,,ii #aah? ,,congress #a/ ,session ,s4 #bccc ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #ah1 #bjbc,mr4 ,casey 7= himself1 ,mr4 ,romney1 ,mr4 ,s&]s1 & ,mr4 ,cassidy7 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 ! ,public ,heal? ,s]vice ,act ) respect to public heal? security & all-haz>ds prep>$ness & response1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,response ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,/ate & local read9ess & response,sec4 #aja4 ,tempor>y reassignm5t ( ,/ate & local p]sonnel dur+ a public heal? em]g5cy4,sec4 #ajb4 ,public ,heal? ,em]g5cy ,prep>$ness program4,sec4 #ajc4 ,improv+ & enhanc+ p>ticipation ( ,,ems organizations 9 ! hospital prep>$ness program4,sec4 #ajd4 ,improv+ m$ical read9ess & response capabilities4,sec4 #aje4 ,pilot program to support ,/ate m$ical /ockpiles4,sec4 #ajf4 ,enhanc+ dome/ic wa/ewat] surveillance = pa?og5 detection4,sec4 #ajg4 ,reau?orization ( ,mosquito ,abatem5t = ,safety & ,heal? program4,,title ,,ii--,f$]al plann+ & coordination,sec4 #bja4 ,all-,haz>ds ,em]g5cy ,prep>$ness & ,response4,sec4 #bjb4 ,national ,heal? ,security ,/rategy4,sec4 #bjc4 ,improv+ developm5t & di/ribution ( diagno/ic te/s4,sec4 #bjd4 ,pilot program = public heal? data availability4,sec4 #bje4 ,combat+ antimicrobial resi/ance4,sec4 #bjf4 ,/rategic ,national ,/ockpile & mat]ial ?reats4,sec4 #bjg4 ,m$ical c\nt]measures = viral ?reats ) p&emic pot5tial4,sec4 #bjh4 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise4,sec4 #bji4 ,/r5g!n+ public heal? communication4,sec4 #baj4 ,fell[%ip & tra9+ programs4,sec4 #baa4 ,assessm5t ( ,,covid-#ai mitigation policies4,,title ,,iii--,address+ ! ne$s ( all individuals,sec4 #cja4 ,transition ( c]ta9 c\nt]measures betwe5 comp5sation programs4,sec4 #cjb4 ,accel]at+ injury comp5sation program adm9i/ration & ensur+ program integrity4,sec4 #cjc4 ,comp5sation = injuries relat+ to ! public heal? em]g5cy caus$ by ,,s>s-,co,v-#b4,sec4 #cjd4 ,review ( regulations4,sec4 #cje4 ,support+ individuals ) disabilities1 old] adults1 & o!r at-risk individuals dur+ em]g5cy responses4,sec4 #cjf4 ,national advisory committees4,sec4 #cjg4 ,rese>* & coord9ation ( activities conc]n+ ! long-t]m heal? effects ( ,,s>s-,co,v-#b infection4,sec4 #cjh4 ,national ,academies /udy on prizes4,,title ,,iv--,/r5g!n+ biosecurity,sec4 #dja4 ,treatm5t ( g5etic v>iants & syn!tic products ( select ag5ts & tox9s4,sec4 #djb4 ,e/abli%m5t ( no-fault report+ sy/em4,sec4 #djc4 ,evaluation ( ! ,f$]al ,select ,ag5t ,program & relat$ policies4,sec4 #djd4 ,support+ rese>* & laboratory surge capacity4,sec4 #dje4 ,g5e syn!sis4,sec4 #djf4 ,limitation relat$ to c\ntries ( conc]n conduct+ c]ta9 rese>*4,sec4 #djg4 ,assessm5t ( artificial intellig5ce ?reats to heal? security4,,title ,v--,prev5t+ drug shortages,sec4 #eja4 ,improv+ notification proc$ures 9 case ( increas$ dem& = critical drugs4,sec4 #ejb4 ,report+ on supply *a9s4,sec4 #ejc4 ,report+ on use ( new au?orities & requirem5ts ) respect to drug %ortages4,,title ,,vi--,additional reau?orizations & te*nical amendments,sec4 #fja4 ,m$ical c\nt]measure priority review v\*]4,sec4 #fjb4 ,epidemic ,intellig5ce ,s]vice loan repaym5t program4,sec4 #fjc4 ,vacc9e track+ & di/ribution4,sec4 #fjd4 ,regional heal? c>e em]g5cy prep>$ness & response sy/ems4,sec4 #fje4 ,em]g5cy sy/em = advance regi/ration ( volunte] heal? pr(essional4,sec4 #fjf4 ,limit$ antitru/ exemption4,sec4 #fjg4 ,trauma c>e4,sec4 #fjh4 ,milit>y & civilian p>tn]%ip = trauma read9ess4,sec4 #fji4 ,national ,disa/] ,m$ical ,sy/em4,sec4 #faj4 ,volunte] ,m$ical ,res]ve ,corps4,sec4 #faa4 ,epidemiology-laboratory capacity grants4,sec4 #fab4 ,vet]ans ,affairs4,sec4 #fac4 ,te*nical am5dm5ts4 ,i ,/ate & local read9ess & response #aja4 ,tempor>y reassignm5t ( ,/ate & local p]sonnel dur+ a public heal? em]g5cy ,section #cai7;e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7e77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ su* ,gov]nor or tribal organization's designee & ins]t+ ! designee ( ! ,gov]nor or ,tribal organization1 or ! ,/ate or ,tribal heal? (ficial2 7#b7 9 p>agraph 7#b77;,b7-- 7,a7 9 ! matt] prec$+ clause 7i71 by /rik+ tribal organization & ins]t+ ,tribal organization1 or ! ,/ate or ,tribal heal? (ficial2 & 7,b7 9 clause 7v71 by /rik+ tribal organization & ins]t+ ,tribal organization or ,/ate or ,tribal heal? (ficial2 7#c7 9 p>agraph 7#f7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ ,reau?orization ,act ( #bjac & ins]t+ & ,response ,act2 & 7ii7 by /rik+ appropriate committees ( ! ,congress & ins]t+ ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 & 7,b7 9 subp>agraph 7,a71 by ins]t+ 1 includ+ reque/s f ,/ate or ,tribal heal? (ficials be=e ! semicolon2 7#d7 9 p>agraph 7#g77;,a71 by /rik+ tribal organization & ins]t+ ,tribal organization2 & 7#e7 9 p>agraph 7#h71 by /rik+ #bjbc & ins]t+ #bjbh4 #ajb4 ,public ,heal? ,em]g5cy ,prep>$ness program ,section #cai;,c-#a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7 is am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 9 subp>agraph 7,a77ii71 by /rik+ influ5za & ins]t+ response plann+2 & 7,b7 9 subp>agraph 7,h71 by ins]t+ 1 su* z community-bas$ organizations1 includ+ fai?-bas$ organizations1 & o!r public & private entities aft] /akehold]s2 7#b7 9 subsection 7g7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ & ! ability ( ea* entity receiv+ an aw>d "u subsection 7a7 to respond to all-haz>ds ?reats be=e ! p]iod at ! end ( ! fir/ s5t5ce2 7,b7 9 p>agraph 7#b7-- 7i7 9 ! p>agraph head+1 by /rik+ influ5za & ins]t+ response2 & 7ii7 9 subp>agraph 7,a7-- 7,i7 by /rik+ to p&emic influ5za & ins]t+ to a pa?og5 caus+ a p&emic1 includ+ p&emic influ5za2 & 7,,ii7 by /rik+ su* p&emic influ5za & ins]t+ su* p&emic response2 7,c7 9 p>agraph 7#e7-- 7i7 9 ! p>agraph head+1 by /rik+ influ5za & ins]t+ p&emic response2 7ii7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjai & ins]t+ #bjbe2 7iii7 9 clause 7i71 by /rik+ #bjah & ins]t+ #bjbd2 & 7iv7 9 subp>agraph 7,b71 by /rik+ p&emic influ5za & ins]t+ a pa?og5 caus+ a p&emic2 & 7,d7 9 p>agraph 7#f7-- 7i7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by /rik+ ,! am\nts describ$ 9 ?is p>agraph are ! foll[+ am\nts t are payable to an entity = activities describ$ 9 ?is section ( section #cai;,c-#b & ins]t+ ,! ,secret>y %all )hold f an entity pursuant to p>agraph 7#e7 = noncompliance ) ! requirem5ts ( ?is section or section #cai;,c-#b z foll[s2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ ) respect to ! requirem5ts ( ?is section or section #cai;,c-#b aft] p>agraph 7#e72 & 7#c7 9 subsection 7h7-- 7,a7 9 p>agraph 7#a77;,a71 by /rik+ #fhe1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #gce1jjj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh2 7,b7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,a71 by /rik+ ,= fiscal ye> #bjbg1 ! ,secret>y & ins]t+ ,! ,secret>y2 & 7ii7 9 subp>agraph 7,d71 by /rik+ = fiscal ye> #bjbf2 & 7,c7 9 p>agraph 7#e77;,a71 by /rik+ ,= fiscal ye> #bjjg1 ! ,secret>y & ins]t+ ,! ,secret>y4 #ajc4 ,improv+ & enhanc+ p>ticipation ( ,,ems organizations 9 ! hospital prep>$ness program 7a7 ,increas+ p>ticipation by ,,ems 9 ! hospital prep>$ness program ,section #cai;,c-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is am5d$-- 7#a7 9 subsection 7b77#a77;,a7-- 7,a7 9 clause 7iii77,,iii71 by /rik+ 2 & & ins]t+ semicolon2 & 7,b7 by /rik+ clause 7iv7 & ins]t+ ! foll[+3 7iv7 "o or m em]g5cy m$ical s]vice organizations2 & 7v7 to ! ext5t practicable1 "o or m em]g5cy managem5t organizations2 & 2 & 7#b7 9 subsection 7g77#a7-- 7,a7 by /rik+ ! head+ & ins]t+3 7#a7 ,local response capabilities 7,a7 ,program coord9ation 2 7,b7 by /rik+ ext5t practicable1 ensure & ins]t+ ! foll[+3 8ext5t practicable-- 7i7 ensure 2 7,c7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,d7 by add+ at ! end ! foll[+3 7ii7 seek to increase p>ticipation ( eligible entities describ$ 9 subsection 7b77#a77;,a7 ) l[] p>ticipation rates relative to coalitions ( o!r eligible entities1 su* z coalitions t include em]g5cy m$ical s]vices organizations & heal? c>e facilities 9 und]s]v$ areas4 4 7b7 ,pref]5ces ,section #cai;,c-#b7;d77#a77;,a77iii7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7d77#a77;,a77iii77 is am5d$ by /rik+ subsection 7b77#a77;,a77ii7 & ins]t+ clauses 7ii7 & 7iv7 ( subsection 7b77#a77;,a74 #ajd4 ,improv+ m$ical read9ess & response capabilities ,section #cai;,c-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by ins]t+ at ! end ! foll[+3 7,c7 designate a lead entity to adm9i/] su* aw>d & support coord9ation betwe5 entities describ$ 9 ?is subsection4 2 7#b7 9 subsection 7g77#a71 z am5d$ by section #ajb7;a77#b71 by add+ at ! end ! foll[+3 7,b7 ,regional op]ations ,an eligible entity %all e/abli% & ma9ta91 or lev]age an exi/+1 capability to enable coord9ation ( regional m$ical op]ations1 :i* may include sy/ems to facilitate in=mation %>+ & coord9ation1 )9 a coalition describ$ "u subsection 7b77#a77;,a7 &1 z appropriate1 betwe5 multiple coalitions t are 9 close geographic proximity to ea* o!r4 2 & 7#c7 9 subsection 7j77#a7-- 7,a7 9 subp>agraph 7,a71 by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh2 & 7,b7 9 subp>agraph 7,b77iii71 by /rik+ #bjbc & ins]t+ #bjbh4 #aje4 ,pilot program to support ,/ate m$ical /ockpiles 7a7 ,9 g5]al ,section #cai;,f-#b7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7i77 is am5d$-- 7#a7 9 p>agraph 7#b77;,b77i7-- 7,a7 9 subclause 7,i71 by /rik+ & #bjbd & ins]t+ ?r\gh #bjbe2 & 7,b7 9 subclause 7,,ii71 by /rik+ #bjbe & ins]t+ #bjbf2 7#b7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,g71 by /rik+ 2 & at ! end & ins]t+ a semicolon2 7,b7 by r$esignat+ subp>agraph 7,h7 z subp>agraph 7,i72 7,c7 by ins]t+ aft] subp>agraph 7,g7 ! foll[+3 7,h7 facilitate ! %>+ ( be/ practices betwe5 ,/ates )9 a consortia ( ,/ates 9 receipt ( fund+ relat$ to e/abli%+ & ma9ta9+ a /ockpile ( m$ical products2 & 2 & 7,d7 9 subp>agraph 7,i71 z s r$esignat$1 by /rik+ ,/ate ef=ts & ins]t+ ,/ate or regional ef=ts2 7#c7 by r$esignat+ p>agraphs 7#e7 ?r\gh 7#i7 z p>agraphs 7#f7 ?r\gh 7#aj71 respectively2 7#d7 by ins]t+ aft] p>agraph 7#d7 ! foll[+3 7#e7 ,coord9ation ,an entity 9 receipt ( an aw>d "u p>agraph 7#a71 9 c>ry+ out ! activities "u ?is subsection1 %all coord9ate ) appropriate heal? c>e entities1 heal? (ficials1 & em]g5cy managem5t (ficials )9 ! jurisdiction ( su* ,/ate or ,/ates4 2 & 7#e7 9 p>agraph 7#aj71 z s r$esignat$1 by /rik+ #c1ejj1jjj1jjj = ea* ( fiscal ye>s #bjbc & #bjbd & ins]t+ su* sums z may be necess>y = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh4 7b7 ,,gao report ,section #bdji7;b7 ( ! ,,prev5t ,p&emics ,act 7,public ,law #aag-cbh7 is am5d$-- 7#a7 9 p>agraph 7#b71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 p>agraph 7#c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#d7 ! impact ( any regional /ockpil+ approa*es c>ri$ out "u su* subsection 7i77#a7 ( section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b74 4 #ajf4 ,enhanc+ dome/ic wa/ewat] surveillance = pa?og5 detection 7a7 ,9 g5]al ,subtitle ,c ( title ,,xxviii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#ca et seq47 is am5d$ by add+ at ! end ! foll[+3 #bhbg4 ,wa/ewat] surveillance = pa?og5 detection 7a7 ,wa/ewat] surveillance sy/em ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) o!r ,f$]al dep>tm5ts & ag5cies1 %all aw>d grants1 contracts1 or coop]ative agreem5ts to eligible entities