,,ii ,cal5d> ,no4 #dbe #aad? ,,congress 
#b;d ,session  ,s4 #ahe  ,,9 ,,! ,,s5ate
 ,,( ,,! ,,unit$ ,,/ates  ,janu>y #af1  
#bjae,mr4 ,hat* 7= himself1 ,mr4 ,b5net1
 ,ms4 ,ayotte1 ,mr4 ,isakson1 ,mr4      
,kirk1 ,mr4 ,c>p]1 & ,mr4 ,blum5?al7    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,april #ah1 #bjaf,report$ by ,mr4       
,alex&]1 ) an amendment,strike out all  
aft] ! enact+ clause & ins]t ! "p pr9t$ 
9 italic  ,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  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,promise
 = ,antibiotics & ,!rapeutics = ,heal?  
,act or ! ,,pa? ,act4  #b4 ,antibact]ial
 resi/ance monitor+ ,section #cai;,e ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bdg;d-#e7 is am5d$-- 7#a7 by 
r$esignat+ subsections 7f7 & 7g7 z      
subsections 7k7 & 7l71 respectively2 &  
7#b7 by ins]t+ aft] subsection 7e71 !   
foll[+3  7f7 ,monitor+ at ,f$]al heal?  
c>e facilities ,! ,secret>y %all        
enc\rage report+ on aggregate           
antibact]ial drug use & bact]ial        
resi/ance to antibact]ial drugs & !     
implem5tation ( antibiotic /ew>d%ip     
programs by heal? c>e facilities ( !    
,dep>tm5t ( ,def5se1 ! ,dep>tm5t (      
,vet]ans ,affairs1 & ! ,indian ,heal?   

,s]vice & %all provide te*nical         
assi/ance to ! ,secret>y ( ,def5se & !  
,secret>y ( ,vet]ans ,affairs1 z        
appropriate & ^u reque/4  7g7 ,report on
 antibact]ial resi/ance 9 humans & use (
 antibact]ial drugs ,n lat] ?an #a ye>  
aft] ! date ( enactm5t ( ?is subsection1
 & annually !reaft]1 ! ,secret>y %all   
prep>e & make publically available data 
& in=mation conc]n+--  7#a7 aggregate   
national & regional tr5ds ( bact]ial    
resi/ance 9 humans to antibact]ial      
drugs1 includ+ ^? approv$ "u section    
#ejf7;g7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act2  7#b7 antibact]ial      
/ew>d%ip1 :i* may include summ>ies (    
,/ate ef=ts to address bact]ial         
resi/ance 9 humans to antibact]ial drugs
 & antibact]ial /ew>d%ip2 &  7#c7       
coord9ation betwe5 ! ,director ( !      
,c5t]s = ,disease ,control & ,prev5tion 
& ! ,commission] ( ,food & ,drugs )     
respect to ! monitor+ (--  7,a7 any     
applicable resi/ance "u p>agraph 7#a72 &
  7,b7 drugs approv$ "u section #ejf7;g7

 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act4  7h7 ,in=mation relat$ to         
antibiotic /ew>d%ip programs ,!         
,secret>y %all1 z appropriate1          
dissem9ate guidance1 educational        
mat]ials1 or o!r appropriate mat]ials   
relat$ to ! developm5t & implem5tation (
 evid5ce-bas$ antibiotic /ew>d%ip       
programs or practices at heal? c>e      
facilities1 su* z nurs+ homes & o!r     
long-t]m c>e facilities1 ambulatory     
surgical c5t]s1 dialysis c5t]s1 &       
community & rural hospitals4  7i7       
,support+ /ate-bas$ activities to combat
 antibact]ial resi/ance ,! ,secret>y    
%all cont9ue to "w ) ,/ate & local      
public heal? dep>tm5ts on /atewide or   
regional programs relat$ to antibact]ial
 resi/ance4 ,su* ef=ts may include      
activities to relat$ to--  7#a7 id5tify+
 patt]ns ( bact]ial resi/ance 9 humans  
to antibact]ial drugs2  7#b7 prev5t+ !  
spread ( bact]ial infections t are      
resi/ant to antibact]ial drugs2 &  7#c7 
promot+ antibiotic /ew>d%ip4  7j7       

