,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #ai ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #i1 #bjai,mr4 ,wald5 7= himself1 ,mr4 ,brady1 ,ms4 ,foxx ( ,nor? ,c>ol9a1 ,mr4 ,coll9s ( ,georgia1 ,mr4 ,burgess1 ,mr4 ,nunes1 ,mr4 ,walb]g1 ,mr4 ,s5s5br5n]1 ,mr4 ,scalise1 ,ms4 ,*5ey1 ,mr4 ,upton1 ,mr4 ,%imkus1 ,mr4 ,latta1 ,mr4 ,gu?rie1 ,mrs4 ,rodg]s ( ,wa%+ton1 ,mr4 ,olson1 ,mr4 ,mc,kinley1 ,mr4 ,k9z+]1 ,mr4 ,griffi?1 ,mr4 ,bilirakis1 ,mr4 ,johnson ( ,ohio1 ,mr4 ,long1 ,mr4 ,buc%on1 ,mr4 ,flores1 ,mrs4 ,brooks ( ,indiana1 ,mr4 ,mull91 ,mr4 ,hudson1 ,mr4 ,c>t] ( ,georgia1 ,mr4 ,gian=te1 ,mr4 ,palm]1 ,mr4 ,cole1 ,mr4 ,williams1 ,mr4 ,abraham1 ,mr4 ,kell]1 ,mr4 ,ru!r=d1 ,mr4 ,f]guson1 ,mr4 ,ku/(f ( ,t5nessee1 ,mr4 ,riggleman1 ,mr4 ,we/]man1 ,mr4 ,graves ( ,l\isiana1 ,mr4 ,la,malfa1 ,mr4 ,baird1 ,mr4 ,huiz5ga1 ,mr4 ,murphy ( ,nor? ,c>ol9a1 ,mr4 ,conaway1 ,mr4 ,all51 ,mr4 ,web] ( ,texas1 ,mr4 ,ne:\se1 ,mr4 ,bab91 ,mr4 ,hag$orn1 ,mr4 ,r\z]1 ,mr4 ,rice ( ,s\? ,c>ol9a1 ,mr4 ,wilson ( ,s\? ,c>ol9a1 ,mr4 ,p5ce1 ,mr4 ,hill ( ,arkansas1 ,mr4 ,m>%all1 ,mr4 ,bald]son1 ,mr4 ,ad]holt1 ,mr4 ,rodney ,davis ( ,ill9ois1 ,mr4 ,mit*ell1 ,mr4 ,cr5%aw1 ,mr4 ,joyce ( ,p5nsylvania1 ,mr4 ,johnson ( ,s\? ,dakota1 ,mr4 ,gre5 ( ,t5nessee1 ,mrs4 ,mill]1 ,ms4 ,/efanik1 ,mr4 ,banks1 ,mr4 ,com]1 ,mr4 ,mc,caul1 ,mr4 ,diaz-,bal>t1 ,mr4 ,amodei1 ,mr4 ,norman1 ,mr4 ,david ,p4 ,roe ( ,t5nessee1 ,mr4 ,budd1 ,mr4 ,cook1 ,mr4 ,kev9 ,h]n ( ,oklahoma1 ,mr4 ,*abot1 ,mr4 ,/eube1 ,mr4 ,curtis1 ,mr4 ,gro?man1 ,mr4 ,/eil1 ,mr4 ,joyce ( ,ohio1 ,mr4 ,smi? ( ,new ,j]sey1 ,mr4 ,gonzalez ( ,ohio1 ,mr4 ,/aub]1 ,mr4 ,bu*anan1 ,mr4 ,smi? ( ,nebraska1 ,mr4 ,arr+ton1 ,mr4 ,m>*ant1 ,mrs4 ,walorski1 ,mr4 ,kelly ( ,p5nsylvania1 ,mr4 ,smi? ( ,miss\ri1 ,mr4 ,la,hood1 ,mr4 ,hold+1 ,mr4 ,e/es1 ,mr4 ,re$1 ,mr4 ,s*weik]t1 ,mr4 ,w5/rup1 ,mrs4 ,roby1 ,mr4 ,res*5?al]1 ,mr4 ,hurd ( ,texas1 ,mr4 ,watk9s1 ,mr4 ,luetkemey]1 ,mr4 ,turn]1 ,mr4 ,?ompson ( ,p5nsylvania1 ,ms4 ,h]r]a ,beutl]1 ,mr4 ,gue/1 ,mrs4 ,h>tzl]1 ,mrs4 ,wagn]1 ,mr4 ,waltz1 ,mr4 ,wright1 & ,mr4 ,gibbs7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 & ! ,judici>y1 = 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 provide = c]ta9 re=ms ) respect to ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 ! ,m$icaid program "u title ,,xix ( su* ,act1 ! ,food & ,drug ,adm9i/ration1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai4 #b4 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4 ,sec4 #b4 ,table ( cont5ts4 ,title ,i--,m$ic>e ,p>ts ,b & ,d ,subtitle ,a--,m$ic>e ,"p ,b ,provisions ,sec4 #aja4 ,improvem5ts to ,m$ic>e site-(-s]vice transp>5cy4 ,sec4 #ajb4 ,requir+ manufactur]s ( c]ta9 s+le-dose conta9] or s+le-use package drugs payable "u "p ,b ( ! ,m$ic>e program to provide refunds ) respect to disc>d$ am\nts ( su* drugs4 ,sec4 #ajc4 ,provid+ = v>iation 9 paym5t = c]ta9 drugs cov]$ "u "p ,b ( ! ,m$ic>e program4 ,sec4 #ajd4 ,e/abli%m5t ( maximum add-on paym5t = drugs & biologicals4 ,sec4 #aje4 ,treatm5t ( drug adm9i/ration s]vices furni%$ by c]ta9 except$ (f-campus outpati5t dep>tm5ts ( a provid]4 ,subtitle ,b--,drug ,price ,transp>5cy ,sec4 #aaa4 ,report+ on explanation = drug price increases4 ,sec4 #aab4 ,public disclosure ( drug disc\nts4 ,sec4 #aac4 ,/udy ( ph>maceutical supply *a9 int]m$i>ies & m]g] activity4 ,sec4 #aad4 ,requir+ c]ta9 manufactur]s to report drug pric+ in=mation ) respect to drugs "u ! ,m$ic>e program4 ,sec4 #aae4 ,mak+ prescription drug m>ket+ sample in=mation report$ by manufactur]s available to c]ta9 individuals & entities4 ,sec4 #aaf4 ,requir+ prescription drug plan sponsors to include real-"t b5efit in=mation z "p ( su* sponsor's electronic prescription program "u ! ,m$ic>e program4 ,sec4 #aag4 ,s5se ( ,congress reg>d+ ! ne$ to exp& comm]cially available drug pric+ comp>ison plat=ms4 ,sec4 #aah4 ,te*nical corrections4 ,subtitle ,c--,m$ic>e ,"p ,d ,b5efit ,r$esign ,sec4 #aba4 ,m$ic>e "p ,d b5efit r$esign4 ,subtitle ,d--,o!r ,m$ic>e ,"p ,d ,provisions ,sec4 #aca4 ,transitional cov]age & retroactive ,m$ic>e "p ,d cov]age = c]ta9 l[-income b5efici>ies4 ,sec4 #acb4 ,all[+ ! (f]+ ( additional prescription drug plans "u ,m$ic>e "p ,d4 ,sec4 #acc4 ,all[+ c]ta9 enrollees ( prescription drugs plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances4 ,sec4 #acd4 ,e/abli%+ a mon?ly cap on b5efici>y incurr$ co/s = insul9 products & supplies "u a prescription drug plan or ,,ma-,,pd plan4 ,sec4 #ace4 ,gr[? rate ( ,m$ic>e "p ,d out-(-pocket co/ ?re%old4 ,subtitle ,e--,med,p,a,c ,sec4 #ada4 ,provid+ ! ,m$ic>e ,paym5t ,advisory ,commission & ,m$icaid & ,,*ip ,paym5t & ,access ,commission ) access to c]ta9 drug paym5t in=mation1 includ+ c]ta9 rebate in=mation4 ,title ,,ii--,m$icaid ,sec4 #bja4 ,sunset ( limit on maximum rebate am\nt = s+le s\rce drugs & innovator multiple s\rce drugs4 ,sec4 #bjb4 ,m$icaid ph>macy & !rapeutics committee improvem5ts4 ,sec4 #bjc4 ,,gao report on conflicts ( int]e/ 9 ,/ate ,m$icaid program drug use review bo>ds & ph>macy & !rapeutics 7,p,t7 committees4 ,sec4 #bjd4 ,ensur+ ! accuracy ( manufactur] price & drug product in=mation "u ! ,m$icaid drug rebate program4 ,sec4 #bje4 ,improv+ transp>5cy & prev5t+ ! use ( abusive spread pric+ & relat$ practices 9 ,m$icaid4 ,sec4 #bjf4 ,t-,,msis drug data analytics reports4 ,sec4 #bjg4 ,risk-%>+ value-bas$ paym5t agreem5ts = cov]$ outpati5t drugs "u ,m$icaid4 ,sec4 #bjh4 ,apply+ ,m$icaid drug rebate requirem5t to drugs provid$ z "p ( outpati5t hospital s]vices4 ,title ,,iii--,food & ,drug ,adm9i/ration ,subtitle ,a--,,creates ,act ,sec4 #cja4 ,actions = delays ( g5]ic drugs & biosimil> biological products4 ,sec4 #cjb4 ,,rems approval process = subsequ5t fil]s4 ,sec4 #cjc4 ,rule ( con/ruction4 ,subtitle ,b--,pay-=-,delay ,sec4 #caa4 ,unlawful agreem5ts4 ,sec4 #cab4 ,notice & c]tification ( agreem5ts4 ,sec4 #cac4 ,=feiture ( #ahj-;day exclusivity p]iod4 ,sec4 #cad4 ,commission litigation au?ority4 ,sec4 #cae4 ,/atute ( limitations4 ,subtitle ,c--,,block+ ,act ,sec4 #cba4 ,*ange conditions ( fir/ g5]ic exclusivity to spur access & competition4 ,subtitle ,d--,purple ,book ,sec4 #cca4 ,public li/+4 ,sec4 #ccb4 ,review & report on types ( in=mation to be li/$4 ,subtitle ,e--,orange ,book ,sec4 #cda4 ,orange ,book4 ,sec4 #cdb4 ,,gao report to ,congress4 ,subtitle ,f--,advanc+ ,education on ,biosimil>s ,sec4 #cea4 ,education on biological products4 ,subtitle ,g--,/reaml9+ ,transition ( ,biological ,products ,sec4 #cfa4 ,/reaml9+ ! transition ( biological products4 ,subtitle ,h--,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m ,sec4 #cgj4 ,%ort title2 ref]5ces 9 subtitle4 ,"p #a--,,otc ,drug ,review ,sec4 #cga4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application4 ,sec4 #cgb4 ,misbr&+4 ,sec4 #cgc4 ,drugs exclud$ f ! ov]-!-c\nt] drug review4 ,sec4 #cgd4 ,treatm5t ( ,sunscre5 ,innovation ,act4 ,sec4 #cge4 ,annual update to ,congress on appropriate p$iatric indication = c]ta9 ,,otc c\gh & cold drugs4 ,sec4 #cgf4 ,te*nical corrections4 ,"p #b--,us] ,fees ,sec4 #cha4 ,%ort title2 f9d+4 ,sec4 #chb4 ,fees relat+ to ov]-!-c\nt] drugs4 ,subtitle ,i--,o!r ,provisions ,sec4 #cia4 ,protect+ access to biological products4 ,sec4 #cib4 ,orphan drug cl>ification4 ,sec4 #cic4 ,conditions ( use = biosimil> biological products4 ,sec4 #cid4 ,cl>ify+ ! mean+ ( new *emical entity4 ,title ,,iv--,rev5ue ,provisions ,sec4 #dja4 ,p]man5t ext5sion ( r$uction 9 m$ical exp5se d$uction floor4 ,sec4 #djb4 ,safe h>bor = high d$uctible heal? plans )\t d$uctible = insul94 ,sec4 #djc4 ,inclusion ( c]ta9 ov]-!-c\nt] m$ical products z qualifi$ m$ical exp5ses4 ,title ,v--,miscellane\s ,sec4 #eja4 ,paym5t = biosimil> biological products dur+ initial p]iod4 ,sec4 #ejb4 ,,gao /udy & report on av]age sales price4 ,sec4 #ejc4 ,requir+ prescription drug plans & ,,ma-,,pd plans to report pot5tial fraud1 wa/e1 & abuse to ! ,secret>y ( ,,hhs4 ,sec4 #ejd4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d4 ,sec4 #eje4 ,improv+ coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 ,sec4 #ejf4 ,pati5t consultation 9 ,m$ic>e national & local cov]age det]m9ations 9 ord] to mitigate b>ri]s to inclusion ( su* p]spectives4 ,sec4 #ejg4 ,med,p,a,c report on %ift+ cov]age ( c]ta9 ,m$ic>e "p ,b drugs to ,m$ic>e "p ,d4 ,sec4 #ejh4 ,requirem5t t direct-to-consum] adv]tisem5ts = prescription drugs & biological products include tru?ful & non-mislead+ pric+ in=mation4 ,sec4 #eji4 ,*ief ,ph>maceutical ,negotiator at ! ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 ,sec4 #eaj4 ,waiv+ ,m$ic>e co9surance = colorectal canc] scre5+ te/s4 ,i ,m$ic>e ,p>ts ,b & ,d ,a ,m$ic>e ,"p ,b ,provisions #aja4 ,improvem5ts to ,m$ic>e site-(-s]vice transp>5cy ,section #ahcd7t7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7t77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! head+1 by /rik+ ,9 g5]al & ins]t+ ,site paym5t2 7,b7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ or to & ins]t+ 1 to2 7ii7 by ins]t+ 1 or to a physician = s]vices furni%$ 9 a physician's (fice aft] surgical c5t]2 & 7iii7 by ins]t+ 7or #bjba ) respect to a physician = s]vices furni%$ 9 a physician's (fice7 aft] #bjah2 & 7,c7 9 subp>agraph 7,a7-- 7i7 by /rik+ & ! & ins]t+ 1 !2 & 7ii7 by ins]t+ 1 & ! physician fee s*$ule "u section #ahdh 7) respect to ! practice exp5se compon5t ( su* paym5t am\nt7 aft] su* section2 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#d7 z p>agraphs 7#c7 ?r\gh 7#e71 respectively2 & 7#c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+ new p>agraph3 7#b7 ,physician paym5t ,beg9n+ 9 #bjba1 ! ,secret>y %all exp& ! in=mation includ$ on ! ,int]net website describ$ 9 p>agraph 7#a7 to include-- 7,a7 ! am\nt paid to a physician "u section #ahdh = an item or s]vice = ! sett+s describ$ 9 p>agraph 7#a72 & 7,b7 ! e/imat$ am\nt ( b5efici>y liability applicable to ! item or s]vice4 4 #ajb4 ,requir+ manufactur]s ( c]ta9 s+le-dose conta9] or s+le-use package drugs payable "u "p ,b ( ! ,m$ic>e program to provide refunds ) respect to disc>d$ am\nts ( su* drugs ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie-c;a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7h7 ,refund = c]ta9 disc>d$ s+le-,dose conta9] or s+le-,use package drugs 7#a7 ,secret>ial provision ( in=mation 7,a7 ,9 g5]al ,= ea* cal5d> qu>t] beg9n+ on or aft] ,july #a1 #bjba1 ! ,secret>y %all1 ) respect to a refundable s+le-dose conta9] or s+le-use package drug 7z def9$ 9 p>agraph 7#h771 report to ea* manufactur] 7z def9$ 9 subsection 7c77#f77;,a77 ( su* refundable s+le-dose conta9] or s+le-use package drug ! foll[+ = ! cal5d> qu>t]3 7i7 ,subject to subp>agraph 7,c71 in=mation on ! total numb] ( units ( ! bill+ & paym5t code ( su* drug1 if any1 t 7 disc>d$ dur+ su* qu>t]1 z det]m9$ us+ a me*anism su* z ! ,,jw modifi] us$ z ( ! date ( enactm5t ( ?is subsection 7or any su* successor modifi] t includes su* data z det]m9$ appropriate by ! ,secret>y74 7ii7 ,! refund am\nt t ! manufactur] is liable = pursuant to p>agraph 7#c74 7,b7 ,det]m9ation ( disc>d$ am\nts ,= purposes ( subp>agraph 7,a77i71 ) respect to a refundable s+le-dose conta9] or s+le-use package drug furni%$ dur+ a qu>t]1 ! am\nt ( su* drug t 0 disc>d$ %all be det]m9$ bas$ on ! am\nt ( su* drug t 0 unus$ & disc>d$ = ea* drug on ! date ( s]vice4 7,c7 ,exclusion ( units ( packag$ drugs ,! total numb] ( units ( ! bill+ & paym5t code ( a refundable s+le-dose conta9] or s+le-use package drug ( a manufactur] furni%$ dur+ a cal5d> qu>t] = purposes ( subp>agraph 7,a77i71 & ! det]m9ation ( ! e/imat$ total all[$ *>ges = ! drug 9 ! qu>t] = purposes ( p>agraph 7#c77;,a77ii71 %all n include su* units t are packag$ into ! paym5t am\nt = an item or s]vice & are n sep>ately payable4 7#b7 ,manufactur] requirem5t ,= ea* cal5d> qu>t] beg9n+ on or aft] ,july #a1 #bjba1 ! manufactur] ( a refundable s+le-dose conta9] or s+le-use package drug %all1 = su* drug1 provide to ! ,secret>y a refund t is equal to ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* qu>t]4 7#c7 ,refund am\nt 7,a7 ,9 g5]al ,! am\nt ( ! refund specifi$ 9 ?is p>agraph is1 ) respect to a refundable s+le-dose conta9] or s+le-use package drug ( a manufactur] assign$ to a bill+ & paym5t code = a cal5d> qu>t] beg9n+ on or aft] ,july #a1 #bjba1 an am\nt equal to ! e/imat$ am\nt 7if any7 by :i*-- 7i7 ! product (-- 7,i7 ! total numb] ( units ( ! bill+ & paym5t code = su* drug t 7 disc>d$ dur+ su* qu>t] 7z det]m9$ "u p>agraph 7#a772 & 7,,ii7 7aa7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t is a s+le s\rce drug or biological1 ! am\nt det]m9$ = su* drug "u subsection 7b77#d72 or 7bb7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t is a biosimil> biological product1 ! av]age sales price det]m9$ "u subsection 7b77#h77;,a72 exce$s 7ii7 an am\nt equal to ! applicable p]c5tage 7z def9$ 9 subp>agraph 7,b77 ( ! e/imat$ total all[$ *>ges = su* drug dur+ ! qu>t]4 7,b7 ,applicable p]c5tage def9$ 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a77ii71 ! t]m applicable p]c5tage means-- 7,i7 subject to subclause 7,,ii71 #aj p]c5t2 & 7,,ii7 if applicable1 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 clause 7ii71 a p]c5tage specifi$ by ! ,secret>y pursuant to su* clause4 7ii7 ,treatm5t ( drugs t h unique circum/ances ,9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t has unique circum/ances involv+ simil> loss ( product z t describ$ 9 p>agraph 7#h77;,b71 ! ,secret>y1 ?r\gh notice & comm5t rulemak+1 may increase ! applicable p]c5tage o!rwise applicable "u clause 7i77,i7 z det]m9$ appropriate by ! ,secret>y4 7#d7 ,frequ5cy ,am\nts requir$ to be refund$ pursuant to p>agraph 7#b7 %all be paid 9 regul> int]vals 7z det]m9$ appropriate by ! ,secret>y74 7#e7 ,refund deposits ,am\nts paid z refunds pursuant to p>agraph 7#b7 %all be deposit$ into ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7#f7 ,en=cem5t 7,a7 ,audits 7i7 ,manufactur] audits ,ea* manufactur] ( a refundable s+le-dose conta9] or s+le-use package drug t is requir$ to provide a refund "u ?is subsection %all be subject to p]iodic audit ) respect to su* drug & su* refunds by ! ,secret>y4 7ii7 ,provid] audits ,! ,secret>y %all conduct p]iodic audits ( claims submitt$ "u ?is "p ) respect to refundable s+le-dose conta9] or s+le-use package drugs 9 accordance ) ! au?ority "u section #ahcc7;e7 to ensure compliance ) ! requirem5ts applicable "u ?is subsection4 7,b7 ,civil money p5alty 7i7 ,9 g5]al ,! ,secret>y %all impose a civil money p5alty on a manufactur] ( a refundable s+le-dose conta9] or s+le-use package drug :o has fail$ to comply ) ! requirem5t "u p>agraph 7#b7 = su* drug = a cal5d> qu>t] 9 an am\nt equal to ! sum (-- 7,i7 ! am\nt t ! manufactur] w\ld h paid "u su* p>agraph ) respect to su* drug = su* qu>t]2 & 7,,ii7 #be p]c5t ( su* am\nt4 7ii7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7#g7 ,implem5tation ,! ,secret>y %all implem5t ?is subsection ?r\gh notice & comm5t rulemak+4 7#h7 ,def9ition ( refundable s+le-dose conta9] or s+le-use package drug 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 9 ?is subsection1 ! t]m refundable s+le-dose conta9] or s+le-use package drug means a s+le s\rce drug or biological 7z def9$ 9 section #ahdg;,a7c77#f77;,d77 or a biosimil> biological product 7z def9$ 9 section #ahdg;,a7c77#f77;,h77 = :i* paym5t is e/abli%$ "u ?is "p & t is furni%$ f a s+le-dose conta9] or s+le-use package4 7,b7 ,exclusions ,! t]m refundable s+le-dose conta9] or s+le-use package drug does n include-- 7i7 a drug or biological t is ei!r a radioph>maceutical or an imag+ ag5t2 7ii7 a drug or biological = :i* dosage & adm9i/ration in/ructions approv$ by ! ,commission] ( ,food & ,drugs require filtration dur+ ! drug prep>ation process1 prior to dilution & adm9i/ration1 & require t any unus$ portion ( su* drug aft] ! filtration process be disc>d$ aft] ! completion ( su* filtration process2 or 7iii7 a drug or biological approv$ by ! ,food & ,drug ,adm9i/ration on or aft] ! date ( enactm5t ( ?is subsection & ) respect to :i* paym5t has be5 made "u ?is "p = less ?an #ah mon?s4 4 #ajc4 ,provid+ = v>iation 9 paym5t = c]ta9 drugs cov]$ "u "p ,b ( ! ,m$ic>e program 7a7 ,9 g5]al ,section #ahdg;,a7b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by ins]t+ aft] or #ajf p]c5t ! foll[+3 7or1 = a multiple s\rce drug 7o!r ?an autolog\s cellul> immuno!rapy7 furni%$ on or aft] ,janu>y #a1 #bjba1 ! applicable p]c5t specifi$ 9 p>agraph 7#i77;,a7 = ! drug & qu>t] involv$72 & 7,b7 9 subp>agraph 7,b7 ( p>agraph 7#a71 by ins]t+ aft] #ajf p]c5t ! foll[+3 7or1 = a s+le s\rce drug or biological 7o!r ?an autolog\s cellul> immuno!rapy7 furni%$ on or aft] ,janu>y #a1 #bjba1 ! applicable p]c5t specifi$ 9 p>agraph 7#i77;,a7 = ! drug or biological & qu>t] involv$72 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,application ( v>iable p]c5tages bas$ on p]c5tile rank+ ( p] b5efici>y all[$ *>ges 7,a7 ,applicable p]c5t to be appli$ 7i7 ,9 g5]al ,subject to clauses 7ii71 ) respect to a drug or biological furni%$ 9 a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjba1 if ! ,secret>y det]m9es t ! p]c5tile rank ( a drug or biological "u subp>agraph 7,b77i77,,iii71 ) respect to p] b5efici>y all[$ *>ges = all su* drugs or biologicals1 is-- 7,i7 at lea/ equal to ! #he? p]c5tile1 ! applicable p]c5t = ! drug = su* qu>t] "u ?is subp>agraph is #ajd p]c5t2 7,,ii7 at lea/ equal to ! #gj? p]c5tile1 b less ?an ! #he? p]c5tile1 su* applicable p]c5t is #ajf p]c5t2 7,,iii7 at lea/ equal to ! #ej? p]c5tile1 b less ?an ! #gj? p]c5tile1 su* applicable p]c5t is #ajh p]c5t2 or 7,,iv7 less ?an ! #ej? p]c5tile1 su* applicable p]c5t is #aaj p]c5t4 7ii7 ,cases :]e data n suffici5tly available to compute p] b5efici>y all[$ *>ges ,subject to clause 7iii71 9 ! case ( a drug or biological furni%$ = :i* ! am\nt ( paym5t is det]m9$ "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 & n "u subsection 7c77#d71 = cal5d> qu>t]s dur+ a p]iod 9 :i* data are n suffici5tly available to compute a p] b5efici>y all[$ *>ges = ! drug or biological1 ! applicable p]c5t is #ajf p]c5t4 7,b7 ,det]m9ation ( p]c5tile rank ( p] b5efici>y all[$ *>ges ( drugs 7i7 ,9 g5]al ,) respect to a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjba1 = drugs & biologicals = :i* ! am\nt ( paym5t is det]m9$ "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a71 except = drugs or biologicals = :i* data are n suffici5tly available1 ! ,secret>y %all-- 7,i7 compute ! p] b5efici>y all[$ *>ges 7z def9$ 9 subp>agraph 7,c77 = ea* su* drug or biological2 7,,ii7 adju/ su* p] b5efici>y all[$ *>ges = ! qu>t]1 to ! ext5t provid$ "u subp>agraph 7,d72 & 7,,iii7 array su* adju/$ p] b5efici>y all[$ *>ges = all su* drugs or biologicals f high to l[ & rank su* drugs or biologicals by p]c5tile ( su* array$ p] b5efici>y all[$ *>ges4 7ii7 ,frequ5cy ,! ,secret>y %all make ! computations "u clause 7i77,i7 e #f mon?s 7or1 if necess>y1 z det]m9$ by ! ,secret>y1 e #i or #ab mon?s7 & su* computations %all apply to succe$+ cal5d> qu>t]s until a new computation has be5 made4 7iii7 ,applicable data p]iod ,= purposes ( ?is p>agraph1 ! t]m applicable data p]iod means ! mo/ rec5t p]iod = :i* ! data necess>y = mak+ ! computations "u clause 7i7 are available1 z det]m9$ by ! ,secret>y4 7,c7 ,p] b5efici>y all[$ *>ges def9$ ,9 ?is p>agraph1 ! t]m p] b5efici>y all[$ *>ges means1 ) respect to a drug or biological = :i* ! am\nt ( paym5t is det]m9$ "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7-- 7i7 ! all[$ *>ges = ! drug or biological = :i* paym5t is s made = ! applicable data p]iod1 z e/imat$ by ! ,secret>y2 divid$ by 7ii7 ! numb] ( individuals = :om any paym5t = ! drug or biological 0 made "u p>agraph 7#a7 = ! applicable data p]iod1 z e/imat$ by ! ,secret>y4 7,d7 ,adju/m5t to reflect *anges 9 av]age sales price ,9 apply+ ?is p>agraph = a p>ticul> cal5d> qu>t]1 ! ,secret>y %all adju/ ! p] b5efici>y all[$ *>ges = a drug or biological by multiply+ su* p] b5efici>y all[$ *>ges "u subp>agraph 7,c7 = ! applicable data p]iod by ! ratio (-- 7i7 ! av]age sales price = ! drug or biological = ! mo/ rec5t cal5d> qu>t] us$ "u subsection 7c77#e77;,b72 to 7ii7 ! av]age sales price = ! drug or biological = ! cal5d> qu>t] 7or ! weight$ av]age = ! qu>t]s involv$7 includ$ 9 ! applicable data p]iod4 4 7b7 ,application ( judicial review provisions ,section #ahdg;,a7g7 ( ! ,social ,security ,act is am5d$-- 7#a7 by /rik+ & at ! end ( p>agraph 7#d72 7#b7 by /rik+ ! p]iod at ! end ( p>agraph 7#e7 & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#f7 ! det]m9ation ( p] b5efici>y all[$ *>ges ( drugs or biologicals & rank+ ( su* *>ges "u subsection 7b77#i74 4 #ajd4 ,e/abli%m5t ( maximum add-on paym5t = drugs & biologicals 7a7 ,9 g5]al ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a71 z am5d$ by section #ajc1 is fur!r am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ p>agraph 7#g7 & ins]t+ p>agraphs 7#g7 & 7#aj72 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,maximum add-on paym5t am\nt 7,a7 ,9 g5]al ,9 det]m9+ ! paym5t am\nt "u ! provisions ( subp>agraph 7,a71 7,b71 or 7,c7 ( p>agraph 7#a7 ( ?is subsection1 subsection 7c77#d77;,a77ii71 or subsection 7d77#c77;,c7 = a drug or biological furni%$ on or aft] ,janu>y #a1 #bjba1 if ! applicable add-on paym5t 7z def9$ 9 subp>agraph 7,b77 = ea* drug or biological on a claim = a date ( s]vice exce$s ! maximum add-on paym5t am\nt specifi$ "u subp>agraph 7,c7 = ! drug or biological1 !n ! paym5t am\nt o!rwise det]m9$ = ! drug or biological "u ^? provisions1 z applicable1 %all be r$uc$ by ! am\nt ( su* excess4 7,b7 ,applicable add-on paym5t def9$ ,9 ?is p>agraph1 ! t]m applicable add-on paym5t means ! foll[+ am\nts1 det]m9$ )\t reg>d to ! application ( subp>agraph 7,a73 7i7 ,9 ! case ( a multiple s\rce drug1 an am\nt equal to ! diff]5ce betwe5-- 7,i7 ! am\nt t w\ld o!rwise be appli$ "u p>agraph 7#a77;,a72 & 7,,ii7 ! am\nt t w\ld be appli$ "u su* p>agraph if #ajj p]c5t 7 sub/itut$ = ! applicable p]c5t 7z def9$ 9 p>agraph 7#i77 = su* drug4 7ii7 ,9 ! case ( a s+le s\rce drug or biological1 an am\nt equal to ! diff]5ce betwe5-- 7,i7 ! am\nt t w\ld o!rwise be appli$ "u p>agraph 7#a77;,b72 & 7,,ii7 ! am\nt t w\ld be appli$ "u su* p>agraph if #ajj p]c5t 7 sub/itut$ = ! applicable p]c5t 7z def9$ 9 p>agraph 7#i77 = su* drug or biological4 7iii7 ,9 ! case ( a biosimil> biological product1 ! am\nt o!rwise det]m9$ "u p>agraph 7#h77;,b74 7iv7 ,9 ! case ( a drug or biological dur+ ! initial p]iod describ$ 9 subsection 7c77#d77;,a71 an am\nt equal to ! diff]5ce betwe5-- 7,i7 ! am\nt t w\ld o!rwise be appli$ "u subsection 7c77#d77;,a77ii72 & 7,,ii7 ! am\nt t w\ld be appli$ "u su* subsection if #ajj p]c5t 7 sub/itut$1 z applicable1 =-- 7aa7 #ajc p]c5t 9 subclause 7,i7 ( su* subsection2 or 7bb7 any p]c5t 9 excess ( #ajj p]c5t appli$ "u subclause 7,,ii7 ( su* subsection4 7v7 ,9 ! case ( a drug or biological to :i* subsection 7d77#c77;,c7 applies1 an am\nt equal to ! diff]5ce betwe5-- 7,i7 ! am\nt t w\ld o!rwise be appli$ "u su* subsection2 & 7,,ii7 ! am\nt t w\ld be appli$ "u su* subsection if #ajj p]c5t 7 sub/itut$1 z applicable1 =-- 7aa7 any p]c5t 9 excess ( #ajj p]c5t appli$ "u clause 7i7 ( su* subsection2 or 7bb7 #ajc p]c5t 9 clause 7ii7 ( su* subsection4 7,c7 ,maximum add-on paym5t am\nt specifi$ ,= purposes ( subp>agraph 7,a71 ! maximum add-on paym5t am\nt specifi$ 9 ?is subp>agraph is-- 7i7 ) respect to a drug or biological 7o!r ?an autolog\s cellul> immuno!rapy7-- 7,i7 = ea* ( #bjba ?r\gh #bjbh1 #a1jjj2 & 7,,ii7 = a subsequ5t ye>1 ! am\nt specifi$ 9 ?is subp>agraph = ! prec$+ ye> increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! previ\s ye>2 or 7ii7 ) respect to a drug or biological consi/+ ( autolog\s cellul> immuno!rapy-- 7,i7 = ea* ( #bjba ?r\gh #bjbh1 #b1jjj2 & 7,,ii7 = a subsequ5t ye>1 ! am\nt specifi$ 9 ?is subp>agraph = ! prec$+ ye> increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! previ\s ye>4 ,any am\nt det]m9$ "u ?is subp>agraph t is n a multiple ( #aj %all be r\nd$ to ! ne>e/ multiple ( #aj4 2 & 7#b7 9 subsection 7c77#d77;,a77ii71 by /rik+ 9 ! case & ins]t+ subject to subsection 7b77#aj71 9 ! case4 7b7 ,con=m+ am5dm5ts relat+ to sep>ately payable drugs 7#a7 ,,opps ,section #ahcc7t77#ad7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ad77 is am5d$-- 7,a7 9 subp>agraph 7,a77iii77,,ii71 by ins]t+ 1 subject to subp>agraph 7,i7 aft] are n available2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,i7 ,application ( maximum add-on paym5t = sep>ately payable drugs & biologicals ,9 e/abli%+ ! am\nt ( paym5t "u subp>agraph 7,a7 = a specifi$ cov]$ outpati5t drug t is furni%$ z "p ( a cov]$ ,,opd s]vice 7or gr\p ( s]vices7 on or aft] ,janu>y #a1 #bjba1 if su* paym5t is det]m9$ bas$ on ! av]age price = ! ye> e/abli%$ "u section #ahdg;,a pursuant to clause 7iii77,,ii7 ( su* subp>agraph1 ! provisions ( subsection 7b77#aj7 ( section #ahdg;,a %all apply to ! am\nt ( paym5t s e/abli%$ 9 ! same mann] z su* provisions apply to ! am\nt ( paym5t "u section #ahdg;,a4 4 7#b7 ,,asc ,section #ahcc7;i77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77;,d77 is am5d$-- 7,a7 by mov+ clause 7v7 #f ems to ! left2 7,b7 by r$esignat+ clause 7vi7 z clause 7vii72 & 7,c7 by ins]t+ aft] clause 7v7 ! foll[+ new clause3 7vi7 ,if !re is a sep>ate paym5t "u ! sy/em describ$ 9 clause 7i7 = a drug or biological furni%$ on or aft] ,janu>y #a1 #bjba1 ! provisions ( subsection 7t77#ad77;,i7 %all apply to ! e/abli%m5t ( ! am\nt ( paym5t = ! drug or biological "u su* sy/em 9 ! same mann] 9 :i* su* provisions apply to ! e/abli%m5t ( ! am\nt ( paym5t "u subsection 7t77#ad77;,a74 4 #aje4 ,treatm5t ( drug adm9i/ration s]vices furni%$ by c]ta9 except$ (f-campus outpati5t dep>tm5ts ( a provid] ,section #ahcc7t77#af7 ( ! ,social ,security ,act 7#db #ab ,u4,s4,c4 #aciel7t77#af77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,special paym5t rule = drug adm9i/ration s]vices furni%$ by an except$ dep>tm5t ( a provid] 7i7 ,9 g5]al ,9 ! case ( a cov]$ ,,opd s]vice t is a drug adm9i/ration s]vice 7z def9$ by ! ,secret>y7 furni%$ by a dep>tm5t ( a provid] describ$ 9 clause 7ii7 or 7iv7 ( p>agraph 7#ba77;,b71 ! paym5t am\nt = su* s]vice furni%$ on or aft] ,janu>y #a1 #bjba1 %all be ! same paym5t am\nt 7z det]m9$ 9 p>agraph 7#ba77;,c77 t w\ld apply if ! drug adm9i/ration s]vice 0 furni%$ by an (f-campus outpati5t dep>tm5t ( a provid] 7z def9$ 9 p>agraph 7#ba77;,b774 7ii7 ,application )\t reg>d to budget neutrality ,! r$uctions made "u ?is subp>agraph-- 7,i7 %all n be consid]$ an adju/m5t "u p>agraph 7#b77;,e72 & 7,,ii7 %all n be implem5t$ 9 a budget neutral mann]4 4 ,b ,drug ,price ,transp>5cy #aaa4 ,report+ on explanation = drug price increases 7a7 ,9 g5]al ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 ,w ,drug ,price ,report+2 ,drug ,value ,fund #cii,,oo4 ,report+ on explanation = drug price increases 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ?is ,act2 or 7,b7 :o is responsible = sett+ ! :olesale acquisition co/ = ! drug4 7#b7 ,qualify+ drug ,! t]m qualify+ drug means any drug t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ?is ,act-- 7,a7 t has a :olesale acquisition co/ ( #ajj or m1 adju/$ = inflation occurr+ aft] ! date ( enactm5t ( ?is section1 = a mon?'s supply or a typical c\rse ( treatm5t t la/s less ?an a mon?1 & is-- 7i7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7ii7 adm9i/]$ or o!rwise disp5s$ to treat a disease or condition affect+ m ?an #bjj1jjj p]sons 9 ! ,unit$ ,/ates2 & 7iii7 n a vacc9e2 & 7,b7 = :i*1 dur+ ! previ\s cal5d> ye>1 at lea/ #a doll> ( ! total am\nt ( sales 7 = individuals enroll$ "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or "u a ,/ate ,m$icaid plan "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 or "u a waiv] ( su* plan4 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y-- 7,a7 = ea* increase 9 ! price ( a qualify+ drug t results 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7i7 #aj p]c5t or m )9 a s+le cal5d> ye> beg9n+ on or aft] ,janu>y #a1 #bjai2 or 7ii7 #be p]c5t or m )9 ?ree consecutive cal5d> ye>s = :i* ! fir/ su* cal5d> ye> beg9s on or aft] ,janu>y #a1 #bjai2 & 7,b7 9 ! case t ! qualify+ drug is fir/ cov]$ "u title ,,xviii ) respect to an applicable ye>1 if ! e/imat$ co/ or sp5d+ "u su* title p] individual or p] us] ( su* drug 7z e/imat$ by ! ,secret>y7 = su* applicable ye> 7or p] c\rse ( treatm5t 9 su* applicable ye>1 z def9$ by ! ,secret>y7 is at lea/ #bf1jjj4 7#b7 ,report deadl9e ,ea* report describ$ 9 p>agraph 7#a7 %all be submitt$ to ! ,secret>y-- 7,a7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjai1 & end+ on ! day t is #fj days aft] ! date ( enactm5t ( ?is section1 n lat] ?an #ij days aft] su* date ( enactm5t2 7,b7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs aft] ! p]iod describ$ 9 subp>agraph 7,a71 n lat] ?an #cj days prior to ! plann$ effective date ( su* price increase = su* qualify+ drug2 & 7,c7 9 ! case ( a report ) respect to a qualify+ drug t meets ! crit]ia describ$ 9 p>agraph 7#a77;,b71 n lat] ?an #cj days aft] su* drug meets su* crit]ia4 7c7 ,cont5ts ,a report "u subsection 7b71 consi/5t ) ! /&>d = disclosures describ$ 9 section #bac4c7;d7 ( title #ab1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ?is section71 %all1 at a m9imum1 include-- 7#a7 ) respect to ! qualify+ drug-- 7,a7 ! p]c5tage by :i* ! manufactur] w raise ! :olesale acquisition co/ ( ! drug )9 ! cal5d> ye> or ?ree consecutive cal5d> ye>s z describ$ 9 subsection 7b77#a77;,a7 or 7b77#a77;,b71 if applicable1 & ! effective date ( su* price increase2 7,b7 an explanation =1 & description (1 ea* price increase = su* drug t w occur dur+ ! cal5d> ye> p]iod describ$ 9 subsection 7b77#a77;,a7 or ! ?ree consecutive cal5d> ye> p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 7,c7 if kn[n & diff]5t f ! manufactur] ( ! qualify+ drug1 ! id5tity (-- 7i7 ! sponsor or sponsors ( any inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = cl9ical inve/igations ) respect to su* drug1 = :i* ! full reports are submitt$ z "p ( ! application-- 7,i7 = approval ( ! drug "u section #eje ( su* ,act2 or 7,,ii7 = lic5sure ( ! drug "u section #cea ( ?is ,act2 & 7ii7 ! sponsor ( an application = ! drug approv$ "u su* section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ?is ,act2 7,d7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ?is ,act1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se1 if applicable2 7,e7 ! curr5t :olesale acquisition co/ ( ! drug2 7,f7 ! total exp5ditures ( ! manufactur] on-- 7i7 mat]ials & manufactur+ = su* drug2 & 7ii7 acquir+ pat5ts & lic5s+ = su* drug2 7,g7 ! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds2 7,h7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is necess>y to demon/rate t x meets applicable /atutory /&>ds = approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea ( ?is ,act1 z applicable2 7,i7 ! total exp5ditures ( ! manufactur] on pursu+ new or exp&$ indications or dosage *anges = su* drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act2 7,j7 ! total exp5ditures ( ! manufactur] on c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ "u section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,k7 ! total rev5ue & ! net pr(it g5]at$ f ! qualify+ drug = ea* cal5d> ye> s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 & 7,l7 ! total co/s associat$ ) m>ket+ & adv]tis+ = ! qualify+ drug2 7#b7 ) respect to ! manufactur]-- 7,a7 ! total rev5ue & ! net pr(it ( ! manufactur] = ea* ( ! #a-ye> p]iod describ$ 9 subsection 7b77#a77;,a7 or ! #c-ye> p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 7,b7 all /ock-bas$ p]=mance metrics us$ by ! manufactur] to det]m9e executive comp5sation = ea* ( ! #a-ye> p]iod describ$ 9 subsection 7b77#a77;,a7 or ! #c-ye> p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 & 7,c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on-- 7i7 drug rese>* & developm5t2 or 7ii7 cl9ical trials1 includ+ on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#c7 su* o!r relat$ in=mation z ! ,secret>y consid]s appropriate & z specifi$ by ! ,secret>y ?r\gh notice-&-comm5t rulemak+4 7d7 ,in=mation provid$ ,! manufactur] ( a qualify+ drug t is requir$ to submit a report "u subsection 7b71 %all ensure t su* report & any explanation =1 & description (1 ea* price increase describ$ 9 subsection 7c77#a77;,b7 %all be tru?ful1 n mislead+1 & accurate4 7e7 ,civil monet>y p5alty ,any manufactur] ( a qualify+ drug t fails to submit a report = ! drug z requir$ by ?is section1 foll[+ notification by ! ,secret>y to ! manufactur] t ! manufactur] is n 9 compliance ) ?is section1 %all be subject to a civil monet>y p5alty ( #ge1jjj = ea* day on :i* ! violation cont9ues4 7f7 ,false in=mation ,any manufactur] t submits a report = a drug z requir$ by ?is section t kn[+ly provides false in=mation 9 su* report is subject to a civil monet>y p5alty 9 an am\nt n to exce$ #ge1jjj = ea* item ( false in=mation4 7g7 ,public po/+ 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 ! ,secret>y %all po/ ea* report submitt$ "u subsection 7b7 on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! day ! price increase ( a qualify+ drug is s*$ul$ to g into effect4 7#b7 ,=mat ,9 develop+ ! =mat 9 :i* reports w be publicly po/$ "u p>agraph 7#a71 ! ,secret>y %all consult ) /akehold]s1 includ+ b5efici>y gr\ps1 & %all seek fe$back f consum] advocates & readability exp]ts on ! =mat & pres5tation ( ! cont5t ( su* reports to ensure t su* reports are-- 7,a7 us]-fri5dly to ! public2 & 7,b7 writt5 9 pla9 language t consum]s c readily und]/&4 7#c7 ,protect$ in=mation ,no?+ 9 ?is section %all be con/ru$ to au?orize ! public disclosure ( in=mation submitt$ by a manufactur] t is prohibit$ f disclosure by applicable laws conc]n+ ! protection ( trade secrets1 comm]cial in=mation1 & o!r in=mation cov]$ "u su* laws4 #cii,,oo-#a4 ,annual report to ,congress 7a7 ,9 ,g5]al ,subject to subsection 7b71 ! ,secret>y %all submit to ,congress1 & po/ on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a way t is us]-fri5dly to ! public & writt5 9 pla9 language t consum]s c readily und]/&1 an annual report-- 7#a7 summ>iz+ ! in=mation report$ pursuant to section #cii,,oo2 7#b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to su* section2 7#c7 detail+ ! co/s & exp5ditures incurr$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 c>ry+ out section #cii,,oo2 & 7#d7 expla9+ h[ ! ,dep>tm5t ( ,heal? & ,human ,s]vices is improv+ consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 7b7 ,protect$ in=mation ,no?