,,ii #aafth ,,congress #b;d ,session ,s4 #dbca ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #bj1 #bjbj,mr4 ,alexander introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to strengthen and sustain on-shore manufacturing capacity and ,state stockpiles1 and to improve the ,strategic ,national ,stockpile4 #a4 ,short title ,this ,act may be cited as the ,preparing for the ,next ,pandemic ,act4 #b4 ,sustained on-shore manufacturing capacity for public health emergencies 7a7 ,in general ,section #cai,l of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is amended-- 7#a7 in subsection 7a77#f77;,b7-- 7,a7 by redesignating clauses 7iv7 and 7v7 as clauses 7v7 and 7vi71 respectively2 7,b7 by inserting after clause 7iii71 the following3 7iv7 activities to support domestic manufacturing surge capacity of products or platform technologies1 including manufacturing capacity and capabilities to utilize platform technologies to provide for flexible manufacturing initiatives2 2 and 7,c7 in clause 7vi7 7as so redesginated71 by inserting manufacture1 after improvement12 7#b7 in subsection 7b7-- 7,a7 in the first sentence of paragraph 7#a71 by inserting support for domestic manufacturing surge capacity1 after initiatives for innovation12 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,b71 by striking and at the end2 7ii7 by redesignating subparagraph 7,c7 as subparagraph 7,d72 and 7iii7 by inserting after subparagraph 7,b71 the following3 7,c7 activities to support manufacturing surge capacities and capabilities to increase the availability of existing medical countermeasures and utilize existing novel platforms to manufacture new medical countermeasures to meet manufacturing demands to address threats that pose a significant level of risk to national security2 and 2 7#c7 in subsection 7c7-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,c71 by striking and at the end2 7ii7 in subparagraph 7,d71 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following3 7,e7 promoting domestic manufacturing surge capacity and capabilities for countermeasure advanced research and development1 including facilitating contracts to support flexible or surge manufacturing4 2 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,b7-- 7,i7 in clause 7iii71 by striking and at the end2 7,,ii7 in clause 7iv71 by striking the period and inserting 2 and2 and 7,,iii7 by adding at the end the following3 7v7 support and maintain domestic manufacturing surge capacity and capabilities1 including through contracts to support flexible or surge manufacturing1 to ensure that additional production of countermeasures is available in the event that the ,secretary determines there is such a need for additional production4 2 7ii7 in subparagraph 7,d7-- 7,i7 in clause 7ii71 by striking and at the end2 7,,ii7 by redesignating clause 7iii7 as clause 7iv72 and 7,,iii7 by inserting after clause 7ii7 the following3 7iii7 research to advance manufacturing capacities and capabilities for medical countermeasures and platform technologies that may be utilized for medical countermeasures2 and 2 and 7iii7 in subparagraph 7,e71 by striking clause 7ix72 and 7,c7 in paragraph 7#g77;,c77i71 by striking up to #ajj highly qualified individuals1 or up to #ej percent of the total number of employees1 whichever is less1 and inserting #ge percent of the total number of employees2 7#d7 in subsection 7d71 by adding at the end the following3 7#c7 ,additional funding ,for necessary expenses to improve and expand manufacturing surge capacity and capabilities1 there is authorized to be appropriated to the ,fund #e1jjj1jjj1jjj1 to remain available until ,september #cj1 #bjcj4 7#d7 ,advance appropriation 7,a7 ,in general ,there is appropriated1 out of amounts in the ,treasury not otherwise appropriated for the fiscal year ending ,september #cj1 #bjba1 for necessary expenses to improve and expand manufacturing surge capacity and capabilities pursuant to subsection 7c77#d77;,b77v71 #e1jjj1jjj1jjj1 to remain available until ,september #cj1 #bjcj4 7,b7 ,emergency designation 7i7 ,in general ,the amounts provided by this paragraph are designated as an emergency requirement pursuant to section #d7;g7 of the ,statutory ,pay-,as-,you-,go ,act of #bjaj 7#b ,u4,s4,c4 #icc7;g774 7ii7 ,designation in senate ,in the ,senate1 this paragraph is designated as an emergency requirement pursuant to section #daab7;a7 of ,h4 ,con4 ,res4 #ga 7#aaeth ,congress71 the concurrent resolution on the budget for fiscal year #bjah4 7,c7 ,application of provisions ,amounts appropriated pursuant to this paragraph for fiscal year #bjba shall be subject to the requirements contained in ,public ,law #aaf-id for funds for programs authorized under section #cai,l of this ,act4 2 7#e7 in subsection 7e77#a7-- 7,a7 by redesignating subparagraphs 7,b7 through 7,d7 as subparagraphs 7,c7 through 