,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #cghj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #bj1 #bjbj,mr4    
,pet]s introduc$ ! foll[+ bill2 :i* 0   
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to enc\rage dome/ic advanc$ 
manufactur+ ( critical drugs & devices 9
 ord] to address economic1 heal?1 &     
security conc]ns1 combat %ortages (     
critical drugs & devices1 & promote     
increas$ dome/ic div]sification (1 &    
indep5d5ce f =eign reliance on1         
ph>maceutical & m$ical device supply    
*a9s4  #a4 ,%ort title ,?is ,act may be 
cit$ z ! ,help ,on%ore ,manufactur+     
,effici5cies = ,drugs & ,devices ,act or
 ! ,,home ,act4  #b4 ,inve/m5ts 9       
dome/ic advanc$ manufactur+ & prep>$ness
 ,"p ,a ( title ,,iii ( ! ,public ,heal?
 ,s]vice ,act 7#db ,u4,s4,c4 #bda et    
seq47 is am5d$ by add+ at ! end !       
foll[+3  #caj;,b4 ,inve/m5ts 9 dome/ic  
advanc$ manufactur+ = critical drugs &  
devices  7a7 ,e/abli%m5t ,!re is        

e/abli%$ )9 ! ,(fice ( ! ,assi/ant      
,secret>y = ,prep>$ness & ,response ( ! 
,dep>tm5t ( ,heal? & ,human ,s]vices1 ! 
,c5t] = ,dome/ic ,advanc$ ,manufactur+ (
 ,critical ,drugs & ,devices 7ref]r$ to 
9 ?is section z ! ,c5t]74  7b7 ,purpose 
,! purpose ( ! ,c5t] = ,dome/ic ,advanc$
 ,manufactur+ ( ,critical ,drugs &      
,devices %all be to implem5t a program  
to inve/ 9 ! advanc$ manufactur+ =      
critical drugs & devices1 & to increase 
dome/ic production ( critical drugs &   
devices1 ?r\gh\t ! ,unit$ ,/ates4  7c7  
,director ,! ,c5t] %all be head$ by a   
,director 7ref]r$ to 9 ?is section z !  
#8,director'7 :o %all be appo9t$ by !   
,secret>y & to :om ! ,secret>y %all     
delegate su* functions & au?orities z   
may be necess>y to implem5t ?is section4
  7d7 ,program  7#a7 ,9 g5]al ,! ,c5t] =
 ,dome/ic ,advanc$ ,manufactur+ (       
,critical ,drugs & ,devices %all-- 7,a7 
n lat] ?an #ah mon?s aft] ! date (      
enactm5t ( ?is section-- 7i7 e/abli% an 
advisory bo>d ( exp]ts f gov]nm5tal     

entities1 manufactur]s1 o!r private     
indu/ry entities1 nonpr(it entities1 &  
in/itutions ( high] education1 & any o!r
 entity z det]m9$ by ! ,c5t]2 &  7ii7   
compile a li/ ( critical drugs & devices
 t %\ld be prioritiz$ = dome/ic advanc$ 
manufactur+ & increas$ dome/ic          
production "u ! program describ$ 9      
p>agraph 7#b71 bas$ on reports to !     
,secret>y "u sections #ejf;,c & #ejf;,j 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act1 ! drug %ortage li/ "u section     
#ejf;,e ( su* ,act1 ! device %ortage li/
 "u section #ejf;,j7g7 ( su* ,act1 & !  
annual risk assessm5ts describ$ 9       
section #e ( ! ,,home ,act1 if          
available1 & update su* li/ qu>t]ly2    
7,b7 e/abli% & ov]see ! grant & =givable
 loan program describ$ 9 p>agraph 7#b71 
includ+ by e/abli%+ requirem5ts =       
p>ticipation 9 su* program1 includ+--   
7i7 t>get goals to sub/antially increase
 advanc$ manufactur+ production =       
critical drugs & devices )9 ! ,unit$    
,/ates2 &  7ii7 condition+ ! receipt (  

fund+ "u su* program on an entity's     
agreem5t to comm]cially di/ribute ! drug
 or device 9 ! ,unit$ ,/ates2 &  7,c7   
review ! effects ( ! program describ$ 9 
p>agraph 7#b7 on ! p]c5tage *ange 9     
dome/ic manufactur+ ( critical drugs1   
devices1 & active ph>maceutical +r$i5ts4
  7#b7 ,grant & =givable loan program   
7,a7 ,9 g5]al ,! ,c5t] = ,dome/ic       
,advanc$ ,manufactur+ ( ,critical ,drugs
 & ,devices %all e/abli% a grant &      
=givable loan program 9 ord] to support 
inve/m5t 9-- 7i7 advanc$ manufactur+ &  
facilities upgrades = ! dome/ic         
production ( critical drugs1 devices1 & 
active ph>maceutical +r$i5ts2 &  7ii7   
increas$ dome/ic production &           
div]sification ( critical drugs1        
devices1 & active ph>maceutical +r$i5ts4
  7,b7 ,eligible entities  7i7 ,9 g5]al 
,to be eligible to receive a grant or   
=givable loan "u ?is p>agraph1 an entity
 %all meet ! requirem5ts e/abli%$ "u    
p>agraphs 7#a77;,a77ii7 & 7#a77;,b7 &   
su* crit]ia z ! ,c5t] %all develop &1 z 

