,i #aag? ,,congress #a/ ,session ,h4 ,r4 #cicb ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,june #af1 #bjba ,mr4 ,mi*ael ,f4 ,doyle ( ,p5nsylvania 7= himself & ,mr4 ,f]guson7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 ,vet]ans' ,affairs1 ,arm$ ,s]vices1 ! ,judici>y1 & ,homel& ,security1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to e/abli% a program to develop antimicrobial innovations t>get+ ! mo/ *all5g+ pa?og5s & mo/ ?reat5+ infections4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pione]+ ,antimicrobial ,subscriptions ,to ,end ,up surg+ ,resi/ance ,act ( #bjba or ! ,,pa/eur ,act ( #bjba4 #b4 ,develop+ antimicrobial innovations ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 ,w ,develop+ antimicrobial innovations #cii,,oo4 ,e/abli%m5t ( ,committee2 subscription model2 advisory gr\p 7a7 ,9 g5]al ,n lat] ?an #fj days aft] ! date ( enactm5t ( ?is "p1 ! ,secret>y %all e/abli% a ,committee on ,critical ,ne$ ,antimicrobials & appo9t memb]s to ! ,committee4 7b7 ,memb]s 7#a7 ,9 g5]al ,! ,committee %all consi/ ( at lea/ "o repres5tative f ea* ( ! ,national ,in/itute ( ,all]gy & ,infecti\s ,diseases1 ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 ! ,food & ,drug ,adm9i/ration1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,vet]ans ,heal? ,adm9i/ration1 & ! ,dep>tm5t ( ,def5se4 7#b7 ,*air ,! ,secret>y %all appo9t "o ( ! memb]s ( ! ,committee to s]ve z ! ,*air ( ! ,committee4 7c7 ,duties ,n lat] ?an #a ye> aft] ! appo9tm5t ( all initial memb]s ( ! ,committee1 ! ,secret>y1 9 collaboration ) ! ,committee1 & 9 consultation ) ! ,critical ,ne$ ,antimicrobials ,advisory ,gr\p e/abli%$ "u subsection 7g71 %all d ! foll[+3 7#a7 ,develop a li/ ( infections = :i* new antimicrobial drug developm5t is ne$$1 tak+ into acc\nt organisms1 sites ( infection1 & type ( infections = :i* !re is an unmet m$ical ne$1 f9d+s f ! mo/ rec5t report entitl$ ,antibiotic ,resi/ance ,?reats 9 ! ,unit$ ,/ates issu$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 or an anticipat$ unmet m$ical ne$1 includ+ a pot5tial global heal? security ?reat4 ,= ! li/ develop$ "u ?is p>agraph1 ! ,secret>y1 9 collaboration ) ! ,committee1 may use ! infection li/ 9 su* mo/ rec5t report = up to #c ye>s foll[+ ! date ( enactm5t ( ?is "p & subsequ5tly update ! li/ "u ?is p>agraph 9 accordance ) subsection 7e74 7#b7 ,develop regulations1 9 accordance ) subsection 7d71 outl9+ favor$ *>act]i/ics ( critical ne$ antimicrobial drugs1 t are evid5ce bas$1 cl9ically focus$1 & design$ to treat ! infections describ$ 9 p>agraph 7#a71 & e/abli%+ crit]ia = h[ ea* su* *>act]i/ic w adju/ ! monet>y value ( a subscription contract aw>d$ "u subsection 7f7 or section #cii,,qq4 ,! favor$ *>act]i/ics %all be weigh$ = purposes ( su* monet>y value su* t meet+ c]ta9 *>act]i/ics1 or meet+ m ?an "o su* *>act]i/ic1 increases ! monet>y value4 ,su* favor$ *>act]i/ics ( an antimicrobial drug %all include-- 7,a7 treat+ infections on ! li/ "u p>agraph 7#a72 7,b7 improv+ cl9ical outcomes = pati5ts ) multi-drug-resi/ant infections2 7,c7 be+ a fir/-approv$ antimicrobial drug t has ! pot5tial to address unmet m$ical ne$s = ! treatm5t ( a s]i\s or life-?reat5+ infection1 &1 to a less] ext5t1 second & ?ird drugs t treat su* infections2 7,d7 r\te ( adm9i/ration1 especially ?r\gh oral adm9i/ration2 7,e7 7i7 conta9+ no active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 t has be5 approv$ 9 any o!r application "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or int5d+ to be ! subject ( a new orig9al biologics lic5se application "u section #cea7;a72 7ii7 be+ a memb] ( a new class ( drugs ) a novel t>get & novel mode ( action t are di/9ctly diff]5t f ! t>get or mode ( any antimicrobial drug approv$ "u section #eje ( su* ,act or lic5s$ "u section #cea1 includ+ r$uc$ toxicity2 7iii7 n be+ affect$ by cross-resi/ance to any antimicrobial drug approv$ "u su* section #eje or lic5s$ "u su* section #cea2 7,f7 address+ a multi-drug resi/ant infection ?r\gh a novel *emical scaffold or me*anism ( action2 7,g7 hav+ receiv$ a transitional subscription contract "u subsection 7f72 & 7,h7 any o!r *>act]i/ic ! ,secret>y1 9 collaboration ) ! ,committee1 det]m9es necess>y4 7d7 ,regulations 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! appo9tm5t ( ! initial memb]s ( ! ,committee1 ! ,secret>y %all issue propos$ regulations :i* %all include-- 7,a7 a process by :i* ! sponsors c apply = an antimicrobial drug to become