,,ii  #aah? ,,congress  #b;d ,session   
,s4 #dhgh  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #ca1 #bjbd,mr4   
,durb9 7= himself & ,mr4 ,cassidy7      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to    
approval ( abbreviat$ new drug          
applications4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,re=m+ ,ev]gre5+ &     
,manipulation t ,ext5ds ,drug ,ye>s ,act
 or ! ,,rem$y ,act4  #b4 ,am5dm5ts to   
,,&a approval provisions ,section #eje (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cee7 is am5d$-- 7#a7 9 
subsection 7c77#b7 by add+ at ! end !   
foll[+3 ,) respect to a drug approv$ on 
or aft] ! date ( enactm5t ( ! ,re=m+    
,ev]gre5+ & ,manipulation t ,ext5ds     
,drug ,ye>s ,act1 :5 a hold] ( an       
approv$ application fir/ files in=mation
 "u ?is p>agraph ) respect to "o or m   
pat5ts describ$ 9 subsection            

7b77#a77;,a77viii71 ! hold] %all select 
"o su* pat5t ) respect to :i* ! own] or 
lic5see may receive ! #cj-mon? /ay "u   
p>agraph 7#c77;,c71 z applicable2 =     
purposes ( p>agraphs 7#c77;,c7 &        
7#c77;,e7 & subsections                 
7j77#e77;,d77iii7 & 7j77#e77;,f77ii71   
su* pat5t %all be ref]r$ to z ! cov]$   
pat5t4 ,! selection ( su* cov]$ pat5t   
may n be *ang$ or am5d$42  7#b7 9       
subsection 7c77#c77;,c7-- 7,a7 9 ! matt]
 prec$+ clause 7i7-- 7i7 by /rik+ an    
action is br\ght = infr+em5t & all t    
foll[s ?r\gh ! p]iod at ! end ( ! fir/  
s5t5ce & ins]t+ ) respect to a drug     
approv$ "u ?is subsection be=e ! date ( 
enactm5t ( ! ,re=m+ ,ev]gre5+ &         
,manipulation t ,ext5ds ,drug ,ye>s     
,act1 an action is br\ght = infr+em5t ( 
any pat5t t is ! subject ( !            
c]tification & = :i* in=mation 0        
submitt$ to ! ,secret>y "u p>agraph 7#b7
 or subsection 7b77#a7 be=e ! date on   
:i* ! application 7exclud+ an am5dm5t or
 supplem5t to ! application7 0 submitt$1

 or1 ) respect to a drug approv$ "u ?is 
subsection on or aft] ! date ( enactm5t 
( ! ,re=m+ ,ev]gre5+ & ,manipulation t  
,ext5ds ,drug ,ye>s ,act1 an action is  
br\ght = infr+em5t ( ! cov]$ pat5t 7z   
describ$ 9 p>agraph 7#b771 be=e ! date  
on :i* ! application 7exclud+ an am5dm5t
 or supplem5t to ! application7 0       
submitt$42 &  7ii7 by /rik+ an action is
 br\ght be=e & ins]t+ an action )       
respect to a pat5t or a cov]$ pat5t1 z  
applicable1 is br\ght be=e2 &  7,b7 9   
clause 7i71 by /rik+ decides t ! pat5t &
 ins]t+ decides t ! pat5t or ! cov]$    
pat5t1 z applicable2  7#c7 9 ! second   
s5t5ce ( subsection 7c77#c77;,e77ii71 by
 ins]t+ ) respect to any pat5t t claims 
a drug t 0 approv$ "u ?is subsection    
be=e ! date ( enactm5t ( ! ,re=m+       
,ev]gre5+ & ,manipulation t ,ext5ds     
,drug ,ye>s ,act1 or1 ) respect to a    
cov]$ pat5t 7z describ$ 9 p>agraph 7#b77
 t claims a drug approv$ "u ?is         
subsection on or aft] ! date ( enactm5t 
( su* ,act1 aft] action = pat5t         

infr+em5t2  7#d7 9 subsection           
7j77#e77;,b77iii7-- 7,a7 9 ! matt]      
prec$+ subclause 7,i7-- 7i7 by /rik+ an 
action is br\ght = infr+em5t & all t    
foll[s ?r\gh ! p]iod at ! end ( ! fir/  
s5t5ce & ins]t+ ) respect to a drug     
approv$ "u subsection 7c7 be=e ! date ( 
enactm5t ( ! ,re=m+ ,ev]gre5+ &         
,manipulation t ,ext5ds ,drug ,ye>s     
,act1 an action is br\ght = infr+em5t ( 
any pat5t t is ! subject ( !            
c]tification & = :i* in=mation 0        
submitt$ to ! ,secret>y "u subsection   
7b77#a7 or 7c77#b7 be=e ! date on :i* ! 
application 7exclud+ an am5dm5t or      
supplem5t to ! application71 :i* !      
,secret>y lat] det]m9es to be           
sub/antially complete1 0 submitt$1 or1 )
 respect to a drug approv$ "u subsection
 7c7 on or aft] ! date ( enactm5t ( !   
,re=m+ ,ev]gre5+ & ,manipulation t      
,ext5ds ,drug ,ye>s ,act1 an action is  
br\ght = infr+em5t ( ! cov]$ pat5t 7z   
describ$ 9 subsection 7c77#b77 be=e !   
date on :i* ! application 7exclud+ an   

am5dm5t or supplem5t to ! application71 
:i* ! ,secret>y lat] det]m9es to be     
sub/antially complete1 0 submitt$42 &   
7ii7 by /rik+ an action is br\ght be=e &
 ins]t+ an action ) respect to a pat5t  
or a cov]$ pat5t1 z applicable1 is      
br\ght be=e2 &  7,b7 9 subclause 7,i71  
by /rik+ decides t ! pat5t & ins]t+     
decides t ! pat5t or cov]$ pat5t1 z     
applicable12 &  7#e7 9 ! second s5t5ce (
 subsection 7j77#e77;,f77ii71 by ins]t+ 
) respect to any pat5t t claims a drug t
 0 approv$ "u subsection 7c7 be=e ! date
 ( enactm5t ( ! ,re=m+ ,ev]gre5+ &      
,manipulation t ,ext5ds ,drug ,ye>s     
,act1 or1 ) respect to a cov]$ pat5t 7z 
describ$ 9 subsection 7c77#b77 t claims 
a drug approv$ "u subsection 7c7 on or  
aft] ! date ( enactm5t ( su* ,act1 aft] 
action = pat5t infr+em5t4