,,ii  #aah? ,,congress  #a/ ,session    
,s4 #aaad  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #cj1 #bjbc,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$]al ,food1 ,drug1 
& ,cosmetic ,act ) respect to !         
#ahj-;day exclusivity p]iod4  #a4 ,%ort 
title ,?is ,act may be cit$ z ! ,exp&+  
,access to ,l[-,co/ ,g5]ics ,act (      
#bjbc4  #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,i7-- 7,a7 by ins]t+ &      
subclause 7,,iii7 aft] subp>agraph 7,d72
 &  7,b7 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 describ$ 9 subclause 7,,iii7  
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 ,! applicant ( su*       
application has submitt$ a c]tification 

to ! abbreviat$ new drug application t  
!re are no conditions t w\ld prev5t !   
applicant f comm]cial m>ket+ )9 #ge days
 aft] ! date ( approval & t ! applicant 
int5ds to s m>ket ! drug4  7cc7 ,at lea/
 #cc mon?s h pass$ s9ce ! date (        
submission ( an application = ! drug by 
at lea/ "o fir/ applicant4  7dd7        
,approval ( an application = ! drug     
submitt$ by at lea/ "o fir/ applicant is
 n preclud$ "u clause 7iii74  7ee7 ,no  
application = ! drug submitt$ by any    
fir/ applicant is effectively approv$ on
 ! date t ! conditions "u items 7aa71   
7bb71 7cc71 & 7dd7 are all met &        
ma9ta9$4  4  7b7 ,special approval /atus
 rule = c]ta9 subsequ5t applicants      
,section #eje7;j77#e77;,d7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee 7j77#e77;,d77 is am5d$ at
 ! end by add+ ! foll[+3  7v7 ,special  
approval /atus rule = c]ta9 subsequ5t   
applicants ,an application t is approv$ 
pursuant to subclause 7,,iii7 (         
subp>agraph 7,b77iv7 is deem$ to be     

t5tatively approv$ & to no long] h an   
effective approval pursuant to su*      
subclause 7,,iii7 on ! date t is #gf    
days aft] ! date on :i* ! approval has  
be5 made effective pursuant to su*      
subclause 7,,iii7 if ! applicant fails  
to comm]cially m>ket su* drug )9 !      
#ge-;day p]iod aft] ! date on :i* !     
approval is made effective4 ,if !       
applicant ( an application approv$      
pursuant to su* subclause 7,,iii7       
submits a notification t x c no long]   
comm5ce comm]cial m>ket+ )9 #ge days    
aft] ! date ( approval1 z requir$ "u    
subp>agraph 7,b77iv77,,iii77bb71 its    
application is deem$ to be t5tatively   
approv$ & to no long] be effectively    
approv$ on ! date t su* a notification  
is receiv$4 ,if an applicant does n     
comm5ce comm]cial m>ket+ )9 ! #ge-;day  
p]iod1 x %all n be eligible = a         
subsequ5t effective approval = !        
application "u subclause 7,,iii7 (      
subp>agraph 7,b77iv7 unless1 9 addition 
to meet+ ea* ( ! conditions 9 su*       

subclause 7,,iii71 x submits a          
c]tification to its abbreviat$ new drug 
application t an ev5t t c\ld n h be5    
reasonably =ese5 by ! applicant prev5t$ 
x f comm5c+ comm]cial m>ket+ & t x has  
fully resolv$ ?is issue4 ,! applicant   
%all submit notification to ! abbreviat$
 new drug application confirm+ t su*    
applicant has comm5c$ comm]cial m>ket+ (
 ! drug n lat] ?an "o bus9ess day aft]  
comm5c+ su* m>ket+4  4  7c7             
,applicability ,! am5dm5ts made by      
subsections 7a7 & 7b7 %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      
#eje7;j7 0 made be=e su* date (         
enactm5t4