,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #cfgh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #a1 #bjae ,mr4
 ,kelly ( ,p5nsylvania 7= himself1 ,mrs4
 ,black1 ,mr4 ,neal1 ,mr4 ,hold+1 ,mr4  
,rangel1 ,ms4 ,j5k9s ( ,kansas1 ,mr4    
,tib]i1 ,mr4 ,m>*ant1 & ,mr4 ,nunes7    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,ways & ,means1 & 9    
addition to ! ,committee on ,en]gy &    
,comm]ce1 = 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]s1 & = o!r purposes4  #a4 ,%ort
 title ,?is ,act may be cit$ z !        
,pres]v+ ,access to ,orphan ,drugs ,act 
( #bjae4  #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  7ii7 ) 
respect to :i* a cr$it 0 all[able = any 
taxable ye> beg9n+ be=e ,janu>y #a1     
#bjaa1 "u su* section #de;,c 7)\t reg>d 
to :e!r su* cr$it 0 claim$ or receiv$72 
or  7iii7 :i* 0 any drug or biological  
product approv$ or lic5s$ prior to      
,janu>y #a1 #bjaa1 by ! ,food & ,drug   
,adm9i/ration1 = m>ket+ solely = #a or m
 r>e diseases or conditions4  7,b7      
,expiration ,subp>agraph 7,a7 %all n    
apply ) respect to any drug or          
biological product aft] ! date on :i*   
su* 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 ( #aihf4  4  7b7 
,hold h>mless = cov]$ entities ) no or  
limit$ orphan drug sales ,subsection 7b7
 ( section #ijjh ( ! ,pati5t ,protection
 & ,af=dable ,c>e ,act 7#bf ,u4,s4,c4   
#djja note prec42 ,public ,law #aaa-adh7
 is am5d$ by add+ at ! end ! foll[+ new 
p>agraph3  7#e7 ,adju/m5t = c]ta9 cov]$ 
entities ) no or limit$ orphan drug     
sales ,if-- 7,a7 ! fee "u ?is section = 
a cal5d> ye> ) respect to a cov]$ entity
 7det]m9$ )\t reg>d to ?is p>agraph71   
exce$s  7,b7 ! fee t w\ld be det]m9$ "u 
?is section = su* ye> ) respect to su*  
entity if br&$ prescription drug sales (
 all cov]$ entities 7 det]m9$ )\t reg>d 
to clauses 7ii7 & 7iii7 ( subsection    
7e77#c77;,a71  !n su* entity's fee "u   
?is section = su* cal5d> ye> %all be    
det]m9$ z describ$ 9 subp>agraph 7,b74  

4  7c7 ,effective date ,! am5dm5ts made 
by ?is section %all apply ) respect to  
fees ! annual paym5t date = :i* "u      
section #ijjh ( ! ,pati5t ,protection & 
,af=dable ,c>e ,act 7#bf ,u4,s4,c4 #djja
 note prec42 ,public ,law #aaa-adh7 is  
aft] ,decemb] #ca1 #bjad4