,,ib  ,union ,cal5d> ,no4 #ega  #aad?   
,,congress  #b;d ,session  ,h4 ,r4 #cbii
  ,report ,no4 #aad-gce  ,,9 ,,! ,,h\se 
,,( ,,repres5tatives  ,july #bi1 #bjae  
,mrs4 ,brooks ( ,indiana 7= h]self &    
,ms4 ,e%oo7 introduc$ ! foll[+ bill2 :i*
 0 ref]r$ to ! ,committee on ,en]gy &   
,comm]ce  ,septemb] #i1 #bjaf           
,additional sponsors3 ,mr4 ,flores1     
,mrs4 ,ellm]s ( ,nor? ,c>ol9a1 ,mrs4    
,blackburn1 ,mr4 ,mull91 ,mr4 ,hunt]1   
,mrs4 ,mimi ,walt]s ( ,cali=nia1 ,mr4   
,bi%op ( ,mi*igan1 ,mr4 ,long1 ,mr4     
,nunes1 ,mr4 ,turn]1 ,mr4 ,burgess1 ,mr4
 ,knight1 ,mr4 ,c>t] ( ,georgia1 ,mr4   
,bilirakis1 ,mr4 ,g>am5di1 ,mr4         
,griffi?1 ,mr4 ,swalwell ( ,cali=nia1   
,mr4 ,coll9s ( ,new ,york1 ,mr4 ,lance1 
,mrs4 ,com/ock1 ,mr4 ,gu?rie1 ,mr4      
,ha/+s1 ,mr4 ,k9z+] ( ,ill9ois1 ,mr4    
,/ew>t1 ,mr4 ,v>gas1 ,mr4 ,buc%on1 ,mr4 
,wald51 ,mr4 ,cram]1 ,mr4 ,hudson1 ,mr4 
,joyce1 ,mr4 ,johnson ( ,ohio1 ,mr4     
,quigley1 ,mr4 ,cr5%aw1 ,mr4 ,olson1    
,mr4 ,david ,scott ( ,georgia1 ,mr4     

,crd5as1 ,mr4 ,wittman1 ,mr4 ,d5ham1    
,mr4 ,mess]1 ,mr4 ,rupp]sb]g]1 ,mr4     
,ru%1 ,ms4 ,spei]1 ,mr4 ,%imkus1 ,mrs4  
,mc,morris ,rodg]s1 ,mr4 ,rodney ,davis 
( ,ill9ois1 & ,mr4 ,pascrell  ,septemb] 
#i1 #bjaf ,report$ ) an am5dm5t1        
committ$ to ! ,committee ( ! ,:ole ,h\se
 on ! ,/ate ( ! ,union1 & ord]$ to be   
pr9t$ ,/rike out all aft] ! enact+      
clause & ins]t ! "p pr9t$ 9 italic ,=   
text ( introduc$ bill1 see copy ( bill z
 introduc$ on ,july #bi1 #bjae  ,a      
,,bill  ,to am5d ! ,public ,heal?       
,s]vice ,act to ensure prep>$ness =     
*emical1 radiological1 biological1 &    
nucle> ?reats1 & = o!r purposes4  #a4   
,%ort title2 table ( cont5ts  7a7 ,%ort 
title ,?is ,act may be cit$ z ! ,/r5g!n+
 ,public ,heal? ,em]g5cy ,response ,act 
( #bjaf4  7b7 ,table ( cont5ts ,! table 
( cont5ts ( ?is ,act is z foll[s3  ,sec4
 #a4 ,%ort title2 table ( cont5ts4 ,sec4
 #b4 ,,gao report on ,/ate1 local1 &    
hospital prep>$ness programs4 ,sec4 #c4 
,/rategic national /ockpile4 ,sec4 #d4  

