,,ii  #aag? ,,congress  #b;d ,session   
,s4 #dcjb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #be1 #bjbb,mr4    
,ka9e 7= himself1 ,mr4 ,m>%all1 ,ms4    
,hassan1 & ,mr4 ,cassidy7 introduc$ !   
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
to require prompt reports ( m>ket+ /atus
 by hold]s ( approv$ applications =     
biological products1 & = o!r purposes4  
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,biologics ,m>ket ,transp>5cy ,act (  
#bjbb 4  #b4 ,prompt reports ( m>ket+   
/atus by hold]s ( approv$ applications =
 biological products  7a7 ,9 g5]al      
,section #ejf;,i ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;i7 is am5d$-- 7#a7 9 subsection    
7a7-- 7,a7 by /rik+ ,! hold] ( an       
application approv$ "u subsection 7c7 or
 7j7 ( section #eje & ins]t+ ,! hold] ( 
an application approv$ "u subsection 7c7
 or 7j7 ( section #eje ( ?is ,act or    

subsection 7a7 or 7k7 ( section #cea ( !
 ,public ,heal? ,s]vice ,act2  7,b7 9   
p>agraph 7#b71 by ins]t+ 7or1 9 ! case (
 a biological product1 ! prop] "n7 aft] 
e/abli%$ "n2 &  7,c7 9 p>agraph 7#c71 by
 /rik+ or abbreviat$ application numb] &
 ins]t+ 1 abbreviat$ application numb]1 
or biologics lic5se application numb]2 &
  7#b7 9 subsection 7b7-- 7,a7 9 ! matt]
 prec$+ p>agraph 7#a71 by /rik+ ,! hold]
 ( an application approv$ "u subsection 
7c7 or 7j7 & ins]t+ ,! hold] ( an       
application approv$ "u subsection 7c7 or
 7j7 ( section #eje ( ?is ,act or       
subsection 7a7 or 7k7 ( section #cea ( !
 ,public ,heal? ,s]vice ,act2  7,b7 9   
p>agraph 7#a71 by ins]t+ 7or1 9 ! case (
 a biological product1 ! prop] "n7 aft] 
e/abli%$ "n2 &  7,c7 9 p>agraph 7#b71 by
 /rik+ or abbreviat$ application numb] &
 ins]t+ 1 abbreviat$ application numb]1 
or biologics lic5se application numb]4  
7b7 ,additional "o-,"t report           
,subsection 7c7 ( section #ejf;,i ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   

7#ba ,u4,s4,c4 #cef;i7 is am5d$ to read 
z foll[s3  7c7 ,additional "o-,"t report
 ,)9 #ahj days ( ! date ( enactm5t ( !  
,biologics ,m>ket ,transp>5cy ,act (    
#bjbb1 all hold]s ( applications approv$
 "u subsection 7a7 or 7k7 ( section #cea
 ( ! ,public ,heal? ,s]vice ,act %all   
review ! in=mation 9 ! li/ publi%$ "u   
section #cea7k77#i77;,a7 & %all submit a
 writt5 notice to ! ,secret>y-- 7#a7    
/at+ t all ( ! application hold]'s      
biological products 9 ! li/ publi%$ "u  
section #cea7k77#i77;,a7 t are n li/$ z 
discont9u$ are available = sale2 or     
7#b7 includ+ ! in=mation requir$        
pursuant to subsection 7a7 or 7b71 z    
applicable1 = ea* ( ! application       
hold]'s biological products t are 9 !   
li/ publi%$ "u section #cea7k77#i77;,a7 
& n li/$ z discont9u$1 b h be5          
discont9u$ f sale or nev] h be5         
available = sale4  4  7c7 ,purple ,book 
,section #ejf;,i ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;i7 is am5d$-- 7#a7 9 subsection    

7d7-- 7,a7 by /rik+ or 7c71 ! ,secret>y 
& ins]t+ ! foll[+3 8or 7c7--  7#a7 !    
,secret>y  2  7,b7 by /rik+ ! p]iod at !
 end & ins]t+ 2 &2 &  7,c7 by add+ at ! 
end ! foll[+3  7#b7 ! ,secret>y may     
id5tify ! application hold]'s biological
 products z discont9u$ 9 ! li/ publi%$  
"u section #cea7k77#i77;,a7 ( ! ,public 
,heal? ,s]vice ,act1 except t !         
,secret>y %all remove f ! li/1 9        
accordance ) section #cea7k77#i77;,b7 ( 
su* ,act1 any biological product = :i* !
 lic5se has be5 revok$ or susp5d$ =     
reasons ( safety1 purity1 or pot5cy4  2 
&  7#b7 9 subsection 7e7-- 7,a7 by      
ins]t+ aft] ! fir/ s5t5ce ! foll[+3 ,!  
,secret>y %all update ! li/ publi%$ "u  
section #cea7k77#i77;,a7 ( ! ,public    
,heal? ,s]vice ,act bas$ on in=mation   
provid$ "u subsections 7a71 7b71 & 7c7  
by id5tify+ z discont9u$ biological     
products t are n available = sale1      
except t any biological product = :i* ! 
lic5se has be5 revok$ or susp5d$ =      
reasons ( safety1 purity1 or pot5cy %all

 be remov$ f ! li/ 9 accordance )       
section #cea7k77#i77;,b7 ( ! ,public    
,heal? ,s]vice ,act42 &  7,b7 9 ! la/   
s5t5ce-- 7i7 by /rik+ updates to ! li/ &
 ins]t+ updates to ! li/s publi%$ "u    
section #eje7;j77#g77;,a7 ( ?is ,act &  
section #cea7k77#i77;,a7 ( ! ,public    
,heal? ,s]vice ,act2 &  7ii7 by /rik+   
update ! li/ & ins]t+ update su* li/s4