,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #chci  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #f1 #bjbc,mr4   
,dunn ( ,florida 7= himself & ,ms4      
,ku/]7 introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
increase transp>5cy 9 g5]ic drug        
applications4  #a4 ,increas+ transp>5cy 
9 g5]ic drug applications  7a7 ,9 g5]al 
,section #eje7;j77#c7 ( ! ,f$]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$i5ts 9 ! same 
conc5trations z ! li/$ drug ref]r$ to1  
or = :i* ! ,secret>y det]m9es !re is a  
sci5tific ju/ification = an approa* t is
 9 vitro 9 :ole or 9 "p to be us$ to    

demon/rate bioequival5ce = a drug if su*
 a drug conta9s "o or m ( ! same        
inactive +r$i5ts 9 ! same conc5trations 
z ! li/$ drug1 ! ,secret>y %all in=m !  
p]son :e!r su* drug is qualitatively &  
quantitatively ! same z ! li/$ drug4 ,! 
,secret>y may also provide su* in=mation
 to su* a p]son on ! ,secret>y's own    
initiative dur+ ! review ( an abbreviat$
 application "u ?is subsection = su*    
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 su* 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 ,! disclosures requir$ by ?is       
subp>agraph are disclosures au?oriz$ by 
law1 includ+ = purposes ( 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