U.S. GOVERNMENT PUBLISHING OFFICE

WASHINGTON : 

1 

59–010 

" ! SENATE 

114TH CONGRESS

2d Session 

REPORT

2016

114–251 

Calendar No. 458 

FIRST RESPONDER ANTHRAX 

PREPAREDNESS ACT 

R E P O R T 

OF THE

COMMITTEE ON HOMELAND SECURITY AND 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE 

TO ACCOMPANY

S. 1915 

TO DIRECT THE SECRETARY OF HOMELAND SECURITY TO MAKE 

ANTHRAX VACCINES AND ANTIMICROBIALS AVAILABLE TO 

EMERGENCY RESPONSE PROVIDERS, AND FOR OTHER PURPOSES 

MAY 9, 2016.—Ordered to be printed 


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(II) 

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

RON JOHNSON, Wisconsin, Chairman 

JOHN MCCAIN, Arizona 

ROB PORTMAN, Ohio 

RAND PAUL, Kentucky 

JAMES LANKFORD, Oklahoma 

MICHAEL B. ENZI, Wyoming 

KELLY AYOTTE, New Hampshire 

JONI ERNST, Iowa 

BEN SASSE, Nebraska 

THOMAS R. CARPER, Delaware 

CLAIRE MCCASKILL, Missouri 

JON TESTER, Montana 

TAMMY BALDWIN, Wisconsin 

HEIDI HEITKAMP, North Dakota 

CORY A. BOOKER, New Jersey 

GARY C. PETERS, Michigan 

CHRISTOPHER R. HIXON, Staff Director 

GABRIELLE D’ADAMO SINGER, Chief Counsel 

DAVID S. LUCKEY, Director of Homeland Security 

BROOKE N. ERICSON, Chief Counsel for Homeland Security 

COLLEEN E. BERNY, Research Assistant 

GABRIELLE A. BATKIN, Minority Staff Director 

JOHN P. KILVINGTON, Minority Deputy Staff Director 

MARY BETH SCHULTZ, Minority Chief Counsel 

ROBERT H. BRADLEY II, Minority Professional Staff Member 

LAURA W. KILBRIDE, Chief Clerk 


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Calendar No. 458 

114TH CONGRESS SENATE REPORT " ! 2d Session 114–251 

FIRST RESPONDER ANTHRAX PREPAREDNESS ACT 

MAY 9, 2016.—Ordered to be printed 

Mr. JOHNSON, from the Committee on Homeland Security and 

Governmental Affairs, submitted the following 

R E P O R T 

[To accompany S. 1915] 

The Committee on Homeland Security and Governmental Affairs, 

to which was referred the bill (S. 1915) to direct the Secretary of 

Homeland Security to make anthrax vaccines and antimicrobials 

available to emergency response providers, and for other purposes, 

having considered the same, reports favorably thereon with an 

amendment and an amendment to the title and recommends that 

the bill, as amended, do pass. 

CONTENTS 

Page 

I. Purpose and Summary .................................................................................. 1 

II. Background and Need for the Legislation ................................................... 2 

III. Legislative History ......................................................................................... 4 

IV. Section-by-Section Analysis .......................................................................... 4 

V. Evaluation of Regulatory Impact .................................................................. 5 

VI. Congressional Budget Office Cost Estimate ................................................ 6 

VII. Changes in Existing Law Made by the Bill, as Reported ........................... 7 

I. PURPOSE AND SUMMARY

The purpose of S. 1915, the First Responder Anthrax Preparedness Act, as reported by the Committee, is to require the Secretary 

of the Department of Homeland Security (‘‘DHS’’ or ‘‘the Department’’) to establish a pilot program to make available anthrax vaccines that are in the Strategic National Stockpile (SNS) and reaching the end of their labeled dates of use to emergency response providers. The program will be coordinated with the Secretary of the 

Department of Health and Human Services (HHS). 


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1 U.S. DEP’T OF HEALTH AND HUMAN SERVICES, CENTERS FOR DISEASE CONTROL AND PREVEN- TION, STRATEGIC NATIONAL STOCKPILE, available at http://www.cdc.gov/phpr/stockpile/stockpile.htm; see also GOV’T ACCOUNTABILITY OFFICE, GAO–14–690, NATIONAL PREPAREDNESS: HHS IS MONITORING THE PROGRESS OF ITS MEDICAL COUNTERMEASURE EFFORTS BUT HAS NOT PRO- VIDED PREVIOUSLY RECOMMENDED SPENDING ESTIMATES 2 (2014), available at http://gao.gov/assets/660/659949.pdf. 2Memorandum from Michael Chertoff, U.S. Sec’y of Homeland Security, to Michael O. Leavitt, 

U.S. Sec’y of Health and Human Services (Sept. 23, 2008), available at http://www.dhs.gov/ 

xlibrary/assets/ofsec_signed_determination092308.pdf. 3 U.S. DEP’T OF HEALTH AND HUMAN SERVICES, OFFICE OF THE ASSISTANT SEC’Y FOR PREPAREDNESS AND RESPONSE, PROJECT BIOSHIELD ANNUAL REPORT TO CONGRESS: JANUARY 2011– 

DECEMBER 2011 4 (undated), available at https://www.medicalcountermeasures.gov/media/10061/ 

pbs_report_2011_final_9-6-2012.pdf. 4 Emergent BioSolutions Receives Award to Supply 44.75 Million Doses of BioThrax to U.S. 

Government over Five Years, Emergent BioSolutions, Inc. (Oct. 3, 2011), available at http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-newsArticle&ID=1612431. 5 Id. 

6 U.S. Food and Drug Admin., Complete List of Vaccines Licensed for Immunization and Distribution in the U.S. (last updated Dec. 3, 2015), available at http://www.fda.gov/ 

BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm; see also U.S. Food and Drug 

Admin., BioThrax (last updated Dec. 1, 2015), available at http://www.fda.gov/ 

BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm133822.htm. 7 Id. 

8 U.S. FOOD AND DRUG ADMIN., PACKAGE INSERT AND INFORMATION FOR PATIENTS—BIOTHRAX

1 (Nov. 2015), available at http://www.fda.gov/downloads/BiologicsBloodVaccines/ 

BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/UCM074923.pdf. 9 Id. 10 Emergent BioSolutions Receives FDA Approval Extending Shelf Life of BioThrax (Anthrax 

Vaccine Adsorbed) to 4 Years, Emergent BioSolutions, Inc. (Jun. 10, 2009), available at http:// 

investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-newsArticle&ID=1298056. 11 21 C.F.R. 610.53 (2011). 12GOV’T ACCOUNTABILITY OFFICE, GAO–14–690, PROJECT BIOSHIELD: ACTIONS NEEDED TO

AVOID REPEATING PAST PROBLEMS WITH PROCURING NEW ANTHRAX VACCINE AND MANAGING

II. BACKGROUND AND THE NEED FOR LEGISLATION

HHS procures and stores medical countermeasures in the SNS to 

ensure the nation is prepared for public health emergencies, such 

as an intentional release of Bacillus anthracis or other high-risk 

pathogens.1

Anthrax has been labeled by DHS as a material threat to national security since 2004.2 Since 2005, HHS has procured 

BioThrax, a vaccine used for prevention of anthrax disease, for the 

SNS.3 In 2011, HHS contracted to purchase up to 44.75 million 

doses of BioThrax to be delivered to the stockpile over five years.4

The total cost of the contract was reported to be worth up to $1.25 

billion.5

BioThrax is the only vaccine currently approved by the Food and 

Drug Administration (FDA) for pre-exposure prophylaxis of anthrax disease in individuals who are at high-risk of exposure.6 The 

vaccine is also approved for post-exposure prophylaxis of anthrax 

disease, when combined with the recommended course of antimicrobial therapy in persons 18 through 65 years of age.7 The dosing schedule for pre-exposure prophylaxis requires five doses over 

18 months, with a booster shot every 12 months thereafter to maintain efficacy of the immunization.8 The post-exposure dosing schedule is three shots over the course of four weeks, combined with 

antimicrobial therapy.9

As with other vaccines and medical countermeasures, purchased 

lots of BioThrax cannot be held in the SNS indefinitely. BioThrax 

has an FDA-approved shelf life of four years.10 The vaccine cannot 

be legally administered after the labeled date has lapsed, without 

a special extension from the FDA.11 Vaccines in the SNS are generally destroyed after reaching the end of their labeled dates of 

use.12


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THE STOCKPILE OF LICENSED VACCINE 27 (2007), available at http://www.gao.gov/assets/270/ 

268295.pdf. 13Taking Measure of Countermeasures (Part 3): Protecting the Protectors: Hearing Before the 

Subcomm. on Emergency Preparedness, Response, and Communications of the H. Comm. on 

Homeland Security, 112th Cong. (2012) (statement of Dr. James Polk, Principal Deputy Assistant Secretary and Deputy Chief Medical Officer, Department of Homeland Security). 

