,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #cdj  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,janu>y #ac1 #bjbe,mr4
 ,cr5%aw 7= himself & ,ms4 ,b>ragn7     
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to direct ! ,secret>y ( ,heal? 
& ,human ,s]vices c>ry out activities to
 /reaml9e regulatory ov]sight ( human   
cell & tissue products1 & = o!r         
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,! ,,hct_/,p ,mod]nization 
,act ( #bjbe4  #b4 ,def9itions ,9 ?is   
,act3 7#a7 ,human cell & tissue product 
,! t]ms human cell & tissue product &   
human cell & tissue products h ! mean+  
giv5 ! t]m human cells1 tissues1 or     
cellul> or tissue-bas$ products 9       
section #abga4c7;d7 ( title #ba1 ,code (
 ,f$]al ,regulations 7or successor      
regulations74  7#b7 ,secret>y ,! t]m    
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices4  7#c7 ,tissue ,ref]5ce 
,gr\p ,! t]m ,tissue ,ref]5ce ,gr\p     
means ! ,tissue ,ref]5ce ,gr\p ( ! ,food

 & ,drug ,adm9i/ration4  #c4 ,/reaml9+  
regulatory ov]sight ( human cell &      
tissue products  7a7 ,in=mation on human
 cell & tissue products  7#a7 ,website  
,! ,secret>y1 act+ ?r\gh ! ,commission] 
( ,food & ,drugs1 %all publi% on !      
public website ( ! ,food & ,drug        
,adm9i/ration-- 7,a7 educational        
mat]ials ab\t ! ,tissue ,ref]5ce ,gr\p2 
&  7,b7 be/ practices = obta9+ a timely1
 accurate recomm5dation reg>d+ human    
cell & tissue products f ! ,tissue      
,ref]5ce ,gr\p4  7#b7 ,public in=mation 
,n lat] ?an #a ye> aft] ! date ( !      
enactm5t ( ?is ,act1 & annually = !     
subsequ5t #c ye>s1 ! ,secret>y1 act+    
?r\gh ! ,commission] ( ,food & ,drugs1  
%all publi% on ! public website ( !     
,food & ,drug ,adm9i/ration-- 7,a7 !    
numb] ( human cell & tissue e/abli%m5ts 
t regi/]$ ) ! ,food & ,drug             
,adm9i/ration on or aft] ,janu>y #a1    
#bjai2  7,b7 ! numb] ( inspections      
conduct$ by ! ,food & ,drug             
,adm9i/ration ( human cell & tissue     

e/abli%m5ts on or aft] ,janu>y #a1      
#bjai1 includ+ a comp>ison ( ! numb] (  
inspections = blood e/abli%m5ts ) !     
numb] ( inspections = su* human cell &  
tissue e/abli%m5ts2  7,c7 ! numb] & type
 ( inquiries to ! ,tissue ,ref]5ce ,gr\p
 9 ! prec$+ ye>2 &  7,d7 ! av]age       
response "t = submissions to ! ,tissue  
,ref]5ce ,gr\p 9 ! prec$+ ye>1 includ+  
av]age initial & f9al response "t4  7#c7
 ,education ,! ,secret>y1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all1 )  
respect to ! regulation ( human cell &  
tissue products-- 7,a7 provide in=mation
 to relevant /akehold]s1 includ+        
indu/ry1 tissue e/abli%m5ts1 academic   
heal? c5t]s1 biom$ical consortia1 rese>*
 organizations1 & pati5ts2 &  7,b7      
conduct work%ops & o!r int]active &     
educational sessions = su* /akehold]s to
 help support regulatory pr$ictability &
 sci5tific advancem5t1 z appropriate4   
7b7 ,human cell & tissue product        
sci5tific & regulatory updates ,section 
#cbje ( ! ,food & ,drug ,omnibus ,re=m  

,act ( #bjbb 7title ,,iii ( division    
,,ff ( ,public ,law #aag-cbh7 is am5d$  
by /rik+ be/ practices & all t foll[s   
?r\gh o!r cellul> !rapies & ins]t+ be/  
practices on g5]at+ sci5tific data      
necess>y to fur!r facilitate !          
developm5t ( c]ta9 human cell-1 tissue-1
 & cellul>-bas$ m$ical products 7& !    
late/ sci5tific in=mation ab\t su*      
products71 namely1 /em cell & o!r       
cellul> !rapies4  7c7 ,public docket ,n 
lat] ?an #fj days aft] ! date ( !       
enactm5t ( ?is ,act1 ! ,secret>y %all   
e/abli% a public docket to receive      
writt5 comm5ts relat$ to-- 7#a7 !       
approa*es recomm5d$ = discussion dur+ ! 
public work%op describ$ 9 section #cbje 
( ! ,food & ,drug ,omnibus ,re=m ,act ( 
#bjbb 7title ,,iii ( division ,,ff (    
,public ,law #aag-cbh72 &  7#b7 mod]niz+
 ! regulation ( human cell & tissue     
products1 includ+ consid]ations         
associat$ ) assess+ m9imal manipulation 
& homolog\s use 7z su* t]ms are def9$ 9 
section #abga4c ( title #ba1 ,code (    

,f$]al ,regulations 7or successor       
regulations77 ( human cell & tissue     
products4  7d7 ,report to ,congress ,n  
lat] ?an ,septemb] #cj1 #bjbf1 !        
,secret>y %all summ>ize ! approa*es     
discuss$ 9 ! public work%op describ$ 9  
section #cbje ( ! ,food & ,drug ,omnibus
 ,re=m ,act ( #bjbb 7title ,,iii (      
division ,,ff ( ,public ,law #aag-cbh7 &
 ! public docket describ$ 9 subsection  
7c71 & develop recomm5dations reg>d+ !  
regulation ( human cell & tissue        
products1 includ+ provisions "u sections
 #abga4aj7;a7 & #abga4c ( title #ba1    
,code ( ,f$]al ,regulations1 tak+ into  
acc\nt-- 7#a7 regulatory burd52  7#b7   
sci5tific developm5ts2  7#c7 access to  
human cell & tissue products regulat$ "u
 section #cfa ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bfd72 &  7#d7     
protect+ public heal?4