PUBLIC LAW 114–268—DEC. 14, 2016 130 STAT. 1387 

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; 

Coordination. 

Coordination. 

First Responder 

Anthrax 

Preparedness 

Act. 

42 USC 247d–6b. 

Dec. 14, 2016 

[S. 1915] 


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130 STAT. 1388 PUBLIC LAW 114–268—DEC. 14, 2016 

(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— 

Coordination. 

State and local 

governments. 

Reimbursement. 

Analysis. 


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PUBLIC LAW 114–268—DEC. 14, 2016 130 STAT. 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 postevent 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. 

Analysis. 

Recommendations. 


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130 STAT. 1390 PUBLIC LAW 114–268—DEC. 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. 

Æ 

(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. 


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