7,e71 respectively2 and 7,b7 by inserting after subparagraph 7,a71 the following3 7,b7 ,temporary flexibility ,during a public health emergency under section #cai1 the ,secretary shall be provided with an additional #fj business days to comply with information requests for the disclosure of information under section #eeb of title #e1 ,united ,states ,code1 related to the activities under this section 7unless such activities are otherwise exempt under subparagraph 7,a774 2 and 7#f7 in subsection 7f7-- 7,a7 in paragraph 7#a71 by striking ,not later than #ahj days after the date of enactment of this subsection and inserting ,not later than #ahj days after the date of enactment of the ,preparing for the ,next ,pandemic ,act2 and 7,b7 in paragraph 7#b71 by striking ,not later than #a year after the date of enactment of this subsection and inserting ,not later than #a year after the date of enactment of the ,preparing for the ,next ,pandemic ,act4 7b7 ,medical ,countermeasure ,innovation ,partner ,the restrictions under section #bjb of division ,a of the ,further ,consolidated ,appropriations ,act1 #bjbj 7,public ,law #aaf-id71 or any other provision of law imposing a restriction on salaries of individuals related to a previous appropriation to the ,department of ,health and ,human ,services1 shall not apply with respect to salaries paid pursuant to an agreement under the medical countermeasure innovation partner program under section #cai,l7c77#d77;,e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,e774 #c4 ,improving and sustaining ,state medical stockpiles ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended by adding at the end the following3 7i7 ,improving and maintaining ,state medical stockpiles 7#a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response1 shall award grants1 contracts1 or cooperative agreements to eligible entities to maintain a stockpile of appropriate drugs1 vaccines and other biological products1 medical devices1 and other medical supplies 7including personal protective equipment1 ancillary medical supplies1 and other applicable supplies required for the administration of drugs1 vaccines and other biological products1 medical devices1 and diagnostic tests7 to be used during a public health emergency declared by the ,governor of a ,state or by the ,secretary under section #cai1 or a major disaster or emergency declared by the ,president under section #dja or #eja1 respectively1 of the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act1 in order to support the preparedness goals described in paragraphs 7#b71 7#c71 and 7#h7 of section #bhjb7;b74 7#b7 ,eligible entities 7,a7 ,in general ,to be eligible to receive an award under paragraph 7#a71 an entity shall-- 7i7 be a ,state or consortium of ,states that is a recipient of an award under section #cai;,c-#a7;b72 and 7ii7 prepare1 in consultation with appropriate health care providers and health officials within the ,state or consortium of ,states1 and submit to the ,secretary an application that contains such information as the ,secretary may require1 including a plan for the ,state stockpile and a description of the activities such entity will carry out under the agreement1 consistent with the requirements of paragraph 7#c74 7,b7 ,limitation ,the ,secretary may make an award under this subsection to not more than one eligible entity in each ,state4 7,c7 ,supplement not supplant ,awards1 contracts1 or grants awarded under this subsection shall supplement1 not supplant1 the reserve amounts of medical supplies procured by and for the ,strategic ,national ,stockpile under subsection 7a74 7,d7 ,administrative expenses ,not more than #e percent of amounts received by an entity pursuant to an award under this subsection may be used for administrative expenses4 7,e7 ,clarification ,an eligible entity receiving an award under this subsection may assign a lead entity to manage the ,state stockpile1 which may be a recipient of an award under section #cai;,c-#b7;b74 7,f7 ,requirement of matching funds 7i7 ,in general ,subject to clause 7ii71 the ,secretary may not make an award under this subsection unless the applicant agrees1 with respect to the costs to be incurred by the applicant in carrying out the purpose described in this subsection1 to make available non-,federal contributions toward such costs in an amount equal to-- 7,i7 for each of fiscal years #bjbc and #bjbd1 not less than #a for each #aj of ,federal funds provided in the award2 7,,ii7 for each of fiscal years #bjbe and #bjbf1 not less than #a for each #e of ,federal funds provided in the award2 and 7,,iii7 for fiscal year #bjbg and each fiscal year thereafter1 not less than #a for each #c of ,federal funds provided in the award4 7ii7 ,waiver 7,i7 ,in general ,the ,secretary may1 upon the request of a ,state1 waive the requirement under clause 