#aaith ,,congress  #b;d ,session  ,h4   
,r4 #bhba  ,,an ,,act  ,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 ,in order 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 #ehba71 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--  7,a7  
to amend the sections of title #ba1     

,code of ,federal ,regulations1         
described in paragraph 7#b7 to replace  
any references to animal tests1 data1   
studies1 models1 and research with a    
reference to nonclinical tests1 data1   
studies1 models1 and research2 and  7,b7
 to add the definition of nonclinical   
test in section #eje7z7 of the ,federal 
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7z77 to sections #cab4c1  
#cad4c1 #cae4b1 and #fja4ca of title    
#ba1 ,code of ,federal ,regulations4    
7#b7 ,,cfr sections described ,the      
sections of title #ba1 ,code of ,federal
 ,regulations1 described in this        
paragraph are the following3 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#c7 ,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 ,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  ,passed 
the ,house of ,representatives ,july    
#bj1 #bjbf4;,clerk4