,,ii  #aai? ,,congress  #a/ ,session    
,s4 #bffe  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,augu/ #a1 #bjbe,ms4   
,klobu*> 7= h]self1 ,ms4 ,coll9s1 ,ms4  
,w>r51 ,ms4 ,murk[ski1 ,ms4 ,smi?1 &    
,mr4 ,pet]s7 introduc$ ! foll[+ bill2   
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
to provide = notification by            
manufactur]s ( critical drugs ( increas$
 dem&1 & = o!r purposes4  #a4 ,%ort     
title ,?is ,act may be cit$ z ! ,drug   
,%ortage ,prev5tion ,act ( #bjbe4  #b4  
,improv+ notification proc$ures 9 case (
 increas$ dem& = critical drugs  7a7 ,9 
g5]al ,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+ ,discont9uance or       
int]ruption 9 ! production ( life-sav+  
drugs & ins]t+ ,notification ( issues   
affect+ dome/ic supply ( critical drugs2
  7#b7 by /rik+ subsections 7a71 7b71 & 

7c71 & ins]t+ ! foll[+3  7a7            
,notification requir$  7#a7 ,9 g5]al ,a 
manufactur] ( a cov]$ drug %all notify !
 ,secret>y1 9 accordance ) subsection   
7b71 (-- 7,a7 7i7 a p]man5t             
discont9uance 9 ! manufacture ( ! drug  
or an int]ruption ( ! manufacture ( !   
drug t is likely to lead to a mean+ful  
disruption 9 ! supply ( su* drug 9 !    
,unit$ ,/ates2  7ii7 a p]man5t          
discont9uance 9 ! manufacture ( an      
active ph>maceutical +r$i5t ( su* drug1 
or an int]ruption 9 ! manufacture ( an  
active ph>maceutical +r$i5t ( su* drug t
 is likely to lead to a mean+ful        
disruption 9 ! supply ( ! active        
ph>maceutical +r$i5t ( su* drug2 or     
7iii7 any o!r circum/ance1 su* z an     
increase 9 dem& or export re/riction1 t 
is likely to leave ! manufactur] unable 
to meet dem& = ! drug )\t a mean+ful    
%ortfall or delay2 &  7,b7 ! reasons =  
su* discont9uance1 int]ruption1 or o!r  
circum/ance1 if kn[n4  7#b7 ,cont5ts    
,notification "u ?is subsection )       

respect to a cov]$ drug %all include--  
7,a7 ) respect to ! reasons = !         
discont9uation1 int]ruption1 or o!r     
circum/ance describ$ 9 p>agraph         
7#a77;,a77iii71 if an active            
ph>maceutical +r$i5t is a reason =1 or  
risk factor 91 su* discont9uation1      
int]ruption1 or o!r circum/ance1 ! s\rce
 ( ! active ph>maceutical +r$i5t & any  
alt]native s\rces = ! active            
ph>maceutical +r$i5t kn[n to !          
manufactur]2  7,b7 :e!r any associat$   
device us$ = prep>ation or adm9i/ration 
includ$ 9 ! drug is a reason =1 or a    
risk factor 91 su* discont9uation1      
int]ruption1 or o!r circum/ance describ$
 9 p>agraph 7#a77;,a77iii72  7,c7 !     
expect$ duration ( ! int]ruption2 &     
7,d7 su* o!r in=mation z ! ,secret>y may
 require4  7b7 ,tim+ ,a notice requir$  
"u subsection 7a7 %all be submitt$ to ! 
,secret>y-- 7#a7 at lea/ #f mon?s prior 
to ! date ( ! discont9uance or          
int]ruption2  7#b7 9 ! case ( su* a     
notice ) respect to a circum/ance       

describ$ 9 subsection 7a77#a77;,a77iii71
 z soon z practicable1 or n lat] ?an #aj
 bus9ess days aft] ! onset ( !          
circum/ance2 or  7#c7 if compliance )   
p>agraph 7#a7 or 7#b7 is n possible1 z  
soon z practicable4  7c7 ,di/ribution   
,to ! maximum ext5t practicable1 !      
,secret>y %all di/ribute1 ?r\gh su*     
means z ! ,secret>y det]m9es            
appropriate1 in=mation on !             
discont9uance or int]ruption ( !        
manufacture (1 or o!r circum/ance       
describ$ 9 subsection 7a77#a77;,a77iii7 
t is likely to lead to a %ortage or     
mean+ful disruption 9 ! supply (1 cov]$ 
drugs to appropriate organizations1     
includ+ physician1 heal? provid]1 &     
pati5t organizations1 z describ$ 9      
section #ejf;,e4  2  7#c7 9 subsection  
7g71 9 ! matt] prec$+ p>agraph 7#a71 by 
/rik+ drug describ$ 9 subsection 7a7 &  
ins]t+ cov]$ drug2 &  7#d7 9 subsection 
7j71 by /rik+ drug describ$ 9 subsection
 7a7 & ins]t+ cov]$ drug4  7b7          
,def9itions ,p>agraph 7#a7 ( section    

#ejf;,c7h7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7h77
 is am5d$ to read z foll[s3  7#a7 ! t]m 
cov]$ drug means a drug t is int5d$ =   
human use & t-- 7,a7 is-- 7i7           
life-support+2  7ii7 life-su/a9+2 or    
7iii7 int5d$ = use 9 ! prev5tion or     
treatm5t ( a debilitat+ disease or      
condition1 includ+ any su* drug us$ 9   
em]g5cy m$ical c>e or dur+ surg]y or any
 su* drug t is critical to ! public     
heal? dur+ a public heal? em]g5cy decl>$
 by ! ,secret>y "u section #cai ( !     
,public ,heal? ,s]vice ,act2  7,b7 is n 
a radio ph>maceutical drug product or   
any o!r product z designat$ by !        
,secret>y2 &  7,c7 is n a biological    
product 7z def9$ 9 section #cea7;i7 ( ! 
,public ,heal? ,s]vice ,act71 unless    
o!rwise provid$ by ! ,secret>y 9 !      
regulations promulgat$ "u subsection    
7i72  4  #c4 ,report+ on supply *a9s    
,section #eaj7;j77#c77;,a7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj7;j77#c77;,a77 is am5d$-- 

7#a7 by /rik+ annually to ! ,secret>y 9 
! fir/ s5t5ce & ins]t+ to ! ,secret>y1  
once dur+ ! mon? ( ,m>* ea* ye> & once  
dur+ ! mon? ( ,septemb] ea* ye>12  7#b7 
by ins]t+ 1 & ! legal names (1 & any    
additional in=mation ! ,secret>y may    
require1 reg>d+ suppli]s ( active       
ph>maceutical +r$i5ts & int]m$iate &    
9-process mat]ials su* p]son us$ = !    
manufacture1 prep>ation1 propagation1   
comp\nd+1 or process+ ( su* drug1 & !   
am\nt ( su* drug manufactur$1 prep>$1   
propagat$1 comp\nd$1 or process$ us+ ea*
 su* active ph>maceutical +r$i5t or     
int]m$iate or 9-process mat]ial s\rc$ f 
ea* su* suppli] be=e ! p]iod at ! end ( 
! fir/ s5t5ce2 &  7#c7 by ins]t+ aft] ! 
fir/ s5t5ce ! foll[+3 ,9 addition to !  
report+ requir$ "u ! prec$+ s5t5ce1 ea* 
p]son :o regi/]s ) ! ,secret>y "u ?is   
section ) reg>d to a drug may volunt>ily
 report on ! in=mation describ$ 9 !     
prec$+ s5t5ce1 at su* o!r times z !     
,secret>y may specify44