,i #aah? ,,congress #a/ ,session ,h4 ,r4 #bidj ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #bg1 #bjbc,mr4 ,f]guson 7= himself1 ,mr4 ,pet]s1 ,mr4 ,la,turner1 & ,mr4 ,lev97 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ov]sight & ,acc\ntability1 ,ways & ,means1 & ! ,budget1 = 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 am5d title ,,iii ( ! ,public ,heal? ,s]vice ,act to e/abli% a program to develop antimicrobial innovations t>get+ ! mo/ *all5g+ pa?og5s & mo/ ?reat5+ infections1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pione]+ ,antimicrobial ,subscriptions ,to ,end ,upsurg+ ,resi/ance ,act ( #bjbc or ! ,,pa/eur ,act ( #bjbc4 #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 z ! ,*air ( ! ,committee a non-vot+1 indep5d5t memb] :o may n be a memb] ( ! ,committee or f an organization repres5t$ "u p>agraph 7#a74 7#c7 ,consultation ,! ,secret>y %all consult ) ! ,"u ,secret>y ( ,vet]ans ,affairs = ,heal? & ,secret>y ( ,def5se :5 appo9t+ memb]s f ! ,vet]ans ,heal? ,adm9i/ration & ! ,dep>tm5t ( ,def5se4 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 ,antibiotic ,resi/ance ,?reats 9 ! ,unit$ ,/ates 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 = purposes ( 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 or comb9ations ( multiple *>act]i/ics w adju/ ! monet>y value ( a subscription contract aw>d$ "u subsection 7f7 or section #cii,,oo-#b4 ,! favor$ *>act]i/ics %all be weigh$ = purposes ( su* monet>y value ( ! subscription contract su* t meet+ c]ta9 *>act]i/ics1 or meet+ m ?an "o su* *>act]i/ic1 increases ! monet>y value ( ! subscription contract4 ,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 address1 or has ! evid5ce ( address+1 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 biological product lic5se application "u section #cea7;a72 7ii7 be+ a memb] ( a new class ( drugs ) a novel t>get or 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 or 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 ! ,committee or ! ,critical ,ne$ ,antimicrobial ,advisory ,gr\p e/abli%$ "u subsection 7g7 det]m9es necess>y4 7d7 ,regulations 7#a7 ,9 g5]al ,n lat] ?an #ah mon?s 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,,oo-#a2 7,b7 h[ subscription contracts "u section #cii,,oo-#b %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 #aej days aft] su* date ( issuance4 ,! ,secret>y %all f9alize & publi% su* regulations n lat] ?an #aej days aft] ! close ( su* p]iod ( public comm5t & meet+s4 7#c7 ,committee recomm5dations ,9 issu+ regulations "u ?is subsection1 ! ,secret>y %all consid] ! recomm5dations ( ! ,committee "u subsection 7c77#b74 7e7 ,li/ ( infections ,! ,secret>y1 9 collaboration ) ! ,committee1 %all update ! li/ ( infections "u subsection 7c77#a7 at lea/ e #b ye>s foll[+ ! developm5t ( ! initial li/ "u t subsection4 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 ! regulations "u subsection 7d71 ! ,secret>y may use up to #aj p]c5t ( ! am\nt appropriat$ "u section #cii,,oo-#d7;a7 to engage 9 transitional subscription contracts ( up to #e 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$]al ,food1 ,drug1 & ,cosmetic ,act71 innovative biological products1 or innovative drugs t a*ieve improv$ cl9ical outcomes4 ,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$1 or drug resi/ance2 7ii7 subject to t]ms includ+-- 7,i7 t ! ,secret>y %all cease any paym5t in/allm5ts "u a transitional subscription contract if ! sponsor does n-- 7aa7 ensure comm]cial availability ( ! antimicrobial drug )9 #cj days ( receiv+ fir/ paym5t "u ! contract2 7bb7 id5tify1 track1 & publicly report drug resi/ance data1 & tr5ds us+ available data relat$ 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+ ! *>act]i/ics ( 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 e/abli% )9 ! ,adm9i/ration = ,/rategic ,prep>$ness & ,response an (fice to manage ! transitional subscription contracts1 includ+ eligibility1 requirem5ts1 & contract am\nts1 dur+ ! p]iod describ$ 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 z ,*air ( ! ,advisory ,gr\p a non-vot+1 indep5d5t memb] :o may n be a memb] repres5t$ "u p>agraph 7#b74 7#d7 ,conflicts ( int]e/ ,9 appo9t+ memb]s "u p>agraph 7#b7 & a ,*air "u p>agraph 7#c71 ! ,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 *apt] #aj ( title #e1 ,unit$ ,/ates ,code1 7commonly kn[n z ! ,f$]al ,advisory ,committee ,act7 %all apply to ! ,advisory ,gr\p4 #cii,,oo-#a4 ,designation ( antimicrobial drug z critical ne$ antimicrobial drug 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$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea7;a74 7#b7 ,cont5t ( reque/ ,a reque/ "u p>agraph 7#a7 %all include in=mation1 su* z cl9ical1 precl9ical1 & po/m>ket+ data1 a li/ ( ! favorable *>act]i/ics describ$ 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 ,n e>li] ?an #b ye>s aft] a designation approval or d5ial "u p>agraph 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 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 %all1 )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 or a plan to coord9ate developm5t ( diagno/ic tools z necess>y2 & 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 #cii,,oo-#b4 ,e/abli%m5t ( ,subscription ,contract ,(fice2 subscription contracts 7a7 ,subscription contract (fice 7#a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is "p1 ! ,secret>y %all e/abli% )9 ! ,adm9i/ration = ,/rategic ,prep>$ness & ,response an (fice1 to be kn[n z ! ,subscription ,contract ,(fice1 ! head ( :i* %all be ! ,director 7ref]r$ to 9 ?is section z ! ,director74 7#b7 ,purpose ,! purpose ( ! ,(fice e/abli%$ "u p>agraph 7#a7 %all be to manage ! e/abli%m5t & paym5t ( subscription contracts aw>d$ "u ?is section1 includ+ eligibility1 requirem5ts1 & contract am\nts4 7b7 ,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,,oo-#a may submit an application = a subscription contract to ! ,director1 "u a proc$ure e/abli%$ by ! ,director4 7#b7 ,review ( applications ,! ,director1 9 consultation ) ! ,committee1 %all-- 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 drug cov]$ by ! application meets ! favor$ *>act]i/ics id5tifi$ "u section #cii,,oo7c77#b72 & 7,c7 d5y any application = a drug t does n meet ! m9imum numb] & k9d ( favor$ *>act]i/ics ne$$ = ! drug to be designat$ z a critical ne$ antimicrobial bas$ on ! regulations issue "u section #cii,,oo7d74 7c7 ,requirem5ts ,z a condition ( ent]+ into a subscription contract "u ?is section1 ! sponsor ( ! critical ne$ antimicrobial drug cov]$ by ! application %all agree to-- 7#a7 ensure comm]cial 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 data1 & 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 ! ,adm9i/rator ( ! ,food & ,drug ,adm9i/ration1 & ! ,director ( ! ,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$ ) ! ,director to ensure pati5t access to ! drug2 7#i7 abide by ! manufactur+ & environm5tal be/ practices 9 ! supply *a9 = ! control ( dis*>ge ( antimicrobial active ph>maceutical +r$i5ts to ensure m9imal dis*>ge into1 or contam9ation (1 ! environm5t by antimicrobial ag5ts or products z a result ( ! manufactur+ process2 & 7#aj7 abide by su* o!r t]ms z ! ,director may require4 7d7 ,monet>y value 7#a7 ,9 g5]al ,! ,director1 9 consultation ) ! ,committee1 %all assign a monet>y value to ea* subscription contract "u ?is section bas$ on ! regulations develop$ "u section #cii,,oo7d74 7#b7 ,consid]ations ,9 assign+ a monet>y value to a subscription contract "u p>agraph 7#a71 ! ,director %all take into acc\nt ! favor$ *>act]i/ic or comb9ation ( favor$ *>act]i/ics ( ! drug cov]$ by ! contract1 z det]m9$ by ! ,director1 9 consultation ) ! ,committee1 "u subsection 7b77#b77;,b74 7e7 ,am\nt ( contracts 7#a7 ,9 g5]al ,a subscription contract "u ?is section %all be = ! sale to ! ,secret>y ( any quantity ( ! antimicrobial drug cov]$ by ! contract ne$$ ov] ! t]m ( ! contract1 at a price agre$ on by ! sponsor & ! ,director1 bas$ on ! monet>y value assign$ to ! contract "u subsection 7d74 7#b7 ,m9imum & maximum am\nt ,! total project$ am\nt to be paid by ! ,director "u a subscription contract "u ?is section %all be n less ?an #gej1jjj1jjj & n m ?an #c1jjj1jjj1jjj1 adju/$ = inflation4 7f7 ,t]m 7#a7 ,initial t]m ,! initial t]m ( a subscription contract "u ?is section %all be-- 7,a7 n less ?an #e ye>s2 & 7,b7 n great] ?an ! great] (-- 7i7 #aj ye>s2 & 7ii7 ! 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 7#b7 ,effect ,a subscription contract %all rema9 9 effect = ! p]iod describ$ 9 p>agraph 7#a7 ev5 if ! infection treat$ by ! antimicrobial drug cov]$ by ! subscription contract is lat] remov$ f ! li/ ( infections "u section #cii,,oo7c77#a74 7#c7 ,ext5sion ( contracts ,! ,director 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,,oo-#d7;a74 7#d7 ,modification ( contracts ,! ,director 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 7g7 ,paym5ts 7#a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date on :i* a subscription contract is grant$ "u subsection 7a71 ! ,director %all provide paym5ts = drugs pur*as$ "u ! contract 9 in/allm5ts e/abli%$ by ! ,director1 9 consultation ) ! sponsor ( ! antimicrobial drug & 9 accordance ) subsection 7j74 7#b7 ,tim+ ( paym5ts ,! ,director-- 7,a7 may make paym5ts "u p>agraph 7#a7 9 equal annual in/allm5ts2 & 7,b7 %all n make su* paym5ts m frequ5tly ?an twice p] ye>4 7#c7 ,option ,! sponsor %all h ! option to receive #ej p]c5t ( ! paym5t am\nt due 9 ! la/ ye> ( ! contract dur+ ! fir/ ye> ( ! contract 9 ord] to (fset co/s ( e/abli%+ manufactur+ capacity4 7#d7 ,fund+ ,paym5ts "u ?is subsection %all be allocat$ f ! am\nt made available "u section #cii,,oo-#d7;a74 7#e7 ,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 7h7 ,use ( contract funds ,funds receiv$ by ! sponsor "u a subscription contract "u ?is section %all be us$-- 7#a7 to meet ! requirem5ts describ$ 9 subsection 7c72 & 7#b7 to support ! completion ( po/m>ket+ cl9ical /udies1 manufactur+1 o!r precl9ical & cl9ical activities1 or o!r activities agre$ to by ! ,director & sponsor 9 ! contract4 7i7 ,contracts = g5]ic & biosimil> v]sions ,not)/&+ any o!r provision ( ?is "p1 ! ,director 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 ! ,director4 7j7 ,antimicrobial drug sponsor rev5ue limitations 7#a7 ,requirem5t 7,a7 ,9 g5]al ,) respect to a paym5t in/allm5t "u a subscription contract ent]$ into "u ?is section1 ! net rev5ue f sales ( ! applicable antimicrobial drug = b5efici>ies or enrollees 9 ,f$]al heal? c>e programs dur+ ! p]iod cov]$ by ! paym5t in/allm5t %all be subtract$ f ! paym5t in/allm5t4 7,b7 ,paym5t ,! am\nt calculat$ "u subp>agraph 7,a7 %all be paid by ! ,secret>y to ! relevant ,f$]al heal? c>e program 7or its tru/ fund7 at ! "t ( ! applicable in/allm5t paym5t4 7,c7 ,coord9ation ,! ,director %all coord9ate ) ! relevant ag5cies ( ! ,f$]al ,gov]nm5t1 includ+ ! ,c5t]s = ,m$ic>e & ,m$icaid ,s]vices1 to c>ry out ?is subsection 9 a mann] t ensures m9imal disruption to h[ a heal? c>e provid] curr5tly acquires applicable antimicrobial drugs4 7#b7 ,regulations 7,a7 ,9 g5]al ,to c>ry out ?is subsection1 ! ,secret>y %all promulgate regulations to id5tify ! ,f$]al heal? c>e programs applicable "u ?is section1 includ+ ,m$ic>e "p ,a & ,m$icaid1 & to e/abli% ! me?odology & data collection requirem5ts necess>y to calculate ! am\nt "u p>agraph 7#a77;,a74 7,b7 ,me?odology ,any me?odology e/abli%$ = ! collection ( data & calculation ( ! am\nt "u p>agraph 7#a77;,a7 %all take into acc\nt any