,,ii #aadth ,,congress #ast ,session ,s4 #bjee ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #ag1 #bjae ,mr4 ,burr 7for himself and ,mr4 ,casey7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,public ,health ,service ,act and the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to national health security4 #a4 ,short title ,this ,act may be cited as the ,medical ,countermeasure ,innovation ,act of #bjae4 #b4 ,medical countermeasure guidelines 7a7 ,strategic national stockpile and security countermeasure procurements ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended-- 7#a7 in subsection 7a71 by adding at the end the following3 7#c7 ,utilization guidelines ,the ,secretary shall ensure timely and accurate recommended utilization guidelines for qualified countermeasures 7as defined in section #cai;,f-#a71 qualified pandemic and epidemic products 7as defined in section #cai;,f-#c71 and security countermeasures 7as defined in subsection 7c771 including for such products in the stockpile4 2 and 7#b7 in subsection 7g7-- 7,a7 by amending paragraph 7#d7 to read as follows3 7#d7 ,report on security countermeasure procurement ,not later than ,march #a of each year in which the ,secretary determines that the amount of funds available for procurement of security countermeasures is less than #a1ejj1jjj1jjj1 the ,secretary shall submit to the ,committee on ,appropriations and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,appropriations and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report detailing the amount of such funds available for procurement and the impact such amount of funding will have-- 7,a7 in meeting the security countermeasure needs identified under this section2 and 7,b7 on the annual ,public ,health ,emergency ,medical ,countermeasures ,enterprise and ,strategy ,implementation ,plan 7pursuant to section #bhaa7;d774 4 #c4 ,clarification on ,,barda contracting authority 7a7 ,in general ,section #cai;,f-#b7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7g77 is amended by adding at the end the following3 7#e7 ,clarification on contracting authority ,the ,secretary1 acting through the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 shall carry out the programs funded by the special reserve fund 7for the procurement of security countermeasures under subsection 7c7 and for carrying out section #cai,l71 including the execution of procurement contracts1 grants1 and cooperative agreements pursuant to this section and section #cai,l4 4 7b7 ,,barda contracting authority ,section #cai,l7c77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;c7 is amended by inserting 1 including the execution of procurement contracts1 grants1 and cooperative agreements pursuant to this section before the period4 #d4 ,countermeasures budget plan ,section #bhaa7;b77#g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#g77 is amended-- 7#a7 by striking the first sentence and inserting ,develop1 and update not later than ,march #a of each year1 a coordinated #e-year budget plan based on the medical countermeasure priorities described in subsection 7d71 including with respect to chemical1 biological1 radiological1 and nuclear agent or agents that may present a threat to the ,nation1 including such agents that are novel or emerging infectious diseases1 and the corresponding efforts to develop qualified countermeasures 7as defined in section #cai;,f-#a71 security countermeasures 7as defined in section #cai;,f-#b71 and qualified pandemic or epidemic products 7as defined in section #cai;,f-#c7 for each such threat42 7#b7 in subparagraph 7,c71 by striking 2 and and inserting a semicolon2 7#c7 in subparagraph 7,d71 by striking to the appropriate committees of ,congress upon request4 and inserting 1 not later than ,march #ae of each year1 to the ,committee on ,appropriations and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,appropriations and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and2 and 7#d7 by adding at the end the following3 7,e7 not later than ,march #ae of each year1 be made publicly available4 4 #e4 ,prioritizing the animal rule guidance ,section #efe7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c77 is amended by adding at the end the following3 7#c7 ,written explanation ,the ,secretary shall provide to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a written explanation1 not later than the last day of each month after the date of enactment of the ,medical ,countermeasure ,innovation ,act of #bjae in which the ,secretary fails to finalize such guidance1 for why the ,secretary has failed to finalize the guidance as required by this subsection4 4 #f4 ,streamlining the project bioshield procurement process ,section #cai;,f-#b7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7c77 is amended-- 7#a7 in paragraph 7#d77;,a77ii71 by striking make a recommendation under paragraph 7#f7 that the special reserve fund as defined in subsection 7h7 be made available for the procurement of such countermeasure and inserting make available the special reserve fund as defined in subsection 7h7 for procurement of such countermeasure1 as applicable2 7#b7 in paragraph 7#f7-- 7,a7 by striking subparagraphs 7,a71 7,b71 and 7,e72 7,b7 by redesignating subparagraphs 7,c7 and 7,d7 as subparagraphs 7,a7 and 7,b71 respectively2 7,c7 by amending subparagraph 7,a71 as so redesignated1 to read as follows3 7,a7 ,notice to appropriate congressional committees ,the ,secretary shall notify the ,committee on ,appropriations and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,appropriations and the ,committee on ,energy and ,commerce of the ,house of ,representatives of each decision to make available the special reserve fund as defined in subsection 7h7 for procurement of a security countermeasure1 including1 where available1 the number of1 the nature of1 and other information concerning potential suppliers of such countermeasure1 and whether other potential suppliers of the same or similar countermeasures were considered and rejected for procurement under this section and the reasons therefore4 2 and 7,d7 in the heading1 by striking ,recommendation for president's approval and inserting ,recommendations for procurement2 and 7#c7 in paragraph 7#g7-- 7,a7 by striking subparagraph 7,a72 7,b7 by striking subparagraph 7,b7 and inserting the following3 7,a7 ,payments from special reserve fund ,the special reserve fund as defined in subsection 7h7 shall be available for payments made by