,,ii  #aac? ,,congress  #b;d ,session   
,s4 #biif  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #aj1 #bjad    
,mr4 ,b5net 7= himself & ,mr4 ,hat*7    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to create a limit$          
population pa?way = approval ( c]ta9    
antibact]ial drugs4  #a4  ,%ort title   
,?is ,act may be cit$ z ! ,promise =    
,antibiotics & ,!rapeutics = ,heal? ,act
 or ! ,,pa? ,act4  #b4  ,limit$         
population pa?way = antibact]ial drugs  
,section #ejf ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is 
am5d$--  7#a7 by transf]r+ subsection   
7e7 s t x appe>s be=e subsection 7f72 & 
7#b7 by add+ at ! end ! foll[+3  7g7    
,limit$ population pa?way = antibact]ial
 drugs  7#a7  ,9 g5]al  ,! ,secret>y    
%all e/abli% a program "u :i* !         
,secret>y may1 at ! reque/ ( a sponsor1 
approve an antibact]ial drug1 alone or 9
 comb9ation ) "o or m drugs1 z a limit$ 

population antibact]ial drug1 ^u a      
det]m9ation t su* drug is int5d$ to     
treat a s]i\s or life-?reat5+ disease1  
condition1 or infection & address an    
unmet m$ical ne$ = su* disease1         
condition1 or infection )9 an           
id5tifiable limit$ population4  7#b7    
,limit$ population pa?way  7,a7  ,9     
g5]al  ,! sponsor ( an antibact]ial drug
 t ! ,secret>y det]m9es to be eligible =
 approval z a limit$ population         
antibact]ial drug %all be requir$ to    
demon/rate ! safety & effectiv5ess ( su*
 drug1 z requir$ "u section #eje7;d7 or 
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act1 = ! int5d$ use ( ! drug4  
,! ,secret>y %all det]m9e ! safety &    
effectiv5ess ( an antibact]ial drug "u !
 limit$ population pa?way = antibact]ial
 drugs 9 accordance ) subp>agraph 7,b74 
,an antibact]ial drug %all be eligible =
 approval "u ! limit$ population pa?way 
only ^u ! reque/ ( ! sponsor4  7,b7     
,consid]ations  7i7 ,b5efit-risk pr(ile 
,! ,secret>y's det]m9ation ( safety &   

effectiv5ess ( a limit$ population      
antibact]ial drug %all reflect !        
b5efit-risk pr(ile ( ! drug 9 ! int5d$  
limit$ population1 tak+ into acc\nt !   
sev]ity1 r>ity1 or preval5ce ( !        
infection ! drug is int5d$ to treat & ! 
availability or lack ( alt]native       
treatm5t = su* infection4 ,approval ( a 
drug "u ! limit$ population antibact]ial
 drug pa?way %all n be d5i$ due to a    
lack ( evid5ce to fully e/abli% a       
favorable b5efit-risk pr(ile 9 a        
population t is broad] ?an ! int5d$     
limit$ population4  7ii7 ,types (       
evid5ce ,9 det]m9+ :e!r to approve a    
drug "u ! limit$ population pa?way1 !   
,secret>y-- 7,i7 %all rely on suffici5t 
evid5ce1 :i* may include traditional    
endpo9ts1 alt]nate endpo9ts1 or a       
comb9ation ( traditional & alt]nate     
endpo9ts1 &1 z appropriate1 small       
cl9ical data sets2 &  7,,ii7 may rely on
 supplem5tal data1 includ+ precl9ical   
evid5ce1 ph>macologic or pa?ophysiologic
 evid5ce1 noncl9ical susceptibility1    

ph>macok9etic data1 & o!r su*           
confirmatory evid5ce z ! ,secret>y      
det]m9es appropriate4  7#c7             
,requirem5ts  ,) respect to a drug      
approv$ ?r\gh ! limit$ population       
pa?way1 ! ,secret>y %all require--  7,a7
 ! label+ ( su* antibact]ial drug1 su* z
 ?r\gh a logo or o!r means1 to indicate 
t ! drug has be5 approv$ = use only 9 a 
limit$ population & t ! safety &        
efficacy ( ! drug has be5 demon/rat$    
only ) respect to su* limit$ population2
 &  7,b7 ! sponsor to submit copies (   
all promotional mat]ials relat$ to !    
limit$ population antibact]ial drug1 at 
lea/ #cj days prior to dissem9ation ( ! 
mat]ials4  7#d7  ,o!r programs  ,a      
sponsor ( a drug t seeks approval ( a   
drug ?r\gh ! limit$ population pa?way = 
antibact]ial drugs may also seek        
approval ( su* drug "u subsections 7a71 
7b71 & 7c71 & sections #eje;,e & #ebd4  
7#e7  ,guidance  ,n lat] ?an #ah mon?s  
aft] ! date ( enactm5t ( ! ,promise =   
,antibiotics & ,!rapeutics = ,heal?     