applicable-- 7,i7 ) respect to a        
critical drug1 %all be ! hold] ( an     
application approv$ "u section #eje ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act or
 section #cea ( ?is ,act1 or a contract 
manufactur] ( ! drug = su* hold] ( an   
approv$ application2  7,,ii7 ) respect  
to an active ph>maceutical +r$i5t1 %all 
be ! manufactur] ( an active            
ph>maceutical +r$i5t ( a drug approv$ "u
 section #eje ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act or section #cea ( ?is   
,act2  7,,iii7 ) respect to a critical  
device1 %all h receiv$ approval "u      
section #eae ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act1 cle>ance "u section     
#eaj7k7 ( su* ,act 7or be exempt f !    
requirem5ts ( su* section #eaj7k771 or  
au?orization "u section #eac7;f77#b7 (  
su* ,act1 or %all be a contract         
manufactur] ( ! device = su* an entity2 
or  7,,iv7 ) respect to a drug or       
device1 %all h submitt$ an application  
"u section #eje or #eae ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act or "u    

section #cea ( ?is ,act1 a report "u    
section #eaj7k71 or a reque/ "u section 
#eac7;f77#b74  7ii7 ,priority ,9 aw>d+  
grants & =givable loans "u ?is p>agraph 
! ,c5t] = ,dome/ic ,advanc$ ,manufactur+
 ( ,critical ,drugs & ,devices %all give
 priority-- 7,i7 9 ! case ( manufactur]s
 ( drugs or active ph>maceutical        
+r$i5ts1 to entities-- 7aa7 describ$ 9  
subclauses 7,i7 & 7,,ii7 ( clause 7i72 &
  7bb7 ^: application = an aw>d "u ?is  
p>agraph relates to a drug t 0 approv$  
"u section #eje7;j7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act2 &  7,,ii7 9 !  
case ( manufactur]s ( devices1 to       
entities describ$ 9 clause 7i77,,iii74  
7,c7 ,use ( funds ,aw>ds receiv$ "u ?is 
p>agraph %all be us$ = ! advanc$        
manufactur+ & increas$ production (     
critical drugs & devices 9 ! ,unit$     
,/ates4  7,d7 ,=givable loans ,! ,c5t]  
may aw>d =givable loans "u ?is p>agraph 
"u :i* a recipi5t %all receive a loan & 
be eligible = =giv5ess ( indebt$ness on 
su* loan1 "u su* conditions = receipt & 

=giv5ess z ! ,c5t] may e/abli%4  7,e7   
,grants ,! ,c5t] may aw>d grants "u ?is 
section1 :i* %all be condition$ ^u !    
recipi5t mat*+ ,f$]al funds s aw>d$4    
7,f7 ,fund+ ,out ( am\nts made available
 to c>ry out ?is section1 ! ,secret>y   
%all allocate #ejj1jjj1jjj t[>d aw>ds ( 
=givable loans & grants "u ?is p>agraph4
  7e7 ,annual report+ ,! ,secret>y %all 
submit to ! relevant committees (       
,congress annual reports on ! program "u
 ?is section4 ,at a m9imum1 ea* su*     
report %all-- 7#a7 id5tify ! li/ (      
critical drugs & devices "u subsection  
7d77#a77;,a77ii7 & acc\nt = any         
alt]ations 9 ! li/2  7#b7 describe !    
p>ticipants 9 ! program "u subsection   
7d77#b7 & crit]ia = eligibility = su*   
p>ticipation2  7#c7 address t>get goals 
= sub/antially increas$ advanc$         
manufactur+ production = critical drugs 
& devices2 &  7#d7 review ! p]c5tage    
*ange 9 dome/ic manufactur+ ( critical  
drugs1 devices1 & active ph>maceutical  
+r$i5ts s9ce ! mo/ rec5t report4  7f7   

