[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1915 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 458
114th CONGRESS
  2d Session
                                S. 1915

                          [Report No. 114-251]

 To direct the Secretary of Homeland Security to make anthrax vaccines 
 and antimicrobials available to emergency response providers, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 3, 2015

  Ms. Ayotte (for herself, Mr. Booker, Mr. Coons, Mrs. Feinstein, Mr. 
Hoeven, Mr. Wicker, Mr. Rounds, Ms. Baldwin, Mr. Cochran, Mrs. Capito, 
   Mr. Peters, Mr. Casey, Mr. Cardin, Mr. Gardner, Mr. Barrasso, Mr. 
  Donnelly, Mr. Daines, and Mr. Kirk) introduced the following bill; 
which was read twice and referred to the Committee on Homeland Security 
                        and Governmental Affairs

                              May 9, 2016

  Reported by Mr. Johnson, with an amendment and an amendment to the 
                                 title
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
 To direct the Secretary of Homeland Security to make anthrax vaccines 
 and antimicrobials available to emergency response providers, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``First Responder Anthrax 
Preparedness Act''.</DELETED>

<DELETED>SEC. 2. PRE-EVENT ANTHRAX VACCINATION PROGRAM FOR EMERGENCY 
              RESPONSE PROVIDERS.</DELETED>

<DELETED>    (a) Anthrax Preparedness.--</DELETED>
        <DELETED>    (1) In general.--Title V of the Homeland Security 
        Act of 2002 (6 U.S.C. 311 et seq.) is amended by adding at the 
        end the following new section:</DELETED>

<DELETED>``SEC. 526. ANTHRAX PREPAREDNESS.</DELETED>

<DELETED>    ``(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 coordination with 
the Secretary of Health and Human Services, shall--</DELETED>
        <DELETED>    ``(1) establish a program to provide 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)) that will be nearing the end of their labeled dates of 
        use at the time such vaccines are to be administered to 
        emergency response providers who are at high risk of exposure 
        to anthrax and who voluntarily consent to such 
        administration;</DELETED>
        <DELETED>    ``(2) establish any necessary logistical and 
        tracking systems to facilitate making the vaccines described in 
        paragraph (1) so available;</DELETED>
        <DELETED>    ``(3) distribute disclosures regarding associated 
        benefits and risks to end users; and</DELETED>
        <DELETED>    ``(4) conduct outreach to educate emergency 
        response providers about the voluntary program.</DELETED>
<DELETED>    ``(b) Threat Assessment.--The Secretary shall--</DELETED>
        <DELETED>    ``(1) support homeland security-focused risk 
        analysis and risk assessments of the threats posed by anthrax 
        from an act of terror;</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.''.</DELETED>
        <DELETED>    (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:</DELETED>

<DELETED>``Sec. 526. Anthrax preparedness.''.
<DELETED>    (b) Pilot Program.--</DELETED>
        <DELETED>    (1) In general.--In carrying out the pre-event 
        vaccination program authorized under 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 24 months from the date the initial vaccines are 
        administered to participants.</DELETED>
        <DELETED>    (2) Preliminary requirements.--Prior to 
        implementing the pilot program under paragraph (1), the 
        Secretary of Homeland Security shall--</DELETED>
                <DELETED>    (A) establish a communication platform for 
                the pilot program;</DELETED>
                <DELETED>    (B) establish education and training 
                modules for the pilot program;</DELETED>
                <DELETED>    (C) conduct economic analysis of the pilot 
                program; and</DELETED>
                <DELETED>    (D) create a logistical platform for the 
                anthrax vaccine request process under the pilot 
                program.</DELETED>
        <DELETED>    (3) Location.--In carrying out the pilot program 
        under this subsection, the Secretary of Homeland Security shall 
        select emergency response providers based in not less than 2 
        States for participation in the pilot program.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (5) Report.--</DELETED>
                <DELETED>    (A) In general.--Not later than 1 year 
                after the date of enactment of this Act, and annually 
                thereafter until 1 year after the completion of the 
                pilot program, the Secretary of Homeland Security shall 
                submit to the Committee on Homeland Security and the 
                Committee on Energy and Commerce 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--
                </DELETED>
                        <DELETED>    (i) the percentage of eligible 
                        emergency response providers, as determined by 
                        each pilot location, that volunteer to 
                        participate;</DELETED>
                        <DELETED>    (ii) the degree to which 
                        participants obtain necessary vaccinations, as 
                        appropriate; and</DELETED>
                        <DELETED>    (iii) recommendations to improve 
                        initial and recurrent participation in the 
                        pilot program.</DELETED>
                <DELETED>    (B) Required plan.--The report required 
                under subparagraph (A) 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).</DELETED>
        <DELETED>    (6) Deadline for implementation.--Not later than 1 
        year after the date of enactment of this Act, the Secretary of 
        Homeland Security shall begin implementing the pilot program 
        under this subsection.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``First Responder Anthrax Preparedness 
Act''.

