,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #ciee  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #ab1 #bjbe ,ms4 
,craig 7= h]self & ,mr4 ,van ,drew7     
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to improve supply *a9 resili5cy
 = critical drug products ) vuln]able   
supply *a9s & ensure t res]ves (        
critical drugs & active ph>maceutical   
+r$i5ts are ma9ta9$ to prev5t supply    
disruptions 9 ! ev5t ( drug %ortages or 
public heal? em]g5cies4  #a4 ,%ort title
 ,?is ,act may be cit$ z ! ,roll+       
,active ,ph>maceutical ,+r$i5t & ,drug  
,res]ve ,act or ! ,,rapid ,res]ve ,act4 
#b4 ,roll+ active ph>maceutical +r$i5t &
 drug res]ve  7a7 ,9 g5]al ,! ,secret>y 
( ,heal? & ,human ,s]vices 7ref]r$ to 9 
?is section z ! ,secret>y7 %all aw>d    
contracts or coop]ative agreem5ts to    
eligible entities ) respect to drugs &  
active ph>maceutical +r$i5ts ( su* drugs
 t ! ,secret>y det]m9es to be critical &
 to h vuln]able supply *a9s4 ,!         

,secret>y %all publi% ! li/ ( su* drugs 
& active ph>maceutical +r$i5ts ( su*    
drugs4  7b7 ,requirem5ts  7#a7 ,9 g5]al 
,an eligible entity1 pursuant to a      
contract or coop]ative agreem5t "u      
subsection 7a71 %all agree to-- 7,a7    
ma9ta91 9 a satisfactory dome/ic        
e/abli%m5t regi/]$ "u section #eaj7;b7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cfj7;b77 or 9 a        
satisfactory =eign e/abli%m5t regi/]$ "u
 section #eaj7;i7 ( su* ,act t is locat$
 9 a c\ntry t is a memb] ( !            
,organisation = ,economic ,coop]ation & 
,developm5t1 :i* may be an e/abli%m5t   
own$ & op]at$ by ! entity1 or by a      
:olesal]1 di/ributor1 or o!r ?ird p>ty  
"u contract ) ! entity1 a #f-mon?       
res]ve1 or o!r reasonable quantity1 z   
det]m9$ by ! ,secret>y1 (--  7i7 !      
active ph>maceutical +r$i5t ( ! eligible
 drug specifi$ 9 ! contract or          
coop]ative agreem5t1 :i* res]ve %all be 
regul>ly repl5i%$ ) a rec5tly           
manufactur$ supply ( su* +r$i5t2 &  7ii7

 ! f9i%$ eligible drug product specifi$ 
9 ! contract or coop]ative agreem5t1 :i*
 res]ve %all be regul>ly repl5i%$ ) a   
rec5tly manufactur$ supply ( su*        
product2  7,b7 implem5t production ( !  
eligible drug or an active ph>maceutical
 +r$i5t ( ! eligible drug1 at !         
direction ( ! ,secret>y1 "u ! t]ms (1 & 
9 su* quantities z specifi$ 91 !        
contract or coop]ative agreem5t2 &  7,c7
 ent] into an arrangem5t ) ! ,secret>y  
"u :i* ! eligible entity--  7i7 agrees  
to transf] a portion1 z det]m9$         
necess>y1 ( ! res]ve ( active           
ph>maceutical +r$i5t ma9ta9$ pursuant to
 subp>agraph 7,a77i7 to ano!r drug      
manufactur] 9 ! ev5t t ! ,secret>y      
det]m9es !re to be a ne$ = additional   
f9i%$ eligible drug product & su*       
eligible entity is unable to use !      
res]ve ( active ph>maceutical +r$i5t to 
manufacture a suffici5t supply ( su*    
drug product2 &  7ii7 p]mits ! ,secret>y
 to direct allocation ( ! res]ve (      
active ph>maceutical +r$i5t s ma9ta9$ 9 

