,,ii  #aagth ,,congress  #ast ,session  
,s4 #bieb  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,october #g1   
#bjba,mr4 ,paul 7for himself1 ,mr4      
,booker1 ,mr4 ,braun1 ,mr4 ,kennedy1 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 amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to allow      
manufacturers and sponsors of a drug to 
use alternative testing methods to      
animal testing to investigate the safety
 and effectiveness of a drug1 and for   
other purposes4  #a4 ,short title ,this 
,act may be cited as the ,,fda          
,modernization ,act of #bjba4  #b4 ,new 
approach methodologies ,section #eje of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7 is amended-- 
7#a7 in subsection                      
7b77#e77;,b77i77,,ii71 by striking      
animal and inserting nonclinical tests  
or studies2  7#b7 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 tests or studies2 and  7#c7 
after subsection 7y71 by inserting the  
following3  7z7 ,nonclinical test or    
study defined ,for purposes of this     
section1 the term nonclinical test or   
study means a test or study conducted in
 vitro1 in silico1 in chemico1 or in    
vivo that occurs before or during the   
clinical trial phase of the             
investigation of the safety and         
effectiveness of a drug1 and may include
 the following3 7#a7 ,cell-based assays4
  7#b7 ,organ chips and                 
microphysiological systems4  7#c7       
,computer models4  7#d7 ,other          
non-animal or human biology-based test  
methods4  7#e7 ,animal tests4  4