,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #agab  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #d1 #bjai,mr4    
,isakson 7= himself & ,mr4 ,casey7      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,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 ( #bjai & z ! ,,dis>m ,act (      
#bjai4  #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 
7,i7 ,effective = dis*>ges beg9n+ on or 
aft] ,octob] #a1 #bjbj1 subject to      
subclause 7,,ii71 ! ,secret>y %all1 aft]

 notice & opportunity = public comm5t 79
 ! publications requir$ by subsection   
7e77#e7 = a fiscal ye> or o!rwise71     
provide = an additional paym5t "u a     
me*anism 7sep>ate f ! me*anism e/abli%$ 
"u subp>agraph 7,k771 ) respect to su*  
dis*>ges involv+ any ,,dis>m            
antimicrobial drug1 9 an am\nt equal    
to--  7aa7 ! am\nt payable "u section   
#ahdg;,a = su* drug dur+ ! cal5d> qu>t] 
9 :i* ! dis*>ge occurr$2 or  7bb7 if no 
am\nt = su* drug is det]m9$ "u section  
#ahdg;,a1 an am\nt to be det]m9$ by !   
,secret>y 9 a mann] simil> to ! mann] 9 
:i* paym5t am\nts are det]m9$ "u section
 #ahdg;,a bas$ on in=mation submitt$ by 
! manufactur] or sponsor ( su* drug 7z  
requir$ "u clause 7v774  7,,ii7 ,9      
det]m9+ ! am\nt payable "u section      
#ahdg;,a = purposes ( items 7aa7 & 7bb7 
( subclause 7,i71 subp>agraphs 7,a7 &   
7,b7 ( subsection 7b77#a7 ( su* section 
%all be appli$ by sub/itut+ #ajb p]c5t =
 #ajf p]c5t ea* place x appe>s &        
p>agraph 7#h77;,b7 ( su* section %all be

 appli$ by sub/itut+ #b p]c5t = #f      
p]c5t4  7ii7 ,= purposes ( ?is          
subp>agraph1 a ,,dis>m antimicrobial    
drug is-- 7,i7 a drug--  7aa7 t-- 7,,aa7
 is approv$ by ! ,food & ,drug          
,adm9i/ration2 7,,bb7 is designat$ by ! 
,food & ,drug ,adm9i/ration z a qualifi$
 infecti\s disease product "u subsection
 7d7 ( section #eje;,e ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act2 & 7,,cc7 has  
receiv$ an ext5sion ( its exclusivity   
p]iod pursuant to subsection 7a7 ( su*  
section2 &  7bb7 t has be5 designat$ by 
! ,secret>y pursuant to ! process       
e/abli%$ "u clause 7iv77,i77bb72 or     
7,,ii7 an antibact]ial or antifungal    
biological product-- 7aa7 t is lic5s$ = 
use1 or an antibact]ial or antifungal   
biological product = :i* an indication  
is fir/ lic5s$ = use1 by ! ,food & ,drug
 ,adm9i/ration on or aft] ,june #e1     
#bjad1 "u section #cea7;a7 ( ! ,public  
,heal? ,s]vice ,act = human use to treat
 s]i\s or life-?reat5+ infections1 z    
det]m9$ by ! ,food & ,drug              

,adm9i/ration1 includ+ ^? caus$ by1 or  
likely to be caus$ by-- 7,,aa7 an       
antibact]ial or antifungal resi/ant     
pa?og51 includ+ novel or em]g+ infecti\s
 pa?og5s2 or 7,,bb7 a qualify+ pa?og5 7z
 def9$ "u section #eje;,e7f7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act72 &  7bb7
 has be5 designat$ by ! ,secret>y       
pursuant to ! process e/abli%$ "u clause
 7iv77,i77bb74  7iii7 ,! me*anism       
e/abli%$ pursuant to clause 7i7 %all    
provide t ! additional paym5t "u clause 
7i7 %all--  7,i7 ) respect to a dis*>ge1
 only be made to a subsection 7d7       
hospital t1 z det]m9$ by ! ,secret>y--  
7aa7 is p>ticipat+ 9 ! ,national        
,heal?c>e ,safety ,network              
,antimicrobial ,use & ,resi/ance ,module
 ( ! ,c5t]s = ,disease ,control &       
,prev5tion or a simil> report+ program1 
z specifi$ by ! ,secret>y1 relat+ to    
antimicrobial drugs2 &  7bb7 has an     
antimicrobial /ew>d%ip program t aligns 
) ! ,core ,elem5ts ( ,hospital          
,antibiotic ,/ew>d%ip ,programs ( !     

,c5t]s = ,disease ,control & ,prev5tion 
or ! ,antimicrobial ,/ew>d%ip ,/&>d set 
by ! ,jo9t ,commission2 &  7,,ii7 apply 
to dis*>ges occurr+ on or aft] ,octob]  
#a ( ! ye> 9 :i* ! drug or biological   
product is designat$ by ! ,secret>y z a 
,,dis>m antimicrobial drug4  7iv7 7,i7  
,! me*anism e/abli%$ pursuant to clause 
7i7 %all provide = a process =-- 7aa7 a 
manufactur] or sponsor ( a drug or      
biological product to reque/ ! ,secret>y
 to designate ! drug or biological      
product z a ,,dis>m antimicrobial drug2 
&  7bb7 ! designation by ! ,secret>y (  
drugs & biological products z ,,dis>m   
antimicrobial drugs4  7,,ii7 ,a         
designation ( a drug or biological      
product z a ,,dis>m antimicrobial drug  
may be revok$ by ! ,secret>y if !       
,secret>y det]m9es t--  7aa7 ! drug or  
biological product no long] meets !     
requirem5ts = a ,,dis>m antimicrobial   
drug "u clause 7ii72  7bb7 ! reque/ =   
su* designation conta9$ an untrue       
/atem5t ( mat]ial fact2 or  7cc7 cl9ical

