#aac? ,,congress  #a/ ,session  ,h4 ,r4 
#cjg  ,,an ,,act  ,to reau?orize c]ta9  
programs "u ! ,public ,heal? ,s]vice    
,act & ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act ) respect to public heal?
 security & all-haz>ds prep>$ness &     
response1 & = o!r purposes4  #a4 ,%ort  
title2 table ( cont5ts  7a7 ,%ort title 
,?is ,act may be cit$ z ! ,p&emic &     
,all-,haz>ds ,prep>$ness ,reau?orization
 ,act ( #bjac4  7b7 ,table ( cont5ts ,! 
table ( cont5ts ( ?is ,act is z foll[s3 
,sec4 #a4 ,%ort title2 table ( cont5ts4 
,title ,i--,/r5g!n+ national prep>$ness 
& response = public heal? em]g5cies     
,sec4 #aja4 ,national ,heal? ,security  
,/rategy4 ,sec4 #ajb4 ,assi/ant         
,secret>y = ,prep>$ness & ,response4    
,sec4 #ajc4 ,national ,advisory         
,committee on ,*ildr5 & ,disa/]s4 ,sec4 
#ajd4 ,mod]nization ( ! ,national       
,disa/] ,m$ical ,sy/em4 ,sec4 #aje4     
,cont9u+ ! role ( ! ,dep>tm5t ( ,vet]ans
 ,affairs4 ,title ,,ii--,optimiz+ ,/ate 
& local all-haz>ds prep>$ness & response

 ,sec4 #bja4 ,tempor>y r$eploym5t (     
f$]ally fund$ p]sonnel dur+ a public    
heal? em]g5cy4 ,sec4 #bjb4 ,improv+     
,/ate & local public heal? security4    
,sec4 #bjc4 ,hospital prep>$ness &      
m$ical surge capacity4 ,sec4 #bjd4      
,enhanc+ situational aw>5ess &          
biosurveillance4 ,sec4 #bje4 ,elim9at+  
duplicative ,project ,bio%ield reports4 
,title ,,iii--,enhanc+ ,m$ical          
,c\nt]measure ,review ,sec4 #cja4       
,special protocol assessm5t4 ,sec4 #cjb4
 ,au?orization = m$ical products = use 9
 em]g5cies4 ,sec4 #cjc4 ,def9itions4    
,sec4 #cjd4 ,enhanc+ m$ical c\nt]measure
 activities4 ,sec4 #cje4 ,regulatory    
managem5t plans4 ,sec4 #cjf4 ,report4   
,sec4 #cjg4 ,p$iatric m$ical            
c\nt]measures4 ,title ,,iv--,accel]at+  
m$ical c\nt]measure advanc$ rese>* &    
developm5t ,sec4 #dja4 ,bio,shield4     
,sec4 #djb4 ,biom$ical ,advanc$ ,rese>* 
& ,developm5t ,au?ority4 ,sec4 #djc4    
,/rategic ,national ,/ockpile4 ,sec4    
#djd4 ,national ,biodef5se ,sci5ce      

,bo>d4  ,i ,/r5g!n+ national prep>$ness 
& response = public heal? em]g5cies     
#aja4 ,national ,heal? ,security        
,/rategy  7a7 ,9 g5]al ,section #bhjb ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #cjj;hh-#a7 is am5d$--  7#a7 9
 subsection 7a77#a71 by /rik+ #bjji &   
ins]t+ #bjad2 &  7#b7 9 subsection 7b7--
  7,a7 9 p>agraph 7#a77;,a71 by ins]t+ 1
 includ+ drills & ex]cises to ensure    
m$ical surge capacity = ev5ts )\t notice
 aft] ex]cises2 &  7,b7 9 p>agraph      
7#c7--  7i7 9 ! matt] prec$+ subp>agraph
 7,a7--  7,i7 by /rik+ facilities71 &   
trauma c>e & ins]t+ & ambulatory c>e    
facilities & :i* may include d5tal heal?
 facilities71 & trauma c>e1 critical    
c>e12 &  7,,ii7 by ins]t+ 7includ+      
relat$ availability1 accessibility1 &   
coord9ation7 aft] public heal?          
em]g5cies2  7ii7 9 subp>agraph 7,a71 by 
ins]t+ & trauma aft] m$ical2  7iii7 9   
subp>agraph 7,b71 by /rik+ ,m$ical      
evacuation & fatality managem5t & ins]t+
 ,fatality managem5t2  7iv7 by          

r$esignat+ subp>agraphs 7,c71 7,d71 &   
7,e7 z subp>agraphs 7,d71 7,e71 & 7,f71 
respectively2  7v7 by ins]t+ aft]       
subp>agraph 7,b71 ! foll[+ ! new        
subp>agraph3  7,c7 ,coord9at$ m$ical    
triage & evacuation to appropriate      
m$ical in/itutions bas$ on pati5t m$ical
 ne$1 tak+ into acc\nt regionaliz$      
sy/ems ( c>e4  2  7vi7 9 subp>agraph    
7,e71 z r$esignat$ by clause 7iv71 by   
ins]t+ 7:i* may include su* d5tal heal? 
assets7 aft] m$ical assets2 &  7vii7 by 
add+ at ! end ! foll[+3  7,g7 ,optimiz+ 
a coord9at$ & flexible approa* to !     
m$ical surge capacity ( hospitals1 o!r  
heal? c>e facilities1 critical c>e1 &   
trauma c>e 7:i* may include trauma      
c5t]s7 & em]g5cy m$ical sy/ems4  2  7,c7
 9 p>agraph 7#d7--  7i7 9 subp>agraph   
7,a71 by ins]t+ 1 includ+ ! unique ne$s 
& consid]ations ( individuals )         
disabilities1 aft] m$ical ne$s ( at-risk
 individuals2 &  7ii7 9 subp>agraph     
7,b71 by ins]t+ ! be=e purpose ( ?is    
section2 &  7,d7 by add+ at ! end !     

foll[+3  7#g7 ,c\nt]measures  7,a7      
,promot+ /rategic initiatives to advance
 c\nt]measures to diagnose1 mitigate1   
prev5t1 or treat h>m f any biological   
ag5t or tox91 *emical1 radiological1 or 
nucle> ag5t or ag5ts1 :e!r naturally    
occurr+1 un9t5tional1 or delib]ate4     
7,b7 ,= purposes ( ?is p>agraph1 ! t]m  
c\nt]measures has ! same mean+ z ! t]ms 
qualifi$ c\nt]measures "u section       
#cai;,f-#a1 qualifi$ p&emic & epidemic  
products "u section #cai;,f-#c1 &       
security c\nt]measures "u section       
#cai;,f-#b4  7#h7 ,m$ical & public heal?
 community resili5cy ,/r5g!n+ ! ability 
( ,/ates1 local communities1 & tribal   
communities to prep>e =1 respond to1 &  
be resili5t 9 ! ev5t ( public heal?     
em]g5cies1 :e!r naturally occurr+1      
un9t5tional1 or delib]ate by--  7,a7    
optimiz+ alignm5t & integration ( m$ical
 & public heal? prep>$ness & response   
plann+ & capabilities ) & into r\t9e    
daily activities2 &  7,b7 promot+       
famili>ity ) local m$ical & public heal?

 sy/ems4  4  7b7 ,at-,risk individuals  
,section #bhad ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#af7
 is am5d$--  7#a7 by /rik+ p>agraphs    
7#e71 7#g71 & 7#h72  7#b7 9 p>agraph    
7#d71 by /rik+ #bhaa7;b77#c77;,b7 &     
ins]t+ #bhjb7;b77#d77;,b72  7#c7 by     
r$esignat+ p>agraphs 7#a7 ?r\gh 7#d7 z  
p>agraphs 7#b7 ?r\gh 7#e71 respectively2
  7#d7 by ins]t+ be=e p>agraph 7#b7 7z s
 r$esignat$71 ! foll[+3  7#a7 monitor   
em]g+ issues & conc]ns z !y relate to   
m$ical & public heal? prep>$ness &      
response = at-risk individuals 9 ! ev5t 
( a public heal? em]g5cy decl>$ by !    
,secret>y "u section #cai2  2  7#e7 by  
am5d+ p>agraph 7#b7 7z s r$esignat$7 to 
read z foll[s3  7#b7 ov]see !           
implem5tation ( ! prep>$ness goals      
describ$ 9 section #bhjb7;b7 ) respect  
to ! public heal? & m$ical ne$s (       
at-risk individuals 9 ! ev5t ( a public 
heal? em]g5cy1 z describ$ 9 section     
#bhjb7;b77#d72  2 &  7#f7 by ins]t+ aft]
 p>agraph 7#f71 ! foll[+3  7#g7         

dissem9ate &1 z appropriate1 update     
novel & be/ practices ( outrea* to & c>e
 ( at-risk individuals be=e1 dur+1 &    
foll[+ public heal? em]g5cies 9 z timely
 a mann] z is practicable1 includ+ f !  
"t a public heal? ?reat is id5tifi$2 &  
7#h7 ensure t public heal? & m$ical     
in=mation di/ribut$ by ! ,dep>tm5t (    
,heal? & ,human ,s]vices dur+ a public  
heal? em]g5cy is deliv]$ 9 a mann] t    
takes into acc\nt ! range (             
communication ne$s ( ! int5d$ recipi5ts1
 includ+ at-risk individuals4  4  #ajb4 
,assi/ant ,secret>y = ,prep>$ness &     
,response  7a7 ,9 g5]al ,section #bhaa (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #cjj;hh-#aj7 is am5d$--  7#a7 
9 subsection 7b7--  7,a7 9 p>agraph     
7#c71 by ins]t+ 1 security c\nt]measures
 7z def9$ 9 section #cai;,f-#b71 aft]   
qualifi$ c\nt]measures 7z def9$ 9       
section #cai;,f-#a72  7,b7 9 p>agraph   
7#d71 by add+ at ! end ! foll[+3  7,d7  
,policy coord9ation & /rategic direction
 ,provide integrat$ policy coord9ation &

 /rategic direction ) respect to all    
matt]s relat$ to ,f$]al public heal? &  
m$ical prep>$ness & execution &         
deploym5t ( ! ,f$]al response = public  
heal? em]g5cies & incid5ts cov]$ by !   
,national ,response ,plan develop$      
pursuant to section #ejd7f7 ( ! ,homel& 
,security ,act ( #bjjb1 or any successor
 plan1 be=e1 dur+1 & foll[+ public heal?
 em]g5cies4  7,e7 ,id5tification (      
ineffici5cies ,id5tify & m9imize gaps1  
duplication1 & o!r ineffici5cies 9      
m$ical & public heal? prep>$ness &      
response activities & ! actions necess>y
 to ov]come ^! ob/acles4  7,f7          
,coord9ation ( grants & agreem5ts ,align
 & coord9ate m$ical & public heal?      
grants & coop]ative agreem5ts z         
applicable to prep>$ness & response     
activities au?oriz$ "u ?is ,act1 to !   
ext5t possible1 includ+ program         
requirem5ts1 timel9es1 & measurable     
goals1 & 9 consultation ) ! ,secret>y ( 
,homel& ,security1 to--  7i7 optimize & 
/reaml9e m$ical & public heal?          

prep>$ness & response capabilities & !  
ability ( local communities to respond  
to public heal? em]g5cies2 &  7ii7 ga!r 
& dissem9ate be/ practices among grant &
 coop]ative agreem5t recipi5ts1 z       
appropriate4  7,g7 ,drill & op]ational  
ex]cises ,c>ry out drills & op]ational  
ex]cises1 9 consultation ) ! ,dep>tm5t (
 ,homel& ,security1 ! ,dep>tm5t (       
,def5se1 ! ,dep>tm5t ( ,vet]ans         
,affairs1 & o!r applicable ,f$]al       
dep>tm5ts & ag5cies1 z necess>y &       
appropriate1 to id5tify1 in=m1 & address
 gaps 9 & policies relat$ to all-haz>ds 
m$ical & public heal? prep>$ness &      
response1 includ+ ex]cises bas$ on--    
7i7 id5tifi$ ?reats = :i* c\nt]measures 
are available & = :i* no c\nt]measures  
are available2 &  7ii7 unkn[n ?reats =  
:i* no c\nt]measures are available4     
7,h7 ,national security priority ,on a  
p]iodic basis consult )1 z applicable & 
appropriate1 ! ,assi/ant to ! ,presid5t 
= ,national ,security ,affairs1 to      
provide an update on1 & discuss1 m$ical 

& public heal? prep>$ness & response    
activities pursuant to ?is ,act & !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act1  
includ+ progress on ! developm5t1       
approval1 cle>ance1 & lic5sure ( m$ical 
c\nt]measures4  2 &  7,c7 by add+ at !  
end ! foll[+3  7#g7 ,c\nt]measures      
budget plan ,develop1 & update on an    
annual basis1 a coord9at$ #e-ye> budget 
plan bas$ on ! m$ical c\nt]measure      
priorities describ$ 9 subsection 7d74   
,ea* su* plan %all--  7,a7 include      
consid]ation ( ! entire m$ical          
c\nt]measures ent]prise1 includ+--  7i7 
basic rese>* & advanc$ rese>* &         
developm5t2  7ii7 approval1 cle>ance1   
lic5sure1 & au?oriz$ uses ( products2 & 
7iii7 procurem5t1 /ockpil+1 ma9t5ance1 &
 repl5i%m5t ( all products 9 ! ,/rategic
 ,national ,/ockpile2  7,b7 in=m        
prioritization ( res\rces & include     
measurable outputs & outcomes to all[ = 
! track+ ( ! progress made t[>d id5tifi$
 priorities2  7,c7 id5tify m$ical       
c\nt]measure life-cycle co/s to in=m    

plann+1 budget+1 & anticipat$ ne$s )9 ! 
cont9uum ( ! m$ical c\nt]measure        
ent]prise consi/5t ) section #cai;,f-#b2
 &  7,d7 be made available to !         
appropriate committees ( ,congress ^u   
reque/4  2  7#b7 by /rik+ subsection 7c7
 & ins]t+ ! foll[+3  7c7 ,functions ,!  
,assi/ant ,secret>y = ,prep>$ness &     
,response %all--  7#a7 h lead           
responsibility )9 ! ,dep>tm5t ( ,heal? &
 ,human ,s]vices = em]g5cy prep>$ness & 
response policy coord9ation & /rategic  
direction2  7#b7 h au?ority ov] &       
responsibility =--  7,a7 ! ,national    
,disa/] ,m$ical ,sy/em pursuant to      
section #bhab2  7,b7 ! ,hospital        
,prep>$ness ,coop]ative ,agreem5t       
,program pursuant to section #cai;,c-#b2
  7,c7 ! ,biom$ical ,advanc$ ,rese>* &  
,developm5t ,au?ority pursuant to       
section #cai,l2  7,d7 ! ,m$ical ,res]ve 
,corps pursuant to section #bhac2  7,e7 
! ,em]g5cy ,sy/em = ,advance            
,regi/ration ( ,volunte] ,heal?         
,pr(essionals pursuant to section       

