,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #fjfb  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #c1 #bjbj,mr4    
,s*neid] 7= himself1 ,mr4 ,hice (       
,georgia1 & ,ms4 ,s*ak[sky7 introduc$ ! 
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d c]ta9 provisions 9 !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
relat+ to ! discont9uance or int]ruption
 9 ! production ( life-sav+ drugs s z to
 apply su* provisions ) respect to      
life-sav+ devices1 & = o!r purposes4    
#a4 ,discont9uance or int]ruption 9 !   
production ( life-sav+ devices  7a7     
,notification requirem5t ,section       
#ejf;,c ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is
 am5d$-- 7#a7 9 ! section head+1 by     
/rik+ life-sav+ drugs & ins]t+ life-sav+
 drugs & devices2  7#b7 9 ! matt] prec$+
 p>agraph 7#a7 9 subsection 7a71 by     
/rik+ a drug & ins]t+ a drug or device2 
7#c7 9 subsection 7a77#a77;,c71 by /rik+
 su* drug & ins]t+ su* drug or device2  

7#d7 9 ! matt] foll[+ p>agraph 7#b7 9   
subsection 7a71 by /rik+ ! drug ea*     
place x appe>s & ins]t+ ! drug or       
device2  7#e7 9 subsection 7c71 by /rik+
 ! drugs & ins]t+ ! drugs or devices2   
7#f7 9 ! matt] be=e p>agraph 7#a7 9     
subsection 7g71 by /rik+ a drug %ortage 
( a drug describ$ 9 subsection 7a7 &    
ins]t+ a drug or device %ortage ( a drug
 or device describ$ 9 subsection 7a72   
7#g7 9 subsection 7g77#a71 by /rik+ or a
 supplem5t to su* an application        
submitt$ "u section #eje7;j71 t c\ld    
help mitigate or prev5t su* %ortage &   
ins]t+ a supplem5t to su* an application
 submitt$ "u section #eje7;j71 or a     
submission = cle>ance ( a device "u     
section #eaj7k71 classification ( a     
device "u section #eac7;f77#b71 or      
approval ( a device "u section #eae1 t  
c\ld help mitigate or prev5t su*        
%ortage2  7#h7 9 subsection 7g77#b71 by 
/rik+ su* drug %ortage & ins]t+ su* drug
 or device %ortage2  7#i7 9 subsection  
7h71 by am5d+ p>agraph 7#b7 to read z   

foll[s3  7#b7 ! t]m drug or device      
%ortage or %ortage1 ) respect to a drug 
or device1 means a p]iod ( "t :5 ! dem& 
or project$ dem& = ! drug or device )9 !
 ,unit$ ,/ates exce$s ! supply ( ! drug 
or device2 &  2 &  7#aj7 9 subsection   
7h77#c77;,a71 by /rik+ a drug & ins]t+ a
 drug or device4  7b7 ,annual report+ on
 %ortages ,section #ejf;,c-#a ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cef;c-#a7 is am5d$-- 7#a7 9 !
 section head+1 by /rik+ drug %ortages &
 ins]t+ drug & device %ortages2  7#b7 9 
subsections 7a7 & 7b71 by /rik+ drug    
%ortages ea* place x appe>s & ins]t+    
drug & device %ortages2  7#c7 9         
subsection 7a77#b71 by /rik+ ! /aff ( ! 
,c5t] = ,drug ,evaluation & ,rese>*'s   
,(fice ( ,compliance & ,drug ,%ortage   
,program & ins]t+ ! /affs ( ! ,c5t] =   
,drug ,evaluation & ,rese>*'s ,(fice (  
,compliance & ,drug ,%ortage ,program & 
! ,c5t] = ,devices & ,radiological      
,heal?2  7#d7 9 subsection              
7a77#c77;,b77i71 by /rik+ applications &

 supplem5ts & ins]t+ applications1      
supplem5ts1 & submissions2 &  7#e7 9    
subsections 7a77#e7 & 7c71 by /rik+ drug
 %ortage & ins]t+ drug or device        
%ortage4  #b4 ,device %ortage li/  7a7  
,9 g5]al ,section #ejf;,e ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef;e7 is am5d$-- 7#a7 9 !   
section head+1 by /rik+ ,drug ,%ortage  
,li/ & ins]t+ ,drug & ,device ,%ortage  
,li/2 &  7#b7 9 subsection 7a71 by /rik+
 li/ ( drugs & ins]t+ li/ ( drugs &     
devices4  7b7 ,cont5ts ,section         
#ejf;,e7b7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7b77
 is am5d$-- 7#a7 9 ! matt] be=e p>agraph
 7#a71 by /rik+ ea* drug & ins]t+ ea*   
drug & device2  7#b7 by /rik+ ! drug ea*
 place x appe>s & ins]t+ ! drug or      
device2  7#c7 9 p>agraph 7#a71 by /rik+ 
! ,national ,drug ,code numb] = su* drug
 & ins]t+ ! ,national ,drug ,code numb] 
= any su* drug2 &  7#d7 9 p>agraph 7#b71
 by /rik+ su* drug & ins]t+ su* device4 
7c7 ,public availability public heal?   

exception ,section #ejf;,e7c7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cef;e7b77 is am5d$ by /rik+  
drug products & ins]t+ drug products or 
devices4  7d7 ,te*nical corrections     
,effective z if includ$ 9 ! enactm5t ( !
 #ba/ ,c5tury ,cures ,act 7,public ,law 
#aad-bee71 section #caja7;a77#b77;,g7 ( 
su* ,act is am5d$1 9 ! am5dm5ts made by 
su* section to section                  
#ejf;,e7b77#c77;,e7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;e7b77#c77;,e77-- 7#a7 by /rik+     
discont9uation & ins]t+ ,discont9uation2
 &  7#b7 by /rik+ discont9uance & ins]t+
 ,discont9uance4  #c4 ,importation (    
devices 9 %ortage ,section #hja7;d7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cha7;d77 is am5d$-- 7#a7
 9 p>agraph 7#a71 by add+ at ! end !    
foll[+ subp>agraph3  7,c7 ,except z     
au?oriz$ by ! ,secret>y 9 ! case ( a    
device t appe>s on ! drug & device      
%ortage li/ "u section #ejf;,e1 no      
device may be import$ into ! ,unit$     

,/ates = comm]cial use if su* device is 
manufactur$ outside ! ,unit$ ,/ates1    
unless ! manufactur] has au?oriz$ !     
device to be m>ket$ 9 ! ,unit$ ,/ates & 
has caus$ ! device to be label$ to be   
m>ket$ 9 ! ,unit$ ,/ates4  2 &  7#b7 9  
p>agraph 7#b71 by /rik+ drug ea* place x
 appe>s & ins]t+ drug or device4