,,ii #aag? ,,congress #b;d ,session ,s4 #cgii ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #aj 7legislative day1 ,m>* #g71 #bjbb ,mrs4 ,murray 7= h]self & ,mr4 ,burr7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to prep>e =1 & respond to1 exi/+ viruses1 em]g+ new ?reats1 & p&emics4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,prep>e = & ,respond to ,exi/+ ,viruses1 ,em]g+ ,new ,?reats1 & ,p&emics ,act or ! ,,prev5t ,p&emics ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,,title ,i--,/r5g!n+ ,f$]al & ,/ate prep>$ness ,subtitle ,a--,f$]al lead]%ip & acc\ntability ,sec4 #aja4 ,compreh5sive review ( ! ,,covid-#ai response4 ,sec4 #ajb4 ,appo9tm5t & au?ority ( ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 ,sec4 #ajc4 ,additional provisions relat$ to ! ,c5t]s = ,disease ,control & ,prev5tion4 ,sec4 #ajd4 ,public heal? & m$ical prep>$ness & response coord9ation4 ,sec4 #aje4 ,/r5g!n+ public heal? communication4 ,sec4 #ajf4 ,(fice ( ,p&emic ,prep>$ness & ,response ,policy4 ,subtitle ,b--,/ate & local read9ess ,sec4 #aaa4 ,improv+ ,/ate & local public heal? security4 ,sec4 #aab4 ,support+ access to m5tal heal? & sub/ance use disord] s]vices dur+ public heal? em]g5cies4 ,sec4 #aac4 ,trauma c>e reau?orization4 ,sec4 #aad4 ,assessm5t ( conta9m5t & mitigation ( infecti\s diseases4 ,,title ,,ii--,improv+ public heal? prep>$ness & response capacity ,subtitle ,a--,address+ disp>ities & improv+ public heal? em]g5cy responses ,sec4 #bja4 ,address+ social det]m9ants ( heal? & improv+ heal? outcomes4 ,sec4 #bjb4 ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e report4 ,subtitle ,b--,improv+ public heal? data ,sec4 #baa4 ,mod]niz+ biosurveillance capabilities & infecti\s disease data collection4 ,sec4 #bab4 ,g5omic sequ5c+1 analytics1 & public heal? surveillance ( pa?og5s4 ,sec4 #bac4 ,support+ public heal? data availability & access4 ,sec4 #bad4 ,epidemic =eca/+ & outbreak analytics4 ,sec4 #bae4 ,report on ,,cdc data portal4 ,sec4 #baf4 ,public heal? data transp>5cy4 ,subtitle ,c--,revitaliz+ ! public heal? work=ce ,sec4 #bba4 ,improv+ recruitm5t & ret5tion ( ! frontl9e public heal? work=ce4 ,sec4 #bbb4 ,aw>ds to support community heal? work]s & community heal?4 ,sec4 #bbc4 ,improv+ public heal? em]g5cy response capacity4 ,sec4 #bbd4 ,ext5sion ( au?orities to support heal? pr(essional volunte]s at community heal? c5t]s4 ,sec4 #bbe4 ,increas+ educational opportunities = alli$ heal? pr(essions4 ,sec4 #bbf4 ,public ,heal? ,s]vice ,corps annual & sick leave4 ,subtitle ,d--,improv+ public heal? responses ,sec4 #bca4 ,c5t]s = public heal? prep>$ness & response4 ,sec4 #bcb4 ,vacc9e di/ribution plans4 ,sec4 #bcc4 ,coord9ation & collaboration reg>d+ blood supply4 ,,title ,,iii--,accel]at+ rese>* & c\nt]measure discov]y ,subtitle ,a--,fo/]+ rese>* & developm5t & improv+ coord9ation ,sec4 #cja4 ,rese>* & activities relat$ to long-t]m heal? effects ( ,,s>s-,co,v-#b infection4 ,sec4 #cjb4 ,rese>* c5t]s = pa?og5s ( p&emic conc]n4 ,sec4 #cjc4 ,improv+ m$ical c\nt]measure rese>* coord9ation4 ,sec4 #cjd4 ,access+ specim5 samples & diagno/ic te/s4 ,subtitle ,b--,improv+ biosafety & biosecurity ,sec4 #caa4 ,improv+ control & ov]sight ( select biological ag5ts & tox9s4 ,sec4 #cab4 ,/rategy = ,f$]al high-conta9m5t laboratories4 ,sec4 #cac4 ,national ,sci5ce ,advisory ,bo>d = ,biosecurity4 ,sec4 #cad4 ,rese>* to improve biosafety4 ,sec4 #cae4 ,f$]ally-fund$ rese>* ) enhanc$ pa?og5s ( p&emic pot5tial4 ,subtitle ,c--,prev5t+ undue =eign influ5ce 9 biom$ical rese>* ,sec4 #cba4 ,=eign tal5t programs4 ,sec4 #cbb4 ,secur+ id5tifiable1 s5sitive in=mation4 ,sec4 #cbc4 ,duties ( ! ,director4 ,sec4 #cbd4 ,protect+ ,am]ica's biom$ical rese>* ent]prise4 ,sec4 #cbe4 ,,gao ,/udy4 ,sec4 #cbf4 ,report on progress to address undue =eign influ5ce4 ,,title ,,iv--,mod]niz+ & /r5g!n+ ! supply *a9 = vital m$ical products ,sec4 #dja4 ,w>m base manufactur+ capacity = m$ical c\nt]measures4 ,sec4 #djb4 ,supply *a9 consid]ations = ! ,/rategic ,national ,/ockpile4 ,sec4 #djc4 ,/rategic ,national ,/ockpile equipm5t ma9t5ance4 ,sec4 #djd4 ,improv+ transp>5cy & pr$ictability ( processes ( ! ,/rategic ,national ,/ockpile4 ,sec4 #dje4 ,improv+ supply *a9 flexibility = ! ,/rategic ,national ,/ockpile4 ,sec4 #djf4 ,reimbursem5t = c]ta9 supplies4 ,sec4 #djg4 ,action report+ on /ockpile depletion4 ,sec4 #djh4 ,provision ( m$ical c\nt]measures to ,indian programs & facilities4 ,sec4 #dji4 ,grants = ,/ate /rategic /ockpiles4 ,,title ,v--,enhanc+ developm5t & combat+ %ortages ( m$ical products ,subtitle ,a--,developm5t & review ,sec4 #eja4 ,advanc+ qualifi$ infecti\s disease product innovation4 ,sec4 #ejb4 ,mod]niz+ cl9ical trials4 ,sec4 #ejc4 ,accel]at+ c\nt]measure developm5t & review4 ,sec4 #ejd4 ,?ird p>ty te/ evaluation dur+ em]g5cies4 ,sec4 #eje4 ,facilitat+ ! use ( real _w evid5ce4 ,sec4 #ejf4 ,plat=m te*nologies4 ,sec4 #ejg4 ,increas+ ,,eua decision transp>5cy4 ,sec4 #ejh4 ,improv+ ,,fda guidance & communication4 ,sec4 #eji4 ,,gao /udy & report on hir+ *all5ges at ,,fda4 ,subtitle ,b--,mitigat+ %ortages ,sec4 #eaa4 ,ensur+ regi/ration ( =eign drug & device manufactur]s4 ,sec4 #eab4 ,ext5d+ expiration dates = c]ta9 drugs4 ,sec4 #eac4 ,unann\nc$ =eign facility inspections pilot program4 ,sec4 #ead4 ,combat+ c\nt]feit devices4 ,sec4 #eae4 ,/r5g!n+ m$ical device supply *a9s4 ,sec4 #eaf4 ,prev5t+ m$ical device %ortages4 ,sec4 #eag4 ,remote records assessm5ts = m$ical devices4 ,sec4 #eah4 ,advanc$ manufactur+ te*nologies designation pilot program4 ,sec4 #eai4 ,te*nical corrections4 ,i ,/r5g!n+ ,f$]al & ,/ate prep>$ness ,a ,f$]al lead]%ip & acc\ntability #aja4 ,compreh5sive review ( ! ,,covid-#ai response 7a7 ,e/abli%m5t ( task =ce ,!re is e/abli%$ 9 ! legislative bran* a task =ce to be kn[n z ! ,national ,task ,=ce on ! ,response ( ! ,unit$ ,/ates to ! ,,covid-#ai ,p&emic 7ref]r$ to 9 ?is section z ! ,task ,=ce74 7b7 ,purposes ,! purposes ( ! ,task ,=ce are to-- 7#a7 exam9e1 assess1 & report ^u ! ,unit$ ,/ates' prep>$ness =1 & response to1 ! ,,covid-#ai p&emic1 includ+-- 7,a7 ! initial ,f$]al1 ,/ate1 local1 & t]ritorial responses 9 ! ,unit$ ,/ates2 7,b7 ! ongo+ ,f$]al1 ,/ate1 local1 & t]ritorial responses 9 ! ,unit$ ,/ates1 includ+ ! activities1 policies1 & decisions ( ! ,trump ,adm9i/ration & ! ,bid5 ,adm9i/ration2 7,c7 ! impact ( ! p&emic on public heal? & heal? c>e sy/ems2 & 7,d7 ! initial outbreak 9 ,wuhan1 ,*9a1 includ+ ef=ts to det]m9e ! pot5tial causes = ! em]g5ce ( ! ,,s>s-,co,v-#b virus1 & ,f$]al actions to mitigate its spread int]nationally2 7#b7 build ^u exi/+ or ongo+ evaluations & avoid unnecess>y duplication1 by review+ ! f9d+s1 conclusions1 & recomm5dations ( o!r appropriate task =ces1 committees1 commissions1 or entities e/abli%$ by o!r public or nonpr(it private entities relat$ to ! ,unit$ ,/ates' prep>$ness =1 & response to1 ! ,,covid-#ai p&emic2 7#c7 id5tify gaps 9 public heal? prep>$ness & m$ical response policies1 processes1 & activities1 includ+ disp>ities 9 ,,covid-#ai infection & mortality rates among p ( color1 old] adults1 p ) disabilities1 & o!r vuln]able or at-risk gr\ps1 & h[ su* gaps impact$ ! ability ( ! ,unit$ ,/ates to respond to ! ,,covid-#ai p&emic2 & 7#d7 submit a report to ! ,presid5t & to ,congress on its f9d+s1 conclusions1 & recomm5dations to improve ! ,unit$ ,/ates prep>$ness =1 & response to1 future public heal? em]g5cies1 includ+ a public heal? em]g5cy result+ f an em]g+ infecti\s disease4 7c7 ,composition ( ,task ,=ce2 meet+s 7#a7 ,memb]s ,! ,task ,=ce %all be compos$ ( #ab memb]s1 ( :om-- 7,a7 #a memb] %all be appo9t$ by ! majority lead] ( ! ,s5ate2 7,b7 #a memb] %all be appo9t$ by ! m9ority lead] ( ! ,s5ate2 7,c7 #b memb]s %all be appo9t$ by ! *air ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7,d7 #b memb]s %all be appo9t$ by ! rank+ memb] ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7,e7 #a memb] %all be appo9t$ by ! ,speak] ( ! ,h\se ( ,repres5tatives2 7,f7 #a memb] %all be appo9t$ by ! m9ority lead] ( ! ,h\se ( ,repres5tatives2 7,g7 #b memb]s %all be appo9t$ by ! *air ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 & 7,h7 #b memb]s %all be appo9t$ by ! rank+ memb] ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 7#b7 ,*air & vice *air ,n lat] ?an #cj days aft] ! date on :i* all memb]s ( ! ,task ,=ce are appo9t$ "u p>agraph 7#a71 su* memb]s %all meet to elect a ,*air & ,vice ,*air f among su* memb]s4 ,! ,*air & ,vice ,*air %all ea* be elect$ to s]ve ^u an affirmative vote f #h memb]s ( ! ,task ,=ce4 ,! ,*air & ,vice ,*air %all n be regi/]$ memb]s ( ! same political p>ty4 7#c7 ,qualifications 7,a7 ,political p>ty affiliation ,n m ?an #f memb]s ( ! ,task ,=ce %all be regi/]$ memb]s ( ! same political p>ty4 7,b7 ,nongov]nm5tal appo9tees ,an individual appo9t$ to ! ,task ,=ce may n be an (fic] or employee ( ! ,f$]al ,gov]nm5t or any ,/ate1 local1 ,tribal1 or t]ritorial gov]nm5t4 7,c7 ,qualifications ,x is ! s5se ( ,congress t individuals appo9t$ to ! ,task ,=ce %\ld be highly qualifi$ citiz5s ( ! ,unit$ ,/ates4 ,memb]s appo9t$ "u p>agraph 7#a7 may include individuals ) exp]tise 9-- 7i7 public heal?1 heal? disp>ities & at-risk populations1 m$ic9e1 & relat$ fields2 7ii7 ,/ate1 local1 ,tribal1 or t]ritorial gov]nm5t1 includ+ public heal? & m$ical prep>$ness & response & em]g5cy managem5t & o!r relevant public adm9i/ration2 7iii7 rese>* reg>d+1 or ! developm5t1 manufactur+1 di/ribution1 & regulation (1 m$ical products2 7iv7 national security & =eign relations1 includ+ global heal?2 & 7v7 comm]ce1 includ+ transportation1 supply *a9s1 & small bus9ess4 7#d7 ,deadl9e = appo9tm5t ,all memb]s ( ! ,task ,=ce %all be appo9t$ n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act4 7#e7 ,meet+s ,! ,task ,=ce %all meet & beg9 ! op]ations ( ! ,task ,=ce z soon z practicable4 ,aft] its initial meet+1 ! ,task ,=ce %all meet ^u ! call ( ! ,*air & ,vice ,*air or #h ( its memb]s4 7#f7 ,quorum2 vacancies 7,a7 ,quorum ,eight memb]s ( ! ,task ,=ce %all con/itute a quorum4 7,b7 ,vacancies ,any vacancy 9 ! ,task ,=ce %all n affect its p[]s1 b %all be fill$ 9 ! same mann] 9 :i* ! orig9al appo9tm5t 0 made4 7d7 ,functions ( ,task ,=ce ,! functions ( ! ,task ,=ce are to-- 7#a7 conduct a review t-- 7,a7 exam9es ! initial outbreak ( ! ,,s>s-,co,v-#b virus 9 ,wuhan1 ,*9a1 includ+-- 7i7 engag+ ) will+ p>tn] gov]nm5ts & global exp]ts2 7ii7 seek+ access to relevant records2 & 7iii7 exam9+ ! pot5tial causes ( ! em]g5ce & s\rce ( ! virus2 7,b7 exam9es ! ,unit$ ,/ates prep>ation =1 & response to1 ! ,,covid-#ai p&emic1 includ+-- 7i7 relevant laws1 policies1 regulations1 & processes t 7 9 place prior to1 or put into place dur+1 ! public heal? em]g5cy decl>$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 ) respect to ,,covid-#ai1 includ+ any t are put into place relat$ to su* public heal? em]g5cy aft] ! date ( enactm5t ( ?is ,act & prior to ! issuance ( ! f9al report pursuant to subsection 7j77#b72 7ii7 relevant actions tak5 by1 & coord9ation betwe51 ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial gov]nm5ts1 nongov]nm5tal organizations1 & int]national organizations on prep>$ness & response ef=ts1 includ+ coord9ation betwe5 gov]nm5ts & o!r public & private entities1 dur+ !