,,ii ,cal5d> ,no4 #dac #aad? ,,congress 
#b;d ,session  ,s4 #aeig  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates  ,june  
#ag1 #bjae,mr4 ,wick] 7= himself1 ,ms4  
,klobu*>1 ,ms4 ,coll9s1 ,mr4 ,frank51   
,mr4 ,isakson1 ,mr4 ,b5net1 ,mr4        
,donnelly1 ,mr4 ,cotton1 & ,ms4         
,murk[ski7 introduc$ ! foll[+ bill2 :i* 
0 read twice & ref]r$ to ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
,april #e1 #bjaf,report$ by ,mr4        
,alex&]1 ) an amendment,strike out all  
aft] ! enact+ clause & ins]t ! "p pr9t$ 
9 italic  ,a ,,bill  ,to enhance pati5t 
engagem5t 9 ! m$ical product developm5t 
process1 & = o!r purposes4  #a4 ,%ort   
title ,?is ,act may be cit$ z !         
,pati5t-,focus$ ,impact ,assessm5t ,act 
( #bjae4  #b4 ,public disclosure (      
safety & effectiv5ess data 9 action     
package ,p>agraph 7#b7 ( section #eje7l7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7l77 is am5d$-- 
7#a7 9 subp>agraph 7,c71 by add+ at !   
end ! foll[+3  7vii7 ,docum5tation ( !  

pati5t engagem5t assessm5t ef=ts made z 
"p ( ! review1 includ+ id5tification ( !
 pati5t-focus$ drug developm5t tools &  
data review$ 9 in=m+ ! decision to      
approve ! application1 & includ+ an     
explanation ( :e!r ! foll[+ 7 review$ or
 exam9$3  7,i7 ,pati5t population b5efit
 & risk data4  7,,ii7 ,draft or f9al    
guidances issu$ by ! ,food & ,drug      
,adm9i/ration4  7,,iii7 ,pati5t-report$ 
or c>egiv]-report$ outcomes data4       
7,,iv7 ,pati5t pref]5ce data4  7,v7     
,p]spectives ( pati5ts s]v+ on advisory 
committees or p>ticipat+ 9 m$ical       
product developm5t proce$+s4  7,,vi7    
,p]spectives ( m$ical & sci5tific       
pr(essionals ) relevant exp]tise4       
7,,vii7 ,o!r measures to assess ! impact
 ( pati5t-focus$ drug developm5t tools1 
z det]m9$ by ! ,secret>y4  2 &  7#b7 by 
add+ at ! end ! foll[+3  7,f7 ,annual   
reports ,! ,secret>y %all prep>e &      
submit to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       

,comm]ce ( ! ,h\se ( ,repres5tatives an 
annual report summ>iz+ ! data collect$ f
 ! action packages "u subp>agraph       
7,c77vii74 ,su* report %all include an  
assessm5t by ! ,food & ,drug            
,adm9i/ration ( ! tr5ds ( su* ag5cy )   
respect to ! use ( pati5t-focus$ drug   
developm5t tools 9 review+ applications 
"u subsection 7b7 & section #cea ( !    
,public ,heal? ,s]vice ,act4  4  #c4    
,guidance to pati5ts & indu/ry on       
pati5t-focus$ drug developm5t  7a7      
,publication ( guidance2 cont5ts ,!     
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y71
 act+ ?r\gh ! ,commission] ( ,food &    
,drugs1 %all publi% guidance t-- 7#a7   
specifies h[ ! ,food & ,drug            
,adm9i/ration views collaboration betwe5
 pati5ts or pati5t advocacy             
organizations & indu/ry sponsors = !    
purposes (--  7,a7 develop+             
pati5t-focus$ drug developm5t tools2 &  
7,b7 obta9+ pati5t p]spectives on m$ical
 products "u developm5t2  7#b7 specifies

