,,ii  #aad? ,,congress  #a/ ,session    
,s4 #bjee  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #ag1 #bjae   
,mr4 ,burr 7= himself & ,mr4 ,casey7    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,public ,heal?    
,s]vice ,act & ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act ) respect to national    
heal? security4  #a4 ,%ort title  ,?is  
,act may be cit$ z ! ,m$ical            
,c\nt]measure ,innovation ,act ( #bjae4 
#b4 ,m$ical c\nt]measure guidel9es  7a7 
,/rategic national /ockpile & security  
c\nt]measure procurem5ts ,section       
#cai;,f-#b ( ! ,public ,heal? ,s]vice   
,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is     
am5d$-- 7#a7 9 subsection 7a71 by add+  
at ! end ! foll[+3  7#c7 ,utilization   
guidel9es ,! ,secret>y %all ensure      
timely & accurate recomm5d$ utilization 
guidel9es = qualifi$ c\nt]measures 7z   
def9$ 9 section #cai;,f-#a71 qualifi$   
p&emic & epidemic products 7z def9$ 9   

section #cai;,f-#c71 & security         
c\nt]measures 7z def9$ 9 subsection     
7c771 includ+ = su* products 9 !        
/ockpile4  2 &  7#b7 9 subsection 7g7-- 
7,a7 by am5d+ p>agraph 7#d7 to read z   
foll[s3  7#d7 ,report on security       
c\nt]measure procurem5t ,n lat] ?an ,m>*
 #a ( ea* ye> 9 :i* ! ,secret>y det]m9es
 t ! am\nt ( funds available =          
procurem5t ( security c\nt]measures is  
less ?an #a1ejj1jjj1jjj1 ! ,secret>y    
%all submit to ! ,committee on          
,appropriations & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on             
,appropriations & ! ,committee on ,en]gy
 & ,comm]ce ( ! ,h\se ( ,repres5tatives 
a report detail+ ! am\nt ( su* funds    
available = procurem5t & ! impact su*   
am\nt ( fund+ w h--  7,a7 9 meet+ !     
security c\nt]measure ne$s id5tifi$ "u  
?is section2 &  7,b7 on ! annual ,public
 ,heal? ,em]g5cy ,m$ical ,c\nt]measures 
,ent]prise & ,/rategy ,implem5tation    
,plan 7pursuant to section #bhaa7;d774  

4  #c4 ,cl>ification on ,,b>da contract+
 au?ority  7a7 ,9 g5]al ,section        
#cai;,f-#b7;g7 ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;d-#f;b7g77 is am5d$ by add+ at !   
end ! foll[+3  7#e7 ,cl>ification on    
contract+ au?ority ,! ,secret>y1 act+   
?r\gh ! ,director ( ! ,biom$ical        
,advanc$ ,rese>* & ,developm5t          
,au?ority1 %all c>ry out ! programs     
fund$ by ! special res]ve fund 7= !     
procurem5t ( security c\nt]measures "u  
subsection 7c7 & = c>ry+ out section    
#cai,l71 includ+ ! execution (          
procurem5t contracts1 grants1 &         
coop]ative agreem5ts pursuant to ?is    
section & section #cai,l4  4  7b7 ,,b>da
 contract+ au?ority ,section            
#cai,l7c77#c7 ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bdg;d-#g;c7 is    
am5d$ by ins]t+ 1 includ+ ! execution ( 
procurem5t contracts1 grants1 &         
coop]ative agreem5ts pursuant to ?is    
section be=e ! p]iod4  #d4              
,c\nt]measures budget plan ,section     

