,,ii  #aai? ,,congress  #b;d ,session   
,s4 #cgaf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,janu>y #bh1 #bjbf,ms4 
,baldw9 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to set =? limitations on    
exclusive approval or lic5sure ( drugs  
designat$ = r>e diseases or conditions4 
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,reta9+ ,access & ,re/or+ ,exclusivity
 ,act or ! ,,r>e ,act4  #b4 ,limitations
 on exclusive approval or lic5sure (    
orphan drugs  7a7 ,9 g5]al ,section #ebg
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$-- 
7#a7 9 subsection 7a71 9 ! matt] foll[+ 
p>agraph 7#b71 by /rik+ same disease or 
condition & ins]t+ same approv$ use or  
indication )9 su* r>e disease or        
condition2  7#b7 9 subsection 7b7-- 7,a7
 9 ! matt] prec$+ p>agraph 7#a71 by     
/rik+ same r>e disease or condition &   
ins]t+ same approv$ use or indication = 
:i* su* #g-ye> p]iod applies to su*     

already approv$ or lic5s$ drug2 &  7,b7 
9 p>agraph 7#a71 by ins]t+ 1 relat+ to !
 approv$ use or indication1 aft] ! ne$s2
  7#c7 9 subsection 7c77#a71 by /rik+   
same r>e disease or condition z !       
already approv$ drug & ins]t+ same use  
or indication = :i* ! already approv$ or
 lic5s$ drug 0 approv$ or lic5s$2 &     
7#d7 by add+ at ! end ! foll[+3  7f7    
,approv$ use or indication def9$ ,9 ?is 
section1 ! t]m approv$ use or indication
 means ! use or indication approv$ "u   
section #eje ( ?is ,act or lic5s$ "u    
section #cea ( ! ,public ,heal? ,s]vice 
,act = a drug designat$ "u section #ebf 
= a r>e disease or condition4  4  7b7   
,application ( am5dm5ts ,! am5dm5ts made
 by subsection 7a7 %all apply ) respect 
to any drug designat$ "u section #ebf ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfj;bb71 reg>dless ( !  
date on :i* ! drug 0 s designat$1 &     
reg>dless ( ! date on :i* ! drug 0      
approv$ "u section #eje ( su* ,act 7#ba 
,u4,s4,c4 #cee7 or lic5s$ "u section    

#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb74