[Congressional Record (Bound Edition), Volume 162 (2016), Part 10]
[Senate]
[Pages 14428-14430]
[From the U.S. Government Publishing Office, www.gpo.gov]




                FIRST RESPONDER ANTHRAX PREPAREDNESS ACT

  Mr. McCONNELL. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 458, S. 1915.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A 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.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on Homeland Security and 
Governmental Affairs, with an amendment and an amendment to the title.
  (Strike out all after the enacting clause and insert the part printed 
in italic.)

     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

[[Page 14429]]

     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.
  Mr. McCONNELL. Mr. President, I ask unanimous consent that the 
committee-reported substitute amendment be withdrawn, that the Ayotte 
substitute amendment be agreed to, that the bill, as amended, be read a 
third time and passed, that the committee-reported title amendment be 
agreed to, and the motions to reconsider be considered made and laid 
upon the table.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee-reported substitute amendment was withdrawn.
  The amendment (No. 5109) in the nature of a substitute was agreed to, 
as follows:

                (Purpose: In the nature of a substitute)

       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. 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 eligible 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 made available to States 
     for administration to emergency response providers who would 
     be at high risk of exposure to anthrax if such an attack 
     should occur and who voluntarily consent to such 
     administration.
       (2) Determination.--The Secretary of Health and Human 
     Services shall determine whether an anthrax vaccine is 
     eligible to be provided to the Secretary of Homeland Security 
     for the pilot program described in paragraph (1) based on--
       (A) a determination that the vaccine is not otherwise 
     allotted for other purposes;
       (B) a determination that the provision of the vaccine will 
     not reduce, or otherwise adversely affect, the capability to 
     meet projected requirements for this product during a public 
     health emergency, including a significant reduction of 
     available quantities of vaccine in the Strategic National 
     Stockpile; and
       (C) such other considerations as determined appropriate by 
     the Secretary of Health and Human Services.
       (3) Preliminary requirements.--Before implementing the 
     pilot program required under this subsection, 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 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;
       (E) establish goals and desired outcomes for the pilot 
     program; and
       (F) establish a mechanism to reimburse the Secretary of 
     Health and Human Services for--
       (i) the costs of shipment and transportation of such 
     vaccines provided to the Secretary of Homeland Security from 
     the Strategic National Stockpile under such pilot program, 
     including staff time directly supporting such shipment and 
     transportation; and
       (ii) the amount, if any, by which the warehousing costs of 
     the Strategic National Stockpile are increased in order to 
     operate such pilot program.
       (4) Location.--
       (A) In general.--In carrying out the pilot program required 
     under this subsection, the Secretary of Homeland Security 
     shall select not fewer than 2 nor more than 5 States for 
     voluntary participation in the pilot program.
       (B) Requirement.--Each State that participates in the pilot 
     program under this subsection shall ensure that such 
     participation is consistent with the All-Hazards Public 
     Health Emergency Preparedness and Response Plan of the State 
     developed under section 319C-1 of the Public Health Service 
     Act (42 U.S.C. 247d-3a).
       (5) Guidance for selection.--To ensure that participation 
     in the pilot program under this subsection strategically 
     increases State and local response readiness in the event of 
     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 require that each State that participates in 
     the pilot program under this subsection submit a written 
     certification to the Secretary of Homeland Security stating 
     that each emergency response provider within the State that 
     participates in the pilot program is provided with 
     disclosures and educational materials designated by the 
     Secretary of Health and Human Services, which may include--
       (A) materials regarding the associated benefits and risks 
     of any vaccine provided under the pilot program, and of 
     exposure to anthrax;
       (B) additional material consistent with the Centers for 
     Disease Control and Prevention's clinical guidance; and
       (C) notice that the Federal Government is not obligated to 
     continue providing anthrax vaccine after the date on which 
     the pilot program ends.
       (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 and policies for 
     the pilot program, as appropriate.
       (8) Report.--
       (A) In general.--Notwithstanding subsection (c), 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 under 
     this section, 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;
       (III) total number of full-time equivalents allocated to 
     the program; and
       (IV) total costs to the Strategic National Stockpile;

       (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 complete the vaccine 
     regimen;
       (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--
       (i) consider whether the pilot program required under this 
     subsection should continue after the date described in 
     subsection (c); and
       (ii) include--

