,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #hfcc  ,,in ,,the ,,house ,,of  
,,representatives  ,october #bj1        
#bjbj,mr4 ,hastings 7for himself1 ,mr4  
,buchanan1 ,mr4 ,bishop of ,georgia1 and
 ,ms4 ,sherrill7 introduced the         
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend the ,public ,health
 ,service ,act to provide for the       
establishment of the ,national ,center  
for ,alternatives to ,animals in        
,research and ,testing1 and for other   
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,humane ,research   
and ,testing ,act of #bjbj4  #b4        
,findings ,the ,congress finds as       
follows3 7#a7 ,the mission of the       
,national ,institutes of ,health 7,,nih7
 is to seek fundamental knowledge about 
the nature and behavior of living       
systems and the application of that     
knowledge to enhance health1 lengthen   
life1 and reduce illness and disability4
  7#b7 ,much of ,,nih's research is     

carried out on animals4 ,however1 the   
precise number of animals used in       
research in the ,united ,states is      
unknown4 ,estimates range between #ag   
million and #ajj million animals used   
annually4 ,such imprecise numbers make  
it impossible to effectively track and  
reduce the numbers of animals used1 as  
mandated by the ,,nih policies to ensure
 the smallest possible number of animals
 are used4  7#c7 ,there is widespread   
agreement among scientists and          
regulatory agencies that animal models  
are poor predictors of the human        
response1 with over #ij percent of new  
candidate drugs never making it to      
market4  7#d7 ,more than #cj percent of 
promising medications have failed in    
human clinical trials because they are  
found to be toxic despite promising     
pre-clinical studies in animal models4  
,an additional #fe percent of candidate 
drugs that pass animal trials fail due  
to lack of efficacy4  7#e7 ,despite the 
ever-increasing growth in animal        

procedures1 there is no corresponding   
increase in the number of human         
medicines making it to the clinic4  7#f7
 ,dramatically rising costs and         
extremely high failure rates in drug    
development have led many to re-evaluate
 the value of animal studies4  7#g7     
,effective alternatives to animals are  
available and growing4 ,cutting-edge    
technology has forged new frontiers in  
biology and medicine that have produced 
human-relevant models1 including        
organoid cell cultures1 organs-on-chips1
 genomics1 induced pluripotent adult    
stem cells1 #c;,d modeling with human   
cells1 high throughput technology1      
molecular imaging1 computer models1 in  
silico trials1 digital imaging1         
artificial intelligence1 and other      
innovative methods--all of which have   
launched a technological revolution in  
biomedical research4  7#h7 ,despite     
these cutting-edge1 human-relevant      
methods1 a preponderance of ,,nih       
research is carried out on animals4 ,a  

#bjai news release from ,,nih indicates 
that #gj percent of ,,nih grant         
applications relate to studies using    
mice4  7#i7 ,the ,american public has   
expressed concern about subjecting      
animals to the pain of experimentation4 
,this concern grows as alternatives to  
research on animals become available4   
7#aj7 ,under the system of oversight    
established by the ,national ,institutes
 of ,health ,revitalization ,act of     
#aiic 7,public ,law #ajc-dc71 ,,nih is  
supposed to outline a plan for reducing 
the use of animals in research4 ,section
 #djd;,c7a77#a7 of the ,public ,health  
,service ,act 7#db ,u4,s4,c4            
#bhc;e7a77#a771 as added by section #bje
 of the ,national ,institutes of ,health
 ,revitalization ,act of #aiic1 calls   
for ,,nih to conduct or support research
 into ''' methods of biomedical research
 and experimentation that do not require
 the use of animals and methods of such 
research and experimentation that reduce
 the number of animals used in such     

research4  7#aa7 ,a dedicated center    
that provides resources1 funding1 and   
training to encourage researchers to    
utilize humane1 cost-effective1 and     
scientifically suitable non-animal      
methods is needed to fulfill the intent 
of the ,national ,institutes of ,health 
,revitalization ,act of #aiic 7,public  
,law #ajc-dc74  #c4 ,national ,center   
for ,alternatives to ,animals in        
,research and ,testing  7a7 ,addition to
 list of institutes and centers ,section
 #dja of the ,public ,health ,service   
,act 7#db ,u4,s4,c4 #bha7 is amended--  
7#a7 by redesignating paragraph 7#be7 as
 paragraph 7#bf72 and  7#b7 by inserting
 after paragraph 7#bd7 the following new
 paragraph3  7#be7 ,national ,center for
 ,alternatives to ,animals in ,research 
and ,testing4  4  7b7 ,conforming change
 to number of institutes and centers    
,section #dja7;d77#a7 of the ,public    
,health ,service ,act 7#db ,u4,s4,c4    
#bha7;d77#a77 is amended by striking #bg
 and inserting #bh4  7c7 ,establishment2