#bhaa7;b77#g7 ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4                    
#cjj;hh-#aj7;b77#g77 is am5d$--  7#a7 by
 /rik+ ! fir/ s5t5ce & ins]t+ ,develop1 
& update n lat] ?an ,m>* #a ( ea* ye>1 a
 coord9at$ #e-ye> budget plan bas$ on ! 
m$ical c\nt]measure priorities describ$ 
9 subsection 7d71 includ+ ) respect to  
*emical1 biological1 radiological1 &    
nucle> ag5t or ag5ts t may pres5t a     
?reat to ! ,nation1 includ+ su* ag5ts t 
are novel or em]g+ infecti\s diseases1 &
 ! correspond+ ef=ts to develop qualifi$
 c\nt]measures 7z def9$ 9 section       
#cai;,f-#a71 security c\nt]measures 7z  
def9$ 9 section #cai;,f-#b71 & qualifi$ 
p&emic or epidemic products 7z def9$ 9  
section #cai;,f-#c7 = ea* su* ?reat42   
7#b7 9 subp>agraph 7,c71 by /rik+ 2 & & 
ins]t+ a semicolon2  7#c7 9 subp>agraph 
7,d71 by /rik+ to ! appropriate         
committees ( ,congress ^u reque/4 &     
ins]t+ 1 n lat] ?an ,m>* #ae ( ea* ye>1 
to ! ,committee on ,appropriations & !  
,committee on ,heal?1 ,education1       

,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,appropriations & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives2 &2 &  7#d7 by  
add+ at ! end ! foll[+3  7,e7 n lat] ?an
 ,m>* #ae ( ea* ye>1 be made publicly   
available4  4  #e4 ,prioritiz+ ! animal 
rule guidance ,section #efe7;c7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb-#d7;c77 is am5d$
 by add+ at ! end ! foll[+3  7#c7       
,writt5 explanation ,! ,secret>y %all   
provide to ! ,committee on ,heal?1      
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives a  
writt5 explanation1 n lat] ?an ! la/ day
 ( ea* mon? aft] ! date ( enactm5t ( !  
,m$ical ,c\nt]measure ,innovation ,act (
 #bjae 9 :i* ! ,secret>y fails to       
f9alize su* guidance1 = :y ! ,secret>y  
has fail$ to f9alize ! guidance z       
requir$ by ?is subsection4  4  #f4      
,/reaml9+ ! project bio%ield procurem5t 
process ,section #cai;,f-#b7;c7 ( !     

,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#f;b7c77 is am5d$--    
7#a7 9 p>agraph 7#d77;,a77ii71 by /rik+ 
make a recomm5dation "u p>agraph 7#f7 t 
! special res]ve fund z def9$ 9         
subsection 7h7 be made available = !    
procurem5t ( su* c\nt]measure & ins]t+  
make available ! special res]ve fund z  
def9$ 9 subsection 7h7 = procurem5t (   
su* c\nt]measure1 z applicable2  7#b7 9 
p>agraph 7#f7-- 7,a7 by /rik+           
subp>agraphs 7,a71 7,b71 & 7,e72  7,b7  
by r$esignat+ subp>agraphs 7,c7 & 7,d7 z
 subp>agraphs 7,a7 & 7,b71 respectively2
  7,c7 by am5d+ subp>agraph 7,a71 z s   
r$esignat$1 to read z foll[s3  7,a7     
,notice to appropriate congressional    
committees ,! ,secret>y %all notify !   
,committee on ,appropriations & !       
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,appropriations & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives ( ea* decision  
to make available ! special res]ve fund 

z def9$ 9 subsection 7h7 = procurem5t ( 
a security c\nt]measure1 includ+1 :]e   
available1 ! numb] (1 ! nature (1 & o!r 
in=mation conc]n+ pot5tial suppli]s (   
su* c\nt]measure1 & :e!r o!r pot5tial   
suppli]s ( ! same or simil>             
c\nt]measures 7 consid]$ & reject$ =    
procurem5t "u ?is section & ! reasons   
!re=e4  2 &  7,d7 9 ! head+1 by /rik+   
,recomm5dation = presid5t's approval &  
ins]t+ ,recomm5dations = procurem5t2 &  
7#c7 9 p>agraph 7#g7--  7,a7 by /rik+   
subp>agraph 7,a72  7,b7 by /rik+        
subp>agraph 7,b7 & ins]t+ ! foll[+3     
7,a7 ,paym5ts f special res]ve fund ,!  
special res]ve fund z def9$ 9 subsection
 7h7 %all be available = paym5ts made by
 ! ,secret>y to a v5dor = procurem5t ( a
 security c\nt]measure 9 accordance ) ! 
provisions ( ?is p>agraph4  2 &  7,c7 by
 r$esignat+ subp>agraph 7,c7 z          
subp>agraph 7,b74  #g4 ,priority review 
to enc\rage treatm5ts = ag5ts t pres5t  
national security ?reats ,sub*apt] ,e ( 
*apt] ,v ( ! ,f$]al ,food1 ,drug1 &     

