,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #ica  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,febru>y #ab1 #bjae   
,ms4 ,de,lauro 7= h]self1 ,ms4          
,slaught]1 & ,ms4 ,m5g7 introduc$ !     
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to provide = approval ( c]ta9  
drugs & biological products indicat$ =  
use 9 a well-def9$ population ( pati5ts 
9 ord] to address increases 9 bact]ial  
resi/ance to drugs & biological         
products1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,help+  
,effective ,antibiotics ,la/ ,act (     
#bjae or ! ,,heal ,act4  #b4 ,approval (
 c]ta9 drugs = use 9 a well-def9$       
population ( pati5ts  7a7 ,approval (   
,c]ta9 ,antibact]ial ,section #eje ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 is am5d$ by add+ at
 ! end ! foll[+3  7x7 ,approval ( c]ta9 
antibact]ial drugs = use 9 a well-,def9$
 population ( pati5ts  7#a7 ,unmet      
m$ical ne$ def9$ ,9 ?is subsection1 !   

t]m unmet m$ical ne$ means t !          
antibact]ial drug involv$-- 7,a7 has    
improv$ efficacy1 z demon/rat$ 9        
adequate1 well-controll$ /udies 9       
humans1 = specific diseases or          
conditions1 :]e curr5t !rapies h be5 %[n
 to be less effective2  7,b7 has        
cl9ically mean+ful decreas$ h>ms1       
demon/rat$ 9 adequate1 well-controll$   
/udies 9 humans1 = diseases or          
conditions1 :]e curr5t !rapies h        
unacceptable adv]se effects2 or  7,c7   
has improv$ conv5i5ce1 z demon/rat$ 9   
adequate1 well-controll$ /udies 9       
humans1 :]e improv$ conv5i5ce results 9 
improv$ effectiv5ess or decreas$ h>ms4  
7#b7 ,approval ,^u receipt ( an         
application "u subsection 7b7 = an      
antibact]ial drug t is int5d$ to treat a
 s]i\s or life-?reat5+ disease or       
condition1 irrespective ( :e!r ! drug is
 int5d$ to address an unmet m$ical ne$1 
! ,secret>y--  7,a7 may approve ! drug  
"u subsection 7c7 only = treat+ a       
well-def9$ population ( pati5ts1 & bas$ 

^u ! results ( cl9ical trials inclusive 
( human subjects repres5tative ( su*    
well-def9$ population2  7,b7 9 det]m9+  
:e!r to grant su* approval1 %all rely on
 sup]ior outcomes ov] available !rapies 
bas$ on direct measures ( pati5t        
b5efits1 z demon/rat$ 9 adequate1       
well-controll$ /udies 9 ! well-def9$    
pati5t population1 su* z--  7i7 decreas$
 mortality2  7ii7 irrev]sible morbidity2
 or  7iii7 validat$ surrogate endpo9ts t
 reflect mortality or irrev]sible       
morbidity2 &  7,c7 %all require ! label+
 ( drugs approv$ pursuant to ?is        
subsection to prom95tly include 9 !     
prescrib+ in=mation requir$ by section  
#bja4eg ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulation7--  7i7 ! population (       
pati5ts ) respect to :i* ! add$ b5efit  
ov] available !rapies is expect$ z /udi$
 9 adequate1 well-controll$ /udies t =m 
! basis = approval2 &  7ii7 ! me?od =   
id5tify+ memb]s ( t population4  7#c7   
,risk evaluation & mitigation /rategy ,!

