,i #aac? ,,congress #b;d ,session ,h4 ,r4 #dahg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #aa1 #bjad ,mr4 ,roskam 7= himself & ,mr4 ,danny ,k4 ,davis ( ,ill9ois7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,ways & ,means1 & 9 addition to ! ,committee on ,en]gy & ,comm]ce1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d title ,,xviii ( ! ,social ,security ,act to enc\rage ! developm5t & use ( new antimicrobial drugs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,develop+ an ,innovative ,/rategy = ,antimicrobial ,resi/ant ,microorganisms ,act ( #bjad & z ! ,,dis>m ,act ( #bjad4 #b4 ,enc\rag+ ! developm5t & use ( new antimicrobial drugs 7a7 ,additional paym5t = new antimicrobial drugs "u ,m$ic>e 7#a7 ,9 g5]al ,section #ahhf7;d77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,m7 7i7 ,effective = dis*>ges beg9n+ on or aft] ,octob] #a1 #bjad1 ! ,secret>y %all1 aft] notice & opportunity = public comm5t 79 ! publications requir$ by subsection 7e77#e7 = a fiscal ye> or o!rwise71 recognize ! co/s ( new antimicrobial drugs "u ! paym5t sy/em e/abli%$ "u ?is subsection4 7ii7 ,pursuant to clause 7i71 ! ,secret>y %all provide = additional paym5t to be made "u ?is subsection ) respect to dis*>ges involv+ new antimicrobial drugs 9 ! am\nt provid$ = "u section #ahdg;,a = drugs & biologicals t are describ$ 9 section #ahdb7o77#a77;,c74 7iii7 ,= purposes ( ?is subp>agraph1 ! t]m new antimicrobial drug means a product t is approv$ = use1 or a product = :i* an indication is fir/ approv$ = use1 by ! ,f$]al ,food & ,drug ,adm9i/ration on or aft] ,janu>y #a1 #bjad1 & t-- 7,i7 is indicat$ to treat an infection caus$ by1 or likely to be caus$ by1 a qualify+ pa?og5 7z def9$ "u section #eje;,e7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7f777 = :i* !re is an unmet m$ical ne$ & :i* is associat$ ) high rates ( mortality or significant pati5t morbidity 7z det]m9$ by ! ,secret>y1 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & ! infecti\s disease pr(essional community72 & 7,,ii7 is us$ 9 facilities t p>ticipate 9 ! ,antimicrobial ,use & ,resi/ance ,module ( ! ,national ,heal?c>e ,safety ,network ( ! ,c5t]s = ,disease ,control & ,prev5tion 7or1 9 ! case t su* ,module is n available1 is us$ 9 facilities t p>ticipate 9 su* successor or simil> report+ module or program relat+ to antimicrobials z ! ,secret>y %all specify to ! ext5t available to su* facilities1 z det]m9$ by ! ,secret>y74 7iv7 ,n lat] ?an ,july #a1 #bjad1 ! ,secret>y %all fir/ publi% 9 ! ,f$]al ,regi/] a li/ ( ! new antimicrobial drugs4 4 7#b7 ,budget neutrality ,section #ahhf7;d77#c77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#c77;,c77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iii7 ,ma9ta9+ budget neutrality = c]ta9 antimicrobial drugs ,= dis*>ges occurr+ 9 a fiscal ye> beg9n+ ) fiscal ye> #bjae1 ! ,secret>y %all fur!r r$uce ea* ( ! av]age /&>diz$ am\nts 9 an am\nt equal to ! am\nt ( ! net additional exp5ditures1 if any1 9 su* fiscal ye> result+ f ! application ( p>agraph 7#e77,m74 4 7b7 ,/udy & report on remov+ b>ri]s to developm5t ( new antimicrobial drugs 7#a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all1 9 consultation ) ! ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice1 ! ,director ( ! ,national ,in/itutes ( ,heal?1 ! ,commission] ( ,food & ,drugs1 & ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 conduct a /udy to-- 7,a7 id5tify & exam9e ! b>ri]s t prev5t ! developm5t ( new antimicrobial drugs1 z def9$ 9 section #ahhf7;d77#e77,m77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,m77iii772 & 7,b7 develop recomm5dations = actions to be tak5 9 ord] to ov]come any b>ri]s id5tifi$ "u subp>agraph 7,a74 7#b7 ,report ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ,congress a report on ! /udy conduct$ "u p>agraph 7#a74