 or o!r in=mation t 0 n available to !  
,secret>y at ! "t su* designation 0 made
 %[s t-- 7,,aa7 su* drug or biological  
product is unsafe = use or n %[n to be  
safe = use = individuals :o are entitl$ 
to b5efits "u "p ,a2 or 7,,bb7 an       
alt]native to su* drug or biological    
product is an advance t sub/antially    
improves ! diagnosis or treatm5t ( su*  
individuals4  7,,iii7 ,n lat] ?an       
,octob] #a1 #bjbj1 & annually !reaft]1 !
 ,secret>y %all publi% 9 ! ,f$]al       
,regi/] a li/ ( ! ,,dis>m antimicrobial 
drugs designat$ "u ?is subp>agraph      
pursuant to ! process e/abli%$ "u clause
 7iv77,i77bb74  7v7 7,i7 ,= purposes (  
det]m9+ additional paym5t am\nts "u     
clause 7i71 a manufactur] or sponsor ( a
 drug or biological product t submits a 
reque/ describ$ 9 clause 7iv77,i77aa7   
%all submit to ! ,secret>y in=mation    
describ$ 9 section                      
#aibg7;b77#c77;,a77iii74  7,,ii7 ,!     
p5alties = failure to provide timely    
in=mation "u clause 7i7 ( subp>agraph   

7,c7 "u section #aibg7;b77#c7 & =       
provid+ false in=mation "u clause 7ii7 (
 su* subp>agraph %all apply to          
manufactur]s & sponsors ( a drug or     
biological product "u ?is section )     
respect to in=mation "u subclause 7,i7 9
 ! same mann] z su* p5alties apply to   
manufactur]s "u su* clauses ) respect to
 in=mation "u subp>agraph 7,a7 ( su*    
section4  7vi7 7,i7 ,! me*anism e/abli%$
 pursuant to clause 7i7 %all provide t--
 7aa7 except z provid$ 9 item 7bb71 no  
additional paym5t %all be made "u ?is   
subp>agraph = dis*>ges involv+ a ,,dis>m
 antimicrobial drug if any additional   
paym5ts h be5 made = dis*>ges involv+   
su* drug z a new m$ical s]vice or       
te*nology "u subp>agraph 7,k72  7bb7    
additional paym5ts may be made "u ?is   
subp>agraph = dis*>ges involv+ a ,,dis>m
 antimicrobial drug if any additional   
paym5ts h be5 made = dis*>ges occurr+   
prior to ! date ( enactm5t ( ?is        
subp>agraph involv+ su* drug z a new    
m$ical s]vice or te*nology "u           

subp>agraph 7,k72 &  7cc7 no additional 
paym5t %all be made "u subp>agraph 7,k7 
= dis*>ges involv+ a ,,dis>m            
antimicrobial drug z a new m$ical s]vice
 or te*nology if any additional paym5ts 
= dis*>ges involv+ su* drug h be5 made  
"u ?is subp>agraph4  4  7#b7 ,con=m+    
am5dm5t ,section                        
#ahhf7;d77#e77,k77ii77,,iii7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#acieww7d77#e77,k77ii77,,iii77 is am5d$ 
by /rik+ provide & ins]t+ subject to    
subp>agraph 7,m77vii71 provide4  7b7    
,/udy & reports on remov+ b>ri]s to !   
developm5t ( ,,dis>m antimicrobial drugs
  7#a7 ,/udy ,! ,comptroll] ,g5]al ( !  
,unit$ ,/ates 79 ?is subsection ref]r$  
to z ! ,comptroll] ,g5]al7 %all1 9      
consultation ) ! ,director ( ! ,national
 ,in/itutes ( ,heal?1 ! ,commission] (  
,food & ,drugs1 ! ,adm9i/rator ( !      
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices1 & !
 ,director ( ! ,c5t]s = ,disease        
,control & ,prev5tion1 conduct a /udy   
to--  7,a7 id5tify & exam9e ! b>ri]s t  

prev5t ! developm5t ( ,,dis>m           
antimicrobial drugs 7z def9$ 9 section  
#ahhf7;d77#e77,m77ii7 ( ! ,social       
,security ,act1 z add$ by subsection    
7a772 &  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 ,reports  7,a7 ,int]im report ,n   
lat] ?an #c ye>s aft] ! date ( !        
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al %all submit to ,congress an      
int]im report conta9+ ! prelim9>y       
results ( ! /udy conduct$ "u p>agraph   
7#a71 toge!r ) recomm5dations = su*     
legislation & adm9i/rative action z !   
,comptroll] ,g5]al det]m9es appropriate4
  7,b7 ,f9al report ,n lat] ?an #e ye>s 
aft] ! date ( ! enactm5t ( ?is ,act1 !  
,comptroll] ,g5]al %all submit to       
,congress a report conta9+ ! results ( !
 /udy conduct$ "u p>agraph 7#a71 toge!r 
) recomm5dations = su* legislation &    
adm9i/rative action z ! ,comptroll]     
,g5]al det]m9es appropriate4