,,ii  #aagth ,,congress  #b;d ,session  
,s4 #dcjb  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #be1      
#bjbb,mr4 ,kaine 7for himself1 ,mr4     
,marshall1 ,ms4 ,hassan1 and ,mr4       
,cassidy7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to require prompt reports
 of marketing status by holders of      
approved applications for biological    
products1 and for other purposes4  #a4  
,short title ,this ,act may be cited as 
the ,biologics ,market ,transparency    
,act of #bjbb 4  #b4 ,prompt reports of 
marketing status by holders of approved 
applications for biological products    
7a7 ,in general ,section #ejf;,i of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cef;i7 is amended--
 7#a7 in subsection 7a7-- 7,a7 by       
striking ,the holder of an application  
approved under subsection 7c7 or 7j7 of 

section #eje and inserting ,the holder  
of an application approved under        
subsection 7c7 or 7j7 of section #eje of
 this ,act or subsection 7a7 or 7k7 of  
section #cea of the ,public ,health     
,service ,act2  7,b7 in paragraph 7#b71 
by inserting 7or1 in the case of a      
biological product1 the proper name7    
after established name2 and  7,c7 in    
paragraph 7#c71 by striking or          
abbreviated application number and      
inserting 1 abbreviated application     
number1 or biologics license application
 number2 and  7#b7 in subsection 7b7--  
7,a7 in the matter preceding paragraph  
7#a71 by striking ,the holder of an     
application approved under subsection   
7c7 or 7j7 and inserting ,the holder of 
an application approved under subsection
 7c7 or 7j7 of section #eje of this ,act
 or subsection 7a7 or 7k7 of section    
#cea of the ,public ,health ,service    
,act2  7,b7 in paragraph 7#a71 by       
inserting 7or1 in the case of a         
biological product1 the proper name7    

after established name2 and  7,c7 in    
paragraph 7#b71 by striking or          
abbreviated application number and      
inserting 1 abbreviated application     
number1 or biologics license application
 number4  7b7 ,additional one-,time     
report ,subsection 7c7 of section       
#ejf;,i of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cef;i7 is amended to read as follows3  
7c7 ,additional one-,time report ,within
 #ahj days of the date of enactment of  
the ,biologics ,market ,transparency    
,act of #bjbb1 all holders of           
applications approved under subsection  
7a7 or 7k7 of section #cea of the       
,public ,health ,service ,act shall     
review the information in the list      
published under section #cea7k77#i77;,a7
 and shall submit a written notice to   
the ,secretary-- 7#a7 stating that all  
of the application holder's biological  
products in the list published under    
section #cea7k77#i77;,a7 that are not   
listed as discontinued are available for

 sale2 or  7#b7 including the           
information required pursuant to        
subsection 7a7 or 7b71 as applicable1   
for each of the application holder's    
biological products that are in the list
 published under section                
#cea7k77#i77;,a7 and not listed as      
discontinued1 but have been discontinued
 from sale or never have been available 
for sale4  4  7c7 ,purple ,book ,section
 #ejf;,i of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cef;i7 is amended-- 7#a7 in subsection 
7d7-- 7,a7 by striking or 7c71 the      
,secretary and inserting the following3 
8or 7c7--  7#a7 the ,secretary  2  7,b7 
by striking the period at the end and   
inserting 2 and2 and  7,c7 by adding at 
the end the following3  7#b7 the        
,secretary may identify the application 
holder's biological products as         
discontinued in the list published under
 section #cea7k77#i77;,a7 of the ,public
 ,health ,service ,act1 except that the 
,secretary shall remove from the list1  

in accordance with section              
#cea7k77#i77;,b7 of such ,act1 any      
biological product for which the license
 has been revoked or suspended for      
reasons of safety1 purity1 or potency4  
2 and  7#b7 in subsection 7e7-- 7,a7 by 
inserting after the first sentence the  
following3 ,the ,secretary shall update 
the list published under section        
#cea7k77#i77;,a7 of the ,public ,health 
,service ,act based on information      
provided under subsections 7a71 7b71 and
 7c7 by identifying as discontinued     
biological products that are not        
available for sale1 except that any     
biological product for which the license
 has been revoked or suspended for      
reasons of safety1 purity1 or potency   
shall be removed from the list in       
accordance with section #cea7k77#i77;,b7
 of the ,public ,health ,service ,act42 
and  7,b7 in the last sentence-- 7i7 by 
striking updates to the list and        
inserting updates to the lists published
 under section #eje7;j77#g77;,a7 of this

 ,act and section #cea7k77#i77;,a7 of   
the ,public ,health ,service ,act2 and  
7ii7 by striking update the list and    
inserting update such lists4