SEC. 2. VOLUNTARY PRE-EVENT ANTHRAX VACCINATION PILOT PROGRAM FOR 
              EMERGENCY RESPONSE PROVIDERS.

    (a) Pilot Program.--
            (1) Establishment.--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 
        from the strategic national stockpile under section 319F-2(a) 
        of the Public Health Service Act (42 U.S.C. 247d-6b(a)) that 
        will be nearing the end of their labeled dates of use at the 
        time such vaccines are to be administered to emergency response 
        providers who are at high risk of exposure to anthrax and who 
        voluntarily consent to such administration.
            (2) Duration.--The duration of the pilot program required 
        under paragraph (1) shall be 36 months beginning on the date on 
        which the initial vaccines are administered.
            (3) Preliminary requirements.--Before implementing the 
        pilot program under paragraph (1), the Secretary of Homeland 
        Security, in coordination with the Secretary of Health and 
        Human Services, shall--
                    (A) establish a communication platform for the 
                pilot program;
                    (B) develop and deliver education and training for 
                the pilot program;
                    (C) conduct an economic analysis of the pilot 
                program, including a preliminary estimate of total 
                costs and expected benefits;
                    (D) create a logistical platform for the anthrax 
                vaccine request process under the pilot program; and
                    (E) establish goals and desired outcomes for the 
                pilot program.
            (4) Location.--In carrying out the pilot program under this 
        subsection, the Secretary of Homeland Security shall select 
        emergency response providers based in not less than 2 nor more 
        than 5 States for participation in the pilot program.
            (5) Guidance for selection.--To ensure that participation 
        in the pilot program strategically increases State and local 
        response readiness for an anthrax release, the Secretary of 
        Homeland Security, in coordination with the Secretary of Health 
        and Human Services, shall provide guidance to participating 
        States and units of local government on identifying emergency 
        response providers who are at high risk of exposure to anthrax.
            (6) 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, consistent with Centers for Disease Control and 
        Prevention clinical guidance, and of exposure to anthrax, 
        including notice that the Federal Government is not obligated 
        to continue providing anthrax vaccines after the pilot program 
        has ended.
            (7) Memorandum of understanding.--Before implementing the 
        pilot program under this subsection, the Secretary of Homeland 
        Security shall enter into a memorandum of understanding with 
        the Secretary of Health and Human Services to--
                    (A) define the roles and responsibilities of each 
                Department for the pilot program; and
                    (B) establish other performance metrics or 
                policies, as appropriate.
            (8) Report.--
                    (A) In general.--Not later than 1 year after the 
                date on which the initial vaccines are administered 
                under this section, and annually thereafter until 1 
                year after the completion of the pilot program, the 
                Secretary of Homeland Security, in coordination with 
                the Secretary of Health and Human Services, shall 
                submit to the Committee on Homeland Security and the 
                Committee on Energy and Commerce of the House of 
                Representatives and the Committee on Homeland Security 
                and Governmental Affairs and the Committee on Health, 
                Education, Labor, and Pensions of the Senate a report 
                on the progress and results of the pilot program, 
                including--
                            (i) a detailed tabulation of the costs to 
                        administer the program, including--
                                    (I) total costs for management and 
                                administration;
                                    (II) total costs to ship vaccines; 
                                and
                                    (III) the total number of full-time 
                                equivalents allocated to the program;
                            (ii) the number and percentage of eligible 
                        emergency response providers, as determined by 
                        each pilot location, that volunteer to 
                        participate;
                            (iii) the degree to which participants 
                        obtain the necessary vaccinations;
                            (iv) the total number of doses of vaccine 
                        administered; and
                            (v) recommendations to improve initial and 
                        recurrent participation in the pilot program.
                    (B) Final report.--The final report required under 
                subparagraph (A) shall include an analysis of the costs 
                and benefits of continuing the program to provide 
                anthrax vaccines to emergency response providers, an 
                explanation of the economic, health, and other benefits 
                of administering vaccines through the pilot program 
                rather than post-event treatment, and a plan under 
                which the program could be continued.
    (b) Deadline for Implementation.--Not later than 1 year after the 
date of enactment of this Act, the Secretary of Homeland Security shall 
begin implementing the pilot program under this section.
    (c) Sunset.--The authority to carry out the pilot program under 
this section shall expire on the date that is 5 years after the date of 
enactment of this Act.
            Amend the title so as to read: ``A bill to direct the 
        Secretary of Homeland Security to make anthrax vaccines 
        available to emergency response providers, and for other 
        purposes.''.
                                                       Calendar No. 458

114th CONGRESS

  2d Session

                                S. 1915

                          [Report No. 114-251]

_______________________________________________________________________

                                 A BILL

 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

        Reported with an amendment and an amendment to the title