-- 7,i7 initial response 9 ! ,unit$ ,/ates2 7,,ii7 response dur+ ! ,trump ,adm9i/ration2 & 7,,iii7 ongo+ response dur+ ! ,bid5 ,adm9i/ration2 7iii7 communication ( public heal? & sci5tific in=mation relat$ to ! ,,covid-#ai p&emic1 includ+ processes = ! developm5t1 approval1 & dissem9ation ( ,f$]al public heal? & o!r relevant public heal? or sci5tific guidance2 7iv7 actions tak5 to support ! developm5t1 manufactur+1 & di/ribution ( m$ical c\nt]measures & relat$ m$ical supplies to prev5t1 detect1 & treat ,,covid-#ai2 & 7,c7 may include assessm5ts relat+ to-- 7i7 ! capacity & capabilities ( ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial gov]nm5ts to respond to ! ,,covid-#ai p&emic2 7ii7 ! capacity & capabilities ( heal? c>e facilities & ! heal? c>e work=ce to respond to ! ,,covid-#ai p&emic2 7iii7 m$ical c\nt]measure rese>* & developm5t & ! supply *a9s ( m$ical products necess>y to respond to ! ,,covid-#ai p&emic2 7iv7 int]national prep>$ness = & response to ,,covid-#ai1 & ,f$]al decision-mak+ processes relat$ to new global heal? ?reats2 7v7 conta9m5t & mitigation measures relat$ to dome/ic & int]national travel 9 response to ,,covid-#ai2 & 7vi7 ! impact ( ! ,,covid-#ai p&emic & relat$ mitigation ef=ts on h>d-to-rea* & at-risk or und]s]v$ populations1 includ+ relat$ heal? disp>ities2 7#b7 id5tify1 review1 & evaluate ! lessons le>n$ f ! ,,covid-#ai p&emic1 includ+ activities to prep>e =1 & respond to1 future pot5tial p&emics & relat$ public heal? em]g5cies2 & 7#c7 submit to ! ,presid5t & ,congress su* reports z are requir$ by ?is ,act conta9+ su* f9d+s1 conclusions1 & recomm5dations z ! ,task ,=ce %all det]m9e4 7e7 ,p[]s ( ,task ,=ce 7#a7 ,he>+s ,! ,task ,=ce may-- 7,a7 hold su* he>+s & sit & act at su* times & places1 take su* te/imony1 receive su* evid5ce z det]m9$ by ! ,*air & ,vice ,*air1 & adm9i/] su* oa?s z ! ,task ,=ce or a designat$ memb]1 z det]m9$ by ! ,*air or ,vice ,*air1 may det]m9e advisable to be necess>y to c>ry out ! functions ( ! ,task ,=ce2 & 7,b7 subject to p>agraph 7#b77;,a71 require1 by subpo5a or o!rwise1 ! att5dance & te/imony ( su* witnesses & ! production ( su* books1 records1 correspond5ce1 memor&a1 pap]s1 & docum5ts1 z ! p]son describ$ 9 p>agraph 7#b77;,a77i7 may det]m9e advisable4 7#b7 ,subpo5as 7,a7 ,issuance 7i7 ,9 g5]al ,a subpo5a may be issu$ "u ?is subsection only-- 7,i7 by ! agreem5t ( ! ,*air & ! ,vice ,*air2 or 7,,ii7 by ! affirmative vote ( #i memb]s ( ! ,task ,=ce4 7ii7 ,signature ,subpo5as issu$ "u ?is subsection may be issu$ "u ! signature ( ! ,*air or any memb] designat$ by a majority ( ! ,task ,=ce1 & may be s]v$ by any p]son designat$ by ! ,*air or by a memb] designat$ by agreem5t ( ! majority ( ! ,task ,=ce4 7,b7 ,en=cem5t ,9 ! case ( contumacy or failure to obey a subpo5a issu$ "u subsection1 ! ,unit$ ,/ates di/rict c\rt = ! judicial di/rict 9 :i* ! subpo5a$ p]son resides1 is s]v$1 or may be f\nd1 or :]e ! subpo5a is returnable1 may issue an ord] requir+ su* p]son to appe> at any designat$ place to te/ify or to produce docum5t>y or o!r evid5ce4 ,any failure to obey ! ord] ( ! c\rt may be puni%$ by ! c\rt z a contempt ( t c\rt4 7#c7 ,contract+ ,! ,task ,=ce may1 to su* ext5t & 9 su* am\nts z are provid$ 9 appropriation ,acts1 ent] into contracts to enable ! ,task ,=ce to dis*>ge its duties "u ?is ,act4 7#d7 ,in=mation f f$]al ag5cies 7,a7 ,9 g5]al ,! ,task ,=ce may access f any executive dep>tm5t1 bureau1 ag5cy1 bo>d1 commission1 (fice1 indep5d5t e/abli%m5t1 or in/rum5tality ( ! ,f$]al ,gov]nm5t1 su* in=mation1 docum5ts1 sugge/ions1 e/imates1 & /ati/ics z ! ,task ,=ce consid]s necess>y to c>ry out ?is section4 7,b7 ,provision ( in=mation ,on writt5 reque/ ( ! ,*air1 ea* dep>tm5t1 bureau1 ag5cy1 bo>d1 commission1 (fice1 indep5d5t e/abli%m5t1 or in/rum5tality %all1 to ! ext5t au?oriz$ by law1 provide su* in=mation to ! ,task ,=ce4 7,c7 ,receipt1 h&l+1 /orage1 & dissem9ation ,in=mation %all only be receiv$1 h&l$1 /or$1 & dissem9at$ by memb]s ( ! ,task ,=ce & its /aff consi/5t ) all applicable /atutes1 regulations1 & executive ord]s4 7#e7 ,assi/ance f ,f$]al ag5cies 7,a7 ,g5]al s]vices adm9i/ration ,on reque/ ( ! ,*air & ,vice ,*air1 ! ,adm9i/rator ( ,g5]al ,s]vices ,adm9i/ration %all provide to ! ,task ,=ce1 on a reimbursable basis1 adm9i/rative support & o!r assi/ance necess>y = ! ,task ,=ce to c>ry out its duties4 7,b7 ,o!r dep>tm5ts & ag5cies ,9 addition to ! assi/ance provid$ = 9 subp>agraph 7,a71 dep>tm5ts & ag5cies ( ! ,unit$ ,/ates may provide to ! ,task ,=ce su* assi/ance z su* dep>tm5ts & ag5cies may det]m9e advisable & z au?oriz$ by law4 7#f7 ,donations ,! ,task ,=ce may accept1 use1 & dispose ( gifts or donations ( s]vices or prop]ty4 ,n lat] ?an #e days aft] ! acceptance ( a donation "u ?is subsection1 ! ,task ,=ce %all publicly disclose-- 7,a7 ! "n ( ! entity t provid$ su* donation2 7,b7 ! s]vice or prop]ty provid$ ?r\gh su* donation2 7,c7 ! value ( su* donation2 & 7,d7 h[ ! ,task ,=ce plans to use su* donation4 7#g7 ,po/al s]vices ,! ,task ,=ce may use ! ,unit$ ,/ates mails 9 ! same mann] & "u ! same conditions z a dep>tm5t or ag5cy ( ! ,unit$ ,/ates4 7f7 ,applicability ( ,f$]al ,advisory ,committee ,act 7#a7 ,9 g5]al ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 %all apply to ! ,task ,=ce4 7#b7 ,public meet+s & release ( public v]sions ( reports ,! ,task ,=ce %all-- 7,a7 hold public he>+s & meet+s to ! ext5t appropriate2 & 7,b7 release public v]sions ( ! reports requir$ "u p>agraph 7#a7 & 7#b7 ( subsection 7j74 7#c7 ,public he>+s ,any public he>+s ( ! ,task ,=ce %all be conduct$ 9 a mann] consi/5t ) ! protection ( in=mation provid$ to or develop$ = or by ! ,task ,=ce z requir$ by any applicable /atute1 regulation1 or ,executive ord]4 7g7 ,/aff ( ,task ,=ce 7#a7 ,9 g5]al 7,a7 ,appo9tm5t & comp5sation ,! ,*air ( ! ,task ,=ce1 9 agreem5t ) ! ,vice ,*air1 9 accordance ) rules agre$ ^u by ! ,task ,=ce1 may appo9t & fix ! comp5sation ( a /aff director & su* o!r p]sonnel z may be necess>y to enable ! ,task ,=ce to c>ry out its functions1 )\t reg>d to ! provisions ( title #e1 ,unit$ ,/ates ,code1 gov]n+ appo9tm5ts 9 ! competitive s]vice1 & )\t reg>d to ! provisions ( *apt] #ea & sub*apt] ,,iii ( *apt] #ec ( su* title relat+ to classification & ,g5]al ,s*$ule pay rates1 except t no rate ( pay fix$ "u ?is subsection may exce$ ! equival5t ( t payable = a position at level ,v ( ! ,executive ,s*$ule "u section #ecaf ( title #e1 ,unit$ ,/ates ,code4 7,b7 ,p]sonnel z ,f$]al employees 7i7 ,9 g5]al ,! /aff director & any p]sonnel ( ! ,task ,=ce :o are employees %all be employees "u section #baje ( title #e1 ,unit$ ,/ates ,code1 = purposes ( *apt]s #fc1 #ha1 #hc1 #hd1 #he1 #hg1 #hi1 & #ij ( t title4 7ii7 ,memb]s ( task =ce ,clause 7i7 %all n be con/ru$ to apply to memb]s ( ! ,task ,=ce4 7#b7 ,detailees ,^u reque/ ( ! ,*air & ,vice ,*air ( ! ,task ,=ce1 ! head ( any executive dep>tm5t1 bureau1 ag5cy1 bo>d1 commission1 (fice1 indep5d5t e/abli%m5t1 or in/rum5tality ( ! ,f$]al ,gov]nm5t employee may detail1 )\t reimbursem5t1 any ( its p]sonnel to ! ,task ,=ce to assi/ 9 c>ry+ out its duties "u ?is section4 ,any su* detailee %all be )\t int]ruption or loss ( civil s]vice /atus or privilege4 7#c7 ,consultant s]vices ,! ,task ,=ce is au?oriz$ to procure ! s]vices ( exp]ts & consultants 9 accordance ) section #caji ( title #e1 ,unit$ ,/ates ,code1 b at rates n to exce$ ! daily rate paid a p]son occupy+ a position at level ,,iv ( ! ,executive ,s*$ule "u section #ecae ( title #e1 ,unit$ ,/ates ,code4 7h7 ,comp5sation & travel exp5ses ,ea* memb] ( ! ,task ,=ce %all s]ve )\t comp5sation1 b %all receive travel exp5ses1 includ+ p] diem 9 lieu ( subsi/5ce1 at rates au?oriz$ = an employee ( an ag5cy "u sub*apt] ,i ( *apt] #eg ( title #e1 ,unit$ ,/ates ,code4 7i7 ,security cle>ances = task =ce memb]s & /aff ,! appropriate ,f$]al ag5cies or dep>tm5ts %all coop]ate ) ! ,task ,=ce 9 exp$iti\sly provid+ to ! ,task ,=ce memb]s & /aff appropriate security cle>ances1 consi/5t ) exi/+ proc$ures & requirem5ts4 ,no p]son %all be provid$ ) access to classifi$ in=mation "u ?is section )\t ! appropriate security cle>ances4 7j7 ,reports ( ,task ,=ce2 t]m9ation 7#a7 ,int]im report ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,task ,=ce %all submit to ! ,presid5t1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives an int]im report conta9+ su* f9d+s1 conclusions1 & recomm5dations z h be5 agre$ to by #h memb]s ( ! ,task ,=ce4 ,su* int]im report %all be made available onl9e 9 a mann] t does n compromise national security4 7#b7 ,f9al ,report 7,a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date on :i* ! la/ memb] ( ! ,task ,=ce is appo9t$1 ! ,task ,=ce %all submit to ! ,presid5t1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a f9al report conta9+ su* f9d+s1 conclusions1 & recomm5dations z h be5 agre$ to by #h memb]s ( ! ,task ,=ce4 ,! f9al report %all be made available onl9e 9 a mann] t does n compromise national security4 7,b7 ,ext5sions 7i7 ,9 g5]al ,! submission & publication ( ! f9al report1 z describ$ 9 subp>agraph 7,a71 may be delay$ by #f mon?s ^u ! agreem5t ( #h memb]s ( ! ,task ,=ce4 7ii7 ,notification ,! ,task ,=ce %all notify ! ,presid5t1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & ! public ( any ext5sion grant$ "u clause 7i74 7,c7 ,special rules & consid]ations 7i7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ z au?oriz+ ! ,task ,=ce to publicly disclose in=mation o!rwise prohibit$ f disclosure by law4 7ii7 ,special tim+ consid]ations ,not)/&+ any o!r provision ( ?is section1 ! ,task ,=ce %all n publi% or make available any int]im or f9al report dur+ ! dur+ ! #fj-;day p]iods end+ ,novemb] #h1 #bjbb1 & ,novemb] #e1 #bjbd4 7#c7 ,t]m9ation 7,a7 ,9 g5]al ,! ,task ,=ce1 & all ! au?orities ( ?is section1 %all t]m9ate #fj days aft] ! date on :i* ! f9al report is submitt$ "u p>agraph 7#b74 7,b7 ,adm9i/rative activities be=e t]m9ation ,! ,task ,=ce may use ! #fj-;day p]iod ref]r$ to 9 subp>agraph 7,a7 = ! purpose ( conclud+ its activities1 includ+ provid+ te/imony to committees ( ,congress conc]n+ its reports & dissem9at+ ! f9al report4 7k7 ,fund+ 7#a7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section1 a total ( #c1jjj1jjj = fiscal ye>s #bjbc & #bjbd4 7#b7 ,duration ( availability ,am\nts made available to ! ,task ,=ce "u p>agraph 7#a7 %all rema9 available until ! t]m9ation ( ! ,task ,=ce4 #ajb4 ,appo9tm5t & au?ority ( ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion 7a7 ,9 g5]al ,"p ,a ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by ins]t+ aft] section #cjd ! foll[+3 #cje4 ,appo9tm5t & au?ority ( ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion 7a7 ,9 g5]al ,! ,c5t]s = ,disease ,control & ,prev5tion 7ref]r$ to 9 ?is section z ! ,,cdc7 %all be head$ by ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion 7ref]r$ to 9 ?is section z ! ,director71 :o %all be appo9t$ by ! ,presid5t1 by & ) ! advice & cons5t ( ! ,s5ate4 ,su* individual %all also s]ve z ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry consi/5t ) section #ajd7;i7 ( ! ,compreh5sive ,environm5tal ,response1 ,comp5sation1 & ,liability ,act4 ,! ,director %all p]=m functions provid$ = 9 subsection 7b7 & su* o!r functions z ! ,secret>y may prescribe4 7b7 ,functions ,! ,secret>y1 act+ ?r\gh ! ,director1 %all-- 7#a7 implem5t & ex]cise applicable au?orities & responsibilities provid$ = 9 ?is ,act or o!r applicable law relat$ to ! inve/igation1 detection1 id5tification1 prev5tion1 or control ( diseases or conditions to pres]ve & improve public heal? dome/ically & globally & address injuries & occupational & environm5tal haz>ds1 z appropriate2 7#b7 be responsible = ! ov]all direction ( ! ,,cdc & = ! e/abli%m5t & implem5tation ( policies relat$ to ! managem5t & op]ation ( programs & activities )9 ! ,,cdc2 7#c7 coord9ate & ov]see ! op]ation ( c5t]s1 in/itutes1 & (fices )9 ! ,,cdc2 7#d7 support1 9 consultation ) ! heads ( su* c5t]s1 in/itutes1 & (fices1 program coord9ation across su* c5t]s1 in/itutes1 & (fices1 includ+ ?r\gh priority sett+ reviews & ! developm5t ( /rategic plans1 to r$uce unnecess>y duplication & enc\rage collaboration betwe5 programs2 7#e7 ov]see ! developm5t1 implem5tation1 & updat+ ( ! /rategic plan e/abli%$ pursuant to subsection 7c72 7#f7 ensure t appropriate /rategic plann+1 includ+ ! use ( p]=mance metrics1 is conduct$ by su* c5t]s1 in/itutes1 & (fices to facilitate & improve ,,cdc programs & activities2 7#g7 communicate1 includ+ ?r\gh conv5+ annual meet+s1 ) public & private entities reg>d+ relevant public heal? programs & activities1 &1 z applicable1 ! /rategic plan e/abli%$ pursuant to subsection 7c74 7c7 ,/rategic plan 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act1 & at lea/ e #d ye>s !reaft]1 ! ,director %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 ( ,repres5tatives1 & po/ on ! website ( ! ,,cdc1 a coord9at$ /rategy to provide /rategic direction & facilitate collaboration across ! c5t]s1 in/itutes1 & (fices )9 ! ,,cdc4 ,su* /rategy %all be kn[n z ! ,,cdc ,/rategic ,plan4 7#b7 ,requirem5ts ,! ,,cdc ,/rategic ,plan %all-- 7,a7 id5tify /rategic priorities & objectives relat$ to-- 7i7 prev5t+1 r$uc+1 & elim9at+ ! spread ( communicable & noncommunicable diseases or conditions1 & address+ injuries1 & occupational & environm5tal haz>ds2 7ii7 support+ ! ef=ts ( ,/ate1 local1 & ,tribal heal? dep>tm5ts to prev5t & r$uce ! preval5ce ( ! diseases or conditions "u clause 7i72 7iii7 conta9+1 mitigat+1 & end+ disease outbreaks2 7iv7 enhanc+ global & dome/ic public heal? capacity1 capabilities1 & prep>$ness1 includ+ public heal? data1 surveillance1 work=ce1 & laboratory capacity & safety2 & 7v7 o!r priorities1 z e/abli%$ by ! ,director2 7,b7 describe ! capacity & capabilities necess>y to a*ieve ! priorities & objectives "u subp>agraph 7,a71 & progress t[>ds a*iev+ su* capacity & capabilities1 z appropriate2 & 7,c7 include a description ( h[ ! ,,cdc ,/rategic ,plan incorporates-- 7i7 /rategic communications2 7ii7 p>tn]%ips ) private sector entities1 & ,/ate1 local1 & ,tribal heal? dep>tm5ts1 & o!r public sector entities1 z appropriate2 & 7iii7 coord9ation ) o!r ag5cies & (fices ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & o!r ,f$]al dep>tm5ts & ag5cies1 z appropriate4 7#c7 ,use ( plans ,/rategic plans develop$ & updat$ by ! c5t]s1 in/itutes1 & (fices ( ! ,,cdc %all be prep>$ regul>ly & 9 su* a mann] t su* plans w be in=m$ by ! ,,cdc ,/rategic ,plan develop$ & updat$ "u ?is subsection4 7d7 ,appe>ances be=e ,congress 7#a7 ,9 g5]al ,ea* fiscal ye>1 ! ,director %all appe> be=e ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives at he>+s on topics su* z-- 7,a7 support = ,/ate1 local1 & ,tribal public heal? prep>$ness & responses to any rec5t or ongo+ public heal? em]g5cy1 includ+-- 7i7 any objectives1 activities1 or initiatives t h be5 c>ri$ out1 or are plann$1 by ! ,director to prep>e =1 or respond to1 ! public heal? em]g5cy1 includ+ relevant /rategic communications or p>tn]%ips & any gaps or *all5ges id5tifi$ 9 su* objectives1 activities1 or initiatives2 7ii7 any objectives & plann$ activities = ! upcom+ fiscal ye> to address gaps 91 or o!rwise improve1 ,/ate1 local1 & ,tribal public heal? prep>$ness2 & 7iii7 o!r pot5tial all-haz>d ?reats t ! ,director is prep>+ to address2 7,b7 activities relat$ to public heal? & functions ( ! ,director describ$ 9 subsection 7b72 & 7,c7 updates on o!r relevant activities support$ or conduct$ by ! ,,cdc1 or 9 collaboration or coord9ation ) ! heads ( o!r ,f$]al dep>tm5ts1 ag5cies1 or /akehold]s1 z appropriate4 7#b7 ,cl>ifications 7,a7 ,waiv] au?ority ,! ,*air ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate or ! ,*air ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives may waive ! requirem5ts ( p>agraph 7#a7 = ! applicable fiscal ye> ) respect to ! applicable ,committee4 7,b7 ,scope ( requirem5ts ,! requirem5ts ( ?is subsection %all n be con/ru$ to impact ! appe>ance ( o!r ,f$]al (ficials or ! ,director at he>+s ( ei!r ,committee describ$ 9 p>agraph 7#a7 at o!r times & = purposes o!r ?an ! times & purposes describ$ 9 p>agraph 7#a74 7#c7 ,clos$ he>+s ,in=mation t is n appropriate = disclosure dur+ an op5 he>+ "u p>agraph 7#a7 9 ord] to protect national security may in/ead be discuss$ 9 a clos$ he>+ t imm$iately foll[s ! op5 he>+4 4 7b7 ,application ,! fir/ s5t5ce ( section #cje7;a7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all n apply to ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion :o is s]v+ on ! date ( enactm5t ( ?is ,act4 #ajc4 ,additional provisions relat$ to ! ,c5t]s = ,disease ,control & ,prev5tion ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by ins]t+ aft] section #cje1 z add$ by section #ajb1 ! foll[+3 #cje;,a4 ,additional provisions relat$ to ! ,c5t]s = ,disease ,control & ,prev5tion 7a7 ,appo9tm5ts 7#a7 ,9 g5]al ,unless o!rwise specifi$ 9 /atute1 ! heads ( ! c5t]s or in/itutes ( ! ,c5t]s = ,disease ,control & ,prev5tion %all be appo9t$ by ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion 7ref]r$ to 9 ?is section z ! ,director74 ,ea* su* individual %all be appo9t$ = #e ye>s4 7#b7 ,reappo9tm5ts ,at ! end ( a #e-ye> t]m1 an individual appo9t$ "u p>agraph 7#a7 %all be reappo9t$ 9 accordance ) /&>ds applicable to ! relevant appo9tm5t me*anism & z det]m9$ by ! ,secret>y1 z applicable4 7#c7 ,no limit on t]ms ,!re %all be no limit on ! numb] ( t]ms t any individual appo9t$ "u ?is subsection may s]ve4 7#d7 ,vacancies ,if ! position ( a head ( a c5t] or in/itute describ$ 9 p>agraph 7#a7 becomes vacant be=e ! end ( a t]m1 ! head ( su* c5t] or in/itute appo9t$ to fill ! vacancy %all be appo9t$ = a #e-ye> t]m />t+ on ! date ( su* appo9tm5t4 7#e7 ,curr5t positions & exemptions 7,a7 ,9 g5]al ,ea* su* individual :o is s]v+ on ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act %all be deem$ to be appo9t$ = a #e-ye> t]m "u ?is subsection beg9n+ on su* date ( enactm5t4 7,b7 ,exemptions ,! ,secret>y may exempt ! head ( a c5t] or in/itute f ! #e-ye> t]m describ$ 9 subp>agraph 7,a7 if su* ,secret>y det]m9es su* exemption is necess>y 9 ord] to hire or reta9 tal5t$ individuals4 7#f7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to limit ! au?ority ( ! ,secret>y or ! ,director to t]m9ate ! appo9tm5t ( a head ( a c5t] or in/itute describ$ 9 p>agraph 7#a7 be=e ! expiration ( su* individual's #e-ye> t]m4 7#g7 ,nature ( appo9tm5t ,appo9tm5ts & reappo9tm5ts "u ?is subsection %all be made on ! basis ( ability & exp]i5ce z x relates to ! mission ( ! ,c5t]s = ,disease ,control & ,prev5tion & its compon5ts1 includ+ compliance ) relevant legal requirem5ts4 7b7 ,o!r transactions 7#a7 ,9 g5]al ,9 c>ry+ out activities ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,director may ent] into transactions o!r ?an a contract1 grant1 or coop]ative agreem5t = purposes ( biosurveillance1 infecti\s disease model+1 & public heal? prep>$ness & response1 includ+ relat$ rese>*4 7#b7 ,writt5 det]m9ation ,) respect to a project t is expect$ to co/ ! ,c5t]s = ,disease ,control & ,prev5tion m ?an #e1jjj1jjj1 ! ,director may ex]cise ! au?ority "u p>agraph 7#a7 only ^u a writt5 det]m9ation by ! ,assi/ant ,secret>y = ,f9ancial ,res\rces ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 t ! use ( su* au?ority is ess5tial to promot+ ! success ( ! project4 ,! au?ority ( ! ,assi/ant ,secret>y = ,f9ancial ,res\rces "u ?is p>agraph may n be delegat$4 7#c7 ,guidel9es ,! ,director1 9 consultation ) ! ,secret>y1 %all e/abli% guidel9es reg>d+ ! use ( ! au?ority "u p>agraph 7#a74 ,su* guidel9es %all include audit+ requirem5ts4 4 #ajd4 ,public heal? & m$ical prep>$ness & response coord9ation 7a7 ,public ,heal? ,em]g5cy ,fund ,section #cai7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7b77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,e71 by /rik+ & at ! end2 7,b7 by r$esignat+ subp>agraph 7,f7 z subp>agraph 7,g72 & 7,c7 by ins]t+ aft] subp>agraph 7,e71 ! foll[+3 7,f7 support ! initial deploym5t & di/ribution ( cont5ts ( ! ,/rategic ,national ,/ockpile1 z appropriate2 & 2 & 7#b7 by am5d+ p>agraph 7#c77;,a7 to read z foll[s3 7,a7 ! exp5ditures made f ! ,public ,heal? ,em]g5cy ,fund 9 su* fiscal ye>1 includ+-- 7i7 ! am\nt obligat$2 7ii7 ! recipi5t or recipi5ts ( su* obligat$ funds2 7iii7 ! specific response activities su* obligat$ funds w support2 & 7iv7 ! decl>$ or pot5tial public heal? em]g5cy = :i* su* funds 7 obligat$2 & 4 7b7 ,improv+ public heal? & m$ical prep>$ness & response coord9ation 7#a7 ,coord9ation ) ,f$]al ag5cies ,section #bhja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh7 is am5d$ by add+ at ! end ! foll[+3 7c7 ,coord9ation ) ,f$]al ag5cies ,9 lead+ ! ,f$]al public heal? & m$ical response to a decl>$ or pot5tial public heal? em]g5cy1 consi/5t ) ?is section1 ! ,secret>y %all coord9ate )1 & may reque/ support f1 o!r ,f$]al dep>tm5ts & ag5cies1 z appropriate 9 ord] to c>ry out necess>y activities & lev]age ! exp]tise ( su* dep>tm5ts & ag5cies1 :i* may include ! provision ( assi/ance at ! direction ( ! ,secret>y relat$ to support+ ! public heal? & m$ical response = ,/ates1 localities1 & ,tribes4 4 7#b7 ,,aspr duties ,section #bhaa7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77 is am5d$-- 7,a7 9 p>agraph 7#a71 by ins]t+ &1 consi/5t ) ! ,national ,response ,framework & o!r applicable provisions ( law1 assi/ ! ,secret>y 9 c>ry+ out ! functions "u section #bhja be=e ! p]iod2 & 7,b7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,e7 by /rik+ ! actions necess>y to ov]come ^! ob/acles4 & ins]t+ 8recomm5d actions necess>y to ov]come ^! ob/acles1 su* z-- 7i7 improv+ coord9ation ) relevant ,f$]al (ficials2 7ii7 p>tn]+ ) o!r public or private entities to lev]age capabilities ma9ta9$ by su* entities1 z appropriate & consi/5t ) ?is subsection2 & 7iii7 coord9at+ ef=ts to support or e/abli% new capabilities1 z appropriate4 2 & 7ii7 9 subp>agraph 7,g7-- 7,i7 by r$esignat+ clauses 7i7 & 7ii7 z subclauses 7,i7 & 7,,ii7 & adju/+ ! m>g9s accord+ly2 7,,ii7 9 ! matt] prec$+ subclause 7,i71 z s r$esignat$-- 7aa7 by ins]t+ ea* ye>1 includ+ national-level & ,/ate-level full-scale ex]cises n less ?an once e #e ye>s aft] op]ational ex]cises2 & 7bb7 by /rik+ ex]cises bas$ on-- & ins]t+ 8ex]cises-- 7i7 bas$ on 2 7,,iii7 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7,,iv7 by add+ at ! end ! foll[+3 7ii7 t assess ! ability ( ! ,/rategic ,national ,/ockpile1 z appropriate1 to provide m$ical c\nt]measures1 m$ical products1 & o!r supplies1 includ+ ancill>y m$ical supplies1 to support ! response to a public heal? em]g5cy or pot5tial public heal? em]g5cy1 includ+ a ?reat t requires ! l>ge-scale & simultane\s deploym5t ( /ockpiles & a long-t]m public heal? & m$ical response2 & 7iii7 conduct$ 9 coord9ation ) ,/ate & local heal? (ficials4 4 7c7 ,appe>ances be=e & reports to ,congress ,section #bhaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7 is am5d$ by add+ at ! end ! foll[+3 7g7 ,appe>ances be=e ,congress 7#a7 ,9 g5]al ,ea* fiscal ye>1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all appe> be=e ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives at he>+s1 on topics su* z-- 7,a7 coord9ation ( ,f$]al activities to prep>e =1 & respond to1 public heal? em]g5cies2 7,b7 activities & capabilities ( ! ,/rategic ,national ,/ockpile1 includ+ :e!r1 & ! degree to :i*1 recomm5dations made pursuant to section #bhaa-a7;c77#a77;,a7 h be5 met2 7,c7 support = ,/ate1 local1 & ,tribal public heal? & m$ical prep>$ness2 7,d7 activities implem5t+ ! c\nt]measures budget plan describ$ "u subsection 7b77#g71 includ+-- 7i7 any *all5ges 9 meet+ ! full range ( id5tifi$ m$ical c\nt]measure ne$s2 & 7ii7 progress 9 support+ advanc$ rese>*1 developm5t1 & procurem5t ( m$ical c\nt]measures1 pursuant to subsection 7b77#c72 7,e7 ! /rategic direction (1 & activities relat$ to1 ! su/a9m5t ( manufactur+ surge capacity & capabilities = m$ical c\nt]measures pursuant to section #cai,l & ! di/ribution & deploym5t ( su* c\nt]measures2 7,f7 any additional objectives1 activities1 or initiatives t h be5 c>ri$ out or are plann$ by ! ,assi/ant ,secret>y = ,prep>$ness & ,response & associat$ *all5ges1 z appropriate2 7,g7 ! specific all-haz>ds ?reats t ! ,assi/ant ,secret>y = ,prep>$ness & ,response is prep>+ to address1 or t are be+ address$1 ?r\gh ! activities describ$ 9 subp>agraphs 7,a7 ?r\gh 7,f72 & 7,h7 objectives1 activities1 or initiatives relat$ to ! coord9ation & consultation requir$ "u subsections 7b77#d77;,h7 & 7b77#d77;,i71 9 a mann] consi/5t ) p>agraph 7#c71 z appropriate4 7#b7 ,cl>ifications 7,a7 ,waiv] au?ority ,! ,*air ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate or ! ,*air ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives may waive ! requirem5ts ( p>agraph 7#a7 = ! applicable fiscal ye> ) respect to ! applicable ,committee4 7,b7 ,scope ( requirem5ts ,! requirem5ts ( ?is subsection %all n be con/ru$ to impact ! appe>ance ( o!r ,f$]al (ficials or ! ,assi/ant ,secret>y at he>+s ( ei!r ,committee describ$ 9 p>agraph 7#a7 at o!r times & = purposes o!r ?an ! times & purposes describ$ 9 p>agraph 7#a74 7#c7 ,clos$ he>+s ,in=mation t is n appropriate = disclosure dur+ an op5 he>+ "u p>agraph 7#a7 9 ord] to protect national security may in/ead be discuss$ 9 a clos$ he>+ t imm$iately foll[s su* op5 he>+4 4 7d7 ,annual report on em]g5cy response & prep>$ness ,section #bhja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh71 z am5d$ by subsection 7b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7d7 ,annual report on em]g5cy response & prep>$ness ,! ,secret>y %all submit a writt5 report ea* fiscal ye> to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 conta9+-- 7#a7 updat$ in=mation relat$ to an assessm5t ( ! response to any public heal? em]g5cy decl>$1 or o!rwise 9 effect1 dur+ ! previ\s fiscal ye>2 7#b7 f9d+s relat$ to drills & op]ational ex]cises complet$ 9 ! previ\s fiscal ye> pursuant to section #bhaa7;b77#d77;,g72 7#c7 ! /ate ( public heal? prep>$ness & response capabilities = *emical1 biological1 radiological1 & nucle> ?reats1 includ+ em]g+ infecti\s diseases2 & 7#d7 any *all5ges 9 prep>+ = or respond+ to su* ?reats1 z appropriate4 4 7e7 ,,gao report on int]ag5cy agreem5ts & coord9ation ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7#a7 conduct a review ( previ\s & curr5t int]ag5cy agreem5ts e/abli%$ betwe5 ! ,secret>y ( ,heal? & ,human ,s]vices & ! heads ( o!r relevant ,f$]al dep>tm5ts or ag5cies pursuant to section #bhja7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh7b771 includ+-- 7,a7 ! specific roles & responsibilities ( ea* ,f$]al dep>tm5t or ag5cy t is a p>ty to any su* int]ag5cy agreem5t2 7,b7 ! mann] 9 :i* specific capabilities ( ea* su* ,f$]al dep>tm5t or ag5cy may be utiliz$ "u su* int]ag5cy agreem5ts2 7,c7 ! frequ5cy ) :i* su* int]ag5cy agreem5ts h be5 utiliz$2 7,d7 gaps1 if any1 9 int]ag5cy agreem5ts t prev5t ! ,secret>y f c>ry+ out ! goals "u section #bhjb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#a72 7,e7 b>ri]s1 if any1 to e/abli%+ or utiliz+ su* int]ag5cy agreem5ts2 & 7,f7 recomm5dations1 if any1 on ! ways 9 :i* su* int]ag5cy agreem5ts c be improv$ to address ! gaps & b>ri]s id5tifi$ "u subp>agraphs 7,d7 & 7,e72 7#b7 conduct a review ( ! implem5tation & utilization ( ! au?orities describ$ "u section #bhja7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh7c772 & 7#c7 submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! reviews "u p>agraphs 7#a7 & 7#b71 includ+ relat$ recomm5dations1 z applicable4 #aje4 ,/r5g!n+ public heal? communication ,subsection 7b7 ( section #cai;,f ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f7 is am5d$ to read z foll[s3 7b7 ,public heal? in=mation & communications advisory committee 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% an advisory committee to be kn[n z ! ,public ,heal? ,in=mation & ,communications ,advisory ,committee 7ref]r$ to 9 ?is subsection z ! ,advisory ,committee74 7#b7 ,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]g5cies1 includ+-- 7i7 ! role & impact ( mis9=mation on ! response to su* public heal? em]g5cies2 7ii7 ! role ( risk communication be=e & dur+ su* public heal? em]g5cies2 & 7iii7 o!r relevant factors1 z ! ,secret>y det]m9es appropriate2 7,b7 in=mation f academic in/itutions1 community-bas$ organizations1 & o!r nongov]nm5tal organizations 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 ! public1 to improve su* communication betwe5 ,f$]al1 ,/ate1 local1 & ,tribal heal? (ficials1 &1 z appropriate1 to address mis9=mation dur+ public heal? em]g5cies1 includ+ /rategies to-- 7i7 id5tify ! mo/ effective me?ods = ! dissem9ation ( in=mation dur+ a public heal? em]g5cy1 ) consid]ation ( ! ne$s ( at-risk populations2 7ii7 det]m9e be/ practices & communicate in=mation to populations t may be impact$ by su* mis9=mation2 & 7iii7 adapt approa*es = ! dissem9ation ( in=mation1 z appropriate1 to address em]g+ tr5ds relat$ to mis9=mation4 7#c7 ,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 ) exp]tise 9 public heal? 7includ+ individuals ) exp]i5ce 9 ,/ate1 local1 & ,tribal heal? dep>tm5ts71 m$ic9e1 communications1 relat$ te*nology1 psy*ology1 m5tal heal? & sub/ance use disord]s1 national security1 & o!r areas1 z ! ,secret>y det]m9es appropriate1 :o %all s]ve z vot+ memb]s4 7#d7 ,dissem9ation ,! ,secret>y %all review ! recomm5dations ( ! ,advisory ,committee &1 n lat] ?an #ahj days aft] receipt ( ! report "u p>agraph 7#b71 %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 ! communication & dissem9ation ( sci5tific & evid5ce-bas$ public heal? in=mation1 includ+ address+ mis9=mation1 z appropriate4 7#e7 ,t]m9ation ,! ,advisory ,committee %all t]m9ate #d ye>s aft] ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act4 4 #ajf4 ,(fice ( ,p&emic ,prep>$ness & ,response ,policy 7a7 ,9 g5]al ,!re is e/abli%$ 9 ! ,executive ,(fice ( ! ,presid5t an ,(fice ( ,p&emic ,prep>$ness & ,response ,policy 7ref]r$ to 9 ?is section z ! ,(fice71 :i* %all be head$ by a ,director 7ref]r$ to 9 ?is section z ! ,director7 appo9t$ by ! ,presid5t & :o %all be comp5sat$ at ! rate provid$ = level ,,ii ( ! ,executive ,s*$ule 9 section #ecac ( title #e1 ,unit$ ,/ates ,code4 ,! ,presid5t is au?oriz$ to appo9t n m ?an #b ,associate ,directors1 :o %all be comp5sat$ at a rate n to exce$ t provid$ = level ,,iii ( ! ,executive ,s*$ule 9 section #ecad ( su* title4 ,associate ,directors %all p]=m su* functions z ! ,director may prescribe4 7b7 ,functions ( ! ,director ,! prim>y function ( ! ,director is to provide advice1 )9 ! ,executive ,(fice ( ! ,presid5t1 on p&emic prep>$ness & response policy1 & support /rategic coord9ation & communication ) respect to relevant activities across ! ,f$]al ,gov]nm5t4 ,9 addition to su* o!r functions & activities z ! ,presid5t may assign1 ! ,director1 consi/5t ) applicable laws & ! ,national ,response ,framework1 %all-- 7#a7 s]ve z ! pr9cipal advisor to ! ,presid5t on all matt]s relat$ to p&emic prep>$ness & response policy & make recomm5dations to ! ,presid5t reg>d+ p&emic & o!r biological ?reats t may impact national security2 7#b7 coord9ate ,f$]al activities to prep>e =1 & respond to1 p&emic & o!r biological ?reats1 by-- 7,a7 provid+ /rategic direction to ! heads ( applicable ,f$]al dep>tm5ts1 ag5cies1 & (fices1 includ+-- 7i7 ! e/abli%m5t1 implem5tation1 prioritization1 & assessm5t ( policy goals & objectives across ! ,executive ,(fice ( ! ,presid5t & su* dep>tm5ts1 ag5cies1 & (fices2 7ii7 support+ ! assessm5t & cl>ification ( roles & responsibilities relat$ to su* ,f$]al activities2 & 7iii7 support+ ! developm5t & implem5tation ( metrics & p]=mance measures to evaluate ! ext5t to :i* applicable activities meet su* goals & objectives2 7,b7 provid+1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! heads ( o!r relevant ,f$]al dep>tm5ts1 ag5cies1 & (fices1 lead]%ip ) respect to ! ,national ,biodef5se ,/rategy & relat$ activities pursuant to section #ajhf ( ! ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjag 7#f ,u4,s4,c4 #ajd7 & section #cfc ( ! ,william ,m4 7,mac7 ,?ornb]ry ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjba 7#f ,u4,s4,c4 #aje72 7,c7 facilitat+ coord9ation & communication betwe5 su* ,f$]al dep>tm5ts1 ag5cies1 & (fices to improve prep>$ness =1 & response to1 su* ?reats2 7,d7 ensur+ t ! au?orities1 capabilities1 & exp]tise ( ea* su* dep>tm5t1 ag5cy1 & (fice are appropriately lev]ag$ to facilitate ! :ole-(-,gov]nm5t response to su* ?reats2 7,e7 ov]see+ coord9ation ( ,f$]al ef=ts to prep>e = & support ! production1 supply1 & di/ribution ( relevant m$ical products & supplies dur+ a response to a p&emic or o!r biological ?reat1 z applicable & appropriate1 includ+ support+ ,f$]al ef=ts to assess any relevant vuln]abilities 9 ! supply *a9 ( su* products & supplies2 7,f7 ov]see+ coord9ation ( ,f$]al ef=ts = ! basic & advanc$ rese>*1 developm5t1 manufacture1 & procurem5t ( m$ical c\nt]measures1 includ+ by-- 7i7 s]v+1 ) ! ,secret>y ( ,heal? & ,human ,s]vices1 z co-,*air ( ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise e/abli%$ pursuant to section #bhaa-a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;a72 & 7ii7 promot+ coord9ation betwe5 ! m$ical c\nt]measure rese>*1 developm5t1 & procurem5t activities ( respective ,f$]al dep>tm5ts & ag5cies1 includ+ to advance ! discov]y & developm5t ( new m$ical products & te*nologies2 7,g7 conv5+ heads ( ,f$]al dep>tm5ts & ag5cies1 z appropriate1 on topics relat$ to capabilities to prep>e =1 & respond to1 su* ?reats2 7,h7 assess+ & advis+ on int]national coop]ation 9 prep>+ =1 & respond+ to1 su* ?reats to advance ! national security objectives ( ! ,unit$ ,/ates2 & 7,i7 ov]see+ o!r ,f$]al activities to assess prep>$ness =1 & responses to1 su* ?reats1 includ+-- 7i7 drills & op]ational ex]cises conduct$ pursuant to applicable provisions ( law2 & 7ii7 ,f$]al aft]-action reports develop$ foll[+ su* drills & ex]cises or a response to a p&emic or o!r biological ?reat2 7#c7 promote & support ! developm5t ( relevant exp]tise & capabilities )9 ! ,f$]al ,gov]nm5t to ensure t ! ,unit$ ,/ates c quickly detect1 id5tify1 & respond to su* ?reats1 & provide recomm5dations1 z appropriate1 to ! ,presid5t2 7#d7 consult ) ! ,director ( ! ,(fice ( ,managem5t & ,budget & o!r relevant (ficials )9 ! ,executive ,(fice ( ! ,presid5t1 includ+ ! ,assi/ant to ! ,presid5t = ,national ,security ,affairs & ! ,director ( ! ,(fice ( ,sci5ce & ,te*nology ,policy1 reg>d+ activities relat$ to prep>+ =1 & respond+ to1 su* ?reats & relevant rese>* & em]g+ te*nologies t may advance ! biosecurity & prep>$ness & response goals ( ! ,f$]al ,gov]nm5t2 7#e7 id5tify opportunities to lev]age curr5t & em]g+ te*nologies1 includ+ ?r\gh public-private p>tn]%ips1 z appropriate1 to address su* ?reats & advance ! prep>$ness & response goals ( ! ,f$]al ,gov]nm5t2 & 7#f7 ensure t f9d+s ( ,f$]al aft]-action reports conduct$ pursuant to p>agraph 7#b77;,i77ii7 are implem5t$ to ! maximum ext5t feasible )9 ! ,f$]al ,gov]nm5t4 7c7 ,support f o!r ag5cies ,ea* dep>tm5t1 ag5cy1 & in/rum5tality ( ! executive bran* ( ! ,f$]al ,gov]nm5t1 includ+ any indep5d5t ag5cy1 is au?oriz$ to support ! ,director by provid+ ! ,director su* in=mation z ! ,director det]m9es necess>y to c>ry out ! functions ( ! ,director "u ?is section4 7d7 ,prep>$ness outlook report 7#a7 ,9 g5]al ,)9 its fir/ ye> ( op]ation1 ! ,director1 9 consultation ) ! heads ( relevant ,f$]al dep>tm5ts & ag5cies & o!r (ficials )9 ! ,executive ,(fice ( ! ,presid5t1 %all ?r\gh a report submitt$ to ! ,presid5t & made available to ! public1 to ! ext5t practicable1 id5tify & describe situations & conditions :i* w>rant special att5tion )9 ! next #e ye>s1 involv+ curr5t & em]g+ problems ( national significance relat$ to p&emic or o!r biological ?reats1 & opportunities =1 & ! b>ri]s to1 ! rese>*1 developm5t1 & procurem5t ( m$ical c\nt]measures to adequately respond to su* ?reats4 7#b7 ,revisions ,! ,(fice %all revise ! report "u p>agraph 7#a7 n less ?an once e #e ye>s & "w ) relevant ,f$]al (ficials to address ! problems1 b>ri]s1 opportunities1 & actions id5tifi$ "u ?is report ?r\gh ! developm5t ( ! ,presid5t's ,budgets & programs4 7e7 ,int]dep>tm5tal work+ gr\p ,! ,director %all lead an int]dep>tm5tal work+ gr\p t w meet on a regul> basis to evaluate national biosecurity & p&emic prep>$ness issues & make recomm5dations to ! heads ( applicable ,f$]al dep>tm5ts1 ag5cies & (fices4 ,! work+ gr\p %all consi/ ( repres5tatives f-- 7#a7 ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy1 to s]ve z ! *air2 7#b7 ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7#c7 ! ,dep>tm5t ( ,homel& ,security2 7#d7 ! ,dep>tm5t ( ,def5se2 7#e7 ! ,(fice ( ,managem5t & ,budget2 & 7#f7 o!r ,f$]al ,dep>tm5ts & ag5cies4 7f7 ,additional functions ( ! director ,! ,director1 9 addition to ! o!r duties & functions set =? 9 ?is section-- 7#a7 %all-- 7,a7 s]ve z a memb] ( ! ,dome/ic ,policy ,c\ncil & ! ,national ,security ,c\ncil2 7,b7 s]ve z a memb] ( ! ,int]gov]nm5tal ,sci5ce1 ,eng9e]+1 & ,te*nology ,advisory ,panel "u section #bje7;b7 ( ! ,national ,sci5ce & ,te*nology ,policy1 ,organization1 & ,priorities ,act ( #aigf 7#db ,u4,s4,c4 #ffad7;b77 & ! ,f$]al ,coord9at+ ,c\ncil = ,sci5ce1 ,eng9e]+ & ,te*nology "u section #dja ( su* ,act 7#db ,u4,s4,c4 #ffea72 7,c7 consult ) ,/ate1 ,tribal1 local1 & t]ritorial gov]nm5ts1 indu/ry1 academia1 pr(essional societies1 & o!r /akehold]s1 z appropriate2 7,d7 use = adm9i/rative purposes1 on a reimbursable basis1 ! available s]vices1 equipm5t1 p]sonnel1 & facilities ( ,f$]al1 ,/ate1 & local ag5cies2 & 7,e7 at ! ,presid5t's reque/1 p]=m su* o!r duties & functions & ent] into contracts & o!r arrangem5ts = /udies1 analyses1 & relat$ s]vices ) public or private entities1 z applicable & appropriate2 & 7#b7 may hold su* he>+s 9 v>i\s p>ts ( ! ,unit$ ,/ates z necess>y to det]m9e ! views ( ! entities & individuals ref]r$ to 9 p>agraph 7#a7 & ( ! g5]al public1 conc]n+ national ne$s & tr5ds 9 p&emic prep>$ness & response4 7g7 ,/aff+ & detailees ,9 c>ry+ out functions "u ?is section1 ! ,director may-- 7#a7 appo9t n m ?an #be individuals to s]ve z employees ( ! ,(fice z necess>y to c>ry out ?is section2 7#b7 fix ! comp5sation ( su* p]sonnel at a rate to be det]m9$ by ! ,director1 up to ! am\nt ( annual comp5sation 7exclud+ exp5ses7 specifi$ 9 section #ajb ( title #c1 ,unit$ ,/ates ,code2 7#c7 utilize ! s]vices ( consultants1 :i* may include by obta9+ s]vices describ$ "u section #caji7;b7 ( title #e1 ,unit$ ,/ates ,code1 at rates n to exce$ ! rate ( basic pay = level ,,iv ( ! ,executive ,s*$ule2 & 7#d7 direct1 ) ! concurr5ce ( ! ,secret>y ( a dep>tm5t or head ( an ag5cy1 ! tempor>y reassignm5t )9 ! ,f$]al ,gov]nm5t ( p]sonnel employ$ by su* dep>tm5t or ag5cy1 9 ord] to c>ry out ! functions ( ! ,(fice4 7h7 ,prep>$ness review & report ,! ,director1 9 consultation ) ! heads ( applicable ,f$]al dep>tm5ts1 ag5cies1 & (fices1 %all-- 7#a7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 conduct a review ( applicable ,f$]al /rategies1 policies1 proc$ures1 & aft]-action reports to id5tify gaps & ineffici5cies relat$ to p&emic prep>$ness & response2 7#b7 n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 & e #b ye>s !reaft]1 submit to ! ,presid5t & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report describ+-- 7,a7 curr5t & em]g+ p&emic & o!r biological ?reats t pose a significant level ( risk to national security2 7,b7 ! roles & responsibilities ( ! ,f$]al ,gov]nm5t 9 prep>+ =1 & respond+ to1 su* ?reats2 7,c7 ! f9d+s ( ! review conduct$ "u p>agraph 7#a72 7,d7 any b>ri]s or limitations relat$ to address+ su* f9d+s2 7,e7 curr5t & plann$ activities to update ,f$]al /rategies1 policies1 & proc$ures to address su* f9d+s1 consi/5t ) applicable laws & ! ,national ,response ,framework2 7,f7 curr5t & plann$ activities to support ! developm5t ( exp]tise )9 ! ,f$]al ,gov]nm5t pursuant to subsection 7b77#c72 & 7,g7 opportunities to improve ,f$]al prep>$ness & response capacities & capabilities ?r\gh ! use ( curr5t & em]g+ te*nologies4 7i7 ,nonduplication ( ef=t ,! ,director %all ensure t activities c>ri$ out "u ?is section d n unnecess>ily duplicate ! ef=ts ( o!r ,f$]al dep>tm5ts1 ag5cies1 & (fices4 7j7 ,con=m+ am5dm5ts 7#a7 ,section #bhaa-a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;a7 is am5d$-- 7,a7 9 ! second s5t5ce ( subsection 7a71 by /rik+ %all s]ve z *air & ins]t+ & ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy %all s]ve z co-*airs2 & 7,b7 9 subsection 7b7-- 7i7 by r$esignat+ p>agraph 7#aj7 z p>agraph 7#aa72 & 7ii7 by ins]t+ aft] p>agraph 7#i7 ! foll[+3 7#aj7 ,! