,i  #aadth ,,congress  #b;d ,session    
,h4 ,r4 #dffi  ,,in ,,the ,,house ,,of  
,,representatives  ,march #b1 #bjaf ,mr4
 ,foster introduced the following bill2 
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
support the establishment of a          
,standards ,coordinating ,body in       
,regenerative ,medicine and ,advanced   
,therapies4  #a4 ,short title ,this ,act
 may be cited as the ,advancing         
,standards in ,regenerative ,medicine   
,act4  #b4 ,support for the             
establishment of a standards            
coordinating body in regenerative       
medicine and advanced therapies         
,subchapter ,a of chapter ,v of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cea et seq47 is    
amended by inserting after section      
#ejf;,f the following3  #ejf;,g4        
,coordinating body in regenerative      
medicine and advanced therapies  7a7 ,in
 general ,the ,secretary1 in            
consultation with stakeholders1         

including regenerative medicine product 
manufacturers and clinical trial        
sponsors1 contract manufacturers1       
academic institutions1 standard setting 
organizations1 the ,national ,institute 
of ,standards and ,technology1 and other
 relevant ,federal agencies1 as         
appropriate1 shall facilitate           
establishment of a public-private       
,standards ,coordinating ,body in       
,regenerative ,medicine and ,advanced   
,therapies4  7b7 ,function of standards 
coordinating body ,upon establishment of
 the ,standards ,coordinating ,body in  
,regenerative ,medicine and ,advanced   
,therapies under subsection 7a71 the    
,secretary shall--  7#a7 identify       
opportunities for the development of    
laboratory regulatory science research  
and documentary standards that the      
,secretary determines would support the 
development1 evaluation1 and review of  
regenerative medicine products2 and     
7#b7 work with such ,standards          
,coordinating ,body1 as appropriate1 in 

the development of standards described  
in paragraph 7#a74  7c7 ,guidance ,the  
,secretary shall issue guidance1 as     
appropriate1 on how standards may be    
used in regulatory review for           
regenerative medicine and advanced      
therapies4  7d7 ,definition ,for        
purposes of this section1 the term      
regenerative medicine and advanced      
therapies includes cell therapy1 gene   
therapy1 gene-modified cell therapy1    
therapeutic tissue engineering products1
 and human cell and tissue products1 and
 combination products using any such    
therapies or products4  7e7 ,no         
additional funds ,the ,secretary shall  
carry out this section using funds      
otherwise made available to the ,food   
and ,drug ,administration4 ,no          
additional funds are authorized to be   
appropriated to carry out this section4 
4