#aadth ,,congress #b;d ,session ,s4 #aiae ,,an ,,act ,to direct the ,secretary of ,homeland ,security to make anthrax vaccines available to emergency response providers1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,first ,responder ,anthrax ,preparedness ,act4 #b4 ,voluntary pre-event anthrax vaccination pilot program for emergency response providers 7a7 ,pilot program 7#a7 ,establishment ,the ,secretary of ,homeland ,security1 in coordination with the ,secretary of ,health and ,human ,services1 shall carry out a pilot program to provide eligible anthrax vaccines from the ,strategic ,national ,stockpile under section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 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 administration4 7#b7 ,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 7#a7 based on-- 7,a7 a determination that the vaccine is not otherwise allotted for other purposes2 7,b7 a determination that the provision of the vaccine will not reduce1 or otherwise adversely affect1 the capability to meet projected requirements for this product during a public health emergency1 including a significant reduction of available quantities of vaccine in the ,strategic ,national ,stockpile2 and 7,c7 such other considerations as determined appropriate by the ,secretary of ,health and ,human ,services4 7#c7 ,preliminary requirements ,before implementing the pilot program required under this subsection1 the ,secretary of ,homeland ,security1 in coordination with the ,secretary of ,health and ,human ,services1 shall-- 7,a7 establish a communication platform for the pilot program2 7,b7 develop and deliver education and training for the pilot program2 7,c7 conduct economic analysis of the pilot program1 including a preliminary estimate of total costs and expected benefits2 7,d7 create a logistical platform for the anthrax vaccine request process under the pilot program2 7,e7 establish goals and desired outcomes for the pilot program2 and 7,f7 establish a mechanism to reimburse the ,secretary of ,health and ,human ,services for-- 7i7 the costs of shipment and transportation of such vaccines provided to the ,secretary of ,homeland ,security from the ,strategic ,national ,stockpile under such pilot program1 including staff time directly supporting such shipment and transportation2 and 7ii7 the amount1 if any1 by which the warehousing costs of the ,strategic ,national ,stockpile are increased in order to operate such pilot program4 7#d7 ,location 7,a7 ,in general ,in carrying out the pilot program required under this subsection1 the ,secretary of ,homeland ,security shall select not fewer than #b nor more than #e ,states for voluntary participation in the pilot program4 7,b7 ,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 #cai;,c-#a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a74 7#e7 ,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 release1 the ,secretary of ,homeland ,security1 in coordination with the ,secretary of ,health and ,human ,services1 shall provide guidance to participating ,states and units of local government on identifying emergency response providers who are at high risk of exposure to anthrax4 7#f7 ,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 ,services1 which may include-- 7,a7 materials regarding the associated benefits and risks of any vaccine provided under the pilot program1 and of exposure to anthrax2 7,b7 additional material consistent with the ,centers for ,disease ,control and ,prevention's clinical guidance2 and 7,c7 notice that the ,federal ,government is not obligated to continue providing anthrax vaccine after the date on which the pilot program ends4 7#g7 ,memorandum of understanding ,before implementing the pilot program under this subsection1 the ,secretary of ,homeland ,security shall enter into a memorandum of understanding with the ,secretary of ,health and ,human ,services to-- 7,a7 define the roles and responsibilities of each ,department for the pilot program2 and 7,b7 establish other performance metrics and policies for the pilot program1 as appropriate4 7#h7 ,report 7,a7 ,in general ,notwithstanding subsection 7c71 not later than #a year after the date on which the initial vaccines are administered under this section1 and annually thereafter until #a year after the completion of the pilot program under this section1 the ,secretary of ,homeland ,security1 in coordination with the ,secretary of ,health and ,human ,services1 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 ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the progress and results of the pilot program1 including-- 7i7 a detailed tabulation of the costs to administer the program1 including-- 7,i7 total costs for management and administration2 7,,ii7 total costs to ship vaccines2 7,,iii7 total number of full-time equivalents allocated to the program2 and 7,,iv7 total costs to the ,strategic ,national ,stockpile2 7ii7 the number and percentage of eligible emergency response providers1 as determined by each pilot location1 that volunteer to participate2 7iii7 the degree to which participants complete the vaccine regimen2 7iv7 the total number of doses of vaccine administered2 and 7v7 recommendations to improve initial and recurrent participation in the pilot program4 7,b7 ,final report ,the final report required under subparagraph 7,a7 shall-- 7i7 consider whether the pilot program required under this subsection should continue after the date described in subsection 7c72 and 7ii7 include-- 7,i7 an analysis of the costs and benefits of continuing the program to provide anthrax vaccines to emergency response providers2 7,,ii7 an explanation of the economic1 health1 and other risks and benefits of administering vaccines through the pilot program rather than post-event treatment2 and 7,,iii7 in the case of a recommendation under clause 7i7 to continue the pilot program after the date described in subsection 7c71 a plan under which the pilot program could be continued4 7b7 ,deadline for implementation ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,homeland ,security shall begin implementing the pilot program under this section4 7c7 ,sunset ,the authority to carry out the pilot program under this section shall expire on the date that is #e years after the date of enactment of this ,act4 ,passed the ,senate ,november #af1 #bjaf4,secretary