7i7 in whole or in part if the ,secretary determines that extraordinary economic conditions in the ,state in the fiscal year involved or in the previous fiscal year justify the waiver4 7,,ii7 ,applicability of waiver ,a waiver provided by the ,secretary under this subparagraph shall apply only to the fiscal year involved4 7#c7 ,stockpiling activities and requirements ,a recipient of a grant1 contract1 or cooperative agreement under this subsection shall use such funds to carry out the following3 7,a7 ,maintaining a stockpile of appropriate drugs1 vaccines and other biological products1 medical devices1 and other supplies 7including personal protective equipment1 ancillary medical supplies1 and other applicable supplies required for the administration of drugs1 vaccines and other biological products1 medical devices1 and diagnostic tests7 to be used during a public health emergency in such numbers1 types1 and amounts as the ,state determines necessary1 consistent with such ,state's stockpile plan4 ,such a recipient may not use funds to support the stockpiling of countermeasures as defined under subsection 7c71 unless the eligible entity provides justification for maintaining such products and the ,secretary determines such appropriate and applicable4 7,b7 ,deploying the stockpile as required by the ,state to respond to an actual or potential public health emergency4 7,c7 ,replenishing and making necessary additions or modifications to the contents of such stockpile or stockpiles1 including to address potential depletion4 7,d7 ,in consultation with ,federal1 ,state1 and local officials1 take into consideration the availability1 deployment1 dispensing1 and administration requirements of medical products within the stockpile4 7,e7 ,ensuring that procedures are followed for inventory management and accounting1 and for the physical security of the stockpile1 as appropriate4 7,f7 ,reviewing and revising1 as appropriate1 the contents of the stockpile on a regular basis to ensure that to the extent practicable1 advanced technologies and medical products are considered4 7,g7 ,carrying out exercises1 drills1 and other training for purposes of stockpile deployment1 dispensing1 and administration of medical products1 and for purposes of assessing the capability of such stockpile to address the medical supply needs of public health emergencies of varying types and scales1 which may be conducted in accordance with requirements related to exercises1 drills1 and other training for recipients of awards under section #cai;,c-#a or #cai;,c-#b1 as applicable4 7,h7 ,carrying out other activities as the ,state determines appropriate1 to support ,state efforts to prepare for1 and respond to1 public health threats4 7#d7 ,state plan coordination ,the eligible entity under this subsection shall ensure appropriate coordination of the ,state stockpile plan developed pursuant to paragraph 7#b77;,a77ii7 and the plans required pursuant to section #cai;,c-#a4 7#e7 ,guidance for ,states ,not later than #ahj days after the date of enactment of this subsection1 the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response1 shall issue guidance for ,states related to maintaining and replenishing a stockpile of medical products4 ,the ,secretary shall update such guidance as appropriate4 7#f7 ,assistance to ,states ,the ,secretary shall provide assistance to ,states1 including technical assistance1 as appropriate1 to maintain and improve ,state and local public health preparedness capabilities to distribute and dispense medical products from a ,state stockpile4 7#g7 ,coordination with the ,strategic ,national ,stockpile ,each recipient of an award under this subsection shall ensure that the ,state stockpile plan developed pursuant to paragraph 7#b77;,a77ii7 contains such information as the ,secretary may require related to current inventory of supplies maintained pursuant to paragraph 7#c71 and any plans to replenish such supplies1 or procure new or alternative supplies4 ,the ,secretary shall use information obtained from ,state stockpile plans to inform the maintenance and management of the ,strategic ,national ,stockpile pursuant to subsection 7a74 7#h7 ,performance and accountability 7,a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response1 shall develop and implement a process to review and audit entities in receipt of an award under this subsection1 including by establishing metrics to ensure that each entity receiving such an award is carrying out activities in accordance with the applicable ,state stockpile plan4 ,the ,secretary may require entities to-- 7i7 measure progress toward achieving the outcome goals2 and 7ii7 at least annually1 test1 exercise1 and rigorously evaluate the stockpile capacity and response capabilities of the entity1 and report to the ,secretary on the results of such test1 exercise1 and