#cai;,i2 &  7,f7 adm9i/]+ grants &      
relat$ au?orities relat$ to trauma c>e  
"u p>ts ,a ?r\gh ,c ( title ,,xii1 su*  
au?ority to be transf]r$ by ! ,secret>y 
f ! ,adm9i/rator ( ! ,heal? ,res\rces & 
,s]vices ,adm9i/ration to su* ,assi/ant 
,secret>y2  7#c7 ex]cise !              
responsibilities & au?orities ( !       
,secret>y ) respect to ! coord9ation (--
  7,a7 ! ,public ,heal? ,em]g5cy        
,prep>$ness ,coop]ative ,agreem5t       
,program pursuant to section #cai;,c-#a2
  7,b7 ! ,/rategic ,national ,/ockpile  
pursuant to section #cai;,f-#b2 &  7,c7 
! ,cities ,read9ess ,initiative2 &  7#d7
 assume o!r duties z det]m9$ appropriate
 by ! ,secret>y4  2 &  7#c7 by add+ at !
 end ! foll[+3  7d7 ,public ,heal?      
,em]g5cy ,m$ical ,c\nt]measures         
,ent]prise ,/rategy & ,implem5tation    
,plan  7#a7 ,9 g5]al ,n lat] ?an #ahj   
days aft] ! date ( enactm5t ( ?is       
subsection1 & e ye> !reaft]1 ! ,assi/ant
 ,secret>y = ,prep>$ness & ,response    
%all develop & submit to ! appropriate  

committees ( ,congress a coord9at$      
/rategy & accompany+ implem5tation plan 
= m$ical c\nt]measures to address       
*emical1 biological1 radiological1 &    
nucle> ?reats4 ,9 develop+ su* a plan1 !
 ,assi/ant ,secret>y = ,prep>$ness &    
,response %all consult ) ! ,director ( !
 ,biom$ical ,advanc$ ,rese>* &          
,developm5t ,au?ority1 ! ,director ( !  
,national ,in/itutes ( ,heal?1 !        
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion1 & ! ,commission] ( ,food 
& ,drugs4 ,su* /rategy & plan %all be   
kn[n z ! ,public ,heal? ,em]g5cy ,m$ical
 ,c\nt]measures ,ent]prise ,/rategy &   
,implem5tation ,plan4  7#b7 ,requirem5ts
 ,! plan "u p>agraph 7#a7 %all--  7,a7  
describe ! *emical1 biological1         
radiological1 & nucle> ag5t or ag5ts t  
may pres5t a ?reat to ! ,nation & !     
correspond+ ef=ts to develop qualifi$   
c\nt]measures 7z def9$ 9 section        
#cai;,f-#a71 security c\nt]measures 7z  
def9$ 9 section #cai;,f-#b71 or qualifi$
 p&emic or epidemic products 7z def9$ 9 

section #cai;,f-#c7 = ea* ?reat2  7,b7  
evaluate ! progress ( all activities )  
respect to su* c\nt]measures or         
products1 includ+ rese>*1 advanc$       
rese>*1 developm5t1 procurem5t1         
/ockpil+1 deploym5t1 di/ribution1 &     
utilization2  7,c7 id5tify & prioritize 
ne>-1 mid-1 & long-t]m ne$s ) respect to
 su* c\nt]measures or products to       
address a *emical1 biological1          
radiological1 & nucle> ?reat or ?reats2 
7,d7 id5tify1 ) respect to ea* category 
( ?reat1 a summ>y ( all aw>ds &         
contracts1 includ+ advanc$ rese>* &     
developm5t & procurem5t1 t includes--   
7i7 ! "t elaps$ f ! issuance ( ! initial
 solicitation or reque/ = a proposal to 
! adjudication 7su* z ! aw>d1 d5ial (   
aw>d1 or solicitation t]m9ation72 &     
7ii7 an id5tification ( project$        
timel9es1 anticipat$ fund+ allocations1 
b5*m>ks1 & mile/ones = ea* m$ical       
c\nt]measure priority "u subp>agraph    
7,c71 includ+ project$ ne$s ) reg>d to  
repl5i%m5t ( ! ,/rategic ,national      

,/ockpile2  7,e7 be in=m$ by !          
recomm5dations ( ! ,national ,biodef5se 
,sci5ce ,bo>d pursuant to section       
#cai,m2  7,f7 evaluate progress made 9  
meet+ timel9es1 allocations1 b5*m>ks1 & 
mile/ones id5tifi$ "u subp>agraph       
7,d77ii72  7,g7 report on ! am\nt (     
funds available = procurem5t 9 ! special
 res]ve fund z def9$ 9 section          
#cai;,f-#b7;h7 & ! impact ?is fund+ w h 
on meet+ ! requirem5ts "u section       
#cai;,f-#b2  7,h7 incorporate input f   
,f$]al1 ,/ate1 local1 & tribal          
/akehold]s2  7,i7 id5tify ! progress    
made 9 meet+ ! m$ical c\nt]measure      
priorities = at-risk individuals 7z     
def9$ 9 #bhjb7;b77#d77;,b771 z          
applicable "u subp>agraph 7,c71 includ+ 
) reg>d to ! project$ ne$s = relat$     
/ockpil+ & repl5i%m5t ( ! ,/rategic     
,national ,/ockpile1 includ+ by address+
 ! ne$s ( p$iatric populations ) respect
 to su* c\nt]measures & products 9 !    
,/rategic ,national ,/ockpile1 includ+--
  7i7 a li/ ( su* c\nt]measures &       

products necess>y to address ! ne$s (   
p$iatric populations2  7ii7 a           
description ( measures tak5 to coord9ate
 ) ! ,(fice ( ,p$iatric ,!rapeutics ( ! 
,food & ,drug ,adm9i/ration to maximize 
! label+1 dosages1 & =mulations ( su*   
c\nt]measures & products = p$iatric     
populations2  7iii7 a description (     
exi/+ gaps 9 ! ,/rategic ,national      
,/ockpile & ! developm5t ( su*          
c\nt]measures & products to address !   
ne$s ( p$iatric populations2 &  7iv7 an 
evaluation ( ! progress made 9 address+ 
priorities id5tifi$ pursuant to         
subp>agraph 7,c72  7,j7 id5tify ! use ( 
au?ority & activities und]tak5 pursuant 
to sections #cai;,f-#a7;b77#a71         
#cai;,f-#a7;b77#b71 #cai;,f-#a7;b77#c71 
#cai;,f-#a7;c71 #cai;,f-#a7;d71         
#cai;,f-#a7;e71                         
#cai;,f-#b7;c77#g77;,c77iii71           
#cai;,f-#b7;c77#g77;,c77iv71 &          
#cai;,f-#b7;c77#g77;,c77v7 ( ?is ,act1 &
 subsections 7a77#a71 7b77#a71 & 7e7 (  
section #efd ( ! ,f$]al ,food1 ,drug1 & 

,cosmetic ,act1 by summ>iz+--  7i7 !    
p>ticul> actions t 7 tak5 "u !          
au?orities specifi$1 includ+1 z         
applicable1 ! id5tification ( ! ?reat   
ag5t1 em]g5cy1 or ! biom$ical           
c\nt]measure ) respect to :i* ! au?ority
 0 us$2  7ii7 ! reasons und]ly+ !       
decision to use su* au?orities1 includ+1
 z applicable1 ! options t 7 consid]$ & 
reject$ ) respect to ! use ( su*        
au?orities2  7iii7 ! numb] (1 nature (1 
& o!r in=mation conc]n+ ! p]sons &      
entities t receiv$ a grant1 coop]ative  
agreem5t1 or contract pursuant to ! use 
( su* au?orities1 & ! p]sons & entities 
t 7 consid]$ & reject$ = su* a grant1   
coop]ative agreem5t1 or contract1 except
 t ! report ne$ n disclose ! id5tity (  
any su* p]son or entity2  7iv7 :e!r1 )  
respect to ea* procurem5t t is approv$  
by ! ,presid5t "u section               
#cai;,f-#b7;c77#f71 a contract 0 ent]$  
into )9 "o ye> aft] su* approval by !   
,presid5t2 &  7v7 ) respect to section  
#cai;,f-#a7;d71 = ! "o-ye> p]iod = :i* !

 report is submitt$1 ! numb] ( p]sons :o
 7 paid am\nts total+ #ajj1jjj or great]
 & ! numb] ( p]sons :o 7 paid am\nts    
total+ at lea/ #ej1jjj b less ?an       
#ajj1jjj2 &  7,k7 be made publicly      
available4  7#c7 ,,gao report  7,a7 ,9  
g5]al ,n lat] ?an #a ye> aft] ! date ( !
 submission to ! ,congress ( ! fir/     
,public ,heal? ,em]g5cy ,m$ical         
,c\nt]measures ,ent]prise ,/rategy &    
,implem5tation ,plan1 ! ,comptroll]     
,g5]al ( ! ,unit$ ,/ates %all conduct an
 indep5d5t evaluation1 & submit to !    
appropriate committees ( ,congress a    
report1 conc]n+ su* ,/rategy &          
,implem5tation ,plan4  7,b7 ,cont5t ,!  
report describ$ 9 subp>agraph 7,a7 %all 
review & assess--  7i7 ! ne>-t]m1       
mid-t]m1 & long-t]m m$ical c\nt]measure 
ne$s & id5tifi$ priorities ( ! ,f$]al   
,gov]nm5t pursuant to p>agraph          
7#b77;,c72  7ii7 ! activities ( !       
,dep>tm5t ( ,heal? & ,human ,s]vices )  
respect to advanc$ rese>* & developm5t  
pursuant to section #cai,l2 &  7iii7 !  

progress made t[>d meet+ ! timel9es1    
allocations1 b5*m>ks1 & mile/ones       
id5tifi$ 9 ! ,public ,heal? ,em]g5cy    
,m$ical ,c\nt]measures ,ent]prise       
,/rategy & ,implem5tation ,plan "u ?is  
subsection4  7e7 ,protection ( national 
security ,9 c>ry+ out subsections       
7b77#g7 & 7d71 ! ,secret>y %all ensure t
 in=mation & items t c\ld compromise    
national security1 conta9 confid5tial   
comm]cial in=mation1 or conta9          
propriet>y in=mation are n disclos$4  4 
7b7 ,int]ag5cy coord9ation plan ,9 !    
fir/ ,public ,heal? ,em]g5cy            
,c\nt]measures ,ent]prise ,/rategy &    
,implem5tation ,plan submitt$ "u        
subsection 7d7 ( section #bhaa ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;hh-#aj7 7z add$ by       
subsection 7a77#c771 ! ,secret>y (      
,heal? & ,human ,s]vices1 9 consultation
 ) ! ,secret>y ( ,def5se1 %all include a
 description ( ! mann] 9 :i* ! ,dep>tm5t
 ( ,heal? & ,human ,s]vices is coord9at+
 ) ! ,dep>tm5t ( ,def5se reg>d+         

c\nt]measure activities to address      
*emical1 biological1 radiological1 &    
nucle> ?reats4 ,su* report %all include 
in=mation ) respect to--  7#a7 ! rese>*1
 advanc$ rese>*1 developm5t1 procurem5t1
 /ockpil+1 & di/ribution ( c\nt]measures
 to meet id5tifi$ ne$s2 &  7#b7 !       
coord9ation ( ef=ts betwe5 ! ,dep>tm5t (
 ,heal? & ,human ,s]vices & ! ,dep>tm5t 
( ,def5se to address c\nt]measure ne$s =
 v>i\s segm5ts ( ! population4  #ajc4   
,national ,advisory ,committee on       
,*ildr5 & ,disa/]s ,subtitle ,b ( title 
,,xxviii ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #cjj;hh et seq47 is     
am5d$ by ins]t+ aft] section #bhaa !    
foll[+3  #bhaa;,a4 ,national ,advisory  
,committee on ,*ildr5 & ,disa/]s  7a7   
,e/abli%m5t ,! ,secret>y1 9 consultation
 ) ! ,secret>y ( ,homel& ,security1 %all
 e/abli% an advisory committee to be    
kn[n z ! ,national ,advisory ,committee 
on ,*ildr5 & ,disa/]s 7ref]r$ to 9 ?is  
section z ! ,advisory ,committee74  7b7 
,duties ,! ,advisory ,committee %all--  

7#a7 provide advice & consultation )    
respect to ! activities c>ri$ out       
pursuant to section #bhad1 z applicable 
& appropriate2  7#b7 evaluate & provide 
input ) respect to ! m$ical & public    
heal? ne$s ( *ildr5 z !y relate to      
prep>ation =1 response to1 & recov]y f  
all-haz>ds em]g5cies2 &  7#c7 provide   
advice & consultation ) respect to ,/ate
 em]g5cy prep>$ness & response          
activities & *ildr51 includ+ relat$     
drills & ex]cises pursuant to !         
prep>$ness goals "u section #bhjb7;b74  
7c7 ,additional duties ,! ,advisory     
,committee may provide advice &         
recomm5dations to ! ,secret>y ) respect 
to *ildr5 & ! m$ical & public heal?     
grants & coop]ative agreem5ts z         
applicable to prep>$ness & response     
activities au?oriz$ "u ?is title & title
 ,,iii4  7d7 ,memb]%ip  7#a7 ,9 g5]al ,!
 ,secret>y1 9 consultation ) su* o!r    
,secret>ies z may be appropriate1 %all  
appo9t n to exce$ #ae memb]s to !       
,advisory ,committee4 ,9 appo9t+ su*    

memb]s1 ! ,secret>y %all ensure t !     
total memb]%ip ( ! ,advisory ,committee 
is an odd numb]4  7#b7 ,requir$ memb]s  
,! ,secret>y1 9 consultation ) su* o!r  
,secret>ies z may be appropriate1 may   
appo9t to ! ,advisory ,committee "u     
p>agraph 7#a7 su* individuals z may be  
appropriate to p]=m ! duties describ$ 9 
subsections 7b7 & 7c71 :i* may include--
  7,a7 ! ,assi/ant ,secret>y =          
,prep>$ness & ,response2  7,b7 !        
,director ( ! ,biom$ical ,advanc$       
,rese>* & ,developm5t ,au?ority2  7,c7 !
 ,director ( ! ,c5t]s = ,disease        
,control & ,prev5tion2  7,d7 !          
,commission] ( ,food & ,drugs2  7,e7 !  
,director ( ! ,national ,in/itutes (    
,heal?2  7,f7 ! ,assi/ant ,secret>y ( ! 
,adm9i/ration = ,*ildr5 & ,families2    
7,g7 ! ,adm9i/rator ( ! ,f$]al ,em]g5cy 
,managem5t ,ag5cy2  7,h7 at lea/ two    
non-,f$]al heal? c>e pr(essionals )     
exp]tise 9 p$iatric m$ical disa/]       
plann+1 prep>$ness1 response1 or        
recov]y2  7,i7 at lea/ two              

repres5tatives f ,/ate1 local1          
t]ritorial1 or tribal ag5cies ) exp]tise
 9 p$iatric disa/] plann+1 prep>$ness1  
response1 or recov]y2 &  7,j7           
repres5tatives f su* ,f$]al ag5cies 7su*
 z ! ,dep>tm5t ( ,education & !         
,dep>tm5t ( ,homel& ,security7 z det]m9$
 necess>y to fulfill ! duties ( !       
,advisory ,committee1 z e/abli%$ "u     
subsections 7b7 & 7c74  7e7 ,meet+s ,!  
,advisory ,committee %all meet n less   
?an biannually4  7f7 ,sunset ,!         
,advisory ,committee %all t]m9ate on !  
date t is #e ye>s aft] ! date ( enactm5t
 ( ! ,p&emic & ,all-,haz>ds ,prep>$ness 
,reau?orization ,act ( #bjac4  4  #ajd4 
,mod]nization ( ! ,national ,disa/]     
,m$ical ,sy/em ,section #bhab ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;hh-#aa7 is am5d$--  7#a7 
9 subsection 7a77#c7--  7,a7 9          
subp>agraph 7,a71 9 clause 7i7 by ins]t+
 1 includ+ at-risk individuals z        
applicable aft] victims ( a public heal?
 em]g5cy2  7,b7 by r$esignat+           

subp>agraph 7,c7 z subp>agraph 7,e72 &  
7,c7 by ins]t+ aft] subp>agraph 7,b71 ! 
foll[+3  7,c7 ,consid]ations = at-risk  
populations ,! ,secret>y %all take /eps 
to ensure t an appropriate specializ$ & 
focus$ range ( public heal? & m$ical    
capabilities are repres5t$ 9 ! ,national
 ,disa/] ,m$ical ,sy/em1 :i* take into  
acc\nt ! ne$s ( at-risk individuals1 9 !
 ev5t ( a public heal? em]g5cy4  4  7,d7
 ,adm9i/ration ,! ,secret>y may det]m9e 
& pay claims = reimbursem5t = s]vices "u
 subp>agraph 7,a7 directly or ?r\gh     
contracts t provide = paym5t 9 advance  
or by way ( reimbursem5t4  2 &  7#b7 9  
subsection 7g71 by /rik+ su* sums z may 
be necess>y = ea* ( ! fiscal ye>s #bjjg 
?r\gh #bjaa & ins]t+ #eb1gjj1jjj = ea* (
 fiscal ye>s #bjac ?r\gh #bjag4  #aje4  
,cont9u+ ! role ( ! ,dep>tm5t ( ,vet]ans
 ,affairs ,section #haag7;g7 ( title    
#ch1 ,unit$ ,/ates ,code1 is am5d$ by   
/rik+ su* sums z may be necess>y to c>ry
 out ?is section = ea* ( fiscal ye>s    
#bjjg ?r\gh #bjaa & ins]t+ #aee1cjj1jjj 

