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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]