! ev5t ( a public heal? em]g5cy1 natural
 disa/]1 or *emical1 biological1        
radiological1 or nucle> ?reat4  7#b7    
,guidance ,n lat] ?an #ahj days aft] !  
date ( enactm5t ( ?is ,act1 ! ,secret>y1
 9 coord9ation ) ! ,commission] ( ,food 
& ,drugs1 %all issue guidance on-- 7,a7 
! factors ! ,secret>y w use to det]m9e  
:i* eligible drugs1 or active           
ph>maceutical +r$i5t ( su* drugs1 h     
vuln]able supply *a9s & h[ a contract or
 coop]ative agreem5t w\ld help m9imize !
 vuln]ability or vuln]abilities         
id5tifi$2  7,b7 ! factors ! ,secret>y w 
consid] 9 det]m9+ eligibility ( an      
entity to p>ticipate 9 ! program "u ?is 
section1 :i* %all include an entity's   
commitm5t to quality sy/ems1 includ+    
/rong manufactur+ infra/ructure1        
reliable processes1 & tra9$ /aff1 z well
 z ! entity's commitm5t to dome/ic      
manufactur+ capacity & surge capacity1 z
 appropriate2 &  7,c7 requirem5ts =     
entities receiv+ an aw>d "u ?is section1
 includ+ ! ext5t ( excess manufactur+   

capacity ! manufactur]s w be requir$ to 
g5]ate1 ! am\nt ( r$undancy requir$1 &  
requirem5ts relat+ to advanc$ quality   
sy/ems4  7#c7 ,pref]5ce ,9 aw>d+        
contracts & coop]ative agreem5ts "u     
subsection 7a71 ! ,secret>y %all-- 7,a7 
give pref]5ce to eligible entities t w--
  7i7 c>ry out ! requirem5ts ( p>agraph 
7#a7 ?r\gh "o or m dome/ic e/abli%m5ts  
regi/]$ "u section #eaj7;b7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj7;b77 capable (           
manufactur+ ! eligible drug2 or  7ii7   
s\rce key />t+ mat]ials or excipi5ts =  
eligible drugs dome/ically or f a c\ntry
 t is a memb] ( ! ,organisation =       
,economic ,coop]ation & ,developm5t2 &  
7,b7 to ! greate/ ext5t practicable1    
aw>d su* contracts & coop]ative         
agreem5ts 9 a mann] t /r5g!ns dome/ic   
manufactur+1 resili5cy1 & capacity (    
eligible drugs & _! active ph>maceutical
 +r$i5ts4  7c7 ,additional contract &   
coop]ative agreem5t t]ms  7#a7 ,9 g5]al 
,ea* contract or coop]ative agreem5t "u 

subsection 7a7 %all be subject to su*   
t]ms & conditions z ! ,secret>y may     
specify1 includ+ t]ms & conditions )    
respect to procurem5t1 ma9t5ance1       
/orage1 te/+1 & deliv]y ( drugs1 9      
alignm5t ) inv5tory managem5t & o!r     
applicable be/ practices1 "u su*        
contract or coop]ative agreem5t1 :i* may
 consid]1 z appropriate1 co/s (         
transport+ & h&l+ su* drugs4  7#b7 ,t]ms
 conc]n+ ! acquisition1 con/ruction1    
alt]ation1 or r5ovation ( e/abli%m5ts   
,not)/&+ section #fcjc ( title #da1     
,unit$ ,/ates ,code1 ! ,secret>y may    
aw>d a contract or coop]ative agreem5t  
"u ?is section to support ! acquisition1
 con/ruction1 alt]ation1 or r5ovation ( 
non-f$]ally own$ e/abli%m5ts-- 7,a7 z   
det]m9$ necess>y to c>ry out or improve 
prep>$ness & response capability at !   
,/ate & local level2 or  7,b7 = !       
production ( drugs1 devices1 & supplies 
:]e ! ,secret>y det]m9es t su* a        
contract or coop]ative agreem5t is      
necess>y to ensure suffici5t am\nts (   

su* drugs1 devices1 & supplies4  7d7    
,requirem5ts 9 aw>d+ contracts ,to !    
greate/ ext5t practicable1 ! ,secret>y  
%all aw>d contracts & coop]ative        
agreem5ts "u ?is section 9 a mann] t--  
7#a7 maximizes quality1 m9imizes co/1   
m9imizes vuln]ability ( ! ,unit$ ,/ates 
to sev]e %ortages or disruptions =      
eligible drugs & _! active ph>maceutical
 +r$i5ts1 gives pref]5ce to dome/ic     
manufactur]s1 & enc\rages competition 9 
! m>ketplace2 &  7#b7 increases dome/ic 
production surge capacity & res]ves (   
dome/ic-bas$ manufactur+ e/abli%m5ts =  
critical drugs & active ph>maceutical   
+r$i5ts ( su* drugs4  7e7 ,def9itions ,9
 ?is section3 7#a7 ,active ph>maceutical
 +r$i5t ,! t]m active ph>maceutical     
+r$i5t has ! mean+ giv5 su* t]m 9       
section #gdd;,a ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cgi;j-#da74  7#b7 ,drug ,! t]m drug has
 ! mean+ giv5 su* t]m 9 section #bja7;g7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cba7;g774  7#c7    

,drug %ortage2 %ortage ,! t]m drug      
%ortage or %ortage has ! mean+ giv5 su* 
t]m 9 section #ejf;,c ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;c74  7#d7 ,eligible drug ,! t]m    
eligible drug means a drug1 z det]m9$ by
 ! ,secret>y1 9 coord9ation ) !         
,assi/ant ,secret>y = ,prep>$ness &     
,response1 ! ,director ( ! ,c5t]s =     
,disease ,control & ,prev5tion1 & !     
,commission] ( ,food & ,drugs-- 7,a7 t  
is approv$ "u section #eje7;j7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j77 or lic5s$ "u   
section #cea7k7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772   
7,b7  7i7 t is reasonably likely to be  
requir$ to respond to a public heal?    
em]g5cy or to a *emical1 biological1    
radiological1 or nucle> ?reat2 or  7ii7 
! %ortage ( :i* w\ld pose a significant 
?reat to ! ,unit$ ,/ates heal? c>e sy/em
 or at-risk populations2 &  7,c7 t has a
 vuln]able supply *a91 su* z a          
geographic conc5tration ( manufactur+1  

poor quality or safety issues1 complex  
manufactur+ or *emi/ry1 or few          
manufactur]s4  7#e7 ,eligible entity ,! 
t]m eligible entity means a p]son t--   
7,a7  7i7 is ! hold] ( an approv$       
application "u subsection 7j7 ( section 
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
subsection 7k7 ( section #cea ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7 = an eligible drug2     
7ii7 ma9ta9s at lea/ "o dome/ic         
e/abli%m5t regi/]$ "u section #eaj7;b7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cfj7;b77 or "o =eign   
e/abli%m5t regi/]$ "u section #eaj7;i7 (
 su* ,act t is locat$ 9 a c\ntry t is a 
memb] ( ! ,organisation = ,economic     
,coop]ation & ,developm5t t is capable (
 manufactur+ ! eligible drug2 &  7iii7  
has a /rong record ( good manufactur+   
practices ( drugs2  7,b7 7i7 is a       
manufactur] ( an active ph>maceutical   
+r$i5t = an eligible drug1 9 p>tn]%ip ) 
an entity t meets ! requirem5ts (       

subp>agraph 7,a72  7ii7 ma9ta9s at lea/ 
"o dome/ic e/abli%m5t regi/]$ "u section
 #eaj7;b7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;b77 
or "o =eign e/abli%m5t regi/]$ "u       
section #eaj7;i7 ( su* ,act t is locat$ 
9 a c\ntry t is a memb] ( !             
,organisation = ,economic ,coop]ation & 
,developm5t t is capable ( manufactur+ !
 active ph>maceutical +r$i5t2 &  7iii7  
has a /rong record ( good manufactur+   
practices ( active ph>maceutical        
+r$i5ts2 or  7,c7 is a di/ributor or    
:olesal] ( an eligible drug1 9 p>tn]%ip 
) an entity t meets ! requirem5ts (     
subp>agraph 7,a74  7f7 ,reports to      
,congress ,n lat] ?an #b ye>s aft] !    
date on :i* ! fir/ aw>d is made "u ?is  
section1 & e #b ye>s !reaft]1 !         
,secret>y %all submit a report to       
,congress detail+--  7#a7 ! li/ ( drugs 
det]m9$ to be eligible drugs1 z describ$
 9 subsection 7e77#b71 & ! rationale    
beh9d select+ ea* su* drug2 &  7#b7 an  
update on ! effectiv5ess ( ! program "u 

?is section1 9 a mann] t does n         
compromise national security4  7g7      
,au?orization ( appropriations ,to c>ry 
out ?is section1 !re is au?oriz$ to be  
appropriat$ #ejj1jjj1jjj = fiscal ye>   
#bjbf4