,i  #aagth ,,congress  #b;d ,session    
,h4 ,r4 #figc  ,,in ,,the ,,house ,,of  
,,representatives  ,march #h1 #bjbb ,mr4
 ,carter of ,georgia introduced the     
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend the ,federal ,food1
 ,drug1 and ,cosmetic ,act to clarify   
the conditions under which the          
,secretary of ,health and ,human        
,services can approve generic drug      
applications with labeling temporarily  
different than the brand name drug1 and 
for other purposes4  #a4 ,short title   
,this ,act may be cited as the ,enhanced
 ,access to ,affordable ,medicines ,act 
of #bjbb4  #b4 ,clarifying the          
conditions of generic drug application  
approval for last-minute brand name drug
 labeling changes ,section              
#eje7;j77#aj77;,a7 of the ,federal      
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7;j77#aj77;,a77 is amended
 by striking clauses 7i7 through 7iv7   
and inserting the following3  7i7 the   

application is otherwise eligible for   
approval under this subsection except   
that-- 7,i7 7aa7 the listed drug has an 
active patent1 the listed drug has an   
active exclusivity period1 or there is a
 delay in approval as described in      
paragraph 7#e77;,b77iii72 and  7bb7 a   
revision to the labeling of the listed  
drug has been approved by the ,secretary
 within #ij days of expiration of a     
patent1 exclusivity period1 or delay in 
approval referenced in item 7aa72 or    
7,,ii7 a revision to the labeling of the
 listed drug has been approved by the   
,secretary1 within #ij days of when the 
application is otherwise eligible for   
approval under this subsection2  7ii7   
the sponsor of the application agrees to
 submit revised labeling for the drug   
that is the subject of the application  
not later than #fj days after approval  
under this subsection of the            
application2 and  7iii7 the labeling    
revision described under clause 7i7 does
 not include a change to the ,warnings  

section of the labeling4  4