,,ii  #aag? ,,congress  #a/ ,session    
,s4 #adfb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #bi1 #bjba,mr4  
,cassidy 7= himself & ,ms4 ,smi?7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to simplify !   
g5]ic drug application process4  #a4    
,%ort title ,?is ,act may be cit$ z !   
,simplify+ ! ,g5]ic ,drug ,application  
,process ,act4  #b4 ,submission =       
suitability ,subp>agraph 7,c7 ( section 
#eje7;j77#b7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;j77#b77 is am5d$ to read z foll[s3
  7,c7 ,submission = suitability        
det]m9ations  7i7 ,9 g5]al ,a p]son may 
submit an abbreviat$ application = a new
 drug t has a diff]5t dosage =m or /r5g?
 f t ( a li/$ drug4  7ii7 ,secret>y's   
det]m9ation on submission ,! ,secret>y  
%all approve or disapprove ! submission 
( su* an abbreviat$ application dur+ !  

c\rse ( its det]m9ation :e!r to receive 
! application pursuant to section       
#cad4aja ( title #ba1 ,code ( ,f$]al    
,regulations 7or any successor          
regulations74  7iii7 ,approval (        
submission ,! ,secret>y %all approve !  
submission ( su* an abbreviat$          
application1 provid$ ! application is   
o!rwise det]m9$ to be eligible to be    
receiv$1 unless ! ,secret>y f9ds t--    
7,i7 cl9ical inve/igations are requir$  
to be conduct$ to %[ ! safety &         
effectiv5ess ( ! drug or ( any ( its    
dosage =ms or /r5g?s :i* diff] f ! li/$ 
drug2 or  7,,ii7 any ( ! propos$ *anges 
f ! li/$ drug w\ld jeop>dize ! safe or  
effective use ( ! product s z to        
necessitate significant label+ *anges to
 address ! newly introduc$ safety or    
effectiv5ess problem4  7iv7 ,disapproval
 ( submission ,if ! ,secret>y           
disapproves ! submission ( an abbreviat$
 application "u ?is subp>agraph1 !      
application %all be consid]$ n to h be5 
receiv$ )9 ! mean+ ( p>agraph 7#e77;,a74

  4