,project ,bio%ield procurem5t process4  
,sec4 #e4 ,,b>da transaction au?orities4
 ,sec4 #f4 ,public heal? em]g5cy m$ical 
c\nt]measures ent]prise /rategy &       
implem5tation plan4 ,sec4 #g4 ,priority 
review to enc\rage treatm5ts = ag5ts t  
pres5t national security ?reats4  #b4   
,,gao report on ,/ate1 local1 & hospital
 prep>$ness programs  7a7 ,9 g5]al ,n   
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is ,act1 ! ,comptroll] ,g5]al ( !     
,unit$ ,/ates %all submit a report to ! 
,congress on ! programs = aw>d+         
coop]ative agreem5ts & grants "u section
 #cai;,c-#a ( ! ,public ,heal? ,s]vice  
,act 7#db ,u4,s4,c4 #bdg;d-#c;a2 improv+
 ,/ate & local public heal? security7 & 
section #cai;,c-#b ( su* ,act 7#db      
,u4,s4,c4 #bdg;d-#c;b2 p>tn]%ips = ,/ate
 & regional hospital prep>$ness to      
improve surge capacity74  7b7 ,cont5ts  
,! report "u subsection 7a7 %all address
 ea* ( ! foll[+3  7#a7 ,! goals ( !     
programs specifi$ 9 subsection 7a74     
7#b7 ,! ext5t to :i* su* goals are be+  

met1 includ+ p]=mance metrics t c\ld    
help to assess :e!r su* programs are    
succe$+ at ! coalition & memb] level4   
7#c7 ,h[ su* programs c\ld be improv$1  
includ+ h[ su* programs c\ld be modifi$ 
to improve ! m$ical prep>$ness (        
hospitals1 heal? c>e coalitions1 & !    
cont9uity ( heal? c>e deliv]y4  7#d7 ,h[
 su* programs complem5t o!r prep>$ness  
programs ( ! ,dep>tm5t ( ,heal? & ,human
 ,s]vices4  7#e7 ,h[ funds aw>d$ ?r\gh  
su* programs %\ld be allocat$ & :e!r t  
allocation %\ld be bas$ on risk4  7#f7  
,progress made t[>d ,/ate & local       
prep>$ness entities be+ self-su/a9+4    
7#g7 ,:e!r ! level ( fund+ = su*        
programs is suffici5t4  7#h7 ,h[ fund+ =
 su* programs is be+ us$ to ensure      
prep>$ness = at-risk populations includ+
 *ildr51 pregnant wom51 s5ior citiz5s1 &
 o!r individuals :o may h unique ne$s 9 
! ev5t ( a public heal? em]g5cy1 su* z  
individuals ) disabilities4  7#i7  7,a7 
,h[1 & to :at ext5t1 entities are us+ ! 
funds aw>d$ to su* entities ?r\gh       

section #cai;,c-#b ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7
 to directly fund regional heal? c>e    
coalitions & memb]s ( su* coalitions4   
7,b7 ,! am\nt ea* su* entity reta9s =   
its own indirect & direct co/s4  7,c7 ,!
 purposes = :i* su* reta9$ funds are us$
 & :e!r ^! uses provide value = !       
program "u su* section #cai;,c-#b1      
regional heal? c>e coalitions1 & memb]s 
( su* coalitions4  7#aj7 ,! ext5t to :i*
 ! funds aw>d$ ?r\gh ! programs "u      
sections #cai;,c-#a & #cai;,c-#b ( !    
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#c;a1 #bdg;d-#c;b7 h   
be5 us$ = ov]lapp+ purposes4  #c4       
,/rategic national /ockpile ,section    
#cai;,f-#b7;a77#b7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;d-#f;b7a77#b77 is am5d$-- 7#a7 9   
subp>agraph 7,g71 by /rik+ & at ! end2  
7#b7 9 subp>agraph 7,h71 by /rik+ !     
p]iod at ! end & ins]t+ 2 &2 &  7#c7 by 
add+ at ! end ! foll[+3  7,i7 ensure    
proc$ures are 9 place to coord9ate !    

