,,ii  #aad? ,,congress  #a/ ,session    
,s4 #aeig  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #ag1 #bjae ,mr4  
,wick] 7= himself1 ,ms4 ,klobu*>1 ,ms4  
,coll9s1 ,mr4 ,frank51 ,mr4 ,isakson1 & 
,mr4 ,b5net7 introduc$ ! foll[+ bill2   
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,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