,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #aebj  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #e1 #bjai,ms4    
,e%oo introduc$ ! foll[+ bill2 :i* 0    
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,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 #fj days aft] ! date ( enactm5t
 ( ! ,purple ,book ,cont9uity ,act (    
#bjai1 ! ,secret>y %all publi% & make   
available to ! public electronically--  
7,i7 a li/ 9 alphabetical ord] ( !      
(ficial & propriet>y "n ( ea* biological
 product = :i* a biologics lic5se "u    
subsection 7a7 or ?is subsection is 9   
effect z ( su* date ( enactm5t2  7,,ii7 

! date ( lic5s+ if ! biological product 
is lic5s$ aft] #aiha & ! numb] ( !      
application :i* 0 approv$2 &  7,,iii7   
:e!r 9 vitro or 9 vivo bioequival5ce    
/udies1 or bo? su* /udies1 are requir$ =
 applications fil$ "u ?is subsection :i*
 w ref] to ! biological product publi%$4
  7ii7 ,revisions ,e #cj days aft] !    
publication ( ! fir/ li/ "u clause 7i71 
! ,secret>y %all revise ! li/ to include
 ea* biological product :i* has be5     
lic5s$ "u subsection 7a7 or ?is         
subsection dur+ ! #cj-;day p]iod4  7iii7
 ,pat5t in=mation ,:5 pat5t in=mation   
has be5 provid$ by ! ref]5ce product    
sponsor to ! subsection 7k7 applicant   
respect+ a biological product includ$ on
 ! li/ publi%$ "u ?is subp>agraph1 !    
,secret>y %all1 9 revisions made "u     
clause 7ii71 include su* in=mation = su*
 biological product4  7,b7 ,date (      
publication ,a biological product = :i* 
a lic5se is 9 effect "u subsection 7a7  
or ?is subsection %all1 = purposes ( ?is
 subsection1 be consid]$ to h be5       

publi%$ "u subp>agraph 7,a7 on ! lat]   
(--  7i7 ! date ( its lic5s+2 or  7ii7 !
 date ( its publication 9 ! li/ t--     
7,i7 0 publi%$ "u ?is section be=e !    
initial publication ( ! li/ "u          
subp>agraph 7,a72 &  7,,ii7 0 equival5t 
to ! li/ publi%$ "u section #eje7;j77#g7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act & compris$ ( pat5ts associat$ )    
applications fil$ "u subsection 7a7 (   
?is section or "u ?is subsection4  7,c7 
,)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/--  7i7 x %all be imm$iately    
remov$ f su* li/-- 7,i7 = ! same p]iod z
 ! )drawal or susp5sion2 or  7,,ii7 if !
 li/$ drug 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$]al ,regi/]4  4  #c4     
,review & report on types ( biological  
product pat5ts ,to be li/$ ,n lat] ?an  
#c ye>s aft] ! date ( enactm5t ( ?is    
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices %all--  7#a7 complete a review 
(1 & =mulate recomm5dations on1 ! types 
( biological product pat5ts t %\ld be   
includ$ 9 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 report su* recomm5dations to
 ! ,congress4