,,ib ,union ,calendar ,no4 #ega #aadth ,,congress #b;d ,session ,h4 ,r4 #cbii ,report ,no4 #aad-gce ,,in ,,the ,,house ,,of ,,representatives ,july #bi1 #bjae ,mrs4 ,brooks of ,indiana 7for herself and ,ms4 ,eshoo7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,september #i1 #bjaf ,additional sponsors3 ,mr4 ,flores1 ,mrs4 ,ellmers of ,north ,carolina1 ,mrs4 ,blackburn1 ,mr4 ,mullin1 ,mr4 ,hunter1 ,mrs4 ,mimi ,walters of ,california1 ,mr4 ,bishop of ,michigan1 ,mr4 ,long1 ,mr4 ,nunes1 ,mr4 ,turner1 ,mr4 ,burgess1 ,mr4 ,knight1 ,mr4 ,carter of ,georgia1 ,mr4 ,bilirakis1 ,mr4 ,garamendi1 ,mr4 ,griffith1 ,mr4 ,swalwell of ,california1 ,mr4 ,collins of ,new ,york1 ,mr4 ,lance1 ,mrs4 ,comstock1 ,mr4 ,guthrie1 ,mr4 ,hastings1 ,mr4 ,kinzinger of ,illinois1 ,mr4 ,stewart1 ,mr4 ,vargas1 ,mr4 ,bucshon1 ,mr4 ,walden1 ,mr4 ,cramer1 ,mr4 ,hudson1 ,mr4 ,joyce1 ,mr4 ,johnson of ,ohio1 ,mr4 ,quigley1 ,mr4 ,crenshaw1 ,mr4 ,olson1 ,mr4 ,david ,scott of ,georgia1 ,mr4 ,crdenas1 ,mr4 ,wittman1 ,mr4 ,denham1 ,mr4 ,messer1 ,mr4 ,ruppersberger1 ,mr4 ,rush1 ,ms4 ,speier1 ,mr4 ,shimkus1 ,mrs4 ,mc,morris ,rodgers1 ,mr4 ,rodney ,davis of ,illinois1 and ,mr4 ,pascrell ,september #i1 #bjaf ,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed ,strike out all after the enacting clause and insert the part printed in italic ,for text of introduced bill1 see copy of bill as introduced on ,july #bi1 #bjae ,a ,,bill ,to amend the ,public ,health ,service ,act to ensure preparedness for chemical1 radiological1 biological1 and nuclear threats1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,strengthening ,public ,health ,emergency ,response ,act of #bjaf4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,,gao report on ,state1 local1 and hospital preparedness programs4 ,sec4 #c4 ,strategic national stockpile4 ,sec4 #d4 ,project ,bioshield procurement process4 ,sec4 #e4 ,,barda transaction authorities4 ,sec4 #f4 ,public health emergency medical countermeasures enterprise strategy and implementation plan4 ,sec4 #g4 ,priority review to encourage treatments for agents that present national security threats4 #b4 ,,gao report on ,state1 local1 and hospital preparedness programs 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a report to the ,congress on the programs for awarding cooperative agreements and grants under section #cai;,c-#a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a2 improving ,state and local public health security7 and section #cai;,c-#b of such ,act 7#db ,u4,s4,c4 #bdg;d-#c;b2 partnerships for ,state and regional hospital preparedness to improve surge capacity74 7b7 ,contents ,the report under subsection 7a7 shall address each of the following3 7#a7 ,the goals of the programs specified in subsection 7a74 7#b7 ,the extent to which such goals are being met1 including performance metrics that could help to assess whether such programs are succeeding at the coalition and member level4 7#c7 ,how such programs could be improved1 including how such programs could be modified to improve the medical preparedness of hospitals1 health care coalitions1 and the continuity of health care delivery4 7#d7 ,how such programs complement other preparedness programs of the ,department of ,health and ,human ,services4 7#e7 ,how funds awarded through such programs should be allocated and whether that allocation should be based on risk4 7#f7 ,progress made toward ,state and local preparedness entities being self-sustaining4 7#g7 ,whether the level of funding for such programs is sufficient4 7#h7 ,how funding for such programs is being used to ensure preparedness for at-risk populations including children1 pregnant women1 senior citizens1 and other individuals who may have unique needs in the event of a public health emergency1 such as individuals with disabilities4 7#i7 7,a7 ,how1 and to what extent1 entities are using the funds awarded to such entities through section #cai;,c-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 to directly fund regional health care coalitions and members of such coalitions4 7,b7 ,the amount each such entity retains for its own indirect and direct costs4 7,c7 ,the purposes for which such retained funds are used and whether these uses provide value for the program under such section #cai;,c-#b1 regional health care coalitions1 and members of such coalitions4 7#aj7 ,the extent to which the funds awarded through the programs under sections #cai;,c-#a and #cai;,c-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a1 #bdg;d-#c;b7 have been used for overlapping purposes4 #c4 ,strategic national stockpile ,section #cai;,f-#b7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#b77 is amended-- 7#a7 in subparagraph 7,g71 by striking and at the end2 7#b7 in subparagraph 7,h71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7,i7 ensure procedures are in place to coordinate the ongoing stockpiling by the ,biomedical ,advanced ,research and ,development ,authority and ,centers for ,disease ,control and ,prevention of qualified countermeasures 7as defined in section #cai;,f-#a7 for which funds have been made available under this part1 security countermeasures 7as defined in this section71 and qualified pandemic or epidemic products 7as defined in section #cai;,f-#c7 for which funds have been made available under section #cai,l in order to avoid any gaps in preparedness4 4 #d4 ,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 countermeasure2 7#b7 in paragraph 7#f7-- 7,a7 by striking subparagraphs 7,a71 7,b71 7,c71 and 7,e72 and 7,b7 by striking 7#f7 ,recommendations for president's approval and all that follows through 7,d7 ,subsequent specific countermeasures4-- and