```

[Senate Report 114-251]
[From the U.S. Government Publishing Office]

                                                              Calendar No. 458
                                                              
114th Congress    }                                            {  Report
                               SENATE                          
 2d Session       }                                            {  114-251
_______________________________________________________________________

                                     

                                                       

                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
                  
                  
                  
                  
                             _________ 
                  U.S. GOVERNMENT PUBLISHING OFFICE
                  
 59-010                  WASHINGTON : 2016       
_________________________________________________________________________________
For sale by the Superintendent of Documents, U.S. Government Publishing Office,
      Internet:bookstore.gpo.gov. Phone:toll free (866)512-1800;DC area (202)512-1800
     Fax:(202) 512-2104 Mail:Stop IDCC,Washington,DC 20402-001                 
                  
                  
                  
                  
        COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

                    RON JOHNSON, Wisconsin, Chairman
JOHN McCAIN, Arizona                 THOMAS R. CARPER, Delaware
ROB PORTMAN, Ohio                    CLAIRE McCASKILL, Missouri
RAND PAUL, Kentucky                  JON TESTER, Montana
JAMES LANKFORD, Oklahoma             TAMMY BALDWIN, Wisconsin
MICHAEL B. ENZI, Wyoming             HEIDI HEITKAMP, North Dakota
KELLY AYOTTE, New Hampshire          CORY A. BOOKER, New Jersey
JONI ERNST, Iowa                     GARY C. PETERS, Michigan
BEN SASSE, Nebraska

                  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
                     
                     
                     
                     
                     
                     
                     
                     
                     
                                                       Calendar No. 458
                                                       
114th Congress    }                                         { Report
                                 SENATE
                                                                 
 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).

              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\
---------------------------------------------------------------------------
    \1\U.S. Dep't of Health and Human Services, Centers for Disease 
Control and Prevention, 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 Provided Previously Recommended Spending Estimates 2 (2014), 
available at http://gao.gov/assets/660/659949.pdf.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \2\Memorandum 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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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).
    \12\Gov't Accountability Office, GAO-14-690, Project Bioshield: 
Actions Needed to Avoid Repeating Past Problems With Procuring New 
Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine 27 
(2007), available at http://www.gao.gov/assets/270/268295.pdf.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \13\Taking 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).
---------------------------------------------------------------------------
    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.
    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 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.

             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 on-budget 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.

       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.
```