,,ii ,cal5d> ,no4 #dae #aad? ,,congress 
#b;d ,session  ,s4 #ahgh  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates  ,july  
#bh1 #bjae,mr4 ,casey 7= himself1 ,mr4  
,isakson1 ,mr4 ,br[n1 & ,mr4 ,kirk7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,april #e1 #bjaf,report$ by ,mr4        
,alex&]1 ) an amendment,strike out all  
aft] ! enact+ clause & ins]t ! "p pr9t$ 
9 italic  ,a ,,bill  ,to ext5d !        
p$iatric priority review v\*] program4  
#a4 ,%ort title ,?is ,act may be cit$ 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$iatric canc]s4  2 &  7,b7 9 p>agraph  
7#d7--  7i7 9 subp>agraph 7,e71 by /rik+
 & at ! end2  7ii7 9 subp>agraph 7,f71  
by /rik+ ! p]iod at ! end & ins]t+ 2 &2 
&  7iii7 by add+ at ! end ! foll[+3     
7,g7 is = a drug or biological product =
 :i* a priority review v\*] has n be5   
issu$ "u section #ebd 7relat+ to        
tropical disease products74  2  7#b7 9  
subsection 7b71 by /rik+ p>agraph 7#e72 
&  7#c7 9 subsection 7d77#b71 9 ! second
 s5t5ce1 by /rik+ ! p]iod & ins]t+ 1 b !
 sponsor ( a drug t int5ds to reque/ a  
priority review v\*] "u ?is section %all
 notify ! ,secret>y ( su* int5t ^u      
submission ( an application "u section  
#eje or section #cea ( ! ,public ,heal? 
,s]vice ,act t is ! basis ( su* reque/44

  #a4 ,%ort title ,?is ,act may be cit$ 
z ! ,advanc+ ,hope ,act ( #bjaf4  #b4   
,reau?orization ( program = priority    
review to enc\rage treatm5ts = r>e      
p$iatric diseases  7a7 ,9 ,g5]al        
,section #ebi ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 
is am5d$--  7#a7 9 subsection 7a7-- 7,a7
 9 p>agraph 7#c71 by am5d+ subp>agraph  
7,a7 to read z foll[s3  7,a7 ,! disease 
is a s]i\s or life-?reat5+ disease 9 :i*
 ! s]i\s or life-?reat5+ manife/ations  
prim>ily affect individuals ag$ f bir?  
to #ah ye>s1 includ+ age gr\ps (t5 call$
 neonates1 infants1 *ildr51 &           
adolesc5ts4  2 &  7,b7 9 p>agraph       
7#d77;,f71 by /rik+ ,prescription ,drug 
,us] ,fee ,am5dm5ts ( #bjab & ins]t+    
,advanc+ ,hope ,act ( #bjaf2  7#b7 9    
subsection 7b7--  7,a7 by /rik+ p>agraph
 7#d7 & ins]t+ ! foll[+3  7#d7          
,notification  7,a7 ,sponsor ( a r>e    
p$iatric disease product  7i7 ,9 ,g5]al 
,beg9n+ on ! date t is #ij days aft] !  
date ( enactm5t ( ! ,advanc+ ,hope ,act 

( #bjaf1 ! sponsor ( a r>e p$iatric     
disease product application t int5ds to 
reque/ a priority review v\*] "u ?is    
section %all notify ! ,secret>y ( su*   
int5t ^u submission ( ! r>e p$iatric    
disease product application t is ! basis
 ( ! reque/ = a priority review v\*]4   
7ii7 ,applications submitt$ b n yet     
approv$ ,! sponsor ( a r>e p$iatric     
disease product application t 0 submitt$
 & t has n be5 approv$ z ( ! date (     
enactm5t ( ! ,advanc+ ,hope ,act ( #bjaf
 %all be consid]$ eligible = a priority 
review v\*]1 if--  7,i7 su* sponsor has 
submitt$ su* r>e p$iatric disease       
product application-- 7aa7 on or aft] ! 
date t is #ij days aft] ! date (        
enactm5t ( ! ,prescription ,drug ,us]   
,fee ,am5dm5ts ( #bjab2 &  7bb7 on or   
be=e ! date ( enactm5t ( ! ,advanc+     
,hope ,act ( #bjaf2 &  7,,ii7 su*       
application o!rwise meets ! crit]ia = a 
priority review v\*] "u ?is section4    
7,b7 ,sponsor ( a drug application us+ a
 priority review v\*]  7i7 ,9 ,g5]al ,! 