inserting 7#f7 ,subsequent specific countermeasures4--2 and 7#c7 in paragraph 7#g7-- 7,a7 by striking subparagraph 7,a72 7,b7 by redesignating subparagraph 7,b7 as subparagraph 7,a7 and amending such subparagraph 7,a71 as redesignated1 to read as follows3 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 #e4 ,,barda transaction authorities ,section #cai,l7c77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#e77 is amended by adding at the end the following3 7,h7 ,contracting authority clarification ,the ,secretary shall delegate authority for negotiating and entering into any contracts1 grants1 or cooperative agreements under this section to the ,director4 4 #f4 ,public health emergency medical countermeasures enterprise strategy and implementation plan ,section #bhaa7;d77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77#b77 is amended-- 7#a7 in subparagraph 7,a71 by inserting after describe the chemical1 biological1 radiological1 and nuclear agent or agents that may present a threat to the ,nation the following3 7which shall include pandemic influenza72 7#b7 by striking and at the end of subparagraph 7,j72 7#c7 by redesignating subparagraph 7,k7 as subparagraph 7,l72 and 7#d7 by inserting after subparagraph 7,j7 the following3 7,k7 report on the amount of time between the issuance of each request for a proposal or task order from the ,biomedical ,advanced ,research and ,development ,authority and the award of a contract pursuant to such request for a proposal or task order2 and 4 #g4 ,priority review to encourage treatments for agents that present national security threats 7a7 ,in general ,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 ,priority review ,the term priority review1 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 of 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 ,act 7,public ,law #aab-add74 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 of this ,act or section #cea7;a7 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 to prevent1 or treat harm from1 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 ,act2 7,b7 the ,secretary deems eligible for priority review2 7,c7 is approved after the date of enactment of the ,strengthening ,public ,health ,emergency ,response ,act of #bjaf2 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 pursuant to any other application under section #eje7;b77#a7 of this ,act or section #cea7;a7 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 application4 7#b7 ,transferability 7,a7 ,in general ,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 of this ,act or section #cea7;a7 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,b7 ,notification of transfer ,each person to whom a voucher is transferred shall notify the ,secretary of such change in ownership of the voucher not later than #cj days after the date of such transfer4 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 #bjaf1 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 notification by a sponsor of the intent of such sponsor to use the voucher1 as specified in subsection 7b77#c77;,a74 ,all other user fees associated with the human drug application shall be due as required by the ,secretary or under applicable law4 7,b7 ,complete application ,an application described in 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 public 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 issued under any section of this ,act with respect to the drug that is the subject of such application4 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 7g7 ,medical countermeasure postapproval report 7#a7 ,in general ,not later than #e years after the date of approval of a material threat medical countermeasure application1 the sponsor of such application shall submit a report to the ,secretary on such medical countermeasure4 7#b7 ,contents ,a report under paragraph 7#a7 shall include1 with respect to each of the first #b years after approval of such material threat medical countermeasure application1 a description of-- 7,a7 the sponsor's activities with ,federal agencies related to the procurement1 including stockpiling1 of the approved medical countermeasure2 7,b7 the sponsor's progress in fulfilling contracts entered into with ,federal agencies1 including the ,biomedical ,advanced ,research and ,development ,authority1 the ,centers for ,disease ,control and ,prevention1 and the ,department of ,defense1 related to such procurement2 7,c7 the extent to which the ,federal ,government has fulfilled its stated medical countermeasure requirements for the threat intended to be treated by the approved medical countermeasure2 and 7,d7 the sponsor's plans1 if any1 to develop additional material threat medical countermeasures4 7#c7 ,availability to congressional committees ,the ,secretary shall make each report submitted under this subsection available to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate upon request by either such ,committee not later than #cj days after receipt of such request4 7#d7 ,rule of construction ,nothing in this subsection shall be construed to permit the disclosure of confidential commercial or trade secret information or the disclosure of information that could compromise national security4 4 7b7 ,,gao report 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the effectiveness of priority review vouchers under section #efe;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 in providing incentives for the development of material threat medical countermeasure applications under such section #efe;,a4 ,in conducting such study1 the ,comptroller ,general shall examine the following3 7,a7 ,the impact of such priority review on the development of material threat medical countermeasures and the impact of such investment1 as applicable1 on the development of such countermeasures4 7,b7 ,how the drugs for which such priority review vouchers were awarded-- 7i7 addressed identified medical countermeasure needs2 and 7ii7 impacted ,united ,states preparedness against chemical1 biological1 radiological1 and nuclear threats1 including both identified threats and naturally occurring threats4 7,c7 ,how many material threat medical countermeasures were licensed or approved1 or otherwise significantly advanced in clinical development1 in the #ae years following the enactment of such section #efe;,a compared to the #ae years prior to the enactment of such section1 including a comparative analysis of ,federal advanced development and procurement dollars available in the #ae years following such enactment compared to the prior #ae years4 7,d7 ,how material threat medical countermeasures developed after the date of enactment of this ,act impact-- 7i7 the supply of products in the strategic national stockpile under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b72 and 7ii7 national preparedness4 7,e7 ,how the ,federal ,government supported sponsors of material threat medical countermeasures during the research1 development1 application review1 and production of such drugs1 including the use of government research1 provision of resources through contracts or grants1 and use of federally funded research facilities4 7,f7 ,an analysis of the drugs for which such priority review vouchers were used1 which shall include-- 7i7 the indications for which such drugs were approved under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a772 7ii7 whether unmet medical needs were addressed through the approval of such drugs1 including1 for each such drug-- 7,i7 if there was a currently marketed therapy approved to prevent or treat the same indication in the same patient population at the time the application was submitted to the ,food and ,drug ,administration2 and 7,,ii7 if the drug provided a significant benefit or improvement in safety and effectiveness compared to such currently marketed product2 7iii7 the price of the priority review voucher if transferred or sold prior to redemption2 and 7iv7 the length of time between the date on which a priority review voucher was awarded and the date on which it was used4 7,g7 ,with respect to the priority review voucher program under such section #efe;,a-- 7i7 how many priority review vouchers were awarded under such section #efe;,a and how many of such awarded vouchers were redeemed for priority review of a drug application in the #ae years following the date of enactment of such section2 7ii7 the resources associated with the ,food and ,drug ,administration implementation of such section #efe;,a and review of applications for which a voucher awarded under such section #efe;,a is redeemed for priority review and if implementation of such section #efe;,a prohibited the ,food and ,drug ,administration from meeting drug application review goals2 7iii7 recommendations on whether appropriate ,federal funding for advanced development and research would necessitate the priority review voucher program for medical countermeasures2 7iv7 the degree to which this incentive program impacts other priority review voucher programs2 and 7v7 the degree to which guaranteed ,federal funding for advanced development and research is a greater incentive for new investment in research and the development of medical countermeasures than the uncertain values of vouchers4 7#b7 ,consultations ,in conducting the study under subsection 7a71 the ,comptroller ,general of the ,united ,states shall consult with-- 7,a7 drug manufacturers involved in the research and development of medical countermeasures to address biological1 chemical1 radiological1 and nuclear threats2 7,b7 stakeholders involved in investing in the research and development of such medical countermeasures1 including venture capitalists2 7,c7 the ,federal ,government agencies responsible for advancing1 reviewing1 and procuring such medical countermeasures1 including-- 7i7 the ,department of ,health and ,human ,services1 including the ,office of the ,assistant ,secretary for ,preparedness and ,response1 the ,biomedical ,advanced ,research and ,development ,authority1 and the ,food and ,drug ,administration2 and 7ii7 the ,department of ,defense2 7,d7 biodefense stakeholders1 as applicable2 and 7,e7 drug manufacturers involved in the research and development of therapies that address-- 7i7 tropical diseases 7as defined in section #ebd7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7a7772 or 7ii7 rare pediatric diseases 7as defined in section #ebi7;a7 of such ,act 7#ba ,u4,s4,c4 #cfj;ff7a7774 7#c7 ,initial assessment ,not later than #aj years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives an initial assessment of the effectiveness of the priority review voucher program set forth in section #efe;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 7#d7 ,report ,not later than #af years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit 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 report containing the results of the study conducted under paragraph 7#a74 7#e7 ,protection of national security ,the ,comptroller ,general of the ,united ,states shall conduct the study under paragraph 7#a7 and issue the assessment and report under paragraphs 7#c7 and 7#d7 in a manner that does not compromise national security4 ,september #i1 #bjaf ,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed