,i  #aad? ,,congress  #b;d ,session  ,h4
 ,r4 #dffi  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #b1 #bjaf ,mr4   
,fo/] introduc$ ! foll[+ bill2 :i* 0    
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to support !      
e/abli%m5t ( a ,/&>ds ,coord9at+ ,body 9
 ,reg5]ative ,m$ic9e & ,advanc$         
,!rapies4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,advanc+ ,/&>ds 9          
,reg5]ative ,m$ic9e ,act4  #b4 ,support 
= ! e/abli%m5t ( a /&>ds coord9at+ body 
9 reg5]ative m$ic9e & advanc$ !rapies   
,sub*apt] ,a ( *apt] ,v ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cea et seq47 is am5d$ by     
ins]t+ aft] section #ejf;,f ! foll[+3   
#ejf;,g4 ,coord9at+ body 9 reg5]ative   
m$ic9e & advanc$ !rapies  7a7 ,9 g5]al  
,! ,secret>y1 9 consultation )          
/akehold]s1 includ+ reg5]ative m$ic9e   
product manufactur]s & cl9ical trial    
sponsors1 contract manufactur]s1        
academic in/itutions1 /&>d sett+        
organizations1 ! ,national ,in/itute (  

,/&>ds & ,te*nology1 & o!r relevant     
,f$]al ag5cies1 z appropriate1 %all     
facilitate e/abli%m5t ( a public-private
 ,/&>ds ,coord9at+ ,body 9 ,reg5]ative  
,m$ic9e & ,advanc$ ,!rapies4  7b7       
,function ( /&>ds coord9at+ body ,^u    
e/abli%m5t ( ! ,/&>ds ,coord9at+ ,body 9
 ,reg5]ative ,m$ic9e & ,advanc$ ,!rapies
 "u subsection 7a71 ! ,secret>y %all--  
7#a7 id5tify opportunities = !          
developm5t ( laboratory regulatory      
sci5ce rese>* & docum5t>y /&>ds t !     
,secret>y det]m9es w\ld support !       
developm5t1 evaluation1 & review (      
reg5]ative m$ic9e products2 &  7#b7 "w )
 su* ,/&>ds ,coord9at+ ,body1 z         
appropriate1 9 ! developm5t ( /&>ds     
describ$ 9 p>agraph 7#a74  7c7 ,guidance
 ,! ,secret>y %all issue guidance1 z    
appropriate1 on h[ /&>ds may be us$ 9   
regulatory review = reg5]ative m$ic9e & 
advanc$ !rapies4  7d7 ,def9ition ,=     
purposes ( ?is section1 ! t]m reg5]ative
 m$ic9e & advanc$ !rapies includes cell 
!rapy1 g5e !rapy1 g5e-modifi$ cell      

!rapy1 !rapeutic tissue eng9e]+         
products1 & human cell & tissue         
products1 & comb9ation products us+ any 
su* !rapies or products4  7e7 ,no       
additional funds ,! ,secret>y %all c>ry 
out ?is section us+ funds o!rwise made  
available to ! ,food & ,drug            
,adm9i/ration4 ,no additional funds are 
au?oriz$ to be appropriat$ to c>ry out  
?is section4  4