,int]ag5cy coop]ation  7#a7 ,9 g5]al ,9 
c>ry+ out activities "u ?is section1 !  
,c5t] is au?oriz$1 subject to p>agraph  
7#b71 to ent] into int]ag5cy agreem5ts &
 o!r collaborative und]tak+s ) o!r      
,f$]al ag5cies4  7#b7 ,limitation ,an   
agreem5t or und]tak+ "u ?is subsection  
%all n au?orize ano!r ag5cy to ex]cise !
 au?orities provid$ by ?is section4  7g7
 ,au?orization ( appropriations ,to c>ry
 out ?is section1 !re is au?oriz$ to be 
appropriat$ su* funds z may be necess>y1
 = ea* ( fiscal ye>s #bjba ?r\gh #bjca4 
7h7 ,def9itions ,9 ?is section-- 7#a7 ! 
t]ms drug & device h ! mean+s giv5 su*  
t]ms 9 section #bja ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act2  7#b7 ! t]m    
in/itution ( high] education has ! mean+
 giv5 su* t]m 9 section #aja7;a7 ( !    
,high] ,education ,act ( #aife2 &  7#c7 
! t]m relevant committees ( ,congress   
means ! ,committee on ,homel& ,security 
& ,gov]nm5tal ,affairs1 ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions1 
& ! ,committee on ,arm$ ,s]vices ( !    

,s5ate & ! ,committee on ,homel&        
,security1 ! ,committee on ,en]gy &     
,comm]ce1 & ! ,committee on ,arm$       
,s]vices ( ! ,h\se ( ,repres5tatives4  4
  #c4 ,exp$it$ review ( c]ta9           
supplem5tal applications ,section #ejf (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cef7 is am5d$ by add+  
at ! end ! foll[+3  7i7 ,exp$it$ review 
( c]ta9 supplem5tal applications  7#a7  
,9 g5]al ,! hold] ( an application      
approv$ "u section #eje ( ?is ,act or   
lic5se "u section #cea ( ! ,public      
,heal? ,s]vice ,act :o submits a        
supplem5tal application ) respect to su*
 application or lic5se may reque/ an    
exp$it$ review ( su* supplem5tal        
application "u ?is subsection4  7#b7    
,application ,to be eligible = exp$it$  
review "u ?is subsection1 ! hold] ( !   
approv$ application or lic5se ) respect 
to a drug includ$ on ! mo/ rec5t li/ (  
critical drugs & devices compil$ "u     
section #caj;,b7d77#a77;,a77ii7 ( !     
,public ,heal? ,s]vice ,act1 %all       

demon/rate 9 ! supplem5tal application  
t-- 7,a7 approval ( su* supplem5tal     
application w\ld enable ! incorporation 
( a manufactur+ *ange t is int5d$ to    
enhance drug quality1 increase dome/ic  
manufactur+ ( ! drug1 or incorporate !  
use ( advanc$ manufactur+2 &  7,b7 !    
applicant's plan = produc+ ! drug       
dome/ically aft] approval ( !           
supplem5tal application4  7#c7 ,review  
by ,secret>y ,if ! ,secret>y det]m9es1  
aft] prelim9>y evaluation ( a           
supplem5tal application1 t ! application
 demon/rates t ! manufactur+ *ange w\ld 
enhance ! ability ( ! hold] ( !         
application to dome/ically manufacture a
 drug on ! li/ ( critical drugs &       
devices describ$ 9 p>agraph 7#b71 !     
,secret>y %all evaluate = fil+1 & may   
comm5ce review ( portions (1 su*        
supplem5tal application be=e ! sponsor  
submits a complete application4 ,!      
,secret>y %all comm5ce su* review only  
if ! applicant provides a s*$ule =      
submission ( in=mation necess>y to make 

! application complete4  4  #d4         
,long-t]m1 high-volume contracts to     
pur*ase critical drugs & devices  7a7   
,contract+ goals ,9 ord] to fur!r ! ne$s
 ( ! ,dep>tm5t ( ,heal? & ,human        
,s]vices & ! ,dep>tm5t ( ,def5se1 inve/ 
9 prep>$ness & ! /rategic national      
/ockpile1 & mitigate drug & device      
%ortages1 ea* ( ! ,secret>y ( ,heal? &  
,human ,s]vices & ! ,assi/ant ,secret>y 
( ,def5se = ,heal? ,affairs may ent]    
into contracts to pur*ase a drug or     
device includ$ on ! li/ ( critical drugs
 & devices compil$ "u section           
#caj;,b7d77#a77;,a77ii7 ( ! ,public     
,heal? ,s]vice ,act 7z add$ by section  
#b71 includ+ multi-ye>1 high-volume     
contracts1 z set =? 9 subsection 7b71 & 
o!rwise 9 accordance ) procurem5t laws &
 regulations4  7b7 ,responsibility      
det]m9ations ,= purposes ( meet+ ! goals
 "u subsection 7a71 a contract+ (fic] ( 
! ,dep>tm5t ( ,heal? & ,human ,s]vices  
or ! ,dep>tm5t ( ,def5se may give       
pref]5ce & aw>d a contract to a program 

