,i  #aad? ,,congress  #b;d ,session  ,h4
 ,r4 #dgfb  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #af1 #bjaf ,mr4  
,c(fman 7= himself1 ,mr4 ,takai1 & ,mr4 
,griffi?7 introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act ) respect
 to cellul> !rapies4  #a4 ,%ort title   
,?is ,act may be cit$ z ! ,reliable &   
,effective ,gr[? = ,reg5]ative ,heal?   
,options t ,improve ,wellness or !      
,,regr[ ,act4  #b4 ,cellul> !rapeutics  
7a7 ,curr5t pa?ways ,no?+ 9 ?is ,act1 or
 ! am5dm5ts made by ?is ,act1 %all be   
appli$ or int]pret$ z re/rict+ or       
o!rwise modify+ any pa?way to m>ket :i* 
is 7z ( ! day imm$iately be=e ! date (  
enactm5t ( ?is ,act7 provid$ "u         
regulations promulgat$ by ! ,food &     
,drug ,adm9i/ration1 includ+ pa?ways "u 
sections #cea & #cfa ( ! ,public ,heal? 
,s]vice ,act 7#db ,u4,s4,c4 #bfb &      
#bfd74  7b7 ,approval = !rapies ,subp>t 
#a ( "p ,f ( title ,,iii ( ! ,public    

,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb 
et seq47 is am5d$ by add+ aft] section  
#cea;,a ! foll[+3  #cea;,b4 ,approval = 
cellul> !rapies  7a7 ,conditional       
approval ( cellul> or tissue !rapeutic  
,n lat] ?an #a ye> aft] ! date (        
enactm5t ( ?is section1 ! ,secret>y %all
 e/abli% a program to conditionally     
approve a cellul> !rapeutic product if !
 sponsor ( su* product demon/rates      
prelim9>y cl9ical evid5ce ( safety1 & a 
reasonable expectation ( effectiv5ess1  
)\t initiation ( phase ,,iii            
inve/igations4  7b7 ,additional         
requirem5ts = conditional approval ,a   
conditionally approv$ product "u        
subsection 7a7 %all1 = a #e-ye>         
conditional use p]iod1 be manufactur$1  
introduc$ into int]/ate comm]ce1 & us$  
consi/5t ) ! regulations 9 effect at !  
"t ( su* use1 includ+ good manufactur+  
practices1 )\t ! approval ( an          
application "u section #cea7;a71 if all 
( ! foll[+ apply3  7#a7 ,su* cells or   
tissues are adult human cells or        

tissues4  7#b7 ,su* cells or tissues h  
be5 evaluat$ to exam9e immunog5icity & d
 n provoke a significant un9t5d$ immune 
response 9 ! recipi5t4  7#c7 ,su* cells 
or tissues are-- 7,a7 m9imally          
manipulat$ = a nonhomolog\s use2 or     
7,b7 m-?an-m9imally manipulat$ = a      
homolog\s or nonhomolog\s use1 b are n  
g5etically modifi$4  7#d7 ,su* cells or 
tissues are produc$ = a specific        
indication4  7#e7 ,su* cells or tissues 
are produc$ exclusively = a use t p]=ms1
 or helps a*ieve or re/ore1 ! same1 or  
simil>1 function 9 ! recipi5t z 9 !     
donor4  7#f7 ,)9 #e ye>s ( ! safety &   
effectiv5ess det]m9ation describ$ 9 ?is 
section1 ! sponsor ( ! conditionally    
approv$ new product prep>es & submits an
 application = approval ( a biological  
product "u section #cea7;a71 demon/rat+ 
pot5cy1 purity1 safety1 & efficacy ( !  
use4 ,! ,secret>y may p]mit cont9u$ use 
( su* product until ! ,secret>y         
completes ! review ( ! application &    
makes a det]m9ation4 ,^u a det]m9ation  

by ! ,secret>y n to approve !           
application1 use ( ! cellul> !rapeutic  
%all n be p]mitt$4  7#g7 ,dur+ !        
conditional approval p]iod1 & be=e      
approval ( an application "u section    
#cea7;a71 ! sponsor %all prep>e & submit
 annual reports & adv]se ev5t reports to
 ! ,secret>y conta9+ all ! in=mation    
requir$ = approv$ biological products4  
7#h7 ,! sponsor has submitt$ an         
application "u section #eje7;i7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act = 
! treatm5t ( ! pati5ts dur+ ! #e-ye>    
conditional use p]iod4  7#i7 ,! sponsor 
has n previ\sly receiv$ conditional     
approval = su* product = ! same         
indication4  7c7 ,in=m$ use ,!          
individual adm9i/]+ a product approv$ "u
 subsection 7b7 %all in=m ea* individual
 :o uses su* product t ! product has be5
 conditionally approv$ bas$ on /udies 9 
a limit$ population1 )\t pro( (         
efficacy1 & t ! ,secret>y is requir+    
additional /udies ( ! product4  7d7 ,/em
 cell bank+ ,to be eligible to provide  

cells = ! uses describ$ "u subsection   
7b71 public & private cord blood banks1 
tissue banks1 & bone m>r[ repositories  
%all be 9 full compliance ) good tissue 
practice requirem5ts "u "p #abga ( title
 #ba1 ,code ( ,f$]al ,regulations 7or   
successor regulations71 z applicable4  4
  #c4 ,devices us$ 9 recov]y1 process+1 
& deliv]y ( cellul> !rapeutics  7a7     
,cle>ance ,section #eaj7k7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj7k77 is am5d$-- 7#a7 9    
p>agraph 7#a71 by /rik+ 1 & & ins]t+ 22 
7#b7 9 p>agraph 7#b71 by /rik+ ! p]iod &
 ins]t+ 2 &2 &  7#c7 by ins]t+ aft]     
p>agraph 7#b7 ! foll[+3  7#c7 9 ! case (
 a cellul> !rapeutic describ$ 9 section 
#cea;,b7a7 ( ! ,public ,heal? ,s]vice   
,act1 ! g5]al function ( ! device us$ = 
! recov]y1 isolation1 process+1 or      
deliv]y ( su* cellul> !rapeutic4  4  7b7
 ,cle>ance or approval ( cellul>        
!rapeutics ,*apt] ,v ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cea et seq47 is am5d$ by ins]t+ aft]   