 ! position ( ! ,food & ,drug           
,adm9i/ration ) respect to advocacy &   
indu/ry collaborations t w\ld be p]mitt$
 to develop su* tools & obta9 su*       
p]spectives2 &  7#c7 specifies !        
position ( ! ,food & ,drug ,adm9i/ration
 ) respect to activities t w\ld n be    
p]mitt$ = su* purposes4  7b7 ,tim+ ,!   
,secret>y %all-- 7#a7 n lat] ?an #f     
mon?s aft] ! date ( enactm5t ( ?is ,act1
 publi% propos$ guidance "u ?is section2
 &  7#b7 n lat] ?an #f mon?s aft] ! date
 ( publication ( su* propos$ guidance1 &
 aft] provid+ an opportunity = ! public 
to comm5t on su* propos$ guidance1      
publi% f9al guidance "u ?is section4    
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,pati5t-,focus$ ,impact ,assessm5t    
,act ( #bjaf4  #b4 ,pati5t exp]i5ce data
 ,section #efi;,c ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;bbb-#h;c7 is am5d$-- 7#a7 9        
subsection 7a7--  7,a7 9 ! subsection   
head+1 by /rik+ ,9 g5]al & ins]t+       
,pati5t ,engagem5t 9 ,drugs & ,devices2 

7,b7 by r$esignat+ p>agraphs 7#a7 & 7#b7
 z subp>agraphs 7,a7 & 7,b71            
respectively1 & adju/+ ! m>g9s          
accord+ly2 &  7,c7 by /rik+ ,! ,secret>y
 & ins]t+ ! foll[+3  7#a7 ,9 ,g5]al ,!  
,secret>y  2  7#b7 by r$esignat+        
subsections 7b7 ?r\gh 7e7 z p>agraphs   
7#b7 ?r\gh 7#e71 respectively1 & adju/+ 
! m>g9s accord+ly2 &  7#c7 by add+ at ! 
end ! foll[+3  7b7 ,/atem5t ( pati5t    
exp]i5ce  7#a7 ,9 g5]al ,foll[+ !       
approval ( an application t 0 submitt$  
"u section #eje7;b7 ( ?is ,act or       
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 at
 lea/ #f mon?s aft] ! date ( enactm5t ( 
! ,pati5t-,focus$ ,impact ,assessm5t    
,act ( #bjaf1 ! ,secret>y %all make     
public a brief /atem5t reg>d+ ! pati5t  
exp]i5ce data & relat$ in=mation1 if    
any1 submitt$ & review$ z "p ( su*      
application4 ,! ,secret>y %all include 9
 ! /atem5t in=mation on :e!r ! data &   
in=mation describ$ 9 p>agraph 7#b7 7    
submitt$ & review$ z "p ( su*           

application4  7#b7 ,data & in=mation ,! 
data & in=mation ref]r$ to 9 p>agraph   
7#a7 are-- 7,a7 pati5t exp]i5ce data2   
7,b7 in=mation on pati5t-focus$ drug    
developm5t tools2 &  7,c7 o!r relevant  
in=mation1 z det]m9$ by ! ,secret>y4    
7c7 ,pati5t exp]i5ce data ,= purposes ( 
?is section1 ! t]m pati5t exp]i5ce data 
includes data t-- 7#a7 are collect$ by  
any p]sons 7includ+ pati5ts1 family     
memb]s & c>egiv]s ( pati5ts1 pati5t     
advocacy organizations1 disease rese>*  
f\ndations1 rese>*]s1 & drug            
manufactur]s72 &  7#b7 are int5d$ to    
provide in=mation ab\t pati5ts'         
exp]i5ces ) a disease or condition1     
includ+--  7,a7 ! impact ( su* disease  
or condition1 or a relat$ !rapy1 on     
pati5ts' lives2 &  7,b7 pati5t pref]5ces
 ) respect to treatm5t ( su* disease or 
condition4  4  #c4 ,guidance to pati5ts 
& indu/ry on pati5t-focus$ drug         
developm5t  7a7 ,publication ( guidance 
docum5ts ,n lat] ?an #f mon?s aft] !    
date ( enactm5t ( ?is ,act1 ! ,secret>y 

