,,ii  #aad? ,,congress  #b;d ,session   
,s4 #cdff  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #bi1 #bjaf   
,mr4 ,paul introduc$ ! foll[+ bill2 :i* 
0 read twice & ref]r$ to ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
,a ,,bill  ,to all[ sponsors ( c]ta9 new
 drug applications to rely ^u           
inve/igations conduct$ 9 c]ta9 =eign    
c\ntries1 & = o!r purposes4  #a4 ,%ort  
title  ,?is ,act may be cit$ z !        
,accel]at+ ,new ,ph>maceutical          
,competition ,act4  #b4 ,drugs approv$ 9
 c]ta9 =eign c\ntries ,section #eje ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 is am5d$-- 7#a7 9  
subsection 7b71 by add+ at ! end !      
foll[+3  7#g7 ,an application describ$ 9
 p>agraph 7#b7 may rely ^u inve/igations
 conduct$ 9 a c\ntry li/$ "u subp>agraph
 7,a7 or designat$ "u subp>agraph 7,b7 (
 section #hjb7;b77#a71 includ+ prem>ket 
cl9ical & noncl9ical inve/igations &    
po/m>ket surveillance /udies1 if ! drug 
t is ! subject ( su* application has be5

 approv$ 9 su* c\ntry4  2 &  7#b7 9     
subsection 7c7-- 7,a7 9 p>agraph 7#a71  
by /rik+ ,)9 & ins]t+ ,except z provid$ 
9 p>agraph 7#e71 )92 &  7,b7 by add+ at 
! end ! foll[+3  7#e7 ,9 ! case ( an    
application t relies on inve/igations   
conduct$ 9 a =eign c\ntry1 z describ$ 9 
subsection 7b77#g71 )9 #ij days aft] !  
fil+ ( su* application "u subsection    
7b71 ! ,secret>y %all approve !         
application if ! ,secret>y f9ds t none (
 ! gr\nds = d5y+ approval specifi$ 9    
subsection 7d7 applies or take action   
describ$ 9 p>agraph 7#a77;,b74 ,if !    
,secret>y does n approve ! application  
or take su* o!r action )9 su* #ij-;day  
p]iod1 ! application %all be consid]$   
approv$ "u ?is subsection4  4  #c4      
,approval ( g5]ic drugs  7a7 ,/ays 9 !  
case if pat5t infr+em5t lawsuits        
,section #eje7;j77#e77;,b77iii7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iii77  
is am5d$ by /rik+ ! expiration ( !      
?irty-mon? p]iod beg9n+ on ! date ( !   

receipt ( ! notice provid$ "u p>agraph  
7#b77;,b77i7 & ins]t+ ! date ^u f9al    
judgm5t is ent]$ 9 su* action4  7b7     
,exp$it$ g5]ic review ,section          
#eje7;j77#e7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;j77#e77 is am5d$-- 7#a7 9         
subp>agraph 7,a71 by /rik+ ,)9 & ins]t+ 
,except z provid$ 9 subp>agraph 7,g71   
)92 &  7#b7 by add+ at ! end ! foll[+3  
7,g7 7i7 ,! ,secret>y %all prioritize ! 
review1 & act n lat] ?an #aej cal5d>    
days aft] ! date ( ! submission ( an    
application1 or supplem5t to an         
application1 9 ! case ( an application  
or supplem5t to an application describ$ 
9 clause 7ii74  7ii7 ,clause 7i7 %all   
apply to an application or supplem5t to 
an application "u ?is subsection )      
respect to :i* ! applicable li/$ drug1  
or ano!r drug approv$ "u ?is subsection 
) ref]5ce to su* li/$ drug--  7,i7 has  
be5 introduc$ into int]/ate comm]ce by n
 m ?an "o manufactur] or sponsor 9 !    
#c-mon? p]iod imm$iately prec$+ ! date (

 submission ( su* application or        
supplem5t & ) respect to :i* t5tative   
approval has be5 grant$ = n m ?an #b    
applications "u ?is subsection2 or      
7,,ii7 has be5 includ$ on ! drug %ortage
 li/ "u section #ejf;,e4  4