+ 9 ?is section %all be con/ru$ to au?orize ! public disclosure ( in=mation submitt$ by a manufactur] t is prohibit$ f disclosure by applicable laws conc]n+ ! protection ( trade secrets1 comm]cial in=mation1 & o!r in=mation cov]$ "u su* laws4 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 takes effect on ! date ( enactm5t ( ?is ,act4 #aab4 ,public disclosure ( drug disc\nts ,section #aaej;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#bc7 is am5d$-- 7#a7 9 subsection 7c71 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ 7o!r ?an z p]mitt$ "u subsection 7e77 aft] disclos$ by ! ,secret>y2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7e7 ,public availability ( c]ta9 in=mation 7#a7 ,9 g5]al ,9 ord] to all[ ! comp>ison ( ,p,b,ms' ability to negotiate rebates1 disc\nts1 direct & indirect remun]ation fees1 adm9i/rative fees1 & price concessions & ! am\nt ( su* rebates1 disc\nts1 direct & indirect remun]ation fees1 adm9i/rative fees1 & price concessions t are pass$ ?r\gh to plan sponsors1 beg9n+ ,janu>y #a1 #bjbj1 ! ,secret>y %all make available on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! in=mation ) respect to ! second prec$+ cal5d> ye> provid$ to ! ,secret>y on g5]ic disp5s+ rates 7z describ$ 9 p>agraph 7#a7 ( subsection 7b77 & in=mation provid$ to ! ,secret>y "u p>agraphs 7#b7 & 7#c7 ( su* subsection t1 z det]m9$ by ! ,secret>y1 is ) respect to ea* ,,pbm4 7#b7 ,availability ( data ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y %all ensure ! foll[+3 7,a7 ,confid5tiality ,! in=mation describ$ 9 su* p>agraph is display$ 9 a mann] t prev5ts ! disclosure ( in=mation1 ) respect to an individual drug or an individual plan1 on rebates1 disc\nts1 direct & indirect remun]ation fees1 adm9i/rative fees1 & price concessions4 7,b7 ,class ( drug ,! in=mation describ$ 9 su* p>agraph is made available by class ( drug1 us+ an exi/+ classification sy/em1 b only if ! class conta9s su* numb] ( drugs1 z specifi$ by ! ,secret>y 7b n few] ?an ?ree drugs71 to ensure confid5tiality ( propriet>y in=mation or o!r in=mation t is prev5t$ to be disclos$ "u subp>agraph 7,a74 4 #aac4 ,/udy ( ph>maceutical supply *a9 int]m$i>ies & m]g] activity 7a7 ,initial report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,commission %all submit to ! appropriate committees ( ,congress a report t-- 7#a7 addresses at m9imum-- 7,a7 :e!r ph>macy b5efit manag]s-- 7i7 *>ge pay]s a high] price ?an ! reimbursem5t rate at :i* ! ph>macy b5efit manag]s reimburse compet+ ph>macies2 7ii7 /e] pati5ts = anticompetitive purposes to any ph>macies1 includ+ retail1 mail-ord]1 or any o!r type ( ph>macy1 9 :i* ! ph>macy b5efit manag] has an own]%ip int]e/2 7iii7 audit or review propriet>y data1 includ+ acquisition co/s1 pati5t in=mation1 or disp5s+ in=mation1 ( compet+ ph>macies t c be us$ = anticompetitive purposes2 or 7iv7 use =mul>y designs to increase ! m>ket %>e ( high] co/ prescription drugs & depress ! m>ket %>e ( l[] co/ prescription drugs 7ea* net ( rebates & disc\nts72 7,b7 h[ companies & pay]s assess ! b5efits1 co/s1 & risks ( contract+ ) int]m$i>ies1 includ+ ph>macy s]vices adm9i/rative organizations1 & :e!r m in=mation ab\t ! roles ( int]m$i>ies %\ld be available to consum]s & pay]s2 & 7,c7 :e!r !re are any specific legal or regulatory ob/acles ! ,commission curr5tly faces 9 ensur+ a competitive & transp>5t m>ketplace 9 ! ph>maceutical supply *a91 includ+ ! ph>macy b5efit manag] m>ketplace & ph>macy s]vices adm9i/rative organizations2 & 7#b7 provides-- 7,a7 obs]vations or conclusions drawn f ! ,novemb] #bjag r\ndtable entitl$ ,und]/&+ ,competition 9 ,prescription ,drug ,m>kets3 ,entry & ,supply ,*a9 ,dynamics1 & any simil> ef=ts2 7,b7 specific actions ! ,commission int5ds to take z a result ( ! ,novemb] #bjag r\ndtable1 & any simil> ef=ts1 includ+ a detail$ description ( relevant =?com+ actions1 additional rese>* or r\ndtable discussions1 consum] education ef=ts1 or en=cem5t actions2 & 7,c7 policy or legislative recomm5dations to-- 7i7 improve transp>5cy & competition 9 ! ph>maceutical supply *a92 7ii7 prev5t & det] anticompetitive behavior 9 ! ph>maceutical supply *a92 & 7iii7 be/ ensure t consum]s b5efit f any co/ sav+s or effici5cies t may result f m]g]s & consolidations4 7b7 ,int]im report ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,commission %all submit to ! appropriate committees ( ,congress an int]im report on ! progress ( ! report requir$ by subsection 7a71 along ) prelim9>y f9d+s & conclusions bas$ on in=mation collect$ to t date4 7c7 ,def9itions ,9 ?is section3 7#a7 ,appropriate committees ( ,congress ,! t]m appropriate committees ( ,congress means-- 7,a7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7,b7 ! ,committee on ! ,judici>y ( ! ,s5ate2 & 7,c7 ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives4 7#b7 ,commission ,! t]m ,commission means ! ,f$]al ,trade ,commission4 #aad4 ,requir+ c]ta9 manufactur]s to report drug pric+ in=mation ) respect to drugs "u ! ,m$ic>e program 7a7 ,9 g5]al ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b77;,a71 by ins]t+ or subsection 7f77#b71 z applicable be=e ! p]iod at ! end2 7,b7 9 p>agraph 7#c71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ or subsection 7f77#b71 z applicable1 be=e det]m9$ by2 & 7,c7 9 p>agraph 7#f77;,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ or subsection 7f77#b71 z applicable1 be=e det]m9$ by2 & 7#b7 9 subsection 7f7-- 7,a7 by /rik+ ,= requirem5ts & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,= requirem5ts 2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,manufactur]s )\t a rebate agreem5t "u title ,,xix 7,a7 ,9 g5]al ,if ! manufactur] ( a drug or biological describ$ 9 subp>agraph 7,c71 7,e71 or 7,g7 ( section #ahdb7o77#a7 or 9 section #ahha7;b77#ad77;,b7 t is payable "u ?is "p has n ent]$ into & does n h 9 effect a rebate agreem5t describ$ 9 subsection 7b7 ( section #aibg1 = cal5d> qu>t]s beg9n+ on or aft] ,janu>y #a1 #bjbj1 su* manufactur] %all report to ! ,secret>y ! in=mation describ$ 9 subsection 7b77#c77;,a77iii7 ( su* section #aibg ) respect to su* drug or biological 9 a "t & mann] specifi$ by ! ,secret>y4 ,= purposes ( apply+ ?is p>agraph1 a drug or biological describ$ 9 ! previ\s s5t5ce includes items1 s]vices1 supplies1 & products t are payable "u ?is "p z a drug or biological4 7,b7 ,audit ,in=mation report$ "u subp>agraph 7,a7 is subject to audit by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7,c7 ,v]ification ,! ,secret>y may survey :olesal]s & manufactur]s t directly di/ribute drugs describ$ 9 subp>agraph 7,a71 :5 necess>y1 to v]ify manufactur] prices & manufactur]'s av]age sales prices 7includ+ :olesale acquisition co/7 if requir$ to make paym5t report$ "u subp>agraph 7,a74 ,! ,secret>y may impose a civil monet>y p5alty 9 an am\nt n to exce$ #ajj1jjj on a :olesal]1 manufactur]1 or direct sell]1 if ! :olesal]1 manufactur]1 or direct sell] ( su* a drug refuses a reque/ = in=mation ab\t *>ges or prices by ! ,secret>y 9 connection ) a survey "u ?is subp>agraph or kn[+ly provides false in=mation4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7,d7 ,confid5tiality ,not)/&+ any o!r provision ( law1 in=mation disclos$ by manufactur]s or :olesal]s "u ?is p>agraph 7o!r ?an ! :olesale acquisition co/ = purposes ( c>ry+ out ?is section7 is confid5tial & %all n be disclos$ by ! ,secret>y 9 a =m :i* discloses ! id5tity ( a specific manufactur] or :olesal] or prices *>g$ = drugs by su* manufactur] or :olesal]1 except-- 7i7 z ! ,secret>y det]m9es to be necess>y to c>ry out ?is section 7includ+ ! det]m9ation & implem5tation ( ! paym5t am\nt71 or to c>ry out section #ahdg;,b2 7ii7 to p]mit ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates to review ! in=mation provid$2 & 7iii7 to p]mit ! ,director ( ! ,congressional ,budget ,(fice to review ! in=mation provid$4 4 7b7 ,en=cem5t ,section #ahdg;,a ( su* ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is fur!r am5d$-- 7#a7 9 subsection 7d77#d7-- 7,a7 9 subp>agraph 7,a71 by /rik+ ,9 g5]al & ins]t+ ,misrepres5tation2 7,b7 9 subp>agraph 7,b71 by /rik+ subp>agraph 7,b7 & ins]t+ subp>agraph 7,a71 7,b71 or 7,c72 7,c7 by r$esignat+ subp>agraph 7,b7 z subp>agraph 7,d72 & 7,d7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+ new subp>agraphs3 7,b7 ,failure to provide timely in=mation ,if ! ,secret>y det]m9es t a manufactur] describ$ 9 subsection 7f77#b7 has fail$ to report on in=mation describ$ 9 section #aibg7;b77#c77;,a77iii7 ) respect to a drug or biological 9 accordance ) su* subsection1 ! ,secret>y %all apply a civil money p5alty 9 an am\nt ( #aj1jjj = ea* day ! manufactur] has fail$ to report su* in=mation & su* am\nt %all be paid to ! ,treasury4 7,c7 ,false in=mation ,any manufactur] requir$ to submit in=mation "u subsection 7f77#b7 t kn[+ly provides false in=mation is subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alties are 9 addition to o!r p5alties z may be prescrib$ by law4 2 & 7#b7 9 subsection 7c77#f77;,a71 by /rik+ ! p]iod at ! end & ins]t+ 1 except t1 = purposes ( subsection 7f77#b71 ! ,secret>y may1 if ! ,secret>y det]m9es appropriate1 exclude repackag]s ( a drug or biological f su* t]m44 7c7 ,manufactur]s ) a rebate agreem5t 7#a7 ,9 g5]al ,section #aibg7;b77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,= purposes ( apply+ clause 7iii71 a drug or biological describ$ 9 ! flu% matt] foll[+ su* clause includes items1 s]vices1 supplies1 & products t are payable "u ?is "p z a drug or biological44 7#b7 ,te*nical am5dm5t ,section #aibg7;b77#c77;,a77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77iii77 is am5d$ by /rik+ section #ahha7;b77#ac77;,a77ii7 & ins]t+ section #ahha7;b77#ad77;,b74 7d7 ,report ,n lat] ?an ,janu>y #a1 #bjba1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all assess & submit to ,congress a report on ! accuracy ( av]age sales price in=mation submitt$ by manufactur]s "u section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a74 ,su* report %all include any recomm5dations on h[ to improve ! accuracy ( su* in=mation4 #aae4 ,mak+ prescription drug m>ket+ sample in=mation report$ by manufactur]s available to c]ta9 individuals & entities 7a7 ,9 g5]al ,section #aabh;,h ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;i7 is am5d$-- 7#a7 by r$esignat+ subsection 7b7 z subsection 7e72 & 7#b7 by ins]t+ aft] subsection 7a7 ! foll[+ new subsections3 7b7 ,data %>+ agreem5ts 7#a7 ,9 g5]al ,! ,secret>y %all ent] into agreem5ts ) ! specifi$ data %>+ individuals & entities describ$ 9 p>agraph 7#b7 "u :i*-- 7,a7 ^u reque/ ( su* an individual or entity1 z applicable1 ! ,secret>y makes available to su* individual or entity ! in=mation submitt$ "u subsection 7a7 by manufactur]s & au?oriz$ di/ributors ( record2 & 7,b7 su* individual or entity agrees to n disclose publicly or to ano!r individual or entity any in=mation t id5tifies a p>ticul> practition] or heal? c>e facility4 7#b7 ,specifi$ data %>+ individuals & entities ,= purposes ( p>agraph 7#a71 ! specifi$ data %>+ individuals & entities describ$ 9 ?is p>agraph are ! foll[+3 7,a7 ,ov]sight ag5cies ,heal? ov]sight ag5cies 7z def9$ 9 section #afd4eja ( title #de1 ,code ( ,f$]al ,regulations71 includ+ ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,gov]nm5t ,acc\ntability ,(fice1 ! ,congressional ,budget ,(fice1 ! ,m$ic>e ,paym5t ,advisory ,commission1 & ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission4 7,b7 ,rese>*]s ,individuals :o conduct sci5tific rese>* 7z def9$ 9 section #afd4eja ( title #de1 ,code ( ,f$]al ,regulations7 9 relevant areas z det]m9$ by ! ,secret>y4 7,c7 ,pay]s ,private & public heal? c>e pay]s1 includ+ gr\p heal? plans1 heal? insurance cov]age (f]$ by heal? insurance issu]s1 ,f$]al heal? programs1 & ,/ate heal? programs4 7#c7 ,exemption f ,fre$om ( ,in=mation ,act ,except z describ$ 9 p>agraph 7#a71 ! ,secret>y may n be compell$ to disclose ! in=mation submitt$ "u subsection 7a7 to any individual or entity4 ,= purposes ( section #eeb ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act71 ?is p>agraph %all be consid]$ a /atute describ$ 9 subsection 7b77#c77;,b7 ( su* section4 7c7 ,p5alties 7#a7 ,data %>+ agreem5ts ,subject to p>agraph 7#c71 any specifi$ data %>+ individual or entity describ$ 9 subsection 7b77#b7 t violates ! t]ms ( a data %>+ agreem5t ! individual or entity has ) ! ,secret>y "u subsection 7b77#a7 %all be subject to a civil money p5alty ( n less ?an #a1jjj1 b n m ?an #aj1jjj1 = ea* su* violation4 ,su* p5alty %all be impos$ & collect$ 9 ! same mann] z civil money p5alties "u subsection 7a7 ( section #aabh;,a are impos$ & collect$ "u t section4 7#b7 ,failure to report ,subject to p>agraph 7#c71 any manufactur] or au?oriz$ di/ributor ( record ( an applicable drug "u subsection 7a7 t fails to submit in=mation requir$ "u su* subsection 9 a timely mann] 9 accordance ) rules or regulations promulgat$ to c>ry out su* subsection %all be subject to a civil money p5alty ( n less ?an #a1jjj1 b n m ?an #aj1jjj1 = ea* su* failure4 ,su* p5alty %all be impos$ & collect$ 9 ! same mann] z civil money p5alties "u subsection 7a7 ( section #aabh;,a are impos$ & collect$ "u t section4 7#c7 ,limitation ,! total am\nt ( civil money p5alties impos$ "u p>agraph 7#a7 or 7#b7 ) respect to a ye> & an individual or entity describ$ 9 p>agraph 7#a7 or a manufactur] or di/ributor describ$ 9 p>agraph 7#b71 respectively1 %all n exce$ #aej1jjj4 7d7 ,drug sample di/ribution in=mation 7#a7 ,9 g5]al ,n lat] ?an ,janu>y #a ( ea* ye> 7beg9n+ ) #bjba71 ! ,secret>y %all ma9ta9 a li/ conta9+ in=mation relat$ to ! di/ribution ( samples ( applicable drugs4 ,su* li/ %all provide ! foll[+ in=mation ) respect to ! prec$+ ye>3 7,a7 ,! "n ( ! manufactur] or au?oriz$ di/ributor ( record ( an applicable drug = :i* samples 7 reque/$ or di/ribut$ "u ?is section4 7,b7 ,! quantity & class ( drug samples reque/$4 7,c7 ,! quantity & class ( drug samples di/ribut$4 7#b7 ,public availability ,! ,secret>y %all make ! in=mation 9 su* li/ available to ! public on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration4 4 7b7 ,,fda ma9t5ance ( in=mation ,! ,food & ,drug ,adm9i/ration %all ma9ta9 in=mation available to affect$ report+ companies to ensure _! ability to fully comply ) ! requirem5ts ( section #aabh;,h ( ! ,social ,security ,act4 7c7 ,prohibition on di/ribution ( samples ( opioids ,section #ejc7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;d77 is am5d$-- 7#a7 by mov+ ! m>g9 ( p>agraph 7#d7 #b ems to ! left2 & 7#b7 by add+ at ! end ! foll[+3 7#e7 ,no p]son may di/ribute a drug sample ( a drug t is-- 7,a7 an applicable drug 7z def9$ 9 section #aabh;,h7e7 ( ! ,social ,security ,act72 7,b7 a controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act7 = :i* ! f9d+s requir$ "u section #bjb7;b77#b7 ( su* ,act h be5 made2 & 7,c7 approv$ "u section #eje = use 9 ! managem5t or treatm5t ( pa9 7o!r ?an = ! managem5t or treatm5t ( a sub/ance use disord]74 4 7d7 ,med,p,a,c report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,m$ic>e ,paym5t ,advisory ,commission %all conduct a /udy on ! impact ( drug samples on provid] prescrib+ practices & heal? c>e co/s & may1 z ! ,commission deems appropriate1 make recomm5dations on su* /udy4 #aaf4 ,requir+ prescription drug plan sponsors to include real-"t b5efit in=mation z "p ( su* sponsor's electronic prescription program "u ! ,m$ic>e program ,section #ahfj;,d-#d7;e77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ ,to ! ext5t & ins]t+ ,except z provid$ 9 subp>agraph 7,f71 to ! ext5t2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,real-"t b5efit in=mation 7i7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjba1 ! program %all implem5t real-"t b5efit tools t are capable ( integrat+ ) a prescrib+ heal? c>e pr(essional's electronic prescrib+ or electronic heal? record sy/em = ! transmission ( =mul>y & b5efit in=mation 9 real "t to prescrib+ heal? c>e pr(essionals4 ,) respect to a cov]$ "p ,d drug1 su* tools %all be capable ( transmitt+ su* in=mation specific to an individual enroll$ 9 a prescription drug plan4 ,su* in=mation %all include ! foll[+3 7,i7 ,a li/ ( any cl9ically-appropriate alt]natives to su* drug includ$ 9 ! =mul>y ( su* plan4 7,,ii7 ,co/-%>+ in=mation = su* drug & su* alt]natives1 includ+ a description ( any v>iance 9 co/-%>+ bas$ on ! ph>macy disp5s+ su* drug or su* alt]natives4 7,,iii7 ,in=mation relat+ to :e!r su* drug is includ$ 9 ! =mul>y ( su* plan & any prior au?orization or o!r utilization managem5t requirem5ts applicable to su* drug & su* alt]natives s includ$4 7ii7 ,electronic transmission ,! provisions ( subclauses 7,i7 & 7,,ii7 ( clause 7ii7 ( subp>agraph 7,e7 %all apply to an electronic transmission describ$ 9 clause 7i7 9 ! same mann] z su* provisions apply ) respect to an electronic transmission describ$ 9 clause 7i7 ( su* subp>agraph4 7iii7 ,special rule = #bjba ,! program %all be deem$ to be 9 compliance ) clause 7i7 = #bjba if ! program complies ) ! provisions ( section #dbc4afj7;b77#g7 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation71 = su* ye>4 7iv7 ,rule ( con/ruction ,no?+ 9 ?is subp>agraph %all be con/ru$ z to all[ a real-"t b5efits tool to /e] an individual1 )\t ! cons5t ( ! individual1 to a p>ticul> ph>macy or ph>macy sett+ ov] _! pref]r$ ph>macy sett+ nor prohibit ! designation ( a pref]r$ ph>macy "u su* tool4 4 #aag4 ,s5se ( ,congress reg>d+ ! ne$ to exp& comm]cially available drug pric+ comp>ison plat=ms ,x is ! s5se ( ,congress t-- 7#a7 comm]cially available drug pric+ comp>ison plat=ms c1 at no co/1 help pati5ts f9d ! l[e/ price = _! m$ications at _! local ph>macy2 7#b7 su* plat=ms %\ld be integrat$1 to ! maximum ext5t possible1 9 ! heal? c>e deliv]y ecosy/em2 & 7#c7 ph>macy b5efit manag]s %\ld "w to disclose g5]ic & br& "n drug prices to su* plat=ms to ensure t-- 7,a7 pati5ts c b5efit f ! l[e/ possible price available to !m2 & 7,b7 ov]all drug prices c be r$uc$ z m educat$ pur*as+ decisions are made bas$ on price transp>5cy4 #aah4 ,te*nical corrections 7a7 ,9 g5]al ,section #cjbb7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#eb7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,application ( au?orities "u ,inspector ,g5]al ,act ( #aigh ,9 c>ry+ out ?is subsection1 ! ,inspector ,g5]al %all h ! same au?orities z provid$ "u section #f ( ! ,inspector ,g5]al ,act ( #aigh 7#e ,u4,s4,c4 ,app474 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all take effect z if includ$ 9 ! enactm5t ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee74 ,c ,m$ic>e ,"p ,d ,b5efit ,r$esign #aba4 ,m$ic>e "p ,d b5efit r$esign 7a7 ,b5efit /ructure r$esign ,section #ahfj;,d-#b7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew- #ajb7;b77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbb & = co/s above ! annual d$uctible specifi$ 9 p>agraph 7#a7 & up to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = #bjbb & ea* subsequ5t ye> aft] p>agraph 7#c72 & 7ii7 9 clause 7i71 by ins]t+ aft] #be p]c5t ! foll[+3 7or1 = #bjbb & ea* subsequ5t ye>1 #ae p]c5t72 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] p>agraph 7#d712 & 7ii7 9 clause 7ii77,,iii71 by /rik+ & ea* subsequ5t ye> & ins]t+ & #bjba2 & 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] p>agraph 7#d712 & 7,,ii7 9 subclause 7,i77bb71 by /rik+ a ye> aft] #bjah & ins]t+ ea* ( ye>s #bjah ?r\gh #bjba2 & 7ii7 9 clause 7ii77,v71 by /rik+ #bjai & ea* subsequ5t ye> & ins]t+ ea* ( ye>s #bjai ?r\gh #bjba2 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] & 7#d712 & 7,b7 9 clause 7ii71 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjjg ?r\gh #bjba2 & 7#c7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i7-- 7,i7 by r$esignat+ subclauses 7,i7 & 7,,ii7 z items 7aa7 & 7bb71 respectively1 & ind5t+ appropriately2 7,,ii7 9 ! matt] prec$+ item 7aa71 z r$esignat$ by subclause 7,i71 by /rik+ is equal to ! great] (-- & ins]t+ is equal to-- 7,i7 = a ye> prec$+ #bjbb1 ! great] (-- 2 7,,iii7 by /rik+ ! p]iod at ! end ( item 7bb71 z r$esignat$ by subclause 7,i71 & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & ea* succe$+ ye>1 #j4 2 & 7ii7 9 clause 7ii7-- 7,i7 by /rik+ clause 7i77,i7 & ins]t+ clause 7i77,i77aa72 & 7,,ii7 by add+ at ! end ! foll[+ new s5t5ce3 ,! ,secret>y %all cont9ue to calculate ! doll> am\nts specifi$ 9 clause 7i77,i77aa71 includ+ ) ! adju/m5t "u ?is clause1 aft] #bjba = purposes ( section #ahfj;,d-#ad7;a77#a77;,d77iii742 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i7-- 7,i7 9 subclause 7,v71 by /rik+ or at ! end2 7,,ii7 9 subclause 7,,vi7-- 7aa7 by /rik+ = a subsequ5t ye> & ins]t+ = #bjba2 & 7bb7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,,iii7 by add+ at ! end ! foll[+ new subclauses3 7,,vii7 = #bjbb1 is equal to #c1ajj2 or 7,,viii7 = a subsequ5t ye>1 is equal to ! am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye>1 increas$ by ! annual p]c5tage increase describ$ 9 p>agraph 7#f7 = ! ye> involv$4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,,ii7 & ins]t+ clause 7i72 7,c7 9 subp>agraph 7,c77i71 by /rik+ & = am\nts & ins]t+ & = a ye> prec$+ #bjbb = am\nts2 & 7,d7 9 subp>agraph 7,e71 by /rik+ ,9 apply+ & ins]t+ ,= ea* ( #bjaa ?r\gh #bjba1 9 apply+4 7b7 ,decreas+ re9surance paym5t am\nt ,section #ahfj;,d-#ae7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77#a77 is am5d$-- 7#a7 by /rik+ equal to #hj p]c5t & ins]t+ equal to-- 7,a7 = a ye> prec$+ #bjbb1 #hj p]c5t 2 7#b7 9 subp>agraph 7,a71 z add$ by p>agraph 7#a71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 = #bjbb & ea* subsequ5t ye>1 ! sum (-- 7i7 an am\nt equal to #bj p]c5t ( ! all[able re9surance co/s 7z specifi$ 9 p>agraph 7#b77 attributable to t portion ( gross cov]$ prescription drug co/s z specifi$ 9 p>agraph 7#c7 incurr$ 9 ! cov]age ye> aft] su* individual has incurr$ co/s t exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b7 ) respect to applicable drugs 7z def9$ 9 section #ahfj;,d-#ad;,b7g77#b772 & 7ii7 an am\nt equal to #cj p]c5t ( ! all[able re9surance co/s 7z specifi$ 9 p>agraph 7#b77 attributable to t portion ( gross cov]$ prescription drug co/s z specifi$ 9 p>agraph 7#c7 incurr$ 9 ! cov]age ye> aft] su* individual has incurr$ co/s t exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b7 ) respect to cov]$ "p ,d drugs t are n applicable drugs 7z s def9$74 4 7c7 ,manufactur] disc\nt program 7#a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act is am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,a 7#db ,u4,s4,c4 #adiew-#aad7 ! foll[+ new section3 #ahfj;,d-#ad;,b4 ,manufactur] disc\nt program 7a7 ,e/abli%m5t ,! ,secret>y %all e/abli% a manufactur] disc\nt program 79 ?is section ref]r$ to z ! program74 ,"u ! program1 ! ,secret>y %all ent] into agreem5ts describ$ 9 subsection 7b7 ) manufactur]s & provide = ! p]=mance ( ! duties describ$ 9 subsection 7c74 ,! ,secret>y %all e/abli% a model agreem5t = use "u ! program by n lat] ?an ,janu>y #a1 #bjba1 9 consultation ) manufactur]s1 & all[ = comm5t on su* model agreem5t4 7b7 ,t]ms ( agreem5t 7#a7 ,9 g5]al 7,a7 ,agreem5t ,an agreem5t "u ?is section %all require ! manufactur] to provide applicable b5efici>ies access to disc\nt$ prices = applicable drugs ( ! manufactur] t are disp5s$ on or aft] ,janu>y #a1 #bjbb4 7,b7 ,provision ( disc\nt$ prices at ! po9t-(-sale ,! disc\nt$ prices describ$ 9 subp>agraph 7,a7 %all be provid$ to ! applicable b5efici>y at ! ph>macy or by ! mail ord] s]vice at ! po9t-(-sale ( an applicable drug4 7#b7 ,provision ( appropriate data ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all collect & h available appropriate data1 z det]m9$ by ! ,secret>y1 to ensure t x c demon/rate to ! ,secret>y compliance ) ! requirem5ts "u ! program4 7#c7 ,compliance ) requirem5ts = adm9i/ration ( program ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all comply ) requirem5ts impos$ by ! ,secret>y or a ?ird p>ty ) a contract "u subsection 7d77#c71 z applicable1 = purposes ( adm9i/]+ ! program1 includ+ any det]m9ation "u subp>agraph 7,a7 ( subsection 7c77#a7 or proc$ures e/abli%$ "u su* subsection 7c77#a74 7#d7 ,l5g? ( agreem5t 7,a7 ,9 g5]al ,an agreem5t "u ?is section %all be effective = an initial p]iod ( n less ?an #ab mon?s & %all be automatically r5ew$ = a p]iod ( n less ?an #a ye> unless t]m9at$ "u subp>agraph 7,b74 7,b7 ,t]m9ation 7i7 ,by ! ,secret>y ,! ,secret>y may provide = t]m9ation ( an agreem5t "u ?is section = a kn[+ & willful violation ( ! requirem5ts ( ! agreem5t or o!r good cause %[n4 ,su* t]m9ation %all n be effective e>li] ?an #cj days aft] ! date ( notice to ! manufactur] ( su* t]m9ation4 ,! ,secret>y %all provide1 ^u reque/1 a manufactur] ) a he>+ conc]n+ su* a t]m9ation1 & su* he>+ %all take place prior to ! effective date ( ! t]m9ation ) suffici5t "t = su* effective date to be repeal$ if ! ,secret>y det]m9es appropriate4 7ii7 ,by a manufactur] ,a manufactur] may t]m9ate an agreem5t "u ?is section = any reason4 ,any su* t]m9ation %all be effective1 ) respect to a plan ye>-- 7,i7 if ! t]m9ation occurs be=e ,janu>y #cj ( a plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #cj ( a plan ye>1 z ( ! day aft] ! end ( ! succe$+ plan ye>4 7iii7 ,effectiv5ess ( t]m9ation ,any t]m9ation "u ?is subp>agraph %all n affect disc\nts = applicable drugs ( ! manufactur] t are due "u ! agreem5t be=e ! effective date ( its t]m9ation4 7iv7 ,notice to ?ird p>ty ,! ,secret>y %all provide notice ( su* t]m9ation to a ?ird p>ty ) a contract "u subsection 7d77#c7 )9 n less ?an #cj days be=e ! effective date ( su* t]m9ation4 7#e7 ,effective date ( agreem5t ,an agreem5t "u ?is section %all take effect on a date det]m9$ appropriate by ! ,secret>y1 :i* may be at ! />t ( a cal5d> qu>t]4 7c7 ,duties describ$ ,! duties describ$ 9 ?is subsection are ! foll[+3 7#a7 ,adm9i/ration ( program ,adm9i/]+ ! program1 includ+-- 7,a7 ! det]m9ation ( ! am\nt ( ! disc\nt$ price ( an applicable drug ( a manufactur]2 7,b7 ! e/abli%m5t ( proc$ures "u :i* disc\nt$ prices are provid$ to applicable b5efici>ies at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( an applicable drug2 7,c7 ! e/abli%m5t ( proc$ures to ensure t1 n lat] ?an ! applicable numb] ( cal5d> days aft] ! disp5s+ ( an applicable drug by a ph>macy or mail ord] s]vice1 ! ph>macy or mail ord] s]vice is reimburs$ = an am\nt equal to ! diff]5ce betwe5-- 7i7 ! negotiat$ price ( ! applicable drug2 & 7ii7 ! disc\nt$ price ( ! applicable drug2 7,d7 ! e/abli%m5t ( proc$ures to ensure t ! disc\nt$ price = an applicable drug "u ?is section is appli$ be=e any cov]age or f9ancial assi/ance "u o!r heal? b5efit plans or programs t provide cov]age or f9ancial assi/ance = ! pur*ase or provision ( prescription drug cov]age on behalf ( applicable b5efici>ies z ! ,secret>y may specify2 & 7,e7 provid+ a reasonable dispute resolution me*anism to resolve disagreem5ts betwe5 manufactur]s1 applicable b5efici>ies1 & ! ?ird p>ty ) a contract "u subsection 7d77#c74 7#b7 ,monitor+ compliance 7,a7 ,9 g5]al ,! ,secret>y %all monitor compliance by a manufactur] ) ! t]ms ( an agreem5t "u ?is section4 7,b7 ,notification ,if a ?ird p>ty ) a contract "u subsection 7d77#c7 det]m9es t ! manufactur] is n 9 compliance ) su* agreem5t1 ! ?ird p>ty %all notify ! ,secret>y ( su* noncompliance = appropriate en=cem5t "u subsection 7e74 7#c7 ,collection ( data f prescription drug plans & ,,ma-,,pd plans ,! ,secret>y may collect appropriate data f prescription drug plans & ,,ma-,,pd plans 9 a timeframe t all[s = disc\nt$ prices to be provid$ = applicable drugs "u ?is section4 7d7 ,adm9i/ration 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! ,secret>y %all provide = ! implem5tation ( ?is section1 includ+ ! p]=mance ( ! duties describ$ 9 subsection 7c74 7#b7 ,limitation ,9 provid+ = ! implem5tation ( ?is section1 ! ,secret>y %all n receive or di/ribute any funds ( a manufactur] "u ! program4 7#c7 ,contract ) ?ird p>ties ,! ,secret>y %all ent] into a contract ) #a or m ?ird p>ties to adm9i/] ! requirem5ts e/abli%$ by ! ,secret>y 9 ord] to c>ry out ?is section4 ,at a m9imum1 ! contract ) a ?ird p>ty "u ! prec$+ s5t5ce %all require t ! ?ird p>ty-- 7,a7 receive & transmit in=mation betwe5 ! ,secret>y1 manufactur]s1 & o!r individuals or entities ! ,secret>y det]m9es appropriate2 7,b7 receive1 di/ribute1 or facilitate ! di/ribution ( funds ( manufactur]s to appropriate individuals or entities 9 ord] to meet ! obligations ( manufactur]s "u agreem5ts "u ?is section2 7,c7 provide adequate & timely in=mation to manufactur]s1 consi/5t ) ! agreem5t ) ! manufactur] "u ?is section1 z necess>y = ! manufactur] to fulfill its obligations "u ?is section2 & 7,d7 p]mit manufactur]s to conduct p]iodic audits1 directly or ?r\gh contracts1 ( ! data & in=mation us$ by ! ?ird p>ty to det]m9e disc\nts = applicable drugs ( ! manufactur] "u ! program4 7#d7 ,p]=mance requirem5ts ,! ,secret>y %all e/abli% p]=mance requirem5ts = a ?ird p>ty ) a contract "u p>agraph 7#c7 & safegu>ds to protect ! indep5d5ce & integrity ( ! activities c>ri$ out by ! ?ird p>ty "u ! program "u ?is section4 7#e7 ,adm9i/ration ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! program "u ?is section4 7e7 ,en=cem5t 7#a7 ,audits ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all be subject to p]iodic audit by ! ,secret>y4 7#b7 ,civil money p5alty 7,a7 ,9 g5]al ,! ,secret>y %all impose a civil money p5alty on a manufactur] t fails to provide applicable b5efici>ies disc\nts = applicable drugs ( ! manufactur] 9 accordance ) su* agreem5t = ea* su* failure 9 an am\nt ! ,secret>y det]m9es is comm5surate ) ! sum (-- 7i7 ! am\nt t ! manufactur] w\ld h paid ) respect to su* disc\nts "u ! agreem5t1 :i* w !n be us$ to pay ! disc\nts :i* ! manufactur] _h fail$ to provide2 & 7ii7 #be p]c5t ( su* am\nt4 7,b7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is p>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7f7 ,cl>ification reg>d+ availability ( o!r cov]$ "p ,d drugs ,no?+ 9 ?is section %all prev5t an applicable b5efici>y f pur*as+ a cov]$ "p ,d drug t is n on ! =mul>y ( ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 94 7g7 ,def9itions ,9 ?is section3 7#a7 ,applicable b5efici>y ,! t]m applicable b5efici>y means an individual :o1 on ! date ( disp5s+ a cov]$ "p ,d drug-- 7,a7 is enroll$ 9 a prescription drug plan or an ,,ma-,,pd plan2 7,b7 is n enroll$ 9 a qualifi$ retiree prescription drug plan2 & 7,c7 has incurr$ co/s = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = su* ye>4 7#b7 ,applicable drug ,! t]m applicable drug means1 ) respect to an applicable b5efici>y1 a cov]$ "p ,d drug-- 7,a7 approv$ "u a new drug application "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or1 9 ! case ( a biologic product1 lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7includ+ a product lic5s$ "u subsection 7k7 ( su* section72 & 7,b7 7i7 if ! ,,pdp sponsor ( ! prescription drug plan or ! ,,ma organization (f]+ ! ,,ma-,,pd plan uses a =mul>y1 :i* is on ! =mul>y ( ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 92 7ii7 if ! ,,pdp sponsor ( ! prescription drug plan or ! ,,ma organization (f]+ ! ,,ma-,,pd plan does n use a =mul>y1 = :i* b5efits are available "u ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 92 or 7iii7 is provid$ ?r\gh an exception or appeal4 7#c7 ,applicable numb] ( cal5d> days ,! t]m applicable numb] ( cal5d> days means-- 7,a7 ) respect to claims = reimbursem5t submitt$ electronically1 #ad days2 & 7,b7 ) respect to claims = reimbursem5t submitt$ o!rwise1 #cj days4 7#d7 ,disc\nt$ price 7,a7 ,9 g5]al ,! t]m disc\nt$ price means1 ) respect to an applicable drug ( a manufactur] furni%$ dur+ a ye> to an applicable b5efici>y1 #ij p]c5t ( ! negotiat$ price ( su* drug4 7,b7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ z affect+ ! responsibility ( an applicable b5efici>y = paym5t ( a disp5s+ fee = an applicable drug4 7,c7 ,special case = claims spann+ d$uctible ,9 ! case :]e ! entire am\nt ( ! negotiat$ price ( an individual claim = an applicable drug ) respect to an applicable b5efici>y does n fall at or above ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = ! ye>1 ! manufactur] ( ! applicable drug %all provide ! disc\nt$ price "u ?is section on only ! portion ( ! negotiat$ price ( ! applicable drug t falls at or above su* annual d$uctible4 7#e7 ,manufactur] ,! t]m manufactur] means any entity :i* is engag$ 9 ! production1 prep>ation1 propagation1 comp\nd+1 conv]sion1 or process+ ( prescription drug products1 ei!r directly or indirectly by extraction f sub/ances ( natural orig91 or indep5d5tly by means ( *emical syn!sis1 or by a comb9ation ( extraction & *emical syn!sis4 ,su* t]m does n include a :olesale di/ributor ( drugs or a retail ph>macy lic5s$ "u ,/ate law4 7#f7 ,negotiat$ price ,! t]m negotiat$ price has ! mean+ giv5 su* t]m 9 section #ahfj;,d-#b7;d77#a77;,b71 except t su* negotiat$ price %all n include any disp5s+ fee = an applicable drug4 7#g7 ,qualifi$ retiree prescription drug plan ,! t]m qualifi$ retiree prescription drug plan has ! mean+ giv5 su* t]m 9 section #aahfj;,d-#bb7;a77#b74 4 7#b7 ,sunset ( ,m$ic>e cov]age gap disc\nt program ,section #ahfj;,d-#ad;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie-aad;a7 is am5d$-- 7,a7 9 subsection 7a71 9 ! fir/ s5t5ce1 by /rik+ ,! ,secret>y & ins]t+ ,subject to subsection 7h71 ! ,secret>y2 & 7,b7 by add+ at ! end ! foll[+ new subsection3 7h7 ,sunset ( program 7#a7 ,9 g5]al ,! program %all n apply to applicable drugs disp5s$ on or aft] ,janu>y #a1 #bjbb1 &1 subject to p>agraph 7#b71 agreem5ts "u ?is section %all be t]m9at$ z ( su* date4 7#b7 ,cont9u$ application = applicable drugs disp5s$ prior to sunset ,! provisions ( ?is section 7includ+ all responsibilities & duties7 %all cont9ue to apply aft] ,janu>y #a1 #bjbb1 ) respect to applicable drugs disp5s$ prior to su* date4 4 7#c7 ,inclusion ( actu>ial value ( manufactur] disc\nts 9 bids ,section #ahfj;,d-#aa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$-- 7,a7 9 subsection 7b77#b77;,c77iii7-- 7i7 by /rik+ assumptions reg>d+ ! re9surance & ins]t+ assumptions reg>d+-- 7,i7 ! re9surance 2 & 7ii7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d- #ad;,b subtract$ f ! actu>ial value to produce su* bid2 & 2 & 7,b7 9 subsection 7c77#a77;,c7-- 7i7 by /rik+ an actu>ial valuation ( ! re9surance & ins]t+ an actu>ial valuation (-- 7i7 ! re9surance 2 7ii7 9 clause 7i71 z add$ by clause 7i7 ( ?is subp>agraph1 by add+ & at ! end2 & 7iii7 by add+ at ! end ! foll[+3 7ii7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,b2 4 7d7 ,det]m9ation ( all[able re9surance co/s ,section #ahfj;,d-#ae7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 by /rik+ ,co/s4--,= purposes & ins]t+ ,co/s4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 = purposes 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,inclusion ( manufactur] disc\nts on applicable drugs ,= purposes ( apply+ subp>agraph 7,a71 ! t]m all[able re9surance co/s %all include ! portion ( ! negotiat$ price 7z def9$ 9 section #ahfj;,d-#ad;,b7g77#f77 ( an applicable drug 7z def9$ 9 section #ahfj;,d-#ad7;g77#b77 t 0 paid by a manufactur] "u ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,b4 2 & 7#b7 9 p>agraph 7#c7-- 7,a7 9 ! fir/ s5t5ce1 by /rik+ ,= purposes & ins]t+ ,subject to p>agraph 7#b77;,b71 = purposes2 & 7,b7 9 ! second s5t5ce1 by ins]t+ or1 9 ! case ( an applicable drug1 by a manufactur] aft] by ! individual or "u ! plan4 7e7 ,updat+ risk adju/m5t me?odologies ,to acc\nt = "p ,d mod]nization r$esign ,section #ahfj;,d-#ae7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,updat+ risk adju/m5t me?odologies to acc\nt = "p ,d mod]nization r$esign ,! ,secret>y %all update ! risk adju/m5t model us$ to adju/ bid am\nts pursuant to ?is subsection z appropriate to take into acc\nt *anges 9 b5efits "u ?is "p pursuant to ! am5dm5ts made by section #aba ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai4 4 7f7 ,conditions = cov]age ( drugs "u ?is "p ,section #ahfj;,d-#dc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#b71 by /rik+ & at ! end2 7,b7 9 p>agraph 7#c71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,c7 by add+ at ! end ! foll[+ new p>agraphs3 7#d7 p>ticipate 9 ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,b2 7#e7 h ent]$ into & h 9 effect an agreem5t describ$ 9 subsection 7b7 ( su* section #ahfj;,d-#ad;,b ) ! ,secret>y2 & 7#f7 h ent]$ into & h 9 effect1 "u t]ms & conditions specifi$ by ! ,secret>y1 a contract ) a ?ird p>ty t ! ,secret>y has ent]$ into a contract ) "u subsection 7d77#c7 ( su* section #ahfj;,d-#ad;,b4 2 7#b7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,effective date ,p>agraphs 7#a7 ?r\gh 7#c7 ( subsection 7a7 %all apply to cov]$ "p ,d drugs disp5s$ "u ?is "p on or aft] ,janu>y #a1 #bjaa1 & be=e ,janu>y #a1 #bjbb1 & p>agraphs 7#d7 ?r\gh 7#f7 ( su* subsection %all apply to cov]$ "p ,d drugs disp5s$ on or aft] ,janu>y #a1 #bjbb4 2 & 7#c7 9 subsection 7c71 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ! ,secret>y det]m9es t 9 ! p]iod beg9n+ on ,janu>y #a1 #bjaa1 & end+ on ,decemb] #ca1 #bjaa 7) respect to p>agraphs 7#a7 ?r\gh 7#c7 ( subsection 7a771 or ! p]iod beg9n+ on ,janu>y #a1 #bjbb1 & end+ ,decemb] #ca1 #bjbb 7) respect to p>agraphs 7#d7 ?r\gh 7#f7 ( su* subsection71 !re 7 ext5uat+ circum/ances4 4 7g7 ,con=m+ am5dm5ts 7#a7 ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7,a7 9 subsection 7a77#b77;,a77i77,i71 by /rik+ 1 or an increase 9 ! initial & ins]t+ or = a ye> prec$+ #bjbb an increase 9 ! initial2 7,b7 9 subsection 7c77#a77;,c7-- 7i7 9 ! subp>agraph head+1 by /rik+ at initial cov]age limit2 & 7ii7 by ins]t+ = a ye> prec$+ #bjbb or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbb & ea* subsequ5t ye> aft] subsection 7b77#c7 = ! ye> ea* place x appe>s2 & 7,c7 9 subsection 7d77#a77;,a71 by /rik+ or an initial & ins]t+ or = a ye> prec$+ #bjbb1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is am5d$ by /rik+ ! initial & ins]t+ = a ye> prec$+ #bjbb1 ! initial4 7#c7 ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 7ii7 9 subp>agraph 7,d77iii71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 7iii7 9 subp>agraph 7,e71 by /rik+ ,! elim9ation & ins]t+ ,= a ye> prec$+ #bjbb1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 & 7ii7 9 subp>agraph 7,e7-- 7,i7 by ins]t+ = a ye> prec$+ #bjbb1 aft] subsection 7c72 & 7,,ii7 by /rik+ #ahfj;,d- #b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa74 7#d7 ,section #ahfj;,d-#ba7;d77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aca7;d77#g77 is am5d$ by /rik+ section #ahfj;,d-#b7;b77#d77;,b77i7 & ins]t+ section #ahfj;,d-#b7;b77#d77;,c77i74 7#e7 ,section #ahfj;,d-#bb7;a77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#acb7;a77#b77;,a77 is am5d$-- 7,a7 by /rik+ ! value ( any disc\nt & ins]t+ ! foll[+3 ! value (-- 7i7 = ye>s prior to #bjbb1 any disc\nt 2 7,b7 9 clause 7i71 z ins]t$ by subp>agraph 7,a7 ( ?is p>agraph1 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new clause3 7ii7 = #bjbb & ea* subsequ5t ye>1 any disc\nt provid$ pursuant to section #ahfj;,d-#ad;,b4 4 7#f7 ,section #ahfj;,d-#da7;a77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea7;a77#f77 is am5d$-- 7,a7 by ins]t+ = a ye> be=e #bjbb aft] #ahfj;,d-#b7;b77#c72 & 7,b7 by ins]t+ = su* ye> be=e ! p]iod4 7h7 ,effective date ,! am5dm5ts made by ?is section %all apply to plan ye> #bjbb & subsequ5t plan ye>s4 ,d ,o!r ,m$ic>e ,"p ,d ,provisions #aca4 ,transitional cov]age & retroactive ,m$ic>e "p ,d cov]age = c]ta9 l[-income b5efici>ies ,section #ahfj;,d-#ad ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7 is am5d$-- 7#a7 by r$esignat+ subsection 7e7 z subsection 7f72 & 7#b7 by add+ aft] subsection 7d7 ! foll[+ new subsection3 7e7 ,limit$ income newly eligible transition program 7#a7 ,9 g5]al ,beg9n+ n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y %all c>ry out a program to provide transitional cov]age = cov]$ "p ,d drugs = ,,li ,,net eligible individuals 9 accordance ) ?is subsection4 7#b7 ,,li net eligible individual def9$ ,= purposes ( ?is subsection1 ! t]m ,,li ,,net eligible individual means a "p ,d eligible individual :o-- 7,a7 meets ! requirem5ts ( clauses 7ii7 & 7iii7 ( subsection 7a77#c77;,a72 & 7,b7 has n yet enroll$ 9 a prescription drug plan or an ,,ma-,,pd plan1 or1 :o has s enroll$1 b ) respect to :om cov]age "u su* plan has n yet tak5 effect4 7#c7 ,transitional cov]age ,= purposes ( ?is subsection1 ! t]m transitional cov]age means1 ) respect to an ,,li ,,net eligible individual-- 7,a7 imm$iate access to cov]$ "p ,d drugs at ! po9t-(-sale dur+ ! p]iod t beg9s on ! fir/ day ( ! mon? su* individual is det]m9$ to meet ! requirem5ts ( clauses 7ii7 & 7iii7 ( subsection 7a77#c77;,a7 & ends on ! date t cov]age "u a prescription drug plan or ,,ma-,,pd plan takes effect ) respect to su* individual2 & 7,b7 9 ! case ( an ,,li ,,net eligible individual :o is a full-b5efit dual eligible individual 7z def9$ 9 section #aice7;c77#f77 or a recipi5t ( supplem5tal security income b5efits "u title ,,xvi1 retroactive cov]age 79 ! =m ( reimbursem5t ( ! am\nts t w\ld h be5 paid "u ?is "p _h su* individual be5 enroll$ 9 a prescription drug plan or ,,ma-,,pd plan7 ( cov]$ "p ,d drugs pur*as$ by su* individual dur+ ! p]iod t beg9s on ! date t is ! lat] (-- 7i7 ! date t su* individual 0 fir/ eligible = a l[-income subsidy "u ?is "p2 or 7ii7 ! date t is #cf mon?s prior to ! date su* individual enrolls 9 a prescription drug plan or ,,ma-,,pd plan1 & ends on ! date t cov]age "u su* plan takes effect4 7#d7 ,program adm9i/ration 7,a7 ,s+le po9t ( contact ,! ,secret>y %all1 to ! ext5t feasible1 adm9i/] ! program "u ?is subsection ?r\gh a contract ) a s+le program adm9i/rator4 7,b7 ,b5efit design ,! ,secret>y %all ensure t ! transitional cov]age provid$ to ,,li ,,net eligible individuals "u ?is subsection-- 7i7 provides access to all cov]$ "p ,d drugs "u an op5 =mul>y2 7ii7 p]mits all ph>macies det]m9$ by ! ,secret>y to be 9 good /&+ to process claims "u ! program2 7iii7 is consi/5t ) su* requirem5ts z ! ,secret>y consid]s necess>y to improve pati5t safety & ensure appropriate disp5s+ ( m$ication2 & 7iv7 meets su* o!r requirem5ts z ! ,secret>y may e/abli%4 7#e7 ,relation%ip to o!r provisions ( ?is title2 waiv] au?ority 7,a7 ,9 g5]al ,! foll[+ provisions %all n apply ) respect to ! program "u ?is subsection3 7i7 ,p>agraphs 7#a7 & 7#c77;,b7 ( section #ahfj;,d-#d7;a7 7relat+ to dissem9ation ( g5]al in=mation2 availability ( in=mation on *anges 9 =mul>y ?r\gh ! int]net74 7ii7 ,subp>agraphs 7,a7 & 7,b7 ( section #ahfj;,d-#d7;b77#c7 7relat+ to requirem5ts on developm5t & application ( =mul>ies2 =mul>y developm5t74 7iii7 ,p>agraphs 7#a77;,c7 & 7#b7 ( section #ahfj;,d-#d7;c7 7relat+ to m$ication !rapy managem5t program74 7,b7 ,waiv] au?ority ,! ,secret>y may waive su* o!r requirem5ts ( title ,,xi & ?is title z may be necess>y to c>ry out ! purposes ( ! program e/abli%$ "u ?is subsection4 4 #acb4 ,all[+ ! (f]+ ( additional prescription drug plans "u ,m$ic>e "p ,d 7a7 ,resc9d+ & issuance ( new guidance ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all-- 7#a7 resc9d sections ( any sub-regulatory guidance t limit ! numb] ( prescription drug plans 9 ea* ,,pdp region t may be (f]$ by a ,,pdp sponsor "u "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq472 & 7#b7 issue new guidance specify+ t a ,,pdp sponsor may (f] up to #d 7or a great] numb] if det]m9$ appropriate by ! ,secret>y7 prescription drug plans 9 ea* ,,pdp region1 except 9 cases :]e ! ,,pdp sponsor may (f] up to #b additional plans 9 a ,,pdp region pursuant to section #ahfj;,d-#aa7;d77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;d77#d771 z add$ by subsection 7b74 7b7 ,(f]+ ( additional plans ,section #ahfj;,d-#aa7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;d77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,(f]+ ( additional plans 7,a7 ,9 g5]al ,= plan ye> #bjbb & ea* subsequ5t plan ye>1 a ,,pdp sponsor may (f] up to #b additional prescription drug plans 9 a ,,pdp region 79 addition to any limit e/abli%$ by ! ,secret>y "u ?is "p7 provid$ t ! ,,pdp sponsor complies ) subp>agraph 7,b7 ) respect to at lea/ "o su* prescription drug plan4 7,b7 ,requirem5ts ,9 ord] to be eligible to (f] up to #b additional plans 9 a ,,pdp region pursuant to subp>agraph 7,a71 a ,,pdp sponsor mu/ ensure t1 ) respect to at lea/ "o su* prescription drug plan1 ! sponsor or any entity t provides ph>macy b5efits managem5t s]vices "u a contract ) any su* sponsor or plan does n receive direct or indirect remun]ation1 z def9$ 9 section #dbc4cjh ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation71 unless at lea/ #be p]c5t ( ! aggregate r$uctions 9 price or o!r remun]ation receiv$ by ! ,,pdp sponsor or entity f drug manufactur]s ) respect to ! plan & plan ye>-- 7i7 are reflect$ at ! po9t-(-sale to ! enrollee2 or 7ii7 are us$ to r$uce total b5efici>y co/-%>+ e/imat$ by ! ,,pdp sponsor = prescription drug cov]age "u ! plan 9 ! annual bid submitt$ by ! ,,pdp sponsor "u section #ahfj;,d-#aa7;b74 7,c7 ,def9ition ( r$uctions 9 price ,= purposes ( subp>agraph 7,b71 ! t]m r$uctions 9 price ref]s only to collectible am\nts1 z det]m9$ by ! ,secret>y1 :i* excludes am\nts :i* aft] adjudication & reconciliation ) ph>macies & manufactur]s are duplicate 9 nature1 contr>y to o!r contractual clauses1 or o!rwise ineligible 7su* z due to b5efici>y dis5rollm5t or coord9ation ( b5efits74 4 7c7 ,rule ( con/ruction ,no?+ 9 ! provisions (1 or am5dm5ts made by1 ?is section %all be con/ru$ z limit+ ! ability ( ! ,secret>y to increase any limit o!rwise applicable on ! numb] ( prescription drug plans t a ,,pdp sponsor may (f]1 at ! discretion ( ! ,,pdp sponsor1 9 a ,,pdp region "u "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq474 #acc4 ,all[+ c]ta9 enrollees ( prescription drugs plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances 7a7 ,/&>d prescription drug cov]age ,section #ahfj;,d-#b7;b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b771 z am5d$ by section #aba1 is fur!r am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ ,subject to subp>agraphs 7,c7 & 7,d7 & ins]t+ ,subject to subp>agraphs 7,c71 7,d71 & 7,e72 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,enrollee option reg>d+ spread+ co/-%>+ 7i7 ,9 g5]al ,! ,secret>y %all e/abli% by regulation a process "u :i*1 ) respect to plan ye> #bjbb & subsequ5t plan ye>s1 a prescription drug plan or an ,,ma-,,pd plan %all1 9 ! case ( a "p ,d eligible individual enroll$ ) su* plan = su* plan ye> ) respect to :om ! plan projects t ! disp5s+ ( a cov]$ "p ,d drug to su* individual w result 9 ! individual incurr+ co/s )9 a #cj-;day p]iod t are equal to a significant p]c5tage 7z specifi$ by ! ,secret>y pursuant to su* regulation7 ( ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = su* plan ye>1 provide su* individual ) ! option to make ! co9surance paym5t requir$ "u subp>agraph 7,a7 = su* co/s 9 ! =m ( equal mon?ly in/allm5ts ov] ! rema9d] ( su* plan ye>4 7ii7 ,significant p]c5tage limitations ,9 specify+ a significant p]c5tage pursuant to ! regulation e/abli%$ by ! ,secret>y "u clause 7i71 ! ,secret>y may n specify a p]c5tage t is less ?an #cj p]c5t or great] ?an #ajj p]c5t4 4 7b7 ,alt]native prescription drug cov]age ,section #ahfj;,d-#b7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,same enrollee option reg>d+ spread+ co/-%>+ ,= plan ye> #bjbb & subsequ5t plan ye>s1 ! cov]age provides ! enrollee option reg>d+ spread+ co/-%>+ describ$ 9 & requir$ "u subsection 7b77#b77;,e74 4 #acd4 ,e/abli%+ a mon?ly cap on b5efici>y incurr$ co/s = insul9 products & supplies "u a prescription drug plan or ,,ma-,,pd plan 7a7 ,9 g5]al ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb71 z am5d$ by sections #aba & #acc1 is fur!r am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & 7,e7 & ins]t+ 7,e71 & 7,f72 7,b7 9 subp>agraph 7,b71 by /rik+ & 7,d7 & ins]t+ 7,d71 & 7,f72 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,cap on incurr$ co/s = insul9 products & supplies 7i7 ,9 g5]al ,! cov]age provides b5efits1 = co/s above ! annual d$uctible specifi$ 9 p>agraph 7#a7 & up to ! annual out-(-pocket ?re%old describ$ 9 p>agraph 7#d77;,b7 & ) respect to a mon? 7beg9n+ ) ,janu>y ( #bjbb71 ) co/ %>+ t is equal to #j = a specifi$ cov]$ "p ,d drug 7z def9$ 9 clause 7iii77 furni%$ to an individual :o has incurr$ co/s dur+ su* mon? ) respect to specifi$ cov]$ "p ,d drugs equal to-- 7,i7 = mon?s occurr+ 9 #bjbb1 #ej2 or 7,,ii7 = mon?s occurr+ 9 a subsequ5t ye>1 ! am\nt applicable "u ?is clause = mon?s occurr+ 9 ! ye> prec$+ su* subsequ5t ye>1 increas$ by ! annual p]c5tage increase specifi$ 9 p>agraph 7#f7 = su* subsequ5t ye> & r\nd$ to ! ne>e/ doll>4 7ii7 ,application ,! provisions ( clauses 7i7 ?r\gh 7iii7 ( p>agraph 7#d77;,c7 %all apply ) respect to ! det]m9ation ( ! incurr$ co/s = specifi$ cov]$ "p ,d drugs = purposes ( clause 7i7 9 ! same mann] z su* provisions apply ) respect to ! det]m9ation ( incurr$ co/s = cov]$ "p ,d drugs = purposes ( p>agraph 7#d77;,a74 7iii7 ,specifi$ cov]$ "p ,d drug ,= purposes ( ?is subp>agraph1 ! t]m specifi$ cov]$ "p ,d drug means a cov]$ "p ,d drug t is-- 7,i7 insul92 or 7,,ii7 a m$ical supply associat$ ) ! injection ( insul9 7z def9$ 9 regulations ( ! ,secret>y promulgat$ pursuant to subsection 7e77#a77;,b774 2 & 7#b7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,same protection ) respect to exp5ditures = insul9 & c]ta9 m$ical supplies ,! cov]age provides ! cov]age requir$ "u subsection 7b77#b77;,f74 4 7b7 ,con=m+ am5dm5ts 7#a7 ,9 g5]al ,section #ahfj;,d-#ad7;a77#a77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#a77;,d771 z am5d$ by section #aba1 is fur!r am5d$-- 7,a7 9 clause 7ii71 by /rik+ section #ahfj;,d-#b7;b77#b7 & ins]t+ section #ahfj;,d-#b7;b77#b77;,a72 & 7,b7 9 clause 7iii71 by /rik+ section #ahfj;,d-#b7;b77#b7 & ins]t+ section #ahfj;,d-#b7;b77#b77;,a74 7#b7 ,effective date ,! am5dm5ts made by p>agraph 7#a7 %all apply ) respect to plan ye> #bjbb & ea* subsequ5t plan ye>4 #ace4 ,gr[? rate ( ,m$ic>e "p ,d out-(-pocket co/ ?re%old 7a7 ,provid+ ,m$ic>e "p ,d b5efici>ies ) c]ta9 #bjbj (fset paym5ts ,section #ahfj;,d-#b7;b77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,f7 #bjbj (fset paym5ts 7i7 ,9 g5]al ,subject to clause 7iv71 ! ,secret>y %all provide = paym5t f ! ,m$ic>e ,prescription ,drug ,acc\nt z foll[s3 7,i7 ,9 ! case ( a specifi$ individual 7z def9$ 9 clause 7ii77,i77 :o z ( ! la/ day ( a cal5d> qu>t] 9 #bjbj has incurr$ co/s = cov]$ "p ,d drugs s t ! individual has exce$$ ! annual out-(-pocket ?re%old appli$ "u subp>agraph 7,b77i77,v7 = #bjbj1 paym5t to ! individual by n lat] ?an #ae? day ( ! ?ird mon? foll[+ ! end ( su* qu>t] ( ! am\nt by :i* su* ?re%old s appli$ exce$$ ! t>get ?re%old = #bjbj4 7,,ii7 ,9 ! case ( a specifi$ individual :o is n describ$ 9 subclause 7,i7 & :o z ( ! la/ day ( #bjbj has incurr$ co/s = cov]$ "p ,d drugs s t ! individual has exce$$ ! t>get ?re%old = #bjbj1 paym5t to ! individual by n lat] ?an ,decemb] #ca1 #bjba1 ( ! am\nt by :i* su* incurr$ co/s exce$$ ! t>get ?re%old = #bjbj4 7ii7 ,def9itions ,= purposes ( ?is subp>agraph3 7,i7 ,specifi$ individual ,! t]m specifi$ individual means an individual :o-- 7aa7 is enroll$ 9 a prescription drug plan or an ,,ma- ,,pd plan2 7bb7 is n enroll$ 9 a qualifi$ retiree prescription drug plan2 & 7cc7 is n entitl$ to an income-relat$ subsidy "u section #ahfj;,d-#ad7;a74 7,,ii7 ,t>get ?re%old = #bjbj ! t]m t>get ?re%old = #bjbj means ! annual out-(-pocket ?re%old t w\ld h be5 appli$ "u subp>agraph 7,b77i7 = #bjbj if su* ?re%old _h be5 det]m9$ 9 accordance ) subclause 7,,iv7 ( su* subp>agraph in/ead ( subclause 7,v7 ( su* subp>agraph4 7iii7 ,notification ,9 ! case ( any specifi$ individual :o dur+ #bjbj has incurr$ co/s = cov]$ "p ,d drugs s t ! individual has exce$$ ! t>get ?re%old = #bjbj1 ! ,secret>y %all1 n lat] ?an ,septemb] #cj1 #bjba1 provide to su* individual a notification in=m+ su* individual ( su* individual's "r to a paym5t describ$ 9 clause 7i7 & ! e/imat$ tim+ ( su* paym5t4 7iv7 ,cl>ification ,! ,secret>y %all provide only #a paym5t "u ?is subp>agraph ) respect to any individual4 7v7 ,implem5tation ,! ,secret>y may implem5t ?is subp>agraph by program in/ruction or o!rwise4 4 7b7 ,r$uc$ gr[? rate = #bjba ( ,m$ic>e "p ,d out-(-,pocket co/ ?re%old ,section #ahfj;,d-#b7;b77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77;,b77i77 is am5d$-- 7#a7 9 subclause 7,v71 by /rik+ at ! end or2 7#b7 by r$esignat+ subclause 7,,vi7 z subclause 7,,viii72 & 7#c7 by ins]t+ aft] subclause 7,v7 ! foll[+ new subclauses3 7,,vi7 = #bjba1 is equal to ! am\nt t w\ld h be5 appli$ "u ?is subp>agraph = #bjbj if su* am\nt _h be5 det]m9$ 9 accordance ) subclause 7,,iv7 in/ead ( subclause 7,v71 increas$ by ! less] (-- 7aa7 ! annual p]c5tage increase describ$ 9 p>agraph 7#g7 = #bjba1 plus #b p]c5tage po9ts2 or 7bb7 ! annual p]c5tage increase describ$ 9 p>agraph 7#f7 = #bjba2 7,,vii7 = #bjbb1 is equal to ! am\nt t w\ld h be5 appli$ "u ?is subp>agraph = #bjbb if ! am5dm5ts made by section #aaja7;d77#a7 ( ! ,heal? ,c>e & ,education ,reconciliation ,act ( #bjaj & by section #ace ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai _h n be5 enact$2 or 4 ,e ,med,p,a,c #ada4 ,provid+ ! ,m$ic>e ,paym5t ,advisory ,commission & ,m$icaid & ,,*ip ,paym5t & ,access ,commission ) access to c]ta9 drug paym5t in=mation1 includ+ c]ta9 rebate in=mation 7a7 ,access to c]ta9 "p ,d paym5t data ,section #ahfj;,d-#ae7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;f77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a77ii71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by ins]t+ at ! end ! foll[+ new subp>agraph3 7,c7 by ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission = purposes ( monitor+1 mak+ recomm5dations1 & analysis ( ! program "u ?is title & by ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission = purposes ( monitor+1 mak+ recomm5dations1 & analysis ( ! ,m$icaid program e/abli%$ "u title ,,xix & ! ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi4 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,additional re/rictions on disclosure ( in=mation ,! ,executive ,directors describ$ 9 p>agraph 7#b77;,c7 %all n disclose any ( ! foll[+ in=mation disclos$ to su* ,executive ,directors or obta9$ by su* ,executive ,directors pursuant to su* p>agraph1 ) respect to a prescription drug plan (f]$ by a ,,pdp sponsor3 7,a7 ,! specific am\nts or ! id5tity ( ! s\rce ( any rebates1 price concessions1 or o!r =ms ( direct or indirect remun]ation "u su* prescription drug plan4 7,b7 ,in=mation submitt$ ) ! bid submitt$ "u section #ahfj;,d-#aa by su* ,,pdp sponsor4 7,c7 ,9 ! case ( su* in=mation f prescription drug ev5t records1 9 a =m t w\ld n be p]mitt$ "u section #dbc4eje7m7 ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation1 if made by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 4 7b7 ,access to c]ta9 rebate & paym5t data "u ,m$ic>e & ,m$icaid ,section #aibg7;b77#c77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77 is am5d$-- 7#a7 9 ! matt] be=e clause 7i71 by /rik+ subsection 7a77#f77;,a77ii7 & ins]t+ subsection 7a77#f77;,a72 7#b7 9 clause 7v71 by /rik+ & at ! end2 7#c7 9 clause 7vi71 by /rik+ ! p]iod at ! end & ins]t+ 1 &2 7#d7 by ins]t+ aft] clause 7vi7 ! foll[+ new clause3 7vii7 to p]mit ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission & ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission to review ! in=mation provid$4 2 7#e7 9 ! matt] at ! end1 by /rik+ #ahfj;,d-#d7;c77#b77;,e7 & ins]t+ #ahfj;,d-#d7;c77#b77;,g72 & 7#f7 by add+ at ! end ! foll[+ new s5t5ce3 ,any in=mation disclos$ to ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission or ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission pursuant to ?is subp>agraph %all n be disclos$ by ei!r su* ,executive ,director 9 a =m :i* discloses ! id5tity ( a specific manufactur] or :olesal] or prices *>g$ = drugs by su* manufactur] or :olesal]44 ,,ii ,m$icaid #bja4 ,sunset ( limit on maximum rebate am\nt = s+le s\rce drugs & innovator multiple s\rce drugs ,section #aibg7;c77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77;,d77 is am5d$ by ins]t+ aft] ,decemb] #ca1 #bjji1 ! foll[+3 & be=e ,janu>y #a1 #bjbc14 #bjb4 ,m$icaid ph>macy & !rapeutics committee improvem5ts 7a7 ,9 g5]al ,subp>agraph 7,a7 ( section #aibg7;d77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;d77#d77 is am5d$ to read z foll[s3 7,a7 7i7 ,! =mul>y is develop$ & review$ by a ph>macy & !rapeutics committee consi/+ ( physicians1 ph>maci/s1 & o!r appropriate individuals appo9t$ by ! ,gov]nor ( ! ,/ate4 7ii7 ,subject to clause 7vi71 ! ,/ate e/abli%es & implem5ts a conflict ( int]e/ policy = ! ph>macy & !rapeutics committee t-- 7,i7 is publicly accessible2 7,,ii7 requires all committee memb]s to complete1 on at lea/ an annual basis1 a disclosure ( relation%ips1 associations1 & f9ancial deal+s t may affect _! indep5d5ce ( judgem5t 9 committee matt]s2 & 7,,iii7 conta9s cle> processes1 su* z recusal f vot+ or discussion1 = ^? memb]s :o report a conflict ( int]e/1 along ) appropriate processes to address any in/ance :]e a memb] fails to report a conflict ( int]e/4 7iii7 ,! memb]%ip ( ! ph>macy & !rapeutics committee-- 7,i7 includes at lea/ #a actively practic+ physician & at lea/ #a actively practic+ ph>maci/1 ea* ( :om-- 7aa7 is indep5d5t & free ( conflict ) respect to manufactur]s & ,m$icaid p>ticipat+ plans or subcontractors1 includ+ ph>macy b5efit manag]s2 & 7bb7 has exp]tise 9 ! c>e ( #a or m ,m$icaid-specific populations su* z eld]ly or disabl$ individuals1 *ildr5 ) complex m$ical ne$s1 or l[-income individuals ) *ronic illnesses2 & 7,,ii7 is made publicly available4 7iv7 ,at ! option ( ! ,/ate1 ! ,/ate's drug use review bo>d e/abli%$ "u subsection 7g77#c7 may s]ve z ! ph>macy & !rapeutics committee provid$ ! ,/ate ensures t su* bo>d meets ! requirem5ts ( clauses 7ii7 & 7iii74 7v7 ,! ,/ate reviews & has f9al approval ( ! =mul>y e/abli%$ by ! ph>macy & !rapeutics committee4 7vi7 ,if ! ,secret>y det]m9es x appropriate or necess>y bas$ on ! f9d+s & recomm5dations ( ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 9 ! report submitt$ to ,congress "u section #bjc ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai1 ! ,secret>y %all issue guidance t ,/ates mu/ foll[ = e/abli%+ conflict ( int]e/ policies = ! ph>macy & !rapeutics committee 9 accordance ) ! requirem5ts ( clause 7ii71 includ+ appropriate /&>ds & requirem5ts = id5tify+1 address+1 & report+ on conflicts ( int]e/4 4 7b7 ,application to ,m$icaid manag$ c>e organizations ,clause 7xiii7 ( section #aijc7m77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a77 is am5d$-- 7#a7 by /rik+ & 7,,iii7 & ins]t+ 7,,iii72 7#b7 by /rik+ ! p]iod at ! end & ins]t+ 1 & 7,,iv7 any =mul>y us$ by ! entity = cov]$ outpati5t drugs disp5s$ to individuals eligible = m$ical assi/ance :o are enroll$ ) ! entity is develop$ & review$ by a ph>macy & !rapeutics committee t meets ! requirem5ts ( clauses 7ii7 & 7iii7 ( section #aibg7;d77#d77;,a742 & 7#c7 by mov+ ! left m>g9 #b ems to ! left4 7c7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #bjc4 ,,gao report on conflicts ( int]e/ 9 ,/ate ,m$icaid program drug use review bo>ds & ph>macy & !rapeutics 7,p,t7 committees 7a7 ,inve/igation ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct an inve/igation ( pot5tial or exi/+ conflicts ( int]e/ among memb]s ( ,/ate ,m$icaid program ,/ate drug use review bo>ds 79 ?is section ref]r$ to z ,,dur ,bo>ds7 & ph>macy & !rapeutics committees 79 ?is section ref]r$ to z ,p,t ,committees74 7b7 ,report ,n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ,congress a report on ! inve/igation conduct$ "u subsection 7a7 t includes ! foll[+3 7#a7 ,a description outl9+ h[ ,,dur ,bo>ds & ,p,t ,committees op]ate 9 ,/ates1 includ+ details ) respect to-- 7,a7 ! /ructure & op]ation ( ,,dur ,bo>ds & /atewide ,p,t ,committees2 7,b7 ,/ates t op]ate sep>ate ,p,t ,committees = _! fee-=-s]vice ,m$icaid program & _! ,m$icaid manag$ c>e organizations or o!r ,m$icaid manag$ c>e arrangem5ts 7collectively ref]r$ to 9 ?is section z ,m$icaid ,m,c,os72 & 7,c7 ,/ates t all[ ,m$icaid ,m,c,os to h _! own ,p,t ,committees & ! ext5t to :i* ph>macy b5efit manag]s adm9i/] or p>ticipate 9 su* ,p,t ,committees4 7#b7 ,a description outl9+ ! diff]5ces betwe5 ,,dur ,bo>ds e/abli%$ 9 accordance ) section #aibg7;g77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr7g77#c77 & ,p,t ,committees4 7#c7 ,a description outl9+ ! tools ,p,t ,committees may use to det]m9e ,m$icaid drug cov]age & utilization managem5t policies4 7#d7 ,an analysis ( :e!r & h[ ,/ates or ,p,t ,committees e/abli% p>ticipation & indep5d5ce requirem5ts = ,,dur ,bo>ds & ,p,t ,committees1 includ+ ) respect to entities ) connections ) drug manufactur]s1 ,/ate ,m$icaid programs1 manag$ c>e organizations1 & o!r entities or individuals 9 ! ph>maceutical indu/ry4 7#e7 ,a description outl9+ h[ ,/ates1 ,,dur ,bo>ds1 or ,p,t ,committees def9e conflicts ( int]e/4 7#f7 ,a description ( h[ ,,dur ,bo>ds & ,p,t ,committees address conflicts ( int]e/1 includ+ :o is responsible = implem5t+ su* policies4 7#g7 ,a description ( ! tools1 if any1 ,/ates use to ensure t !re are no conflicts ( int]e/ on ,,dur ,bo>ds & ,p,t ,committees4 7#h7 ,an analysis ( ! effectiv5ess ( tools ,/ates use to ensure t !re are no conflicts ( int]e/ on ,,dur ,bo>ds & ,p,t ,committees &1 if applicable1 recomm5dations z to h[ su* tools c\ld be improv$4 7#i7 ,a review ( /rategies ,/ates may use to gu>d aga9/ conflicts ( int]e/ on ,,dur ,bo>ds & ,p,t ,committees & to ensure compliance ) ! requirem5ts ( titles ,,xi & ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq41 #acif et seq47 & access to effective1 cl9ically appropriate1 & m$ically necess>y drug treatm5ts = ,m$icaid b5efici>ies1 includ+ recomm5dations = su* legislative & adm9i/rative actions z ! ,comptroll] ,g5]al det]m9es appropriate4 #bjd4 ,ensur+ ! accuracy ( manufactur] price & drug product in=mation "u ! ,m$icaid drug rebate program 7a7 ,audit ( manufactur] price & drug product in=mation 7#a7 ,9 g5]al ,subp>agraph 7,b7 ( section #aibg7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77 is am5d$ to read z foll[s3 7,b7 ,audits & surveys ( manufactur] price & drug product in=mation 7i7 ,audits ,! ,secret>y %all conduct ongo+ audits ( ! price & drug product in=mation report$ by manufactur]s "u subp>agraph 7,a7 = ! mo/ rec5tly end$ rebate p]iod to ensure ! accuracy & timel9ess ( su* in=mation4 ,9 conduct+ su* audits1 ! ,secret>y may employ evaluations1 surveys1 /ati/ical sampl+1 pr$ictive analytics & o!r relevant tools & me?ods4 7ii7 ,v]ifications surveys ( av]age manufactur] price & manufactur]'s av]age sales price ,9 addition to ! audits requir$ "u clause 7i71 ! ,secret>y may survey :olesal]s & manufactur]s 7includ+ manufactur]s t directly di/ribute _! cov]$ outpati5t drugs 79 ?is subp>agraph ref]r$ to z direct sell]s771 :5 necess>y1 to v]ify manufactur] prices & manufactur]'s av]age sales prices 7includ+ :olesale acquisition co/7 to make paym5t report$ "u subp>agraph 7,a74 7iii7 ,p5alties ,9 addition to o!r p5alties z may be prescrib$ by law1 includ+ "u subp>agraph 7,c7 ( ?is p>agraph1 ! ,secret>y may impose a civil monet>y p5alty 9 an am\nt n to exce$ #ahe1jjj on an annual basis on a :olesal]1 manufactur]1 or direct sell]1 if ! :olesal]1 manufactur]1 or direct sell] ( a cov]$ outpati5t drug refuses a reque/ = in=mation ab\t *>ges or prices by ! ,secret>y 9 connection ) an audit or survey "u ?is subp>agraph or kn[+ly provides false in=mation4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is clause 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7iv7 ,reports 7,i7 ,report to ,congress ,! ,secret>y %all1 n lat] ?an #ah mon?s aft] date ( enactm5t ( ?is subp>agraph1 submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance ( ! ,s5ate reg>d+ additional regulatory or /atutory *anges t may be requir$ 9 ord] to ensure accurate & timely report+ & ov]sight ( manufactur] price & drug product in=mation1 includ+ :e!r *anges %\ld be made to reasonable assumption requirem5ts to ensure su* assumptions are reasonable & accurate or :e!r ano!r me?odology = ensur+ accurate & timely report+ ( price & drug product in=mation %\ld be consid]$ to ensure ! integrity ( ! drug rebate program "u ?is section4 7,,ii7 ,annual reports ,! ,secret>y %all1 on at lea/ an annual basis1 submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance ( ! ,s5ate summ>iz+ ! results ( ! audits & surveys conduct$ "u ?is subp>agraph dur+ ! p]iod t is ! subject ( ! report4 7,,iii7 ,cont5t ,ea* report submitt$ "u subclause 7,,ii7 %all1 ) respect to ! p]iod t is ! subject ( ! report1 include summ>ies (-- 7aa7 error rates 9 ! price1 drug product1 & o!r relevant in=mation suppli$ by manufactur]s "u subp>agraph 7,a72 7bb7 ! timel9ess ) :i* manufactur]s1 :olesal]s1 & direct sell]s provide in=mation requir$ "u subp>agraph 7,a7 or "u clause 7i7 or 7ii7 ( ?is subp>agraph2 7cc7 ! numb] ( manufactur]s1 :olesal]s1 & direct sell]s & drug products audit$ "u ?is subp>agraph2 7dd7 ! types ( price & drug product in=mation review$ "u ! audits conduct$ "u ?is subp>agraph2 7ee7 ! tools & me?odologies employ$ 9 su* audits2 7ff7 ! f9d+s ( su* audits1 includ+ :i* manufactur]s1 if any1 7 p5aliz$ "u ?is subp>agraph2 & 7gg7 su* o!r relevant in=mation z ! ,secret>y %all deem appropriate4 7,,iv7 ,protection ( in=mation ,9 prep>+ a report requir$ "u subclause 7,,ii71 ! ,secret>y %all r$act su* propriet>y in=mation z ! ,secret>y det]m9es appropriate to prev5t disclosure (1 & to safegu>d1 su* in=mation4 7v7 ,appropriations ,out ( any funds 9 ! ,treasury n o!rwise appropriat$1 !re is appropriat$ to ! ,secret>y #b1jjj1jjj = fiscal ye> #bjbj & ea* fiscal ye> !reaft] to c>ry out ?is subp>agraph4 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all take effect on ! fir/ day ( ! fir/ fiscal qu>t] t beg9s aft] ! date ( enactm5t ( ?is ,act4 7b7 ,increas$ p5alties = noncompliance ) report+ requirem5ts 7#a7 ,increas$ p5alty = late report+ ( in=mation ,section #aibg7;b77#c77;,c77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,c77i77 is am5d$ by /rik+ increas$ by #aj1jjj = ea* day 9 :i* su* in=mation has n be5 provid$ & su* am\nt %all be paid to ! ,treasury & ins]t+ 1 = ea* cov]$ outpati5t drug ) respect to :i* su* in=mation is n provid$1 #ej1jjj = ! fir/ day t su* in=mation is n provid$ on a timely basis & #ai1jjj = ea* subsequ5t day t su* in=mation is n provid$4 7#b7 ,increas$ p5alty = kn[+ly report+ false in=mation ,section #aibg7;b77#c77;,c77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,c77ii77 is am5d$ by /rik+ #ajj1jjj & ins]t+ #ejj1jjj4 7#c7 ,effective date ,! am5dm5ts made by ?is subsection %all take effect on ! fir/ day ( ! fir/ fiscal qu>t] t beg9s aft] ! date ( enactm5t ( ?is ,act4 #bje4 ,improv+ transp>5cy & prev5t+ ! use ( abusive spread pric+ & relat$ practices 9 ,m$icaid 7a7 ,pass-,?r\gh pric+ requir$ 7#a7 ,9 g5]al ,section #aibg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e77 is am5d$ by add+ at ! end ! foll[+3 7#f7 ,pass-?r\gh pric+ requir$ ,a contract betwe5 ! ,/ate & a ph>macy b5efit manag] 7ref]r$ to 9 ?is p>agraph z a ,,pbm71 or a contract betwe5 ! ,/ate & a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d77 t includes provisions mak+ ! entity responsible = cov]age ( cov]$ outpati5t drugs disp5s$ to individuals enroll$ ) ! entity1 %all require t paym5t = su* drugs & relat$ adm9i/rative s]vices 7z applicable71 includ+ paym5ts made by a ,,pbm on behalf ( ! ,/ate or entity1 is bas$ on a pass-?r\gh pric+ model "u :i*-- 7,a7 any paym5t made by ! entity ( ! ,,pbm 7z applicable7 = su* a drug-- 7i7 is limit$ to-- 7,i7 +r$i5t co/2 & 7,,ii7 a pr(essional disp5s+ fee t is n less ?an ! pr(essional disp5s+ fee t ! ,/ate plan or waiv] w\ld pay if ! plan or waiv] 0 mak+ ! paym5t directly2 7ii7 is pass$ ?r\gh 9 its entirety by ! entity or ,,pbm to ! ph>macy t disp5ses ! drug2 & 7iii7 is made 9 a mann] t is consi/5t ) section #aijb7;a77#cj77;,a7 & sections #ddg4eab1 #ddg4ead1 & #ddg4eah ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation71 z if su* requirem5ts appli$ directly to ! entity or ! ,,pbm2 7,b7 paym5t to ! entity or ! ,,pbm 7z applicable7 = adm9i/rative s]vices p]=m$ by ! entity or ,,pbm is limit$ to a reasonable adm9i/rative fee t cov]s ! reasonable co/ ( provid+ su* s]vices2 7,c7 ! entity or ! ,,pbm 7z applicable7 %all make available to ! ,/ate1 & ! ,secret>y ^u reque/1 all co/s & paym5ts relat$ to cov]$ outpati5t drugs & accompany+ adm9i/rative s]vices incurr$1 receiv$1 or made by ! entity or ! ,,pbm1 includ+ +r$i5t co/s1 pr(essional disp5s+ fees1 adm9i/rative fees1 po/-sale & po/-9-voice fees4 ,disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees1 & any & all remun]ation2 & 7,d7 any =m ( spread pric+ :]eby any am\nt *>g$ or claim$ by ! entity or ! ,,pbm 7z applicable7 is 9 excess ( ! am\nt paid to ! ph>macies on behalf ( ! entity1 includ+ any po/-sale or po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees or assessm5ts 7aft] all[+ = a reasonable adm9i/rative fee z describ$ 9 subp>agraph 7,b77 is n all[able = purposes ( claim+ ,f$]al mat*+ paym5ts "u ?is title4 4 7#b7 ,con=m+ am5dm5t ,clause 7xiii7 ( section #aijc7m77#b77;,a7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a771 z am5d$ by section #bjb1 is fur!r am5d$-- 7,a7 by /rik+ & 7,,iv7 & ins]t+ 7,,iv72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,v7 ph>macy b5efit managem5t s]vices provid$ by ! entity1 or provid$ by a ph>macy b5efit manag] on behalf ( ! entity "u a contract or o!r arrangem5t betwe5 ! entity & ! ph>macy b5efit manag]1 %all comply ) ! requirem5ts ( section #aibg7;e77#f74 7#c7 ,effective date ,! am5dm5ts made by ?is subsection apply to contracts betwe5 ,/ates & manag$ c>e entities1 o!r specifi$ entities1 or ph>macy b5efits manag]s t are ent]$ into or r5ew$ on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7b7 ,survey ( retail prices 7#a7 ,9 g5]al ,section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is am5d$-- 7,a7 by /rik+ & aft] ! semicolon at ! end ( p>agraph 7#a77;,a77i7 & all t prec$es x ?r\gh 7#a7 & ins]t+ ! foll[+3 7#a7 ,survey ( retail prices ,! ,secret>y %all conduct a survey ( retail community drug prices1 to include at lea/ ! national av]age drug acquisition co/1 z foll[s3 7,a7 ,use ( v5dor ,! ,secret>y may contract s]vices =-- 7i7 ) respect to retail community ph>macies1 ! det]m9ation on a mon?ly basis ( retail survey prices ( ! national av]age drug acquisition co/ = cov]$ outpati5t drugs = su* ph>macies1 net ( all disc\nts & rebates 7to ! ext5t any in=mation ) respect to su* disc\nts & rebates is available71 ! av]age reimbursem5t receiv$ = su* drugs by su* ph>macies f all s\rces ( paym5t1 includ+ ?ird p>ties1 &1 to ! ext5t available1 ! usual & cu/om>y *>ges to consum]s = su* drugs2 & 2 7,b7 by add+ at ! end ( p>agraph 7#a7 ! foll[+3 7,f7 ,survey report+ ,9 ord] to meet ! requirem5t ( section #aijb7;a77#ed71 a ,/ate %all require t any retail community ph>macy 9 ! ,/ate t receives any paym5t1 adm9i/rative fee1 disc\nt1 or rebate relat$ to ! disp5s+ ( cov]$ outpati5t drugs to individuals receiv+ b5efits "u ?is title1 reg>dless ( :e!r su* paym5t1 fee1 disc\nt1 or rebate is receiv$ f ! ,/ate or a manag$ c>e entity directly or f a ph>macy b5efit manag] or ano!r entity t has a contract ) ! ,/ate or a manag$ c>e entity1 %all respond to surveys ( retail prices conduct$ "u ?is subsection4 7,g7 ,survey in=mation ,in=mation on retail community prices obta9$ "u ?is p>agraph %all be made publicly available & %all include at lea/ ! foll[+3 7i7 ,! mon?ly response rate ( ! survey includ+ a li/ ( ph>macies n 9 compliance ) subp>agraph 7,f74 7ii7 ,! sampl+ frame & numb] ( ph>macies sampl$ mon?ly4 7iii7 ,*>act]i/ics ( report+ ph>macies1 includ+ type 7su* z indep5d5t or *a971 geographic or regional location1 & disp5s+ volume4 7iv7 ,report+ ( a sep>ate national av]age drug acquisition co/ = ea* drug = indep5d5t retail ph>macies & *a9 op]at$ ph>macies4 7v7 ,in=mation on price concessions includ+ on & (f invoice disc\nts1 rebates1 & o!r price concessions4 7vi7 ,in=mation on av]age pr(essional disp5s+ fees paid4 7,h7 ,p5alties 7i7 ,failure to provide timely in=mation ,a retail community ph>macy t fails to respond to a survey conduct$ "u ?is subsection on a timely basis may be subject to a civil monet>y p5alty 9 ! am\nt ( #aj1jjj = ea* day 9 :i* su* in=mation has n be5 provid$4 7ii7 ,false in=mation ,a retail community ph>macy t kn[+ly provides false in=mation 9 response to a survey conduct$ "u ?is subsection may be subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 7iii7 ,o!r p5alties ,any civil money p5alties impos$ "u ?is subp>agraph %all be 9 addition to o!r p5alties z may be prescrib$ by law4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+s "u section #aabh;,a7a74 7,i7 ,report on specialty ph>macies 7i7 ,9 g5]al ,n lat] ?an #a ye> aft] ! effective date ( ?is subp>agraph1 ! ,secret>y %all submit a report to ,congress exam9+ specialty drug cov]age & reimbursem5t "u ?is title4 7ii7 ,cont5t ( report ,su* report %all include a description ( h[ ,/ate ,m$icaid programs def9e specialty drugs1 h[ mu* ,/ate ,m$icaid programs pay = specialty drugs1 h[ ,/ates & manag$ c>e plans det]m9e paym5t = specialty drugs1 ! sett+s 9 :i* specialty drugs are disp5s$ 7su* z retail community ph>macies or specialty ph>macies71 :e!r acquisition co/s = specialty drugs are captur$ 9 ! national av]age drug acquisition co/ survey1 & recomm5dations z to :e!r specialty ph>macies %\ld be includ$ 9 ! survey ( retail prices to ensure national av]age drug acquisition co/s capture drugs sold at specialty ph>macies & h[ su* specialty ph>macies %\ld be def9$4 2 7,c7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ 1 includ+ paym5ts rates "u ,m$icaid manag$ c>e plans1 aft] "u ?is title2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ & ! basis = su* disp5s+ fees be=e ! semicolon2 & 7,d7 9 p>agraph 7#d71 by ins]t+ 1 & #e1jjj1jjj = fiscal ye> #bjbj & ea* fiscal ye> !reaft]1 aft] #bjaj4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection take effect on ! #a/ day ( ! #a/ qu>t] t beg9s on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7c7 ,manufactur] report+ ( :olesale acquisition co/ ,section #aibg7;b77#c7 ( su* ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c771 z am5d$ by section #ada1 is fur!r am5d$-- 7#a7 9 subp>agraph 7,a77i7-- 7,a7 9 subclause 7,i71 by /rik+ & aft] ! semicolon2 7,b7 9 subclause 7,,ii71 by add+ & aft] ! semicolon2 7,c7 by mov+ ! left m>g9s ( subclauses 7,i7 & 7,,ii7 #b ems to ! "r2 & 7,d7 by add+ at ! end ! foll[+3 7,,iii7 9 ! case ( rebate p]iods t beg9 on or aft] ! date ( enactm5t ( ?is subclause1 on ! :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 = cov]$ outpati5t drugs = ! rebate p]iod "u ! agreem5t 7includ+ = all su* drugs t are sold "u a new drug application approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act72 2 & 7#b7 9 subp>agraph 7,d7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ & clause 7vii7 ( ?is subp>agraph aft] #ahdg;,a2 7,b7 9 clause 7vi71 by /rik+ & aft] ! comma2 7,c7 9 clause 7vii71 by /rik+ ! p]iod & ins]t+ 1 &2 & 7,d7 by ins]t+ aft] clause 7vii7 ! foll[+3 7viii7 to ! ,secret>y to disclose 7?r\gh a website accessible to ! public7 ! mo/ rec5tly report$ :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 = ea* cov]$ outpati5t drug 7includ+ = all su* drugs t are sold "u a new drug application approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 z report$ "u subp>agraph 7,a77i77,,iii74 4 #bjf4 ,t-,,msis drug data analytics reports 7a7 ,9 g5]al ,n lat] ?an ,may #a ( ea* cal5d> ye> beg9n+ ) cal5d> ye> #bjba1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all publi% on a website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices t is accessible to ! public a report ( ! mo/ rec5tly available data on provid] prescrib+ patt]ns "u ! ,m$icaid program4 7b7 ,cont5t ( report 7#a7 ,requir$ cont5t ,ea* report requir$ "u subsection 7a7 = a cal5d> ye> %all include ! foll[+ in=mation ) respect to ea* ,/ate 7&1 to ! ext5t available1 ) respect to ,pu]to ,rico1 ! ,unit$ ,/ates ,virg9 ,isl&s1 ,guam1 ! ,nor!rn ,m>iana ,isl&s1 & ,am]ican ,samoa73 7,a7 ,a comp>ison ( cov]$ outpati5t drug 7z def9$ 9 section #aibg7k77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#b777 prescrib+ patt]ns "u ! ,/ate ,m$icaid plan or waiv] ( su* plan 7includ+ drugs prescrib$ on a fee-=-s]vice basis & drugs prescrib$ "u manag$ c>e arrangem5ts "u su* plan or waiv]7-- 7i7 across all =ms or models ( reimbursem5t us$ "u ! plan or waiv]2 7ii7 )9 specialties & subspecialties1 z def9$ by ! ,secret>y2 7iii7 by episodes ( c>e =-- 7,i7 ea* *ronic disease category1 z def9$ by ! ,secret>y1 t is repres5t$ 9 ! #aj conditions t acc\nt$ = ! greate/ %>e ( total sp5d+ "u ! plan or waiv] dur+ ! ye> t is ! subject ( ! report2 7,,ii7 proc$ural gr\p+s2 & 7,,iii7 r>e disease diagnosis codes2 7iv7 by pati5t demographic *>act]i/ics1 includ+ race 7to ! ext5t t ! ,secret>y det]m9es t !re is suffici5t data available ) respect to su* *>act]i/ic 9 a majority ( ,/ates71 g5d]1 & age2 7v7 by pati5t high-utiliz] or risk /atus2 & 7vi7 by high & l[ res\rce sett+s by facility & place ( s]vice categories1 z det]m9$ by ! ,secret>y4 7,b7 ,9 ! case ( m$ical assi/ance = cov]$ outpati5t drugs 7z s def9$7 provid$ "u a ,/ate ,m$icaid plan or waiv] ( su* plan 9 a manag$ c>e sett+1 an analysis ( ! diff]5ces 9 manag$ c>e prescrib+ patt]ns :5 a cov]$ outpati5t drug is prescrib$ 9 a manag$ c>e sett+ z comp>$ to :5 ! drug is prescrib$ 9 a fee-=-s]vice sett+4 7#b7 ,additional cont5t ,a report requir$ "u subsection 7a7 = a cal5d> ye> may include ,/ate-specific in=mation ab\t prescription utilization managem5t tools "u ,/ate ,m$icaid plans or waiv]s ( su* plans1 includ+-- 7,a7 a description ( prescription utilization managem5t tools "u ,/ate programs to provide long-t]m s]vices & supports "u a ,/ate ,m$icaid plan or a waiv] ( su* plan2 7,b7 a comp>ison ( prescription utilization managem5t tools applicable to populations cov]$ "u a ,/ate ,m$icaid plan waiv] "u section #aaae ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae7 & ! models applicable to populations t are n cov]$ "u ! waiv]2 7,c7 a comp>ison ( ! prescription utilization managem5t tools employ$ by diff]5t ,m$icaid manag$ c>e organizations1 ph>macy b5efit manag]s1 & relat$ entities )9 ! ,/ate2 7,d7 a comp>ison ( ! prescription utilization managem5t tools applicable to ea* enrollm5t category "u a ,/ate ,m$icaid plan or waiv]2 & 7,e7 a comp>ison ( ! prescription utilization managem5t tools applicable "u ! ,/ate ,m$icaid plan or waiv] by pati5t high-utiliz] or risk /atus4 7#c7 ,additional analysis ,to ! ext5t practicable1 ! ,secret>y %all include 9 ea* report publi%$ "u subsection 7a7-- 7,a7 analyses ( national1 ,/ate1 & local patt]ns ( ,m$icaid population-bas$ prescrib+ behaviors2 & 7,b7 recomm5dations = adm9i/rative or legislative action to improve ! effectiv5ess (1 & r$uce co/s =1 cov]$ outpati5t drugs "u ,m$icaid :ile ensur+ timely b5efici>y access to m$ically necess>y cov]$ outpati5t drugs4 7c7 ,use ( ,t-,,msis data ,ea* report requir$ "u subsection 7a7 %all-- 7#a7 be prep>$ us+ data & def9itions f ! ,trans=m$ ,m$icaid ,/ati/ical ,in=mation ,sy/em 7,t-,,msis7 data set 7or a successor data set7 t is n m ?an #bd mon?s old on ! date t ! report is publi%$2 & 7#b7 z appropriate1 include a description ) respect to ea* ,/ate ( ! quality & complet5ess ( ! data1 z well z any necess>y caveats describ+ ! limitations ( ! data report$ to ! ,secret>y by ! ,/ate t are suffici5t to communicate ! appropriate uses = ! in=mation4 7d7 ,prep>ation ( report ,ea* report requir$ "u subsection 7a7 %all be prep>$ by ! ,adm9i/rator = ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7e7 ,appropriation ,= fiscal ye> #bjbj & ea* fiscal ye> !reaft]1 !re is appropriat$ to ! ,secret>y #b1jjj1jjj to c>ry out ?is section4 #bjg4 ,risk-%>+ value-bas$ paym5t agreem5ts = cov]$ outpati5t drugs "u ,m$icaid 7a7 ,9 g5]al ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7l7 ,/ate option ,to pay = cov]$ outpati5t drugs ?r\gh risk-,%>+ value-,bas$ agreem5ts 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbb1 a ,/ate %all h ! option to pay 7:e!r on a fee-=-s]vice or manag$ c>e basis7 = cov]$ outpati5t drugs t are pot5tially curative treatm5ts int5d$ = "o-"t use t are adm9i/]$ to individuals "u ?is title by ent]+ into a risk-%>+ value-bas$ paym5t agreem5t ) ! manufactur] ( ! drug 9 accordance ) ! requirem5ts ( ?is subsection4 7#b7 ,secret>ial approval 7,a7 ,9 g5]al ,a ,/ate %all submit a reque/ to ! ,secret>y to ent] into a risk-%>+ value bas$ paym5t agreem5t1 & ! ,secret>y %all n approve a propos$ risk-%>+ value-bas$ paym5t agreem5t betwe5 a ,/ate & a manufactur] = paym5t = a cov]$ outpati5t drug ( ! manufactur] unless ! foll[+ requirem5ts are met3 7i7 ,manufactur] is p>ty to rebate agreem5t & 9 compliance ) requirem5ts ,! manufactur] has a rebate agreem5t 9 effect z requir$ "u subsections 7a7 & 7b7 ( ?is section & is 9 compliance ) all applicable requirem5ts "u ?is title4 7ii7 ,no increase to project$ net ,f$]al sp5d+ 7,i7 ,9 g5]al ,! ,*ief ,actu>y c]tifies t ! project$ paym5ts = ea* cov]$ outpati5t drug "u su* propos$ agreem5t w\ld n result 9 great] e/imat$ ,f$]al sp5d+ "u ?is title ?an ! net ,f$]al sp5d+ t w\ld result 9 ! abs5ce ( ! agreem5t4 7,,ii7 ,net f$]al sp5d+ def9$ ,= purposes ( ?is subsection1 ! t]m net ,f$]al sp5d+ means ! am\nt ( ,f$]al paym5ts ! ,*ief ,actu>y e/imates w\ld be made "u ?is title = adm9i/]+ a cov]$ outpati5t drug to an individual eligible = m$ical assi/ance "u a ,/ate plan or a waiv] ( su* plan1 r$uc$ by ! am\nt ( all rebates ! ,*ief ,actu>y e/imates w\ld be paid ) respect to ! adm9i/]+ ( su* drug1 includ+ all rebates "u ?is title & any supplem5tal or o!r additional rebates1 9 ! abs5ce ( su* an agreem5t4 7,,iii7 ,in=mation ,! ,*ief ,actu>y %all make ! c]tifications requir$ "u ?is clause bas$ on ! mo/ rec5tly available & reliable drug pric+ & product in=mation4 ,! ,/ate & manufactur] %all provide ! ,secret>y & ! ,*ief ,actu>y ) all necess>y in=mation requir$ to make ! e/imates ne$$ = su* c]tifications4 7iii7 ,laun* & li/ price ju/ifications ,! manufactur] submits all relevant in=mation & support+ docum5tation necess>y = pric+ decisions z deem$ appropriate by ! ,secret>y1 :i* %all be tru?ful & non-mislead+1 includ+ manufactur] in=mation & support+ docum5tation = laun* price or li/ price increases1 & any applicable ju/ification requir$ "u section #aabh,l4 7iv7 ,confid5tiality ( in=mation2 p5alties ,! provisions ( subp>agraphs 7,c7 & 7,d7 ( subsection 7b77#c7 %all apply to a manufactur] t fails to submit ! in=mation & docum5tation requir$ "u clauses 7ii7 & 7iii7 on a timely basis1 or t kn[+ly provides false or mislead+ in=mation1 9 ! same mann] z su* provisions apply to a manufactur] ) a rebate agreem5t "u ?is section4 7,b7 ,consid]ation ( ,/ate reque/ = approval 7i7 ,9 g5]al ,! ,secret>y %all treat a ,/ate reque/ = approval ( a risk-%>+ value-bas$ paym5t agreem5t 9 ! same mann] t ! ,secret>y treats a ,/ate plan am5dm5t1 & subp>t ,b ( "p #dcj ( title #db1 ,code ( ,f$]al ,regulations1 includ+1 subject to clause 7ii71 ! tim+ requirem5ts ( section #dcj4af ( su* title 7z 9 effect on ! date ( enactm5t ( ?is subsection71 %all apply to a reque/ = approval ( a risk-%>+ value-bas$ paym5t agreem5t 9 ! same mann] z su* subp>t applies to a ,/ate plan am5dm5t4 7ii7 ,tim+ ,! ,secret>y %all consult ) ! ,commission] ( ,food & ,drugs z requir$ "u subp>agraph 7,c7 & make a det]m9ation on :e!r to approve a reque/ f a ,/ate = approval ( a propos$ risk-%>+ value-bas$ paym5t agreem5t 7or reque/ additional in=mation necess>y to all[ ! ,secret>y to make a det]m9ation ) respect to su* reque/ = approval7 )9 ! "t p]iod1 to ! ext5t practicable1 specifi$ 9 section #dcj4af ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ?is subsection71 b 9 no case %all ! ,secret>y take m ?an #ahj days aft] ! receipt ( su* reque/ = approval or response to su* reque/ = additional in=mation to make su* a det]m9ation 7or reque/ additional in=mation74 7,c7 ,consultation ) ! ,commission] ( ,food & ,drugs ,9 consid]+ :e!r to approve a risk-%>+ value-bas$ paym5t agreem5t1 ! ,secret>y1 to ! ext5t necess>y1 %all consult ) ! ,commission] ( ,food & ,drugs to det]m9e :e!r ! relevant cl9ical p>amet]s specifi$ 9 su* agreem5t are appropriate4 7#c7 ,in/allm5t-bas$ paym5t /ructure 7,a7 ,9 g5]al ,a risk-%>+ value-bas$ paym5t agreem5t %all provide = a paym5t /ructure "u :i*1 = e in/allm5t ye> ( ! agreem5t 7subject to subp>agraph 7,b771 ! ,/ate %all pay ! total in/allm5t ye> am\nt 9 equal in/allm5ts to be paid at regul> int]vals ov] a p]iod ( "t t %all be specifi$ 9 ! agreem5t4 7,b7 ,requirem5ts = in/allm5t paym5ts 7i7 ,tim+ ( fir/ paym5t ,! ,/ate %all make ! fir/ ( ! in/allm5t paym5ts describ$ 9 subp>agraph 7,a7 = an in/allm5t ye> n lat] ?an #cj days aft] ! end ( su* ye>4 7ii7 ,l5g? ( in/allm5t p]iod ,! p]iod ( "t ov] :i* ! ,/ate %all make ! in/allm5t paym5ts describ$ 9 subp>agraph 7,a7 = an in/allm5t ye> %all n be long] ?an #e ye>s4 7iii7 ,nonpaym5t or r$uc$ paym5t ( in/allm5ts foll[+ a failure to meet cl9ical p>amet] ,if1 prior to ! paym5t date 7z specifi$ 9 ! agreem5t7 ( any in/allm5t paym5t describ$ 9 subp>agraph 7,a7 or any o!r alt]native date or "t frame 7z o!rwise specifi$ 9 ! agreem5t71 ! cov]$ outpati5t drug :i* is subject to ! agreem5t fails to meet a relevant cl9ical p>amet] ( ! agreem5t1 ! agreem5t %all provide t-- 7,i7 ! in/allm5t paym5t %all n be made2 or 7,,ii7 ! in/allm5t paym5t %all be r$uc$ by a p]c5tage specifi$ 9 ! agreem5t t is bas$ on ! outcome a*iev$ by ! drug relative to ! relevant cl9ical p>amet]4 7#d7 ,notice ( int5t 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 a manufactur] ( a cov]$ outpati5t drug %all n be eligible to ent] into a risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection ) respect to su* drug unless ! manufactur] notifies ! ,secret>y t ! manufactur] is int]e/$ 9 ent]+ into su* an agreem5t ) respect to su* drug4 ,! decision to submit & tim+ ( a reque/ to ent] into a propos$ risk-%>+ value-bas$ paym5t agreem5t %all rema9 solely )9 ! discretion ( ! ,/ate & %all only be effective ^u ,secret>ial approval z requir$ "u ?is subsection4 7,b7 ,treatm5t ( subsequ5tly approv$ drugs 7i7 ,9 g5]al ,9 ! case ( a manufactur] ( a cov]$ outpati5t drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act aft] ! date ( enactm5t ( ?is subsection1 n m ?an #ij days aft] meet+ ) ! ,food & ,drug ,adm9i/ration foll[+ phase ,,ii cl9ical trials = su* drug 7or1 9 ! case ( a drug describ$ 9 clause 7ii71 n lat] ?an ,m>* #ca1 #bjbb71 ! manufactur] mu/ notify ! ,secret>y ( ! manufactur]'s int5t to ent] into a risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection ) respect to su* drug4 ,if no su* meet+ has occurr$1 ! ,secret>y may use discretion z to :e!r a pot5tially curative treatm5t int5d$ = "o-"t use may qualify = a risk-%>+ value-bas$ paym5t agreem5t "u ?is section4 ,a manufactur] notification ( int]e/ %all n h any influ5ce on a decision = approval by ! ,food & ,drug ,adm9i/ration4 7ii7 ,application to c]ta9 subsequ5tly approv$ drugs ,a drug describ$ 9 ?is clause is a cov]$ outpati5t drug ( a manufactur]-- 7,i7 t is approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act aft] ! date ( enactm5t ( ?is subsection2 & 7,,ii7 ) respect to :i*1 z ( ,janu>y #a1 #bjbb1 m ?an #ij days h pass$ aft] ! manufactur]'s meet+ ) ! ,food & ,drug ,adm9i/ration foll[+ phase ,,ii cl9ical trials = su* drug4 7iii7 ,p>allel approval ,! ,secret>y1 9 coord9ation ) ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,commission] ( ,food & ,drugs1 %all1 to ! ext5t practicable1 approve a ,/ate's reque/ to ent] into a propos$ risk-%>+ value-bas$ paym5t agreem5t t o!rwise meets ! requirem5ts ( ?is subsection at ! "t t su* a drug is approv$ by ! ,food & ,drug ,adm9i/ration to help provide t no ,/ate t wi%es to ent] into su* an agreem5t is requir$ to pay = ! drug 9 full at "o "t if ! ,/ate is seek+ to pay ov] a p]iod ( "t z outl9$ 9 ! propos$ agreem5t4 7iv7 ,rule ( con/ruction ,no?+ 9 ?is p>agraph %all be appli$ or con/ru$ to modify or affect ! timeframes or factors involv$ 9 ! ,secret>y's det]m9ation ( :e!r to approve or lic5se a drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act4 7#e7 ,special paym5t rules 7,a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is p>agraph1 ) respect to an individual :o is adm9i/]$ a unit ( a cov]$ outpati5t drug t is pur*as$ "u a ,/ate plan by a ,/ate ,m$icaid ag5cy "u a risk-%>+ value-bas$ paym5t agreem5t 9 an in/allm5t ye>1 ! ,/ate %all rema9 liable to ! manufactur] ( su* drug = paym5t = su* unit )\t reg>d to :e!r ! individual rema9s enroll$ 9 ! ,/ate plan "u ?is title 7or a waiv] ( su* plan7 = ea* in/allm5t ye> = :i* ! ,/ate is to make in/allm5t paym5ts = cov]$ outpati5t drugs pur*as$ "u ! agreem5t 9 su* ye>4 7,b7 ,dea? ,9 ! case ( an individual describ$ 9 subp>agraph 7,a7 :o dies dur+ ! p]iod describ$ 9 su* subp>agraph1 ! ,/ate plan %all n be liable = any rema9+ paym5t = ! unit ( ! cov]$ outpati5t drug adm9i/]$ to ! individual :i* is ow$ "u ! agreem5t describ$ 9 su* subp>agraph4 7,c7 ,)drawal ( approval ,9 ! case ( a cov]$ outpati5t drug t is ! subject ( a risk-%>+ value-bas$ agreem5t betwe5 a ,/ate & a manufactur] "u ?is subsection1 includ+ a drug approv$ 9 accordance ) section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & su* drug is ! subject ( an application t has be5 )drawn by ! ,secret>y1 ! ,/ate plan %all n be liable = any rema9+ paym5t t is ow$ "u ! agreem5t4 7,d7 ,alt]native arrangem5t "u agreem5t ,subject to approval by ! ,secret>y1 ! t]ms ( a propos$ risk-%>+ value-bas$ paym5t agreem5t submitt$ = approval by a ,/ate may provide t subp>agraph 7,a7 %all n apply4 7,e7 ,guidance ,n lat] ?an ,janu>y #a1 #bjbb1 ! ,secret>y %all issue guidance to ,/ates e/abli%+ a process = ,/ates to notify ! ,secret>y :5 an individual :o is adm9i/]$ a unit ( a cov]$ outpati5t drug t is pur*as$ by a ,/ate plan "u a risk-%>+ value-bas$ paym5t agreem5t ceases to be enroll$ "u ! ,/ate plan "u ?is title 7or a waiv] ( su* plan7 or dies be=e ! end ( ! in/allm5t p]iod applicable to su* unit "u ! agreem5t4 7#f7 ,treatm5t ( paym5ts "u risk-%>+ value-bas$ agreem5ts = purposes ( av]age manufactur] price2 be/ price ,! ,secret>y %all treat any paym5ts made to ! manufactur] ( a cov]$ outpati5t drug "u a risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection dur+ a rebate p]iod 9 ! same mann] t ! ,secret>y treats paym5ts made "u a ,/ate supplem5tal rebate agreem5t "u sections #ddg4ejd7;c77#ai7 & #ddg4eje7;c77#g7 ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations71 = purposes ( det]m9+ av]age manufactur] price & be/ price "u ?is section ) respect to ! cov]$ outpati5t drug & a rebate p]iod & = purposes ( (fsets requir$ "u subsection 7b77#a77;,b74 7#g7 ,assessm5ts & report to ,congress 7,a7 ,assessm5ts 7i7 ,9 g5]al ,n lat] ?an #ahj days aft] ! end ( ea* assessm5t p]iod ( any risk-%>+ value-bas$ paym5t agreem5t = a ,/ate approv$ "u ?is subsection1 ! ,secret>y %all conduct an evaluation ( su* agreem5t :i* %all include an evaluation by ! ,*ief ,actu>y to det]m9e :e!r program sp5d+ "u ! risk-%>+ value-bas$ paym5t agreem5t align$ ) ! projections = ! agreem5t made "u p>agraph 7#b77;,a77ii71 includ+ an assessm5t ( :e!r actual ,f$]al sp5d+ "u ?is title "u ! agreem5t 0 less or m ?an net ,f$]al sp5d+ w\ld h be5 9 ! abs5ce ( ! agreem5t4 7ii7 ,assessm5t p]iod ,= purposes ( clause 7i7-- 7,i7 ! fir/ assessm5t p]iod = a risk-%>+ value-bas$ paym5t agreem5t %all be ! p]iod ( "t ov] :i* paym5ts are s*$ul$ to be made "u ! agreem5t = ! fir/ #aj individuals :o are adm9i/]$ cov]$ outpati5t drugs "u ! agreem5t except t su* p]iod %all n exce$ ! #e-ye> p]iod aft] ! date on :i* ! ,secret>y approves ! agreem5t2 & 7,,ii7 ea* subsequ5t assessm5t p]iod = a risk-%>+ value-bas$ paym5t agreem5t %all be ! #e-ye> p]iod foll[+ ! end ( ! previ\s assessm5t p]iod4 7,b7 ,results ( assessm5ts 7i7 ,t]m9ation option ,if ! ,secret>y det]m9es z a result ( ! assessm5t by ! ,*ief ,actu>y "u subp>agraph 7,a7 t ! actual ,f$]al sp5d+ "u ?is title = any cov]$ outpati5t drug t 0 ! subject ( ! ,/ate's risk-%>+ value-bas$ paym5t agreem5t 0 great] ?an ! net ,f$]al sp5d+ t w\ld h result$ 9 ! abs5ce ( ! agreem5t1 ! ,secret>y may t]m9ate approval ( su* agreem5t & %all imm$iately conduct an assessm5t "u ?is p>agraph ( any o!r ongo+ risk-%>+ value-bas$ paym5t agreem5t to :i* ! same manufactur] is a p>ty4 7ii7 ,repaym5t requir$ 7,i7 ,9 g5]al ,if ! ,secret>y det]m9es z a result ( ! assessm5t by ! ,*ief ,actu>y "u subp>agraph 7,a7 t ! ,f$]al sp5d+ "u ! risk-%>+ value-bas$ agreem5t = a cov]$ outpati5t drug t 0 subject to su* agreem5t 0 great] ?an ! net ,f$]al sp5d+ t w\ld h result$ 9 ! abs5ce ( ! agreem5t1 ! manufactur] %all repay ! diff]5ce to ! ,/ate & ,f$]al gov]nm5ts 9 a timely mann] z det]m9$ by ! ,secret>y4 7,,ii7 ,t]m9ation = failure to pay ,! failure ( a manufactur] to make repaym5ts requir$ "u subclause 7,i7 9 a timely mann] %all result 9 imm$iate t]m9ation ( all risk-%>+ value-bas$ agreem5ts to :i* ! manufactur] is a p>ty4 7,,iii7 ,additional p5alties ,9 ! case ( a manufactur] t fails to make repaym5ts requir$ "u subclause 7,i71 ! ,secret>y may treat su* manufactur] 9 ! same mann] z a manufactur] t fails to pay requir$ rebates "u ?is section1 & ! ,secret>y may-- 7aa7 susp5d or t]m9ate ! manufactur]'s rebate agreem5t "u ?is section2 & 7bb7 pursue any o!r rem$y t w\ld be available if ! manufactur] _h fail$ to pay requir$ rebates "u ?is section4 7,c7 ,report to ,congress ,n lat] ?an #e ye>s aft] ! fir/ risk-%>+ value-bas$ paym5t agreem5t is approv$ "u ?is subsection1 ! ,secret>y %all submit to ,congress & make available to ! public a report t includes-- 7i7 an assessm5t ( ! impact ( risk-%>+ value-bas$ paym5t agreem5ts on access = individuals :o are eligible = b5efits "u a ,/ate plan or waiv] "u ?is title to m$ically necess>y cov]$ outpati5t drugs & relat$ treatm5ts2 7ii7 an analysis ( ! impact ( su* agreem5ts on ov]all ,/ate & ,f$]al sp5d+ "u ?is title2 7iii7 an assessm5t ( ! impact ( su* agreem5ts on drug prices1 includ+ laun* price & price increases2 & 7iv7 su* recomm5dations to ,congress z ! ,secret>y deems appropriate4 7#h7 ,guidance & regulations 7,a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbb1 ! ,secret>y %all issue guidance to ,/ates seek+ to ent] into risk-%>+ value-bas$ paym5t agreem5ts "u ?is subsection t includes a model template = su* agreem5ts4 ,! ,secret>y may issue any additional guidance or promulgate regulations z necess>y to implem5t & en=ce ! provisions ( ?is subsection4 7,b7 ,model agreem5ts 7i7 ,9 g5]al ,if a ,/ate expresses an int]e/ 9 pursu+ a risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection ) a manufactur] = ! pur*ase ( a cov]$ outpati5t drug1 ! ,secret>y may %>e ) su* ,/ate any risk-%>+ value-bas$ agreem5t betwe5 a ,/ate & ! manufactur] = ! pur*ase ( su* drug t has be5 approv$ "u ?is subsection4 ,:ile su* %>$ agreem5t may s]ve z a template = a ,/ate t wi%es to propose1 ! use ( a previ\sly approv$ agreem5t %all n affect ! submission & approval process = approval ( a propos$ risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection1 includ+ ! requirem5ts "u p>agraph 7#b77;,a74 7ii7 ,confid5tiality ,9 ! case ( a risk-%>+ value-bas$ paym5t agreem5t t is disclos$ to a ,/ate by ! ,secret>y "u ?is subp>agraph & t is only 9 effect ) respect to a s+le ,/ate1 ! confid5tiality ( in=mation provisions describ$ 9 subsection 7b77#c77;,d7 %all apply to su* in=mation4 7,c7 ,,oig consultation 7i7 ,9 g5]al ,! ,secret>y %all consult ) ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices to det]m9e :e!r !re are pot5tial program integrity conc]ns ) agreem5t approvals or templates & address accord+ly4 7ii7 ,,oig policy updates z necess>y ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all review & update1 z necess>y1 any policies or guidel9es ( ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,human ,s]vices 7includ+ policies relat$ to ! en=cem5t ( section #aabh;,b7 to accommodate ! use ( risk-%>+ value-bas$ paym5t agreem5ts 9 accordance ) ?is section4 7#i7 ,rules ( con/ruction 7,a7 ,modifications ,no?+ 9 ?is subsection or any regulations promulgat$ "u ?is subsection %all prohibit a ,/ate f reque/+ a modification f ! ,secret>y to ! t]ms ( a risk-%>+ value-bas$ paym5t agreem5t4 ,a modification t is expect$ to result 9 any increase to project$ net ,/ate or ,f$]al sp5d+ "u ! agreem5t %all be subject to rec]tification by ! ,*ief ,actu>y z describ$ 9 p>agraph 7#b77;,a77ii7 be=e ! modification may be approv$4 7,b7 ,rebate agreem5ts ,no?+ 9 ?is subsection %all be con/ru$ z requir+ a ,/ate to ent] into a risk-%>+ value-bas$ paym5t agreem5t or z limit+ or sup]s$+ ! ability ( a ,/ate to ent] into a supplem5tal rebate agreem5t = a cov]$ outpati5t drug4 7,c7 ,,ffp = paym5ts "u risk-%>+ value-bas$ paym5t agreem5ts ,f$]al f9ancial p>ticipation %all be available "u ?is title = any paym5t made by a ,/ate to a manufactur] = a cov]$ outpati5t drug "u a risk-%>+ value-bas$ paym5t agreem5t 9 accordance ) ?is subsection1 except t no ,f$]al f9ancial p>ticipation %all be available = any paym5t made by a ,/ate to a manufactur] "u su* an agreem5t on & aft] ! effective date ( a disapproval ( su* agreem5t by ! ,secret>y4 7,d7 ,cont9u$ application ( o!r provisions ,except z expressly provid$ 9 ?is subsection1 no?+ 9 ?is subsection or 9 any regulations promulgat$ "u ?is subsection %all affect ! application ( any o!r provision ( ?is ,act4 7#aj7 ,appropriations ,= fiscal ye> #bjbj & ea* fiscal ye> !reaft]1 !re are appropriat$ to ! ,secret>y #e1jjj1jjj = ! purpose ( c>ry+ out ?is subsection4 7#aa7 ,def9itions ,9 ?is subsection3 7,a7 ,*ief ,actu>y ,! t]m ,*ief ,actu>y means ! ,*ief ,actu>y ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7,b7 ,in/allm5t ye> ,! t]m in/allm5t ye> means1 ) respect to a risk-%>+ value-bas$ paym5t agreem5t1 a #ab-mon? p]iod dur+ :i* a cov]$ outpati5t drug is adm9i/]$ "u ! agreem5t4 7,c7 ,pot5tially curative treatm5t int5d$ = "o-"t use ,! t]m pot5tially curative treatm5t int5d$ = "o-"t use means a treatm5t t consi/s ( ! adm9i/ration ( a cov]$ outpati5t drug t-- 7i7 is a =m ( g5e !rapy = a r>e disease1 z def9$ by ! ,commission] ( ,food & ,drugs1 designat$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetics ,act1 & approv$ "u section #eje ( su* ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act to treat a s]i\s or life-?reat5+ disease or condition2 7ii7 if adm9i/]$ 9 accordance ) ! label+ ( su* drug1 is expect$ to result 9 ei!r-- 7,i7 ! cure ( su* disease or condition2 or 7,,ii7 a r$uction 9 ! symptoms ( su* disease or condition to ! ext5t t su* disease or condition is n expect$ to lead to e>ly mortality2 & 7iii7 is expect$ to a*ieve a result describ$ 9 clause 7ii71 :i* may be a*iev$ ov] an ext5d$ p]iod ( "t1 aft] n m ?an #c adm9i/rations4 7,d7 ,relevant cl9ical p>amet] ,! t]m relevant cl9ical p>amet] means1 ) respect to a cov]$ outpati5t drug t is ! subject ( a risk-%>+ value-bas$ paym5t agreem5t-- 7i7 a cl9ical endpo9t specifi$ 9 ! drug's label+ or support$ by "o or m ( ! comp5dia describ$ 9 section #ahfa7t77#b77;,b77ii77,i7 t-- 7,i7 is able to be measur$ or evaluat$ on an annual basis = ea* ye> ( ! agreem5t on an indep5d5t basis by a provid] or o!r entity2 & 7,,ii7 is requir$ to be a*iev$ 7bas$ on obs]v$ metrics 9 pati5t populations7 "u ! t]ms ( ! agreem5t2 or 7ii7 a surrogate endpo9t 7z def9$ 9 section #ejg7;e77#i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 includ+ ^? develop$ by pati5t-focus$ drug developm5t tools1 t-- 7,i7 is able to be measur$ or evaluat$ on an annual basis = ea* ye> ( ! agreem5t on an indep5d5t basis by a provid] or o!r entity2 & 7,,ii7 has be5 qualifi$ by ! ,food & ,drug ,adm9i/ration4 7,e7 ,risk-%>+ value-bas$ paym5t agreem5t ,! t]m risk-%>+ value-bas$ paym5t agreem5t means an agreem5t betwe5 a ,/ate plan & a manufactur]-- 7i7 = ! pur*ase ( a cov]$ outpati5t drug ( ! manufactur] t is a pot5tially curative treatm5t int5d$ = "o-"t use2 7ii7 "u :i* paym5t = su* drug %all be made pursuant to an in/allm5t-bas$ paym5t /ructure t meets ! requirem5ts ( p>agraph 7#c72 7iii7 :i* conditions paym5t on ! a*ievem5t ( at lea/ #b relevant cl9ical p>amet]s 7z def9$ 9 subp>agraph 7,c772 7iv7 :i* provides t-- 7,i7 ! ,/ate plan w directly reimburse ! manufactur] = ! drug2 or 7,,ii7 a ?ird p>ty w reimburse ! manufacture 9 a mann] approv$ by ! ,secret>y2 & 7v7 is approv$ by ! ,secret>y 9 accordance ) p>agraph 7#b74 7,f7 ,total in/allm5t ye> am\nt ,! t]m total in/allm5t ye> am\nt means1 ) respect to a risk-%>+ value-bas$ paym5t agreem5t = ! pur*ase ( a cov]$ outpati5t drug & an in/allm5t ye>1 an am\nt equal to ! product (-- 7i7 ! unit price ( ! drug *>g$ "u ! agreem5t2 & 7ii7 ! numb] ( units ( su* drug adm9i/]$ "u ! agreem5t dur+ su* in/allm5t ye>4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #aijc7;i77#aj77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#aj77;,a77 is am5d$ by /rik+ or unless section #aibg7;a77#c7 applies & ins]t+ 1 section #aibg7;a77#c7 applies ) respect to su* drugs1 or su* drugs are ! subject ( a risk-%>+ value-bas$ paym5t agreem5t "u section #aibg7l74 7#b7 ,section #aibg7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77 is am5d$-- 7,a7 9 p>agraph 7#a77;,a71 by ins]t+ 7except = drugs = :i* paym5t is made by a ,/ate "u a risk-%>+ value-bas$ paym5t agreem5t "u subsection 7l77 aft] "u ! ,/ate plan = su* p]iod2 & 7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,c77i71 by ins]t+ or subsection 7l77#b77;,a7 aft] subp>agraph 7,a72 & 7ii7 9 subp>agraph 7,d71 9 ! matt] prec$+ clause 7i71 by ins]t+ 1 "u subsection 7l77#b77;,a71 aft] "u ?is p>agraph4 #bjh4 ,apply+ ,m$icaid drug rebate requirem5t to drugs provid$ z "p ( outpati5t hospital s]vices 7a7 ,9 g5]al ,section #aibg7k77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#c77 is am5d$ to read z foll[s3 7#c7 ,limit+ def9ition 7,a7 ,9 g5]al ,! t]m cov]$ outpati5t drug does n include any drug1 biological product1 or insul9 provid$ z "p (1 or z incid5t to & 9 ! same sett+ z1 any ( ! foll[+ 7& = :i* paym5t may be made "u ?is title z "p ( paym5t = ! foll[+ & n z direct reimbursem5t = ! drug73 7i7 ,inpati5t hospital s]vices4 7ii7 ,hospice s]vices4 7iii7 ,d5tal s]vices1 except t drugs = :i* ! ,/ate plan au?orizes direct reimbursem5t to ! disp5s+ d5ti/ are cov]$ outpati5t drugs4 7iv7 ,physicians' s]vices4 7v7 ,outpati5t hospital s]vices4 7vi7 ,nurs+ facility s]vices & s]vices provid$ by an int]m$iate c>e facility = ! m5tally ret>d$4 7vii7 ,o!r laboratory & x-ray s]vices4 7viii7 ,r5al dialysis4 7,b7 ,o!r exclusions ,su* t]m also does n include any su* drug or product = :i* a ,national ,drug ,code numb] is n requir$ by ! ,food & ,drug ,adm9i/ration or a drug or biological us$ = a m$ical indication :i* is n a m$ically accept$ indication4 7,c7 ,/ate option ,at ! option ( a ,/ate1 su* t]m may include any drug1 biological product1 or insul9 = :i* ! ,/ate is ! prim>y pay] "u ?is title or a demon/ration project conc]n+ ?is title1 & t is provid$ on an outpati5t basis z "p (1 or z incid5t to & 9 ! same sett+ z1 describ$ 9 clause 7iv7 or 7v7 ( subp>agraph 7,a7 & = :i* paym5t is made z "p ( paym5t = su* s]vices4 7,d7 ,no effect on be/ price ,any drug1 biological product1 or insul9 exclud$ f ! def9ition ( su* t]m z a result ( ?is p>agraph %all be treat$ z a cov]$ outpati5t drug = purposes ( det]m9+ ! be/ price 7z def9$ 9 subsection 7c77#a77;,c77 = su* drug1 biological product1 or insul94 4 7b7 ,effective date2 implem5tation guidance 7#a7 ,9 g5]al ,! am5dm5t made by subsection 7a7 %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 7#b7 ,implem5tation & guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance & relevant in=mational bullet9s = ,/ates1 manufactur]s 7z def9$ 9 section #aibg7k77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#e7771 & o!r relevant /akehold]s1 includ+ heal? c>e provid]s1 reg>d+ implem5tation ( ! am5dm5t made by subsection 7a74 ,,iii ,food & ,drug ,adm9i/ration ,a ,,creates ,act #cja4 ,actions = delays ( g5]ic drugs & biosimil> biological products 7a7 ,def9itions ,9 ?is section-- 7#a7 ! t]m comm]cially reasonable1 m>ket-bas$ t]ms means-- 7,a7 a nondiscrim9atory price = ! sale ( ! cov]$ product at or bel[1 b n great] ?an1 ! mo/ rec5t :olesale acquisition co/ = ! drug1 z def9$ 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 7,b7 a s*$ule = deliv]y t results 9 ! transf] ( ! cov]$ product to ! eligible product develop] consi/5t ) ! tim+ "u subsection 7b77#b77;,a77iv72 & 7,c7 no additional conditions are impos$ on ! sale ( ! cov]$ product2 7#b7 ! t]m cov]$ product-- 7,a7 means-- 7i7 any drug approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any comb9ation ( a drug or biological product describ$ 9 clause 7i72 or 7iii7 :5 reasonably necess>y to support approval ( an application "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 z applicable1 or o!rwise meet ! requirem5ts = approval "u ei!r su* section1 any product1 includ+ any device1 t is m>ket$ or int5d$ = use ) su* a drug or biological product2 & 7,b7 does n include any drug or biological product t appe>s on ! drug %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless-- 7i7 ! drug or biological product has be5 on ! drug %ortage li/ 9 effect "u su* section #ejf;,e cont9u\sly = m ?an #f mon?s2 or 7ii7 ! ,secret>y det]m9es t inclusion ( ! drug or biological product z a cov]$ product is likely to contribute to alleviat+ or prev5t+ a %ortage2 7#c7 ! t]m device has ! mean+ giv5 ! t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#d7 ! t]m eligible product develop] means a p]son t seeks to develop a product = approval pursuant to an application = approval "u subsection 7b77#b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or = lic5s+ pursuant to an application "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 7#e7 ! t]m lic5se hold] means ! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or ! hold] ( a lic5se "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = a cov]$ product2 7#f7 ! t]m ,,rems means a risk evaluation & mitigation /rategy "u section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 ! t]m ,,rems ) ,,etasu means a ,,rems t conta9s elem5ts to assure safe use "u section #eje-a7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 7#h7 ! