,,ii  #aad? ,,congress  #b;d ,session   
,s4 #cbci  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #ad1 #bjaf,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$]al ,food1     
,drug1 & ,cosmetic ,act to e/abli% a    
program to provide additional inc5tives 
= ! developm5t ( new drugs to treat     
p$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 ,requir$ p$iatric assessm5ts 
7a7 ,molecul> t>gets reg>d+ canc] drugs 
,section #eje;,b ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;c7 is am5d$--  7#a7 9 subsection   
7a77#a7-- 7,a7 9 subp>agraph 7,a71 by   
/rik+ or at ! end2  7,b7 9 subp>agraph  
7,b71 by ins]t+ or aft] adm9i/ration12 &
  7,c7 by ins]t+ aft] subp>agraph 7,b7 !
 foll[+3  7,c7 "u section #eje ( ?is    

,act or section #cea ( ! ,public ,heal? 
,s]vice ,act1 z describ$ 9 subp>agraph  
7,a7 or 7,b71 t is direct$ at a molecul>
 t>get pres5t 9 "o or m canc]s 9 "o or m
 p$iatric populations1  2 &  7#b7 9     
subsection 7b77#a7-- 7,a7 by am5d+      
subp>agraph 7,a77i7 to read z foll[s3   
7,a7 7i7 ! drug or biological product is
 us$ = a sub/antial numb] ( p$iatric    
pati5ts-- 7,i7 = ! label$ indications2  
or  7,,ii7 ) respect to #a or m specific
 molecul> t>gets pres5t 9 canc]s 9      
p$iatric populations2 &  2  7,b7 by     
am5d+ subp>agraph 7,b7 to read z foll[s3
  7,b7 !re is reason to believe t ! drug
 or biological product w\ld repres5t a  
mean+ful !rapeutic b5efit ov] exi/+     
!rapies = p$iatric pati5ts--  7i7 = #a  
or m ( ! claim$ indications2 or  7ii7 ) 
respect to #a or m specific molecul>    
t>gets pres5t 9 canc]s 9 p$iatric       
populations2 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 pres5t 9 canc]s 9       
p$iatric populations1 = :i* !re is ne$ =
 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 direct$ at a molecul>   
t>get t is pres5t 9 "o or m canc]s 9 "o 
or m p$iatric populations1 z describ$ 9 
subsection 7a77#a77;,c71 to discuss1 n  
lat] ?an ! end-(-,phase #a meet+ 7z su* 
t]m is us$ 9 section #cab4hb7;b7 ( title
 #ba1 ,code ( ,f$]al ,regulations1 or   
successor regulations71 prep>ation ( !  
initial p$iatric /udy plan2  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 ! subject ( an application describ$ 9
 subsection 7a77#a77;,c71 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 ( ?is section 7includ+ ! 
am5dm5ts made by ?is section71 includ+  
/udy designs & molecul> t>gets likely to
 be pres5t 9 "o or m canc]s 9 p$iatric  
populations t are appropriate =         
assessm5t "u ! am5dm5ts made by ?is     
,act4  7e7 ,applicability ,?is ,act & ! 
am5dm5ts made by ?is ,act apply )       
respect to applications = a drug        
submitt$ "u section #eje ( ! ,f$]al     
,food1 ,drug1 & ,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 ,n lat] 
?an ,july #ab1 #bjba1 ! ,secret>y (     
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all     
submit to ,congress a report on !       
implem5tation ( ! am5dm5ts made by ?is  
section1 toge!r ) any recomm5dations ( !
 ,secret>y reg>d+ su* am5dm5ts4  7g7    

,rule ( con/ruction ,no?+ 9 ?is ,act1   
includ+ ! am5dm5ts made by ?is ,act1    
%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