,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #ifce  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #i1 #bjbf,mr4   
,mull9 introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
e/abli% special rules to provide =      
cont9u$ review ( human drug & device    
submissions dur+ a lapse (              
appropriations1 & = o!r purposes4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,gett+ ,innovations to ,pati5ts ,dur+   
,%utd[ns ,act4  #b4 ,special rules to   
provide = cont9u$ review ( human drug & 
device submissions dur+ a lapse (       
appropriations  7a7 ,human drug         
submissions ,section #gcf7;e7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cgi;h7e77 is am5d$--  7#a7 by
 /rik+ ,a human drug application &      
ins]t+ ! foll[+3  7#a7 ,9 g5]al ,a human
 drug application  2 &  7#b7 by add+ at 
! end ! foll[+3  7#b7 ,special rule =   
lapse ( appropriations  7,a7 ,9 g5]al   

,not)/&+ p>agraph 7#a71 dur+ any p]iod =
 :i* !re is a lapse ( appropriations = !
 programs & activities ( ! ,food & ,drug
 ,adm9i/ration1 or = ! collection ( fees
 us$ to support ! process = ! review (  
drug applications1 ! ,secret>y--  7i7   
may accept = fil+ an application or     
supplem5t describ$ 9 p>agraph 7#a7 if ! 
application or supplem5t is complete    
except = ! paym5t ( a fee requir$ "u    
subsection 7a72 &  7ii7 %all ext5d !    
deadl9e = ! paym5t ( su* fee to ! date t
 is #g days aft] ! la/ day ( su* p]iod4 
7,b7 ,effect ( failure to pay fees on or
 be=e ext5d$ deadl9e date ,if !         
,secret>y accepts an application or     
supplem5t subject to an ext5d$ deadl9e =
 ! paym5t ( a fee "u subp>agraph 7,a71 &
 ! p]son subject to ! fee does n pay !  
fee on or be=e ! date ( ! ext5d$        
deadl9e-- 7i7 ! ,secret>y %all consid] !
 application or supplem5t to be         
incomplete & deem ! application or      
supplem5t n accept$2 &  7ii7 9 no case  
%all ! ,secret>y cle>1 au?orize1 or     

approve ! application or supplem5t 7or  
any relat$ application or supplem5t7    
until su* fee is paid4  4  7b7 ,device  
submissions ,section #gch7;f77#a7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;j7f77#a77 is am5d$--
  7#a7 by /rik+ ,a prem>ket application 
& ins]t+ ! foll[+3  7,a7 ,9 g5]al ,a    
prem>ket application  2 &  7#b7 by add+ 
at ! end ! foll[+3  7,b7 ,special rule =
 lapse ( appropriations  7i7 ,9 g5]al   
,not)/&+ subp>agraph 7,a71 dur+ any     
p]iod = :i* !re is a lapse (            
appropriations = ! programs & activities
 ( ! ,food & ,drug ,adm9i/ration1 or = !
 collection ( fees us$ to support !     
process = ! review ( device             
applications1 ! ,secret>y--  7,i7 may   
accept a submission describ$ 9          
subp>agraph 7,a7 if ! submission is     
complete except = ! paym5t ( a fee      
requir$ "u subsection 7a77#b7 or 7a77#c7
 relat+ to ! submission2 &  7,,ii7 %all 
ext5d ! deadl9e = ! paym5t ( su* fee to 
! date t is #g days aft] ! la/ day ( su*

 p]iod4  7ii7 ,effect ( failure to pay  
fees on or be=e ext5d$ deadl9e date ,if 
! ,secret>y accepts a submission subject
 to an ext5d$ deadl9e = ! paym5t ( a fee
 "u clause 7i71 & ! p]son subject to !  
fee does n pay ! fee on or be=e ! date (
 ! ext5d$ deadl9e-- 7,i7 ! ,secret>y    
%all deem ! submission n accept$2 &     
7,,ii7 9 no case %all ! ,secret>y cle>1 
au?orize1 or approve ! submission 7or   
any relat$ submission7 until su* fee is 
paid4  4