p>ticipant "u section #caj;,b7d77#b7 ( !
 ,public ,heal? ,s]vice ,act 7z add$ by 
section #b71 if-- 7#a7 ! program        
p>ticipant is det]m9$ by ! contract+    
(fic]1 9 consultation ) ! ,c5t] =       
,dome/ic ,advanc$ ,manufactur+ (        
,critical ,drugs & ,devices ) respect to
 ! p>ticipant's p]=mance 9 ! program "u 
section #caj;,b7d77#b7 ( ! ,public      
,heal? ,s]vice ,act1 to be a responsible
 s\rce ) respect to p]=mance ( !        
contract2 &  7#b7 9 ! e/imation ( !     
contract+ (fic]1 ! contract aw>d c be   
made at a fair & reasonable price t (f]s
 be/ value to ! ,unit$ ,/ates4  #e4     
,annual risk assessm5t  7a7 ,9 g5]al ,n 
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is ,act1 & annually !reaft]1 !        
,secret>y ( ,homel& ,security1 !        
,secret>y ( ,heal? & ,human ,s]vices1 & 
! ,secret>y ( ,def5se %all ea* conduct  
sep>ate indep5d5t risk assessm5ts ( !   
m$ical supply *a9 & report to ! relevant
 committees ( ,congress on ! f9d+s ( su*
 assessm5ts4 ,at a m9imum1 ea* risk     

assessm5t %all-- 7#a7 id5tify drugs &   
devices critical to ea* ag5cy 9 respond+
 to a public heal? em]g5cy1 biological  
or *emical ?reat1 or o!r national       
security ?reat2  7#b7 id5tify ! drugs & 
devices id5tifi$ "u p>agraph 7#a7 = :i* 
!re is a s+le manufactur] or di/ribut] 9
 ! ,unit$ ,/ates2  7#c7 li/ ! drugs &   
devices id5tifi$ "u p>agraph 7#a7 t are 
s\rc$ exclusively f =eign s\rces2  7#d7 
assess curr5t dome/ic manufactur+       
capability ) respect to drugs & devices 
id5tifi$ "u p>agraph 7#a71 includ+      
advanc$ manufactur+ capabilities2 &     
7#e7 id5tify critical vuln]abilities &  
e/abli% cont+5cy plans 9 ! ev5t ( a     
public heal? em]g5cy1 biological or     
*emical ?reat1 or o!r national security 
?reat4  7b7 ,risk assessm5t report      
conclusions ,ea* risk assessm5t ( ea*   
secret>y "u subsection 7a7 %all         
indicate1 at a m9imum-- 7#a7 ! exi/+    
/atutory au?orities ! dep>tm5t has to   
address public heal? or national        
security risks t may arise z a result ( 

vuln]abilities 9 ! m$ical supply *a92   
7#b7 any defici5cies1 lack ( au?orities1
 or limitations 9 policy or process t   
limit ! dep>tm5t's ability to address   
vuln]abilities id5tifi$ 9 ! applicable  
risk assessm5t2 &  7#c7 ! secret>y's    
plans to address drug & device %ortages1
 control co/s1 & prep>e = public heal?  
em]g5cies1 biological or *emical ?reats1
 & o!r national security ?reats4  7c7   
,review by ,secret>ies ,! ,secret>y (   
,homel& ,security1 ! ,secret>y ( ,heal? 
& ,human ,s]vices1 & ! ,secret>y (      
,def5se1 9 provid+ ! risk assessm5ts "u 
subsection 7a7 may consult ) ea* o!r1 z 
appropriate1 reg>d+ any simil>ities 9   
vuln]abilities exp]i5c$ by ea* su*      
secret>y & any coord9ation among !      
secret>ies t may address su*            
vuln]abilities4  7d7 ,def9itions ,9 ?is 
section-- 7#a7 ! t]ms device & drug h ! 
mean+s giv5 su* t]ms 9 section #bja ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cba72 &  7#b7 ! t]m     
relevant committees ( ,congress means ! 

,committee on ,homel& ,security &       
,gov]nm5tal ,affairs1 ! ,committee on   
,heal?1 ,education1 ,labor1 & ,p5sions1 
& ! ,committee on ,arm$ ,s]vices ( !    
,s5ate & ! ,committee on ,homel&        
,security1 ! ,committee on ,en]gy &     
,comm]ce1 & ! ,committee on ,arm$       
,s]vices ( ! ,h\se ( ,repres5tatives4