,i  #aag? ,,congress  #a/ ,session  ,h4 
,r4 #deaa  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,july #ai1 #bjba,mr4  
,burgess 7= himself & ,ms4 ,craig7      
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to au?orize ! use (    
em]g5cy use au?orization data & real _w 
evid5ce ga!r$ dur+ an em]g5cy to support
 prem>ket applications = drugs1         
biological products1 & devices1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,,fda ,advanc+ ,collection 
( ,trans=mative ,sci5ce ,act or !       
,,facts ,act4  #b4 ,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 ,section 
#efd7k7 ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#c7k77 is am5d$-- 7#a7 by /rik+
 ,if a product & ins]t+ ! foll[+3  7#a7 
,9 g5]al ,if a product  2 &  7#b7 by    

add+ at ! end ! foll[+3  7#b7 ,data     
relat+ to a drug1 biological product1 or
 device g5]at$ dur+ em]g5cy use ,em]g5cy
 use-relat$ data submitt$ by a sponsor 9
 an application =1 or submission relat+ 
to1 ! approval1 lic5sure1 or cle>ance ( 
a drug1 biological product1 or device   
may con/itute valid sci5tific evid5ce or
 o!rwise satisfy ! /&>d ( evid5ce =     
approval1 lic5sure1 or cle>ance ( su*   
drug1 biological product1 or device1 &  
%all be consid]$ = purposes (-- 7,a7    
review+ submissions & approv+1 lic5s+1  
or cle>+ su* drug1 biological product1  
or device pursuant to1 z applicable1    
sections #eje1 #eaj7k71 #eac7;f71 & #eae
 ( ?is ,act & section #cea ( ! ,public  
,heal? ,s]vice ,act2 &  7,b7 o!rwise    
meet+ ! requirem5ts ( ?is ,act or       
section #cea ( ! ,public ,heal? ,s]vice 
,act4  7#c7 ,applicability ( c]ta9      
categorizations = prem>ket device review
 ,9 ! case ( a device receiv+ an        
au?orization "u ?is section = :i* !     
,secret>y has det]m9$1 9 accordance )   

subsection 7m71 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 ,act1 su* det]m9ation %all apply
 ) reg>d to a submission pursuant to    
section #eaj7k71 #eac7;f71 or #eae = su*
 device1 unless ! ,secret>y 7tak+ into  
acc\nt any applicable conditions        
specifi$ pursuant to subsection 7m77#b7 
( ?is section7 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 are n met4  7#d7 ,rule (           
con/ruction ,no?+ 9 ?is subsection %all 
be con/ru$ z alt]+ ! review /&>ds or    
o!rwise affect+ ! requirem5ts "u section
 #eje1 #eaj7k71 #eac7;f71 or #eae ( ?is 
,act1 or section #cea ( ! ,public ,heal?
 ,s]vice ,act = ! approval1 lic5sure1 or
 cle>ance ( a drug1 biological product1 
or device4  7#e7 ,em]g5cy use-relat$    
data def9$  7,a7 ,9 g5]al ,9 ?is        

subsection1 ! t]m em]g5cy use-relat$    
data means-- 7i7 data t is us$ to       
support ! issuance ( an au?orization "u 
?is section ) respect to a drug1        
biological product1 or device2  7ii7    
data g5]at$ dur+ ! p]iod "u :i* su*     
au?orization is 9 effect1 ) respect to  
su* drug1 biological product1 or device2
 &  7iii7 real _w evid5ce relat+ to su* 
drug1 biological product1 or device us$ 
pursuant to su* au?orization4  7,b7     
,exclusion ,su* t]m does n include data 
previ\sly review$ & det]m9$ to be       
inadequate or insuffici5t to support su*
 an au?orization4  4