,,ii  #aag? ,,congress  #a/ ,session    
,s4 #aejh  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #bi1 #bjba,mr4  
,m>%all 7= himself1 ,ms4 ,smi?1 & ,mr4  
,cassidy7 introduc$ ! foll[+ bill2 :i* 0
 read twice & ref]r$ to ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to provide = ! use ( em]g5cy
 use au?orization data & real _w evid5ce
 ga!r$ dur+ an em]g5cy to support       
prem>ket applications = drugs1          
biological products1 & devices1 & = o!r 
purposes4  #a4 ,us+ em]g5cy use         
au?orization data & real _w evid5ce     
ga!r$ dur+ an em]g5cy to support        
prem>ket applications = drugs1          
biological products1 & devices  7a7 ,9  
g5]al ,data g5]at$ to support an        
au?orization "u section #efd ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb-#c7 ) respect to a   
drug1 biological product1 or device1 &  
real _w evid5ce relat+ to su* drug1     
biological product1 or device us$       
pursuant to su* au?orization1 may       

con/itute valid sci5tific evid5ce1 &    
%all be consid]$ = purposes (-- 7#a7    
review+ submissions pursuant to section 
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 &   
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb72  7#b7 review+
 submissions pursuant to sections       
#eaj7k71 #eac7;f71 & #eae ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #ba ,u4,s4,c4 #cfj7k71        
#cfj;c7f71 or #cfj;e72 &  7#c7 o!rwise  
meet+ ! requirem5ts ( su* ,act & su*    
section #cea ( ! ,public ,heal? ,s]vice 
,act4  7b7 ,applicability ( c]ta9       
categorizations = prem>ket device review
 ,9 ! case ( a device receiv+ an        
au?orization "u section #efd ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb-#c7 = :i* ! ,secret>y
 has det]m9$1 9 accordance ) subsection 
7m7 ( su* section1 t a laboratory       
exam9ation or proc$ure associat$ ) su*  
device is deem$ to be 9 ! category (    
exam9ations & proc$ures describ$ 9      

section #cec7;d77#c7 ( ! ,public ,heal? 
,s]vice ,act 7#db ,u4,s4,c4 #bfb71 su*  
det]m9ation %all apply ) reg>d to a     
submission pursuant to section #eaj7k71 
#eac7;f71 or #eae ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ba ,u4,s4,c4 #cfj7k71 #cfj;c7f71 or    
#cfj;e7 = su* device1 unless ! ,secret>y
 7tak+ into acc\nt any applicable       
conditions specifi$ pursuant to         
subsection 7m77#b7 ( section #efd ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb-#c77 id5tifies  
new in=mation n includ$ 9 ! reque/ =    
au?orization t indicates t ! crit]ia "u 
section #cec7;d77#c7 ( ! ,public ,heal? 
,s]vice ,act 7#db ,u4,s4,c4 #bfb7 are n 
met4  7c7 ,rule ( con/ruction ,no?+ 9   
?is section %all be con/ru$ z alt]+ !   
review /&>ds or o!rwise affect+ !       
requirem5ts "u section #eje1 #eaj7k71   
#eac7;f71 or #eae ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj;c7f71 
or #cfj;e7 or "u section #cea ( !       

,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7 = ! cle>ance or approval
 ( a device1 approval ( a drug1 or      
lic5sure ( a biological product4