,,ib  ,union ,calendar ,no4 #bd  #aafth 
,,congress  #ast ,session  ,h4 ,r4 #ich 
,report ,no4 #aaf-df  ,,in ,,the ,,house
 ,,of ,,representatives  ,january #ca1  
#bjai ,mr4 ,schrader 7for himself and   
,mr4 ,carter of ,georgia7 introduced the
 following bill2 which was referred to  
the ,committee on ,energy and ,commerce 
,may #b1 #bjai ,additional sponsors3    
,mrs4 ,craig1 ,mrs4 ,dingell1 ,mr4      
,ruiz1 ,mr4 ,pallone1 ,ms4 ,eshoo1 ,mr4 
,kennedy1 ,ms4 ,matsui1 ,mr4 ,rush1 ,mr4
 ,van ,drew1 ,ms4 ,clarke of ,new ,york1
 ,mr4 ,walden1 ,ms4 ,schakowsky1 ,mr4   
,mc,adams1 ,ms4 ,mucarsel-,powell1 and  
,mr4 ,meadows  ,may #b1 #bjai ,committed
 to the ,committee of the ,whole ,house 
on the ,state of the ,union and ordered 
to be printed  ,a ,,bill  ,to amend the 
,federal ,food1 ,drug1 and ,cosmetic    
,act1 with respect to eligibility for   
approval of a subsequent generic drug1  
to remove the barrier to that approval  
posed by the #ahj-;day exclusivity      
period afforded to a first generic      

applicant that has not yet received     
final approval1 and for other purposes4 
#a4 ,short title ,this ,act may be cited
 as the ,bringing ,low-cost ,options and
 ,competition while ,keeping ,incentives
 for ,new ,generics ,act of #bjai or the
 ,,blocking ,act of #bjai4  #b4 ,change 
conditions of first generic exclusivity 
to spur access and competition ,section 
#eje7;j77#e77;,b77iv7 of the ,federal   
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7;j77#e77;,b77iv77 is     
amended--  7#a7 in subclause 7,i71 by   
striking #ahj days after and all that   
follows through the period at the end   
and inserting the following3 #ahj days  
after the earlier of--  7aa7 the date of
 the first commercial marketing of the  
drug 7including the commercial marketing
 of the listed drug7 by any first       
applicant2 or  7bb7 the applicable date 
specified in subclause 7,,iii74  2 and  
7#b7 by adding at the end the following 
new subclause3  7,,iii7 ,applicable date
 ,the applicable date specified in this 

subclause1 with respect to an           
application for a drug described in     
subclause 7,i71 is the date on which    
each of the following conditions is     
first met3  7aa7 ,the approval of such  
an application could be made effective1 
but for the eligibility of a first      
applicant for #ahj-;day exclusivity     
under this clause4  7bb7 ,at least #cj  
months have passed since the date of    
submission of an application for the    
drug by at least one first applicant4   
7cc7 ,approval of an application for the
 drug submitted by at least one first   
applicant is not precluded under clause 
7iii74  7dd7 ,no application for the    
drug submitted by any first applicant is
 approved at the time the conditions    
under items 7aa71 7bb71 and 7cc7 are all
 met1 regardless of whether such an     
application is subsequently approved4  4
  ,may #b1 #bjai ,committed to the      
,committee of the ,whole ,house on the  
,state of the ,union and ordered to be  
printed