Rather than dispose of these doses, the Federal Government 

could identify stockpiled anthrax vaccine doses that are close to 

being cycled out and offer them to emergency responders across the 

nation who are at high-risk of exposure to anthrax. Since 2011, 

DHS has been developing a pilot program to test the feasibility of 

this use for BioThrax held in the SNS.13

Having a cadre of emergency responders who are immunized 

against anthrax may enable a quicker and more effective response 

to an anthrax attack. Immunized responders may be more willing 

to render their service, knowing they are protected from infection. 

It is unclear, however, whether creating a permanent Federal 

program to distribute such a vaccine on a voluntary basis would be 

effective in increasing pre-exposure prophylaxis among emergency 

responders. BioThrax is already commercially available to emergency responders and emergency response agencies, with valid prescriptions. 

A pilot program will enable DHS to work with emergency responders in a limited number of states to assess the potential opportunities and interest in increasing the use of the vaccine among 

emergency responders, and to promote improved preparedness for 

a release of anthrax. This bill will provide statutory authority for 

such a pilot program and strengthen accountability in this ongoing 

effort. The Department will be required to provide an annual report to several Congressional committees on the costs resulting 

from the program, associated staff resources, and data about the 

number of participants. In a final report after the program ends, 

DHS will provide analysis on the costs and benefits of whether the 

program should be continued. 

Implementing the pilot program in close coordination with HHS 

will be essential to its success. HHS is the lead department tasked 

with planning and overseeing the Federal response to a public 

health emergency. Utilizing this experience will be vital to the pilot 

program. DHS and HHS also need to collaborate to ensure the resources of the SNS are adequately maintained and planned for 

through the duration of the pilot program. 

Because resources to operate the pilot program are limited, the 

Secretary of DHS should focus the efforts of the pilot program on 

regions and emergency response jurisdictions that are at highest 

risk of a terrorist attack utilizing anthrax. Efforts to vaccinate first 

responders in each state or jurisdiction should be part of a holistic 

response strategy that incorporates the risks and benefits for communities and first responders themselves. 

The Secretary of DHS should work closely with participating 

state and local governments and entities, whose emergency response providers may be eligible for the program, to ensure the 

pilot program is optimally utilized to improve any potential response to a release of anthrax. For example, a community may benefit the most when efforts are focused on vaccinating a cadre of responders who will likely be the primary responders in the event of 

a release. 


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This pilot program, or any similar program, should not impact 

what kinds and quantities of medical countermeasures are procured for the SNS. At any point in the future, the type and amount 

of anthrax vaccine in the stockpile may change, potentially limiting 

the ability of the Federal Government to distribute excess vaccines. 

Procurement decisions for the stockpile are solely made on the 

basis of the threats and risks posed by high-risk pathogens and 

other chemical, radiological, or nuclear agents. 

III. LEGISLATIVE HISTORY

Representative Peter King introduced H.R. 1300, the First Responder Anthrax Preparedness Act, on March 4, 2015, which was 

referred to the House Committee on Homeland Security, and House 

Committee on Energy and Commerce. The House of Representatives passed the act on July 29, 2015. It was received in the Senate, read twice, and referred to the Committee on Homeland Security and Governmental Affairs. 

On August 3, 2015, Senators Kelly Ayotte, Cory Booker, and 

Christopher Coons introduced S. 1915, an identical companion to 

H.R. 1300, which was referred to the Committee on Homeland Security and Governmental Affairs. 

The Committee considered S. 1915 at a business meeting on December 9, 2015. A modified substitute amendment was offered by 

Senator Ayotte and Senator Ron Johnson that removed the permanent authorization for the program, bolstered reporting requirements, required stronger coordination between DHS and HHS, and 

added a five-year sunset to the pilot program. The amendment also 

increased the duration of the pilot program from 24 to 36 months, 

and required information about the anthrax vaccine, published by 

the Centers for Disease Control and Prevention (CDC), to be distributed to program participants, rather than similar information 

published by the FDA. 

The Committee approved the Ayotte-Johnson modified substitute 

amendment, and ordered the bill, as amended, be reported favorably by voice vote. Senators present for both the vote on the 

amendment and the vote on final passage were: Johnson, Portman, 

Lankford, Ayotte, Ernst, Carper, Tester, Baldwin, and Booker. 

IV. SECTION-BY-SECTION ANALYSIS OF THE BILL, AS REPORTED

Section 1. Short title 

This section provides the bill’s short title, the ‘‘First Responder 

Anthrax Preparedness Act.’’ 

Section 2. Voluntary pre-event anthrax vaccination pilot program 

for emergency response providers 

Subsection (a) requires the Secretary of DHS, in coordination 

with the Secretary of HHS, to carry out a pilot program to provide 

anthrax vaccines reaching the end of their labeled dates of use 

from the SNS to emergency response providers. Participation in the 

pilot program is voluntary for first responders. The duration of the 

pilot program is set at 36 months from the date on which the initial vaccines are administered. 

