,i  #aag? ,,congress  #a/ ,session  ,h4 
,r4 #bhec  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #bf1 #bjba,mr4 
,s*rad] introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act1 )       
respect to eligibility = approval ( a   
subsequ5t g5]ic drug1 to remove ! b>ri] 
to t approval pos$ by ! #ahj-;day       
exclusivity p]iod af=d$ to a fir/ g5]ic 
applicant t has n yet receiv$ f9al      
approval1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,br++   
,l[-co/ ,options & ,competition :ile    
,keep+ ,inc5tives = ,new ,g5]ics ,act ( 
#bjba or ! ,,block+ ,act ( #bjba4  #b4  
,*ange conditions ( fir/ g5]ic          
exclusivity to spur access & competition
 ,clause 7iv7 ( section                 
#eje7;j77#e77;,b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#e77;,b77 is am5d$-- 7#a7 9    
subclause 7,i71 aft] #ahj days aft] !   
date ( ! fir/ comm]cial m>ket+ ( ! drug 

7includ+ ! comm]cial m>ket+ ( ! li/$    
drug7 by any fir/ applicant by ins]t+ or
 by an applicant ^: application is      
approv$ pursuant to subclause 7,,iii72 &
  7#b7 by add+ at ! end ! foll[+ new    
subclause3  7,,iii7 ,applicant approval 
,an application conta9+ a c]tification  
describ$ 9 p>agraph 7#b77;,a77vii77,,iv7
 t is = a drug = :i* a fir/ applicant   
has submitt$ an application conta9+ su* 
a c]tification c be approv$ not)/&+ !   
eligibility ( a fir/ applicant = !      
#ahj-;day exclusivity p]iod describ$ 9  
subclause 7,,ii77aa7 if ea* ( ! foll[+  
conditions is met3 7aa7 ,! approval (   
su* an application c\ld be made         
effective1 b = ! eligibility ( a fir/   
applicant = #ahj-;day exclusivity "u ?is
 clause4  7bb7 ,at lea/ #cj mon?s h     
pass$ s9ce ! date ( submission ( an     
application = ! drug by at lea/ "o fir/ 
applicant4  7cc7 ,approval ( an         
application = ! drug submitt$ by at lea/
 "o fir/ applicant is n preclud$ "u     
clause 7iii74  7dd7 ,no application = ! 

drug submitt$ by any fir/ applicant is  
approv$ at ! "t ! conditions "u items   
7aa71 7bb71 & 7cc7 are all met1         
reg>dless ( :e!r su* an application is  
subsequ5tly approv$4  4