First Responder Anthrax Preparedness Act

Bill: 114-s-1915
Sponsor: full_name: Sen. Ayotte, Kelly [R-NH]
Introduced: 2015-08-03
Policy area: Health
Subjects: Chemical and biological weapons

Congressional oversight

Emergency Management

Emergency medical services and trauma care

First responders and emergency personnel

Government information and archives

Health information and medical records

Health programs administration and funding

Immunology and vaccination

Infectious and parasitic diseases

Terrorism
Latest action: action_date: 2016-12-14
text: Became Public Law No: 114-268.

Summaries:
action_date: 2015-08-03
action_desc: Introduced in Senate
text: <p><strong>First Responder Anthrax Preparedness Act</strong></p> <p> Amends the Homeland Security Act of 2002 to direct the Department of Homeland Security (DHS), for the purpose of domestic preparedness for and collective response to terrorism, in coordination with the Department of Health and Human Services (HHS), to: (1) establish a program to provide anthrax vaccines nearing the end of their labeled dates of use from the strategic national stockpile to be administered to emergency response providers who are at high risk of exposure to anthrax and who voluntarily consent, (2) establish any necessary logistical and tracking systems to facilitate making such vaccines available, (3) distribute disclosures regarding associated benefits and risks to end users, and (4) conduct outreach to educate emergency response providers about the program.</p> <p>Requires DHS to: (1) support homeland security-focused risk analysis and assessments of the threats posed by anthrax from an act of terror; (2) leverage 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.</p> <p>Directs DHS, in coordination with HHS, to carry out a pilot program to provide anthrax vaccines to emergency response providers. Requires DHS to: (1) establish a communication platform and education and training modules for the program
, to conduct economic analysis of the program, and to create a logistical platform for the anthrax vaccine request process; (2) select providers based in at least two states to participate in the program; and (3) provide to each participating provider disclosures and educational materials regarding the benefits and risks of any vaccine administered and of exposure to anthrax. Directs DHS to report annually on: (1) program results, including the percentage of eligible emergency response providers that volunteer to participate, the degree to which participants obtain necessary vaccinations, and recommendations to improve program participation; (2) DHS plans to continue the program. </p>

action_date: 2016-05-09
action_desc: Reported to Senate with amendment(s)
text: <p><strong>First Responder Anthrax Preparedness Act</strong></p> <p>(Sec. 2) This bill requires the Department of Homeland Security (DHS), in coordination with the Department of Health and Human Services (HHS), to carry out a three-year pilot program to provide anthrax vaccines nearing the end of their labeled dates of use from the strategic national stockpile to be administered to emergency response providers who are at high risk of exposure to anthrax and who voluntarily consent. </p> <p>DHS shall establish a communication platform, develop and deliver education and training, conduct an economic analysis, create a logistical platform, and establish goals and desired outcomes for the program. </p> <p>DHS must: </p> <ul> <li>select providers based in at least two and not more than five states to participate;</li> <li>provide guidance to participating states and local governments on identifying providers who are at high risk of exposure; and </li> <li>provide to each participating provider disclosures and educational materials regarding the benefits and risks of exposure to anthrax and of any vaccine provided. </li> </ul> <p>DHS shall enter into a memorandum of understanding with HHS to: (1) define each department's roles and responsibilities, and (2) establish appropriate performance metrics or policies.</p> <p>DHS must submit annual reports on program progress and results, which shall include the costs to administer the program, the number of eligible providers that volunteer to participate and that obtain the necessary vaccinations, the total number of doses of vaccine administered, and recommendations to improve participation. </p> <p> The final report shall include an analysis of the costs and benefits of continuing the program, an explanation of the economic, health, and other benefits of administering vaccines through the program rather than post-event treatment, and a plan under which the program could be continued.</p>

