,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #dfig  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,july #ah1 #bjbc ,ms4 
,s*ri] 7= h]self1 ,ms4 ,e%oo1 ,mr4      
,pallone1 ,ms4 ,de,gette1 ,ms4          
,s*ak[sky1 ,ms4 ,matsui1 ,ms4 ,ca/or (  
,florida1 ,mr4 ,s>banes1 ,mr4 ,tonko1   
,ms4 ,cl>ke ( ,new ,york1 ,mr4 ,crd5as1 
,mr4 ,ruiz1 ,mr4 ,pet]s1 ,mrs4 ,d+ell1  
,mr4 ,veasey1 ,ms4 ,ku/]1 ,ms4 ,kelly ( 
,ill9ois1 ,ms4 ,b>ragn1 ,ms4 ,blunt     
,ro*e/]1 ,mr4 ,soto1 ,ms4 ,craig1 ,mrs4 
,trahan1 & ,mrs4 ,flet*]7 introduc$ !   
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,public ,heal?       
,s]vice ,act to reau?orize c]ta9        
programs ) respect to public heal?      
security & all-haz>ds prep>$ness &      
response relat$ to ! ,adm9i/ration =    
,/rategic ,prep>$ness & ,response &     
c]ta9 programs ) respect to public heal?
 security & all-haz>ds prep>$ness &     
response relat$ to ! ,c5t]s = ,disease  
,control & ,prev5tion1 & = o!r purposes4

  #a4 ,%ort title2 table ( cont5ts  7a7 
,%ort title ,?is ,act may be cit$ z !   
,protect+ ,p&emic & ,all-,haz>ds        
,prep>$ness ,act ( #bjbc or ! ,protect+ 
,,pahpa ,act ( #bjbc4  7b7 ,table (     
cont5ts ,! table ( cont5ts = ?is ,act is
 z foll[s3  ,sec4 #a4 ,%ort title2 table
 ( cont5ts4 ,title ,i--,prep>+ = &      
respond+ to public heal? security ?reats
 ,sec4 #aja4 ,national heal? security   
/rategy4 ,sec4 #ajb4 ,protection (      
national security f ?reats4 ,sec4 #ajc4 
,p>tn]%ips = ,/ate & regional hospital  
prep>$ness to improve surge capacity4   
,sec4 #ajd4 ,guidel9es = regional heal? 
c>e em]g5cy prep>$ness & response       
sy/ems4 ,sec4 #aje4 ,/rategic ,national 
,/ockpile4 ,sec4 #ajf4 ,diagno/ic te/+  
prep>$ness plan4 ,sec4 #ajg4 ,biom$ical 
,advanc$ ,rese>* & ,developm5t          
,au?ority4 ,sec4 #ajh4 ,ensur+          
collaboration & coord9ation 9 m$ical    
c\nt]measure developm5t4 ,sec4 #aji4    
,review ( ,,aspr ef=ts to ensure supply 
*a9 resili5cy & acc\ntability4 ,sec4    

#aaj4 ,review ( ,,hhs ef=ts ,to ensure  
rapid production & dome/ic manufactur+  
capacity ( m$ical c\nt]measures4 ,sec4  
#aaa4 ,crisis /&>ds ( c>e4 ,title       
,,ii--,ensur+ work=ce to prep>e = &     
respond to public heal? security ?reats 
,sec4 #bja4 ,em]g5cy sy/em = advance    
regi/ration ( volunte] heal?            
pr(essional4 ,sec4 #bjb4 ,milit>y &     
civilian p>tn]%ip = trauma read9ess4    
,sec4 #bjc4 ,national advisory          
committees on disa/]s4 ,sec4 #bjd4      
,national ,disa/] ,m$ical ,sy/em4 ,sec4 
#bje4 ,volunte] ,m$ical ,res]ve ,corps4 
,title ,,iii--,prep>+ = & respond+ to   
public heal? security ?reats ,sec4 #cja4
 ,improv+ ,/ate & local public heal?    
security4 ,sec4 #cjb4 ,facilities &     
capacities ( ! ,c5t]s = ,disease        
,control & ,prev5tion to combat public  
heal? security ?reats4 ,sec4 #cjc4      
,monitor+ & di/ribution ( c]ta9 m$ical  
c\nt]measures4 ,sec4 #cjd4 ,enhanc$     
control ( dang]\s biological ag5ts &    
tox9s4 ,sec4 #cje4 ,mosquito-borne      

diseases4 ,sec4 #cjf4                   
,epidemiology-laboratory capacity4 ,sec4
 #cjg4 ,support+ public heal? data      
availability & access4 ,title           
,,iv--,ensur+ work=ce to prep>e = &     
respond to public heal? security ?reats 
,sec4 #dja4 ,tempor>y reassignm5t (     
,/ate & local p]sonnel dur+ a public    
heal? em]g5cy4 ,sec4 #djb4 ,epidemic    
,intellig5ce ,s]vice4 ,title            
,v--,address+ drug & supply *a9 %ortages
 ,subtitle ,a--,ensur+ access to        
lifesav+ drugs ,sec4 #eja4 ,ext5d$      
expiration dates = life-sav+ drugs4     
,subtitle ,b--,drug orig9 transp>5cy    
,sec4 #eaa4 ,enhanc$ drug manufactur+   
am\nt in=mation report+4 ,sec4 #eab4    
,require drug label+ to include orig9al 
manufactur] & supply *a9 in=mation4     
,subtitle ,c--,m$ical device %ortage    
r$uction ,sec4 #eba4 ,cl>ify+ device    
%ortage notifications4 ,sec4 #ebb4      
,supply *a9 risk managem5t4 ,sec4 #ebc4 
,cl>ify+ volunt>y notifications4        
,subtitle ,d--,drug %ortage prev5tion   

,sec4 #eca4 ,improv+ notification       
proc$ures 9 case ( increas$ dem& =      
critical ess5tial m$ic9es4 ,subtitle    
,e--,protect+ ,am]icans f unsafe drugs  
,sec4 #eda4 ,notification1              
nondi/ribution1 & recall ( drugs4  ,i   
,prep>+ = & respond+ to public heal?    
security ?reats  #aja4 ,national heal?  
security /rategy  7a7 ,public heal?     
work=ce ,section #bhjb7;a77#c7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;hh-#a7;a77#c77 is am5d$  
by /rik+ ,9 #bjbb1 ! & ins]t+ ,!4  7b7  
,m$ical & public heal? community        
prep>$ness goal ,section                
#bhjb7;b77#h77;,a7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#cjj;hh-#a7;b77#h77;,a77 is am5d$ by    
ins]t+ be=e ! semicolon ! foll[+3 1     
includ+ by protect+ aga9/ cyb]security  
?reats4  7c7 ,cyb]security resili5cy (  
heal? c>e deliv]y sy/ems ,section       
#bhjb7;b7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77 is  
am5d$ by add+ at ! end ! foll[+3  7#aa7 

,cyb]security resili5cy ( heal? c>e     
deliv]y sy/ems ,/r5g!n+ ! ability (     
,/ates1 local communities1 ,tribal      
communities1 & t]ritorial entities to   
protect aga9/1 mitigate1 or o!rwise     
address ! impact ( cyb]security risks or
 cyb]security attacks t affect public   
heal? ?r\gh me*anisms 7includ+ aw>ds (  
grants or coop]ative agreem5ts "u       
section #cai;,c-#b7 t enc\rage hospitals
 & o!r facilities involv$ 9 ! deliv]y ( 
heal? c>e items & s]vices to use        
recogniz$ security practices meet+ or   
exce$+ ! approa*es promulgat$ "u section
 #dje7;d7 ( ! ,cyb]security ,act (      
#bjae4  4  #ajb4 ,protection ( national 
security f ?reats ,section              
#bhaa7;f77#b77;,a7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#cjj;hh-#aj7;f77#b77;,a77 is am5d$ by   
/rik+ #bej1jjj1jjj = ea* ( fiscal ye>s  
#bjai ?r\gh #bjbc & ins]t+ #cbg1iia1jjj 
= ea* ( fiscal ye>s #bjbd ?r\gh #bjbh4  
#ajc4 ,p>tn]%ips = ,/ate & regional     
hospital prep>$ness to improve surge    

capacity  7a7 ,au?orization (           
appropriations ,section                 
#cai;,c-#b7;j77#a77;,a7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d-#c;b7j77#a77;,a77 is am5d$--     
7#a7 by /rik+ is au?oriz$ to be         
appropriat$ & ins]t+ are au?oriz$ to be 
appropriat$2 &  7#b7 by ins]t+ &        
#ejj1jjj1jjj = ea* ( fiscal ye>s #bjbd  
?r\gh #bjbh be=e ! p]iod at ! end4  7b7 
,sunset ,section                        
#cai;,c-#b7;j77#a77;,b77iii7 ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#bdg;d-#c;b7j77#a77;,b77iii77 is am5d$  
by /rik+ #bjbc & ins]t+ #bjbh4  #ajd4   
,guidel9es = regional heal? c>e em]g5cy 
prep>$ness & response sy/ems  7a7       
,guidel9es ,section #cai;,c-#c7;b77#c7 (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #bdg;d-#c;c7b77#c77 is am5d$  
by /rik+ ! ,p&emic & ,all-,haz>ds       
,prep>$ness & ,advanc+ ,innovation ,act 
( #bjai 7includ+ any am5dm5ts made by   
su* ,act7 & ins]t+ ! ,p&emic &          
,all-,haz>ds ,prep>$ness & ,advanc+     

