,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #def  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,janu>y #bd1 #bjbc,mr4
 ,c>t] ( ,georgia introduc$ ! foll[+    
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act )
 respect to limitations on exclusive    
approval or lic5sure ( orphan drugs1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,fairness 9 ,orphan
 ,drug ,exclusivity ,act4  #b4          
,limitations on exclusive approval or   
lic5sure ( orphan drugs ,section #ebg ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfj;cc7 is am5d$-- 7#a7 
9 subsection 7a71 by /rik+ ,except z    
provid$ 9 subsection 7b7 & ins]t+       
,except z provid$ 9 subsection 7b7 or   
7f72 &  7#b7 by add+ at ! end ! foll[+3 
7f7 ,limitations on exclusive approval1 
c]tification1 or lic5se  7#a7 ,9 g5]al  
,= a drug designat$ "u section #ebf = a 
r>e disease or condition pursuant to !  
crit]ia set =? 9 subsection 7a77#b77;,b7

 ( su* section1 ! ,secret>y %all n      
grant1 recognize1 or apply exclusive    
approval or lic5sure "u subsection 7a71 
&1 if su* exclusive approval or lic5sure
 has be5 grant$1 recogniz$1 or appli$1  
%all revoke su* exclusive approval or   
lic5sure1 unless ! sponsor ( !          
application = su* drug demon/rates )    
respect to an application approv$ or a  
lic5se issu$ aft] ! date ( enactm5t (   
?is subsection1 ^u su* approval or      
issuance1 t !re is no reasonable        
expectation at ! "t ( su* approval or   
issuance t ! co/ ( develop+ & mak+      
available 9 ! ,unit$ ,/ates su* drug =  
su* disease or condition w be recov]$ f 
sales 9 ! ,unit$ ,/ates ( su* drug1 tak+
 into acc\nt all sales made or          
reasonably expect$ to be made )9 #ab    
ye>s ( fir/ m>ket+ ! drug4  7#b7        
,consid]ations ,= purposes ( p>agraph   
7#a71 ! ,secret>y & ! sponsor ( !       
application = ! drug designat$ = a r>e  
disease or condition describ$ 9 su*     
p>agraph %all consid] sales f all drugs 

t-- 7,a7 are develop$ or m>ket$ by !    
same sponsor or manufactur] ( ! drug 7or
 a lic5sor1 pr$ecessor 9 int]e/1 or o!r 
relat$ entity to ! sponsor or           
manufactur]72 &  7,b7 are cov]$ by !    
same designation "u section #ebf4  7#c7 
,crit]ia ,no drug designat$ "u section  
#ebf = a r>e disease or condition       
pursuant to ! crit]ia set =? 9          
subsection 7a77#b77;,b7 ( su* section   
%all be eligible = exclusive approval or
 lic5sure "u ?is section unless x met   
su* crit]ia "u su* subsection on ! date 
on :i* ! drug 0 approv$ or lic5s$4  4