= ea* ( fiscal ye>s #bjac ?r\gh #bjag to
 c>ry out ?is section4  ,,ii ,optimiz+  
,/ate & local all-haz>ds prep>$ness &   
response  #bja4 ,tempor>y r$eploym5t (  
f$]ally fund$ p]sonnel dur+ a public    
heal? em]g5cy ,section #cai ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d7 is am5d$ by add+ at ! end !     
foll[+3  7e7 ,tempor>y r$eploym5t (     
f$]ally fund$ p]sonnel dur+ a public    
heal? em]g5cy  7#a7 ,em]g5cy r$eploym5t 
( f$]ally fund$ p]sonnel ,not)/&+ any   
o!r provision ( law1 & subject to       
p>agraph 7#b71 ^u reque/ by ! ,gov]nor (
 a ,/ate or ! *ief ( a tribe or su*     
,gov]nor or *ief's designee1 ! ,secret>y
 may au?orize ! reque/+ ,/ate or tribe  
to tempor>ily r$eploy1 = purposes (     
imm$iately address+ a public heal?      
em]g5cy 9 ! ,/ate or tribe1 non-,f$]al  
p]sonnel fund$ 9 :ole or 9 "p ?r\gh1 z  
appropriate1 programs "u ?is ,act4  7#b7
 ,activation ( em]g5cy r$eploym5t  7,a7 
,public heal? em]g5cy ,! ,secret>y may  
au?orize a tempor>y r$eploym5t (        

p]sonnel "u p>agraph 7#a7 only dur+ !   
p]iod ( a public heal? em]g5cy det]m9$  
pursuant to subsection 7a74  7,b7       
,cont5ts ( reque/ ,to seek au?ority = a 
tempor>y r$eploym5t ( p]sonnel "u       
p>agraph 7#a71 ! ,gov]nor ( a ,/ate or !
 *ief ( a tribe %all submit to !        
,secret>y a reque/ = su* au?ority & %all
 include 9 ! reque/ ea* ( ! foll[+3  7i7
 ,an assurance t ! public heal? em]g5cy 
9 ! geographic area ( ! reque/+ ,/ate or
 tribe _c be adequately & appropriately 
address$ by ! public heal? work=ce      
o!rwise available4  7ii7 ,an assurance t
 ! public heal? em]g5cy w\ld be address$
 m effici5tly & effectively ?r\gh !     
reque/$ tempor>y r$eploym5t ( p]sonnel4 
7iii7 ,an assurance t ! reque/$ tempor>y
 r$eploym5t ( p]sonnel is consi/5t ) any
 applicable ,all-,haz>ds ,public ,heal? 
,em]g5cy ,prep>$ness & ,response ,plan  
"u section #cai;,c-#a4  7iv7 ,an        
id5tification (--  7,i7 ea* ,f$]al      
program f :i* p]sonnel w\ld be          
tempor>ily r$eploy$ pursuant to !       

reque/$ au?ority2 &  7,,ii7 ! numb] (   
p]sonnel :o w\ld be s r$eploy$ f ea* su*
 program4  7v7 ,su* o!r in=mation &     
assurances z ! ,secret>y may require4   
7,c7 ,consid]ation ,9 review+ a reque/ =
 tempor>y r$eploym5t "u p>agraph 7#a7 ( 
p]sonnel fund$ ?r\gh a ,f$]al program1 !
 ,secret>y %all consid] ! degree to :i* 
! program w\ld be adv]sely affect$ by ! 
r$eploym5t4  7,d7 ,t]m9ation & ext5sion 
7i7 ,t]m9ation ,a ,/ate or tribe's      
au?ority = a tempor>y r$eploym5t (      
p]sonnel "u p>agraph 7#a7 %all t]m9ate  
^u ! e>li] ( ! foll[+3  7,i7 ,!         
,secret>y's det]m9ation t ! public heal?
 em]g5cy no long] exi/s4  7,,ii7        
,subject to clause 7ii71 ! expiration ( 
! #cj-;day p]iod foll[+ ! date on :i* ! 
,secret>y approv$ ! ,/ate or tribe's    
reque/ = su* au?ority4  7ii7 ,ext5sion  
au?ority ,! ,secret>y may ext5d !       
au?ority to au?orize a tempor>y         
r$eploym5t ( p]sonnel "u p>agraph 7#a7  
beyond ! date o!rwise applicable "u     
clause 7i77,,ii7 if ! public heal?      

em]g5cy /ill exi/s z ( su* date1 b only 
if--  7,i7 ! ,/ate or tribe t submitt$ !
 initial reque/ = au?ority = a tempor>y 
r$eploym5t ( p]sonnel submits a reque/ =
 an ext5sion ( su* au?ority2 &  7,,ii7 !
 reque/ = an ext5sion conta9s ! same    
type ( in=mation & assurances necess>y =
 ! approval ( an initial reque/ = su*   
au?ority4  7#c7 ,notice to p]sonnel (   
possibility ( r$eploym5t ,! ,secret>y   
%all ensure t1 if a ,/ate or tribe      
receives ,f$]al funds = p]sonnel :o are 
subject to ! ,secret>y's r$eploym5t     
au?ority "u ?is subsection1 ! ,/ate or  
tribe gives notice to su* p]sonnel ( !  
possibility ( r$eploym5t--  7,a7 at ! "t
 ( hir+2 or  7,b7 9 ! case ( p]sonnel   
hir$ be=e ! date ( ! enactm5t ( ?is     
subsection1 z soon z practicable4  7#d7 
,notice to ,congress ,! ,secret>y %all  
give notice to ! ,congress 9 conjunction
 ) ! approval "u ?is subsection (--     
7,a7 any initial reque/ = au?ority = a  
tempor>y r$eploym5t ( p]sonnel2 &  7,b7 
any reque/ = an ext5sion ( su* au?ority4

  7#e7 ,guidance ,! ,secret>y %all--    
7,a7 n lat] ?an #f mon?s aft] ! enactm5t
 ( ?is subsection1 issue propos$        
guidance on ! tempor>y r$eploym5t (     
p]sonnel "u ?is subsection2 &  7,b7 aft]
 provid+ notice & a #fj-;day p]iod =    
public comm5t1 f9alize su* guidance4    
7#f7 ,report to ,congress ,n lat] ?an #d
 ye>s aft] ! date ( enactm5t ( ! ,p&emic
 & ,all-,haz>ds ,prep>$ness             
,reau?orization ,act ( #bjac1 !         
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all conduct an indep5d5t evaluation1 & 
submit to ! appropriate committees ( !  
,congress a report1 on ! ,secret>y's    
au?ority "u ?is subsection1 includ+--   
7,a7 a description ( h[1 & "u :at       
circum/ances1 su* au?ority has be5 us$  
by ,/ates & tribes2  7,b7 an analysis ( 
h[ su* au?ority has assi/$ ,/ates &     
tribes 9 respond+ to public heal?       
em]g5cies2  7,c7 an evaluation ( h[ su* 
au?ority has improv$ op]ational         
effici5cies 9 respond+ to public heal?  
em]g5cies2  7,d7 an analysis ( ! ext5t  

to :i*1 if any1 ,f$]al programs f :i*   
p]sonnel h be5 tempor>ily r$eploy$      
pursuant to su* au?ority h be5 adv]sely 
affect$ by ! r$eploym5t2 &  7,e7        
recomm5dations on h[ su* au?ority c\ld  
be improv$ to fur!r assi/ 9 respond+ to 
public heal? em]g5cies4  7#g7 ,def9ition
 ,9 ?is subsection1 ! t]m ,/ate         
includes1 9 addition to ! entities li/$ 
9 ! def9ition ( su* t]m 9 section #b1 ! 
,freely ,associat$ ,/ates4  7#h7 ,sunset
 ,! au?ority "u ?is subsection %all     
t]m9ate on ! date t is #e ye>s aft] !   
date ( enactm5t ( ! ,p&emic &           
,all-,haz>ds ,prep>$ness ,reau?orization
 ,act ( #bjac4  4  #bjb4 ,improv+ ,/ate 
& local public heal? security  7a7      
,coop]ative agreem5ts ,section          
#cai;,c-#a ( ! ,public ,heal? ,s]vice   
,act 7#db ,u4,s4,c4 #bdg;d-#c;a7 is     
am5d$--  7#a7 9 subsection 7b77#a77;,c71
 by /rik+ consortium ( entities describ$
 9 subp>agraph 7,a7 & ins]t+ consortium 
( ,/ates2  7#b7 9 subsection 7b77#b7--  
7,a7 9 subp>agraph 7,a7--  7i7 by /rik+ 

clauses 7i7 & 7ii7 & ins]t+ ! foll[+3   
7i7 a description ( ! activities su*    
entity w c>ry out "u ! agreem5t to meet 
! goals id5tifi$ "u section #bhjb1      
includ+ ) respect to *emical1           
biological1 radiological1 or nucle>     
?reats1 :e!r naturally occurr+1         
un9t5tional1 or delib]ate2  7ii7 a      
description ( ! activities su* entity w 
c>ry out ) respect to p&emic influ5za1 z
 a compon5t ( ! activities c>ri$ out "u 
clause 7i71 & consi/5t ) ! requirem5ts (
 p>agraphs 7#b7 & 7#e7 ( subsection 7g72
  2  7ii7 9 clause 7iv71 by /rik+ & at !
 end2 &  7iii7 by add+ at ! end !       
foll[+3  7vi7 a description ( h[1 z     
appropriate1 ! entity may p>tn] )       
relevant public & private /akehold]s 9  
public heal? em]g5cy prep>$ness &       
response2  7vii7 a description ( h[ !   
entity1 z applicable & appropriate1 w   
coord9ate ) ,/ate em]g5cy prep>$ness &  
response plans 9 public heal? em]g5cy   
prep>$ness1 includ+ ,/ate educational   
ag5cies 7z def9$ 9 section #iaja7da7 ( !

 ,elem5t>y & ,second>y ,education ,act (
 #aife7 & ,/ate *ild c>e lead ag5cies   
7designat$ "u section #feh;,d ( ! ,*ild 
,c>e & ,developm5t ,block ,grant ,act ( 
#aiij72  7viii7 9 ! case ( entities t   
op]ate on ! ,unit$ ,/ates-,mexico bord] 
or ! ,unit$ ,/ates-,canada bord]1 a     
description ( ! activities su* entity w 
c>ry out "u ! agreem5t t are specific to
 ! bord] area includ+ disease detection1
 id5tification1 inve/igation1 &         
prep>$ness & response activities relat$ 
to em]g+ diseases & infecti\s disease   
outbreaks :e!r naturally occurr+ or due 
to biot]rorism1 consi/5t ) ! requirem5ts
 ( ?is section2 &  7ix7 a description ( 
any activities t su* entity w use to    
analyze real-"t cl9ical specim5s =      
pa?og5s ( public heal? or biot]rorism   
significance1 includ+ any utilization ( 
poison control c5t]s2  2 &  7,b7 9      
subp>agraph 7,c71 by ins]t+ 1 includ+   
address+ ! ne$s ( at-risk individuals1  
aft] capabilities ( su* entity2  7#c7 9 
subsection 7f7--  7,a7 9 p>agraph 7#b71 

by add+ & at ! end2  7,b7 9 p>agraph    
7#c71 by /rik+ 2 & & ins]t+ a p]iod2 &  
7,c7 by /rik+ p>agraph 7#d72  7#d7 9    
subsection 7g7--  7,a7 9 p>agraph 7#a71 
by /rik+ subp>agraph 7,a7 & ins]t+ !    
foll[+3  7,a7 include outcome goals     
repres5t+ op]ational a*ievem5ts ( !     
,national ,prep>$ness ,goals develop$ "u
 section #bhjb7;b7 ) respect to         
all-haz>ds1 includ+ *emical1 biological1
 radiological1 or nucle> ?reats2 &  2 & 
7,b7 9 p>agraph 7#b77;,a71 by add+ at ! 
end ! foll[+3 ,! ,secret>y %all         
p]iodically update1 z necess>y &        
appropriate1 su* p&emic influ5za plan   
crit]ia & %all require ! integration (  
su* crit]ia into ! b5*m>ks & /&>ds      
describ$ 9 p>agraph 7#a742  7#e7 by     
/rik+ subsection 7h72  7#f7 9 subsection
 7i7--  7,a7 9 p>agraph 7#a7--  7i7 9   
subp>agraph 7,a7--  7,i7 by /rik+       
#hbd1jjj1jjj = fiscal ye> #bjjg1 ( :i*  
#ce1jjj1jjj %all be us$ to c>ry out     
subsection 7h71 & ins]t+ #fda1ijj1jjj = 
fiscal ye> #bjac2 &  7,,ii7 by /rik+ su*

 sums z may be necess>y = ea* ( fiscal  
ye>s #bjjh ?r\gh #bjaa & ins]t+         
#fda1ijj1jjj = ea* ( fiscal ye>s #bjad  
?r\gh #bjag2  7ii7 by /rik+ subp>agraph 
7,b72  7iii7 by r$esignat+ subp>agraphs 
7,c7 & 7,d7 z subp>agraphs 7,b7 & 7,c71 
respectively2 &  7iv7 9 subp>agraph     
7,c71 z s r$esignat$1 by /rik+          
subp>agraph 7,c7 & ins]t+ subp>agraph   
7,b72  7,b7 9 subp>agraphs 7,c7 & 7,d7 (
 p>agraph 7#c71 by /rik+                
7#a77;,a77i77,i7 ea* place x appe>s &   
ins]t+ 7#a77;,a72  7,c7 9 p>agraph      
7#d77;,b71 by /rik+ subsection 7c7 &    
ins]t+ subsection 7b72 &  7,d7 by add+  
at ! end ! foll[+3  7#g7 ,availability (
 coop]ative agreem5t funds  7,a7 ,9     
g5]al ,am\nts provid$ to an eligible    
entity "u a coop]ative agreem5t "u      
subsection 7a7 = a fiscal ye> & rema9+  
unobligat$ at ! end ( su* ye> %all rema9
 available to su* entity = ! next fiscal
 ye> = ! purposes = :i* su* funds 7     
provid$4  7,b7 ,funds cont+5t on a*iev+ 
b5*m>ks ,! cont9u$ availability ( funds 