,innovation ,act ( #bjai1 ! ,,prev5t    
,p&emics ,act 7title ,,ii ( division    
,,ff ( ,public ,law #aag-cbh71 & !      
,protect+ ,p&emic & ,all-,haz>ds        
,prep>$ness ,act ( #bjbc4  7b7          
,demon/ration project = regional heal?  
c>e prep>$ness & response sy/ems        
,section #cai;,c-#c7;e77#b7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d-#c;c7e77#b77 is am5d$ by /rik+   
#bjbc & ins]t+ #bjbh4  #aje4 ,/rategic  
,national ,/ockpile  7a7 ,v5dor-,manag$ 
inv5tory & w>m-,bas$ surge capacity     
contracts & coop]ative agreem5ts )      
cl9ical laboratories ,section           
#cai;,f-#b7;a77#e77;,a7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d-#f;b7a77#e77;,a77 is am5d$--     
7#a7 by ins]t+ aft] contracts or        
coop]ative agreem5ts ) v5dors1 :i* may  
include manufactur]s or di/ributors (   
m$ical products1 ! foll[+3 z well z     
cl9ical laboratories12 &  7#b7 9 clause 
7ii71 by /rik+ dome/ic manufactur+      
capacity & ins]t+ dome/ic manufactur+ & 

laboratory capacity4  7b7 ,au?orization 
( appropriations  7#a7 ,9 g5]al ,section
 #cai;,f-#b7;f7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;d-#f;b7f77 is am5d$-- 7,a7 9       
p>agraph 7#a71 by /rik+ #faj1jjj1jjj =  
ea* ( fiscal ye>s #bjai ?r\gh #bjba1 &  
#gej1jjj1jjj = ea* ( fiscal ye>s #bjbb &
 #bjbc & ins]t+ #a1ifc1jjj1jjj = ea* (  
fiscal ye>s #bjbd ?r\gh #bjbh2  7,b7 by 
/rik+ p>agraph 7#b72 &  7,c7 by /rik+   
,au?orization ( appropriations & all t  
foll[s ?r\gh ,= ! purpose ( c>ry+ out   
subsection 7a71 !re are au?oriz$ to be  
appropriat$ & ins]t+ ,au?orization (    
appropriations4--,= ! purpose ( c>ry+   
out subsection 7a71 !re is au?oriz$ to  
be appropriat$4  7#b7 ,pilot program to 
support ,/ate m$ical /ockpiles ,section 
#cai;,f-#b7;i77#i7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;d-#f;b7i77#i77 is am5d$ by /rik+   
#bjbd & ins]t+ #bjbh4  #ajf4 ,diagno/ic 
te/+ prep>$ness plan ,! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bja et     

seq47 is am5d$ by ins]t+ aft] section   
#cai;,f-#e ( su* ,act 7#db ,u4,s4,c4    
#bdg;d-#f;f7 ! foll[+3  #cai;,f-#f4     
,diagno/ic te/+ prep>$ness plan  7a7 ,9 
g5]al ,! ,secret>y1 act+ ?r\gh !        
,assi/ant ,secret>y = ,prep>$ness &     
,response1 & 9 consultation ) ! heads ( 
relevant ,f$]al ag5cies1 %all develop n 
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is section & update n less ?an e #c   
ye>s !reaft] a plan = rapid developm5t1 
au?orization1 scal+1 procurem5t1 &      
di/ribution ( diagno/ics & cl9ical &    
diagno/ic laboratory te/+ capacity dur+ 
a public heal? em]g5cy decl>$ "u section
 #cai4  7b7 ,purposes ,! purposes ( !   
plan "u subsection 7a7 %all be--  7#a7  
to facilitate ! developm5t & utilization
 ( diagno/ics = use ) respect to a novel
 *emical1 biological1 radiological1 or  
nucle> ?reat or an em]g+ infecti\s      
disease1 includ+ any su* high-?r\ghput  
laboratory diagno/ic1 po9t-(-c>e        
diagno/ic1 or rapid at-home or          
po9t-(-use diagno/ic2 &  7#b7 to        

describe ! processes = rapid developm5t1
 au?orization1 scal+1 procurem5t1 &     
di/ribution ( diagno/ics & cl9ical &    
diagno/ic laboratory te/+ capacity4  7c7
 ,public-,private coord9ation  7#a7 ,9  
g5]al ,! ,secret>y1 act+ ?r\gh !        
,assi/ant ,secret>y = ,prep>$ness &     
,response1 %all include )9 ! plan "u    
subsection 7a7 a plan = public-private  
coord9ation on national diagno/ic te/+  
dur+ a public heal? em]g5cy4  7#b7      
,cont5ts ,! plan "u p>agraph 7#a7 %all  
be design$ to facilitate coord9ation &  
collaboration among--  7,a7 gov]nm5t    
ag5cies2 &  7,b7 critical private-sector
 diagno/ic te/+ /akehold]s1 includ+     
private-sector cl9ical & diagno/ic      
laboratories1 diagno/ic manufactur]s1   
heal? c>e product di/ributors1 & rese>* 
laboratories4  7d7 ,public availability 
,! ,secret>y1 act+ ?r\gh ! ,assi/ant    
,secret>y = ,prep>$ness & ,response1    
%all make ! plan "u subsection 7a7      
publicly available4  7e7 ,reports to    
,congress ,n lat] ?an #a ye> aft]       

comm5c+ implem5tation ( ! plan "u       
subsection 7a7 = a public heal? em]g5cy1
 ! ,secret>y1 act+ ?r\gh ! ,assi/ant    
,secret>y = ,prep>$ness & ,response1    
%all submit to ! ,congress a report     
evaluat+ ! effectiv5ess ( activities    
implem5t$ "u ! plan4  4  #ajg4          
,biom$ical ,advanc$ ,rese>* &           
,developm5t ,au?ority  7a7 ,m$ical      
c\nt]measures = viral ?reats ) p&emic   
pot5tial ,section #cai,l7c77#d7 ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#g;e7c77#d77 is am5d$--
 7#a7 9 subp>agraph 7,d7--  7,a7 9      
clause 7ii71 by /rik+ 2 & & ins]t+ a    
semicolon2  7,b7 by r$esignat+ clause   
7iii7 z clause 7v72 &  7,c7 by ins]t+   
aft] clause 7ii7 ! foll[+3  7iii7 !     
id5tification & developm5t ( plat=m     
manufactur+ te*nologies ne$$ = advanc$  
developm5t & manufactur+ ( m$ical       
c\nt]measures = viral families :i* h    
significant pot5tial to cause a p&emic2 
7iv7 advanc$ rese>* & developm5t (      
flexible m$ical c\nt]measures aga9/     

priority respiratory virus families &   
o!r respiratory viral pa?og5s ) a       
significant pot5tial to cause a p&emic1 
) bo? pa?og5-specific & pa?og5-agno/ic  
approa*es2 &  2 &  7#b7 9 subp>agraph   
7,f7--  7,a7 9 clause 7ii71 by /rik+ 2 &
 at ! end & ins]t+ a semicolon2  7,b7 9 
clause 7iii71 by /rik+ ! p]iod & ins]t+ 
2 &2 &  7,c7 by add+ at ! end ! foll[+3 
7iv7 priority virus families & o!r viral
 pa?og5s ) a significant pot5tial to    
cause a p&emic4  4  7b7 ,au?orization ( 
appropriations ,section #cai,l7d77#b7 ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bdg;d-#g;e7d77#b77 is am5d$  
by /rik+ #faa1gjj1jjj = ea* ( fiscal    
ye>s #bjai ?r\gh #bjbc & ins]t+         
#iej1jjj1jjj = ea* ( fiscal ye>s #bjbd  
?r\gh #bjbh4  7c7 ,inapplicability (    
c]ta9 provisions sunset ,section        
#cai,l7e77#a77;,d7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;d-#g;e7e77#a77;,d77 is am5d$ by    
/rik+ on ! date t is #ag ye>s aft] !    
date ( enactm5t ( ! ,p&emic &           

,all-,haz>ds ,prep>$ness ,act & ins]t+  
on ,octob] #a1 #bjbh4  #ajh4 ,ensur+    
collaboration & coord9ation 9 m$ical    
c\nt]measure developm5t ,section        
#cai,l-#a7;b7 ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bgd;d-#g;f7b77 is 
am5d$ by /rik+ at ! end ( ! #ag-ye>     
p]iod t beg9s on ! date ( enactm5t ( ?is
 ,act & ins]t+ on ,octob] #a1 #bjbh4    
#aji4 ,review ( ,,aspr ef=ts to ensure  
supply *a9 resili5cy & acc\ntability    
7a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] 
! date ( enactm5t ( ?is ,act1 !         
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all complete a review (--  7#a7 !      
,supply ,*a9 ,control ,t[] ,program 79  
?is section ref]r$ to z ! ,,scct        
,program7 "u ! ,adm9i/ration = ,/rategic
 ,prep>$ness & ,response ( ! ,dep>tm5t (
 ,heal? & ,human ,s]vices2 &  7#b7 any  
relat$ ef=ts ( ! ,adm9i/ration =        
,/rategic ,prep>$ness & ,response--     
7,a7 to create supply *a9 visibility    
into inv5tory1 capacity1 & di/ribution  
fl[ ( c]ta9 products critical to        

prep>$ness & response ef=ts2  7,b7 to   
provide insights into dem& =eca/+ &     
model+ ( c]ta9 products critical to     
prep>$ness & response ef=ts2 or  7,c7 to
 in=m prep>$ness & response ef=ts by    
t>get+ di/ribution & coord9at+ supply ) 
dem& = c]ta9 products critical to       
prep>$ness & response ef=ts4  7b7       
,issues ,! review "u ?is section %all   
include exam9ation (--  7#a7 ! data be+ 
collect$ & ma9ta9$ pursuant to ! ,,scct 
,program2  7#b7 h[ ! ,dep>tm5t ( ,heal? 
& ,human ,s]vices1 act+ ?r\gh !         
,adm9i/ration = ,/rategic ,prep>$ness & 
,response1 uses su* data to provide     
supply *a9 visibility & address actual  
or pot5tial supply gaps2  7#c7 ! ext5t  
to :i* su* data is provid$ & %>$ ) end  
us]s1 includ+ ,/ates1 localities1       
,t]ritories1 ,tribes1 & indu/ry p>tn]s2 
7#d7 ! frequ5cy & cad5ce ( data report+ 
& %>+ by & among ,/ates1 localities1    
,t]ritories1 ,tribes1 & indu/ry p>tn]s2 
7#e7 in=mation relat$ to ! type & numb] 
( ,/ates1 localities1 ,t]ritories1      

