,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #ajea  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,febru>y #f1 #bjbe,ms4
 ,budz9ski introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,en]gy &    
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to all[ =
 ! approval ( an abbreviat$ new drug    
application submitt$ by a subsequ5t     
applicant 9 ! case ( a failure by a fir/
 applicant to comm5ce comm]cial m>ket+  
)9 a c]ta9 p]iod1 & = o!r purposes4  #a4
 #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 may n receive effective   
approval until #ahj days aft] ! fir/    
applicant beg9s comm]cial m>ket+ ( !    
drug2 &  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$4  4  7b7     
,special =feiture rule = c]ta9 subsequ5t
 applicants ,section #eje7;j77#e77;,d7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cee 7j77#e77;,d77 is   
am5d$ by add+ at ! end ! foll[+3  7v7   
,special =feiture rule = c]ta9 subsequ5t
 applicants  7,i7 ,9 g5]al ,except z    
specifi$ 9 subclause 7,,ii71 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 beg9n+
 on ! day aft] ! end ( ! #ge-;day p]iod 
specifi$ 9 item 7bb7 ( su* subclause    
7,,iii7 if ! applicant fails to comm5ce 
comm]cial m>ket+ z requir$ "u su* item4 
7,,ii7 ,opportunity to cure  7aa7 ,9    
g5]al ,if ! applicant ( an application  
approv$ pursuant to subclause 7,,iii7 ( 
subp>agraph 7,b77iv7 submits1 pursuant  
to item 7bb7 ( su* subclause1 a         
notification t x c no long] comm5ce     
comm]cial m>ket+ )9 ! #ge-;day p]iod    
specifi$ 9 su* item1 su* application is 
deem$ to be t5tatively approv$ & to no  
long] be effectively approv$ beg9n+ on !
 date t su* a notification is receiv$4  
7bb7 ,ineligibility = subsequ5t         
effective approval ,if an applicant     
describ$ 9 item 7aa7 does n comm5ce     
comm]cial m>ket+ )9 su* #ge-;day p]iod1 
! applicant %all n be eligible = a      
subsequ5t effective approval = !        
application involv$ "u subclause 7,,iii7
 ( subp>agraph 7,b77iv7 unless1 9       

addition to meet+ ea* ( ! conditions 9  
su* subclause 7,,iii71 ! applicant      
submits a c]tification to its abbreviat$
 new drug application t-- 7,,aa7 an ev5t
 t c\ld n h be5 reasonably =ese5 by !   
applicant prev5t$ x f comm5c+ comm]cial 
m>ket+2 & 7,,bb7 x has fully resolv$ any
 issues prev5t+ su* comm]cial m>ket+ f  
comm5c+ z a result ( su* ev5t4  7cc7    
,tim+ = submission ,an applicant        
describ$ 9 item 7aa7 %all1 n lat] ?an "o
 bus9ess day aft] comm5c+ m>ket+ ( !    
drug t is ! subject ( ! application     
describ$ 9 su* item1 submit a           
notification to ! abbreviat$ new drug   
application confirm+ t su* applicant has
 comm5c$ comm]cial m>ket+ ( ! drug4  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 0    
made be=e su* date ( enactm5t4