,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #bhba  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #aj1 #bjbe,mr4 
,c>t] ( ,georgia 7= himself1 ,ms4       
,b>ragn1 ,mr4 ,bu*anan1 ,ms4 ,de,lauro1 
,mrs4 ,h>%b>g]1 & ,mr4 ,c>t] (          
,l\isiana7 introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,en]gy &    
,comm]ce  ,a ,,bill  ,to require !      
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 to publi% a f9al rule relat+ to 
noncl9ical te/+ me?ods4  #a4 ,%ort title
 ,?is ,act may be cit$ z ! ,,fda        
,mod]nization ,act #c4j4  #b4           
,regulations on noncl9ical te/+ me?ods  
7a7 ,int]im f9al rule  7#a7 ,9 g5]al ,9 
ord] to ensure implem5tation ( !        
am5dm5ts to section #eje7;i7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;i77 made by section     
#cbji7;a7 ( ! ,consolidat$              
,appropriations ,act1 #bjbc 7,public    
,law #aag-cbh2 #acf ,/at4 #ehba71 n lat]
 ?an #a ye> aft] ! date ( enactm5t ( ?is

 ,act1 ! ,secret>y ( ,heal? & ,human    
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all publi% an int]im   
f9al rule--  7,a7 to am5d ! sections (  
title #ba1 ,code ( ,f$]al ,regulations1 
describ$ 9 p>agraph 7#b7 to replace any 
ref]5ces to animal te/s1 data1 /udies1  
models1 & rese>* ) a ref]5ce to         
noncl9ical te/s1 data1 /udies1 models1 &
 rese>*2 &  7,b7 to add ! def9ition (   
noncl9ical te/ 9 section #eje7z7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7z77 to sections     
#cab4c1 #cad4c1 #cae4b1 & #fja4ca (     
title #ba1 ,code ( ,f$]al ,regulations4 
7#b7 ,,cfr sections describ$ ,! sections
 ( title #ba1 ,code ( ,f$]al            
,regulations1 describ$ 9 ?is p>agraph   
are ! foll[+3 7,a7 ,section #cab4bb7;c74
  7,b7 ,section #cab4bc7;a77#c77;iv74   
7,c7 ,section #cab4bc7;a77#e77;ii74     
7,d7 ,section #cab4bc7;a77#e77;iii74    
7,e7 ,section #cab4bc7;a77#h74  7,f7    
,section #cab4bc7;a77#h77;i74  7,g7     
,section #cab4bc7;a77#h77;ii74  7,h7    

,section #cab4bc7;a77#aj77;i74  7,i7    
,section #cab4bc7;a77#aj77;ii74  7,j7   
,section #cab4cc7;b77#f74  7,k7 ,section
 #cab4hb7;a74  7,l7 ,section #cab4hh4   
7,m7 ,section #cad4ej7;d77#b74  7,n7    
,section #cad4ej7;d77#b77;iv74  7,o7    
,section #cad4ej7;d77#e77;i74  7,p7     
,section #cad4ej7;d77#e77vi77a74  7,q7  
,section #cad4ej7;d77#e77vi77b74  7,r7  
,section #cad4ic7;e77#b74  7,s7 ,section
 #cae4f7;d74  7,t7 ,section             
#ccj4aj7;a77#b74  7,u7 ,section         
#fja4ce7;d74  7,v7 ,any o!r section     
necess>y to ensure regulatory consi/5cy 
) ! am5dm5ts to section #eje7;i7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;i77 made by section
 #cbji7;a7 ( ! ,consolidat$             
,appropriations ,act1 #bjbc 7,public    
,law #aag-cbh2 #acf ,/at4 #ehba74  7#c7 
,effectiv5ess ( int]im f9al rule        
,not)/&+ subp>agraph 7,b7 ( section     
#eec7;b7 ( title #e1 ,unit$ ,/ates      
,code1 ! int]im f9al rule issu$ by !    
,secret>y ( ,heal? & ,human ,s]vices "u 

p>agraph 7#a7 %all become imm$iately    
effective z an int]im f9al rule )\t     
requir+ ! ,secret>y ( ,heal? & ,human   
,s]vices to demon/rate good cause !re=4 
7b7 ,te*nical am5dm5t ,section #eje ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 is am5d$ by        
designat+ ! second subsection 7z7       
7relat+ to cl9ical trial div]sity action
 plans71 z add$ by section #cfja7;a7 ( !
 ,heal? ,ext5d]s1 ,improv+ ,access to   
,m$ic>e1 ,m$icaid1 & ,,*ip1 & ,/r5g!n+  
,public ,heal? ,act ( #bjbb 7division   
,,ff ( ,public ,law #aag-cbh71 z        
subsection 7aa74