,,ii  #aae? ,,congress  #a/ ,session    
,s4 #def  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #bg1 #bjag,mr4
 ,b5net 7= himself1 ,mr4 ,rubio1 ,mr4   
,van ,holl51 & ,mr4 ,g>dn]7 introduc$ ! 
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
to e/abli% a program to increase !      
developm5t ( new drugs to treat p$iatric
 canc]s1 & = o!r purposes4  #a4 ,%ort   
title ,?is ,act may be cit$ z ! ,rese>* 
to ,accel]ate ,cures & ,equity = ,*ildr5
 ,act or ! ,,race = ,*ildr5 ,act4  #b4  
,drug developm5t = p$iatric canc]  7a7  
,molecul> t>gets reg>d+ canc] drugs     
,section #eje;,b ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;c7 is am5d$--  7#a7 9 subsection   
7a77#b77;,a77i7 by /rik+ product = !    
claim$ indications 9 all relevant       
p$iatric subpopulations2 & & ins]t+     
8product 9 all relevant p$iatric        
subpopulations--  7,i7 = ! claim$       

indications2 or  2  7,,ii7 = a p$iatric 
canc] indication1 if ! drug is int5d$ = 
! treatm5t ( an adult canc] & is direct$
 at a molecul> t>get consid]$ to be     
g]mane to ! gr[? & progression ( su*    
p$iatric canc]2 &  2  7#b7 9 subsection 
7b77#a7-- 7,a7 by am5d+ subp>agraph     
7,a77i7 to read z foll[s3  7,a7 7i7 !   
drug or biological product is us$ = a   
sub/antial numb] ( p$iatric pati5ts--   
7,i7 = ! label$ indications2 or  7,,ii7 
= a p$iatric canc] indication1 if ! drug
 is int5d$ = ! treatm5t ( an adult canc]
 & is direct$ at a molecul> t>get       
consid]$ to be g]mane to ! gr[? &       
progression ( su* p$iatric canc]2 &  2 &
  7,b7 by am5d+ subp>agraph 7,b7 to read
 z foll[s3  7,b7 !re is reason to       
believe t ! drug or biological product  
w\ld repres5t a mean+ful !rapeutic      
b5efit ov] exi/+ !rapies = p$iatric     
pati5ts--  7i7 = "o or m ( ! claim$     
indications2 or  7ii7 = a p$iatric canc]
 indication1 if ! drug is int5d$ = !    
treatm5t ( an adult canc] & is direct$  

at a molecul> t>get consid]$ to be      
g]mane to ! gr[? & progression ( su*    
p$iatric canc]2 or  2 &  7#c7 by am5d+  
p>agraph 7#b7 ( subsection 7c7 to read z
 foll[s3  7#b7 ! drug or biological     
product is 9 a class ( products1 is = an
 indication1 or is direct$ at a specific
 molecul> t>get 9 an adult canc] & su*  
molecul> t>get is g]mane to ! gr[? or   
progression ( canc] 9 a p$iatric canc]1 
= :i* !re is ne$ = additional options4  
4  7b7 ,e>ly meet+ on p$iatric /udy plan
  7#a7 ,9 g5]al ,clause 7i7 ( section   
#eje;,b7e77#b77;,c7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;c7e77#b77;,c77 is am5d$ to read z  
foll[s3  7i7 %all meet ) ! applicant--  
7,i7 if reque/$ by ! applicant ) respect
 to a drug t is int5d$ to treat a s]i\s 
or life-?reat5+ disease or condition1 to
 discuss prep>ation ( ! initial p$iatric
 /udy plan1 n lat] ?an ! end-(-,phase #a
 meet+ 7z su* t]m is us$ 9 section      
#cab4dg7;b7 ( title #ba1 ,code ( ,f$]al 
,regulations1 or successor regulations7 

