,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #eddd  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #ag1         
#bjai,ms4 ,und]wood 7= h]self1 ,ms4     
,s*ak[sky1 ,mr4 ,gu?rie1 ,mr4 ,kelly (  
,p5nsylvania1 & ,mr4 ,lev9 ( ,mi*igan7  
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,biologics ,price    
,competition & ,innovation ,act ( #bjji 
to /reaml9e ! transition ( c]ta9        
products f approval z a drug to lic5sure
 z a biological product1 & = o!r        
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,l[] ,insul9 ,co/s ,n[     
,act4  #b4 ,/reaml9+ ! transition (     
biological products ,section            
#gjjb7;e77#d7 ( ! ,biologics ,price     
,competition & ,innovation ,act ( #bjji 
7,public ,law #aaa-adh7 is am5d$--  7#a7
 by /rik+ ,an approv$ application &     
ins]t+ ! foll[+3  7,a7 ,9 g5]al ,an     
approv$ application  2 &  7#b7 by add+  
at ! end ! foll[+3  7,b7 ,treatm5t (    
c]ta9 applications  7i7 ,9 g5]al ,)     

respect to an application = a biological
 product submitt$ "u subsection 7b7 or  
7j7 ( section #eje ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7 t is fil$ n lat] ?an ,m>* #bc1    
#bjai1 & is n approv$ z ( ,m>* #bc1     
#bjbj1 ! ,secret>y %all cont9ue to      
review su* application "u su* section   
#eje1 aft] ,m>* #bc1 #bjbj4  7ii7       
,effect on li/$ drugs ,only = purposes (
 c>ry+ out clause 7i71 ) respect to any 
applicable li/$ drug ) respect to su*   
application1 ! foll[+ %all apply3  7,i7 
,any drug t is a biological product t   
has be5 deem$ lic5s$ "u section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb7 pursuant to subp>agraph 
7,a7 & t is ref]5c$ 9 an application    
describ$ 9 clause 7i71 %all cont9ue to  
be id5tifi$ z a li/$ drug on ! li/      
publi%$ pursuant to section #eje7;j77#g7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act1 & ! in=mation = su* drug on su*   
li/ %all n be revis$ aft] ,m>* #bj1     
#bjbj1 until--  7aa7 su* drug is remov$ 

f su* li/ 9 accordance ) subclause      
7,,iii7 or subp>agraph 7,c7 ( su*       
section #eje7;j77#g72 or  7bb7 ?is      
subp>agraph no long] has =ce or effect4 
7,,ii7 ,any drug t is a biological      
product t has be5 deem$ lic5s$ "u       
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7 pursuant to   
subp>agraph 7,a7 & t is ref]5c$ 9 an    
application describ$ 9 clause 7i7 %all  
be subject only to requirem5ts          
applicable to biological products lic5s$
 "u su* section4  7,,iii7 ,^u approval  
"u subsection 7c7 or 7j7 ( section #eje 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act ( an application describ$ 9 clause 
7i71 ! ,secret>y %all remove f ! li/    
publi%$ pursuant to section #eje7;j77#g7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act any li/$ drug t is a biological    
product t has be5 deem$ lic5s$ "u       
section #cea ( ! ,public ,heal? ,s]vice 
,act pursuant to subp>agraph 7,a7 & t is
 ref]5c$ 9 su* approv$ application1     
unless su* li/$ drug is ref]5c$ 9 "o or 

m additional applications describ$ 9    
clause 7i74  7iii7 ,deem$ lic5sure ,^u  
approval ( an application describ$ 9    
clause 7i71 su* approv$ application %all
 be deem$ to be a lic5se = ! biological 
product "u section #cea ( ! ,public     
,heal? ,s]vice ,act4  7iv7 ,rule (      
con/ruction  7,i7 ,application ( c]ta9  
provisions  7aa7 ,pat5t c]tification or 
/atem5t ,an application describ$ 9      
clause 7i7 %all conta9 a pat5t          
c]tification or /atem5t describ$ 91 z   
applicable1 section #eje7;b77#b7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act or
 clauses 7vii7 & 7viii7 ( section       
#eje7;j77#b77;,a7 ( su* ,act &1 )       
respect to any li/$ drug ref]5c$ 9 su*  
application1 comply ) relat$ requirem5ts
 conc]n+ any timely fil$ pat5t in=mation
 li/$ pursuant to section #eje7;j77#g74 
7bb7 ,date ( approval ,! e>lie/ possible
 date on :i* any p5d+ application       
describ$ 9 clause 7i7 may be approv$    
%all be det]m9$ bas$ on-- 7,,aa7 ! la/  
expiration date ( any applicable p]iod (

 exclusivity t w\ld prev5t su* approval 
& t is describ$ 9 section               
#eje7;c77#c77;,e71                      
#eje7;j77#e77;,b77iv71                  
#eje7;j77#e77;,f71 #eje;,a1 #eje;,e1 or 
#ebg ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act2 & 7,,bb7 if !           
application 0 submitt$ pursuant to      
section #eje7;b77#b7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act & ref]5ces any  
li/$ drug1 ! la/ applicable date det]m9$
 "u subp>agraph 7,a71 7,b71 or 7,c7 (   
section #eje7;c77#c7 ( su* ,act1 or1 if 
! application 0 submitt$ "u section     
#eje7;j7 ( su* ,act1 ! la/ applicable   
date det]m9$ "u clause 7i71 7ii71 or    
7iii7 ( section #eje7;j77#e77;,b74      
7,,ii7 ,exclusivity ,no?+ 9 ?is         
subp>agraph %all be con/ru$ to affect   
section #cea7k77#g77;,d7 ( ! ,public    
,heal? ,s]vice ,act4  7v7 ,li/+ ,!      
,secret>y may cont9ue to review an      
application aft] ,m>* #bc1 #bjbj1       
pursuant to clause 7i71 & cont9ue to    
id5tify any applicable li/$ drug        

pursuant to clause 7ii7 on ! li/ publi%$
 pursuant to section #eje7;j77#g7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act1  
ev5 if su* review or li/+ may reveal !  
exi/5ce ( su* application & ! id5tity ( 
any li/$ drug = :i* ! inve/igations     
describ$ 9 section #eje7;b77#a77;,a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
are reli$ ^u by ! applicant = approval (
 ! p5d+ application4 ,no?+ 9 ?is        
subp>agraph %all be con/ru$ z au?oriz+ !
 ,secret>y to disclose any o!r in=mation
 t is a trade secret or confid5tial     
in=mation describ$ 9 section            
#eeb7;b77#d7 ( title #e1 ,unit$ ,/ates  
,code4  7vi7 ,sunset ,beg9n+ on ,octob] 
#a1 #bjbb1 ?is subp>agraph %all h no =ce
 or effect & any applications describ$ 9
 clause 7i7 t h n be5 approv$ %all be   
deem$ )drawn4  4