,,ii  #aad? ,,congress  #a/ ,session    
,s4 #adba  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #ba1 #bjae,mr4    
,hat* 7= himself & ,ms4 ,klobu*>7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to au?orize a   
#f-mon? ext5sion ( c]ta9 exclusivity    
p]iods 9 ! case ( approv$ drugs t are   
subsequ5tly approv$ = a new indication  
to prev5t1 diagnose1 or treat a r>e     
disease or condition1 & = o!r purposes4 
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,orphan ,product ,ext5sions ,n[       
,accel]at+ ,cures & ,treatm5ts ,act (   
#bjae4  #b4 ,ext5sion ( exclusivity     
p]iods = a drug approv$ = a new         
indication = a r>e disease or condition 
7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act is am5d$ by    
ins]t+ aft] section #eje;,e ! foll[+3   
#eje;,f4 ,ext5sion ( exclusivity p]iods 
= a drug approv$ = a new indication = a 

r>e disease or condition  7a7           
,designation  7#a7 ,9 g5]al ,! ,secret>y
 %all designate a drug z a drug approv$ 
= a new indication to prev5t1 diagnose1 
or treat a r>e disease or condition =   
purposes ( grant+ ! ext5sions "u        
subsection 7b7 if--  7,a7 prior to      
approval ( an application or supplem5tal
 application = ! new indication1 ! drug 
0 approv$ or lic5s$ = m>ket+ "u section 
#eje7;c7 ( ?is ,act or section #cea7;a7 
( ! ,public ,heal? ,s]vice ,act1 b 0 n s
 approv$ or lic5s$ = ! new indication2  
7,b7  7i7 ! sponsor ( ! approv$ or      
lic5s$ drug files an application or a   
supplem5tal application = approval ( !  
new indication = use ( ! drug to prev5t1
 diagnose1 or treat ! r>e disease or    
condition2 &  7ii7 ! ,secret>y approves 
! application or supplem5tal            
application2 &  7,c7 ! application or   
supplem5tal application = ! new         
indication conta9s ! cons5t ( !         
applicant to notice be+ giv5 by !       
,secret>y "u p>agraph 7#d7 respect+ !   

designation ( ! drug4  7#b7 ,revocation 
( designation  7,a7 ,9 g5]al ,except z  
provid$ 9 subp>agraph 7,b71 a           
designation "u ?is subsection %all n be 
revok$ = any reason4  7,b7 ,exception ,!
 ,secret>y may revoke a designation ( a 
drug "u p>agraph 7#a7 if ! ,secret>y    
f9ds t ! application or supplem5tal     
application result+ 9 su* designation   
conta9$ an untrue /atem5t ( mat]ial     
fact4  7#c7 ,notification prior to      
discont9uance ( production = solely     
comm]cial reasons ,a designation ( a    
drug "u p>agraph 7#a7 %all be subject to
 ! condition t ! sponsor ( ! drug w     
notify ! ,secret>y ( any discont9uance (
 ! production ( ! drug = solely         
comm]cial reasons at lea/ "o ye> be=e   
su* discont9uance4  7#d7 ,notice to     
public ,notice respect+ ! designation ( 
a drug "u p>agraph 7#a7 %all be made    
available to ! public4  7b7 ,ext5sion   
,if ! ,secret>y designates a drug z a   
drug approv$ = a new indication = a r>e 
disease or condition1 z describ$ 9      

subsection 7a77#a7--  7#a7  7,a7 ! #d-1 
#e-1 & #g-ye> p]iods describ$ 9         
subsections 7c77#c77;,e77ii7 &          
7j77#e77;,f77ii7 ( section #eje1 !      
#c-ye> p]iods describ$ 9 clauses 7iii7 &
 7iv7 ( subsection 7c77#c77;,e7 &       
clauses 7iii7 & 7iv7 ( subsection       
7j77#e77;,f7 ( section #eje1 & ! #g-ye> 
p]iod describ$ 9 section #ebg1 z        
applicable1 %all be ext5d$ by #f mon?s2 
or  7,b7 ! #d- & #ab-ye> p]iods describ$
 9 subp>agraphs 7,a7 & 7,b7 ( section   
#cea7k77#g7 ( ! ,public ,heal? ,s]vice  
,act & ! #g-ye> p]iod describ$ 9 section
 #ebg1 z applicable1 %all be ext5d$ by  
#f mon?s2 &  7#b7  7,a7 if ! drug is !  
subject ( a li/$ pat5t = :i* a          
c]tification has be5 submitt$ "u        
subsection 7b77#b77;,a77ii7 or          
7j77#b77;,a77vii77,,ii7 ( section #eje  
or a li/$ pat5t = :i* a c]tification has
 be5 submitt$ "u subsections            
7b77#b77;,a77iii7 or                    
7j77#b77;,a77vii77,,iii7 ( section #eje1
 ! p]iod dur+ :i* an application may n  

