,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #dfcc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #aa1 #bjai,ms4
 ,e%oo 7= h]self & ,mr4 ,pet]s7         
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! #ba/ ,c5tury ,cures  
,act to reau?orize fund+ = ,,fda        
innovation projects1 & = o!r purposes4  
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,inve/+ 9 ,safety & ,innovation ,act (
 #bjai4  #b4 ,reau?orization ( ,,fda    
,innovation ,projects  7a7 ,transf] (   
direct sp5d+ sav+s ,section             
#ajjb7;b77#b77;,a7 ( ! #ba/ ,c5tury     
,cures ,act 7,public ,law #aad-bee7 is  
am5d$--  7#a7 9 ! matt] prec$+ clause   
7i71 by /rik+ #bjbe & ins]t+ #bjbi2 &   
7#b7 by /rik+ clauses 7iv7 ?r\gh 7ix7 & 
ins]t+ ! foll[+3  7iv7 ,= fiscal ye>    
#bjbj1 #gdf1jjj1jjj4  7v7 ,= fiscal ye> 
#bjba1 #eea1jjj1jjj4  7vi7 ,= ea* (     
fiscal ye>s #bjbb ?r\gh #bjbd1          
#eca1jjj1jjj4  7vii7 ,= fiscal ye>      
#bjbe1 #ecf1jjj1jjj4  7viii7 ,= ea* (   

fiscal ye>s #bjbf ?r\gh #bjbi1          
#eca1jjj1jjj4  4  7b7 ,,fda ,activities 
,p>agraph 7#d7 ( section #ajjb7;b7 ( !  
#ba/ ,c5tury ,cures ,act 7,public ,law  
#aad-bee7 is am5d$ to read z foll[s3    
7#d7 ,,fda activities ,! activities     
au?oriz$ to be fund$ "u ?is section %all
 consi/ ( ! foll[+1 & ( ! total am\nts  
au?oriz$ to be appropriat$ "u p>agraph  
7#c7 !re are au?oriz$ to be appropriat$ 
to ea* category ( activities a total    
am\nt n to exce$ ! foll[+3 7,a7 ,9      
addition to ! allocations specifi$ 9    
subp>agraphs 7,b7 ?r\gh 7,k71 = !       
activities "u subtitles ,a ?r\gh ,f     
7includ+ ! am5dm5ts made by su*         
subtitles7 ( title ,,iii ( ?is ,act &   
section #ajad ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act1 z add$ by section #cjgc
 ( ?is ,act3  7i7 ,= fiscal ye> #bjbj1  
#ge1jjj1jjj4  7ii7 ,= fiscal ye> #bjba1 
#gj1jjj1jjj4  7iii7 ,= ea* ( fiscal ye>s
 #bjbb ?r\gh #bjbd1 #ej1jjj1jjj4  7iv7  
,= fiscal ye> #bjbe1 #ee1jjj1jjj4  7v7  
,= ea* ( fiscal ye>s #bjbf ?r\gh #bjbi1 

#ej1jjj1jjj4  7,b7 ,= mod]nization ( !  
te*nical infra/ructure ( ! ,food & ,drug
 ,adm9i/ration1 includ+ enhancem5ts su* 
z int]op]ability across ! ag5cy1 &      
additional capabilities to develop an   
advanc$ in=mation te*nology             
infra/ructure to support ! ag5cy's      
regulatory mission3  7i7 ,= fiscal ye>  
#bjbj1 #cjj1jjj1jjj4  7ii7 ,= ea* (     
fiscal ye>s #bjba ?r\gh #bjbi1          
#bjj1jjj1jjj4  7,c7 ,= support =        
cont9u\s manufactur+ ( drugs &          
biological products1 includ+ complex    
biological products su* z reg5]ative    
m$ic9e !rapies1 ?r\gh grants to         
in/itutions ( high] education & nonpr(it
 organizations & o!r appropriate        
me*anisms1 = ea* ( fiscal ye>s #bjbj    
?r\gh #bjbi1 #ej1jjj1jjj4  7,d7 ,=      
support = ! ,commission] ( ,food &      
,drugs to engage exp]ts1 su* z ?r\gh !  
=mation & op]ation ( public-private     
p>tn]%ips or o!r appropriate            
collaborative ef=ts1 to advance !       
developm5t & deliv]y ( individualiz$    

human g5e !rapy products3  7i7 ,= fiscal
 ye> #bjbj1 #ej1jjj1jjj4  7ii7 ,= ea* ( 
fiscal ye>s #bjba ?r\gh #bjbi1          
#aj1jjj1jjj4  7,e7 ,= support =         
inspections & en=cem5t activities across
 ! ,food & ,drug ,adm9i/ration1 includ+ 
=eign & dome/ic facility inspections    
across products1 = ea* ( fiscal ye>s    
#bjbj ?r\gh #bjbi1 #hb1ejj1jjj4  7,f7 ,=
 support = activities ( ! ,food & ,drug 
,adm9i/ration relat$ to cu/oms & bord]  
protection to provide improvem5ts to    
te*nologies1 inspection capacity1 &     
int]national mail facilities 9 :i* !    
,food & ,drug ,adm9i/ration op]ates1 =  
ea* ( fiscal ye>s #bjbj ?r\gh #bjbi1    
#be1jjj1jjj4  7,g7 ,to fur!r advance !  
developm5t ( a coord9at$ po/m>ket       
surveillance sy/em = all m$ical         
products1 includ+ drugs1 biological     
products1 & devices1 l9k$ to electronic 
heal? records 9 fur!rance ( ! ,food &   
,drug ,adm9i/ration's po/m>ket          
surveillance capabilities3 7i7 ,= fiscal
 ye> #bjbj1 #ajj1jjj1jjj4  7ii7 ,= ea* (

 fiscal ye>s #bjba ?r\gh #bjbi1         
#ej1jjj1jjj4  7,h7 ,= support = ,food & 
,drug ,adm9i/ration activities to keep  
pace ) ! project$ product developm5t (  
reg5]ative !rapies1 includ+ human       
somatic cellul> & g5e !rapies1 = ea* (  
fiscal ye>s #bjbj ?r\gh #bjbi1          
#be1jjj1jjj4  7,i7 ,= support = !       
developm5t ( non-opioid ph>macological  
!rapies z alt]natives = opioids1 = ea* (
 fiscal ye>s #bjbj ?r\gh #bjbi1         
#c1ejj1jjj4  7,j7 ,= c>ry+ out section  
#gad;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;d-#c;a2 relat+ to hir+ au?ority =  
sci5tific1 te*nical1 & pr(essional      
p]sonnel71 = ea* ( fiscal ye>s #bjbj    
?r\gh #bjbi1 #bj1jjj1jjj4  7,k7 ,= !    
,food & ,drug ,adm9i/ration to support  
improvem5ts to ! te*nological           
infra/ructure = report+ & analysis (    
adv]se ev5ts associat$ ) ! use ( drugs &
 biological products1 = ea* ( fiscal    
ye>s #bjbj ?r\gh #bjbi1 #ae1jjj1jjj4  4 
7c7 ,annual reports ,section            

#ajjb7;c77#b77;,a7 ( ! #ba/ ,c5tury     
,cures ,act 7,public ,law #aad-bee7 is  
am5d$ by /rik+ #bjbf & ins]t+ #bjbi4    
7d7 ,sunset ,section #ajjb7;e7 ( ! #ba/ 
,c5tury ,cures ,act 7,public ,law       
#aad-bee7 is am5d$ by /rik+ ,septemb]   
#cj1 #bjbf & ins]t+ ,septemb] #cj1      
#bjbi4