#aaf? ,,congress  #b;d ,session  ,s4    
#afcf  ,,an ,,act  ,to am5d ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act ) respect
 to ! scope ( new *emical exclusivity4  
#a4 ,cl>ify+ ! mean+ ( new *emical      
entity  7a7 ,9 g5]al ,*apt] ,v ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act is
 am5d$-- 7#a7 9 section #eje 7#ba       
,u4,s4,c4 #cee7-- 7,a7 9 subsection     
7c77#c77;,e71 by /rik+ active +r$i5t    
7includ+ any e/] or salt ( ! active     
+r$i5t7 ea* place x appe>s & ins]t+     
active moiety 7z def9$ by ! ,secret>y 9 
section #cad4c ( title #ba1 ,code (     
,f$]al ,regulations 7or any successor   
regulations772  7,b7 9 subsection       
7j77#e77;,f71 by /rik+ active +r$i5t    
7includ+ any e/] or salt ( ! active     
+r$i5t7 ea* place x appe>s & ins]t+     
active moiety 7z def9$ by ! ,secret>y 9 
section #cad4c ( title #ba1 ,code (     
,f$]al ,regulations 7or any successor   
regulations772  7,c7 9 subsection       
7l77#b77;,a7-- 7i7 by am5d+ clause 7i7  
to read z foll[s3  7i7 n lat] ?an #cj   

days aft] ! date ( approval ( su*       
applications-- 7,i7 = a drug1 no active 
moiety 7z def9$ by ! ,secret>y 9 section
 #cad4c ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations77 ( :i* has be5 approv$ 9   
any o!r application "u ?is section2 or  
7,,ii7 = a biological product1 no active
 +r$i5t ( :i* has be5 approv$ 9 any o!r 
application "u section #cea ( ! ,public 
,heal? ,s]vice ,act2 &  2 &  7ii7 9     
clause 7ii71 by ins]t+ or biological    
product be=e ! p]iod2  7,d7 by am5d+    
subsection 7s7 to read z foll[s3  7s7   
,ref]ral to advisory committee ,!       
,secret>y %all-- 7#a7 ref] a drug or    
biological product to a ,food & ,drug   
,adm9i/ration advisory committee =      
review at a meet+ ( su* advisory        
committee prior to ! approval ( su* drug
 or biological if x is-- 7,a7 a drug1 no
 active moiety 7z def9$ by ! ,secret>y 9
 section #cad4c ( title #ba1 ,code (    
,f$]al ,regulations 7or any successor   
regulations77 ( :i* has be5 approv$ 9   

any o!r application "u ?is section2 or  
7,b7 a biological product1 no active    
+r$i5t ( :i* has be5 approv$ 9 any o!r  
application "u section #cea ( ! ,public 
,heal? ,s]vice ,act2 or  7#b7 if !      
,secret>y does n ref] a drug or         
biological product describ$ 9 p>agraph  
7#a7 to a ,food & ,drug ,adm9i/ration   
advisory committee prior to su*         
approval1 provide 9 ! action lett] on ! 
application = ! drug or biological      
product a summ>y ( ! reasons :y !       
,secret>y did n ref] ! drug or          
biological product to an advisory       
committee prior to approval4  2 &  7,e7 
9 subsection 7u77#a71 9 ! matt] prec$+  
subp>agraph 7,a7-- 7i7 by /rik+ active  
+r$i5t 7includ+ any e/] or salt ( !     
active +r$i5t7 & ins]t+ active moiety 7z
 def9$ by ! ,secret>y 9 section #cad4c (
 title #ba1 ,code ( ,f$]al ,regulations 
7or any successor regulations772 &  7ii7
 by /rik+ same active +r$i5t & ins]t+   
same active moiety2  7#b7 9 section     
#eab7;c77#b77;,f7 7#ba ,u4,s4,c4        

#cfj;b7c77#b77;,f771 by /rik+ active    
+r$i5t 7includ+ any e/] or salt ( !     
active +r$i5t7 ea* place x appe>s &     
ins]t+ active moiety 7z def9$ by !      
,secret>y 9 section #cad4c ( title #ba1 
,code ( ,f$]al ,regulations 7or any     
successor regulations772  7#c7 9 section
 #ebd7;a77#d7 7#ba ,u4,s4,c4            
#cfjn7a77#d771 by am5d+ subp>agraph 7,c7
 to read z foll[s3  7,c7 is =-- 7i7 a   
human drug1 no active moiety 7z def9$ by
 ! ,secret>y 9 section #cad4c ( title   
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulations77 ( :i* has be5  
approv$ 9 any o!r application "u section
 #eje7;b77#a72 or  7ii7 a biological    
product1 no active +r$i5t ( :i* has be5 
approv$ 9 any o!r application "u section
 #cea ( ! ,public ,heal? ,s]vice ,act4  
2  7#d7 9 section #ebi7;a77#d7 7#ba     
,u4,s4,c4 #ba ,u4,s4,c4 #cfj;ff7a77#d771
 by /rik+ subp>agraphs 7,a7 & 7,b7 &    
ins]t+ ! foll[+3  7,a7 is = a drug or   
biological product t is = ! prev5tion or
 treatm5t ( a r>e p$iatric disease2     

7,b7 7i7 is = su* a drug-- 7,i7 t       
conta9s no active moiety 7z def9$ by !  
,secret>y 9 section #cad4c ( title #ba1 
,code ( ,f$]al ,regulations 7or any     
successor regulations77 t has be5       
previ\sly approv$ 9 any o!r application 
"u subsection 7b77#a71 7b77#b71 or 7j7 (
 section #eje2 &  7,,ii7 t is ! subject 
( an application submitt$ "u section    
#eje7;b77#a72 or  7ii7 is = su* a       
biological product-- 7,i7 t conta9s no  
active +r$i5t t has be5 previ\sly       
approv$ 9 any o!r application "u section
 #cea7;a7 or #cea7k7 ( ! ,public ,heal? 
,s]vice ,act2 &  7,,ii7 t is ! subject (
 an application submitt$ "u section     
#cea7;a7 ( ! ,public ,heal? ,s]vice     
,act2  2 &  7#e7 9 section              
#efe;,a7a77#d7 7#ba ,u4,s4,c4           
#cfj;bbb-#d;a7a77#d771 by am5d+         
subp>agraph 7,d7 to read z foll[s3  7,d7
 is =-- 7i7 a human drug1 no active     
moiety 7z def9$ by ! ,secret>y 9 section
 #cad4c ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          

regulations77 ( :i* has be5 approv$ 9   
any o!r application "u section          
#eje7;b77#a72 or  7ii7 a biological     
product1 no active +r$i5t ( :i* has be5 
approv$ 9 any o!r application "u section
 #cea ( ! ,public ,heal? ,s]vice ,act4  
4  7b7 ,te*nical corrections ,*apt] ,v (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cea et seq7 is am5d$-- 
7#a7 9 section #eje 7#ba ,u4,s4,c4      
#cee7-- 7,a7 9 subsection 7c77#c77;,e71 
by repeal+ clause 7i72 &  7,b7 9        
subsection 7j77#e77;,f71 by repeal+     
clause 7i72 &  7#b7 9 section           
#eje;,a7c77#a77;,a77i77,,ii7 7#ba       
,u4,s4,c4 #cee;a7c77#a77;,a77i77,,ii771 
by /rik+ 7c77#c77;,d7 & ins]t+          
7c77#c77;,e74  ,pass$ ! ,s5ate ,decemb] 
#ad1 #bjbj4,secret>y