evaluation1 and on progress toward achieving outcome goals1 based on criteria established by the ,secretary4 7,b7 ,notification of failure ,the ,secretary shall develop and implement a process to notify entities that are determined by the ,secretary to have failed to meet the requirements of the terms of an award under this subsection4 ,such process shall provide such entities with the opportunity to correct such noncompliance4 ,an entity that fails to correct such noncompliance shall be subject to subparagraph 7,c74 7,c7 ,withholding of certain amounts from entities that fail to achieve benchmarks or submit ,state stockpile plan ,beginning with fiscal year #bjbb1 and in each succeeding fiscal year1 the ,secretary shall withhold from each entity that has failed substantially to meet the terms of an award under this subsection for at least #a of the #b immediately preceding fiscal years 7beginning with fiscal year #bjbb71 the amount allowed for administrative expenses described in described in paragraph 7#b77;,d74 7#i7 ,authorization of appropriations ,for the purpose of carrying out this subsection1 there are authorized to be appropriated #a1jjj1jjj1jjj for each of fiscal years #bjba through #bjcj1 to remain available until expended4 7#aj7 ,advance appropriation 7,a7 ,in general ,there is appropriated1 out of amounts in the ,treasury not otherwise appropriated1 for fiscal year #bjba1 for necessary expenses to establish and maintain ,state medical stockpiles pursuant to this subsection1 #aj1jjj1jjj1jjj1 to remain available until ,september #cj1 #bjcj4 7,b7 ,emergency designation 7i7 ,in general ,the amounts provided by this paragraph are designated as an emergency requirement pursuant to section #d7;g7 of the ,statutory ,pay-,as-,you-,go ,act of #bjaj 7#b ,u4,s4,c4 #icc7;g774 7ii7 ,designation in ,senate ,in the ,senate1 this paragraph is designated as an emergency requirement pursuant to section #daab7;a7 of ,h4 ,con4 ,res4 #ga 7#aaeth ,congress71 the concurrent resolution on the budget for fiscal year #bjah4 7,c7 ,application of provisions ,amounts appropriated pursuant to this paragraph for fiscal year #bjba shall be subject to the requirements contained in ,public ,law #aaf-id for funds for programs authorized under section #cai;,f-#b of this ,act4 4 #d4 ,strengthening the ,strategic ,national ,stockpile ,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 7a7-- 7,a7 in paragraph 7#b77;,a71 by adding and the contracts issued under paragraph 7#e7 after paragraph 7#a72 7,b7 in paragraph 7#c77;,f71 by striking ,secretary of ,homeland ,security and inserting ,secretary of ,health and ,human ,services1 in coordination with or at the request of1 the ,secretary of ,homeland ,security12 7,c7 by redesignating paragraph 7#e7 as paragraph 7#f72 7,d7 by inserting after paragraph 7#d7 the following3 7#e7 ,surge capacity ,the ,secretary1 in maintaining the stockpile under paragraph 7#a7 and carrying out procedures under paragraph 7#c71 may-- 7,a7 enter into contracts or cooperative agreements with vendors for procurement1 maintenance1 and storage of reserve amounts of drugs1 vaccines and other biological products1 medical devices1 and other medical supplies 7including personal protective equipment1 ancillary medical supplies1 and other applicable supplies required for the administration of drugs1 vaccines and other biological products1 medical devices1 and diagnostic tests in the stockpile71 under such terms and conditions 7including quantity1 production schedule1 maintenance costs1 and price of product7 as the ,secretary may specify1 including for purposes of-- 7i7 maintenance and storage of reserve amounts of products intended to be delivered to the ownership of the ,federal ,government under the contract1 which may consider costs of shipping1 or otherwise transporting1 handling1 storage1 and related costs for such product or products2 and 7ii7 maintaining domestic manufacturing capacity of such products to ensure additional reserved production capacity of such products is available1 and that such products are provided in a timely manner1 to be delivered to the ownership of the ,federal ,government under the contract and deployed in the event that the ,secretary determines that there is a need to quickly purchase additional quantities of such product2 and 7,b7 promulgate such regulations as the ,secretary determines necessary to implement this paragraph4 2 and 7,e7 in subparagraph 7,a7 of paragraph 7#f71 as so redesignated-- 7i7 in clause 7viii71 by striking 2 and and inserting a semicolon2 7ii7 in clause 7ix71 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following3 7x7 an assessment of the contracts or cooperative agreements entered into pursuant to paragraph 7#e74 2 and 7#b7 in subsection 7c77#b77;,c71 by striking on an annual basis and inserting not later than ,march #ae of each year4