,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #egia  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #ag1 #bjbe,mr4
 ,wi$ 7= himself1 ,ms4 ,s*ri]1 & ,mr4   
,tiffany7 introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce  ,a ,,bill  ,to direct !       
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 to e/abli% an exp$it$ process = 
! approval ( c]ta9 biologics lic5se     
application supplem5ts = blood c5t]s1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,boo/+ ,lifesav+   
,op]ations1 ,op5+ ,donation ,c5t]s ,act 
or ! ,,blood ,c5t]s ,act4  #b4 ,exp$it$ 
process = approval ( c]ta9 ,,bla        
supplem5ts = blood c5t]s  7a7           
,e/abli%m5t ,n lat] ?an #ahj days aft] !
 date ( enactm5t ( ?is ,act1 !          
,secret>y1 act+ pursuant to section     
#cea7;a77#b7 ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7;a77#b771 %all 
e/abli% an exp$it$ process = ! approval 
( a supplem5tal application submitt$ by 

! own] or op]ator ( a blood c5t] seek+  
to add an aph]esis collection device to 
an exi/+ ,,bla lic5se at a location n   
previ\sly lic5s$ = su* a device4  7b7   
,deadl9e ,"u ! exp$it$ proc$ure1 !      
,secret>y %all approve a supplem5tal    
application describ$ 9 subsection 7a7 n 
lat] ?an #cj days aft] ! date (         
submission ( ! application unless !     
,secret>y makes a %[+ t !re is-- 7#a7 a 
specific conc]n = ! safety1 purity1 or  
pot5cy ( products produc$ at ! specific 
location subject to ! supplem5tal       
application2 or  7#b7 a sy/emic failure 
by ! own] or op]ator to meet /&>ds      
design$ to ensure ! cont9u$ safety1     
purity1 & pot5cy ( products produc$ at  
o!r locations "u a biologics lic5se4    
7c7 ,applicability ,! exp$it$ proc$ure  
%all apply ) respect to a supplem5tal   
application describ$ 9 subsection 7a7 if
 ! own] or op]ator t submits !          
application--  7#a7 holds a biologics   
lic5se = at lea/ "o blood c5t] site2 &  
7#b7 7,a7 has be5 approv$ = a biologics 

lic5se at #c or m ,food & ,drug         
,adm9i/ration regi/]$ locations "u !    
biologics lic5se ref]r$ to 9 p>agraph   
7#a72 or  7,b7 is accr$it$ & 9 good /&+ 
= blood collection by an accr$itation   
organization ) /&>ds t meet or exce$1 z 
det]m9$ by ! ,secret>y1 all applicable  
regulatory requirem5ts = blood          
collections4  7d7 ,def9itions ,9 ?is    
section3  7#a7 ,,bla ,! t]m ,,bla means 
a biologics lic5se application4  7#b7   
,blood c5t] ,! t]m blood c5t] means a   
human blood donation c5t]4  7#c7        
,exp$it$ proc$ure ,! t]m exp$it$        
proc$ure means ! exp$it$ proc$ure to be 
e/abli%$ "u subsection 7a74  7#d7       
,secret>y ,! t]m ,secret>y means !      
,secret>y ( ,heal? & ,human ,s]vices    
act+ ?r\gh ! ,commission] ( ,food &     
,drugs4