,tribes1 & indu/ry p>tn]s p>ticipat+ 9 !
 ,,scct ,program2  7#f7 ! process by :i*
 ,/ates1 localities1 ,t]ritories1       
,tribes1 & indu/ry p>tn]s volunt>ily    
*oose to p>ticipate 9 ! ,,scct ,program2
 &  7#g7 any ineffici5cies1 defici5cies1
 or *all5ges relat$ to ! application or 
op]ation ( ! ,,scct ,program4  7c7      
,report to ,congress ,n lat] ?an !      
deadl9e describ$ 9 subsection 7a7 = !   
completion ( ! review "u ?is section1 ! 
,comptroll] ,g5]al %all submit to !     
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives & ! ,committee  
on ,heal?1 ,education1 ,labor1 &        
,p5sions ( ! ,s5ate a report on !       
results ( su* review4  #aaj4 ,review (  
,,hhs ef=ts to ensure rapid production &
 dome/ic manufactur+ capacity ( m$ical  
c\nt]measures  7a7 ,9 g5]al ,n lat] ?an 
#a ye> aft] ! date ( ! enactm5t ( ?is   
,act1 ! ,comptroll] ,g5]al ( ! ,unit$   
,/ates %all conduct & complete a review 
exam9+ ! ef=ts ( ! ,secret>y ( ,heal? & 
,human ,s]vices to ensure t ! ,unit$    

,/ates is prep>$ to rapidly produce     
qualifi$ c\nt]measures 7z def9$ 9       
section #cai;,f-#a ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;d-#f;a77 9 ! ev5t ( a public heal? 
em]g5cy decl>$ "u section #cai ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bgd;d74  7b7 ,cont5ts ,!     
review conduct$ "u subsection 7a7 %all  
include a review (--  7#a7 ! ef=ts      
describ$ 9 su* subsection1 includ+ !    
,secret>y's ef=ts to transition f !     
,c5t]s = ,innovation & ,advanc$ ,drug   
,manufactur+ program to any new ef=ts1  
includ+ ! ,national ,bioph>maceutical   
,manufactur+ ,p>tn]%ip & ,indu/rial     
,base ,expansion ,connect2  7#b7 !      
progress made t[>d ! implem5tation ( su*
 ef=ts2 &  7#c7 ! plann+ )9 ! ,dep>tm5t 
( ,heal? & ,human ,s]vices to assess    
risks & *all5ges associat$ ) advanc$    
developm5t & manufactur+ ( qualifi$     
c\nt]measures4  7c7 ,report to ,congress
 ,n lat] ?an #a ye> aft] complet+ !     
review "u subsection 7a71 ! ,comptroll] 

,g5]al ( ! ,unit$ ,/ates %all submit to 
! ,congress a report conta9+--  7#a7 !  
results ( ! review2 &  7#b7 !           
,comptroll] ,g5]al's recomm5dations =   
ensur+ t ! ,unit$ ,/ates is prep>$ to   
rapidly produce qualifi$ c\nt]measures 9
 ! ev5t ( a public heal? em]g5cy4  #aaa4
 ,crisis /&>ds ( c>e ,n lat] ?an #b ye>s
 aft] ! date ( enactm5t ( ?is ,act1 !   
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,director ( ! ,(fice =     
,civil ,rights ( ! ,dep>tm5t ( ,heal? & 
,human ,s]vices1 %all issue guidance on 
h[ to develop or modify ,/ate & local   
crisis /&>ds ( c>e = use dur+ an em]g5cy
 p]iod 7z def9$ 9 section #aace7;g77#a7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #acbj;b-#e7;g77#a77 s z to br+
 su* /&>ds ( c>e into compliance ) !    
nondiscrim9ation requirem5ts ( section  
#ejd ( ! ,rehabilitation ,act ( #aigc   
7#bi ,u4,s4,c4 #gid74  ,,ii ,ensur+     
work=ce to prep>e = & respond to public 
heal? security ?reats  #bja4 ,em]g5cy   
sy/em = advance regi/ration ( volunte]  

heal? pr(essional  7a7 ,9 g5]al ,section
 #cai;,i7a7 ( ! ,public ,heal? ,s]vice  
,act 7#db ,u4,s4,c4 #bdg;d-#g;b7 is     
am5d$ by /rik+ ,n lat] ?an #ab mon?s    
aft] ! date ( enactm5t ( ! ,p&emic &    
,all-,haz>ds ,prep>$ness ,act1 !        
,secret>y %all l9k exi/+ ,/ate          
v]ification sy/ems to ma9ta9 & ins]t+ ,!
 ,secret>y %all cont9ue to ma9ta94  7b7 
,au?orization ( appropriations ,section 
#cai;,i7k7 ( ! ,public ,heal? ,s]vice   
,act 7#db ,u4,s4,c4 #bdg;d-#g;b7k77 is  
am5d$ by /rik+ #bjai ?r\gh #bjbc &      
ins]t+ #bjbd ?r\gh #bjbh4  #bjb4        
,milit>y & civilian p>tn]%ip = trauma   
read9ess ,section #abia7;g7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#cjj;d-#ia7;g77 is am5d$ by /rik+ #bjai 
?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh4 
#bjc4 ,national advisory committees on  
disa/]s  7a7 ,national ,advisory        
,committee on ,*ildr5 & ,disa/]s        
,subsection 7g7 ( section #bhaa;,a ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;hh-#aj;b7 is am5d$ to    

read z foll[s3  7g7 ,sunset  7#a7 ,9    
g5]al ,! ,advisory ,committee %all      
t]m9ate on ,septemb] #cj1 #bjbh4  7#b7  
,ext5sion ( committee ,n lat] ?an       
,octob] #a1 #bjbg1 ! ,secret>y %all     
submit to ,congress a recomm5dation on  
:e!r ! ,advisory ,committee %\ld be     
ext5d$4  4  7b7 ,national ,advisory     
,committee on ,s5iors & ,disa/]s        
,section #bhaa;,b ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4             
#cjj;hh-#aj;c7 is am5d$--  7#a7 9       
subsection 7d7-- 7,a7 9 p>agraph 7#a71  
by /rik+ 9 consultation ) su* o!r heads 
( ag5cies z appropriate1 %all appo9t n m
 ?an #ag memb]s & ins]t+ 9 consultation 
) su* o!r ,secret>ies z may be          
appropriate1 %all appo9t n m ?an #bc    
memb]s2  7,b7 by r$esignat+ p>agraph    
7#b7 z p>agraph 7#c72  7,c7 by am5d+    
p>agraph 7#c71 z s r$esignat$--  7i7 9 !
 p>agraph head+1 by /rik+ ,requir$      
memb]s & ins]t+ ,requir$ ,f$]al memb]s2 
7ii7 9 ! matt] prec$+ subp>agraph 7,a71 
by /rik+ & non-,f$]al memb]s12  7iii7 by

 /rik+ subp>agraphs 7,j7 & 7,k72 &  7iv7
 by r$esignat+ subp>agraph 7,l7 z       
subp>agraph 7,j72  7,d7 by ins]t+ aft]  
p>agraph 7#a7 ! foll[+ new p>agraph3    
7#b7 ,requir$ non-,f$]al memb]s ,!      
,secret>y1 9 consultation ) su* o!r     
heads ( ,f$]al ag5cies z may be         
appropriate1 %all appo9t to ! ,advisory 
,committee "u p>agraph 7#a7 at lea/ #ac 
individuals1 includ+--  7,a7 at lea/ #d 
non-,f$]al heal? c>e provid]s ) exp]tise
 9 g]iatric m$ical disa/] plann+1       
prep>$ness1 response1 or recov]y2  7,b7 
at lea/ #c repres5tatives ( ,/ate1      
local1 ,tribal1 or t]ritorial ag5cies ) 
exp]tise 9 g]iatric disa/] plann+1      
prep>$ness1 response1 or recov]y2 &     
7,c7 at lea/ #d non-,f$]al pr(essionals 
) tra9+ 9 g]ontology1 includ+ social    
work]s1 sci5ti/s1 human s]vices         
speciali/s1 or o!r non-m$ical           
pr(essionals1 ) exp]i5ce 9 disa/]       
plann+1 prep>$ness1 response1 or recov]y
 among o!r adults4  2 &  7,e7 by add+ at
 ! end ! foll[+ new p>agraphs3  7#d7    