be approv$ "u section #eje7;c77#c7 or   
section #eje7;j77#e77;,b7 %all be ext5d$
 by a p]iod ( #f mon?s aft] ! date !    
pat5t expires 7includ+ any pat5t        
ext5sions72 or  7,b7 if ! drug is !     
subject ( a li/$ pat5t = :i* a          
c]tification has be5 submitt$ "u        
subsection 7b77#b77;,a77iv7 or          
7j77#b77;,a77vii77,,iv7 ( section #eje1 
& 9 ! pat5t infr+em5t litigation result+
 f ! c]tification ! c\rt det]m9es t !   
pat5t is valid & w\ld be infr+$1 ! p]iod
 dur+ :i* an application may n be       
approv$ "u section #eje7;c77#c7 or      
section #eje7;j77#e77;,b7 %all be ext5d$
 by a p]iod ( #f mon?s aft] ! date !    
pat5t expires 7includ+ any pat5t        
ext5sions74  7c7 ,relation to p$iatric &
 qualifi$ infecti\s disease product     
exclusivity ,any ext5sion "u subsection 
7b7 ( a p]iod %all be 9 addition to any 
ext5sion ( ! p]iods "u sections #eje;,a 
& #eje;,e ( ?is ,act & section #cea7m7 (
 ! ,public ,heal? ,s]vice ,act1 z       
applicable1 ) respect to ! drug4  7d7   

,limitations ,! ext5sion describ$ 9     
subsection 7b7 %all n apply if ! drug   
designat$ "u subsection 7a77#a7 has     
previ\sly receiv$ an ext5sion by        
op]ation ( subsection 7b74  7e7         
,def9ition ,9 ?is section1 ! t]m r>e    
disease or condition has ! mean+ giv5 to
 su* t]m 9 section #ebf7;a77#b74  4  7b7
 ,application ,section #eje;,f ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z
 add$ by subsection 7a71 applies only ) 
respect to a drug = :i* an application  
or supplem5tal application describ$ 9   
subsection 7a77#a77;,b77i7 ( su* section
 #eje;,f is fir/ approv$ "u section     
#eje7;c7 ( su* ,act 7#ba ,u4,s4,c4      
#cee7;c77 or section #cea7;a7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a77 on or aft] ! date ( 
! enactm5t ( ?is ,act4  7c7 ,con=m+     
am5dm5ts  7#a7 ,relation to p$iatric    
exclusivity = drugs ,section #eje;,a ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee;a7 is am5d$-- 7,a7 9
 subsection 7b71 by add+ at ! end !     

foll[+3  7#c7 ,relation to exclusivity =
 a drug approv$ = a new indication = a  
r>e disease or condition ,not)/&+ !     
ref]5ces 9 subsection 7b77#a7 to ! l5g?s
 ( ! exclusivity p]iods aft] application
 ( p$iatric exclusivity1 ! #f-mon?      
ext5sions describ$ 9 subsection 7b77#a7 
%all be 9 addition to any ext5sions "u  
section #eje;,f4  2 &  7,b7 9 subsection
 7c71 by add+ at ! end ! foll[+3  7#c7  
,relation to exclusivity = a drug       
approv$ = a new indication = a r>e      
disease or condition ,not)/&+ ! ref]5ces
 9 subsection 7c77#a7 to ! l5g?s ( !    
exclusivity p]iods aft] application (   
p$iatric exclusivity1 ! #f-mon?         
ext5sions describ$ 9 subsection 7c77#a7 
%all be 9 addition to any ext5sions "u  
section #eje;,f4  4  7#b7 ,relation to  
exclusivity = new qualifi$ infecti\s    
disease products t are drugs ,subsection
 7b7 ( section #eje;,e ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee;f7 is am5d$--  7,a7 by am5d+ !     
subsection head+ to read z foll[s3      

,relation to p$iatric exclusivity &     
exclusivity = a drug approv$ = a new    
indication = a r>e disease or condition2
 &  7,b7 by /rik+ any ext5sion ( ! p]iod
 "u section #eje;,a & ins]t+ any        
ext5sion ( ! p]iods "u sections #eje;,a 
& #eje;,f1 z applicable14  7#c7         
,relation to p$iatric exclusivity =     
biological products ,section #cea7m7 ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb7m77 is am5d$ by add+ at !
 end ! foll[+3  7#e7 ,relation to       
exclusivity = a biological product      
approv$ = a new indication = a r>e      
disease or condition ,not)/&+ ! ref]5ces
 9 p>agraphs 7#b77;,a71 7#b77;,b71      
7#c77;,a71 & 7#c77;,b7 to ! l5g?s ( !   
exclusivity p]iods aft] application (   
p$iatric exclusivity1 ! #f-mon?         
ext5sions describ$ 9 su* p>agraphs %all 
be 9 addition to any ext5sions "u       
section #eje;,f4  4