"u subp>agraph 7,a7 ) respect to an     
entity %all be cont+5t ^u su* entity    
a*iev+ ! b5*m>ks & submitt+ ! p&emic    
influ5za plan z describ$ 9 subsection   
7g74  2 &  7#g7 9 subsection 7j71 by    
/rik+ p>agraph 7#c74  7b7 ,vacc9e track+
 & di/ribution ,section #cai;,a7e7 ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#a7;e77 is am5d$ by    
/rik+ su* sums = ea* ( fiscal ye>s #bjjg
 ?r\gh #bjaa & ins]t+ #cj1hjj1jjj = ea* 
( fiscal ye>s #bjac ?r\gh #bjag4  #bjc4 
,hospital prep>$ness & m$ical surge     
capacity  7a7 ,all-,haz>ds public heal? 
& m$ical response curricula & tra9+     
,section #cai;,f7a77#e77;,b7 ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#bdg;d-#f7;a77#e77;,b77 is am5d$ by     
/rik+ public heal? or m$ical & ins]t+   
public heal?1 m$ical1 or d5tal4  7b7    
,enc\rag+ heal? pr(essional volunte]s   
7#a7 ,em]g5cy sy/em = advance           
regi/ration ( volunte] heal?            
pr(essionals ,section #cai;,i7k7 ( !    
,public ,heal? ,s]vice ,act 7#db        

,u4,s4,c4 #bdg;d-#g;b7k77 is am5d$ by   
/rik+ #b1jjj1jjj = fiscal ye> #bjjb1 &  
su* sums z may be necess>y = ea* ( !    
fiscal ye>s #bjjc ?r\gh #bjaa & ins]t+  
#e1jjj1jjj = ea* ( fiscal ye>s #bjac    
?r\gh #bjag4  7#b7 ,volunte]s ,section  
#bhac ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #cjj;hh-#ae7 is am5d$--  
7,a7 9 subsection 7d77#b71 by add+ at ! 
end ! foll[+3 ,su* tra9+ ex]cises %all1 
z appropriate & applicable1 incorporate 
! ne$s ( at-risk individuals 9 ! ev5t ( 
a public heal? em]g5cy42 &  7,b7 9      
subsection 7i71 by /rik+ #bb1jjj1jjj =  
fiscal ye> #bjjg1 & su* sums z may be   
necess>y = ea* ( fiscal ye>s #bjjh ?r\gh
 #bjaa & ins]t+ #aa1bjj1jjj = ea* (     
fiscal ye>s #bjac ?r\gh #bjag4  7c7     
,p>tn]%ips = ,/ate & regional prep>$ness
 ,to improve surge capacity ,section    
#cai;,c-#b ( ! ,public ,heal? ,s]vice   
,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is     
am5d$--  7#a7 9 subsection 7a71 by      
ins]t+ 1 includ+ capacity & prep>$ness  
to address ! ne$s ( p$iatric & o!r      

at-risk populations be=e ! p]iod at !   
end2  7#b7 9 subsection                 
7b77#a77;,a77ii71 by /rik+ c5t]s1 prim>y
 & ins]t+ c5t]s1 community heal? c5t]s1 
prim>y2  7#c7 by /rik+ subsection 7c7 & 
ins]t+ ! foll[+3  7c7 ,use ( funds ,an  
aw>d "u subsection 7a7 %all be exp5d$ = 
activities to a*ieve ! prep>$ness goals 
describ$ "u p>agraphs 7#a71 7#c71 7#d71 
7#e71 & 7#f7 ( section #bhjb7;b7 )      
respect to all-haz>ds1 includ+ *emical1 
biological1 radiological1 or nucle>     
?reats4  2  7#d7 by /rik+ subsection 7g7
 & ins]t+ ! foll[+3  7g7 ,coord9ation   
7#a7 ,local response capabilities ,an   
eligible entity %all1 to ! ext5t        
practicable1 ensure t activities c>ri$  
out "u an aw>d "u subsection 7a7 are    
coord9at$ ) activities ( relevant local 
,metropolitan ,m$ical ,response ,sy/ems1
 local ,m$ical ,res]ve ,corps1 ! local  
,cities ,read9ess ,initiative1 & local  
em]g5cy plans4  7#b7 ,national          
collaboration ,p>tn]%ips consi/+ ( "o or
 m eligible entities "u ?is section may1

 to ! ext5t practicable1 collaborate )  
o!r p>tn]%ips consi/+ ( "o or m eligible
 entities "u ?is section = purposes (   
national coord9ation & collaboration )  
respect to activities to a*ieve !       
prep>$ness goals describ$ "u p>agraphs  
7#a71 7#c71 7#d71 7#e71 & 7#f7 ( section
 #bhjb7;b74  2  7#e7 9 subsection 7i7-- 
7,a7 by /rik+ ,! requirem5ts ( & ins]t+ 
! foll[+3  7#a7 ,9 g5]al ,! requirem5ts 
(  2 &  7,b7 by add+ at ! end ! foll[+3 
7#b7 ,meet+ goals ( ,national ,heal?    
,security ,/rategy ,! ,secret>y %all    
implem5t objective1 evid5ce-bas$ metrics
 to ensure t entities receiv+ aw>ds "u  
?is section are meet+1 to ! ext5t       
practicable1 ! applicable goals ( !     
,national ,heal? ,security ,/rategy "u  
section #bhjb4  2 &  7#f7 9 subsection  
7j7--  7,a7 by am5d+ p>agraph 7#a7 to   
read z foll[s3  7#a7 ,9 g5]al ,=        
purposes ( c>ry+ out ?is section1 !re is
 au?oriz$ to be appropriat$ #cgd1gjj1jjj
 = ea* ( fiscal ye>s #bjac ?r\gh #bjag4 
2 &  7,b7 by add+ at ! end ! foll[+3    

7#d7 ,availability ( coop]ative agreem5t
 funds  7,a7 ,9 g5]al ,am\nts provid$ to
 an eligible entity "u a coop]ative     
agreem5t "u subsection 7a7 = a fiscal   
ye> & rema9+ unobligat$ at ! end ( su*  
ye> %all rema9 available to su* entity =
 ! next fiscal ye> = ! purposes = :i*   
su* funds 7 provid$4  7,b7 ,funds       
cont+5t on a*iev+ b5*m>ks ,! cont9u$    
availability ( funds "u subp>agraph 7,a7
 ) respect to an entity %all be cont+5t 
^u su* entity a*iev+ ! b5*m>ks &        
submitt+ ! p&emic influ5za plan z       
requir$ "u subsection 7i74  4  #bjd4    
,enhanc+ situational aw>5ess &          
biosurveillance ,section #cai;,d ( !    
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#d7 is am5d$--  7#a7 9 
subsection 7b7--  7,a7 9 p>agraph       
7#a77;,b71 by ins]t+ poison control     
c5t]s1 aft] hospitals12  7,b7 9 p>agraph
 7#b71 by ins]t+ be=e ! p]iod at ! end !
 foll[+3 1 all[+ = coord9ation to       
maximize all-haz>ds m$ical & public     
heal? prep>$ness & response & to m9imize

 duplication ( ef=t2 &  7,c7 9 p>agraph 
7#c71 by ins]t+ be=e ! p]iod at ! end ! 
foll[+3 & update su* /&>ds z necess>y2  
7#b7 by /rik+ subsection 7c72 &  7#c7 9 
subsection 7d7--  7,a7 9 ! subsection   
head+1 by /rik+ ,public ,heal?          
,situational ,aw>5ess & ins]t+ ,mod]niz+
 ,public ,heal? ,situational ,aw>5ess & 
,biosurveillance2  7,b7 9 p>agraph      
7#a7--  7i7 by /rik+ ,p&emic &          
,all-,haz>ds ,prep>$ness ,act & ins]t+  
,p&emic & ,all-,haz>ds ,prep>$ness      
,reau?orization ,act ( #bjac2 &  7ii7 by
 ins]t+ 1 novel em]g+ ?reats1 aft]      
disease outbreaks2  7,c7 by /rik+       
p>agraph 7#b7 & ins]t+ ! foll[+3  7#b7  
,/rategy & implem5tation plan ,n lat]   
?an #ahj days aft] ! date ( enactm5t ( !
 ,p&emic & ,all-,haz>ds ,prep>$ness     
,reau?orization ,act ( #bjac1 !         
,secret>y %all submit to ! appropriate  
committees ( ,congress a coord9at$      
/rategy & an accompany+ implem5tation   
plan t id5tifies & demon/rates !        
measurable /eps ! ,secret>y w c>ry out  

to--  7,a7 develop1 implem5t1 & evaluate
 ! network describ$ 9 p>agraph 7#a71    
utiliz+ ! elem5ts describ$ 9 p>agraph   
7#c72  7,b7 mod]nize & enhance          
biosurveillance activities2 &  7,c7     
improve in=mation %>+1 coord9ation1 &   
communication among disp>ate            
biosurveillance sy/ems support$ by !    
,dep>tm5t ( ,heal? & ,human ,s]vices4  2
  7,d7 9 p>agraph 7#c77;,d71 by ins]t+  
community heal? c5t]s1 heal? c5t]s aft] 
poison control12  7,e7 9 p>agraph 7#e71 
by /rik+ subp>agraph 7,a7 & ins]t+ !    
foll[+3  7,a7 utilize applicable        
int]op]ability /&>ds z det]m9$ by !     
,secret>y1 & 9 consultation ) ! ,(fice (
 ! ,national ,coord9ator = ,heal?       
,in=mation ,te*nology1 ?r\gh a jo9t     
public & private sector process2  2 &   
7,f7 by add+ at ! end ! foll[+3  7#f7   
,consultation ) ! ,national ,biodef5se  
,sci5ce ,bo>d ,9 c>ry+ out ?is section &
 consi/5t ) section #cai,m1 ! ,national 
,biodef5se ,sci5ce ,bo>d %all provide   
exp]t advice & guidance1 includ+        

recomm5dations1 reg>d+ ! measurable /eps
 ! ,secret>y %\ld take to mod]nize &    
enhance biosurveillance activities      
pursuant to ! ef=ts ( ! ,dep>tm5t (     
,heal? & ,human ,s]vices to ensure      
compreh5sive1 real-"t1 all-haz>ds       
biosurveillance capabilities4 ,9 comply+
 ) ! prec$+ s5t5ce1 ! ,national         
,biodef5se ,sci5ce ,bo>d %all--  7,a7   
id5tify ! /eps necess>y to a*ieve a     
national biosurveillance sy/em = human  
heal?1 ) int]national connectivity1 :]e 
appropriate1 t is pr$icat$ on ,/ate1    
regional1 & community level capabilities
 & creates a network$ sy/em to all[ =   
two-way in=mation fl[ betwe5 & among    
,f$]al1 ,/ate1 & local gov]nm5t public  
heal? au?orities & cl9ical heal? c>e    
provid]s2  7,b7 id5tify any duplicative 
surveillance programs "u ! au?ority ( ! 
,secret>y1 or *anges t are necess>y to  
exi/+ programs1 9 ord] to enhance &     
mod]nize su* activities1 m9imize        
duplication1 /r5g!n & /reaml9e su*      
activities "u ! au?ority ( ! ,secret>y1 

& a*ieve real-"t & appropriate data t   
relate to disease activity1 bo? human & 
zoonotic2 &  7,c7 coord9ate ) applicable
 exi/+ advisory committees ( ! ,director
 ( ! ,c5t]s = ,disease ,control &       
,prev5tion1 includ+ su* advisory        
committees consi/+ ( repres5tatives f   
,/ate1 local1 & tribal public heal?     
au?orities & appropriate public &       
private sector heal? c>e entities &     
academic in/itutions1 9 ord] to provide 
guidance on public heal? surveillance   
activities4  2  7#d7 9 subsection       
7e77#e71 by /rik+ #d ye>s aft] ! date ( 
enactm5t ( ! ,p&emic & ,all-,haz>ds     
,prep>$ness ,act & ins]t+ #c ye>s aft] !
 date ( enactm5t ( ! ,p&emic &          
,all-,haz>ds ,prep>$ness ,reau?orization
 ,act ( #bjac2  7#e7 9 subsection 7g71  
by /rik+ su* sums z may be necess>y 9   
ea* ( fiscal ye>s #bjjg ?r\gh #bjaa &   
ins]t+ #ach1cjj1jjj = ea* ( fiscal ye>s 
#bjac ?r\gh #bjag2 &  7#f7 by add+ at ! 
end ! foll[+3  7h7 ,def9ition ,=        
purposes ( ?is section ! t]m            

biosurveillance means ! process ( ga!r+ 
ne> real-"t biological data t relates to
 human & zoonotic disease activity &    
?reats to human or animal heal?1 9 ord] 
to a*ieve e>ly w>n+ & id5tification (   
su* heal? ?reats1 e>ly detection &      
prompt ongo+ track+ ( heal? ev5ts1 &    
ov]all situational aw>5ess ( disease    
activity4  4  #bje4 ,elim9at+           
duplicative ,project ,bio%ield reports  
,section #e ( ! ,project ,bio%ield ,act 
( #bjjd 7#db ,u4,s4,c4 #bdg;d-#f;c7 is  
repeal$4  ,,iii ,enhanc+ ,m$ical        
,c\nt]measure ,review  #cja4 ,special   
protocol assessm5t ,section             
#eje7;b77#e77;,b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77#e77;,b77 is am5d$ by /rik+    
size ( cl9ical trials int5d$ & all t    
foll[s ?r\gh 4 ,! sponsor or applicant &
 ins]t+ ! foll[+3 8size--  7i7  7,i7 (  
cl9ical trials int5d$ to =m ! prim>y    
basis ( an effectiv5ess claim2 or       
7,,ii7 9 ! case :]e human efficacy      
/udies are n e?ical or feasible1 (      