( ,heal? & ,human ,s]vices 7ref]r$ to 9 
?is section z ! ,secret>y71 act+ ?r\gh !
 ,commission] ( ,food & ,drugs1 %all    
develop a plan to issue draft & f9al    
v]sions ( "o or m guidance docum5ts1 ov]
 a p]iod ( #e ye>s1 reg>d+ ! collection 
( pati5t exp]i5ce data1 & ! use ( su*   
data & relat$ in=mation 9 drug          
developm5t4 ,n lat] ?an #ah mon?s aft] t
 date ( enactm5t1 ! ,secret>y %all issue
 a draft v]sion ( at lea/ "o su*        
guidance docum5t4 ,n lat] ?an #a ye>    
aft] ! public comm5t p]iod on ! draft   
docum5t ends1 ! ,secret>y %all issue a  
f9al v]sion ( t docum5t4  7b7 ,pati5t   
exp]i5ce data ,= purposes ( ?is section1
 ! t]m pati5t exp]i5ce data includes    
data t-- 7#a7 are collect$ by any p]sons
 7includ+ pati5ts1 family memb]s &      
c>egiv]s ( pati5ts1 pati5t advocacy     
organizations1 disease rese>*           
f\ndations1 rese>*]s1 & drug            
manufactur]s72 &  7#b7 are int5d$ to    
provide in=mation ab\t pati5ts'         
exp]i5ces ) a disease or condition1     

includ+--  7,a7 ! impact ( su* disease  
or condition1 or a relat$ !rapy1 on     
pati5ts' lives2 &  7,b7 pati5t pref]5ces
 ) respect to treatm5t ( su* disease or 
condition4  7c7 ,cont5ts ,! guidance    
docum5ts describ$ 9 subsection 7a7 %all 
address-- 7#a7 h[ a p]son seek+ to      
collect pati5t exp]i5ce data =          
submission to & propos$ use by ! ,food &
 ,drug ,adm9i/ration 9 regulatory       
decisionmak+ may--  7,a7 submit initial 
concepts ab\t h[ su* p]son plans to ga!r
 pati5t exp]i5ce data2  7,b7 develop &  
collect pati5t exp]i5ce data us+        
me?odologies t--  7i7 ensure data are   
accurate2  7ii7 ensure data are         
repres5tative ( ! int5d$ population2 &  
7iii7 are relevant & objective2 &  7,c7 
submit pati5t exp]i5ce data1 analysis1  
or o!r applicable relat$ in=mation1     
includ+ ?r\gh a regulatory application1 
a public docket1 or o!r means2  7#b7 h[ 
a p]son seek+ to develop & submit       
propos$ draft guidance relat+ to pati5t 
exp]i5ce data = consid]ation by ! ,food 

& ,drug ,adm9i/ration may submit su*    
propos$ draft guidance to ! ,food &     
,drug ,adm9i/ration2  7#c7 ! =mat &     
cont5t requir$ = submissions "u ?is     
section to ! ,food & ,drug              
,adm9i/ration1 includ+ ) respect to !   
in=mation describ$ 9 p>agraph 7#a72     
7#d7 h[ ! ,secret>y int5ds to respond to
 submissions "u p>agraph 7#a71 if       
appropriate giv5 ! mann] 9 :i* a        
submission is made1 includ+ any         
timeframe = response :5 su* submission  
is n "p ( a regulatory application or   
o!r submission t has an associat$       
timeframe = response2 &  7#e7 h[1 :5 !  
,commission] ( ,food & ,drugs det]m9es  
appropriate1 su* ,commission]           
anticipates us+ relevant pati5t exp]i5ce
 data & relat$ in=mation1 includ+ )     
respect to ! /ructur$ risk-b5efit       
assessm5t framework describ$ 9 section  
#eje7;d7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d774
  #d4 ,pati5t input exempt f pap]work   
r$uction act ,*apt] #ce ( title #dd1    

,unit$ ,/ates ,code1 %all n apply to    
collections ( in=mation to :i* a        
response is volunt>y1 t are initiat$ by 
! ,secret>y "u section #c ( !           
,pati5t-,focus$ ,impact ,assessm5t ,act 
( #bjaf4  #e4 ,report to congress on    
pati5t exp]i5ce drug developm5t ,n lat] 
?an ,june #a ( #bjba1 #bjbf1 & #bjca1 ! 
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all prep>e & publi% on !       
website ( ! ,food & ,drug ,adm9i/ration 
a report assess+ ! tr5ds ( ! ,food &    
,drug ,adm9i/ration ) respect to !      
review ( pati5t exp]i5ce data &         
in=mation on pati5t-focus$ drug         
developm5t tools z "p ( approv$         
applications submitt$ "u section        
#eje7;b7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 
& section #cea7;a7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774  
,april #e1 #bjaf,report$ ) an am5dm5t