,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #cdfh  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #ab1 #bjbj,mrs4   
,loeffl] 7= h]self & ,mr4 ,casey7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to require ! manufactur]s ( 
c]ta9 ess5tial m$ical devices to notify 
! ,food & ,drug ,adm9i/ration :5 su*    
manufactur]s become aw>e ( a circum/ance
 t c\ld lead to a %ortage ( su* devices1
 & = o!r purposes4  #a4 ,%ort title ,?is
 ,act may be cit$ z ! ,prev5t+ ,ess5tial
 ,m$ical ,device ,%ortages ,act ( #bjbj4
  #b4 ,discont9uance or int]ruption 9 ! 
production ( ess5tial m$ical devices    
,*apt] ,v ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cea et   
seq47 is am5d$ by ins]t+ aft] section   
#ejf;,i ! foll[+3  #ejf;,j4             
,discont9uance or int]ruption 9 !       
production ( ess5tial m$ical devices    
7a7 ,9 g5]al ,! manufactur] ( an        
ess5tial device %all notify ! ,secret>y1

 9 accordance ) subsection 7b71 ( a     
p]man5t discont9uance 9 ! manufacture ( 
! ess5tial device or an int]ruption ( ! 
manufacture ( ! ess5tial device t is    
likely to lead to a mean+ful disruption 
9 ! supply ( t device 9 ! ,unit$ ,/ates1
 & ! reasons = su* discont9uance or     
int]ruption4  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 or  7#b7  
if compliance ) p>agraph 7#a7 is n      
possible1 z soon z practicable4  7c7    
,di/ribution  7#a7 ,public availability 
,to ! maximum ext5t practicable1 subject
 to p>agraph 7#b71 ! ,secret>y %all     
di/ribute1 ?r\gh su* means z ! ,secret>y
 det]m9es appropriate1 in=mation on !   
discont9uance or int]ruption ( !        
manufacture ( ess5tial devices report$  
"u subsection 7a7 to appropriate        
organizations1 includ+ physician1 heal? 
provid]1 & pati5t organizations1 z      
appropriate & applicable4  7#b7 ,public 

heal? exception ,! ,secret>y may *oose n
 to make in=mation collect$ "u ?is      
section publicly available pursuant to  
?is section if ! ,secret>y det]m9es t   
disclosure ( su* in=mation w\ld adv]sely
 affect ! public heal?1 su* z by        
increas+ ! possibility ( ho>d+ or o!r   
disruption ( ! availability ( drug      
products to pati5ts4  7d7               
,confid5tiality ,no?+ 9 ?is section %all
 be con/ru$ z au?oriz+ ! ,secret>y to   
disclose any in=mation t is a trade     
secret or confid5tial in=mation subject 
to section #eeb7;b77#d7 ( title #e1     
,unit$ ,/ates ,code1 or section #aije ( 
title #ah1 ,unit$ ,/ates ,code4  7e7    
,failure ,to meet requirem5ts ,if a     
p]son fails to submit in=mation requir$ 
"u subsection 7a7 9 accordance )        
subsection 7b7-- 7#a7 ! ,secret>y %all  
issue a lett] to su* p]son in=m+ su*    
p]son ( su* failure2  7#b7 n lat] ?an   
#cj cal5d> days aft] ! issuance ( a     
lett] "u p>agraph 7#a71 ! p]son :o      
receives su* lett] %all submit to !     

,secret>y a writt5 response to su* lett]
 sett+ =? ! basis = noncompliance &     
provid+ in=mation requir$ "u subsection 
7a72 &  7#c7 n lat] ?an #de cal5d> days 
aft] ! issuance ( a lett] "u p>agraph   
7#a71 ! ,secret>y %all make su* lett] & 
any response to su* lett] "u p>agraph   
7#b7 available to ! public on ! int]net 
website ( ! ,food & ,drug ,adm9i/ration1
 ) appropriate r$actions made to protect
 in=mation describ$ 9 subsection 7d71   
except t1 if ! ,secret>y det]m9es t !   
lett] "u p>agraph 7#a7 0 issu$ 9 error  
or1 aft] review ( su* response1 ! p]son 
_h a reasonable basis = n notify+ z     
requir$ "u subsection 7a71 ! requirem5ts
 ( ?is p>agraph %all n apply4  7f7      
,exp$it$ ,inspections & ,reviews ,if1   
bas$ on notifications describ$ 9        
subsection 7a7 or any o!r relevant      
in=mation1 ! ,secret>y concludes t !re  
is1 or is likely to be1 a %ortage ( an  
ess5tial device1 ! ,secret>y may-- 7#a7 
exp$ite ! review ( an application =     
prem>ket review "u section #eae or      

review ( a notification "u section      
#eaj7k7 = a device t c\ld help mitigate 
or prev5t su* %ortage2 or  7#b7 exp$ite 
an inspection or re9spection ( an       
e/abli%m5t t c\ld help mitigate or      
prev5t su* %ortage4  7g7 ,def9itions    
7#a7 ,ess5tial device  7,a7 ,9 g5]al ,n 
lat] ?an #ahj days aft] ! date (        
enactm5t ( ! ,prev5t+ ,ess5tial ,m$ical 
,device ,%ortages ,act ( #bjbj1 !       
,secret>y %all1 = ! purposes ( ?is      
section1 promulgate a notice ( propos$  
rulemak+ def9+ ! t]m ess5tial device &  
%all1 n lat] ?an #a ye> aft] su* date ( 
enactm5t1 promulgate f9al regulations   
def9+ su* t]m4  7,b7 ,ess5tial devices  
dur+ public heal? em]g5cies ,^u         
decl>ation by ! ,secret>y ( a public    
heal? em]g5cy "u section #cai ( !       
,public ,heal? ,s]vice ,act1 ! ,secret>y
 %all issue a li/ ( devices deem$       
ess5tial devices = ! purpose ( ensur+ ! 
public heal? & safety = ! duration ( !  
decl>$ public heal? em]g5cy4  7#b7 ,o!r 
def9itions ,9 ?is section-- 7,a7 ! t]m  

