,,ii  #aai? ,,congress  #a/ ,session    
,s4 #cee  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #c1 #bjbe,mr4 
,book] 7= himself1 ,mr4 ,s*mitt1 ,mr4   
,k+1 ,mr4 ,k5n$y1 ,mr4 ,:iteh\se1 ,mr4  
,m>%all1 ,mr4 ,blum5?al1 ,mr4 ,paul1 &  
,mr4 ,lujn7 introduc$ ! foll[+ bill2 :i*
 0 read twice & ref]r$ to ! ,committee  
on ,heal?1 ,education1 ,labor1 &        
,p5sions  ,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 ,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 pursuant to subsections 7b7 & 
7c7 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     
#ehba74  7#b7 ,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$iately effective z an int]im f9al   
rule )\t requir+ ! ,secret>y ( ,heal? & 
,human ,s]vices to demon/rate good cause
 !re=4  7b7 ,inclusions  7#a7 ,9 g5]al  
,! int]im f9al rule %all replace any    
ref]5ces to animal te/s1 data1 /udies1  
models1 & rese>* ) a ref]5ce to         
noncl9ical te/s1 data1 /udies1 models1 &
 rese>* 9 ! foll[+ sections ( title #ba1
 ,code ( ,f$]al ,regulations3 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#b7 
,additional *anges ,! ,secret>y may make
 su* additional *anges to ! sections (  
title #ba1 ,code ( ,f$]al ,regulations1 

describ$ 9 subp>agraphs 7,a7 ?r\gh 7,v7 
( p>agraph 7#a7 z ! ,secret>y det]m9es  
appropriate to fully implem5t !         
replacem5t requir$ "u su* p>agraph4  7c7
 ,def9ition ( noncl9ical te/ ,!         
def9ition ( noncl9ical te/ 9 section    
#eje7z7 ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7z77  
%all be add$ to sections #cab4c1 #cad4c1
 #cae4b1 & #fja4ca ( title #ba1 ,code ( 
,f$]al ,regulations4  7d7 ,te*nical     
am5dm5t ,section #eje ( ! ,f$]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