action_date: 2016-11-16
action_desc: Passed Senate amended
text: <p><strong>First Responder Anthrax Preparedness Act</strong></p> <p>(Sec. 2) This bill requires the Department of Homeland Security (DHS), in coordination with the Department of Health and Human Services (HHS), to carry out a pilot program to provide eligible anthrax vaccines nearing the end of their labeled dates of use from the strategic national stockpile to emergency response providers who would be at high risk of exposure to anthrax if an attack should occur and who voluntarily consent. </p> <p>HHS shall determine whether an anthrax vaccine is eligible to be provided to DHS for the program based on determinations that: (1) the vaccine is not otherwise allotted for other purposes; and (2) the provision of the vaccine will not reduce or otherwise adversely affect the capability to meet projected requirements for such product during a public health emergency.</p> <p>DHS shall establish a communication platform, develop and deliver education and training, conduct an economic analysis, create a logistical platform, establish goals and desired outcomes for the program, and establish a mechanism to reimburse HHS for the costs of shipment and transportation of such vaccines provided to DHS under such program and the amount by which the warehousing costs of the stockpile are increased in order to operate such program.</p> <p>DHS must: (1) select between two and five states for voluntary participation in the program; (2) provide guidance to participating states and local governments on identifying providers who are at high risk of exposure; and (3) require each participating state to submit a written certification that each participating emergency response provider is provided with disclosures and educational materials regarding the associated benefits and risks of any vaccine provided and of exposure to anthrax, additional material consistent with the Centers for Disease Control and Prevention's clinical guidance, and notice that the federal government is not obligated to continue providing anthrax vaccine after the program ends.</p> <p>Each state that participates in the program shall ensure that such participation is consistent with the state's All-Hazards Public Health Emergency Preparedness and Response Plan.</p> <p>DHS shall enter into a memorandum of understanding with HHS to: (1) define each department's roles and responsibilities, and (2) establish appropriate performance metrics and policies for the program.</p> <p>DHS must submit annual reports on program progress and results, which shall include the costs to administer the program, the number and percentage of eligible providers that volunteer to participate, the degree to which participants complete the vaccine regimen, the total number of doses of vaccine administered, and recommendations to improve participation.</p> <p> The final report shall consider whether the program should continue beyond five years after enactment of this bill and shall include: (1) an analysis of the costs and benefits of continuing the program; (2) an explanation of the economic, health, and other risks and benefits of administering vaccines through the program rather than post-event treatment; and (3) a plan under which the program could be continued.</p>

action_date: 2016-11-29
action_desc: Passed House without amendment
text: <p>(This measure has not been amended since it was passed by the Senate on November 16, 2016. The summary of that version is repeated here.)</p> <p><strong>First Responder Anthrax Preparedness Act</strong></p> <p>(Sec. 2) This bill requires the Department of Homeland Security (DHS), in coordination with the Department of Health and Human Services (HHS), to carry out a pilot program to provide eligible anthrax vaccines nearing the end of their labeled dates of use from the strategic national stockpile to emergency response providers who would be at high risk of exposure to anthrax if an attack should occur and who voluntarily consent. </p> <p>HHS shall determine whether an anthrax vaccine is eligible to be provided to DHS for the program based on determinations that: (1) the vaccine is not otherwise allotted for other purposes; and (2) the provision of the vaccine will not reduce or otherwise adversely affect the capability to meet projected requirements for such product during a public health emergency.</p> <p>DHS shall establish a communication platform, develop and deliver education and training, conduct an economic analysis, create a logistical platform, establish goals and desired outcomes for the program, and establish a mechanism to reimburse HHS for the costs of shipment and transportation of such vaccines provided to DHS under such program and the amount by which the warehousing costs of the stockpile are increased in order to operate such program.</p> <p>DHS must: (1) select between two and five states for voluntary participation in the program; (2) provide guidance to participating states and local governments on identifying providers who are at high risk of exposure; and (3) require each participating state to submit a written certification that each participating emergency response provider is provided with disclosures and educational materials regarding the associated benefits and risks of any vaccine provided and of exposure to anthrax, additional material consistent with the Centers for Disease Control and Prevention's clinical guidance, and notice that the federal government is not obligated to continue providing anthrax vaccine after the program ends.</p> <p>Each state that participates in the program shall ensure that such participation is consistent with the state's All-Hazards Public Health Emergency Preparedness and Response Plan.</p> <p>DHS shall enter into a memorandum of understanding with HHS to: (1) define each department's roles and responsibilities, and (2) establish appropriate performance metrics and policies for the program.</p> <p>DHS must submit annual reports on program progress and results, which shall include the costs to administer the program, the number and percentage of eligible providers that volunteer to participate, the degree to which participants complete the vaccine regimen, the total number of doses of vaccine administered, and recommendations to improve participation.</p> <p> The final report shall consider whether the program should continue beyond five years after enactment of this bill and shall include: (1) an analysis of the costs and benefits of continuing the program; (2) an explanation of the economic, health, and other risks and benefits of administering vaccines through the program rather than post-event treatment; and (3) a plan under which the program could be continued.</p>