a critical ne$ antimicrobial drug "u section #cii,,pp2 7,b7 h[ subscription contracts "u su* section %all be e/abli%$ & paid2 7,c7 ! favor$ *>act]i/ics "u subsection 7c77#b71 h[ su* *>act]i/ics w be weigh$1 & ! m9imum numb] & k9d ( favor$ *>act]i/ics ne$$ = an antimicrobial drug to be designat$ a critical ne$ antimicrobial drug2 & 7,d7 o!r elem5ts ( ! subscription contract process1 9 accordance ) ?is "p4 7#b7 ,developm5t ( f9al regulations ,be=e f9aliz+ ! regulations "u p>agraph 7#a71 ! ,secret>y %all solicit public comm5t & hold public meet+s = ! p]iod beg9n+ on ! date on :i* ! propos$ regulations are issu$ & end+ on ! date t is #abj days aft] su* date ( issuance4 ,! ,secret>y %all f9alize & publi% su* regulations n lat] ?an #abj days aft] ! close ( su* p]iod ( public comm5t & meet+s4 7#c7 ,subscription contract (fice ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is "p1 ! ,secret>y %all propose an ag5cy or (fice 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to manage ! e/abli%m5t & paym5t ( subscription contracts aw>d$ "u section #cii,,qq1 includ+ eligibility1 requirem5ts1 & contract am\nts4 ,! ,secret>y %all solicit public comm5t & f9alize ! ag5cy or (fice no lat] ?an #de days foll[+ ! propos$ ag5cy or (fice4 ,su* ag5cy or (fice %all be ref]r$ to z ! ,subscription ,contract ,(fice4 7e7 ,li/ ( infections ,! ,secret>y1 9 collaboration ) ! ,committee1 %all update ! li/ ( infections "u subsection 7c77#a7 at lea/ e #b ye>s4 7f7 ,transitional subscription contracts 7#a7 ,9 g5]al ,n e>li] ?an #cj days aft] ! date ( enactm5t ( ?is "p & end+ on ! date t ! ,secret>y f9alizes ! subscription contract regulations "u subsection 7d71 ! ,secret>y may use up to #a1jjj1jjj1jjj ( ! am\nt appropriat$ "u section #cii,,ss7a7 to engage 9 transitional subscription contracts ( up to #c ye>s 9 l5g? ) antimicrobial develop]s1 z det]m9$ by ! ,secret>y1 t h develop$ antimicrobial drugs treat+ infections li/$ 9 ! mo/ rec5t report entitl$ ,antibiotic ,resi/ance ,?reats 9 ! ,unit$ ,/ates issu$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 & may include antimicrobial drugs t are qualifi$ infecti\s disease products 7z def9$ 9 section #eje;,e7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 innovative biological products1 or innovative drugs t a*ieve a cl9ical outcome ?r\gh immunomodulation4 ,su* a contract may au?orize ! contractor to use funds made available "u ! contract = completion ( po/m>ket+ cl9ical /udies1 manufactur+1 & o!r precl9ical & cl9ical ef=ts4 7#b7 ,requirem5ts 7,a7 ,9 g5]al ,! ,secret>y1 ?r\gh ! (fice describ$ 9 p>agraph 7#d71 may ent] into a contract "u p>agraph 7#a7-- 7i7 if ! ,secret>y det]m9es t ! antimicrobial drug is int5d$ to treat an infection = :i* !re is an unmet cl9ical ne$1 an anticipat$ cl9ical ne$1 or drug resi/ance2 7ii7 subject to t]ms includ+-- 7,i7 t ! ,secret>y %all cease any paym5t in/allm5ts "u a transitional subscription contract if ! sponsor does n-- 7aa7 ensure comm]cial & ,f$]al availability ( ! antimicrobial drug )9 #cj days ( receiv+ fir/ paym5t "u ! contract2 7bb7 id5tify1 track1 & publicly report drug resi/ance data & tr5ds us+ available data relat$ to ! antimicrobial drug2 7cc7 develop & implem5t education & communications /rategies1 includ+ communications = individuals ) limit$ ,engli% pr(ici5cy & individuals ) disabilities1 = heal? c>e pr(essionals & pati5ts ab\t appropriate use ( ! antimicrobial drug2 7dd7 submit a plan = regi/]+ ! antimicrobial drug 9 additional c\ntries :]e an unmet m$ical ne$ exi/s1 :i* su* plan may be consi/5t ) ! ,/ew>d%ip & ,access ,plan 7,,sap7 ,developm5t ,guide 7#bjba72 7ee7 subject to subp>agraph 7,b71 ensure a reliable drug supply *a91 ?us lead+ to an int]ruption ( ! supply ( ! antimicrobial drug 9 ! ,unit$ ,/ates = m ?an #fj days2 or 7ff7 make mean+ful progress t[>d completion ( ,food & ,drug ,adm9i/ration-requir$ po/m>ket+ /udies1 includ+ su* /udies t are evid5ce bas$2 & 7,,ii7 o!r t]ms z det]m9$ by ! ,secret>y2 & 7iii7 if-- 7,i7 a phase #c cl9ical /udy has be5 initiat$ = ! antimicrobial drug2 or 7,,ii7 ! antimicrobial drug has be5 approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea7;a74 7,b7 ,waiv] ,! requirem5t "u subp>agraph 7,a77ii77,i77ee7 may be waiv$ 9 ! case t an em]g5cy prohibits access to a reliable drug supply *a94 7#c7 ,transitional guidance ,n lat] ?an #abj days aft] ! appo9tm5t ( ! initial memb]s ( ! ,committee1 ! ,secret>y %all issue1 9 consultation ) ! ,committee1 