[House Report 114-222]
[From the U.S. Government Publishing Office]
114th Congress ] [ Rept. 114-222
HOUSE OF REPRESENTATIVES
1st Session ] [ Part 1
======================================================================
FIRST RESPONDER ANTHRAX PREPAREDNESS ACT
_______
July 22, 2015.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. McCaul, from the Committee on Homeland Security, submitted the
following
R E P O R T
[To accompany H.R. 1300]
[Including cost estimate of the Congressional Budget Office]
The Committee on Homeland Security, to whom was referred
the bill (H.R. 1300) 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, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Hearings......................................................... 3
Committee Consideration.......................................... 4
Committee Votes.................................................. 5
Committee Oversight Findings..................................... 5
New Budget Authority, Entitlement Authority, and Tax Expenditures 5
Congressional Budget Office Estimate............................. 5
Statement of General Performance Goals and Objectives............ 6
Duplicative Federal Programs..................................... 6
Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits....................................................... 6
Federal Mandates Statement....................................... 7
Preemption Clarification......................................... 7
Disclosure of Directed Rule Makings.............................. 7
Advisory Committee Statement..................................... 7
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
Committee Correspondence......................................... 10
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``First Responder Anthrax Preparedness
Act''.
SEC. 2. PRE-EVENT ANTHRAX VACCINATION PROGRAM FOR EMERGENCY RESPONSE
PROVIDERS.
(a) Anthrax Preparedness.--
(1) In general.--Title V of the Homeland Security Act of 2002
(Public Law 107-296; 6 U.S.C. 311 et seq.) is amended by adding
at the end the following new section:
``SEC. 526. ANTHRAX PREPAREDNESS.
``(a) Pre-event Anthrax Vaccination Program for Emergency Response
Providers.--For the purpose of domestic preparedness for and collective
response to terrorism, the Secretary, in consultation with the
Secretary of Health and Human Services, shall establish a program to
provide surplus 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)) to emergency response providers for administration to such
providers who voluntarily consent to such administration, and shall--
``(1) establish any necessary logistical and tracking systems
to facilitate making such vaccines so available;
``(2) distribute disclosures regarding associated benefits
and risks to end users; and
``(3) conduct outreach to educate emergency response
providers about the voluntary program.
``(b) Threat Assessment.--The Secretary shall--
``(1) support homeland security-focused risk analysis and
risk assessments of the threats posed by anthrax from an act of
terror;
``(2) leverage existing and emerging homeland security
intelligence capabilities and structures to enhance prevention,
protection, response, and recovery efforts with respect to an
anthrax terror attack; and
``(3) share information and provide tailored analytical
support on threats posed by anthrax to State, local, and tribal
authorities, as well as other national biosecurity and
biodefense stakeholders.''.
(2) Clerical amendment.--The table of contents in section
1(b) of such Act is amended by inserting at the end of the
items relating to title V the following new item:
``Sec. 526. Anthrax preparedness.''.
(b) Pilot Program.--
(1) In general.--In carrying out the pre-event vaccination
program authorized in section 526(a) of the Homeland Security
Act of 2002, as added by subsection (a), the Secretary of
Homeland Security, in coordination with the Secretary of Health
and Human Services, shall carry out a pilot program to provide
anthrax vaccines to emergency response providers as so
authorized. The duration of the pilot program shall be at least
18 months.
(2) Preliminary requirements.--By not later than one year
after the date of the enactment of this Act, and prior to
implementing the pilot program under paragraph (1), the
Secretary of Homeland Security shall--
(A) establish a communication platform for the pilot
program;
(B) establish education and training modules for the
pilot program;
(C) conduct economic analysis of the pilot program;
and
(D) create a logistical platform for the anthrax
vaccine request process under the pilot program.
(3) Location.--In carrying out the pilot program under this
subsection, the Secretary of Homeland Security shall select
emergency response providers based in at least two States for
participation in the pilot program.
