,9 ! ,s5ate ( ! ,unit$ ,/ates1  ,decemb]
 #aj1 #bjbj4  ,am5dm5t3  ,t ! bill f !  
,h\se ( ,repres5tatives 7,h4,r4 #aebj7  
entitl$ ,an ,act to am5d ! ,public      
,heal? ,s]vice ,act to provide = !      
publication ( a li/ ( lic5s$ biological 
products1 & = o!r purposes41 d pass ) ! 
foll[+ ,/rike all aft] ! enact+ clause &
 ins]t ! foll[+3 #a4 ,%ort title ,! ,act
 may be cit$ z ! ,purple ,book          
,cont9uity ,act ( #bjbj4  #b4           
,biological product pat5t transp>5cy    
7a7 ,9 g5]al ,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 ( #bjbj1 ! ,secret>y %all publi% & 
make available to ! public 9 a se>*able1
 electronic =mat-- 7,i7 a li/ ( ea*     
biological product1 by nonpropriet>y "n 
7prop] "n71 = :i*1 z ( su* date (       
enactm5t1 a biologics lic5se "u         

subsection 7a7 or ?is subsection is 9   
effect1 or t1 z ( su* date ( enactm5t1  
is deem$ to be lic5s$ "u ?is section    
pursuant to section #gjjb7;e77#d7 ( !   
,biologics ,price ,competition &        
,innovation ,act ( #bjji2  7,,ii7 ! date
 ( lic5sure ( ! m>ket+ application & !  
application numb]2 &  7,,iii7 ) respect 
to ea* biological product describ$ 9    
subclause 7,i71 ! lic5sure /atus1 &1 z  
available1 ! m>ket+ /atus4  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]iod or     
deem$ lic5s$ "u ?is section pursuant to 
section #gjjb7;e77#d7 ( ! ,biologics    
,price ,competition & ,innovation ,act (
 #bjji4  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 "u p>agraph 7#f7  
or p>agraph 7#g7 = :i* ! ,secret>y has  
det]m9$ su* biological product to be    
eligible & t has n conclud$4  7,b7      
,revocation or susp5sion ( lic5se ,if ! 

lic5se ( a biological product is det]m9$
 by ! ,secret>y to h be5 revok$ or      
susp5d$ = safety1 purity1 or pot5cy     
reasons1 x may n be publi%$ 9 ! li/ "u  
subp>agraph 7,a74 ,if su* revocation or 
susp5sion occurr$ aft] inclusion ( su*  
biological product 9 ! li/ publi%$ "u   
subp>agraph 7,a71 ! ref]5ce product     
sponsor %all notify ! ,secret>y t-- 7i7 
! biological product %all be imm$iately 
remov$ f su* li/ = ! same p]iod z !     
revocation or susp5sion2 &  7ii7 a      
notice ( ! removal %all be publi%$ 9 !  
,f$]al ,regi/]4  4  7b7 ,review & report
 on types ( ,in=mation ,to be li/$ ,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      
subsection 7a72 &  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  ,secret>y