,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #cgdb  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #ab1         
#bjac,mr4 ,g+rey ( ,georgia 7= himself1 
,mr4 ,g5e ,gre5 ( ,texas1 ,mr4 ,%imkus1 
,ms4 ,e%oo1 ,mr4 ,:itfield1 ,ms4        
,de,gette1 ,mrs4 ,blackburn1 ,mr4       
,engel1 ,mr4 ,griffi? ( ,virg9ia1 & ,mr4
 ,butt]field7 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 limit$      
population ( pati5ts 9 ord] to address  
increases 9 bact]ial & fungal resi/ance 
to drugs & biological products1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,antibiotic ,developm5t to 
,advance ,pati5t ,treatm5t ,act ( #bjac4
  #b4 ,approval ( c]ta9 drugs = use 9 a 
limit$ population ( pati5ts  7a7        
,approval ( c]ta9 antibact]ial &        
antifungal drugs ,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 & antifungal drugs = use 9 
a limit$ population ( pati5ts  7#a7     
,approval ,at ! reque/ ( ! sponsor ( an 
antibact]ial or antifungal drug t is    
int5d$ to treat a s]i\s or life-?reat5+ 
disease or condition1 ! ,secret>y-- 7,a7
 may approve ! drug "u subsection 7c7 to
 treat a limit$ population ( pati5ts =  
:i* !re is an unmet m$ical ne$2  7,b7 9 
det]m9+ :e!r to grant su* approval = a  
limit$ population ( pati5ts1 may rely on
 traditional endpo9ts1 alt]native       
endpo9ts1 or a comb9ation ( traditional 
& alt]native endpo9ts2 datasets ( limit$
 size2 ph>macologic or pa?ophysiologic  
data2 data f phase #b cl9ical /udies2 & 
su* o!r confirmatory evid5ce z !        
,secret>y deems necess>y2 &  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 ! foll[+ /atem5t3 ,?is drug 

is indicat$ = use 9 a limit$ & specific 
population ( pati5ts44  7#b7            
,promotional mat]ials ,! provisions (   
section #ejf7;c77#b77;,b7 %all apply )  
respect to approval "u ?is subsection to
 ! same ext5t & 9 ! same mann] z su*    
provisions apply ) respect to accel]at$ 
approval "u section #ejf7;c77#a74  7#c7 
,)drawal ( limit$ population approval   
requirem5ts ,if a drug is approv$       
pursuant to ?is subsection to treat a   
limit$ population ( pati5ts & is        
subsequ5tly approv$ or lic5s$ "u ?is    
section or section #cea ( ! ,public     
,heal? ,s]vice ,act1 respectively1 )\t  
su* a limitation1 ! ,secret>y may remove
 any label+ requirem5ts or po/m>ket+    
conditions made applicable to ! drug    
dur+ ! e>li] approval process4  7#d7    
,relation to o!r provisions ,no?+ 9 ?is 
subsection %all be con/ru$ to prohibit  
designation & exp$it$ review ( a drug z 
a break?r\gh !rapy "u section #ejf7;a71 
designation & treatm5t ( a drug z a fa/ 
track product "u section #ejf7;b71 or   

accel]at$ approval ( ! drug "u section  
#ejf7;c71 9 comb9ation ) approval ( !   
drug = use 9 a limit$ population (      
pati5ts "u ?is subsection4  7#e7 ,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#f7 ,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 or antifungal drug t is    
int5d$ to treat a s]i\s or life-?reat5+ 
disease or condition %all be con/ru$ to 
ref] to biological products int5d$ to   
treat a bact]ial or fungal infection    
associat$ ) a s]i\s or life-?reat5+     
disease2 &  7,b7 ref]5ces to approval ( 
a drug "u section #eje7;c7 ( su* ,act   
%all be con/ru$ to ref] to lic5sure ( a 
biological product "u subsection 7a7 (  
?is section4  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 &        
antifungal drug use & 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 ! use ( antibact]ial & antifungal  
drugs1 includ+ ^? receiv+ approval or   
lic5sure = a limit$ population pursuant 
to section #eje7x7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act2 &  7#b7 *anges 
9 bact]ial & fungal resi/ance to drugs4 
7b7 ,public availability ( data ,!      
,secret>y1 act+ ?r\gh ! ,director ( !   
,c5t]s = ,disease ,control & ,prev5tion1
 %all make ! data d]iv$ f monitor+ "u   
?is section publicly available = !      
purposes (-- 7#a7 improv+ ! monitor+ (  
important tr5ds 9 antibact]ial &        
antifungal resi/ance2 &  7#b7 ensur+    
appropriate /ew>d%ip ( antibact]ial &   
antifungal drugs1 includ+ ^? receiv+    
approval or lic5sure = a limit$         
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 id5tify ^u approval & subsequ5tly  
update susceptibility te/ int]pretive   
crit]ia = 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 by rely+ ^u1
 to ! ext5t available-- 7#a7 precl9ical 
& cl9ical data1 includ+ ph>macok9etic1  
ph>macodynamic1 & epidemiological data2 
7#b7 ,bayesian & ph>macometric /ati/ical
 me?odologies2 &  7#c7 su* o!r          
confirmatory evid5ce z ! ,secret>y deems
 necess>y4  7b7 ,respond+ to            
susceptibility te/ int]pretive crit]ia  
id5tifi$ or updat$ by private entities  
7#a7 ,9 g5]al ,ea* qu>t] ( ea* fiscal   

ye>1 ! ,secret>y %all-- 7,a7 evaluate   
any appropriate new or updat$           
susceptibility te/ int]pretive crit]ia  
publi%$ by a nationally or              
int]nationally recogniz$ /&>d developm5t
 organization2 &  7,b7 publi% on !      
public ,website ( ! ,food & ,drug       
,adm9i/ration a notice-- 7i7 adopt+ !   
new or updat$ int]pretive crit]ia2  7ii7
 decl9+ to adopt ! new or updat$        
int]pretive crit]ia & expla9+ ! reason =
 su* decision2 or  7iii7 adopt+ "o or m 
p>ts ( ! new or updat$ int]pretive      
crit]ia1 decl9+ to adopt ! rema9d] ( su*
 crit]ia1 & expla9+ ! reason = s decl9+4
  7#b7 ,annual compilation ( notices    
,ea* ye>1 ! ,secret>y %all compile !    
notices publi%$ "u p>agraph 7#a77;,b7 & 
publi% su* compilation 9 ! ,f$]al       
,regi/]4  7#c7 ,relation to section     
#ead7;c7 ,any susceptibility te/        
int]pretive crit]ion = :i* an approval  
is 9 effect "u p>agraph 7#a7 may be     
recogniz$ z a /&>d by ! ,secret>y "u    
section #ead7;c77#a74  7#d7 ,use (      

non-adopt$ crit]ia ,no?+ 9 ?is section  
prohibits ! sponsor ( a drug or device f
 seek+ approval or cle>ance ( ! drug or 
device1 or *anges to ! drug1 ! device1  
or its label+1 on ! basis (             
susceptibility te/ int]pretive crit]ia  
:i* diff] f ^? adopt$ pursuant to       
p>agraph 7#a74  7c7 ,def9itions ,9 ?is  
section3 7#a7 ,! t]m qualifi$ infecti\s 
disease product means a qualifi$        
infecti\s disease product designat$ "u  
#eje;,e7d74  7#b7 ,! t]m susceptibility 
te/ int]pretive crit]ia means "o or m   
specific values :i* *>act]ize ! degree  
to :i* bact]ia or o!r microbes are      
resi/ant to ! drug 7or drugs7 te/$1 su* 
z cl9ically susceptible1 int]m$iate1 or 
resi/ant4  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   
,no effect on heal? c>e practice ,no?+ 9
 ! ,antibiotic ,developm5t to ,advance  
,pati5t ,treatm5t ,act ( #bjac 7includ+ 
! am5dm5ts made !reby7 %all be con/ru$  
to re/rict1 9 any mann]1 ! prescrib+ (  
antibiotics or o!r products by heal? c>e
 pr(essionals1 or to limit ! practice ( 
heal? c>e4