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices2 7#i7 ! t]m s+le1 %>$ sy/em ( elem5ts to assure safe use means a s+le1 %>$ sy/em ( elem5ts to assure safe use "u section #eje-a7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 & 7#aj7 ! t]m suffici5t quantities means an am\nt ( a cov]$ product t ! eligible product develop] det]m9es all[s x to-- 7,a7 conduct te/+ to support an application "u-- 7i7 subsection 7b77#b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 & 7,b7 fulfill any regulatory requirem5ts relat+ to approval ( su* an application4 7b7 ,civil action = failure ,to provide suffici5t quantities ( a cov]$ product 7#a7 ,9 g5]al ,an eligible product develop] may br+ a civil action aga9/ ! lic5se hold] = a cov]$ product seek+ relief "u ?is subsection 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates alleg+ t ! lic5se hold] has decl9$ to provide suffici5t quantities ( ! cov]$ product to ! eligible product develop] on comm]cially reasonable1 m>ket-bas$ t]ms4 7#b7 ,elem5ts 7,a7 ,9 g5]al ,to prevail 9 a civil action br\ght "u p>agraph 7#a71 an eligible product develop] %all prove1 by a prepond]ance ( ! evid5ce-- 7i7 t-- 7,i7 ! cov]$ product is n subject to a ,,rems ) ,,etasu2 or 7,,ii7 if ! cov]$ product is subject to a ,,rems ) ,,etasu-- 7aa7 ! eligible product develop] has obta9$ a cov]$ product au?orization f ! ,secret>y 9 accordance ) subp>agraph 7,b72 & 7bb7 ! eligible product develop] has provid$ a copy ( ! cov]$ product au?orization to ! lic5se hold]2 7ii7 t1 z ( ! date on :i* ! civil action is fil$1 ! product develop] has n obta9$ suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms2 7iii7 t ! eligible product develop] has submitt$ a writt5 reque/ to pur*ase suffici5t quantities ( ! cov]$ product to ! lic5se hold] & su* reque/-- 7,i7 0 s5t to a nam$ corporate (fic] ( ! lic5se hold]2 7,,ii7 0 made by c]tifi$ or regi/]$ mail ) return receipt reque/$2 7,,iii7 specifi$ an individual z ! po9t ( contact = ! lic5se hold] to direct communications relat$ to ! sale ( ! cov]$ product to ! eligible product develop] & a means = electronic & writt5 communications ) t individual2 & 7,,iv7 specifi$ an address to :i* ! cov]$ product 0 to be %ipp$ ^u rea*+ an agreem5t to transf] ! cov]$ product2 & 7iv7 t ! lic5se hold] has n deliv]$ to ! eligible product develop] suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms-- 7,i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 by ! date t is #ca days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product2 & 7,,ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 by #ca days aft] ! lat] (-- 7aa7 ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product2 or 7bb7 ! date on :i* ! lic5se hold] receiv$ a copy ( ! cov]$ product au?orization issu$ by ! ,secret>y 9 accordance ) subp>agraph 7,b74 7,b7 ,au?orization = cov]$ product subject to a rems ) etasu 7i7 ,reque/ ,an eligible product develop] may submit to ! ,secret>y a writt5 reque/ = ! eligible product develop] to be au?oriz$ to obta9 suffici5t quantities ( an individual cov]$ product subject to a ,,rems ) ,,etasu4 7ii7 ,au?orization ,n lat] ?an #abj days aft] ! date on :i* a reque/ "u clause 7i7 is receiv$1 ! ,secret>y %all1 by writt5 notice1 au?orize ! eligible product develop] to obta9 suffici5t quantities ( an individual cov]$ product subject to a ,,rems ) ,,etasu = purposes (-- 7,i7 developm5t & te/+ t does n involve human cl9ical trials1 if ! eligible product develop] has agre$ to comply ) any conditions ! ,secret>y det]m9es necess>y2 or 7,,ii7 developm5t & te/+ t involves human cl9ical trials1 if ! eligible product develop] has-- 7aa7 7,,aa7 submitt$ protocols1 in=m$ cons5t docum5ts1 & in=mational mat]ials = te/+ t include protections t provide safety protections comp>able to ^? provid$ by ! ,,rems = ! cov]$ product2 or 7,,bb7 o!rwise satisfi$ ! ,secret>y t su* protections w be provid$2 & 7bb7 met any o!r requirem5ts ! ,secret>y may e/abli%4 7iii7 ,notice ,a cov]$ product au?orization issu$ "u ?is subp>agraph %all /ate t ! provision ( ! cov]$ product by ! lic5se hold] "u ! t]ms ( ! au?orization w n be a violation ( ! ,,rems = ! cov]$ product4 7#c7 ,affirmative def5se ,9 a civil action br\ght "u p>agraph 7#a71 x %all be an affirmative def5se1 on :i* ! def5dant has ! burd5 ( p]suasion by a prepond]ance ( ! evid5ce-- 7,a7 t1 on ! date on :i* ! eligible product develop] reque/$ to pur*ase suffici5t quantities ( ! cov]$ product f ! lic5se hold]-- 7i7 nei!r ! lic5se hold] nor any ( its ag5ts1 :olesal]s1 or di/ributors 0 engag$ 9 ! manufactur+ or comm]cial m>ket+ ( ! cov]$ product2 & 7ii7 nei!r ! lic5se hold] nor any ( its ag5ts1 :olesal]s1 or di/ributors o!rwise _h access to inv5tory ( ! cov]$ product to supply to ! eligible product develop] on comm]cially reasonable1 m>ket-bas$ t]ms2 7,b7 t-- 7i7 ! lic5se hold] sells ! cov]$ product ?r\gh ag5ts1 di/ributors1 or :olesal]s2 7ii7 ! lic5se hold] has plac$ no re/rictions1 explicit or implicit1 on its ag5ts1 di/ributors1 or :olesal]s to sell cov]$ products to eligible product develop]s2 & 7iii7 ! cov]$ product c be pur*as$ by ! eligible product develop] 9 suffici5t quantities on comm]cially reasonable1 m>ket-bas$ t]ms f ! ag5ts1 di/ributors1 or :olesal]s ( ! lic5se hold]2 or 7,c7 t ! lic5se hold] made an (f] to ! individual specifi$ pursuant to p>agraph 7#b77;,a77iii77,,iii71 by a means ( communication 7electronic1 writt51 or bo?7 specifi$ pursuant to su* p>agraph1 to sell suffici5t quantities ( ! cov]$ product to ! eligible product develop] at comm]cially reasonable m>ket-bas$ t]ms-- 7i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 by ! date t is #ad days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product1 & ! eligible product develop] did n accept su* (f] by ! date t is #g days aft] ! date on :i* ! eligible product develop] receiv$ su* (f] f ! lic5se hold]2 or 7ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 by ! date t is #bj days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product1 & ! eligible product develop] did n accept su* (f] by ! date t is #aj days aft] ! date on :i* ! eligible product develop] receiv$ su* (f] f ! lic5se hold]4 7#d7 ,rem$ies 7,a7 ,9 g5]al ,if an eligible product develop] prevails 9 a civil action br\ght "u p>agraph 7#a71 ! c\rt %all-- 7i7 ord] ! lic5se hold] to provide to ! eligible product develop] )\t delay suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms2 7ii7 aw>d to ! eligible product develop] reasonable attorney's fees & co/s ( ! civil action2 & 7iii7 aw>d to ! eligible product develop] a monet>y am\nt suffici5t to det] ! lic5se hold] f fail+ to provide eligible product develop]s ) suffici5t quantities ( a cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms1 if ! c\rt f9ds1 by a prepond]ance ( ! evid5ce-- 7,i7 t ! lic5se hold] delay$ provid+ suffici5t quantities ( ! cov]$ product to ! eligible product develop] )\t a legitimate bus9ess ju/ification2 or 7,,ii7 t ! lic5se hold] fail$ to comply ) an ord] issu$ "u clause 7i74 7,b7 ,maximum monet>y am\nt ,a monet>y am\nt aw>d$ "u subp>agraph 7,a77iii7 %all n be great] ?an ! rev5ue t ! lic5se hold] e>n$ on ! cov]$ product dur+ ! p]iod-- 7i7 beg9n+ on-- 7,i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 ! date t is #ca days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/2 or 7,,ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 ! date t is #ca days aft] ! lat] (-- 7aa7 ! date on :i* ! lic5se hold] receiv$ ! reque/2 or 7bb7 ! date on :i* ! lic5se hold] receiv$ a copy ( ! cov]$ product au?orization issu$ by ! ,secret>y 9 accordance ) p>agraph 7#b77;,b72 & 7ii7 end+ on ! date on :i* ! eligible product develop] receiv$ suffici5t quantities ( ! cov]$ product4 7,c7 ,avoidance ( delay ,! c\rt may issue an ord] "u subp>agraph 7,a77i7 be=e conduct+ fur!r proce$+s t may be necess>y to det]m9e :e!r ! eligible product develop] is entitl$ to an aw>d "u clause 7ii7 or 7iii7 ( subp>agraph 7,a71 or ! am\nt ( any su* aw>d4 7c7 ,limitation ( liability ,a lic5se hold] = a cov]$ product %all n be liable = any claim "u ,f$]al1 ,/ate1 or local law aris+ out ( ! failure ( an eligible product develop] to foll[ adequate safegu>ds to assure safe use ( ! cov]$ product dur+ developm5t or te/+ activities describ$ 9 ?is section1 includ+ transportation1 h&l+1 use1 or disposal ( ! cov]$ product by ! eligible product develop]4 7d7 ,no violation ( ,,rems ,section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7l7 ,provision ( samples n a violation ( /rategy ,! provision ( samples ( a cov]$ product to an eligible product develop] 7z ^? t]ms are def9$ 9 section #cja7;a7 ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai7 %all n be consid]$ a violation ( ! requirem5ts ( any risk evaluation & mitigation /rategy t may be 9 place "u ?is section = su* drug4 4 7e7 ,rule ( con/ruction 7#a7 ,def9ition ,9 ?is subsection1 ! t]m antitru/ laws-- 7,a7 has ! mean+ giv5 ! t]m 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab72 & 7,b7 includes section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t su* section applies to unfair me?ods ( competition4 7#b7 ,antitru/ laws ,no?+ 9 ?is section %all be con/ru$ to limit ! op]ation ( any provision ( ! antitru/ laws4 #cjb4 ,,rems approval process = subsequ5t fil]s ,section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 z am5d$ by section #cja1 is fur!r am5d$-- 7#a7 9 subsection 7g77#d77;,b7-- 7,a7 9 clause 7i7 by /rik+ or aft] ! semicolon2 7,b7 9 clause 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+3 7iii7 accommodate diff]5t1 comp>able aspects ( ! elem5ts to assure safe use = a drug t is ! subject ( an application "u section #eje7;j71 & ! applicable li/$ drug4 2 7#b7 9 subsection 7i77#a71 by /rik+ subp>agraph 7,c7 & ins]t+ ! foll[+3 7,c7 7i7 ,elem5ts to assure safe use1 if requir$ "u subsection 7f7 = ! li/$ drug1 :i*1 subject to clause 7ii71 = a drug t is ! subject ( an application "u section #eje7;j7 may use-- 7,i7 a s+le1 %>$ sy/em ) ! li/$ drug "u subsection 7f72 or 7,,ii7 a diff]5t1 comp>able aspect ( ! elem5ts to assure safe use "u subsection 7f74 7ii7 ,! ,secret>y may require a drug t is ! subject ( an application "u section #eje7;j7 & ! li/$ drug to use a s+le1 %>$ sy/em "u subsection 7f71 if ! ,secret>y det]m9es t no diff]5t1 comp>able aspect ( ! elem5ts to assure safe use c\ld satisfy ! requirem5ts ( subsection 7f74 2 7#c7 9 subsection 7i71 by add+ at ! end ! foll[+3 7#c7 ,%>$ rems ,if ! ,secret>y approves1 9 accordance ) p>agraph 7#a77;,c77i77,,ii71 a diff]5t1 comp>able aspect ( ! elem5ts to assure safe use "u subsection 7f7 = a drug t is ! subject ( an abbreviat$ new drug application "u section #eje7;j71 ! ,secret>y may require t su* diff]5t comp>able aspect ( ! elem5ts to assure safe use c be us$ ) respect to any o!r drug t is ! subject ( an application "u section #eje7;j7 or #eje7;b7 t ref]5ces ! same li/$ drug4 2 & 7#d7 by add+ at ! end ! foll[+3 7m7 ,sep>ate ,,rems ,:5 us$ 9 ?is section1 ! t]ms diff]5t1 comp>able aspect ( ! elem5ts to assure safe use or diff]5t1 comp>able approv$ risk evaluation & mitigation /rategies means a risk evaluation & mitigation /rategy = a drug t is ! subject ( an application "u section #eje7;j7 t uses diff]5t me?ods or op]ational means ?an ! /rategy requir$ "u subsection 7a7 = ! applicable li/$ drug1 or o!r application "u section #eje7;j7 ) ! same su* li/$ drug1 b a*ieves ! same level ( safety z su* /rategy4 4 #cjc4 ,rule ( con/ruction 7a7 ,9 g5]al ,no?+ 9 ?is subtitle1 ! am5dm5ts made by ?is subtitle1 or 9 section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 %all be con/ru$ z-- 7#a7 prohibit+ a lic5se hold] f provid+ an eligible product develop] access to a cov]$ product 9 ! abs5ce ( an au?orization "u ?is subtitle2 or 7#b7 9 any way negat+ ! applicability ( a ,,rems ) ,,etasu1 z o!rwise requir$ "u su* section #eje-a1 ) respect to su* cov]$ product4 7b7 ,def9itions ,9 ?is section1 ! t]ms cov]$ product1 eligible product develop]1 lic5se hold]1 & ,,rems ) ,,etasu h ! mean+s giv5 su* t]ms 9 section #cja7;a74 ,b ,pay-=-,delay #caa4 ,unlawful agreem5ts 7a7 ,agreem5ts prohibit$ ,subject to subsections 7b7 & 7c71 x %all be unlawful = an ,,nda or ,,bla hold] & a subsequ5t fil] 7or = two subsequ5t fil]s7 to ent] into1 or c>ry out1 an agreem5t resolv+ or settl+ a cov]$ pat5t infr+em5t claim on a f9al or int]im basis if "u su* agreem5t-- 7#a7 a subsequ5t fil] directly or indirectly receives f su* hold] 7or 9 ! case ( su* an agreem5t betwe5 two subsequ5t fil]s1 ! o!r subsequ5t fil]7 any?+ ( value1 includ+ a lic5se2 & 7#b7 ! subsequ5t fil] agrees to limit or =ego rese>* on1 or developm5t1 manufactur+1 m>ket+1 or sales1 = any p]iod ( "t1 ( ! cov]$ product t is ! subject ( ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7g77#h74 7b7 ,exclusion ,x %all n be unlawful "u subsection 7a7 if a p>ty to an agreem5t describ$ 9 su* subsection demon/rates by cle> & conv9c+ evid5ce t ! value describ$ 9 subsection 7a77#a7 is comp5sation solely = o!r goods or s]vices t ! subsequ5t fil] has promis$ to provide4 7c7 ,limitation ,no?+ 9 ?is section %all prohibit an agreem5t resolv+ or settl+ a cov]$ pat5t infr+em5t claim 9 :i* ! consid]ation grant$ by ! ,,nda or ,,bla hold] to ! subsequ5t fil] 7or f "o subsequ5t fil] to ano!r7 z "p ( ! resolution or settlem5t includes only "o or m ( ! foll[+3 7#a7 ,! "r to m>ket ! cov]$ product t is ! subject ( ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7g77#h7 9 ! ,unit$ ,/ates be=e ! expiration (-- 7,a7 any pat5t t is ! basis ( ! cov]$ pat5t infr+em5t claim2 or 7,b7 any pat5t "r or o!r /atutory exclusivity t w\ld prev5t ! m>ket+ ( su* cov]$ product4 7#b7 ,a paym5t = reasonable litigation exp5ses n to exce$ #g1ejj1jjj 9 ! aggregate4 7#c7 ,a cov5ant n to sue on any claim t su* cov]$ product infr+es a pat5t4 7d7 ,en=cem5t by ,f$]al ,trade ,commission 7#a7 ,g5]al application ,! requirem5ts ( ?is section apply1 accord+ to _! t]ms1 to an ,,nda or ,,bla hold] or subsequ5t fil] t is-- 7,a7 a p]son1 p>tn]%ip1 or corporation ov] :i* ! ,commission has au?ority pursuant to section #e7;a77#b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#b772 or 7,b7 a p]son1 p>tn]%ip1 or corporation ov] :i* ! ,commission w\ld h au?ority pursuant to su* section b = ! fact t su* p]son1 p>tn]%ip1 or corporation is n organiz$ to c>ry on bus9ess = its own pr(it or t ( its memb]s4 7#b7 ,unfair or deceptive acts or practices en=cem5t au?ority 7,a7 ,9 g5]al ,a violation ( ?is section %all be treat$ z an unfair or deceptive act or practice 9 violation ( section #e7;a77#a7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a774 7,b7 ,p[]s ( ,commission ,except z provid$ 9 subp>agraph 7,c7 & p>agraphs 7#a77;,b7 & 7#c7-- 7i7 ! ,commission %all en=ce ?is section 9 ! same mann]1 by ! same means1 & ) ! same jurisdiction1 p[]s1 & duties z ?\gh all applicable t]ms & provisions ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 7 incorporat$ into & made a "p ( ?is section2 & 7ii7 any ,,nda or ,,bla hold] or subsequ5t fil] t violates ?is section %all be subject to ! p5alties & entitl$ to ! privileges & immunities provid$ 9 ! ,f$]al ,trade ,commission ,act4 7,c7 ,judicial review ,9 ! case ( a cease & desi/ ord] issu$ by ! ,commission "u section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 = violation ( ?is section1 a p>ty to su* ord] may obta9 judicial review ( su* ord] z provid$ 9 su* section #e1 except t-- 7i7 su* review may only be obta9$ 9-- 7,i7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia ,circuit2 7,,ii7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! circuit 9 :i* ! ultimate p>5t entity1 z def9$ 9 section #hja4a7;a77#c7 ( title #af1 ,code ( ,f$]al ,regulations1 or any successor !reto1 ( ! ,,nda or ,,bla hold] 7if any su* hold] is a p>ty to su* ord]7 is incorporat$ z ( ! date t ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7g77#h7 or an approv$ application t is deem$ to be a lic5se = a biological product "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji 7,public ,law #aaa-adh2 #abd ,/at4 #hag7 is submitt$ to ! ,commission] ( ,food & ,drugs2 or 7,,iii7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! circuit 9 :i* ! ultimate p>5t entity1 z s def9$1 ( any subsequ5t fil] t is a p>ty to su* ord] is incorporat$ z ( ! date t ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7g77#h7 is submitt$ to ! ,commission] ( ,food & ,drugs2 & 7ii7 ! petition = review %all be fil$ 9 ! c\rt n lat] ?an #cj days aft] su* ord] is s]v$ on ! p>ty seek+ review4 7#c7 ,additional en=cem5t au?ority 7,a7 ,civil p5alty ,! ,commission may comm5ce a civil action to recov] a civil p5alty 9 a di/rict c\rt ( ! ,unit$ ,/ates aga9/ any ,,nda or ,,bla hold] or subsequ5t fil] t violates ?is section4 7,b7 ,special rule = recov]y ( p5alty if cease & desi/ ord] issu$ 7i7 ,9 g5]al ,if ! ,commission has issu$ a cease & desi/ ord] 9 a proce$+ "u section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 = violation ( ?is section-- 7,i7 ! ,commission may comm5ce a civil action "u subp>agraph 7,a7 to recov] a civil p5alty aga9/ any p>ty to su* ord] at any "t be=e ! expiration ( ! #a-ye> p]iod beg9n+ on ! date on :i* su* ord] becomes f9al "u section #e7;g7 ( su* ,act 7#ae ,u4,s4,c4 #de7;g772 & 7,,ii7 9 su* civil action1 ! f9d+s ( ! ,commission z to ! mat]ial facts 9 su* proce$+ %all be conclusive1 unless-- 7aa7 ! t]ms ( su* ord] expressly provide t ! ,commission's f9d+s %all n be conclusive2 or 7bb7 su* ord] became f9al by reason ( section #e7;g77#a7 ( su* ,act 7#ae ,u4,s4,c4 #de7;g77#a771 9 :i* case su* f9d+s %all be conclusive if support$ by evid5ce4 7ii7 ,relation%ip to p5alty = violation ( an ord] ,! p5alty provid$ 9 clause 7i7 = violation ( ?is section is sep>ate f & 9 addition to any p5alty t may be incurr$ = violation ( an ord] ( ! ,commission "u section #e7l7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7l774 7,c7 ,am\nt ( p5alty 7i7 ,9 g5]al ,! am\nt ( a civil p5alty impos$ 9 a civil action "u subp>agraph 7,a7 on a p>ty to an agreem5t describ$ 9 subsection 7a7 %all be suffici5t to det] violations ( ?is section1 b 9 no ev5t great] ?an-- 7,i7 if su* p>ty is ! ,,nda or ,,bla hold] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 ! subsequ5t fil] :o gave ! value describ$ 9 subsection 7a77#a771 ! great] (-- 7aa7 #c times ! value receiv$ by su* ,,nda or ,,bla hold] 7or by su* subsequ5t fil]7 t is reasonably attributable to ! violation ( ?is section2 or 7bb7 #c times ! value giv5 to ! subsequ5t fil] 7or to ! o!r subsequ5t fil]7 reasonably attributable to ! violation ( ?is section2 & 7,,ii7 if su* p>ty is ! subsequ5t fil] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 ! subsequ5t fil] :o receiv$ ! value describ$ 9 subsection 7a77#a771 #c times ! value receiv$ by su* subsequ5t fil] t is reasonably attributable to ! violation ( ?is section4 7ii7 ,factors = consid]ation ,9 det]m9+ su* am\nt1 ! c\rt %all take into acc\nt-- 7,i7 ! nature1 circum/ances1 ext5t1 & gravity ( ! violation2 7,,ii7 ) respect to ! violator1 ! degree ( culpability1 any hi/ory ( violations1 ! ability to pay1 any effect on ! ability to cont9ue do+ bus9ess1 pr(its e>n$ by ! ,,nda or ,,bla hold] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 ! subsequ5t fil] :o gave ! value describ$ 9 subsection 7a77#a771 comp5sation receiv$ by ! subsequ5t fil] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 ! subsequ5t fil] :o receiv$ ! value describ$ 9 subsection 7a77#a771 & ! am\nt ( comm]ce affect$2 & 7,,iii7 o!r matt]s t ju/ice requires4 7,d7 ,injunctions & o!r equitable relief ,9 a civil action "u subp>agraph 7,a71 ! ,unit$ ,/ates di/rict c\rts are emp[]$ to grant m&atory injunctions & su* o!r & fur!r equitable relief z !y deem appropriate4 7#d7 ,rem$ies 9 addition ,rem$ies provid$ 9 ?is subsection are 9 addition to1 & n 9 lieu (1 any o!r rem$y provid$ by ,f$]al law4 7#e7 ,pres]vation ( au?ority ( ,commission ,no?+ 9 ?is section %all be con/ru$ to affect any au?ority ( ! ,commission "u any o!r provision ( law4 7e7 ,f$]al ,trade ,commission rulemak+ ,! ,commission may1 9 its discretion1 by rule promulgat$ "u section #eec ( title #e1 ,unit$ ,/ates ,code1 exempt f ?is section c]ta9 agreem5ts describ$ 9 subsection 7a7 if ! ,commission f9ds su* agreem5ts to be 9 fur!rance ( m>ket competition & = ! b5efit ( consum]s4 7f7 ,antitru/ laws ,no?+ 9 ?is section %all modify1 impair1 limit1 or sup]s$e ! applicability ( ! antitru/ laws z def9$ 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 & ( section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t su* section #e applies to unfair me?ods ( competition4 ,no?+ 9 ?is section %all modify1 impair1 limit1 or sup]s$e ! "r ( a subsequ5t fil] to ass]t claims or c\nt]claims aga9/ any p]son1 "u ! antitru/ laws or o!r laws relat+ to unfair competition4 7g7 ,def9itions ,9 ?is section3 7#a7 ,agreem5t resolv+ or settl+ a cov]$ pat5t infr+em5t claim ,! t]m agreem5t resolv+ or settl+ a cov]$ pat5t infr+em5t claim means any agreem5t t-- 7,a7 resolves or settles a cov]$ pat5t infr+em5t claim2 or 7,b7 is cont+5t ^u1 provides = a cont+5t condition =1 or is o!rwise relat$ to ! resolution or settlem5t ( a cov]$ pat5t infr+em5t claim4 7#b7 ,commission ,! t]m ,commission means ! ,f$]al ,trade ,commission4 7#c7 ,cov]$ pat5t infr+em5t claim ,! t]m cov]$ pat5t infr+em5t claim means an allegation made by ! ,,nda or ,,bla hold] to a subsequ5t fil] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 by "o subsequ5t fil] to ano!r71 :e!r or n includ$ 9 a compla9t fil$ ) a c\rt ( law1 t-- 7,a7 ! submission ( ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#i71 or ! manufacture1 use1 (f]+ = sale1 sale1 or importation into ! ,unit$ ,/ates ( a cov]$ product t is ! subject ( su* an application-- 7i7 9 ! case ( an agreem5t betwe5 an ,,nda or ,,bla hold] & a subsequ5t fil]1 infr+es any pat5t own$ by1 or exclusively lic5s$ to1 ! ,,nda or ,,bla hold] ( ! cov]$ product2 or 7ii7 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 infr+es any pat5t own$ by ! subsequ5t fil]2 or 7,b7 9 ! case ( an agreem5t betwe5 an ,,nda or ,,bla hold] & a subsequ5t fil]1 ! cov]$ product to be manufactur$ "u su* application uses a cov]$ product z claim$ 9 a publi%$ pat5t application4 7#d7 ,cov]$ product ,! t]m cov]$ product means a drug 7z def9$ 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g7771 includ+ a biological product 7z def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i7774 7#e7 ,,nda or ,,bla hold] ,! t]m ,,nda or ,,bla hold] means-- 7,a7 ! hold] (-- 7i7 an approv$ new drug application fil$ "u section #eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 = a cov]$ product2 or 7ii7 a biologics lic5se application fil$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 ) respect to a biological product2 7,b7 a p]son own+ or controll+ en=cem5t ( ! pat5t on-- 7i7 ! li/ publi%$ "u section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 9 connection ) ! application describ$ 9 subp>agraph 7,a77i72 or 7ii7 any li/ publi%$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 compris$ ( pat5ts associat$ ) biologics lic5se applications fil$ "u section #cea7;a7 ( su* ,act 7#db ,u4,s4,c4 #bfb7;a772 or 7,c7 ! pr$ecessors1 subsidi>ies1 divisions1 gr\ps1 & affiliates controll$ by1 controll+1 or "u common control ) any entity describ$ 9 subp>agraph 7,a7 or 7,b7 7su* control to be presum$ by direct or indirect %>e own]%ip ( #ej p]c5t or great]71 z well z ! lic5sees1 lic5sors1 successors1 & assigns ( ea* ( ! entities4 7#f7 ,pat5t ,! t]m pat5t means a pat5t issu$ by ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice4 7#g7 ,/atutory exclusivity ,! t]m /atutory exclusivity means ^? prohibitions on ! submission or approval ( drug applications "u clauses 7ii7 ?r\gh 7iv7 ( section #eje7;c77#c77;,e7 7#e- & #c-ye> exclusivity71 clauses 7ii7 ?r\gh 7iv7 ( section #eje7;j77#e77;,f7 7#e-ye> & #c-ye> exclusivity71 section #eje7;j77#e77;,b77iv7 7#ahj-;day exclusivity71 section #ebg 7orphan drug exclusivity71 section #eje;,a 7p$iatric exclusivity71 or section #eje;,e 7qualifi$ infecti\s disease product exclusivity7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e71 #cee7;j77#e77;,b77iv71 #cee7;j77#e77;,f71 #cfj;cc1 #cee;a1 #cee;f71 or prohibitions on ! submission or lic5s+ ( biologics lic5se applications "u section #cea7k77#f7 7int]*angeable biological product exclusivity7 or section #cea7k77#g7 7biological product ref]5ce product exclusivity7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#f71 7#g774 7#h7 ,subsequ5t fil] ,! t]m subsequ5t fil] means-- 7,a7 9 ! case ( a drug1 a p>ty t owns or controls an abbreviat$ new drug application submitt$ pursuant to section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or a new drug application submitt$ pursuant to section #eje7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b77 & fil$ "u section #eje7;b77#a7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or has ! exclusive rights to di/ribute ! cov]$ product t is ! subject ( su* application2 or 7,b7 9 ! case ( a biological product1 a p>ty t owns or controls an application fil$ ) ! ,food & ,drug ,adm9i/ration "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 or has ! exclusive rights to di/ribute ! biological product t is ! subject ( su* application4 7h7 ,effective date ,?is section applies ) respect to agreem5ts describ$ 9 subsection 7a7 ent]$ into on or aft] ! date ( ! enactm5t ( ?is ,act4 #cab4 ,notice & c]tification ( agreem5ts 7a7 ,notice ( all agreem5ts ,section #aaaa7g7 ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7#ba ,u4,s4,c4 #cee note7 is am5d$ by ins]t+ or ! own] ( a pat5t = :i* a claim ( infr+em5t c\ld reasonably be ass]t$ aga9/ any p]son = mak+1 us+1 (f]+ to sell1 sell+1 or import+ into ! ,unit$ ,/ates a biological product t is ! subject ( a biosimil> biological product application be=e ! p]iod at ! end4 7b7 ,c]tification ( agreem5ts ,section #aaab ( su* ,act 7#ba ,u4,s4,c4 #cee note7 is am5d$ by add+ at ! end ! foll[+3 7d7 ,c]tification ,! ,*ief ,executive ,(fic] or ! company (ficial responsible = negotiat+ any agreem5t "u subsection 7a7 or 7b7 t is requir$ to be fil$ "u subsection 7c7 %all1 )9 #cj days ( su* fil+1 execute & file ) ! ,assi/ant ,attorney ,g5]al & ! ,commission a c]tification z foll[s3 ,i decl>e t ! foll[+ is true1 correct1 & complete to ! be/ ( my k3 ,! mat]ials fil$ ) ! ,f$]al ,trade ,commission & ! ,dep>tm5t ( ,ju/ice "u section #aaab ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc1 ) respect to ! agreem5t ref]5c$ 9 ?is c]tification-- 7#a7 repres5t ! complete1 f9al1 & exclusive agreem5t betwe5 ! p>ties2 7#b7 include any ancill>y agreem5ts t are cont+5t ^u1 provide a cont+5t condition =1 7 ent]$ into )9 #cj days (1 or are o!rwise relat$ to1 ! ref]5c$ agreem5t2 & 7#c7 include writt5 descriptions ( any oral agreem5ts1 repres5tations1 commitm5ts1 or promises betwe5 ! p>ties t are responsive to subsection 7a7 or 7b7 ( su* section #aaab & h n be5 r$uc$ to writ+4 4 4 #cac4 ,=feiture ( #ahj-;day exclusivity p]iod ,section #eje7;j77#e77;,d77i77,v7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is am5d$ by ins]t+ section #caa ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai or aft] t ! agreem5t has violat$4 #cad4 ,commission litigation au?ority ,section #af7;a77#b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #ef7;a77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ or aft] ! semicolon2 7#b7 9 subp>agraph 7,e71 by ins]t+ or aft] ! semicolon2 & 7#c7 by ins]t+ aft] subp>agraph 7,e7 ! foll[+3 7,f7 "u section #caa7;d77#c77;,a7 ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai2 4 #cae4 ,/atute ( limitations 7a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 ! ,commission %all comm5ce any adm9i/rative proce$+ or civil action to en=ce section #caa ( ?is ,act n lat] ?an #f ye>s aft] ! date on :i* ! p>ties to ! agreem5t file ! ,notice ( ,agreem5t z provid$ by section #aaab7;c77#b7 & 7d7 ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7#ba ,u4,s4,c4 #cee note74 7b7 ,civil action aft] issuance ( cease & desi/ ord] ,if ! ,commission has issu$ a cease & desi/ ord] "u section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 = violation ( section #caa ( ?is ,act & ! proce$+ = ! issuance ( su* ord] 0 comm5c$ )9 ! p]iod requir$ by subsection 7a7 ( ?is section1 su* subsection does n prohibit ! comm5cem5t1 aft] su* p]iod1 ( a civil action "u section #caa7;d77#c77;,a7 aga9/ a p>ty to su* ord] or a civil action "u subsection 7l7 ( su* section #e = violation ( su* ord]4 ,c ,,block+ ,act #cba4 ,*ange conditions ( fir/ g5]ic exclusivity to spur access & competition 7a7 ,9 g5]al ,section #eje7;j77#e77;,b77iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 is am5d$-- 7#a7 9 subclause 7,i71 by /rik+ #ahj days aft] & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ! foll[+3 #ahj days aft] ! e>li] (-- 7aa7 ! date ( ! fir/ comm]cial m>ket+ ( ! drug 7includ+ ! comm]cial m>ket+ ( ! li/$ drug7 by any fir/ applicant2 or 7bb7 ! applicable date specifi$ 9 subclause 7,,iii74 2 & 7#b7 by add+ at ! end ! foll[+ new subclause3 7,,iii7 ,applicable date ,! applicable date specifi$ 9 ?is subclause1 ) respect to an application = a drug describ$ 9 subclause 7,i71 is ! date on :i* ea* ( ! foll[+ conditions is fir/ met3 7aa7 ,! approval ( su* an application c\ld be made effective1 b = ! eligibility ( a fir/ applicant = #ahj-;day exclusivity "u ?is clause4 7bb7 ,at lea/ #cj mon?s h pass$ s9ce ! date ( submission ( an application = ! drug by at lea/ "o fir/ applicant4 7cc7 ,approval ( an application = ! drug submitt$ by at lea/ "o fir/ applicant is n preclud$ "u clause 7iii74 7dd7 ,no application = ! drug submitt$ by any fir/ applicant is approv$ at ! "t ! conditions "u items 7aa71 7bb71 & 7cc7 are all met1 reg>dless ( :e!r su* an application is subsequ5tly approv$4 4 7b7 ,in=mation ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 n lat] ?an #abj days aft] ! date ( enactm5t ( ?is ,act1 publi%1 z appropriate & available1 in=mation suffici5t to all[ applicants to assess :e!r ! conditions describ$ 9 section #eje7;j77#e77;,b77iv77,,iii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a77 are satisfi$ = all applications :]e ! exclusivity p]iod "u clause 7iv77,i7 ( section #eje7;j77#e77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z am5d$ by su* subsection7 has n expir$2 & 7#b7 publi% updates to su* in=mation to reflect ! mo/ rec5t in=mation available to ! ,secret>y4 ,d ,purple ,book #cca4 ,public li/+ ,section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 is am5d$ by add+ at ! end ! foll[+3 7#i7 ,public li/+ 7,a7 ,9 g5]al 7i7 ,initial publication ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai1 ! ,secret>y %all publi% & make available to ! public 9 a se>*able1 electronic =mat-- 7,i7 a li/ 9 alphabetical ord] ( ! nonpropriet>y or prop] "n ( ea* biological product = :i* a biologics lic5se "u subsection 7a7 or ?is subsection is 9 effect1 or t has be5 deem$ to be lic5s$ "u ?is section pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji1 z ( su* date ( enactm5t2 7,,ii7 ! date ( approval ( ! m>ket+ application & ! application numb]2 & 7,,iii7 ! m>ket+ or lic5sure /atus ( ! biological product = :i* a biologics lic5se "u subsection 7a7 or ?is subsection is 9 effect or t has be5 deem$ to be lic5s$ "u ?is section pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji4 7ii7 ,revisions ,e #cj days aft] ! publication ( ! fir/ li/ "u clause 7i71 ! ,secret>y %all revise ! li/ to include ea* biological product :i* has be5 lic5s$ "u subsection 7a7 or ?is subsection dur+ ! #cj-;day p]iod4 7iii7 ,pat5t in=mation ,n lat] ?an #cj days aft] a li/ ( pat5ts "u subsection 7l77#c77;,a71 or a supplem5t to su* li/ "u subsection 7l77#g71 has be5 provid$ by ! ref]5ce product sponsor to ! subsection 7k7 applicant respect+ a biological product includ$ on ! li/ publi%$ "u ?is subp>agraph1 ! ref]5ce product sponsor %all provide su* li/ ( pat5ts 7or supplem5t !reto7 & _! correspond+ expiry dates to ! ,secret>y1 & ! ,secret>y %all1 9 revisions made "u clause 7ii71 include su* in=mation = su* biological product4 ,)9 #cj days ( provid+ any subsequ5t or supplem5tal li/ ( pat5ts to any subsequ5t subsection 7k7 applicant "u subsection 7l77#c77;,a7 or 7l77#g71 ! ref]5ce product sponsor %all update ! in=mation provid$ to ! ,secret>y "u ?is clause ) any additional pat5ts f su* subsequ5t or supplem5tal li/ & _! correspond+ expiry dates4 7iv7 ,li/+ ( exclusivities ,= ea* biological product includ$ on ! li/ publi%$ "u ?is subp>agraph1 ! ,secret>y %all specify ea* exclusivity p]iod t is applicable & has n conclud$ "u p>agraph 7#f7 or p>agraph 7#g74 7,b7 ,)drawal or susp5sion ( lic5sure ,if ! lic5s+ ( a biological product 0 )drawn or susp5d$ = safety1 purity1 or pot5cy reasons1 x may n be publi%$ 9 ! li/ "u subp>agraph 7,a74 ,if ! )drawal or susp5sion occurr$ aft] its publication 9 su* li/1 ! ref]5ce product sponsor %all notify ! ,secret>y t-- 7i7 ! biological product %all be imm$iately remov$ f su* li/-- 7,i7 = ! same p]iod z ! )drawal or susp5sion2 or 7,,ii7 if ! biological product has be5 )drawn f sale1 = ! p]iod ( )drawal f sale or1 if e>li]1 ! p]iod end+ on ! date ! ,secret>y det]m9es t ! )drawal f sale is n = safety1 purity1 or pot5cy reasons2 & 7ii7 a notice ( ! removal %all be publi%$ 9 ! ,f$]al ,regi/]4 4 #ccb4 ,review & report on types ( in=mation to be li/$ ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 solicit public comm5t reg>d+ ! type ( in=mation1 if any1 t %\ld be add$ to or remov$ f ! li/ requir$ by p>agraph 7#i7 ( section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k771 z add$ by section #cca2 & 7#b7 transmit to ,congress an evaluation ( su* comm5ts1 includ+ any recomm5dations ab\t ! types ( in=mation t %\ld be add$ to or remov$ f ! li/4 ,e ,orange ,book #cda4 ,orange ,book 7a7 ,submission ( pat5t in=mation = br& "n drugs ,p>agraph 7#a7 ( section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is am5d$ to read z foll[s3 7b7 7#a7 ,any p]son may file ) ! ,secret>y an application ) respect to any drug subject to ! provisions ( subsection 7a74 ,su* p]sons %all submit to ! ,secret>y z "p ( ! application-- 7,a7 full reports ( inve/igations :i* h be5 made to %[ :e!r or n su* drug is safe = use & :e!r su* drug is effective 9 use2 7,b7 a full li/ ( ! articles us$ z compon5ts ( su* drug2 7,c7 a full /atem5t ( ! composition ( su* drug2 7,d7 a full description ( ! me?ods us$ 91 & ! facilities & controls us$ =1 ! manufacture1 process+1 & pack+ ( su* drug2 7,e7 su* samples ( su* drug & ( ! articles us$ z compon5ts !re( z ! ,secret>y may require2 7,f7 specim5s ( ! label+ propos$ to be us$ = su* drug2 7,g7 any assessm5ts requir$ "u section #eje;,b2 & 7,h7 pat5t in=mation1 ) respect to ea* pat5t = :i* a claim ( pat5t infr+em5t c\ld reasonably be ass]t$ if a p]son n lic5s$ by ! own] engag$ 9 ! manufacture1 use1 or sale ( ! drug1 & consi/5t ) ! foll[+ requirem5ts3 7i7 ,! applicant %all file ) ! application ! pat5t numb] & ! expiration date (-- 7,i7 any pat5t :i* claims ! drug = :i* ! applicant submitt$ ! application & is a drug sub/ance 7includ+ active +r$i5t7 pat5t or a drug product 7includ+ =mulation & composition7 pat5t2 & 7,,ii7 any pat5t :i* claims ! me?od ( us+ su* drug4 7ii7 ,if an application is fil$ "u ?is subsection = a drug & a pat5t ( ! type describ$ 9 clause 7i7 :i* claims su* drug or a me?od ( us+ su* drug is issu$ aft] ! fil+ date b be=e approval ( ! application1 ! applicant %all am5d ! application to include su* pat5t in=mation4 ,^u approval ( ! application1 ! ,secret>y %all publi% ! in=mation submitt$ "u subp>agraph 7,h74 ,! ,secret>y %all1 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,heal? & ) repres5tatives ( ! drug manufactur+ indu/ry1 review & develop guidance1 z appropriate1 on ! inclusion ( wom5 & m9orities 9 cl9ical trials requir$ by subp>agraph 7,a74 4 7b7 ,con=m+ *anges to requirem5ts = subsequ5t submission ( pat5t in=mation ,section #eje7;c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$-- 7#a7 by ins]t+ aft] ! pat5t numb] & ! expiration date ( any pat5t :i* ! foll[+3 fulfills ! crit]ia 9 subsection 7b7 &2 7#b7 by ins]t+ aft] ! fir/ s5t5ce ! foll[+3 ,pat5t in=mation t is n ! type ( pat5t in=mation requir$ by subsection 7b7 %all n be submitt$42 & 7#c7 by ins]t+ aft] c\ld n file pat5t in=mation "u subsection 7b7 because no pat5t ! foll[+3 ( ! type requir$ to be submitt$ 9 subsection 7b74 7c7 ,li/+ ( exclusivities ,subp>agraph 7,a7 ( section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$ by add+ at ! end ! foll[+3 7iv7 ,= ea* drug includ$ on ! li/1 ! ,secret>y %all specify ea* exclusivity p]iod t is applicable & has n conclud$ "u-- 7,i7 clause 7ii71 7iii71 or 7iv7 ( subsection 7c77#c77;,e7 ( ?is section2 7,,ii7 clause 7iv7 or 7v7 ( p>agraph 7#e77;,b7 ( ?is subsection2 7,,iii7 clause 7ii71 7iii71 or 7iv7 ( p>agraph 7#e77;,f7 ( ?is subsection2 7,,iv7 section #eje;,a2 7,v7 section #eje;,e2 or 7,,vi7 section #ebg7;a74 4 7d7 ,removal ( invalid pat5ts 7#a7 ,9 g5]al ,section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$ by add+ at ! end ! foll[+3 7,d7 7i7 ,! hold] ( an application approv$ "u subsection 7c7 = a drug on ! li/ %all notify )9 #ad days ! ,secret>y 9 writ+ if ei!r ( ! foll[+ occurs3 7,i7 ,! ,pat5t ,trial & ,appeals ,bo>d issues a decision f :i* no appeal has be5 or c be tak5 t a pat5t = su* drug is invalid4 7,,ii7 ,a c\rt issues a decision f :i* no appeal has be5 or c be tak5 t a pat5t = su* drug is invalid4 7ii7 ,! hold] ( an approv$ application %all include 9 any notification "u clause 7i7 a copy ( ! decision describ$ 9 subclause 7,i7 or 7,,ii7 ( clause 7i74 7iii7 ,! ,secret>y %all remove f ! li/ any pat5t t is det]m9$ to be invalid 9 a decision describ$ 9 subclause 7,i7 or 7,,ii7 ( clause 7i7-- 7,i7 promptly2 b 7,,ii7 n be=e ! expiration ( any #ahj-;day exclusivity p]iod "u p>agraph 7#e77;,b77iv7 t relies on a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv7 t su* pat5t 0 invalid4 4 7#b7 ,applicability ,subp>agraph 7,d7 ( section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g771 z add$ by p>agraph 7#a71 applies only ) respect to a decision describ$ 9 su* subp>agraph t is issu$ on or aft] ! date ( enactm5t ( ?is ,act4 7e7 ,review & report ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all-- 7#a7 solicit public comm5t reg>d+ ! types ( pat5t in=mation t %\ld be includ$ on ! li/ "u section #ejg7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g772 & 7#b7 transmit to ! ,congress an evaluation ( su* comm5ts1 includ+ any recomm5dations ab\t ! types ( pat5t in=mation t %\ld be includ$ on or remov$ f su* li/4 #cdb4 ,,gao report to ,congress 7a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! ,comptroll] ,g5]al7 %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! pat5ts includ$ 9 ! li/ publi%$ "u section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g771 includ+ an analysis & evaluation ( ! types ( pat5ts includ$ 9 su* li/ & ! claims su* pat5ts make ab\t ! products !y claim4 7b7 ,cont5ts ,! ,comptroll] ,g5]al %all include 9 ! report "u subsection 7a7-- 7#a7 