,,ii #aae? ,,congress #b;d ,session ,s4 #bheb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #ae1 #bjah,mr4 ,burr 7= himself1 ,mr4 ,casey1 ,mr4 ,alex&]1 & ,mrs4 ,murray7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to reau?orize c]ta9 programs "u ! ,p&emic & ,all-,haz>ds ,prep>$ness ,reau?orization ,act4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,ref]5ces 9 ,act4 ,,title ,i--,/r5g!n+ ! national heal? security /rategy ,sec4 #aja4 ,national ,heal? ,security ,/rategy4 ,,title ,,ii--,improv+ prep>$ness & response ,sec4 #bja4 ,improv+ b5*m>ks & /&>ds = prep>$ness & response4 ,sec4 #bjb4 ,am5dm5ts to prep>$ness & response programs4 ,sec4 #bjc4 ,regional heal? c>e em]g5cy prep>$ness & response sy/ems4 ,sec4 #bjd4 ,public heal? & heal? c>e sy/em situational aw>5ess & biosurveillance capabilities4 ,sec4 #bje4 ,/r5g!n+ & support+ ! public heal? em]g5cy rapid response fund4 ,sec4 #bjf4 ,improv+ prep>$ness = & response to all-haz>ds by public heal? em]g5cy volunte]s4 ,,title ,,iii--,rea*+ all communities ,sec4 #cja4 ,/r5g!n+ & assess+ ! em]g5cy response work=ce4 ,sec4 #cjb4 ,heal? sy/em infra/ructure to improve prep>$ness & response4 ,sec4 #cjc4 ,consid]ations = at-risk individuals4 ,sec4 #cjd4 ,improv+ em]g5cy prep>$ness & response consid]ations = *ildr54 ,sec4 #cje4 ,reau?oriz+ ! ,national ,advisory ,committee on ,*ildr5 & ,disa/]s4 ,sec4 #cjf4 ,guidance = p>ticipation 9 ex]cises & drills4 ,,title ,,iv--,prioritiz+ a ?reat-bas$ approa* ,sec4 #dja4 ,assi/ant ,secret>y = ,prep>$ness & ,response4 ,sec4 #djb4 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise4 ,sec4 #djc4 ,/rategic ,national ,/ockpile4 ,sec4 #djd4 ,prep>+ = p&emic influ5za1 antimicrobial resi/ance1 & o!r significant ?reats4 ,sec4 #dje4 ,report+ on ! ,f$]al ,select ,ag5t ,program4 ,,title ,v--,increas+ communication 9 m$ical c\nt]measure advanc$ rese>* & developm5t ,sec4 #eja4 ,m$ical c\nt]measure budget plan4 ,sec4 #ejb4 ,mat]ial ?reat & m$ical c\nt]measure notifications4 ,sec4 #ejc4 ,availability ( regulatory managem5t plans4 ,sec4 #ejd4 ,! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority & ! ,bio,shield ,special ,res]ve ,fund4 ,,title ,,vi--,advanc+ te*nologies = m$ical c\nt]measures ,sec4 #fja4 ,adm9i/ration ( c\nt]measures4 ,sec4 #fjb4 ,m$ical c\nt]measure ma/] files4 ,sec4 #fjc4 ,animal rule report4 ,,title ,,vii--,miscellane\s provisions ,sec4 #gja4 ,reau?orizations & ext5sions4 ,sec4 #gjb4 ,te*nical am5dm5ts4 #b4 ,ref]5ces 9 ,act ,except z o!rwise specifi$1 am5dm5ts made by ?is ,act to a section or o!r provision ( law are am5dm5ts to su* section or o!r provision ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq474 ,i ,/r5g!n+ ! national heal? security /rategy #aja4 ,national ,heal? ,security ,/rategy ,section #bhjb 7#db ,u4,s4,c4 #cjj;hh-#a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ #bjad & ins]t+ #bjah2 & 7ii7 by /rik+ ! second s5t5ce & ins]t+ ! foll[+3 ,su* ,national ,heal? ,security ,/rategy %all describe pot5tial em]g5cy heal? security ?reats & id5tify ! process = a*iev+ ! prep>$ness goals describ$ 9 subsection 7b7 to be prep>$ to id5tify & respond to su* ?reats & %all be consi/5t ) ! national prep>$ness goal 7z describ$ 9 section #ejd7;a77#ai7 ( ! ,homel& ,security ,act ( #bjjb71 ! ,national ,incid5t ,managem5t ,sy/em 7z def9$ 9 section #eja7g7 ( su* ,act71 & ! ,national ,response ,plan develop$ pursuant to section #ejd ( su* ,act1 or any successor plan42 7,b7 9 p>agraph 7#b71 by ins]t+ be=e ! p]iod at ! end ( ! second s5t5ce ! foll[+3 1 & an analysis ( any *anges to ! evid5ce-bas$ b5*m>ks & objective /&>ds "u sections #cai;,c-#a & #cai;,c-#b2 & 7,c7 9 p>agraph 7#c7-- 7i7 by /rik+ #bjji & ins]t+ #bjbb2 7ii7 by ins]t+ 7includ+ gaps 9 ! environm5tal heal? work=ce71 describ+ ! /atus ( su* work=ce aft] gaps 9 su* work=ce2 7iii7 by /rik+ & id5tify+ /rategies & ins]t+ id5tify+ /rategies2 & 7iv7 by ins]t+ be=e ! p]iod at ! end 1 & id5tify+ curr5t capabilities to meet ! requirem5ts ( section #bhjc2 & 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by /rik+ & inve/igation & ins]t+ inve/igation1 & relat$ in=mation te*nology activities2 7ii7 9 subp>agraph 7,b71 by /rik+ & decontam9ation & ins]t+ decontam9ation1 relevant heal? c>e s]vices & supplies1 & transportation & disposal ( m$ical wa/e2 & 7iii7 by add+ at ! end ! foll[+3 7,e7 ,response to environm5tal haz>ds4 2 7,b7 9 p>agraph 7#c77;,f71 by ins]t+ or exposures to ag5ts t c\ld cause a public heal? em]g5cy be=e ! p]iod2 7,c7 9 p>agraph 7#e71 by ins]t+ & o!r applicable compacts aft] ,compact2 & 7,d7 by add+ at ! end ! foll[+3 7#i7 ,zoonotic disease1 food1 & agriculture ,9 consultation ) ! ,secret>y ( ,agriculture1 improv+ coord9ation among ,f$]al1 ,/ate1 local1 tribal1 & t]ritorial entities to prev5t1 detect1 & respond to outbreaks ( plant or animal disease 7includ+ zoonotic disease7 t c\ld compromise national security result+ f a delib]ate attack1 a naturally occurr+ ?reat1 ! int5tional adult]ation ( food1 or o!r public heal? ?reats1 tak+ into acc\nt int]actions betwe5 animal heal?1 human heal?1 & animals' & humans' %>$ environm5t z directly relat$ to public heal? em]g5cy prep>$ness & response capabilities1 z applicable4 7#aj7 ,global heal? security ,assess+ curr5t or pot5tial heal? security ?reats f abroad to in=m dome/ic public heal? prep>$ness & response capabilities4 4 ,,ii ,improv+ prep>$ness & response #bja4 ,improv+ b5*m>ks & /&>ds = prep>$ness & response 7a7 ,evaluat+ measurable evid5ce-,bas$ b5*m>ks & objective /&>ds ,section #cai;,c-#a 7#db ,u4,s4,c4 #bdg;d-#c;a7 is am5d$ by ins]t+ aft] subsection 7j7 ! foll[+3 7k7 ,evaluation 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah & e #b ye>s !reaft]1 ! ,secret>y %all conduct an evaluation ( ! evid5ce-bas$ b5*m>ks & objective /&>ds requir$ "u subsection 7g74 ,su* evaluation %all be submitt$ to ! congressional committees ( jurisdiction toge!r ) ! ,national ,heal? ,security ,/rategy "u section #bhjb1 at su* "t z su* /rategy is submitt$4 7#b7 ,cont5t ,! evaluation "u ?is p>agraph %all include-- 7,a7 a review ( evid5ce-bas$ b5*m>ks & objective /&>ds1 & associat$ metrics & t>gets2 7,b7 a discussion ( *anges to any evid5ce-bas$ b5*m>ks & objective /&>ds1 & ! effect ( su* *anges on ! ability to track :e!r entities are meet+ or mak+ progress t[>d ! goals "u ?is section &1 to ! ext5t practicable1 ! applicable goals ( ! ,national ,heal? ,security ,/rategy "u section #bhjb2 7,c7 a description ( am\nts receiv$ by eligible entities1 z describ$ 9 subsection 7b7 & section #cai;,c-#b7;b71 & am\nts receiv$ by sub-recipi5ts & ! effect ( su* fund+ on meet+ evid5ce-bas$ b5*m>ks & objective /&>ds2 & 7,d7 recomm5dations1 z applicable & appropriate1 to improve evid5ce-bas$ b5*m>ks & objective /&>ds to m accurately assess ! ability ( entities receiv+ aw>ds "u ?is section to bett] a*ieve ! goals "u ?is section & section #bhjb4 4 7b7 ,evaluat+ ! p>tn]%ip = ,/ate & regional hospital prep>$ness ,section #cai;,c-#b7;i77#a7 7#db ,u4,s4,c4 #bdg-c;b7i77#a77 is am5d$ by /rik+ section #cai;,c-#a7;g71 7i71 & 7j7 & ins]t+ section #cai;,c-#a7;g71 7i71 7j71 & 7k74 #bjb4 ,am5dm5ts to prep>$ness & response programs 7a7 ,coop]ative agreem5t applications = improv+ ,/ate & local public heal? security ,section #cai;,c-#a 7#db ,u4,s4,c4 #bdg;d-#c;a7 is am5d$-- 7#a7 9 subsection 7a71 by ins]t+ 1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 aft] ! ,secret>y2 & 7#b7 9 subsection 7b77#b77;,a7-- 7,a7 9 clause 7vi71 by ins]t+ 1 includ+ public heal? ag5cies ) specific exp]tise t may be relevant to public heal? security1 su* z environm5tal heal? ag5cies1 aft] /akehold]s2 7,b7 by r$esignat+ clauses 7vii7 ?r\gh 7ix7 z clauses 7viii7 ?r\gh 7x72 & 7,c7 by ins]t+ aft] clause 7vi7 ! foll[+3 7vii7 a description ( h[1 z applicable1 su* entity may integrate in=mation to acc\nt = individuals ) behavioral heal? ne$s foll[+ a public heal? em]g5cy2 4 7b7 ,p>tn]%ip = ,/ate & regional hospital prep>$ness ,to improve surge capacity ,section #cai;,c-#b 7#db ,u4,s4,c4 #bdg;d-#c;b7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by ins]t+ 1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 aft] ,! ,secret>y2 & 7,b7 by /rik+ prep>$ness = public heal? em]g5cies & ins]t+ prep>$ness =1 & response to1 public heal? em]g5cies 9 accordance ) subsection 7c72 & 7#b7 9 subsection 7b77#a77;,a7-- 7,a7 9 clause 7iii71 by r$esignat+ subclauses 7,i7 ?r\gh 7,,iii7 z items 7aa7 ?r\gh 7cc71 respectively1 & adju/+ ! m>g9s accord+ly2 7,b7 by r$esignat+ clauses 7i7 ?r\gh 7iii7 z subclauses 7,i7 ?r\gh 7,,iii7 respectively1 & adju/+ ! m>g9s accord+ly2 7,c7 by /rik+ p>tn]%ip consi/+ (-- & ins]t+ 8p>tn]%ip-- 7i7 consi/+ (-- 2 & 7,d7 by add+ at ! end ! foll[+3 7ii7 t may include "o or m em]g5cy m$ical s]vice organizations or em]g5cy managem5t organizations2 & 4 7c7 ,public heal? security grants au?orization ( appropriations ,section #cai;,c-#a7;h77#a77;,a7 7#db ,u4,s4,c4 #bdg;d-#c;a7h77#a77;,a77 is am5d$ by /rik+ #fda1ijj1jjj = fiscal ye> #bjad & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ #fhe1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc = aw>ds pursuant to p>agraph 7#c7 7subject to ! au?ority ( ! ,secret>y to make aw>ds pursuant to p>agraphs 7#d7 & 7#e7744 7d7 ,p>tn]%ip = ,/ate & regional hospital prep>$ness au?orization ( appropriations ,section #cai;,c-#b7;j7 7#db ,u4,s4,c4 #bdg;d-#c;b7j77 is am5d$-- 7#a7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,9 g5]al 7,a7 ,au?orization ( appropriations ,= purposes ( c>ry+ out ?is section & section #cai;,c-#c1 9 accordance ) subp>agraph 7,b71 !re is au?oriz$ to be appropriat$ #che1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 7,b7 ,res]vations ( am\nts = regional sy/ems 7i7 ,9 g5]al ,subject to clause 7ii71 ( ! am\nt appropriat$ "u subp>agraph 7,a7 = a fiscal ye>1 ! ,secret>y may res]ve up to #e p]c5t = ! purpose ( c>ry+ out section #cai;,c-#c4 7ii7 ,res]vations cont+5t on cont9u$ appropriations ,if ! am\nt appropriat$ "u subp>agraph 7,a7 = fiscal ye> #bjai or a subsequ5t fiscal ye> is less ?an or equal ! am\nt s appropriat$ = ! previ\s fiscal ye>1 ! am\nt t may be res]v$ "u clause 7i7 %all be r$uc$ su* t ! am\nt rema9+ = ! purpose ( c>ry+ out ?is section is n less ?an ! am\nt