[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.