,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb  
et seq47 is am5d$ by ins]t+ aft] section
 #efe ! foll[+3  #efe;,a4 ,priority     
review to enc\rage treatm5ts = ag5ts t  
pres5t national security ?reats  7a7    
,def9itions ,9 ?is section3 7#a7 ,! t]m 
priority review ) respect to a human    
drug application z def9$ 9 section      
#gce7a71 means review & action by !     
,secret>y on su* application n lat] ?an 
#f mon?s aft] receipt by ! ,secret>y (  
su* application1 z describ$ 9 ! ,manual 
( ,policies & ,proc$ures 9 ! ,food &    
,drug ,adm9i/ration & goals id5tifi$ 9 !
 lett]s describ$ 9 section #aja7;b7 ( ! 
,food & ,drug ,adm9i/ration ,safety &   
,innovation ,act4  7#b7 ,priority review
 v\*] ,! t]m priority review v\*] means 
a v\*] issu$ by ! ,secret>y to ! sponsor
 ( a mat]ial ?reat m$ical c\nt]measure  
application t entitles ! hold] ( su*    
v\*] to priority review ( a s+le human  
drug application submitt$ "u section    
#eje7;b77#a7 or section #cea ( ! ,public
 ,heal? ,s]vice ,act aft] ! date (      

approval ( ! mat]ial ?reat m$ical       
c\nt]measure application4  7#c7 ,mat]ial
 ?reat m$ical c\nt]measure application  
,! t]m mat]ial ?reat m$ical c\nt]measure
 application means an application t--   
7,a7 is a human drug application z def9$
 9 section #gce7a7--  7i7 to prev5t1 or 
treat h>m f a biological1 *emical1      
radiological1 or nucle> ag5t id5tifi$ z 
a mat]ial ?reat "u section              
#cai;,f-#b7;c77#b77;,a77ii7 ( ! ,public 
,heal? ,s]vice ,act1 or  7ii7 to        
mitigate1 prev5t1 or treat h>m f a      
condition t may result 9 adv]se heal?   
consequ5ces or dea? & may be caus$ by   
adm9i/]+ a drug1 or biological product  
aga9/ su* ag5t2  7,b7 ! ,secret>y deems 
eligible = priority review2  7,c7 is    
approv$ aft] ! date ( enactm5t ( !      
,m$ical ,c\nt]measure ,innovation ,act (
 #bjae2 &  7,d7 is = a human drug1 no   
active +r$i5t 7includ+ any e/] or salt (
 ! active +r$i5t7 ( :i* has be5 approv$ 
9 any o!r application "u section        
#eje7;b77#a7 or section #cea ( ! ,public

 ,heal? ,s]vice ,act4  7b7 ,priority    
review v\*]  7#a7 ,9 g5]al ,! ,secret>y 
%all aw>d a priority review v\*] to !   
sponsor ( a mat]ial ?reat m$ical        
c\nt]measure application ^u approval by 
! ,secret>y ( su* mat]ial ?reat m$ical  
c\nt]measure application4  7#b7         
,transf]ability ,! sponsor ( a mat]ial  
?reat m$ical c\nt]measure application t 
receives a priority review v\*] "u ?is  
section may transf] 7includ+ by sale7 ! 
entitlem5t to su* v\*] to a sponsor ( a 
human drug = :i* an application "u      
section #eje7;b77#a7 or section #cea ( !
 ,public ,heal? ,s]vice ,act w be       
submitt$ aft] ! date ( ! approval ( !   
mat]ial ?reat m$ical c\nt]measure       
application4 ,!re is no limit on ! numb]
 ( times a priority review v\*] may be  
transf]r$ be=e su* v\*] is us$4  7#c7   
,notification  7,a7 ,9 g5]al ,! sponsor 
( a human drug application %all notify !
 ,secret>y n lat] ?an #ij cal5d> days   
prior to submission ( ! human drug      
application t is ! subject ( a priority 

