,,ib  ,union ,calendar ,no4 #bf  #aafth 
,,congress  #ast ,session  ,h4 ,r4 #aebj
  ,report ,no4 #aaf-dh  ,,in ,,the      
,,house ,,of ,,representatives  ,march  
#e1 #bjai ,ms4 ,eshoo introduced the    
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,may #c1 #bjai ,additional sponsors3    
,mrs4 ,craig1 ,mrs4 ,dingell1 ,mr4      
,ruiz1 ,mr4 ,rush1 ,mr4 ,pallone1 ,mr4  
,kennedy1 ,mr4 ,burgess1 ,ms4 ,matsui1  
,ms4 ,clarke of ,new ,york1 ,mr4 ,van   
,drew1 ,mr4 ,walden1 and ,ms4           
,mucarsel-,powell  ,may #c1 #bjai       
,reported with an amendment1 committed  
to the ,committee of the ,whole ,house  
on the ,state of the ,union1 and ordered
 to be printed ,strike out all after the
 enacting clause and insert the part    
printed in italic ,for text of          
introduced bill1 see copy of bill as    
introduced on ,march #e1 #bjai  ,a      
,,bill  ,to amend the ,public ,health   
,service ,act to provide for the        
publication of a list of licensed       

biological products1 and for other      
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,purple ,book       
,continuity ,act of #bjai4  #b4 ,public 
,listing ,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 #bjai1
 the ,secretary shall publish and make  
available to the public in a searchable1
 electronic format-- 7,i7 a list in     
alphabetical order of the nonproprietary
 or proper name of each biological      
product for which a biologics license   
under subsection 7a7 or this subsection 
is in effect1 or that has been deemed to
 be licensed under this section pursuant
 to section #gjjb7;e77#d7 of the        
,biologics ,price ,competition and      
,innovation ,act of #bjji1 as of such   
date of enactment2  7,,ii7 the date of  

approval of the marketing application   
and the application number2 and  7,,iii7
 the marketing or licensure status of   
the biological product for which a      
biologics license under subsection 7a7  
or this subsection is in effect or that 
has been deemed to be licensed under    
this section pursuant to section        
#gjjb7;e77#d7 of the ,biologics ,price  
,competition and ,innovation ,act of    
#bjji4  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 period4  
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 that is applicable   
and has not concluded under paragraph   
7#f7 or paragraph 7#g74  7,b7           

,withdrawal or suspension of licensure  
,if the licensing of a biological       
product was withdrawn or suspended for  
safety1 purity1 or potency reasons1 it  
may not be published in the list under  
subparagraph 7,a74 ,if the withdrawal or
 suspension occurred after its          
publication in such list1 the reference 
product sponsor shall notify the        
,secretary that--  7i7 the biological   
product shall be immediately removed    
from such list-- 7,i7 for the same      
period as the withdrawal or suspension2 
or  7,,ii7 if the biological product has
 been withdrawn from sale1 for the      
period of withdrawal from sale or1 if   
earlier1 the period ending on the date  
the ,secretary determines that the      
withdrawal from sale is not for safety1 
purity1 or potency reasons2 and  7ii7 a 
notice of the removal shall be published
 in the ,federal ,register4  4  #c4     
,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 section #b2 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  ,may #c1 #bjai  
,reported with an amendment1 committed  
to the ,committee of the ,whole ,house  
on the ,state of the ,union1 and ordered
 to be printed