transitional guidance outl9+ ! antimicrobial drugs t are eligible = transitional subscription contracts "u p>agraph 7#a71 ! requirem5ts to ent] into a transitional subscription contract "u p>agraph 7#b71 & ! process by :i* drug develop]s c ent] into transitional subscription contracts ) ! ,secret>y "u ?is subsection4 7#d7 ,paym5t (fice & me*anism ,n lat] ?an #cj days aft] ! date ( enactm5t ( ?is "p1 ! ,secret>y %all det]m9e ! ag5cy or (fice 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices t w manage ! transitional subscription contracts1 includ+ eligibility1 requirem5ts1 & contract am\nts1 dur+ ! p]iod describ$ 9 p>agraph 7#a74 7g7 ,critical ne$ antimicrobial advisory gr\p 7#a7 ,9 g5]al ,n lat] ?an #cj days aft] ! appo9tm5t ( all initial memb]s ( ! ,committee1 ! ,secret>y1 9 collaboration ) ! ,committee1 %all e/abli% a ,critical ,ne$ ,antimicrobial ,advisory ,gr\p 7ref]r$ to 9 ?is subsection z ! ,advisory ,gr\p7 & appo9t memb]s to ! ,advisory ,gr\p4 7#b7 ,memb]s ,! memb]s ( ! ,advisory ,gr\p %all include-- 7,a7 n few] ?an #f individuals :o are-- 7i7 infecti\s disease speciali/s2 or 7ii7 o!r heal? exp]ts ) exp]tise 9 rese>*+ antimicrobial resi/ance1 heal? economics1 or comm]cializ+ antimicrobial drugs2 & 7,b7 n few] ?an #e pati5t advocates4 7#c7 ,*air ,! ,secret>y %all appo9t "o ( ! memb]s ( ! ,advisory ,gr\p to s]ve z ! ,*air4 7#d7 ,conflicts ( int]e/ ,9 appo9t+ memb]s "u p>agraph 7#b71 ! ,secret>y %all ensure t no memb] receives comp5sation 9 any mann] f a comm]cial or =-pr(it entity t develops antimicrobials or t might b5efit f antimicrobial developm5t4 7#e7 ,applicability ( ,,faca ,except z o!rwise provid$ 9 ?is subsection1 ! ,f$]al ,advisory ,committee ,act %all apply to ! ,advisory ,gr\p4 #cii,,pp4 ,critical ne$ antimicrobial drug application & paym5t ?r\gh subscription contracts 7a7 ,9 g5]al 7#a7 ,submission ( reque/ ,! sponsor ( an application "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a7 = an antimicrobial drug may reque/ t ! ,secret>y designate ! drug z a critical ne$ antimicrobial4 ,a reque/ = su* designation may be submitt$ aft] ! ,secret>y grants = su* drug an inve/igational new drug exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a77#c71 & %all be submitt$ n lat] ?an #e ye>s aft] ! date ( approval "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea7;a74 7#b7 ,cont5t ( reque/ ,a reque/ "u p>agraph 7#a7 %all include in=mation1 su* z cl9ical1 precl9ical & po/m>ket+ data1 a li/ ( ! favorable *>act]i/ics describ$ 9 section #cii,,oo7c77#b71 & any o!r mat]ial t ! ,secret>y 9 consultation ) ! ,committee requires4 7#c7 ,review by secret>y ,! ,secret>y %all promptly review all reque/s = designation submitt$ "u ?is subsection1 assess all requir$ application compon5ts1 & det]m9e if ! antimicrobial drug is likely to meet ! favorable *>act]i/ics id5tifi$ 9 ! application ^u ! completion ( cl9ical developm5t4 ,aft] review1 ! ,secret>y %all approve or d5y ea* reque/ = designation n lat] ?an #ij days aft] receiv+ a reque/4 ,if ! ,secret>y approves a reque/1 x %all publi% ! value ( ! contract t ! critical ne$ antimicrobial develop] w\ld be eligible to receive if su* develop] successfully demon/rates t ! drug meets ! maximum value ( ! favor$ *>act]i/ics li/$ 9 ! application4 7#d7 ,l5g? ( designation p]iod ,a designation grant$ "u ?is section %all be 9 effect = a p]iod ( #aj ye>s aft] ! date t ! designation is approv$1 & %all rema9 9 effect = su* p]iod ev5 if ! infection treat$ by su* drug is lat] remov$ f ! li/ ( infections "u section #cii,,oo7c77#a74 7#e7 ,subsequ5t reviews ,no soon] ?an #b ye>s aft] a designation approval or d5ial "u subsection 7#c71 ! sponsor may reque/ a subsequ5t review to re-evaluate ! value ( a contract to include any new in=mation4 7b7 ,developm5t ( designat$ drugs ,if a critical ne$ antimicrobial designation is grant$ dur+ cl9ical developm5t ( an antimicrobial drug1 ! ,secret>y may "w ) ! sponsor to maximize ! opportunity = ! sponsor to successfully demon/rate t ! antimicrobial drug possesses ! favor$ *>act]i/ics ( high-monet>y valu$ products id5tifi$ "u section #cii,,oo7c77#b74 7c7 ,appropriate use ( critical ne$ antimicrobial 7#a7 ,9 g5]al ,! sponsor ( an antimicrobial drug t receives designation "u subsection 7a7 %all )9 #ij days ( su* designation1 submit to ! ,secret>y a plan = appropriate use ( diagno/ics1 9 ord] = ! ,secret>y & ,committee to consid] su* plan 9 develop+ cl9ical guidel9es4 ,an appropriate use plan-- 