review v\*] ( an int5t to submit ! human
 drug application1 includ+ ! date on :i*
 ! sponsor int5ds to submit !           
application4 ,su* notification %all be a
 legally b9d+ commitm5t to pay = ! us]  
fee to be assess$ 9 accordance ) ?is    
section4  7,b7 ,transf] aft] notice ,!  
sponsor ( a human drug application t    
provides notification ( ! int5t ( su*   
sponsor to use ! v\*] = ! human drug    
application "u subp>agraph 7,a7 may     
transf] ! v\*] aft] su* notification is 
provid$1 if su* sponsor has n yet       
submitt$ ! human drug application       
describ$ 9 ! notification4  7c7         
,priority review us] fee  7#a7 ,9 g5]al 
,! ,secret>y %all e/abli% a us] fee     
program "u :i* a sponsor ( a human drug 
application t is ! subject ( a priority 
review v\*] %all pay to ! ,secret>y a   
fee det]m9$ "u p>agraph 7#b74 ,su* fee  
%all be 9 addition to any fee requir$ to
 be submitt$ by ! sponsor "u *apt]      
,,vii4  7#b7 ,fee am\nt ,! am\nt ( !    
priority review us] fee %all be det]m9$ 

ea* fiscal ye> by ! ,secret>y & bas$ on 
! av]age co/ incurr$ by ! ag5cy 9 !     
review ( a human drug application       
subject to priority review 9 ! previ\s  
fiscal ye>4  7#c7 ,annual fee sett+ ,!  
,secret>y %all e/abli%1 be=e ! beg9n+ ( 
ea* fiscal ye> beg9n+ aft] ,septemb]    
#cj1 #bjae1 = t fiscal ye>1 ! am\nt ( ! 
priority review us] fee4  7#d7 ,paym5t  
7,a7 ,9 g5]al ,! priority review us] fee
 requir$ by ?is subsection %all be due  
^u ! submission ( a human drug          
application "u section #eje7;b77#a7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act = :i* ! priority review v\*] is    
us$4  7,b7 ,complete application ,an    
application describ$ "u subp>agraph 7,a7
 = :i* ! sponsor reque/s ! use ( a      
priority review v\*] %all be consid]$   
incomplete if ! fee requir$ by ?is      
subsection & all o!r applicable us] fees
 are n paid 9 accordance ) ! ,secret>y's
 proc$ures = pay+ su* fees4  7,c7 ,no   
waiv]s1 exemptions1 r$uctions1 or       
refunds ,! ,secret>y may n grant a      

waiv]1 exemption1 r$uction1 or refund ( 
any fees due & payable "u ?is section4  
7#e7 ,(fsett+ collections ,fees collect$
 pursuant to ?is subsection = any fiscal
 ye>-- 7,a7 %all be deposit$ & cr$it$ z 
(fsett+ collections to ! acc\nt provid+ 
appropriations to ! ,food & ,drug       
,adm9i/ration2 &  7,b7 %all n be        
collect$ = any fiscal ye> except to !   
ext5t provid$ 9 advance 9 appropriation 
,acts4  7d7 ,notice ( ,issuance ( ,v\*] 
& ,approval ( ,products ,"u ,v\*] ,!    
,secret>y %all publi% a notice 9 !      
,f$]al ,regi/] & on ! ,int]net ,website 
( ! ,food & ,drug ,adm9i/ration n lat]  
?an #cj cal5d> days aft] ! occurr5ce (  
ea* ( ! foll[+3  7#a7 ,! ,secret>y      
issues a priority review v\*] "u ?is    
section4  7#b7 ,! ,secret>y approves a  
drug pursuant to an application submitt$
 "u section #eje7;b7 ( ?is ,act or      
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act = :i* ! sponsor ( !        
application us$ a priority review v\*]  
"u ?is section4  7e7 ,eligibility = o!r 

programs ,no?+ 9 ?is section precludes a
 sponsor :o seeks a priority review v\*]
 "u ?is section f p>ticipat+ 9 any o!r  
inc5tive program1 includ+ "u ?is ,act1  
except t no sponsor ( a mat]ial ?reat   
m$ical c\nt]measure application may     
receive m ?an "o priority review v\*] ) 
respect to su* drug4  7f7 ,relation to  
o!r provisions ,! provisions ( ?is      
section %all supplem5t1 n supplant1 any 
o!r provisions ( ?is ,act or ! ,public  
,heal? ,s]vice ,act t enc\rage !        
developm5t ( m$ical c\nt]measures4  4