or )9 #cj days ( receipt ( su* reque/1  
:i*ev] is lat]2  7,,ii7 to discuss !    
initial p$iatric /udy plan z soon z     
practicable1 b n lat] ?an #ij cal5d>    
days aft] ! receipt ( su* plan "u       
subp>agraph 7,a72 &  7,,iii7 to discuss 
any sci5tific or op]ational *all5ges t  
may be ! basis ( a def]ral "u subsection
 7a77#c7 or a full or p>tial waiv] "u   
subsection 7a77#d72  4  7#b7 ,con=m+    
*anges ,section #eje;,b7e7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee;c7e77 is am5d$-- 7,a7 9 !
 head+ ( p>agraph 7#b71 by /rik+ meet+ &
 ins]t+ meet+s2  7,b7 9 ! head+ (       
p>agraph 7#b77;,c71 by /rik+ ,meet+ &   
ins]t+ ,meet+s2  7,c7 9 clauses 7ii7 &  
7iii7 ( p>agraph 7#b77;,c71 by /rik+ no 
meet+ ea* place x appe>s & ins]t+ no    
meet+ "u clause 7i77,,ii72 &  7,d7 9    
p>agraph 7#c7 by /rik+ meet+ "u p>agraph
 7#b77;,c77i7 & ins]t+ meet+ "u p>agraph
 7#b77;,c77i77,,ii74  7c7 ,orphan drugs 
,section #eje;,b7k7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  

#cee;c7k77 is am5d$ by ins]t+ except 9 !
 case ( a drug or biological product t  
is int5d$ = ! treatm5t ( an adult canc] 
& is direct$ at a molecul> t>get        
consid]$ to be g]mane to ! gr[? &       
progression ( a p$iatric canc]1 aft]    
regulation14  7d7 ,guidance ,n lat] ?an 
#a ye> aft] ! date ( enactm5t ( ?is     
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all issue guidance on !
 implem5tation ( ! am5dm5ts to section  
#eje;,b ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7   
made by ?is section1 includ+--  7#a7    
/udy designs2  7#b7 molecul> t>gets     
consid]$ to be g]mane to ! gr[? &       
progression pres5t 9 "o or m canc]s 9   
p$iatric populations t may be           
appropriate = assessm5t "u su* section  
#eje;,b1 z s am5d$2 &  7#c7             
consid]ations = implem5tation ( su*     
section #eje;,b1 z s am5d$1 & waiv]s ( !
 requirem5ts ( su* section #eje;,b )    
reg>d to molecul> t>gets = :i* sev]al   

drugs may be "u inve/igation4  7e7      
,applicability ,?is section & ! am5dm5ts
 made by ?is section apply ) respect to 
applications = a drug submitt$ "u       
section #eje ( ! ,f$]al ,food1 ,drug1 or
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or 
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7 on or aft] !  
date t is #ah mon?s aft] ! date (       
enactm5t ( ?is ,act4  7f7 ,report to    
,congress ,section #ejh7;b7 ( ! ,,fda   
,safety & ,innovation ,act 7#ba         
,u4,s4,c4 #cee;c-#a7;b77 is am5d$-- 7#a7
 9 p>agraph 7#aj71 by /rik+ 2 & & ins]t+
 22 &  7#b7 by /rik+ p>agraph 7#aa7 &   
ins]t+ ! foll[+3  7#aa7 an assessm5t ( !
 impact ( ! am5dm5ts to su* section     
#eje;,b made by ! ,,race = ,*ildr5 ,act 
on p$iatric label+ ( drugs & p$iatric   
label+ ( molecul>ly t>get$ drugs = !    
treatm5t ( canc]2  7#ab7 an assessm5t ( 
! ef=ts ( ! ,secret>y to implem5t ! plan
 develop$ "u section #eje;,c-#a ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act1  
reg>d+ e>li] submission ( p$iatric      