legally m&at$ or volunt>y disc\nts & rebates provid$ by ! manufactur] ( ! applicable antimicrobial drug to ! ,f$]al heal? c>e programs t pay = su* drug1 on ! condition t ! ,secret>y may presume t disc\nts n describ$ 9 subclauses 7,i7 & 7,,ii7 ( subp>agraph 7,c77ii7 are captur$ 9 ! price det]m9$ "u subp>agraph 7,c77i77,,ii74 7,c7 ,e/imat+ annual net rev5ue 7i7 ,9 g5]al ,9 det]m9+ ! net rev5ue f sales ( ! applicable antimicrobial drug = b5efici>ies or enrollees 9 ,f$]al heal? c>e programs = ! purpose ( calculat+ ! am\nt "u p>agraph 7#a77;,a71 ! ,secret>y %all det]m9e su* net rev5ue am\nt by multiply+-- 7,i7 ! total numb] ( bill+ units ( su* antimicrobial drugs report$ "u ! process describ$ 9 subp>agraph 7,d77ii7 = ! applicable paym5t in/allm5t p]iod2 by 7,,ii7 ! av]age sales price 7z def9$ 9 section #ahdg;,a7c7 ( ! ,social ,security ,act71 ! av]age manufactur] price 7z def9$ 9 section #aibg7k77#a7 ( ! ,social ,security ,act71 or ano!r pric+ metric us$ 9 ,f$]al heal? c>e programs1 = su* antimicrobial drugs4 7ii7 ,requirem5t ,! ,secret>y %all adju/ ! am\nt det]m9$ "u clause 7i77,,ii7 to acc\nt =-- 7,i7 rebates1 disc\nts1 add-on paym5ts1 or o!r adju/m5ts provid$ "u-- 7aa7 section #cdj;,b2 or 7bb7 section #aibg ( ! ,social ,security ,act2 or 7,,ii7 negotiat$ price concessions describ$ 9 section #ahfj;,d-#b7;d77#a77;,b7 ( ! ,social ,security ,act t are n captur$ 9 ! applicable price4 7,d7 ,cod+ 7i7 ,9 g5]al ,9 promulgat+ regulations "u subp>agraph 7,a71 ! ,secret>y %all1 z appropriate1 e/abli% & assign codes1 "u exi/+ or new cod+ sy/ems1 to id5tify units ( ! applicable antimicrobial drug = b5efici>ies or enrollees 9 ,f$]al heal? c>e programs4 7ii7 ,cod+ use requirem5ts ,9 promulgat+ regulations "u subp>agraph 7,a71 ! ,secret>y %all require hospitals 7or o!r provid]s or suppli]s7 t adm9i/] applicable antimicrobial drugs 9 ! inpati5t or outpati5t sett+ to report on _! claims to su* ,f$]al heal? c>e programs ! bill+ units ( su* antimicrobial drugs us$ 9 ! c>e ( b5efici>ies or enrollees 9 ea* ,f$]al heal? c>e program1 reg>dless ( :e!r paym5t = ^? units are sep>ately reimburs$4 7#c7 ,def9itions ,9 ?is subsection3 7,a7 ,applicable antimicrobial drug ,! t]m applicable antimicrobial drug means an antimicrobial drug = :i* ! sponsor ( su* drug receives a subscription contract "u subsection 7a74 7,b7 ,f$]al heal? c>e program ,! t]m ,f$]al heal? c>e program has ! mean+ giv5 su* t]m 9 section #aabh;,b7f7 ( ! ,social ,security ,act1 except t1 = purposes ( ?is subsection1 su* t]m includes ! heal? insurance program "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code4 7k7 ,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 ! requirem5ts describ$ 9 subsection 7c72 or 7,c7 does n complete a po/m>ket /udy requir$ by ! ,food & ,drug ,adm9i/ration dur+ ! 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 gov]nm5t programs t pay = drugs subject to a contract agreem5t ent]$ into pursuant to ?is section = a ye> exce$s ! am\nt ( ! subscription contract paid by ! ,secret>y = t ye>4 7l7 ,private pay] & int]national pay] p>ticipation ,! ,secret>y %all make ef=ts to increase ! p>ticipation ( dome/ic private payors & int]national payors 9 subscription contracts or o!r types ( value-bas$ arrangem5ts t are simil> to ! subscription contracts au?oriz$ "u ?is section4 7m7 ,effect ,no?