animal & any associat$ cl9ical trials   
:i*1 9 comb9ation1 are int5d$ to =m !   
prim>y basis ( an effectiv5ess claim2 or
  7ii7 ) respect to an application =    
approval ( a biological product "u      
section #cea7k7 ( ! ,public ,heal?      
,s]vice ,act1 ( any necess>y cl9ical    
/udy or /udies4  ,! sponsor or applicant
 4  #cjb4 ,au?orization = m$ical        
products = use 9 em]g5cies  7a7 ,9 g5]al
 ,section #efd ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4         
#cfj;bbb-#c7 is am5d$--  7#a7 9         
subsection 7a7--  7,a7 9 p>agraph 7#a71 
by /rik+ sections #eje1 #eaj7k71 & #eae 
( ?is ,act & ins]t+ any provision ( ?is 
,act2  7,b7 9 p>agraph 7#b77;,a71 by    
/rik+ "u a provision ( law ref]r$ to 9  
su* p>agraph & ins]t+ "u section #eje1  
#eaj7k71 or #eae ( ?is ,act or section  
#cea ( ! ,public ,heal? ,s]vice ,act2 & 
7,c7 9 p>agraph 7#c71 by /rik+ a        
provision ( law ref]r$ to 9 su* p>agraph
 & ins]t+ a section ( ?is ,act or !     
,public ,heal? ,s]vice ,act ref]r$ to 9 

p>agraph 7#b77;,a72  7#b7 9 subsection  
7b7--  7,a7 9 ! subsection head+1 by    
/rik+ ,em]g5cy & ins]t+ ,em]g5cy or     
,?reat ,ju/ify+ ,em]g5cy ,au?oriz$ ,use2
  7,b7 9 p>agraph 7#a7--  7i7 9 ! matt] 
prec$+ subp>agraph 7,a71 by /rik+ may   
decl>e an em]g5cy & ins]t+ may make a   
decl>ation t ! circum/ances exi/2  7ii7 
9 subp>agraph 7,a71 by /rik+ specifi$2  
7iii7 9 subp>agraph 7,b7--  7,i7 by     
/rik+ specifi$2 &  7,,ii7 by /rik+ 2 or 
& ins]t+ a semicolon2  7iv7 by am5d+    
subp>agraph 7,c7 to read z foll[s3  7,c7
 a det]m9ation by ! ,secret>y t !re is a
 public heal? em]g5cy1 or a significant 
pot5tial = a public heal? em]g5cy1 t    
affects1 or has a significant pot5tial  
to affect1 national security or ! heal? 
& security ( ,unit$ ,/ates citiz5s liv+ 
abroad1 & t involves a biological1      
*emical1 radiological1 or nucle> ag5t or
 ag5ts1 or a disease or condition t may 
be attributable to su* ag5t or ag5ts2 or
  2 &  7v7 by add+ at ! end ! foll[+3   
7,d7 ! id5tification ( a mat]ial ?reat  

pursuant to section #cai;,f-#b ( !      
,public ,heal? ,s]vice ,act suffici5t to
 affect national security or ! heal? &  
security ( ,unit$ ,/ates citiz5s liv+   
abroad4  2  7,c7 9 p>agraph 7#b7--  7i7 
9 subp>agraph 7,a71 by am5d+ clause 7ii7
 to read z foll[s3  7ii7 a *ange 9 !    
approval /atus ( ! product su* t !      
circum/ances describ$ 9 subsection      
7a77#b7 h ceas$ to exi/4  2  7ii7 by    
/rik+ subp>agraph 7,b72 &  7iii7 by     
r$esignat+ subp>agraph 7,c7 z           
subp>agraph 7,b72  7,d7 9 p>agraph 7#d71
 by /rik+ advance notice ( t]m9ation1 & 
r5ewal "u ?is subsection4 & ins]t+ 1 &  
advance notice ( t]m9ation "u ?is       
subsection42 &  7,e7 by add+ at ! end ! 
foll[+3  7#e7 ,explanation by ,secret>y 
,if an au?orization "u ?is section )    
respect to an unapprov$ product or an   
unapprov$ use ( an approv$ product has  
be5 9 effect = m ?an #a ye>1 ! ,secret>y
 %all provide 9 writ+ to ! sponsor ( su*
 product an explanation ( ! sci5tific1  
regulatory1 or o!r ob/acles to approval1

 lic5sure1 or cle>ance ( su* product or 
use1 includ+ specific actions to be tak5
 by ! ,secret>y & ! sponsor to ov]come  
su* ob/acles4  2  7#c7 9 subsection     
7c7--  7,a7 9 ! matt] prec$+ p>agraph   
7#a7--  7i7 by ins]t+ ! ,assi/ant       
,secret>y = ,prep>$ness & ,response1    
aft] consultation )2  7ii7 by /rik+     
,heal? & & ins]t+ ,heal?1 &2 &  7iii7 by
 /rik+ circum/ances ( ! em]g5cy involv$ 
& ins]t+ applicable circum/ances        
describ$ 9 subsection 7b77#a72  7,b7 9  
p>agraph 7#a71 by /rik+ specifi$ &      
ins]t+ ref]r$ to2 &  7,c7 9 p>agraph    
7#b77;,b71 by ins]t+ 1 tak+ into        
consid]ation ! mat]ial ?reat pos$ by !  
ag5t or ag5ts id5tifi$ 9 a decl>ation "u
 subsection 7b77#a77;,d71 if applicable 
aft] risks ( ! product2  7#d7 9         
subsection 7d77#c71 by ins]t+ 1 to !    
ext5t practicable giv5 ! circum/ances ( 
! em]g5cy1 aft] includ+2  7#e7 9        
subsection 7e7--  7,a7 9 p>agraph       
7#a77;,a71 by /rik+ circum/ances ( !    
em]g5cy & ins]t+ applicable circum/ances

 describ$ 9 subsection 7b77#a72  7,b7 9 
p>agraph 7#a77;,b71 by am5d+ clause     
7iii7 to read z foll[s3  7iii7          
,appropriate conditions ) respect to    
collection & analysis ( in=mation       
conc]n+ ! safety & effectiv5ess ( !     
product ) respect to ! use ( su* product
 dur+ ! p]iod :5 ! au?orization is 9    
effect & a reasonable "t foll[+ su*     
p]iod4  2  7,c7 9 p>agraph 7#b7--  7i7 9
 subp>agraph 7,a7--  7,i7 by /rik+      
manufactur] ( ! product & ins]t+ p]son2 
7,,ii7 by /rik+ circum/ances ( ! em]g5cy
 & ins]t+ applicable circum/ances       
describ$ 9 subsection 7b77#a72 &        
7,,iii7 by ins]t+ at ! end be=e ! p]iod 
or 9 p>agraph 7#a77;,b72  7ii7 9        
subp>agraph 7,b77i71 by ins]t+ be=e !   
p]iod at ! end 1 except z provid$ 9     
section #efd;,a ) respect to au?oriz$   
*anges to ! product expiration date2 &  
7iii7 by am5d+ subp>agraph 7,c7 to read 
z foll[s3  7,c7 ,9 e/abli%+ conditions  
"u ?is p>agraph ) respect to !          
di/ribution & adm9i/ration ( ! product =

 ! unapprov$ use1 ! ,secret>y %all n    
impose conditions t w\ld re/rict        
di/ribution or adm9i/ration ( ! product 
:5 di/ribut$ or adm9i/]$ = ! approv$    
use4  2 &  7,d7 by am5d+ p>agraph 7#c7  
to read z foll[s3  7#c7 ,good           
manufactur+ practice2 prescription ,)   
respect to ! em]g5cy use ( a product =  
:i* an au?orization "u ?is section is   
issu$ 7:e!r an unapprov$ product or an  
unapprov$ use ( an approv$ product71 !  
,secret>y may waive or limit1 to ! ext5t
 appropriate giv5 ! applicable          
circum/ances describ$ 9 subsection      
7b77#a7--  7,a7 requirem5ts reg>d+      
curr5t good manufactur+ practice o!rwise
 applicable to ! manufacture1 process+1 
pack+1 or hold+ ( products subject to   
regulation "u ?is ,act1 includ+ su*     
requirem5ts e/abli%$ "u section #eja or 
#ebj7;f77#a71 & includ+ relevant        
conditions prescrib$ ) respect to !     
product by an ord] "u section           
#ebj7;f77#b72  7,b7 requirem5ts e/abli%$
 "u section #ejc7;b72 &  7,c7           

requirem5ts e/abli%$ "u section         
#ebj7;e74  2  7#f7 9 subsection 7g7--   
7,a7 9 ! subsection head+1 by ins]t+    
,review & be=e ,revocation2  7,b7 9     
p>agraph 7#a71 by ins]t+ aft] ! p]iod at
 ! end ! foll[+3 8,z "p ( su* review1 ! 
,secret>y %all regul>ly review !        
progress made ) respect to ! approval1  
lic5sure1 or cle>ance (--  7,a7 an      
unapprov$ product = :i* an au?orization 
0 issu$ "u ?is section2 or  7,b7 an     
unapprov$ use ( an approv$ product = :i*
 an au?orization 0 issu$ "u ?is section4
  2 &  7,c7 by am5d+ p>agraph 7#b7 to   
read z foll[s3  7#b7 ,revision &        
revocation ,! ,secret>y may revise or   
revoke an au?orization "u ?is section   
if--  7,a7 ! circum/ances describ$ "u   
subsection 7b77#a7 no long] exi/2  7,b7 
! crit]ia "u subsection 7c7 = issuance (
 su* au?orization are no long] met2 or  
7,c7 o!r circum/ances make su* revision 
or revocation appropriate to protect !  
public heal? or safety4  2  7#g7 9      
subsection 7h77#a71 by add+ aft] ! p]iod

 at ! end ! foll[+3 ,! ,secret>y %all   
make any revisions to an au?orization "u
 ?is section available on ! ,int]net    
,web site ( ! ,food & ,drug             
,adm9i/ration42  7#h7 by add+ at ! end (
 subsection 7j7 ! foll[+3  7#d7 ,no?+ 9 
?is section %all be con/ru$ z au?oriz+ a
 delay 9 ! review or o!r consid]ation by
 ! ,secret>y ( any application or       
submission p5d+ be=e ! ,food & ,drug    
,adm9i/ration = a product = :i* an      
au?orization "u ?is section is issu$4  2
 &  7#i7 by add+ at ! end ! foll[+3  7m7
 ,categorization ( laboratory te/s      
associat$ ) devices subject to          
au?orization  7#a7 ,9 g5]al ,9 issu+ an 
au?orization "u ?is section ) respect to
 a device1 ! ,secret>y may1 subject to !
 provisions ( ?is section1 det]m9e t a  
laboratory exam9ation or proc$ure       
associat$ ) su* device %all be deem$1 = 
purposes ( section #cec ( ! ,public     
,heal? ,s]vice ,act1 to be 9 a p>ticul> 
category ( exam9ations & proc$ures      
7includ+ ! category describ$ by         

subsection 7d77#c7 ( su* section7 if1   
bas$ on ! totality ( sci5tific evid5ce  
available to ! ,secret>y--  7,a7 su*    
categorization w\ld be b5eficial to     
protect+ ! public heal?2 &  7,b7 ! kn[n 
& pot5tial b5efits ( su* categorization 
"u ! circum/ances ( ! au?orization      
outweigh ! kn[n & pot5tial risks ( !    
categorization4  7#b7 ,conditions (     
det]m9ation ,! ,secret>y may e/abli%    
appropriate conditions on ! p]=mance ( !
 exam9ation or proc$ure pursuant to su* 
det]m9ation4  7#c7 ,effective p]iod ,a  
det]m9ation "u ?is subsection %all be   
effective = purposes ( section #cec ( ! 
,public ,heal? ,s]vice ,act not)/&+ any 
o!r provision ( t section dur+ !        
effective p]iod ( ! relevant decl>ation 
"u subsection 7b74  4  7b7 ,em]g5cy use 
( m$ical products ,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 #efd !    
foll[+3  #efd;,a4 ,em]g5cy use ( m$ical 
products  7a7 ,def9itions ,9 ?is        

section3  7#a7 ,eligible product ,! t]m 
eligible product means a product t--    
7,a7 is approv$ or cle>$ "u ?is *apt] or
 lic5s$ "u section #cea ( ! ,public     
,heal? ,s]vice ,act2  7,b7  7i7 is      
int5d$ = use to prev5t1 diagnose1 or    
treat a disease or condition involv+ a  
biological1 *emical1 radiological1 or   
nucle> ag5t or ag5ts2 or  7ii7 is int5d$
 = use to prev5t1 diagnose1 or treat a  
s]i\s or life-?reat5+ disease or        
condition caus$ by a product describ$ 9 
clause 7i72 &  7,c7 is int5d$ = use dur+
 ! circum/ances "u :i*--  7i7 a         
det]m9ation describ$ 9 subp>agraph 7,a71
 7,b71 or 7,c7 ( section #efd7;b77#a7   
has be5 made by ! ,secret>y ( ,homel&   
,security1 ! ,secret>y ( ,def5se1 or !  
,secret>y1 respectively2 or  7ii7 !     
id5tification ( a mat]ial ?reat describ$
 9 subp>agraph 7,d7 ( section           
#efd7;b77#a7 has be5 made pursuant to   
section #cai;,f-#b ( ! ,public ,heal?   
,s]vice ,act4  7#b7 ,product ,! t]m     
product means a drug1 device1 or        

biological product4  7b7 ,expiration    
dat+  7#a7 ,9 g5]al ,! ,secret>y may    
ext5d ! expiration date & au?orize !    
introduction or deliv]y = introduction  
into int]/ate comm]ce ( an eligible     
product aft] ! expiration date provid$  
by ! manufactur] if--  7,a7 ! expiration
 date ext5sion is int5d$ to support !   
,unit$ ,/ates ability to protect--  7i7 
! public heal?2 or  7ii7 milit>y        
prep>$ness & effectiv5ess2 &  7,b7 !    
expiration date ext5sion is support$ by 
an appropriate sci5tific evaluation t is
 conduct$ or accept$ by ! ,secret>y4    
7#b7 ,requirem5ts & conditions ,any     
ext5sion ( an expiration date "u        
p>agraph 7#a7 %all1 z "p ( ! ext5sion1  
id5tify--  7,a7 ea* specific lot1 bat*1 
or o!r unit ( ! product = :i* ext5d$    
expiration is au?oriz$2  7,b7 ! duration
 ( ! ext5sion2 &  7,c7 any o!r          
requirem5ts or conditions z ! ,secret>y 
may deem appropriate = ! protection ( ! 
public heal?1 :i* may include           
requirem5ts =1 or conditions on1 product

 sampl+1 /orage1 packag+ or repackag+1  
transport1 label+1 notice to product    
recipi5ts1 recordkeep+1 p]iodic te/+ or 
rete/+1 or product disposition4  7#c7   
,effect ,not)/&+ any o!r provision ( ?is
 ,act or ! ,public ,heal? ,s]vice ,act1 
an eligible product %all n be consid]$  
an unapprov$ product 7z def9$ 9 section 
#efd7;a77#b77;,a77 & %all n be deem$    
adult]at$ or misbr&$ "u ?is ,act        
because1 ) respect to su* product1 !    
,secret>y has1 "u p>agraph 7#a71 ext5d$ 
! expiration date & au?oriz$ !          
introduction or deliv]y = introduction  
into int]/ate comm]ce ( su* product aft]
 ! expiration date provid$ by !         
manufactur]4  7#d7 ,expiration date ,=  
purposes ( ?is subsection1 ! t]m        
expiration date means ! date e/abli%$   
?r\gh appropriate /ability te/+ requir$ 
by ! regulations issu$ by ! ,secret>y to
 ensure t ! product meets applicable    
/&>ds ( id5tity1 /r5g?1 quality1 &      
purity at ! "t ( use4  7c7 ,curr5t good 
manufactur+ practice  7#a7 ,9 g5]al ,!  