,t]m ( appo9tm5t ,ea* memb] ( !         
,advisory ,committee appo9t$ "u p>agraph
 7#b7 %all s]ve = a t]m ( #c ye>s1      
except t ! ,secret>y may adju/ ! t]ms ( 
! ,advisory ,committee appo9tees s]v+ on
 ! date ( enactm5t ( ! ,prep>+ = ,all   
,haz>ds & ,pa?og5s ,reau?orization ,act1
 or appo9tees :o are initially appo9t$  
aft] su* date ( enactm5t1 9 ord] to     
provide = a /agg]$ t]m ( appo9tm5t = all
 memb]s4  7#e7 ,consecutive appo9tm5ts2 
maximum t]ms ,a memb] appo9t$ "u        
p>agraph 7#b7 may s]ve n m ?an #c t]ms  
on ! ,advisory ,committee1 & n m ?an #b 
( su* t]ms may be s]v$ consecutively4  2
 &  7#b7 9 subsection 7g7-- 7,a7 9      
p>agraph 7#a71 by /rik+ #bjbc & ins]t+  
#bjbh2 &  7,b7 9 p>agraph 7#b71 by /rik+
 #bjbb & ins]t+ #bjbg4  7c7 ,national   
,advisory ,committee on ,individuals )  
,disabilities ,section #bhaa;,c ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;hh-#aj;d7 is am5d$--     
7#a7 by r$esignat+ subsections 7c7 ?r\gh
 7g7 z subsections 7d7 ?r\gh 7h71       

respectively2  7#b7 by ins]t+ aft]      
subsection 7b7 ! foll[+ new subsection3 
7c7 ,additional duties ,! ,advisory     
,committee may provide advice &         
recomm5dations to ! ,secret>y ) respect 
to individuals ) disabilities1 & m$ical 
& public heal? grants & coop]ative      
agreem5ts1 z applicable to prep>$ness & 
response activities "u ?is title & title
 ,,iii4  2  7#c7 9 subsection 7d71 z s  
r$esignat$--  7,a7 9 p>agraph 7#a71 by  
/rik+ 9 consultation ) su* o!r heads (  
ag5cies & dep>tm5ts z appropriate1 %all 
appo9t n m ?an #ag memb]s & ins]t+ 9    
consultation ) su* o!r ,secret>ies z may
 be appropriate1 %all appo9t n m ?an #bc
 memb]s2  7,b7 by r$esignat+ p>agraph   
7#b7 z p>agraph 7#c72  7,c7 by am5d+    
p>agraph 7#c71 z r$esignat$-- 7i7 9 !   
p>agraph head+1 by /rik+ ,requir$ memb]s
 & ins]t+ ,requir$ ,f$]al memb]s2  7ii7 
9 ! matt] prec$+ subp>agraph 7,a71 by   
/rik+ & non-,f$]al memb]s12  7iii7 by   
/rik+ subp>agraph 7,k7 & ins]t+ !       
foll[+3  7,k7 ,repres5tatives ( su* o!r 

,f$]al ag5cies z ! ,secret>y det]m9es   
necess>y to fulfill ! duties ( !        
,advisory ,committee4  2 &  7iv7 by     
/rik+ subp>agraphs 7,l7 & 7,m72  7,d7 by
 ins]t+ aft] p>agraph 7#a7 ! foll[+ new 
p>agraph3  7#b7 ,requir$ non-,f$]al     
memb]s ,! ,secret>y1 9 consultation )   
su* o!r heads ( ,f$]al ag5cies z may be 
appropriate1 %all appo9t to ! ,advisory 
,committee "u p>agraph 7#a7 at lea/ #ac 
individuals1 includ+--  7,a7 at lea/ #d 
non-,f$]al heal? c>e pr(essionals )     
exp]tise 9 disability accessibility     
be=e1 dur+1 & aft] disa/]s1 m$ical &    
mass c>e disa/] plann+1 prep>$ness1     
response1 or recov]y2  7,b7 at lea/ #c  
repres5tatives f ,/ate1 local1 ,tribal1 
or t]ritorial ag5cies ) exp]tise 9      
disa/] plann+1 prep>$ness1 response1 or 
recov]y = individuals ) disabilities2 & 
7,c7 at lea/ #d individuals ) a         
disability ) exp]tise 9 disa/] plann+1  
prep>$ness1 response1 or recov]y =      
individuals ) disabilities4  2 &  7,e7  
by add+ at ! end ! foll[+ new p>agraphs3

  7#d7 ,t]m ( appo9tm5t ,ea* memb] ( !  
,advisory ,committee appo9t$ "u p>agraph
 7#b7 %all s]ve = a t]m ( #c ye>s1      
except t ! ,secret>y may adju/ ! t]ms ( 
! ,advisory ,committee appo9tees s]v+ on
 ! date ( enactm5t ( ! ,prep>+ = ,all   
,haz>ds & ,pa?og5s ,reau?orization ,act1
 or appo9tees :o are initially appo9t$  
aft] su* date ( enactm5t1 9 ord] to     
provide = a /agg]$ t]m ( appo9tm5t = all
 memb]s4  7#e7 ,consecutive appo9tm5ts2 
maximum t]ms ,a memb] appo9t$ "u        
p>agraph 7#b7 may s]ve n m ?an #c t]ms  
on ! ,advisory ,committee1 & n m ?an #b 
( su* t]ms may be s]v$ consecutively4  2
 &  7#d7 9 subsection 7g7-- 7,a7 9      
p>agraph 7#a71 by /rik+ #bjbc & ins]t+  
#bjbh2 &  7,b7 9 p>agraph 7#b71 by /rik+
 #bjbb & ins]t+ #bjbg4  #bjd4 ,national 
,disa/] ,m$ical ,sy/em  7a7 ,elim9ation 
( sunset ( au?ority ,to make c]ta9      
appo9tm5ts = ,national ,disa/] ,m$ical  
,sy/em ,section #bhab7;c77#d7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;hh-#aa7;c77#d77 is       

am5d$--  7#a7 by /rik+ 7,a7 ,9          
g5]al4--,if ! ,secret>y det]m9es &      
ins]t+ ,if ! ,secret>y det]m9es2 &  7#b7
 by /rik+ subp>agraph 7,b74  7b7        
,au?orization ( appropriations ,section 
#bhab7;g7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #cjj;hh-#aa7;g77 is 
am5d$ by /rik+ #eg1djj1jjj = ea* (      
fiscal ye>s #bjai ?r\gh #bjbc & ins]t+  
#if1ijd1jjj = ea* ( fiscal ye>s #bjbd   
?r\gh #bjbh4  #bje4 ,volunte] ,m$ical   
,res]ve ,corps ,section #bhac7;i7 ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;hh-#ae7;i77 is am5d$ by  
/rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd  
?r\gh #bjbh4  ,,iii ,prep>+ = & respond+
 to public heal? security ?reats  #cja4 
,improv+ ,/ate & local public heal?     
security  7a7 ,au?orization (           
appropriations ,section                 
#cai;,c-#a7;h77#a77;,a7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d-#c;a7h77#a77;,a77 is am5d$ by    
/rik+ #fhe1jjj1jjj = ea* ( fiscal ye>s  
#bjai ?r\gh #bjbc & ins]t+              

#a1jjj1jjj1jjj = ea* ( fiscal ye>s #bjbd
 ?r\gh #bjbh4  7b7 ,elim9ation (        
deadwood ,section #cai;,c-#a7;h7 ( !    
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#c;a7h77 is am5d$--    
7#a7 by /rik+ p>agraphs 7#d7 & 7#e72 &  
7#b7 by r$esignat+ p>agraphs 7#f7 & 7#g7
 z p>agraphs 7#d7 & 7#e74  #cjb4        
,facilities & capacities ( ! ,c5t]s =   
,disease ,control & ,prev5tion to combat
 public heal? security ?reats  7a7 ,/udy
 ,section #cai;,d7a77#d7 ( ! ,public    
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bdg;d-#d7;a77#d77 is am5d$ by /rik+ ,n 
lat] ?an ,june #a1 #bjbb1 ! ,comptroll] 
,g5]al ( ! ,unit$ ,/ates %all conduct a 
/udy on ,f$]al sp5d+ 9 fiscal ye>s #bjac
 ?r\gh #bjah & ins]t+ ,n lat] ?an ,june 
#a1 #bjbg1 ! ,comptroll] ,g5]al ( !     
,unit$ ,/ates %all conduct a /udy on    
,f$]al sp5d+ 9 fiscal ye>s #bjba ?r\gh  
#bjbf4  7b7 ,au?orization (             
appropriations ,section #cai;,d7h7 ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#d7;h77 is am5d$--     

7#a7 9 p>agraph 7#a71 by /rik+          
#be1jjj1jjj = ea* ( fiscal ye>s #bjbb & 
#bjbc & ins]t+ #dj1jjj1jjj = ea* (      
fiscal ye>s #bjbd ?r\gh #bjbh2 &  7#b7 9
 p>agraph 7#b71 by /rik+ #bjbb & #bjbc &
 ins]t+ #bjbd ?r\gh #bjbh4  #cjc4       
,monitor+ & di/ribution ( c]ta9 m$ical  
c\nt]measures ,section #cai;,a7e7 ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#a7;e77 is am5d$ by    
/rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd  
?r\gh #bjbh4  #cjd4 ,enhanc$ control (  
dang]\s biological ag5ts & tox9s        
,section #cea;,a7m7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb;a7m77  
is am5d$ by /rik+ #bjbg & ins]t+ #bjbh4 
#cje4 ,mosquito-borne diseases ,section 
#cag,s7f7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bdg;b-#ba7;f77 is  
am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+  
#bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh  
#bjbh2 &  7#b7 by /rik+ p>agraph 7#c74  
#cjf4 ,epidemiology-laboratory capacity 
,section #bhba7;b7 7#db ,u4,s4,c4       
#cjj;hh-#ca7;b77 is am5d$ by /rik+ #bjai