/udies "u sections #eje;,a & #eje;,b1   
includ+--  7,a7 ! av]age l5g? ( "t aft] 
! approval ( an application "u section  
#eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;b77#a77 be=e /udies conduct$      
pursuant to su* sections #eje;,a or     
#eje;,b are complet$1 submitt$1 &       
incorporat$ into label+2  7,b7 ! av]age 
l5g? ( "t aft] ! receipt ( a propos$    
p$iatric /udy reque/ be=e ! ,secret>y   
responds to su* reque/2  7,c7 ! av]age  
l5g? ( "t aft] ! submission ( a propos$ 
p$iatric /udy reque/ be=e ! ,secret>y   
issues a writt5 reque/ = su* /udies2    
7,d7 ! numb] ( writt5 reque/s issu$ =   
ea* inve/igational new drug prior to !  
submission ( an application "u section  
#eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act2 &  7,e7 ! av]age numb]1 
& range ( numb]s1 ( am5dm5ts to writt5  
reque/s issu$2  7#ac7 a li/ ( sponsors (
 applications or hold]s ( approv$       
applications :o receiv$ exclusivity "u  
su* section #eje;,a aft] receiv+ a lett]

 issu$ "u su* section #eje;,b7d77#a7 &  
be=e ! /udies ref]r$ to 9 su* lett] 7   
complet$ & submitt$2 &  7#ad7 a li/ (   
assessm5ts requir$ "u subsection        
7a77#b77;,a77i77,,ii71 &                
7b77#a77;,b77ii7 ( section #eje;,b4  4  
7g7 ,rule ( con/ruction ,no?+ 9 ?is     
section1 includ+ ! am5dm5ts made by ?is 
section1 %all limit ! au?ority ( !      
,secret>y ( ,heal? & ,human ,s]vices to 
issue writt5 reque/s "u section #eje;,a 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee;a74  #c4       
,improv+ ! timel9ess ( p$iatric /udies  
7a7 ,in=m+ int]nal review committee     
,section #eje;,a7f7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;a7f77 is am5d$ by add+ at ! end !  
foll[+3  7#g7 ,in=m+ int]nal review     
committee ,! ,secret>y %all provide to !
 committee ref]r$ to 9 p>agraph 7#a7 any
 response issu$ to an applicant or hold]
 ) respect to a propos$ p$iatric /udy   
reque/4  4  7b7 ,action on submissions  
,section #eje;,a7d7 ( ! ,f$]al ,food1   

,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;a7d77 is am5d$-- 7#a7 by r$esignat+
 p>agraphs 7#c7 ?r\gh 7#e7 z p>agraphs  
7#d7 ?r\gh 7#f71 respectively2 &  7#b7  
by ins]t+ aft] p>agraph 7#b7 ! foll[+3  
7#c7 ,action on submissions ,! ,secret>y
 %all review & act ^u a submission ( a  
propos$ p$iatric /udy reque/ or a       
sponsor's propos$ am5dm5t to a writt5   
reque/ = p$iatric /udies )9 #abj days ( 
! submission4  4  7c7 ,/udy ,! ,secret>y
 ( ,heal? & ,human ,s]vices1 act+ ?r\gh 
! int]nal review committee e/abli%$ "u  
section #eje;,c ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;d7
 %all1 n lat] ?an "o ye> aft] ! date (  
enactm5t ( ?is ,act1 develop & implem5t 
a plan to a*ieve1 :5 appropriate1 e>li] 
submission ( p$iatric /udies "u section 
#eje;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a74  
,su* plan %all include recomm5dations to
 a*ieve--  7#a7 e>li] discussion (      
propos$ p$iatric /udy reque/s & writt5  
reque/s ) sponsors1 & if appropriate1 at

 ! meet+ requir$ "u section             
#eje;,b7e77#b77;,c7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;c7e77#b77;,c771 z am5d$ by section 
#b2  7#b7 e>li] issuance ( writt5       
reque/s = a p$iatric /udy "u su* section
 #eje;,a1 includ+ = inve/igational new  
drugs prior to ! submission ( an        
application "u section #eje7;b77#a7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;b77#a772 &  7#c7   
%ort] timel9es1 :5 appropriate1 = !     
completion ( /udies pursuant to a writt5
 reque/ "u su* section #eje;,a4  #d4    
,neonatology exp]tise ,section #f7;d7 ( 
! ,be/ ,ph>maceuticals = ,*ildr5 ,act   
7#ba ,u4,s4,c4 #cic;a7d77 is am5d$ by   
/rik+ ,= ! #e-ye> p]iod beg9n+ on ! date
 ( enactm5t ( ?is subsection1 at &      
ins]t+ ,at4