to e/abli%1 ma9ta91 or improve activities relat$ to ! detection & monitor+ ( infecti\s diseases ?r\gh wa/ewat] = public heal? em]g5cy prep>$ness & response purposes4 7b7 ,eligible entities ,to be eligible to receive an aw>d "u ?is section1 an entity %all-- 7#a7 be a ,/ate1 ,tribal1 or local heal? dep>tm5t1 or a p>tn]%ip betwe5 su* a heal? dep>tm5t & o!r public & private entities2 & 7#b7 submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may reasonably require1 :i* %all include-- 7,a7 a description ( activities propos$ to be c>ri$ out pursuant to an aw>d "u subsection 7a72 7,b7 factors su* entity proposes to use to select wa/ewat] sampl+ sites2 7,c7 a plan = respond+1 z appropriate1 to f9d+s f su* wa/ewat] sampl+1 consi/5t ) applicable plans develop$ by su* entity pursuant to section #cai;,c-#a2 7,d7 a plan to su/a9 su* wa/ewat] surveillance activities describ$ 9 su* application foll[+ ! conclusion ( ! aw>d p]iod2 & 7,e7 any additional in=mation ! ,secret>y may require4 7c7 ,consid]ation ,9 mak+ aw>ds "u subsection 7a71 ! ,secret>y may give priority to eligible entities t h submitt$ an application t-- 7#a7 details plans to provide public access to data g5]at$ ?r\gh su* wa/ewat] surveillance activities 9 a mann] t enables comp>ison to su* data g5]at$ by o!r recipi5ts ( an aw>d "u subsection 7a72 & 7#b7 provides an assessm5t ( community ne$s relat$ to ongo+ infecti\s disease monitor+1 includ+ burd5 ( infecti\s diseases t c be detect$ 9 wa/ewat] & availability ( o!r =ms ( infecti\s disease surveillance4 7d7 ,use ( funds ,an eligible entity %all1 z appropriate1 use am\nts aw>d$ "u ?is section to-- 7#a7 e/abli%1 or enhance exi/+1 capacity & capabilities to conduct wa/ewat] sampl+1 te/+1 & relat$ analysis2 7#b7 conduct wa/ewat] surveillance1 z appropriate1 at individual facilities1 in/itutions1 & locations 9 rural areas1 9 :i* !re is an increas$ risk ( infecti\s disease outbreaks1 or areas 9 :i* wa/ewat] is n treat$ ?r\gh ! relevant local utility ( ! jurisdiction2 & 7#c7 implem5t projects t use evid5ce-bas$ or promis+ practices to conduct wa/ewat] surveillance activities4 7e7 ,p>tn]%ips ,9 c>ry+ out activities "u ?is section1 eligible entities %all id5tify opportunities to p>tn] ) o!r public or private entities to lev]age relevant capabilities ma9ta9$ by su* entities1 z appropriate & consi/5t ) ?is section4 7f7 ,te*nical assi/ance ,! ,secret>y1 9 consultation ) ! heads ( o!r applicable ,f$]al ag5cies & dep>tm5ts1 z appropriate1 %all provide te*nical assi/ance to recipi5ts ( aw>ds "u ?is section to facilitate ! plann+1 developm5t1 & implem5tation ( activities describ$ 9 subsection 7d74 7g7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ su* sums z may be necess>y = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh4 4 7b7 ,wa/ewat] surveillance rese>* 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is subsection ref]r$ to z ! ,secret>y7 %all cont9ue to conduct or support rese>* on ! use ( wa/ewat] surveillance to detect & monitor em]g+ infecti\s diseases1 :i* may include-- 7,a7 rese>* to improve ! effici5cy ( wa/ewat] sample collection & analysis & increase ! s5sitivity & specificity ( wa/ewat] te/+ me?ods2 & 7,b7 implem5tation & developm5t ( evid5ce-bas$ practices to facilitate ! e/imation ( population-level data )9 a community4 7#b7 ,non-duplication ( ef=t ,! ,secret>y %all ensure t activities c>ri$ out "u ?is subsection d n unnecess>ily duplicate ef=ts ( o!r ag5cies & (fices )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices relat$ to wa/ewat] surveillance4 #ajg4 ,reau?orization ( ,mosquito ,abatem5t = ,safety & ,heal? program ,section #cag,s ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ba7 is am5d$-- 7#a7 9 subsection 7a77#c77;,a71 by /rik+ subsection 7b77#c7 & ins]t+ subsection 7b77#d72 7#b7 9 subsection 7b7-- 7,a7 by r$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 ,consid]ations ,! ,secret>y may consid] ! use ( innovative & novel te*nology = mosquito prev5tion & control 9 mak+ grants "u p>agraph 7#a74 2 7#c7 by am5d+ subsection 7d7 to read z foll[s3 7d7 ,uses ( funds ,am\nts appropriat$ "u subsection 7f7 may be us$ by ! ,secret>y to provide tra9+ & te*nical assi/ance ) respect to ! plann+1 developm5t1 & op]ation ( assessm5ts & plans "u subsection 7a7 & control programs "u subsection 7b74 ,! ,secret>y may provide su* tra9+ & te*nical assi/ance directly or ?r\gh aw>ds ( grants or contracts to public & private entities4 2 & 7#d7 9 subsection 7f77#a71 by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh4 ,,ii ,f$]al plann+ & coord9ation #bja4 ,all-,haz>ds ,em]g5cy ,prep>$ness & ,response ,section #bhaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#c7-- 7i7 by /rik+ ,ov]see advanc$ & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,ov]see advanc$ 2 & 7ii7 by add+ at ! end foll[+3 7,b7 ,developm5t ( requirem5ts ,lead ! developm5t & approval1 &1 on a r\t9e basis1 ! review & update1 ( requirem5ts = su* c\nt]measures & products1 includ+ relat$ capabilities1 to in=m ! advanc$ rese>*1 developm5t1 procurem5t1 & repl5i%m5t decisions ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 2 7,b7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,f7-- 7,i7 9 ! matt] prec$+ clause 7i71 by /rik+ & 9 consultation ) ! ,secret>y ( ,homel& ,security12 & 7,,ii7 9 clause 7i71 by ins]t+ enhance aft] capabilities &2 & 7ii7 9 subp>agraph 7,g7-- 7,i7 9 clause 7i71 by /rik+ bas$ on & ins]t+ bas$ on--2 7,,ii7 9 clause 7ii71 by /rik+ 2 & at ! end & ins]t+ a semicolon2 7,,iii7 9 clause 7iii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7iv7 t include1 z appropriate1 p>ticipation by relevant indu/ry1 academia1 pr(essional societies1 & o!r /akehold]s4 2 7iii7 9 subp>agraph 7,h7-- 7,i7 by ins]t+ & ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response aft] ,security ,affairs2 & 7,,ii7 by ins]t+ & m$ical product & supply capacity plann+ pursuant to subp>agraph 7,j71 includ+ discussion ( any relevant id5tifi$ supply *a9 vuln]abilities be=e ! p]iod at ! end2 7iv7 9 subp>agraph 7,i71 by ins]t+ ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy1 aft] ,security ,affairs12 & 7v7 9 subp>agraph 7,j77i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ 7includ+ ancill>y m$ical supplies & compon5ts ( m$ical products1 su* z active ph>maceutical +r$i5ts1 key />t+ mat]ials1 & m$ical device compon5ts7 aft] supply ne$s2 & 7,c7 9 p>agraph 7#g7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ & ! requirem5ts develop$ pursuant to p>agraph 7#c77;,b7 aft] subsection 7d72 7ii7 by r$esignat+ subp>agraphs 7,e7 & 7,f7 z subp>agraphs 7,f7 & 7,g71 respectively2 & 7iii7 by ins]t+ aft] subp>agraph 7,d7 ! foll[+3 7,e7 include a pr(essional judgm5t ( anticipat$ budget ne$s = ea* future fiscal ye> acc\nt$ = 9 su* plan to acc\nt = ! full range ( anticipat$ m$ical c\nt]measure ne$s & life-cycle co/s to address su* priorities & requirem5ts2 2 7#b7 9 subsection 7d7-- 7,a7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,9 g5]al ,n lat] ?an ,m>* #ae1 #bjbj1 & bi5nially !reaft]1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all develop & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a coord9at$ /rategy = m$ical c\nt]measures to address *emical1 biological1 radiological1 & nucle> ?reats1 in=m$ by ! requirem5ts develop$ pursuant to subsection 7b77#c77;,b74 ,n lat] ?an #ahj days aft] ! submission ( su* /rategy to su* committees1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all submit an accompany+ implem5tation plan to su* committees4 ,9 develop+ su* a /rategy & plan1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all consult ) ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise e/abli%$ "u section #bhaa-a4 2 & 7,b7 9 p>agraph 7#b71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ /rategy & be=e plan2 & 7#c7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ 1 includ+ an em]g+ infecti\s disease1 aft] any su* ag5t2 & 7,b7 9 p>agraph 7#b77;,a71 by /rik+ #bej1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #cce1jjj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh4 #bjb4 ,national ,heal? ,security ,/rategy ,section #bhjb ( ! ,public ,heal? ,s]vice ,act is am5d$-- 7#a7 9 subsection 7a77#c7-- 7,a7 by /rik+ ,9 #bjbb1 ! & ins]t+ ,!2 & 7,b7 by ins]t+ 1 ma9ta9+1 & su/a9+ aft] e/abli%+2 & 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ t support int]ag5cy coord9ation & availability ( in=mation1 z appropriate be=e ! p]iod2 7ii7 9 subp>agraph 7,b71 by ins]t+ rapid te/+1 aft] & supplies12 7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,c71 by ins]t+ & curr5t capacity ( facilities )9 su* sy/ems1 z applicable be=e ! p]iod2 7ii7 9 subp>agraph 7,d71 by ins]t+ & o!r m$ical products & m$ical supplies directly relat$ to respond+ to *emical1 biological1 radiological1 or nucle> ?reats1 includ+ em]g+ infecti\s diseases1 & incid5ts cov]$ by ! ,national ,response ,framework1 z applicable & consi/5t ) ! activities c>ri$ out "u section #bhaa7;b77#d77;,j7 be=e ! p]iod2 & 7iii7 by add+ at ! end ! foll[+3 7,h7 ,support+ ! availability ( blood & blood products ) respect to public heal? em]g5cies4 2 7,c7 9 p>agraph 7#e71 by ins]t+ applicable f$]ally-fund$ activities & aft] 7includ+2 7,d7 9 p>agraph 7#h7-- 7i7 9 subp>agraph 7,a71 by ins]t+ public heal? & m$ical be=e activities2 & 7ii7 9 subp>agraph 7,b71 by /rik+ famili>ity ) & ins]t+ und]/&+ (1 & coord9ation betwe512 7,e7 by r$esignat+ p>agraphs 7#i7 & 7#aj7 z p>agraphs 7#aj7 & 7#ab71 respectively2 7,f7 by ins]t+ aft] p>agraph 7#h7 ! foll[+3 7#i7 ,o!r sett+s ,support+ ,f$]al1 ,/ate1 local1 & ,tribal coord9ation & plann+ ) respect to facilities 9 :i* !re is an increas$ risk ( infecti\s disease outbreaks1 includ+ su* facilities t address ! ne$s ( at-risk individuals1 9 ! ev5t ( a public heal? em]g5cy decl>$ "u section #cai4 2 7,g7 by ins]t+ aft] subp>agraph 7#aj71 z s r$esignat$1 ! foll[+3 7#aa7 ,o!r haz>ds ,assess+ curr5t & pot5tial heal? security ?reats f natural disa/]s or o!r extreme wea!r ev5ts ) respect to public heal? & m$ical prep>$ness & response4 2 & 7,h7 by /rik+ tribal ea* place x appe>s & ins]t+ ,tribal4 #bjc4 ,improv+ developm5t & di/ribution ( diagno/ic te/s ,section #cai;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#b7 is am5d$ to read z foll[s3 #cai;,b4 ,improv+ developm5t & di/ribution ( diagno/ic te/s 7a7 ,framework ,! ,secret>y %all develop1 make publicly available n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,response ,act1 & update n less frequ5tly ?an e #c ye>s !reaft]1 a /rategic framework = ! rapid developm5t1 validation1 au?orization1 manufacture1 procurem5t1 & di/ribution ( diagno/ic te/s1 & = rapid scal+ ( te/+ capacity1 9 response to *emical1 biological1 radiological1 or nucle> ?reats1 includ+ infecti\s diseases = :i* a public heal? em]g5cy is decl>$ "u section #cai1 or t has significant pot5tial to cause su* a public heal? em]g5cy4 ,su* /rategic framework %all take into consid]ation-- 7#a7 dome/ic capacity1 includ+ any su* capacity e/abli%$ ?r\gh p>tn]%ips ) public & private entities pursuant to subsection 7c71 to support ! developm5t1 validation1 au?orization1 manufacture1 procurem5t1 & di/ribution ( te/s2 7#b7 novel te*nologies & plat=ms t may be us$ to improve te/+ capabilities1 includ+ high-?r\ghput laboratory diagno/ics1 & po9t-(-c>e diagno/ics1 & any su* te*nologies to improve ! accessibility ( su* te/s1 & facilitate ! developm5t & manufacture ( diagno/ic