,i  #aaeth ,,congress  #ast ,session    
,h4 ,r4 #bbdd  ,,in ,,the ,,house ,,of  
,,representatives  ,april #bh1 #bjag,mr4
 ,lance 7for himself and ,ms4 ,de,gette7
 introduced the following bill2 which   
was referred to the ,committee on       
,energy and ,commerce  ,a ,,bill  ,to   
direct the ,secretary of ,health and    
,human ,services to carry out a pilot   
project under which no more than #c     
sponsors agree to evaluate the          
psychological and social distress       
experienced by patients participating in
 a clinical trial1 conducted by the     
respective sponsor1 of a drug or        
biological product that is intended to  
treat a serious or life-threatening     
disease or condition1 and for other     
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,patient ,experience
 in ,research ,act of #bjag4  #b4 ,pilot
 project for evaluation of psychological
 and social distress experienced by     
patients in certain clinical trials  7a7
 ,in general ,the ,secretary shall carry

 out a pilot project under which--  7#a7
 no more than #c sponsors each agree to 
evaluate-- 7,a7 the psychological and   
social distress experienced by patients 
participating in a qualified clinical   
trial1 conducted by the respective      
sponsor1 of a drug or biological product
 that is intended to treat a serious or 
life-threatening disease or condition2  
and  7,b7 the effects of providing      
psychological and social support to any 
such patients showing signs of distress 
on the primary outcome measures in the  
clinical trial2 and  7#b7 the ,secretary
 waives the fee that would otherwise    
apply under section #gcf7;a77#a7 of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cgi;h7a77#a77 to   
the submission by the respective sponsor
 of one human drug application for such 
drug or biological product that includes
 the data resulting from such           
evaluation4  7b7 ,selection ,the        
,secretary shall select the sponsors    
referred to in subsection 7a7 on a      

competitive basis not later than the    
date that is #b years after the date of 
enactment of this ,act4  7c7 ,meeting   
,the ,secretary shall grant at least one
 meeting to each sponsor selected under 
subsection 7b7 for the specific purpose 
of discussing the activities to be      
carried out by the sponsor pursuant to  
this ,act4  7d7 ,definitions ,in this   
,act3 7#a7 ,the term biological product 
has the meaning given to such term in   
section #cea of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb74     
7#b7 ,the term drug has the meaning     
given to such term in section #bja of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cba74  7#c7 ,the  
term human drug application has the     
meaning given to such term in section   
#gce of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g74  
7#d7 ,the term qualified clinical trial 
means a clinical trial in which all     
participating patients will be enrolled 
not later than the date that is #e years

 after the date of the enactment of this
 ,act4  7#e7 ,the term ,secretary means 
the ,secretary of ,health and ,human    
,services1 acting through the           
,commissioner of ,food and ,drugs4  7#f7
 ,the term sponsor means the sponsor of 
a drug or biological product4