ongo+ /ockpil+ by ! ,biom$ical ,advanc$ 
,rese>* & ,developm5t ,au?ority & ,c5t]s
 = ,disease ,control & ,prev5tion (     
qualifi$ c\nt]measures 7z def9$ 9       
section #cai;,f-#a7 = :i* funds h be5   
made available "u ?is "p1 security      
c\nt]measures 7z def9$ 9 ?is section71 &
 qualifi$ p&emic or epidemic products 7z
 def9$ 9 section #cai;,f-#c7 = :i* funds
 h be5 made available "u section #cai,l 
9 ord] to avoid any gaps 9 prep>$ness4  
4  #d4 ,project ,bio%ield procurem5t    
process ,section #cai;,f-#b7;c7 ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#f;b7c77 is am5d$--    
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]measure2  7#b7 9 p>agraph      
7#f7--  7,a7 by /rik+ subp>agraphs 7,a71
 7,b71 7,c71 & 7,e72 &  7,b7 by /rik+   

7#f7 ,recomm5dations = presid5t's       
approval & all t foll[s ?r\gh 7,d7      
,subsequ5t specific c\nt]measures4-- &  
ins]t+ 7#f7 ,subsequ5t specific         
c\nt]measures4--2 &  7#c7 9 p>agraph    
7#g7-- 7,a7 by /rik+ subp>agraph 7,a72  
7,b7 by r$esignat+ subp>agraph 7,b7 z   
subp>agraph 7,a7 & am5d+ su* subp>agraph
 7,a71 z r$esignat$1 to read z foll[s3  
7,a7 ,paym5ts f special res]ve fund ,!  
special res]ve fund z def9$ 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$esignat+ subp>agraph 7,c7 z          
subp>agraph 7,b74  #e4 ,,b>da           
transaction au?orities ,section         
#cai,l7c77#e7 ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#e77
 is am5d$ by add+ at ! end ! foll[+3    
7,h7 ,contract+ au?ority cl>ification ,!
 ,secret>y %all delegate au?ority =     
negotiat+ & ent]+ into any contracts1   
grants1 or coop]ative agreem5ts "u ?is  

