,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #cjjh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #bh1 #bjbc,ms4 
,jacobs 7= h]self1 ,mr4 ,allr$1 ,ms4    
,cl>ke ( ,new ,york1 ,mr4 ,doggett1 ,mr4
 ,g>ca ( ,ill9ois1 ,mr4 ,grijalva1 ,mr4 
,huffman1 ,mr4 ,khanna1 ,mr4 ,l>son (   
,connecticut1 ,ms4 ,lee ( ,cali=nia1    
,mr4 ,mc,govern1 ,ms4 ,ocasio-,cortez1  
,ms4 ,pressley1 ,mr4 ,veasey1 ,ms4      
,velzquez1 ,mrs4 ,watson ,coleman1 ,mr4 
,c>t] ( ,l\isiana1 ,ms4 ,norton1 ,mr4   
,coh51 ,mr4 ,cleav]1 ,mr4 ,smi? (       
,wa%+ton1 ,ms4 ,blunt ,ro*e/]1 ,ms4     
,crockett1 ,ms4 ,ku/]1 ,ms4 ,tokuda1    
,ms4 ,c>aveo1 ,mr4 ,s*iff1 ,ms4 ,jackson
 ,lee1 ,mr4 ,kim ( ,new ,j]sey1 & ,mr4  
,mills7 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
provide = notification by manufactur]s (
 critical ess5tial m$ic9es ( increas$   
dem& ( su* drugs1 & = o!r purposes4  #a4
 ,%ort title ,?is ,act may be cit$ z !  

,drug ,%ortage ,prev5tion ,act ( #bjbc4 
#b4 ,improv+ notification proc$ures 9   
case ( increas$ dem& = critical ess5tial
 m$ic9es  7a7 ,9 g5]al ,section #ejf;,c 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cef;c7 is am5d$--  
7#a7 9 ! section head+1 by /rik+        
,discont9uance or int]ruption 9 !       
production ( life-sav+ drugs & ins]t+   
,notification ( issues affect+ dome/ic  
supply ( critical ess5tial m$ic9es2     
7#b7 by /rik+ subsections 7a71 7b71 &   
7c71 & ins]t+ ! foll[+3  7a7            
,notification requir$  7#a7 ,9 g5]al ,a 
manufactur] ( a critical ess5tial m$ic9e
 %all notify ! ,secret>y1 9 accordance )
 subsection 7b71 (-- 7,a7 7i7 a p]man5t 
discont9uance 9 ! manufacture ( ! drug  
or an int]ruption ( ! manufacture ( !   
drug t is likely to lead to a mean+ful  
disruption 9 ! supply ( su* drug 9 !    
,unit$ ,/ates2  7ii7 a p]man5t          
discont9uance 9 ! manufacture ( an      
active ph>maceutical +r$i5t1 an         
excipi5t1 or any o!r input 9 ! f9al     

dosage =m ( su* drug or an int]ruption 9
 ! manufacture ( ! active ph>maceutical 
+r$i5t1 an excipi5t1 or any o!r input 9 
! f9al dosage =m ( su* drug ( su* drug t
 is likely to lead to a mean+ful        
disruption 9 ! supply ( ! active        
ph>maceutical +r$i5t ( su* drug2  7iii7 
an increas$ dem& 7o!r ?an an anticipat$ 
seasonal surge7 = su* drug or an active 
ph>maceutical +r$i5t1 an excipi5t1 or   
any o!r input 9 ! f9al dosage =m ( su*  
drug t is likely to lead to a %ortage ( 
! drug or ! active ph>maceutical +r$i5t1
 an excipi5t1 or any o!r input 9 ! f9al 
dosage =m ( su* drug2 &  7,b7 ! reasons 
= su* discont9uance1 int]ruption1 or    
increas$ dem&4  7#b7 ,cont5ts           
,notification "u ?is subsection )       
respect to a critical ess5tial m$ic9e   
%all include-- 7,a7 ) respect to !      
reasons = ! discont9uation1 int]ruption1
 or increas$ dem& ref]r$ to 9 p>agraph  
7#a77;,c71 if an active ph>maceutical   
+r$i5t1 an excipi5t1 or any o!r input 9 
! f9al dosage =m ( su* drug is a reason 

