,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #hdc  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,janu>y #ca1 #bjbe,ms4
 ,b>ragn introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
provide = ! prompt approval ( drugs :5  
safety in=mation is add$ to label+1 & = 
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,prompt ,approval (    
,safe ,g5]ic ,drugs ,act4  #b4 ,prompt  
approval ( drugs :5 safety in=mation is 
add$ to label+ ,section #eje ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 is am5d$ by add+ at !   
end ! foll[+3  7aa7 ,prompt approval (  
drugs :5 safety in=mation is add$ to    
label+  7#a7 ,g5]al rule ,a drug = :i*  
an application has be5 submitt$ or      
approv$ "u subsection 7b77#b7 or 7j7    
%all n be consid]$ ineligible = approval
 "u ?is section or misbr&$ "u section   
#ejb on ! basis t ! label+ ( ! drug     
omits safety in=mation1 includ+         

contra9dications1 w>n+s1 precautions1   
dos+1 adm9i/ration1 or o!r in=mation    
p]ta9+ to safety1 :5 ! omitt$ safety    
in=mation is protect$-- 7,a7 by         
exclusivity "u clause 7iii7 or 7iv7 (   
subsection 7c77#c77;,e71 clause 7iii7 or
 7iv7 ( subsection 7j77#e77;,f71 or     
section #ebg7;a72  7,b7 by an ext5sion (
 su* exclusivity "u section #eje;,a or  
#eje;,e2 or  7,c7 by pat5t4  7#b7       
,label+ ,not)/&+ clauses 7iii7 & 7iv7 ( 
subsection 7c77#c77;,e71 clauses 7iii7 &
 7iv7 ( subsection 7j77#e77;,f71 or     
section #ebg1 ! ,secret>y %all require t
 ! label+ ( a drug approv$ pursuant to  
an application submitt$ "u subsection   
7b77#b7 or 7j7 t omits safety in=mation 
describ$ 9 p>agraph 7#a7 include a      
/atem5t ( any appropriate safety        
in=mation t ! ,secret>y consid]s        
necess>y to assure safe use4  7#c7      
,availability & scope ( exclusivity ,?is
 subsection does n affect-- 7,a7 !      
availability or scope ( exclusivity or  
an ext5sion ( exclusivity describ$ 9    

subp>agraph 7,a7 or 7,b7 ( section      
#eje;,a7o77#c72  7,b7 ! "q ( !          
eligibility = approval "u ?is section ( 
any application describ$ 9 subsection   
7b77#b7 or 7j7 t omits any o!r aspect ( 
label+ protect$ by exclusivity "u-- 7i7 
clause 7iii7 or 7iv7 ( subsection       
7c77#c77;,e72  7ii7 clause 7iii7 or 7iv7
 ( subsection 7j77#e77;,f72 or  7iii7   
section #ebg7;a72 or  7,c7 except z     
expressly provid$ 9 p>agraphs 7#a7 &    
7#b71 ! op]ation ( ?is section or       
section #ebg4  4