,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #fbhh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,novemb] #h1 #bjbc,mr4
 ,b]a 7= himself & ,mr4 ,kelly (        
,p5nsylvania7 introduc$ ! foll[+ bill2  
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act to       
provide = a ,p$iatric ,bra9 ,tumor      
,real-,_w ,data ,regi/ry ,program1 & =  
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,data = ,p$iatric ,bra9
 ,canc] ,act ( #bjbc4  #b4 ,f9d+s       
,congress f9ds ! foll[+3 7#a7 ,r&omiz$  
cl9ical trials require ! use ( control  
gr\ps to s]ve z ! basel9e = det]m9+ !   
effectiv5ess ( a /udy treatm5t4  7#b7   
,because ( ! r>ity ( "s diseases1 x is  
(t5 h>d to f9d en\gh /udy p>ticipants 9 
a suffici5t am\nt ( "t1 mak+ r&omiz$    
cl9ical trials = ^! treatm5ts           
infeasible4 ,c\ple ?is ) ! fact t !     
curr5t /&>d ( c>e = _m r>e diseases is  
ineffective 7(t5 lead+ to dea?71 mak+   
adm9i/]+ ! curr5t /&>d ( c>e une?ical4  

7#c7 ,9 ^! cases1 data reflect+ pati5t  
treatm5t 9 r\t9e cl9ical practice c be  
us$ to develop ext]nal control gr\ps =  
s+learm trials4 ,cl9ical trials us+     
ext]nal control cohorts c provide       
valuable b5*m>k results on pot5tial     
comp>ator treatm5t efficacy4  7#d7 ,!   
,food & ,drug ,adm9i/ration 79 ?is      
section ref]r$ to z ! ,,fda7 has        
di/ribut$ draft guidance on ?is issue   
comm5t+ on consid]ations = ! use (      
real-_w data = ! design & conduct (     
ext]nally controll$ trials4  7#e7 ,?r\gh
 collaboration ) community advocates &  
indu/ry p>tn]s ) input f ! ,,fda1       
rese>*]s focus$ on atypical t]atoid     
rhabdoid tumor 79 ?is section ref]r$ to 
z ,,atrt71 an ultra-r>e & poor prognosis
 p$iatric bra9 tumor1 h tak5 ! lead 9 ! 
design ( real-_w data sets4  7#f7       
,because ( ! advancem5ts 9 ! rese>*1    
,,atrt has pres5t$ itself z ! ideal     
c&idate to pilot ! developm5t ( real-_w 
data sets = use 9 ext]nal control       
cohorts4  #c4 ,p$iatric ,bra9 ,tumor    

,real-,_w ,data ,regi/ry ,program ,*apt]
 ,x ( ! ,f$]al ,food1 ,drug1 & ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cia et seq47 is   
am5d$ by add+ at ! end ! foll[+3  #ajae4
 ,p$iatric ,bra9 ,tumor ,real-,_w ,data 
,regi/ry ,program  7a7 ,9 g5]al ,!      
,secret>y %all c>ry out a program1 to be
 kn[n z ! ,p$iatric ,bra9 ,tumor        
,real-,_w ,data ,regi/ry ,program1 to   
/r5g!n & exp& activities relat$ to !    
collection1 %>+1 & use ( real-_w data = 
*ildr5 ) bra9 tumors4  7b7 ,requirem5ts 
,9 c>ry+ out ! program "u ?is section1 !
 ,secret>y %all-- 7#a7 develop & ma9ta9 
7or support ! developm5t & ma9t5ance (7 
a regi/ry ( real-_w data = *ildr5 )     
atypical t]atoid rhabdoid tumors2  7#b7 
consid] new & innovative approa*es &    
te*nology = data collection1            
integration1 & analysis2  7#c7 cont9ue &
 exp& activities1 :i* may include exi/+ 
data collection activities1 to e/abli%  
real-_w database infra/ructure2  7#d7   
provide support = data integration1     
bio9=matics1 & /ati/ical analyses2 &    

7#e7 id5tify pot5tial uses ( real-_w    
data regi/ries z ext]nal control cohorts
 = p$iatric bra9 tumor cl9ical trial    
design4  7c7 ,collaboration &           
consultation ,9 c>ry+ out ! program "u  
?is section1 ! ,secret>y %all           
collaborate & consult1 z appropriate1 ) 
public & private entities1 includ+      
relevant dep>tm5ts & ag5cies1 academic  
in/itutions1 & indu/ry4  7d7 ,grants1   
contracts1 & coop]ative agreem5ts  7#a7 
,aw>ds ,9 c>ry+ out ! program "u ?is    
section1 ! ,secret>y %all aw>d grants1  
contracts1 & coop]ative agreem5ts to    
academic in/itutions & o!r entities )   
relevant exp]tise 9 p$iatric            
neuro-oncology or ! collection1         
integration1 & analysis ( real-^w data4 
7#b7 ,application  7,a7 ,9 g5]al ,to    
seek an aw>d "u p>agraph 7#a71 an entity
 describ$ 9 su* p>agraph %all submit to 
! ,secret>y an application at su* "t1 9 
su* mann]1 & conta9+ su* in=mation z !  
,secret>y may require4  7,b7 ,cont5ts   
,an application "u subp>agraph 7,a7 %all

 include a description ( h[ ! applicant 
w p>tn]1 z applicable1 ) academic       
in/itutions or a consortium ( academic  
in/itutions t h relevant exp]tise1 su* z
 exp]tise 9 p$iatric neuro-oncology1    
cl9ical rese>*1 or ! application (      
bio9=matics or /ati/ics4  7e7           
,au?orization ( appropriations ,= c>ry+ 
out ?is section1 !re are au?oriz$ to be 
appropriat$ #b1jjj1jjj = fiscal ye>     
#bjbe4  4