,9 ! ,s5ate ( ! ,unit$ ,/ates1  ,decemb]
 #g1 #bjbj4  ,am5dm5t3  ,t ! bill f !   
,h\se ( ,repres5tatives 7,h4,r4 #aejc7  
entitl$ ,an ,act to am5d ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act reg>d+ ! li/ "u
 section #eje7;j77#g7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act1 & = o!r        
purposes41 d pass ) ! foll[+ ,/rike all 
aft] ! enact+ clause & ins]t ! foll[+3  
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,orange ,book ,transp>5cy ,act (      
#bjbj4  #b4 ,orange ,book mod]nization  
7a7 ,submission ( pat5t in=mation = br& 
"n drugs  7#a7 ,9 g5]al ,p>agraph 7#a7 (
 section #eje7;b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77 is am5d$ to read z foll[s3    
7b7 7#a7 7,a7 ,any p]son may file ) !   
,secret>y an application ) respect to   
any drug subject to ! provisions (      
subsection 7a74 ,su* p]sons %all submit 
to ! ,secret>y z "p ( ! application--   
7i7 full reports ( inve/igations :i* h  
be5 made to %[ :e!r su* drug is safe =  
use & :e!r su* drug is effective 9 use2 

7ii7 a full li/ ( ! articles us$ z      
compon5ts ( su* drug2  7iii7 a full     
/atem5t ( ! composition ( su* drug2     
7iv7 a full description ( ! me?ods us$  
91 & ! facilities & controls us$ =1 !   
manufacture1 process+1 & pack+ ( su*    
drug2  7v7 su* samples ( su* drug & ( ! 
articles us$ z compon5ts !re( z !       
,secret>y may require2  7vi7 specim5s ( 
! label+ propos$ to be us$ = su* drug2  
7vii7 any assessm5ts requir$ "u section 
#eje;,b2 &  7viii7 ! pat5t numb] &      
expiration date ( ea* pat5t = :i* a     
claim ( pat5t infr+em5t c\ld reasonably 
be ass]t$ if a p]son n lic5s$ by ! own] 
( ! pat5t engag$ 9 ! manufacture1 use1  
or sale ( ! drug1 & t-- 7,i7 claims !   
drug = :i* ! applicant submitt$ !       
application & is a drug sub/ance 7active
 +r$i5t7 pat5t or a drug product        
7=mulation or composition7 pat5t2 or    
7,,ii7 claims a me?od ( us+ su* drug =  
:i* approval is s\ght or has be5 grant$ 
9 ! application4  7,b7 ,if an           
application is fil$ "u ?is subsection = 

a drug1 & a pat5t ( ! type describ$ 9   
subp>agraph 7,a77viii7 is issu$ aft] !  
fil+ date b be=e approval ( !           
application1 ! applicant %all am5d !    
application to include ! pat5t numb] &  
expiration date4  4  7b7 ,subsequ5t     
submission ( pat5t in=mation  7#a7 ,9   
g5]al ,section #eje7;c77#b7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;c77#b77 is am5d$-- 7,a7 
by ins]t+ be=e ! fir/ s5t5ce ! foll[+3  
,n lat] ?an #cj days aft] ! date (      
approval ( an application submitt$ "u   
subsection 7b71 ! hold] ( ! approv$     
application %all file ) ! ,secret>y !   
pat5t numb] & ! expiration date ( any   
pat5t describ$ 9 subsection             
7b77#a77;,a77viii71 except t a pat5t t  
is id5tifi$ z claim+ a me?od ( us+ su*  
drug %all be fil$ only if ! pat5t claims
 a me?od ( use approv$ 9 ! application4 
,if a pat5t describ$ 9 subsection       
7b77#a77;,a77viii7 is issu$ aft] ! date 
( approval ( an application submitt$ "u 
subsection 7b71 ! hold] ( ! approv$     