data on ! numb] (-- 7,a7 pat5ts includ$ 9 ! li/ publi%$ "u p>agraph 7#g7 ( section #eje7;j7 ( ! ,f$]al ,food1 ,drug & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771 t claim ! active +r$i5t or =mulation ( a drug 9 comb9ation ) a device t is us$ = deliv]y ( ! drug1 toge!r compris+ ! f9i%$ dosage =m ( ! drug2 & 7,b7 claims 9 ea* pat5t t claim a device t is us$ = ! deliv]y ( ! drug1 b d n claim su* device 9 comb9ation ) an active +r$i5t or =mulation ( a drug2 7#b7 data on ! date ( inclusion 9 ! li/ "u p>agraph 7#g7 ( su* section #eje7;j7 = all pat5ts "u su* li/1 z comp>$ to pat5ts t claim a me?od ( us+ ! drug 9 comb9ation ) a device2 7#c7 an analysis reg>d+ ! impact ( includ+ on ! li/ "u p>agraph 7#g7 ( su* section #eje7;j7 c]ta9 types ( pat5t in=mation = drug product applicants & approv$ application hold]s1 includ+ an analysis ( :e!r-- 7,a7 ! li/+ ( ! pat5ts describ$ 9 p>agraph 7#a77;,a7 delay$ ! m>ket entry ( "o or m drugs approv$ "u su* section #eje7;j72 & 7,b7 n li/+ ! pat5ts describ$ 9 p>agraph 7#a77;,a7 w\ld delay ! m>ket entry ( "o or m su* drugs2 & 7#d7 recomm5dations ab\t :i* k9ds ( pat5ts relat+ to devices describ$ 9 p>agraph 7#a77;,a7 %\ld be submitt$ to ! ,secret>y ( ,heal? & ,human ,s]vices = inclusion on ! li/ "u p>agraph 7#g7 ( su* section #eje7;j7 & :i* pat5ts %\ld n be requir$ to be s submitt$4 ,f ,advanc+ ,education on ,biosimil>s #cea4 ,education on biological products 7a7 ,website2 cont9u+ education ,subp>t #a ( "p ,f ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb et seq47 is am5d$ by add+ at ! end ! foll[+3 #ceb;,a4 ,education on biological products 7a7 ,int]net website 7#a7 ,9 g5]al ,! ,secret>y %all ma9ta9 & op]ate an int]net website to provide educational mat]ials = heal? c>e provid]s1 pati5ts1 & c>egiv]s1 reg>d+ ! mean+ ( ! t]ms1 & ! /&>ds = review & lic5s+ (1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 7#b7 ,cont5t ,educational mat]ials provid$ "u p>agraph 7#a7 may include-- 7,a7 explanations ( key /atutory & regulatory t]ms1 includ+ biosimil> & int]*angeable1 & cl>ification reg>d+ ! use ( int]*angeable biosimil> biological products2 7,b7 in=mation relat$ to developm5t programs = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products & relevant cl9ical consid]ations = prescrib]s1 :i* may include1 z appropriate & applicable1 in=mation relat$ to ! comp>ability ( su* biological products2 7,c7 an explanation ( ! process = report+ adv]se ev5ts = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products2 & 7,d7 an explanation ( ! relation%ip betwe5 biosimil> biological products & int]*angeable biosimil> biological products lic5s$ "u section #cea7k7 & ref]5ce products 7z def9$ 9 section #cea7;i771 includ+ ! /&>ds = review & lic5s+ ( ea* su* type ( biological product4 7#c7 ,=mat ,! educational mat]ials provid$ "u p>agraph 7#a7 may be-- 7,a7 9 =mats su* z web9>s1 cont9u+ m$ical education modules1 videos1 fact %eets1 infographics1 /akehold] toolkits1 or o!r =mats z appropriate & applicable2 & 7,b7 tailor$ = ! unique ne$s ( heal? c>e provid]s1 pati5ts1 c>egiv]s1 & o!r audi5ces1 z ! ,secret>y det]m9es appropriate4 7#d7 ,o!r in=mation ,9 addition to ! in=mation describ$ 9 p>agraph 7#b71 ! ,secret>y %all cont9ue to publi% ! foll[+ in=mation3 7,a7 ,! action package ( ea* biological product lic5s$ "u subsection 7a7 or 7k74 7,b7 ,! summ>y review ( ea* biological product lic5s$ "u subsection 7a7 or 7k74 7#e7 ,confid5tial & trade secret in=mation ,?is subsection does n au?orize ! disclosure ( any trade secret1 confid5tial comm]cial or f9ancial in=mation1 or o!r matt] describ$ 9 section #eeb7;b7 ( title #e4 7b7 ,cont9u+ education ,! ,secret>y %all advance education & aw>5ess among heal? c>e provid]s reg>d+ biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products1 z appropriate1 includ+ by develop+ or improv+ cont9u+ education programs t advance ! education ( su* provid]s on ! prescrib+ (1 & relevant cl9ical consid]ations ) respect to1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 4 7b7 ,application "u ! ,m$ic>e ,m]it-,bas$ ,inc5tive ,paym5t ,sy/em ,section #ahdh7q77#e77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#e77;,c77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iv7 ,cl9ical m$ical education program on biosimil> biological products ,completion ( a cl9ical m$ical education program develop$ or improv$ "u section #ceb;,a7b7 ( ! ,public ,heal? ,s]vice ,act by a ,,mips eligible pr(essional dur+ a p]=mance p]iod %all e>n su* eligible pr(essional "o-half ( ! highe/ pot5tial score = ! p]=mance category describ$ 9 p>agraph 7#b77;,a77iii7 = su* p]=mance p]iod4 ,a ,,mips eligible pr(essional may only c\nt ! completion ( su* a program = purposes ( su* category "o "t dur+ ! eligible pr(essional's lifetime4 4 ,g ,/reaml9+ ,transition ( ,biological ,products #cfa4 ,/reaml9+ ! transition ( biological products ,section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji 7,public ,law #aaa-adh7 is am5d$-- 7#a7 by /rik+ ,an approv$ application & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,an approv$ application 2 7#b7 by add+ at ! end ! foll[+3 7,b7 ,treatm5t ( c]ta9 applications 7i7 ,9 g5]al ,) respect to an application = a biological product submitt$ "u subsection 7b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 t is fil$ n lat] ?an ,m>* #bc1 #bjai1 ! ,secret>y %all cont9ue to review su* application "u su* section #eje1 ev5 if su* review cont9ues aft] ,m>* #bc1 #bjbj4 7ii7 ,effect on li/$ drugs ,only = purposes ( c>ry+ out clause 7i71 ) respect to any applicable li/$ drug ) respect to su* application1 ! foll[+ %all apply3 7,i7 ,any drug t is a biological product t has be5 deem$ lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 pursuant to subp>agraph 7,a7 & t is ref]5c$ 9 an application describ$ 9 clause 7i71 %all cont9ue to be id5tifi$ z a li/$ drug on ! li/ publi%$ pursuant to section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & ! in=mation = su* drug on su* li/ %all n be revis$ aft] ,m>* #bj1 #bjbj1 until-- 7aa7 su* drug is remov$ f su* li/ 9 accordance ) subclause 7,,iii7 or subp>agraph 7,c7 ( su* section #eje7;j77#g72 or 7bb7 ?is subp>agraph no long] has =ce or effect4 7,,ii7 ,any drug t is a biological product t has be5 deem$ lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 pursuant to subp>agraph 7,a7 & t is ref]5c$ 9 an application describ$ 9 clause 7i7 %all be subject only to requirem5ts applicable to biological products lic5s$ "u su* section4 7,,iii7 ,^u approval "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ( an application describ$ 9 clause 7i71 ! ,secret>y %all remove f ! li/ publi%$ pursuant to section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act any li/$ drug t is a biological product t has be5 deem$ lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act pursuant to subp>agraph 7,a7 & t is ref]5c$ 9 su* approv$ application1 unless su* li/$ drug is ref]5c$ 9 "o or m additional applications describ$ 9 clause 7i74 7iii7 ,deem$ lic5sure ,^u approval ( an application describ$ 9 clause 7i71 su* approv$ application %all be deem$ to be a lic5se = ! biological product "u section #cea ( ! ,public ,heal? ,s]vice ,act1 pursuant to subp>agraph 7,a71 & any p]iod ( exclusivity1 z applicable1 %all be det]m9$ 9 accordance ) su* section4 7iv7 ,rule ( con/ruction 7,i7 ,application ( c]ta9 provisions 7aa7 ,pat5t c]tification or /atem5t ,an application describ$ 9 clause 7i7 %all conta9 a pat5t c]tification or /atem5t describ$ 91 z applicable1 section #eje7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or clauses 7vii7 & 7viii7 ( section #eje7;j77#b77;,a7 ( su* ,act &1 ) respect to any li/$ drug ref]5c$ 9 su* application1 comply ) relat$ requirem5ts conc]n+ any timely fil$ pat5t in=mation li/$ pursuant to section #eje7;j77#g74 7bb7 ,date ( approval ,! e>lie/ possible date on :i* any p5d+ application describ$ 9 clause 7i7 may be approv$ %all be det]m9$ bas$ on-- 7,,aa7 ! la/ expiration date ( any applicable p]iod ( exclusivity t w\ld prev5t su* approval & t is describ$ 9 section #eje7;c77#c77;,e71 #eje7;j77#e77;,b77iv71 #eje7;j77#e77;,f71 #eje;,a1 #eje;,e1 or #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7,,bb7 if ! application 0 submitt$ "u section #eje7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & ref]5ces any li/$ drug1 ! la/ applicable date det]m9$ "u subp>agraph 7,a71 7,b71 or 7,c7 ( section #eje7;c77#c7 ( su* ,act1 or1 if ! application 0 submitt$ "u section #eje7;j7 ( su* ,act1 ! la/ applicable date det]m9$ "u clause 7i71 7ii71 or 7iii7 ( section #eje7;j77#e77;,b74 7,,ii7 ,rule ( con/ruction ) respect to exclusivity ,no?+ 9 ?is subp>agraph %all be con/ru$ to affect section #cea7k77#g77;,d7 ( ! ,public ,heal? ,s]vice ,act4 7v7 ,au?oriz$ disclosure ,! ,secret>y may cont9ue to review an application aft] ,m>* #bc1 #bjbj1 pursuant to clause 7i71 & cont9ue to id5tify any applicable li/$ drug pursuant to clause 7ii7 on ! li/ publi%$ pursuant to section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 ev5 if su* review or li/+ may reveal ! exi/5ce ( su* application & ! id5tity ( any li/$ drug = :i* ! inve/igations describ$ 9 section #eje7;b77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act are reli$ ^u by ! applicant = approval ( ! p5d+ application4 ,no?+ 9 ?is subp>agraph %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any o!r in=mation t is a trade secret or confid5tial in=mation describ$ 9 section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 7vi7 ,sunset ,beg9n+ on ,octob] #a1 #bjbb1 ?is subp>agraph %all h no =ce or effect & any applications describ$ 9 clause 7i7 t h n be5 approv$ %all be deem$ )drawn4 4 ,h ,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m #cgj4 ,%ort title2 ref]5ces 9 subtitle 7a7 ,%ort title ,?is subtitle may be cit$ z ! ,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m ,act ( #bjai4 7b7 ,ref]5ces ,except z o!rwise specifi$1 any ref]5ce to ?is ,act conta9$ 9 ?is subtitle %all be treat$ z ref]r+ only to ! provisions ( ?is subtitle4 #a ,,otc ,drug ,review #cga4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #eje;,f ( su* ,act 7#ba ,u4,s4,c4 #cee;g7 ! foll[+3 #eje;,g4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application 7a7 ,nonprescription drugs m>ket$ )\t an approv$ application ,nonprescription drugs m>ket$ )\t an approv$ drug application "u section #eje1 z ( ! date ( ! enactm5t ( ?is section1 %all be treat$ 9 accordance ) ?is subsection4 7#a7 ,drugs subject to a f9al monograph2 category ,i drugs subject to a t5tative f9al monograph ,a drug is deem$ to be g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 n a new drug "u section #bja7p71 & n subject to section #ejc7;b77#a71 if-- 7,a7 ! drug is-- 7i7 9 con=mity ) ! requirem5ts = nonprescription use ( a f9al monograph issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations 7except z provid$ 9 p>agraph 7#b771 ! g5]al requirem5ts = nonprescription drugs1 & conditions or requirem5ts "u subsections 7b71 7c71 & 7k72 & 7ii7 except z p]mitt$ by an ord] issu$ "u subsection 7b7 or1 9 ! case ( a m9or *ange 9 ! drug1 9 con=mity ) an ord] issu$ "u subsection 7c71 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 has be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b72 or 7,b7 ! drug is-- 7i7 classifi$ 9 category ,i = safety & effectiv5ess "u a t5tative f9al monograph t is ! mo/ rec5tly applicable proposal or det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7ii7 9 con=mity ) ! propos$ requirem5ts = nonprescription use ( su* t5tative f9al monograph1 any applicable subsequ5t det]m9ation by ! ,secret>y1 ! g5]al requirem5ts = nonprescription drugs1 & conditions or requirem5ts "u subsections 7b71 7c71 & 7k72 & 7iii7 except z p]mitt$ by an ord] issu$ "u subsection 7b7 or1 9 ! case ( a m9or *ange 9 ! drug1 9 con=mity ) an ord] issu$ "u subsection 7c71 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 has be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b74 7#b7 ,treatm5t ( sunscre5 drugs ,) respect to sunscre5 drugs subject to ?is section1 ! applicable requirem5ts 9 t]ms ( con=mity ) a f9al monograph1 = purposes ( p>agraph 7#a77;,a77i71 %all be ! requirem5ts specifi$ 9 "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations1 z publi%$ on ,may #ba1 #aiii1 beg9n+ on page #bgfhg ( volume #fd ( ! ,f$]al ,regi/]1 except t ! applicable requirem5ts gov]n+ effectiv5ess & label+ %all be ^? specifi$ 9 section #bja4cbg ( title #ba1 ,code ( ,f$]al ,regulations4 7#c7 ,category ,,iii drugs subject to a t5tative f9al monograph2 category ,i drugs subject to propos$ monograph or advance notice ( propos$ rulemak+ ,a drug t is n describ$ 9 p>agraph 7#a71 7#b71 or 7#d7 is n requir$ to be ! subject ( an application approv$ "u section #eje1 & is n subject to section #ejc7;b77#a71 if-- 7,a7 ! drug is-- 7i7 classifi$ 9 category ,,iii = safety or effectiv5ess 9 ! preamble ( a propos$ rule e/abli%+ a t5tative f9al monograph t is ! mo/ rec5tly applicable proposal or det]m9ation = su* drug issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7ii7 9 con=mity )-- 7,i7 ! conditions ( use1 includ+ indication & dosage /r5g?1 if any1 describ$ = su* category ,,iii drug 9 su* preamble or 9 an applicable subsequ5t propos$ rule2 7,,ii7 ! propos$ requirem5ts = drugs classifi$ 9 su* t5tative f9al monograph 9 category ,i 9 ! mo/ rec5tly propos$ rule e/abli%+ requirem5ts relat$ to su* t5tative f9al monograph & 9 any f9al rule e/abli%+ requirem5ts t are applicable to ! drug2 & 7,,iii7 ! g5]al requirem5ts = nonprescription drugs & conditions or requirem5ts "u subsection 7b7 or 7k72 & 7iii7 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 _h be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b72 or 7,b7 ! drug is-- 7i7 classifi$ 9 category ,i = safety & effectiv5ess "u a propos$ monograph or advance notice ( propos$ rulemak+ t is ! mo/ rec5tly applicable proposal or det]m9ation = su* drug issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7ii7 9 con=mity ) ! requirem5ts = nonprescription use ( su* propos$ monograph or advance notice ( propos$ rulemak+1 any applicable subsequ5t det]m9ation by ! ,secret>y1 ! g5]al requirem5ts = nonprescription drugs1 & conditions or requirem5ts "u subsection 7b7 or 7k72 & 7iii7 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 has be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b74 7#d7 ,category ,,ii drugs deem$ new drugs ,a drug t is classifi$ 9 category ,,ii = safety or effectiv5ess "u a t5tative f9al monograph or t is subject to a det]m9ation to be n g5]ally recogniz$ z safe & effective 9 a propos$ rule t is ! mo/ rec5tly applicable proposal issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 %all be deem$ to be a new drug "u section #bja7p71 misbr&$ "u section #ejb7;ee71 & subject to ! requirem5t = an approv$ new drug application "u section #eje beg9n+ on ! day t is #ahj cal5d> days aft] ! date ( ! enactm5t ( ?is section1 unless1 be=e su* day1 ! ,secret>y det]m9es t x is 9 ! int]e/ ( public heal? to ext5d ! p]iod dur+ :i* ! drug may be m>ket$ )\t su* an approv$ new drug application4 7#e7 ,drugs n ,,grase deem$ new drugs ,a drug t ! ,secret>y has det]m9$ n to be g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 "u a f9al det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 %all be deem$ to be a new drug "u section #bja7p71 misbr&$ "u section #ejb7;ee71 & subject to ! requirem5t = an approv$ new drug application "u section #eje4 7#f7 ,o!r drugs deem$ new drugs ,except z provid$ 9 subsection 7m71 a drug is deem$ to be a new drug "u section #bja7p7 & misbr&$ "u section #ejb7;ee7 if ! drug-- 7,a7 is n subject to section #ejc7;b77#a72 & 7,b7 is n describ$ 9 p>agraph 7#a71 7#b71 7#c71 7#d71 or 7#e71 or subsection 7b77#a77;,b74 7b7 ,adm9i/rative ord]s 7#a7 ,9 g5]al 7,a7 ,det]m9ation ,! ,secret>y may1 on ! initiative ( ! ,secret>y or at ! reque/ ( "o or m reque/ors1 issue an adm9i/rative ord] det]m9+ :e!r !re are conditions "u :i* a specific drug1 a class ( drugs1 or a comb9ation ( drugs1 is det]m9$ to be-- 7i7 n subject to section #ejc7;b77#a72 & 7ii7 g5]ally recogniz$ z safe & effective "u section #bja7p77#a74 7,b7 ,effect ,a drug or comb9ation ( drugs %all be deem$ to n require approval "u section #eje if su* drug or comb9ation ( drugs-- 7i7 is det]m9$ by ! ,secret>y to meet ! conditions specifi$ 9 clauses 7i7 & 7ii7 ( subp>agraph 7,a72 7ii7 is m>ket$ 9 con=mity ) an adm9i/rative ord] "u ?is subsection2 7iii7 meets ! g5]al requirem5ts = nonprescription drugs2 & 7iv7 meets ! requirem5ts "u subsections 7c7 & 7k74 7,c7 ,/&>d ,! ,secret>y %all f9d t a drug is n g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 if-- 7i7 ! evid5ce %[s t ! drug is n g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 or 7ii7 ! evid5ce is inadequate to %[ t ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a74 7#b7 ,adm9i/rative ord]s initiat$ by ! secret>y 7,a7 ,9 g5]al ,9 issu+ an adm9i/rative ord] "u p>agraph 7#a7 ^u ! ,secret>y's initiative1 ! ,secret>y %all-- 7i7 make reasonable ef=ts to notify in=mally1 n lat] ?an #b bus9ess days be=e ! issuance ( ! propos$ ord]1 ! sponsors ( drugs :o h a li/+ 9 effect "u section #eaj7;j7 = ! drugs or comb9ation ( drugs t w be subject to ! adm9i/rative ord]2 7ii7 aft] any su* reasonable ef=ts ( notification-- 7,i7 issue a propos$ adm9i/rative ord] by publi%+ x on ! website ( ! ,food & ,drug ,adm9i/ration & include 9 su* ord] ! reasons = ! issuance ( su* ord]2 & 7,,ii7 publi% a notice ( availability ( su* propos$ ord] 9 ! ,f$]al ,regi/]2 7iii7 except z provid$ 9 subp>agraph 7,b71 provide = a public comm5t p]iod ) respect to su* propos$ ord] ( n less ?an #de cal5d> days2 & 7iv7 if1 aft] completion ( ! proce$+s specifi$ 9 clauses 7i7 ?r\gh 7iii71 ! ,secret>y det]m9es t x is appropriate to issue a f9al adm9i/rative ord]-- 7,i7 issue ! f9al adm9i/rative ord]1 toge!r ) a detail$ /atem5t ( reasons1 :i* ord] %all n take effect until ! "t = reque/+ judicial review "u p>agraph 7#c77;,d77ii7 has expir$2 7,,ii7 publi% a notice ( su* f9al adm9i/rative ord] 9 ! ,f$]al ,regi/]2 7,,iii7 af=d reque/ors ( drugs t w be subject to su* ord] ! opportunity = =mal dispute resolution up to ! level ( ! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 :i* initially mu/ be reque/$ )9 #de cal5d> days ( ! issuance ( ! ord]1 &1 = subsequ5t levels ( appeal1 )9 #cj cal5d> days ( ! prior decision2 & 7,,iv7 except ) respect to drugs describ$ 9 p>agraph 7#c77;,b71 ^u completion ( ! =mal dispute resolution proc$ure1 in=m ! p]sons :i* s\ght su* dispute resolution ( _! "r to reque/ a he>+4 7,b7 ,exceptions ,:5 issu+ an adm9i/rative ord] "u p>agraph 7#a7 on ! ,secret>y's initiative propos+ to det]m9e t a drug describ$ 9 subsection 7a77#c7 is n g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 ! ,secret>y %all foll[ ! proc$ures 9 subp>agraph 7,a71 except t-- 7i7 ! propos$ ord] %all include notice (-- 7,i7 ! g5]al categories ( data ! ,secret>y has det]m9$ necess>y to e/abli% t ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 & 7,,ii7 ! =mat = submissions by int]e/$ p]sons2 7ii7 ! ,secret>y %all provide = a public comm5t p]iod ( no less ?an #ahj cal5d> days ) respect to su* propos$ ord]1 except :5 ! ,secret>y det]m9es1 = good cause1 t a %ort] p]iod is 9 ! int]e/ ( public heal?2 & 7iii7 any p]son :o submits data 9 su* comm5t p]iod %all include a c]tification t ! p]son has submitt$ all evid5ce creat$1 obta9$1 or receiv$ by t p]son t is bo? )9 ! categories ( data id5tifi$ 9 ! propos$ ord] & relevant to a det]m9ation z to :e!r ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a74 7#c7 ,he>+s2 judicial review 7,a7 ,9 g5]al ,only a p]son :o p>ticipat$ 9 ea* /age ( =mal dispute resolution "u subclause 7,,iii7 ( p>agraph 7#b77;,a77iv7 ( an adm9i/rative ord] ) respect to a drug may reque/ a he>+ conc]n+ a f9al adm9i/rative ord] issu$ "u su* p>agraph ) respect to su* drug4 ,if a he>+ is s\ght1 su* p]son mu/ submit a reque/ = a he>+1 :i* %all be bas$ solely on in=mation 9 ! adm9i/rative record1 to ! ,secret>y n lat] ?an #cj cal5d> days aft] receiv+ notice ( ! f9al decision ( ! =mal dispute resolution proc$ure4 7,b7 ,no he>+ requir$ ) respect to ord]s relat+ to c]ta9 drugs 7i7 ,9 g5]al ,! ,secret>y %all n be requir$ to provide notice & an opportunity = a he>+ pursuant to p>agraph 7#b77;,a77iv7 if ! f9al adm9i/rative ord] involv$ relates to a drug-- 7,i7 t is describ$ 9 subsection 7a77#c77;,a72 & 7,,ii7 ) respect to :i* no human or non-human data /udies relevant to ! safety or effectiv5ess ( su* drug h be5 submitt$ to ! adm9i/rative record s9ce ! issuance ( ! mo/ rec5t t5tative f9al monograph relat+ to su* drug4 7ii7 ,human data /udies & non-human data def9$ ,9 ?is subp>agraph3 7,i7 ,! t]m human data /udies means cl9ical trials ( safety or effectiv5ess 7includ+ actual use /udies71 ph>macok9etics /udies1 or bioavailability /udies4 7,,ii7 ,! t]m non-human data means data f te/+ o!r ?an ) human subjects :i* provides in=mation conc]n+ safety or effectiv5ess4 7,c7 ,he>+ proc$ures 7i7 ,d5ial ( reque/ = he>+ ,if ! ,secret>y det]m9es t in=mation submitt$ 9 a reque/ = a he>+ "u subp>agraph 7,a7 ) respect to a f9al adm9i/rative ord] issu$ "u p>agraph 7#b77;,a77iv7 does n id5tify ! exi/5ce ( a g5u9e & sub/antial "q ( mat]ial fact1 ! ,secret>y may d5y su* reque/4 ,9 mak+ su* a det]m9ation1 ! ,secret>y may consid] only in=mation & data t are bas$ on relevant & reliable sci5tific pr9ciples & me?odologies4 7ii7 ,s+le he>+ = multiple relat$ reque/s ,if m ?an "o reque/ = a he>+ is submitt$ ) respect to ! same adm9i/rative ord] "u subp>agraph 7,a71 ! ,secret>y may direct t a s+le he>+ be conduct$ 9 :i* all p]sons ^: he>+ reque/s 7 grant$ may p>ticipate4 7iii7 ,presid+ (fic] ,! presid+ (fic] ( a he>+ reque/$ "u subp>agraph 7,a7 %all-- 7,i7 be designat$ by ! ,secret>y2 7,,ii7 n be an employee ( ! ,c5t] = ,drug ,evaluation & ,rese>*2 & 7,,iii7 n h be5 previ\sly involv$ 9 ! developm5t ( ! adm9i/rative ord] involv$ or proce$+s relat+ to t adm9i/rative ord]4 7iv7 ,rights ( p>ties to he>+ ,! p>ties to a he>+ reque/$ "u subp>agraph 7,a7 %all h ! "r to pres5t te/imony1 includ+ te/imony ( exp]t witnesses1 & to cross-exam9e witnesses pres5t$ by o!r p>ties4 ,:]e appropriate1 ! presid+ (fic] may require t cross-exam9ation by p>ties repres5t+ sub/antially ! same int]e/s be consolidat$ to promote effici5cy & avoid duplication4 7v7 ,f9al decision 7,i7 ,at ! conclusion ( a he>+ reque/$ "u subp>agraph 7,a71 ! presid+ (fic] ( ! he>+ %all issue a decision conta9+ f9d+s ( fact & conclusions ( law4 ,! decision ( ! presid+ (fic] %all be f9al4 7,,ii7 ,! f9al decision may n take effect until ! p]iod "u subp>agraph 7,d77ii7 = submitt+ a reque/ = judicial review ( su* decision expires4 7,d7 ,judicial review ( f9al adm9i/rative ord] 7i7 ,9 g5]al ,! proc$ures describ$ 9 section #eje7;h7 %all apply ) respect to judicial review ( f9al adm9i/rative ord]s issu$ "u ?is subsection 9 ! same mann] & to ! same ext5t z su* section applies to an ord] describ$ 9 su* section except t ! judicial review %all be tak5 by fil+ 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates 9 lieu ( ! appellate c\rts specifi$ 9 su* section4 7ii7 ,p]iod to submit a reque/ = judicial review ,a p]son eligible to reque/ a he>+ "u ?is p>agraph & seek+ judicial review ( a f9al adm9i/rative ord] issu$ "u ?is subsection %all file su* reque/ = judicial review n lat] ?an #fj cal5d> days aft] ! late/ (-- 7,i7 ! date on :i* notice ( su* ord] is publi%$2 7,,ii7 ! date on :i* a he>+ ) respect to su* ord] is d5i$ "u subp>agraph 7,b7 or 7,c77i72 7,,iii7 ! date on :i* a f9al decision is made foll[+ a he>+ "u subp>agraph 7,c77v72 or 7,,iv7 if no he>+ is reque/$1 ! date on :i* ! "t = reque/+ a he>+ expires4 7#d7 ,exp$it$ proc$ure ) respect to adm9i/rative ord]s initiat$ by ! ,secret>y 7,a7 ,imm95t haz>d to ! public heal? 7i7 ,9 g5]al ,9 ! case ( a det]m9ation by ! ,secret>y t a drug1 class ( drugs1 or comb9ation ( drugs subject to ?is section poses an imm95t haz>d to ! public heal?1 ! ,secret>y1 aft] fir/ mak+ reasonable ef=ts to notify1 n lat] ?an #dh h\rs be=e issuance ( su* ord] "u ?is subp>agraph1 sponsors :o h a li/+ 9 effect "u section #eaj7;j7 = su* drug or comb9ation ( drugs-- 7,i7 may issue an int]im f9al adm9i/rative ord] = su* drug1 class ( drugs1 or comb9ation ( drugs "u p>agraph 7#a71 toge!r ) a detail$ /atem5t ( ! reasons = su* ord]2 7,,ii7 %all publi% 9 ! ,f$]al ,regi/] a notice ( availability ( any su* ord]2 & 7,,iii7 %all provide = a public comm5t p]iod ( at lea/ #de cal5d> days ) respect to su* int]im f9al ord]4 7ii7 ,nondelegation ,! ,secret>y may n delegate ! au?ority to issue an int]im f9al adm9i/rative ord] "u ?is subp>agraph4 7,b7 ,safety label+ *anges 7i7 ,9 g5]al ,9 ! case ( a det]m9ation by ! ,secret>y t a *ange 9 ! label+ ( a drug1 class ( drugs1 or comb9ation ( drugs subject to ?is section is reasonably expect$ to mitigate a significant or unreasonable risk ( a s]i\s adv]se ev5t associat$ ) use ( ! drug1 ! ,secret>y may-- 7,i7 make reasonable ef=ts to notify in=mally1 n lat] ?an #dh h\rs be=e ! issuance ( ! int]im f9al ord]1 ! sponsors ( drugs :o h a li/+ 9 effect "u section #eaj7;j7 = su* drug or comb9ation ( drugs2 7,,ii7 aft] reasonable ef=ts ( notification1 issue an int]im f9al adm9i/rative ord] 9 accordance ) p>agraph 7#a7 to require su* *ange1 toge!r ) a detail$ /atem5t ( ! reasons = su* ord]2 7,,iii7 publi% 9 ! ,f$]al ,regi/] a notice ( availability ( su* ord]2 & 7,,iv7 provide = a public comm5t p]iod ( at lea/ #de cal5d> days ) respect to su* int]im f9al ord]4 7ii7 ,cont5t ( ord] ,an int]im f9al ord] issu$ "u ?is subp>agraph ) respect to ! label+ ( a drug may provide = new w>n+s & o!r in=mation requir$ = safe use ( ! drug4 7,c7 ,effective date ,an ord] "u subp>agraph 7,a7 or 7,b7 %all take effect on a date specifi$ by ! ,secret>y4 7,d7 ,f9al ord] ,aft] ! completion ( ! proce$+s 9 subp>agraph 7,a7 or 7,b71 ! ,secret>y %all-- 7i7 issue a f9al ord] 9 accordance ) p>agraph 7#a72 7ii7 publi% a notice ( availability ( su* f9al adm9i/rative ord] 9 ! ,f$]al ,regi/]2 & 7iii7 af=d sponsors ( su* drugs t w be subject to su* an ord] ! opportunity = =mal dispute resolution up to ! level ( ! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 :i* mu/ initially be )9 #de cal5d> days ( ! issuance ( ! ord]1 & = subsequ5t levels ( appeal1 )9 #cj cal5d> days ( ! prior decision4 7,e7 ,he>+s ,a sponsor ( a drug subject to a f9al ord] issu$ "u subp>agraph 7,d7 & t p>ticipat$ 9 ea* /age ( =mal dispute resolution "u clause 7iii7 ( su* subp>agraph may reque/ a he>+ on su* ord]4 ,! provisions ( subp>agraphs 7,a71 7,b71 & 7,c7 ( p>agraph 7#c71 o!r ?an p>agraph 7#c77;,c77v77,,ii71 %all apply ) respect to a he>+ on su* ord] 9 ! same mann] & to ! same ext5t z su* provisions apply ) respect to a he>+ on an adm9i/rative ord] issu$ "u p>agraph 7#b77;,a77iv74 7,f7 ,tim+ 7i7 ,f9al ord] & he>+ ,! ,secret>y %all-- 7,i7 n lat] ?an #f mon?s aft] ! date on :i* ! comm5t p]iod closes "u subp>agraph 7,a7 or 7,b71 issue a f9al ord] 9 accordance ) p>agraph 7#a72 & 7,,ii7 n lat] ?an #ab mon?s aft] ! date on :i* su* f9al ord] is issu$1 complete any he>+ "u subp>agraph 7,e74 7ii7 ,dispute resolution reque/ ,! ,secret>y %all specify 9 an int]im f9al ord] issu$ "u subp>agraph 7,a7 or 7,b7 su* %ort] p]iods = reque/+ dispute resolution "u subp>agraph 7,d77iii7 z are necess>y to meet ! requirem5ts ( ?is subp>agraph4 7,g7 ,judicial review ,a f9al ord] issu$ pursuant to subp>agraph 7,f7 %all be subject to judicial review 9 accordance ) p>agraph 7#c77;,d74 7#e7 ,adm9i/rative ord] initiat$ at ! reque/ ( a reque/or 7,a7 ,9 g5]al ,9 issu+ an adm9i/rative ord] "u p>agraph 7#a7 at ! reque/ ( a reque/or ) respect to c]ta9 drugs1 classes ( drugs1 or comb9ations ( drugs-- 7i7 ! ,secret>y %all1 aft] receiv+ a reque/ "u ?is subp>agraph1 det]m9e :e!r ! reque/ is suffici5tly complete & =matt$ to p]mit a sub/antive review2 7ii7 if ! ,secret>y det]m9es t ! reque/ is suffici5tly complete & =matt$ to p]mit a sub/antive review1 ! ,secret>y %all-- 7,i7 file ! reque/2 & 7,,ii7 initiate proce$+s ) respect to issu+ an adm9i/rative ord] 9 accordance ) p>agraphs 7#b7 & 7#c72 & 7iii7 except z provid$ 9 p>agraph 7#f71 if ! ,secret>y det]m9es t a reque/ does n meet ! requirem5ts = fil+ or is n suffici5tly complete & =matt$ to p]mit a sub/antive review1 ! reque/or may dem& t ! reque/ be fil$ ov] prote/1 & ! ,secret>y %all initiate proce$+s to review ! reque/ 9 accordance ) p>agraph 7#b77;,a74 7,b7 ,reque/ to initiate proce$+s 7i7 ,9 g5]al ,a reque/or seek+ an adm9i/rative ord] "u p>agraph 7#a7 ) respect to c]ta9 drugs1 classes ( drugs1 or comb9ations ( drugs1 %all submit to ! ,secret>y a reque/ to initiate proce$+s = su* ord] 9 ! =m & mann] z specifi$ by ! ,secret>y4 ,su* reque/or may submit a reque/ "u ?is subp>agraph = ! issuance ( an adm9i/rative ord]-- 7,i7 det]m9+ :e!r a drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 exempt f section #ejc7;b77#a71 & n requir$ to be ! subject ( an approv$ application "u section #eje2 or 7,,ii7 det]m9+ :e!r a *ange to a condition ( use ( a drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 exempt f section #ejc7;b77#a71 & n requir$ to be ! subject ( an approv$ application "u section #eje1 if1 abs5t su* a *ang$ condition ( use1 su* drug is-- 7aa7 g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 9 accordance ) subsection 7a77#a71 7a77#b71 or an ord] "u ?is subsection2 or 7bb7 subject to subsection 7a77#c71 b only if su* reque/or initiates su* reque/ 9 conjunction ) a reque/ = ! ,secret>y to det]m9e :e!r su* drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 :i* is fil$ by ! ,secret>y "u subp>agraph 7,a77ii74 7ii7 ,exception ,! ,secret>y is n requir$ to complete review ( a reque/ = a *ange describ$ 9 clause 7i77,,ii7 if ! ,secret>y det]m9es t !re is an inadequate basis to f9d ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 "u p>agraph 7#a7 & issues a f9al ord] ann\nc+ t det]m9ation4 7iii7 ,)drawal ,! reque/or may )draw a reque/ "u ?is p>agraph1 accord+ to ! proc$ures set =? pursuant to subsection 7d77#b77;,b74 ,not)/&+ any o!r provision ( ?is section1 if su* reque/ is )drawn1 ! ,secret>y may cease proce$+s "u ?is subp>agraph4 7,c7 ,exclusivity 7i7 ,9 g5]al ,a f9al adm9i/rative ord] issu$ 9 response to a reque/ "u ?is section %all h ! effect ( au?oriz+ solely ! ord] reque/or 7or ! lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* ord]71 = a p]iod ( #ah mon?s foll[+ ! effective date ( su* f9al ord] & beg9n+ on ! date ! reque/or may lawfully m>ket su* drugs pursuant to ! ord]1 to m>ket drugs-- 7,i7 incorporat+ *anges describ$ 9 clause 7ii72 & 7,,ii7 subject to ! limitations "u clause 7iv74 7ii7 ,*anges describ$ ,a *ange describ$ 9 ?is clause is a *ange subject to an ord] specifi$ 9 clause 7i71 :i*-- 7,i7 provides = a drug to conta9 an active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 n previ\sly incorporat$ 9 a drug describ$ 9 clause 7iii72 or 7,,ii7 provides = a *ange 9 ! conditions ( use ( a drug1 = :i* new human data /udies conduct$ or sponsor$ by ! reque/or 7or = :i* ! reque/or has an exclusive "r ( ref]5ce7 7 ess5tial to ! issuance ( su* ord]4 7iii7 ,drugs describ$ ,! drugs describ$ 9 ?is clause are drugs-- 7,i7 specifi$ 9 subsection 7a77#a71 7a77#b71 or 7a77#c72 7,,ii7 subject to a f9al ord] issu$ "u ?is section2 7,,iii7 subject to a f9al sunscre5 ord] 7z def9$ 9 section #ehf7b77;,a772 or 7,,iv7 describ$ 9 subsection 7m77#a71 o!r ?an drugs subject to an active en=cem5t action "u *apt] ,,iii ( ?is ,act4 7iv7 ,limitations on exclusivity 7,i7 ,9 g5]al ,only "o #ah-mon? p]iod "u ?is subp>agraph %all be grant$1 "u ea* ord] describ$ 9 clause 7i71 ) respect to *anges 7to ! drug subject to su* ord]7 :i* are ei!r-- 7aa7 *anges describ$ 9 clause 7ii77,i71 relat+ to active +r$i5ts2 or 7bb7 *anges describ$ 9 clause 7ii77,,ii71 relat+ to conditions ( use4 7,,ii7 ,no exclusivity all[$ ,no exclusivity %all apply to *anges to a drug :i* are-- 7aa7 ! subject ( a ,ti] #b ,,otc monograph ord] reque/ 7z def9$ 9 section #gdd,l72 7bb7 safety-relat$ *anges1 z def9$ by ! ,secret>y1 or any o!r *anges ! ,secret>y consid]s necess>y to assure safe use2 or 7cc7 *anges relat$ to me?ods ( te/+ safety or efficacy4 7v7 ,new human data /udies def9$ ,9 ?is subp>agraph1 ! t]m new human data /udies means cl9ical trials ( safety or effectiv5ess 7includ+ actual use /udies71 ph>macok9etics /udies1 or bioavailability /udies1 ! results ( :i*-- 7,i7 h n be5 reli$ on by ! ,secret>y to support-- 7aa7 a propos$ or f9al det]m9ation t a drug describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 ( clause 7iii7 is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 or 7bb7 approval ( a drug t 0 approv$ "u section #eje2 & 7,,ii7 d n duplicate ! results ( ano!r /udy t 0 reli$ on by ! ,secret>y to support-- 7aa7 a propos$ or f9al det]m9ation t a drug describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 ( clause 7iii7 is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 or 7bb7 approval ( a drug t 0 approv$ "u section #eje4 7#f7 ,in=mation reg>d+ safe nonprescription m>ket+ & use z condition = fil+ a g5]ally recogniz$ z safe & effective reque/ 7,a7 ,9 g5]al ,9 response to a reque/ "u ?is section t a drug describ$ 9 subp>agraph 7,b7 be g5]ally recogniz$ z safe & effective1 ! ,secret>y-- 7i7 may file su* reque/1 if ! reque/ includes in=mation specifi$ "u subp>agraph 7,c7 ) respect to safe nonprescription m>ket+ & use ( su* drug2 or 7ii7 if ! reque/ fails to include in=mation specifi$ "u subp>agraph 7,c71 %all refuse to file su* reque/ & require t nonprescription m>ket+ ( ! drug be pursuant to a new drug application z describ$ 9 subp>agraph 7,d74 7,b7 ,drug describ$ ,a drug describ$ 9 ?is subp>agraph is a nonprescription drug :i* conta9s an active +r$i5t n previ\sly incorporat$ 9 a drug-- 7i7 specifi$ 9 subsection 7a77#a71 7a77#b71 or 7a77#c72 7ii7 subject to a f9al ord] "u ?is section2 or 7iii7 subject to a f9al sunscre5 ord] 7z def9$ 9 section #ehf7b77;,a774 7,c7 ,in=mation demon/rat+ prima facie safe nonprescription m>ket+ & use ,in=mation specifi$ 9 ?is subp>agraph1 ) respect to a reque/ describ$ 9 subp>agraph 7,a77i71 is-- 7i7 in=mation suffici5t = a prima facie demon/ration t ! drug subject to su* reque/ has a v]ifiable hi/ory ( be+ m>ket$ & safely us$ by consum]s 9 ! ,unit$ ,/ates z a nonprescription drug "u comp>able conditions ( use2 7ii7 if ! drug has n be5 previ\sly m>ket$ 9 ! ,unit$ ,/ates z a nonprescription drug1 in=mation suffici5t = a prima facie demon/ration t ! drug 0 m>ket$ & safely us$ "u comp>able conditions ( m>ket+ & use 9 a c\ntry li/$ 9 section #hjb7;b77#a77;,a7 or designat$ by ! ,secret>y 9 accordance ) section #hjb7;b77#a77;,b7-- 7,i7 = su* p]iod z ne$$ to provide reasonable assurances conc]n+ ! safe nonprescription use ( ! drug2 & 7,,ii7 dur+ su* "t 0 subject to suffici5t monitor+ by a regulatory body consid]$ acceptable by ! ,secret>y = su* monitor+ purposes1 includ+ = adv]se ev5ts associat$ ) nonprescription use ( ! drug2 or 7iii7 if ! ,secret>y det]m9es t in=mation describ$ 9 clause 7i7 or 7ii7 is n ne$$ to provide a prima facie demon/ration t ! drug c be safely m>ket$ & us$ z a nonprescription drug1 su* o!r in=mation ! ,secret>y det]m9es is suffici5t = su* purposes4 7,d7 ,m>ket+ pursuant to new drug application ,9 ! case ( a reque/ describ$ 9 subp>agraph 7,a77ii71 ! drug subject to su* reque/ may be resubmitt$ = fil+ only if-- 7i7 ! drug is m>ket$ z a nonprescription drug1 "u conditions ( use comp>able to ! conditions specifi$ 9 ! reque/1 = su* p]iod z ! ,secret>y det]m9es appropriate 7n to exce$ #e consecutive ye>s7 pursuant to an application approv$ "u section #eje2 & 7ii7 dur+ su* p]iod1 #a1jjj1jjj retail packages ( ! drug1 or an equival5t quantity z det]m9$ by ! ,secret>y1 7 di/ribut$ = retail sale1 z det]m9$ 9 su* mann] z ! ,secret>y f9ds appropriate4 7,e7 ,rule ( application ,except 9 ! case ( a reque/ involv+ a drug describ$ 9 section #ehf7i71 z 9 effect on ,janu>y #a1 #bjag1 if ! ,secret>y refuses to file a reque/ "u ?is