,i  #aag? ,,congress  #a/ ,session  ,h4 
,r4 #ddgb  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,july #af1 #bjba ,ms4 
,matsui 7= h]self & ,mr4 ,w5/rup7       
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to /r5g!n ! use (              
pati5t-exp]i5ce data )9 ! b5efit-risk   
framework = approval ( new drugs4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,bett] ,emp[]m5t ,n[ to ,enhance        
,framework & ,improve ,treatm5ts ,act ( 
#bjba or ! ,,b5efit ,act ( #bjba4  #b4  
,/r5g!n+ ! use ( pati5t-exp]i5ce data )9
 b5efit-risk framework ,section #efi;,c 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is   
am5d$--  7#a7 9 subsection 7a77#a7--    
7,a7 9 subp>agraph 7,a71 by /rik+ 2 & & 
ins]t+ a semicolon2  7,b7 9 subp>agraph 
7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 &  
7,c7 by add+ at ! end ! foll[+3  7,c7 z 
"p ( ! risk-b5efit assessm5t framework 9
 ! new drug approval process describ$ 9 
section #eje7;d71 consid]+ relevant     

pati5t-focus$ drug developm5t data1 su* 
z data f pati5t pref]5ce /udies         
7b5efit-risk71 pati5t report$ outcome   
data1 or pati5t exp]i5ce data1 develop$ 
by ! sponsor ( an application or ano!r  
p>ty4  2 &  7#b7 9 subsection 7b77#a71  
by ins]t+ 1 includ+ a description ( h[  
su* data & in=mation 7 consid]$ 9 !     
risk-b5efit assessm5t describ$ 9 section
 #eje7;d7 be=e ! p]iod4