,antibact]ial ,resi/ance & ,/ew>d%ip    
activities  7#a7 ,9 g5]al ,= ! purposes 
( support+ /ew>d%ip activities1 exam9+  
*anges 9 bact]ial resi/ance1 & evaluat+ 
! effectiv5ess ( section #ejf7;g7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 !
 ,secret>y %all--  7,a7 provide a       
me*anism = facilities to report data    
relat$ to _! antimicrobial /ew>d%ip     
activities 7includ+ analyz+ ! outcomes (
 su* activities72 &  7,b7 evaluate-- 7i7
 antimicrobial resi/ance data us+ a     
/&>diz$ approa*2 &  7ii7 tr5ds 9 !      
utilization ( drugs approv$ "u su*      
section #ejf7;g7 ) respect to pati5t    
populations4  7#b7 ,use ( sy/ems ,!     
,secret>y %all use available sy/ems1    
includ+ ! ,national ,heal?c>e ,safety   
,network or o!r sy/ems id5tifi$ by !    
,secret>y1 to fulfill ! requirem5ts or  
conduct activities "u ?is section4  7#c7
 ,availability ( data ,! ,secret>y %all 
make ! data collect$ pursuant to ?is    
subsection public4 ,no?+ 9 ?is          
subsection %all be con/ru$ z au?oriz+ ! 

,secret>y to disclose any in=mation t is
 a trade secret or confid5tial in=mation
 subject to section #eeb7;b77#d7 ( title
 #e1 ,unit$ ,/ates ,code1 or section    
#aije ( title #ah1 ,unit$ ,/ates ,code4 
4  #c4 ,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 may approve an       
antibact]ial drug1 alone or 9 comb9ation
 ) "o or m o!r drugs1 z a limit$        
population drug pursuant to ?is         
subsection only if--  7,a7 ! drug is    
int5d$ to treat a s]i\s or life-?reat5+ 
infection 9 a limit$ population (       
pati5ts ) unmet ne$s2  7,b7 ! /&>ds =   
approval "u section #eje7;c7 & 7d71 or !
 /&>ds = lic5sure "u section #cea ( !   
,public ,heal? ,s]vice ,act1 z          
applicable1 are met2 &  7,c7 ! ,secret>y

 receives a writt5 reque/ f ! sponsor to
 approve ! drug z a limit$ population   
drug pursuant to ?is subsection4  7#b7  
,b5efit-risk consid]ation ,! ,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 9 su* limit$        
population4 ,su* drug may be approv$ "u 
?is subsection not)/&+ a lack ( evid5ce 
to fully e/abli% a favorable b5efit-risk
 pr(ile 9 a population t is broad] ?an !
 int5d$ limit$ population4  7#c7        
,additional requirem5ts ,a drug approv$ 
"u ?is subsection %all be subject to !  
requirem5ts ( ?is p>agraph1 9 addition  
to any o!r applicable requirem5ts ( ?is 
,act3  7,a7 ,label+ ,to indicate t !    
safety & effectiv5ess ( a drug approv$  
"u ?is subsection has be5 demon/rat$    
only ) respect to a limit$ population-- 

7i7 all label+ & adv]tis+ ( an          
antibact]ial drug approv$ "u ?is        
subsection %all conta9 ! /atem5t ,limit$
 ,population 9 a prom95t mann] & adjac5t
 to1 & n m prom95t ?an--  7,i7 !        
propriet>y "n ( su* drug1 if any2 or    
7,,ii7 if !re is no propriet>y "n1 !    
e/abli%$ "n ( ! drug1 if any1 z def9$ 9 
section #ejc7;e77#c71 or = drugs :i* are
 biological products1 ! prop] "n1 z     
def9$ by regulation2 &  7ii7 ! prescrib+
 in=mation = su* antibact]ial drug      
requir$ by section #bja4eg ( title #ba1 
,code ( ,f$]al ,regulations 7or any     
successor regulation7 %all also include 
! foll[+ /atem5t3 ,?is drug is indicat$ 
= use 9 a limit$ & specific population (
 pati5ts44  7,b7 ,promotional mat]ial ,!
 sponsor ( an antibact]ial drug subject 
to ?is subsection %all submit to !      
,secret>y copies ( all promotional      
mat]ials relat$ to su* drug at lea/ #cj 
cal5d> days prior to dissem9ation ( !   
mat]ials4  7#d7 ,o!r programs ,a sponsor
 ( a drug t seeks approval ( a drug "u  