p>agraph1 ! reque/or may n file su* reque/ ov] prote/ "u p>agraph 7#e77;,a77iii74 7#g7 ,packag+ ,an adm9i/rative ord] issu$ "u p>agraph 7#b71 7#d77;,a71 or 7#e7 may include requirem5ts = ! packag+ ( a drug to enc\rage use 9 accordance ) label+4 ,su* requirem5ts may include unit dose packag+1 requirem5ts = products int5d$ = use by p$iatric populations1 requirem5ts to r$uce risk ( h>m f unsup]vis$ +e/ion1 & o!r appropriate requirem5ts4 ,?is p>agraph does n au?orize ! ,food & ,drug ,adm9i/ration to require /&>ds or te/+ proc$ures z describ$ 9 "p #agjj ( title #af1 ,code ( ,f$]al ,regulations4 7#h7 ,f9al & t5tative f9al monographs = category ,i drugs deem$ f9al adm9i/rative ord]s 7,a7 ,9 g5]al ,a f9al monograph or t5tative f9al monograph describ$ 9 subp>agraph 7,b7 %all be deem$ to be a f9al adm9i/rative ord] "u ?is subsection & may be am5d$1 revok$1 or o!rwise modifi$ 9 accordance ) ! proc$ures ( ?is subsection4 7,b7 ,monographs describ$ ,= purposes ( subp>agraph 7,a71 a f9al monograph or t5tative f9al monograph is describ$ 9 ?is subp>agraph if x-- 7i7 e/abli%es conditions ( use = a drug describ$ 9 p>agraph 7#a7 or 7#b7 ( subsection 7a72 & 7ii7 repres5ts ! mo/ rec5tly promulgat$ v]sion ( su* conditions1 includ+ z modifi$1 9 :ole or 9 "p1 by any propos$ or f9al rule4 7,c7 ,deem$ ord]s include h>moniz+ te*nical am5dm5ts ,! deem$ e/abli%m5t ( a f9al adm9i/rative ord] "u subp>agraph 7,a7 %all be con/ru$ to include any te*nical am5dm5ts to su* ord] z ! ,secret>y det]m9es necess>y to ensure t su* ord] is appropriately h>moniz$1 9 t]ms ( t]m9ology or cross-ref]5ces1 ) ! applicable provisions ( ?is ,act 7& regulations !reund]7 & any o!r ord]s issu$ "u ?is section4 7c7 ,proc$ure = m9or *anges 7#a7 ,9 g5]al ,m9or *anges 9 ! dosage =m ( a drug t is describ$ 9 p>agraph 7#a7 or 7#b7 ( subsection 7a7 or ! subject ( an ord] issu$ "u subsection 7b7 may be made by a reque/or )\t ! issuance ( an ord] "u subsection 7b7 if-- 7,a7 ! reque/or ma9ta9s su* in=mation z is necess>y to demon/rate t ! *ange-- 7i7 w n affect ! safety or effectiv5ess ( ! drug2 & 7ii7 w n mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t 9 comp>ison to a suitable ref]5ce product2 & 7,b7 ! *ange is 9 con=mity ) ! requirem5ts ( an applicable adm9i/rative ord] issu$ by ! ,secret>y "u p>agraph 7#c74 7#b7 ,additional in=mation 7,a7 ,access to records ,a sponsor %all submit records reque/$ by ! ,secret>y relat+ to su* a m9or *ange "u section #gjd7;a77#d71 )9 #ae bus9ess days ( receiv+ su* a reque/1 or su* long] p]iod z ! ,secret>y may provide4 7,b7 ,insuffici5t in=mation ,if ! ,secret>y det]m9es t ! in=mation conta9$ 9 su* records is n suffici5t to demon/rate t ! *ange does n affect ! safety or effectiv5ess ( ! drug or mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t1 ! ,secret>y-- 7i7 may s in=m ! sponsor ( ! drug 9 writ+2 & 7ii7 if ! ,secret>y s in=ms ! sponsor1 %all provide ! sponsor ( ! drug ) a reasonable opportunity to provide additional in=mation4 7,c7 ,failure to submit suffici5t in=mation ,if ! sponsor fails to provide su* additional in=mation )9 a "t prescrib$ by ! ,secret>y1 or if ! ,secret>y det]m9es t su* additional in=mation does n demon/rate t ! *ange does n-- 7i7 affect ! safety or effectiv5ess ( ! drug2 or 7ii7 mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t 9 comp>ison to a suitable ref]5ce product1 ! drug z modifi$ is a new drug "u section #bja7p7 & %all be deem$ to be misbr&$ "u section #ejb7;ee74 7#c7 ,det]m9+ :e!r a *ange w affect safety or effectiv5ess 7,a7 ,9 g5]al ,! ,secret>y %all issue "o or m adm9i/rative ord]s specify+ requirem5ts = det]m9+ :e!r a m9or *ange made by a sponsor pursuant to ?is subsection w affect ! safety or effectiv5ess ( a drug or mat]ially affect ! ext5t ( absorption or o!r exposure to an active +r$i5t 9 ! drug 9 comp>ison to a suitable ref]5ce product1 toge!r ) guidance = apply+ ^? ord]s to specific dosage =ms4 7,b7 ,/&>d practices ,! ord]s & guidance issu$ by ! ,secret>y "u subp>agraph 7,a7 %all take into acc\nt relevant public /&>ds & /&>d practices = evaluat+ ! quality ( drugs1 & may take into acc\nt ! special ne$s ( populations1 includ+ *ildr54 7d7 ,confid5tiality ( in=mation submitt$ to ! ,secret>y 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 any in=mation1 includ+ reports ( te/+ conduct$ on ! drug or drugs involv$1 t is submitt$ by a reque/or 9 connection ) proce$+s on an ord] "u ?is section 7includ+ any m9or *ange "u subsection 7c77 & is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code1 %all n be disclos$ to ! public unless ! reque/or cons5ts to t disclosure4 7#b7 ,public availability 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ! ,secret>y %all-- 7i7 make any in=mation submitt$ by a reque/or 9 support ( a reque/ "u subsection 7b77#e77;,a7 available to ! public n lat] ?an ! date on :i* ! propos$ ord] is issu$2 & 7ii7 make any in=mation submitt$ by any o!r p]son ) respect to an ord] reque/$ 7or initiat$ by ! ,secret>y7 "u subsection 7b71 available to ! public ^u su* submission4 7,b7 ,limitations on public availability ,in=mation describ$ 9 subp>agraph 7,a7 %all n be made public if-- 7i7 ! in=mation p]ta9s to ph>maceutical quality in=mation1 unless su* in=mation is necess>y to e/abli% /&>ds "u :i* a drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 7ii7 ! in=mation is submitt$ 9 a reque/or-initiat$ reque/1 b ! reque/or )draws su* reque/1 9 accordance ) )drawal proc$ures e/abli%$ by ! ,secret>y1 be=e ! ,secret>y issues ! propos$ ord]2 7iii7 ! ,secret>y reque/s & obta9s ! in=mation "u subsection 7c7 & su* in=mation is n submitt$ 9 relation to an ord] "u subsection 7b72 or 7iv7 ! in=mation is ( ! type conta9$ 9 raw datasets4 7e7 ,updates to drug li/+ in=mation ,a sponsor :o makes a *ange to a drug subject to ?is section %all submit updat$ drug li/+ in=mation = ! drug 9 accordance ) section #eaj7;j7 )9 #cj cal5d> days ( ! date :5 ! drug is fir/ comm]cially m>ket$1 except t a sponsor :o 0 ! ord] reque/or ) respect to an ord] subject to subsection 7b77#e77;,c7 7or a lic5see1 assignee1 or successor 9 int]e/ ( su* reque/or7 %all submit updat$ drug li/+ in=mation on or be=e ! date :5 ! drug is fir/ comm]cially m>ket$4 7f7 ,approvals "u section #eje ,! provisions ( ?is section %all n be con/ru$ to preclude a p]son f seek+ or ma9ta9+ ! approval ( an application = a drug "u sections #eje7;b77#a71 #eje7;b77#b71 & #eje7;j74 ,a det]m9ation "u ?is section t a drug is n subject to section #ejc7;b77#a71 is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 & is n a new drug "u section #bja7p7 %all con/itute a f9d+ t ! drug is safe & effective t may be reli$ ^u = purposes ( an application "u section #eje7;b77#b71 s t ! applicant %all be requir$ to submit = purposes ( su* application only in=mation ne$$ to support any modification ( ! drug t is n cov]$ by su* det]m9ation "u ?is section4 7g7 ,public availability ( adm9i/rative ord]s ,! ,secret>y %all e/abli%1 ma9ta91 update 7z det]m9$ necess>y by ! ,secret>y b no less frequ5tly ?an annually71 & make publicly available1 ) respect to ord]s issu$ "u ?is section-- 7#a7 a repository ( ea* f9al ord] & int]im f9al ord] 9 effect1 includ+ ! complete text ( ! ord]2 & 7#b7 a li/+ ( all ord]s propos$ & "u developm5t "u subsection 7b77#b71 includ+-- 7,a7 a brief description ( ea* su* ord]2 & 7,b7 ! ,secret>y's expectations1 if res\rces p]mit1 = issuance ( propos$ ord]s ov] a #c-ye> p]iod4 7h7 ,developm5t advice to sponsors or reque/ors ,! ,secret>y %all e/abli% proc$ures "u :i* sponsors or reque/ors may meet ) appropriate (ficials ( ! ,food & ,drug ,adm9i/ration to obta9 advice on ! /udies & o!r in=mation necess>y to support submissions "u ?is section & o!r matt]s relevant to ! regulation ( nonprescription drugs & ! developm5t ( new nonprescription drugs "u ?is section4 7i7 ,p>ticipation ( multiple sponsors or reque/ors ,! ,secret>y %all e/abli% proc$ures to facilitate effici5t p>ticipation by multiple sponsors or reque/ors 9 proce$+s "u ?is section1 includ+ provision = jo9t meet+s ) multiple sponsors or reque/ors or ) organizations nom9at$ by sponsors or reque/ors to repres5t _! int]e/s 9 a proce$+4 7j7 ,electronic =mat ,all submissions "u ?is section %all be 9 electronic =mat4 7k7 ,effect on exi/+ regulations gov]n+ nonprescription drugs 7#a7 ,regulations ( g5]al applicability to nonprescription drugs ,except z provid$ 9 ?is subsection1 no?+ 9 ?is section sup]s$es regulations e/abli%+ g5]al requirem5ts = nonprescription drugs1 includ+ regulations ( g5]al applicability conta9$ 9 p>ts #bja1 #bej1 & #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 or any successor regulations4 ,! ,secret>y %all e/abli% or modify su* regulations by means ( rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,regulations e/abli%+ requirem5ts = specific nonprescription drugs 7,a7 ,! provisions ( section #caj4ede ( title #ba1 ,code ( ,f$]al ,regulations1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section1 %all be deem$ to be a f9al ord] "u subsection 7b74 7,b7 ,regulations 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section1 e/abli%+ requirem5ts = specific nonprescription drugs m>ket$ pursuant to ?is section 7includ+ su* requirem5ts 9 p>ts #bja & #bej ( title #ba1 ,code ( ,f$]al ,regulations71 %all be deem$ to be f9al ord]s "u subsection 7b71 only z !y apply to drugs-- 7i7 subject to p>agraph 7#a71 7#b71 7#c71 or 7#d7 ( subsection 7a72 or 7ii7 o!rwise subject to an ord] "u ?is section4 7#c7 ,)drawal ( regulations ,! ,secret>y %all )draw regulations e/abli%+ f9al monographs & ! proc$ures gov]n+ ! ov]-!-c\nt] drug review "u "p #ccj & o!r relevant p>ts ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section71 or make te*nical *anges to su* regulations to ensure con=mity ) appropriate t]m9ology & cross ref]5ces4 ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 any su* )drawal or te*nical *anges %all be made )\t public notice & comm5t & %all be effective ^u publication ?r\gh notice 9 ! ,f$]al ,regi/] 7or ^u su* date z specifi$ 9 su* notice74 7l7 ,guidance ,! ,secret>y %all issue guidance t specifies-- 7#a7 ! proc$ures & pr9ciples = =mal meet+s betwe5 ! ,secret>y & sponsors or reque/ors = drugs subject to ?is section2 7#b7 ! =mat & cont5t ( data submissions to ! ,secret>y "u ?is section2 7#c7 ! =mat ( electronic submissions to ! ,secret>y "u ?is section2 7#d7 consolidat$ proce$+s = appeal & ! proc$ures = su* proce$+s :]e appropriate2 & 7#e7 = m9or *anges 9 drugs1 recomm5dations on h[ to comply ) ! requirem5ts 9 ord]s issu$ "u subsection 7c77#c74 7m7 ,rule ( con/ruction 7#a7 ,9 g5]al ,?is section %all n affect ! treatm5t or /atus ( a nonprescription drug-- 7,a7 t is m>ket$ )\t an application approv$ "u section #eje z ( ! date ( ! enactm5t ( ?is section2 7,b7 t is n subject to an ord] issu$ "u ?is section2 & 7,c7 to :i* p>agraphs 7#a71 7#b71 7#c71 7#d71 or 7#e7 ( subsection 7a7 d n apply4 7#b7 ,treatm5t ( products previ\sly f\nd to be subject to "t & ext5t requirem5ts 7,a7 ,not)/&+ subsection 7a71 a drug describ$ 9 subp>agraph 7,b7 may only be lawfully m>ket$1 )\t an application approv$ "u section #eje1 pursuant to an ord] issu$ "u ?is section4 7,b7 ,a drug describ$ 9 ?is subp>agraph is a drug :i*1 prior to ! date ( ! enactm5t ( ?is section1 ! ,secret>y det]m9$ 9 a propos$ or f9al rule to be ineligible = review "u ! ,,otc drug review 7z su* phrase ,,otc drug review 0 us$ 9 section #ccj4ad ( title #ba1 ,code ( ,f$]al ,regulations1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section74 7#c7 ,pres]vation ( au?ority 7,a7 ,no?+ 9 p>agraph 7#a7 %all be con/ru$ to preclude or limit ! applicability ( any provision ( ?is ,act o!r ?an ?is section4 7,b7 ,no?+ 9 subsection 7a7 %all be con/ru$ to prohibit ! ,secret>y f issu+ an ord] "u ?is section f9d+ a drug to be n g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 z ! ,secret>y det]m9es appropriate4 7n7 ,inve/igational new drugs ,a drug is n subject to ?is section if an exemption = inve/igational use "u section #eje7;i7 is 9 effect = su* drug4 7o7 ,inapplicability ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to collections ( in=mation made "u ?is section4 7p7 ,inapplicability ( notice & comm5t rulemak+ & o!r requirem5ts ,! requirem5ts ( subsection 7b7 %all apply ) respect to ord]s issu$ "u ?is section in/ead ( ! requirem5ts ( sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7q7 ,def9itions ,9 ?is section3 7#a7 ,! t]m nonprescription drug ref]s to a drug n subject to ! requirem5ts ( section #ejc7;b77#a74 7#b7 ,! t]m sponsor ref]s to any p]son m>ket+1 manufactur+1 or process+ a drug t-- 7,a7 is li/$ pursuant to section #eaj7;j72 & 7,b7 is or w be subject to an adm9i/rative ord] "u ?is section ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,! t]m reque/or ref]s to any p]son or gr\p ( p]sons m>ket+1 manufactur+1 process+1 or develop+ a drug4 4 7b7 ,,gao /udy ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a /udy to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate address+ ! effectiv5ess & ov]all impact ( exclusivity "u section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 & section #ehf;,c ( su* ,act 7#ba ,u4,s4,c4 #cfj;fff-#c71 includ+ ! impact ( su* exclusivity on consum] access4 ,su* /udy %all include-- 7#a7 an analysis ( ! impact ( exclusivity "u su* section #eje;,g = nonprescription drug products1 includ+-- 7,a7 ! numb] ( nonprescription drug products t 7 grant$ exclusivity & ! indication = :i* ! nonprescription drug products 7 det]m9$ to be g5]ally recogniz$ z safe & effective2 7,b7 :e!r ! exclusivity = su* drug products 0 grant$ =-- 7i7 a new active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t72 or 7ii7 *anges 9 ! conditions ( use ( a drug1 = :i* new human data /udies conduct$ or sponsor$ by ! reque/or 7 ess5tial2 7,c7 :e!r1 & to :at ext5t1 ! exclusivity impact$ ! reque/or's or sponsor's decision to develop ! drug product2 7,d7 an analysis ( ! implem5tation ( ! exclusivity provision 9 su* section #eje;,g1 includ+-- 7i7 ! res\rces us$ by ! ,food & ,drug ,adm9i/ration2 7ii7 ! impact ( su* provision on innovation1 z well z rese>* & developm5t 9 ! nonprescription drug m>ket2 7iii7 ! impact ( su* provision on competition 9 ! nonprescription drug m>ket2 7iv7 ! impact ( su* provision on consum] access to nonprescription drug products2 7v7 ! impact ( su* provision on ! prices ( nonprescription drug products2 & 7vi7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #eje;,g h be5 suffici5t to enc\rage ! developm5t ( nonprescription drug products t w\ld likely n be o!rwise develop$1 or develop$ 9 z timely a mann]2 & 7,e7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #eje;,g h be5 suffici5t inc5tive to enc\rage innovation 9 ! nonprescription drug m>ket2 & 7#b7 an analysis ( ! impact ( exclusivity "u su* section #ehf;,c = sunscre5 +r$i5ts1 includ+-- 7,a7 ! numb] ( sunscre5 +r$i5ts t 7 grant$ exclusivity & ! specific +r$i5t t 0 det]m9$ to be g5]ally recogniz$ z safe & effective2 7,b7 :e!r1 & to :at ext5t1 ! exclusivity impact$ ! reque/or's or sponsor's decision to develop ! sunscre5 +r$i5t2 7,c7 :e!r1 & to :at ext5t1 ! sunscre5 +r$i5t grant$ exclusivity _h previ\sly be5 available outside ( ! ,unit$ ,/ates2 7,d7 an analysis ( ! implem5tation ( ! exclusivity provision 9 su* section #ehf;,c1 includ+-- 7i7 ! res\rces us$ by ! ,food & ,drug ,adm9i/ration2 7ii7 ! impact ( su* provision on innovation1 z well z rese>* & developm5t 9 ! sunscre5 m>ket2 7iii7 ! impact ( su* provision on competition 9 ! sunscre5 m>ket2 7iv7 ! impact ( su* provision on consum] access to sunscre5 products2 7v7 ! impact ( su* provision on ! prices ( sunscre5 products2 & 7vi7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #eje;,g h be5 utiliz$ by sunscre5 +r$i5t sponsors & :e!r su* process has be5 suffici5t to enc\rage ! developm5t ( sunscre5 +r$i5ts t w\ld likely n be o!rwise develop$1 or develop$ 9 z timely a mann]2 & 7,e7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #ehf;,c h be5 suffici5t inc5tive to enc\rage innovation 9 ! sunscre5 m>ket4 7c7 ,con=m+ am5dm5t ,section #gea7;d77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgir7d77#a77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7 by /rik+ f9al regulation promulgat$ & ins]t+ f9al ord] "u section #eje;,g2 & 7,b7 by /rik+ & n misbr&$2 & 7#b7 9 subp>agraph 7,a71 by /rik+ regulation 9 effect & ins]t+ regulation or ord] 9 effect4 #cgb4 ,misbr&+ ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7ee7 ,if x is a nonprescription drug t is subject to section #eje;,g1 is n ! subject ( an application approv$ "u section #eje1 & does n comply ) ! requirem5ts "u section #eje;,g4 7ff7 ,if x is a drug & x 0 manufactur$1 prep>$1 propagat$1 comp\nd$1 or process$ 9 a facility = :i* fees h n be5 paid z requir$ by section #gdd,m4 4 #cgc4 ,drugs exclud$ f ! ov]-!-c\nt] drug review 7a7 ,9 g5]al ,no?+ 9 ?is ,act 7or ! am5dm5ts made by ?is ,act7 %all apply to any nonprescription drug 7z def9$ 9 section #eje;,g7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act7 :i* 0 exclud$ by ! ,food & ,drug ,adm9i/ration f ! ,ov]-!-,c\nt] ,drug ,review 9 accordance ) ! p>agraph numb]$ #be on page #idff ( volume #cg ( ! ,f$]al ,regi/]1 publi%$ on ,may #aa1 #aigb4 7b7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to preclude or limit ! applicability ( any o!r provision ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #cgd4 ,treatm5t ( ,sunscre5 ,innovation ,act 7a7 ,review ( nonprescription sunscre5 active +r$i5ts 7#a7 ,applicability ( section #eje;,g = p5d+ submissions 7,a7 ,9 g5]al ,a sponsor ( a nonprescription sunscre5 active +r$i5t or comb9ation ( nonprescription sunscre5 active +r$i5ts t1 z ( ! date ( enactm5t ( ?is ,act1 is subject to a propos$ sunscre5 ord] "u section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 may elect1 by means ( giv+ writt5 notification to ! ,secret>y ( ,heal? & ,human ,s]vices )9 #ahj cal5d> days ( ! enactm5t ( ?is ,act1 to transition into ! review ( su* +r$i5t or comb9ation ( +r$i5ts pursuant to ! process set out 9 section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act4 7,b7 ,election ex]cis$ ,^u receipt by ! ,secret>y ( ,heal? & ,human ,s]vices ( a timely notification "u subp>agraph 7,a7-- 7i7 ! propos$ sunscre5 ord] involv$ is deem$ to be a reque/ = an ord] "u subsection 7b7 ( section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act2 & 7ii7 su* ord] is deem$ to h be5 accept$ = fil+ "u subsection 7b77#f77;,a77i7 ( su* section #eje;,g4 7,c7 ,election n ex]cis$ ,if a notification "u subp>agraph 7,a7 is n receiv$ by ! ,secret>y ( ,heal? & ,human ,s]vices )9 #ahj cal5d> days ( ! date ( enactm5t ( ?is ,act1 ! review ( ! propos$ sunscre5 ord] describ$ 9 subp>agraph 7,a7-- 7i7 %all cont9ue "u section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c72 & 7ii7 %all n be eligible = review "u section #eje;,g1 add$ by section #ajja ( ?is ,act4 7#b7 ,def9itions ,9 ?is subsection1 ! t]ms sponsor1 nonprescription1 sunscre5 active +r$i5t1 & propos$ sunscre5 ord] h ! mean+s giv5 to ^? t]ms 9 section #ehf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff74 7b7 ,am5dm5ts to sunscre5 provisions 7#a7 ,f9al sunscre5 ord]s ,p>agraph 7#c7 ( section #ehf;,c7e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;e77 is am5d$ to read z foll[s3 7#c7 ,relation%ip to ord]s "u section #eje;,g ,a f9al sunscre5 ord] %all be deem$ to be a f9al ord] "u section #eje;,g4 4 7#b7 ,meet+s ,p>agraph 7#g7 ( section #ehf;,c7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;b77 is am5d$-- 7,a7 by /rik+ ,a sponsor may reque/ & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,a sponsor may reque/ 2 & 7,b7 by add+ at ! end ! foll[+3 7,b7 ,confid5tial meet+s ,a sponsor may reque/ "o or m confid5tial meet+s ) respect to a propos$ sunscre5 ord]1 includ+ a lett] deem$ to be a propos$ sunscre5 ord] "u p>agraph 7#c71 to discuss matt]s relat+ to data requirem5ts to support a g5]al recognition ( safety & effectiv5ess involv+ confid5tial in=mation & public in=mation relat$ to su* propos$ sunscre5 ord]1 z appropriate4 ,! ,secret>y %all conv5e a confid5tial meet+ ) su* sponsor 9 a reasonable "t p]iod4 ,if a sponsor reque/s m ?an "o confid5tial meet+ = ! same propos$ sunscre5 ord]1 ! ,secret>y may refuse to grant an additional confid5tial meet+ reque/ if ! ,secret>y det]m9es t su* additional confid5tial meet+ is n reasonably necess>y = ! sponsor to advance its propos$ sunscre5 ord]1 or if ! reque/ = a confid5tial meet+ fails to include suffici5t in=mation ^u :i* to base a sub/antive discussion4 ,! ,secret>y %all publi% a po/-meet+ summ>y ( ea* confid5tial meet+ "u ?is subp>agraph t does n disclose confid5tial comm]cial in=mation or trade secrets4 ,?is subp>agraph does n au?orize ! disclosure ( confid5tial comm]cial in=mation or trade secrets subject to #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 7#c7 ,exclusivity ,section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,exclusivity 7#a7 ,9 g5]al ,a f9al sunscre5 ord] %all h ! effect ( au?oriz+ solely ! ord] reque/or 7or ! lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* reque/ & li/$ "u p>agraph 7#e77 = a p]iod ( #ah mon?s1 to m>ket a sunscre5 +r$i5t "u ?is section incorporat+ *anges describ$ 9 p>agraph 7#b7 subject to ! limitations "u p>agraph 7#d71 beg9n+ on ! date ! reque/or 7or any lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* reque/ & li/$ "u p>agraph 7#e77 may lawfully m>ket su* sunscre5 +r$i5t pursuant to ! ord]4 7#b7 ,*anges describ$ ,a *ange describ$ 9 ?is p>agraph is a *ange subject to an ord] specifi$ 9 p>agraph 7#a7 t p]mits a sunscre5 to conta9 an active sunscre5 +r$i5t n previ\sly incorporat$ 9 a m>ket$ sunscre5 li/$ 9 p>agraph 7#c74 7#c7 ,m>ket$ sunscre5 ,! m>ket$ sunscre5 +r$i5ts describ$ 9 ?is p>agraph are sunscre5 +r$i5ts-- 7,a7 m>ket$ 9 accordance ) a f9al monograph = sunscre5 drug products set =? at "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations 7z publi%$ at #fd ,f$4 ,reg4 #bgfhg72 or 7,b7 m>ket$ 9 accordance ) a f9al ord] issu$ "u ?is section4 7#d7 ,limitations on exclusivity ,only "o #ah-mon? p]iod may be grant$ p] +r$i5t "u p>agraph 7#a74 7#e7 ,li/+ ( lic5sees1 assignees1 or successors 9 int]e/ ,reque/ors %all submit to ! ,secret>y at ! "t :5 a drug subject to su* reque/ is introduc$ or deliv]$ = introduction into int]/ate comm]ce1 a li/ ( lic5sees1 assignees1 or successors 9 int]e/ "u p>agraph 7#a74 4 7#d7 ,sunset provision ,sub*apt] ,i ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff et seq47 is am5d$ by add+ at ! end ! foll[+3 #ehf;,h4 ,sunset ,?is sub*apt] %all cease to be effective at ! end ( fiscal ye> #bjbb4 4 7#e7 ,treatm5t ( f9al sunscre5 ord] ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by /rik+ section #ehf;,e ( su* ,act 7#ba ,u4,s4,c4 #cfj;fff-#e74 7c7 ,treatm5t ( ,au?ority ,reg>d+ ,f9alization ( ,sunscre5 ,monograph 7#a7 ,9 g5]al 7,a7 ,revision ( f9al sunscre5 ord] ,n lat] ?an ,novemb] #bf1 #bjai1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all am5d & revise ! f9al adm9i/rative ord] conc]n+ nonprescription sunscre5 7ref]r$ to 9 ?is subsection z ! sunscre5 ord]7 = :i* ! cont5t1 prior to ! date ( enactm5t ( ?is ,act1 0 repres5t$ by ! f9al monograph = sunscre5 drug products set =? 9 "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect on ,may #ba1 #aiii74 7,b7 ,issuance ( revis$ sunscre5 ord]2 effective date ,a revis$ sunscre5 ord] describ$ 9 subp>agraph 7,a7 %all be-- 7i7 issu$ 9 accordance ) ! proc$ures describ$ 9 section #eje;,g7c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7ii7 issu$ 9 propos$ =m n lat] ?an ,may #bh1 #bjai2 7iii7 effective n lat] ?an ,novemb] #bf1 #bjbj2 & 7iv7 issu$ by ! ,secret>y at lea/ #a ye> prior to ! effective date ( ! revis$ ord]4 7#b7 ,reports ,if a revis$ sunscre5 ord] issu$ "u p>agraph 7#a7 does n include provisions relat$ to ! effectiv5ess ( v>i\s sun protection factor levels1 & does n address all dosage =ms kn[n to ! ,secret>y to be us$ 9 sunscre5s m>ket$ 9 ! ,unit$ ,/ates )\t a new drug application approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 ! ,secret>y %all submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate on ! rationale = omission ( su* provisions f su* ord]1 & a plan & timel9e to compile any in=mation necess>y to address su* provisions ?r\gh su* ord]4 7d7 ,treatm5t ( non-,sunscre5 "t & ext5t applications 7#a7 ,9 g5]al ,any application describ$ 9 section #ehf;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#f7 t 0 submitt$ to ! ,secret>y pursuant to section #ccj4ad ( title #ba1 ,code ( ,f$]al ,regulations1 z su* provisions 7 9 effect imm$iately prior to ! date ( enactm5t date ( ?is ,act1 %all be ext+ui%$ z ( su* date ( enactm5t1 subject to p>agraph 7#b74 7#b7 ,ord] reque/ ,no?+ 9 p>agraph 7#a7 precludes ! submission ( an ord] reque/ "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act1 ) respect to a drug t 0 ! subject ( an application ext+ui%$ "u p>agraph 7#a74 #cge4 ,annual update to ,congress on appropriate p$iatric indication = c]ta9 ,,otc c\gh & cold drugs 7a7 ,9 g5]al ,subject to subsection 7c71 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 annually submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a lett] describ+ ! progress ( ! ,food & ,drug ,adm9i/ration-- 7#a7 9 evaluat+ ! c\gh & cold monograph describ$ 9 subsection 7b7 ) respect to *ildr5 "u age #f2 & 7#b7 z appropriate1 revis+ su* c\gh & cold monograph to address su* *ildr5 ?r\gh ! ord] process "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act4 7b7 ,c\gh & cold monograph describ$ ,! c\gh & cold monograph describ$ 9 ?is subsection consi/s ( ! conditions "u :i* nonprescription drugs conta9+ antitussive1 expectorant1 nasal deconge/ant1 or antihi/am9e active +r$i5ts 7or comb9ations !re(7 are g5]ally recogniz$ z safe & effective1 z specifi$ 9 "p #cda ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect imm$iately prior to ! date ( enactm5t ( ?is ,act71 & includ$ 9 an ord] deem$ to be e/abli%$ "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act4 7c7 ,duration ( au?ority ,! requirem5t "u subsection 7a7 %all t]m9ate z ( ! date ( a lett] submitt$ by ! ,secret>y ( ,heal? & ,human ,s]vices pursuant to su* subsection 9 :i* ! ,secret>y indicates t ! ,food & ,drug ,adm9i/ration has complet$ its evaluation & revis$1 9 a f9al ord]1 z applicable1 ! c\gh & cold monograph z describ$ 9 subsection 7a77#b74 #cgf4 ,te*nical corrections 7a7 ,imports & exports ,section #hja7;e77#d77;,e77iii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77;,e77iii77 is am5d$ by /rik+ subp>agraph ea* place su* t]m appe>s & ins]t+ p>agraph4 7b7 ,,fda ,reau?orization ,act ( #bjag 7#a7 ,9 g5]al ,section #ije7;b77#d7 ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 is am5d$ by /rik+ ,section #gdd;,h7e77#b77;,b7 & ins]t+ ,section #gdd;,h7f77#b77;,b74 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all take effect z ( ! enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb74 #b ,us] ,fees #cha4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is "p may be cit$ z ! ,ov]-!-,c\nt] ,monograph ,us] ,fee ,act ( #bjai4 7b7 ,f9d+ ,! ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is "p w be d$icat$ to ,,otc monograph drug activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #aj ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #chb4 ,fees relat+ to ov]-!-c\nt] drugs ,sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is am5d$ by ins]t+ aft] "p #i ! foll[+3 #aj ,fees ,relat+ to ,ov]-!-,c\nt] ,drugs #gdd,l4 ,def9itions ,9 ?is "p3 7#a7 ,! t]m affiliate means a bus9ess entity t has a relation%ip ) a second bus9ess entity if1 directly or indirectly-- 7,a7 "o bus9ess entity controls1 or has ! p[] to control1 ! o!r bus9ess entity2 or 7,b7 a ?ird p>ty controls1 or has p[] to control1 bo? ( ! bus9ess entities4 7#b7 ,! t]m contract manufactur+ organization facility means an ,,otc monograph drug facility :]e nei!r ! own] ( su* manufactur+ facility nor any affiliate ( su* own] or facility sells ! ,,otc monograph drug produc$ at su* facility directly to :olesal]s1 retail]s1 or consum]s 9 ! ,unit$ ,/ates4 7#c7 ,! t]m co/s ( res\rces allocat$ = ,,otc monograph drug activities means ! exp5ses 9 connection ) ,,otc monograph drug activities =-- 7,a7 (fic]s & employees ( ! ,food & ,drug ,adm9i/ration1 contractors ( ! ,food & ,drug ,adm9i/ration1 advisory committees1 & co/s relat$ to su* (fic]s1 employees1 & committees & co/s relat$ to contracts ) su* contractors2 7,b7 managem5t ( in=mation1 & ! acquisition1 ma9t5ance1 & repair ( comput] res\rces2 7,c7 leas+1 ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture1 sci5tific equipm5t1 & o!r necess>y mat]ials & supplies2 & 7,d7 collect+ fees "u section #gdd,m & acc\nt+ = res\rces allocat$ = ,,otc monograph drug activities4 7#d7 ,! t]m ,,fda e/abli%m5t id5tifi] is ! unique numb] automatically g5]at$ by ,food & ,drug ,adm9i/ration's ,field ,accompli%m5ts & ,compliance ,track+ ,sy/em 7,,facts7 7or any successor sy/em74 7#e7 ,! t]m ,,otc monograph drug means a nonprescription drug )\t an approv$ new drug application :i* is gov]n$ by ! provisions ( section #eje;,g4 7#f7 ,! t]m ,,otc monograph drug activities means activities ( ! ,secret>y associat$ ) ,,otc monograph drugs & inspection ( facilities associat$ ) su* products1 includ+ ! foll[+ activities3 7,a7 ,! activities necess>y = review & evaluation ( ,,otc monographs & ,,otc monograph ord] reque/s1 includ+-- 7i7 ord]s propos+ or f9aliz+ applicable conditions ( use = ,,otc monograph drugs2 7ii7 ord]s affect+ /atus reg>d+ g5]al recognition ( safety & effectiv5ess ( an ,,otc monograph +r$i5t or comb9ation ( +r$i5ts "u specifi$ conditions ( use2 7iii7 all ,,otc monograph drug developm5t & review activities1 includ+ intra-ag5cy collaboration2 7iv7 regulation & policy developm5t activities relat$ to ,,otc monograph drugs2 7v7 developm5t ( product /&>ds = products subject to review & evaluation2 7vi7 meet+s ref]r$ to 9 section #eje;,g7i72 7vii7 review ( label+ prior to issuance ( ord]s relat$ to ,,otc monograph drugs or conditions ( use2 & 7viii7 regulatory sci5ce activities relat$ to ,,otc monograph drugs4 7,b7 ,inspections relat$ to ,,otc monograph drugs4 7,c7 ,monitor+ ( cl9ical & o!r rese>* conduct$ 9 connection ) ,,otc monograph drugs4 7,d7 ,safety activities ) respect to ,,otc monograph drugs1 includ+-- 7i7 collect+1 develop+1 & review+ safety in=mation on ,,otc monograph drugs1 includ+ adv]se ev5t reports2 7ii7 develop+ & us+ improv$ adv]se ev5t data-collection sy/ems1 includ+ in=mation te*nology sy/ems2 & 7iii7 develop+ & us+ improv$ analytical tools to assess pot5tial safety risks1 includ+ access to ext]nal databases4 7,e7 ,o!r activities necess>y = implem5tation ( section #eje;,g4 7#g7 ,! t]m ,,otc monograph ord] reque/ means a reque/ = an ord] submitt$ "u section #eje;,g7b77#e74 7#h7 ,! t]m ,ti] #a ,,otc monograph ord] reque/ means any ,,otc monograph ord] reque/ n det]m9$ to be a ,ti] #b ,,otc monograph ord] reque/4 7#i7 7,a7 ,! t]m ,ti] #b ,,otc monograph ord] reque/ means1 subject to subp>agraph 7,b71 an ,,otc monograph ord] reque/ =-- 7i7 ! reord]+ ( exi/+ in=mation 9 ! drug facts label ( an ,,otc monograph drug2 7ii7 ! addition ( in=mation to ! o!r in=mation section ( ! drug facts label ( an ,,otc monograph drug1 z limit$ by section #bja4ff7;c77#g7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7iii7 modification to ! directions = use section ( ! drug facts label ( an ,,otc monograph drug1 if su* *anges con=m to *anges made pursuant to section #eje;,g7c77#c77;,a72 7iv7 ! /&>dization ( ! conc5tration or dose ( a specific f9aliz$ +r$i5t )9 a p>ticul> f9aliz$ monograph2 7v7 a *ange to +r$i5t nom5clature to align ) nom5clature ( a /&>ds-sett+ organization2 or 7vi7 addition ( an int]*angeable t]m 9 accordance ) section #ccj4a ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,b7 ,! ,secret>y may1 bas$ on program implem5tation exp]i5ce or o!r factors f\nd appropriate by ! ,secret>y1 *>act]ize any ,,otc monograph ord] reque/ z a ,ti] #b ,,otc monograph ord] reque/ 7includ+ re*>act]iz+ a reque/ f ,ti] #a to ,ti] #b7 & publi% su* det]m9ation 9 a propos$ ord] issu$ pursuant to section #eje;,g4 7#aj7 7,a7 ,! t]m ,,otc monograph drug facility means a =eign or dome/ic bus9ess or o!r entity t-- 7i7 is-- 7,i7 "u "o managem5t1 ei!r direct or indirect2 & 7,,ii7 at "o geographic location or address engag$ 9 manufactur+ or process+ ! f9i%$ dosage =m ( an ,,otc monograph drug2 7ii7 includes a f9i%$ dosage =m manufactur] facility 9 a contractual relation%ip ) ! sponsor ( "o or m ,,otc monograph drugs to manufacture or process su* drugs2 & 7iii7 does n include a bus9ess or o!r entity ^: only manufactur+ or process+ activities are "o or m ( ! foll[+3 production ( cl9ical rese>* supplies1 te/+1 or placem5t ( out] packag+ on packages conta9+ multiple products1 = su* purposes z creat+ multipacks1 :5 ea* monograph drug product conta9$ )9 ! ov]packag+ is already 9 a f9al packag$ =m prior to placem5t 9 ! out] ov]packag+4 7,b7 ,= purposes ( subp>agraph 7,a77i77,,ii71 sep>ate build+s or locations )9 close proximity are consid]$ to be at "o geographic location or address if ! activities conduct$ 9 su* build+s or locations are-- 7i7 closely relat$ to ! same bus9ess ent]prise2 7ii7 "u ! sup]vision ( ! same local managem5t2 & 7iii7 "u a s+le ,,fda e/abli%m5t id5tifi] & capable ( be+ inspect$ by ! ,food & ,drug ,adm9i/ration dur+ a s+le inspection4 7,c7 ,if a bus9ess or o!r entity w\ld meet crit]ia specifi$ 9 subp>agraph 7,a71 b = be+ "u multiple managem5t1 ! bus9ess or o!r entity is deem$ to con/itute multiple facilities1 "o p] managem5t entity1 = purposes ( ?is p>agraph4 7#aa7 ,! t]m ,,otc monograph drug meet+ means any meet+ reg>d+ ! cont5t ( a propos$ ,,otc monograph ord] reque/4 7#ab7 ,! t]m p]son includes an affiliate ( a p]son4 7#ac7 ,! t]ms reque/or & sponsor h ! mean+s giv5 su* t]ms 9 section #eje;,g4 #gdd,m4 ,au?ority to assess & use ,,otc monograph fees 7a7 ,types ( fees ,beg9n+ ) fiscal ye> #bjai1 ! ,secret>y %all assess & collect fees 9 accordance ) ?is section z foll[s3 7#a7 ,facility fee 7,a7 ,9 g5]al ,ea* p]son t owns a facility id5tifi$ z an ,,otc monograph drug facility on ,decemb] #ca ( ! fiscal ye> or at any "t dur+ ! prec$+ #ab-mon? p]iod %all be assess$ an annual fee = ea* su* facility z det]m9$ "u subsection 7c74 7,b7 ,exceptions 7i7 ,a fee %all n be assess$ "u subp>agraph 7,a7 if ! id5tifi$ ,,otc monograph drug facility-- 7,i7 has ceas$ all activities relat$ to ,,otc monograph drugs prior to ,janu>y #ca1 #bjai1 = ! fir/ program ye>1 & ,decemb] #ca ( ! fiscal ye> = subsequ5t fiscal ye>s2 & 7,,ii7 has updat$ its regi/ration to reflect su* *ange "u ! requirem5ts = drug e/abli%m5t regi/ration set =? 