,i #aaf? ,,congress #b;d ,session ,h4 ,r4 #hdgi ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,octob] #a1 #bjbj,mr4 ,c>t] ( ,georgia 7= himself & ,ms4 ,blunt ,ro*e/]7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to provide = /ockpiles to ensure t all ,am]icans h access to g5]ic drugs at risk ( %ortage1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,ess5tial ,m$ic9es ,/rategic ,/ockpile ,act ( #bjbj4 #b4 ,pilot program on ensur+ m$ication supply /ability ,"p ,d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;b et seq47 is am5d$ by add+ at ! end ! foll[+ new subp>t3 ,,xiii ,ensur+ ,m$ication ,supply ,/ability #cdj;,j4 ,ensur+ m$ication supply /ability 7a7 ,aw>d ( contracts ,beg9n+ n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y %all aw>d contracts to eligible entities to ea* implem5t & te/ ! effectiv5ess ( acquir+1 ma9ta9+1 manag+1 & di/ribut+ a /ockpile t-- 7#a7 consi/s ( g5]ic drugs at risk ( %ortage2 & 7#b7 is ( suffici5t quantity to ensure t cu/om]s 9 ! ,unit$ ,/ates ( ! respective eligible entity h access to su* drugs = at lea/ #f mon?s 7z specifi$ by ! ,secret>y bas$ on ! hi/oric dem& = ^? drugs74 7b7 ,selection ( drugs 7#a7 ,9 g5]al ,! ,secret>y %all-- 7,a7 select n m ?an #ej types ( drugs t may be includ$ by eligible entities 9 a /ockpile pursuant to a contract "u ?is section2 & 7,b7 ma9ta9 an up-to-date li/ ( su* drugs2 & 7,c7 make su* li/ publicly available4 7#b7 ,*oice ( eligible entities ,a contract aw>d$ to an eligible entity "u ?is section ne$ n require ! /ockpile ( ! eligible entity to include all #ej types ( drugs li/$ pursuant to p>agraph 7#a74 7c7 ,suffici5t quantity ,= ea* g5]ic drug 9 a /ockpile ma9ta9$ pursuant to subsection 7a71 ! ,secret>y %all specify ! quantity ( su* drug t is suffici5t = purposes ( su* subsection to ensure t consum]s 9 ! ,unit$ ,/ates ( ! respective eligible entity h access to su* drug = at lea/ #f mon?s4 7d7 ,duration2 liquidation ( inv5tory 7#a7 ,duration ,a contract aw>d$ "u ?is section %all be = a t]m ( no m ?an #c ye>s4 7#b7 ,liquidation ( inv5tory ,a drug held 9 a /ockpile pursuant to a contract "u ?is section may be liquidat$ by ! eligible entity at ! end ( ! p]iod ( ! contract4 7e7 ,/ockpile requirem5ts 7#a7 ,ensur+ availability ( unexpir$ products ,ea* eligible entity ) a contract "u ?is section = a /ockpile ( g5]ic drugs at risk ( %ortage %all-- 7,a7 ensure t ea* drug ma9ta9$ 9 ! /ockpile has an expiration date at lea/ #a ye> beyond ! curr5t date2 & 7,b7 to comply ) subp>agraph 7,a7-- 7i7 sell drugs 9 ! /ockpile ?r\gh normal comm]cial *annels & replace ^? drugs2 or 7ii7 if !re is no comm]cial m>ket = a drug 9 ! /ockpile1 dispose ( ! drug1 report su* disposal to ! ,secret>y1 & replace ! drug4 7#b7 ,managem5t ( /ockpile 7,a7 ,9 g5]al ,ea* eligible entity ) a contract "u ?is section = a /ockpile ( g5]ic drugs at risk ( %ortage %all-- 7i7 acquire n lat] ?an #f mon?s foll[+ ! date ! contract is aw>d$1 & ma9ta9 !reaft]1 a #f-mon? supply ( ea* type ( drug ! eligible entity has contract$ to /ockpile1 :i* #f-mon? supply %all be 9 addition to ! av]age levels ( inv5tory held by su* eligible entity ov] ! previ\s ye> = su* drug2 & 7ii7 if x is n possible to comply ) clause 7i71 notify ! ,secret>y1 cit+ ! reason :y x is n possible & ! expect$ "t ( acquisition ( ! drug4 7,b7 ,inv5tory managem5t ,ea* eligible entity ) a contract "u ?is section = a /ockpile ( g5]ic drugs at risk ( %ortage %all manage inv5tory to ensure t drugs 9 ! /ockpile are effici5tly cycl$ to ! comm]cial m>ket &-- 7i7 may /ockpile inv5tory at ! eligible entity's di/ribution c5t] ) specifi$ inv5tory am\nts virtually res]v$ = ! ,f$]al ,gov]nm5t ) con/ant cycl+ to r$uce product expiration2 or 7ii7 may /ore /ockpil$ inv5tory sep>ately 9 a diff]5t location & replace drugs 9 ! /ockpile inv5tory ) ! same drug ) new] dat+4 7,c7 ,insuffici5t funds ,if am\nts available to an eligible entity ?r\gh contracts "u ?is section are n suffici5t to acquire or ma9ta9 a #f-mon? supply ( any drug 9 ! /ockpile ( ! eligible entity fund$ "u ?is section1 ! eligible entity-- 7i7 may acquire & ma9ta9 less ?an a #f-mon? supply1 b 9 no case less ?an a #c-mon? supply2 & 7ii7 %all submit a report to ! ,secret>y id5tify+-- 7,i7 ea* su* drug2 & 7,,ii7 ! reasons :y su* am\nts are n suffici5t to acquire or ma9ta9 a #f-mon? supply4 7,d7 ,annual audits ,n m ?an annually1 ! ,secret>y may reque/ a physical audit c\nt ( ! inv5tories ( all eligible entities ) a contract "u ?is section to validate t ea* su* entity is ma9ta9+ ! appropriate am\nt ( /ockpil$ inv5tory4 7#c7 ,p]iodic product review 7,a7 ,use ( proce$s ,an eligible entity ) a contract "u ?is section = a /ockpile ( g5]ic drugs at risk ( %ortage %all use ! proce$s ( ! sale ( any drugs 9 ! /ockpile to pur*ase drugs = ! /ockpile 9 accordance ) ?is section4 7,b7 ,m>ket inflation or deflation ,9 ! case ( m>ket inflation or deflation affect+ ! price ( a drug 9 ! /ockpile ( an eligible entity ma9ta9$ pursuant to a contract "u ?is section1 ! contract %all ensure t ! ,f$]al ,gov]nm5t does n pr(it or suff] loss on items ( su* drug z a result ( su* inflation or deflation4 7#d7 ,report+ ,ea* eligible entity ) a contract "u ?is section %all submit reports at su* "t & 9 su* mann] z ! ,secret>y may require reg>d+-- 7,a7 curr5t inv5tory levels ( /ockpil$ drugs at a drug level2 7,b7 indicators ( curr5t inv5tory levels ( /ockpil$ drugs relative to acceptable m9imums2 & 7,c7 su* o!r matt]s z ! ,secret>y det]m9es appropriate4 7f7 ,contract t]ms 7#a7 ,paym5t ( mon?ly fees = managem5t ,subject to p>agraph 7#b71 ! ,secret>y %all pay to ea* eligible entity ) a contract "u ?is section = a /ockpile ( g5]ic drugs at risk ( %ortage appropriate mon?ly fees = ! managem5t ( ! /ockpile4 7#b7 ,paym5t condition$ on /ockpile adequacy 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ea* contract ) an eligible entity "u ?is section %all provide t no paym5t "u ! contract may be made until ! entity demon/rates to ! ,secret>y t ! entity has /ockpil$ su* portion ( ! total quantity ( drugs to be /ockpil$ "u ! contract z ! ,secret>y det]m9es to be acceptable = paym5t4 7,b7 ,exceptions = advance paym5ts 7i7 ,9 g5]al ,a contract "u ?is section may provide t1 if ! ,secret>y det]m9es 79 ! ,secret>y's discretion7 t an advance paym5t1 p>tial paym5t = significant mile/ones1 or paym5t to increase capacity is necess>y to ensure success ( ! t]ms ( ! contract1 ! ,secret>y %all pay1 9 advance ( deliv]y1 an am\nt n to exce$ #aj p]c5t ( ! total contract am\nt to be paid to ! eligible entity by ! ,secret>y pursuant to ! contract ov] ! full p]iod ( ! contract4 7ii7 ,co/ ( capital ,a contract "u ?is section may provide = paym5ts to comp5sate ! contract+ eligible entity = additional capital requirem5ts relat$ to ! additional inv5tory to be ma9ta9$4 7iii7 ,tim+ ,! ,secret>y %all1 to ! ext5t practicable1 make any det]m9ation "u clause 7i7 to make an advance paym5t at ! same "t z ! issuance ( a solicitation4 7iv7 ,repaym5t ,if ! ,secret>y makes an advance paym5t pursuant to clause 7i71 ! ,secret>y %all require ! eligible entity receiv+ su* advance paym5t to repay x if !re is a failure to p]=m by ! eligible entity4 7#c7 ,t]m9ation 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 no?