application %all1 n lat] ?an #cj days   
aft] ! date ( issuance ( ! pat5t1 file !
 pat5t numb] & ! expiration date ( !    
pat5t1 except t a pat5t t claims a me?od
 ( us+ su* drug %all be fil$ only if    
approval = su* use has be5 grant$ 9 !   
application42  7,b7 9 ! fir/ s5t5ce     
foll[+ ! s5t5ces add$ by subp>agraph    
7,a71 by /rik+ :i* claims ! drug = :i* &
 all t foll[s ?r\gh ( ! drug4 & ins]t+  
describ$ 9 subsection                   
7b77#a77;,a77viii742  7,c7 9 ! second   
s5t5ce foll[+ ! s5t5ces add$ by         
subp>agraph 7,a71 by ins]t+ aft] c\ld n 
file pat5t in=mation "u subsection 7b7  
because no pat5t ! foll[+3 ( ! type =   
:i* in=mation is requir$ to be submitt$ 
9 subsection 7b77#a77;,a77viii72 &  7,d7
 by add+ at ! end ! foll[+3 ,pat5t      
in=mation t is n ! type ( pat5t         
in=mation requir$ by subsection         
7b77#a77;,a77viii7 %all n be submitt$ "u
 ?is p>agraph44  7#b7 ,updat+ li/       
,clause 7iii7 ( section                 
#eje7;j77#g77;,a7 ( ! ,f$]al ,food1     

,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#g77 is am5d$ by /rik+ 7b7 or4 
7c7 ,li/+ ( exclusivities ,subp>agraph  
7,a7 ( section #eje7;j77#g7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#g77 is am5d$ by add+
 at ! end ! foll[+3  7iv7 ,= ea* drug   
includ$ on ! li/1 ! ,secret>y %all      
specify any exclusivity p]iod t is      
applicable1 = :i* ! ,secret>y has       
det]m9$ ! expiration date1 & = :i* su*  
p]iod has n yet expir$1 "u-- 7,i7 clause
 7ii71 7iii71 or 7iv7 ( subsection      
7c77#c77;,e72  7,,ii7 clause 7iv7 or 7v7
 ( p>agraph 7#e77;,b72  7,,iii7 clause  
7ii71 7iii71 or 7iv7 ( p>agraph         
7#e77;,f72  7,,iv7 section #eje;,a2     
7,v7 section #eje;,e2  7,,vi7 section   
#ebg7;a72 or  7,,vii7 subsection 7u74  4
  7d7 ,orange book updates ) respect to 
invalidat$ pat5ts  7#a7 ,am5dm5t        
,section #eje7;j77#g7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#g77 is am5d$ by add+ at ! end 
! foll[+3  7,d7 ,9 ! case ( a li/$ drug 

= :i* ! li/ "u subp>agraph 7,a77i7      
includes a pat5t = su* drug1 & any claim
 ( ! pat5t has be5 cancell$ or          
invalidat$ pursuant to a f9al decision  
issu$ by ! ,pat5t ,trial & ,appeal ,bo>d
 ( ! ,unit$ ,/ates ,pat5t & ,tradem>k   
,(fice or by a c\rt1 f :i* no appeal has
 be51 or c be1 tak51 if ! hold] ( !     
applicable application approv$ "u       
subsection 7c7 det]m9es t a pat5t = su* 
drug1 or any pat5t in=mation = su* drug1
 no long] meets ! li/+ requirem5ts "u   
?is section-- 7i7 ! hold] ( su* approv$ 
application %all notify ! ,secret>y1 9  
writ+1 )9 #ad days ( su* decision ( su* 
cancellation or invalidation & reque/ t 
su* pat5t or pat5t in=mation1 z         
applicable1 be am5d$ or )drawn 9        
accordance ) ! decision issu$ by !      
,pat5t ,trial & ,appeal ,bo>d or a c\rt2
  7ii7 ! hold] ( su* approv$ application
 %all include 9 any notification "u     
clause 7i7 in=mation relat$ to su* pat5t
 cancellation or invalidation decision &
 submit su* in=mation1 includ+ a copy ( 

su* decision1 to ! ,secret>y2 &  7iii7 !
 ,secret>y %all1 9 response to a        
notification "u clause 7i71 am5d or     
remove pat5t or pat5t in=mation 9       
accordance ) ! relevant decision f !    
,pat5t ,trial & ,appeals ,bo>d or c\rt1 
z applicable1 except t ! ,secret>y %all 
n remove f ! li/ any pat5t or pat5t     
in=mation be=e ! expiration ( any       
#ahj-;day exclusivity p]iod "u p>agraph 
7#e77;,b77iv7 t relies on a c]tification
 describ$ 9 p>agraph                    
7#b77;,a77vii77,,iv74  4  7#b7          
,applicability ,subp>agraph 7,d7 (      
section #eje7;j77#g7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#g771 z add$ by p>agraph 7#a71 
applies only ) respect to a decision    
describ$ 9 su* subp>agraph t is issu$ on
 or aft] ! date ( enactm5t ( ?is ,act4  
7e7 ,review & report ,n lat] ?an #a ye> 
aft] ! date ( enactm5t ( ?is ,act1 !    
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all-- 7#a7 solicit public      