section #eae;,a ! foll[+3  #eae;,b4     
,classification ( cellul> !rapeutics    
,cle>ance or approval ( a device t is a 
cellul> !rapeutic describ$ 9 section    
#cea;,b7a7 ( ! ,public ,heal? ,s]vice   
,act %all be bas$ on 9 vitro p]=mance   
te/+ & n 9 vivo human cl9ical trials1 z 
appropriate4 ,! ,secret>y %all classify 
devices 9 accordance ) section #eac us$ 
= cell !rapy 7z describ$ 9 section      
#cea;,b7a7 ( ! ,public ,heal? ,s]vice   
,act71 focus+ on ! g5]al use ( su*      
devices = h>ve/+1 deliv]y1 or process+  
cells & su/a9+ ! viability & functions (
 ! cells 9 vivo4 ,! classification      
regulation %all n require t su* devices 
be cle>$ "u section #eaj7k7 or approv$  
"u section #eae = use ) only specific   
types ( cells or = specific uses unless 
unique to ! int5d$ use ( ! device4 ,if !
 ,secret>y det]m9es t no pr$icate exi/s1
 or t a device classifi$ z class ,,iii  
is suffici5tly l[ risk to ju/ify a l[]  
classification1 ! ,secret>y %all apply !
 proc$ure outl9$ 9 section #eac7;f77#b7 

to p]mit ! review & m>ket+ ( ! device4  
4  7c7 ,comb9ation products ,section    
#ejc7;g77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cec7;g77#a77 is am5d$-- 7#a7 9         
subp>agraph 7,b71 by /rik+ or2  7#b7 9  
subp>agraph 7,c71 by /rik+ ! p]iod &    
ins]t+ 1 or2 &  7#c7 by add+ at ! end ! 
foll[+3  7,d7 cellul> compon5ts1 ! ag5cy
 c5t] *>g$ ) prem>ket review (          
biological products %all h prim>y       
jurisdiction4  4  #d4 ,guidance2 am5d$  
regulations  7a7 ,guidance ,)9 #a ye> ( 
! date ( enactm5t ( ?is ,act1 !         
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y7 
may issue draft guidance on cl>ify+ !   
requirem5ts ) respect to cellul>        
!rapeutics1 z set =? 9 section #cea;,b (
 ! ,public ,heal? ,s]vice ,act1 z add$  
by section #b1 & devices us$ 9 process+ 
or deliv]y ( cellul> !rapeutics1 z set  
=? 9 section #eaj7k77#c7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj7k77#c77 & section #eae;,b

 ( su* ,act1 z add$ by section #c7;b74  
,! ,secret>y %all issue f9al guidance n 
lat] ?an #ahj days aft] ! close ( !     
comm5t p]iod 7includ+ any ext5sions (   
su* p]iod7 = ! draft guidance4 ,su*     
comm5t p]iod may n exce$ #fj days4  7b7 
,am5d$ regulations  7#a7 ,9 g5]al ,if ! 
,secret>y det]m9es t x is appropriate to
 am5d ! regulations "u title #ba1 ,code 
( ,f$]al ,regulations1 9 ord] to cl>ify 
! requirem5ts ( section #cea;,b ( !     
,public ,heal? ,s]vice ,act1 z add$ by  
section #b1 ! ,secret>y %all am5d su*   
regulations n lat] ?an #a ye> aft] !    
date ( enactm5t ( ?is ,act4  7#b7       
,proc$ure ,9 am5d+ regulations "u       
p>agraph 7#a71 ! ,secret>y %all-- 7,a7  
issue a notice ( propos$ rulemak+ t     
includes ! propos$ regulations2  7,b7   
provide a p]iod ( n m ?an #fj days =    
comm5ts on ! propos$ regulations2 &     
7,c7 publi% ! f9al regulations n less   
?an #cj days be=e ! effective date ( su*
 regulations4  7c7 ,public meet+ ,9     
c>ry+ out ?is ,act1 includ+ ! am5dm5t   

made by section #b & ! am5dm5ts made by 
section #c1 ! ,secret>y1 n lat] ?an #ij 
days aft] ! date ( enactm5t ( ?is ,act1 
%all h n less ?an #a public meet+ on !  
relevant regulatory policies relat+ to  
cell & tissue products1 includ+ any     
*anges to su* policies necess>y to      
enc\rage innovation & regulatory c]ta9ty
 ) reg>d to ! developm5t ( reg5]ative   
m$ic9e products4  #e4 ,reg5]ative m$ic9e
 /&>ds ,! ,secret>y %all "w )           
/akehold]s1 includ+ reg5]ative product  
manufactur]s1 academic in/itutions1     
/&>ds sett+ organizations1 & ! ,national
 ,in/itute ( ,/&>ds & ,te*nology1 to    
promote & facilitate an ef=t to develop1
 ?r\gh a transp>5t public process1 /&>ds
 t w facilitate regulatory pr$ictability
 reg>d+ manufactur+ processes & controls
 = reg5]ative m$ic9e products4