 ,secret>y--  7,a7 %all require a risk  
evaluation & mitigation /rategy 7,,rems7
 "u section #eje-a = ea* drug approv$ "u
 ?is subsection2 &  7,b7 may include 9  
any su* /rategy additional elem5ts to   
assure ! safe use ( ! drug "u           
subsections 7e7 & 7f7 ( section #eje-a4 
7#d7 ,rule ( con/ruction ,no?+ 9 ?is    
subsection %all be con/ru$ to alt] !    
/&>ds ( evid5ce "u subsection 7c7 or 7d7
 7includ+ ! sub/antial evid5ce /&>d 9   
subsection 7d774 ,subsections 7c7 & 7d7 
& su* /&>ds ( evid5ce apply to ! review 
& approval ( drugs "u ?is subsection1   
includ+ :e!r a drug is safe & effective4
 ,no?+ 9 ?is subsection %all be con/ru$ 
to limit ! au?ority ( ! ,secret>y to    
approve products pursuant to ?is ,act & 
! ,public ,heal? ,s]vice ,act z au?oriz$
 prior to ! date ( enactm5t ( ?is       
subsection4  7#e7 ,effective imm$iately 
,! ,secret>y %all h ! au?orities ve/$ 9 
! ,secret>y by ?is subsection beg9n+ on 
! date ( enactm5t ( ?is subsection1     
irrespective ( :5 & :e!r ! ,secret>y    

promulgates f9al regulations to c>ry out
 ?is subsection4  4  7b7 ,lic5sure (    
c]ta9 biological products ,section      
#cea7;j7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;j77 is am5d$--    
7#a7 by /rik+ 7j7 & ins]t+ 7j77#a72     
7#b7 by ins]t+ #eje7x71 aft] #eje7p712 &
  7#c7 by add+ at ! end ! foll[+3  7#b7 
,9 apply+ section #eje7x7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act to !     
lic5sure ( biological products "u ?is   
section--  7,a7 ref]5ces to an          
antibact]ial drug ) add$ b5efits ov]    
available !rapies = a well-def9$        
population t is int5d$ to treat a s]i\s 
or life-?reat5+ disease or condition    
%all be con/ru$ to ref] to biological   
products ) add$ b5efits ov] available   
!rapies = a well-def9$ population int5d$
 to treat a bact]ial infection associat$
 ) a s]i\s or life-?reat5+ disease2 &   
7,b7 ref]5ces to an application submitt$
 "u section #eje7;b7 ( su* ,act & to    
approval ( a drug "u section #eje7;c7 ( 
su* ,act %all be con/ru$ to ref] to an  

application submitt$ "u subsection 7a7 (
 ?is section & to lic5sure ( a          
biological product "u su* subsection    
7a71 respectively4  4  7c7 ,monitor+    
,title ,,iii ( ! ,public ,heal? ,s]vice 
,act is am5d$ by ins]t+ aft] section    
#cag,t 7#db ,u4,s4,c4 #bdg;b-#bb7 !     
foll[+3  #cag,u4 ,monitor+ (            
,antibact]ial ,drug ,use1 ,pati5t       
,outcomes1 & ,resi/ance  7a7 ,monitor+  
,! ,secret>y1 act+ ?r\gh ! ,director ( !
 ,c5t]s = ,disease ,control &           
,prev5tion1 %all use ! ,national        
,heal?c>e ,safety ,network or ano!r     
appropriate monitor+ sy/em to monitor-- 
7#a7 *anges 9 pati5t outcomes su* z     
mortality & irrev]sible morbidity       
causally relat$ to antibact]ial         
resi/ance2 &  7#b7 *anges 9 bact]ial    
resi/ance to drugs 9 relation to pati5t 
outcomes4  7b7 ,public availability (   
data ,! ,secret>y1 act+ ?r\gh !         
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion1 %all make ! data d]iv$ f 
monitor+ "u ?is section publicly        

available = ! purposes (--  7#a7 improv+
 ! monitor+ ( important tr5ds 9 pati5t  
outcomes 9 relation to antibact]ial     
resi/ance2 &  7#b7 ensur+ appropriate   
/ew>d%ip ( antibact]ial drugs1 includ+  
^? receiv+ approval or lic5sure = a     
well-def9$ population pursuant to       
section #eje7x7 ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act4  4  #c4              
,susceptibility te/ int]pretive crit]ia 
= microbial organisms  7a7 ,9 g5]al     
,section #eaa ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a7  
is am5d$ to read z foll[s3  #eaa4       
,susceptibility te/ int]pretive crit]ia 
= microbial organisms  7a7 ,9 g5]al ,!  
,secret>y %all-- 7#a7 id5tify ^u        
approval or lic5s+ ( antibact]ial drugs 
7includ+ biological products int5d$ to  
treat a bact]ial infection & o!r types (
 antimicrobial drugs1 z deem$           
appropriate by ! ,secret>y71 includ+    
qualifi$ infecti\s disease products1    
susceptibility te/ int]pretive crit]ia =
 su* drugs bas$ ^u pati5t outcomes (    

