,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bdee  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ai1 #bjae ,mr4  
,pitts introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act ) respect
 to precision m$ic9e4  #a4 ,precision   
m$ic9e guidance & o!r programs ( ,food &
 ,drug ,adm9i/ration ,*apt] ,v ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by
 add+ at ! end ! foll[+3  ,j ,precision 
,m$ic9e  #eia4 ,g5]al ag5cy guidance on 
precision m$ic9e  7a7 ,9 g5]al ,!       
,secret>y %all issue & p]iodically      
update guidance to assi/ sponsors 9 !   
developm5t ( a precision drug or        
biological product4 ,su* guidance %all--
  7#a7 def9e ! t]m precision drug or    
biological product2 &  7#b7 address !   
topics describ$ 9 subsection 7b74  7b7  
,c]ta9 issues ,! topics to be address$  
by guidance "u subsection 7a7 are-- 7#a7
 ! evid5ce ne$$ to support ! use (      

biom>k]s 7z def9$ 9 section #ejg7;e77 t 
id5tify subsets ( pati5ts z likely      
respond]s to !rapies 9 ord] to /reaml9e 
! conduct ( cl9ical trials2  7#b7       
recomm5dations = ! design ( /udies to   
demon/rate ! validity ( a biom>k] z a   
pr$ictor ( drug or biological product   
response2  7#c7 ! mann] & ext5t to :i* a
 b5efit-risk assessm5t may be affect$ :5
 cl9ical trials are limit$ to pati5t    
population subsets t are id5tifi$ us+   
biom>k]s2  7#d7 ! developm5t ( companion
 diagno/ics 9 ! context ( a drug        
developm5t program2 &  7#e7             
consid]ations = develop+ biom>k]s t aid 
prescrib+ decisions = a drug or         
biological product1 & :5 in=mation      
reg>d+ a biom>k] may be includ$ 9 !     
label+ = a drug or biological product   
approv$ "u section #eje ( ?is ,act or   
section #cea ( ! ,public ,heal? ,s]vice 
,act4  7c7 ,date c]ta9 = initial        
guidance ,! ,secret>y %all issue        
guidance "u subsection 7a7 n lat] ?an   
#ah mon?s aft] ! date ( ! enactm5t ( !  

#ba/ ,c5tury ,cures ,act4  #eib4        
,precision m$ic9e reg>d+ orphan-drug &  
exp$it$-approval programs ,9 ! case ( an
 application = a precision drug or      
biological product "u section           
#eje7;b77#a71 or section #cea7;a7 ( !   
,public ,heal? ,s]vice ,act1 t has be5  
designat$ "u section #ebf z a drug = a  
r>e disease = a s]i\s condition1 !      
,secret>y may--  7#a7 consi/5t )        
applicable /&>ds = approval1 rely ^u    
data or in=mation previ\sly develop$ by 
! sponsor ( ! precision drug or         
biological product = a prior approv$    
drug or indication 7or t ( ano!r        
sponsor1 provid$ ! sponsor ( ! precision
 drug or biological product has obta9$ a
 contractual "r ( ref]5ce to su* o!r    
sponsor's data & in=mation7 9 ord] to   
exp$ite cl9ical developm5t = a precision
 drug or indication t is us+ ! same or  
simil> approa* z t ( ! prior approv$    
drug or indication2 &  7#b7 z           
appropriate "u section #ejf1 consid] !  
application = approval ( su* precision  

drug or biological product to be        
eligible = exp$it$ review1 includ+ "u   
section #ejf7;c7 7relat+ to accel]at$   
approval74  4