available = su* purpose = ! previ\s fiscal ye>4 2 7#b7 9 p>agraph 7#b71 by /rik+ p>agraph 7#a7 = a fiscal ye> & ins]t+ p>agraph 7#a77;,a7 = a fiscal ye> & n res]v$ = ! purpose describ$ 9 p>agraph 7#a77;,b77i72 & 7#c7 9 p>agraph 7#c77;,a71 by /rik+ p>agraph 7#a7 & n res]v$ "u p>agraph 7#b7 & ins]t+ p>agraph 7#a77;,a7 & n res]v$ "u p>agraph 7#a77;,b77i7 or 7#b74 #bjc4 ,regional heal? c>e em]g5cy prep>$ness & response sy/ems 7a7 ,9 g5]al ,"p ,b ( title ,,iii 7#db ,u4,s4,c4 #bdc et seq47 is am5d$ by ins]t+ aft] section #cai;,c-#b ! foll[+3 #cai;,c-#c4 ,guidel9es = regional heal? c>e em]g5cy prep>$ness & response sy/ems 7a7 ,purpose ,x is ! purpose ( ?is section to id5tify & provide guidel9es = regional sy/ems ( hospitals1 heal? c>e facilities1 & o!r public & private sector entities1 ) v>y+ levels ( capability to treat pati5ts & increase m$ical surge capacity dur+1 & 9 advance (1 a public heal? em]g5cy1 includ+ ?reats pos$ by "o or m *emical1 biological1 radiological1 & nucle> ag5ts1 includ+ em]g+ infecti\s diseases4 7b7 ,guidel9es ,! ,assi/ant ,secret>y = ,prep>$ness & ,response1 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 ! ,commission] ( ,food & ,drugs1 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal?1 ! ,secret>y ( ,vet]ans ,affairs1 heads ( su* o!r ,f$]al ag5cies z ! ,secret>y det]m9es to be appropriate1 & ,/ate1 local1 tribal1 & t]ritorial public heal? (ficials1 %all1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section-- 7#a7 id5tify & develop a set ( guidel9es relat+ to practices & protocols = all-haz>ds public heal? em]g5cy prep>$ness & response = hospitals & heal? c>e facilities to provide appropriate pati5t c>e dur+1 9 advance (1 or imm$iately foll[+1 a public heal? em]g5cy1 result+ f "o or m *emical1 biological1 radiological1 or nucle> ag5ts1 includ+ em]g+ infecti\s diseases 7:i* may include exi/+ practices1 su* z trauma c>e & m$ical surge capacity & capabilities71 ) respect to-- 7,a7 a regional approa* to id5tify+ hospitals & heal? c>e facilities bas$ on v>y+ capabilities & capacity to treat pati5ts affect$ by su* em]g5cy1 includ+-- 7i7 ! mann] 9 :i* ! sy/em w coord9ate ) & integrate ! p>tn]%ips e/abli%$ "u section #cai;,c-#b7;b72 & 7ii7 in=m+ & educat+ appropriate fir/ respond]s & heal? c>e supply *a9 p>tn]s ( ! regional em]g5cy prep>$ness & response capabilities & m$ical surge capacity ( su* hospitals & heal? c>e facilities 9 ! community2 7,b7 physical & te*nological infra/ructure1 laboratory capacity1 /aff+1 blood supply1 & o!r supply *a9 ne$s1 tak+ into acc\nt resili5cy1 geographic consid]ations1 & rural consid]ations2 7,c7 protocols or be/ practices = ! safety & p]sonal protection ( work]s :o h&le human rema9s & heal? c>e work]s 7includ+ ) respect to protective equipm5t & supplies1 wa/e managem5t processes1 & decontam9ation71 %>+ ( specializ$ exp]i5ce among ! heal? c>e work=ce1 behavioral heal?1 psy*ological resili5ce1 & tra9+ ( ! work=ce1 z applicable2 7,d7 9 a mann] t all[s = disease conta9m5t 7)9 ! mean+ ( section #bhjb7;b77#b77;,b771 coord9at$ m$ical triage1 treatm5t1 & transportation ( pati5ts1 bas$ on pati5t m$ical ne$ 7includ+ pati5ts 9 rural areas71 to ! appropriate hospitals or heal? c>e facilities )9 ! regional sy/em or1 z applicable & appropriate1 betwe5 sy/ems 9 diff]5t ,/ates or regions2 & 7,e7 ! ne$s ( *ildr5 & o!r at-risk individuals2 7#b7 make su* guidel9es available on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a mann] t does n compromise national security2 & 7#c7 update su* guidel9es z appropriate1 includ+ bas$ on input receiv$ pursuant to subsections 7c71 7e71 & 7f71 to address new & em]g+ public heal? ?reats4 7c7 ,consid]ations ,9 id5tify+1 develop+1 & updat+ guidel9es "u subsection 7b71 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all-- 7#a7 include input f hospitals & heal? c>e facilities1 includ+ heal? c>e coalitions "u section #cai;,c-#b1 ,/ate1 local1 tribal1 & t]ritorial public heal? dep>tm5ts1 & heal? c>e or subject matt] exp]ts1 includ+ exp]ts ) relevant exp]tise 9 *emical1 biological1 radiological1 or nucle> ?reats1 & em]g+ infecti\s disease z ! ,assi/ant ,secret>y det]m9es appropriate1 to meet ! goals "u section #bhjb7;b77#c72 7#b7 consult & engage ) appropriate heal? c>e provid]s & pr(essionals1 includ+ physicians1 nurses1 fir/ respond]s1 heal? c>e facilities 7includ+ hospitals1 prim>y c>e cl9ics1 community heal? c5t]s1 m5tal heal? facilities1 ambulatory c>e facilities1 & d5tal heal? facilities71 ph>macies1 em]g5cy m$ical provid]s1 trauma c>e provid]s1 environm5tal heal? ag5cies1 public heal? laboratories1 poison control c5t]s1 blood banks1 & o!r exp]ts t ! ,assi/ant ,secret>y det]m9es appropriate1 to meet ! goals "u section #bhjb7;b77#c72 7#c7 consid] fe$back relat$ to f9ancial implications = hospitals1 heal? c>e facilities1 public heal? ag5cies1 laboratories1 & o!r entities engag$ 9 regional prep>$ness plann+ to implem5t & foll[ su* guidel9es1 z applicable2 & 7#d7 consid] f9ancial requirem5ts & pot5tial inc5tives = entities to prep>e =1 & respond to1 public heal? em]g5cies z "p ( ! regional heal? c>e em]g5cy prep>$ness & response sy/em4 7d7 ,te*nical assi/ance ,! ,assi/ant ,secret>y = ,prep>$ness & ,response1 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal?1 may provide te*nical assi/ance & consultation t[>ds meet+ ! guidel9es describ$ 9 subsection 7b74 7e7 ,demon/ration project = regional heal? c>e prep>$ness & response sy/ems 7#a7 ,9 g5]al ,! ,assi/ant ,secret>y = ,prep>$ness & ,response may e/abli% a demon/ration project pursuant to ! developm5t & implem5tation ( guidel9es "u subsection 7b7 to improve m$ical surge capacity = all haz>ds1 build & integrate regional m$ical response capabilities1 improve specialty c>e exp]tise = all-haz>ds response1 & coord9ate m$ical prep>$ness & response across ,/ate1 local1 tribal1 t]ritorial1 & regional jurisdictions4 7#b7 ,sunset ,! au?ority "u ?is subsection %all expire on ,septemb] #cj1 #bjbc4 7f7 ,,gao report to ,congress 7#a7 ,report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is section1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is subsection z ! ,comptroll] ,g5]al7 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,f9ance ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives1 a report on ! ext5t to :i* hospitals & heal? c>e facilities h implem5t$ ! recomm5d$ guidel9es "u subsection 7b71 includ+ an analysis & evaluation ( any *all5ges hospitals or heal? c>e facilities exp]i5c$ 9 implem5t+ su* guidel9es4 7#b7 ,cont5t ,! ,comptroll] ,g5]al %all include 9 ! report "u p>agraph 7#a7-- 7,a7 data on ! prep>$ness & response capabilities t h be5 in=m$ by ! guidel9es "u subsection 7b7 to improve regional em]g5cy heal? c>e prep>$ness & response capability1 includ+ hospital & heal? c>e facility capacity & m$ical surge capabilities to prep>e =1 & respond to1 public heal? em]g5cies2 & 7,b7 recomm5dations to r$uce gaps 9 inc5tives = regional heal? p>tn]s1 includ+ hospitals & heal? c>e facilities to improve capacity & m$ical surge capabilities to prep>e =1 & respond to1 public heal? em]g5cies1 consi/5t ) subsection 7a71 :i* may include consid]ation ( facilities p>ticipat+ 9 programs "u section #cai;,c-#b1 programs "u ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7includ+ innovative heal? c>e deliv]y & paym5t models71 & input f private sector f9ancial in/itutions4 7#c7 ,consultation ,9 c>ry+ out p>agraphs 7#a7 & 7#b71 ! ,comptroll] ,g5]al %all consult ) ! heads ( appropriate ,f$]al ag5cies1 includ+-- 7,a7 ! ,assi/ant ,secret>y = ,prep>$ness & ,response2 7,b7 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion2 7,c7 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7,d7 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use2 7,e7 ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal?2 7,f7 ! ,secret>y ( ,vet]ans ,affairs2 & 7,g7 ! heads ( su* o!r ,f$]al ag5cies z ! ,secret>y det]m9es appropriate4 4 7b7 ,annual reports ,section #cai;,c-#b7;i77#a7 7#db ,u4,s4,c4 #bdg;d-#c;b7i77#a77 is am5d$ by ins]t+ aft] ! fir/ s5t5ce ! foll[+ ,! reports submitt$ "u ?is p>agraph %all also include progress t[>ds ! implem5tation ( section #cai;,c-#c44 7c7 ,national heal? security /rategy incorporation ( regionaliz$ em]g5cy prep>$ness & response ,section #bhjb7;b77#c7 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#c77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ includ+ m5tal heal? & ins]t+ 8includ+ ph>macies1 m5tal heal? facilities102 & 7#b7 by am5d+ subp>agraph 7,g7 to read z foll[s3 7,g7 ,optimiz+ a coord9at$ & flexible approa* to ! em]g5cy response & m$ical surge capacity ( hospitals1 o!r heal? c>e facilities1 critical c>e1 trauma c>e 7:i* may include trauma c5t]s71 & em]g5cy m$ical sy/ems1 :i* may include ! implem5tation ( guidel9es = regional heal? c>e em]g5cy prep>$ness & response sy/ems "u section #cai;,c-#c4 4 7d7 ,improv+ ,/ate & local public heal? security 7#a7 ,/ate & local security ,section #cai;,c-#a7;e7 7#db ,u4,s4,c4 #bdg;d-#c;a7e77 is am5d$ by /rik+ 1 & local em]g5cy plans4 & ins]t+ 1 local em]g5cy plans1 & any regional heal? c>e em]g5cy prep>$ness & response sy/em e/abli%$ pursuant to ! applicable guidel9es "u section #cai;,c-#c44 7#b7 ,p>tn]%ips ,section #cai;,c-#b7;d77#a77;,a7 7#db ,u4,s4,c4 #bdg;d-#c;b7d77#a77;,a77 is am5d$-- 7,a7 9 clause 7i71 by /rik+ 2 & & ins]t+ 22 7,b7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7,c7 ins]t+ aft] clause 7i71 ! foll[+3 7ii7 among "o or m facilities 9 a regional heal? c>e em]g5cy sy/em "u section #cai;,c-#c2 & 4 #bjd4 ,public heal? & heal? c>e sy/em situational aw>5ess & biosurveillance capabilities 7a7 ,facilities1 capacities1 & biosurveillance capabilities ,section #cai;,d 7#db ,u4,s4,c4 #bdg;d-#d7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ ,revitaliz+ & ins]t+ ,facilities & capacities (2 7#b7 9 subsection 7a7-- 7,a7 9 ! subsection head+1 by /rik+ ,facilities2 capacities & ins]t+ ,9 g5]al2 7,b7 9 p>agraph 7#a71 by /rik+ & improv$ & ins]t+ 1 improv$1 & appropriately ma9ta9$2 7,c7 9 p>agraph 7#c71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ exp&1 enhance1 & improve & ins]t+ exp&1 improve1 enhance1 & appropriately ma9ta92 & 7,d7 by add+ at ! end ! foll[+3 7#d7 ,/udy ( res\rces = facilities & capacities ,n lat] ?an ,june #a1 #bjbb1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ,f$]al sp5d+ 9 fiscal ye>s #bjac ?r\gh #bjah = activities au?oriz$ "u ?is subsection4 ,su* /udy %all include a review & assessm5t ( obligations & exp5ditures directly relat$ to ea* activity "u p>agraphs 7#b7 & 7#c71 includ+ a specific acc\nt+ (1 & del9eation betwe51 obligations & exp5ditures incurr$ = ! con/ruction1 r5ovation1 equipp+1 & security upgrades ( facilities & associat$ contracts "u ?is subsection1 & ! obligations & exp5ditures incurr$ to e/abli% & improve ! situational aw>5ess & biosurveillance network "u subsection 7b71 & %all id5tify ! ag5cy or ag5cies incurr+ su* obligations & exp5ditures4 2 7#c7 9 subsection 7b7-- 7,a7 9 ! subsection head+1 by /rik+ national & ins]t+ ,e/abli%m5t ( sy/ems ( public heal? 2 7,b7 9 p>agraph 7#a77;,b71 by ins]t+ immunization in=mation sy/ems1 aft] c5t]s12 7,c7 9 p>agraph 7#b7-- 7i7 by ins]t+ develop a plan to1 & aft] ,! ,secret>y %all2 & 7ii7 by ins]t+ & 9 a =m readily usable = analytical approa*es aft] 9 a secure mann]2 & 7,d7 by am5d+ p>agraph 7#c7 to read z foll[s3 7#c7 ,/&>ds 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 ! ,secret>y1 9 coop]ation ) heal? c>e provid]s1 ,/ate1 local1 tribal1 & t]ritorial public heal? (ficials1 & relevant ,f$]al ag5cies 7includ+ ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology & ! ,national ,in/itute ( ,/&>ds & ,te*nology71 %all1 z necess>y1 adopt te*nical & report+ /&>ds1 includ+ /&>ds = int]op]ability z def9$ by section #cjjj1 = networks "u p>agraph 7#a7 & update su* /&>ds z necess>y4 ,su* /&>ds %all be made available on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 9 a mann] t does n compromise national security4 7,b7 ,def]5ce to /&>ds developm5t organizations ,9 adopt+ & implem5t+ /&>ds "u ?is subsection & subsection 7c71 ! ,secret>y %all give def]5ce to /&>ds publi%$ by /&>ds developm5t organizations & volunt>y cons5sus-bas$ /&>ds entities4 2 7#d7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,reau?orization ,act ( #bjac1 ! ,secret>y & ins]t+ ,! ,secret>y2 7ii7 by ins]t+ 1 & improve z applicable & appropriate1 aft] %all e/abli%2 7iii7 by /rik+ ( rapid & ins]t+ (1 rapid2 & 7iv7 by /rik+ su* connectivity & ins]t+ su* int]op]ability2 7,b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,coord9ation & consultation ,9 e/abli%+ & improv+ ! network "u p>agraph 7#a7 ! ,secret>y %all-- 7,a7 facilitate coord9ation among ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices t provide or h ! pot5tial to provide in=mation & data to1 & analyses =1 ! situational aw>5ess & biosurveillance network "u p>agraph 7#a71 includ+ coord9ation among relevant ag5cies relat$ to heal? c>e s]vices1 ! facilitation ( heal? in=mation ex*ange 7includ+ ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology71 & public heal? em]g5cy prep>$ness & response2 & 7,b7 consult ) ! ,secret>y ( ,agriculture1 ! ,secret>y ( ,comm]ce 7& ! ,director ( ! ,national ,in/itute ( ,/&>ds & ,te*nology71 ! ,secret>y ( ,def5se1 ! ,secret>y ( ,homel& ,security1 & ! ,secret>y ( ,vet]ans ,affairs1 & ! heads ( o!r ,f$]al ag5cies1 z ! ,secret>y det]m9es appropriate4 2 7,c7 9 p>agraph 7#c7-- 7i7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,e7 z clauses 7i7 ?r\gh 7v71 respectively1 & adju/+ ! m>g9s accord+ly2 7ii7 9 clause 7iv71 z s r$esignat$-- 7,i7 by ins]t+ immunization in=mation programs1 aft] poison control12 & 7,,ii7 by /rik+ & cl9ical laboratories & ins]t+ 1 cl9ical laboratories1 & public environm5tal heal? ag5cies2 7iii7 by /rik+ ,! network & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,! network 2 & 7iv7 by add+ at ! end ! foll[+3 7,b7 ,review ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah & e #f ye>s !reaft]1 ! ,secret>y %all conduct a review ( ! elem5ts describ$ 9 subp>agraph 7,a74 ,su* review %all include a discussion ( ! addition ( any elem5ts pursuant to clause 7v71 includ+ elem5ts add$ to advanc+ new te*nologies1 & id5tify any *all5ges 9 ! incorporation ( elem5ts "u subp>agraph 7,a74 ,! ,secret>y %all provide su* review to ! congressional committees ( jurisdiction4 2 7,d7 9 p>agraph 7#e7-- 7i7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,d7 z clauses 7i7 ?r\gh 7iv71 respectively1 & adju/+ ! m>g9s accord+ly2 7ii7 by /rik+ ,9 e/abli%+ & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,9 e/abli%+ 2 7iii7 by add+ at ! end ! foll[+3 7,b7 ,public meet+ 7i7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 ! ,secret>y %all conv5e a public meet+ = purposes ( discuss+ & provid+ input on ! pot5tial goals1 functions1 & uses ( ! network describ$ 9 p>agraph 7#a7 & incorporat+ ! elem5ts describ$ 9 p>agraph 7#c77;,a74 7ii7 ,exp]ts ,! public meet+ %all include repres5tatives ( relevant ,f$]al ag5cies 7includ+ repres5tatives f ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology & ! ,national ,in/itute ( ,/&>ds & ,te*nology71 ,/ate1 local1 tribal1 & t]ritorial public heal? (ficials1 /akehold]s ) exp]tise 9 biosurveillance & situational aw>5ess1 & /akehold]s ) exp]tise 9 capabilities relevant to biosurveillance & situational aw>5ess1 su* z exp]ts 9 in=matics & data analytics 7includ+ exp]ts 9 pr$iction & =eca/+71 & o!r repres5tatives z ! ,secret>y det]m9es appropriate4 7iii7 ,topics ,su* public meet+ %all include a discussion (-- 7,i7 data elem5ts1 includ+ m9imal or ess5tial data elem5ts1 t are volunt>ily provid$ = su* network1 :i* may include elem5ts f public heal? & public & private heal? c>e entities1 to ! ext5t practicable2 7,,ii7 /&>ds & implem5tation specifications t may improve ! collection1 analysis1 & int]pretation ( data dur+ a public heal? em]g5cy2 7,,iii7 /rategies to enc\rage ! access1 ex*ange1 & use ( in=mation2 7,,iv7 consid]ations = ,/ate1 local1 tribal1 & t]ritorial capabilities & infra/ructure relat$ to data ex*ange & int]op]ability2 7,v7 privacy & security protections provid$ at ! ,f$]al1 ,/ate1 local1 tribal1 & t]ritorial levels1 & by nongov]nm5tal /akehold]s2 & 7,,vi7 opportunities = ! incorporation ( innovative te*nologies to improve ! network4 2 & 7iv7 9 subp>agraph 7,a71 z s designat$ by clause 7ii7-- 7,i7 9 clause 7i71 z s r$esignat$-- 7aa7 by /rik+ z det]m9$ & ins]t+ z adopt$2 & 7bb7 by ins]t+ & ! ,national ,in/itute ( ,/&>ds & ,te*nology aft] ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology2 7,,ii7 9 clause 7iii71 z s r$esignat$1 by /rik+ 2 & & ins]t+ a semicolon2 7,,iii7 9 clause 7iv71 z s r$esignat$1 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7v7 pilot te/ /&>ds & implem5tation specifications1 consi/5t ) ! process describ$ 9 section #cjjb7;b77#c77;,c71 :i* ,/ate1 local1 tribal1 & t]ritorial public heal? entities may utilize1 on a volunt>y basis1 z a "p ( ! network4 2 7,e7 by r$esignat+ p>agraph 7#f7 z p>agraph 7#g72 7,f7 by ins]t+ aft] p>agraph 7#e7 ! foll[+3 7#f7 ,/rategy & implem5tation plan 7,a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 ! ,secret>y %all submit to ! appropriate committees ( ,congress a coord9at$ /rategy & an accompany+ implem5tation plan t-- 7i7 is in=m$ by ! public meet+ "u p>agraph 7#e77;,b72 7ii7 includes a review & assessm5t ( exi/+ capabilities ( ! network & relat$ infra/ructure1 includ+ input provid$ by ! public meet+ "u p>agraph 7#e77;,b72 7iii7 id5tifies & demon/rates ! measurable /eps ! ,secret>y w c>ry out to-- 7,i7 develop1 implem5t1 & evaluate ! network describ$ 9 p>agraph 7#a71 utiliz+ elem5ts describ$ 9 p>agraph 7#c77;,a72 7,,ii7 mod]nize & enhance biosurveillance activities1 includ+ /rategies to include innovative te*nologies & analytical approa*es 7includ+ pr$iction & =eca/+ = p&emics & all-haz>ds7 f public & private entities2 7,,iii7 improve in=mation %>+1 coord9ation1 & communication among disp>ate biosurveillance sy/ems support$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+ ! id5tification ( me?ods to improve acc\ntability1 bett] utilize res\rces & work=ce capabilities1 & incorporate innovative te*nologies )9 & across ag5cies2 & 7,,iv7 te/ & evaluate capabilities ( ! int]op]able network ( sy/ems to improve situational aw>5ess & biosurveillance capabilities2 7iv7 includes p]=mance measures & ! metrics by :i* p]=mance measures w be assess$ ) respect to ! measurable /eps "u clause 7iii72 & 7v7 e/abli%es dates by :i* ea* measurable /ep "u clause 7iii7 w be implem5t$4 4 7,b7 ,annual budget plan ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah & on an annual basis !reaft]1 9 accordance ) ! /rategy & implem5tation plan "u ?is p>agraph1 ! ,secret>y %all1 tak+ into acc\nt recomm5dations provid$ by ! ,national ,biodef5se ,sci5ce ,bo>d1 develop a budget plan bas$ on ! /rategy & implem5tation plan "u ?is section4 ,su* budget plan %all include-- 7i7 a summ>y ( res\rces previ\sly exp5d$ to e/abli%1 improve1 & utilize ! nationwide public heal? situational aw>5ess & biosurveillance network "u p>agraph 7#a72 7ii7 e/imates ( co/s & res\rces ne$$ to e/abli% & improve ! network "u p>agraph 7#a7 accord+ to ! /rategy & implem5tation plan "u subp>agraph 7,a72 7iii7 ! id5tification ( gaps & ineffici5cies 9 nationwide public heal? situational aw>5ess & biosurveillance capabilities1 res\rces1 & au?orities ne$$ to address su* gaps2 & 7iv7 a /rategy to m9imize & address su* gaps & improve ineffici5cies4 2 7,g7 9 p>agraph 7#g71 z s r$esignat$-- 7i7 9 subp>agraph 7,a71 by ins]t+ 7tak+ into acc\nt zoonotic disease1 includ+ gaps 9 sci5tific und]/&+ ( ! int]actions betwe5 human1 animal1 & environm5tal heal?7 aft] human heal?2 7ii7 9 subp>agraph 7,b7-- 7,i7 by ins]t+ & gaps 9 surveillance programs aft] surveillance programs2 & 7,,ii7 by /rik+ 2 & & ins]t+ a semicolon2 7iii7 9 subp>agraph 7,c7-- 7,i7 by ins]t+ 1 animal heal? organizations relat$ to zoonotic disease1 aft] heal? c>e entities2 & 7,,ii7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+3 7,d7 provide recomm5dations to ! ,secret>y on policies & proc$ures to complete ! /eps describ$ 9 ?is p>agraph 9 a mann] t is consi/5t ) section #bhjb4 2 & 7,h7 by add+ at ! end ! foll[+3 7#h7 ,situational aw>5ess & biosurveillance z a national security priority ,! ,secret>y1 on a p]iodic basis z applicable & appropriate1 %all meet ) ! ,director ( ,national ,intellig5ce to in=m ! developm5t & capabilities ( ! nationwide public heal? situational aw>5ess & biosurveillance network4 2 7#e7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a7-- 7i7 by ins]t+ environm5tal heal? ag5cies1 aft] public heal? ag5cies12 & 7ii7 by ins]t+ immunization programs1 aft] poison control c5t]s12 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ aft] subp>agraph 7,c7 ! foll[+3 7,d7 an implem5tation plan t may include measurable /eps to a*ieve ! purposes describ$ 9 p>agraph 7#a74 2 & 7,c7 by /rik+ p>agraph 7#e7 & ins]t+ ! foll[+3 7#e7 ,te*nical assi/ance ,! ,secret>y may provide te*nical assi/ance to ,/ates1 localities1 tribes1 & t]ritories or a consortium ( ,/ates1 localities1 tribes1 & t]ritories receiv+ an aw>d "u ?is subsection reg>d+ int]op]ability & ! te*nical /&>ds set =? by ! ,secret>y4 2 7#f7 by r$esignat+ subsections 7f7 & 7g7 z subsections 7h7 & 7i71 respectively2 & 7#g7 by ins]t+ aft] subsection 7e7 ! foll[+3 7f7 ,timel9e ,! ,secret>y %all accompli% ! purposes "u subsections 7b7 & 7c7 no lat] ?an ,septemb] #cj1 #bjbc1 & %all provide a ju/ification to ,congress = any miss$ or delay$ implem5tation ( measurable /eps id5tifi$ "u subsection 7c77#f77;,a77iii74 7g7 ,indep5d5t evaluation ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct an indep5d5t evaluation1 & submit to ! ,secret>y & ! appropriate committees ( ,congress a report conc]n+ ! activities conduct$ "u subsections 7b7 & 7c71 & provide recomm5dations1 z applicable & appropriate1 on necess>y improvem5ts to ! biosurveillance & situational aw>5ess network4 4 7b7 ,au?orization ( appropriations ,subsection 7h7 ( section #cai;,d 7#db ,u4,s4,c4 #bdg;d-#d71 z r$esignat$ by subsection 7a77#f71 is am5d$ by /rik+ #ach1cjj1jjj = ea* ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #afa1hjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 #bje4 ,/r5g!n+ & support+ ! public heal? em]g5cy rapid response fund ,section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 ! fir/ s5t5ce1 by ins]t+ or if ! ,secret>y det]m9es !re is ! significant pot5tial = a public heal? em]g5cy1 to all[ ! ,secret>y to rapidly respond to ! imm$iate ne$s result+ f su* public heal? em]g5cy or pot5tial public heal? em]g5cy be=e ! p]iod2 & 7ii7 by ins]t+ ,! ,secret>y %all plan = ! exp$it$ di/ribution ( funds to appropriate ag5cies & entities4 aft] ! fir/ s5t5ce2 7,b7 by r$esignat+ p>agraph 7#b7 z p>agraph 7#c72 7,c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,uses ,! ,secret>y may use am\nts 9 ! ,fund e/abli%$ "u p>agraph 7#a71 to-- 7,a7 facilitate coord9ation betwe5 & among ,f$]al1 ,/ate1 local1 tribal1 & t]ritorial entities & public & private heal? c>e entities t ! ,secret>y det]m9es may be affect$ by a public heal? em]g5cy or pot5tial public heal? em]g5cy 7includ+ communication ( su* entities ) relevant int]national entities1 z applicable72 7,b7 make grants1 provide = aw>ds1 ent] into contracts1 & conduct supportive inve/igations p]ta9+ to a public heal? em]g5cy or pot5tial public heal? em]g5cy1 includ+ fur!r support+ programs "u section #cai;,c-#a or #cai;,c-#b2 7,c7 facilitate & accel]ate1 z applicable1 advanc$ rese>* & developm5t ( security c\nt]measures 7z def9$ 9 section #cai;,f-#b71 qualifi$ c\nt]measures 7z def9$ 9 section #cai;,f-#a71 or qualifi$ p&emic or epidemic products 7z def9$ 9 section #cai;,f-#c71 t are applicable to ! public heal? em]g5cy or pot5tial public heal? em]g5cy "u p>agraph 7#a72 7,d7 /r5g!n biosurveillance capabilities & laboratory capacity to id5tify1 collect1 & analyze in=mation on su* public heal? em]g5cy or pot5tial public heal? em]g5cy1 includ+ ! sy/ems "u section #cai;,d2 7,e7 support initial em]g5cy op]ations & assets relat$ to prep>ation & deploym5t ( int]mitt5t disa/] response p]sonnel exp5ses "u section #bhab1 & ! ,m$ical ,res]ve ,corps "u section #bhac2 & 7,f7 o!r activities1 z ! ,secret>y det]m9es applicable & appropriate4 2 & 7,d7 by ins]t+ aft] p>agraph 7#c71 z s r$esignat$1 ! foll[+3 7#d7 ,review ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 ! ,secret>y1 9 coord9ation ) ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 %all conduct a review ( ! ,fund "u ?is section1 & provide recomm5dations to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives on policies to improve su* ,fund = ! uses describ$ 9 p>agraph 7#b74 7#e7 ,,gao report ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a review ( ! ,fund "u ?is section1 includ+ ! uses & ! res\rces available 9 ! ,fund4 2 & 7#b7 9 subsection 7c7-- 7,a7 by ins]t+ rapidly respond to public heal? em]g5cies or pot5tial public heal? em]g5cies & aft] us$ to2 & 7,b7 by /rik+ section4 & ins]t+ ,act or funds o!rwise provid$ = em]g5cy response44 #bjf4 ,improv+ prep>$ness = & response to all-haz>ds by public heal? em]g5cy volunte]s ,section #cai;,i 7#db ,u4,s4,c4 #bdg;d-#g;b7 is am5d$3 7#a7 9 subsection 7a71 by add+ at ! end ! foll[+3 ,su* heal? c>e pr(essionals may include memb]s ( ! ,national ,disa/] ,m$ical ,sy/em1 memb]s ( ! ,m$ical ,res]ve ,corps1 & individual heal? c>e pr(essionals42 7#b7 9 subsection 7i7 by add+ at ! end ,9 ord] to in=m ! developm5t ( su* me*anisms by ,/ates1 ! ,secret>y %all make available in=mation & mat]ial provid$ by ,/ates t h develop$ me*anisms to waive ! application ( lic5s+ requirem5ts to applicable heal? pr(essionals seek+ to provide m$ical s]vices dur+ a public heal? em]g5cy4 ,su* in=mation %all be made publicly available 9 a mann] t does n jeop>dize national security42 & 7#c7 9 subsection 7k7 by /rik+ #bjad ?r\gh #bjah & ins]t+ #bjai ?r\gh #bjbc4 ,,iii ,rea*+ all communities #cja4 ,/r5g!n+ & assess+ ! em]g5cy response work=ce 7a7 ,national ,disa/] ,m$ical ,sy/em ,clause 7ii7 ( section #bhab7;a77#c77;,a7 7#db ,u4,s4,c4 #cjj;hh-#aa7;a77#c77;,a77 is am5d$ to read z foll[s3 7ii7 be pres5t at locations1 & = limit$ p]iods ( "t1 specifi$ by ! ,secret>y on ! basis t ! ,secret>y has det]m9$ t a location is at risk ( a public heal? em]g5cy dur+ ! "t specifi$1 or !re is a significant pot5tial = a public heal? em]g5cy4 4 7b7 ,volunte] ,m$ical ,res]ve ,corps ,section #bhac7;a7 7#db ,u4,s4,c4 #db ,u4,s4,c4 #cjj;hh-#ae7;a77 is am5d$ by /rik+ ! second s5t5ce & ins]t+ ,! ,secret>y may appo9t a ,director to head ! ,corps & ov]see ! activities ( ! ,corps *apt]s t exi/ at ! ,/ate1 local1 & tribal levels4 7c7 ,review ( ! national disa/] m$ical sy/em ,section #bhab7;b77#b7 7#db ,u4,s4,c4 #cjj;hh-#aa7;b77#b77 is am5d$ to read z foll[s3 7#b7 ,jo9t review & m$ical surge capacity /rategic plan 7,a7 ,review ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 ! ,secret>y1 9 coord9ation ) ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,def5se1 & ! ,secret>y ( ,vet]ans ,affairs1 %all conduct a jo9t review ( ! ,national ,disa/] ,m$ical ,sy/em4 ,su* review %all include-- 7i7 an evaluation ( m$ical surge capacity1 z describ$ 9 section #bhjc7;a72 7ii7 an assessm5t ( ! available work=ce ( ! int]mitt5t disa/] response p]sonnel describ$ 9 subsection 7c72 7iii7 ! capacity ( ! work=ce describ$ 9 clause 7ii7 to respond to all haz>ds1 includ+ capacity to simultane\sly respond to multiple public heal? em]g5cies & ! capacity to respond to a nationwide public heal? em]g5cy2 7iv7 ! effectiv5ess ( ef=ts to recruit1 reta91 & tra9 su* work=ce2 & 7v7 gaps t may exi/ 9 su* work=ce & recomm5dations = address+ su* gaps4 7,b7 ,updates ,z "p ( ! ,national ,heal? ,security ,/rategy "u section #bhjb1 ! ,secret>y %all update ! f9d+s f ! review "u subp>agraph 7,a7 & provide recomm5dations to modify ! policies ( ! ,national ,disa/] ,m$ical ,sy/em z necess>y4 4 7d7 ,notification ( ,,ndms ,%ortage ,section #bhab7;c7 7#db ,u4,s4,c4 #cjj;hh-#aa7;c77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,s]vice b5efit ,individuals appo9t$ to s]ve "u ?is subsection %all be consid]$ public safety (fic]s "u "p ,l ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh4 ,! ,secret>y %all provide notification to eligible individuals ( any effect su* designation may h on o!r b5efits = :i* su* individuals are eligible1 includ+ b5efits f private entities4 7#d7 ,notification ,n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es ! numb] ( int]mitt5t disa/] response p]sonnel ( su* ,sy/em is insuffici5t to address a public heal? em]g5cy or pot5tial public heal? em]g5cy1 ! ,secret>y %all submit to ! congressional committees ( jurisdiction a notification detail+ ! impact su* %ortage c\ld h on meet+ public heal? ne$s & em]g5cy m$ical p]sonnel ne$s dur+ a public heal? em]g5cy1 & any id5tifi$ measures to address su* %ortage4 7#e7 ,c]ta9 appo9tm5ts 7,a7 ,9 g5]al ,if ! ,secret>y det]m9es t ! numb] ( int]mitt5t disa/] response p]sonnel )9 ! ,national ,disa/] ,m$ical ,sy/em "u ?is section is insuffici5t to address a public heal? em]g5cy or pot5tial public heal? em]g5cy1 ! ,secret>y may appo9t c&idates directly to p]sonnel positions = int]mitt5t disa/] response )9 su* sy/em4 ,! ,secret>y %all provide updates on ! numb] ( vacant or unfill$ positions )9 su* sy/em to ! congressional committees ( jurisdiction ea* qu>t] = :i* ?is au?ority is 9 effect4 7,b7 ,sunset ,! au?ority "u ?is p>agraph %all expire on ,septemb] #cj1 #bjba4 4 7e7 ,public safety (fic] b5efits ,section #abjd7i7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#cd ,u4,s4,c4 #ajbhd7i77 is am5d$-- 7#a7 9 subp>agraph 7,c77ii71 by /rik+ or at ! end2 7#b7 9 subp>agraph 7,d71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7#c7 by ins]t+ aft] subp>agraph 7,d7 ! foll[+3 7,e7 an individual appo9t$ to ! ,national ,disa/] ,m$ical ,sy/em "u section #bhab ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7 :o is p]=m+ (ficial duties ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 if ^? (ficial duties are relat$ to respond+ to a public heal? em]g5cy or pot5tial public heal? em]g5cy1 or o!r activities = :i* ! ,secret>y ( ,heal? & ,human ,s]vices has activat$ su* ,national ,disa/] ,m$ical ,sy/em4 4 7f7 ,national disa/] m$ical sy/em au?orization ( appropriations ,section #bhab7;g7 7#db ,u4,s4,c4 #cjj;hh-#aa7;g77 is am5d$ by /rik+ #eb1gjj1jjj = ea* ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #eg1djj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 7g7 ,m$ical ,res]ve ,corps ,au?orization ( ,appropriations ,section #bhac7;i7 7#db ,u4,s4,c4 #cjj;hh-#ae7;i77 is am5d$ by /rik+ #bjad ?r\gh #bjah & ins]t+ #bjai ?r\gh #bjbc4 #cjb4 ,heal? sy/em infra/ructure to improve prep>$ness & response 7a7 ,coord9ation ( prep>$ness ,section #bhaa7;b77#e7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#e77 is am5d$ by add+ at ! end ! foll[+3 ,su* logi/ical support %all include work+ ) o!r relevant ,f$]al1 ,/ate1 local1 tribal1 & t]ritorial public heal? (ficials & private sector p>tn]s to id5tify ! critical infra/ructure assets1 sy/ems1 & networks ne$$ = ! prop] function+ ( ! heal? c>e & public heal? sectors t ne$ to be ma9ta9$ ?r\gh any em]g5cy or disa/]1 includ+ entities capable ( assi/+ )1 respond+ to1 & mitigat+ ! effect ( a public heal? em]g5cy1 includ+ an em]g5cy "u section #cai1 an em]g5cy or major disa/] "u ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act1 or ! ,national ,em]g5cies ,act1 includ+ by e/abli%+ me?ods to ex*ange critical in=mation & deliv] products consum$ or us$ to pres]ve1 protect1 or su/a9 life1 heal?1 or safety1 & %>+ ( specializ$ exp]tise44 7b7 ,manufactur+ ,capacity ,section #bhaa7;d77#b77;,c7 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77#b77;,c77 is am5d$ by ins]t+ 1 & ancill>y m$ical supplies to assi/ ) ! utilization ( su* products1 aft] products4 #cjc4 ,consid]ations = at-risk individuals 7a7 ,at-,risk individuals 9 ! ,national ,heal? ,security ,/rategy ,section #bhjb7;b77#d77;,b7 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d77;,b77 is am5d$-- 7#a7 by /rik+ ?is section & sections #cai;,c-#a1 #cai;,f1 & #cai,l1 & ins]t+ ?is ,act 2 & 7#b7 by /rik+ special & ins]t+ access or functional4 7b7 ,c\nt]measure consid]ations ,section #cai,l7c77#f7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#f77 is am5d$-- 7#a7 by /rik+ eld]ly & ins]t+ s5ior citiz5s2 & 7#b7 by ins]t+ ) relevant *>act]i/ics t w>rant consid]ation dur+ ! process ( rese>*+ & develop+ su* c\nt]measures & products be=e ! p]iod4 #cjd4 ,improv+ em]g5cy prep>$ness & response consid]ations = *ildr5 ,"p ,b ( title ,,iii 7#db ,u4,s4,c4 #bdc et seq47 is am5d$ by ins]t+ aft] section #cai;,d ! foll[+3 #cai;,d-#a4 ,*ildr5's prep>$ness unit 7a7 ,enhanc+ em]g5cy prep>$ness = *ildr5 ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion 7ref]r$ to 9 ?is subsection z ! ,director71 %all ma9ta9 an int]nal team ( exp]ts1 to be kn[n z ! ,*ildr5's ,prep>$ness ,unit 7ref]r$ to 9 ?is subsection z ! ,unit71 to "w collaboratively to provide guidance on ! consid]ations =1 & ! specific ne$s (1 *ildr5 be=e1 dur+1 & aft] public heal? em]g5cies4 ,! ,unit %all in=m ! ,director reg>d+ em]g5cy prep>$ness & response ef=ts p]ta9+ to *ildr5 at ! ,c5t]s = ,disease ,control & ,prev5tion4 7b7 ,exp]tise ,! team describ$ 9 subsection 7a7 %all include "o or m p$iatricians1 :i* may be a developm5tal-behavior p$iatrician1 & may also include behavioral sci5ti/s1 *ild psy*ologi/s1 epidemiologi/s1 bio/ati/icians1 heal? communications /aff1 & individuals ) o!r areas ( exp]tise1 z ! ,secret>y det]m9es appropriate4 7c7 ,duties ,! team describ$ 9 subsection 7a7 may-- 7#a7 assi/ ,/ate1 local1 tribal1 & t]ritorial em]g5cy plann+ & response activities relat$ to *ildr51 :i* may include develop+1 id5tify+1 & %>+ be/ practices2 7#b7 provide te*nical assi/ance1 tra9+1 & consultation to ,f$]al1 ,/ate1 local1 tribal1 & t]ritorial public heal? (ficials to improve prep>$ness & response capabilities ) respect to ! ne$s ( *ildr51 includ+ provid+ su* te*nical assi/ance1 tra9+1 & consultation to eligible entities 9 ord] to support ! a*ievem5t ( measurable evid5ce-bas$ b5*m>ks & objective /&>ds applicable to sections #cai;,c-#a & #cai;,c-#b2 7#c7 improve ! utilization ( me?ods to incorporate ! ne$s ( *ildr5 9 plann+ = & respond+ to a public heal? em]g5cy1 includ+ public aw>5ess ( su* me?ods2 7#d7 coord9ate )1 & improve1 public-private p>tn]%ips1 su* z heal? c>e coalitions pursuant to sections #cai;,c-#b & #cai;,c-#c1 to address gaps & ineffici5cies 9 em]g5cy prep>$ness & response ef=ts = *ildr52 7#e7 provide exp]tise & input dur+ ! developm5t ( guidance & cl9ical recomm5dations to address ! ne$s ( *ildr5 :5 prep>+ =1 & respond+ to1 public heal? em]g5cies2 & 7#f7 c>ry out o!r duties relat$ to prep>$ness & response activities = *ildr51 z ! ,secret>y det]m9es appropriate4 4 #cje4 ,reau?oriz+ ! ,national ,advisory ,committee on ,*ildr5 & ,disa/]s ,section #bhaa;,a 7#db ,u4,s4,c4 #cjj;hh-#aj;a7 is am5d$-- 7#a7 9 subsection 7b77#b71 by ins]t+ 1 m5tal & behavioral1 aft] m$ical2 7#b7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a71 by /rik+ #ae & ins]t+ #be2 & 7,b7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,requir$ 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 individuals to p]=m ! duties describ$ 9 subsections 7b7 & 7c71 includ+-- 7,a7 at lea/ #b non-,f$]al pr(essionals ) exp]tise 9 p$iatric m$ical disa/] plann+1 prep>$ness1 response1 or recov]y2 7,b7 at lea/ #b repres5tatives f ,/ate1 local1 tribal1 or t]ritorial ag5cies ) exp]tise 9 p$iatric disa/] plann+1 prep>$ness1 response1 or recov]y2 7,c7 at lea/ #d memb]s repres5t+ heal? c>e pr(essionals1 :i* may include memb]s ) exp]tise 9 p$iatric em]g5cy m$ic9e2 p$iatric trauma1 critical c>e1 or surg]y2 ! treatm5t ( p$iatric pati5ts affect$ by *emical1 biological1 radiological1 or nucle> ag5ts & em]g+ infecti\s diseases2 p$iatric m5tal or behavioral heal? relat$ to *ildr5 affect$ by a public heal? em]g5cy2 or p$iatric prim>y c>e2 & 7,d7 o!r memb]s z ! ,secret>y det]m9es appropriate1 ( :om-- 7i7 at lea/ "o su* memb] %all repres5t a *ildr5's hospital2 7ii7 at lea/ "o su* memb] %all be an individual ) exp]tise 9 s*ools or *ild c>e sett+s2 7iii7 at lea/ "o su* memb] %all be an individual ) exp]tise 9 *ildr5 & y\? ) special heal? c>e ne$s2 & 7iv7 at lea/ "o su* memb] %all be an individual ) exp]tise 9 ! ne$s ( p>5ts or family c>egiv]s1 includ+ ! p>5ts or c>egiv]s ( *ildr5 ) disabilities4 4 7#c7 ,f$]al memb]s ,! ,advisory ,committee "u p>agraph 7#a7 %all include ! foll[+ ,f$]al memb]s or _! designees3 7,a7 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7,b7 ,! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority4 7,c7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7,d7 ,! ,commission] ( ,food & ,drugs4 7,e7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7,f7 ,! ,assi/ant ,secret>y ( ! ,adm9i/ration = ,*ildr5 & ,families4 7,g7 ,! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration4 7,h7 ,! ,adm9i/rator ( ! ,f$]al ,em]g5cy ,managem5t ,ag5cy4 7,i7 ,! ,adm9i/rator ( ! ,adm9i/ration = ,community ,liv+4 7,j7 ,! ,secret>y ( ,education4 7,k7 ,repres5tatives f su* ,f$]al ag5cies 7su* z ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration & ! ,dep>tm5t ( ,homel& ,security7 z ! ,secret>y det]m9es appropriate to fulfill ! duties ( ! ,advisory ,committee "u subsections 7b7 & 7c74 4 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 ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 or appo9tees :o are initially appo9t$ 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 ( :i* may be s]v$ consecutively4 2 7#c7 9 subsection 7e71 by add+ at ! end ,at lea/ "o meet+ p] ye> %all be an 9-p]son meet+42 & 7#d7 9 subsection 7f7 by /rik+ #bjah & ins]t+ #bjbc4 #cjf4 ,guidance = p>ticipation 9 ex]cises & drills ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue f9al guidance reg>d+ ! p>ticipation ( ,/ate1 local1 tribal1 & t]ritorial public heal? dep>tm5t or ag5cy p]sonnel fund$ 9 :ole or 9 "p ?r\gh programs au?oriz$ "u ?is ,act 9 drills & op]ational ex]cises 9 ord] to id5tify1 in=m1 & address ! gaps 9 & policies relat$ to all-haz>ds m$ical & public heal? prep>$ness & response1 :i* may include drills & op]ational ex]cises t incorporate m$ical surge capacity plann+1 m$ical c\nt]measure di/ribution & adm9i/ration1 & prep>+ = & respond+ to id5tifi$ ?reats = t region4 ,! ,secret>y %all consult ) ! ,dep>tm5t ( ,homel& ,security1 ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,vet]ans ,affairs1 & o!r applicable ,f$]al dep>tm5ts & ag5cies z necess>y & appropriate 9 ! developm5t ( su* guidance4 ,! ,secret>y %all make ! guidance available on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 ,,iv ,prioritiz+ a ?reat-bas$ approa* #dja4 ,assi/ant ,secret>y = ,prep>$ness & ,response ,section #bhaa7;b7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a7 by ins]t+ utilize exp]i5ce relat$ to public heal? em]g5cy prep>$ness & response1 biodef5se1 m$ical c\nt]measures1 & o!r relevant topics to aft] %all2 & 7#b7 9 p>agraph 7#d7 by add+ at ! end ! foll[+3 7,i7 ,?reat aw>5ess ,coord9ate ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,director ( ,national ,intellig5ce1 ! ,secret>y ( ,homel& ,security1 ! ,assi/ant to ! ,presid5t = ,national ,security ,affairs1 ! ,secret>y ( ,def5se1 & o!r relevant ,f$]al (ficials1 to ma9ta9 a curr5t assessm5t ( national security ?reats & in=m prep>$ness & response capabilities bas$ on ! range ( ! ?reats t h ! pot5tial to result 9 a public heal? em]g5cy4 4 #djb4 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise 7a7 ,9 g5]al ,title ,,xxviii is am5d$ by ins]t+ aft] section #bhaa 7#db ,u4,s4,c4 #cjj;hh-#aj7 ! foll[+3 #bhaa-a4 ,public heal? em]g5cy m$ical c\nt]measures ent]prise 7a7 ,9 g5]al ,! ,secret>y %all e/abli% ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise 7ref]r$ to 9 ?is section z ! ,,phemce74 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response %all s]ve z *air ( ! ,,phemce4 7b7 ,memb]s ,! ,,phemce %all include ea* ( ! foll[+ memb]s1 or ! designee ( su* memb]s3 7#a7 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7#b7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7#c7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7#d7 ,! ,commission] ( ,food & ,drugs4 7#e7 ,! ,secret>y ( ,def5se4 7#f7 ,! ,secret>y ( ,homel& ,security4 7#g7 ,! ,secret>y ( ,agriculture4 7#h7 ,! ,secret>y ( ,vet]ans ,affairs4 7#i7 ,repres5tatives ( any o!r ,f$]al ag5cy1 :i* may include ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 & ! ,director ( ! ,/rategic ,national ,/ockpile1 z ! ,secret>y det]m9es appropriate4 7c7 ,functions 7#a7 ,9 g5]al ,! functions ( ! ,,phemce %all include ! foll[+3 7,a7 ,e/abli% a process pursuant to