,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #bcae  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #aa1 #bjac ,mr4 
,g]la* 7= himself & ,mr4 ,neal7         
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce1 & 9 
addition to ! ,committee on ,ways &     
,means1 = a p]iod to be subsequ5tly     
det]m9$ by ! ,speak]1 9 ea* case =      
consid]ation ( su* provisions z fall )9 
! jurisdiction ( ! committee conc]n$  ,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,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 ,drug1 & ,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,public ,law       
#aaa-adh74