action_date: 2016-12-14
action_desc: Public Law
text: <p>(This measure has not been amended since it was passed by the Senate on November 16, 2016. The summary of that version is repeated here.)</p> <p><strong>First Responder Anthrax Preparedness Act</strong></p> <p>(Sec. 2) This bill requires the Department of Homeland Security (DHS), in coordination with the Department of Health and Human Services (HHS), to carry out a pilot program to provide eligible anthrax vaccines nearing the end of their labeled dates of use from the strategic national stockpile to emergency response providers who would be at high risk of exposure to anthrax if an attack should occur and who voluntarily consent. </p> <p>HHS shall determine whether an anthrax vaccine is eligible to be provided to DHS for the program based on determinations that: (1) the vaccine is not otherwise allotted for other purposes; and (2) the provision of the vaccine will not reduce or otherwise adversely affect the capability to meet projected requirements for such product during a public health emergency.</p> <p>DHS shall establish a communication platform, develop and deliver education and training, conduct an economic analysis, create a logistical platform, establish goals and desired outcomes for the program, and establish a mechanism to reimburse HHS for the costs of shipment and transportation of such vaccines provided to DHS under such program and the amount by which the warehousing costs of the stockpile are increased in order to operate such program.</p> <p>DHS must: (1) select between two and five states for voluntary participation in the program; (2) provide guidance to participating states and local governments on identifying providers who are at high risk of exposure; and (3) require each participating state to submit a written certification that each participating emergency response provider is provided with disclosures and educational materials regarding the associated benefits and risks of any vaccine provided and of exposure to anthrax, additional material consistent with the Centers for Disease Control and Prevention's clinical guidance, and notice that the federal government is not obligated to continue providing anthrax vaccine after the program ends.</p> <p>Each state that participates in the program shall ensure that such participation is consistent with the state's All-Hazards Public Health Emergency Preparedness and Response Plan.</p> <p>DHS shall enter into a memorandum of understanding with HHS to: (1) define each department's roles and responsibilities, and (2) establish appropriate performance metrics and policies for the program.</p> <p>DHS must submit annual reports on program progress and results, which shall include the costs to administer the program, the number and percentage of eligible providers that volunteer to participate, the degree to which participants complete the vaccine regimen, the total number of doses of vaccine administered, and recommendations to improve participation.</p> <p> The final report shall consider whether the program should continue beyond five years after enactment of this bill and shall include: (1) an analysis of the costs and benefits of continuing the program; (2) an explanation of the economic, health, and other risks and benefits of administering vaccines through the program rather than post-event treatment; and (3) a plan under which the program could be continued.</p>

tv_txt: II 114th CONGRESS 1st Session S. 1915 IN THE SENATE OF THE UNITED STATES August 3, 2015 Ms. Ayotte (for herself, Mr. Booker , and Mr. Coons ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs A BILL To direct the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers, and for other purposes.

1. Short title This Act may be cited as the First Responder Anthrax Preparedness Act . 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 ( 6 U.S.C. 311 et seq. ) is amended by adding at the end the following new section: 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 coordination with the Secretary of Health and Human Services, shall— (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; (2) establish any necessary logistical and tracking systems to facilitate making the vaccines described in paragraph (1) so available; (3) distribute disclosures regarding associated benefits and risks to end users; and (4) 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 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. (2) Preliminary requirements 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 not less than 2 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 (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— (i) the percentage of eligible emergency response providers, as determined by each pilot location, that volunteer to participate; (ii) the degree to which participants obtain necessary vaccinations, as appropriate; and (iii) recommendations to improve initial and recurrent participation in the pilot program. (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). (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.

tv_txt: II Calendar No. 458 114th CONGRESS 2d Session S. 1915 [Report No. 114–251] 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.

1. Short title This Act may be cited as the First Responder Anthrax Preparedness Act . 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 ( 6 U.S.C. 311 et seq. ) is amended by adding at the end the following new section: 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 coordination with the Secretary of Health and Human Services, shall— (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; (2) establish any necessary logistical and tracking systems to facilitate making the vaccines described in paragraph (1) so available; (3) distribute disclosures regarding associated benefits and risks to end users; and (4) 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 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. (2) Preliminary requirements 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 not less than 2 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 (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— (i) the percentage of eligible emergency response providers, as determined by each pilot location, that volunteer to participate; (ii) the degree to which participants obtain necessary vaccinations, as appropriate; and (iii) recommendations to improve initial and recurrent participation in the pilot program. (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). (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.

1. Short title This Act may be cited as the First Responder Anthrax Preparedness Act . 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. .

May 9, 2016 Reported with an amendment and an amendment to the title

tv_txt: 114th CONGRESS 2d Session S. 1915 IN THE SENATE OF THE UNITED STATES AN ACT To direct the Secretary of Homeland Security to make anthrax vaccines available to emergency response providers, and for other purposes.

1. Short title This Act may be cited as the First Responder Anthrax Preparedness Act . 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.

Passed the Senate November 16, 2016. Secretary

tv_txt: One Hundred Fourteenth Congress of the United States of America 2d Session Begun and held at the City of Washington on Monday, the fourth day of January, two thousand and sixteen S. 1915 IN THE SENATE OF THE UNITED STATES AN ACT To direct the Secretary of Homeland Security to make anthrax vaccines available to emergency response providers, and for other purposes.

1. Short title This Act may be cited as the First Responder Anthrax Preparedness Act . 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.

Speaker of the House of Representatives Vice President of the United States and President of the Senate