,,ii  #aaith ,,congress  #ast ,session  
,s4 #caje  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,november #e1  
#bjbe,mr4 ,lee 7for himself and ,mr4    
,budd7 introduced the following bill2   
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
regulate human cadaveric islets for     
transplantation as organs4  #a4 ,short  
title ,this ,act may be cited as the    
,increase ,support for ,life-saving     
,endocrine ,transplantation ,act or the 
,,islet ,act4  #b4 ,regulation of human 
cadaveric islet transplants  7a7 ,in    
general ,section #cgd7;d77#b7 of the    
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bgd;b7d77#b77 is amended by  
striking pancreas1 and inserting and    
pancreas1 human cadaveric islets14  7b7 
,clarification ,notwithstanding any     
other provision of law1 none of the     
following terms includes human cadaveric
 islets3 7#a7 ,the term drug1 as defined
 in section #bja7;g7 of the ,federal    

,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cba7;g774  7#b7 ,the term    
biological product1 as defined in       
section #cea7;i7 of the ,public ,health 
,service ,act 7#db ,u4,s4,c4 #bfb7;i774 
7#c7 ,the term human cells1 tissues1 or 
cellular or tissue-based products       
7,,hct_/,ps71 as defined in section     
#abga4c of title #ba1 ,code of ,federal 
,regulations 7or any successor          
regulations74  7c7 ,regulations  7#a7   
,in general ,not later than #a year     
after the date of enactment of this     
,act1 the ,secretary of ,health and     
,human ,services 7referred to in this   
section as the ,secretary7 shall update 
regulations promulgated under parts ,f1 
,g1 and ,h of title ,,iii of the ,public
 ,health ,service ,act 7#db ,u4,s4,c4   
#bfb et seq41 #bfd et seq41 #bgc et     
seq47 and the ,federal ,food1 ,drug1 and
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et  
seq471 and such other regulations as the
 ,secretary determines appropriate1 to  
carry out the amendment made by         

subsection 7a74  7#b7 ,report ,not later
 than #f months after the date of       
enactment of this ,act1 the ,secretary  
shall report to ,congress on the        
progress made in updating regulations as
 required under paragraph 7#a74