section #bhaa7;d77#b77;,b7 to make recomm5dations to ! ,secret>y reg>d+ ! prioritization ( rese>*1 developm5t1 & procurem5t ( c\nt]measures1 z def9$ 9 section #cai;,f-#b7;c71 bas$ on ! heal? security ne$s ( ! ,unit$ ,/ates4 ,su* recomm5dations %all be in=m$ by ! ,national ,heal? ,security ,/rategy pursuant to section #bhjb1 ! ,/rategic ,national ,/ockpile review requir$ "u section #cai;,f-#b7;a77#b71 ! c\nt]measures budget plan pursuant to section #bhaa7;b77#g71 & an assessm5t ( curr5t national security ?reats1 includ+ *emical1 biological1 radiological & nucle> ?reats1 includ+ em]g+ infecti\s diseases4 ,9 ! ev5t t memb]s ( ! ,,phemce d n agree ^u a recomm5dation1 ! ,secret>y %all provide a det]m9ation reg>d+ su* recomm5dation4 7,b7 ,id5tify national heal? security ne$s1 includ+ gaps 9 public heal? prep>$ness & response relat$ to c\nt]measures & *all5ges to address+ su* ne$s 7includ+ any regulatory *all5ges71 & provide = alignm5t ( c\nt]measure procurem5t ) recomm5dations "u subp>agraph 7,a74 7,c7 ,develop /rategies relat$ to logi/ics1 deploym5t1 di/ribution1 disp5s+1 & use ( c\nt]measures t may be applicable to ! activities ( ! /rategic national /ockpile "u section #cai;,f-#b7;a74 7,d7 ,provide consultation = ! developm5t ( ! /rategy & implem5tation plan "u section #bhaa7;d74 7#b7 ,input ,9 c>ry+ out subp>agraphs 7,b7 & 7,c7 ( p>agraph 7#a71 ! ,,phemce %all solicit & consid] input f ,/ate1 local1 tribal1 & t]ritorial public heal? dep>tm5ts1 z appropriate4 4 7b7 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise ,/rategy & ,implem5tation ,plan ,section #bhaa7;d77#a7 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77#a77 is am5d$-- 7#a7 by /rik+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subsection1 & e ye> !reaft] & ins]t+ ,n lat] ?an ,m>* #ae1 #bjbj1 & bi5nially !reaft]2 & 7#b7 by /rik+ ,director ( ,biom$ical & all t foll[s ?r\gh ,food & ,drugs & ins]t+ ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise e/abli%$ "u section #bhaa-a4 #djc4 ,/rategic ,national ,/ockpile 7a7 ,section #cai;,f-#b7;a7 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#b7 & 7#c7 z p>agraphs 7#c7 & 7#d71 respectively2 & 7#b7 9 p>agraph 7#a7-- 7,a7 by ins]t+ & optimize aft] provide =2 7,b7 by ins]t+ &1 z in=m$ by exi/+ recomm5dations (1 or consultations )1 ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measure ,ent]prise e/abli%$ "u section #bhaa-a1 make necess>y additions or modifications to ! cont5ts ( su* /ockpile or /ockpiles bas$ on ! review conduct$ "u p>agraph 7#b7 be=e ! p]iod ( ! fir/ s5t5ce2 & 7,c7 by /rik+ ! second s5t5ce2 7#c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,?reat-bas$ review 7,a7 ,9 g5]al ,! ,secret>y %all conduct a bi5nial ?reat-bas$ review 7tak+ into acc\nt at-risk individuals7 ( ! cont5ts ( ! /ockpile "u p>agraph 7#a71 includ+ non-ph>maceutical supplies1 &1 9 consultation ) ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise e/abli%$ "u section #bhaa-a1 review cont5ts )9 ! /ockpile & assess :e!r su* cont5ts are consi/5t ) ! recomm5dations made pursuant to section #bhaa-a7;c77#a77;,a74 ,su* review %all be submitt$ bi5nially1 beg9n+ on ,m>* #ae1 #bjai1 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 9 a mann] t does n compromise national security4 7,b7 ,additions1 modifications1 & repl5i%m5ts ,ea* bi5nial ?reat-bas$ review "u subp>agraph 7,a7 %all1 = ea* new or modifi$ c\nt]measure procurem5t or repl5i%m5t1 provide-- 7i7 in=mation reg>d+-- 7,i7 ! quantities ( ! additional or modifi$ c\nt]measure procur$ =1 or contract$ to be procur$ =1 ! /ockpile2 7,,ii7 plann+ consid]ations = appropriate manufactur+ capacity & capability to meet ! goals ( su* additions or modifications 7)\t disclos+ propriet>y in=mation71 includ+ consid]ation ( ! effect su* additions or modifications may h on ! availability ( su* products & ancill>y m$ical supplies 9 ! heal? c>e sy/em2 7,,iii7 ! pres5ce or lack ( a comm]cial m>ket = ! c\nt]measure at ! "t ( procurem5t2 7,,iv7 ! em]g5cy heal? security ?reat or ?reats su* c\nt]measure procurem5t is int5d$ to address1 includ+ :e!r su* procurem5t is consi/5t ) meet+ em]g5cy heal? security ne$s associat$ ) su* ?reat or ?reats2 7,v7 an assessm5t ( :e!r ! em]g5cy heal? security ?reat or ?reats describ$ 9 subclause 7,,iv7 c\ld be address$ 9 a mann] t bett] utilizes ! res\rces ( ! /ockpile & p]mits ! greate/ possible increase 9 ! level ( em]g5cy prep>$ness to address su* ?reats2 7,,vi7 :e!r su* c\nt]measure is repl5i%+ an expir$ c\nt]measure1 is a diff]5t c\nt]measure ) ! same indication t is replac+ an expir$ c\nt]measure1 or is a new addition to ! /ockpile2 7,,vii7 a description ( h[ su* additions or modifications align ) ! c\nt]measures budget plan z requir$ "u section #bhaa7;b77#g71 includ+ expect$ life-cycle co/s1 exp5ditures relat$ to c\nt]measure procurem5t to address ! ?reat or ?reats describ$ 9 subclause 7,,iv71 repl5i%m5t dates 7includ+ ! ability to ext5d ! maximum %elf life ( a c\nt]measure71 & ! manufactur+ capacity requir$ to repl5i% su* c\nt]measure2 & 7,,viii7 appropriate protocols & processes = ! deploym5t1 di/ribution1 or disp5s+ ( ! c\nt]measure at ! ,/ate & local level1 includ+ plans = relevant capabilities ( ,/ate & local entities to disp5se1 di/ribute1 & adm9i/] ! c\nt]measure2 & 7ii7 an assurance t = ea* c\nt]measure produc$ or repl5i%$ "u ?is subsection1 ! ,secret>y complet$ a review address+ ea* item li/$ "u ?is subsection 9 advance ( su* procurem5t or repl5i%m5t1 :i* ne$ n be provid$ 9 advance ( procurem5t4 2 7#d7 9 p>agraph 7#c71 z s r$esignat$-- 7,a7 9 subp>agraph 7,a71 by ins]t+ & ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise e/abli%$ "u section #bhaa-a be=e ! semicolon2 7,b7 9 subp>agraph 7,c71 by ins]t+ 1 & ! availability1 deploym5t1 disp5s+1 & adm9i/ration ( c\nt]measures be=e ! semicolon2 & 7,c7 by am5d+ subp>agraph 7,e7 to read z foll[s3 7,e7 devise plans = effective & timely supply-*a9 managem5t ( ! /ockpile1 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,secret>y ( ,transportation1 ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,vet]ans ,affairs1 & ! heads ( o!r appropriate ,f$]al ag5cies1 ,/ate1 local1 tribal1 & t]ritorial ag5cies1 & ! public & private heal? c>e infra/ructure1 z applicable1 tak+ into acc\nt ! manufactur+ capacity & o!r available s\rces ( products & appropriate alt]natives to supplies 9 ! /ockpile 2 & 7#e7 by add+ at ! end ! foll[+3 7#e7 ,,gao report 7,a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 & e #e ye>s !reaft]1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a review ( any *anges to ! cont5ts or managem5t ( ! /ockpile s9ce ,janu>y #a1 #bjae4 ,su* review %all include-- 7i7 an assessm5t ( ! compreh5siv5ess & complet5ess ( ea* bi5nial ?reat-bas$ review "u p>agraph 7#b71 includ+ :e!r all newly procur$ or repl5i%$ c\nt]measures )9 ! /ockpile 7 describ$ 9 ea* annual review1 & :e!r1 consi/5t ) p>agraph 7#b77;,b71 ! ,secret>y conduct$ ! necess>y int]nal review 9 advance ( su* procurem5t or repl5i%m5t2 7ii7 an assessm5t ( :e!r ! ,secret>y e/abli%$ heal? security & sci5ce-bas$ ju/ifications1 & a description ( su* ju/ifications = procurem5t decisions relat$ to heal? security ne$s ) respect to ! id5tifi$ ?reat1 = additions or modifications to ! /ockpile bas$ on ! in=mation provid$ 9 su* reviews "u p>agraph 7#b77;,b71 includ+ :e!r su* review 0 conduct$ prior to procurem5t1 modification1 or repl5i%m5t2 7iii7 an assessm5t ( ! plans develop$ by ! ,secret>y = ! deploym5t1 di/ribution1 & disp5s+ ( c\nt]measures procur$1 modifi$1 or repl5i%$ "u p>agraph 7#a71 includ+ :e!r su* plans 7 develop$ prior to procurem5t1 modification1 or repl5i%m5t2 7iv7 an acc\nt+ ( c\nt]measures procur$1 modifi$1 or repl5i%$ "u p>agraph 7#a7 t receiv$ advanc$ rese>* & developm5t fund+ f ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority2 7v7 an analysis ( h[ su* procurem5t decisions made progress t[>ds meet+ em]g5cy heal? security ne$s relat$ to ! id5tifi$ ?reats = c\nt]measures add$1 modifi$1 or repl5i%$ "u p>agraph 7#a72 7vi7 a description ( ! res\rces exp5d$ relat$ to ! procurem5t ( c\nt]measures 7includ+ additions1 modifications1 & repl5i%m5ts7 9 ! /ockpile1 & h[ su* exp5ditures relate to ! em]g5cy heal? security ne$s ( ! /ockpile2 7vii7 an assessm5t ( ! ext5t to :i* additions1 modifications1 & repl5i%m5ts review$ "u p>agraph 7#b7 align ) previ\s relevant reports or reviews by ! ,secret>y or ! ,comptroll] ,g5]al2 & 7viii7 ) respect to any *ange 9 ! ,f$]al organizational managem5t ( ! /ockpile1 an assessm5t & comp>ison ( ! processes affect$ by su* *ange1 includ+ plann+ = pot5tial c\nt]measure deploym5t1 di/ribution1 or disp5s+ capabilities & processes relat$ to procurem5t decisions1 use ( /ockpil$ c\nt]measures1 & use ( res\rces = su* activities4 7,b7 ,submission ,n lat] ?an #f mon?s aft] complet+ a classifi$ v]sion ( ! review "u subp>agraph 7,a71 ! ,comptroll] ,g5]al %all submit an unclassifi$ v]sion ( ! review to ! appropriate committees ( ,congress4 4 7b7 ,au?orization ( appropriations1 /rategic national /ockpile ,section #cai;,f-#b7;f77#a7 7#db ,u4,s4,c4 #bdg;d-#f;b7f77#a77 is am5d$ by /rik+ #ecc1hjj1jjj = ea* ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #faj1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 #djd4 ,prep>+ = p&emic influ5za1 antimicrobial resi/ance1 & o!r significant ?reats ,section #cai,l7c77#d7 7#bdg;d-#g;e7c77#d77 is am5d$ by add+ at ! end ! foll[+3 7,f7 ,/rategic initiatives ,! ,secret>y1 act+ ?r\gh ! ,director ( ,,b>da1 may implem5t /rategic initiatives1 includ+ by build+ on exi/+ programs1 support+ innovative c&idate products 9 precl9ical & cl9ical developm5t1 to address priority1 naturally occurr+ & man-made ?reats t1 z det]m9$ by ! ,secret>y1 pose a significant level ( risk to national security bas$ on ! *>act]i/ics ( a *emical1 biological1 radiological or nucle> ?reat1 or exi/+ capabilities to respond to su* a ?reat 7includ+ m$ical response & treatm5t capabilities & manufactur+ infra/ructure74 ,su* initiatives %all accel]ate & support ! advanc$ rese>*1 developm5t1 & procurem5t (1 c\nt]measures & products1 z applicable1 to address areas includ+-- 7i7 *emical1 biological1 radiological1 or nucle> ?reats1 includ+ em]g+ infecti\s diseases1 = :i* insuffici5t approv$1 lic5s$1 or au?oriz$ c\nt]measures exi/1 or = :i* su* ?reat1 or ! result ( an exposure to su* ?reat1 may become resi/ant to c\nt]measures or exi/+ c\nt]measures may be r5d]$ ineffective2 7ii7 ?reats t consi/5tly exi/ or cont9ually circulate & h significant pot5tial to become a p&emic1 su* z p&emic influ5za1 :i* may include ! advanc$ rese>* & developm5t1 manufactur+1 & appropriate /ockpil+ ( qualifi$ p&emic or epidemic products1 & products1 te*nologies1 or processes to support ! advanc$ rese>* & developm5t ( su* c\nt]measures 7includ+ multiuse plat=m te*nologies = diagno/ics1 vacc9es1 & !rapeutics2 virus se$s2 cl9ical trial lots2 novel virus /ra9s2 & antig5 & adjuvant mat]ial72 & 7iii7 ?reats t may result prim>ily or second>ily f a *emical1 biological1 radiological1 or nucle> ag5t1 or em]g+ infecti\s disease1 & :i* may pres5t increas$ treatm5t complications su* z ! occurr5ce ( resi/ance to available c\nt]measures or pot5tial c\nt]measures1 includ+ antimicrobial resi/ant pa?og5s4 4 #dje4 ,report+ on ! ,f$]al ,select ,ag5t ,program ,section #cea;,a7k7 7#db ,u4,s4,c4 #bfb;a7 is am5d$-- 7#a7 by /rik+ ,! ,secret>y & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,! ,secret>y 2 & 7#b7 by add+ at ! end ! foll[+3 7#b7 ,implem5tation ( recomm5dations ( ! ,f$]al exp]ts security advisory panel & ! fa/ track action committee on select ag5t regulations 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah1 ! ,secret>y %all provide an update to ! appropriate committees ( ,congress on ! implem5tation ( recomm5dations ( ! ,f$]al ,exp]ts ,security ,advisory ,panel conc]n+ ! select ag5t program4 7,b7 ,cont9u$ updates ,! ,secret>y %all provide /atus updates at #f-mon? int]vals foll[+ ! submission ( ! update "u subp>agraph 7,a7 until ! recomm5dations describ$ 9 su* subp>agraph are fully implem5t$1 or a ju/ification is provid$ = ! delay 91 or lack (1 implem5tation4 4 ,v ,increas+ communication 9 m$ical c\nt]measure advanc$ rese>* & developm5t #eja4 ,m$ical c\nt]measure budget plan ,section #bhaa7;b77#g7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#g77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ,m>* #a ( ea* ye> & ins]t+ ,m>* #ae1 #bjbj & e #b ye>s !reaft]2 7#b7 by /rik+ subp>agraph 7,a7 & ins]t+ ! foll[+3 7,a7 include consid]ation ( ! entire m$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 & pot5tial repl5i%m5t 7includ+ manufactur+ capabilities7 ( all products 9 ! ,/rategic ,national ,/ockpile2 & 7iv7 ! availability ( te*nologies t may assi/ 9 ! advanc$ rese>* & developm5t ( c\nt]measures & opportunities to use su* te*nologies to accel]ate & navigate *all5ges unique to c\nt]measure rese>* & developm5t2 4 7#c7 by r$esignat+ subp>agraphs 7,d7 & 7,e7 z subp>agraphs 7,e7 & 7,f71 respectively2 7#d7 by ins]t+ aft] subp>agraph 7,c71 ! foll[+3 7,d7 id5tify ! full range ( anticipat$ m$ical c\nt]measure ne$s relat$ to rese>* & developm5t1 procurem5t1 & /ockpil+1 includ+ ! pot5tial ne$ = indications1 dos+1 & adm9i/ration te*nologies1 & o!r c\nt]measure ne$s z applicable & appropriate2 2 & 7#e7 9 subp>agraph 7,e71 z s r$esignat$1 by /rik+ ,m>* #ae ( ea* ye> & ins]t+ ,m>* #ae1 #bjbj1 & e #b ye>s !reaft]4 #ejb4 ,mat]ial ?reat & m$ical c\nt]measure notifications 7a7 ,congressional notification ( mat]ial ?reat det]m9ation ,section #cai;,f-#b7;c77#b77;,c7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#b77;,c77 is am5d$ by /rik+ ,! ,secret>y & ! ,homel& ,security ,secret>y %all promptly notify ! appropriate committees ( ,congress & ins]t+ ,! ,secret>y & ! ,secret>y ( ,homel& ,security %all s5d to ,congress1 on an annual basis1 all curr5t mat]ial ?reat det]m9ations & %all promptly notify ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,homel& ,security & ,gov]nm5t ,affairs ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,homel& ,security ( ! ,h\se ( ,repres5tatives4 7b7 ,contract+ communications 7#a7 ,contract duration ,section #cai;,f-#b7;c77#g77;,b77ii77,,iii7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#g77;,b77ii77,,iii77 is am5d$ by add+ at ! end ! foll[+3 ,! ,secret>y %all notify ! v5dor )9 #ij days ( a det]m9ation by ! ,secret>y to r5ew su* contract44 7#b7 ,exp$it$ au?orities ,section #cai,l7c77#e77;,b77i7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#e77;,b77i77 is am5d$ by add+ at ! end ! foll[+3 ,^u aw>d1 ext5sion1 or t]m9ation ( any su* contract1 grant1 coop]ative agreem5t1 & o!r transaction1 ! ,secret>y %all provide a writt5 notification to ! receiv+ entity t includes a ju/ification = su* aw>d1 ext5sion1 or t]m9ation44 #ejc4 ,availability ( regulatory managem5t plans ,section #efe7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;f77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#f7 z p>agraphs 7#d7 ?r\gh 7#g71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 ,publication ,! ,secret>y %all make available on ! int]net website ( ! ,food & ,drug ,adm9i/ration in=mation reg>d+ regulatory managem5t plans1 includ+-- 7,a7 ! process by :i* an applicant may submit a reque/ = a regulatory managem5t plan2 7,b7 ! timeframe by :i* ! ,secret>y is requir$ to respond to su* reque/2 7,c7 ! in=mation requir$ = ! submission ( su* reque/2 7,d7 a description ( ! types ( developm5t mile/ones & p]=mance t>gets t c\ld be discuss$ & includ$ 9 su* plans2 & 7,e7 contact in=mation = beg9n+ ! regulatory managem5t plan process4 2 7#c7 9 p>agraph 7#f71 z s r$esignat$1 9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7 by /rik+ p>agraph 7#d77;,a7 & ins]t+ p>agraph 7#e77;,a72 & 7,b7 by /rik+ p>agraph 7#d77;,b7 & ins]t+ p>agraph 7#e77;,b72 & 7#d7 9 p>agraph 7#g77;,a71 z s r$esignat$1 by /rik+ p>agraph 7#c77;,a7 & ins]t+ p>agraph 7#d77;,a74 #ejd4 ,! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority & ! ,bio,shield ,special ,res]ve ,fund 7a7 ,bio%ield special res]ve fund ,section #cai;,f-#b7;g77#a7 7#db ,u4,s4,c4 #bdg;d-#f;b7g77#a77 is am5d$-- 7#a7 by /rik+ #b1hjj1jjj1jjj = ! p]iod ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #c1ejj1jjj1jjj = ! p]iod ( fiscal ye>s #bjai ?r\gh #bjbc1 to rema9 available until exp5d$2 & 7#b7 by /rik+ ! second s5t5ce4 7b7 ,! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority ,section #cai,l7d77#b7 7#db ,u4,s4,c4 #bdg;d-#g;e7d77#b77 is am5d$ by /rik+ #dae1jjj1jjj = ea* ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #faa1gjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 ,,vi ,advanc+ te*nologies = m$ical c\nt]measures #fja4 ,adm9i/ration ( c\nt]measures ,section #cai,l7c77#d77;,d77iii7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,d77iii77 is am5d$ by /rik+ & plat=m te*nologies ins]t+ plat=m te*nologies1 te*nologies to adm9i/] c\nt]measures1 te*nologies to improve /orage1 & transportation ( c\nt]measures4 #fjb4 ,m$ical c\nt]measure ma/] files 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #efe;,a ! foll[+3 #efe;,b4 ,m$ical c\nt]measure ma/] files 7a7 ,purpose ,! purpose ( ?is section is to support & accel]ate ! developm5t or manufacture ( security c\nt]measures1 qualifi$ c\nt]measures1 & qualifi$ p&emic or epidemic products by facilitat+ & enc\rag+ submission ( data & in=mation to support su* products to ma/] files1 & ?r\gh cl>ify+ ! au?ority to cross-ref]5ce to data & in=mation previ\sly submitt$ to ! ,secret>y4 7b7 ,applicability ( ref]5ce 7#a7 ,9 g5]al ,a p]son may submit data & in=mation to ! ,secret>y ) ! int5t to ref]5ce1 or to au?orize1 9 writ+1 ano!r p]son to ref]5ce1 su* data or in=mation1 9 accordance ) subsections 7d7 & 7e7 ( section #cad4dbj ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 to support a m$ical c\nt]measure submission 7includ+ a supplem5t or am5dm5t to any su* submission71 )\t requir+ ! ma/] file hold] to disclose ! data & in=mation to any su* p]sons au?oriz$ to ref]5ce ! ma/] file4 7#b7 ,ma/] file hold] ,9 ?is section1 ! t]m ma/] file hold] means a p]son :o submits data & in=mation to ! ,secret>y ) ! int5t to ref]5ce or au?orize to ref]5ce su* data or in=mation to support a m$ical c\nt]measure submission1 z describ$ 9 p>agraph 7#a74 7c7 ,m$ical c\nt]measure ma/] file cont5t 7#a7 ,9 g5]al ,a ma/] file "u ?is section may include in=mation to support & accel]ate-- 7,a7 ! developm5t ( m$ical c\nt]measure submissions to support ! approval1 lic5sure1 classification1 cle>ance1 conditional approval1 or au?orization ( "o or m security c\nt]measures1 qualifi$ c\nt]measures1 or qualifi$ p&emic or epidemic products2 & 7,b7 ! manufacture ( security c\nt]measures1 qualifi$ c\nt]measures1 or qualifi$ p&emic or epidemic products4 7#b7 ,requir$ updates ,! ,secret>y may require1 z appropriate1 t ! ma/] file hold] ensure t ! cont5ts ( su* ma/] file are updat$ dur+ ! "t su* ma/] file is ref]5c$ = a m$ical c\nt]measure submission4 7d7 ,sponsor ref]5ce 7#a7 ,9 g5]al ,ea* incorporation ( in=mation or data conta9$ 9 a ma/] file by ref]5ce %all describe ! incorporat$ mat]ial 9 a mann] 9 :i* ! ,secret>y det]m9es appropriate & t p]mits ! review ( su* in=mation )\t necessitat+ resubmission ( su* in=mation or data4 ,ma/] files %all be submitt$ 9 an electronic =mat 9 accordance ) section #gde;,a & z specifi$ 9 applicable guidance4 7#b7 ,ref]5ce by a ma/] file hold] ,a ma/] file hold] t is ! sponsor ( a m$ical c\nt]measure submission %all notify ! ,secret>y 9 writ+ ( ! int5t to ref]5ce ! m$ical c\nt]measure ma/] file z a "p ( ! submission4 7#c7 ,ref]5ce by an au?oriz$ p]son ,a sponsor ( a m$ical c\nt]measure submission may1 :]e ! ,secret>y det]m9es appropriate1 incorporate by ref]5ce all or "p ( ! cont5ts ( a m$ical c\nt]measure ma/] file1 if ! ma/] file hold] au?orizes ! incorporation 9 writ+4 7e7 ,ackn[l$gem5t ( ma/] file by ! ,secret>y ,! ,secret>y %all provide ! ma/] file hold] ) a writt5 notification indicat+ t ! ,secret>y has review$ & reli$ ^u specifi$ in=mation or data )9 a ma/] file & ! purposes = :i* su* in=mation or data 0 incorporat$ by ref]5ce if ! ,secret>y has review$ & reli$ ^u su* specifi$ in=mation or data to support ! approval1 classification1 conditional approval1 cle>ance1 lic5sure1 or au?orization ( a security c\nt]measure1 qualifi$ c\nt]measure1 or qualifi$ p&emic or epidemic product4 ,! ,secret>y may rely ^u ! data & in=mation )9 ! m$ical c\nt]measure