te/s2 7#c7 m$ical supply ne$s relat$ to te/+1 includ+ diagno/ic te/+1 equipm5t1 supplies1 & compon5t p>ts1 & any pot5tial vuln]abilities relat$ to ! availability ( su* m$ical supplies & relat$ plann+1 consi/5t ) section #bhaa7;b77#d77;,j72 7#d7 /rategies = ! rapid & effici5t di/ribution ( te/s locally1 regionally1 or nationwide & scal+ laboratory te/+ capacity2 & 7#e7 assess+ su* /rategies ?r\gh drills & op]ational ex]cises c>ri$ out "u section #bhaa7;b77#d77;,g71 z appropriate4 7b7 ,coord9ation ,to in=m ! developm5t & update ( ! framework "u subsection 7a71 & 9 c>ry+ out activities to implem5t su* framework1 ! ,secret>y %all coord9ate ) indu/ry1 ,/ates1 local gov]nm5tal entities1 ,indian ,tribes & ,tribal organizations1 & o!r relevant public & private entities4 7c7 ,capacity build+ ,! ,secret>y may contract ) public & private entities1 z appropriate1 to increase dome/ic capacity 9 ! rapid developm5t1 validation1 au?orization1 manufacture1 procurem5t1 & di/ribution ( diagno/ic te/s1 z appropriate1 to ,/ate1 local1 & ,tribal heal? dep>tm5ts & o!r appropriate entities = imm$iate public heal? response activities to address an infecti\s disease ) respect to :i* a public heal? em]g5cy is decl>$ "u section #cai1 or t has significant pot5tial to cause su* a public heal? em]g5cy4 4 #bjd4 ,pilot program = public heal? data availability 7a7 ,situational aw>5ess sy/em ,section #cai;,d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#d7 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a71 by ins]t+ 1 & facilitate ! lev]ag+ ( relevant public heal? data across ! ,dep>tm5t ( ,heal? & ,human ,s]vices aft] ext5t practicable2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a7-- 7,i7 by /rik+ among ag5cies & ins]t+ among1 & direct communication betwe51 ag5cies2 7,,ii7 by ins]t+ ! %>+ ( in=mation f applicable public heal? data sy/ems1 aft] ,te*nology712 & 7,,iii7 by /rik+ 2 & at ! end & ins]t+ a semicolon2 7ii7 9 subp>agraph 7,b71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,c7 facilitate communication1 includ+ bidirectional communication or o!r means ( communication1 to enable timely in=mation %>+ ) ,/ate1 local1 & ,tribal public heal? (ficials1 betwe5 ag5cies & (fices ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 & ) heal? c>e provid]s1 z applicable & appropriate4 2 7#b7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ 1 ! ,secret>y may & ins]t+ & support ! ne> real-"t public availability ( data1 z appropriate1 pursuant to section #cai;,d-#b1 ! ,secret>y %all e/abli% a pilot program to2 & 7ii7 by /rik+ 1 9 collaboration ) appropriate & ins]t+ 4 ,su* ,/ates or consortia ( ,/ates %all c>ry out su* activities 9 collaboration ) appropriate /akehold]s1 su* z heal? in=mation ex*anges1 laboratory in=mation sy/ems12 7,b7 9 p>agraph 7#b77;,a71 by ins]t+ pursuant to p>agraph 7#c7 aft] may require2 7,c7 by /rik+ p>agraph 7#f72 7,d7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#e7 z p>agraphs 7#d7 ?r\gh 7#f71 respectively2 7,e7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 ,data plan ,= purposes ( ?is subsection1 ! ,secret>y %all develop a plan = data elem5ts to be report$ to ! ,secret>y p]ta9+ to pot5tially cata/rophic infecti\s disease outbreaks1 9 su* =m & mann] & at su* tim+ & frequ5cy z det]m9$ by ! ,secret>y4 ,:5 develop+ ! plan "u ?is subsection1 ! ,secret>y %all-- 7,a7 align ) ! /&>ds & implem5tation specifications adopt$ by ! ,secret>y "u section #cjjd1 :]e applicable1 & update1 z necess>y & consi/5t ) applicable requirem5ts ( subsection 7b77#c7 & section #bhbc1 uni=m /&>ds = applicable entities to report data elem5ts2 7,b7 consid] ! use ( te*nologies t enable fa/ bulk ex*ange ( data2 & 7,c7 ensure ! data elem5ts report$ "u ?is subsection & made publicly available pursuant to section #cai;,d-#b are made available consi/5t ) applicable ,f$]al & ,/ate privacy law1 at a m9imum4 2 & 7,f7 9 p>agraph 7#d71 z s r$esignat$-- 7i7 9 subp>agraph 7,a71 by /rik+ em]g5cies2 & ins]t+ em]g5cies1 includ+ su* diseases recomm5d$ by ! ,national ,public ,heal? ,data ,bo>d e/abli%$ "u section #cai;,d-#b2 &2 7ii7 9 subp>agraph 7,b71 by /rik+ 2 & & ins]t+ a p]iod2 & 7iii7 by /rik+ subp>agraph 7,c72 & 7#c7 9 subsection 7h7-- 7,a7 9 p>agraph 7#a71 by /rik+ #bjbb & #bjbc & ins]t+ #bjbd ?r\gh #bjbh2 & 7,b7 9 p>agraph 7#b71 by /rik+ #bjbb & #bjbc & ins]t+ #bjbd ?r\gh #bjbh4 7b7 ,data selection & access ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by ins]t+ aft] section #cai;,d-#a ! foll[+3 #cai;,d-#b4 ,public heal? data pilot program 7a7 ,9 g5]al ,! ,secret>y %all-- 7#a7 e/abli% & ma9ta9 a ne> real-"t1 op5 s\rce1 public-fac+1 & publicly available website to provide deid5tifi$1 aggregat$ data on pot5tially cata/rophic disease outbreaks1 9 accordance ) subsection 7b72 & 7#b7 collect ! data elem5ts p]ta9+ to su* diseases recomm5d$ pursuant to subsection 7b77#a77;,b71 us+ exi/+ processes or any new processes e/abli%$ pursuant to section #cai;,d7d74 7b7 ,national ,public ,heal? ,data ,bo>d 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a ,national ,public ,heal? ,data ,bo>d to advise1 & make recomm5dations to ! ,secret>y ) respect to pot5tially cata/rophic infecti\s diseases appropriate = inclusion 9 ! public heal? situational aw>5ess sy/em pilot program e/abli%$ pursuant to section #cai;,d7d7 & ! website e/abli%$ "u subsection 7a77#a74 7#b7 ,memb]%ip ,! ,bo>d e/abli%$ "u p>agraph 7#a7 %all consi/ ( ! foll[+ memb]s3 7,a7 ,f$]al memb]s ,! foll[+ ,f$]al memb]s3 7i7 ,! ,secret>y ( ,heal? & ,human ,s]vices4 7ii7 ,! ,secret>y ( ,def5se4 7iii7 ,! ,secret>y ( ,vet]ans ,affairs4 7iv7 ,! ,national ,coord9ator = ,heal? ,in=mation ,te*nology4 7v7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7vi7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7vii7 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7viii7 ,! ,director ( ! ,indian ,heal? ,s]vice4 7ix7 ,! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7x7 ,! ,commission] ( ,food & ,drugs4 7xi7 ,su* o!r heads ( dep>tm5ts1 ag5cies1 & (fices z ! ,secret>y det]m9es appropriate4 7,b7 ,non-,f$]al memb]s ,su* o!r individuals appo9t$ by ! ,secret>y-- 7i7 :o h relevant public heal?1 m$ical1 or sci5tific exp]tise1 includ+-- 7,i7 individuals ) exp]tise or exp]i5ce 9-- 7aa7 ,/ate1 local1 or ,tribal heal? data sy/ems or practices2 or 7bb7 heal? data /&>ds & te*nology sy/ems1 :i* may include hospital1 ph>macy1 laboratory in=mation sy/ems & heal? in=mation ex*anges2 & 7,,ii7 repres5tatives ( national public heal? organizations2 & 7ii7 individuals ) su* o!r specific exp]tise z ! ,secret>y det]m9es appropriate4 7c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to alt] exi/+ obligations "u regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif1 & ?is section %all be appli$ 9 a mann] t is consi/5t ) applicable ,f$]al & ,/ate privacy law1 at a m9imum4 7d7 ,nonduplication ( ef=ts ,! ,secret>y %all ensure t ! activities c>ri$ out by ! ,bo>d "u ?is section d n duplicate ! ef=ts ( o!r ,f$]al advisory committees t advise & make recomm5dations to ! ,secret>y4 7e7 ,sunset ,?is section %all cease to h =ce or effect on ,septemb] #cj1 #bjbh4 4 #bje4 ,combat+ antimicrobial resi/ance ,section #cai;,e ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 by ins]t+ & activities aft] ,f$]al programs2 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ public heal? con/itu5cies1 manufactur]s1 vet]9>y & m$ical pr(essional societies & o!rs & ins]t+ ! ,advisory ,c\ncil describ$ 9 subsection 7b7 & relevant public & private entities2 & 7ii7 by ins]t+ 1 pursuant to p>agraph 7#d71 aft] compreh5sive plan2 7,c7 by am5d+ p>agraph 7#c7 to read z foll[3 7#c7 ,ag5da ,! task =ce describ$ 9 p>agraph 7#a7 %all consid] factors ! ,secret>y consid]s appropriate1 includ+ factors to-- 7,a7 sl[ ! em]g5ce ( resi/ant bact]ia & fungi & prev5t ! spread ( resi/ant infections2 7,b7 /r5g!n activities to combat resi/ance ) respect to zoonotic diseases2 7,c7 advance developm5t & use ( rapid & innovative capabilities1 includ+ diagno/ic te/s1 = id5tification & *>act]ization ( resi/ant bact]ia & fungi2 7,d7 accel]ate basic & appli$ rese>* & developm5t = new antibiotics1 antifungals1 & o!r relat$ !rapeutics & vacc9es2 & 7,e7 support int]national collaboration & capacities = antimicrobial-resi/ance prev5tion1 detection1 & control4 2 7,d7 by r$esignat+ p>agraph 7#d7 z p>agraph 7#e72 & 7,e7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,action plan ,n lat] ?an ,octob] #a1 #bjbe1 & e #e ye>s !reaft]1 ! task =ce describ$ 9 p>agraph 7#a7 %all develop & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives a plan reg>d+ ,f$]al programs & activities to combat antimicrobial resi/ance1 includ+ measurable outcomes1 z appropriate1 in=m$ by ! ag5da describ$ 9 p>agraph 7#c7 & input provid$ by ! ,advisory ,c\ncil describ$ 9 subsection 7b7 & o!r relevant /akehold]s provid$ pursuant to p>agraph 7#b74 2 7#b7 by r$esignat+ subsections 7b7 ?r\gh 7o7 z subsections 7c7 ?r\gh 7p71 respectively2 7#c7 by ins]t+ aft] subsection 7a7 ! foll[+3 7b7 ,advisory c\ncil 7#a7 ,9 g5]al ,! ,secret>y may cont9ue ! ,presid5tial ,advisory ,c\ncil on ,combat+ ,antibiotic-,resi/ant ,bact]ia1 ref]r$ to 9 ?is subsection z ! ,advisory ,c\ncil4 7#b7 ,duties ,! ,advisory ,c\ncil %all advise & provide in=mation & recomm5dations to ! ,secret>y1 act+ ?r\gh ! ,task ,=ce e/abli%$ "u subsection 7a71 reg>d+ ,f$]al programs & activities int5d$ to r$uce or combat antimicrobial-resi/ant bact]ia or fungi t may pres5t a public heal? ?reat & improve capabilities to prev5t1 diagnose1 mitigate1 or treat su* resi/ance4 ,su* advice1 in=mation1 & recomm5dations may be relat$ to improv+ ,f$]al ef=ts relat$ to factors describ$ 9 subsection 7a77#c7 & o!r topics relat$ to antimicrobial resi/ance1 z appropriate4 7#c7 ,meet+s & coord9ation 7,a7 ,meet+s ,! ,advisory ,c\ncil %all meet n less ?an biannually &1 to ! ext5t practicable1 9 coord9ation ) meet+s ( ! task =ce e/abli%$ "u subsection 7a74 7,b7 ,coord9ation ,! ,advisory ,c\ncil %all1 to ! greate/ ext5t practicable1 coord9ate activities c>ri$ out by ! ,c\ncil ) ! task =ce e/abli%$ "u subsection 7a74 7#d7 ,,faca ,*apt] #aj ( title #e1 ,unit$ ,/ates ,code1 %all apply to ! activities & duties ( ! ,advisory ,c\ncil4 2 & 7#d7 9 subsection 7n71 z s r$esignat$1 by /rik+ 7f7 ?r\gh 7j7 & ins]t+ 7g7 ?r\gh 7k74 #bjf4 ,/rategic ,national ,/ockpile & mat]ial ?reats ,section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#b77;,b77i71 by /rik+ subclause 7,,iv7 & ins]t+ ! foll[+3 7,,iv7 ! em]g5cy heal? security ?reat or ?reats su* c\nt]measure procurem5t is int5d$ to address1 includ+-- 7aa7 :e!r su* procurem5t is consi/5t ) meet+ em]g5cy heal? security ne$s associat$ ) su* ?reat or ?reats2 & 7bb7 9 ! case ( a c\nt]measure t addresses a biological ag5t1 :e!r su* ag5t has an increas$ likelihood to become resi/ant to1 m resi/ant to1 or evade1 su* c\nt]measure relative to o!r available m$ical c\nt]measures2 2 & 7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,b71 by /rik+ are foll[$1 regul>ly review$1 & updat$ ) respect to su* /ockpile & ins]t+ ) respect to su* /ockpile are foll[$1 regul>ly review$1 & updat$ to reflect be/ practices2 7ii7 by r$esignat+ subp>agraphs 7,h7 ?r\gh 7,k7 z subp>agraphs 7,i7 ?r\gh 7,l71 respectively2 & 7iii7 by ins]t+ aft] subp>agraph 7,g7 ! foll[+3 7,h7 utilize tools to enable ! timely & accurate track+1 includ+ ! location & geographic di/ribution & utilization1 ( ! cont5ts ( ! /ockpile ?r\gh\t ! deploym5t ( su* cont5ts2 2 7#b7 9 subsection 7c77#b77;,c7-- 7,a7 by /rik+ promptly2 & 7,b7 by ins]t+ 1 n lat] ?an #fj days aft] su* det]m9ation2 7#c7 9 subsection 7f77#a71 by /rik+ #faj1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjba1 & #gej1jjj1jjj = ea* ( fiscal ye>s #bjbb & #bjbc & ins]t+ #ife1jjj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh2 & 7#d7 9 subsection 7g77#a71 by /rik+ #bjai ?r\gh #bjbh & ins]t+ #bjbd ?r\gh #bjcc4 #bjg4 ,m$ical c\nt]measures = viral ?reats ) p&emic pot5tial ,section #cai,l ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is am5d$-- 7#a7 9 subsection 7c77#d7-- 7,a7 9 subp>agraph 7,d71 by am5d+ clause 7iii7 to read z foll[s3 7iii7 conduct rese>* to promote /rategic initiatives1 su* z-- 7,i7 rapid diagno/ics2 7,,ii7 broad spectrum antimicrobials2 7,,iii7 m$ical c\nt]measures = virus families t h significant pot5tial to cause a p&emic1 includ+ su* c\nt]measures t take ei!r pa?og5-specific or broad spectrum approa*es2 & 7,,iv7 te*nologies to improve ! production & use ( m$ical c\nt]measures1 :i* may include vacc9e-manufactur+ te*nologies1 dose-sp>+ te*nologies1 efficacy-increas+ te*nologies1 plat=m te*nologies1 te*nologies to adm9i/] c\nt]measures1 & te*nologies to improve /orage & transportation ( c\nt]measures4 2 & 7,b7 9 subp>agraph 7,f71 by am5d+ clause 7ii7 to read z foll[s3 7ii7 ?reats t-- 7,i7 7aa7 consi/5tly exi/ or cont9ually circulate & h a significant pot5tial to become a p&emic1 su* z p&emic influ5za2 or 7bb7 include priority virus families & o!r viral pa?og5s ) a significant pot5tial to cause a p&emic2 & 7,,ii7 may include ! advanc$ 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$s2 cl9ical trial lots2 novel virus /ra9s2 & antig5 & adjuvant mat]ial72 2 7#b7 9 subsection 7d77#b71 by /rik+ #faa1gjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #iej1jjj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh2 & 7#c7 9 subsection 7e77#a71 by am5d+ subp>agraph 7,d7 to read z foll[s3 7,d7 ,sunset ,?is p>agraph %all cease to h =ce or effect aft] ,septemb] #cj1 #bjbh4 4 #bjh4 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise ,section #bhaa-a7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;a7c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by r$esignat+ subp>agraph 7,d7 z subp>agraph 7,e72 & 7,b7 by ins]t+ aft] subp>agraph 7,c7 ! foll[+3 7,d7 ,assi/ ! ,secret>y 9 develop+ /rategies = appropriate & evid5ce-bas$ allocation & di/ribution ( c\nt]measures to jurisdictions1 9 a mann] t supports ! availability & use ( su* c\nt]measures1 = public heal? & m$ical prep>$ness & response ne$s4 2 7#b7 9 p>agraph 7#b71 by /rik+ 1 z appropriate2 & 7#c7 by add+ at ! end ! foll[+3 7#c7 ,in=mation %>+ ,! ,secret>y %all1 z appropriate & 9 a mann] t does n compromise national security1 %>e in=mation relat$ to recomm5dations made & /rategies develop$ "u subp>agraphs 7,a7 & 7,c7 ( p>agraph 7#a7 ) relevant /akehold]s1 includ+ indu/ry & ,/ate1 local1 & ,tribal public heal? dep>tm5ts4 4 #bji4 ,/r5g!n+ public heal? communication 7a7 ,public heal? communications advisory committee ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all e/abli% an advisory committee to be kn[n z ! ,public ,heal? ,communications ,advisory ,committee 7ref]r$ to 9 ?is subsection z ! ,advisory ,committee74 7b7 ,duties ,! ,advisory ,committee %all make recomm5dations to ! ,secret>y & report on-- 7#a7 critical aspects ( communication & dissem9ation ( sci5tific & evid5ce-bas$ public heal? in=mation dur+ public heal? em]g5cies2 7#b7 rese>* f relevant ext]nal /akehold]s relat$ to evid5ce-bas$ or evid5ce-in=m$ /rategies & be/ practices to effectively communicate & dissem9ate su* in=mation2 & 7#c7 /rategies to improve communication & dissem9ation ( sci5tific & evid5ce-bas$ public heal? in=mation to ! public & to improve communication betwe5 ,f$]al1 ,/ate1 local1 & ,tribal heal? (ficials4 7c7 ,composition ,! ,advisory ,committee %all be compos$ (-- 7#a7 appropriate ,f$]al (ficials1 appo9t$ by ! ,secret>y1 :o %all s]ve z nonvot+ memb]s2 & 7#b7 individuals1 appo9t$ by ! ,secret>y1 repres5t+ a v>iety ( ,/ates & rural & urban areas1 & ea* ( :om t has-- 7,a7 exp]tise 9 public heal?1 includ+ individuals ) exp]i5ce 9 ,/ate1 local1 & ,tribal heal? dep>tm5ts1 m$ic9e1 communications1 relat$ te*nology1 psy*ology1 m5tal heal? & sub/ance use disord]s1 national security2 7,b7 exp]i5ce 9 lead+ community outrea*2 or 7,c7 exp]tise 9 o!r areas1 z ! ,secret>y det]m9es appropriate4 7d7 ,dissem9ation ,! ,secret>y %all review ! recomm5dations ( ! ,advisory ,committee &1 n lat] ?an #ahj days aft] receipt ( ! report "u subsection 7b71 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report describ+ any actions plann$ by ! ,secret>y relat$ to ?is section4 7e7 ,t]m9ation ,! ,advisory ,committee %all t]m9ate #b ye>s aft] ! date ( enactm5t ( ?is ,act4 #baj4 ,fell[%ip & tra9+ programs ,section #cag;,g ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#h7 is am5d$-- 7#a7 by /rik+ ,! ,secret>y1 & ins]t+ ! foll[+3 7a7 ,9 g5]al ,! ,secret>y1 2 & 7#b7 by add+ at ! end ! foll[+3 7b7 ,noncompetitive conv]sion 7#a7 ,9 g5]al ,! ,secret>y may noncompetitively conv]t an individual :o has complet$ an epidemiology1 surveillance1 or laboratory fell[%ip or tra9+ program "u subsection 7a7 to a c>e]-conditional appo9tm5t )\t reg>d to ! provisions ( sub*apt] ,i ( *apt] #cc ( title #e1 ,unit$ ,/ates ,code1 provid$ t individual meets qualification requirem5ts = ! appo9tm5t4 4 #baa4 ,assessm5t ( ,,covid-#ai mitigation policies 7a7 ,,gao /udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! economic impact & heal? outcomes associat$ ) ! response to ! ,,covid-#ai p&emic 9 ! ,unit$ ,/ates4 ,su* /udy %all include-- 7#a7 a summ>y ( /rategies us$ by local gov]nm5tal entities1 ,/ates1 & ! ,f$]al ,gov]nm5t to conta9 & mitigate ! spread ( ,,covid-#ai dur+ ! public heal? em]g5cy decl>$ "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 on ,janu>y #ca1 #bjbj1 includ+-- 7,a7 limitations on l>ge ga!r+s ( p2 7,b7 ! closure ( s*ools1 bus9esses1 h\ses ( wor%ip1 & o!r facilities2 7,c7 mask+ policies2 7,d7 te/+ policies2 & 7,e7 vacc9ation policies2 7#b7 an analysis & review ( ! sci5tific evid5ce relat$ to ! effectiv5ess ( su* /rategies 9 prev5t+ or mitigat+ ! spread ( ,,covid-#ai1 includ+ e/imates ( ! burd5 ( disease & dea? t 7 avoid$ ?r\gh su* int]v5tions2 7#c7 an analysis & review ( ! economic & heal? impacts ( su* /rategies1 includ+ impacts relat$ to m5tal & physical heal? & /ud5t le>n+ loss2 & 7#d7 an acc\nt+ ( ,f$]al fund+ us$ to implem5t su* /rategies4 7b7 ,report ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a report on ! /udy "u subsection 7a7 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 ,su* report %all include recomm5dations bas$ on ! f9d+s ( ! /udy conduct$ "u subsection 7a7 reg>d+ ! impact ( su* /rategies dur+ ! ,,covid-#ai public heal? em]g5cy1 includ+ h[ to improve future responses4 ,,iii ,address+ ! ne$s ( all individuals #cja4 ,transition ( c]ta9 c\nt]measures betwe5 comp5sation programs 7a7 ,treatm5t ( c]ta9 ineligible reque/s relat$ to ,,covid-#ai c\nt]measures 7#a7 ,reque/s initially submitt$ "u ,,cicp 7,a7 ,9 g5]al ,9 ! case ( a reque/ = comp5sation submitt$ "u section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 = an injury or dea? relat$ to a ,,covid-#ai vacc9e t ! ,secret>y det]m9es to be ineligible pursuant to subp>agraph 7,b7 ( su* section #cai;,f-#d7;b77#d71 z add$ by subsection 7b77#a71 ! ,secret>y %all1 n lat] ?an #cj days aft] su* det]m9ation1 notify ! individual submitt+ ! reque/ ( su* det]m9ation4 7,b7 ,submission ( petition ,an individual :o receives a notification describ$ 9 subp>agraph 7,a7 %all be eligible to submit a petition to ! ,unit$ ,/ates ,c\rt ( ,f$]al ,claims "u section #baaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 ) respect to ! same vacc9e adm9i/ration claim$ 9 ! reque/ submitt$ "u section #cai;,f-#d ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#f;e71 provid$ t su* petition is submitt$ n lat] ?an ! lat] (-- 7i7 #a ye> aft] receiv+ su* notification "u subp>agraph 7,a72 or 7ii7 ! la/ date on :i* ! individual o!rwise w\ld be eligible to submit a petition relat+ to su* injury1 z specifi$ 9 section #baaf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#af74 7,c7 ,eligibility ,to be eligible to submit a petition 9 accordance ) subp>agraph 7,b71 ! petition] %all h submitt$ ! reque/ = comp5sation "u section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act t 0 det]m9$ to be ineligible n lat] ?an ! deadl9e = fil+ a petition "u section #baaf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#af7 t applies ) respect to ! adm9i/ration ( su* vacc9e4 7#b7 ,reque/s initially submitt$ "u ,,vicp 7,a7 ,9 g5]al ,if a special ma/] det]m9es t-- 7i7 a petition submitt$ "u section #baaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 relat$ to a ,,covid-#ai vacc9e is ineligible = ! ,national ,vacc9e ,injury ,comp5sation ,program "u subtitle #b ( title ,,xxi ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aj et seq47 because x relates to a vacc9e adm9i/]$ at a "t :5 ! vacc9e 0 n includ$ 9 ! ,vacc9e ,injury ,table "u section #baad ( su* ,act 7#db ,u4,s4,c4 #cjj;aa-#ad72 & 7ii7 ! vacc9e 0 adm9i/]$ :5 x 0 a cov]$ c\nt]measure subject to a decl>ation "u section #cai;,f-#c7;b7 ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7b771 ! special ma/] %all1 n lat] ?an #cj days aft] su* det]m9ation1 notify ! petition] ( su* det]m9ation4 7,b7 ,submission ( reque/ ,an individual :o receives a notification describ$ 9 subp>agraph 7,a7 %all be eligible to submit a reque/ = comp5sation "u section #cai;,f-#d7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 ) respect to ! same vacc9e adm9i/ration claim$ 9 ! petition submitt$ "u section #baaa ( su* ,act-- 7i7 n lat] ?an #a ye> aft] receiv+ su* notification2 or 7ii7 9 ! case t ! notification is issu$ aft] judicial review ( ! petition "u subsection 7e7 or 7f7 ( section #baab ( su* ,act 7#db ,u4,s4,c4 #cjj;aa-#ab71 n lat] ?an #a ye> aft] ! decision ( ! ,unit$ ,/ates ,c\rt ( ,f$]al ,claim or ! m&ate is issu$ by ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,f$]al ,circuit pursuant to su* subsection 7e7 or 7f74 7,c7 ,eligibility ,to be eligible to submit a reque/ = comp5sation 9 accordance ) subp>agraph 7,b71 ! individual submitt+ ! reque/ %all h submitt$ ! petition "u section #baaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 t 0 det]m9$ to be ineligible n lat] ?an "o ye> aft] ! date ( adm9i/ration ( ! vacc9e4 7b7 ,*anges to c]ta9 programs 7#a7 ,,cicp ,section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 is am5d$-- 7,a7 9 subsection 7b77#d7-- 7i7 by /rik+ ,except z provid$ & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,except z provid$ 2 & 7ii7 by add+ at ! end ! foll[+3 7,b7 ,exclusion ( injuries caus$ by vacc9es on ! vacc9e injury table ,not)/&+ any o!r provision ( ?is section1 no individual may be eligible = comp5sation "u ?is section ) respect to a vacc9e t1 at ! "t x 0 adm9i/]$1 0 includ$ 9 ! ,vacc9e ,injury ,table "u section #baad4 2 & 7,b7 9 subsection 7d77#c7-- 7i7 by /rik+ ,?is section & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,?is section 2 & 7ii7 by add+ at ! end ! foll[+3 7,b7 ,exhau/ion ( rem$ies ,a cov]$ individual %all n be consid]$ to h exhau/$ rem$ies z describ$ 9 p>agraph 7#a71 nor be eligible to seek rem$y "u section #cai;,f-#c7;d71 unless su* individual has provid$ to ! ,secret>y all support+ docum5tation necess>y to facilitate ! det]m9ations requir$ "u subsection 7b77#d74 4 7#b7 ,,vicp ,title ,,xxi ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#a et seq47 is am5d$-- 7,a7 9 section #baaa7;a77#b77;,a7 7#db ,u4,s4,c4 #cjj;aa-#aa7;a77#b77;,a771 9 ! matt] prec$+ clause 7i71 by ins]t+ conta9+ ! in=mation requir$ "u subsection 7c7 aft] unless a petition2 7,b7 9 section #baab7;d7 7#db ,u4,s4,c4 #cjj;aa-#ab7;d77-- 7i7 by add+ at ! end ( p>agraph 7#a7 ! foll[+3 ,su* designation %all n occur until ! petition] has fil$ all mat]ials requir$ "u section #baaa7;c742 & 7ii7 9 p>agraph 7#c77;,a77ii71 by /rik+ ! petition 0 fil$ & ins]t+ on :i* ! *ief special ma/] makes ! designation pursuant to p>agraph 7#a72 7,c7 9 section #baad7;e7 7#db ,u4,s4,c4 #cjj;aa-#ad7;e77-- 7i7 9 p>agraph 7#b71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #b ye>s & ins]t+ #f mon?s2 & 7ii7 by add+ at ! end ! foll[+3 7#d7 ,lic5sure requirem5t ,not)/&+ p>agraphs 7#b7 & 7#c71 ! ,secret>y may n revise ! ,vacc9e ,injury ,table to include a vacc9e = :i* ! ,c5t]s = ,disease ,control & ,prev5tion has issu$ a recomm5dation = r\t9e use 9 *ildr5 or pregnant wom5 until at lea/ "o application = su* vacc9e has be5 approv$ "u section #cea4 ,^u su* revision ( ! ,vacc9e ,injury ,table1 all vacc9es to prev5t ! same infecti\s disease1 includ+ vacc9es au?oriz$ "u em]g5cy use pursuant to section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 %all be consid]$ includ$ 9 ! ,vacc9e ,injury ,table4 2 & 7,d7 9 section #baaf 7#db ,u4,s4,c4 #cjj;aa-#af71 by add+ at ! end ! foll[+3 7d7 ,cl>ification ,not)/&+ subsections 7a7 & 7b71 an injury or dea? relat$ to a vacc9e adm9i/]$ at a "t :5 ! vacc9e 0 a cov]$ c\nt]measure subject to a decl>ation "u section #cai;,f-#c7;b7 %all n be eligible = comp5sation "u ! ,program4 4 #cjb4 ,accel]at+ injury comp5sation program adm9i/ration & ensur+ program integrity 7a7 ,9 g5]al ,section #baab7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa#ab7;c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ n m ?an #h special ma/]s & ins]t+ n few] ?an #aj special ma/]s2 & 7#b7 9 p>agraph 7#d7-- 7,a7 by /rik+ a t]m ( #d ye>s & ins]t+ an initial t]m ( #d ye>s2 7,b7 by /rik+ ! second & ?ird s5t5ces2 & 7,c7 by add+ at ! end ! foll[+3 ,an individual appo9t$ z special ma/] may be reappo9t$ to s]ve "o or m additional t]ms ( up to #h ye>s ea*1 pursuant to p>agraph 7#a71 & subject to t]m9ation "u p>agraphs 7#b7 & 7#c744 7b7 ,petitions = comp5sation ,section #baaa7;a77#b77;,a77i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7;a77#b77;,a77i77 is am5d$-- 7#a7 9 subclause 7,i71 by /rik+ 1 & & ins]t+ a semicolon2 7#b7 9 subclause 7,,ii7-- 7,a7 by mov+ ! m>g9 #b ems to ! "r2 & 7,b7 by /rik+ 1 or & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,,iii7 ! judgm5t describ$ 9 subclause 7,i7 does n result f a petition]'s motion to dismiss ! case2 or 4 7c7 ,comp5sation ,section #baae7;e77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#ae7;e77#a77 is am5d$ by add+ at ! end ! foll[+3 ,:5 mak+ a det]m9ation ( good fai? "u ?is p>agraph1 ! special ma/] or c\rt may consid] :e!r ! petition] demon/rat$ an int5tion to obta9 comp5sation on su* petition & 0 n m]ely seek+ to satisfy ! exhau/ion requirem5t "u section #baba7;b744 #cjc4 ,comp5sation = injuries relat+ to ! public heal? em]g5cy caus$ by ,,s>s-,co,v-#b 7a7 ,9 g5]al ,) respect to claims fil$ "u ! ,c\nt]measure ,injury ,comp5sation ,program 7ref]r$ to 9 ?is section z ! ,program7 "u section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 alleg+ a cov]$ injury caus$ by ! adm9i/ration or use ( a cov]$ c\nt]measure pursuant to a decl>ation "u section #cai;,f-#c7;b7 ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7b77 relat+ to ,,covid-#ai1 ! foll[+ %all apply3 7#a7 ,not)/&+ ! fil+ deadl9e applicable "u section #cai;,f-#d1 ! claim %all be fil$ )9 #c ye>s ( ! adm9i/ration or use ( ! cov]$ c\nt]measure1 or "o ye> aft] enactm5t ( ?is section1 :i*ev] is lat]1 &1 if a claim fil$ "u ! ,program ) respect to su* adm9i/ration or use 0 fil$ be=e ! date ( enactm5t ( ?is ,act & d5i$ on ! basis ( hav+ n be5 fil$ )9 ! "t p]iod requir$ "u subsection 7b77#d7 ( su* section #cai;,f-#d1 su* claim may be refil$ pursuant to ?is p>agraph4 7#b7 ,) respect to a claim relat+ to ! adm9i/ration ( a ,,covid-#ai vacc9e1 su* a claim may be fil$ "u ! ,program only if ! adm9i/ration ( su* vacc9e occurr$ prior to ! addition ( ! vacc9e to ! ,vacc9e ,injury ,table "u section #baad ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#ad74 7#c7 ,n lat] ?an #i mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices %all promulgate a cov]$ c\nt]measure injury table pursuant to subsection 7b77#e7 ( section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7b77#e774 7b7 ,pr(essional judgm5t budget 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices-- 7,a7 9 consultation ) ! ,attorney ,g5]al1 %all submit a budget outl9+ ! res\rce ne$s = ea* ag5cy = purposes ( c>ry+ out ! ,national ,vacc9e ,injury ,comp5sation ,program "u subtitle #b ( title ,,xxi ( su* ,act 7#db ,u4,s4,c4 #cjj;aa-#aj et seq47 = fiscal ye>s #bjbd ?r\gh #bjbh2 & 7,b7 %all submit a budget outl9+ res\rce ne$s = purposes ( c>ry+ out ! ,c\nt]measures ,injury ,comp5sation ,program "u section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 = fiscal ye>s #bjbd ?r\gh #bjbh4 7#b7 ,inclusions ,! budgets describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a7 %all include e/imates ( bo? ! res\rces necess>y to process curr5t backlogs & ea* program's ability to r$uce process+ times ) respect to su* pr(essional judgm5ts4 7c7 ,,nasem report ,! ,secret>y ( ,heal? & ,human ,s]vices %all seek to ent] into a contract ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e "u :i* su* ,national ,academies %all report1 n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 on ! ,c\nt]measure ,injury ,comp5sation ,program "u section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e71 includ+ recomm5dations to improve ! adm9i/ration ( su* program & :e!r ,congress %\ld adju/ ! comp5sation paym5ts available "u su* program4 #cjd4 ,review ( regulations ,! ,secret>y ( ,heal? & ,human ,s]vices %all update regulations1 z ne$$ = purposes ( c>ry+ out ! am5dm5ts made by sections #cja & #cjb4 #cje4 ,support+ individuals ) disabilities1 old] adults1 & o!r at-risk individuals dur+ em]g5cy responses 7a7 ,te*nical assi/ance c5t]s on at-,risk individuals & disa/]s 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 may1 ?r\gh grants1 contracts1 or coop]ative agreem5ts to eligible entities1 e/abli% m ?an "o rese>*1 tra9+1 & te*nical assi/ance c5t]s to provide appropriate in=mation1 tra9+1 & te*nical assi/ance to ,/ates1 localities1 ,tribes1 & o!r applicable entities relat$ to address+ ! unique ne$s & consid]ations ( at-risk individuals1 z def9$ 9 section #bhjb7;b77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d771 9 ! ev5t ( a public heal? em]g5cy decl>$ by ! ,secret>y pursuant to section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d74 7#b7 ,responsibilities ( ! c5t]s ,! c5t]s e/abli%$ "u p>agraph 7#a7 %all conduct activities = ! purpose (-- 7,a7 develop+1 id5tify+1 evaluat+1 & dissem9at+ evid5ce-bas$ or evid5ce-in=m$ /rategies to improve heal? & o!r relat$ outcomes = at-risk individuals relat$ to public heal? em]g5cies1 includ+ by address+ su* unique ne$s & consid]ations 9 c>ry+ out public heal? & m$ical activities to prep>e =1 respond to1 & recov] f1 su* public heal? em]g5cies2 & 7,b7 assi/+ applicable entities 9 ! implem5tation ( su* evid5ce-bas$ /rategies1 includ+ ?r\gh sub-grants1 contracts1 or coop]ative agreem5ts4 7#c7 ,priority ,9 aw>d+ grants = activities describ$ 9 ?is subsection1 ! ,secret>y %all give priority to eligible entities ) demon/rat$ exp]tise 91 & ability to c>ry out1 ! activities describ$ 9 p>agraph 7#b74 7#d7 ,consultation ,9 c>ry+ out activities "u p>agraph 7#b71 ! c5t]s e/abli%$ "u p>agraph 7#a7 %all take into consid]ation relevant f9d+s & recomm5dations (1 &1 z appropriate1 consult )1 ! ,national ,advisory ,committee on ,individuals ) ,disabilities & ,disa/]s e/abli%$ "u section #bhaa;,c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;d71 ! ,national ,advisory ,committee on ,*ildr5 & ,disa/]s "u section #bhaa;,a ( su* ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;b71 & ! ,national ,advisory ,committee on ,s5iors & ,disa/]s "u section #bhaa;,b ( su* ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;c74 7#e7 ,reports ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act & e #b ye>s !reaft]1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report describ+ ! activities c>ri$ out "u ?is subsection dur+ ! prec$+ #b fiscal ye>s4 7#f7 ,sunset ,?is subsection %all cease to h =ce or ef=t on ,septemb] #cj1 #bjbh4 7b7 ,crisis /&>ds ( c>e ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all issue guidance to ,/ates & localities on ! developm5t or modification ( ,/ate & local crisis /&>ds ( c>e = use dur+ ! response to a public heal? em]g5cy decl>$ by ! gov]nor ( a ,/ate or by ! ,secret>y "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d71 or a major disa/] or em]g5cy decl>$ by ! ,presid5t "u section #dja or #eja1 respectively1 ( ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act 7#db ,u4,s4,c4 #eagj1 #eaia7 to ensure t su* /&>ds ( c>e are consi/5t ) ! nondiscrim9ation requirem5ts ( section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 title ,,ii ( ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaca et seq471 & ! ,age ,discrim9ation ,act ( #aige 7#db ,u4,s4,c4 #faja et seq474 #cjf4 ,national advisory committees 7a7 ,national advisory committee on *ildr5 & disa/]s ,section #bhaa;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;b7 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 by /rik+ may provide advice & ins]t+ ! foll[+3 8may provide-- 7#a7 advice 2 7,b7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7#b7 recomm5dations to ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy & to ,congress ) respect to ! public heal? & em]g5cy prep>$ness ne$s ( *ildr54 2 & 7#b7 9 subsection 7g71 by /rik+ #bjbc & ins]t+ #bjbh4 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 7c7-- 7,a7 by /rik+ may provide advice & ins]t+ ! foll[+3 8may provide-- 7#a7 advice 2 7,b7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7#b7 recomm5dations to ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy & to ,congress ) respect to ! public heal? & em]g5cy prep>$ness ne$s ( s5iors4 2 7#b7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a71 by /rik+ #ag memb]s & ins]t+ #be memb]s2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,j71 by /rik+ #b & ins]t+ #c2 7ii7 9 subp>agraph 7,k71 by /rik+ #b & ins]t+ #c2 7iii7 by r$esignat+ subp>agraphs 7,k7 ?r\gh 7,l7 z subp>agraphs 7,l7 ?r\gh 7,m71 respectively2 & 7iv7 by ins]t+ aft] subp>agraph 7,j7 ! foll[+3 7,k7 ,at lea/ #b non-,f$]al heal? c>e pr(essionals ) exp]tise 9 g]ontology4 2 & 7#c7 by am5d+ subsection 7g7 to read z foll[s3 7g7 ,sunset ,! ,advisory ,committee %all t]m9ate on ,septemb] #cj1 #bjbh4 4 7c7 ,national advisory committee on individuals ) disabilities & disa/]s ,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[+3 7c7 ,additional duties ,! ,advisory ,committee may provide-- 7#a7 advice & recomm5dations to ! ,secret>y & to ,congress ) respect to individuals ) disabilities & ! m$ical & public heal? grants & coop]ative agreem5ts z applicable to prep>$ness & response activities "u ?is title & title ,,iii2 & 7#b7 recomm5dations to ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy & to ,congress ) respect to ! public heal? & em]g5cy prep>$ness ne$s ( individuals ) disabilities4 2 7#c7 9 subsection 7d71 z s r$esignat$-- 7,a7 9 p>agraph 7#a71 by /rik+ #ag memb]s & ins]t+ #be memb]s2 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ subp>agraphs 7,k7 ?r\gh 7,m72 & 7ii7 by ins]t+ aft] subp>agraph 7,j7 ! foll[+3 7,k7 #ae non-,f$]al memb]s 7at lea/ #d ( :om %all be individuals ) disabilities7 f div]se backgr\nds1 includ+ ! foll[+3 7i7 ,"o repres5tative f ea* ( ! foll[+3 7,i7 ,a nongov]nm5tal organization t provides disa/] prep>$ness & response s]vices4 7,,ii7 ,a community-bas$ organization t repres5ts individuals ) multiple types ( disabilities4 7,,iii7 ,a ,/ate-bas$ organization t repres5ts individuals ) multiple types ( disabilities4 7,,iv7 ,a national organization t repres5ts individuals ) multiple types ( disabilities4 7,v7 ,a national organization t repres5ts old] adults4 7,,vi7 ,an organization t provides relevant h\s+ s]vices1 includ+ dur+ ! response to1 & recov]y f1 disa/]s4 7,,vii7 ,an organization t repres5ts disabl$ vet]ans4 7ii7 ,f\r individuals ) geographically div]se exp]tise 9 em]g5cy managem5t4 7iii7 ,two 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]y4 2 & 7,c7 by add+ at ! end ! foll[+3 7#c7 ,consid]ation ,9 appo9t+ memb]s1 includ+ ! ,*air1 to ! ,committee "u ?is subsection1 ! ,secret>y may give consid]ation to disability /atus4 2 & 7#d7 by am5d+ subsection 7h71 z s r$esignat$1 to read z foll[s3 7h7 ,sunset ,! ,advisory ,committee %all t]m9ate on ,septemb] #cj1 #bjbh4 4 #cjg4 ,rese>* & coord9ation ( activities conc]n+ ! long-t]m heal? effects ( ,,s>s-,co,v-#b infection 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all1 z appropriate-- 7#a7 coord9ate activities among relevant ,f$]al dep>tm5ts & ag5cies ) respect to address+ ! long-t]m heal? effects ( ,,s>s-,co,v-#b infection1 :i* may include conditions t arise z a result ( su* infection2 7#b7 cont9ue to conduct or support basic1 cl9ical1 epidemiological1 behavioral1 & translational rese>* & public heal? surveillance relat$ to ! pa?og5esis1 prev5tion1 diagnosis1 & treatm5t ( ! long-t]m heal? effects ( ,,s>s-,co,v-#b infection & re-infection1 :i* may include conditions & any effects on developm5t1 cognition1 & neural /ructure & function t arise z a result ( su* infection2 & 7#c7 consi/5t ) ! f9d+s ( /udies & rese>* "u p>agraph 7#a71 9 consultation ) heal? & public heal? pr(essional associations1 sci5tific & m$ical rese>*]s1 & o!r relevant exp]ts1 develop & in=m recomm5dations1 guidance1 & educational mat]ials on ! long-t]m effects ( ,,s>s-,co,v-#b infection1 :i* may include conditions t arise z a result ( su* infection1 & provide su* recomm5dations1 guidance1 & educational mat]ials to heal? c>e provid]s & ! g5]al public4 7b7 ,consid]ations ,9 conduct+ or support+ rese>* "u ?is section1 ! ,secret>y %all consid] ! div]sity ( rese>* p>ticipants or cohorts to ensure inclusion ( a broad range ( p>ticipants1 z applicable & appropriate4 7c7 ,additional activities ,! ,secret>y may-- 7#a7 act+ ?r\gh ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality1 conduct or support rese>* relat$ to-- 7,a7 ! improvem5t ( heal? c>e deliv]y = individuals exp]i5c+ long-t]m heal? effects ( ,,s>s-,co,v-#b1 :i* may include conditions t arise z a result ( su* infection2 7,b7 ! id5tification ( any tr5ds associat$ ) diff]5ces 9 diagnosis & treatm5t ( ! long-t]m heal? effects ( ,,s>s-,co,v-#b infection & relat$ conditions2 & 7,c7 ! developm5t or id5tification ( tools & /rategies to help heal? c>e entities & provid]s c>e = su* populations1 :i* may include address+ any diff]5ces id5tifi$ pursuant to subp>agraph 7,b72 7#b7 publicly dissem9ate ! results ( su* rese>*2 & 7#c7 e/abli% a prim>y c>e te*nical assi/ance initiative to conv5e prim>y c>e provid]s & organizations1 :i* may include support = cont9u+ tra9+ & education = su* provid]s1 z applicable & appropriate1 9 ord] to collect & dissem9ate be/ practices relat$ to ! c>e ( individuals ) long-t]m heal? effects ( ,,s>s-,co,v-#b infection1 :i* may include conditions t arise z a result ( su* infection4 7d7 ,annual reports ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft] = ! next #d ye>s1 ! ,secret>y %all prep>e & submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives reg>d+ an ov]view ( ! rese>* conduct$ or support$ "u ?is section & any relevant f9d+s4 ,su* reports may include in=mation ab\t h[ ! rese>* & relevant f9d+s "u ?is section relate to o!r rese>* ef=ts support$ by o!r public or private entities4 7e7 ,public availability ( in=mation ,9 mak+ in=mation or reports publicly available "u ?is section1 ! ,secret>y %all take into consid]ation ! deliv]y ( su* in=mation 9 a mann] t takes into acc\nt ! range ( communication ne$s ( ! int5d$ recipi5ts1 includ+ at-risk individuals4 #cjh4 ,national ,academies /udy on prizes 7a7 ,9 g5]al ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all seek to ent] into an agreem5t ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e 7ref]r$ to 9 ?is section z ! ,national ,academies7 to conduct a /udy to exam9e-- 7#a7 alt]native models = directly fund+1 or /imulat+ inve/m5t 91 biom$ical rese>* & developm5t t del9k rese>* & developm5t co/s f ! prices ( drugs1 includ+ ! progressive replacem5t ( pat5ts & regulatory exclusivities on new drugs ) a comb9ation ( exp&$ support = rese>* & innovation prizes to rew>d ! successful developm5t ( drugs or a*ievem5t ( relat$ mile/ones2 7#b7 ! doll> am\nt ( innovation prizes = diff]5t /ages ( rese>* & developm5t ( diff]5t classes or types ( drugs1 & total annual fund+1 t w\ld be necess>y to /imulate inve/m5t suffici5t to a*ieve su* successful drug developm5t & relat$ mile/ones2 7#c7 ! relative effectiv5ess & effici5cy ( su* alt]native models 9 /imulat+ innovation1 comp>$ to ! /atus quo t includes pat5ts & regulatory exclusivities2 7#d7 /rategies to implem5t su* alt]native models describ$ 9 p>agraph 7#a71 includ+ a phas$ transition ov] "t2 & 7#e7 ! anticipat$ economic & societal impacts ( su* alt]native models1 includ+ an assessm5t ( impact on-- 7,a7 ! numb] & v>iety ( new drugs t w\ld be develop$1 approv$1 & m>ket$ 9 ! ,unit$ ,/ates1 includ+ su* new drugs int5d$ to prev5t1 diagnose1 or treat a r>e disease or condition2 7,b7 ! rate at :i* new drugs w\ld be develop$1 approv$1 & m>ket$ 9 ! ,unit$ ,/ates2 7,c7 access to m$ication & heal? outcomes2 7,d7 av]age lifespan & disease burd5 9 ! ,unit$ ,/ates2 7,e7 ! numb] ( manufactur]s t w\ld be seek+ approval = a drug or br++ a drug to m>ket = ! fir/ "t2 7,f7 ,f$]al discretion>y & m&atory sp5d+2 & 7,g7 public & private insurance m>kets4 7b7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #c1jjj1jjj = fiscal ye> #bjbd4 7c7 ,requirem5ts ,9 conduct+ ! /udy pursuant to subsection 7a71 ! ,national ,academies %all hold n few] ?an #b public li/5+ sessions to solicit fe$back f int]e/$ p>ties1 includ+ repres5tatives ( academia1 pr(essional societies1 pati5t advocates1 public heal? organizations1 relevant ,f$]al dep>tm5ts & ag5cies1 drug develop]s1 repres5tatives ( o!r relevant indu/ries1 & subject matt] exp]ts4 7d7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,national ,academies %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives a report on ! /udy conduct$ pursuant to subsection 7a74 ,,iv ,/r5g!n+ biosecurity #dja4 ,treatm5t ( g5etic v>iants & syn!tic products ( select ag5ts & tox9s ,section #cea;,a7a77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb;a7a77#a77 is am5d$ by add+ at ! end ! foll[+3 7,c7 ,inclusions 7i7 ,9 g5]al ,= purposes ( ! li/ "u ?is p>agraph1 ! foll[+ %all be consid]$ to be a biological ag5t or tox9 includ$ on ! li/3 7,i7 ,any biological ag5t t incorporates nucleic acids cod+ = a virul5ce factor f a li/$ ag5t or tox94 7,,ii7 ,any biological ag5t or tox9 t is g5etically homolog\s to a li/$ ag5t or tox9 ) respect to nucleotides cod+ = virul5ce factors or toxicity4 7,,iii7 ,any biological ag5t or tox9 t is syn!tically d]iv$ ) virul5ce or toxicity *>act]i/ics ( a li/$ ag5t or tox94 7,,iv7 ,any nucleic acid t encodes = compon5ts contribut+ to pa?og5icity1 transmissibility1 or toxicity ( a li/$ ag5t or tox94 7ii7 ,exemptions ,! ,secret>y may exempt f inclusion on ! li/ "u ?is p>agraph any biological ag5t1 tox91 or nucleic acid describ$ 9 clause 7i71 if su* ag5t1 tox91 or nucleic acid does n meet ! crit]ia "u subp>agraph 7,b74 4 #djb4 ,e/abli%m5t ( no-fault report+ sy/em ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #cea;,a 7#db ,u4,s4,c4 #bfb;a7 ! foll[+3 #cea;,b4 ,no-fault report+ sy/em 7a7 ,def9itions ,9 ?is section3 7#a7 ,! t]m li/$ ag5ts & tox9s has ! mean+ giv5 ! t]m 9 section #cea;,a7l74 7#b7 ,! t]m report+ sy/em means ! report+ sy/em e/abli%$ "u subsection 7b77#a74 7b7 ,e/abli%m5t 7#a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,response ,act1 ! ,secret>y %all e/abli% a confid5tial1 anonym\s1 volunt>y1 no-fault report+ sy/em relat$ to accid5ts1 ne>-accid5ts1 or o!r safety incid5ts involv+ biological ag5ts & tox9s1 9 ord] to support cont9u\s improvem5t & %>+ ( lessons le>n$ relat$ to su* incid5ts4 7#b7 ,availability ,! ability to submit reports on a volunt>y basis to ! report+ sy/em %all be made available to individuals affiliat$ ) laboratories locat$ 9 ! ,unit$ ,/ates1 or at f$]ally-fund$ entities outside ! ,unit$ ,/ates1 t conduct rese>* involv+ biological ag5ts & tox9s4 7#c7 ,data ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,response ,act1 ! ,secret>y %all publi% a notice 9 ! ,f$]al ,regi/] on plans = ! report+ sy/em1 includ+-- 7,a7 data elem5ts t w be includ$ 9 ! submission ( reports2 7,b7 proc$ures & processes = ! submission ( reports2 7,c7 crit]ia = incid5ts t may be report$ to su* sy/em2 & 7,d7 proc$ures = privacy & anonymization4 7#d7 ,prototyp+ & te/+ ,! ,secret>y %all te/ & prototype ! report+ sy/em = n less ?an #a ye> be=e f9aliz+ ! report+ sy/em4 7#e7 ,ext]nal fe$back ,! ,secret>y %all seek fe$back on developm5t ( ! report+ sy/em f ext]nal /akehold]s1 includ+ prior to publication ( ! in=mation "u p>agraph 7#c7 & prior to introduction ( prototypes & f9alization ( su* sy/em "u p>agraph 7#d74 7c7 ,,foia 7#a7 ,9 g5]al ,in=mation submitt$ to1 or d]iv$ f1 ! report+ sy/em %all be exempt f disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,applicability ,= purposes ( p>agraph 7#a71 ?is section %all be consid]$ a /atute describ$ 9 section #eeb7;b77#c77;,b7 ( title #e1 ,unit$ ,/ates ,code4 7d7 ,prohibition on use z evid5ce ,in=mation submitt$ to1 or d]iv$ f1 ! report+ sy/em %all n be us$ 9 any ,f$]al or ,/ate en=cem5t action or crim9al prosecution4 7e7 ,privacy2 discipl9>y action = unau?oriz$ disclosure ,an individual or entity t submits in=mation to ! report+ sy/em "u subsection 7b7 %all n be requir$ to provide _! "n4 7f7 ,relation%ip to o!r report+ sy/ems ,! volunt>y report+ sy/em e/abli%$ "u ?is section %all supplem5t1 & n supplant1 any o!r requirem5ts to submit reports "u any o!r report+ sy/em4 4 #djc4 ,evaluation ( ! ,f$]al ,select ,ag5t ,program & relat$ policies 7a7 ,9 g5]al ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,national ,sci5ce ,advisory ,bo>d = ,biosecurity 7ref]r$ to 9 ?is section z ! ,bo>d7 e/abli%$ pursuant to section #djd,o ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhcr7 %all be *>g$ ) assess+ ! framework = biosafety & biosecurity ov]sight1 p>ticul>ly ) respect to mitigat+ risks to ! ,unit$ ,/ates population ) respect to biological ?reats4 ,! f9d+s ( ! ,bo>d %all address sci5tific advancem5ts & integration ( ! ,program & o!r relat$ ,f$]al policies & frameworks = biosafety & biosecurity4 ,! f9d+s ( ! ,bo>d %all be transmitt$ to ! ,presid5t4 7b7 ,framework 7#a7 ,9 g5]al ,! recomm5dations develop$ "u subsection 7a7 %all include a propos$ framework = an integrat$ approa* to ! ov]sight ( biological rese>* t raises significant biosafety & biosecurity conc]ns1 :i* may include proposals to h>monize & mod]nize relevant ,f$]al policies su* z ! foll[+3 7,a7 ,! ,f$]al ,select ,ag5t ,program4 7,b7 ,f$]al policies relat+ to dual-use rese>* ( conc]n4 7,c7 ,f$]al policies relat$ to f$]ally fund$ rese>* involv+ enhanc$ pa?og5s ( p&emic pot5tial4 7,d7 ,! ,biosafety 9 ,microbiological & ,biom$ical ,laboratories ,manual ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 & o!r relat$ guidance docum5ts4 7,e7 ,! ,guidel9es = ,rese>* ,involv+ ,recomb9ant or ,syn!tic ,nucleic ,acid ,molecules ( ! ,national ,in/itutes ( ,heal?4 7#b7 ,requirem5ts = framework ,! framework propos$ "u p>agraph 7#a7 %all-- 7,a7 be develop$ 9 consultation ) /akehold]s & exp]ts f in/itutions ( high] education1 indu/ry1 & o!r gov]nm5t ag5cies2 & 7,b7 make recomm5dations relat$ to mitigat+ any id5tifi$ risks associat$ ) exi/+ gaps 9 ov]sight ( su* rese>*1 :i* may include rese>* t does n receive ,f$]al fund+1 tak+ into consid]ation any national security conc]ns1 ! pot5tial b5efits ( su* rese>*1 consid]ations relat$ to ! rese>* community1 transp>5cy1 & public availability ( in=mation1 & int]national rese>* collaboration4 7c7 ,reorganization ,9 c>ry+ out ?is section1 ! ,bo>d may make recomm5dations relat$ to ! cl>ification ( ! au?orities & responsibilities ( relevant ,f$]al dep>tm5ts & ag5cies & any necess>y reorganization ( su* au?orities & responsibilities among su* dep>tm5ts & ag5cies4 7d7 ,report ,n lat] ?an #a ye> aft] ! issuance ( recomm5dations "u subsection 7a71 ! ,presid5t %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 &1 z applicable1 o!r appropriate committees ( ,congress1 a report t describes plans to consid] & implem5t su* recomm5dations1 includ+ ! id5tification (-- 7#a7 any b>ri]s to implem5tation2 & 7#b7 any areas 9 :i* ! ,presid5t disagrees ) ! f9d+s or recomm5dations ( ! ,bo>d4 #djd4 ,support+ rese>* & laboratory surge capacity 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all make aw>ds to e/abli% or ma9ta91 z applicable1 n few] ?an #ab regional bioconta9m5t laboratories1 = purposes (-- 7#a7 conduct+ biom$ical rese>* to support public heal? & m$ical prep>$ness =1 & rapid response to1 biological ag5ts1 includ+ em]g+ infecti\s diseases2 7#b7 ensur+ ! availability ( surge capacity = purposes ( respond+ to su* biological ag5ts2 7#c7 support+ in=mation-%>+ betwe51 & ! dissem9ation ( f9d+s to1 rese>*]s & o!r relevant individuals to facilitate collaboration betwe5 indu/ry & academia2 & 7#d7 provid+1 z appropriate & applicable1 te*nical assi/ance & tra9+ to rese>*]s & o!r relevant individuals to support ! biom$ical rese>* work=ce 9 improv+ ! managem5t & mitigation ( safety & security risks 9 ! conduct ( rese>* involv+ su* biological ag5ts4 7b7 ,requirem5ts ,z a condition ( receiv+ a grant "u ?is section1 a regional bioconta9m5t laboratory %all agree-- 7#a7 to su* ov]sight activities z ! ,secret>y det]m9es appropriate1 includ+ p]iodic meet+s ) relevant (ficials ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 facility inspections1 & o!r activities z necess>y & appropriate to ensure compliance ) ! t]ms & conditions ( su* aw>d2 & 7#b7 to report accid5ts1 ne>-accid5ts1 or o!r safety incid5ts involv+ biological ag5ts & tox9s into ! no-fault report+ sy/em e/abli%$ pursuant to section #cea;,b ( ! ,public ,heal? ,s]vice ,act1 z add$ by section #djb4 7c7 ,bo>d ,! ,secret>y %all e/abli% a ,bo>d consi/+ ( a repres5tative f ea* entity 9 receipt ( an aw>d "u subsection 7a71 :i* %all be head$ by an executive committee ( #c memb]s elect$ ^u an affirmative vote f a majority ( su* repres5tatives4 ,! ,bo>d %all make recomm5dations to ! ,secret>y 9 adm9i/]+ aw>ds "u ?is section1 = purposes (-- 7#a7 improv+ ! quality & consi/5cy ( applicable proc$ures & practices )9 laboratories fund$ pursuant to subsection 7a72 & 7#b7 ensur+ coord9ation1 z appropriate1 ( f$]ally fund$ activities c>ri$ out at su* laboratories4 7d7 ,def9ition ,9 ?is section1 ! t]m regional bioconta9m5t laboratory means a ,biosafety or ,animal ,biosafety ,level-#c & ,level-#b facility locat$ at an in/itution 9 ! ,unit$ ,/ates t is designat$ by ! ,secret>y to c>ry out ! activities describ$ 9 subsection 7a74 7e7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #eb1jjj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh4 7f7 ,adm9i/rative exp5ses ,( ! am\nt available to c>ry out ?is section = a fiscal ye>1 ! ,secret>y may use n m ?an #e p]c5t = ! adm9i/rative exp5ses ( c>ry+ out ?is section1 includ+ exp5ses relat$ to c>ry+ out subsection 7c74 7g7 ,report to ,congress ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & biannually !reaft]1 ! ,secret>y1 9 consultation ) ! heads ( applicable ,f$]al dep>tm5ts & ag5cies %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on-- 7#a7 ! activities & accompli%m5ts ( ! regional bioconta9m5t laboratories2 7#b7 any publi%$ or dissem9at$ rese>* f9d+s bas$ on rese>* conduct$ 9 su* laboratories 9 ! applicable ye>2 7#c7 ov]sight activities c>ri$ out by ! ,secret>y pursuant to subsection 7b72 7#d7 activities und]tak5 by ! ,secret>y to take into consid]ation ! capacity & capabilities ( ! network ( regional bioconta9m5t laboratories 9 activities to prep>e = & respond to biological ag5ts1 :i* may include lev]ag+ su* capacity & capabilities to support ! ,laboratory ,response ,network1 z applicable & appropriate2 7#e7 plans = ! ma9t5ance & su/a9m5t ( f$]ally fund$ activities conduct$ at ! regional bioconta9m5t laboratories1 consi/5t ) ! /rategy requir$ "u section #bcab ( ! ,,prev5t ,p&emics ,act 7,public ,law #aag-cbh72 & 7#f7 activities und]tak5 by ! ,secret>y to coord9ate ) applicable ag5cies to ensure "w c>ri$ out by su* facilities is prioritiz$ & complem5t>y to "o ano!r1 & avoid+ unnecess>y duplication4 #dje4 ,g5e syn!sis 7a7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all update ! ,scre5+ ,framework ,guidance = ,provid]s ( ,syn!tic ,d\ble-,/r&$ ,,dna to acc\nt = sci5tific & te*nological advancem5ts ) respect to mitigat+ risk ( unau?oriz$ individuals or individuals ) malici\s int5t f us+ nucleic acid syn!sis te*nologies to obta9 biological ag5ts or tox9s ( conc]n4 ,su* guidance %all include recomm5dations relat$ to-- 7#a7 scre5+ = sequ5ces t ! ,secret>y det]m9es may contribute to toxicity1 pa?og5icity1 or virul5ce2 7#b7 scre5+ & v]ification ( ! id5tity & legitimacy ( cu/om]s2 7#c7 ! id5tification1 evaluation1 & use ( appropriate s(tw>e or o!r tools to enable ! scre5+ describ$ 9 p>agraphs 7#a7 & 7#b72 7#d7 ensur+ nucleic acid syn!sis activities are c>ri$ out 9 compliance ) exi/+ regulations "u "p #gc ( title #db1 ,code ( ,f$]al ,regulations1 "p #cca ( title #g1 ,code ( ,f$]al ,regulations1 "p #aba ( title #i1 ,code ( ,f$]al ,regulations1 & "p #ggd ( title #ae ,code ( ,f$]al ,regulations 7or successor regulations72 7#e7 implem5t+ appropriate safegu>ds1 :i* may include ! use ( su* s(tw>e or o!r tools1 9 g5e syn!sis equipm5t to facilitate scre5+ ( nucleic acid sequ5ces &1 z applicable1 cu/om]s2 7#f7 ma9ta9+ records ( cu/om] ord]s1 metadata1 & scre5+ sy/em or protocol p]=mance 9 specifi$ =mats1 :i* may include /&>diz$ ma*9e-readable & int]op]able data =mats2 & 7#g7 o!r recomm5dations z det]m9$ appropriate by ! ,secret>y4 7b7 ,sequ5ces ( conc]n ,! ,secret>y %all ma9ta9 a public docket to solicit recomm5dations on pot5tial sequ5ces ( conc]n &1 9 consultation ) o!r ,f$]al dep>tm5ts & ag5cies & non-,f$]al exp]ts1 z appropriate1 review & update1 on a regul> basis1 a li/ ( sequ5ces ( conc]n to facilitate scre5+ "u subsection 7a77#a74 7c7 ,l&scape review ,! ,secret>y1 9 coord9ation ) o!r ,f$]al dep>tm5ts & ag5cies1 z appropriate1 %all conduct a l&scape review ( provid]s & manufactur]s ( g5e syn!sis equipm5t1 products1 s(tw>e1 & o!r tools ) ! purpose ( und]/&+ ! numb]1 types1 & capabilities ( products & equipm5t t exi/ dome/ically & to in=m ! developm5t ( any updates to ! guidance "u subsection 7a74 7d7 ,te*nical assi/ance ,! ,secret>y1 9 consultation ) o!r ,f$]al dep>tm5ts & ag5cies1 %all provide te*nical assi/ance ^u reque/ ( a g5e syn!sis provid]1 manufactur] ( g5e syn!sis equipm5t1 or develop] ( s(tw>e or o!r scre5+ tools to support implem5tation ( ! recomm5dations includ$ 9 ! guidance "u subsection 7a74 7e7 ,def9itions ,= purposes ( ?is section3 7#a7 ,! t]m g5e syn!sis equipm5t means equipm5t ne$$ to produce g5e syn!sis products4 7#b7 ,! t]m g5e syn!sis product-- 7,a7 means cu/om s+le-/r&$ or d\ble-/r&$ ,,dna1 or s+le-/r&$ or d\ble-/r&$ ,,rna1 :i* has be5 *emically or enzymatically syn!siz$ or o!rwise manufactur$ de novo & is ( a l5g? exce$+ ! scre5+ ?re%old1 z det]m9$ by ! ,secret>y2 & 7,b7 does n include-- 7i7 base *emical subunits1 su* z individual nucleotides or nucleosides1 or oligonucleotides %ort] ?an ! scre5+ ?re%old typically us$ z polym]ase *a9 reaction prim]s1 z det]m9$ by ! ,secret>y2 7ii7 by-products g5]at$ dur+ sequ5c+ t are n useful = assembly or clon+1 z det]m9$ by ! ,secret>y2 or 7iii7 products g5]at$ f clon+ or assembl+ ( exi/+ g5e or g5e fragm5t mat]ial1 9 circum/ances 9 :i* ! g5e syn!sis provid] has no access or notice to ! sequ5ce design1 z det]m9$ by ! ,secret>y4 7#c7 ,! t]m g5e syn!sis provid] means an entity t syn!sizes & di/ributes g5e syn!sis products1 includ+ bact]ia1 viruses1 or fungi conta9+ recomb9ant or syn!tic nucleic acid molecules1 = deliv]y to a cu/om]4 7#d7 ,! t]m manufactur]s ( g5e syn!sis equipm5t means an entity t produces & sells equipm5t = syn!siz+ g5e syn!sis products4 #djf4 ,limitation relat$ to c\ntries ( conc]n conduct+ c]ta9 rese>* ,section #bcae7;c7 ( ! ,,prev5t ,p&emics ,act 7,public ,law #aag-cbh7 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by ins]t+ t may reasonably be anticipat$ to involve ! creation1 transf]1 & use ( enhanc$ pa?og5s ( p&emic pot5tial or biological ag5ts or tox9s li/$ pursuant to section #cea;,a7a77#a7 if su* rese>* is aft] n fund rese>*2 & 7,b7 by /rik+ 1 involv+ pa?og5s ( p&emic pot5tial & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ a p]iod2 7#b7 9 p>agraph 7#b7-- 7,a7 9 ! head+1 by /rik+ ,conditions = li/+ or susp5d+ prohibition & ins]t+ ,limitations2 & 7,b7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ ,! ,secret>y & ins]t+ ,beg9n+ #e ye>s aft] an initial det]m9ation ( a c\ntry ( conc]n1 ! ,director ( ,national ,intellig5ce or ! ,secret>y2 & 7ii7 by ins]t+ ) respect to su* c\ntry ( conc]n aft] p>agraph 7#a72 & 7#c7 by add+ at ! end ! foll[+3 7#c7 ,cl>ification 7,a7 ,9 g5]al ,! requirem5t ( p>agraph 7#a7 may be waiv$ by ! ,presid5t = ! duration ( ! initial response to an outbreak ( a novel em]g+ infecti\s disease if ! ,presid5t det]m9es t su* requirem5t imp$es ! ability ( ! ,f$]al ,gov]nm5t to imm$iately respond to su* outbreak4 7,b7 ,notification ,! ,presid5t %all notify ,congress n lat] ?an #dh h\rs aft] ex]cis+ ! waiv] "u