,,ii  #aag? ,,congress  #a/ ,session    
,s4 #biaj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #cj1         
#bjba,ms4 ,smi? 7= h]self & ,mr4 ,braun7
 introduc$ ! foll[+ bill2 :i* 0 read    
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to !  
#ahj-;day exclusivity p]iod1 & = o!r    
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,exp&+ ,access to ,l[-,co/ 
,g5]ics ,act ( #bjba4  #b4 #ahj-;day    
exclusivity p]iod  7a7 ,9 g5]al ,section
 #eje7;j77#e77;,b77iv7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee7;j77#e77;,b77iv77 is am5d$-- 7#a7 9
 subclause 7,i71 by ins]t+ be=e ! p]iod 
at ! end ! foll[+3 or an applicant ^:   
application 0 approv$ pursuant to       
subclause 7,,iii74 ,if an applicant     
describ$ 9 subclause 7,,iii7 is eligible
 = effective approval on ! same day a   
t5tatively approv$ fir/ applicant :o has
 reque/$ f9al approval is det]m9$ by !  

,secret>y to be eligible = effective    
approval by meet+ all ! approval        
requirem5ts ( ?is subsection1 su*       
applicant may n receive effective       
approval until #ahj days aft] ! fir/    
applicant beg9s comm]cial m>ket+ ( !    
drug42 &  7#b7 by add+ at ! end ! foll[+
 new subclause3  7,,iii7 ,applicant     
approval ,! ,secret>y may approve 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]tification1 not)/&+ ! eligibility ( 
a fir/ applicant = ! #ahj-;day          
exclusivity p]iod describ$ 9 subclause  
7,,ii77aa71 if ea* ( ! foll[+ conditions
 is met3 7aa7 ,! approval ( su*         
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 effectively approv$ on
 ! date t ! conditions "u items 7aa71   
7bb71 & 7cc7 are all met1 reg>dless (   
:e!r su* application is subsequ5tly     
approv$4  4  7b7 ,applicability ,!      
am5dm5ts made by subsection 7a7 %all    
apply only ) respect to an application  
fil$ "u section #eje7;j7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77 aft] ! date (       
enactm5t ( ?is ,act t id5tifies a li/$  
drug = :i* no c]tification "u p>agraph  
7#b77;,a77vii77,,iv7 ( su* section 0    
made be=e su* date ( enactm5t4