+ 9 ?is section p]mits ! ,secret>y to use evid5ce f comp>ative cl9ical effectiv5ess rese>* 9 a mann] t treats ext5d+ ! life ( an eld]ly1 disabl$1 or t]m9ally ill individual z ( l[] value ?an ext5d+ ! life ( an individual :o is y\ng]1 nondisabl$1 or n t]m9ally ill 9 det]m9+ ! value ( an antimicrobial drug or a subscription contract 7or a transitional subscription contract71 includ+ 9 su* a way t w\ld limit pati5t access4 #cii,,oo-#c4 ,enc\rag+ appropriate use ( antimicrobials & combat+ resi/ance 7a7 ,e/abli%m5t ( heal? facility grant program 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is "p1 ! ,secret>y %all e/abli% a grant program "u ! ,c5t]s = ,disease ,control & ,prev5tion to support hospital1 skill$ nurs+ facility1 & o!r heal? c>e 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+ & prev5tion ef=ts1 & 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 heal? c>e facilities )\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 7b7 ,surveillance & report+ ( antimicrobial 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 tr5ds 9 antimicrobial resi/ance & antibiotic & antifungal use1 su* z-- 7,a7 appropriate conditions & measures causally relat$ to antimicrobial resi/ance1 includ+ types ( infections1 ! s\rce or body sites ( infections1 ! demographic in=mation ( pati5ts ) infections1 & infection onset 9 a community or hospital sett+1 increas$ l5g?s ( hospital /ay1 increas$ co/s1 & rates ( mortality2 & 7,b7 *anges 9 bact]ial & fungal resi/ance to antimicrobial drugs1 includ+ *anges 9 p]c5t resi/ance1 preval5ce ( antimicrobial-resi/ant infections1 rates ( mortality1 & o!r su* *anges4 7#b7 ,antimicrobial use data ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all obta9 reliable & comp>able human antibiotic & antifungal drug consumption data 7includ+1 z available & appropriate1 volume antimicrobial di/ribution data & antibiotic & antifungal use data1 includ+ prescription data7 by ,/ate or metropolitan areas4 ,to accompli% ?is1 ! ,c5t]s = ,disease ,control & ,prev5tion may "w )1 z appropriate1 ,f$]al dep>tm5ts & ag5cies 7includ+ ! ,dep>tm5t ( ,vet]ans ,affairs1 ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,homel& ,security1 ! ,bureau ( ,prisons1 ! ,indian ,heal? ,s]vice1 & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices71 private v5dors1 heal? c>e organizations1 ph>macy b5efit manag]s1 & o!r entities4 7#c7 ,antimicrobial resi/ance tr5d data ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all int5sify & exp& ef=ts to collect antimicrobial 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 ,beg9n+ on ! date t is #b ye>s aft] ! date ( enactm5t ( ?is "p1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all1 = ! purposes ( improv+ ! monitor+ ( important tr5ds 9 antimicrobial use & resi/ance1 &1 z appropriate1 pati5t outcomes 9 relation to antimicrobial resi/ance-- 7,a7 make ! data describ$ "u ?is subsection publicly available ?r\gh reports & web updates issu$ on a regul> basis t is n less ?an annually2 & 7,b7 exam9e opportunities to make su* data available 9 ne> real "t4 7c7 ,publication ( cl9ical guidel9es ,n lat] ?an #a ye> aft] ! date ! ,secret>y makes ! fir/ designation "u section #cii,,oo-#a7;a71 & n less ?an e #c ye>s !reaft]1 ! ,secret>y %all publi% at lea/ "o update to cl9ical guidel9es 9 consultation ) relevant pr(essional societies4 ,z appropriate1 guidel9e updates %all include ea* antimicrobial drug t has be5 approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea7;a7 & t has be5 designat$ "u section #cii,,oo-#a7;a71 :i* guidel9es %all set =? ! evid5ce-bas$ recomm5dations = prescrib+ ! drug = ! relevant infection "t1 9 accordance ) ! available evid5ce aft] consultation "u section #cii,,oo-#a7;c77#b71 z appropriate4 7d7 ,fund+ ,! ,secret>y may use n m ?an #e p]c5t ( ! am\nts appropriat$ "u section #cii,,oo-#d7;a7 to c>ry out ?is section4 #cii,,oo-#d4 ,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 #f1jjj1jjj1jjj = fiscal ye> #bjbd1 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,,oo-#e4 ,/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 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,,oo-#f4 ,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 fungi1 or acts on ! sub/ances produc$ by su* bact]ia or fungi1 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,,oo7a74 4