,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #gjcb  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #i1 #bjbb ,ms4   
,ku/] introduc$ ! foll[+ bill2 :i* 0    
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d section   
#eje7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 
) respect to a process to in=m p]sons   
submitt+ an abbreviat$ application = a  
new drug :e!r ! new drug is             
qualitatively or quantitatively ! same z
 a li/$ drug1 & = o!r purposes4  #a4    
,%ort title ,?is ,act may be cit$ z !   
,increas+ ,transp>5cy 9 ,g5]ic ,drug    
,applications ,act ( #bjbb4  #b4        
,det]m9+ :e!r propos$ new g5]ic drugs   
are qualitatively or quantitatively !   
same z ! li/$ drug  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 o!rwise7 by a
 p]son t has submitt$ or int5ds to      

submit an abbreviat$ application = a new
 drug "u ?is subsection or on !         
,secret>y's own initiative dur+ ! review
 ( su* abbreviat$ application1 !        
,secret>y %all in=m ! p]son :e!r su* new
 drug is qualitatively & quantitatively 
! same z ! li/$ drug4  7ii7 ,if !       
,secret>y det]m9es t su* new 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 ! new drug n to be     
qualitatively or quantitatively ! same z
 ! li/$ drug2 &  7,,ii7 ! quantity or   
proportion ( any +r$i5t 9 ! li/$ drug = 
:i* !re is an id5tifi$ quantitative     
deviation4  7iii7 ,if ! ,secret>y       
det]m9es t su* new drug is qualitatively
 & quantitatively ! same z ! li/$ drug1 
! ,secret>y %all n *ange or resc9d su*  
det]m9ation aft] ! submission ( an      
abbreviat$ application = su* new 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 ,!           
disclosures requir$ by ?is subp>agraph  
are disclosures au?oriz$ by law "u      
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     
guidance describ+ h[ ! ,secret>y w      
det]m9e :e!r a new 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 z requir$ by p>agraph    
7#a71 ! ,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$1 publi% f9al guidance4  
7c7 ,applicability ,section             
#eje7;j77#c77;,h7 ( ! ,f$]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