mortality & morbidity f adequate &      
well-controll$ /udies & su* o!r         
confirmatory evid5ce z ! ,secret>y deems
 necess>y2 &  7#b7 update1 consi/5t )   
subsection 7b71 su* crit]ia z ne$$ bas$ 
^u sci5tific evid5ce ( *anges 9 pati5t  
outcomes4  7b7 ,respond+ to ,*anges 9   
,pati5t ,outcomes ,to ,evaluate         
,susceptibility ,te/ ,int]pretive       
,crit]ia  7#a7 ,9 g5]al ,z ne$$ bas$ on 
evid5ce relat$ to *anges 9 pati5t       
outcomes1 ! ,secret>y %all-- 7,a7       
evaluate any new sci5tific /udies on    
*anges 9 pati5t outcomes 9 relation to  
susceptibility te/ int]pretive crit]ia2 
&  7,b7 publi% on ! public ,website ( ! 
,food & ,drug ,adm9i/ration a notice--  
7i7 pres5t+ sugge/$ new or updat$       
int]pretive crit]ia2 &  7ii7 if ne$$1   
hold a public advisory committee to     
discuss sci5tific evid5ce relat$ to     
*anges 9 int]pretative crit]ia4  7#b7   
,annual compilation ( notices ,ea* ye>1 
! ,secret>y %all compile ! notices      
publi%$ "u p>agraph 7#a77;,b7 not+ any  

*anges f prior notices & publi% su*     
compilation 9 ! ,f$]al ,regi/]4  7c7    
,def9ition ,9 ?is section1 ! t]m        
susceptibility te/ int]pretive crit]ia  
means "o or m specific values :i*       
*>act]ize pati5t outcomes 9 relation to 
! degree to :i* bact]ia or o!r microbes 
are m resi/ant to treatm5t z measur$ by 
pati5t outcomes4  4  7b7 ,con=m+ am5dm5t
 ,section #aaaa ( ! ,food & ,drug       
,adm9i/ration ,am5dm5ts ,act ( #bjjg    
7#db ,u4,s4,c4 #bdg;d-#e;a2 relat+ to   
id5tification ( cl9ically susceptible   
conc5trations ( antimicrobials7 is      
repeal$4  7c7 ,report to congress ,n    
lat] ?an "o ye> aft] ! date ( enactm5t (
 ?is ,act1 ! ,secret>y ( ,heal? & ,human
 ,s]vices %all submit to ! ,committee on
 ,en]gy & ,comm]ce ( ! ,h\se (          
,repres5tatives & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate a report on ! progress made 9 
implem5t+ section #eaa ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cfj;a71 z am5d$ by ?is section4  #d4   

,requir+ demon/ration ( sup]ior outcomes
 = qualifi$ infecti\s disease products  
,to receive an ext5d$ exclusivity p]iod 
,section #eje;,e7g7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;f7g77 is am5d$ by /rik+ means an   
antibact]ial or antifungal drug = human 
use int5d$ to treat & ins]t+ means an   
antibact]ial or antifungal drug = human 
use t is demon/rat$ to produce sup]ior  
outcomes ov] available !rapies1 bas$ on 
direct measures ( pati5t b5efits 9      
cl9ical trials1 & t is int5d$ to treat4 
#e4 ,guidance on t>get product pr(iles  
,n lat] ?an #ah mon?s aft] ! date (     
enactm5t ( ?is ,act1 ! ,commission] (   
,food & ,drugs1 9 consultation ) !      
,adm9i/rator ( ! ,c5t]s = ,m$ic>e       
,m$icaid ,s]vices1 ! ,director ( !      
,indian ,heal? ,s]vice1 ! ,secret>y (   
,def5se1 & ! ,secret>y ( ,vet]ans       
,affairs1 %all issue guidance on !      
developm5t ( t>get product pr(iles =    
novel antibact]ial drugs focus$ on      
public heal? priorities4