7,a7 %all include-- 7i7 ! appropriate use ( ! drug2 & 7ii7 ! appropriate use ( diagno/ic tools1 :]e available1 su* z diagno/ic te/+ = biom>k]s relat$ to antimicrobial-resi/ant pa?og5s1 or o!r t>get$ diagno/ic approa*es1 to in=m use ( ! drug2 & 7,b7 may be develop$ 9 p>tn]%ip ) ! ,secret>y1 infecti\s disease exp]ts1 diagno/ic exp]ts or develop]s1 laboratory exp]ts1 or ano!r entity4 7#b7 ,consultation ,! ,secret>y %all consult ) relevant pr(essional societies & ! ,critical ,ne$ ,antimicrobial ,advisory ,gr\p e/abli%$ "u section #cii,,oo7g7 to ensure t cl9ical guidel9es issu$ by ! ,secret>y "u p>agraph 7#c71 ) respect to an antimicrobial drug designat$ "u subsection 7a71 includes ! use ( appropriate diagno/ic approa*es1 tak+ into consid]ation ! diagno/ic plan submitt$ by a sponsor "u p>agraph 7#a74 7#c7 ,publication ( cl9ical guidel9es ,n lat] ?an #a ye> aft] ! ,secret>y makes ! fir/ designation "u subsection 7a71 & n less ?an e #c ye>s !reaft]1 ! ,secret>y %all publi% cl9ical guidel9es 9 consultation ) relevant pr(essional societies ) respect to ea* antimicrobial drug t has be5 approv$ or lic5s$ z describ$ 9 subsection 7a77#a7 & t has be5 designat$ "u subsection 7a71 :i* guidel9es %all set =? ! evid5ce-bas$ recomm5dations = prescrib+ ! drug1 9 accordance ) ! submissions ( ! sponsor "u p>agraph 7#a7 & aft] consultation "u p>agraph 7#b71 z appropriate4 #cii,,qq4 ,subscription contracts 7a7 ,application = a subscription contract 7#a7 ,submission ( applications ,aft] approval "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea7;a71 ! sponsor ( an antimicrobial drug designat$ z a critical ne$ antimicrobial "u section #cii,,pp may submit an application = a subscription contract ) ! ,secret>y1 "u a proc$ure e/abli%$ by ! ,secret>y4 7#b7 ,review ( applications ,! ,secret>y %all1 9 consultation ) ! ,committee-- 7,a7 review all applications = subscription contracts "u p>agraph 7#a7 & assess all requir$ application compon5ts2 7,b7 det]m9e ! ext5t to :i* ! critical ne$ antimicrobial meets ! favor$ *>act]i/ics id5tifi$ "u section #cii,,oo7c77#b71 & d5y any application = a drug t meets none ( su* *>act]i/ics2 & 7,c7 assign a monet>y value to ! contract bas$ on ! regulations develop$ "u section #cii,,oo7d74 7b7 ,crit]ia ,to qualify = a subscription contract "u ?is section1 ! sponsor ( an antimicrobial drug designat$ z a critical ne$ antimicrobial %all agree to-- 7#a7 ensure comm]cial & ,f$]al availability ( ! antimicrobial drug )9 #cj days ( receiv+ fir/ paym5t "u ! contract1 & suffici5t supply = susceptibility device manufactur]s2 7#b7 id5tify1 track1 & publicly report drug resi/ance data & tr5ds us+ available data relat$ to ! antimicrobial drug2 7#c7 develop & implem5t education & communications /rategies1 includ+ communications = individuals ) limit$ ,engli% pr(ici5cy & individuals ) disabilities1 = heal? c>e pr(essionals & pati5ts ab\t appropriate use ( ! antimicrobial drug2 7#d7 submit an appropriate use assessm5t to ! ,secret>y1 ,committee1 ,food & ,drug ,adm9i/ration1 & ,c5t]s = ,disease ,control & ,prev5tion e #b ye>s reg>d+ use ( ! antimicrobial drug1 includ+ h[ ! drug is be+ m>ket$2 7#e7 submit a plan = regi/]+ ! drug 9 additional c\ntries :]e an unmet m$ical ne$ exi/s2 7#f7 ensure a reliable drug supply *a91 :]e any int]ruption to ! supply *a9 w n la/ = m ?an #fj days 9 ! ,unit$ ,/ates2 7#g7 complete any po/m>ket+ /udies requir$ by ! ,food & ,drug ,adm9i/ration 9 a timely mann]2 7#h7 produce ! drug at a reasonable volume det]m9$ ) ! ,secret>y to ensure pati5t access to ! drug2 7#i7 price ! drug at a price t is n l[] ?an a comp>able g5]ic drug2 7#aj7 abide by ! manufactur+ & environm5tal be/ practices 9 ! supply *a9 to ensure t !re is no dis*>ge into1 or contam9ation (1 ! environm5t by antimicrobial ag5ts or products z a result ( ! manufactur+ process2 & 7#aa7 abide by o!r t]ms z ! ,secret>y may require4 7c7 ,am\nt & t]ms ( contracts 7#a7 ,am\nts ,a subscription contract "u ?is section %all be = ! sale to ! ,secret>y ( any quantity ( ! antimicrobial drug ne$$ ov] ! t]m ( ! contract "u p>agraph 7#b71 at an agre$ ^u price1 = a total project$ am\nt det]m9$ by ! ,secret>y t is n less ?an #gej1jjj1jjj & n m ?an #c1jjj1jjj1jjj1 adju/$ = inflation1 acc\nt+ = ! favor$ *>act]i/ics ( ! drug1 z det]m9$ by ! ,secret>y1 9 consultation ) ! ,committee1 "u subsection 7a77#b71 & %all be allocat$ f ! am\nt made available "u section #cii,,ss7a74 ,n lat] ?an #f mon?s aft] ! subscription