9 section #eaj4 7ii7 ,! am\nt ( ! fee = a contract manufactur+ organization facility %all be equal to two-?irds ( ! am\nt ( ! fee = an ,,otc monograph drug facility t is n a contract manufactur+ organization facility4 7,c7 ,am\nt ,! am\nt ( fees e/abli%$ "u subp>agraph 7,a7 %all be e/abli%$ "u subsection 7c74 7,d7 ,due date 7i7 ,= fir/ program ye> ,= fiscal ye> #bjai1 ! facility fees requir$ "u subp>agraph 7,a7 %all be due #de cal5d> days aft] publication ( ! ,f$]al ,regi/] notice provid$ = "u subsection 7c77#d77;,a74 7ii7 ,subsequ5t fiscal ye>s ,= ea* fiscal ye> aft] fiscal ye> #bjai1 ! facility fees requir$ "u subp>agraph 7,a7 %all be due on ! lat] (-- 7,i7 ! fir/ bus9ess day ( ,june ( su* ye>2 or 7,,ii7 ! fir/ bus9ess day aft] ! enactm5t ( an appropriations ,act provid+ = ! collection & obligation ( fees "u ?is section = su* ye>4 7#b7 ,,otc monograph ord] reque/ fee 7,a7 ,9 g5]al ,ea* p]son t submits an ,,otc monograph ord] reque/ %all be subject to a fee = an ,,otc monograph ord] reque/4 ,! am\nt ( su* fee %all be-- 7i7 = a ,ti] #a ,,otc monograph ord] reque/1 #ejj1jjj1 adju/$ = inflation = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a77;,b772 & 7ii7 = a ,ti] #b ,,otc monograph ord] reque/1 #ajj1jjj adju/$ = inflation = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a77;,b774 7,b7 ,due date ,! ,,otc monograph ord] reque/ fees requir$ "u subp>agraph 7,a7 %all be due on ! date ( submission ( ! ,,otc monograph ord] reque/4 7,c7 ,exception = c]ta9 safety *anges ,a p]son :o is nam$ z ! reque/or 9 an ,,otc monograph ord] %all n be subject to a fee "u subp>agraph 7,a7 if ! ,secret>y f9ds t ! ,,otc monograph ord] reque/ seeks to *ange ! drug facts label+ ( an ,,otc monograph drug 9 a way t w\ld add to or /r5g!n-- 7i7 a contra9dication1 w>n+1 or precaution2 7ii7 a /atem5t ab\t risk associat$ ) misuse or abuse2 or 7iii7 an in/ruction ab\t dosage & adm9i/ration t is int5d$ to increase ! safe use ( ! ,,otc monograph drug4 7,d7 ,refund ( fee if ord] reque/ is recategoriz$ z a ,ti] #b ,,otc monograph ord] reque/ ,if ! ,secret>y det]m9es t an ,,otc monograph reque/ initially *>act]iz$ z ,ti] #a %all be re-*>act]iz$ z a ,ti] #b ,,otc monograph ord] reque/1 & ! reque/or has paid a ,ti] #a fee 9 accordance ) subp>agraph 7,a77i71 ! ,secret>y %all refund ! reque/or ! diff]5ce betwe5 ! ,ti] #a & ,ti] #b fees det]m9$ "u subp>agraphs 7,a77i7 & 7,a77ii71 respectively4 7,e7 ,refund ( fee if ord] reque/ refus$ = fil+ or )drawn be=e fil+ ,! ,secret>y %all refund #ge p]c5t ( ! fee paid "u subp>agraph 7,b7 = any ord] reque/ :i* is refus$ = fil+ or 0 )drawn be=e be+ accept$ or refus$ = fil+4 7,f7 ,fees = ord] reque/s previ\sly refus$ = fil+ or )drawn be=e fil+ ,an ,,otc monograph ord] reque/ t 0 submitt$ b 0 refus$ = fil+1 or 0 )drawn be=e be+ accept$ or refus$ = fil+1 %all be subject to ! full fee "u subp>agraph 7,a7 ^u be+ resubmitt$ or fil$ ov] prote/4 7,g7 ,refund ( fee if ord] reque/ )drawn ,if an ord] reque/ is )drawn aft] ! ord] reque/ 0 fil$1 ! ,secret>y may refund ! fee or a portion ( ! fee if no sub/antial "w 0 p]=m$ on ! ord] reque/ aft] ! application 0 fil$4 ,! ,secret>y %all h ! sole discretion to refund a fee or a portion ( ! fee "u ?is subp>agraph4 ,a det]m9ation by ! ,secret>y conc]n+ a refund "u ?is subp>agraph %all n be reviewable4 7#c7 ,refunds 7,a7 ,9 g5]al ,o!r ?an refunds provid$ pursuant to any ( subp>agraphs 7,d7 ?r\gh 7,g7 ( p>agraph 7#b71 ! ,secret>y %all n refund any fee paid "u p>agraph 7#a7 except z provid$ 9 subp>agraph 7,b74 7,b7 ,disputes conc]n+ fees ,to qualify = ! return ( a fee claim$ to h be5 paid 9 error "u p>agraph 7#a7 or 7#b71 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* return )9 #ahj cal5d> days aft] su* fee 0 paid4 7#d7 ,notice ,)9 ! timeframe specifi$ 9 subsection 7c71 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! am\nt ( ! fees "u p>agraph 7#a7 = su* fiscal ye>4 7b7 ,fee rev5ue am\nts 7#a7 ,fiscal ye> #bjai ,= fiscal ye> #bjai1 fees "u subsection 7a77#a7 %all be e/abli%$ to g5]ate a total facility fee rev5ue am\nt equal to ! sum (-- 7,a7 ! annual base rev5ue = fiscal ye> #bjai 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#b772 & 7,c7 additional direct co/ adju/m5ts 7z det]m9$ "u subsection 7c77#c774 7#b7 ,subsequ5t fiscal ye>s ,= ea* ( ! fiscal ye>s #bjbj ?r\gh #bjbc1 fees "u subsection 7a77#a7 %all be e/abli%$ to g5]ate a total facility fee rev5ue am\nt equal to ! sum (-- 7,a7 ! annual base rev5ue = ! fiscal ye> 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! inflation adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a772 7,c7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#b772 7,d7 additional direct co/ adju/m5ts 7z det]m9$ "u subsection 7c77#c772 & 7,e7 additional doll> am\nts = ea* fiscal ye> z foll[s3 7i7 #g1jjj1jjj = fiscal ye> #bjbj4 7ii7 #f1jjj1jjj = fiscal ye> #bjba4 7iii7 #g1jjj1jjj = fiscal ye> #bjbb4 7iv7 #c1jjj1jjj = fiscal ye> #bjbc4 7#c7 ,annual base rev5ue ,= purposes ( p>agraphs 7#a77;,a7 & 7#b77;,a71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be-- 7,a7 = fiscal ye> #bjai1 #h1jjj1jjj2 & 7,b7 = fiscal ye>s #bjbj ?r\gh #bjbc1 ! doll> am\nt ( ! total rev5ue am\nt e/abli%$ "u ?is subsection = ! previ\s fiscal ye>1 n includ+ any adju/m5ts made "u subsection 7c77#b7 or 7c77#c74 7c7 ,adju/m5ts2 annual fee sett+ 7#a7 ,inflation adju/m5t 7,a7 ,9 g5]al ,= purposes ( subsection 7b77#b77;,b71 ! doll> am\nt ( ! inflation adju/m5t to ! annual base rev5ue = fiscal ye> #bjbj & ea* subsequ5t fiscal ye> %all be equal to ! product (-- 7i7 su* annual base rev5ue = ! fiscal ye> "u subsection 7b77#b72 & 7ii7 ! inflation adju/m5t p]c5tage "u subp>agraph 7,c74 7,b7 ,,otc monograph ord] reque/ fees ,= purposes ( subsection 7a77#b71 ! doll> am\nt ( ! inflation adju/m5t to ! fee = ,,otc monograph ord] reque/s = fiscal ye> #bjbj & ea* subsequ5t fiscal ye> %all be equal to ! product (-- 7i7 ! applicable fee "u subsection 7a77#b7 = ! prec$+ fiscal ye>2 & 7ii7 ! inflation adju/m5t p]c5tage "u subp>agraph 7,c74 7,c7 ,inflation adju/m5t p]c5tage ,! inflation adju/m5t p]c5tage "u ?is subp>agraph = a fiscal ye> is equal to-- 7i7 = ea* ( fiscal ye>s #bjbj & #bjba1 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ! fir/ #c ye>s ( ! prec$+ #d ye>s ( available data2 & 7ii7 = ea* ( fiscal ye>s #bjbb & #bjbc1 ! sum (-- 7,i7 ! av]age annual p]c5t *ange 9 ! co/1 p] full-"t equival5t position ( ! ,food & ,drug ,adm9i/ration1 ( all p]sonnel comp5sation & b5efits paid ) respect to su* positions = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s1 multipli$ by ! proportion ( p]sonnel comp5sation & b5efits co/s to total co/s ( ,,otc monograph drug activities = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s2 & 7,,ii7 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ! fir/ #c ye>s ( ! prec$+ #d ye>s ( available data multipli$ by ! proportion ( all co/s o!r ?an p]sonnel comp5sation & b5efits co/s to total co/s ( ,,otc monograph drug activities = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s4 7#b7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjai & subsequ5t fiscal ye>s1 = purposes ( subsections 7b77#a77;,b7 & 7b77#b77;,c71 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraph 7#a71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide op]at+ res]ves ( c>ryov] us] fees = ,,otc monograph drug activities = n m ?an ! numb] ( weeks specifi$ 9 subp>agraph 7,b74 7,b7 ,numb] ( weeks ,! numb] ( weeks specifi$ 9 ?is subp>agraph is-- 7i7 #c weeks = fiscal ye> #bjai2 7ii7 #g weeks = fiscal ye> #bjbj2 7iii7 #aj weeks = fiscal ye> #bjba2 7iv7 #aj weeks = fiscal ye> #bjbb2 & 7v7 #aj weeks = fiscal ye> #bjbc4 7,c7 ,decrease ,if ! ,secret>y has c>ryov] balances = su* process 9 excess ( #aj weeks ( ! op]at+ res]ves ref]r$ to 9 subp>agraph 7,a71 ! ,secret>y %all decrease ! fee rev5ue & fees ref]r$ to 9 su* subp>agraph to provide = n m ?an #aj weeks ( su* op]at+ res]ves4 7,d7 ,rationale = adju/m5t ,if an adju/m5t "u ?is p>agraph is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u p>agraph 7#d7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 7#c7 ,additional direct co/ adju/m5t ,! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees = purposes ( subsection 7b77#b77;,d7 by an am\nt equal to-- 7,a7 #ad1jjj1jjj = fiscal ye> #bjai2 7,b7 #g1jjj1jjj = fiscal ye> #bjbj2 7,c7 #d1jjj1jjj = fiscal ye> #bjba2 7,d7 #c1jjj1jjj = fiscal ye> #bjbb2 & 7,e7 #c1jjj1jjj = fiscal ye> #bjbc4 7#d7 ,annual fee sett+ 7,a7 ,fiscal ye> #bjai ,! ,secret>y %all1 n lat] ?an ! second ,monday 9 ,m>* ( #bjai-- 7i7 e/abli% ,,otc monograph drug facility fees = fiscal ye> #bjai "u subsection 7a71 bas$ on ! rev5ue am\nt = su* ye> "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection2 & 7ii7 publi% fee rev5ue1 facility fees1 & ,,otc monograph ord] reque/s 9 ! ,f$]al ,regi/]4 7,b7 ,subsequ5t fiscal ye>s ,! ,secret>y %all1 n lat] ?an ! second ,monday 9 ,m>* ( ea* fiscal ye> t beg9s aft] ,septemb] #cj1 #bjai-- 7i7 e/abli% = ea* su* fiscal ye>1 bas$ on ! rev5ue am\nts "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection-- 7,i7 ,,otc monograph drug facility fees "u subsection 7a77#a72 & 7,,ii7 ,,otc monograph ord] reque/ fees "u subsection 7a77#b72 & 7ii7 publi% su* fee rev5ue am\nts1 facility fees1 & ,,otc monograph ord] reque/ fees 9 ! ,f$]al ,regi/]4 7d7 ,id5tification ( facilities ,ea* p]son t owns an ,,otc monograph drug facility %all submit to ! ,secret>y ! in=mation requir$ "u ?is subsection ea* ye>4 ,su* in=mation %all1 = ea* fiscal ye>-- 7#a7 be submitt$ z "p ( ! requirem5ts = drug e/abli%m5t regi/ration set =? 9 section #eaj2 & 7#b7 include = ea* su* facility1 at a m9imum1 id5tification ( ! facility's bus9ess op]ation z t ( an ,,otc monograph drug facility4 7e7 ,effect ( failure ,to pay fees 7#a7 ,,otc ,monograph ,drug ,facility ,fee 7,a7 ,9 g5]al ,failure to pay ! fee "u subsection 7a77#a7 )9 #bj cal5d> days ( ! due date z specifi$ 9 subp>agraph 7,d7 ( su* subsection %all result 9 ! foll[+3 7i7 ,! ,secret>y %all place ! facility on a publicly available arre>s li/4 7ii7 ,all ,,otc monograph drugs manufactur$ 9 su* a facility or conta9+ an +r$i5t manufactur$ 9 su* a facility %all be deem$ misbr&$ "u section #ejb7;ff74 7,b7 ,application ( p5alties ,! p5alties "u ?is p>agraph %all apply until ! fee e/abli%$ by subsection 7a77#a7 is paid4 7#b7 ,ord] reque/s ,an ,,otc monograph ord] reque/ submitt$ by a p]son subject to fees "u subsection 7a7 %all be consid]$ incomplete & %all n be accept$ = fil+ by ! ,secret>y until all fees ow$ by su* p]son "u ?is section h be5 paid4 7#c7 ,meet+s ,a p]son subject to fees "u ?is section %all be consid]$ ineligible = ,,otc monograph drug meet+s until all su* fees ow$ by su* p]son h be5 paid4 7f7 ,cr$it+ & availability ( fees 7#a7 ,9 g5]al ,fees au?oriz$ "u subsection 7a7 %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts4 ,su* fees are au?oriz$ to rema9 available until exp5d$4 ,su* sums z may be necess>y may be transf]r$ f ! ,food & ,drug ,adm9i/ration sal>ies & exp5ses appropriation acc\nt )\t fiscal ye> limitation to su* appropriation acc\nt = sal>ies & exp5ses ) su* fiscal ye> limitation4 ,! sums transf]r$ %all be available solely = ,,otc monograph drug activities4 7#b7 ,collections & appropriation ,acts 7,a7 ,9 g5]al ,subject to subp>agraph 7,c71 ! fees au?oriz$ by ?is section %all be collect$ & available 9 ea* fiscal ye> 9 an am\nt n to exce$ ! am\nt specifi$ 9 appropriation ,acts1 or o!rwise made available = obligation1 = su* fiscal ye>4 7,b7 ,use ( fees & limitation ,! fees au?oriz$ by ?is section %all be available to defray increases 9 ! co/s ( ! res\rces allocat$ = ,,otc monograph drug activities 7includ+ increases 9 su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* activities71 only if ! ,secret>y allocates = su* purpose an am\nt = su* fiscal ye> 7exclud+ am\nts f fees collect$ "u ?is section7 no less ?an #ab1jjj1jjj1 multipli$ by ! adju/m5t factor applicable to ! fiscal ye> involv$ "u subsection 7c77#a74 7,c7 ,compliance ,! ,secret>y %all be consid]$ to h met ! requirem5ts ( subp>agraph 7,b7 9 any fiscal ye> if ! co/s fund$ by appropriations & allocat$ = ,,otc monograph drug activities are n m ?an #ae p]c5t bel[ ! level specifi$ 9 su* subp>agraph4 7,d7 ,provision = e>ly paym5ts 9 subsequ5t ye>s ,paym5t ( fees au?oriz$ "u ?is section = a fiscal ye> 7aft] fiscal ye> #bjai71 prior to ! due date = su* fees1 may be accept$ by ! ,secret>y 9 accordance ) au?ority provid$ 9 advance 9 a prior ye> appropriations ,act4 7#c7 ,au?orization ( appropriations ,= ea* ( ! fiscal ye>s #bjai ?r\gh #bjbc1 !re is au?oriz$ to be appropriat$ = fees "u ?is section an am\nt equal to ! total am\nt ( fees assess$ = su* fiscal ye> "u ?is section4 7g7 ,collection ( unpaid fees ,9 any case :]e ! ,secret>y does n receive paym5t ( a fee assess$ "u subsection 7a7 )9 #cj cal5d> days aft] x is due1 su* fee %all be treat$ z a claim ( ! ,unit$ ,/ates ,gov]nm5t subject to sub*apt] ,,ii ( *apt] #cg ( title #ca1 ,unit$ ,/ates ,code4 7h7 ,con/ruction ,?is section may n be con/ru$ to require t ! numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 = (fic]s1 employ]s1 & advisory committees n engag$ 9 ,,otc monograph drug activities1 be r$uc$ to (fset ! numb] ( (fic]s1 employees1 & advisory committees s engag$4 #gdd,n4 ,reau?orization2 report+ requirem5ts 7a7 ,p]=mance report ,beg9n+ ) fiscal ye> #bjai1 & n lat] ?an #abj cal5d> days aft] ! end ( ea* fiscal ye> !reaft] = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conc]n+ ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals id5tifi$ 9 ! lett]s describ$ 9 section #bjja7;b7 ( ! ,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m ,act ( #bjai dur+ su* fiscal ye> & ! future plans ( ! ,food & ,drug ,adm9i/ration = meet+ su* goals4 7b7 ,fiscal report ,n lat] ?an #abj cal5d> days aft] ! end ( fiscal ye> #bjai & ea* subsequ5t fiscal ye> = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! implem5tation ( ! au?ority = su* fees dur+ su* fiscal ye> & ! use1 by ! ,food & ,drug ,adm9i/ration1 ( ! fees collect$ = su* fiscal ye>4 7c7 ,public availability ,! ,secret>y %all make ! reports requir$ "u subsections 7a7 & 7b7 available to ! public on ! int]net website ( ! ,food & ,drug ,adm9i/ration4 7d7 ,reau?orization 7#a7 ,consultation ,9 develop+ recomm5dations to pres5t to ! ,congress ) respect to ! goals describ$ 9 subsection 7a71 & plans = meet+ ! goals1 = ,,otc monograph drug activities = ! fir/ #e fiscal ye>s aft] fiscal ye> #bjbc1 & = ! reau?orization ( ?is "p = su* fiscal ye>s1 ! ,secret>y %all consult )-- 7,a7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7,b7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7,c7 sci5tific & academic exp]ts2 7,d7 heal? c>e pr(essionals2 7,e7 repres5tatives ( pati5t & consum] advocacy gr\ps2 & 7,f7 ! regulat$ indu/ry4 7#b7 ,public review ( recomm5dations ,aft] negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all-- 7,a7 pres5t ! recomm5dations develop$ "u p>agraph 7#a7 to ! congressional committees specifi$ 9 su* p>agraph2 7,b7 publi% su* recomm5dations 9 ! ,f$]al ,regi/]2 7,c7 provide = a p]iod ( #cj cal5d> days = ! public to provide writt5 comm5ts on su* recomm5dations2 7,d7 hold a meet+ at :i* ! public may pres5t its views on su* recomm5dations2 & 7,e7 aft] consid]ation ( su* public views & comm5ts1 revise su* recomm5dations z necess>y4 7#c7 ,transmittal ( recomm5dations ,n lat] ?an ,janu>y #ae1 #bjbc1 ! ,secret>y %all transmit to ! ,congress ! revis$ recomm5dations "u p>agraph 7#b71 a summ>y ( ! views & comm5ts receiv$ "u su* p>agraph1 & any *anges made to ! recomm5dations 9 response to su* views & comm5ts4 4 ,i ,o!r ,provisions #cia4 ,protect+ access to biological products ,section #cea7k77#g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#g77 is am5d$ by add+ at ! end ! foll[+3 7,d7 ,deem$ lic5ses 7i7 ,no additional exclusivity ?r\gh deem+ ,an approv$ application t is deem$ to be a lic5se = a biological product "u ?is section pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji %all n be treat$ z hav+ be5 fir/ lic5s$ "u subsection 7a7 = purposes ( subp>agraphs 7,a7 & 7,b74 7ii7 ,application ( limitations on exclusivity ,subp>agraph 7,c7 %all apply ) respect to a ref]5ce product ref]r$ to 9 su* subp>agraph t 0 ! subject ( an approv$ application t 0 deem$ to be a lic5se pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji4 7iii7 ,applicability ,! exclusivity p]iods describ$ 9 section #ebg1 section #eje;,a7b77#a77;,a77ii71 & section #eje;,a7c77#a77;,a77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %all cont9ue to apply to a biological product aft] an approv$ application = ! biological product is deem$ to be a lic5se = ! biological product "u subsection 7a7 pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji4 4 #cib4 ,orphan drug cl>ification ,section #ebg7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7c77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,applicability ,?is subsection applies to any drug designat$ "u section #ebf = :i* an application 0 approv$ "u section #eje ( ?is ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act aft] ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag1 reg>dless ( ! date on :i* su* drug 0 designat$ "u section #ebf4 4 #cic4 ,conditions ( use = biosimil> biological products ,section #cea7k77#b77;,a77iii7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77iii77 is am5d$-- 7#a7 9 subclause 7,i71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,,iii7 may include in=mation to %[ t ! conditions ( use prescrib$1 recomm5d$1 or sugge/$ 9 ! label+ propos$ = ! biological product h be5 previ\sly approv$ = ! ref]5ce product4 4 #cid4 ,cl>ify+ ! mean+ ( new *emical entity ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$-- 7#a7 9 section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 9 subsection 7c77#c77;,e7-- 7i7 9 clause 7ii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 9 clause 7iii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,b7 9 subsection 7j77#e77;,f7-- 7i7 9 clause 7ii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 9 clause 7iii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,c7 9 subsection 7l77#b77;,a77i71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,d7 9 subsection 7s71 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7,e7 9 subsection 7u77#a71 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 by /rik+ same active +r$i5t & ins]t+ same active moiety2 7#b7 9 section #eab7;c77#b77;,f7 7#ba ,u4,s4,c4 #cfj;b7c77#b77;,f77-- 7,a7 9 clause 7i71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,b7 9 clause 7ii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7,c7 9 clause 7v71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7#c7 9 section #ebd7;a77#d77;,c7 7#ba ,u4,s4,c4 #cfjn7a77#d77;,c771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7#d7 9 section #ebi7;a77#d77;,a77ii7 7#ba ,u4,s4,c4 #cfj;ff7a77#d77;,a77ii771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7#e7 9 section #efe;,a7a77#d77;,d7 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7a77#d77;,d771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations774 ,,iv ,rev5ue ,provisions #dja4 ,p]man5t ext5sion ( r$uction 9 m$ical exp5se d$uction floor 7a7 ,9 g5]al ,section #bac7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #aj p]c5t & ins]t+ #g4e p]c5t4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #bac ( su* ,code is am5d$ by /rik+ subsection 7f74 7#b7 ,section #ef7;b77#a7 ( su* ,code is am5d$ by /rik+ subp>agraph 7,b7 & by r$esignat+ subp>agraphs 7,c71 7,d71 7,e71 & 7,f71 z subp>agraphs 7,b71 7,c71 7,d71 & 7,e71 respectively4 7c7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s end+ aft] ,decemb] #ca1 #bjai4 #djb4 ,safe h>bor = high d$uctible heal? plans )\t d$uctible = insul9 7a7 ,9 g5]al ,section #bbc7;c77#b77;,c7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ or = insul9 or any device = ! deliv]y ( insul9 be=e ! p]iod at ! end4 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to mon?s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 #djc4 ,inclusion ( c]ta9 ov]-!-c\nt] m$ical products z qualifi$ m$ical exp5ses 7a7 ,h,s,as ,section #bbc7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7#a7 by /rik+ ! la/ s5t5ce ( subp>agraph 7,a7 & ins]t+ ! foll[+3 ,= purposes ( ?is subp>agraph1 am\nts paid = m5/rual c>e products %all be treat$ z paid = m$ical c>e42 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,m5/rual c>e product ,= purposes ( ?is p>agraph1 ! t]m m5/rual c>e product means a tampon1 pad1 l9]1 cup1 sponge1 or simil> product us$ by individuals ) respect to m5/ruation or o!r g5ital-tract secretions4 4 7b7 ,ar*] ,m,s,as ,section #bbj7;d77#b77;,a7 ( su* ,code is am5d$ by /rik+ ! la/ s5t5ce & ins]t+ ! foll[+3 ,= purposes ( ?is subp>agraph1 am\nts paid = m5/rual c>e products 7z def9$ 9 section #bbc7;d77#b77;,d77 %all be treat$ z paid = m$ical c>e44 7c7 ,heal? flexible sp5d+ arrangem5ts & heal? reimbursem5t arrangem5ts ,section #ajf ( su* ,code is am5d$ by /rik+ subsection 7f7 & ins]t+ ! foll[+ new subsection3 7f7 ,reimbursem5ts = m5/rual c>e products ,= purposes ( ?is section & section #aje1 exp5ses incurr$ = m5/rual c>e products 7z def9$ 9 section #bbc7;d77#b77;,d77 %all be treat$ z incurr$ = m$ical c>e4 4 7d7 ,effective dates 7#a7 ,di/ributions f sav+s acc\nts ,! am5dm5t made by subsections 7a7 & 7b7 %all apply to am\nts paid aft] ,decemb] #ca1 #bjai4 7#b7 ,reimbursem5ts ,! am5dm5t made by subsection 7c7 %all apply to exp5ses incurr$ aft] ,decemb] #ca1 #bjai4 ,v ,miscellane\s #eja4 ,paym5t = biosimil> biological products dur+ initial p]iod ,section #ahdg;,a7c77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#d77 is am5d$-- 7#a7 9 ea* ( subp>agraphs 7,a7 & 7,b71 by r$esignat+ clauses 7i7 & 7ii7 z subclauses 7,i7 & 7,,ii71 respectively1 & mov+ su* subclauses #b ems to ! "r2 7#b7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii7 & mov+ su* clauses #b ems to ! "r2 7#c7 by /rik+ unavailable4--,9 ! case & ins]t+ 8unavailable4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 9 ! case 2 & 7#d7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,limitation on paym5t am\nt = biosimil> biological products dur+ initial p]iod ,9 ! case ( a biosimil> biological product furni%$ on or aft] ,july #a1 #bjbj1 9 lieu ( apply+ subp>agraph 7,a7 dur+ ! initial p]iod describ$ 9 su* subp>agraph ) respect to ! biosimil> biological product1 ! am\nt payable "u ?is section = ! biosimil> biological product is ! less] ( ! foll[+3 7i7 ,! am\nt det]m9$ "u clause 7ii7 ( su* subp>agraph = ! biosimil> biological product4 7ii7 ,! am\nt det]m9$ "u subsection 7b77#a77;,b7 = ! ref]5ce biological product4 4 #ejb4 ,,gao /udy & report on av]age sales price 7a7 ,/udy 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79 ?is section ref]r$ to z ! ,comptroll] ,g5]al7 %all conduct a /udy on sp5d+ = applicable drugs "u "p ,b ( title ,,xviii ( ! ,social ,security ,act4 7#b7 ,applicable drugs def9$ ,9 ?is section1 ! t]m applicable drugs means drugs & biologicals-- 7,a7 = :i* reimbursem5t "u su* "p ,b is bas$ on ! av]age sales price ( ! drug or biological2 & 7,b7 t acc\nt = ! l>ge/ p]c5tage ( total sp5d+ on drugs & biologicals "u su* "p ,b 7z det]m9$ by ! ,comptroll] ,g5]al1 b 9 no case less ?an #be drugs or biologicals74 7#c7 ,requirem5ts ,! /udy "u p>agraph 7#a7 %all include an analysis ( ! foll[+3 7,a7 ,! ext5t to :i* ea* applicable drug is paid =-- 7i7 "u su* "p ,b = ,m$ic>e b5efici>ies2 or 7ii7 by private pay]s 9 ! comm]cial m>ket4 7,b7 ,any *ange 9 ,m$ic>e sp5d+ or ,m$ic>e b5efici>y co/-%>+ t w\ld occur if ! av]age sales price ( an applicable drug 0 bas$ solely on paym5ts by private pay]s 9 ! comm]cial m>ket4 7,c7 ,! ext5t to :i* drug manufactur]s provide rebates1 disc\nts1 or o!r price concessions to private pay]s 9 ! comm]cial m>ket = applicable drugs1 :i* ! manufactur] includes 9 its av]age sales price calculation1 =-- 7i7 =mul>y placem5t2 7ii7 utilization managem5t consid]ations2 or 7iii7 o!r purposes4 7,d7 ,b>ri]s to drug manufactur]s provid+ su* price concessions = applicable drugs4 7,e7 ,o!r areas det]m9$ appropriate by ! ,comptroll] ,g5]al4 7b7 ,report ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ,congress a report on ! /udy conduct$ "u subsection 7a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,secret>y det]m9es appropriate4 #ejc4 ,requir+ prescription drug plans & ,,ma-,,pd plans to report pot5tial fraud1 wa/e1 & abuse to ! ,secret>y ( ,,hhs ,section #ahfj;,d-#d ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7p7 ,report+ pot5tial fraud1 wa/e1 & abuse ,beg9n+ ,janu>y #a1 #bjba1 ! ,,pdp sponsor ( a prescription drug plan %all report to ! ,secret>y1 z specifi$ by ! ,secret>y-- 7#a7 any sub/antiat$ or suspici\s activities 7z def9$ by ! ,secret>y7 ) respect to ! program "u ?is "p z x relates to fraud1 wa/e1 & abuse2 & 7#b7 any /eps made by ! ,,pdp sponsor aft] id5tify+ su* activities to take corrective actions4 4 #ejd4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,application ( ph>macy quality measures 7,a7 ,9 g5]al ,a ,,pdp sponsor t implem5ts inc5tive paym5ts to a ph>macy or price concessions paid by a ph>macy bas$ on quality measures %all use measures e/abli%$ or approv$ by ! ,secret>y "u subp>agraph 7,b7 ) respect to paym5t = cov]$ "p ,d drugs disp5s$ by su* ph>macy4 7,b7 ,/&>d ph>macy quality measures ,! ,secret>y %all e/abli% or approve /&>d quality measures f a cons5sus & evid5ce-bas$ organization = paym5ts describ$ 9 subp>agraph 7,a74 ,su* measures %all focus on pati5t heal? outcomes & be bas$ on prov5 crit]ia measur+ ph>macy p]=mance4 7,c7 ,effective date ,! requirem5t "u subp>agraph 7,a7 %all take effect = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbc1 or su* e>li] date specifi$ by ! ,secret>y if ! ,secret>y det]m9es !re are suffici5t measures e/abli%$ or approv$ "u subp>agraph 7,b7 to meet ! requirem5t "u subp>agraph 7,a74 4 #eje4 ,improv+ coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7a7 ,9 g5]al 7#a7 ,public meet+ 7,a7 ,9 g5]al ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all conv5e a public meet+ = ! purposes ( discuss+ & provid+ input on improvem5ts to coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 9 prep>+ = ! availability ( novel m$ical products describ$ 9 subsection 7c7 on ! m>ket 9 ! ,unit$ ,/ates4 7,b7 ,att5dees ,! public meet+ %all include-- 7i7 repres5tatives ( relevant ,f$]al ag5cies1 includ+ repres5tatives f ea* ( ! m$ical product c5t]s )9 ! ,food & ,drug ,adm9i/ration & repres5tatives f ! cod+1 cov]age1 & paym5t (fices )9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7ii7 /akehold]s ) exp]tise 9 ! rese>* & developm5t ( novel m$ical products1 includ+ manufactur]s ( su* products2 7iii7 repres5tatives ( comm]cial heal? insurance pay]s2 7iv7 /akehold]s ) exp]tise 9 ! adm9i/ration & use ( novel m$ical products1 includ+ physicians2 & 7v7 /akehold]s repres5t+ pati5ts & ) exp]tise 9 ! utilization ( pati5t exp]i5ce data 9 m$ical product developm5t4 7,c7 ,topics ,! public meet+ %all include a discussion (-- 7i7 ! /atus ( ! drug & m$ical device developm5t pipel9e relat$ to ! availability ( novel m$ical products2 7ii7 ! anticipat$ exp]tise necess>y to review ! safety & effectiv5ess ( su* products at ! ,food & ,drug ,adm9i/ration & curr5t gaps 9 su* exp]tise1 if any2 7iii7 ! exp]tise necess>y to make cod+1 cov]age1 & paym5t decisions ) respect to su* products )9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 & curr5t gaps 9 su* exp]tise1 if any2 7iv7 tr5ds 9 ! diff]5ces 9 ! data necess>y to det]m9e ! safety & effectiv5ess ( a novel m$ical product & ! data necess>y to det]m9e :e!r a novel m$ical product meets ! reasonable & necess>y requirem5ts = cov]age & paym5t "u title ,,xviii ( ! ,social ,security ,act pursuant to section #ahfb7;a77#a77;,a7 ( su* ,act 7#db ,u4,s4,c4 #aciey7a77#a77;,a772 7v7 ! availability ( in=mation = sponsors ( su* novel m$ical products to meet ea* ( ^? requirem5ts2 & 7vi7 ! coord9ation ( in=mation relat$ to significant cl9ical improvem5t ov] exi/+ !rapies = pati5ts betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ) respect to novel m$ical products4 7,d7 ,trade secrets & confid5tial in=mation ,no in=mation discuss$ z a "p ( ! public meet+ "u ?is p>agraph %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any in=mation t is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,improv+ transp>5cy ( crit]ia = ,m$ic>e cov]age 7,a7 ,draft guidance ,n lat] ?an #ah mon?s aft] ! public meet+ "u p>agraph 7#a71 ! ,secret>y %all update ! f9al guidance titl$ ,national ,cov]age ,det]m9ations ) ,data ,collection z a ,condition ( ,cov]age3 ,cov]age ) ,evid5ce ,developm5t to address any opportunities to improve ! availability & coord9ation ( in=mation z describ$ 9 clauses 7iv7 ?r\gh 7vi7 ( p>agraph 7#a77;,c74 7,b7 ,f9al guidance ,n lat] ?an #ab mon?s aft] issu+ draft guidance "u subp>agraph 7,a71 ! ,secret>y %all f9alize ! updat$ guidance to address any su* opportunities4 7b7 ,report on cod+1 cov]age1 & paym5t processes "u m$ic>e = novel m$ical products ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all publi% a report on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices reg>d+ processes "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 ) respect to ! cod+1 cov]age1 & paym5t ( novel m$ical products describ$ 9 subsection 7c74 ,su* report %all include ! foll[+3 7#a7 ,a description ( *all5ges 9 ! cod+1 cov]age1 & paym5t processes "u ! ,m$ic>e program = novel m$ical products4 7#b7 ,recomm5dations to-- 7,a7 incorporate pati5t exp]i5ce data 7su* z ! impact ( a disease or condition on ! lives ( pati5ts & pati5t treatm5t pref]5ces7 into ! cov]age & paym5t processes )9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7,b7 decrease ! l5g? ( "t to make national & local cov]age det]m9ations "u ! ,m$ic>e program 7z ^? t]ms are def9$ 9 subp>agraph 7,a7 & 7,b71 respectively1 ( section #ahfb7l77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#f7772 7,c7 /reaml9e ! cov]age process "u ! ,m$ic>e program & incorporate input f relevant /akehold]s into su* cov]age det]m9ations2 & 7,d7 id5tify pot5tial me*anisms to incorporate novel paym5t designs simil> to ^? 9 developm5t 9 comm]cial insurance plans & ,/ate plans "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 into ! ,m$ic>e program4 7c7 ,novel m$ical products describ$ ,= purposes ( ?is section1 a novel m$ical product describ$ 9 ?is subsection is a m$ical product1 includ+ a drug1 biological 7includ+ g5e & cell !rapy71 or m$ical device1 t has be5 designat$ z a break?r\gh !rapy "u section #ejf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a771 a break?r\gh device "u section #eae;,b ( su* ,act 7#ba ,u4,s4,c4 #cfj;e-#c71 or a reg5]ative advanc$ !rapy "u section #ejf7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cef7;g774 #ejf4 ,pati5t consultation 9 ,m$ic>e national & local cov]age det]m9ations 9 ord] to mitigate b>ri]s to inclusion ( su* p]spectives ,section #ahfb7l7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,pati5t consultation 9 national & local cov]age det]m9ations ,! ,secret>y may consult ) pati5ts & organizations repres5t+ pati5ts 9 mak+ national & local cov]age det]m9ations4 4 #ejg4 ,med,p,a,c report on %ift+ cov]age ( c]ta9 ,m$ic>e "p ,b drugs to ,m$ic>e "p ,d 7a7 ,/udy ,! ,m$ic>e ,paym5t ,advisory ,commission 79 ?is section ref]r$ to z ! ,commission7 %all conduct a /udy on %ift+ cov]age ( c]ta9 drugs & biologicals = :i* paym5t is curr5tly made "u "p ,b ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 to "p ,d ( su* title 7#db ,u4,s4,c4 #aciew-#ba et seq474 ,su* /udy %all include an analysis (-- 7#a7 diff]5ces 9 program /ructures & paym5t me?ods = drugs & biologicals cov]$ "u su* p>ts ,b & ,d1 includ+ effects ( su* a %ift on program sp5d+1 b5efici>y co/-%>+ liability1 & utilization managem5t te*niques = su* drugs & biologicals2 & 7#b7 ! feasibility & policy implications ( %ift+ cov]age ( drugs & biologicals = :i* paym5t is curr5tly made "u su* "p ,b to su* "p ,d4 7b7 ,report 7#a7 ,9 g5]al ,n lat] ?an ,june #cj1 #bjba1 ! ,commission %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a74 7#b7 ,cont5ts ,! report "u p>agraph 7#a7 %all include in=mation1 & recomm5dations z ! ,commission deems appropriate1 reg>d+-- 7,a7 =mul>y design "u su* "p ,d2 7,b7 ! ability ( ! b5efit /ructure "u su* "p ,d to control total sp5d+ on drugs & biologicals = :i* paym5t is curr5tly made "u su* "p ,b2 7,c7 *anges to ! bid process "u su* "p ,d1 if any1 t may be necess>y to integrate cov]age ( su* drugs & biologicals into su* "p ,d2 7,d7 any o!r *anges to ! program t ,congress %\ld consid] 9 det]m9+ :e!r to %ift cov]age ( su* drugs & biologicals f su* "p ,b to su* "p ,d2 & 7,e7 ! feasibility & policy implications ( creat+ a me?odology to pres]ve ! heal?c>e provid]'s ability to take title ( ! drug1 includ+ a me?odology "u :i*-- 7i7 prescription drug plans negotiate reimbursem5t rates & o!r arrangem5ts ) drug manufactur]s on behalf ( a :olesal]2 7ii7 :olesal]s pur*ase ! drugs f ! manufactur]s at ! negotiat$ rate & %ip !m ?r\gh di/ributors to physicians to adm9i/] to pati5ts2 7iii7 physicians & hospitals pur*ase ! drug f ! :olesal] via ! di/ributor2 7iv7 aft] adm9i/]+ ! drug1 ! physician submits a claim to ! ,,mac = _! drug adm9i/ration fee2 7v7 to be reimburs$ = ! pur*ase ( ! drug f ! di/ributor1 ! physician furni%es ! claim = ! drug itself to ! :olesal] & ! :olesal] w\ld refund ! co/ ( ! drug to ! physician2 & 7vi7 ! :olesal] passes ?is claim to ! ,,pdp to receive reimbursem5t4 #ejh4 ,requirem5t t direct-to-consum] adv]tisem5ts = prescription drugs & biological products include tru?ful & non-mislead+ pric+ in=mation ,"p ,a ( title ,,xi ( ! ,social ,security ,act is am5d$ by add+ at ! end ! foll[+ new section3 #aaej;,c4 ,requirem5t t direct-to-consum] adv]tisem5ts = prescription drugs & biological products include tru?ful & non-mislead+ pric+ in=mation 7a7 ,9 g5]al ,! ,secret>y %all require t ea* direct-to-consum] adv]tisem5t = a prescription drug or biological product = :i* paym5t is available "u title ,,xviii or ,,xix includes an appropriate disclosure ( tru?ful & non-mislead+ pric+ in=mation ) respect to ! drug or product4 7b7 ,det]m9ation by ,,cms ,! ,secret>y1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all det]m9e ! compon5ts ( ! requirem5t "u subsection 7a71 su* z ! =ms ( adv]tis+1 ! mann] ( disclosure1 ! price po9t li/+1 & ! price in=mation = disclosure4 4 #eji4 ,*ief ,ph>maceutical ,negotiator at ! ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative 7a7 ,9 g5]al ,section #ada ( ! ,trade ,act ( #aigd 7#ai ,u4,s4,c4 #baga7 is am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 by /rik+ & "o ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator & ins]t+ "o ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 & "o ,*ief ,ph>maceutical ,negotiator2 7,b7 by /rik+ or ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator & ins]t+ ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 or ! ,*ief ,ph>maceutical ,negotiator2 & 7,c7 by /rik+ & ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator & ins]t+ ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 & ! ,*ief ,ph>maceutical ,negotiator2 & 7#b7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,! pr9cipal function ( ! ,*ief ,ph>maceutical ,negotiator %all be to conduct trade negotiations & to en=ce trade agreem5ts relat+ to ,unit$ ,/ates ph>maceutical products & s]vices4 ,! ,*ief ,ph>maceutical ,negotiator %all be a vigor\s advocate on behalf ( ,unit$ ,/ates ph>maceutical int]e/s4 ,! ,*ief ,ph>maceutical ,negotiator %all p]=m su* o!r functions z ! ,unit$ ,/ates ,trade ,repres5tative may direct4 4 7b7 ,comp5sation ,section #ecad ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 & ins]t+ ! foll[+3 ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4,*ief ,ph>maceutical ,negotiator1 ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 4 7c7 ,report requir$ ,n lat] ?an ! date t is "o ye> aft] ! appo9tm5t ( ! fir/ ,*ief ,ph>maceutical ,negotiator pursuant to p>agraph 7#b7 ( section #ada7;b7 ( ! ,trade ,act ( #aigd1 z am5d$ by subsection 7a71 & annually !reaft]1 ! ,unit$ ,/ates ,trade ,repres5tative %all submit to ! ,committee on ,f9ance ( ! ,s5ate & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives a report describ+ 9 detail-- 7#a7 en=cem5t actions tak5 by ! ,unit$ ,/ates ,trade ,repres5tative dur+ ! "o-ye> p]iod prec$+ ! submission ( ! report to ensure ! protection ( ,unit$ ,/ates ph>maceutical products & s]vices2 & 7#b7 o!r actions tak5 by ! ,unit$ ,/ates ,trade ,repres5tative to advance ,unit$ ,/ates ph>maceutical products & s]vices4 #eaj4 ,waiv+ ,m$ic>e co9surance = colorectal canc] scre5+ te/s ,section #ahcc7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77 is am5d$-- 7#a7 by mov+ ! flu% text foll[+ p>agraph 7#i7 #b ems to ! left2 & 7#b7 by add+ at ! end ( su* flu% text ! foll[+ new s5t5ce3 ,= items & s]vices furni%$ on or aft] ,janu>y #a1 #bjba1 p>agraph 7#a77,y7 %all apply ) respect to a colorectal canc] scre5+ te/ reg>dless ( ! code t is bill$ = ! e/abli%m5t ( a diagnosis z a result ( ! te/1 or = ! removal ( tissue or o!r matt] or o!r proc$ure t is furni%$ 9 connection )1 z a result (1 & 9 ! same cl9ical enc\nt] z ! scre5+ te/44