comm5t reg>d+ ! types ( pat5t in=mation 
t %\ld be includ$ on1 or remov$ f1 ! li/
 "u section #ejg7;j77#g7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#g772 &  7#b7        
transmit to ,congress a summ>y ( su*    
comm5ts & actions ! ,food & ,drug       
,adm9i/ration is consid]+ tak+1 if any1 
9 response to public comm5t pursuant to 
p>agraph 7#a7 ab\t ! types ( pat5t      
in=mation t %\ld be includ$ or remov$ f 
su* li/4  7f7 ,,gao report to congress  
7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] !
 date ( enactm5t ( ?is ,act1 !          
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
7ref]r$ to 9 ?is section z ! ,comptroll]
 ,g5]al7 %all submit to ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report on ! pat5ts includ$ 9 ! li/      
publi%$ "u section #eje7;j77#g7 ( !     
,f$]al ,food1 ,drug & ,cosmetic ,act    
7#ba ,u4,s4,c4 #cee7;j77#g77 t claim an 
active +r$i5t or =mulation ( a drug 9   

comb9ation ) a device t is us$ = deliv]y
 ( su* drug1 includ+ an analysis ( su*  
pat5ts & _! claims4  7#b7 ,cont5t ,!    
,comptroll] ,g5]al %all include 9 !     
report "u p>agraph 7#a7-- 7,a7 data on--
 7i7 ! numb] ( pat5ts includ$ 9 ! li/   
publi%$ "u section #eje7;j77#g7 ( !     
,f$]al ,food1 ,drug & ,cosmetic ,act    
7#ba ,u4,s4,c4 #cee7;j77#g77 t claim !  
active +r$i5t or =mulation ( a drug 9   
comb9ation ) a device t is us$ = deliv]y
 ( ! drug1 & t toge!r claim ! f9i%$     
dosage =m ( ! drug2 &  7ii7 ! numb] (   
claims ) respect to ea* pat5t includ$ 9 
! li/ publi%$ "u su* section            
#eje7;j77#g7 t claim a device t is us$ =
 ! deliv]y ( ! drug1 b d n claim su*    
device 9 comb9ation ) an active +r$i5t  
or =mulation ( a drug2  7,b7 an analysis
 ( ! li/+ ( pat5ts describ$ 9           
subp>agraph 7,a77ii71 includ+ ! tim+ (  
li/+ su* pat5ts 9 relation to pat5ts    
describ$ 9 subp>agraph 7,a77i71 & !     
effect li/+ ! pat5ts describ$ 9         
subp>agraph 7,a77ii7 has on m>ket entry 

( "o or m drugs approv$ "u section      
#eje7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act z comp>$ to ! effect ( n 
li/+ ! pat5ts describ$ 9 subp>agraph    
7,a77ii72 &  7,c7 recomm5dations ab\t   
:i* k9ds ( pat5ts relat+ to devices     
describ$ 9 subp>agraph 7,a77i7 %\ld be  
submitt$ to ! ,secret>y ( ,heal? &      
,human ,s]vices = inclusion on ! li/ "u 
section #eje7;j77#g7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act & :i* pat5ts    
%\ld n be requir$ to be s submitt$ 9    
ord] to r$uce b>ri]s to approval & m>ket
 entry4  7g7 ,con=m+ am5dm5ts ,section  
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is  
am5d$-- 7#a7 9 subsection 7c77#c77;,e71 
by /rik+ clause 7,a7 ( subsection       
7b77#a7 ea* place x appe>s & ins]t+     
subsection 7b77#a77;,a77i72 &  7#b7 9   
subsection 7j77#b77;,a77vi71 by /rik+   
clauses 7,b7 ?r\gh 7,f7 ( subsection    
7b77#a7 & ins]t+ clauses 7ii7 ?r\gh 7vi7
 ( subsection 7b77#a77;,a74  ,secret>y