,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bdaf  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ai1 #bjae ,mr4  
,burgess introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
evaluate ! pot5tial use ( evid5ce f     
cl9ical exp]i5ce to help support !      
approval ( new indications = approv$    
drugs1 & = o!r purposes4  #a4 ,utiliz+  
evid5ce f cl9ical exp]i5ce ,*apt] ,v ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
is am5d$ by ins]t+ aft] section #eje;,e 
( su* ,act 7#ba ,u4,s4,c4 #cee;f7 !     
foll[+3  #eje;,f4 ,utiliz+ evid5ce f    
cl9ical exp]i5ce  7a7 ,9 g5]al ,!       
,secret>y %all e/abli% a program to     
evaluate ! pot5tial use ( evid5ce f     
cl9ical exp]i5ce--  7#a7 to help support
 ! approval ( a new indication = a drug 
approv$ "u section #eje7;b72 &  7#b7 to 
help support or satisfy po/-approval    
/udy requirem5ts4  7b7 ,evid5ce f       
cl9ical exp]i5ce def9$ ,9 ?is section1 !

 t]m evid5ce f cl9ical exp]i5ce means   
data reg>d+ ! usage1 or pot5tial b5efits
 or risks1 ( a drug d]iv$ f s\rces o!r  
?an r&omiz$ cl9ical trials1 includ+ f   
obs]vational /udies1 regi/ries1 &       
!rapeutic use4  7c7 ,program framework  
7#a7 ,9 g5]al ,n lat] ?an #ah mon?s aft]
 ! date ( enactm5t ( ?is section1 !     
,secret>y %all e/abli% a draft framework
 = implem5tation ( ! program "u ?is     
section4  7#b7 ,cont5ts ( framework ,!  
framework %all include in=mation        
describ+-- 7,a7 ! curr5t s\rces ( data  
develop$ ?r\gh cl9ical exp]i5ce1 includ+
 ongo+ safety surveillance1 regi/ry1    
claims1 & pati5t-c5t]$ outcomes rese>*  
activities2  7,b7 ! gaps 9 curr5t data  
collection activities2  7,c7 ! curr5t   
/&>ds & me?odologies = collection &     
analysis ( data g5]at$ ?r\gh cl9ical    
exp]i5ce2 &  7,d7 ! priority areas1     
rema9+ *all5ges1 & pot5tial pilot       
opportunities t ! program e/abli%$ "u   
?is section w address4  7#c7            
,consultation  7,a7 ,9 g5]al ,9 develop+

 ! program framework "u ?is subsection1 
! ,secret>y %all consult ) regulat$     
indu/ry1 academia1 m$ical pr(essional   
organizations1 repres5tatives ( pati5t  
advocacy organizations1 disease rese>*  
f\ndations1 & o!r int]e/$ p>ties4  7,b7 
,process ,! consultation "u subp>agraph 
7,a7 may be c>ri$ out ?r\gh approa*es   
su* z-- 7i7 a public-private p>tn]%ip ) 
! entities describ$ 9 su* subp>agraph1 9
 :i* ! ,secret>y may p>ticipate2 or     
7ii7 a contract1 grant1 or o!r          
arrangem5t1 z det]m9$ appropriate by !  
,secret>y ) su* a p>tn]%ip or an        
indep5d5t rese>* organization4  7d7     
,program implem5tation ,! ,secret>y     
%all1 n lat] ?an #bd mon?s aft] ! date (
 enactm5t ( ?is section & 9 accordance )
 ! framework e/abli%$ "u subsection 7c71
 implem5t ! program to evaluate !       
pot5tial use ( evid5ce f cl9ical        
exp]i5ce4  7e7 ,guidance = indu/ry ,!   
,secret>y %all-- 7#a7 utilize ! program 
e/abli%$ 9 subsection 7d71 its          
activities1 & any subsequ5t pilots or   

writt5 reports1 to in=m a guidance =    
indu/ry on--  7,a7 ! circum/ances "u :i*
 sponsors ( drugs & ! ,secret>y may rely
 on evid5ce f cl9ical exp]i5ce = !      
purposes describ$ 9 subsections 7a77#a7 
or 7a77#b72 &  7,b7 ! appropriate /&>ds 
& me?odologies = collection & analysis (
 evid5ce f cl9ical exp]i5ce submitt$ =  
su* purposes2  7#b7 n lat] ?an #cf mon?s
 aft] ! date ( enactm5t ( ?is section1  
issue draft guidance = indu/ry z        
describ$ 9 p>agraph 7#a72 &  7#c7 n lat]
 ?an #dh mon?s aft] ! date ( enactm5t ( 
?is section1 aft] provid+ an opportunity
 = public comm5t on ! draft guidance1   
issue f9al guidance4  7f7 ,rule (       
con/ruction  7#a7 ,subject to p>agraph  
7#b71 no?+ 9 ?is section prohibits !    
,secret>y f us+ evid5ce f cl9ical       
exp]i5ce = purposes n specifi$ 9 ?is    
section1 provid$ ! ,secret>y det]m9es t 
suffici5t basis exi/s = any su*         
non-specifi$ use4  7#b7 ,?is section    
%all n be con/ru$ to alt]--  7,a7 !     
/&>ds ( evid5ce "u-- 7i7 subsection 7c7 

or 7d7 ( section #eje1 includ+ !        
sub/antial evid5ce /&>d 9 su* subsection
 7d72 or  7ii7 section #cea7;a7 ( !     
,public ,heal? ,s]vice ,act2 or  7,b7 ! 
,secret>y's au?ority to require         
po/-approval /udies or cl9ical trials1  
or ! /&>ds ( evid5ce "u :i* /udies or   
trials are evaluat$4  4