,,ii #aaf? ,,congress #b;d ,session ,s4 #dbca ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #bj1 #bjbj,mr4 ,alex&] introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to /r5g!n & su/a9 on-%ore manufactur+ capacity & ,/ate /ockpiles1 & to improve ! ,/rategic ,national ,/ockpile4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,prep>+ = ! ,next ,p&emic ,act4 #b4 ,su/a9$ on-%ore manufactur+ capacity = public heal? em]g5cies 7a7 ,9 g5]al ,section #cai,l ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is am5d$-- 7#a7 9 subsection 7a77#f77;,b7-- 7,a7 by r$esignat+ clauses 7iv7 & 7v7 z clauses 7v7 & 7vi71 respectively2 7,b7 by ins]t+ aft] clause 7iii71 ! foll[+3 7iv7 activities to support dome/ic manufactur+ surge capacity ( products or plat=m te*nologies1 includ+ manufactur+ capacity & capabilities to utilize plat=m te*nologies to provide = flexible manufactur+ initiatives2 2 & 7,c7 9 clause 7vi7 7z s r$esg9at$71 by ins]t+ manufacture1 aft] improvem5t12 7#b7 9 subsection 7b7-- 7,a7 9 ! fir/ s5t5ce ( p>agraph 7#a71 by ins]t+ support = dome/ic manufactur+ surge capacity1 aft] initiatives = innovation12 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7ii7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,d72 & 7iii7 by ins]t+ aft] subp>agraph 7,b71 ! foll[+3 7,c7 activities to support manufactur+ surge capacities & capabilities to increase ! availability ( exi/+ m$ical c\nt]measures & utilize exi/+ novel plat=ms to manufacture new m$ical c\nt]measures to meet manufactur+ dem&s to address ?reats t pose a significant level ( risk to national security2 & 2 7#c7 9 subsection 7c7-- 7,a7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,d71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,e7 promot+ dome/ic manufactur+ surge capacity & capabilities = c\nt]measure advanc$ rese>* & developm5t1 includ+ facilitat+ contracts to support flexible or surge manufactur+4 2 7,b7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,b7-- 7,i7 9 clause 7iii71 by /rik+ & at ! end2 7,,ii7 9 clause 7iv71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+3 7v7 support & ma9ta9 dome/ic manufactur+ surge capacity & capabilities1 includ+ ?r\gh contracts to support flexible or surge manufactur+1 to ensure t additional production ( c\nt]measures is available 9 ! ev5t t ! ,secret>y det]m9es !re is su* a ne$ = additional production4 2 7ii7 9 subp>agraph 7,d7-- 7,i7 9 clause 7ii71 by /rik+ & at ! end2 7,,ii7 by r$esignat+ clause 7iii7 z clause 7iv72 & 7,,iii7 by ins]t+ aft] clause 7ii7 ! foll[+3 7iii7 rese>* to advance manufactur+ capacities & capabilities = m$ical c\nt]measures & plat=m te*nologies t may be utiliz$ = m$ical c\nt]measures2 & 2 & 7iii7 9 subp>agraph 7,e71 by /rik+ clause 7ix72 & 7,c7 9 p>agraph 7#g77;,c77i71 by /rik+ up to #ajj highly qualifi$ individuals1 or up to #ej p]c5t ( ! total numb] ( employees1 :i*ev] is less1 & ins]t+ #ge p]c5t ( ! total numb] ( employees2 7#d7 9 subsection 7d71 by add+ at ! end ! foll[+3 7#c7 ,additional fund+ ,= necess>y exp5ses to improve & exp& manufactur+ surge capacity & capabilities1 !re is au?oriz$ to be appropriat$ to ! ,fund #e1jjj1jjj1jjj1 to rema9 available until ,septemb] #cj1 #bjcj4 7#d7 ,advance appropriation 7,a7 ,9 g5]al ,!re is appropriat$1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$ = ! fiscal ye> end+ ,septemb] #cj1 #bjba1 = necess>y exp5ses