contract is grant$ "u subsection 7a71 ! ,secret>y %all provide paym5ts = pur*as$ drugs 9 in/allm5ts e/abli%$ by ! ,secret>y 9 consultation ) ! sponsor ( ! antimicrobial drug & 9 accordance ) subsection 7d77#c74 ,funds receiv$ by ! sponsor %all be us$ to support crit]ia qualification "u subsection 7b71 ! completion ( po/m>ket+ cl9ical /udies1 manufactur+1 o!r precl9ical & cl9ical activities1 or o!r activities agre$ to by ! ,secret>y & sponsor 9 ! contract4 7#b7 ,t]ms 7,a7 ,initial t]m ,! initial t]m ( a contract "u ?is subsection %all be no less ?an #e ye>s or great] ?an ! great] ( #aj ye>s or ! rema9+ p]iod ( "t dur+ :i* ! sponsor has pat5t protections or a rema9+ exclusivity p]iod ) respect to ! antimicrobial drug 9 ! ,unit$ ,/ates1 z li/$ 9 ! publication ( ! ,food & ,drug ,adm9i/ration entitl$ ,approv$ ,drug ,products ) ,!rapeutic ,equival5ce ,evaluations4 ,paym5ts may be 9 equal annual in/allm5ts ) ! option to r$eem #ej p]c5t ( ! la/ ye>'s reimbursem5t 9 ye> #a ( ! contract 9 ord] to (fset co/s ( e/abli%+ manufactur+ capacity1 or ano!r subscription arrangem5t to :i* ! ,secret>y & sponsor agree4 ,subscription contracts %all rema9 9 effect = su* p]iod ev5 if ! infection treat$ by su* antimicrobial drug is lat] remov$ f ! li/ ( infections "u section #cii,,oo7c77#a74 7,b7 ,ext5sion ( contracts ,! ,secret>y may ext5d a subscription contract ) a sponsor "u ?is subsection beyond ! initial contract p]iod4 ,a s+le contract ext5sion may be 9 effect n lat] ?an ! date on :i* all p]iods ( exclusivity grant$ by ! ,food & ,drug ,adm9i/ration expire & %all be 9 an am\nt n to exce$ #be1jjj1jjj p] ye>4 ,all o!r t]ms ( an ext5d$ contract %all be ! same z ! t]ms ( ! initial contract4 ,! total am\nt ( fund+ us$ on su* contract ext5sions %all be no m ?an #a1jjj1jjj1jjj1 & %all be allocat$ f ! am\nt made available "u section #cii,,ss4 7,c7 ,modification ( contracts ,! ,secret>y or sponsor1 #a ye> aft] ! />t ( ! contract p]iod "u ?is subsection & e #b ye>s !reaft]1 may reque/ a modification ( ! am\nt ( ! contract bas$ on in=mation t adju/s favor$ *>act]i/ics 9 section #cii,,oo7c77#b74 7#c7 ,adju/m5t ,9 ! case ( an antimicrobial drug t receiv$ a transitional subscription contract "u section #cii,,oo7f71 ! am\nt ( a subscription contract = su* drug "u ?is section %all be r$uc$ by ! am\nt ( ! transitional subscription contract "u su* section #cii,,oo7f7 = su* drug4 7#d7 ,contracts = g5]ic & biosimil> v]sions ,not)/&+ any o!r provision 9 ?is "p1 ! ,secret>y may aw>d a subscription contract "u ?is section to a manufactur] ( a g5]ic or biosimil> v]sion ( an antimicrobial drug = :i* a subscription contract has be5 aw>d$ "u ?is section4 ,su* contracts %all be aw>d$ 9 accordance ) a proc$ure1 includ+ = det]m9+ ! t]ms & am\nts ( su* contracts1 e/abli%$ by ! ,secret>y4 7d7 ,annual antimicrobial drug sponsor rev5ue limitations 7#a7 ,report+ requirem5t 7,a7 ,9 g5]al ,n lat] ?an a date det]m9$ appropriate by ! ,secret>y foll[+ ! end ( ea* cal5d> ye>1 & n e>li] ?an #f mon?s aft] ! end ( ea* cal5d> ye>1 ! head 7or a designee ( su* head7 ( ea* ,f$]al ag5cy c>ry+ out a specifi$ gov]nm5t program %all1 9 accordance ) ?is p>agraph1 report to ! ,subscription ,contract ,(fice e/abli%$ "u section #cii,,oo7d77#c7 ! total prescription drug sales = ea* applicable antimicrobial drug "u contract ) respect to su* program = su* cal5d> ye>4 7,b7 ,m$ic>e ,"p ,d program ,= purposes ( subp>agraph 7,a71 ! ,secret>y %all report1 = ea* applicable antimicrobial drug cov]$ "u "p ,d ( title ,,xviii ( ! ,social ,security ,act1 ! product (-- 7i7 ! p]-unit +r$i5t co/1 z report$ to ! ,secret>y by prescription drug plans & ,m$ic>e ,advantage prescription drug plans1 m9us any p]-unit rebate1 disc\nt1 or o!r price concession provid$ by ! sponsor ( su* applicable antimicrobial drug1 z report$ to ! ,secret>y by ! prescription drug plans & ! ,m$ic>e ,advantage prescription drug plans2 & 7ii7 ! numb] ( units ( su* applicable antimicrobial drug paid = "u su* "p ,d4 7,c7 ,m$ic>e ,"p ,b program 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a71 ! ,secret>y %all report1 = ea* applicable antimicrobial drug cov]$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act1 ! product (-- 7,i7 ! p]-unit av]age sales price 7z def9$ 9 section #ahdg;,a7c7 ( su* ,act7 or ! p]-unit paym5t rate "u su* "p ,b = a sep>ately paid prescription drug )\t a report$ av]age sales price2 & 7,,ii7 ! numb] ( units ( su* applicable antimicrobial drug paid = "u