subp>agraph 7,a71 & %all provide updates to ,congress relat$ to ! use ( su* waiv] e #ae days !reaft]4 4 #djg4 ,assessm5t ( artificial intellig5ce ?reats to heal? security 7a7 ,9 g5]al ,n lat] ?an #de days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all seek to ent] into a contract ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e 7ref]r$ to 9 ?is section z ! ,national ,academies7 to conduct a /udy assess+ ! pot5tial vuln]abilities to heal? security pres5t$ by ! curr5t or prospective use or misuse ( artificial intellig5ce1 includ+ ) respect to op5-s\rce artificial intellig5ce models1 su* z l>ge language models4 7b7 ,inclusions ,! /udy conduct$ pursuant to ! contract "u subsection 7a7 %all include-- 7#a7 an assessm5t ( ! pot5tial vuln]abilities pos$ by te*nical advancem5ts 9 artificial intellig5ce to heal? security1 includ+ any risks relat$ to ! developm5t (1 enhancem5t (1 or protection f1 *emical1 biological1 radiological1 or nucle> ?reats2 7#b7 a description ( roles1 responsibilities1 & capabilities ( ag5cies & (fices ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 &1 z applicable & appropriate1 o!r ,f$]al dep>tm5ts & ag5cies1 ) respect to ! id5tification & mitigation ( su* pot5tial vuln]abilities2 7#c7 a summ>y ( any ongo+ ,f$]al activities relat$ to ! id5tification1 und]/&+1 & mitigation ( su* pot5tial risks2 7#d7 ! id5tification ( any pot5tial gaps1 :e!r curr5t or anticipat$1 relat$ to su* roles1 responsibilities1 & capabilities2 & 7#e7 recomm5dations to improve ,f$]al ef=ts to id5tify1 prep>e =1 & mitigate su* pot5tial vuln]abilities4 7c7 ,reports 7#a7 ,national ,academies report ,n lat] ?an #b ye>s aft] ! date ( ! contract "u subsection 7a71 ! ,national ,academies %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! /udy conduct$ pursuant to subsection 7a74 7#b7 ,,hhs report ,n lat] ?an #a ye> aft] ! issuance ( ! report requir$ "u p>agraph 7#a71 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report detail+ actions tak5 to mitigate & monitor risks to heal? security pos$ by misuse ( artificial intellig5ce1 z detail$ 9 ! report "u p>agraph 7#a74 ,v ,prev5t+ drug %ortages #eja4 ,improv+ notification proc$ures 9 case ( increas$ dem& = critical drugs 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 drugs2 7#b7 by /rik+ subsections 7a71 7b71 & 7c71 & ins]t+ ! foll[+3 7a7 ,notification requir$ 7#a7 ,9 g5]al ,a manufactur] ( a cov]$ drug %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$i5t ( su* drug1 or an int]ruption 9 ! manufacture ( an active ph>maceutical +r$i5t ( su* drug t is likely to lead to a mean+ful disruption 9 ! supply ( ! active ph>maceutical +r$i5t ( su* drug2 or 7iii7 any o!r circum/ance1 su* z an increase 9 dem& or export re/riction1 t is likely to leave ! manufactur] unable to meet dem& = ! drug )\t a mean+ful %ortfall or delay2 & 7,b7 ! reasons = su* discont9uance1 int]ruption1 or o!r circum/ance1 if kn[n4 7#b7 ,cont5ts ,notification "u ?is subsection ) respect to a cov]$ drug %all include-- 7,a7 ) respect to ! reasons = ! discont9uation1 int]ruption1 or o!r circum/ance describ$ 9 p>agraph 7#a77;,a77iii71 if an active ph>maceutical +r$i5t is a reason =1 or risk factor 91 su* discont9uation1 int]ruption1 or o!r circum/ance1 ! s\rce ( ! active ph>maceutical +r$i5t & any alt]native s\rces = ! active ph>maceutical +r$i5t kn[n to ! manufactur]2 7,b7 :e!r any associat$ device us$ = prep>ation or adm9i/ration includ$ 9 ! drug is a reason =1 or a risk factor 91 su* discont9uation1 int]ruption1 or o!r circum/ance describ$ 9 p>agraph 7#a77;,a77iii72 7,c7 ! expect$ duration ( ! int]ruption2 & 7,d7 su* o!r in=mation z ! ,secret>y may require4 7b7 ,tim+ ,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 a circum/ance describ$ 9 subsection 7a77#a77;,a77iii71 z soon z practicable1 or n lat] ?an #aj bus9ess days aft] ! onset ( ! circum/ance2 or 7#c7 if compliance ) p>agraph 7#a7 or 7#b7 is n possible1 z soon z practicable4 7c7 ,di/ribution ,to ! maximum ext5t practicable1 ! ,secret>y %all di/ribute1 ?r\gh su* means z ! ,secret>y det]m9es appropriate1 in=mation on ! discont9uance or int]ruption ( ! manufacture (1 or o!r circum/ance describ$ 9 subsection 7a77#a77;,a77iii7 t is likely to lead to a %ortage or mean+ful disruption 9 ! supply (1 cov]$ drugs 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+ cov]$ drug2 & 7#d7 9 subsection 7j71 by /rik+ drug describ$ 9 subsection 7a7 & ins]t+ cov]$ drug4 7b7 ,def9itions ,p>agraph 7#a7 ( section #ejf;,c7h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7h77 is am5d$ to read z foll[s3 7#a7 ! t]m cov]$ drug means a drug t is int5d$ = human use & 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 & 7,c7 is n a biological product 7z def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act71 unless o!rwise provid$ by ! ,secret>y 9 ! regulations promulgat$ "u subsection 7i72 4 #ejb4 ,report+ on supply *a9s ,section #eaj7;j77#c77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j77#c77;,a77 is am5d$-- 7#a7 by ins]t+ 1 & ! names & unique facility id5tifi]s ( ! manufactur]s ( ! active ph>maceutical +r$i5ts su* p]son us$ = ! manufacture1 prep>ation1 propagation1 comp\nd+1 or process+ ( su* drug1 & ! am\nt ( su* drug manufactur$1 prep>$1 propagat$1 comp\nd$1 or process$ us+ ea* su* active ph>maceutical +r$i5t f ea* su* manufactur] be=e ! p]iod at ! end ( ! fir/ s5t5ce2 & 7#b7 by ins]t+ aft] ! fir/ s5t5ce ! foll[+3 ,9 addition to ! report+ requir$ "u ! prec$+ s5t5ce1 ! ,secret>y may receive volunt>y submissions ( su* in=mation at m frequ5t int]vals44 #ejc4 ,report+ on use ( new au?orities & requirem5ts ) respect to drug %ortages ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on-- 7#a7 ! ext5t to :i* ! ,secret>y has implem5t$ ! au?orities & requirem5ts "u sections #ejf;,c7g71 #ejf;,c7j71 #ejf;,e7d71 #eaj7;j77#c71 & #gjd7;b77#b7 7#ba ,u4,s4,c4 #cef;c7g71 #cef;c7j71 #cef;e7d71 #cfj7;j77#c71 #cgd7;b77#b77 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by section #caaa & #caab ( ! ,coronavirus ,aid1 ,relief1 & ,economic ,security ,act 7,public ,law #aaf-acf71 includ+-- 7,a7 specific examples ( uses ( su* au?orities & requirem5ts2 & 7,b7 an assessm5t ( ! ext5t to :i* su* au?orities & requirem5ts h help$ mitigate drug %ortages2 & 7#b7 ! /atus ( ! guidance docum5ts t ! ,secret>y int5ds to issue ) respect to report+ & risk managem5t plan requirem5ts applicable to manufactur]s ( drugs & active ph>maceutical +r$i5ts1 pursuant to ! am5dm5ts made to section #ejf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 by subsections 7a7 & 7b7 ( section #caab ( ! ,coronavirus ,aid1 ,relief1 & ,economic ,security ,act 7,public ,law #aaf-acf74 ,,vi ,additional reau?orizations & te*nical am5dm5ts #fja4 ,m$ical c\nt]measure priority review v\*] ,section #efe;,a7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7 is am5d$ by /rik+ #bjbc & ins]t+ #bjbh4 #fjb4 ,epidemic ,intellig5ce ,s]vice loan repaym5t program ,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 #fjc4 ,vacc9e track+ & di/ribution ,section #cai;,a7e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is am5d$ by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh4 #fjd4 ,regional heal? c>e em]g5cy 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 #fje4 ,em]g5cy sy/em = advance regi/ration ( volunte] heal? pr(essional ,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 #fjf4 ,limit$ antitru/ exemption ,section #cai,l-#a7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;f7b77 is am5d$ by /rik+ at ! end ( ! #ag-ye> p]iod t beg9s on ! date ( enactm5t ( ?is ,act & ins]t+ on ,septemb] #cj1 #bjbh4 #fjg4 ,trauma c>e ,section #abcb7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#cb7;a77 is am5d$ by /rik+ #bd1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg & ins]t+ #ci1jjj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh4 #fjh4 ,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 #fji4 ,national ,disa/] ,m$ical ,sy/em 7a7 ,9 g5]al ,section #bhab ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7 is am5d$-- 7#a7 9 subsection 7c77#d77;,b71 by /rik+ #bjbc & ins]t+ #bjbh2 & 7#b7 9 subsection 7g71 by /rik+ #eg1djj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #fe1ijj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh4 7b7 ,repeal ( sunset 7#a7 ,9 g5]al ,section #cja7;d77#c7 ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai 7,public ,law #aaf-bb2 #cd ,u4,s4,c4 #ajbhd note7 is repeal$4 7#b7 ,effective date ,p>agraph 7#a7 %all take effect z if enact$ on ,septemb] #cj1 #bjba4 #faj4 ,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 #faa4 ,epidemiology-laboratory capacity grants ,section #bhba7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#ca7;b77 is am5d$1 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh4 #fab4 ,vet]ans ,affairs ,section #haag7;g7 ( title #ch1 ,unit$ ,/ates ,code is am5d$ by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh4 #fac4 ,te*nical am5dm5ts 7a7 ,title ,,xxi ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#a et seq47 is am5d$-- 7#a7 9 section #baje7;b71 by /rik+ 1 #bajc1 & #bajd ea* place x appe>s & ins]t+ & #bajc2 7#b7 9 section #baaj7;b71 by /rik+ ! program & ins]t+ ,! ,program2 7#c7 9 section #baaa7;a7-- 7,a7 9 p>agraph 7#f71 by /rik+ #aihh = & ins]t+ #aihh1 =2 & 7,b7 9 p>agraph 7#aj71 by /rik+ ,unit$ ,/ates ,claims ,c\rt & ins]t+ ,unit$ ,/ates ,c\rt ( ,f$]al ,claims2 7#d7 9 section #baab-- 7,a7 9 subsection 7c77#f77;,a71 by /rik+ ,unit$ ,/ates ,claims ,c\rts & ins]t+ ,unit$ ,/ates ,c\rt ( ,f$]al ,claims2 & 7,b7 9 subsection 7f7-- 7i7 by /rik+ ,unit$ ,/ates ,claims ,c\rt on & ins]t+ ,unit$ ,/ates ,c\rt ( ,f$]al ,claims on2 & 7ii7 by /rik+ ,unit$ ,/ates ,claims ,c\rt's judgm5t & ins]t+ judgm5t ( ! ,unit$ ,/ates ,c\rt ( ,f$]al ,claims2 7#e7 9 section #baae7;b77#c71 by /rik+ subsection 7e7 & ins]t+ subsection 7e772 7#f7 9 section #baag-- 7,a7 9 ! section head+1 by /rik+ ,subrogration & ins]t+ ,subrogation2 & 7,b7 9 subsection 7a71 by /rik+ subrograt$ & ins]t+ subrogat$2 & 7#g7 9 section #babg-- 7,a7 9 subsection 7b77#a71 by ins]t+ & ,prev5tion be=e ! p]iod2 & 7,b7 9 subsection 7c71 by /rik+ ,committee on ,labor & ,human ,res\rces & ins]t+ ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions4 7b7 ,section #cai;,f-#c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7 is am5d$-- 7#a7 9 subsection 7c77#e77;,b77ii77,i71 by /rik+ *apt] #e & ins]t+ *apt] ,v2 & 7#b7 9 subsection 7i77#g7-- 7,a7 by /rik+ #cba7;g77#a77 & ins]t+ #cba7;g77#a7772 & 7,b7 by /rik+ #cba7;h77 & ins]t+ #cba7;h7774 7c7 ,section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 is am5d$-- 7#a7 9 subsection 7b77#a71 by /rik+ "u #cai;,f-#c7;b7 & ins]t+ "u section #cai;,f-#c7;b72 & 7#b7 9 subsection 7d77#e71 by /rik+ "u subsection 7a7 ! ,secret>y det]m9es t a cov]$ individual qualifies = comp5sation & ins]t+ a cov]$ individual is det]m9$ "u subsection 7a7 to be eligible = comp5sation "u ?is section4 7d7 ,"p ,c ( title ,,ii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bci et seq47 is am5d$-- 7#a7 9 section #bfa7;a77#b77;,a71 by /rik+ specialities & ins]t+ specialties2 7#b7 9 section #bfe7;c77#e71 by /rik+ involves & ins]t+ involv$2 7#c7 9 section #bff7;b77#c77;,b77ii71 by /rik+ to ) respect to an eligible & ins]t+ ) respect to an eligible2 & 7#d7 9 section #bfg7;b71 by /rik+ su* ,act & ins]t+ su* "p4 7e7 ,section #cea;,a7e77#g77;,b77ii7 is am5d$ by /rik+ judical & ins]t+ judicial4