,,ib  ,union ,cal5d> ,no4 #bd  #aaf?    
,,congress  #a/ ,session  ,h4 ,r4 #ich  
,report ,no4 #aaf-df  ,,9 ,,! ,,h\se ,,(
 ,,repres5tatives  ,janu>y #ca1 #bjai   
,mr4 ,s*rad] 7= himself & ,mr4 ,c>t] (  
,georgia7 introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce  ,may #b1 #bjai ,additional    
sponsors3 ,mrs4 ,craig1 ,mrs4 ,d+ell1   
,mr4 ,ruiz1 ,mr4 ,pallone1 ,ms4 ,e%oo1  
,mr4 ,k5n$y1 ,ms4 ,matsui1 ,mr4 ,ru%1   
,mr4 ,van ,drew1 ,ms4 ,cl>ke ( ,new     
,york1 ,mr4 ,wald51 ,ms4 ,s*ak[sky1 ,mr4
 ,mc,adams1 ,ms4 ,muc>sel-,p[ell1 & ,mr4
 ,mead[s  ,may #b1 #bjai ,committ$ to ! 
,committee ( ! ,:ole ,h\se on ! ,/ate ( 
! ,union & ord]$ to be pr9t$  ,a ,,bill 
,to am5d ! ,f$]al ,food1 ,drug1 &       
,cosmetic ,act1 ) respect to eligibility
 = approval ( a subsequ5t g5]ic drug1 to
 remove ! b>ri] to t approval pos$ by ! 
#ahj-;day exclusivity p]iod af=d$ to a  
fir/ g5]ic applicant t has n yet receiv$
 f9al approval1 & = o!r purposes4  #a4  
,%ort title ,?is ,act may be cit$ z !   

,br++ ,l[-co/ ,options & ,competition   
:ile ,keep+ ,inc5tives = ,new ,g5]ics   
,act ( #bjai or ! ,,block+ ,act ( #bjai4
  #b4 ,*ange conditions ( fir/ g5]ic    
exclusivity to spur access & competition
 ,section #eje7;j77#e77;,b77iv7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 is
 am5d$--  7#a7 9 subclause 7,i71 by     
/rik+ #ahj days aft] & all t foll[s     
?r\gh ! p]iod at ! end & ins]t+ !       
foll[+3 #ahj days aft] ! e>li] (--  7aa7
 ! date ( ! fir/ comm]cial m>ket+ ( !   
drug 7includ+ ! comm]cial m>ket+ ( !    
li/$ drug7 by any fir/ applicant2 or    
7bb7 ! applicable date specifi$ 9       
subclause 7,,iii74  2 &  7#b7 by add+ at
 ! end ! foll[+ new subclause3  7,,iii7 
,applicable date ,! applicable date     
specifi$ 9 ?is subclause1 ) respect to  
an application = a drug describ$ 9      
subclause 7,i71 is ! date on :i* ea* ( !
 foll[+ conditions is fir/ met3  7aa7 ,!
 approval ( su* an application c\ld be  
made effective1 b = ! eligibility ( a   

fir/ applicant = #ahj-;day exclusivity  
"u ?is clause4  7bb7 ,at lea/ #cj mon?s 
h pass$ s9ce ! date ( submission ( an   
application = ! drug by at lea/ "o fir/ 
applicant4  7cc7 ,approval ( an         
application = ! drug submitt$ by at lea/
 "o fir/ applicant is n preclud$ "u     
clause 7iii74  7dd7 ,no application = ! 
drug submitt$ by any fir/ applicant is  
approv$ at ! "t ! conditions "u items   
7aa71 7bb71 & 7cc7 are all met1         
reg>dless ( :e!r su* an application is  
subsequ5tly approv$4  4  ,may #b1 #bjai 
,committ$ to ! ,committee ( ! ,:ole     
,h\se on ! ,/ate ( ! ,union & ord]$ to  
be pr9t$