,i  #aad? ,,congress  #b;d ,session  ,h4
 ,r4 #fdfc  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,decemb] #g1 #bjaf,mr4
 ,coll9s ( ,new ,york 7= himself & ,mr4 
,long7 introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to direct !       
,secret>y ( ,heal? & ,human ,s]vices to 
issue guidance ) respect to             
?ree-dim5sional human tissue models1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,pati5t ,safety &  
,toxicology ,mod]nization ,act ( #bjaf4 
#b4 ,f9d+s ,congress f9ds ! foll[+3     
7#a7 ,precl9ical te/+ s]ves a fundam5tal
 role 9 *>act]iz+ ! pot5tial risks &    
b5efits associat$ ) regulat$ m$ic9es &  
products4  7#b7 ,critical gaps rema9 9 !
 und]/&+ ( ! relation%ip betwe5 pati5t  
response & precl9ical f9d+s4  7#c7      
,s]i\s1 r>e1 & unexpect$ adv]se ev5ts   
may be obs]v$ 9 cl9ical trials or       
po/approval1 p>ticul>ly toxicology      
effects n id5tifi$ 9 animals t may h>m  
human organs4  7#d7 ,pati5t efficacy1   

safety1 dosage in=mation1 & spe$i]      
access to new m$ic9es w b5efit f models 
t are m pr$ictive ?an animals & t mimic 
key elem5ts ( human organs4  7#e7 ,a    
#bjaa report by ! ,food & ,drug         
,adm9i/ration1 entitl$ ,advanc+         
,regulatory ,sci5ce at ,,fda1 prioritiz$
 toxicology te/+ & ! developm5t ( models
 ( human adv]se response z "o ( ! areas 
( regulatory sci5ce :]e new or enhanc$  
engagem5t by ! ag5cy is ess5tial to !   
cont9u$ success ( ! public heal? &      
regulatory mission ( ! ,food & ,drug    
,adm9i/ration4  7#f7 ,! ,food & ,drug   
,adm9i/ration's #bjaf draft commitm5t   
lett] conc]n+ ! reau?orization ( fees   
relat+ to drugs "u "p #b ( sub*apt] ,c (
 *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et 
seq47 proposes a process to add new     
precl9ical models t w n be f9aliz$ until
 at lea/ #bjba4  7#g7 ,pe]-review$ data 
is readily available to illu/rate !     
b5efits ( comm]cially available human   
tissue models to improve ! drug discov]y

 process by replicat+ key elem5ts ( liv+
 human tissue4  7#h7 ,! ,food & ,drug   
,adm9i/ration %\ld take imm$iate /eps to
 validate new models1 includ+           
?ree-dim5sional human tissue models1 t  
improve regulatory decisionmak+ 9       
precl9ical1 cl9ical1 label+1 & po/m>ket 
safety & efficacy te/+1 or o!r uses by  
product sponsors4  #c4 ,guidance )      
respect to ?ree-dim5sional human tissue 
models  7a7 ,9 g5]al ,n lat] ?an        
,decemb] #ca1 #bjah1 ! ,secret>y (      
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all     
issue guidance address+--  7#a7 !       
developm5t & use ( novel tools =        
toxicology & efficacy te/+1 includ+     
?ree-dim5sional human tissue models2 &  
7#b7 ! use ( ?ree-dim5sional human      
tissue models = precl9ical1 cl9ical1 &  
po/m>ket safety & efficacy te/+1 label+1
 or o!r uses by product sponsors4  7b7  
,p]iodic updates ,! ,secret>y %all      
p]iodically update ! guidance issu$ "u  
subsection 7a74  #d4 ,rule ( con/ruction

 ,no?+ 9 ?is ,act %all be con/ru$ to    
prohibit or limit ! use (               
?ree-dim5sional human tissue models by  
product sponsors ) respect to--  7#a7   
obta9+ approval or lic5sure ( a drug or 
biological product1 includ+ a comb9ation
 product1 "u section #eje ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 or section #cea ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb72 or  7#b7 meet+ !       
requirem5ts ( a regulatory decision     
issu$ by ! ,secret>y ( ,heal? & ,human  
,s]vices4  #e4 ,def9itions ,9 ?is ,act3 
7#a7 ,biological product ,! t]m         
biological product has ! mean+ giv5 su* 
t]m 9 section #cea7;i7 ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7;i774  7#b7 ,comb9ation product ,! 
t]m comb9ation product means a          
comb9ation product describ$ 9 section   
#ejc7;g7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g774
  7#c7 ,drug ,! t]m drug has ! mean+    
giv5 su* t]m 9 section #bja ( ! ,f$]al  

,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba74  7#d7 ,?ree-dim5sional 
human tissue model ,! t]m               
?ree-dim5sional human tissue model means
 a ?ree-dim5sional model t-- 7,a7       
approximates human tissue composition & 
physiology us+ spatially controll$      
deposition ( adult human cells or       
cell-conta9+ mat]ials 9 us]-def9$1      
geometric patt]ns2  7,b7 c be us$ to    
detect toxicity t is n id5tifiable 9    
animal models2  7,c7 c be us$ to te/ !  
efficacy ( a drug t is n possible or n  
able to be suffici5tly te/$ 9 an animal 
model2 &  7,d7 c pr$ict toxicity 9      
cl9ical te/+ or detect toxicity 9 kn[n  
cl9ical failures4