,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #bgbc  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,octob] #bi1 #bjai,ms4 
,coll9s 7= h]self & ,ms4 ,smi?7         
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to r$uce drug   
%ortages1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z !         
,mitigat+ ,em]g5cy ,drug ,%ortages ,act4
  #b4 ,prioritize reviews ( drug        
applications2 inc5tives  7a7 ,prioritiz$
 reviews & inspections ,section         
#ejf;,c7g7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7g77
 is am5d$--  7#a7 9 ! matt] prec$+      
p>agraph 7#a71 by /rik+ ! ,secret>y may 
& ins]t+ ! ,secret>y %all2  7#b7 9      
p>agraph 7#a71 by ins]t+ prioritize &   
be=e exp$ite ! review2 &  7#c7 9        
p>agraph 7#b71 by ins]t+ prioritize &   
be=e exp$ite an inspection4  7b7 ,report
 ,n lat] ?an "o ye> aft] ! date (       

enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all develop & 
submit to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report conta9+ legislative & regulatory 
recomm5dations--  7#a7 to create        
m>ket-bas$ inc5tives or o!r appropriate 
me*anisms1 suffici5t to enc\rage--  7,a7
 ! manufacture ( drugs 9 %ortage or at  
risk ( %ortage2  7,b7 ! dome/ic         
manufacture ( f9i%$ dosage =ms ( su*    
drugs2 &  7,c7 ! dome/ic manufacture (  
active ph>maceutical +r$i5ts = su*      
drugs2 &  7#b7 to exp& ! ,em]g+         
,te*nology ,program ( ! ,food & ,drug   
,adm9i/ration to create or upgrade exi/+
 te*nologies to address drug %ortage    
*all5ges & promote mod]n1 reliable      
manufactur+ /rategies4  #c4 ,additional 
manufactur] report+ requirem5ts 9       
response to drug %ortages  7a7          
,expansion ,to include active           
ph>maceutical +r$i5ts ,subsection 7a7 ( 

section #ejf;,c ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7
 is am5d$--  7#a7 9 ! matt] prec$+      
p>agraph 7#a71 by ins]t+ or its active  
ph>maceutical +r$i5ts aft] a drug2 &    
7#b7 9 ! flu% text at ! end--  7,a7 by  
ins]t+ or its active ph>maceutical      
+r$i5ts be=e t is likely2  7,b7 or its  
active ph>maceutical +r$i5ts aft] t     
drug2 &  7,c7 by add+ at ! end ! foll[+3
 ,notification "u ?is subsection %all   
include full disclosure ( ! problems    
result+ 9 ! %ortage1 ! s\rce ( ! active 
ph>maceutical +r$i5t1 associat$ m$ical  
devices us$ = prep>ation or adm9i/ration
 includ$ 9 ! f9i%$ dosage =m1 any       
alt]native s\rces = ! active            
ph>maceutical +r$i5t t are kn[n or      
contact$ by manufactur]1 in=mation      
conc]n+ ! ext5t ( ! %ortage1 ! expect$  
duration ( ! %ortage1 ! expect$ impact  
to di/ribution & availability 9         
ph>macies1 & su* o!r in=mation z !      
,secret>y may require44  7b7            
,manufactur+ report+ ,section #ejf;,c ( 

! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cef;c7 is am5d$ by add+ 
at ! end ! foll[+3  7j7 ,manufactur]    
report+ ,ea* manufactur] ( a drug       
describ$ 9 subsection 7a7 or ( any      
active ph>maceutical +r$i5t or associat$
 m$ical devices us$ = prep>ation or     
adm9i/ration includ$ 9 ! f9i%$ dosage =m
 ( su* a drug1 %all report 9 su*        
manufactur]'s annual e/abli%m5t         
regi/ration & product li/+ "u           
subsections 7b7 & 7j7 ( section #eaj !  
specific facilities 9 :i* su* drug or   
+r$i5t is manufactur$ & cont+5cy &      
r$undancy plans to help ensure          
un9t]rupt$ supply ( ! drug or +r$i5t4   
,additional manufactur] report+         
requirem5ts "u ?is section %all be      
ma9ta9$ by ! ,secret>y 9 a confid5tial &
 int]nal mann] = use by ! ag5cy to help 
ensure cont9u$ supply ( su* drugs4  4   
7c7 ,consum] notification ,n lat] ?an "o
 ye> aft] ! date ( enactm5t ( ?is ,act1 
! ,secret>y %all develop & submit to !  
,committee on ,heal?1 ,education1       

,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives legislative &   
regulatory recomm5dations = consum]     
notification 9 ! case ( a drug %ortage1 
discont9uance1 or int]ruption ( !       
manufacture ( a drug describ$ 9 section 
#ejf;,c7a7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4           
#cef;c7a771 includ+ recomm5dations =    
notification to pati5ts & physicians1   
ph>maci/s1 & o!r practition]s au?oriz$  
"u applicable ,/ate law to prescribe or 
disp5se drugs4  7d7 ,report+ aft]       
factory inspections ,section #gjd7;b7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cgd7;b77 is am5d$-- 7#a7
 by r$esignat+ p>agraphs 7#a7 & 7#b7 &  
subp>agraphs 7,a7 & 7,b72  7#b7 by /rik+
 7b7 ,^u completion & ins]t+ 7b77#a7 ,^u
 completion2 &  7#c7 by add+ at ! end ! 
foll[+3  7#b7 ,9 c>ry+ out ?is          
subsection ) respect to any e/abli%m5t  
manufactur+ a drug approv$ "u subsection
 7c7 or 7j7 ( section #eje t is describ$