to improve & exp& manufactur+ surge capacity & capabilities pursuant to subsection 7c77#d77;,b77v71 #e1jjj1jjj1jjj1 to rema9 available until ,septemb] #cj1 #bjcj4 7,b7 ,em]g5cy designation 7i7 ,9 g5]al ,! am\nts provid$ by ?is p>agraph are designat$ z an em]g5cy requirem5t pursuant to section #d7;g7 ( ! ,/atutory ,pay-,z-,y-,g ,act ( #bjaj 7#b ,u4,s4,c4 #icc7;g774 7ii7 ,designation 9 s5ate ,9 ! ,s5ate1 ?is p>agraph is designat$ z an em]g5cy requirem5t pursuant to section #daab7;a7 ( ,h4 ,con4 ,res4 #ga 7#aae? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjah4 7,c7 ,application ( provisions ,am\nts appropriat$ pursuant to ?is p>agraph = fiscal ye> #bjba %all be subject to ! requirem5ts conta9$ 9 ,public ,law #aaf-id = funds = programs au?oriz$ "u section #cai,l ( ?is ,act4 2 7#e7 9 subsection 7e77#a7-- 7,a7 by r$esignat+ subp>agraphs 7,b7 ?r\gh 7,d7 z subp>agraphs 7,c7 ?r\gh 7,e71 respectively2 & 7,b7 by ins]t+ aft] subp>agraph 7,a71 ! foll[+3 7,b7 ,tempor>y flexibility ,dur+ a public heal? em]g5cy "u section #cai1 ! ,secret>y %all be provid$ ) an additional #fj bus9ess days to comply ) in=mation reque/s = ! disclosure ( in=mation "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 relat$ to ! activities "u ?is section 7unless su* activities are o!rwise exempt "u subp>agraph 7,a774 2 & 7#f7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 by /rik+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subsection & ins]t+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,prep>+ = ! ,next ,p&emic ,act2 & 7,b7 9 p>agraph 7#b71 by /rik+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is subsection & ins]t+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,prep>+ = ! ,next ,p&emic ,act4 7b7 ,m$ical ,c\nt]measure ,innovation ,p>tn] ,! re/rictions "u section #bjb ( division ,a ( ! ,fur!r ,consolidat$ ,appropriations ,act1 #bjbj 7,public ,law #aaf-id71 or any o!r provision ( law impos+ a re/riction on sal>ies ( individuals relat$ to a previ\s appropriation to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all n apply ) respect to sal>ies paid pursuant to an agreem5t "u ! m$ical c\nt]measure innovation p>tn] program "u section #cai,l7c77#d77;,e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,e774 #c4 ,improv+ & su/a9+ ,/ate m$ical /ockpiles ,section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is am5d$ by add+ at ! end ! foll[+3 7i7 ,improv+ & ma9ta9+ ,/ate m$ical /ockpiles 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 %all aw>d grants1 contracts1 or coop]ative agreem5ts to eligible entities to ma9ta9 a /ockpile ( appropriate drugs1 vacc9es & o!r biological products1 m$ical devices1 & o!r m$ical supplies 7includ+ p]sonal protective equipm5t1 ancill>y m$ical supplies1 & o!r applicable supplies requir$ = ! adm9i/ration ( drugs1 vacc9es & o!r biological products1 m$ical devices1 & diagno/ic te/s7 to be us$ dur+ a public heal? em]g5cy decl>$ by ! ,gov]nor ( a ,/ate or by ! ,secret>y "u section #cai1 or a major disa/] or em]g5cy decl>$ by ! ,presid5t "u section #dja or #eja1 respectively1 ( ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act1 9 ord] to support ! prep>$ness goals describ$ 9 p>agraphs 7#b71 7#c71 & 7#h7 ( section #bhjb7;b74 7#b7 ,eligible entities 7,a7 ,9 g5]al ,to be eligible to receive an aw>d "u p>agraph 7#a71 an entity %all-- 7i7 be a ,/ate or consortium ( ,/ates t is a recipi5t ( an aw>d "u section #cai;,c-#a7;b72 & 7ii7 prep>e1 9 consultation ) appropriate heal? c>e provid]s & heal? (ficials )9 ! ,/ate or consortium ( ,/ates1 & submit to ! ,secret>y an application t conta9s su* in=mation z ! ,secret>y may require1 includ+ a plan = ! ,/ate /ockpile & a description ( ! activities su* entity w c>ry out "u ! agreem5t1 consi/5t ) ! requirem5ts ( p>agraph 7#c74 7,b7 ,limitation ,! ,secret>y may make an aw>d "u ?is subsection to n m ?an "o eligible entity 9 ea* ,/ate4 7,c7 ,supplem5t n supplant ,aw>ds1 contracts1 or grants aw>d$ "u ?is subsection %all supplem5t1 n supplant1 ! res]ve am\nts ( m$ical supplies procur$ by & = ! ,/rategic ,national ,/ockpile "u subsection 7a74 7,d7 ,adm9i/rative exp5ses ,n m ?an #e p]c5t ( am\nts receiv$ by an entity pursuant to an aw>d "u ?is subsection may be us$ = adm9i/rative exp5ses4 7,e7 ,cl>ification ,an eligible entity receiv+ an aw>d "u ?is subsection may assign a lead entity to manage ! ,/ate /ockpile1 :i* may be a recipi5t ( an aw>d "u section #cai;,c-#b7;b74 7,f7 ,requirem5t ( mat*+ funds 7i7 ,9 g5]al ,subject to clause 7ii71 ! ,secret>y may n make an aw>d "u ?is subsection unless ! applicant agrees1 ) respect to ! co/s to be incurr$ by ! applicant 9 c>ry+ out ! purpose describ$ 9 ?is subsection1 to make available non-,f$]al contributions t[>d su* co/s 9 an am\nt equal to-- 7,i7 = ea* ( fiscal ye>s #bjbc & #bjbd1 n less ?an #a = ea* #aj ( ,f$]al funds provid$ 9 ! aw>d2 7,,ii7 = ea* ( fiscal ye>s #bjbe & #bjbf1 n less ?an #a = ea* #e ( ,f$]al funds provid$ 9 ! aw>d2 & 7,,iii7 = fiscal ye> #bjbg & ea* fiscal ye> !reaft]1 n less ?an #a = ea* #c ( ,f$]al funds provid$ 9 ! aw>d4 7ii7 ,waiv] 7,i7 ,9 g5]al ,! ,secret>y may1 ^u ! reque/ ( a ,/ate1 waive ! requirem5t "u clause 7i7 9 :ole or 9 "p if ! ,secret>y det]m9es t extraord9>y economic conditions 9 ! ,/ate 9 ! fiscal ye> involv$ or 9 ! previ\s fiscal ye> ju/ify ! waiv]4 7,,ii7 ,applicability ( waiv] ,a waiv] provid$ by ! ,secret>y "u ?is subp>agraph %all apply only to ! fiscal ye> involv$4 7#c7 ,/ockpil+ activities & requirem5ts ,a recipi5t ( a grant1 contract1 or coop]ative agreem5t "u ?is subsection %all use su* funds to c>ry out ! foll[+3 7,a7 ,ma9ta9+ a /ockpile ( appropriate drugs1 vacc9es & o!r biological products1 m$ical devices1 & o!r supplies 7includ+ p]sonal protective equipm5t1 ancill>y m$ical supplies1 & o!r applicable supplies requir$ = ! adm9i/ration ( drugs1 vacc9es & o!r biological products1 m$ical devices1 & diagno/ic te/s7 to be us$ dur+ a public heal? em]g5cy 9 su* numb]s1 types1 & am\nts z ! ,/ate det]m9es necess>y1 consi/5t ) su* ,/ate's /ockpile plan4 ,su* a recipi5t may n use funds to support ! /ockpil+ ( c\nt]measures z def9$ "u subsection 7c71 unless ! eligible entity provides ju/ification = ma9ta9+ su* products & ! ,secret>y det]m9es su* appropriate & applicable4 7,b7 ,deploy+ ! /ockpile z requir$ by ! ,/ate to respond to an actual or pot5tial public heal? em]g5cy4 7,c7 ,repl5i%+ & mak+ necess>y additions or modifications to ! cont5ts ( su* /ockpile or /ockpiles1 includ+ to address pot5tial depletion4 7,d7 ,9 consultation ) ,f$]al1 ,/ate1 & local (ficials1 take into consid]ation ! availability1 deploym5t1 disp5s+1 & adm9i/ration requirem5ts ( m$ical products )9 ! /ockpile4 7,e7 ,ensur+ t proc$ures are foll[$ = inv5tory managem5t & acc\nt+1 & = ! physical