 ?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh4
  #cjg4 ,support+ public heal? data     
availability & access  7a7 ,designation 
( public heal? data /&>ds ,section      
#bhbc7;a77#b7 ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4                    
#cjj;hh-#cc7;a77#b77 is am5d$ by add+ at
 ! end ! foll[+3  7,d7 ,selection ( data
 & te*nology /&>ds ,! /&>ds designat$ z 
describ$ 9 subp>agraph 7,a7 may include 
/&>ds to improve--  7i7 ! ex*ange (     
electronic heal? in=mation =-- 7,i7     
electronic case report+2  7,,ii7        
syndromic surveillance2  7,,iii7 report+
 ( vital /ati/ics2 &  7,,iv7 report+ te/
 ord]s & results electronically1 includ+
 f laboratories2  7ii7 automat$         
electronic report+ to relevant public   
heal? data sy/ems ( ! ,c5t]s = ,disease 
,control & ,prev5tion2 &  7iii7 su* o!r 
uses z ! ,secret>y det]m9es appropriate4
  7,e7 ,consid]ations ,/&>ds designat$  
"u ?is p>agraph %all include /&>ds &    
implem5tation specifications necess>y to
 ensure ! appropriate capture1 ex*ange1 

access1 & use ( in=mation reg>d+ race1  
e?nicity1 sex 7includ+ sexual ori5tation
 & g5d] id5tity71 disability /atus1     
vet]an /atus1 h\s+ /atus1 age1          
functional /atus1 & o!r elem5ts4  4  7b7
 ,improv+ in=mation %>+ & availability (
 public heal? data ,section #caj;,b ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdbu7 is am5d$ to read z     
foll[s3  #caj;,b4 ,improv+ in=mation %>+
 & availability ( public heal? data  7a7
 ,9 g5]al ,! ,secret>y act+ ?r\gh !     
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion 79 ?is section ref]r$ to z
 ! ,secret>y7 may require ! report+ (   
public heal? & heal? c>e data &         
in=mation to ! ,c5t]s = ,disease        
,control & ,prev5tion by--  7#a7 heal?  
c>e provid]s & facilities1 includ+      
ph>macies2  7#b7 public heal?1 cl9ical1 
& o!r laboratories & diagno/ic te/+     
entities2  7#c7 ,/ate1 local1 & ,tribal 
heal? dep>tm5ts2 &  7#d7 o!r entities1 z
 det]m9$ appropriate by ! ,secret>y4    
7b7 ,cont5t1 =m1 mann]1 & frequ5cy  7#a7

 ,collaboration ,! ,secret>y %all       
collaborate ) repres5tatives ( ,/ate1   
local1 & ,tribal heal? dep>tm5ts & o!r  
entities on det]m9+ ! cont5t1 =m1 mann]1
 & frequ5cy ( ! report+ ( public heal? &
 heal? c>e data & in=mation requir$     
pursuant to subsection 7a74  7#b7       
,simultane\s report+ ,9 det]m9+ !       
cont5t1 =m1 mann]1 & frequ5cy ( !       
report+ ( public heal? & heal? c>e data 
& in=mation pursuant to subsection 7a71 
:]e a disease1 condition1 or relat$ ev5t
 is reportable "u applicable ,/ate or   
local law1 ! ,secret>y %all require !   
data & in=mation to be report$ fir/ or  
simultane\sly to ! appropriate ,/ate or 
local jurisdiction4  7#c7 ,alignm5t )   
/&>ds & implem5tation specifications ,! 
cont5t1 =m1 mann]1 & frequ5cy           
requirem5ts requir$ pursuant to ?is     
section %all align ) ! /&>ds &          
implem5tation specifications adopt$ by !
 ,secret>y "u section #cjjd1 :]e        
applicable4  7#d7 ,reasonable ef=ts to  
limit report+ ,! ,secret>y %all make    

reasonable ef=ts to limit ! public heal?
 & heal? c>e data & in=mation requir$ to
 be report$ "u ?is section to ! m9imum  
necess>y to accompli% ! int5d$ public   
heal? purpose4  7#e7 ,implem5tation &   
regulations ,! ,secret>y-- 7,a7 may     
promulgate by regulation ! cont5t1 =m1  
mann]1 & frequ5cy 9 :i* public heal? &  
heal? c>e data & in=mation is requir$ to
 be report$ "u ?is section2 &  7,b7 9 ! 
ev5t ( a public heal? em]g5cy decl>$ "u 
section #cai1 or :]e ! ,secret>y        
det]m9es !re is a significant pot5tial =
 su* an em]g5cy to exi/1 may issue su*  
requirem5ts-- 7i7 by guidance 9         
accordance ) ?is section2 &  7ii7 )\t   
reg>d to ! proc$ures o!rwise requir$ by 
section #eec ( title #e1 ,unit$ ,/ates  
,code4  7c7 ,ensur+ t data is accessible
 9 a timely mann] to ,/ate1 local1 &    
,tribal heal? au?orities  7#a7          
,collaboration ,! ,secret>y %all        
collaborate ) repres5tatives ( ,/ate1   
local1 & ,tribal heal? dep>tm5ts1 &     
entities repres5t+ su* dep>tm5ts1 to    

ensure t data & in=mation t is collect$ 
by ! ,c5t]s = ,disease ,control &       
,prev5tion pursuant to ?is section are  
accessible1 z appropriate1 9 a timely   
mann]1 to ,/ate1 local1 & ,tribal heal? 
au?orities4  7#b7 ,rules ( con/ruction  
,no?+ 9 ?is section %all be con/ru$--   
7,a7 to prev5t any ,f$]al ag5cy1 ,/ate1 
local1 or ,tribal heal? dep>tm5t1 or o!r
 entity f collect+ data or in=mation "u 
o!r applicable law2 or  7,b7 to limit ! 
au?ority ( ! ,c5t]s = ,disease ,control 
& ,prev5tion to %>e public heal?        
surveillance data ) ,/ate1 local1 or    
,tribal heal? au?orities4  7#c7         
,reasonable ef=ts to r$uce report+      
burd5s & pot5tial duplication ,!        
,secret>y %all make reasonable ef=ts to 
collaborate ) repres5tatives ( ,f$]al   
ag5cies & ,/ate1 local1 & ,tribal heal? 
dep>tm5ts to r$uce report+ burd5s &     
pot5tial duplication ( report+          
requirem5ts4 ,su* ef=ts may include     
ensur+ simultane\s %>+ ( data &         
in=mation describ$ 9 subsection 7b7 )   

,/ate1 local1 & ,tribal public heal?    
au?orities4  7d7 ,confid5tiality &      
protection ( data ,any id5tifiable1     
s5sitive in=mation report$ to ! ,c5t]s =
 ,disease ,control & ,prev5tion pursuant
 to ?is section %all n be fur!r disclos$
 or provid$ to any o!r individual or    
p>ty1 includ+ any p>ty involv$ 9 civil1 
crim9al1 or adm9i/rative litigation1    
except-- 7#a7 z necess>y = public heal? 
purposes1 includ+ ) relevant ,f$]al1    
,/ate1 local1 or tribal public heal?    
au?orities2  7#b7 z requir$ "u section  
#eeb;a7d77#a7 ( title #e1 ,unit$ ,/ates 
,code2  7#c7 z requir$ by applicable    
,f$]al laws1 exclud+ in/ances (         
disclosure 9 any ,f$]al1 ,/ate1 or local
 civil1 crim9al1 adm9i/rative1          
legislative1 or o!r proce$+2 or  7#d7 ) 
! cons5t ( ea* individual to :om !      
in=mation p]ta9s4  7e7 ,exemption (     
c]ta9 public heal? data f disclosure ,! 
,secret>y may exempt f disclosure "u    
section #eeb7;b77#c7 ( title #e1 ,unit$ 
,/ates ,code1 public heal? & heal? c>e  

data & in=mation collect$ by ! ,c5t]s = 
,disease ,control & ,prev5tion pursuant 
to ?is section or any o!r au?ority "u   
:i* ! ,c5t]s collects public heal? or   
heal? c>e data & in=mation if--  7#a7 an
 individual is id5tifi$ ?r\gh su* data  
or in=mation2 or  7#b7 !re is at lea/ a 
v small risk1 z det]m9$ by curr5t       
sci5tific practices or /ati/ical me?ods1
 t "s comb9ation ( ! data or in=mation1 
! reque/ = disclosure "u su* section    
#eeb7;b77#c71 & o!r available data      
s\rces or ! application ( te*nology c\ld
 be us$ to d$uce ! id5tity ( !          
individuals to :i* su* data or in=mation
 p]ta9s4  4  7c7 ,public ,heal?         
,in=mation ,%>+ & ,availability         
,advisory ,committee ,"p ,a ( title     
,,iii ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bda et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #caj;,c4      
,public ,heal? ,in=mation ,%>+ &        
,availability ,advisory ,committee  7a7 
,e/abli%m5t ,! ,secret>y1 act+ ?r\gh !  
,director ( ! ,c5t]s = ,disease ,control

 & ,prev5tion1 %all e/abli% an advisory 
committee1 to be kn[n z ! ,public ,heal?
 ,in=mation ,%>+ & ,availability        
,advisory ,committee1 to advise1 & make 
recomm5dations to1 ! ,director ) respect
 to ! implem5tation ( public heal? &    
heal? c>e data & in=mation report+ & %>+
 "u section #caj;,b4  7b7 ,memb]%ip ,!  
memb]%ip ( ! advisory committee e/abli%$
 pursuant to ?is section %all include-- 
7#a7 individuals ) subject matt]        
exp]tise or exp]i5ce 9 ! foll[+ areas ( 
public heal? & heal? c>e data &         
in=mation1 includ+--  7,a7 ,/ate1       
t]ritorial1 local1 & ,tribal heal?      
dep>tm5t data sy/ems or practices2 &    
7,b7 heal? c>e data2  7#b7 ex (ficio    
memb]s1 includ+ f relevant ,f$]al       
ag5cies su* z ! ,(fice ( ! ,national    
,coord9ator = ,heal? ,in=mation         
,te*nology1 ! ,c5t]s = ,m$ic>e  ,m$icaid
 ,s]vices1 ! ,c5t]s = ,disease ,control 
& ,prev5tion1 & ! ,(fice ( ! ,assi/ant  
,secret>y = ,heal?2  7#c7 repres5tatives
 ( national organizations1 includ+ !    

