,in the ,senate of the ,united ,states1 
,december #aj1 #bjbj4  ,amendment3      
,that the bill from the ,house of       
,representatives 7,h4,r4 #aebj7 entitled
 ,an ,act to amend the ,public ,health  
,service ,act to provide for the        
publication of a list of licensed       
biological products1 and for other      
purposes41 do pass with the following   
,strike all after the enacting clause   
and insert the following3 #a4 ,short    
title ,the ,act may be cited as the     
,purple ,book ,continuity ,act of #bjbj4
  #b4 ,biological product patent        
transparency  7a7 ,in general ,section  
#cea7k7 of the ,public ,health ,service 
,act 7#db ,u4,s4,c4 #bfb7k77 is amended 
by adding at the end the following3     
7#i7 ,public listing  7,a7 ,in general  
7i7 ,initial publication ,not later than
 #ahj days after the date of enactment  
of the ,purple ,book ,continuity ,act of
 #bjbj1 the ,secretary shall publish and
 make available to the public in a      
searchable1 electronic format-- 7,i7 a  

list of each biological product1 by     
nonproprietary name 7proper name71 for  
which1 as of such date of enactment1 a  
biologics license under subsection 7a7  
or this subsection is in effect1 or     
that1 as of such date of enactment1 is  
deemed to be licensed under this section
 pursuant to section #gjjb7;e77#d7 of   
the ,biologics ,price ,competition and  
,innovation ,act of #bjji2  7,,ii7 the  
date of licensure of the marketing      
application and the application number2 
and  7,,iii7 with respect to each       
biological product described in         
subclause 7,i71 the licensure status1   
and1 as available1 the marketing status4
  7ii7 ,revisions ,every #cj days after 
the publication of the first list under 
clause 7i71 the ,secretary shall revise 
the list to include each biological     
product which has been licensed under   
subsection 7a7 or this subsection during
 the #cj-;day period or deemed licensed 
under this section pursuant to section  
#gjjb7;e77#d7 of the ,biologics ,price  

,competition and ,innovation ,act of    
#bjji4  7iii7 ,patent information ,not  
later than #cj days after a list of     
patents under subsection 7l77#c77;,a71  
or a supplement to such list under      
subsection 7l77#g71 has been provided by
 the reference product sponsor to the   
subsection 7k7 applicant respecting a   
biological product included on the list 
published under this subparagraph1 the  
reference product sponsor shall provide 
such list of patents 7or supplement     
thereto7 and their corresponding expiry 
dates to the ,secretary1 and the        
,secretary shall1 in revisions made     
under clause 7ii71 include such         
information for such biological product4
 ,within #cj days of providing any      
subsequent or supplemental list of      
patents to any subsequent subsection 7k7
 applicant under subsection 7l77#c77;,a7
 or 7l77#g71 the reference product      
sponsor shall update the information    
provided to the ,secretary under this   
clause with any additional patents from 

such subsequent or supplemental list and
 their corresponding expiry dates4  7iv7
 ,listing of exclusivities ,for each    
biological product included on the list 
published under this subparagraph1 the  
,secretary shall specify each           
exclusivity period under paragraph 7#f7 
or paragraph 7#g7 for which the         
,secretary has determined such          
biological product to be eligible and   
that has not concluded4  7,b7           
,revocation or suspension of license ,if
 the license of a biological product is 
determined by the ,secretary to have    
been revoked or suspended for safety1   
purity1 or potency reasons1 it may not  
be published in the list under          
subparagraph 7,a74 ,if such revocation  
or suspension occurred after inclusion  
of such biological product in the list  
published under subparagraph 7,a71 the  
reference product sponsor shall notify  
the ,secretary that-- 7i7 the biological
 product shall be immediately removed   
from such list for the same period as   

the revocation or suspension2 and  7ii7 
a notice of the removal shall be        
published in the ,federal ,register4  4 
7b7 ,review and report on types of      
,information ,to be listed ,not later   
than #c years after the date of         
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services shall-- 
7#a7 solicit public comment regarding   
the type of information1 if any1 that   
should be added to or removed from the  
list required by paragraph 7#i7 of      
section #cea7k7 of the ,public ,health  
,service ,act 7#db ,u4,s4,c4 #bfb7k771  
as added by subsection 7a72 and  7#b7   
transmit to ,congress an evaluation of  
such comments1 including any            
recommendations about the types of      
information that should be added to or  
removed from the list4  ,secretary