security ( ! /ockpile1 z appropriate4 7,f7 ,review+ & revis+1 z appropriate1 ! cont5ts ( ! /ockpile on a regul> basis to ensure t to ! ext5t practicable1 advanc$ te*nologies & m$ical products are consid]$4 7,g7 ,c>ry+ out ex]cises1 drills1 & o!r tra9+ = purposes ( /ockpile deploym5t1 disp5s+1 & adm9i/ration ( m$ical products1 & = purposes ( assess+ ! capability ( su* /ockpile to address ! m$ical supply ne$s ( public heal? em]g5cies ( v>y+ types & scales1 :i* may be conduct$ 9 accordance ) requirem5ts relat$ to ex]cises1 drills1 & o!r tra9+ = recipi5ts ( aw>ds "u section #cai;,c-#a or #cai;,c-#b1 z applicable4 7,h7 ,c>ry+ out o!r activities z ! ,/ate det]m9es appropriate1 to support ,/ate ef=ts to prep>e =1 & respond to1 public heal? ?reats4 7#d7 ,/ate plan coord9ation ,! eligible entity "u ?is subsection %all ensure appropriate coord9ation ( ! ,/ate /ockpile plan develop$ pursuant to p>agraph 7#b77;,a77ii7 & ! plans requir$ pursuant to section #cai;,c-#a4 7#e7 ,guidance = ,/ates ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 %all issue guidance = ,/ates relat$ to ma9ta9+ & repl5i%+ a /ockpile ( m$ical products4 ,! ,secret>y %all update su* guidance z appropriate4 7#f7 ,assi/ance to ,/ates ,! ,secret>y %all provide assi/ance to ,/ates1 includ+ te*nical assi/ance1 z appropriate1 to ma9ta9 & improve ,/ate & local public heal? prep>$ness capabilities to di/ribute & disp5se m$ical products f a ,/ate /ockpile4 7#g7 ,coord9ation ) ! ,/rategic ,national ,/ockpile ,ea* recipi5t ( an aw>d "u ?is subsection %all ensure t ! ,/ate /ockpile plan develop$ pursuant to p>agraph 7#b77;,a77ii7 conta9s su* in=mation z ! ,secret>y may require relat$ to curr5t inv5tory ( supplies ma9ta9$ pursuant to p>agraph 7#c71 & any plans to repl5i% su* supplies1 or procure new or alt]native supplies4 ,! ,secret>y %all use in=mation obta9$ f ,/ate /ockpile plans to in=m ! ma9t5ance & managem5t ( ! ,/rategic ,national ,/ockpile pursuant to subsection 7a74 7#h7 ,p]=mance & acc\ntability 7,a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 %all develop & implem5t a process to review & audit entities 9 receipt ( an aw>d "u ?is subsection1 includ+ by e/abli%+ metrics to ensure t ea* entity receiv+ su* an aw>d is c>ry+ out activities 9 accordance ) ! applicable ,/ate /ockpile plan4 ,! ,secret>y may require entities to-- 7i7 measure progress t[>d a*iev+ ! outcome goals2 & 7ii7 at lea/ annually1 te/1 ex]cise1 & rigor\sly evaluate ! /ockpile capacity & response capabilities ( ! entity1 & report to ! ,secret>y on ! results ( su* te/1 ex]cise1 & evaluation1 & on progress t[>d a*iev+ outcome goals1 bas$ on crit]ia e/abli%$ by ! ,secret>y4 7,b7 ,notification ( failure ,! ,secret>y %all develop & implem5t a process to notify entities t are det]m9$ by ! ,secret>y to h fail$ to meet ! requirem5ts ( ! t]ms ( an aw>d "u ?is subsection4 ,su* process %all provide su* entities ) ! opportunity to correct su* noncompliance4 ,an entity t fails to correct su* noncompliance %all be subject to subp>agraph 7,c74 7,c7 ,)hold+ ( c]ta9 am\nts f entities t fail to a*ieve b5*m>ks or submit ,/ate /ockpile plan ,beg9n+ ) fiscal ye> #bjbb1 & 9 ea* succe$+ fiscal ye>1 ! ,secret>y %all )hold f ea* entity t has fail$ sub/antially to meet ! t]ms ( an aw>d "u ?is subsection = at lea/ #a ( ! #b imm$iately prec$+ fiscal ye>s 7beg9n+ ) fiscal ye> #bjbb71 ! am\nt all[$ = adm9i/rative