,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #dbdd  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #i1         
#bjai,mr4 ,kelly ( ,p5nsylvania         
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to provide = a pa?way =        
*emically syn!siz$ insul9 to be approv$ 
"u an abbreviat$ new drug application   
submitt$ "u ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act1 & = o!r purposes4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,m>ket ,access = ,g5]ic ,insul9         
,competition or ! ,,magic ,act4  #b4    
,provid+ = a pa?way = approval (        
*emically syn!siz$ insul9 "u an         
abbreviat$ new drug application  7a7 ,9 
g5]al ,section #gjjb7;e77#b7 ( ! ,pati5t
 ,protection & ,af=dable ,c>e ,act 7#db 
,u4,s4,c4 #bfb note7 is am5d$--  7#a7 9 
subp>agraph 7,b71 by r$esignat+ clauses 
7i7 & 7ii7 z subclauses 7,i7 & 7,,ii71  
respectively1 & mov+ ! m>g9s ( su*      
subclauses 7z s r$esignat$7 two ems to !
 "r2  7#b7 9 subp>agraph 7,a71 by /rik+ 

su* biological product & ins]t+ 7i7 su* 
biological product2  7#c7 by r$esignat+ 
subp>agraph 7,b7 z clause 7ii7 & mov+ ! 
m>g9 ( su* clause 7z s r$esignat$7 two  
ems to ! "r2  7#d7 9 clause 7ii7 7z s   
r$esignat$71 by /rik+ ! p]iod at ! end &
 ins]t+ 2 or2 &  7#e7 by add+ at ! end !
 foll[+3  7,b7 not)/&+ p>agraphs 7#c7 & 
7#d71 ! application is submitt$ "u      
subsection 7j7 ( su* section = *emically
 syn!siz$ insul9 or any analogue (      
*emically syn!siz$ insul9 = :i* ! li/$  
drug is a biological product t is1      
pursuant to p>agraph 7#d71 deem$ to be  
lic5s$ "u section #cea ( ! ,public      
,heal? ,s]vice ,act4  4  7b7 ,effective 
date ,! am5dm5ts made by ?is section    
%all apply ) respect to applications    
submitt$ on or aft] ,janu>y #a1 #bjbj4