This subsection also requires the Secretary of DHS, before implementing the pilot program, to develop communication, education 


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and training tools, as well as a system to manage requests for vaccine under the pilot program. The Secretary of DHS is also required to develop a comprehensive economic analysis of expected 

costs and benefits prior to implementation of the pilot program, as 

well as establish goals and desired outcomes for the pilot. 

The Secretary of DHS must select emergency response providers 

in no less than two states, but not more than five states, for participation in the pilot program. The Secretary of DHS, in coordination with the Secretary of HHS, is required to provide guidance to 

states and units of local governments to aid them in determining 

which emergency response providers are at high risk of exposure 

to anthrax. 

Participating emergency responders are to receive information 

published by the CDC about anthrax vaccines and a notice that the 

Federal Government is not obligated to continue providing doses of 

the vaccine to participants after the pilot program ends. 

This subsection also requires the Secretary of DHS to enter into 

a memorandum of understanding with the Secretary of HHS to define roles and responsibilities for the pilot program, and to establish other performance metrics and policies as appropriate. 

This subsection also establishes reporting requirements for the 

pilot program. The Secretary of DHS, in coordination with the Secretary of HHS, is required to submit an annual report to relevant 

Congressional committees providing detailed tabulations of the 

costs of the program, data on participation and the number of vaccine doses administered, and recommendations for improving participation. The final report shall include an analysis of the costs 

and benefits of continuing the program, an explanation of the benefits of administering vaccines through the pilot program rather 

than post-event treatment, and a plan under which the program 

could be continued. 

Subsection (b) requires the Secretary of DHS to implement the 

program not later than one year after the date of enactment of this 

Act. 

Subsection (c) terminates the statutory authority to operate the 

pilot program five years after the enactment of S. 1915. This sunset 

provides a clear deadline for Congress and DHS to examine the 

merits of whether the program should be modified and continued. 

V. EVALUATION OF REGULATORY IMPACT

Pursuant to the requirements of paragraph 11(b) of rule XXVI of 

the Standing Rules of the Senate, the Committee has considered 

the regulatory impact of this bill and determined that the bill will 

have no regulatory impact within the meaning of the rules. The 

Committee agrees with the Congressional Budget Office’s statement that the bill contains no intergovernmental or private-sector 

mandates as defined in the Unfunded Mandates Reform Act 

(UMRA) and would impose no costs on state, local, or tribal governments. 


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VI. CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

JANUARY 15, 2016. 

Hon. RON JOHNSON, Chairman, 

Committee on Homeland Security and Governmental Affairs, 

U.S. Senate, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 1915, the First Responder 

Anthrax Preparedness Act. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contacts are Mark Grabowicz and 

Rebecca Yip. 

Sincerely, 

KEITH HALL. 

Enclosure. 

S. 1915—First Responder Anthrax Preparedness Act 

S. 1915 would direct the Department of Homeland Security 

(DHS), in consultation with the Department of Health and Human 

Services (HHS), to provide anthrax vaccines from the Strategic National Stockpile to first responders who volunteer to receive them. 

Under the bill, DHS would establish a tracking system for the vaccine and would provide educational outreach for the program. The 

bill would direct DHS, in coordination with HHS, to establish a 

pilot program in at least two states to begin providing the vaccine. 

Based on information provided by DHS and HHS, CBO estimates that implementing S. 1915 would cost about $4 million over the 

2016–2020 period, assuming appropriation of the necessary 

amounts. 

Enacting S. 1915 would not affect direct spending or revenues; 

therefore, pay-as-you-go procedures do not apply. CBO estimates 

that enacting S. 1915 would not increase net direct spending or onbudget deficits in any of the four consecutive 10-year periods beginning in 2026. 

S. 1915 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would 

not affect the budgets of state, local, or tribal governments. 

On June 24, 2015, CBO transmitted a cost estimate for H.R. 

1300, the First Responder Anthrax Preparedness Act, as ordered 

reported by the House Committee on Homeland Security on May 

20, 2015. CBO’s estimate of the budgetary effects of implementing 

both pieces of legislation is the same. 

The CBO staff contacts for this estimate are Mark Grabowicz (for 

the Department of Homeland Security) and Rebecca Yip (for the 

Department of Health and Human Services). The estimate was approved by H. Samuel Papenfuss, Deputy Assistant Director for 

Budget Analysis. 


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VII. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

Because S. 1915 would not repeal or amend any provision of current law, it would make no changes in existing law within the 

meaning of clauses (a) and (b) of paragraph 12 of rule XXVI of the 

Standing Rules of the Senate. 

Æ 


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