?is subsection = antibact]ial drugs may 
also seek designation or approval1 z    
applicable1 ( su* drug "u o!r applicable
 sections or subsections ( ?is ,act ( ! 
,public ,heal? ,s]vice ,act4  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 drugs4 ,!       
,secret>y %all publi% f9al guidance )9  
#ah mon?s ( ! close ( ! public comm5t   
p]iod on su* draft guidance4 ,!         
,secret>y may approve antibact]ial drugs
 "u ?is subsection prior to issu+       
guidance "u ?is p>agraph4  7#f7 ,advice 
,! ,secret>y %all provide prompt advice 
to ! sponsor ( a drug = :i* ! sponsor   
seeks approval "u ?is subsection =      
antibact]ial drugs to enable ! sponsor  
to plan a developm5t program to obta9 ! 
necess>y data = approval ( su* drug "u  

?is subsection = antibact]ial drugs & to
 conduct any additional /udies t w\ld be
 requir$ to ga9 approval ( su* drug =   
use 9 a broad] population4  7#g7        
,t]m9ation ( limitations ,if1 aft]      
approval ( a drug "u ?is subsection1 !  
,secret>y approves a broad] indication =
 su* drug = :i* ! sponsor applies "u    
section #eje7;b7 or section #cea7;a7 ( !
 ,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#c71 applicable  
to ! approval ( ! drug "u ?is           
subsection4  7#h7 ,rules ( con/ruction  
,no?+ 9 ?is subsection %all be con/ru$  
to alt] ! au?ority ( ! ,secret>y to     
approve drugs pursuant to ?is ,act &    
section #cea ( ! ,public ,heal? ,s]vice 
,act1 includ+ ! /&>ds ( evid5ce1 &      
applicable conditions1 = approval "u su*
 ,acts1 ! /&>ds ( approval ( a drug "u  
?is ,act or ! ,public ,heal? ,s]vice    
,act1 or to alt] ! au?ority ( !         

,secret>y to monitor drugs pursuant to  
?is ,act or ! ,public ,heal? ,s]vice    
,act4  7#i7 ,report+ & acc\ntability    
7,a7 ,biannual report+ ,! ,secret>y %all
 report to ,congress n less (t5 ?an once
 e #b ye>s on ! numb] ( reque/s =       
approval1 & ! numb] ( approvals1 ( an   
antibact]ial drug "u ?is subsection4    
7,b7 ,gao report ,n lat] ?an ,decemb]   
#bjba1 ! ,comptroll] ,g5]al ( ! ,unit$  
,/ates %all report on ! coord9ation (   
activities requir$ "u section #cai;,e ( 
! ,public ,heal? ,s]vice ,act1 a review 
( su* activities1 & ! ext5t to :i* ! use
 ( ! pa?way e/abli%$ "u ?is subsection  
has /reaml9$ prem>ket approval =        
antibact]ial drugs = limit$ populations1
 if su* pa?way has function$ z int5d$1  
if su* pa?way has help$ provide = safe &
 effective treatm5t = pati5ts1 if su*   
prem>ket approval w\ld be appropriate = 
o!r categories ( drugs1 & if !          
au?orities "u ?is subsection h affect$  
antibiotic resi/ance4  4  #d4 ,prescrib+
 au?ority ,no?+ 9 ?is ,act1 or an       

am5dm5t made by ?is ,act1 %all be       
con/ru$ to re/rict ! prescrib+ (        
antibact]ial drugs or o!r products1     
includ+ drugs approv$ "u section        
#ejf7;g7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;g771
 by heal? c>e pr(essionals1 or to limit 
! practice ( heal? c>e4  ,april #ah1    
#bjaf,report$ ) an am5dm5t