,,ib ,union ,calendar ,no4 #fad #aaith  
,,congress  #b;d ,session  ,h4 ,r4 #bhba
 ,report ,no4 #aai-gjf ,,in ,,the       
,,house ,,of ,,representatives  ,april  
#aj1 #bjbe,mr4 ,carter of ,georgia 7for 
himself1 ,ms4 ,barragn1 ,mr4 ,buchanan1 
,ms4 ,de,lauro1 ,mrs4 ,harshbarger1 and 
,mr4 ,carter of ,louisiana7 introduced  
the following bill2 which was referred  
to the ,committee on ,energy and        
,commerce  ,june #ah1 #bjbf;,additional 
sponsors3 ,mr4 ,doggett1 ,mr4 ,nadler1  
,mr4 ,carey1 ,mr4 ,fitzpatrick1 ,ms4    
,malliotakis1 ,mr4 ,crenshaw1 ,ms4 ,chu1
 ,ms4 ,scholten1 ,mr4 ,soto1 ,mr4       
,goldman of ,new ,york1 ,mr4 ,obernolte1
 ,mr4 ,gottheimer1 ,mr4 ,crow1 ,mr4     
,lieu1 ,ms4 ,tenney1 ,mr4 ,smith of ,new
 ,jersey1 ,ms4 ,norton1 ,ms4 ,salazar1  
,ms4 ,lois ,frankel of ,florida1 ,mr4   
,valadao1 ,mr4 ,harder of ,california1  
,mr4 ,fitzgerald1 ,mr4 ,bilirakis1 ,ms4 
,lee of ,florida1 ,mr4 ,calvert1 ,mr4   
,vindman1 ,mr4 ,pocan1 ,mr4 ,lawler1    
,mr4 ,weber of ,texas1 ,mr4 ,neguse1    

,mr4 ,krishnamoorthi1 ,mr4 ,kean1 ,ms4  
,johnson of ,texas1 ,mrs4 ,kim1 ,mr4    
,langworthy1 and ,mr4 ,thanedar  ,june  
#ah1 #bjbf;,committed to the ,committee 
of the ,whole ,house on the ,state of   
the ,union and ordered to be printed  ,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 ,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  ,june   
#ah1 #bjbf;,committed to the ,committee 
of the ,whole ,house on the ,state of   
the ,union and ordered to be printed