,secret>y may1 :5 ! circum/ances ( a    
dome/ic1 milit>y1 or public heal?       
em]g5cy or mat]ial ?reat describ$ 9     
subsection 7a77#a77;,c7 s w>rant1       
au?orize1 ) respect to an eligible      
product1 deviations f curr5t good       
manufactur+ practice requirem5ts o!rwise
 applicable to ! manufacture1 process+1 
pack+1 or hold+ ( products subject to   
regulation "u ?is ,act1 includ+         
requirem5ts "u section #eja or          
#ebj7;f77#a7 or applicable conditions   
prescrib$ ) respect to ! eligible       
product by an ord] "u section           
#ebj7;f77#b74  7#b7 ,effect ,not)/&+ any
 o!r provision ( ?is ,act or ! ,public  
,heal? ,s]vice ,act1 an eligible product
 %all n be consid]$ an unapprov$ product
 7z def9$ 9 section #efd7;a77#b77;,a77 &
 %all n be deem$ adult]at$ or misbr&$ "u
 ?is ,act because1 ) respect to su*     
product1 ! ,secret>y has au?oriz$       
deviations f curr5t good manufactur+    
practices "u p>agraph 7#a74  7d7        
,em]g5cy disp5s+ ,! requirem5ts (       

sections #ejc7;b7 & #ebj7;e7 %all n     
apply to an eligible product1 & !       
product %all n be consid]$ an unapprov$ 
product 7z def9$ 9 section              
#efd7;a77#b77;,a77 & %all n be deem$    
adult]at$ or misbr&$ "u ?is ,act because
 x is disp5s$ )\t an individual         
prescription1 if--  7#a7 ! product is   
disp5s$ dur+ ! circum/ances describ$ 9  
subsection 7a77#a77;,c72 &  7#b7 su*    
disp5s+ )\t an individual prescription  
occurs--  7,a7 z p]mitt$ "u ! law ( !   
,/ate 9 :i* ! product is disp5s$2 or    
7,b7 9 accordance ) an ord] issu$ by !  
,secret>y1 = ! purposes & duration ( !  
circum/ances describ$ 9 subsection      
7a77#a77;,c74  7e7 ,em]g5cy use         
in/ructions  7#a7 ,9 g5]al ,! ,secret>y1
 act+ ?r\gh an appropriate (ficial )9 ! 
,dep>tm5t ( ,heal? & ,human ,s]vices1   
may create & issue em]g5cy use          
in/ructions to in=m heal? c>e provid]s  
or individuals to :om an eligible       
product is to be adm9i/]$ conc]n+ su*   
product's approv$1 lic5s$1 or cle>$     

conditions ( use4  7#b7 ,effect ,not)/&+
 any o!r provisions ( ?is ,act or !     
,public ,heal? ,s]vice ,act1 a product  
%all n be consid]$ an unapprov$ product 
& %all n be deem$ adult]at$ or misbr&$  
"u ?is ,act because ( ! issuance (      
em]g5cy use in/ructions "u p>agraph 7#a7
 ) respect to su* product or !          
introduction or deliv]y = introduction (
 su* product into int]/ate comm]ce      
accompani$ by su* in/ructions--  7,a7   
dur+ an em]g5cy response to an actual   
em]g5cy t is ! basis = a det]m9ation    
describ$ 9 subsection 7a77#a77;,c77i72  
or  7,b7 by a gov]nm5t entity 7includ+ a
 ,f$]al1 ,/ate1 local1 or tribal        
gov]nm5t entity71 or a p]son act+ on    
behalf ( su* a gov]nm5t entity1 9       
prep>ation = an em]g5cy response4  4    
7c7 ,risk evaluation & mitigation       
/rategies ,section #eje-a ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee-a71 is am5d$--  7#a7 9   
subsection 7f71 by /rik+ p>agraph 7#g72 
&  7#b7 by add+ at ! end ! foll[+3  7k7 

,waiv] 9 public heal? em]g5cies ,!      
,secret>y may waive any requirem5t ( ?is
 section ) respect to a qualifi$        
c\nt]measure 7z def9$ 9 section         
#cai;,f-#a7;a77#b7 ( ! ,public ,heal?   
,s]vice ,act7 to :i* a requirem5t "u ?is
 section has be5 appli$1 if ! ,secret>y 
det]m9es t su* waiv] is requir$ to      
mitigate ! effects (1 or r$uce ! sev]ity
 (1 ! circum/ances "u :i*--  7#a7 a     
det]m9ation describ$ 9 subp>agraph 7,a71
 7,b71 or 7,c7 ( section #efd7;b77#a7   
has be5 made by ! ,secret>y ( ,homel&   
,security1 ! ,secret>y ( ,def5se1 or !  
,secret>y1 respectively2 or  7#b7 !     
id5tification ( a mat]ial ?reat describ$
 9 subp>agraph 7,d7 ( section           
#efd7;b77#a7 has be5 made pursuant to   
section #cai;,f-#b ( ! ,public ,heal?   
,s]vice ,act4  4  7d7 ,products held =  
em]g5cy use ,! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq47 is am5d$ by ins]t+ aft] section   
#efd;,a1 z add$ by subsection 7b71 !    
foll[+3  #efd;,b4 ,products held =      

em]g5cy use ,x is n a violation ( any   
section ( ?is ,act or ( ! ,public ,heal?
 ,s]vice ,act = a gov]nm5t entity       
7includ+ a ,f$]al1 ,/ate1 local1 or     
tribal gov]nm5t entity71 or a p]son act+
 on behalf ( su* a gov]nm5t entity1 to  
introduce into int]/ate comm]ce a       
product 7z def9$ 9 section #efd7;a77#d77
 int5d$ = em]g5cy use1 if t product--   
7#a7 is int5d$ to be held & n us$2 &    
7#b7 is held & n us$1 unless & until t  
product--  7,a7 is approv$1 cle>$1 or   
lic5s$ "u section #eje1 #eaj7k71 or #eae
 ( ?is ,act or section #cea ( ! ,public 
,heal? ,s]vice ,act2  7,b7 is au?oriz$ =
 inve/igational use "u section #eje or  
#ebj ( ?is ,act or section #cea ( !     
,public ,heal? ,s]vice ,act2 or  7,c7 is
 au?oriz$ = use "u section #efd4  4     
#cjc4 ,def9itions ,section #efe ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb-#d7 is am5d$ by 
/rik+ ,! ,secret>y1 9 consultation &    
ins]t+ ! foll[+3  7a7 ,def9itions ,9 ?is
 section--  7#a7 ! t]m c\nt]measure     

means a qualifi$ c\nt]measure1 a        
security c\nt]measure1 & a qualifi$     
p&emic or epidemic product2  7#b7 ! t]m 
qualifi$ c\nt]measure has ! mean+ giv5  
su* t]m 9 section #cai;,f-#a ( ! ,public
 ,heal? ,s]vice ,act2  7#c7 ! t]m       
security c\nt]measure has ! mean+ giv5  
su* t]m 9 section #cai;,f-#b ( su* ,act2
 &  7#d7 ! t]m qualifi$ p&emic or       
epidemic product means a product t meets
 ! def9ition giv5 su* t]m 9 section     
#cai;,f-#c ( ! ,public ,heal? ,s]vice   
,act &--  7,a7 t has be5 id5tifi$ by !  
,dep>tm5t ( ,heal? & ,human ,s]vices or 
! ,dep>tm5t ( ,def5se z receiv+ fund+   
directly relat$ to address+ *emical1    
biological1 radiological1 or nucle>     
?reats1 includ+ p&emic influ5za2 or     
7,b7 is includ$ "u ?is p>agraph pursuant
 to a det]m9ation by ! ,secret>y4  7b7  
,g5]al duties ,! ,secret>y1 9           
consultation  4  #cjd4 ,enhanc+ m$ical  
c\nt]measure activities ,section #efe ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfj;bbb-#d71 z am5d$ by 

section #cjc1 is fur!r am5d$--  7#a7 9 !
 section head+1 by /rik+ ,te*nical      
,assi/ance & ins]t+ ,c\nt]measure       
,developm5t1 ,review1 & ,te*nical       
,assi/ance2  7#b7 9 subsection 7b71 by  
/rik+ ! subsection enum]ator & all t    
foll[s ?r\gh %all e/abli% & ins]t+ !    
foll[+3  7b7 ,g5]al duties ,9 ord] to   
accel]ate ! developm5t1 /ockpil+1       
approval1 lic5sure1 & cle>ance (        
qualifi$ c\nt]measures1 security        
c\nt]measures1 & qualifi$ p&emic or     
epidemic products1 ! ,secret>y1 9       
consultation ) ! ,assi/ant ,secret>y =  
,prep>$ness & ,response1 %all--  7#a7   
ensure ! appropriate involvem5t ( ,food 
& ,drug ,adm9i/ration p]sonnel 9        
int]ag5cy activities relat$ to          
c\nt]measure advanc$ rese>* &           
developm5t1 consi/5t ) sections #cai;,f1
 #cai;,f-#a1 #cai;,f-#b1 #cai;,f-#c1    
#cai,l1 & #bhaa ( ! ,public ,heal?      
,s]vice ,act2  7#b7 ensure ! appropriate
 involvem5t & consultation ( ,food &    
,drug ,adm9i/ration p]sonnel 9 any      

flexible manufactur+ activities c>ri$   
out "u section #cai,l ( ! ,public ,heal?
 ,s]vice ,act1 includ+ ) respect to     
meet+ regulatory requirem5ts set =? 9   
?is ,act2  7#c7 promote c\nt]measure    
exp]tise )9 ! ,food & ,drug             
,adm9i/ration by--  7,a7 ensur+ t ,food 
& ,drug ,adm9i/ration p]sonnel involv$ 9
 review+ c\nt]measures = approval1      
lic5sure1 or cle>ance are in=m$ by !    
,assi/ant ,secret>y = ,prep>$ness &     
,response on ! mat]ial ?reat assessm5t  
conduct$ "u section #cai;,f-#b ( !      
,public ,heal? ,s]vice ,act = ! ag5t or 
ag5ts = :i* ! c\nt]measure "u review is 
int5d$2  7,b7 tra9+ ,food & ,drug       
,adm9i/ration p]sonnel reg>d+ review (  
c\nt]measures = approval1 lic5sure1 or  
cle>ance2  7,c7 hold+ public meet+s at  
lea/ twice annually to enc\rage !       
ex*ange ( sci5tific ideas2 &  7,d7      
e/abli%+ protocols to ensure t          
c\nt]measure review]s h suffici5t tra9+ 
or exp]i5ce ) c\nt]measures2  7#d7      
ma9ta9 teams1 compos$ ( ,food & ,drug   

,adm9i/ration p]sonnel ) exp]tise on    
c\nt]measures1 includ+ specific         
c\nt]measures1 populations ) special    
cl9ical ne$s 7includ+ *ildr5 & pregnant 
wom5 t may use c\nt]measures1 z         
applicable & appropriate71 classes or   
gr\ps ( c\nt]measures1 or o!r           
c\nt]measure-relat$ te*nologies &       
capabilities1 t %all--  7,a7 consult )  
c\nt]measure exp]ts1 includ+            
c\nt]measure sponsors & applicants1 to  
id5tify & help resolve sci5tific issues 
relat$ to ! approval1 lic5sure1 or      
cle>ance ( c\nt]measures1 ?r\gh work%ops
 or public meet+s2 &  7,b7 improve &    
advance ! sci5ce relat+ to ! developm5t 
( new tools1 /&>ds1 & approa*es to      
assess+ & evaluat+ c\nt]measures--  7i7 
9 ord] to in=m ! process = c\nt]measure 
approval1 cle>ance1 & lic5sure2 &  7ii7 
) respect to ! developm5t (             
c\nt]measures = populations ) special   
cl9ical ne$s1 includ+ *ildr5 & pregnant 
wom51 9 ord] to meet ! ne$s ( su*       
populations1 z necess>y & appropriate2 &

  7#e7 e/abli%  2 &  7#c7 by add+ at !  
end ! foll[+3  7c7 ,f9al ,guidance on   
developm5t ( animal models  7#a7 ,9     
g5]al ,n lat] ?an #a ye> aft] ! date ( !
 enactm5t ( ! ,p&emic & ,all-,haz>ds    
,prep>$ness ,reau?orization ,act (      
#bjac1 ! ,secret>y %all provide f9al    
guidance to indu/ry reg>d+ ! developm5t 
( animal models to support approval1    
cle>ance1 or lic5sure ( c\nt]measures   
ref]r$ to 9 subsection 7a7 :5 human     
efficacy /udies are n e?ical or         
feasible4  7#b7 ,au?ority to ext5d      
deadl9e ,! ,secret>y may ext5d ! deadl9e
 = provid+ f9al guidance "u p>agraph    
7#a7 by n m ?an #f mon?s ^u submission  
by ! ,secret>y ( a report on ! /atus (  
su* guidance to ! ,committee on ,en]gy &
 ,comm]ce ( ! ,h\se ( ,repres5tatives & 
! ,committee on ,heal?1 ,education1     
,labor1 & ,p5sions ( ! ,s5ate4  7d7     
,developm5t & animal model+ proc$ures   
7#a7 ,availability ( animal model meet+s
 ,to facilitate ! timely developm5t (   
animal models & support ! developm5t1   

/ockpil+1 lic5sure1 approval1 & cle>ance
 ( c\nt]measures1 ! ,secret>y %all1 n   
lat] ?an #ahj days aft] ! enactm5t ( ?is
 subsection1 e/abli% a proc$ure by :i* a
 sponsor or applicant t is develop+ a   
c\nt]measure = :i* human efficacy /udies
 are n e?ical or practicable1 & t has an
 approv$ inve/igational new drug        
application or inve/igational device    
exemption1 may reque/ & receive--  7,a7 
a meet+ to discuss propos$ animal model 
developm5t activities2 &  7,b7 a meet+  
prior to initiat+ pivotal animal /udies4
  7#b7 ,p$iatric models ,to facilitate !
 developm5t & selection ( animal models 
t c\ld translate to p$iatric /udies1 any
 meet+ conduct$ "u p>agraph 7#a7 %all   
include discussion ( animal models =    
p$iatric populations1 z appropriate4    
7e7 ,review & approval ( c\nt]measures  
7#a7 ,mat]ial ?reat ,:5 evaluat+ an     
application or submission = approval1   
lic5sure1 or cle>ance ( a c\nt]measure1 
! ,secret>y %all take into acc\nt !     
mat]ial ?reat pos$ by ! *emical1        

biological1 radiological1 or nucle> ag5t
 or ag5ts id5tifi$ "u section #cai;,f-#b
 ( ! ,public ,heal? ,s]vice ,act = :i* !
 c\nt]measure "u review is int5d$4  7#b7
 ,review exp]tise ,:5 practicable &     
appropriate1 teams ( ,food & ,drug      
,adm9i/ration p]sonnel review+          
applications or submissions describ$ "u 
p>agraph 7#a7 %all include a review] )  
suffici5t tra9+ or exp]i5ce )           
c\nt]measures pursuant to ! protocols   
e/abli%$ "u subsection 7b77#c77;,d74  4 
#cje4 ,regulatory managem5t plans       
,section #efe ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4          
#cfj;bbb-#d71 z am5d$ by section #cjd1  
is fur!r am5d$ by add+ at ! end !       
foll[+3  7f7 ,regulatory managem5t plan 
7#a7 ,def9ition ,9 ?is subsection1 ! t]m
 eligible c\nt]measure means--  7,a7 a  
security c\nt]measure ) respect to :i* !
 ,secret>y has ent]$ into a procurem5t  
contract "u section #cai;,f-#b7;c7 ( !  
,public ,heal? ,s]vice ,act2 or  7,b7 a 
c\nt]measure ) respect to :i* !         

