,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #fgje  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #aa1         
#bjbc,mr4 ,mool5a> 7= himself1 ,mrs4    
,d+ell1 & ,mr4 ,correa7 introduc$ !     
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to require ! ,secret>y ( ,heal?
 & ,human ,s]vices to treat c]ta9 te/s =
 tub]culosis z break?r\gh devices       
eligible = exp$it$ developm5t & priority
 review1 to require c]ta9 e/abli%m5ts t 
p]=m donor scre5+ or te/+ to scre5 or   
te/ = active & lat5t tub]culosis1 & =   
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,effective ,scre5+ &   
,te/+ = ,tub]culosis ,act4  #b4         
,treatm5t ( c]ta9 te/s = tub]culosis z  
break?r\gh devices ,! ,secret>y ( ,heal?
 & ,human ,s]vices %all treat a device z
 a break?r\gh device eligible = exp$it$ 
developm5t & priority review "u section 
#eae;,b ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c7
 if x is a new & innovative donor scre5+

 te/ ) height5$ s5sitivity to           
effectively scre5 human cell1 tissue1 & 
cellul> & tissue-bas$ product donors =  
evid5ce ( active or lat5t tub]culosis   
infection4  #c4 ,requir+ c]ta9          
e/abli%m5ts t p]=m donor scre5+ or te/+ 
to scre5 or te/ = active & lat5t        
tub]culosis  7a7 ,9 g5]al ,! ,secret>y (
 ,heal? & ,human ,s]vices1 act+ ?r\gh ! 
,commission] ( ,food & ,drugs1 %all     
promulgate regulations revis+ "p #abga (
 title #ba1 ,code ( ,f$]al ,regulations1
 includ+ sections #abga4ge & #abga4he1 &
 any o!r applicable regulations1 to     
require-- 7#a7 an e/abli%m5t t p]=ms    
donor scre5+ to scre5 = active & lat5t  
tub]culosis2 &  7#b7 an e/abli%m5t t    
p]=ms donor te/+ to te/ = active & lat5t
 tub]culosis4  7b7 ,regulations ,!      
,secret>y ( ,heal? & ,human ,s]vices    
%all-- 7#a7 n lat] ?an #a ye> aft] !    
date ( enactm5t ( ?is ,act1 propose !   
regulations requir$ by subsection 7a72  
7#b7 n lat] ?an #c mon?s aft] ! close ( 
! comm5t p]iod = su* propos$            

regulations1 promulgate su* regulations 
z f9al2 &  7#c7 n lat] ?an #f mon?s aft]
 ! date su* regulations are promulgat$ z
 f9al1 beg9 implem5tation ( su*         
regulations4  7c7 ,def9itions ,9 ?is    
section1 ! t]ms e/abli%m5t t p]=ms donor
 scre5+ & e/abli%m5t t p]=ms donor te/+ 
h ! mean+s giv5 to su* t]ms "u "p #abga 
( title #ba1 ,code ( ,f$]al             
,regulations4  #d4 ,guidance on curr5t  
good tissue practice & additional       
requirem5ts = manufactur]s ( human      
cells1 tissues1 & cellul> & tissue-bas$ 
products ,n lat] ?an #f mon?s aft] !    
date ( enactm5t ( ?is ,act1 ! ,secret>y 
( ,heal? & ,human ,s]vices1 act+ ?r\gh !
 ,commission] ( ,food & ,drugs1 & 9     
coord9ation ) ! ,director ( ! ,c5t]s =  
,disease ,control & ,prev5tion1 %all--  
7#a7 review ! guidance titl$ ,guidance =
 ,indu/ry--,curr5t ,good ,tissue        
,practice 7,,cgtp7 & ,additional        
,requirem5ts = ,manufactur]s ( ,human   
,cells1 ,tissues1 & ,cellul> &          
,tissue-,bas$ ,products 7,,hct_/,ps7    

7,decemb] #bjaa72 &  7#b7 issue an      
updat$ v]sion ( su* guidance4  #e4      
,compliance ) ,,cutgo ,no additional    
funds are au?oriz$ to be appropriat$ to 
c>ry out ?is ,act1 & ?is ,act %all be   
c>ri$ out us+ am\nts o!rwise available =
 su* purpose4