ma/] file = :i* su* writt5 notification 0 provid$ 9 additional applications1 z applicable & appropriate & ^u ! reque/ ( ! ma/] file hold] s notifi$ 9 writ+ or by an au?oriz$ p]son ( su* hold]4 7f7 ,rules ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to-- 7#a7 alt] ! au?ority ( ! ,secret>y to approve1 lic5se1 classify1 cle>1 conditionally approve1 or au?orize drugs1 biological products1 or devices pursuant to ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act 7z au?oriz$ prior to ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjah71 includ+ ! /&>ds ( evid5ce1 & applicable conditions1 = approval "u ! applicable ,act2 or 7#b7 alt] ! au?ority ( ! ,secret>y "u ?is ,act or ! ,public ,heal? ,s]vice ,act to det]m9e ! types ( in=mation or data previ\sly submitt$ by a sponsor or any o!r p]son t may be incorporat$ by ref]5ce 9 an application1 reque/1 or notification = a drug1 biological product1 or device submitt$ "u sections #eje7;i71 #eje7;b71 #eje7;j71 #eab7;b77#a71 #eab7;b77#b71 #efd1 #ega1 #ebj7;g71 #eae7;c71 #eac7;f77#b71 or #eaj7k7 ( ?is ,act1 or subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ a supplem5t or am5dm5t to any su* submission1 & ! requirem5ts associat$ ) su* ref]5ce4 7g7 ,def9itions ,9 ?is section3 7#a7 ,! t]m m$ical c\nt]measure submission means an inve/igational new drug application "u section #eje7;i71 a new drug application "u section #eje7;b71 or an abbreviat$ new drug application "u section #eje7;j7 ( ?is ,act1 a biological product lic5se application "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act or a biosimil> biological product lic5se application "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act1 a new animal drug application "u section #eab7;b77#a7 or abbreviat$ new animal drug application "u section #eab7;b77#b71 an application = conditional approval ( a new animal drug "u #ega1 an inve/igational device application "u section #ebj7;g71 an application ) respect to a device "u section #eae7;c71 a reque/ = classification ( a device "u section #eac7;f77#b71 a notification ) respect to a device "u section #eaj7k71 or reque/ = an em]g5cy use au?orization "u section #efd to support-- 7,a7 ! approval1 lic5sure1 classification1 cle>ance1 conditional approval1 or au?orization ( a security c\nt]measure1 qualifi$ c\nt]measure1 or qualifi$ p&emic or epidemic product2 or 7,b7 a new indication to an approv$ security c\nt]measure1 qualifi$ c\nt]measure1 or qualifi$ p&emic or epidemic product4 7#b7 ,! t]ms qualifi$ c\nt]measure1 security c\nt]measure1 & qualifi$ p&emic or epidemic product h ! mean+s giv5 su* t]ms 9 sections #cai;,f-#a1 #cai;,f-#b1 & #cai;,f-#c1 respectively1 ( ! ,public ,heal? ,s]vice ,act4 4 7b7 ,/akehold] ,input ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 act+ ?r\gh ! ,commission] ( ,food & ,drugs & 9 consultation ) ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 %all solicit input f /akehold]s1 includ+ /akehold]s develop+ security c\nt]measures1 qualifi$ c\nt]measures1 or qualifi$ p&emic or epidemic products1 & /akehold]s develop+ te*nologies to assi/ 9 ! developm5t ( su* c\nt]measures ) respect to h[ ! ,food & ,drug ,adm9i/ration c advance ! use ( tools & te*nologies to support & accel]ate ! developm5t or manufacture ( security c\nt]measures1 qualifi$ c\nt]measures1 & qualifi$ p&emic or epidemic products1 includ+ ?r\gh ! reliance on cross-ref]5c$ data & in=mation conta9$ )9 ma/] files & submissions previ\sly submitt$ to ! ,secret>y z set =? 9 section #efe;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 7c7 ,guidance ,n lat] ?an #b ye>s aft] ! aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all publi% draft guidance ab\t h[ reliance on cross-ref]5c$ data & in=mation conta9$ )9 ma/] files "u section #efe;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a7 or submissions o!rwise submitt$ to ! ,secret>y may be us$ = specific tools or te*nologies 7includ+ plat=m te*nologies7 t h ! pot5tial to support & accel]ate ! developm5t or manufacture ( security c\nt]measures1 qualifi$ c\nt]measures1 qualifi$ p&emic or epidemic products4 ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all publi% ! f9al guidance n lat] ?an #c ye>s aft] ! enactm5t ( ?is ,act4 #fjc4 ,animal rule report 7a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! application ( ! requirem5ts "u section #efe7;d7 ( ! ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;d77 7ref]r$ to 9 ?is section z ! animal rule7 z a compon5t ( m$ical c\nt]measure advanc$ developm5t "u ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority & regulatory review by ! ,food & ,drug ,adm9i/ration4 ,9 conduct+ su* /udy1 ! ,comptroll] ,g5]al %all exam9e ! foll[+3 7#a7 ,! ext5t to :i* advanc$ developm5t & review ( a m$ical c\nt]measure are coord9at$ betwe5 ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority & ! ,food & ,drug ,adm9i/ration1 includ+ activities facilitate appropriate & effici5t design ( /udies to support approval1 lic5sure1 & au?orization "u ! animal rule1 consi/5t ) ! recomm5dations 9 ! animal rule guidance1 issu$ pursuant to section #efe7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c77 & entitl$ ,product ,developm5t ,"u ! ,animal ,rule ,guidance = ,indu/ry 7issu$ 9 ,octob] #bjae71 to resolve discrepancies 9 ! design ( adequate & well-controll$ efficacy /udies conduct$ 9 animal models relat$ to ! provision ( sub/antial evid5ce ( effectiv5ess = ! product approv$1 lic5s$1 or au?oriz$ "u ! animal rule4 7#b7 ,! consi/5cy ( ! application ( ! animal rule among & betwe5 review divisions )9 ! ,food & ,drug ,adm9i/ration4 7#c7 ,! flexibilities pursuant to ! animal rule to address v>iations 9 c\nt]measure developm5t & review processes1 includ+ ! ext5t to :i* qualifi$ animal models are adopt$ & us$ )9 ! ,food & ,drug ,adm9i/ration 9 regulatory decisionmak+ ) respect to m$ical c\nt]measures4 7#d7 ,! ext5t to :i* ! guidance issu$ "u section #efe7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c771 entitl$1 ,product ,developm5t ,"u ! ,animal ,rule ,guidance = ,indu/ry 7issu$ 9 ,octob] #bjae71 has assi/$ 9 a*iev+ ! purposes describ$ 9 p>agraphs 7#a71 7#b71 & 7#c74 7b7 ,consultations ,9 conduct+ ! /udy "u subsection 7a71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all consult )-- 7#a7 ! ,f$]al ag5cies responsible = advanc+1 review+1 & procur+ m$ical c\nt]measures1 includ+ ! ,(fice ( ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 ! ,food & ,drug ,adm9i/ration1 & ! ,dep>tm5t ( ,def5se2 7#b7 manufactur]s involv$ 9 ! rese>* & developm5t ( m$ical c\nt]measures to address biological1 *emical1 radiological1 & nucle> ?reats2 & 7#c7 o!r biodef5se /akehold]s1 z applicable4 7c7 ,report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a7 & recomm5dations to improve ! application & consi/5cy ( ! requirem5ts "u subsections 7c7 & 7d7 ( section #efe ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7 to support & exp$ite ! rese>* & developm5t ( m$ical c\nt]measures1 z applicable4 7d7 ,protection ( national security ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct ! /udy & issue ! assessm5t & report "u ?is section 9 a mann] t does n compromise national security4 ,,vii ,miscellane\s provisions #gja4 ,reau?orizations & ext5sions 7a7 ,vet]ans ,affairs ,section #haag7;g7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ #bjad ?r\gh #bjah & ins]t+ #bjai ?r\gh #bjbc4 7b7 ,vacc9e track+ & di/ribution ,section #cai;,a7e7 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is am5d$ by /rik+ #bjad ?r\gh #bjah & ins]t+ #bjai ?r\gh #bjbc4 7c7 ,tempor>y reassignm5t ,section #cai7;e77#h7 7#db ,u4,s4,c4 #bdg;d7e77#h77 is am5d$ by /rik+ #bjah & ins]t+ #bjbc4 7d7 ,/rategic ,innovation ,p>tn] ,section #cai,l7c77#d77;,e77ix7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,e77ix77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbc4 7e7 ,public disclosure exemption ,section #cai,l7e77#a77;,c7 7#db ,u4,s4,c4 #bdg;d-#g;e7e77#a77;,c77 is am5d$ by /rik+ #ab & ins]t+ #ag4 7f7 ,limit$ antitru/ exemption 7#a7 ,9 g5]al ,section #dje ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,act 7#db ,u4,s4,c4 #bdg;d-#f;a note7 is am5d$-- 7,a7 by r$esignat+ su* section z section #cai,l-#a2 7,b7 transf]r+ su* section to ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq471 to appe> aft] section #cai,l ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#g;e72 7,c7 9 subsection 7a77#a7-- 7i7 by /rik+ ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 & ins]t+ ,secret>y2 7ii7 by /rik+ ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b77 7z am5d$ by ?is ,act2 7iii7 by /rik+ ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;a77 7z am5d$ by ?is ,act2 & 7iv7 by /rik+ ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;d72 & 7,d7 9 subsection 7b71 by /rik+ #ab-ye> & ins]t+ #ag-ye>4 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a77;,d7 %all take effect z if enact$ on ,decemb] #ag1 #bjab4 7#c7 ,con=m+ am5dm5t ,! table ( cont5ts 9 section #a7;b7 ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,act 7,public ,law #aji-dag7 is am5d$ by /rik+ ! item relat$ to section #dje4 #gjb4 ,te*nical am5dm5ts 7a7 ,public ,heal? ,s]vice ,act ,title ,,iii 7#db ,u4,s4,c4 #bda et seq47 is am5d$-- 7#a7 9 p>agraphs 7#a7 & 7#e7 ( section #cai;,f-#a7;a7 7#db ,u4,s4,c4 #bdg;d-#f;a7a771 by /rik+ section #cai;,f7h7 ea* place su* t]m appe>s & ins]t+ section #cai;,f7e72 & 7#b7 9 section #cai,k7a7 7#db ,u4,s4,c4 #bdg;d-#g;d7a771 by /rik+ section #cai;,f7h77#d7 & ins]t+ section #cai;,f7e77#d74 7b7 ,public heal? security grants ,section #cai;,c-#a7;b77#b7 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,c71 by /rik+ individuals11 & ins]t+ individuals12 & 7#b7 9 subp>agraph 7,f71 by /rik+ make satisfactory annual improvem5t & describe & ins]t+ makes satisfactory annual improvem5t & describes4 7c7 ,f$]al ,food1 ,drug1 & ,cosmetic ,act ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$-- 7#a7 9 section #efd;,a7e77#b77;,a7 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7e77#b77;,a771 by /rik+ subsection 7a77#a77;,c77i7 & ins]t+ subsection 7a77#a77;,c72 & 7#b7 9 section #efd;,b7#b77;,c7 7#ba ,u4,s4,c4 #cfj;bbb-#c;b7#b77;,c771 by ins]t+ or section #efd;,a4