exp5ses describ$ 9 describ$ 9 p>agraph 7#b77;,d74 7#i7 ,au?orization ( appropriations ,= ! purpose ( c>ry+ out ?is subsection1 !re are au?oriz$ to be appropriat$ #a1jjj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjcj1 to rema9 available until exp5d$4 7#aj7 ,advance appropriation 7,a7 ,9 g5]al ,!re is appropriat$1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 = fiscal ye> #bjba1 = necess>y exp5ses to e/abli% & ma9ta9 ,/ate m$ical /ockpiles pursuant to ?is subsection1 #aj1jjj1jjj1jjj1 to rema9 available until ,septemb] #cj1 #bjcj4 7,b7 ,em]g5cy designation 7i7 ,9 g5]al ,! am\nts provid$ by ?is p>agraph are designat$ z an em]g5cy requirem5t pursuant to section #d7;g7 ( ! ,/atutory ,pay-,z-,y-,g ,act ( #bjaj 7#b ,u4,s4,c4 #icc7;g774 7ii7 ,designation 9 ,s5ate ,9 ! ,s5ate1 ?is p>agraph is designat$ z an em]g5cy requirem5t pursuant to section #daab7;a7 ( ,h4 ,con4 ,res4 #ga 7#aae? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjah4 7,c7 ,application ( provisions ,am\nts appropriat$ pursuant to ?is p>agraph = fiscal ye> #bjba %all be subject to ! requirem5ts conta9$ 9 ,public ,law #aaf-id = funds = programs au?oriz$ "u section #cai;,f-#b ( ?is ,act4 4 #d4 ,/r5g!n+ ! ,/rategic ,national ,/ockpile ,section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#b77;,a71 by add+ & ! contracts issu$ "u p>agraph 7#e7 aft] p>agraph 7#a72 7,b7 9 p>agraph 7#c77;,f71 by /rik+ ,secret>y ( ,homel& ,security & ins]t+ ,secret>y ( ,heal? & ,human ,s]vices1 9 coord9ation ) or at ! reque/ (1 ! ,secret>y ( ,homel& ,security12 7,c7 by r$esignat+ p>agraph 7#e7 z p>agraph 7#f72 7,d7 by ins]t+ aft] p>agraph 7#d7 ! foll[+3 7#e7 ,surge capacity ,! ,secret>y1 9 ma9ta9+ ! /ockpile "u p>agraph 7#a7 & c>ry+ out proc$ures "u p>agraph 7#c71 may-- 7,a7 ent] into contracts or coop]ative agreem5ts ) v5dors = procurem5t1 ma9t5ance1 & /orage ( res]ve am\nts ( drugs1 vacc9es & o!r biological products1 m$ical devices1 & o!r m$ical supplies 7includ+ p]sonal protective equipm5t1 ancill>y m$ical supplies1 & o!r applicable supplies requir$ = ! adm9i/ration ( drugs1 vacc9es & o!r biological products1 m$ical devices1 & diagno/ic te/s 9 ! /ockpile71 "u su* t]ms & conditions 7includ+ quantity1 production s*$ule1 ma9t5ance co/s1 & price ( product7 z ! ,secret>y may specify1 includ+ = purposes (-- 7i7 ma9t5ance & /orage ( res]ve am\nts ( products int5d$ to be deliv]$ to ! own]%ip ( ! ,f$]al ,gov]nm5t "u ! contract1 :i* may consid] co/s ( %ipp+1 or o!rwise transport+1 h&l+1 /orage1 & relat$ co/s = su* product or products2 & 7ii7 ma9ta9+ dome/ic manufactur+ capacity ( su* products to ensure additional res]v$ production capacity ( su* products is available1 & t su* products are provid$ 9 a timely mann]1 to be deliv]$ to ! own]%ip ( ! ,f$]al ,gov]nm5t "u ! contract & deploy$ 9 ! ev5t t ! ,secret>y det]m9es t !re is a ne$ to quickly pur*ase additional quantities ( su* product2 & 7,b7 promulgate su* regulations z ! ,secret>y det]m9es necess>y to implem5t ?is p>agraph4 2 & 7,e7 9 subp>agraph 7,a7 ( p>agraph 7#f71 z s r$esignat$-- 7i7 9 clause 7viii71 by /rik+ 2 & & ins]t+ a semicolon2 7ii7 9 clause 7ix71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7x7 an assessm5t ( ! contracts or coop]ative agreem5ts ent]$ into pursuant to p>agraph 7#e74 2 & 7#b7 9 subsection 7c77#b77;,c71 by /rik+ on an annual basis & ins]t+ n lat] ?an ,m>* #ae ( ea* ye>4