#aagth ,,congress  #b;d ,session  ,s4   
#ejjb  ,,an ,,act  ,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 
,passed the ,senate ,september #bi1     
#bjbb4,secretary