

8 emergency response providers, an explanation of 

9 the economic, health, and other benefits of ad10 ministering vaccines through the pilot program 

11 rather than post-event treatment, and a plan 

12 under which the program could be continued. 

13 (b) DEADLINE FOR IMPLEMENTATION.—Not later than 

14 1 year after the date of enactment of this Act, the Secretary 

15 of Homeland Security shall begin implementing the pilot 

16 program under this section. 

17 (c) SUNSET.—The authority to carry out the pilot pro18 gram under this section shall expire on the date that is 5 

19 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.’’. 


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Calendar No. 458 

114TH CONGRESS 

2D SESSION S. 1915 

[Report No. 114–251] 

A BILL 

To direct the Secretary of Homeland Security to 

other purposes. able to emergency response providers, and for make anthrax vaccines and antimicrobials availMAY 9, 2016 

Reported with an amendment and an amendment to the 

title 


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