,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #bihe  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,augu/ #b1 #bjac ,mr4 
,*affetz 7= himself1 ,mr4 ,coble1 & ,mr4
 ,salmon7 introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce  ,a ,,bill  ,to am5d section   
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act to provide inc5tives = ! 
developm5t ( new comb9ation drugs4  #a4 
,%ort title ,?is ,act may be cit$ z !   
,comb9ation ,drug ,developm5t ,inc5tive 
,act ( #bjac 4  #b4 ,applicability to   
comb9ation drugs submitt$ "u a new drug 
application  7a7 ,9 g5]al ,clause 7ii7 (
 section #eje7;c77#c77;,e7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;c77#c77;,e77ii77 is     
am5d$--  7#a7 by /rik+ 7ii7 ,if an      
application submitt$ "u subsection 7b7 =
 a drug1 no active +r$i5t 7includ+ any  
e/] or salt ( ! active +r$i5t7 ( :i* has
 be5 approv$ 9 any o!r application "u   
subsection 7b71 & ins]t+ 7ii77,i7 ,if an
 application submitt$ "u subsection 7b7 

= a drug1 & describ$ 9 subclause 7,,ii7 
or 7,,iii712 &  7#b7 by add+ at ! end ! 
foll[+3  7,,ii7 ,an application is      
describ$ 9 ?is subclause if no active   
+r$i5t 7includ+ any e/] or salt ( !     
active +r$i5t7 ( ! drug = :i* !         
application has be5 submitt$ has be5    
approv$ 9 any o!r application "u        
subsection 7b74  7,,iii7 ,an application
 is describ$ 9 ?is subclause if--  7aa7 
! application conta9s reports ( new     
cl9ical inve/igations 7o!r ?an          
bioavailability /udies7 ess5tial to !   
approval ( ! application & conduct$ or  
sponsor$ by ! applicant2  7bb7 !        
application is = a drug :i* conta9s a   
comb9ation ( active +r$i5ts2 &  7cc7 no 
su* comb9ation ( active +r$i5ts has be5 
approv$ 9 any o!r application "u        
subsection 7b74  4  7b7 ,applicability  
,subclause 7,i7 ( section               
#eje7;c77#c77;,e77ii7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act1 z designat$ by 
subsection 7a77#a71 is am5d$ by /rik+ is
 approv$ aft] ! date ( ! enactm5t ( ?is 

clause & ins]t+ is approv$ aft] ,janu>y 
#a1 #bjad1 9 ! case ( an application    
describ$ 9 subclause 7,,ii7 or subclause
 7,,iii74  7c7 ,con=m+ am5dm5t ,clause  
7iii7 ( section #eje7;c77#c77;,e7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;c77#c77;,e77 is    
am5d$ by /rik+ ,if & ins]t+ ,except z   
provid$ 9 clause 7ii71 if4  #c4         
,applicability to comb9ation drugs      
submitt$ "u an abbreviat$ new drug      
application  7a7 ,9 g5]al ,clause 7ii7 (
 section #eje7;j77#e77;,f7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#e77;,f77 is am5d$-- 
7#a7 by /rik+ 7ii7 ,if an application   
submitt$ "u subsection 7b7 = a drug1 no 
active +r$i5t 7includ+ any e/] or salt (
 ! active +r$i5t7 ( :i* has be5 approv$ 
9 any o!r application "u subsection 7b71
 & ins]t+ 7ii77,i7 ,if an application   
submitt$ "u subsection 7b7 = a drug1 &  
describ$ 9 subclause 7,,ii7 or 7,,iii712
 &  7#b7 by add+ at ! end ! foll[+3     
7,,ii7 ,an application is describ$ 9 ?is

 subclause if no active +r$i5t 7includ+ 
any e/] or salt ( ! active +r$i5t7 ( !  
drug = :i* ! application has be5        
submitt$ has be5 approv$ 9 any o!r      
application "u subsection 7b74  7,,iii7 
,an application is describ$ 9 ?is       
subclause if--  7aa7 ! application      
conta9s reports ( new cl9ical           
inve/igations 7o!r ?an bioavailability  
/udies7 ess5tial to ! approval ( !      
application & conduct$ or sponsor$ by ! 
applicant2  7bb7 ! application is = a   
drug :i* conta9s a comb9ation ( active  
+r$i5ts2 &  7cc7 no su* comb9ation (    
active +r$i5ts has be5 approv$ 9 any o!r
 application "u subsection 7b74  4  7b7 
,applicability ,subclause 7,i7 ( section
 #eje7;j77#e77;,f7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act1 z designat$ by 
subsection 7a77#a71 is am5d$ by /rik+ is
 approv$ aft] ! date ( ! enactm5t ( ?is 
subsection & ins]t+ is approv$ aft]     
,janu>y #a1 #bjad1 9 ! case ( an        
application describ$ 9 subclause 7,,ii7 
or subclause 7,,iii74  7c7 ,con=m+      

am5dm5t ,clause 7iii7 ( section         
#eje7;j77#e77;,f7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#e77;,f77 is am5d$ by /rik+ ,if
 & ins]t+ ,except z provid$ 9 clause    
7ii71 if4