,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #bbdd  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #bh1 #bjag,mr4 
,lance 7= himself & ,ms4 ,de,gette7     
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to direct ! ,secret>y ( ,heal? 
& ,human ,s]vices to c>ry out a pilot   
project "u :i* no m ?an #c sponsors     
agree to evaluate ! psy*ological &      
social di/ress exp]i5c$ by pati5ts      
p>ticipat+ 9 a cl9ical trial1 conduct$  
by ! respective sponsor1 ( a drug or    
biological product t is int5d$ to treat 
a s]i\s or life-?reat5+ disease or      
condition1 & = o!r purposes4  #a4 ,%ort 
title ,?is ,act may be cit$ z ! ,pati5t 
,exp]i5ce 9 ,rese>* ,act ( #bjag4  #b4  
,pilot project = evaluation (           
psy*ological & social di/ress exp]i5c$  
by pati5ts 9 c]ta9 cl9ical trials  7a7  
,9 g5]al ,! ,secret>y %all c>ry out a   
pilot project "u :i*--  7#a7 no m ?an #c
 sponsors ea* agree to evaluate-- 7,a7 !
 psy*ological & social di/ress exp]i5c$ 

by pati5ts p>ticipat+ 9 a qualifi$      
cl9ical trial1 conduct$ by ! respective 
sponsor1 ( a drug or biological product 
t is int5d$ to treat a s]i\s or         
life-?reat5+ disease or condition2 &    
7,b7 ! effects ( provid+ psy*ological & 
social support to any su* pati5ts %[+   
signs ( di/ress on ! prim>y outcome     
measures 9 ! cl9ical trial2 &  7#b7 !   
,secret>y waives ! fee t w\ld o!rwise   
apply "u section #gcf7;a77#a7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cgi;h7a77#a77 to ! submission
 by ! respective sponsor ( "o human drug
 application = su* drug or biological   
product t includes ! data result+ f su* 
evaluation4  7b7 ,selection ,! ,secret>y
 %all select ! sponsors ref]r$ to 9     
subsection 7a7 on a competitive basis n 
lat] ?an ! date t is #b ye>s aft] ! date
 ( enactm5t ( ?is ,act4  7c7 ,meet+ ,!  
,secret>y %all grant at lea/ "o meet+ to
 ea* sponsor select$ "u subsection 7b7 =
 ! specific purpose ( discuss+ !        
activities to be c>ri$ out by ! sponsor 

pursuant to ?is ,act4  7d7 ,def9itions  
,9 ?is ,act3 7#a7 ,! t]m biological     
product has ! mean+ giv5 to su* t]m 9   
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb74  7#b7 ,! t]m 
drug has ! mean+ giv5 to su* t]m 9      
section #bja ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cba74    
7#c7 ,! t]m human drug application has !
 mean+ giv5 to su* t]m 9 section #gce ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cgi;g74  7#d7 ,! t]m    
qualifi$ cl9ical trial means a cl9ical  
trial 9 :i* all p>ticipat+ pati5ts w be 
enroll$ n lat] ?an ! date t is #e ye>s  
aft] ! date ( ! enactm5t ( ?is ,act4    
7#e7 ,! t]m ,secret>y means ! ,secret>y 
( ,heal? & ,human ,s]vices1 act+ ?r\gh !
 ,commission] ( ,food & ,drugs4  7#f7 ,!
 t]m sponsor means ! sponsor ( a drug or
 biological product4