,c\ncil ( ,/ate & ,t]ritorial           
,epidemiologi/s1 ! ,association (       
,public ,heal? ,laboratories1 !         
,association ( ,/ate & ,t]ritorial      
,heal? ,(ficials1 ! ,national           
,association ( ,c\nty & ,city ,heal?    
,(ficials1 & ! ,big ,cities ,heal?      
,coalition2 &  7#d7 su* additional      
memb]s z ! ,secret>y det]m9es           
appropriate4  7c7 ,,faca applicability  
,! advisory committee e/abli%$ pursuant 
to ?is section is deem$ to be an        
advisory committee subject to ! ,f$]al  
,advisory ,committee ,act4  4  7d7      
,improv+ public heal? data collection   
7#a7 ,9 g5]al ,! ,secret>y ( ,heal? &   
,human ,s]vices 7ref]r$ to 9 ?is        
subsection z ! ,secret>y7 %all aw>d     
grants1 contracts1 or coop]ative        
agreem5ts to eligible entities =        
purposes ( id5tify+1 develop+1 or       
dissem9at+ be/ practices 9 ! collection 
( electronic heal? in=mation & ! use (  
designat$ data /&>ds & implem5tation    
specifications-- 7,a7 to improve !      

quality & complet5ess ( data1 includ+   
demographic data1 collect$1 access$1 or 
us$ = public heal? purposes2 &  7,b7 to 
address heal? disp>ities & relat$ heal? 
outcomes4  7#b7 ,eligible entities ,to  
be eligible to receive an aw>d "u ?is   
subsection an entity %all--  7,a7 be a  
heal? c>e provid]1 academic m$ical c5t]1
 community-bas$ organization1 ,/ate1    
local gov]nm5tal entity1 ,indian ,tribe 
or ,tribal organization 7z su* t]ms are 
def9$ 9 section #d ( ! ,indian ,self    
,det]m9ation & ,education ,assi/ance    
,act 7#be ,u4,s4,c4 #ecjd771 ,urban     
,indian organization 7z def9$ 9 section 
#d ( ! ,indian ,heal? ,c>e ,improvem5t  
,act 7#be ,u4,s4,c4 #afjc771 or o!r     
appropriate public or private nonpr(it  
entity1 or a consortia ( any su*        
entities2 &  7,b7 submit an application 
to ! ,secret>y at su* "t1 9 su* mann]1 &
 conta9+ su* in=mation z ! ,secret>y may
 require4  7#c7 ,activities ,entities   
receiv+ aw>ds "u ?is subsection %all use
 su* aw>d to develop & te/ be/ practices

 = tra9+ heal? c>e provid]s to use /&>ds
 & implem5tation specifications t assi/ 
9 ! capture1 access1 ex*ange1 & use (   
electronic heal? in=mation1 includ+     
demographic in=mation1 disability /atus1
 vet]an /atus1 h\s+ /atus1 functional   
/atus1 & o!r data elem5ts4 ,su*         
activities %all1 at a m9imum1 include-- 
7,a7 improv+1 und]/&+1 & us+ data /&>ds 
& implem5tation specifications2  7,b7   
develop+ or id5tify+ me?ods to improve  
communication ) pati5ts 9 a culturally &
 l+ui/ically appropriate mann]1 includ+ 
to bett] capture in=mation relat$ to    
demographics ( su* individuals2  7,c7   
develop+ me?ods = accurately categoriz+ 
& record+ pati5t responses us+ available
 data /&>ds2  7,d7 educat+ provid]s     
reg>d+ ! utility ( su* in=mation =      
public heal? purposes & ! importance (  
accurate collection & record+ ( su*     
data2 &  7,e7 o!r activities1 z !       
,secret>y det]m9es appropriate4  7#d7   
,report+  7,a7 ,report+ by aw>d         
recipi5ts ,ea* recipi5t ( an aw>d "u ?is

 subsection %all submit to ! ,secret>y a
 report on ! results ( be/ practices    
id5tifi$1 develop$1 or dissem9at$ ?r\gh 
su* aw>d4  7,b7 ,report to congress ,n  
lat] ?an #a ye> aft] ! completion ( !   
program "u ?is subsection1 ! ,secret>y  
%all submit a report to ,congress on !  
success ( ! be/ practices develop$ "u   
su* program1 opportunities = fur!r      
dissem9ation ( su* be/ practices1 &     
recomm5dations = improv+ ! capture1     
access1 ex*ange1 & use ( in=mation to   
improve public heal? & r$uce heal?      
disp>ities4  7#e7 ,nonduplication (     
ef=ts ,! ,secret>y %all ensure t !      
activities & programs c>ri$ out "u ?is  
subsection are free ( unnecess>y        
duplication ( ef=t4  7#f7 ,au?orization 
( appropriations ,!re is au?oriz$ to be 
appropriat$ #aj1jjj1jjj = ea* ( fiscal  
ye>s #bjbd ?r\gh #bjbf to c>ry out ?is  
subsection4  7e7 ,in=mation collection  
,section #cai;,d7a7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;d-#d7;a77 is am5d$ by add+ at ! end

 ! foll[+3  7#e7 ,in=mation collection  
,sub*apt] ,i ( *apt] #ce ( title #dd1   
,unit$ ,/ates ,code1 %all n apply to    
in=mation collection by ! ,c5t]s =      
,disease ,control & ,prev5tion1 includ+ 
! ,ag5cy = ,toxic ,sub/ances & ,disease 
,regi/ry1 t are "p ( inve/igations1     
rese>*1 surveillance1 or evaluations    
und]tak5 = public heal? purposes "u any 
available au?ority4  4  ,,iv ,ensur+    
work=ce to prep>e = & respond to public 
heal? security ?reats  #dja4 ,tempor>y  
reassignm5t ( ,/ate & local p]sonnel    
dur+ a public heal? em]g5cy  7a7 ,report
 to ,congress ,section #cai7;e77#f7 ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d7e77#f77 is am5d$ by    
/rik+ ,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 & ins]t+ ,n lat] ?an #d ye>s
 aft] ! date ( enactm5t ( ! ,protect+   
,,pahpa ,act ( #bjbc1 ! ,comptroll]     
,g5]al ( ! ,unit$ ,/ates %all4  7b7     

,sunset ,section #cai7;e77#h7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d7e77#h77 is am5d$ by    
/rik+ #bjbc & ins]t+ #bjbh4  #djb4      
,epidemic ,intellig5ce ,s]vice ,section 
#cag;,f7c77#b7 ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;b-#g7;c77#b77 is am5d$ by /rik+    
#bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh  
#bjbh4  ,v ,address+ drug & supply *a9  
%ortages  ,a ,ensur+ access to lifesav+ 
drugs  #eja4 ,ext5d$ expiration dates = 
life-sav+ drugs  7a7 ,9 g5]al ,! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja et seq47 is am5d$ by     
ins]t+ aft] section #ejf,l ( su* ,act   
7#ba ,u4,s4,c4 #cefl7 ! foll[+ new      
section3  #ejf,m4 ,ext5d$ expiration    
dates = life-sav+ drugs  7a7 ,9 g5]al ,a
 manufactur] ( a life-sav+ drug %all--  
7#a7 submit to ! ,secret>y data &       
in=mation z requir$ by subsection       
7b77#a72  7#b7 conduct & submit !       
results1 data1 & in=mation g5]at$ by any
 /udies requir$ "u subsection 7b77#b72 &

  7#c7 make any label+ *ange describ$ 9 
subsection 7c7 by ! date specifi$ by !  
,secret>y pursuant to su* subsection4   
7b7 ,data & in=mation  7#a7 ,9 g5]al ,! 
,secret>y may issue an ord] requir+ !   
manufactur] ( a life-sav+ drug to       
submit1 9 su* mann] z ! ,secret>y may   
prescribe1 data & in=mation f any /age (
 developm5t ( ! drug t are adequate to  
assess ! /ability ( ! drug to det]m9e ! 
longe/ support$ expiration date4  7#b7  
,lack ( data & in=mation ,if ! data &   
in=mation requir$ pursuant to an ord]   
issu$ "u p>agraph 7#a7 are n available  
or are insuffici5t1 z det]m9$ by !      
,secret>y1 ! ,secret>y may issue an ord]
 requir+ ! manufactur] ( ! drug--  7,a7 
to conduct /udies1 :i* may be a         
cont9uation ( ongo+ /udies1 to provide  
data & in=mation adequate to assess !   
/ability ( ! drug & to det]m9e ! longe/ 
support$ expiration date2 &  7,b7 to    
submit su* data & in=mation to !        
,secret>y 9 su* mann] z ! ,secret>y may 
prescribe 9 ! ord]4  7c7 ,label+ ,!     

,secret>y may issue an ord] requir+ !   
manufactur] ( a life-sav+ drug1 by a    
date det]m9$ by ! ,secret>y 9           
consultation ) ! sponsor ( ! drug1 to   
make any label+ *ange reg>d+ !          
expiration date or /orage & h&l+ ( !    
drug t ! ,secret>y det]m9es to be       
appropriate bas$ on ! data & in=mation  
requir$ to be submitt$ "u ?is section or
 any o!r data & in=mation available to !
 ,secret>y4  7d7 ,def9itions ,9 ?is     
section3  7#a7 ,life-sav+ drug ,! t]m   
life-sav+ drug means a drug1 t is-- 7,a7
 7i7 a m$ical c\nt]measure2 or  7ii7 on 
! drug %ortage li/ "u section #ejf;,e or
 det]m9$ by ! ,secret>y to be at risk ( 
%ortage2 &  7,b7 7i7 life-support+2     
7ii7 life-su/a9+2 or  7iii7 int5d$ = use
 9 ! prev5tion or treatm5t ( a          
debilitat+ disease or condition 9 humans
 or animals1 includ+ any su* drug us$ 9 
em]g5cy m$ical c>e or dur+ surg]y or any
 su* drug t is critical to ! public     
heal? dur+ a public heal? em]g5cy decl>$
 by ! ,secret>y "u section #cai ( !     