(4) Distribution of information.--The Secretary of Homeland
Security shall provide to each emergency response provider who
participates in the pilot program under this subsection
disclosures and educational materials regarding the associated
benefits and risks of any vaccine provided under the pilot
program and of exposure to anthrax.
(5) Report.--Not later than one year after the date of the
enactment of this Act, and annually thereafter until the
completion of the pilot program, the Secretary of Homeland
Security shall submit to the Committee on Homeland Security of
the House of Representatives and the Committee on Homeland
Security and Governmental Affairs of the Senate a report on the
progress and results of the pilot program, including the
percentage of eligible emergency response providers, as
determined by each pilot location, that volunteer to
participate, the degree to which participants obtain necessary
vaccinations, as appropriate, and recommendations to improve
initial and recurrent participation in the pilot program. The
report shall include a plan under which the Secretary plans to
continue the program to provide vaccines to emergency response
providers under section 526(a) of the Homeland Security Act of
2002, as added by subsection (a).
(6) Deadline for implementation.--The Secretary of Homeland
Security shall begin implementing the pilot program under this
subsection by not later than the date that is one year after
the date of the enactment of this Act.
Purpose and Summary
The purpose of H.R. 1300 is to direct the Secretary of
Homeland Security to make anthrax vaccines and antimicrobials
available to emergency response providers, and for other
purposes.
Background and Need for Legislation
An anthrax attack is a serious mass casualty threat. Our
national response capability to a wide-area anthrax attack
would be greatly enhanced by having pre-vaccinated responders,
able to deploy immediately and confidently, knowing that they
have been afforded as much protection as possible. Pre-event
vaccination is a safe, effective way to protect these
responders so they can respond in an anthrax attack without
fear of contracting disease. In fact, the first responder
community has been asking for this capability. The Committee
has received letters of support for H.R. 1300 from the
International Association of Fire Chiefs, the International
Association of Emergency Medical Services Chiefs, and the
Alliance for Biosecurity.
The Department of Homeland Security (DHS) Office of Health
Affairs (OHA) has been working with the Centers for Disease
Control and Prevention (CDC) on a pilot program to provide
surplus pre-event anthrax vaccine from the Strategic National
Stockpile (SNS) to emergency response providers on a voluntary
basis and free of charge. This legislation authorizes that
program.
Hearings
The Committee did not hold any hearings specifically on
H.R. 1300. However, the Subcommittee on Emergency Preparedness,
Response, and Communications has held a number of hearings
relevant to the legislation in the 112th, 113th, and 114th
Congresses.
112th Congress
In the 112th Congress, the Subcommittee held a series of
hearing on medical countermeasures, including ``Taking Measure
of Countermeasures: Protecting the Protectors.'' The
Subcommittee received testimony from Dr. James D. Polk,
Principal Deputy Assistant Secretary of the Department of
Homeland Security's Office of Health Affairs, Mr. Edward
Gabriel, Principal Deputy Assistant Secretary for Preparedness
and Response at the Department of Health and Human Services,
Chief Al Gillespie, President and Chairman of the Board of the
International Association of Fire Chiefs, Mr. Bruce Lockwood,
Second Vice President of the International Association of
Emergency Managers, Sheriff Chris Nocco of Pasco County,
Florida, and Mr. Manual Peralta, the Director of Safety and
Health for the National Association of Letter Carriers. At that
hearing, Chief Gillespie, stated that a ``pilot program that
rotates non-expired, potent, and safe vaccines and drugs from
the SNS to voluntary emergency responder immunization programs
would greatly improve preparedness levels and better utilize
federal resources and tax dollars.''
