,,ii  #aah? ,,congress  #a/ ,session    
,s4 #bhig  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #ba1         
#bjbc,mr4 ,b5net 7= himself & ,mr4      
,rubio7 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to    
molecul>ly t>get$ p$iatric canc]        
inve/igations1 & = o!r purposes4  #a4   
,%ort title ,?is ,act may be cit$ z !   
,give ,kids a ,*ance ,act ( #bjbc4  #b4 
,rese>* into p$iatric uses ( drugs2     
additional au?orities ( ,food & ,drug   
,adm9i/ration reg>d+ molecul>ly t>get$  
canc] drugs  7a7 ,9 g5]al  7#a7         
,additional active +r$i5t = application 
drug2 limitation reg>d+ novel-comb9ation
 application drug ,section              
#eje;,b7a77#c7 ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4         
#cee;c7a77#c77 is am5d$-- 7,a7 by       
r$esignat+ subp>agraphs 7,b7 & 7,c7 z   
subp>agraphs 7,c7 & 7,d71 respectively2 

&  7,b7 by /rik+ subp>agraph 7,a7 &     
ins]t+ ! foll[+3  7,a7 ,9 g5]al ,=      
purposes ( p>agraph 7#a77;,b71 !        
inve/igation describ$ 9 ?is p>agraph is 
7z det]m9$ by ! ,secret>y7 a molecul>ly 
t>get$ p$iatric canc] inve/igation (--  
7i7 ! drug or biological product = :i* !
 application ref]r$ to 9 su* p>agraph is
 submitt$2 or  7ii7 su* drug or         
biological product 9 comb9ation )-- 7,i7
 an active +r$i5t ( a drug or biological
 product-- 7aa7 = :i* an approv$        
application "u section #eje7;j7 "u ?is  
,act or "u section #cea7k7 ( ! ,public  
,heal? ,s]vice ,act is 9 effect2 &  7bb7
 t is det]m9$ by ! ,secret>y to be !    
/&>d ( c>e = treat+ a p$iatric canc]2 or
  7,,ii7 an active +r$i5t ( a drug or   
biological product-- 7aa7 = :i* an      
approv$ application "u section #eje7;b7 
( ?is ,act or section #cea7;a7 ( !      
,public ,heal? ,s]vice ,act to treat an 
adult canc] is 9 effect & is held by !  
same p]son submitt+ ! application "u    
p>agraph 7#a77;,b72 &  7bb7 t is direct$

 at a molecul> t>get t ! ,secret>y      
det]m9es to be sub/antially relevant to 
! gr[? or progression ( a p$iatric      
canc]4  7,b7 ,additional requirem5ts    
7i7 ,design ( inve/igation ,a molecul>ly
 t>get$ p$iatric canc] inve/igation     
ref]r$ to 9 subp>agraph 7,a7 %all be    
design$ to yield cl9ically mean+ful     
p$iatric /udy data t is ga!r$ us+       
appropriate =mulations = ea* age gr\p = 
:i* ! /udy is requir$1 reg>d+ dos+1     
safety1 & prelim9>y efficacy to in=m    
pot5tial p$iatric label+4  7ii7         
,limitation ,an inve/igation describ$ 9 
subp>agraph 7,a77ii7 may be requir$ only
 if ! drug or biological product = :i* !
 application ref]r$ to 9 p>agraph       
7#a77;,b7 conta9s ei!r-- 7,i7 a s+le new
 active +r$i5t2 or  7,,ii7 m ?an "o     
active +r$i5t1 if an application = !    
comb9ation ( active +r$i5ts has n       
previ\sly be5 approv$ b ea* active      
+r$i5t has be5 previ\sly approv$ to     
treat an adult canc]4  7iii7 ,results ( 
already-complet$ precl9ical /udies (    