 9 #ejf;,c7a7 or #eje7;j77#aa77;,a71 a  
copy ( ! report %all be s5t promptly to 
! appropriate (fices ( ! ,food & ,drug  
,adm9i/ration ) exp]tise reg>d+ drug    
%ortages4 ,su* (fices %all ensure timely
 & effective coord9ation reg>d+ !       
reviews ( su* report & ov]see+ !        
alignm5t ( any fe$back reg>d+ su*       
report1 or corrective or prev5tative    
actions1 aft] consid]ation ( ! sy/ematic
 b5efits & risks to public heal?1 pati5t
 safety1 ! drug supply & drug supply    
*a91 & timely pati5t access to su*      
drugs4  4  7e7 ,effective date ,!       
am5dm5ts made by ?is section & section  
#b %all take effect on ! date t is #ahj 
days aft] ! date ( enactm5t ( ?is ,act4 
#d4 ,,gao report on intra-ag5cy         
coord9ation  7a7 ,9 g5]al ,n lat] ?an   
#ah mon?s aft] ! date ( enactm5t ( ?is  
,act1 ! ,comptroll] ,g5]al ( ! ,unit$   
,/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+ drug %ortage risks1 & tak+      
corrective action4  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+ sl[-d[ns 
or %ut-d[ns on pot5tial drug %ortages1  
includ+ ! discont9uance ( drug          
manufactur+ & m>ket+2  7,d7 ef=ts to    
prioritize review ( applications = drugs
 t ! ,secret>y has det]m9$ "u section   
#ejf;,e ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7 to
 be 9 %ortage2 &  7,e7 ef=ts to         
prioritize inspections ( facilities     
necess>y = approval ( applications =    
drugs describ$ 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$4  #e4 ,modifications to   
drug %ortage li/ ma9ta9$ by ,,fda  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    
subsection 7a71 by /rik+ ! p]iod &      
ins]t+ ! foll[+3 1 by region1 includ+   
,/ates & localities1 :]e ! %ortages     
exi/4 ,! ,secret>y may ent] into a      
private-public p>tn]%ip to ma9ta9 su*   
li/42 &  7#b7 9 subsection 7b77#c77;,c71
 by ins]t+ be=e ! p]iod ! foll[+3 1     
/r5g?1 or dosage =m4  7b7 ,effective    
date ,! am5dm5ts made by subsection 7a7 
%all take effect on ! date ( enactm5t ( 
?is ,act1 & %all apply to updates made  
to ! drug %ortage li/ "u section #ejf;,e
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act aft] ! date ( enactm5t ( ?is ,act4 

#f4 ,national security risk assessm5t ( 
drug1 active ph>maceutical +r$i5t &     
m$ical device manufactur+ op]ations  7a7
 ,assessm5t & report  7#a7 ,9 g5]al ,!  
,secret>y ( ,heal? & ,human ,s]vices1 9 
collaboration ) ! ,secret>y ( ,homel&   
,security & 9 consultation ) /akehold]s 
7includ+ ph>maci/s1 hospitals1          
physicians1 & ph>maceutical & m$ical    
device manufactur]s71 %all conduct a    
risk assessm5t ( national security      
?reats aris+ f1 or relat$ to1 !         
manufacture & di/ribution ( drugs       
describ$ 9 #ejf;,c7a7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;c7a77 or ( any active ph>maceutical
 +r$i5ts ( su* drugs or associat$ m$ical
 devices us$ = prep>ation or            
adm9i/ration ( su* drugs4 ,n lat] ?an   
#ah mon?s aft] ! date ( enactm5t ( ?is  
,act1 ! ,secret>y %all submit to !      
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report outl9+ 

f9d+s "u su* assessm5t & any recomm5d$  
actions4  7#b7 ,cont5t ,! assessm5t &   
report "u p>agraph 7#a7 %all include--  
7,a7 a review ( manufactur+ &           
di/ribution ( drugs describ$ 9 su*      
section #ejf;,c7a71 active ph>maceutical
 +r$i5ts ( su* drugs1 & associat$ m$ical
 devices us$ = prep>ation or            
adm9i/ration ( su* drugs1 t includes    
consid]ation ( :e!r manufactur+ sites & 
di/ribution sy/ems %\ld be consid]$     
critical infra/ructure 7z def9$ 9       
section #ajaf7;e7 ( ! ,critical         
,infra/ructures ,protection ,act ( #bjja
 7#db ,u4,s4,c4 #eaie;c7e7772  7,b7 a   
review ( risks associat$ ) ! =eign      
manufacture ( su* drugs1 +r$i5ts1 or    
devices2 &  7,c7 recomm5dations on h[ to
 mitigate any su* risks4  7b7 ,/&+ =um  
,! ,secret>y ( ,heal? & ,human ,s]vices1
 9 collaboration ) ! ,secret>y ( ,homel&
 ,security1 %all e/abli% a /&+ =um to   
engage /akehold]s1 includ+ ph>maci/s1   
hospitals1 physicians1 & ph>maceutical &
 m$ical device manufactur]s1 to mitigate

 risks id5tifi$ ?r\gh ! assessm5t       
conduct$ "u subsection 7a74