,,ii  #aaith ,,congress  #ast ,session  
,s4 #cee  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,february #c1       
#bjbe,mr4 ,booker 7for himself1 ,mr4    
,schmitt1 ,mr4 ,king1 ,mr4 ,kennedy1    
,mr4 ,whitehouse1 ,mr4 ,marshall1 ,mr4  
,blumenthal1 ,mr4 ,paul1 and ,mr4 ,lujn7
 introduced the following bill2 which   
was read twice and referred to the      
,committee on ,health1 ,education1      
,labor1 and ,pensions  ,a ,,bill  ,to   
require the ,secretary of ,health and   
,human ,services1 acting through the    
,commissioner of ,food and ,drugs1 to   
publish a final rule relating to        
nonclinical testing methods4  #a4 ,short
 title ,this ,act may be cited as the   
,,fda ,modernization ,act #c4j4  #b4    
,regulations on nonclinical testing     
methods  7a7 ,interim final rule  7#a7  
,in general ,not later than #a year     
after the date of enactment of this     
,act1 the ,secretary of ,health and     
,human ,services1 acting through the    
,commissioner of ,food and ,drugs1 shall

 publish an interim final rule pursuant 
to subsections 7b7 and 7c7 to ensure    
implementation of the amendments to     
section #eje7;i7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;i77 made by section #cbji7;a7 of 
the ,consolidated ,appropriations ,act1 
#bjbc 7,public ,law #aag-cbh2 #acf      
,stat4 #ehba74  7#b7 ,effectiveness of  
interim final rule ,notwithstanding     
subparagraph 7,b7 of section #eec7;b7 of
 title #e1 ,united ,states ,code1 the   
interim final rule issued by the        
,secretary of ,health and ,human        
,services under paragraph 7#a7 shall    
become immediately effective as an      
interim final rule without requiring the
 ,secretary of ,health and ,human       
,services to demonstrate good cause     
therefor4  7b7 ,inclusions  7#a7 ,in    
general ,the interim final rule shall   
replace any references to animal tests1 
data1 studies1 models1 and research with
 a reference to nonclinical tests1 data1
 studies1 models1 and research in the   

following sections of title #ba1 ,code  
of ,federal ,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 other section   
necessary to ensure regulatory          
consistency with the amendments to      
section #eje7;i7 of the ,federal ,food1 

,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;i77 made by section #cbji7;a7 of 
the ,consolidated ,appropriations ,act1 
#bjbc 7,public ,law #aag-cbh2 #acf      
,stat4 #ehba74  7#b7 ,additional changes
 ,the ,secretary may make such          
additional changes to the sections of   
title #ba1 ,code of ,federal            
,regulations1 described in subparagraphs
 7,a7 through 7,v7 of paragraph 7#a7 as 
the ,secretary determines appropriate to
 fully implement the replacement        
required under such paragraph4  7c7     
,definition of nonclinical test ,the    
definition of nonclinical test in       
section #eje7z7 of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7z77 shall be added to sections    
#cab4c1 #cad4c1 #cae4b1 and #fja4ca of  
title #ba1 ,code of ,federal            
,regulations4  7d7 ,technical amendment 
,section #eje of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7 is amended by designating the    
second subsection 7z7 7relating to      

clinical trial diversity action plans71 
as added by section #cfja7;a7 of the    
,health ,extenders1 ,improving ,access  
to ,medicare1 ,medicaid1 and ,,chip1 and
 ,strengthening ,public ,health ,act of 
#bjbb 7division ,,ff of ,public ,law    
#aag-cbh71 as subsection 7aa74