,public ,heal? ,s]vice ,act4  7#b7      
,m$ical c\nt]measure ,! t]m m$ical      
c\nt]measure means a c\nt]measure z     
def9$ 9 section #efe7;a74  7e7          
,confid5tiality ,no?+ 9 ?is section %all
 be con/ru$ z au?oriz+ ! ,secret>y to   
disclose any in=mation t is a trade     
secret or confid5tial in=mation subject 
to section #eeb7;b77#d7 ( title #e1     
,unit$ ,/ates ,code1 or section #aije ( 
title #ah1 ,unit$ ,/ates ,code4  4  7b7 
,prohibit$ act ,section #cja ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cca71 z am5d$ by section     
#cejc7;a77#a77;,a7 ( division ,,ff (    
,public ,law #aag-cbh1 is am5d$ by      
ins]t+ at ! end ! foll[+ new subsection3
  7jjj7 ,! failure to comply ) any ord] 
issu$ "u section #ejf,m4  4  7c7        
,p5alties ,subsection 7b7 ( section #cjc
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #ccc7 is am5d$ by   
ins]t+ at ! end ! foll[+3  7#i7 ,if a   
manufactur] ( a life-sav+ drug fails to 
submit data & in=mation z requir$ "u    

section #ejf,m7b77#a71 fails to conduct 
or submit ! data & in=mation g5]at$ by  
/udies z requir$ "u section             
#ejf,m7b77#b71 or fails to make a label+
 *ange z requir$ "u section #ejf,m7c71  
su* manufactur] %all be subject to a    
civil p5alty ( n m ?an #aj1jjj = ! fir/ 
day on :i* ! violation occurs & n m ?an 
#aj1jjj = ea* subsequ5t day on :i* !    
violation is n correct$4  4  ,b ,drug   
orig9 transp>5cy  #eaa4 ,enhanc$ drug   
manufactur+ am\nt in=mation report+  7a7
 ,9 g5]al ,section #eaj7;j77#c7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj7;j77#c77 is am5d$-- 
7#a7 9 subp>agraph 7,a71 by add+ or 7#b7
 aft] p>agraph 7#a72 &  7#b7 by add+ at 
! end ! foll[+3  7,c7 ,ea* report       
submitt$ pursuant to subp>agraph 7,a7 ) 
respect to a drug %all--  7i7 include   
additional in=mation z may be specifi$  
by ! ,secret>y 9 regulation or guidance 
reg>d+ ! supply *a9 = su* drug1 su* z-- 
7,i7 ! id5tity ( ! respective suppli]s (
 ea* active ph>maceutical +r$i5t1 active

 ph>maceutical +r$i5t int]m$iate1 &     
9-process mat]ial us$ 9 su* manufacture1
 prep>ation1 propagation1 comp\nd+1 or  
process+ ( ! drug2 &  7,,ii7 !          
respective am\nts ( su* drug t 7        
manufactur$1 prep>$1 propagat$1         
comp\nd$1 or process$ us+ an active     
ph>maceutical +r$i5t1 active            
ph>maceutical +r$i5t int]m$iate1 &      
9-process mat]ial f ea* su* id5tifi$    
suppli]2 &  7ii7 be submitt$ m frequ5tly
 ?an annually1 9 accordance ) a report+ 
s*$ule z may be specifi$ by ! ,secret>y 
9 su* regulation or guidance1 b n m     
frequ5tly ?an #d times p] ye>4  7,d7    
,any additional in=mation specifi$ 9    
regulation or guidance pursuant to      
subp>agraph 7,c7 %all be a requir$      
elem5t ( reports "u ?is p>agraph n e>li]
 ?an #f mon?s aft] ! date on :i* su*    
regulation or guidance is issu$ 9 f9al  
=m 7& 9 no ev5t %all ! abs5ce ( any     
regulation or guidance issu$ "u         
subp>agraph 7,c7 affect ! requirem5t to 
report z describ$ 9 subp>agraph 7,a774  

4  7b7 ,con=m+ am5dm5t ,section         
#eaj7;j77#c77;,b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#eaj7;j77#c77;,b77 is am5d$ by /rik+    
subp>agraph 7,a7 & ins]t+ ?is p>agraph4 
#eab4 ,require drug label+ to include   
orig9al manufactur] & supply *a9        
in=mation ,section #ejb ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #ceb7 is am5d$-- 7#a7 9       
p>agraph 7b7--  7,a7 by /rik+ 7b7 ,if 9 
a package & ins]t+ 7b77#a7 ,if 9 a      
package2  7,b7 by /rik+ a label conta9+ 
7#a7 ! "n & place & ins]t+  a label     
conta9+-- 7,a7 ! "n & place  2  7,c7 by 
/rik+ or di/ributor2 & 7#b7 an accurate 
/atem5t & ins]t+ or di/ributor2 &  7,b7 
an accurate /atem5t  2  7,d7 by /rik+ "u
 clause 7#b7 ( ?is p>agraph & ins]t+ "u 
?is clause2 &  7,e7 by ins]t+ at ! end !
 foll[+3  7#b7 7,a7 ,subject to clause  
7,c71 if x is a drug1 includ+ an active 
ph>maceutical +r$i5t1 unless x be>s a   
label conta9+ ! "n & place ( bus9ess1 & 
unique facility id5tifi] ( ! orig9al    

manufactur] ( su* drug or active        
ph>maceutical +r$i5t1 except t !        
,secret>y may provide1 by regulation1 = 
reasonable v>iations 9 ! implem5tation (
 su* label+ requirem5ts4  7,b7 ,subject 
to clause 7,c71 if x is a drug t is an  
active ph>maceutical +r$i5t1 unless any 
accompany+ c]tificate ( analysis conta9s
 ! "n & place ( bus9ess1 & unique       
facility id5tifi] ( ! orig9al           
manufactur] ( ! active ph>maceutical    
+r$i5t4  7,c7 ,! ,secret>y may provide1 
by regulation1 = reasonable v>iations 9 
! implem5tation ( label+ requirem5ts    
specifi$ 9 ?is subp>agraph4  2 &  7#b7  
by ins]t+ aft] p>agraph 7c7 ! foll[+3   
7d7 7#a7 ,subject to subp>agraph 7#b71  
if x is a drug1 includ+ an active       
ph>maceutical +r$i5t1 unless x be>s     
label+ conta9+ ! "n & place ( bus9ess   
(--  7,a7 ! orig9al manufactur] ( ea*   
active ph>maceutical +r$i5t2  7,b7 ea*  
manufactur]1 if diff]5t f ! orig9al     
manufactur]2 &  7,c7 ! pack] or         
di/ributor1 if any4  7#b7 ,! ,secret>y  

may provide1 by regulation1 = reasonable
 v>iations or an alt]native placem5t = !
 label+ requirem5ts specifi$ 9          
subp>agraph 7#a71 includ+ by electronic 
means4  4  ,c ,m$ical device %ortage    
r$uction  #eba4 ,cl>ify+ device %ortage 
notifications ,section #ejf;,j7a7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cef;j7a77 is am5d$--    
7#a7 9 p>agraph 7#b71 by /rik+ dur+1 or 
9 advance (1 a public heal? em]g5cy2 &  
7#b7 9 ! matt] foll[+ p>agraph 7#b71 by 
/rik+ 1 dur+1 or 9 advance (1 a public  
heal? em]g5cy decl>$ by ! ,secret>y "u  
section #cai ( ! ,public ,heal? ,s]vice 
,act14  #ebb4 ,supply *a9 risk managem5t
  7a7 ,section #ejf;,j ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cef;j7 is am5d$ by /rik+ subsection 7h7
 & ins]t+ ! foll[+3  7h7 ,risk managem5t
 plans ,ea* manufactur] ( a device      
describ$ 9 subsection 7a7 %all develop1 
ma9ta91 &1 z appropriate1 implem5t a    
risk managem5t plan t id5tifies &       
evaluates risks to ! supply ( ! device1 

z applicable1 = ea* e/abli%m5t 9 :i* su*
 device is manufactur$4 ,su* risk       
managem5t plan-- 7#a7 may id5tify &     
evaluate risks to ! supply ( m ?an #a   
device1 or device category1 manufactur$ 
at ! same e/abli%m5t2 &  7#b7 %all be   
subject to inspection & copy+ by !      
,secret>y pursuant to section #gjd or at
 ! reque/ ( ! ,secret>y4  4  7b7 ,con=m+
 am5dm5t ,section #ejf;,j7f7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef;j7f77 is am5d$ by /rik+  
or 7h7 aft] subsection 7a74  #ebc4      
,cl>ify+ volunt>y notifications ,section
 #ejf;,j7i7 ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7i77
 is am5d$ by add+ at ! end ! foll[+3    
,no?+ 9 ?is section %all be con/ru$ to  
limit ! au?ority ( ! ,secret>y to reque/
 t a manufactur] 7or o!r p]son involv$ 9
 ! device supply *a97 provide1 on a     
volunt>y basis1 in=mation to ! ,secret>y
 or ! au?ority ( ! ,secret>y to receive 
su* in=mation44  ,d ,drug %ortage       
prev5tion  #eca4 ,improv+ notification  

proc$ures 9 case ( increas$ dem& =      
critical ess5tial m$ic9es  7a7 ,9 g5]al 
,section #ejf;,c ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;c7 is am5d$--  7#a7 9 ! section    
head+1 by /rik+ ,discont9uance or       
int]ruption 9 ! production ( life-sav+  
drugs & ins]t+ ,notification ( issues   
affect+ dome/ic supply ( critical       
ess5tial m$ic9es2  7#b7 by /rik+        
subsections 7a71 7b71 & 7c71 & ins]t+ ! 
foll[+3  7a7 ,notification requir$  7#a7
 ,9 g5]al ,a manufactur] ( a critical   
ess5tial m$ic9e %all notify ! ,secret>y1
 9 accordance ) subsection 7b71 (-- 7,a7
 7i7 a p]man5t discont9uance 9 !        
manufacture ( ! drug or an int]ruption (
 ! manufacture ( ! drug t is likely to  
lead to a mean+ful disruption 9 ! supply
 ( su* drug 9 ! ,unit$ ,/ates2  7ii7 a  
p]man5t discont9uance 9 ! manufacture ( 
an active ph>maceutical +r$i5t1 an      
excipi5t1 or any o!r input 9 ! f9al     
dosage =m ( su* drug or an int]ruption 9
 ! manufacture ( ! active ph>maceutical 