+ 9 ?is section %all be con/ru$ z affect+ ! rights ( eligible entities "u provisions ( /atute or regulation 7includ+ ! ,f$]al ,acquisition ,regulation7 relat+ to ! t]m9ation ( contracts = ! conv5i5ce ( ! ,gov]nm5t4 7,b7 ,liquidation ( /ockpile ,if a contract "u ?is section is t]m9at$1 ! eligible entity ) ! contract %all liquidate ! drugs compris+ ! /ockpile fund$ ?r\gh ! contract & return to ! ,gov]nm5t any am\nts ow$ 9 relation to su* drugs1 b %all collect ! managem5t fees associat$ ) su* liquidation4 7g7 ,congressional ov]sight 7#a7 ,indep5d5t evaluation & report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section & annually !reaft]1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct an indep5d5t evaluation1 & submit to ! appropriate congressional committees a report1 conc]n+ ! program "u ?is section4 7#b7 ,cont5ts ( report ,! report "u p>agraph 7#a7 %all review1 assess1 & provide recomm5dations1 z appropriate1 on ! foll[+3 7,a7 ,details on likely co/s & resultant sav+s z comp>$ to a /ockpil+ me?od t does n incorporate p]petual inv5tory cycl+4 7,b7 ,id5tification ( drawd[ns f ! /ockpile1 z evid5ce ( m>ket %ortage avoidance4 7,c7 ,! allocation ( drugs includ$ 9 ! /ockpiles fund$ pursuant to ?is section to ! cu/om]s ( ! eligible entities ) contracts "u ?is section4 7,d7 ,! degree to :i* eligible entities ) contracts "u ?is section fulfill$ _! obligations "u su* contracts4 7h7 ,def9itions ,9 ?is section3 7#a7 ,! t]m eligible entity means an entity t meets ea* ( ! foll[+ crit]ia3 7,a7 ,! entity is lic5s$ or regi/]$ 9 accordance ) applicable ,f$]al & ,/ate law & 9 good /&+ ) respect to su* lic5sure or regi/ration4 7,b7 ,! entity agrees-- 7i7 to pur*ase all drugs to be ma9ta9$ 9 its /ockpile fund$ "u ?is section directly f ! manufactur]s ( ! drugs or ! exclusive di/ributors ( su* manufactur]s2 or 7ii7 9 ! case ( an entity t is a co-op or *a9 ph>macy w>eh\se-- 7,i7 to pur*ase drugs to be ma9ta9$ 9 its /ockpile fund$ "u ?is section f an au?oriz$ di/ributor2 & 7,,ii7 di/ribute ^? drugs only to its memb] ph>macies4 7,c7 ,! entity holds a v]ifi$ au?oriz$ :olesale di/ributor c]tification issu$ by ! ,national ,association ( ,bo>ds ( ,ph>macy4 7,d7 ,! entity sells m ?an #ij p]c5t ( its drugs to disp5s]s4 7,e7 ,! entity agrees to di/ribute inv5tory f its /ockpile fund$ "u ?is section only to disp5s]s t are cu/om]s ( ! entity4 7#b7 ,! t]m g5]ic drug at risk ( %ortage means a drug 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 t-- 7,a7 is approv$ pursuant to section #eje7;j7 ( su* ,act2 7,b7 is includ$ 9 ! ,_w ,heal? ,organization's mo/ rec5t ,model ,li/ ( ,ess5tial ,m$ic9es2 7,c7 is includ$1 at any po9t dur+ ! prec$+ #cf mon?s1 on ! drug %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7,d7 is manufactur$ by #c or few] p]sons t are regi/]$ "u section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = purposes ( su* manufacture4 7i7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #abj1jjj1jjj = fiscal ye>s #bjba ?r\gh #bjbc1 to rema9 available until exp5d$4 4