section to ! ,director4  4  #f4 ,public 
heal? em]g5cy m$ical c\nt]measures      
ent]prise /rategy & implem5tation plan  
,section #bhaa7;d77#b7 ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#cjj;hh-#aj7;d77#b77 is am5d$--  7#a7 9 
subp>agraph 7,a71 by ins]t+ aft]        
describe ! *emical1 biological1         
radiological1 & nucle> ag5t or ag5ts t  
may pres5t a ?reat to ! ,nation !       
foll[+3 7:i* %all include p&emic        
influ5za72  7#b7 by /rik+ & at ! end (  
subp>agraph 7,j72  7#c7 by r$esignat+   
subp>agraph 7,k7 z subp>agraph 7,l72 &  
7#d7 by ins]t+ aft] subp>agraph 7,j7 !  
foll[+3  7,k7 report on ! am\nt ( "t    
betwe5 ! issuance ( ea* reque/ = a      
proposal or task ord] f ! ,biom$ical    
,advanc$ ,rese>* & ,developm5t ,au?ority
 & ! aw>d ( a contract pursuant to su*  
reque/ = a proposal or task ord]2 &  4  
#g4 ,priority review to enc\rage        
treatm5ts = ag5ts t pres5t national     
security ?reats  7a7 ,9 g5]al ,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        
,priority review ,! t]m priority review1
 ) 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$ures ( ! ,food & ,drug  
,adm9i/ration & goals id5tifi$ 9 !      
lett]s describ$ 9 section #aja7;b7 ( !  
,food & ,drug ,adm9i/ration ,safety &   
,innovation ,act 7,public ,law          
#aab-add74  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 ( ?is ,act or section      
#cea7;a7 ( ! ,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 to
 prev5t1 or treat h>m f1 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 ,act2  7,b7 ! ,secret>y  
deems eligible = priority review2  7,c7 
is approv$ aft] ! date ( enactm5t ( !   
,/r5g!n+ ,public ,heal? ,em]g5cy        
,response ,act ( #bjaf2 &  7,d7 is = a  
human drug1 no active +r$i5t 7includ+   
any e/] or salt ( ! active +r$i5t7 ( :i*
 has be5 approv$ pursuant to any o!r    
application "u section #eje7;b77#a7 (   
?is ,act or section #cea7;a7 ( ! ,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$ical        
c\nt]measure application ^u approval by 
! ,secret>y ( su* application4  7#b7    
,transf]ability  7,a7 ,9 g5]al ,!       
sponsor ( a mat]ial ?reat m$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 ( ?is ,act or section      
#cea7;a7 ( ! ,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$4  7,b7   
,notification ( transf] ,ea* p]son to   
:om a v\*] is transf]r$ %all notify !   
,secret>y ( su* *ange 9 own]%ip ( ! v\*]
 n lat] ?an #cj days aft] ! date ( su*  
transf]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 #bjaf1 = 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 ! notification by a     
sponsor ( ! int5t ( su* sponsor to use !
 v\*]1 z specifi$ 9 subsection          
7b77#c77;,a74 ,all o!r us] fees         
associat$ ) ! human drug application    
%all be due z requir$ by ! ,secret>y or 
"u applicable law4  7,b7 ,complete      
application ,an application describ$ 9  
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$]al ,regi/]
 & on ! public website ( ! ,food & ,drug
 ,adm9i/ration n lat] ?an #cj cal5d>    
days aft] ! occurr5ce ( ea* ( ! foll[+3 
7#a7 ,! ,secret>y issues a priority     
review v\*] "u ?is section4  7#b7 ,!    
,secret>y approves a drug pursuant to an
 application submitt$ "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$ical c\nt]measure  
application may receive m ?an "o        
priority review v\*] issu$ "u any       
section ( ?is ,act ) respect to ! drug t
 is ! subject ( su* application4  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$ical          
c\nt]measures4  7g7 ,m$ical c\nt]measure
 po/approval report  7#a7 ,9 g5]al ,n   
lat] ?an #e ye>s aft] ! date ( approval 
( a mat]ial ?reat m$ical c\nt]measure   
application1 ! sponsor ( su* application
 %all submit a report to ! ,secret>y on 
su* m$ical c\nt]measure4  7#b7 ,cont5ts 

,a report "u p>agraph 7#a7 %all include1
 ) respect to ea* ( ! fir/ #b ye>s aft] 
approval ( su* mat]ial ?reat m$ical     
c\nt]measure application1 a description 
(-- 7,a7 ! sponsor's activities ) ,f$]al
 ag5cies relat$ to ! procurem5t1 includ+
 /ockpil+1 ( ! approv$ m$ical           
c\nt]measure2  7,b7 ! sponsor's progress
 9 fulfill+ contracts ent]$ into )      
,f$]al ag5cies1 includ+ ! ,biom$ical    
,advanc$ ,rese>* & ,developm5t          
,au?ority1 ! ,c5t]s = ,disease ,control 
& ,prev5tion1 & ! ,dep>tm5t ( ,def5se1  
relat$ to su* procurem5t2  7,c7 ! ext5t 
to :i* ! ,f$]al ,gov]nm5t has fulfill$  
its /at$ m$ical c\nt]measure requirem5ts
 = ! ?reat int5d$ to be treat$ by !     
approv$ m$ical c\nt]measure2 &  7,d7 !  
sponsor's plans1 if any1 to develop     
additional mat]ial ?reat m$ical         
c\nt]measures4  7#c7 ,availability to   
congressional committees ,! ,secret>y   
%all make ea* report submitt$ "u ?is    
subsection available to ! ,committee on 
,en]gy & ,comm]ce ( ! ,h\se (           

