,,ii #aahth ,,congress #ast ,session ,s4 #aabb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #cj1 #bjbc,ms4 ,ernst introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve the program to provide for priority review of human drug applications to encourage treatment for agents that present national security threats4 #a4 ,short title ,this ,act may be cited as the ,prioritizing ,medical ,countermeasures for ,national ,security ,act of #bjbc4 #b4 ,extension and expansion of medical countermeasure priority review voucher program 7a7 ,definition of medical countermeasure application ,subsection 7a77#d7 of section #efe;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7 is amended-- 7#a7 in the paragraph heading1 by striking ,material threat medical and inserting ,medical2 7#b7 in the matter preceding subparagraph 7,a71 by striking material threat2 and 7#c7 by amending subparagraph 7,a7 to read as follows3 7,a7 is a human drug application for a drug that is-- 7i7 labeled for an indication to prevent or treat a disease or condition specifically caused by a chemical1 biological1 radiological1 or nuclear agent2 and 7ii7 part of a class or category of drug on the list described in subsection 7b7 at the time of approval of the application4 4 7b7 ,list of medical countermeasures for national security threats ,section #efe;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7 is amended-- 7#a7 by redesignating subsections 7b7 through 7g7 as subsections 7c7 through 7g7 and 7i71 respectively2 and 7#b7 by inserting after subsection 7a71 the following3 7b7 ,list of medical countermeasures for national security threats 7#a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary of ,preparedness and ,response1 in consultation with the ,public ,health ,emergency ,medical ,enterprise established under section #bhja of the ,public ,health ,service ,act1 including the ,secretary of ,defense1 shall establish and maintain a list of potentially eligible classes and categories of drugs that are identified as necessary to prevent or treat the diseases and conditions specifically caused by a chemical1 biological1 radiological1 or nuclear agent that-- 7,a7 has the potential to lead to a public health emergency with significant potential to affect national security2 or 7,b7 may present a specific threat to the ,armed ,forces4 7#b7 ,factors ,in establishing and revising the list under paragraph 7#a71 the ,secretary may consider-- 7,a7 whether an eligible class or category of drugs that is identified is-- 7i7 needed to protect the public health1 using the same standard that applies with respect to determinations of material threats under section #cai;,f-#b7;c77#b77;,b77ii7 of the ,public ,health ,service ,act2 and 7ii7 determined to be a priority 7consistent with sections #cjb7b7 and #cjd7;a7 of the ,homeland ,security ,act of #bjjb72 7,b7 for any class or category of drugs under consideration to address specific threats to the ,armed ,forces1 information provided by the ,secretary of ,defense to help evaluate whether a priority review voucher is necessary and beneficial to incentivize product development for the ,department of ,defense use and fielding2 7,c7 whether the class or category of drug requires incentivization in the form a priority review voucher based upon economic factors1 such as whether there is a sufficient market to support the development of the potential medical countermeasures and the maturity of the medical countermeasure pipeline2 7,d7 the potential effect of an addition of a class or category of drug on the potential sale value of priority review vouchers2 and 7,e7 such other factors as the ,secretary determines appropriate4 7#c7 ,duties ,the ,secretary1 acting through the ,assistant ,secretary of ,preparedness and ,response1 shall-- 7,a7 in coordination with the ,assistant ,secretary of ,defense for ,nuclear1 ,chemical1 and ,biological ,defense ,program1 disclose to interested priority review applicants the list developed under paragraph 7#a72 7,b7 periodically review the list developed under paragraph 7#a7 for continued necessity and appropriateness1 and add1 amend1 or remove any classes or categories of drugs if no longer necessary or appropriate2 and 7,c7 maintain a publicly available archive of the list over time4 7#d7 ,transition period ,before the date of the initial publication of the list developed under paragraph 7#a71 the most recent priority list developed under this section before the date of enactment of the ,prioritizing ,medical ,countermeasures for ,national ,security ,act of #bjbc shall remain in effect4 4 7c7 ,,gao report ,section #efe;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7 is amended by inserting after subsection 7g71 as redesignated by subsection 7b77#a71 the following3 7h7 ,,gao report 7#a7 ,in general ,not later than ,september #cj1 #bjbg1 the ,comptroller ,general of the ,united ,states shall transmit to ,congress a report on the effectiveness of this section in encouraging the development of the medical countermeasures needed to protect and prepare for emerging threats to public health and national security4 7#b7 ,contents ,the report shall include-- 7,a7 input from the ,secretary of ,defense and the ,secretary of ,health and ,human ,services2 and 7,b7 recommendations of the ,comptroller ,general of the ,united ,states1 if any1 on necessary modifications to this section4 4 7d7 ,sunset ,subsection 7i7 of such section1 as redesignated by subsection 7b77#a7 of this section1 is amended-- 7#a7 by striking subsection 7b7 and inserting subsection 7c72 and 7#b7 by striking ,october #a1 #bjbc and inserting ,october #a1 #bjbi4 7e7 ,conforming amendments ,to remove references to material threats ,section #efe;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7 is amended by striking material threat each place it appears in-- 7#a7 subsection 7a77#c72 7#b7 paragraphs 7#a7 and 7#b7 of subsection 7c71 as redesignated by subsection 7b77#a72 and 7#c7 subsection 7f71 as so redesignated4