,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #gjce  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #i1 #bjbb,ms4    
,mann+ 7= h]self & ,mr4 ,hudson7        
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,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#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 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#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$1 b h be5 )drawn f  
sale or nev] h be5 available = sale4  4 
7c7 ,purple ,book ,subsections 7d7 & 7e7
 ( section #ejf;,i ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;i7 are ea* am5d$-- 7#a7 by /rik+ ! 
li/ publi%$ "u subsection               
#eje7;j77#g77;,a7 & ins]t+ ! li/ publi%$
 "u section #eje7;j77#g77;,a7 ( ?is ,act
 or section #cea7k77#i77;,a7 ( ! ,public
 ,heal? ,s]vice ,act1 z applicable12 &  
7#b7 by /rik+ 9 accordance ) subsection 
#eje7;j77#g77;,c7 & ins]t+ 9 accordance 

) section #eje7;j77#g77;,c7 ( ?is ,act  
or section #cea7k77#i77;,b7 ( ! ,public 
,heal? ,s]vice ,act 7z applicable74