,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #aebj  ,,in ,,the ,,house ,,of  
,,representatives  ,march #e1 #bjai,ms4 
,eshoo introduced the following bill2   
which was referred to the ,committee on 
,energy and ,commerce  ,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 #fj days    
after the date of enactment of the      
,purple ,book ,continuity ,act of #bjai1
 the ,secretary shall publish and make  
available to the public electronically--
 7,i7 a list in alphabetical order of   
the official and proprietary name of    
each biological product for which a     

biologics license under subsection 7a7  
or this subsection is in effect as of   
such date of enactment2  7,,ii7 the date
 of licensing if the biological product 
is licensed after #aiha and the number  
of the application which was approved2  
and  7,,iii7 whether in vitro or in vivo
 bioequivalence studies1 or both such   
studies1 are required for applications  
filed under this subsection which will  
refer to the biological product         
published4  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 ,when patent  
information 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  
,secretary shall1 in revisions made     

under clause 7ii71 include such         
information for such biological product4
  7,b7 ,date of publication ,a          
biological product for which a license  
is in effect under subsection 7a7 or    
this subsection shall1 for purposes of  
this subsection1 be considered to have  
been published under subparagraph 7,a7  
on the later of--  7i7 the date of its  
licensing2 or  7ii7 the date of its     
publication in the list that--  7,i7 was
 published under this section before the
 initial publication of the list under  
subparagraph 7,a72 and  7,,ii7 was      
equivalent to the list published under  
section #eje7;j77#g7 of the ,federal    
,food1 ,drug1 and ,cosmetic ,act and    
comprised of patents associated with    
applications filed under subsection 7a7 
of this section or under this           
subsection4  7,c7 ,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 list--  7i7 it shall
 be immediately removed from such list--
 7,i7 for the same period as the        
withdrawal or suspension2 or  7,,ii7 if 
the listed drug 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      
biological product patents ,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 complete a      
review of1 and formulate recommendations
 on1 the types of biological product    
patents that should be included in 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 report such               
recommendations to the ,congress4