,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bcch  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ad1 #bjae ,mr4  
,pitts introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
provide = ! developm5t & use ( pati5t   
exp]i5ce data to enhance ! /ructur$     
risk-b5efit assessm5t framework1 & = o!r
 purposes4  #a4 ,developm5t & use (     
pati5t exp]i5ce data to enhance /ructur$
 risk-,b5efit assessm5t framework  7a7  
,9 g5]al ,section #eje ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee7 is am5d$-- 7#a7 9 subsection 7d71 
by /rik+ ,! ,secret>y %all implem5t &   
all t foll[s ?r\gh prem>ket approval ( a
 drug42 &  7#b7 by add+ at ! end !      
foll[+ new subsections3  7x7 ,/ructur$  
risk-,b5efit assessm5t framework  7#a7  
,9 g5]al ,! ,secret>y %all implem5t a   
/ructur$ risk-b5efit assessm5t framework
 9 ! new drug approval process--  7,a7  
to facilitate ! balanc$ consid]ation (  

b5efits & risks2 &  7,b7 to develop &   
implem5t a consi/5t & sy/ematic approa* 
to ! discussion (1 regulatory           
decisionmak+ ) respect to1 & !          
communication (1 ! b5efits & risks ( new
 drugs4  7#b7 ,rule ( con/ruction ,no?+ 
9 p>agraph 7#a7 %all alt] ! crit]ia =   
evaluat+ an application = prem>ket      
approval ( a drug4  7y7 ,developm5t &   
use ( pati5t exp]i5ce data ,to enhance  
/ructur$ risk-,b5efit assessm5t         
framework  7#a7 ,9 g5]al ,n lat] ?an two
 ye>s aft] ! date ( ! enactm5t ( ?is    
subsection1 ! ,secret>y %all e/abli% &  
implem5t processes "u :i*--  7,a7 an    
entity seek+ to develop pati5t exp]i5ce 
data may submit to ! ,secret>y-- 7i7    
initial rese>* concepts = fe$back f !   
,secret>y2 &  7ii7 ) respect to pati5t  
exp]i5ce data collect$ by ! entity1     
draft guidance docum5ts1 complet$ data1 
& summ>ies & analyses ( su* data2  7,b7 
! ,secret>y may reque/ su* an entity to 
submit su* docum5ts1 data1 & summ>ies & 
analyses2 &  7,c7 pati5t exp]i5ce data  

may be develop$ & us$ to enhance !      
/ructur$ risk-b5efit assessm5t framework
 "u subsection 7x74  7#b7 ,pati5t       
exp]i5ce data ,9 ?is subsection1 ! t]m  
pati5t exp]i5ce data means data collect$
 by pati5ts1 p>5ts1 c>egiv]s1 pati5t    
advocacy organizations1 disease rese>*  
f\ndations1 m$ical rese>*]s1 rese>*     
sponsors or o!r p>ties det]m9$          
appropriate by ! ,secret>y t is int5d$  
to facilitate or enhance ! ,secret>y's  
risk-b5efit assessm5ts1 includ+         
in=mation ab\t ! impact ( a disease or a
 !rapy on pati5ts' lives4  4  7b7       
,guidance  7#a7 ,9 g5]al ,! ,secret>y ( 
,heal? & ,human ,s]vices %all publi%    
guidance on ! implem5tation ( subsection
 7y7 ( section #eje ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee71 z add$ by subsection 7a74 ,su*   
guidance %all include-- 7,a7 ) respect  
to draft guidance docum5ts1 data1 or    
summ>ies & analyses submitt$ to !       
,secret>y "u p>agraph 7#a77;,a7 ( su*   
subsection1 guidance--  7i7 specify+ !  

timel9es = ! review ( su* docum5ts1     
data1 or summ>ies & analyses by !       
,secret>y2 &  7ii7 on h[ ! ,secret>y w  
use su* docum5ts1 data1 or summ>ies &   
analyses to update any guidance docum5ts
 publi%$ "u ?is subsection or publi% new
 guidance2  7,b7 ) respect to !         
collection & analysis ( pati5t exp]i5ce 
data 7z def9$ 9 p>agraph 7#b7 ( su*     
subsection 7y771 guidance on-- 7i7      
me?odological consid]ations = !         
collection ( pati5t exp]i5ce data1 :i*  
may include /ructur$ approa*es to ga!r+ 
in=mation on--  7,i7 ! exp]i5ce ( a     
pati5t liv+ ) a p>ticul> disease2       
7,,ii7 ! burd5 ( liv+ ) or manag+ !     
disease2  7,,iii7 ! impact ( ! disease  
on daily life & long-t]m function+2 &   
7,,iv7 ! effect ( curr5t !rapeutic      
options on diff]5t aspects ( ! disease2 
&  7ii7 ! e/abli%m5t & ma9t5ance (      
regi/ries design$ to increase und]/&+ ( 
! natural hi/ory ( a disease2  7,c7     
me?odological approa*es t may be us$ to 
assess pati5ts' beliefs ) respect to !  

b5efits & risks 9 ! managem5t ( !       
pati5t's disease2 &  7,d7 me?odologies1 
/&>ds1 & pot5tial exp]im5tal designs =  
pati5t-report$ outcomes4  7#b7 ,tim+ ,n 
lat] ?an ?ree ye>s aft] ! date ( !      
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all issue     
draft guidance on ! implem5tation (     
subsection 7y7 ( section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee71 z add$ by subsection   
7a74 ,! ,secret>y %all issue f9al       
guidance on ! implem5tation ( su*       
subsection n lat] ?an "o ye> aft] ! date
 on :i* ! comm5t p]iod = ! draft        
guidance closes4  7#c7 ,work%ops  7,a7  
,9 g5]al ,n lat] ?an #f mon?s aft] !    
date ( ! enactm5t ( ?is ,act & once e #f
 mon?s dur+ ! foll[+ #ab-mon? p]iod1 !  
,secret>y ( ,heal? & ,human ,s]vices    
%all conv5e a work%op to obta9 input    
reg>d+ me?odologies = develop+ !        
guidance "u p>agraph 7#a71 includ+ !    
collection ( pati5t exp]i5ce data4  7,b7
 ,att5dees ,a work%op conv5$ "u ?is     

p>agraph %all include--  7i7 pati5ts2   
7ii7 repres5tatives f pati5t advocacy   
organizations1 bioph>maceutical         
companies1 & disease rese>* f\ndations2 
7iii7 repres5tatives ( ! review+        
divisions ( ! ,food & ,drug             
,adm9i/ration2 &  7iv7 me?odological    
exp]ts ) significant exp]tise 9 pati5t  
exp]i5ce data4  7#d7 ,public meet+ ,n   
lat] ?an #ij days aft] ! date on :i* !  
draft guidance is publi%$ "u ?is        
subsection1 ! ,secret>y ( ,heal? &      
,human ,s]vices %all conv5e a public    
meet+ to solicit input on ! guidance4