,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #aecg  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #bc1 #bjae ,mr4  
,butt]field 7= himself1 ,mr4 ,mc,caul1  
,mr4 ,van ,holl51 ,mr4 ,kelly (         
,p5nsylvania1 & ,mr4 ,coh57 introduc$ ! 
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to reau?orize a program
 ( priority review to enc\rage treatm5ts
 = r>e p$iatric diseases1 & = o!r       
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,advanc+ ,hope ,act (      
#bjae4  #b4 ,reau?orization ( program = 
priority review ,to enc\rage treatm5ts =
 r>e p$iatric diseases ,section #ebi ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;ff7 is am5d$--  7#a7
 9 subsection 7a7-- 7,a7 by am5d+       
p>agraph 7#c7 to read z foll[s3  7#c7   
,r>e p$iatric disease ,! t]m r>e        
p$iatric disease means any ( ! foll[+3  
7,a7 ,a disease t meets ea* ( ! foll[+  
crit]ia3  7i7 ,! disease prim>ily       

affects individuals ag$ f bir? to #ah   
ye>s1 includ+ age gr\ps (t5 call$       
neonates1 infants1 *ildr51 & adolesc5ts4
  7ii7 ,! disease is a r>e disease or   
condition1 )9 ! mean+ ( section #ebf4   
7,b7 ,any =m ( sickle cell disease4     
7,c7 ,any p$iatric canc]s4  2 &  7,b7 9 
p>agraph 7#d77;,a7--  7i7 9 subp>agraph 
7,e71 by /rik+ & at ! end2  7ii7 9      
subp>agraph 7,f71 by /rik+ ! p]iod at ! 
end & ins]t+ 2 &2 &  7iii7 by add+ at ! 
end ! foll[+3  7,g7 is = a drug or      
biological product = :i* a priority     
review v\*] has n be5 issu$ "u section  
#ebd 7relat+ to tropical disease        
products74  2 &  7#b7 9 subsection 7b71 
by /rik+ p>agraph 7#e74  #c4 ,limitation
 on priority review v\*]s = tropical    
disease products ,subp>agraph 7,a7 (    
section #ebd7;a77#d7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfjn7a77#d77 is am5d$--  7#a7 9 clause 
7i71 by /rik+ & at ! end2  7#b7 9 clause
 7ii71 by ins]t+ & at ! end2 &  7#c7 by 
add+ at ! end ! foll[+3  7iii7 conta9s  

an assurance 7satisfactory to !         
,secret>y7 t ! drug = :i* ! application 
is submitt$ has n be5 approv$ =         
comm]cial m>ket+ = any tropical disease 
indication by a gov]nm5t au?ority       
outside ( ! ,unit$ ,/ates = m ?an #bd   
mon?s be=e ! application is submitt$2  4