,,ii ,cal5d> ,no4 #ajh #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  
,june #bb1 #bjbc,report$ by ,mr4 ,s&]s1 
) an amendment,strike out all aft] !    
enact+ clause & ins]t ! "p pr9t$ 9      
italic  ,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  #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  
%all 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 its 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 #cee7;j77#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  #c4 ,increas+ transp>5cy 9   
g5]ic drug applications  7a7 ,9 g5]al   
,section #eje7;j77#c7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#c77 is am5d$ by add+ at ! end 
! foll[+3  7,h7 7i7 ,^u reque/ 79       
controll$ correspond5ce or an analog\s  
process7 by a p]son t has submitt$ or   
int5ds to submit an abbreviat$          
application "u ?is subsection = a drug t
 is requir$ by regulation to conta9 "o  
or m ( ! same inactive +r$i5ts 9 ! same 
conc5tration z ! li/$ drug ref]r$ to1 or
 = :i* ! ,secret>y det]m9es !re is a    
sci5tific ju/ification = an approa* t is

 9 vitro1 9 :ole or 9 "p1 to be us$ to  
demon/rate bioequival5ce = a drug if su*
 a drug conta9s "o or m ( ! same        
inactive +r$i5ts 9 ! same conc5tration z
 ! li/$ drug ref]r$ to1 or on !         
,secret>y's own initiative dur+ ! review
 ( an application "u ?is subsection =   
su* a drug1 ! ,secret>y %all in=m !     
p]son :e!r su* drug is qualitatively &  
quantitatively ! same z ! li/$ drug4    
7ii7 ,not)/&+ section #cja7;j71 if !    
,secret>y det]m9es t su* drug is n      
qualitatively or quantitatively ! same z
 ! li/$ drug1 ! ,secret>y %all id5tify &
 disclose to ! p]son-- 7,i7 ! +r$i5t or 
+r$i5ts t cause ! drug n to be          
qualitatively or quantitatively ! same z
 ! li/$ drug2 &  7,,ii7 = any +r$i5t =  
:i* !re is an id5tifi$ quantitative     
deviation1 ! am\nt ( su* deviation4     
7iii7 ,if ! ,secret>y det]m9es t su*    
drug is qualitatively & quantitatively !
 same z ! li/$ drug1 ! ,secret>y %all n 
*ange or resc9d su* det]m9ation aft] !  
submission ( an abbreviat$ application =

 su* drug "u ?is subsection unless--    
7,i7 ! =mulation ( ! li/$ drug has be5  
*ang$ & ! ,secret>y has det]m9$ t !     
prior li/$ drug =mulation 0 )drawn =    
reasons ( safety or effectiv5ess2 or    
7,,ii7 ! ,secret>y makes a writt5       
det]m9ation t ! prior det]m9ation mu/ be
 *ang$ because an error has be5         
id5tifi$4  7iv7 ,if ! ,secret>y makes a 
writt5 det]m9ation describ$ 9 clause    
7iii77,,ii71 ! ,secret>y %all provide   
notice & a copy ( ! writt5 det]m9ation  
to ! p]son mak+ ! reque/ "u clause 7i74 
7v7 ,except z set =? 9 clauses 7i7 &    
7ii71 no?+ 9 ?is subp>agraph %all be    
con/ru$ to au?orize ! disclosure (      
nonpublic qualitative or quantitative   
in=mation ab\t ! +r$i5ts 9 a li/$ drug1 
or to affect ! /atus1 if any1 ( su*     
in=mation z trade secret or confid5tial 
comm]cial in=mation = purposes ( section
 #cja7;j7 ( ?is ,act1 section #eeb (    
title #e1 ,unit$ ,/ates ,code1 or       
section #aije ( title #ah1 ,unit$ ,/ates
 ,code4  4  7b7 ,guidance  7#a7 ,9 g5]al

 ,n lat] ?an "o ye> aft] ! date (       
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all issue     
draft guidance1 or update guidance1     
describ+ h[ ! ,secret>y w det]m9e :e!r a
 drug is qualitatively & quantitatively 
! same z ! li/$ drug 7z su* t]ms are us$
 9 section #eje7;j77#c77;,h7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act1 z add$  
by subsection 7a771 includ+ ) respect to
 assess+ p,h adju/]s4  7#b7 ,process ,9 
issu+ guidance "u ?is subsection1 !     
,secret>y ( ,heal? & ,human ,s]vices    
%all-- 7,a7 publi% draft guidance2  7,b7
 provide a p]iod ( at lea/ #fj days =   
comm5t on ! draft guidance2 &  7,c7 aft]
 consid]+ any comm5ts receiv$ & n lat]  
?an "o ye> aft] ! close ( ! comm5t p]iod
 on ! draft guidance1 publi% f9al       
guidance4  7c7 ,applicability ,section  
#eje7;j77#c77;,h7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act1 z add$ by      
subsection 7a71 applies beg9n+ on ! date
 ( enactm5t ( ?is ,act1 irrespective ( !
 date on :i* ! guidance requir$ by      

subsection 7b7 is f9aliz$4  ,june #bb1  
#bjbc,report$ ) an am5dm5t