,act1 ! ,secret>y %all issue draft      
guidance describ+ crit]ia1 processes1 & 
o!r g5]al consid]ations = demon/rat+ !  
safety & effectiv5ess ( limit$          
population antibact]ial drugs & h[ !    
pa?way c be exp&$ to o!r !rapeutic areas
 9 addition to antibact]ial infections4 
,! ,secret>y may approve antibact]ial   
drugs ?r\gh su* limit$ population pa?way
 prior to issu+ guidance "u ?is         
p>agraph4  7#f7  ,po/approval monitor+  
programs = antibact]ial drugs  ,!       
,secret>y1 9 consultation ) !           
,commission] & o!r relevant heads (     
ag5cies1 %all conduct po/approval       
monitor+ programs to /udy h[            
antibact]ial drugs approv$ ?r\gh !      
pa?way "u ?is subsection are us$ & to   
monitor *anges 9 bact]ial resi/ance to  
drugs1 includ+ drugs approv$ "u ?is     
pa?way4  7#g7  ,advice  ,! ,secret>y    
%all provide prompt advice to ! sponsor 
( a drug = :i* ! sponsor seeks approval 
?r\gh ! limit$ population pa?way =      
antibact]ial drugs to enable ! sponsor  

to plan a developm5t program to obta9 ! 
necess>y data = approval ( su* drug     
?r\gh ! limit$ population pa?way =      
antibact]ial drugs & to conduct any     
additional /udies t w\ld be requir$ to  
ga9 approval ( su* drug = use 9 a broad]
 population4  7#h7  ,t]m9ation (        
limitations  ,if1 aft] approval ( a drug
 ?r\gh ! limit$ population pa?way =     
antibact]ial drugs1 ! ,secret>y approves
 a broad] indication = su* drug = :i* ! 
sponsor applies "u section #eje7;b7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act1 ! ,secret>y may remove any        
po/m>ket+ conditions1 includ+           
requirem5ts ) respect to label+ & review
 ( promotional mat]ials "u p>agraph 7#c7
 & po/approval monitor+ "u p>agraph     
7#f71 applicable to ! approval ( ! drug 
?r\gh ! limit$ population pa?way =      
antibact]ial drugs4  7#i7  ,rules (     
con/ruction  7,a7 ,/&>ds ( evid5ce &    
au?ority ( ,secret>y ,no?+ 9 ?is        
subsection %all be con/ru$ to alt] !    
/&>ds ( evid5ce applicable to ! review &

 approval ( a drug "u ?is ,act or !     
,public ,heal? ,s]vice ,act1 or to      
modify or limit ! au?ority ( ! ,secret>y
 to approve or monitor drugs pursuant to
 ?is ,act or ! ,public ,heal? ,s]vice   
,act z au?oriz$ prior to ! date (       
enactm5t ( ! ,promise = ,antibiotics &  
,!rapeutics = ,heal? ,act4  7,b7        
,prescrib+ au?ority ,no?+ 9 ?is         
subsection %all be con/ru$ to re/rict ! 
prescrib+ ( antibiotics or o!r products1
 includ+ drugs approv$ "u ! limit$      
population pa?way1 by heal? c>e         
pr(essionals1 or to limit ! practice (  
heal? c>e4  7#aj7 ,expansion ( pa?way   
,beg9n+ on ,octob] #a1 #bjaf1 ! limit$  
population pa?way = antibiotic drugs may
 be exp&$ to apply to approval ( o!r    
drugs int5d$ to treat a s]i\s or        
life-?reat5+ illness4 ,! approval ( su* 
drugs %all be subject to ! consid]ations
 & requirem5ts describ$ 9 ?is           
subsection1 unless ! ,secret>y deliv]s a
 report to ,congress prior to t date    
expla9+ :y su* pa?way %\ld n be us$ =   

o!r !rapeutic areas 9 addition to       
antibact]ial infections4  4