mean+ful disruption-- 7i7 means a *ange 
9 production t is reasonably likely to  
lead to a r$uction 9 ! supply ( an      
ess5tial device by a manufactur] t is m 
?an negligible & affects ! ability ( !  
manufactur] to fill ord]s or meet       
expect$ dem& = its product2 &  7ii7 does
 n include int]ruptions 9 manufactur+   
due to matt]s su* z r\t9e ma9t5ance or  
insignificant *anges 9 manufactur+ s    
long z ! manufactur] expects to resume  
op]ations 9 a %ort p]iod ( "t2 &  7,b7 !
 t]m %ortage1 ) respect to an ess5tial  
device1 means a p]iod ( "t :5 ! dem& or 
project$ dem& = ! device )9 ! ,unit$    
,/ates exce$s ! supply ( ! device4  7h7 
,annual report ,! ,secret>y %all publi% 
a public li/1 updat$ annually1 ( m$ical 
devices-- 7#a7 approv$ "u section #eae1 
cle>$ "u section #eaj7k71 or = :i* an   
exemption is grant$ "u subsection 7l7 or
 7m7 ( section #eaj2 &  7#b7 meet+ !    
def9ition ( ess5tial device z describ$ 9
 subsection 7g77#a74  4  #c4 ,drug &    
ess5tial device %ortage li/ ,section    

#ejf;,e ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7 is
 am5d$-- 7#a7 9 ! head+1 by ins]t+ &    
ess5tial device aft] drug2  7#b7 9      
subsection 7a71 by ins]t+ & ess5tial    
devices 7z su* t]m is def9$ pursuant to 
section #ejf;,j7g77#a77 aft] drugs2     
7#c7 9 subsection 7b7-- 7,a7 9 ! matt]  
prec$+ p>agraph 7#a71 by ins]t+ & ea*   
ess5tial device aft] drug2  7,b7 by     
am5d+ p>agraph 7#a7 to read z foll[s3   
7#a7 ,! "n ( ! drug or ess5tial device 9
 %ortage1 includ+1 ) respect to a drug1 
! ,national ,drug ,code numb]1 or1 )    
respect to an ess5tial device1 ! unique 
device id5tifi] or national product     
code1 if applicable4  2 &  7,c7 9       
p>agraph 7#c7-- 7i7 by am5d+ subp>agraph
 7,e7 to read z foll[s3  7,e7           
,discont9uance ( ! manufacture ( ! drug 
or ess5tial device4  2 &  7ii7 9 ea* (  
subp>agraphs 7,f7 & 7,g71 by ins]t+ or  
ess5tial device be=e ! p]iod2 &  7#d7 9 
subsection 7c77#c7-- 7,a7 by /rik+ or   
section #ejf;,c7c7 & ins]t+ 1 section   

#ejf;,c7c71 or section #ejf;,j7c72 &    
7,b7 by ins]t+ or ess5tial devices aft] 
drug products4  #d4 ,,gao report on     
intra-ag5cy coord9ation  7a7 ,9 g5]al ,n
 lat] ?an #ah mon?s aft] ! date (       
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all submit to 
! ,committee on ,heal?1 ,education1     
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report exam9+ 
! ,food & ,drug ,adm9i/ration's         
intra-ag5cy coord9ation1 communication1 
& decision mak+ 9 assess+ device        
%ortages & risks associat$ ) ! supply ( 
ess5tial devices1 & any ef=ts by ! ,food
 & ,drug ,adm9i/ration to mitigate any  
ess5tial device %ortages or to take     
corrective actions4  7b7 ,cont5t ,!     
report %all include-- 7#a7 consid]ation 
(-- 7,a7 risks associat$ ) violations ( 
curr5t good manufactur+ practices2  7,b7
 corrective & prev5tative actions )     
respect to su* violations reque/$ by !  
,food & ,drug ,adm9i/ration2  7,c7 !    

effects ( pot5tial manufactur+          
disruptions or %ut-d[ns on pot5tial     
ess5tial device %ortages1 includ+ !     
discont9uance ( ess5tial device         
manufactur+ & m>ket+2  7,d7 ef=ts to    
prioritize review ( applications =      
ess5tial devices t ! ,secret>y has      
det]m9$ "u section #ejf;,e ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef;e7 to be 9 %ortage2 &    
7,e7 ef=ts to prioritize inspections (  
facilities necess>y = approval or       
cle>ance ( ess5tial devices describ$ 9  
subp>agraph 7,d72  7#b7 a description ( 
h[ ! ,food & ,drug ,adm9i/ration        
proactively coord9ates /rategies to     
mitigate ! consequ5ces ( ! violations1  
sl[-d[ns1 & %ut-d[ns describ$ 9 p>agraph
 7#a7 across ag5cies2 &  7#c7 an        
evaluation ( *anges 9 relevant ,food &  
,drug ,adm9i/ration practices t su*     
ag5cy has propos$ b n yet implem5t$4    
7c7 ,def9ition ,9 ?is section1 ! t]m    
ess5tial device has ! mean+ giv5 su* t]m
 "u section #ejf;,j7g77#a7 ( ! ,f$]al   

,food1 ,drug1 & ,cosmetic ,act1 z add$  
by section #b4