+r$i5t1 an excipi5t1 or any o!r input 9 
! f9al dosage =m ( su* drug ( su* drug t
 is likely to lead to a mean+ful        
disruption 9 ! supply ( ! active        
ph>maceutical +r$i5t ( su* drug2  7iii7 
an increas$ dem& 7o!r ?an an anticipat$ 
seasonal surge7 = su* drug or an active 
ph>maceutical +r$i5t1 an excipi5t1 or   
any o!r input 9 ! f9al dosage =m ( su*  
drug t is likely to lead to a %ortage ( 
! drug or ! active ph>maceutical +r$i5t1
 an excipi5t1 or any o!r input 9 ! f9al 
dosage =m ( su* drug2 &  7,b7 ! reasons 
= su* discont9uance1 int]ruption1 or    
increas$ dem&4  7#b7 ,cont5ts           
,notification "u ?is subsection )       
respect to a critical ess5tial m$ic9e   
%all include--  7,a7 ) respect to !     
reasons = ! discont9uation1 int]ruption1
 or increas$ dem& ref]r$ to 9 p>agraph  
7#a77;,c71 if an active ph>maceutical   
+r$i5t1 an excipi5t1 or any o!r input 9 
! f9al dosage =m ( su* drug is a reason 
=1 or risk factor 91 su* discont9uation1
 int]ruption1 or increas$ dem&1 ! s\rce 

( ! active ph>maceutical +r$i5t1        
excipi5t1 or o!r input & any alt]native 
s\rces = ! an active ph>maceutical      
+r$i5t1 an excipi5t1 or any o!r input by
 ! manufactur]2  7,b7 :e!r any associat$
 device us$ = prep>ation or adm9i/ration
 includ$ 9 ! drug is a reason =1 or a   
risk factor 91 su* discont9uation1      
int]ruption1 or increas$ dem&2  7,c7 !  
expect$ duration ( ! int]ruption or     
increas$ dem&2 &  7,d7 su* o!r in=mation
 z ! ,secret>y may require4  7b7 ,tim+  
7#a7 ,9 g5]al ,a notice requir$ "u      
subsection 7a7 %all be submitt$ to !    
,secret>y-- 7,a7 at lea/ #f mon?s prior 
to ! date ( ! discont9uance or          
int]ruption2  7,b7 9 ! case ( su* a     
notice ) respect to increas$ dem& = a   
critical ess5tial m$ic9e1 n lat] ?an #cj
 days aft] ! submission ( ! initial     
notification "u p>agraph 7#b72 or  7,c7 
if compliance ) subp>agraph 7,a7 or 7,b7
 is n possible1 z soon z practicable4   
7#b7 ,initial notification ) respect to 
increas$ dem& ,9 ! case a notification  

requir$ "u subsection 7a7 ) respect to  
increas$ dem& = a critical ess5tial     
m$ic9e1 ! manufactur] ( ! drug involv$  
%all submit to ! ,secret>y an initial   
notification n lat] ?an #dh h\rs aft] ! 
date on :i* !re has be5 increas$ dem& = 
! critical ess5tial m$ic9e = a p]iod (  
at lea/ #f consecutive weeks4  7c7      
,di/ribution ,to ! maximum ext5t        
practicable1 ! ,secret>y %all di/ribute1
 ?r\gh su* means z ! ,secret>y deems    
appropriate1 in=mation on !             
discont9uance or int]ruption ( !        
manufacture (1 or ! increas$ dem& =1    
critical ess5tial m$ic9es to appropriate
 organizations1 includ+ physician1 heal?
 provid]1 & pati5t organizations1 z     
describ$ 9 section #ejf;,e4  2  7#c7 9  
subsection 7g71 9 ! matt] prec$+        
p>agraph 7#a71 by /rik+ drug describ$ 9 
subsection 7a7 & ins]t+ critical        
ess5tial m$ic9e2 &  7#d7 9 subsection   
7j71 by /rik+ drug describ$ 9 subsection
 7a7 & ins]t+ critical ess5tial m$ic9e4 
7b7 ,application to nonprescription     

drugs ,section #ejf;,c7h7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef;c7h77 is am5d$-- 7#a7 by 
r$esignat+ p>agraphs 7#a71 7#b71 & 7#c7 
z p>agraphs 7#b71 7#c71 & 7#d71         
respectively2  7#b7 9 p>agraph 7#b77;,a7
 7z s r$esignat$71 by /rik+ & t is      
subject to section #ejc7;b77#a7 & ins]t+
 1 includ+ a drug t is n subject to     
section #ejc7;b77#a72 &  7#c7 by ins]t+ 
be=e p>agraph 7#b7 7z s r$esignat$7 !   
foll[+3  7#a7 ! t]m critical ess5tial   
m$ic9e means a drug t-- 7,a7 is--  7i7  
life-support+2  7ii7 life-su/a9+2 or    
7iii7 int5d$ = use 9 ! prev5tion or     
treatm5t ( a debilitat+ disease or      
condition1 includ+ any su* drug us$ 9   
em]g5cy m$ical c>e or dur+ surg]y or any
 su* drug t is critical to ! public     
heal? dur+ a public heal? em]g5cy decl>$
 by ! ,secret>y "u section #cai ( !     
,public ,heal? ,s]vice ,act2 &  7,b7 is 
n a radio ph>maceutical drug product or 
any o!r product z designat$ by !        
,secret>y2  4  7c7 ,regulations ,n lat] 

?an #ah mon?s aft] ! date ( ! enactm5t (
 ?is ,act1 ! ,secret>y ( ,heal? & ,human
 ,s]vices %all issue f9al regulations to
 implem5t ! am5dm5ts made by subsections
 7a7 & 7b74  7d7 ,guidance  7#a7 ,9     
g5]al ,! ,secret>y ( ,heal? & ,human    
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all issue guidance on !
 requirem5ts = notifications requir$ to 
be submitt$ "u section #ejf;,c ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cef;c71 z am5d$ by      
subsections 7a7 & 7b71 ) respect to     
increas$ dem& = critical ess5tial       
m$ic9es 7z def9$ 9 su* section #ejf;,c74
 ,su* guidance %all specifically        
address--  7,a7 ! ways 9 :i*            
manufactur]s ( critical ess5tial m$ic9es
 c improve dem& pr$ictability2  7,b7 :at
 in=mation manufactur]s ( critical      
ess5tial m$ic9es %\ld s5d to !          
,secret>y2 &  7,c7 :at communications f 
! manufactur] ! ,secret>y w\ld reque/ ) 
respect to increases 9 dem& foll[+ su*  
notifications4  7#b7 ,consultation ,9   

develop+ su* guidance1 ! ,secret>y %all 
consult ) relevant /akehold]s1 includ+  
manufactur]s ( critical ess5tial m$ic9es
 & local1 ,/ate1 or ,f$]al public heal? 
(ficials4  7#c7 ,tim+ ,! ,secret>y (    
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all     
issue-- 7,a7 draft guidance "u p>agraph 
7#a7 n lat] ?an #abj days aft] ! date ( 
! enactm5t ( ?is ,act2 &  7,b7 f9al     
guidance "u su* p>agraph n lat] ?an #ahj
 days aft] ! date ( ! enactm5t ( ?is    
,act4  ,e ,protect+ ,am]icans f unsafe  
drugs  #eda4 ,notification1             
nondi/ribution1 & recall ( drugs  7a7   
,ord] ,to cease di/ribution & recall    
,section #efi;,d ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;bbb-#h;d7 is am5d$--  7#a7 9 !     
section head+1 by /rik+ controll$       
sub/ances & ins]t+ drugs2  7#b7 by /rik+
 controll$ sub/ance ea* place su* t]m   
appe>s & ins]t+ drug2  7#c7 9 subsection
 7b7-- 7,a7 by /rik+ controll$ sub/ances
 & ins]t+ drugs2 &  7,b7 by ins]t+ (    

subsection 7a7 aft] an ord] pursuant to 
p>agraph 7#a7 or an am5d$ ord] pursuant 
to subp>agraph 7,b7 or 7,c7 ( p>agraph  
7#c72 &  7#d7 9 subsection 7c71 by /rik+
 or an (ficial s5ior to su* ,director & 
ins]t+ or ! ,director ( ! ,c5t] =       
,biologics ,evaluation & ,rese>* 7or an 
(ficial s5ior to ei!r su* ,director74   
7b7 ,imports & exports ,section #hja7;a7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cha7;a771 z am5d$  
by section #cejc7;a77#d77;,c7 ( division
 ,,ff ( ,public ,law #aag-cbh1 is am5d$ 
by /rik+ is a controll$ sub/ance subject
 to an ord] "u section #efi;,d & ins]t+ 
is a drug subject to an ord] "u section 
#efi;,d4