,repres5tatives & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate ^u reque/ by ei!r su*         
,committee n lat] ?an #cj days aft]     
receipt ( su* reque/4  7#d7 ,rule (     
con/ruction ,no?+ 9 ?is subsection %all 
be con/ru$ to p]mit ! disclosure (      
confid5tial comm]cial or trade secret   
in=mation or ! disclosure ( in=mation t 
c\ld compromise national security4  4   
7b7 ,,gao report  7#a7 ,/udy ,!         
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all conduct a /udy on ! effectiv5ess ( 
priority review v\*]s "u section #efe;,a
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act1 z add$ by subsection 7a71 9       
provid+ inc5tives = ! developm5t (      
mat]ial ?reat m$ical c\nt]measure       
applications "u su* section #efe;,a4 ,9 
conduct+ su* /udy1 ! ,comptroll] ,g5]al 
%all exam9e ! foll[+3  7,a7 ,! impact ( 
su* priority review on ! developm5t (   
mat]ial ?reat m$ical c\nt]measures & !  
impact ( su* inve/m5t1 z applicable1 on 
! developm5t ( su* c\nt]measures4  7,b7 

,h[ ! drugs = :i* su* priority review   
v\*]s 7 aw>d$--  7i7 address$ id5tifi$  
m$ical c\nt]measure ne$s2 &  7ii7       
impact$ ,unit$ ,/ates prep>$ness aga9/  
*emical1 biological1 radiological1 &    
nucle> ?reats1 includ+ bo? id5tifi$     
?reats & naturally occurr+ ?reats4  7,c7
 ,h[ _m mat]ial ?reat m$ical            
c\nt]measures 7 lic5s$ or approv$1 or   
o!rwise significantly advanc$ 9 cl9ical 
developm5t1 9 ! #ae ye>s foll[+ !       
enactm5t ( su* section #efe;,a comp>$ to
 ! #ae ye>s prior to ! enactm5t ( su*   
section1 includ+ a comp>ative analysis (
 ,f$]al advanc$ developm5t & procurem5t 
doll>s available 9 ! #ae ye>s foll[+ su*
 enactm5t comp>$ to ! prior #ae ye>s4   
7,d7 ,h[ mat]ial ?reat m$ical           
c\nt]measures develop$ aft] ! date (    
enactm5t ( ?is ,act impact--  7i7 !     
supply ( products 9 ! /rategic national 
/ockpile "u section #cai;,f-#b ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#f;b72 &  7ii7 national
 prep>$ness4  7,e7 ,h[ ! ,f$]al         

,gov]nm5t support$ sponsors ( mat]ial   
?reat m$ical c\nt]measures dur+ !       
rese>*1 developm5t1 application review1 
& production ( su* drugs1 includ+ ! use 
( gov]nm5t rese>*1 provision ( res\rces 
?r\gh contracts or grants1 & use (      
f$]ally fund$ rese>* facilities4  7,f7  
,an analysis ( ! drugs = :i* su*        
priority review v\*]s 7 us$1 :i* %all   
include--  7i7 ! indications = :i* su*  
drugs 7 approv$ "u section #eje7;b77#a7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or    
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a772  
7ii7 :e!r unmet m$ical ne$s 7 address$  
?r\gh ! approval ( su* drugs1 includ+1 =
 ea* su* drug--  7,i7 if !re 0 a        
curr5tly m>ket$ !rapy approv$ to prev5t 
or treat ! same indication 9 ! same     
pati5t population at ! "t ! application 
0 submitt$ to ! ,food & ,drug           
,adm9i/ration2 &  7,,ii7 if ! drug      
provid$ a significant b5efit or         
improvem5t 9 safety & effectiv5ess      

