,i  #aaith ,,congress  #b;d ,session    
,h4 ,r4 #ifce  ,,in ,,the ,,house ,,of  
,,representatives  ,july #i1 #bjbf,mr4  
,mullin introduced the following bill2  
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to establish special     
rules to provide for continued review of
 human drug and device submissions      
during a lapse of appropriations1 and   
for other purposes4  #a4 ,short title   
,this ,act may be cited as the ,getting 
,innovations to ,patients ,during       
,shutdowns ,act4  #b4 ,special rules to 
provide for continued review of human   
drug and device submissions during a    
lapse of appropriations  7a7 ,human drug
 submissions ,section #gcf7;e7 of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cgi;h7e77 is       
amended--  7#a7 by striking ,a human    
drug application and inserting the      
following3  7#a7 ,in general ,a human   
drug application  2 and  7#b7 by adding 

at the end the following3  7#b7 ,special
 rule for lapse of appropriations  7,a7 
,in general ,notwithstanding paragraph  
7#a71 during any period for which there 
is a lapse of appropriations for the    
programs and activities of the ,food and
 ,drug ,administration1 or for the      
collection of fees used to support the  
process for the review of drug          
applications1 the ,secretary--  7i7 may 
accept for filing an application or     
supplement described in paragraph 7#a7  
if the application or supplement is     
complete except for the payment of a fee
 required under subsection 7a72 and     
7ii7 shall extend the deadline for the  
payment of such fee to the date that is 
#g days after the last day of such      
period4  7,b7 ,effect of failure to pay 
fees on or before extended deadline date
 ,if the ,secretary accepts an          
application or supplement subject to an 
extended deadline for the payment of a  
fee under subparagraph 7,a71 and the    
person subject to the fee does not pay  

the fee on or before the date of the    
extended deadline-- 7i7 the ,secretary  
shall consider the application or       
supplement to be incomplete and deem the
 application or supplement not accepted2
 and  7ii7 in no case shall the         
,secretary clear1 authorize1 or approve 
the application or supplement 7or any   
related application or supplement7 until
 such fee is paid4  4  7b7 ,device      
submissions ,section #gch7;f77#a7 of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cgi;j7f77#a77 is   
amended--  7#a7 by striking ,a premarket
 application and inserting the          
following3  7,a7 ,in general ,a         
premarket application  2 and  7#b7 by   
adding at the end the following3  7,b7  
,special rule for lapse of              
appropriations  7i7 ,in general         
,notwithstanding subparagraph 7,a71     
during any period for which there is a  
lapse of appropriations for the programs
 and activities of the ,food and ,drug  
,administration1 or for the collection  

of fees used to support the process for 
the review of device applications1 the  
,secretary--  7,i7 may accept a         
submission described in subparagraph    
7,a7 if the submission is complete      
except for the payment of a fee required
 under subsection 7a77#b7 or 7a77#c7    
relating to the submission2 and  7,,ii7 
shall extend the deadline for the       
payment of such fee to the date that is 
#g days after the last day of such      
period4  7ii7 ,effect of failure to pay 
fees on or before extended deadline date
 ,if the ,secretary accepts a submission
 subject to an extended deadline for the
 payment of a fee under clause 7i71 and 
the person subject to the fee does not  
pay the fee on or before the date of the
 extended deadline-- 7,i7 the ,secretary
 shall deem the submission not accepted2
 and  7,,ii7 in no case shall the       
,secretary clear1 authorize1 or approve 
the submission 7or any related          
submission7 until such fee is paid4  4