,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #acec  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #ac1 #bjae ,mr4  
,bilirakis 7= himself1 ,mr4 ,connolly1  
,mr4 ,israel1 & ,mr4 ,griffi?7 introduc$
 ! foll[+ bill2 :i* 0 ref]r$ to !       
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to ext5d ! p]iod (     
exclusivity ) respect to c]ta9 drugs1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,promot+ ,access = 
,treatm5ts ,ideal 9 ,enhanc+ ,new       
,!rapies ,act ( #bjae1 or ! ,,pati5t    
,act ( #bjae4  #b4 ,ext5d$ exclusivity  
p]iod = c]ta9 new drug applications &   
abbreviat$ new drug applications  7a7   
,new drug applications ,section         
#eje7;c77#c77;,e7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;c77#c77;,e77 is am5d$ by add+ at !
 end ! foll[+ new clause3  7vi7 ,)      
respect to an application describ$ 9    
clause 7iii7 or a supplem5t to an       
application describ$ 9 clause 7iv71 !   

?ree-ye> p]iod specifi$ 9 su* clause    
%all be ext5d$ = an additional #bd-mon? 
p]iod if ! p]son submitt+ su*           
application or supplem5t provides       
docum5tation to ! ,secret>y demon/rat+  
t-- 7,i7 ! new cl9ical inve/igations    
ess5tial to ! approval ( ! application  
or supplem5t & conduct$ or sponsor$ by !
 p]son submitt+ ! application or        
supplem5t support ! approval ( a new    
indication or use = ! drug t is !       
subject ( ! application or supplem5t2 or
  7,,ii7 ! drug t is ! subject ( !      
application or supplem5t has be5        
re=mulat$ or r$esign$ s t ! drug c      
reasonably 7z det]m9$ by ! ,secret>y 9  
consultation ) ! p]son submitt+ su*     
application or supplem5t7 be expect$--  
7aa7 to promote great] pati5t adh]5ce to
 an approv$ treatm5t regime relative to 
! previ\sly approv$ =mulation or design 
( ! drug2  7bb7 to r$uce ! public-heal? 
risks associat$ ) ! drug relative to !  
previ\sly approv$ =mulation or design ( 
! drug2  7cc7 to r$uce ! mann] or ext5t 

( side effects or adv]se ev5ts associat$
 ) ! previ\sly approv$ =mulation or     
design ( ! drug2  7dd7 to provide       
sy/emic b5efits to ! heal?-c>e sy/em    
relative to ! previ\sly approv$         
=mulation or design ( ! drug2 or  7ee7  
to provide o!r pati5t b5efits t are     
comp>able to ! b5efits describ$ 9 items 
7aa7 ?r\gh 7dd74  4  7b7 ,abbreviat$ new
 drug applications ,section             
#eje7;j77#e77;,f7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#e77;,f77 is am5d$ by add+ at !
 end ! foll[+ new clause3  7vi7 ,)      
respect to an application describ$ 9    
clause 7iii7 or a supplem5t to an       
application describ$ 9 clause 7iv71 !   
?ree-ye> p]iod specifi$ 9 su* clause    
%all be ext5d$ = an additional #bd-mon? 
p]iod if ! p]son submitt+ su*           
application or supplem5t provides       
docum5tation to ! ,secret>y demon/rat+  
t--  7,i7 ! new cl9ical inve/igations   
ess5tial to ! approval ( ! application  
or supplem5t & conduct$ or sponsor$ by !

 p]son submitt+ ! application or        
supplem5t support ! approval ( a new    
indication or use = ! drug t is !       
subject ( ! application or supplem5t2 or
  7,,ii7 ! drug t is ! subject ( !      
application or supplem5t has be5        
re=mulat$ or r$esign$ s t ! drug may    
reasonably 7z det]m9$ by ! ,secret>y 9  
consultation ) ! p]son submitt+ su*     
application or supplem5t7 be expect$--  
7aa7 to promote great] pati5t adh]5ce to
 an approv$ treatm5t regime relative to 
! previ\sly approv$ =mulation or design 
( ! drug2  7bb7 to r$uce ! public-heal? 
risks associat$ ) ! drug relative to !  
previ\sly approv$ =mulation or design ( 
! drug2  7cc7 to r$uce ! mann] or ext5t 
( side effects or adv]se ev5ts associat$
 ) ! previ\sly approv$ =mulation or     
design ( ! drug2  7dd7 to provide       
sy/emic b5efits to ! heal?-c>e sy/em    
relative to ! previ\sly approv$         
=mulation or design ( ! drug2 or  7ee7  
to provide o!r pati5t b5efits t are     
comp>able to ! b5efits describ$ 9 items 

7aa7 ?r\gh 7dd74  4  7c7 ,regulations ,n
 lat] ?an #ahj days aft] ! date ( !     
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all promulgate
 f9al regulations to c>ry out ! am5dm5ts
 made by ?is section1 includ+           
regulations e/abli%+ a process "u :i* ! 
,secret>y consults ) p]sons :o claim    
eligibility = ! ext5sion provid$ by     
clause 7vi7 ( subsection 7c77#c77;,e7 or
 7j77#e77;,f7 ( section #eje ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 7z add$ by subsections  
7a7 & 7b77 reg>d+ h[ ! drug t is !      
subject ( su* a claim may reasonably be 
expect$ to provide a b5efit describ$ 9  
item 7aa71 7bb71 7cc71 7dd71 or 7ee7 (  
clause 7vi77,,ii7 ( ea* su* subsection4