su* "p ,b4 7ii7 ,units & allocat$ prices ,! ,secret>y %all e/abli% a process = det]m9+ ! units & ! allocat$ price = purposes ( ?is subp>agraph = ^? applicable antimicrobial drugs t are n sep>ately payable or = :i* ,national ,drug ,codes are n report$4 7,d7 ,m$ic>e ,"p ,a program 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a71 ! ,secret>y %all report1 = ea* applicable antimicrobial drug cov]$ "u "p ,a ( title ,,xviii ( ! ,social ,security ,act1 ! product (-- 7,i7 ! p]-unit price "u su* "p ,a = ! antimicrobial drug2 & 7,,ii7 ! numb] ( units ( su* antimicrobial drug paid = "u su* "p ,a4 7ii7 ,special rule ,= purposes ( clause 7i71 ! ,secret>y %all e/abli% a process = det]m9+ ! units & ! allocat$ price = ^? prescription drugs t are n sep>ately payable or = :i* ,national ,drug ,codes are n report$ 9 ! diagnosis-relat$ gr\ps4 7,e7 ,m$icaid program ,"u ! au?ority ( section #aijb7;a77#f7 ( ! ,social ,security ,act1 ! ,secret>y %all require ea* ,/ate t makes m$ical assi/ance available "u ! ,/ate plan "u title ,,xix ( su* ,act 7or any waiv] ( su* plan7 = an applicable antimicrobial drug 7includ+1 if applicable1 any su* drug :i* is a cov]$ outpati5t drug "u a rebate agreem5t ent]$ into "u section #aibg ( su* ,act7 to report1 9 a =m consi/5t ) a /&>d report+ =mat e/abli%$ by ! ,secret>y1 n lat] ?an ! date det]m9$ "u subp>agraph 7,a7-- 7i7 in=mation on ! total numb] ( units ( ea* dosage =m & /r5g? & package size ( ea* applicable antimicrobial drug disp5s$ dur+ ! prec$+ cal5d> ye> "u su* ,/ate plan or waiv] 7includ+ any su* drugs disp5s$ to an individual enroll$ ) a m$icaid manag$ c>e organization or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m7 ( su* ,act772 & 7ii7 ) respect to ea* dosage =m & /r5g? & package size ( ea* su* drug1 ! am\nt equal to-- 7,i7 ! product (-- 7aa7 ! total numb] ( units disp5s$ "u ! ,/ate plan or waiv] dur+ ! prec$+ cal5d> ye> 7z det]m9$ "u clause 7i772 & 7bb7 ! p]-unit +r$i5t co/ paid by ! ,/ate = ea* su* unit2 m9us 7,,ii7 any disc\nts or o!r price concessions provid$ & rebates paid to ! ,/ate ) respect to ! dosage =m & /r5g? & package size ( su* drug & su* cal5d> ye> 7includ+ rebates paid "u a rebate agreem5t "u section #aibg ( su* ,act & any ,/ate supplem5tal rebates paid "u a supplem5tal rebate agreem5t74 7,f7 ,dep>tm5t ( ,vet]ans ,affairs ,= purposes ( subp>agraph 7,a71 ! ,secret>y ( ,vet]ans ,affairs %all report ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,vet]ans ,heal? ,adm9i/ration = individuals :o receive heal? c>e f ! ,adm9i/ration4 7,g7 ,dep>tm5t ( ,def5se & ,,tric>e program ,= purposes ( subp>agraph 7,a71 ! ,secret>y ( ,def5se %all report ! sum (-- 7i7 ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,dep>tm5t ( ,def5se = individuals :o receive heal? c>e f ! ,dep>tm5t2 & 7ii7 = ea* applicable antimicrobial drug disp5s$ "u ! ,,tric>e retail ph>macy program "u section #ajgd;g7a77#b77;,e77ii7 ( title #aj1 ,unit$ ,/ates ,code1 ! product (-- 7,i7 ! p]-unit +r$i5t co/1 m9us any p]-unit rebate paid by ! sponsor ( ! applicable antimicrobial drug2 & 7,,ii7 ! numb] ( units ( su* applicable antimicrobial drug disp5s$ "u su* program4 7,h7 ,dep>tm5t ( ,homel& ,security ,= purposes ( subp>agraph 7,a71 ! ,secret>y ( ,homel& ,security %all report ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,dep>tm5t ( ,homel& ,security = individuals :o receive heal? c>e ?r\gh a program c>ri$ out by ! ,dep>tm5t4 7,i7 ,bureau ( ,prisons ,= purposes ( subp>agraph 7,a71 ! ,director ( ! ,bureau ( ,prisons %all report ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,bureau ( ,prisons = individuals :o receive heal? c>e ?r\gh ! ,bureau4 7,j7 ,indian ,heal? ,s]vice ,= purposes ( subp>agraph 7,a71 ! ,secret>y1 act+ ?r\gh ! ,indian ,heal? ,s]vice1 %all report ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,s]vice = individuals :o receive heal? c>e ?r\gh ! ,s]vice4 7#b7 ,regulations ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is "p1 ! ,secret>y1 9 consultation ) ! heads ( ,f$]al ag5cies c>ry+ out specifi$ gov]nm5t programs1 %all issue regulations to assi/ su* heads 7or _! designees7 9 c>ry+ out ! requirem5ts "u ?is section4 7#c7 ,subscription contract adju/m5t ,pursuant to ! contract ent]$ into "u ?is section ) respect to an applicable antimicrobial drug1 = ea* ye> ( ! t]m ( su* contract1 ! ,secret>y %all1 n e>li] ?an #f mon?s aft] ! end ( ea* cal5d> ye>1 subtract f ! paym5t in/allm5ts det]m9$ = su* contract "u subsection 