#aaf? ,,congress  #a/ ,session  ,h4 ,r4 
#aebj  ,,an ,,act  ,to am5d ! ,public   
,heal? ,s]vice ,act to provide = !      
publication ( a li/ ( lic5s$ biological 
products1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,purple 
,book ,cont9uity ,act ( #bjai4  #b4     
,public ,li/+ ,section #cea7k7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k77 is am5d$ by add+ at !
 end ! foll[+3  7#i7 ,public li/+  7,a7 
,9 g5]al  7i7 ,initial publication ,n   
lat] ?an #ahj days aft] ! date (        
enactm5t ( ! ,purple ,book ,cont9uity   
,act ( #bjai1 ! ,secret>y %all publi% & 
make available to ! public 9 a se>*able1
 electronic =mat-- 7,i7 a li/ 9         
alphabetical ord] ( ! nonpropriet>y or  
prop] "n ( ea* biological product = :i* 
a biologics lic5se "u subsection 7a7 or 
?is subsection is 9 effect1 or t has be5
 deem$ to be lic5s$ "u ?is section      
pursuant to section #gjjb7;e77#d7 ( !   
,biologics ,price ,competition &        
,innovation ,act ( #bjji1 z ( su* date (

 enactm5t2  7,,ii7 ! date ( approval ( !
 m>ket+ application & ! application     
numb]2 &  7,,iii7 ! m>ket+ or lic5sure  
/atus ( ! biological product = :i* a    
biologics lic5se "u subsection 7a7 or   
?is subsection is 9 effect or t has be5 
deem$ to be lic5s$ "u ?is section       
pursuant to section #gjjb7;e77#d7 ( !   
,biologics ,price ,competition &        
,innovation ,act ( #bjji4  7ii7         
,revisions ,e #cj days aft] !           
publication ( ! fir/ li/ "u clause 7i71 
! ,secret>y %all revise ! li/ to include
 ea* biological product :i* has be5     
lic5s$ "u subsection 7a7 or ?is         
subsection dur+ ! #cj-;day p]iod4  7iii7
 ,pat5t in=mation ,n lat] ?an #cj days  
aft] a li/ ( pat5ts "u subsection       
7l77#c77;,a71 or a supplem5t to su* li/ 
"u subsection 7l77#g71 has be5 provid$  
by ! ref]5ce product sponsor to !       
subsection 7k7 applicant respect+ a     
biological product includ$ on ! li/     
publi%$ "u ?is subp>agraph1 ! ref]5ce   
product sponsor %all provide su* li/ (  

pat5ts 7or supplem5t !reto7 & _!        
correspond+ expiry dates to ! ,secret>y1
 & ! ,secret>y %all1 9 revisions made "u
 clause 7ii71 include su* in=mation =   
su* biological product4 ,)9 #cj days (  
provid+ any subsequ5t or supplem5tal li/
 ( pat5ts to any subsequ5t subsection   
7k7 applicant "u subsection 7l77#c77;,a7
 or 7l77#g71 ! ref]5ce product sponsor  
%all update ! in=mation provid$ to !    
,secret>y "u ?is clause ) any additional
 pat5ts f su* subsequ5t or supplem5tal  
li/ & _! correspond+ expiry dates4  7iv7
 ,li/+ ( exclusivities ,= ea* biological
 product includ$ on ! li/ publi%$ "u ?is
 subp>agraph1 ! ,secret>y %all specify  
ea* exclusivity p]iod t is applicable & 
has n conclud$ "u p>agraph 7#f7 or      
p>agraph 7#g74  7,b7 ,)drawal or        
susp5sion ( lic5sure ,if ! lic5s+ ( a   
biological product 0 )drawn or susp5d$ =
 safety1 purity1 or pot5cy reasons1 x   
may n be publi%$ 9 ! li/ "u subp>agraph 
7,a74 ,if ! )drawal or susp5sion occurr$
 aft] its publication 9 su* li/1 !      

ref]5ce product sponsor %all notify !   
,secret>y t--  7i7 ! biological product 
%all be imm$iately remov$ f su* li/--   
7,i7 = ! same p]iod z ! )drawal or      
susp5sion2 or  7,,ii7 if ! biological   
product has be5 )drawn f sale1 = ! p]iod
 ( )drawal f sale or1 if e>li]1 ! p]iod 
end+ on ! date ! ,secret>y det]m9es t ! 
)drawal f sale is n = safety1 purity1 or
 pot5cy reasons2 &  7ii7 a notice ( !   
removal %all be publi%$ 9 ! ,f$]al      
,regi/]4  4  #c4 ,review & report on    
types ( ,in=mation ,to be li/$ ,n lat]  
?an #c ye>s aft] ! date ( enactm5t ( ?is
 ,act1 ! ,secret>y ( ,heal? & ,human    
,s]vices %all-- 7#a7 solicit public     
comm5t reg>d+ ! type ( in=mation1 if    
any1 t %\ld be add$ to or remov$ f ! li/
 requir$ by p>agraph 7#i7 ( section     
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k771 z add$ by      
section #b2 &  7#b7 transmit to         
,congress an evaluation ( su* comm5ts1  
includ+ any recomm5dations ab\t ! types 
( in=mation t %\ld be add$ to or remov$ 

f ! li/4  ,pass$ ! ,h\se (              
,repres5tatives ,may #h1 #bjai4;,cl]k4