,,ii  #aagth ,,congress  #b;d ,session  
,s4 #ejjb  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,september #bi1
 #bjbb,mr4 ,paul 7for himself1 ,mr4     
,booker1 ,mr4 ,braun1 ,mr4 ,crapo1 ,mr4 
,marshall1 ,ms4 ,collins1 ,mr4 ,king1   
,mr4 ,padilla1 ,mr4 ,sanders1 ,mr4      
,tuberville1 ,mr4 ,lujn1 and ,mr4 ,scott
 of ,florida7 introduced the following  
bill2 which was read twice1 considered1 
read the third time1 and passed  ,a     
,,bill  ,to allow for alternatives to   
animal testing for purposes of drug and 
biological product applications4  #a4   
,short title ,this ,act may be cited as 
the ,,fda ,modernization ,act #b4j4  #b4
 ,alternatives to animal testing  7a7   
,in general ,section #eje of the        
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7 is amended--  
7#a7 in subsection 7i7-- 7,a7 in        
paragraph 7#a77;,a71 by striking        
preclinical tests 7including tests on   
animals7 and inserting nonclinical      
tests2 and  7,b7 in paragraph 7#b77;,b71

 by striking animal and inserting       
nonclinical tests2 and  7#b7 after      
subsection 7y71 by inserting the        
following3  7z7 ,nonclinical test       
defined ,for purposes of this section1  
the term nonclinical test means a test  
conducted in vitro1 in silico1 or in    
chemico1 or a non-human in vivo test    
that occurs before or during the        
clinical trial phase of the             
investigation of the safety and         
effectiveness of a drug1 and may include
 animal tests1 or non-animal or human   
biology-based test methods1 such as     
cell-based assays1 microphysiological   
systems1 or bioprinted or computer      
models4  4  7b7 ,biosimilar biological  
product applications ,item 7bb7 of      
section #cea7k77#b77;,a77i77,i7 of the  
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bfb7k77#b77;,a77i77,i77 is   
amended to read as follows3  7bb7 an    
assessment of toxicity 7which may rely  
on1 or consist of1 a study or studies   
described in item 7aa7 or 7cc772 and  4