,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bedg  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ba1 #bjae ,mrs4 
,mc,morris ,rodg]s introduc$ ! foll[+   
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
to provide = ! developm5t ( accel]at$   
approval developm5t plans =             
inve/igational drugs & biological       
products4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,surrogate ,endpo9t        
,improvem5t & ,utilization ,act ( #bjae4
  #b4 ,accel]at$ approval developm5t    
plan  7a7 ,9 g5]al ,section #ejf ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cef7 is am5d$ by add+ ! 
foll[+ subsection3  7g7 ,accel]at$      
approval developm5t plan  7#a7 ,9 g5]al 
,9 ! case ( a drug det]m9$ to be        
eligible = accel]at$ approval "u        
subsection 7c71 at any "t aft] !        
submission ( an application = !         
inve/igation ( ! drug "u section        
#eje7;i7 ( ?is ,act or section          

#cea7;a77#c7 ( ! ,public ,heal? ,s]vice 
,act1 ! sponsor ( su* drug may          
volunt>ily reque/ agreem5t by !         
,secret>y to an accel]at$ approval      
developm5t plan ) respect to a surrogate
 endpo9t to be us$ to /udy ! drug4  7#b7
 ,plan ,a plan describ$ 9 p>agraph 7#a7 
%all include agreem5t on-- 7,a7 !       
surrogate endpo9t to be assess$ "u !    
plan2  7,b7 ! design ( ! /udy t w       
utilize ! surrogate endpo9t2 &  7,c7 !  
magnitude ( ! effect ( ! drug on !      
surrogate endpo9t t is ! subject ( !    
agreem5t t w\ld be suffici5t to =m !    
prim>y basis ( a claim t ! drug is      
effective4  7#c7 ,modification2         
t]m9ation ,! ,secret>y may require !    
sponsor ( a drug t is ! subject ( an    
accel]at$ approval developm5t plan to   
modify or t]m9ate ! plan if additional  
data or in=mation indicates t--  7,a7 ! 
plan z orig9ally agre$ ^u is no long]   
suffici5t to demon/rate ! safety &      
effectiv5ess ( ! drug involv$2 or  7,b7 
! drug is no long] eligible = accel]at$ 

approval "u subsection 7c74  7#d7       
,sponsor consultation ,if ! ,secret>y   
requires ! modification or t]m9ation (  
an accel]at$ approval developm5t plan "u
 p>agraph 7#c71 ! sponsor %all be grant$
 a reque/ = a meet+ to discuss ! basis (
 ! ,secret>y's decision be=e ! effective
 date ( ! modification or t]m9ation4    
7#e7 ,def9ition ,9 ?is section1 ! t]m   
accel]at$ approval developm5t plan means
 a developm5t plan agre$ ^u by !        
,secret>y & ! sponsor submitt+ ! plan t 
conta9s /udy p>amet]s = ! use ( a       
surrogate endpo9t t--  7,a7 is          
reasonably likely to pr$ict cl9ical     
b5efit2 &  7,b7 is int5d$ to be ! basis 
( ! accel]at$ approval ( a drug "u      
subsection 7c74  4  7b7 ,te*nical       
am5dm5ts ,section #ejf ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cef7 is am5d$-- 7#a7 by /rik+ 7f7      
,aw>5ess ef=ts & ins]t+ 7e7 ,aw>5ess    
ef=ts2 &  7#b7 by /rik+ 7e7 ,con/ruction
 & ins]t+ 7f7 ,con/ruction4