,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bdch  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ai1 #bjae ,mr4  
,coll9s ( ,new ,york introduc$ ! foll[+ 
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act )
 respect to broad] application (        
,bayesian /ati/ics & adaptive trial     
designs4  #a4 ,broad] application (     
,bayesian /ati/ics & adaptive trial     
designs  7a7 ,proposals = use (         
innovative /ati/ical me?ods 9 cl9ical   
protocols = drugs & biological products 
,= purposes ( assi/+ sponsors 9         
incorporat+ adaptive trial design &     
,bayesian me?ods into propos$ cl9ical   
protocols & applications = new drugs "u 
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 &   
biological products "u section #cea ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb71 ! ,secret>y %all       
conduct a public meet+ & issue guidance 
9 accordance ) subsection 7b74  7b7     

,guidance address+ use ( adaptive trial 
designs & ,bayesian me?ods  7#a7 ,9     
g5]al ,! ,secret>y ( ,heal? & ,human    
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs 79 ?is subsection ref]r$ 
to z ! ,secret>y71 %all--  7,a7 update &
 f9alize ! draft guidance address+ ! use
 ( adaptive trial design = drugs &      
biological products2 &  7,b7 issue draft
 guidance on ! use ( ,bayesian me?ods 9 
! developm5t & regulatory review &      
approval or lic5sure ( drugs &          
biological products4  7#b7 ,cont5ts ,!  
guidances "u p>agraph 7#a7 %all         
address-- 7,a7 ! use ( adaptive trial   
designs & ,bayesian me?ods 9 cl9ical    
trials1 includ+ cl9ical trials propos$  
or submitt$ to help satisfy ! sub/antial
 evid5ce /&>d "u section #eje7;d7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;d772  7,b7 h[      
sponsors may obta9 fe$back f ! ,secret>y
 on te*nical issues relat$ to model+ &  
simulations prior to-- 7i7 completion ( 
su* model+ or simulations2 or  7ii7 !   

submission ( result+ in=mation to !     
,secret>y2  7,c7 ! types ( quantitative 
& qualitative in=mation t %\ld be       
submitt$ = review2 &  7,d7 recomm5d$    
analysis me?odologies4  7#c7 ,public    
meet+ ,prior to updat+ or develop+ !    
guidances requir$ by p>agraph 7#a71 !   
,secret>y %all consult ) /akehold]s1    
includ+ repres5tatives ( regulat$       
indu/ry1 academia1 pati5t advocacy      
organizations1 & disease rese>*         
f\ndations1 ?r\gh a public meet+ to be  
held n lat] ?an #a ye> aft] ! date (    
enactm5t ( ?is ,act4  7#d7 ,s*$ule ,!   
,secret>y %all publi%-- 7,a7 ! f9al     
guidance requir$ by p>agraph 7#a77;,a7 n
 lat] ?an #ah mon?s aft] ! date ( !     
public meet+ requir$ by p>agraph 7#c72 &
  7,b7 ! guidance requir$ by p>agraph   
7#a77;,b7 n lat] ?an #dh mon?s aft] !   
date ( ! public meet+ requir$ by        
p>agraph 7#c74