113th Congress
In the 113th Congress, the Subcommittee held a hearing,
``Bioterrorism: Assessing the Threat.'' The Subcommittee
received testimony from Dr. Robert Kadlec, former Special
Assistant to the President for Biodefense, Dr. Tom Inglesby,
CEO and Director of the UPMC Center for Health Security, and
Dr. Leonard Cole, Director of Terror Medicine and Security at
the Rutgers Medical School. This hearing provided an assessment
of the bioterrorism threat from experts in the biodefense field
and discussed the potential impact of an attack, particularly
on first responders.
114th Congress
During a hearing on biological threats on April 22, 2015,
``Strategic Perspectives on the Bioterrorism Threat,'' the
Subcommittee on Emergency Preparedness, Response, and
Communications received testimony from the Honorable Jim
Talent, former Senator and Co-Chair of the WMD Commission, Dr.
Charles Cairns, Interim Dean of the University of Arizona
Medical School, and Ms. Marisa Raphael, Deputy Commissioner of
the New York City Department of Public Health and Mental
Hygiene. At this hearing, Members discussed with the witnesses
the benefits of having a program, such as the one authorized by
H.R. 1300, in place to protect emergency response providers.
Committee Consideration
The Committee met on May 20, 2015, to consider H.R. 1300,
and ordered the measure to be reported to the House with a
favorable recommendation, amended, by voice vote. The Committee
took the following actions:
The following amendments were offered:
An Amendment in the Nature of a Substitute offered by Mr.
King of New York (#1); was AGREED TO by voice vote.
An Amendment by Ms. Jackson Lee to the Amendment in the
Nature of a Substitute (#1A); was AGREED TO by voice vote.
Page 4, line 24, insert after ``including'' the following: ``the
percentage of eligible emergency response providers, as determined by
each pilot location, that volunteer to participate,''
The Subcommittee on Emergency Preparedness, Response, and
Communications met on May 14, 2015, to consider H.R. 1300, and
ordered the measure to be reported to the Full Committee with a
favorable recommendation, amended, by voice vote. The Committee
took the following actions:
The following amendments were offered:
An Amendment in the Nature of a Substitute offered by Ms.
McSally (#1); was AGREED TO, amended, by voice vote.
An Amendment by Mrs. Watson Coleman to the Amendment in the
Nature of a Substitute (#1A); was AGREED TO by voice vote.
Page 2, line 7, strike ``and''.
Page 2, line 9, strike the period and insert ``; and''.
Page 2, after line 10, insert the following: ``(3) conduct outreach
to educate emergency response providers about the voluntary program.''.
An Amendment by Mr. Payne to the Amendment in the Nature of
a Substitute (#1B); was AGREED TO by voice vote.
Page 4, line 19, before the period insert the following: ``,
including the degree to which participants obtain necessary
vaccinations, as appropriate, and recommendations to improve initial
and recurrent participation in the program''.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the recorded
votes on the motion to report legislation and amendments
thereto.
No recorded votes were requested during consideration of
H.R. 1300.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has held oversight
hearings and made findings that are reflected in this report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
1300, the First Responder Anthrax Preparedness Act, would
result in no new or increased budget authority, entitlement
authority, or tax expenditures or revenues.
Congressional Budget Office Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
U.S. Congress,
Congressional Budget Office,
Washington, DC, June 24, 2015.
Hon. Michael McCaul,
Chairman, Committee on Homeland Security, House of Representatives,
Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 1300, 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 Martin von
Gnechten, and Rebecca Yip.
Sincerely,
Keith Hall.
Enclosure.
H.R. 1300--First Responder Anthrax Preparedness Act
H.R. 1300 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 H.R. 1300 would cost about $4 million over
the 2016-2020 period, assuming appropriation of the necessary
amounts. Enacting H.R. 1300 would not affect direct spending or
revenues; therefore, pay-as-you-go procedures do not apply.
H.R. 1300 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.
