,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #eab  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,janu>y #bb1 #bjae    
,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 ( ,,dis>m antimicrobial
 drugs1 & = o!r purposes4  #a4 ,%ort    
title ,?is ,act may be cit$ z !         
,develop+ an ,innovative ,/rategy =     
,antimicrobial ,resi/ant ,microorganisms
 ,act ( #bjae & z ! ,,dis>m ,act (      
#bjae4  #b4 ,enc\rag+ ! developm5t & use
 ( ,,dis>m antimicrobial drugs  7a7     
,additional paym5t = ,,dis>m            
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 #bjae1 ! ,secret>y %all1   
aft] notice & opportunity = public      
comm5t 79 ! publications requir$ by     
subsection 7e77#e7 = a fiscal ye> or    
o!rwise71 recognize ! co/s ( ,,dis>m    
antimicrobial drugs "u ! paym5t sy/em   
e/abli%$ "u ?is subp>agraph4  7ii7      
,pursuant to clause 7i71 ! ,secret>y    
%all provide = additional paym5t to be  
made "u ?is subsection ) respect to     
dis*>ges involv+ ,,dis>m antimicrobial  
drugs 9 ! am\nt provid$ = "u section    
#ahdg;,a = drugs & biological products t
 are describ$ 9 section                 
#ahdb7o77#a77;,c74  7iii7 ,= purposes ( 
?is subp>agraph1 ! t]m ,,dis>m          
antimicrobial drug means a product t is 
approv$ or lic5s$ = use1 or a product = 
:i* an indication is fir/ approv$ or    
lic5s$ = use1 by ! ,food & ,drug        
,adm9i/ration on or aft] ,janu>y #a1    

#bjae1 &--  7,i7  7aa7 is int5d$ to     
treat an infection caus$ by1 or likely  
to be caus$ by1 a qualify+ pa?og5 7z    
def9$ "u section #eje;,e7f7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act72 or     
7bb7 meets ! def9ition ( a qualifi$     
infecti\s disease product "u section    
#eje;,e7g7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act2  7,,ii7 is int5d$ to    
treat an infection = :i* !re is an unmet
 m$ical ne$ z det]m9$ by ! ,food & ,drug
 ,adm9i/ration2  7,,iii7 is int5d$ to   
treat an infection t is associat$ ) high
 rates ( mortality or significant pati5t
 morbidity1 z det]m9$ by ! ,secret>y1 9 
consultation ) ! ,director ( ! ,c5t]s = 
,disease ,control & ,prev5tion & !      
infecti\s disease pr(essional community2
 &  7,,iv7 is us$ 9 facilities t1 to !  
ext5t available to su* facilities1 z    
det]m9$ by ! ,secret>y1 p>ticipate 9--  
7aa7 ! ,national ,heal?c>e ,safety      
,network ( ! ,c5t]s = ,disease ,control 
& ,prev5tion2 or  7bb7 a simil> report+ 
program relat+ to antimicrobial drugs1 z

 specifi$ by ! ,secret>y4  7iv7  7,i7 ,!
 manufactur] or sponsor ( a drug may    
reque/ ! ,secret>y to designate a drug z
 a ,,dis>m antimicrobial drug at any "t 
be=e or aft] ! submission ( an          
application "u section #eje7;b7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act or
 section #cea7;a7 ( ! ,public ,heal?    
,s]vice ,act = su* drug4 ,pursuant to ! 
previ\s s5t5ce1 ! ,secret>y %all1 n lat]
 ?an #fj days aft] ! submission ( su* a 
reque/1 det]m9e :e!r ! drug w be        
consid]$ a ,,dis>m antimicrobial drug 9 
! case t x is approv$ or lic5s$ = use1  
or is fir/ approv$ or lic5s$ = an       
indication4  7,,ii7 ,except z provid$ 9 
subclause 7,,iii71 a designation "u ?is 
clause %all n be )drawn = any reason4   
7,,iii7 ,! ,secret>y may revoke a       
designation ( a drug z a ,,dis>m        
antimicrobial drug product if !         
,secret>y f9ds t ! reque/ = su*         
designation conta9$ an untrue /atem5t ( 
mat]ial fact4  7v7 ,n lat] ?an ,octob]  
#a1 #bjaf1 ! ,secret>y %all fir/ publi% 

9 ! ,f$]al ,regi/] a li/ ( ! ,,dis>m    
antimicrobial drugs4  7vi7 ,! ,secret>y 
%all make a proportional adju/m5t 9 !   
/&>diz$ am\nt det]m9$ "u p>agraph 7#c7  
to assure t ! provisions ( ?is          
subp>agraph d n result 9 aggregate      
paym5ts "u ?is subsection t are great]  
or less ?an ^? t w\ld o!rwise be made "u
 su* subsection = a fiscal ye>4  4  7#b7
 ,relation%ip to ,,ntap paym5ts ,section
 #ahhf7;d77#e7 ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #acieww7d77#e771 z  
am5d$ by p>agraph 7#a71 is fur!r am5d$ 9
 subp>agraph 7,k7--  7,a7 9 clause 7i71 
by ins]t+ t are n ,,dis>m antimicrobial 
drugs 7z def9$ 9 subp>agraph 7,m77iii77 
aft] new m$ical s]vices & te*nologies2 &
  7,b7 9 clause 7ii77,i71 by ins]t+ if !
 s]vice or te*nology is n a ,,dis>m     
antimicrobial drug & aft] a new m$ical  
s]vice or te*nology4  7b7 ,/udy & report
 on remov+ b>ri]s to developm5t (       
,,dis>m antimicrobial drugs  7#a7 ,/udy 
,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 
%all1 9 consultation ) ! ,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 ( ,,dis>m antimicrobial      
drugs1 z def9$ 9 section                
#ahhf7;d77#e77,m77iii7 ( ! ,social      
,security ,act1 z add$ by subsection    
7a72 &  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 #a ye> aft] !  
date ( ! enactm5t ( ?is ,act1 !         
,comptroll] ,g5]al %all submit to       
,congress a report on ! /udy conduct$ "u
 p>agraph 7#a74