,,ii  #aah? ,,congress  #a/ ,session    
,s4 #aabb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #cj1 #bjbc,ms4    
,ern/ introduc$ ! foll[+ bill2 :i* 0    
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to improve ! program to     
provide = priority review ( human drug  
applications to enc\rage treatm5t =     
ag5ts t pres5t national security ?reats4
  #a4 ,%ort title ,?is ,act may be cit$ 
z ! ,prioritiz+ ,m$ical ,c\nt]measures =
 ,national ,security ,act ( #bjbc4  #b4 
,ext5sion & expansion ( m$ical          
c\nt]measure priority review v\*]       
program  7a7 ,def9ition ( m$ical        
c\nt]measure application ,subsection    
7a77#d7 ( section #efe;,a ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb-#d;a7 is am5d$-- 7#a7
 9 ! p>agraph head+1 by /rik+ ,mat]ial  
?reat m$ical & ins]t+ ,m$ical2  7#b7 9 !
 matt] prec$+ subp>agraph 7,a71 by /rik+
 mat]ial ?reat2 &  7#c7 by am5d+        
subp>agraph 7,a7 to read z foll[s3  7,a7

 is a human drug application = a drug t 
is-- 7i7 label$ = an indication to      
prev5t or treat a disease or condition  
specifically caus$ by a *emical1        
biological1 radiological1 or nucle>     
ag5t2 &  7ii7 "p ( a class or category (
 drug on ! li/ describ$ 9 subsection 7b7
 at ! "t ( approval ( ! application4  4 
7b7 ,li/ ( m$ical c\nt]measures =       
national security ?reats ,section       
#efe;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#d;a7 is am5d$-- 7#a7 by       
r$esignat+ subsections 7b7 ?r\gh 7g7 z  
subsections 7c7 ?r\gh 7g7 & 7i71        
respectively2 &  7#b7 by ins]t+ aft]    
subsection 7a71 ! foll[+3  7b7 ,li/ (   
m$ical c\nt]measures = national security
 ?reats  7#a7 ,9 g5]al ,! ,secret>y1    
act+ ?r\gh ! ,assi/ant ,secret>y (      
,prep>$ness & ,response1 9 consultation 
) ! ,public ,heal? ,em]g5cy ,m$ical     
,ent]prise e/abli%$ "u section #bhja ( !
 ,public ,heal? ,s]vice ,act1 includ+ ! 
,secret>y ( ,def5se1 %all e/abli% &     

ma9ta9 a li/ ( pot5tially eligible      
classes & categories ( drugs t are      
id5tifi$ z necess>y to prev5t or treat !
 diseases & conditions specifically     
caus$ by a *emical1 biological1         
radiological1 or nucle> ag5t t-- 7,a7   
has ! pot5tial to lead to a public heal?
 em]g5cy ) significant pot5tial to      
affect national security2 or  7,b7 may  
pres5t a specific ?reat to ! ,arm$      
,=ces4  7#b7 ,factors ,9 e/abli%+ &     
revis+ ! li/ "u p>agraph 7#a71 !        
,secret>y may consid]-- 7,a7 :e!r an    
eligible class or category ( drugs t is 
id5tifi$ is-- 7i7 ne$$ to protect !     
public heal?1 us+ ! same /&>d t applies 
) respect to det]m9ations ( mat]ial     
?reats "u section                       
#cai;,f-#b7;c77#b77;,b77ii7 ( ! ,public 
,heal? ,s]vice ,act2 &  7ii7 det]m9$ to 
be a priority 7consi/5t ) sections      
#cjb7b7 & #cjd7;a7 ( ! ,homel& ,security
 ,act ( #bjjb72  7,b7 = any class or    
category ( drugs "u consid]ation to     
address specific ?reats to ! ,arm$      

