,,ii  #aac? ,,congress  #a/ ,session    
,s4 #aabh  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #aa1 #bjac ,mr4  
,toomey 7= himself1 ,mr4 ,casey1 & ,mr4 
,crapo7 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,f9ance  ,a ,,bill  ,to cl>ify ! orphan 
drug exception to ! annual fee on br&$  
prescription ph>maceutical manufactur]s 
& import]s4  #a4 ,%ort title ,?is ,act  
may be cit$ z ! ,pres]v+ ,access to     
,orphan ,drugs ,act ( #bjac4  #b4       
,cl>ification ( orphan drug exception to
 annual fee on br&$ prescription        
ph>maceutical manufactur]s & import]s   
7a7 ,9 g5]al ,p>agraph 7#c7 ( section   
#ijjh7;e7 ( ! ,pati5t ,protection &     
,af=dable ,c>e ,act 7#bf ,u4,s4,c4 #djja
 note prec42 ,public ,law #aaa-adh7 is  
am5d$ to read z foll[s3  7#c7 ,exclusion
 ( orphan drug sales  7,a7 ,9 g5]al ,!  
t]m br&$ prescription drug sales %all n 
include sales ( any drug or biological  
product--  7i7 ) respect to :i* a cr$it 
0 all[$ = any taxable ye> "u section    

#de;,c ( ! ,int]nal ,rev5ue ,code (     
#aihf2 or  7ii7 :i* is approv$ or lic5s$
 by ! ,food & ,drug ,adm9i/ration =     
m>ket+ solely = "o or m r>e diseases or 
conditions4  7,b7 ,limitation           
,subp>agraph 7,a7 %all n apply ) respect
 to any drug or biological product aft] 
! date on :i* ! drug or biological      
product is approv$ or lic5s$ by ! ,food 
& ,drug ,adm9i/ration = m>ket+ = any    
indication o!r ?an ! treatm5t ( a r>e   
disease or condition4  7,c7 ,r>e disease
 or condition ,9 ?is p>agraph1 ! t]m r>e
 disease or condition has ! mean+ giv5  
su* t]m "u section #de;,c7d77#a7 ( !    
,int]nal ,rev5ue ,code ( #aihf1 except t
 9 ! case ( any drug or biological      
product t has n be5 designat$ "u section
 #ebf ( ! ,f$]al ,food1 ,drug &         
,cosmetic ,act = a p>ticul> indication1 
det]m9ations "u su* section             
#de;,c7d77#a7 %all be made on ! basis ( 
! facts & circum/ances z ( ! date su*   
drug or biological product is approv$ or
 lic5s$ by ! ,food & ,drug ,adm9i/ration

 = m>ket+ = ! treatm5t ( su* disease or 
condition4  4  7b7 ,effective date ,!   
am5dm5t made by ?is section %all take   
effect z if includ$ 9 section #ijjh ( ! 
,pati5t ,protection & ,af=dable ,c>e    
,act 7#bf ,u4,s4,c4 #djja note prec42   
,public ,law #aaa-adh74