,,ii  #aad? ,,congress  #b;d ,session   
,s4 #cchg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #bb1 #bjaf   
,mr4 ,cotton introduc$ ! foll[+ bill2   
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to      
provide = ! fa/ track review ( c]ta9    
g5]ic drugs4  #a4 ,%ort title  ,?is ,act
 may be cit$ z ! ,safely ,advanc+       
,valuable & ,inexp5sive ,new ,g5]ic     
,solutions ,act or ! ,,sav+s ,act4  #b4 
,fa/ track review = c]ta9 g5]ic drugs   
,section #eje7;j7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77 is am5d$ by add+ at ! end !   
foll[+3  7#aa7 7,a7 ,not)/&+ any o!r    
provision ( law1 ! ,secret>y %all       
prioritize ! review ( a qualify+        
application "u ?is subsection & %all1 )9
 #aej days ( ! initial receipt ( su*    
qualify+ application1 take f9al ag5cy   
action on ! application4  7,b7 ,=       
purposes ( ?is p>agraph1 ! t]m qualify+ 
application means an application-- 7i7 t

 does n conta9 a c]tification "u        
subclause 7,,iv7 ( p>agraph             
7#b77;,a77vii72  7ii7 t may conta9 a    
c]tification "u subclause 7,,iii7 (     
p>agraph 7#b77;,a77vii7 only if su*     
c]tification ass]ts t an exi/+ pat5t w  
expire n m ?an #e mon?s aft] ! date (   
su* c]tification2  7iii7 = a drug :]e ! 
ref]5ce drug is a drug = :i* !re is no  
exclusivity p]iod 9 effect1 includ+ an  
exclusivity p]iod "u p>agraph 7#e77;,f71
 or "u section #eje;,a1 section #ebg1 or
 section #eje;,e2 &  7iv7 = a drug :]e !
 ref]5ce drug has n be5 ! ref]5ce drug =
 m ?an "o o!r drug t--  7,i7 is approv$ 
"u ?is subsection2 &  7,,ii7 has be5    
introduc$ into int]/ate comm]ce 9 !     
#c-mon? p]iod prec$+ ! date ( ! qualify+
 application4  7,c7 ,not)/&+ any o!r    
provision ( ?is p>agraph & reg>dless ( !
 date ( submission1 a qualify+          
application %all lose /atus z an        
application = priority review1 & !      
,secret>y's timel9e = tak+ action on su*
 an application describ$ 9 subp>agraph  

7,a7 %all no long] apply1 if !          
application no long] meets ! def9ition (
 a qualify+ application4  4  #c4        
,transp>5cy  7a7 ,9 g5]al ,n lat] ?an #f
 mon?s aft] enactm5t & e #f mon?s       
!reaft]1 ! ,secret>y ( ,heal? & ,human  
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all submit a report to 
! ,committee on ,heal?1 ,education1     
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives conta9+ !       
in=mation describ$ 9 subsection 7c74    
7b7 ,def9ition ,9 ?is section ! t]m     
g5]ic fa/ track review means review "u  
p>agraph 7#aa7 ( section #eje7;j7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j771 z add$ by     
section #b ( ?is ,act4  7c7 ,cont5ts (  
report ,! report describ$ 9 subsection  
7a7 %all include ! foll[+ in=mation3    
7#a7 ,! numb] ( applications 9 ! mo/    
rec5t #f-mon? p]iod t are subject to    
g5]ic fa/ track review1 & :i* ( ^?      
applications--  7,a7 are = a drug :]e ! 

ref]5ce drug has n be5 ! ref]5ce drug = 
any o!r application t is approv$ "u     
subsection 7j7 ( section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee72  7,b7 are = a drug :]e 
! ref]5ce drug has be5 ! ref]5ce drug = 
n m ?an "o o!r application t is approv$ 
"u subsection 7j7 ( su* section2 &  7,c7
 are = a drug t is on ! drug %ortage li/
 e/abli%$ "u section #ejf;,e ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef;e74  7#b7 ,! av]age &    
m$ian "t be=e an applicant receives an  
approval decision = an application      
subject to g5]ic fa/ track review4  7#c7
 ,! numb] ( applications subject to     
g5]ic fa/ track review t 7 approv$4     
7#d7 ,at ! "t su* report is submitt$1 ! 
numb] ( applications subject to fa/     
track review--  7,a7 t h be5 )drawn by !
 applicant2  7,b7 t h be5 grant$        
t5tative approval2  7,c7 ) respect to   
:i* ! ,food & ,drug ,adm9i/ration has   
reque/$ additional in=mation f ! sponsor
 ( ! application2  7,d7 t are await+    

review by ! ,food & ,drug ,adm9i/ration 
aft] additional in=mation has be5       
suppli$1 z describ$ 9 subp>agraph 7,c72 
&  7,e7 ) respect to :i* ! ,food & ,drug
 ,adm9i/ration has record$ reception ( !
 application b has yet to contact !     
sponsor reg>d+ ! /atus ( ! application4 
7#e7 ,a pr$iction ( h[ long ! ,food &   
,drug ,adm9i/ration w take to respond to
 su* applications t are await+ review ) 
ei!r an approval or a rejection1 & h[ _m
 ( su* applications are expect$ to be   
)drawn by ! applicant4  7#f7 ,! av]age  
review "t = su* applications t are      
receiv+ g5]ic fa/ track review v]sus !  
/&>d review p]iod4  7#g7 ,! in=mation   
describ$ 9 p>agraphs 7#a7 ?r\gh 7#f7 )  
respect to applications = drugs "u      
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 t   
are subject to ano!r =m ( priority      
review or fa/-track review4  7#h7 ,an   
annual acc\nt+ ( h[ ! ,food & ,drug     
,adm9i/ration has sp5t ! fees x has     
receiv$ "u "p #g ( sub*apt] ,c ( *apt]  

,,vii ( su* ,act 7#ba ,u4,s4,c4 #cgi;f  
et seq47 to include ! proportion ( su*  
fees t su* ,adm9i/ration has sp5t on    
p]sonnel co/s4