The CBO staff contacts for this estimate are Martin von
Gnechten (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.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII of the Rules of the
House of Representatives, H.R. 1300 contains the following
general performance goals and objectives, including outcome
related goals and objectives authorized. H.R. 1300 directs the
Secretary of DHS to carry out a pilot program with a duration
of at least 18 months to provide, on a voluntary basis, anthrax
vaccines to emergency response providers. Within one year of
the enactment of this act, the Secretary of DHS must establish
certain preliminary requirements prior to the implementation of
the pilot program to include a communication platform,
education and training modules, economic analysis, and a
logistical platform for the anthrax vaccine request process.
H.R. 1300 also directs the Secretary of DHS to report
within one year of enactment of H.R. 1300 on the progress and
results of the pilot program, in addition to a plan to continue
to make vaccines and antimicrobials available to emergency
response providers.
Duplicative Federal Programs
Pursuant to clause 3(c) of rule XIII, the Committee finds
that H.R. 1300 does not contain any provision that establishes
or reauthorizes a program known to be duplicative of another
Federal program.
Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits
In compliance with rule XXI of the Rules of the House of
Representatives, this bill, as reported, contains no
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(e), 9(f), or 9(g) of the rule
XXI.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Preemption Clarification
In compliance with section 423 of the Congressional Budget
Act of 1974, requiring the report of any Committee on a bill or
joint resolution to include a statement on the extent to which
the bill or joint resolution is intended to preempt State,
local, or Tribal law, the Committee finds that H.R. 1300 does
not preempt any State, local, or Tribal law.
Disclosure of Directed Rule Makings
The Committee estimates that H.R. 1300 would require no
directed rule makings.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
This section provides that bill may be cited as the ``First
Responder Anthrax Preparedness Act.''
Section 2. Anthrax vaccination program for first responders
This section amends Title V of the Homeland Security Act of
2002 (Public Law 107-296; 6 U.S.C. 311 et seq.) by adding a new
section at the end titled ``Anthrax Preparedness'' and
establishes a voluntary anthrax vaccination program for
emergency response providers.
This Section directs the Secretary of Homeland Security, in
consultation with the Secretary of Health and Human Services,
to establish a program to provide surplus vaccines from the
Strategic National Stockpile under section 319F-2(a) of the
Public Health Service Act (42 U.S.C. 247d-6b(a)) to emergency
response providers who voluntarily consent. It specifies that
the program shall establish necessary logistical and tracking
systems to facilitate making such vaccines available and shall
distribute disclosures regarding associated benefits and risks
to emergency response providers.
Threat assessment
This section directs the Secretary of DHS to support
homeland security-focused risk analysis and risk assessments of
the threats posed by anthrax from an act of terror; leverage
existing and emerging homeland security intelligence
capabilities and structures to enhance prevention, protection,
response, and recovery efforts with respect to an anthrax
terror attack; and share information and provide analytical
support on threats posed by anthrax to State, local, and tribal
authorities, as well as national biosecurity and biodefense
stakeholders.
Pilot program
This section directs the Secretary of DHS to carry out a
pilot program to administer anthrax vaccines to emergency
response providers, on a voluntary basis. The pilot program
shall have a duration of at least 18 months and shall have
participation of at least two states. This section delineates
preliminary requirements for implementing the pilot program and
requires the Secretary to provide information to pilot
participants on benefits and risks of the anthrax vaccine and
exposure to anthrax.
Report
This section requires an annual report on progress of the
pilot and future plans for the program.
The Committee understands that there will be data and
information generated as the pilot program is implemented.
Therefore the Committee directs that the report include
information on the percentage of eligible responders in a pilot
location who elect to participate in the voluntary vaccination
program. Additionally, since the anthrax vaccine requires a
number of immunizations over many months, the Committee
requires OHA to report on the degree to which participants
receive all necessary immunizations.
Deadline
This section requires that the Department begin
implementation of the pilot program within one year of
enactment of H.R. 1300.
The Committee is supportive of the pre-event anthrax
vaccine program. The Committee is concerned that OHA has been
working on this pilot effort since 2012 and there are still
many milestones to achieve before the pilot program rolls out.