sponsor ( a human drug application %all 
notify ! ,secret>y n lat] ?an #ij days  
prior to submission ( ! human drug      
application t is ! subject ( a priority 
review v\*] ( an int5t to submit ! human
 drug application1 includ+ ! date on :i*
 ! sponsor int5ds to submit !           
application4 ,su* notification %all be a
 legally b9d+ commitm5t to pay ! us] fee
 to be assess$ 9 accordance ) ?is       
section4  7ii7 ,transf] aft] notice ,!  
sponsor ( a human drug application t    
provides notification ( ! int5t ( su*   
sponsor to use ! v\*] = ! human drug    
application "u clause 7i7 may transf] ! 
v\*] aft] su* notification is provid$1  
if su* sponsor has n yet submitt$ !     
human drug application describ$ 9 !     
notification4  2 &  7,b7 by /rik+       
p>agraph 7#e7 & ins]t+ ! foll[+3  7#e7  
,t]m9ation ( au?ority ,! ,secret>y may n
 aw>d any priority review v\*]s "u      
p>agraph 7#a7 aft] ,septemb] #cj1 #bjbb1
 unless ! r>e p$iatric disease product  
application--  7,a7 is = a drug t1 n    

lat] ?an ,septemb] #cj1 #bjbb1 is       
designat$ "u subsection 7d7 z a drug = a
 r>e p$iatric disease2 &  7,b7 is1 n    
lat] ?an ,septemb] #cj1 #bjbg1 approv$  
"u section #eje7;b77#a7 ( ?is ,act or   
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act4  2 &  7#c7 9 subsection   
7g71 by ins]t+ be=e ! p]iod 1 except t  
no sponsor ( a r>e p$iatric disease     
product application may receive m ?an "o
 priority review v\*] issu$ "u any      
section ( ?is ,act ) respect to ! drug =
 :i* ! application is made4  7b7 ,rule (
 con/ruction ,no?+ 9 ?is ,act1 or !     
am5dm5ts made by ?is ,act1 %all be      
con/ru$ to affect ! validity ( a        
priority review v\*] t 0 issu$ "u       
section #ebi ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7  
be=e ! date ( enactm5t ( ?is ,act4  #c4 
,,gao report  7a7 ,/udy ,! ,comptroll]  
,g5]al ( ! ,unit$ ,/ates %all conduct a 
/udy on ! effectiv5ess ( aw>d+ priority 
review v\*]s "u section #ebi ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     

,u4,s4,c4 #cfj;ff7 9 provid+ inc5tives =
 ! developm5t ( drugs t treat or prev5t 
r>e p$iatric diseases 7z def9$ 9        
subsection 7a77#c7 ( su* section7 t w\ld
 n o!rwise h be5 develop$4 ,9 conduct+  
su* /udy1 ! ,comptroll] ,g5]al %all     
exam9e ! foll[+3  7#a7 ,! indications = 
:i* ea* drug = :i* a priority review    
v\*] 0 aw>d$ "u su* section #ebi 0      
approv$ "u section #eje7;b77#a7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;b77#a77 or section 
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a774  7#b7 ,:e!r !
 priority review v\*] impact$ sponsors' 
decisions to inve/ 9 develop+ a drug to 
treat or prev5t a r>e p$iatric disease4 
7#c7 ,an analysis ( ! drugs = :i* su*   
priority review v\*]s 7 us$1 :i* %all   
include-- 7,a7 ! indications = :i* su*  
drugs 7 approv$ "u section #eje7;b77#a7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or    
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a772  

7,b7 :e!r unmet m$ical ne$s 7 address$  
?r\gh ! approval ( su* drugs1 includ+1 =
 ea* su* drug--  7i7 if an alt]native   
!rapy 0 previ\sly available to treat !  
indication2 &  7ii7 if ! drug provid$ a 
b5efit or advantage ov] ano!r available 
!rapy2  7,c7 ! numb] ( pati5ts          
pot5tially treat$ by su* drugs2  7,d7 ! 
value ( ! priority review v\*] if       
transf]r$2 &  7,e7 ! l5g? ( "t betwe5 ! 
date on :i* a priority review v\*] 0    
aw>d$ & ! date on :i* x 0 us$4  7#d7 ,) 
respect to ! priority review v\*]       
program "u section #ebi ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;ff7--  7,a7 ! res\rces   
us$ by ! ,food & ,drug ,adm9i/ration 9  
implem5t+ su* program1 includ+ ! effect 
( su* program on ! ,food & ,drug        
,adm9i/ration's review ( drugs = :i* a  
priority review v\*] 0 n aw>d$ or us$2  
7,b7 ! impact ( ! program on ! public   
heal? z a result ( ! review & approval (
 drugs t receiv$ a priority review v\*] 
& products t 7 ! subject ( a r$eem$     

priority review v\*]2 &  7,c7 alt]native
 approa*es to improv+ su* program s t ! 
program is appropriately t>get$ t[>d    
provid+ inc5tives = ! developm5t (      
cl9ically important drugs t--  7i7      
prev5t or treat r>e p$iatric diseases2 &
  7ii7 w\ld likely n o!rwise h be5      
develop$ to prev5t or treat su*         
diseases4  7b7 ,report ,n lat] ?an      
,janu>y #ca1 #bjbb1 ! ,comptroll] ,g5]al
 ( ! ,unit$ ,/ates %all submit to !     
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report conta9+
 ! results ( ! /udy ( conduct$ "u       
subsection 7a74  ,april #e1             
#bjaf,report$ ) an am5dm5t