 duties ,part ,e of title ,,iv of the   
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bhg et seq47 is amended by   
inserting after subpart #e of such part 
,e 7#db ,u4,s4,c4 #bhg;c-#ba7 the       
following new subpart3  #f ,national    
,center for ,alternatives to ,animals in
 ,research and ,testing  #dhe;,e4       
,establishment2 duties  7a7             
,establishment ,not later than one year 
after the date of enactment of the      
,humane ,research and ,testing ,act of  
#bjbj the ,secretary shall establish a  
,national ,center for ,alternatives to  
,animals in ,research and ,testing 7in  
this subpart referred to as the         
,national ,center7 within the ,national 
,institutes of ,health4  7b7 ,purposes  
,the sole purposes of the ,national     
,center shall be-- 7#a7 developing1     
promoting1 and funding alternatives to  
animal research and testing2 and  7#b7  
developing a plan for reducing the      
number of animals used in federally     
funded research and testing4  7c7       

,duties ,the ,director of the ,national 
,center shall-- 7#a7 provide assistance 
7including funding7 to federally funded 
researchers to incentivize research and 
testing without the use of animals1     
based on advanced cell cultures or      
technology such as #c;,d organoids1     
microphysiological systems1 induced     
pluripotent adult stem cell models1 in  
silico modeling1 advanced imaging       
systems1 artificial intelligence1 and   
other innovative methods2  7#b7 train   
and inform scientists about these       
available methods of research and       
testing without the use of animals2     
7#c7 establish collaborations among     
research scientists to assist those     
working in institutions where research  
and testing scientists may lack         
resources 7such as bioengineering and   
advanced bio-imaging equipment7 to carry
 out new and emerging high-tech methods 
of research and testing without the use 
of animals2 and  7#d7 tally and make    
publicly available information on the   

numbers of animals used in federally    
funded research and testing in order to 
implement adequate steps to measure the 
reduction of animals so used4  4  #d4   
,reporting by federally funded research 
entities on numbers of animals used in  
research and testing  7a7 ,in general   
,each covered reporting entity shall do 
the following3 7#a7 ,not later than #a  
year after the date of enactment of this
 ,act1 report to the ,national ,center  
for ,alternatives to ,animals in        
,research and ,testing and make publicly
 available-- 7,a7 the total number of   
animals used in federally funded        
research and testing at any facilities  
of the covered reporting entity1        
disaggregated by species2 and  7,b7 the 
total number of such animals that were  
bred or acquired for research or testing
 purposes1 disaggregated by species4    
7#b7 ,every #b years thereafter1 update 
the latest report of the entity under   
this section and make publicly available
 such updated report to measure the     

progress of the covered reporting entity
 in reducing the number of animals used 
in federally funded research and        
testing4  7#c7 ,on an annual basis1     
develop and submit to the ,national     
,center for ,alternatives to ,animals in
 ,research and ,testing and make        
publicly available a plan for reducing  
the numbers described in subparagraphs  
7,a7 and 7,b7 of paragraph 7#a74  7b7   
,standardized process ,the ,director of 
the ,national ,center for ,alternatives 
to ,animals in ,research and ,testing   
shall establish a standardized process  
for submitting and updating reports and 
plans under subsection 7a71 including   
for making such reports and plans       
publicly available4  7c7 ,definition ,in
 this section3 7#a7 ,the term animal--  
7,a7 means any vertebrate2 and  7,b7    
includes all warm-blooded and           
cold-blooded species4  7#b7 ,the term   
covered reporting entity means-- 7,a7   
any entity that-- 7i7 receives ,federal 
funds for research or testing2 and  7ii7

 uses animals in research and testing2  
and  7,b7 any ,federal department or    
agency that uses animals in research or 
testing4