,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #dacd  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #ad1 #bjbc,mr4  
,s*iff 7= himself & ,ms4 ,ku/]7         
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to direct ! ,secret>y (
 ,heal? & ,human ,s]vices to e/abli% a  
process to all[ ! hold]s ( abbreviat$   
new drug applications to make label+    
*anges to include new or updat$         
safety-relat$ in=mation1 & = o!r        
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,updat$ ,drug ,label+ =    
,pati5t ,safety ,act4  #b4 ,safety      
label+ *anges initiat$ by ,,&a hold]s   
7a7 ,9 g5]al ,section #eje7;j7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j77 is am5d$ by    
add+ at ! end ! foll[+3  7#ad7 ,not)/&+ 
p>agraph 7#b77;,a77v71 ! ,secret>y %all 
e/abli% a process to all[ ! hold] ( an  
abbreviat$ new drug application to *ange
 ! label+ ( ! drug t is ! subject ( !   

application to include new or updat$    
safety-relat$ in=mation1 includ+ a      
process to make su* *anges prior to be+ 
approv$ by ! ,secret>y4  4  7b7         
,regulations  7#a7 ,9 g5]al ,n lat] ?an 
#ah mon?s aft] ! date ( enactm5t ( ?is  
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices %all issue a f9al rule to      
implem5t p>agraph 7#ad7 ( section       
#eje7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771
 z add$ by subsection 7a74  7#b7        
,cont5ts ,! f9al rule issu$ "u p>agraph 
7#a7 %all include a process = con=m+ !  
label+ ( a drug t is label$ pursuant to 
su* p>agraph 7#ad71 ! li/$ drug 7z su*  
t]m is us$ 9 su* section #eje7;j771 &   
o!r drugs approv$ "u su* section        
#eje7;j7 t ref]5ce su* li/$ drug4  7#c7 
,effective date ,! f9al rule issu$ "u   
p>agraph 7#a7 %all become effective n   
lat] ?an #ahj days aft] ! date on :i*   
su* f9al rule is issu$4