,biom$ical ,advanc$ ,rese>* &           
,developm5t ,au?ority has provid$ fund+ 
"u section #cai,l ( ! ,public ,heal?    
,s]vice ,act = advanc$ rese>* &         
developm5t4  7#b7 ,regulatory managem5t 
plan process ,! ,secret>y1 9            
consultation ) ! ,assi/ant ,secret>y =  
,prep>$ness & ,response & ! ,director ( 
! ,biom$ical ,advanc$ ,rese>* &         
,developm5t ,au?ority1 %all e/abli% a   
=mal process = obta9+ sci5tific fe$back 
& int]actions reg>d+ ! developm5t &     
regulatory review ( eligible            
c\nt]measures by facilitat+ ! developm5t
 ( writt5 regulatory managem5t plans 9  
accordance ) ?is subsection4  7#c7      
,submission ( reque/ & propos$ plan by  
sponsor or applicant  7,a7 ,9 g5]al ,a  
sponsor or applicant ( an eligible      
c\nt]measure may initiate ! process     
describ$ "u p>agraph 7#b7 ^u submission 
( a writt5 reque/ to ! ,secret>y4 ,su*  
reque/ %all include a propos$ regulatory
 managem5t plan4  7,b7 ,tim+ (          
submission ,a sponsor or applicant may  

submit a writt5 reque/ "u subp>agraph   
7,a7 aft] ! eligible c\nt]measure has an
 inve/igational new drug or             
inve/igational device exemption 9       
effect4  7,c7 ,response by ,secret>y ,! 
,secret>y %all direct ! ,food & ,drug   
,adm9i/ration1 ^u submission ( a writt5 
reque/ by a sponsor or applicant "u     
subp>agraph 7,a71 to "w ) ! sponsor or  
applicant to agree on a regulatory      
managem5t plan )9 a reasonable "t n to  
exce$ #ij days4 ,if ! ,secret>y det]m9es
 t no plan c be agre$ ^u1 ! ,secret>y   
%all provide to ! sponsor or applicant1 
9 writ+1 ! sci5tific or regulatory      
rationale :y su* agreem5t _c be rea*$4  
7#d7 ,plan ,! cont5t ( a regulatory     
managem5t plan agre$ to by ! ,secret>y &
 a sponsor or applicant %all include--  
7,a7 an agreem5t betwe5 ! ,secret>y & ! 
sponsor or applicant reg>d+ developm5tal
 mile/ones t w trigg] responses by !    
,secret>y z describ$ 9 subp>agraph 7,b72
  7,b7 p]=mance t>gets & goals = timely 
& appropriate responses by ! ,secret>y  

to ! trigg]s describ$ "u subp>agraph    
7,a71 includ+ meet+s betwe5 ! ,secret>y 
& ! sponsor or applicant1 writt5        
fe$back1 decisions by ! ,secret>y1 & o!r
 activities c>ri$ out z "p ( !          
developm5t & review process2 &  7,c7 an 
agreem5t on h[ ! plan %all be modifi$1  
if ne$$4  7#e7 ,mile/ones & p]=mance    
t>gets ,! developm5tal mile/ones        
describ$ 9 p>agraph 7#d77;,a7 & !       
p]=mance t>gets & goals describ$ 9      
p>agraph 7#d77;,b7 %all include--  7,a7 
fe$back f ! ,secret>y reg>d+ ! data     
requir$ to support ! approval1 cle>ance1
 or lic5sure ( ! eligible c\nt]measure  
involv$2  7,b7 fe$back f ! ,secret>y    
reg>d+ ! data necess>y to in=m any      
au?orization "u section #efd2  7,c7     
fe$back f ! ,secret>y reg>d+ ! data     
necess>y to support ! position+ &       
deliv]y ( ! eligible c\nt]measure1      
includ+ to ! ,/rategic ,national        
,/ockpile2  7,d7 fe$back f ! ,secret>y  
reg>d+ ! data necess>y to support !     
submission ( protocols = review "u      

section #eje7;b77#e77;,b72  7,e7 fe$back
 f ! ,secret>y reg>d+ any gaps 9        
sci5tific k t w ne$ resolution prior to 
approval1 lic5sure1 or cle>ance ( !     
eligible c\nt]measure & plans = conduct+
 ! necess>y sci5tific rese>*2  7,f7     
id5tification ( ! population = :i* !    
c\nt]measure sponsor or applicant seeks 
approval1 lic5sure1 or cle>ance & !     
population = :i* desir$ label+ w\ld n be
 appropriate1 if kn[n2 &  7,g7 z        
necess>y & appropriate1 & to ! ext5t    
practicable1 a plan = demon/rat+ safety 
& effectiv5ess 9 p$iatric populations1 &
 = develop+ p$iatric dos+1 =mulation1 & 
adm9i/ration ) respect to ! eligible    
c\nt]measure1 provid$ t su* plan w\ld n 
delay au?orization "u section #efd1     
approval1 lic5sure1 or cle>ance =       
adults4  7#f7 ,prioritization  7,a7     
,plans = security c\nt]measures ,!      
,secret>y %all e/abli% regulatory       
managem5t plans = all security          
c\nt]measures = :i* a reque/ is submitt$
 "u p>agraph 7#c77;,a74  7,b7 ,plans =  

o!r eligible c\nt]measures ,! ,secret>y 
%all det]m9e :e!r res\rces are available
 to e/abli% regulatory managem5t plans =
 eligible c\nt]measures t are n security
 c\nt]measures4 ,if res\rces are        
available to e/abli% regulatory         
managem5t plans = eligible c\nt]measures
 t are n security c\nt]measures1 & if   
res\rces are n available to e/abli%     
regulatory managem5t plans = all        
eligible c\nt]measures = :i* reque/s h  
be5 submitt$1 ! ,director ( ! ,biom$ical
 ,advanc$ ,rese>* & ,developm5t         
,au?ority1 9 consultation ) !           
,commission]1 %all prioritize :i*       
eligible c\nt]measures may receive      
regulatory managem5t plans4  4  #cjf4   
,report ,section #efe ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;bbb-#d71 z am5d$ by section #cje1  
is fur!r am5d$ by add+ at ! end !       
foll[+3  7g7 ,annual report ,n lat] ?an 
#ahj days aft] ! date ( enactm5t ( ?is  
subsection1 & annually !reaft]1 !       
,secret>y %all make publicly available  

on ! ,web site ( ! ,food & ,drug        
,adm9i/ration a report t details !      
c\nt]measure developm5t & review        
activities ( ! ,food & ,drug            
,adm9i/ration1 includ+--  7#a7 ) respect
 to ! developm5t ( new tools1 /&>ds1 &  
approa*es to assess & evaluate          
c\nt]measures--  7,a7 ! id5tification ( 
! priorities ( ! ,food & ,drug          
,adm9i/ration & ! progress made on su*  
priorities2 &  7,b7 ! id5tification (   
sci5tific gaps t imp$e ! developm5t1    
approval1 lic5sure1 or cle>ance (       
c\nt]measures = populations ) special   
cl9ical ne$s1 includ+ *ildr5 & pregnant 
wom51 & ! progress made on resolv+ ^!   
*all5ges2  7#b7 ) respect to            
c\nt]measures = :i* a regulatory        
managem5t plan has be5 agre$ ^u "u      
subsection 7f71 ! ext5t to :i* !        
p]=mance t>gets & goals set =? 9        
subsection 7f77#d77;,b7 & ! regulatory  
managem5t plan h be5 met1 includ+1 = ea*
 su* c\nt]measure--  7,a7 :e!r !        
regulatory managem5t plan 0 complet$ )9 

! requir$ timeframe1 & ! l5g? ( "t tak5 
to complete su* plan2  7,b7 :e!r !      
,secret>y adh]$ to ! timely &           
appropriate response times set =? 9 su* 
plan2 &  7,c7 explanations = any failure
 to meet su* p]=mance t>gets & goals2   
7#c7 ! numb] ( regulatory teams e/abli%$
 pursuant to subsection 7b77#d71 ! numb]
 ( products1 classes ( products1 or     
te*nologies assign$ to ea* su* team1 & !
 numb] (1 type (1 & any progress made z 
a result ( consultations c>ri$ out "u   
subsection 7b77#d77;,a72  7#d7 an       
e/imate ( res\rces obligat$ to          
c\nt]measure developm5t & regulatory    
assessm5t1 includ+--  7,a7              
,c5t]-specific objectives &             
accompli%m5ts2 &  7,b7 ! numb] ( full-"t
 equival5t employees ( ! ,food & ,drug  
,adm9i/ration :o directly support !     
review ( c\nt]measures2  7#e7 ! numb] ( 
c\nt]measure applications & submissions 
submitt$1 ! numb] ( c\nt]measures       
approv$1 lic5s$1 or cle>$1 ! /atus (    
rema9+ submitt$ applications &          

submissions1 & ! numb] ( ea* type (     
au?orization issu$ pursuant to section  
#efd2  7#f7 ! numb] ( writt5 reque/s = a
 regulatory managem5t plan submitt$ "u  
subsection 7f77#c77;,a71 ! numb] (      
regulatory managem5t plans develop$1 & !
 numb] ( su* plans develop$ = security  
c\nt]measures2 &  7#g7 ! numb]1 type1 & 
frequ5cy ( meet+s betwe5 ! ,food & ,drug
 ,adm9i/ration &--  7,a7 sponsors ( a   
c\nt]measure z def9$ 9 subsection 7a72  
or  7,b7 ano!r ag5cy engag$ 9 developm5t
 or managem5t ( portfolios = su*        
c\nt]measures1 includ+ ! ,c5t]s =       
,disease ,control & ,prev5tion1 !       
,biom$ical ,advanc$ ,rese>* &           
,developm5t ,au?ority1 ! ,national      
,in/itutes ( ,heal?1 & ! appropriate    
ag5cies ( ! ,dep>tm5t ( ,def5se4  4     
#cjg4 ,p$iatric m$ical c\nt]measures    
7a7 ,p$iatric /udies ( drugs ,section   
#eje;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 is
 am5d$--  7#a7 9 subsection 7d71 by add+
 at ! end ! foll[+3  7#e7 ,consultation 

,) respect to a drug t is a qualifi$    
c\nt]measure 7z def9$ 9 section         
#cai;,f-#a ( ! ,public ,heal? ,s]vice   
,act71 a security c\nt]measure 7z def9$ 
9 section #cai;,f-#b ( ! ,public ,heal? 
,s]vice ,act71 or a qualifi$ p&emic or  
epidemic product 7z def9$ 9 section     
#cai;,f-#c ( ! ,public ,heal? ,s]vice   
,act71 ! ,secret>y %all solicit input f 
! ,assi/ant ,secret>y = ,prep>$ness &   
,response reg>d+ ! ne$ = &1 f !         
,director ( ! ,biom$ical ,advanc$       
,rese>* & ,developm5t ,au?ority reg>d+ !
 conduct (1 p$iatric /udies "u ?is      
section4  2 &  7#b7 9 subsection        
7n77#a71 by add+ at ! end ! foll[+3     
7,c7 ,= a drug t is a qualifi$          
c\nt]measure 7z def9$ 9 section         
#cai;,f-#a ( ! ,public ,heal? ,s]vice   
,act71 a security c\nt]measure 7z def9$ 
9 section #cai;,f-#b ( ! ,public ,heal? 
,s]vice ,act71 or a qualifi$ p&emic or  
epidemic product 7z def9$ 9 section     
#cai;,f-#c ( su* ,act71 9 addition to   
any action ) respect to su* drug "u     

subp>agraph 7,a7 or 7,b71 ! ,secret>y   
%all notify ! ,assi/ant ,secret>y =     
,prep>$ness & ,response & ! ,director ( 
! ,biom$ical ,advanc$ ,rese>* &         
,developm5t ,au?ority ( all p$iatric    
/udies 9 ! writt5 reque/ issu$ by !     
,commission] ( ,food & ,drugs4  4  7b7  
,addition to priority li/ consid]ations 
,section #dji;,i ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bhdm7 is   
am5d$--  7#a7 by /rik+ subsection       
7a77#b7 & ins]t+ ! foll[+3  7#b7        
,consid]ation ( available in=mation ,9  
develop+ & prioritiz+ ! li/ "u p>agraph 
7#a71 ! ,secret>y--  7,a7 %all consid]--
  7i7 !rapeutic gaps 9 p$iatrics t may  
include developm5tal ph>macology1       
ph>macog5etic det]m9ants ( drug         
response1 metabolism ( drugs & biologics
 9 *ildr51 & p$iatric cl9ical trials2   
7ii7 p>ticul> p$iatric diseases1        
disord]s or conditions :]e m complete k 
& te/+ ( !rapeutics1 includ+ drugs &    
biologics1 may be b5eficial 9 p$iatric  
populations2 &  7iii7 ! adequacy (      

necess>y infra/ructure to conduct       
p$iatric ph>macological rese>*1 includ+ 
rese>* networks & tra9$ p$iatric        
inve/igators2 &  7,b7 may consid] !     
availability ( qualifi$ 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 to address ! ne$s ( p$iatric
 populations1 9 consultation ) !        
,assi/ant ,secret>y = ,prep>$ness &     
,response1 consi/5t ) ! purposes ( ?is  
section4  2 &  7#b7 9 subsection 7b71 by
 /rik+ subsection 7a7 & ins]t+ p>agraphs
 7#a7 & 7#b77;,a7 ( subsection 7a74  7c7
 ,advice & recomm5dations ( ! p$iatric  
advisory committee reg>d+ c\nt]measures 
= p$iatric populations ,subsection      
7b77#b7 ( section #ad ( ! ,be/          
,ph>maceuticals = ,*ildr5 ,act 7#db     
,u4,s4,c4 #bhdm note7 is am5d$--  7#a7 9
 subp>agraph 7,c71 by /rik+ ! p]iod &   
ins]t+ 2 &2 &  7#b7 by add+ at ! end !  
foll[+3  7,d7 ! developm5t (            

c\nt]measures 7z def9$ 9 section        
#efe7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act7 = p$iatric populations4 
4  ,,iv ,accel]at+ m$ical c\nt]measure  
advanc$ rese>* & developm5t  #dja4      
,bio,shield  7a7 ,procurem5t (          
c\nt]measures ,section #cai;,f-#b7;c7 ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bdg;d-#f;b7c77 is am5d$--    
7#a7 9 p>agraph 7#a77;,b77i77,,iii77bb71
 by /rik+ eight ye>s & ins]t+ #aj ye>s2 
7#b7 9 p>agraph 7#b77;,c71 by /rik+ !   
designat$ congressional committees 7z   
def9$ 9 p>agraph 7#aj77 & ins]t+ !      
appropriate committees ( ,congress2     
7#c7 9 p>agraph 7#e77;,b77ii71 by /rik+ 
eight ye>s & ins]t+ #aj ye>s2  7#d7 9   
subp>agraph 7,c7 ( p>agraph 7#f7--  7,a7
 9 ! subp>agraph head+1 by /rik+        
designat$ congressional committees &    
ins]t+ appropriate congressional        
committees2 &  7,b7 by /rik+ ! designat$
 congressional committees & ins]t+ !    
appropriate congressional committees2 & 
7#e7 9 p>agraph 7#g77;,c7--  7,a7 9     