=1 or risk factor 91 su* discont9uation1
 int]ruption1 or increas$ dem&1 ! s\rce 
( ! active ph>maceutical +r$i5t1        
excipi5t1 or o!r input & any alt]native 
s\rces = ! an active ph>maceutical      
+r$i5t1 an excipi5t1 or any o!r input by
 ! 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 increas$ dem&2  7,c7 !  
expect$ duration ( ! int]ruption or     
increas$ dem&2 &  7,d7 su* o!r in=mation
 z ! ,secret>y may require4  7b7 ,tim+  
7#a7 ,9 g5]al ,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 increas$ dem& = a   
critical ess5tial m$ic9e1 n lat] ?an #cj
 days aft] ! submission ( ! initial     
notification "u p>agraph 7#b72 or  7,c7 
if compliance ) subp>agraph 7,a7 or 7,b7
 is n possible1 z soon z practicable4   

7#b7 ,initial notification ) respect to 
increas$ dem& ,9 ! case a notification  
requir$ "u subsection 7a7 ) respect to  
increas$ dem& = a critical ess5tial     
m$ic9e1 ! manufactur] ( ! drug involv$  
%all submit to ! ,secret>y an initial   
notification n lat] ?an #dh h\rs aft] ! 
date on :i* !re has be5 increas$ dem& = 
! critical ess5tial m$ic9e = a p]iod (  
at lea/ #f consecutive weeks4  7c7      
,di/ribution ,to ! maximum ext5t        
practicable1 ! ,secret>y %all di/ribute1
 ?r\gh su* means z ! ,secret>y deems    
appropriate1 in=mation on !             
discont9uance or int]ruption ( !        
manufacture (1 or ! increas$ dem& =1    
critical ess5tial m$ic9es to appropriate
 organizations1 includ+ physician1 heal?
 provid]1 & pati5t organizations1 z     
describ$ 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+ critical        
ess5tial m$ic9e2 &  7#d7 9 subsection   
7j71 by /rik+ drug describ$ 9 subsection

 7a7 & ins]t+ critical ess5tial m$ic9e4 
7b7 ,application to nonprescription     
drugs ,section #ejf;,c7h7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef;c7h77 is am5d$-- 7#a7 by 
r$esignat+ p>agraphs 7#a71 7#b71 & 7#c7 
z p>agraphs 7#b71 7#c71 & 7#d71         
respectively2  7#b7 9 p>agraph 7#b77;,a7
 7z s r$esignat$71 by /rik+ & t is      
subject to section #ejc7;b77#a7 & ins]t+
 1 includ+ a drug t is n subject to     
section #ejc7;b77#a72 &  7#c7 by ins]t+ 
be=e p>agraph 7#b7 7z s r$esignat$7 !   
foll[+3  7#a7 ! t]m critical ess5tial   
m$ic9e means a drug 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  4  7c7 ,regulations ,n lat] 
?an #ah mon?s aft] ! date ( ! enactm5t (
 ?is ,act1 ! ,secret>y ( ,heal? & ,human
 ,s]vices %all issue f9al regulations to
 implem5t ! am5dm5ts made by subsections
 7a7 & 7b74  7d7 ,guidance  7#a7 ,9     
g5]al ,! ,secret>y ( ,heal? & ,human    
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all issue guidance on !
 requirem5ts = notifications requir$ to 
be submitt$ "u section #ejf;,c ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cef;c71 z am5d$ by      
subsections 7a7 & 7b71 ) respect to     
increas$ dem& = critical ess5tial       
m$ic9es 7z def9$ 9 su* section #ejf;,c74
 ,su* guidance %all specifically        
address-- 7,a7 ! ways 9 :i* manufactur]s
 ( critical ess5tial m$ic9es c improve  
dem& pr$ictability2  7,b7 :at in=mation 
manufactur]s ( critical ess5tial m$ic9es
 %\ld s5d to ! ,secret>y2 &  7,c7 :at   
communications f ! manufactur] !        
,secret>y w\ld reque/ ) respect to      

increases 9 dem& foll[+ su*             
notifications4  7#b7 ,consultation ,9   
develop+ su* guidance1 ! ,secret>y %all 
consult ) relevant /akehold]s1 includ+  
manufactur]s ( critical ess5tial m$ic9es
 & local1 ,/ate1 or ,f$]al public heal? 
(ficials4  7#c7 ,tim+ ,! ,secret>y (    
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all     
issue-- 7,a7 draft guidance "u p>agraph 
7#a7 n lat] ?an #abj days aft] ! date ( 
! enactm5t ( ?is ,act2 &  7,b7 f9al     
guidance "u su* p>agraph n lat] ?an #ahj
 days aft] ! date ( ! enactm5t ( ?is    
,act4