7c77#a7 = su* ye> ! rev5ue ( ! sponsor ( su* drug f ! previ\s ye> f sales ( ! applicable antimicrobial drug report$ "u p>agraph 7#a7 = specifi$ gov]nm5t programs4 7#d7 ,def9itions ,9 ?is subsection3 7,a7 ,applicable antimicrobial drug ,! t]m applicable antimicrobial drug means an antimicrobial drug = :i* ! sponsor ( su* drug receives a subscription contract "u subsection 7a74 7,b7 ,specifi$ gov]nm5t program ,! t]m specifi$ gov]nm5t program means-- 7i7 ! ,m$ic>e "p ,d program "u "p ,d ( title ,,xviii ( ! ,social ,security ,act2 7ii7 ! ,m$ic>e ,"p ,b program "u "p ,b ( su* title ,,xviii2 7iii7 ! ,m$ic>e ,"p ,a program "u "p ,a ( su* title ,,xviii2 7iv7 ! ,m$icaid program e/abli%$ "u title ,,xix ( ! ,social ,security ,act & includes1 ) respect to a ,/ate1 any waiv] 9 effect ) respect to su* program2 7v7 any program "u :i* prescription drugs are procur$ by ! ,dep>tm5t ( ,vet]ans ,affairs2 7vi7 any program "u :i* prescription drugs are procur$ by ! ,dep>tm5t ( ,def5se2 7vii7 ! ,,tric>e retail ph>macy program "u section #ajgd;g7a77#b77;,e77ii7 ( title #aj1 ,unit$ ,/ates ,code2 7viii7 any program "u :i* prescription drugs are procur$ by ! ,dep>tm5t ( ,homel& ,security2 7ix7 any program "u :i* prescription drugs are procur$ by ! ,bureau ( ,prisons2 or 7x7 any program "u :i* prescription drugs are procur$ by ! ,indian ,heal? ,s]vice4 7e7 ,failure ,to adh]e to t]ms ,! ,secret>y %all cease any paym5t in/allm5ts "u a contract "u ?is section if-- 7#a7 ! sponsor-- 7,a7 p]man5tly )draws ! antimicrobial drug f ! m>ket 9 ! ,unit$ ,/ates2 7,b7 fails to meet crit]ia "u subsection 7b72 or 7,c7 does n complete a po/m>ket /udy requir$ by ! ,food & ,drug ,adm9i/ration dur+ ! l5g? ( ! t]m ( ! contract2 7#b7 ! annual int]national & private insurance m>ket rev5ues ) respect to an antimicrobial drug 7n c\nt+ any subscription rev5ues f any s\rce pursuant to a contract "u ?is section or o!r int]national or private entities7 exce$ #e times ! av]age annual am\nt ( ! subscription contract paid by ! ,secret>y z c]tifi$ by ! sponsor annually2 or 7#c7 if ! total rev5ue ( ! sponsor f specifi$ gov]nm5t programs1 z def9$ 9 subsection 7d77#d71 = a ye> exce$s ! am\nt ( ! subscription contract paid by ! ,secret>y = t ye>4 7f7 ,private pay] & int]national pay] p>ticipation ,! ,secret>y %all make ef=ts to increase ! p>ticipation ( dome/ic private payors & int]national payors 9 subscription contracts or o!r types ( value-bas$ arrangem5ts t are simil> to ! subscription contracts au?oriz$ "u ?is section4 #cii,,rr4 ,enc\rag+ appropriate use ( antibiotics & combat+ resi/ance 7a7 ,e/abli%m5t ( hospital grant program 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is "p1 ! ,secret>y & ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all coord9ate ) ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 & o!r relevant ag5cies1 to e/abli% a grant program "u ! ,c5t]s = ,disease ,control & ,prev5tion to support hospital & o!r inpati5t facility ef=ts-- 7,a7 to judici\sly use antimicrobial drugs1 su* z by e/abli%+ or implem5t+ appropriate use programs1 includ+ infecti\s disease teleheal? programs1 us+ appropriate diagno/ic tools1 p>tn]+ ) academic hospitals1 increas+ heal? c>e-associat$ infection report+1 & monitor+ antimicrobial resi/ance2 & 7,b7 to p>ticipate 9 ! ,national ,heal?c>e ,safety ,network ,antimicrobial ,use & ,resi/ance ,module or ! ,em]g+ ,infections ,program ,heal?c>e-,associat$ ,infections ,community ,int]face activity ( ! ,c5t]s = ,disease ,control & ,prev5tion or a simil> report+ program1 z specifi$ by ! ,secret>y1 relat+ to antimicrobial drugs4 7#b7 ,prioritization ,9 aw>d+ grants "u p>agraph 7#a71 ! ,secret>y %all prioritize hospitals )\t an exi/+ program to judici\sly use antimicrobial drugs1 subsection 7d7 hospitals 7z def9$ 9 subp>agraph 7,b7 ( section #ahhf7;d77#b7 ( ! ,social ,security ,act t are locat$ 9 rural areas 7z def9$ 9 subp>agraph 7,d7 ( su* section71 critical access hospitals 7z def9$ 9 section #ahfa7mm77#a7 ( su* ,act71 hospitals s]v+ ,tribal-populations1 & safety-net hospitals4 7#c7 ,fund+ ,( ! am\nts appropriat$ "u section #cii,,ss1 ! ,secret>y %all res]ve #ejj1jjj1jjj to c>ry out ?is subsection4 7b7 ,surveillance & report+ ( antibiotic use & resi/ance 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all use ! ,national ,heal?c>e ,safety ,network & o!r appropriate surveillance sy/ems to assess-- 7,a7 appropriate conditions1 outcomes1 & measures causally relat$ to antibact]ial