,,ii  #aad? ,,congress  #a/ ,session    
,s4 #bjcj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #ae1 #bjae   
,mr4 ,b5net 7= himself1 ,mr4 ,burr1 ,ms4
 ,w>r51 & ,mr4 ,hat*7 introduc$ ! foll[+
 bill2 :i* 0 read twice & ref]r$ to !   
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to all[ 
! sponsor ( an application = ! approval 
( a t>get$ drug to rely ^u data &       
in=mation ) respect to su* sponsor's    
previ\sly approv$ t>get$ drugs4  #a4    
,%ort title  ,?is ,act may be cit$ z !  
,advanc+ ,t>get$ ,!rapies = ,r>e        
,diseases ,act ( #bjae4  #b4 ,t>get$    
drugs = r>e diseases ,title ,v ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by
 ins]t+ aft] section #ejf;,f ! foll[+3  
#ejf;,g4 ,t>get$ drugs = r>e diseases   
7a7 ,purpose ,! purpose ( ?is section1  
?r\gh ! approa* provid$ = 9 subsection  
7b71 is to-- 7#a7 facilitate !          
developm5t1 review1 & approval (        
g5etically t>get$ drugs to address an   

unmet m$ical ne$ 9 "o or m pati5t       
subgr\ps 7or g5e v>iant subpopulations7 
) respect to r>e diseases or conditions 
t are s]i\s or life-?reat5+2 &  7#b7    
maximize ! use ( sci5tific tools or     
me?ods1 includ+ surrogate endpo9ts & o!r
 biom>k]s = su* purposes4  7b7 ,lev]ag+ 
( data f previ\sly approv$ drug         
application or applications ,! ,secret>y
 may1 consi/5t ) applicable /&>ds =     
approval "u ?is ,act or section #cea ( !
 ,public ,heal? ,s]vice ,act1 all[ !    
sponsor ( a g5etically t>get$ drug to   
rely ^u data & in=mation--  7#a7        
previ\sly develop$ by ! same sponsor 7or
 ano!r sponsor t has provid$ ! sponsor )
 a contractual "r ( ref]5ce to su* data 
& in=mation72 &  7#b7 submitt$ by a     
sponsor describ$ 9 p>agraph 7#a7 9      
support ( "o or m applications previ\sly
 approv$ "u ?is ,act or section #cea ( !
 ,public ,heal? ,s]vice ,act1  = a drug 
t incorporates or utilizes ! same or    
simil> g5etically t>get$ te*nology1 or !
 same v>iant prote9 t>get$ te*nology1 z 

! drug or drugs t are ! subject ( an    
application or applications describ$ 9  
p>agraph 7#b74  7c7 ,def9itions ,=      
purposes ( ?is section-- 7#a7 ! t]m     
g5etically t>get$ drug means a drug     
:i*--  7,a7 is ! subject ( an           
application "u section #eje7;b77#a7 (   
?is ,act or section #cea7;a7 ( ! ,public
 ,heal? ,s]vice ,act = ! treatm5t ( a   
r>e disease or condition 7z su* t]m is  
def9$ 9 section #ebf7 t is s]i\s or     
life-?reat5+2  7,b7 incorporates or     
utilizes a g5etically t>get$ te*nology  
or a v>iant prote9 t>get$ te*nology2 &  
7,c7 may result 9 ! modulation 7includ+ 
suppression1 up-regulation1 or          
activation7 ( ! function ( a g5e or its 
associat$ g5e product2  7#b7 ! t]m      
g5etically t>get$ te*nology means a     
te*nology compris+ non-replicat+ nucleic
 acid or analog\s comp\nds ) a common or
 simil> *emi/ry t is int5d$ to treat "o 
or m subsets ( pati5ts ) ! same disease1
 includ+ due to o!r v>iants 9 ! same    
g5e2 &  7#c7 ! t]m v>iant prote9 t>get$ 

te*nology means a te*nology or comp\nd t
 modulates ! function ( a v>iant prote91
 due to a g5e v>iant1 int5d$ to treat "o
 or m subsets ( pati5ts ) ! same        
disease1 due to o!r v>iants 9 ! same    
g5e4  7d7 ,rule ( con/ruction ,no?+ 9   
?is section %all be con/ru$ to-- 7#a7   
alt] ! au?ority ( ! ,secret>y to approve
 drugs pursuant to ?is ,act or section  
#cea ( ! ,public ,heal? ,s]vice ,act 7z 
au?oriz$ prior to ! date ( enactm5t ( ! 
,advanc+ ,t>get$ ,!rapies = ,r>e        
,diseases ,act ( #bjae71 includ+ ! /&>ds
 ( evid5ce1 & applicable conditions1 =  
approval "u su* ,act2 or  7#b7 conf] any
 new rights1 beyond ^? au?oriz$ "u ?is  
section1 ) respect to ! p]missibility ( 
ref]5c+ in=mation conta9$ 9 ano!r       
application submitt$ "u section         
#eje7;b77#a7 ( ?is ,act or section      
#cea7;a7 ( ! ,public ,heal? ,s]vice     
,act4  4