the ,secretary to a vendor for procurement of a security countermeasure in accordance with the provisions of this paragraph4 2 and 7,c7 by redesignating subparagraph 7,c7 as subparagraph 7,b74 #g4 ,priority review to encourage treatments for agents that present national security threats ,subchapter ,e of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is amended by inserting after section #efe the following3 #efe;,a4 ,priority review to encourage treatments for agents that present national security threats 7a7 ,definitions ,in this section3 7#a7 ,the term priority review with respect to a human drug application as defined in section #gce7a71 means review and action by the ,secretary on such application not later than #f months after receipt by the ,secretary of such application1 as described in the ,manual of ,policies and ,procedures in the ,food and ,drug ,administration and goals identified in the letters described in section #aja7;b7 of the ,food and ,drug ,administration ,safety and ,innovation ,act4 7#b7 ,priority review voucher ,the term priority review voucher means a voucher issued by the ,secretary to the sponsor of a material threat medical countermeasure application that entitles the holder of such voucher to priority review of a single human drug application submitted under section #eje7;b77#a7 or section #cea of the ,public ,health ,service ,act after the date of approval of the material threat medical countermeasure application4 7#c7 ,material threat medical countermeasure application ,the term material threat medical countermeasure application means an application that-- 7,a7 is a human drug application as defined in section #gce7a7-- 7i7 to prevent1 or treat harm from a biological1 chemical1 radiological1 or nuclear agent identified as a material threat under section #cai;,f-#b7;c77#b77;,a77ii7 of the ,public ,health ,service ,act1 or 7ii7 to mitigate1 prevent1 or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug1 or biological product against such agent2 7,b7 the ,secretary deems eligible for priority review2 7,c7 is approved after the date of enactment of the ,medical ,countermeasure ,innovation ,act of #bjae2 and 7,d7 is for a human drug1 no active ingredient 7including any ester or salt of the active ingredient7 of which has been approved in any other application under section #eje7;b77#a7 or section #cea of the ,public ,health ,service ,act4 7b7 ,priority review voucher 7#a7 ,in general ,the ,secretary shall award a priority review voucher to the sponsor of a material threat medical countermeasure application upon approval by the ,secretary of such material threat medical countermeasure application4 7#b7 ,transferability ,the sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer 7including by sale7 the entitlement to such voucher to a sponsor of a human drug for which an application under section #eje7;b77#a7 or section #cea of the ,public ,health ,service ,act will be submitted after the date of the approval of the material threat medical countermeasure application4 ,there is no limit on the number of times a priority review voucher may be transferred before such voucher is used4 7#c7 ,notification 7,a7 ,in general ,the sponsor of a human drug application shall notify the ,secretary not later than #ij calendar days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application1 including the date on which the sponsor intends to submit the application4 ,such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section4 7,b7 ,transfer after notice ,the sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph 7,a7 may transfer the voucher after such notification is provided1 if such sponsor has not yet submitted the human drug application described in the notification4 7c7 ,priority review user fee 7#a7 ,in general ,the ,secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the ,secretary a fee determined under paragraph 7#b74 ,such fee shall be in addition to any fee required to be submitted by the sponsor under chapter ,,vii4 7#b7 ,fee amount ,the amount of the priority review user fee shall be determined each fiscal year by the ,secretary and based on the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year4 7#c7 ,annual fee setting ,the ,secretary shall establish1 before the beginning of each fiscal year beginning after ,september #cj1 #bjae1 for that fiscal year1 the amount of the priority review user fee4 7#d7 ,payment 7,a7 ,in general ,the priority review user fee required by this subsection shall be due upon the submission of a human drug application under section #eje7;b77#a7 or section #cea of the ,public ,health ,service ,act for which the priority review voucher is used4 7,b7 ,complete application ,an application described under subparagraph 7,a7 for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the ,secretary's procedures for paying such fees4 7,c7 ,no waivers1 exemptions1 reductions1 or refunds ,the ,secretary may not grant a waiver1 exemption1 reduction1 or refund of any fees due and payable under this section4 7#e7 ,offsetting collections ,fees collected pursuant to this subsection for any fiscal year-- 7,a7 shall be deposited and credited as offsetting collections to the account providing appropriations to the ,food and ,drug ,administration2 and 7,b7 shall not be collected for any fiscal year except to the extent provided in advance in appropriation ,acts4 7d7 ,notice of ,issuance of ,voucher and ,approval of ,products ,under ,voucher ,the ,secretary shall publish a notice in the ,federal ,register and on the ,internet ,website of the ,food and ,drug ,administration not later than #cj calendar days after the occurrence of each of the following3 7#a7 ,the ,secretary issues a priority review voucher under this section4 7#b7 ,the ,secretary approves a drug pursuant to an application submitted under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act for which the sponsor of the application used a priority review voucher under this section4 7e7 ,eligibility for other programs ,nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program1 including under this ,act1 except that no sponsor of a material threat medical countermeasure application may receive more than one priority review voucher with respect to such drug4 7f7 ,relation to other provisions ,the provisions of this section shall supplement1 not supplant1 any other provisions of this ,act or the ,public ,health ,service ,act that encourage the development of medical countermeasures4 4