resi/ance1 includ+ types ( infections1 ! causes = infections1 & :e!r infections are acquir$ 9 a community or hospital sett+1 increas$ l5g?s ( hospital /ay1 increas$ co/s1 & rates ( mortality2 & 7,b7 *anges 9 bact]ial resi/ance to antimicrobial drugs 9 relation to pati5t outcomes1 includ+ *anges 9 p]c5t resi/ance1 preval5ce ( antibiotic-resi/ant infections1 & o!r su* *anges4 7#b7 ,antibiotic use data ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all "w ) ,f$]al ag5cies 7includ+ ! ,dep>tm5t ( ,vet]ans ,affairs1 ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,homel& ,security1 ! ,bureau ( ,prisons1 ! ,indian ,heal? ,s]vice1 & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices71 private v5dors1 heal? c>e organizations1 ph>macy b5efit manag]s1 & o!r entities z appropriate to obta9 reliable & comp>able human antibiotic drug consumption data 7includ+1 z available & appropriate1 volume antibiotic di/ribution data & antibiotic use data1 includ+ prescription data7 by ,/ate or metropolitan areas4 7#c7 ,antibiotic resi/ance tr5d data ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all int5sify & exp& ef=ts to collect antibiotic resi/ance data & enc\rage adoption ( ! ,antibiotic ,use & ,resi/ance ,module )9 ! ,national ,heal?c>e ,safety ,network among all heal? c>e facilities across ! cont9uum ( c>e1 includ+1 z appropriate1 acute c>e hospitals1 dialysis facilities1 nurs+ homes1 ambulatory surgical c5t]s1 & o!r ambulatory heal? c>e sett+s 9 :i* antimicrobial drugs are r\t9ely prescrib$4 ,! ,secret>y %all seek to collect su* data f electronic m$ication adm9i/ration reports & laboratory sy/ems to produce ! reports describ$ 9 p>agraph 7#d74 7#d7 ,public availability ( data ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all1 = ! purposes ( improv+ ! monitor+ ( important tr5ds 9 pati5t outcomes 9 relation to antibact]ial resi/ance-- 7,a7 make ! data d]iv$ f surveillance "u ?is subsection publicly available ?r\gh reports issu$ on a regul> basis t is n less ?an annually2 & 7,b7 exam9e opportunities to make su* data available 9 ne> real "t4 #cii,,ss4 ,appropriations 7a7 ,9 g5]al ,to c>ry out ?is "p1 !re are h]eby appropriat$ to ! ,secret>y1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #aa1jjj1jjj1jjj1 = fiscal ye> #bjbb1 to rema9 available until exp5d$4 7b7 ,em]g5cy designation 7#a7 ,9 g5]al ,! am\nts provid$ by ?is section are designat$ z an em]g5cy requirem5t pursuant to section #d7;g7 ( ! ,/atutory ,pay-,z-,y-,g ,act ( #bjaj4 7#b7 ,designation 9 s5ate ,9 ! ,s5ate1 ?is section 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 #cii,,tt4 ,/udies & reports 7a7 ,9 g5]al ,n lat] ?an #f ye>s aft] ! date ( enactm5t ( ?is "p1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all complete a /udy on ! effectiv5ess ( ?is "p 9 develop+ priority antimicrobial drugs4 ,su* /udy %all exam9e ! indications =1 usage (1 developm5t ( resi/ance ) respect to1 & private & societal value ( critical ne$ antimicrobial drugs1 & ! impact ( ! programs "u ?is "p on pati5ts & m>kets ( critical ne$ antimicrobial drugs4 ,! ,comptroll] ,g5]al %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on ! f9d+s ( su* /udy4 7b7 ,antibiotic use 9 ! ,unit$ ,/ates2 annual reports ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all1 ea* ye>1 update ! report entitl$ ,antibiotic ,use 9 ! ,unit$ ,/ates to include updat$ in=mation on progress & opportunities ) respect to data1 programs1 & res\rces = prescrib]s to promote appropriate use ( antimicrobial drugs4 7c7 ,report on antimicrobial prophylactics ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is "p1 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all publi% a report on antimicrobial prophylactics4 #cii,,uu4 ,def9itions ,9 ?is "p-- 7#a7 ! t]m antimicrobial drug-- 7,a7 means1 subject to subp>agraph 7,b71 a product t is-- 7i7 a drug t directly inhibits replication ( or kills bact]ia or fungi relevant to ! propos$ indication at conc5trations likely to be atta9able 9 humans to a*ieve ! int5d$ !rapeutic effect2 or 7ii7 a biological product t acts directly on bact]ia or fungi or on ! sub/ances produc$ by su* bact]ia or fungi2 & 7,b7 does n include-- 7i7 a drug t a*ieves ! effect describ$ by subp>agraph 7,a77i7 only at a conc5tration t _c reasonably be /udi$ 9 humans because ( its anticipat$ toxicity2 or 7ii7 a vacc9e2 & 7#b7 ! t]m ,committee means ! ,committee on ,critical ,ne$ ,antimicrobials e/abli%$ "u section #cii,,oo4 4