However, the Committee is encouraged that DHS has hired
dedicated personnel to support the effort.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
HOMELAND SECURITY ACT OF 2002
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Homeland
Security Act of 2002''.
(b) Table of Contents.--The table of contents for this Act is
as follows:
* * * * * * *
TITLE V--NATIONAL EMERGENCY MANAGEMENT
* * * * * * *
Sec. 526. Anthrax preparedness.
* * * * * * *
TITLE V--NATIONAL EMERGENCY MANAGEMENT
* * * * * * *
SEC. 526. ANTHRAX PREPAREDNESS.
(a) Pre-event Anthrax Vaccination Program for Emergency
Response Providers.--For the purpose of domestic preparedness
for and collective response to terrorism, the Secretary, in
consultation with the Secretary of Health and Human Services,
shall establish a program to provide surplus 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)) to
emergency response providers for administration to such
providers who voluntarily consent to such administration, and
shall--
(1) establish any necessary logistical and tracking
systems to facilitate making such vaccines so
available;
(2) distribute disclosures regarding associated
benefits and risks to end users; and
(3) conduct outreach to educate emergency response
providers about the voluntary program.
(b) Threat Assessment.--The Secretary shall--
(1) support homeland security-focused risk analysis
and risk assessments of the threats posed by anthrax
from an act of terror;
(2) leverage existing and emerging homeland security
intelligence capabilities and structures to enhance
prevention, protection, response, and recovery efforts
with respect to an anthrax terror attack; and
(3) share information and provide tailored analytical
support on threats posed by anthrax to State, local,
and tribal authorities, as well as other national
biosecurity and biodefense stakeholders.
* * * * * * *
Committee Correspondence
House of Representatives,
Committee on Energy and Commerce,
Washington, DC, July 21, 2015.
Hon. Michael T. McCaul,
Chairman, Committee on Homeland Security,
Ford House Office Building, Washington, DC.
Dear Chairman McCaul: I write in regard to H.R. 1300, First
Responder Anthrax Preparedness Act, which was ordered to be
reported by the Committee on Homeland Security on May 20, 2015.
As you are aware, the bill also was referred to the Committee
on Energy and Commerce. I wanted to notify you that the
Committee on Energy and Commerce will forgo action on H.R. 1300
so that it may proceed expeditiously to the House floor for
consideration.
This is done with the understanding that the Committee on
Energy and Commerce's jurisdictional interests over this and
similar legislation are in no way diminished or altered. In
addition, the Committee reserves the right to seek conferees on
H.R. 1300 and requests your support when such a request is
made.
I would appreciate your response confirming this
understanding with respect to H.R. 1300 and ask that a copy of
our exchange of letters on this matter be included in the
Congressional Record during consideration of the bill on the
House floor.
Sincerely,
Fred Upton,
Chairman.
------
House of Representatives,
Committee on Homeland Security,
Washington, DC, July 22, 2015.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
Rayburn House Office Building, Washington, DC.
Dear Chairman Upton: Thank you for your letter regarding
H.R. 1300, the ``First Responder Anthrax Preparedness Act.'' I
appreciate your support in bringing this legislation before the
House of Representatives, and accordingly, understand that the
Committee on Energy and Commerce will forego consideration of
the bill.
The Committee on Homeland Security concurs with the mutual
understanding that by foregoing consideration on this bill at
this time, the Committee on Energy and Commerce does not waive
any jurisdiction over the subject matter contained in this bill
or similar legislation in the future. In addition, should a
conference on this bill be necessary, I would support a request
by the Committee on Energy and Commerce for conferees on those
provisions within your jurisdiction.
I will insert copies of this exchange in the Congressional
Record during consideration of this bill on the House floor. I
thank you for your cooperation in this matter.
Sincerely,
Michael T. McCaul,
Chairman.
[all]