,i  #aacth ,,congress  #ast ,session    
,h4 ,r4 #bihe  ,,in ,,the ,,house ,,of  
,,representatives  ,august #b1 #bjac    
,mr4 ,chaffetz 7for himself1 ,mr4       
,coble1 and ,mr4 ,salmon7 introduced the
 following bill2 which was referred to  
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend section #eje of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act to provide incentives for the      
development of new combination drugs4   
#a4 ,short title ,this ,act may be cited
 as the ,combination ,drug ,development 
,incentive ,act of #bjac 4  #b4         
,applicability to combination drugs     
submitted under a new drug application  
7a7 ,in general ,clause 7ii7 of section 
#eje7;c77#c77;,e7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee7;c77#c77;,e77ii77 is     
amended--  7#a7 by striking 7ii7 ,if an 
application submitted under subsection  
7b7 for a drug1 no active ingredient    
7including any ester or salt of the     
active ingredient7 of which has been    

approved in any other application under 
subsection 7b71 and inserting 7ii77,i7  
,if an application submitted under      
subsection 7b7 for a drug1 and described
 in subclause 7,,ii7 or 7,,iii712 and   
7#b7 by adding at the end the following3
  7,,ii7 ,an application is described in
 this subclause if no active ingredient 
7including any ester or salt of the     
active ingredient7 of the drug for which
 the application has been submitted has 
been approved in any other application  
under subsection 7b74  7,,iii7 ,an      
application is described in this        
subclause if--  7aa7 the application    
contains reports of new clinical        
investigations 7other than              
bioavailability studies7 essential to   
the approval of the application and     
conducted or sponsored by the applicant2
  7bb7 the application is for a drug    
which contains a combination of active  
ingredients2 and  7cc7 no such          
combination of active ingredients has   
been approved in any other application  

under subsection 7b74  4  7b7           
,applicability ,subclause 7,i7 of       
section #eje7;c77#c77;,e77ii7 of the    
,federal ,food1 ,drug1 and ,cosmetic    
,act1 as designated by subsection       
7a77#a71 is amended by striking is      
approved after the date of the enactment
 of this clause and inserting is        
approved after ,january #a1 #bjad1 in   
the case of an application described in 
subclause 7,,ii7 or subclause 7,,iii74  
7c7 ,conforming amendment ,clause 7iii7 
of section #eje7;c77#c77;,e7 of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e77  
is amended by striking ,if and inserting
 ,except as provided in clause 7ii71 if4
  #c4 ,applicability to combination     
drugs submitted under an abbreviated new
 drug application  7a7 ,in general      
,clause 7ii7 of section                 
#eje7;j77#e77;,f7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee7;j77#e77;,f77 is         
amended--  7#a7 by striking 7ii7 ,if an 

application submitted under subsection  
7b7 for a drug1 no active ingredient    
7including any ester or salt of the     
active ingredient7 of which has been    
approved in any other application under 
subsection 7b71 and inserting 7ii77,i7  
,if an application submitted under      
subsection 7b7 for a drug1 and described
 in subclause 7,,ii7 or 7,,iii712 and   
7#b7 by adding at the end the following3
  7,,ii7 ,an application is described in
 this subclause if no active ingredient 
7including any ester or salt of the     
active ingredient7 of the drug for which
 the application has been submitted has 
been approved in any other application  
under subsection 7b74  7,,iii7 ,an      
application is described in this        
subclause if--  7aa7 the application    
contains reports of new clinical        
investigations 7other than              
bioavailability studies7 essential to   
the approval of the application and     
conducted or sponsored by the applicant2
  7bb7 the application is for a drug    

which contains a combination of active  
ingredients2 and  7cc7 no such          
combination of active ingredients has   
been approved in any other application  
under subsection 7b74  4  7b7           
,applicability ,subclause 7,i7 of       
section #eje7;j77#e77;,f7 of the        
,federal ,food1 ,drug1 and ,cosmetic    
,act1 as designated by subsection       
7a77#a71 is amended by striking is      
approved after the date of the enactment
 of this subsection and inserting is    
approved after ,january #a1 #bjad1 in   
the case of an application described in 
subclause 7,,ii7 or subclause 7,,iii74  
7c7 ,conforming amendment ,clause 7iii7 
of section #eje7;j77#e77;,f7 of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,f77  
is amended by striking ,if and inserting
 ,except as provided in clause 7ii71 if4