       (I) an analysis of the costs and benefits of continuing the 
     program to provide anthrax vaccines to emergency response 
     providers;
       (II) an explanation of the economic, health, and other 
     risks and benefits of administering vaccines through the 
     pilot program rather than post-event treatment; and
       (III) in the case of a recommendation under clause (i) to 
     continue the pilot program after

[[Page 14430]]

     the date described in subsection (c), a plan under which the 
     pilot 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.
  The bill (S. 1915), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed, as follows:

                                S. 1915

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

     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 eligible 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 made available to States 
     for administration to emergency response providers who would 
     be at high risk of exposure to anthrax if such an attack 
     should occur and who voluntarily consent to such 
     administration.
       (2) Determination.--The Secretary of Health and Human 
     Services shall determine whether an anthrax vaccine is 
     eligible to be provided to the Secretary of Homeland Security 
     for the pilot program described in paragraph (1) based on--
       (A) a determination that the vaccine is not otherwise 
     allotted for other purposes;
       (B) a determination that the provision of the vaccine will 
     not reduce, or otherwise adversely affect, the capability to 
     meet projected requirements for this product during a public 
     health emergency, including a significant reduction of 
     available quantities of vaccine in the Strategic National 
     Stockpile; and
       (C) such other considerations as determined appropriate by 
     the Secretary of Health and Human Services.
       (3) Preliminary requirements.--Before implementing the 
     pilot program required under this subsection, 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 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;
       (E) establish goals and desired outcomes for the pilot 
     program; and
       (F) establish a mechanism to reimburse the Secretary of 
     Health and Human Services for--
       (i) the costs of shipment and transportation of such 
     vaccines provided to the Secretary of Homeland Security from 
     the Strategic National Stockpile under such pilot program, 
     including staff time directly supporting such shipment and 
     transportation; and
       (ii) the amount, if any, by which the warehousing costs of 
     the Strategic National Stockpile are increased in order to 
     operate such pilot program.
       (4) Location.--
       (A) In general.--In carrying out the pilot program required 
     under this subsection, the Secretary of Homeland Security 
     shall select not fewer than 2 nor more than 5 States for 
     voluntary participation in the pilot program.
       (B) Requirement.--Each State that participates in the pilot 
     program under this subsection shall ensure that such 
     participation is consistent with the All-Hazards Public 
     Health Emergency Preparedness and Response Plan of the State 
     developed under section 319C-1 of the Public Health Service 
     Act (42 U.S.C. 247d-3a).
       (5) Guidance for selection.--To ensure that participation 
     in the pilot program under this subsection strategically 
     increases State and local response readiness in the event of 
     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 require that each State that participates in 
     the pilot program under this subsection submit a written 
     certification to the Secretary of Homeland Security stating 
     that each emergency response provider within the State that 
     participates in the pilot program is provided with 
     disclosures and educational materials designated by the 
     Secretary of Health and Human Services, which may include--
       (A) materials regarding the associated benefits and risks 
     of any vaccine provided under the pilot program, and of 
     exposure to anthrax;
       (B) additional material consistent with the Centers for 
     Disease Control and Prevention's clinical guidance; and
       (C) notice that the Federal Government is not obligated to 
     continue providing anthrax vaccine after the date on which 
     the pilot program ends.
       (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 and policies for 
     the pilot program, as appropriate.
       (8) Report.--
       (A) In general.--Notwithstanding subsection (c), 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 under 
     this section, 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;
       (III) total number of full-time equivalents allocated to 
     the program; and
       (IV) total costs to the Strategic National Stockpile;

       (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 complete the vaccine 
     regimen;
       (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--
       (i) consider whether the pilot program required under this 
     subsection should continue after the date described in 
     subsection (c); and
       (ii) include--

       (I) an analysis of the costs and benefits of continuing the 
     program to provide anthrax vaccines to emergency response 
     providers;
       (II) an explanation of the economic, health, and other 
     risks and benefits of administering vaccines through the 
     pilot program rather than post-event treatment; and
       (III) in the case of a recommendation under clause (i) to 
     continue the pilot program after the date described in 
     subsection (c), a plan under which the pilot 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.
  The committee-reported title amendment was agreed to, as follows:

       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.''.

                          ____________________