clause 7i77,i71 by ins]t+ includ+       
advanc$ rese>* & developm5t1 aft] z may 
reasonably be requir$12  7,b7 9 clause  
7ii7--  7i7 9 subclause 7,,iii71 by     
/rik+ eight ye>s & ins]t+ #aj ye>s2 &   
7ii7 by /rik+ subclause 7,,ix7 & ins]t+ 
! foll[+3  7,,ix7 ,contract t]ms ,!     
,secret>y1 9 any contract = procurem5t  
"u ?is section--  7aa7 may specify--    
7,,aa7 ! dos+ & adm9i/ration requirem5ts
 = ! c\nt]measure to be develop$ &      
procur$2 7,,bb7 ! am\nt ( fund+ t w be  
d$icat$ by ! ,secret>y = advanc$ rese>*1
 developm5t1 & procurem5t ( !           
c\nt]measure2 & 7,,cc7 ! specifications 
! c\nt]measure mu/ meet to qualify =    
procurem5t "u a contract "u ?is section2
 &  7bb7 %all provide a cle> /atem5t (  
def9$ ,gov]nm5t purpose limit$ to uses  
relat$ to a security c\nt]measure1 z    
def9$ 9 p>agraph 7#a77;,b74  2 &  7,c7  
by add+ at ! end ! foll[+3  7viii7      
,flexibility ,9 c>ry+ out ?is section1 !
 ,secret>y may1 consi/5t ) ! applicable 
provisions ( ?is section1 ent] into     

contracts & o!r agreem5ts t are 9 ! be/ 
int]e/ ( ! ,gov]nm5t 9 meet+ id5tifi$   
security c\nt]measure ne$s1 includ+ )   
respect to reimbursem5t ( ! co/ (       
advanc$ rese>* & developm5t z a         
reasonable1 all[able1 & allocable direct
 co/ ( ! contract involv$4  4  7b7      
,reau?orization ( ! special res]ve fund 
,section #cai;,f-#b ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7
 is am5d$--  7#a7 9 subsection 7c7--    
7,a7 by /rik+ special res]ve fund "u    
p>agraph 7#aj7 ea* place x appe>s &     
ins]t+ special res]ve fund z def9$ 9    
subsection 7h72 &  7,b7 by /rik+        
p>agraphs 7#i7 & 7#aj72 &  7#b7 by add+ 
at ! end ! foll[+3  7g7 ,special res]ve 
fund  7#a7 ,au?orization (              
appropriations ,9 addition to am\nts    
appropriat$ to ! special res]ve fund    
prior to ! date ( ! enactm5t ( ?is      
subsection1 !re is au?oriz$ to be       
appropriat$1 = ! procurem5t ( security  
c\nt]measures "u subsection 7c7 & =     
c>ry+ out section #cai,l 7relat+ to !   

,biom$ical ,advanc$ ,rese>* &           
,developm5t ,au?ority71 #b1hjj1jjj1jjj =
 ! p]iod ( fiscal ye>s #bjad ?r\gh      
#bjah4 ,am\nts appropriat$ pursuant to !
 prec$+ s5t5ce are au?oriz$ to rema9    
available until ,septemb] #cj1 #bjai4   
7#b7 ,use ( special res]ve fund =       
advanc$ rese>* & developm5t ,! ,secret>y
 may utilize n m ?an #ej p]c5t ( !      
am\nts au?oriz$ to be appropriat$ "u    
p>agraph 7#a7 to c>ry out section #cai,l
 7relat$ to ! ,biom$ical ,advanc$       
,rese>* & ,developm5t ,au?ority74       
,am\nts au?oriz$ to be appropriat$ "u   
?is subsection to c>ry out section      
#cai,l are 9 addition to am\nts o!rwise 
au?oriz$ to be appropriat$ to c>ry out  
su* section4  7#c7 ,re/rictions on use (
 funds ,am\nts 9 ! special res]ve fund  
%all n be us$ to pay co/s o!r ?an       
paym5ts made by ! ,secret>y to a v5dor =
 advanc$ developm5t 7"u section #cai,l7 
or = procurem5t ( a security            
c\nt]measure "u subsection 7c77#g74     
7#d7 ,report ,n lat] ?an #cj days aft]  

any date on :i* ! ,secret>y det]m9es t !
 am\nt ( funds 9 ! special res]ve fund  
available = procurem5t is less ?an      
#a1ejj1jjj1jjj1 ! ,secret>y %all submit 
to ! appropriate committees ( ,congress 
a report detail+ ! am\nt ( su* funds    
available = procurem5t & ! impact su*   
r$uction 9 fund+ w h--  7,a7 9 meet+ !  
security c\nt]measure ne$s id5tifi$ "u  
?is section2 &  7,b7 on ! annual ,public
 ,heal? ,em]g5cy ,m$ical ,c\nt]measures 
,ent]prise & ,/rategy ,implem5tation    
,plan 7pursuant to section #bhaa7;d774  
7h7 ,def9itions ,9 ?is section3  7#a7 ,!
 t]m advanc$ rese>* & developm5t has !  
mean+ giv5 su* t]m 9 section #cai,l7a74 
7#b7 ,! t]m special res]ve fund means ! 
,biodef5se ,c\nt]measures appropriations
 acc\nt1 any appropriation made         
available pursuant to section #eba7;a7 (
 ! ,homel& ,security ,act ( #bjjb1 & any
 appropriation made available pursuant  
to subsection 7g77#a74  4  #djb4        
,biom$ical ,advanc$ ,rese>* &           
,developm5t ,au?ority  7a7 ,duties      

,section #cai,l7c77#d7 ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d-#g;e7c77#d77 is am5d$--  7#a7 9  
subp>agraph 7,b77iii71 by ins]t+ 7:i*   
may include advanc$ rese>* & developm5t 
= purposes ( fulfill+ requirem5ts "u !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act or
 section #cea ( ?is ,act7 aft]          
developm5t2 &  7#b7 9 subp>agraph       
7,d77iii71 by /rik+ & vacc9e manufactur+
 te*nologies & ins]t+ vacc9e-manufactur+
 te*nologies1 dose-sp>+ te*nologies1    
efficacy-increas+ te*nologies1 & plat=m 
te*nologies4  7b7 ,transaction          
au?orities ,section #cai,l7c77#e7 ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#g;e7c77#e77 is am5d$  
by add+ at ! end ! foll[+3  7,g7        
,gov]nm5t purpose ,9 aw>d+ contracts1   
grants1 & coop]ative agreem5ts "u ?is   
section1 ! ,secret>y %all provide a cle>
 /atem5t ( def9$ ,gov]nm5t purpose      
relat$ to activities includ$ 9          
subsection 7a77#f77;,b7 = a qualifi$    
c\nt]measure or qualifi$ p&emic or      

epidemic product4  4  7c7 ,fund         
,p>agraph 7#b7 ( section #cai,l7d7 ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#g;e7d77#b77 is am5d$  
to read z foll[s3  7#b7 ,fund+ ,to c>ry 
out ! purposes ( ?is section1 !re is    
au?oriz$ to be appropriat$ to ! ,fund   
#dae1jjj1jjj = ea* ( fiscal ye>s #bjac  
?r\gh #bjag1 su* am\nts to rema9        
available until exp5d$4  4  7d7 ,cont9u$
 ,inapplicability ( ,c]ta9 ,provisions  
,section #cai,l7e77#a77;,c7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d-#g;e7e77#a77;,c77 is am5d$ by    
/rik+ #g ye>s & ins]t+ #aa ye>s4  7e7   
,ext5sion ( limit$ antitru/ exemption   
7#a7 ,9 g5]al ,section #dje7;b7 ( !     
,p&emic & ,all-,haz>ds ,prep>$ness ,act 
7#db ,u4,s4,c4 #bdg;d-#f;a note7 is     
am5d$ by /rik+ #f-ye> & ins]t+ #aa-ye>4 
7#b7 ,effective date ,?is subsection    
%all take effect z if enact$ on ,decemb]
 #ag1 #bjab4  7f7 ,indep5d5t evaluation 
,section #cai,l ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7

 is am5d$ by add+ at ! end ! foll[+3    
7f7 ,indep5d5t evaluation  7#a7 ,9 g5]al
 ,n lat] ?an #ahj days aft] ! date (    
enactm5t ( ?is subsection1 ! ,comptroll]
 ,g5]al ( ! ,unit$ ,/ates %all conduct  
an indep5d5t evaluation ( ! activities  
c>ri$ out to facilitate flexible        
manufactur+ capacity pursuant to ?is    
section4  7#b7 ,report ,n lat] ?an #a   
ye> aft] ! date ( enactm5t ( ?is        
subsection1 ! ,comptroll] ,g5]al ( !    
,unit$ ,/ates %all submit to !          
appropriate committees ( ,congress a    
report conc]n+ ! results ( ! evaluation 
conduct$ "u p>agraph 7#a74 ,su* report  
%all review & assess--  7,a7 ! ext5t to 
:i* flexible manufactur+ capacity "u ?is
 section is d$icat$ to *emical1         
biological1 radiological1 & nucle>      
?reats2  7,b7 ! activities support$ by  
flexible manufactur+ initiatives2 &     
7,c7 ! ability ( flexible manufactur+   
activities c>ri$ out "u ?is section to--
  7i7 secure & lev]age lead+ te*nical   
exp]tise ) respect to c\nt]measure      

advanc$ rese>*1 developm5t1 &           
manufactur+ processes2 &  7ii7 meet !   
surge manufactur+ capacity ne$s pres5t$ 
by novel & em]g+ ?reats1 includ+        
*emical1 biological1 radiological1 &    
nucle> ag5ts4  4  7g7 ,def9itions  7#a7 
,qualifi$ c\nt]measure ,section         
#cai;,f-#a7;a77#b77;,a7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d-#f;a7a77#b77;,a77 is am5d$--     
7,a7 9 ! matt] prec$+ clause 7i71 by    
/rik+ to-- & ins]t+ --2  7,b7 9 clause  
7i7--  7i7 by /rik+ diagnose & ins]t+ to
 diagnose2 &  7ii7 by /rik+ 2 or &      
ins]t+ a semicolon2  7,c7 9 clause      
7ii7--  7i7 by /rik+ diagnose & ins]t+  
to diagnose2 &  7ii7 by /rik+ ! p]iod at
 ! end & ins]t+ 2 or2 &  7,d7 by add+ at
 ! end ! foll[+3  7iii7 is a product or 
te*nology int5d$ to enhance ! use or    
effect ( a drug1 biological product1 or 
device describ$ 9 clause 7i7 or 7ii74  4
  7#b7 ,qualifi$ p&emic or epidemic     
product ,section #cai;,f-#c7;i77#g77;,a7
 ( ! ,public ,heal? ,s]vice ,act 7#db   

,u4,s4,c4 #bdg;d-#f;d7i77#g77;,a77 is   
am5d$--  7,a7 9 clause 7i77,,ii71 by    
/rik+ 2 or & ins]t+ 22  7,b7 9 clause   
7ii71 by /rik+ 2 & & ins]t+ 2 or2 &     
7,c7 by add+ at ! end ! foll[+3  7iii7 a
 product or te*nology int5d$ to enhance 
! use or effect ( a drug1 biological    
product1 or device describ$ 9 clause 7i7
 or 7ii72 &  4  7#c7 ,te*nical am5dm5ts 
,section #cai;,f-#c7;i7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d-#f;d7i77 is am5d$--  7,a7 9      
p>agraph 7#a77;,c71 by ins]t+ 1 #efd;,a1
 or #efd;,b aft] #efd2 &  7,b7 9        
p>agraph 7#g77;,b77iii71 by ins]t+ 1    
#efd;,a1 or #efd;,b aft] #efd4  #djc4   
,/rategic ,national ,/ockpile ,section  
#cai;,f-#b ( ! ,public ,heal? ,s]vice   
,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is     
am5d$--  7#a7 9 subsection 7a7--  7,a7 9
 p>agraph 7#a7--  7i7 by ins]t+ consi/5t
 ) section #bhaa be=e by ! ,secret>y to 
be appropriate2 &  7ii7 by ins]t+ be=e !
 p]iod at ! end ( ! second s5t5ce !     
foll[+3 & %all submit su* review        

annually to ! appropriate congressional 
committees ( jurisdiction to ! ext5t t  
disclosure ( su* in=mation does n       
compromise national security2 &  7,b7 9 
p>agraph 7#b77;,d71 by ins]t+ be=e !    
semicolon at ! end ! foll[+3 & t !      
pot5tial depletion ( c\nt]measures      
curr5tly 9 ! /ockpile is id5tifi$ &     
appropriately address$1 includ+ ?r\gh   
necess>y repl5i%m5t2 &  7#b7 9          
subsection 7f77#a71 by /rik+            
#fdj1jjj1jjj = fiscal ye> #bjjb1 & su*  
sums z may be necess>y = ea* ( fiscal   
ye>s #bjjc ?r\gh #bjjf4 ,su*            
au?orization is 9 addition to am\nts 9 !
 special res]ve fund ref]r$ to 9        
subsection 7c77#aj77;,a74 & ins]t+      
#ecc1hjj1jjj = ea* ( fiscal ye>s #bjac  
?r\gh #bjag4 ,su* au?orization is 9     
addition to am\nts 9 ! special res]ve   
fund ref]r$ to 9 subsection 7h744  #djd4
 ,national ,biodef5se ,sci5ce ,bo>d     
,section #cai,m7a7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-f7a77
 is am5d$--  7#a7 9 p>agraph 7#b7--     

7,a7 9 subp>agraph 7,d7--  7i7 9 clause 
7i71 by /rik+ & at ! end2  7ii7 9 clause
 7ii71 by /rik+ ! p]iod & ins]t+ a      
semicolon2 &  7iii7 by add+ at ! end !  
foll[+3  7iii7 "o su* memb] %all be an  
individual ) p$iatric subject matt]     
exp]tise2 &  7iv7 "o su* memb] %all be a
 ,/ate1 tribal1 t]ritorial1 or local    
public heal? (ficial4  2 &  7,b7 by add+
 at ! end ! foll[+ flu% s5t5ce3  ,no?+ 9
 ?is p>agraph %all preclude a memb] ( ! 
,bo>d f satisfy+ two or m ( !           
requirem5ts describ$ 9 subp>agraph      
7,d742 &  7#b7 9 p>agraph 7#e7--  7,a7 9
 subp>agraph 7,b71 by /rik+ & at ! end2 
7,b7 9 subp>agraph 7,c71 by /rik+ !     
p]iod & ins]t+ 2 &2 &  7,c7 by add+ at !
 end ! foll[+3  7,d7 provide any        
recomm5dation1 f9d+1 or report provid$  
to ! ,secret>y "u ?is p>agraph to !     
appropriate committees ( ,congress4  4  
,pass$ ! ,h\se ( ,repres5tatives ,janu>y
 #bb1 #bjac4;,cl]k4