,i  #aadth ,,congress  #b;d ,session    
,h4 ,r4 #fdfc  ,,in ,,the ,,house ,,of  
,,representatives  ,december #g1        
#bjaf,mr4 ,collins of ,new ,york 7for   
himself and ,mr4 ,long7 introduced the  
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to direct the ,secretary of 
,health and ,human ,services to issue   
guidance with respect to                
three-dimensional human tissue models1  
and for other purposes4  #a4 ,short     
title ,this ,act may be cited as the    
,patient ,safety and ,toxicology        
,modernization ,act of #bjaf4  #b4      
,findings ,congress finds the following3
  7#a7 ,preclinical testing serves a    
fundamental role in characterizing the  
potential risks and benefits associated 
with regulated medicines and products4  
7#b7 ,critical gaps remain in the       
understanding of the relationship       
between patient response and preclinical
 findings4  7#c7 ,serious1 rare1 and    
unexpected adverse events may be        

observed in clinical trials or          
postapproval1 particularly toxicology   
effects not identified in animals that  
may harm human organs4  7#d7 ,patient   
efficacy1 safety1 dosage information1   
and speedier access to new medicines    
will benefit from models that are more  
predictive than animals and that mimic  
key elements of human organs4  7#e7 ,a  
#bjaa report by the ,food and ,drug     
,administration1 entitled ,advancing    
,regulatory ,science at ,,fda1          
prioritized toxicology testing and the  
development of models of human adverse  
response as one of the areas of         
regulatory science where new or enhanced
 engagement by the agency is essential  
to the continued success of the public  
health and regulatory mission of the    
,food and ,drug ,administration4  7#f7  
,the ,food and ,drug ,administration's  
#bjaf draft commitment letter concerning
 the reauthorization of fees relating to
 drugs under part #b of subchapter ,c of
 chapter ,,vii of the ,federal ,food1   

,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cgi;g et seq47 proposes a process to  
add new preclinical models that will not
 be finalized until at least #bjba4     
7#g7 ,peer-reviewed data is readily     
available to illustrate the benefits of 
commercially available human tissue     
models to improve the drug discovery    
process by replicating key elements of  
living human tissue4  7#h7 ,the ,food   
and ,drug ,administration should take   
immediate steps to validate new models1 
including three-dimensional human tissue
 models1 that improve regulatory        
decisionmaking in preclinical1 clinical1
 labeling1 and postmarket safety and    
efficacy testing1 or other uses by      
product sponsors4  #c4 ,guidance with   
respect to three-dimensional human      
tissue models  7a7 ,in general ,not     
later than ,december #ca1 #bjah1 the    
,secretary of ,health and ,human        
,services1 acting through the           
,commissioner of ,food and ,drugs1 shall
 issue guidance addressing--  7#a7 the  

development and use of novel tools for  
toxicology and efficacy testing1        
including three-dimensional human tissue
 models2 and  7#b7 the use of           
three-dimensional human tissue models   
for preclinical1 clinical1 and          
postmarket safety and efficacy testing1 
labeling1 or other uses by product      
sponsors4  7b7 ,periodic updates ,the   
,secretary shall periodically update the
 guidance issued under subsection 7a74  
#d4 ,rule of construction ,nothing in   
this ,act shall be construed to prohibit
 or limit the use of three-dimensional  
human tissue models by product sponsors 
with respect to--  7#a7 obtaining       
approval or licensure of a drug or      
biological product1 including a         
combination product1 under section #eje 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
section #cea of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb72 or  
7#b7 meeting the requirements of a      
regulatory decision issued by the       

,secretary of ,health and ,human        
,services4  #e4 ,definitions ,in this   
,act3 7#a7 ,biological product ,the term
 biological product has the meaning     
given such term in section #cea7;i7 of  
the ,public ,health ,service ,act 7#db  
,u4,s4,c4 #bfb7;i774  7#b7 ,combination 
product ,the term combination product   
means a combination product described in
 section #ejc7;g7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cec7;g774  7#c7 ,drug ,the   
term drug has the meaning given such    
term in section #bja of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cba74  7#d7                  
,three-dimensional human tissue model   
,the term three-dimensional human tissue
 model means a three-dimensional model  
that-- 7,a7 approximates human tissue   
composition and physiology using        
spatially controlled deposition of adult
 human cells or cell-containing         
materials in user-defined1 geometric    
patterns2  7,b7 can be used to detect   

toxicity that is not identifiable in    
animal models2  7,c7 can be used to test
 the efficacy of a drug that is not     
possible or not able to be sufficiently 
tested in an animal model2 and  7,d7 can
 predict toxicity in clinical testing or
 detect toxicity in known clinical      
failures4