application drug ,! ,secret>y may       
require t reports on an inve/igation    
requir$ pursuant to p>agraph 7#a77;,b7  
include ! results ( all precl9ical      
/udies on :i* ! decision to conduct su* 
inve/igation 0 bas$4  7iv7 ,rule (      
con/ruction reg>d+ inactive +r$i5ts ,)  
respect to a comb9ation ( active +r$i5ts
 ref]r$ to 9 subp>agraph 7,a77ii71 su*  
subp>agraph %all n be con/ru$ z address+
 ! use ( inactive +r$i5ts ) su*         
comb9ation4  4  7#b7 ,det]m9ation (     
applicable requirem5ts ,section         
#eje;,b7e77#a7 ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4         
#cee;c7e77#a77 is am5d$ by add+ at ! end
 ! foll[+3 ,! ,secret>y %all det]m9e    
:e!r subp>agraph 7,a7 or 7,b7 (         
subsection 7a77#a7 %all apply ) respect 
to an application be=e ! date on :i* !  
applicant is requir$ to submit ! initial
 p$iatric /udy plan "u p>agraph         
7#b77;,a744  7#c7 ,cl>ify+ applicability
 ,section #eje;,b7a77#a7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     

,u4,s4,c4 #cee;c7a77#a77 is am5d$ by    
add+ at ! end ! foll[+3  7,c7 ,rule (   
con/ruction ,no application t is subject
 to ! requirem5ts ( subp>agraph 7,b7    
%all be subject to ! requirem5ts (      
subp>agraph 7,a71 & no application 7or  
supplem5t to an application7 t is       
subject to ! requirem5ts ( subp>agraph  
7,a7 %all be subject to ! requirem5ts ( 
subp>agraph 7,b74  4  7#d7 ,con=m+      
am5dm5ts ,section #eje;,b7a7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee;c7a77 is am5d$-- 7,a7 9  
p>agraph 7#c77;,c71 z r$esignat$ by     
p>agraph 7#a77;,a7 ( ?is subsection1 by 
/rik+ inve/igations describ$ 9 ?is      
p>agraph & ins]t+ inve/igations ref]r$  
to 9 subp>agraph 7,a72 &  7,b7 9        
p>agraph 7#c77;,d71 z r$esignat$ by     
p>agraph 7#a77;,a7 ( ?is subsection1 by 
/rik+ ! assessm5ts "u p>agraph 7#b77;,b7
 & ins]t+ ! assessm5ts requir$ "u       
p>agraph 7#a77;,a74  7b7 ,guidance ,!   
,secret>y %all-- 7#a7 n lat] ?an #a ye> 
aft] ! date ( enactm5t ( ?is ,act1 issue

 draft guidance on ! implem5tation ( !  
requirem5ts 9 subsection 7a72 &  7#b7 n 
lat] ?an #a ye> aft] clos+ ! comm5t     
p]iod on su* draft guidance1 f9alize su*
 guidance4  7c7 ,applicability ,!       
am5dm5ts made by ?is section apply )    
respect to any application "u section   
#eje7;b7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 
& any application "u section #cea7;a7 ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bfb7;a771 t is submitt$ on or
 aft] ! date t is #c ye>s aft] ! date ( 
enactm5t ( ?is ,act4  7d7 ,reports to   
,congress  7#a7 ,secret>y ( ,heal? &    
,human ,s]vices ,n lat] ?an #b ye>s aft]
 ! date ( enactm5t ( ?is ,act1 !        
,secret>y ( ,heal? & ,human ,s]vices    
%all submit to ! ,committee on ,en]gy & 
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate a report  
on ! ,secret>y's ef=ts1 9 coord9ation ) 
indu/ry1 to ensure implem5tation ( !    
am5dm5ts made by subsection 7a74  7#b7  

,,gao /udy & report  7,a7 ,/udy ,n lat] 
?an #c ye>s aft] ! date ( enactm5t ( ?is
 ,act1 ! ,comptroll] ,g5]al ( ! ,unit$  
,/ates %all conduct a /udy ( !          
effectiv5ess ( requir+ assessm5ts &     
inve/igations describ$ 9 section #eje;,b
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee;c71 z am5d$ by 
subsection 7a71 9 ! developm5t ( drugs &
 biological products = p$iatric canc]   
indications4  7,b7 ,f9d+s ,n lat] ?an #g
 ye>s aft] ! date ( enactm5t ( ?is ,act1
 ! ,comptroll] ,g5]al %all submit to !  
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives & ! ,committee  
on ,heal?1 ,education1 ,labor1 &        
,p5sions ( ! ,s5ate a report conta9+ !  
f9d+s ( ! /udy conduct$ "u subp>agraph  
7,a74