,=ces1 in=mation provid$ by ! ,secret>y 
( ,def5se to help evaluate :e!r a       
priority review v\*] is necess>y &      
b5eficial to inc5tivize product         
developm5t = ! ,dep>tm5t ( ,def5se use &
 field+2  7,c7 :e!r ! class or category 
( drug requires inc5tivization 9 ! =m a 
priority review v\*] bas$ ^u economic   
factors1 su* z :e!r !re is a suffici5t  
m>ket to support ! developm5t ( !       
pot5tial m$ical c\nt]measures & !       
maturity ( ! m$ical c\nt]measure        
pipel9e2  7,d7 ! pot5tial effect ( an   
addition ( a class or category ( drug on
 ! pot5tial sale value ( priority review
 v\*]s2 &  7,e7 su* o!r factors z !     
,secret>y det]m9es appropriate4  7#c7   
,duties ,! ,secret>y1 act+ ?r\gh !      
,assi/ant ,secret>y ( ,prep>$ness &     
,response1 %all-- 7,a7 9 coord9ation ) !
 ,assi/ant ,secret>y ( ,def5se =        
,nucle>1 ,*emical1 & ,biological ,def5se
 ,program1 disclose to int]e/$ priority 
review applicants ! li/ develop$ "u     
p>agraph 7#a72  7,b7 p]iodically review 

! li/ develop$ "u p>agraph 7#a7 =       
cont9u$ necessity & appropriat5ess1 &   
add1 am5d1 or remove any classes or     
categories ( drugs if no long] necess>y 
or appropriate2 &  7,c7 ma9ta9 a        
publicly available ar*ive ( ! li/ ov]   
"t4  7#d7 ,transition p]iod ,be=e ! date
 ( ! initial publication ( ! li/        
develop$ "u p>agraph 7#a71 ! mo/ rec5t  
priority li/ develop$ "u ?is section    
be=e ! date ( enactm5t ( ! ,prioritiz+  
,m$ical ,c\nt]measures = ,national      
,security ,act ( #bjbc %all rema9 9     
effect4  4  7c7 ,,gao report ,section   
#efe;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#d;a7 is am5d$ by ins]t+ aft]  
subsection 7g71 z r$esignat$ by         
subsection 7b77#a71 ! foll[+3  7h7 ,,gao
 report  7#a7 ,9 g5]al ,n lat] ?an      
,septemb] #cj1 #bjbg1 ! ,comptroll]     
,g5]al ( ! ,unit$ ,/ates %all transmit  
to ,congress a report on ! effectiv5ess 
( ?is section 9 enc\rag+ ! developm5t ( 
! m$ical c\nt]measures ne$$ to protect &

 prep>e = em]g+ ?reats to public heal? &
 national security4  7#b7 ,cont5ts ,!   
report %all include-- 7,a7 input f !    
,secret>y ( ,def5se & ! ,secret>y (     
,heal? & ,human ,s]vices2 &  7,b7       
recomm5dations ( ! ,comptroll] ,g5]al ( 
! ,unit$ ,/ates1 if any1 on necess>y    
modifications to ?is section4  4  7d7   
,sunset ,subsection 7i7 ( su* section1 z
 r$esignat$ by subsection 7b77#a7 ( ?is 
section1 is am5d$-- 7#a7 by /rik+       
subsection 7b7 & ins]t+ subsection 7c72 
&  7#b7 by /rik+ ,octob] #a1 #bjbc &    
ins]t+ ,octob] #a1 #bjbi4  7e7 ,con=m+  
am5dm5ts ,to remove ref]5ces to mat]ial 
?reats ,section #efe;,a ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb-#d;a7 is am5d$ by    
/rik+ mat]ial ?reat ea* place x appe>s  
9-- 7#a7 subsection 7a77#c72  7#b7      
p>agraphs 7#a7 & 7#b7 ( subsection 7c71 
z r$esignat$ by subsection 7b77#a72 &   
7#c7 subsection 7f71 z s r$esignat$4