comp>$ to su* curr5tly m>ket$ product2  
7iii7 ! price ( ! priority review v\*]  
if transf]r$ or sold prior to r$emption2
 &  7iv7 ! l5g? ( "t betwe5 ! date on   
:i* a priority review v\*] 0 aw>d$ & !  
date on :i* x 0 us$4  7,g7 ,) respect to
 ! priority review v\*] program "u su*  
section #efe;,a-- 7i7 h[ _m priority    
review v\*]s 7 aw>d$ "u su* section     
#efe;,a & h[ _m ( su* aw>d$ v\*]s 7     
r$eem$ = priority review ( a drug       
application 9 ! #ae ye>s foll[+ ! date (
 enactm5t ( su* section2  7ii7 !        
res\rces associat$ ) ! ,food & ,drug    
,adm9i/ration implem5tation ( su*       
section #efe;,a & review ( applications 
= :i* a v\*] aw>d$ "u su* section       
#efe;,a is r$eem$ = priority review & if
 implem5tation ( su* section #efe;,a    
prohibit$ ! ,food & ,drug ,adm9i/ration 
f meet+ drug application review goals2  
7iii7 recomm5dations on :e!r appropriate
 ,f$]al fund+ = advanc$ developm5t &    
rese>* w\ld necessitate ! priority      
review v\*] program = m$ical            

c\nt]measures2  7iv7 ! degree to :i* ?is
 inc5tive program impacts o!r priority  
review v\*] programs2 &  7v7 ! degree to
 :i* gu>ante$ ,f$]al fund+ = advanc$    
developm5t & rese>* is a great] inc5tive
 = new inve/m5t 9 rese>* & ! developm5t 
( m$ical c\nt]measures ?an ! unc]ta9    
values ( v\*]s4  7#b7 ,consultations ,9 
conduct+ ! /udy "u subsection 7a71 !    
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all consult )-- 7,a7 drug manufactur]s 
involv$ 9 ! rese>* & developm5t ( m$ical
 c\nt]measures to address biological1   
*emical1 radiological1 & nucle> ?reats2 
7,b7 /akehold]s involv$ 9 inve/+ 9 !    
rese>* & developm5t ( su* m$ical        
c\nt]measures1 includ+ v5ture           
capitali/s2  7,c7 ! ,f$]al ,gov]nm5t    
ag5cies responsible = advanc+1 review+1 
& procur+ su* m$ical c\nt]measures1     
includ+--  7i7 ! ,dep>tm5t ( ,heal? &   
,human ,s]vices1 includ+ ! ,(fice ( !   
,assi/ant ,secret>y = ,prep>$ness &     
,response1 ! ,biom$ical ,advanc$ ,rese>*
 & ,developm5t ,au?ority1 & ! ,food &   

,drug ,adm9i/ration2 &  7ii7 ! ,dep>tm5t
 ( ,def5se2  7,d7 biodef5se /akehold]s1 
z applicable2 &  7,e7 drug manufactur]s 
involv$ 9 ! rese>* & developm5t (       
!rapies t address--  7i7 tropical       
diseases 7z def9$ 9 section #ebd7;a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfjn7a7772 or  7ii7 r>e 
p$iatric diseases 7z def9$ 9 section    
#ebi7;a7 ( su* ,act 7#ba ,u4,s4,c4      
#cfj;ff7a7774  7#c7 ,initial assessm5t  
,n lat] ?an #aj ye>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 an initial      
assessm5t ( ! effectiv5ess ( ! priority 
review v\*] program set =? 9 section    
#efe;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act1 z add$ by subsection    
7a74  7#d7 ,report ,n lat] ?an #af ye>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 conta9+ ! results ( ! /udy       
conduct$ "u p>agraph 7#a74  7#e7        
,protection ( national security ,!      
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all conduct ! /udy "u p>agraph 7#a7 &  
issue ! assessm5t & report "u p>agraphs 
7#c7 & 7#d7 9 a mann] t does n          
compromise national security4  ,septemb]
 #i1 #bjaf ,report$ ) an am5dm5t1       
committ$ to ! ,committee ( ! ,:ole ,h\se
 on ! ,/ate ( ! ,union1 & ord]$ to be   
pr9t$