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy4 4 7#b7 ,section #aja7;c77#a7 ( ! ,national ,security ,act ( #aidg 7#ej ,u4,s4,c4 #cjba7;c77#a77 is am5d$ by ins]t+ ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy aft] ,treasury14 7#c7 ,! ,national ,sci5ce & ,te*nology ,policy1 ,organization1 & ,priorities ,act ( #aigf 7#db ,u4,s4,c4 #ffja et seq47 is am5d$-- 7,a7 9 section #bje7;b77#b7 7#db ,u4,s4,c4 #ffad7;b77#b77-- 7i7 by /rik+ & 7,c7 & ins]t+ 7,c72 & 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 & 7,d7 ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy42 & 7,b7 9 section #dja7;b7 7#db ,u4,s4,c4 #ffea7;b771 by ins]t+ 1 ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy1 aft] ,te*nology ,policy4 ,b ,/ate & local read9ess #aaa4 ,improv+ ,/ate & local public heal? security 7a7 ,9 g5]al ,section #cai;,c-#a7;b77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,a7-- 7,a7 9 clause 7vii71 by ins]t+ dur+ & be=e foll[+ a public heal? em]g5cy2 7,b7 by am5d+ clause 7viii7 to read z foll[s3 7viii7 a description ( h[ ! entity1 z applicable & appropriate1 w coord9ate ) ,/ate em]g5cy prep>$ness & response plans 9 public heal? em]g5cy prep>$ness1 includ+ ,/ate education ag5cies 7z def9$ 9 section #haja ( ! ,elem5t>y & ,second>y ,education ,act ( #aife71 ,/ate *ild c>e lead ag5cies 7designat$ "u section #feh;,d ( ! ,*ild ,c>e & ,developm5t ,block ,grant ,act ( #aiij71 & o!r relevant ,/ate ag5cies 2 7,c7 9 clause 7xi71 by /rik+ 2 & & ins]t+ a semicolon2 7,d7 by r$esignat+ clause 7xii7 z clause 7xiii72 & 7,e7 by ins]t+ aft] clause 7xi7 ! foll[+3 7xii7 a description ( h[ ! entity w provide te*nical assi/ance to improve public heal? prep>$ness & response1 z appropriate1 to ag5cies or o!r entities t op]ate facilities )9 ! entity's jurisdiction 9 :i* !re is an increas$ risk ( infecti\s disease outbreaks 9 ! ev5t ( a public heal? em]g5cy decl>$ "u section #cai1 su* z resid5tial c>e facilities1 gr\p homes1 & o!r simil> sett+s2 & 2 7#b7 by r$esignat+ subp>agraphs 7,d7 ?r\gh 7,h7 z subp>agraphs 7,e7 ?r\gh 7,i71 respectively2 & 7#c7 by ins]t+ aft] subp>agraph 7,c7 ! foll[+3 7,d7 an assurance t ! entity w require relevant /aff to complete relevant prep>$ness & response tra9+s1 includ+ tra9+s relat$ to effici5t & effective op]ation dur+ an incid5t or ev5t )9 an ,incid5t ,comm& ,sy/em2 4 7b7 ,applicability ,! am5dm5ts made by subsection 7a7 %all n apply ) respect to any coop]ative agreem5t ent]$ into prior to ! date ( enactm5t ( ?is ,act4 #aab4 ,support+ access to m5tal heal? & sub/ance use disord] s]vices dur+ public heal? em]g5cies 7a7 ,au?orities ,section #eja7;d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa7d77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#bd7 & 7#be7 z p>agraphs 7#be7 & 7#bf71 respectively2 & 7#b7 by ins]t+ aft] p>agraph 7#bc7 ! foll[+3 7#bd7 support ! cont9u$ access to1 or availability (1 m5tal heal? & sub/ance use disord] s]vices dur+1 or 9 response to1 a public heal? em]g5cy decl>$ "u section #cai1 includ+ 9 consultation )1 z appropriate1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response & ! heads ( o!r relevant ag5cies1 9 prep>+ =1 & respond+ to1 a public heal? em]g5cy2 4 7b7 ,/rategic plan ,section #eja7l77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa7l77#d77 is am5d$-- 7#a7 9 subp>agraph 7,e71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,f71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,g7 specify a /rategy to support ! cont9u$ access to1 or availability (1 m5tal heal? & sub/ance use disord] s]vices1 includ+ to at-risk individuals 7z def9$ 9 section #bhjb7;b77#d771 dur+1 or 9 response to1 public heal? em]g5cies decl>$ pursuant to section #cai4 4 7c7 ,bi5nial report conc]n+ activities & progress ,section #eja7m7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa7m77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#g7 z p>agraphs 7#e7 ?r\gh 7#h71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 a description ( ! ,adm9i/ration's activities to support ! cont9u$ provision ( m5tal heal? & sub/ance use disord] s]vices1 z applicable1 9 response to public heal? em]g5cies decl>$ pursuant to section #cai2 2 & 7#c7 9 p>agraph 7#e71 z s r$esignat$-- 7,a7 by r$esignat+ subp>agraphs 7,d7 & 7,e7 z subp>agraphs 7,e7 & 7,f71 respectively2 & 7,b7 by ins]t+ aft] subp>agraph 7,c7 ! foll[+3 7,d7 relevant prep>$ness & response activities2 4 7d7 ,advisory c\ncils ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use %all issue a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 reflect+ ! fe$back ( ! advisory c\ncils = ! ,c5t] = ,sub/ance ,abuse ,treatm5t1 ! ,c5t] = ,sub/ance ,abuse ,prev5tion1 & ! ,c5t] = ,m5tal ,heal? ,s]vices1 pursuant to section #ejb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa-#a71 ) recomm5dations to improve ! cont9u$ provision ( m5tal heal? & sub/ance use disord] s]vices dur+ a public heal? em]g5cy decl>$ "u section #cai ( su* ,act 7#db ,u4,s4,c4 #bdg;d71 & ! provision ( su* s]vices z "p ( ! public heal? & m$ical response to su* an em]g5cy1 consi/5t ) title ,,xxviii ( su* ,act 7#db ,u4,s4,c4 #cjj;hh et seq471 includ+ relat$ to ! capacity ( ! m5tal heal? & sub/ance use disord] work=ce & flexibilities provid$ to aw>dees ( m5tal heal? & sub/ance use disord] programs4 7e7 ,,gao report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on programs & activities ( ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration to support ! provision ( m5tal heal? & sub/ance use disord] s]vices & relat$ activities dur+ ! ,,covid-#ai p&emic1 includ+ ! provision ( su* s]vices z "p ( ! m$ical & public heal? response to su* p&emic4 ,su* report %all-- 7#a7 exam9e ! role play$ by ! advisory c\ncils describ$ 9 section #ejb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa-#a7 & ! ,national ,m5tal ,heal? & ,sub/ance ,use ,policy ,laboratory e/abli%$ "u section #eja;,a ( su* ,act 7#db ,u4,s4,c4 #bij;aa-#j7 9 provid+ te*nical assi/ance & recomm5dations to ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration to support ! response ( su* ag5cy to ! public heal? em]g5cy decl>$ "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 ) respect to ,,covid-#ai2 7#b7 describe ! mann] 9 :i* exi/+ aw>dees ( m5tal heal? & sub/ance use disord] programs provid$ & alt]$ deliv]y ( s]vices dur+ su* public heal? em]g5cy1 includ+ in=mation on ! populations s]v$ by su* aw>dees & any b>ri]s fac$ 9 deliv]+ s]vices2 & 7#c7 describe activities ( ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration to support ! response to su* public heal? em]g5cy1 includ+ ?r\gh te*nical assi/ance1 provision ( s]vices1 & any flexibilities provid$ to su* exi/+ aw>dees1 & any b>ri]s fac$ 9 implem5t+ su* activities4 #aac4 ,trauma c>e reau?orization 7a7 ,9 g5]al ,section #abja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#c7-- 7i7 by ins]t+ analyze1 aft] compile12 & 7ii7 by ins]t+ & m$ically und]s]v$ areas be=e ! semicolon2 7,b7 9 p>agraph 7#d71 by add+ & aft] ! semicolon2 7,c7 by /rik+ p>agraph 7#e72 & 7,d7 by r$esignat+ p>agraph 7#f7 z p>agraph 7#e72 7#b7 by r$esignat+ subsection 7b7 z subsection 7c72 & 7#c7 by ins]t+ aft] subsection 7a7 ! foll[+3 7b7 ,trauma c>e read9ess & coord9ation ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 %all support ! ef=ts ( ,/ates & consortia ( ,/ates to coord9ate & improve em]g5cy m$ical s]vices & trauma c>e dur+ a public heal? em]g5cy decl>$ by ! ,secret>y pursuant to section #cai 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 ,act4 ,su* support may include-- 7#a7 develop+1 issu+1 & updat+ guidance1 z appropriate1 to support ! coord9at$ m$ical triage & evacuation to appropriate m$ical in/itutions bas$ on pati5t m$ical ne$1 tak+ into acc\nt regionaliz$ sy/ems ( c>e2 7#b7 dissem9at+1 z appropriate1 in=mation on evid5ce-bas$ or evid5ce-in=m$ trauma c>e practices1 tak+ into consid]ation em]g5cy m$ical s]vices & trauma c>e sy/ems1 includ+ su* practices id5tifi$ ?r\gh activities conduct$ "u subsection 7a7 & :i* may include ! id5tification & dissem9ation ( p]=mance metrics1 z applicable & appropriate2 & 7#c7 o!r activities1 z appropriate1 to optimize a coord9at$ & flexible approa* to ! em]g5cy response & m$ical surge capacity ( hospitals1 o!r heal? c>e facilities1 critical c>e1 & em]g5cy m$ical sy/ems4 4 7b7 ,grants ,to improve trauma c>e 9 rural areas ,section #abjb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#c7 is am5d$-- 7#a7 by am5d+ ! section head+ to read z foll[s3 ,grants to improve trauma c>e 9 rural areas2 7#b7 by am5d+ subsections 7a7 & 7b7 to read z foll[s3 7a7 ,9 g5]al ,! ,secret>y %all aw>d grants to eligible entities = ! purpose ( c>ry+ out rese>* & demon/ration projects to support ! improvem5t ( em]g5cy m$ical s]vices & trauma c>e 9 rural areas ?r\gh ! developm5t ( innovative uses ( te*nology1 tra9+ & education1 transportation ( s]i\sly injur$ pati5ts = ! purposes ( receiv+ su* em]g5cy m$ical s]vices1 access to prehospital c>e1 evaluation ( protocols = ! purposes ( improvem5t ( outcomes & dissem9ation ( any relat$ be/ practices1 activities to facilitate cl9ical rese>*1 z applicable & appropriate1 & increas+ communication & coord9ation ) applicable ,/ate or ,tribal trauma sy/ems4 7b7 ,eligible entities 7#a7 ,9 g5]al ,to be eligible to receive a grant "u ?is section1 an entity %all be a public or private entity t provides trauma c>e 9 a rural area4 7#b7 ,priority ,9 aw>d+ grants "u ?is section1 ! ,secret>y %all give priority to eligible entities t w provide s]vices "u ! grant 9 any rural area id5tifi$ by a ,/ate "u section #abad7;d77#a74 2 & 7#c7 by add+ at ! end ! foll[+3 7d7 ,reports ,an entity t receives a grant "u ?is section %all submit to ! ,secret>y su* reports z ! ,secret>y may require to in=m adm9i/ration ( ! program "u ?is section4 4 7c7 ,pilot grants = trauma c5t]s ,section #abjd ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#f7 is am5d$-- 7#a7 by am5d+ ! section head+ to read z foll[s3 ,pilot grants = trauma c5t]s2 7#b7 9 subsection 7a7-- 7,a7 by /rik+ n few] ?an #d & ins]t+ #aj2 7,b7 by /rik+ t design1 implem5t1 & evaluate & ins]t+ to design1 implem5t1 & evaluate new or exi/+2 7,c7 by /rik+ em]g5cy c>e & ins]t+ em]g5cy m$ical2 & 7,d7 by ins]t+ 1 & improve access to trauma c>e )9 su* sy/ems be=e ! p]iod2 7#c7 9 subsection 7b77#a71 by /rik+ subp>agraphs 7,a7 & 7,b7 & ins]t+ ! foll[+3 7,a7 a ,/ate or consortia ( ,/ates2 7,b7 an ,indian ,tribe or ,tribal organization 7z def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act72 7,c7 a consortium ( level ,i1 ,,ii1 or ,,iii trauma c5t]s designat$ by applicable ,/ate or local ag5cies )9 an applicable ,/ate or region1 &1 z applicable1 o!r em]g5cy s]vices provid]s2 or 7,d7 a consortium or p>tn]%ip ( nonpr(it ,indian ,heal? ,s]vice1 ,indian ,tribal1 & urban ,indian trauma c5t]s4 2 7#d7 9 subsection 7c7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a7-- 7i7 by /rik+ t proposes a pilot project2 7ii7 by /rik+ an em]g5cy m$ical & trauma sy/em t-- & ins]t+ a new or exi/+ em]g5cy m$ical & trauma sy/em4 ,su* eligible entity %all use am\nts aw>d$ "u ?is subsection to c>ry out #b or m ( ! foll[+ activities32 7,b7 9 p>agraph 7#a7 -- 7i7 by /rik+ coord9ates & ins]t+ ,/r5g!n+ coord9ation & communication2 & 7ii7 by /rik+ an approa* to em]g5cy m$ical & trauma sy/em access ?r\gh\t ! region1 includ+ #i-a-a ,public ,safety ,answ]+ ,po9ts & em]g5cy m$ical dispat*2 & ins]t+ approa*es to improve situational aw>5ess & em]g5cy m$ical & trauma sy/em access1 includ+ di/ribution ( pati5ts dur+ a mass casualty incid5t1 ?r\gh\t ! region42 7,c7 9 p>agraph 7#b7-- 7i7 by /rik+ includes & ins]t+ ,provid+2 7ii7 by ins]t+ support pati5t movem5t to aft] region to2 & 7iii7 by /rik+ ! semicolon & ins]t+ a p]iod2 7,d7 9 p>agraph 7#c7-- 7i7 by /rik+ all[s = & ins]t+ ,improv+2 & 7ii7 by /rik+ 2 & & ins]t+ a p]iod2 7,e7 9 p>agraph 7#d71 by /rik+ includes a consi/5t & ins]t+ ,support+ a consi/5t2 & 7,f7 by add+ at ! end ! foll[+3 7#e7 ,e/abli%+1 implem5t+1 & dissem9at+1 or utiliz+ exi/+1 z applicable1 evid5ce-bas$ or evid5ce-in=m$ practices across facilities )9 su* em]g5cy m$ical & trauma sy/em to improve heal? outcomes1 includ+ su* practices relat$ to managem5t ( injuries1 & ! ability ( su* facilities to surge4 7#f7 ,conduct+ activities to facilitate cl9ical rese>*1 z applicable & appropriate4 2 7#e7 9 subsection 7d77#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ ! propos$ & ins]t+ ! applicable em]g5cy m$ical & trauma sy/em2 7ii7 9 clause 7i71 by ins]t+ or ,tribal entity aft] equival5t ,/ate (fice2 & 7iii7 9 clause 7vi71 by /rik+ 2 & & ins]t+ a semicolon2 7,b7 by r$esignat+ subp>agraph 7,b7 z subp>agraph 7,c72 & 7,c7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+3 7,b7 = eligible entities describ$ 9 subp>agraph 7,c7 or 7,d7 ( subsection 7b77#a71 a description (1 & evid5ce (1 coord9ation ) ! applicable ,/ate ,(fice ( ,em]g5cy ,m$ical ,s]vices 7or equival5t ,/ate ,(fice7 or applicable su* (fice = a ,tribe or ,tribal organization2 & 2 7#f7 9 subsection 7e7-- 7,a7 9 p>agraph 7#a71 by /rik+ #a = ea* #c & ins]t+ #a = ea* #e2 & 7,b7 by add+ at ! end ! foll[+3 7#c7 ,waiv] ,! ,secret>y may waive all or "p ( ! mat*+ requirem5t describ$ 9 p>agraph 7#a7 = any fiscal ye> = a ,/ate1 consortia ( ,/ates1 ,indian ,tribe or ,tribal organization1 or trauma c5t]1 if ! ,secret>y det]m9es t apply+ su* mat*+ requirem5t w\ld result 9 s]i\s h>d%ip or an inability to c>ry out ! purposes ( ! pilot program4 2 7#g7 9 subsection 7f71 by /rik+ population 9 a m$ically und]s]v$ area & ins]t+ m$ically und]s]v$ population2 7#h7 9 subsection 7g7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ describ$ 92 7,b7 9 p>agraph 7#b71 by /rik+ ! sy/em *>act]i/ics t contribute to & ins]t+ opportunities = improvem5t1 includ+ recomm5dations = h[ to improve2 7,c7 by /rik+ p>agraph 7#d72 7,d7 by r$esignat+ p>agraphs 7#e7 & 7#f7 z p>agraphs 7#d7 & 7#e71 respectively2 7,e7 9 p>agraph 7#d71 z s r$esignat$1 by /rik+ 2 & & ins]t+ a semicolon2 7,f7 9 p>agraph 7#e71 z s r$esignat$1 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,g7 by add+ at ! end ! foll[+3 7#f7 any evid5ce-bas$ or evid5ce-in=m$ /rategies develop$ or utiliz$ pursuant to subsection 7c77#e74 2 & 7#i7 by am5d+ subsection 7h7 to read z foll[s3 7h7 ,dissem9ation ( f9d+s ,n lat] ?an #a ye> aft] ! completion ( ! f9al project "u subsection 7a71 ! ,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+ ! in=mation conta9$ 9 ea* report submitt$ pursuant to subsection 7g7 & any additional actions plann$ by ! ,secret>y relat$ to regionaliz$ em]g5cy c>e & trauma sy/ems4 4 7d7 ,program fund+ ,section #abcb7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#cb7;a77 is am5d$ by /rik+ #bjaj ?r\gh #bjad & ins]t+ #bjbc ?r\gh #bjbg4 #aad4 ,assessm5t ( conta9m5t & mitigation ( infecti\s diseases 7a7 ,,gao /udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy t reviews a geographically div]se sample ( ,/ates & t]ritories t1 9 response to ! ,,covid-#ai p&emic1 implem5t$ prep>$ness & response plans t includ$ isolation & qu>ant9e recomm5dations or requirem5ts4 ,su* /udy %all include-- 7#a7 a review ( su* ,/ate & t]ritorial prep>$ness & response plans 9 place dur+ ! ,,covid-#ai p&emic1 an assessm5t ( ! ext5t to :i* su* plans facilitat$ or pres5t$ *all5ges to ,/ate & t]ritorial responses to su* public heal? em]g5cy1 includ+ response activities relat+ to isolation & qu>ant9e to prev5t ! spread ( ,,covid-#ai2 & 7#b7 a description ( ! te*nical assi/ance provid$ by ! ,f$]al ,gov]nm5t to help ,/ates & t]ritories facilitate su* response activities dur+ responses to relevant public heal? em]g5cies decl>$ by ! ,secret>y ( ,heal? & ,human ,s]vices pursuant to section #cai ( ! ,public ,heal? ,s]vice ,act1 includ+ ! public heal? em]g5cy ) respect to ,,covid-#ai1 & a review ( ! degree to :i* su* ,/ate & t]ritorial plans 7 implem5t$ & subsequ5tly revis$ 9 response to ! ,,covid-#ai p&emic to address any *all5ges4 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 ,,ii ,improv+ public heal? prep>$ness & response capacity ,a ,address+ disp>ities & improv+ public heal? em]g5cy responses #bja4 ,address+ social det]m9ants ( heal? & improv+ heal? outcomes 7a7 ,9 g5]al ,"p ,b ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdc et seq47 is am5d$-- 7#a7 by ins]t+ aft] section #cag,u ! foll[+3 #cag,v4 ,address+ social det]m9ants ( heal? & improv+ heal? outcomes 7a7 ,9 g5]al ,! ,secret>y %all1 z appropriate1 aw>d grants1 contracts1 or coop]ative agreem5ts to eligible entities = ! conduct ( evid5ce-bas$ or evid5ce-in=m$ projects1 :i* may include ! developm5t ( networks to improve heal? outcomes & r$uce heal? disp>ities by improv+ ! capacity ( su* entities to address social det]m9ants ( heal? 9 communities4 7b7 ,eligible entities ,to be eligible to receive an aw>d "u ?is section1 an entity %all-- 7#a7 7,a7 be a ,/ate1 local1 or ,tribal heal? dep>tm5t1 community-bas$ organization1 ,indian ,tribe or ,tribal organization 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 urban ,indian organization 7z def9$ 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act71 or o!r public or private entity1 z ! ,secret>y det]m9es appropriate2 or 7,b7 be a consortia or public-private p>tn]%ip ( entities describ$ 9 subp>agraph 7,a72 7#b7 submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y %all require2 7#c7 9 ! case ( an entity o!r ?an a community-bas$ organization1 demon/rate a hi/ory ( successfully work+ ) an e/abli%$ community-bas$ organization to address heal? disp>ities2 7#d7 submit a plan to conduct activities describ$ 9 subsection 7a7 bas$ on a community ne$s assessm5t t takes into acc\nt community input2 & 7#e7 demon/rate ! capacity to effectively implem5t evid5ce-bas$ or evid5ce-in=m$ /rategies to address heal? disp>ities among und]s]v$ populations1 :i* may include rural1 racial1 & e?nic m9ority populations & p ) disabilities1 9 a timely mann]4 7c7 ,use ( funds ,an entity describ$ 9 subsection 7b7 %all use funds receiv$ "u subsection 7a71 9 consultation ) ,/ate1 local1 & ,tribal heal? dep>tm5ts1 community-bas$ organizations1 & o!r entities ) exp]i5ce address+ social det]m9ants ( heal? or r$uc+ heal? disp>ities1 z applicable1 = "o or m ( ! foll[+ purposes3 7#a7 ,support+ ! implem5tation1 evaluation1 & dissem9ation ( /rategies1 includ+ culturally-appropriate /rategies1 to address social det]m9ants ( heal?1 bas$ on ! id5tifi$ ne$s ( ! community t is ! subject ( ! assessm5t submitt$ "u subsection 7b77#d71 ?r\gh evid5ce-in=m$ or evid5ce-bas$ programs & ?r\gh ! support & use ( public heal? & heal? c>e pr(essionals to address su* social det]m9ants ( heal?4 7#b7 ,e/abli%+1 ma9ta9+1 or improv+1 9 consultation ) ,/ate1 local1 or ,tribal heal? dep>tm5ts1 te*nology plat=ms or networks to support coord9ation among appropriate entities1 & provid+ in=mation on heal? & relat$ social s]vices1 :i* may include activities to improve data collection = public heal? purposes1 9 a mann] t is consi/5t ) applicable ,f$]al & ,/ate privacy law4 7#c7 ,implem5t+ be/ practices = improv+ heal? outcomes & r$uc+ disease among und]s]v$ populations1 includ+ rural or racial & e?nic m9ority populations4 7#d7 ,support+ consid]ation ( social det]m9ants ( heal? 9 prep>+ =1 & respond+ to1 public heal? em]g5cies1 ?r\gh outrea*1 education1 rese>*1 & o!r relevant activities4 7d7 ,be/ practices & te*nical assi/ance ,! ,secret>y1 9 consultation ) ! ,director ( ! ,(fice ( ,m9ority ,heal?1 may aw>d grants1 contracts1 & coop]ative agreem5ts to public or nonpr(it private entities1 includ+ m9ority s]v+ in/itutions 7def9$1 = purposes ( ?is subsection1 z in/itutions & programs describ$ 9 section #cbf7;e77#a7 ( ! ,high] ,education ,act ( #aife & in/itutions describ$ 9 section #cga7;a7 ( su* ,act ( #aife71 to-- 7#a7 id5tify or facilitate ! developm5t ( be/ practices to support improv$ heal? outcomes & r$uce heal? disp>ities by address+ social det]m9ants ( heal?2 7#b7 provide te*nical assi/ance1 tra9+1 & evaluation assi/ance to aw>d recipi5ts "u subsection 7a72 7#c7 dissem9ate be/ practices1 includ+ to aw>d recipi5ts "u subsection 7a72 & 7#d7 e/abli% or op]ate regional c5t]s to develop1 evaluate1 & dissem9ate effective /rategies on ! utilization ( prev5tive heal? c>e s]vices to address social det]m9ants ( heal?1 includ+ support+ rese>* & tra9+ relat$ to su* /rategies4 7e7 ,aw>d p]iods ,! ,secret>y %all issue aw>ds "u ?is section = p]iods ( n m ?an #e ye>s & may issue ext5sions ( su* aw>d p]iods = an additional p]iod ( up to #c ye>s4 7f7 ,report ,n lat] ?an ,septemb] #cj1 #bjbf1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t includes in=mation on activities fund$ "u ?is section4 ,su* report %all include a description (-- 7#a7 *anges 9 ! capacity ( public heal? entities to address social det]m9ants ( heal? 9 communities1 includ+ any applicable plat=ms or networks develop$ or utiliz$ to coord9ate heal? & relat$ social s]vices & any *anges 9 work=ce capacity or capabilities2 7#b7 improvem5ts 9 heal? outcomes & 9 r$uc+ heal? disp>ities 9 m$ically und]s]v$ communities2 7#c7 activities conduct$ to support consid]ation ( social det]m9ants ( heal? 9 prep>+ =1 & respond+ to1 public heal? em]g5cies1 ?r\gh outrea*1 education1 & o!r relevant activities2 7#d7 communities & populations s]v$ by recipi5ts ( aw>ds "u subsection 7a72 7#e7 activities support$ "u subsection 7e72 & 7#f7 o!r relevant activities & outcomes1 z det]m9$ by ! ,secret>y4 7g7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #gj1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 2 & 7#b7 by /rik+ section #ccj;,d 7#db ,u4,s4,c4 #bed;c-#d74 7b7 ,,gao /udy & report ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,en]gy & ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! program au?oriz$ "u section #cag,v ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 includ+ a review ( ! outcomes & effectiv5ess ( ! program & coord9ation ) o!r programs 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices ) simil> goals to ensure t !re 0 no unnecess>y duplication ( ef=ts4 #bjb4 ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e report 7a7 ,9 g5]al ,n lat] ?an #de days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all seek to ent] into a contract ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e 7ref]r$ to 9 ?is section z ! ,national ,academies7 to conduct a /udy to exam9e heal? disp>ities & ! effect ( su* disp>ities on heal? outcomes1 :i* may include heal? outcomes relat$ to p&emic & o!r public heal? em]g5cies4 7b7 ,report ,pursuant to ! contract "u subsection 7a71 ! ,national ,academies %all1 n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 issue a report in=m$ by ! /udy conduct$ "u su* subsection t includes-- 7#a7 consid]ation ( previ\s recomm5dations made by ! ,national ,academies relat$ to heal? disp>ities1 includ+ 9 ! report titl$ ,unequal ,treatm5t3 ,confront+ ,racial & ,e?nic ,disp>ities 9 ,heal?c>e2 7#b7 recomm5dations = /rategies to improve heal? outcomes by r$uc+ heal? disp>ities1 :i* may include education & tra9+2 & 7#c7 an assessm5t ( ongo+ rese>* & /rategies to r$uce heal? disp>ities & improve heal? outcomes1 includ+ effective s]vice deliv]y models4 7c7 ,cl>ification ,9 complet+ ! requirem5ts ( ! contract "u ?is section1 ! ,national ,academies may lev]age relevant ongo+ "w ( ! ,national ,academies1 includ+ ongo+ "w relat$ to ! impact ( ,f$]al policies on heal? disp>ities4 7d7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #b1jjj1jjj = fiscal ye> #bjbc to c>ry out ?is section4 ,b ,improv+ public heal? data #baa4 ,mod]niz+ biosurveillance capabilities & infecti\s disease data collection ,section #cai;,d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#d7 is am5d$-- 7#a7 9 subsection 7b77#a77;,a71 by /rik+ 1 & local & ins]t+ 1 local1 & ,tribal2 7#b7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a71 by ins]t+ mod]nize1 aft] e/abli%12 7,b7 9 p>agraph 7#c77;,b71 by ins]t+ 1 & make recomm5dations to improve ! quality ( data collect$ pursuant to subp>agraph 7,a7 to ensure complete1 accurate1 & timely %>+ ( su* data1 z appropriate1 across su* elem5ts z describ$ 9 subp>agraph 7,a7 aft] "u subp>agraph 7,a72 7,c7 9 p>agraph 7#e7-- 7i7 9 subp>agraph 7,a7-- 7,i7 9 ! matt] prec$+ clause 7i71 by /rik+ & op]at+ & ins]t+ 1 op]at+1 & updat+1 z appropriate12 7,,ii7 9 clause 7iv71 by /rik+ & at ! end2 7,,iii7 9 clause 7v71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7vi7 9 collaboration ) ,/ate1 local1 & ,tribal public heal? (ficials1 integrate & update applicable exi/+ public heal? data sy/ems & networks ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices to reflect te*nological advancem5ts1 consi/5t ) section #bhbc1 z applicable4 2 & 7ii7 9 subp>agraph 7,b7-- 7,i7 9 clause 7i71 by ins]t+ & #ahj days aft] ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act1 aft] ,innovation ,act ( #bjai12 7,,ii7 9 clause 7ii71 by ins]t+ exp]ts 9 privacy & data security2 aft] =eca/+722 & 7,,iii7 9 clause 7iii7-- 7aa7 9 subclause 7,v71 by /rik+ & at ! end2 7bb7 9 subclause 7,,vi71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7cc7 by add+ at ! end ! foll[+3 7,,vii7 /rategies to integrate laboratory & public heal? data sy/ems & capabilities to support rapid & accurate report+ ( laboratory te/ results & associat$ relevant data2 7,,viii7 /rategies to improve ! collection & report+ ( relevant1 aggregat$1 deid5tifi$ demographic data to in=m responses to public heal? em]g5cies1 includ+ id5tification ( at-risk populations & to address pot5tial heal? disp>ities2 & 7,,ix7 /rategies to improve ! electronic ex*ange ( heal? in=mation betwe5 ,/ate & local heal? dep>tm5ts & heal? c>e provid]s & facilities to improve public heal? surveillance4 2 & 7,d7 9 p>agraph 7#f77;,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by ins]t+ & e #e ye>s !reaft]1 aft] ,innovation ,act ( #bjai1 7ii7 9 clause 7iii7-- 7,i7 9 subclause 7,,iii71 by /rik+ & at ! end2 & 7,,ii7 by add+ at ! end ! foll[+3 7,v7 improve coord9ation & collaboration1 z appropriate1 ) o!r ,f$]al dep>tm5ts2 & 7,,vi7 implem5t applicable lessons le>n$ f rec5t public heal? em]g5cies to address gaps 9 situational aw>5ess & biosurveillance capabilities2 2 7iii7 9 clause 7iv71 by /rik+ & at ! end2 7iv7 9 clause 7v71 by /rik+ ! p]iod & ins]t+ 1 includ+ a description ( h[ su* /eps w fur!r ! goals ( ! network1 consi/5t ) p>agraph 7#a72 &2 & 7v7 by add+ at ! end ! foll[+3 7vi7 id5tifies & demon/rates measurable /eps ! ,secret>y w take to fur!r develop & integrate infecti\s disease detection1 support rapid & accurate report+ ( laboratory te/ results dur+ a public heal? em]g5cy1 & improve coord9ation & collaboration ) ,/ate1 local1 & ,tribal public heal? (ficials1 cl9ical laboratories1 & o!r entities ) exp]tise 9 public heal? surveillance4 2 7#c7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a71 by ins]t+ 1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) ! heads ( o!r appropriate ag5cies & (fices )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 aft] ! ,secret>y2 7,b7 9 p>agraph 7#b77;,c71 by ins]t+ 1 includ+ any public-private p>tn]%ips or o!r p>tn]%ips ent]$ into to improve su* capacity be=e ! semicolon2 & 7,c7 by add+ at ! end ! foll[+3 7#f7 ,non-duplication ( ef=t ,! ,secret>y %all ensure t activities c>ri$ out "u an aw>d "u ?is subsection d n unnecess>ily duplicate ef=ts ( o!r ag5cies & (fices )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 2 7#d7 by am5d+ subsection 7i7 to read z foll[s3 7i7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$-- 7#a7 to c>ry out subsection 7a71 #be1jjj1jjj = ea* ( fiscal ye>s #bjbb & #bjbc2 & 7#b7 to c>ry out subsections 7b71 7c71 & 7d71 #acf1hjj1jjj = ea* ( fiscal ye>s #bjbb & #bjbc4 2 & 7#e7 by /rik+ tribal ea* place x appe>s & ins]t+ ,tribal4 #bab4 ,g5omic sequ5c+1 analytics1 & public heal? surveillance ( pa?og5s 7a7 ,guidance support+ g5omic sequ5c+ ( pa?og5s collaboration ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 9 consultation ) ! heads ( o!r ,f$]al dep>tm5ts or ag5cies1 z appropriate1 %all issue guidance to support collaboration relat+ to g5omic sequ5c+ ( pa?og5s1 includ+ ! use ( new & innovative approa*es & te*nology = ! detection1 *>act]ization1 & sequ5c+ ( pa?og5s1 to improve public heal? surveillance & prep>$ness & response activities1 consi/5t ) section #bhbd ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7b74 ,su* guidance %all address ! secure %>+1 = public heal? surveillance purposes1 ( specim5s ( su* pa?og5s1 betwe5 appropriate entities & public heal? au?orities1 consi/5t ) ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 z applicable1 & 9 a mann] t protects p]sonal privacy to ! ext5t requir$ by applicable privacy law1 at a m9imum1 & ! appropriate use ( sequ5ce data d]iv$ f su* specim5s4 7b7 ,g5omic sequ5c+ program ,title ,,xxviii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh et seq47 is am5d$ by add+ at ! end ! foll[+ #bhbd4 ,g5omic sequ5c+1 analytics1 & public heal? surveillance ( pa?og5s program 7a7 ,g5omic sequ5c+1 analytics1 & public heal? surveillance ( pa?og5s program ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,heal? & heads ( o!r dep>tm5ts & ag5cies1 z appropriate1 %all /r5g!n & exp& activities relat$ to g5omic sequ5c+ ( pa?og5s1 includ+ new & innovative approa*es & te*nology = ! detection1 *>act]ization1 & sequ5c+ ( pa?og5s1 analytics1 & public heal? surveillance1 includ+-- 7#a7 cont9u+ & exp&+ activities1 :i* may include exi/+ g5omic sequ5c+ activities relat$ to advanc$ molecul> detection1 to-- 7,a7 id5tify & respond to em]g+ infecti\s disease ?reats2 & 7,b7 id5tify ! pot5tial use ( g5omic sequ5c+ te*nologies1 advanc$ comput+1 & o!r advanc$ te*nology to in=m surveillance activities & incorporate ! use ( su* te*nologies1 z appropriate1 into relat$ activities2 7#b7 provid+ te*nical assi/ance & guidance to ,/ate1 ,tribal1 local1 & t]ritorial public heal? dep>tm5ts to increase ! capacity ( su* dep>tm5ts to p]=m g5omic sequ5c+ ( pa?og5s1 includ+ recipi5ts ( fund+ "u section #bhba2 7#c7 c>ry+ out activities to enhance ! capabilities ( ! public heal? work=ce ) respect to pa?og5 g5omics1 epidemiology1 & bio9=matics1 includ+ ?r\gh tra9+2 & 7#d7 cont9u+ & exp&+ activities1 z applicable1 ) public & private entities1 includ+ relevant dep>tm5ts & ag5cies1 laboratories1 academic in/itutions1 & indu/ry4 7b7 ,p>tn]%ips ,= ! purposes ( c>ry+ out ! activities describ$ 9 subsection 7a71 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 may aw>d grants1 contracts1 or coop]ative agreem5ts to entities1 includ+ academic & o!r laboratories1 ) exp]tise 9 g5omic sequ5c+ = public heal? purposes1 includ+ new & innovative approa*es to1 & relat$ te*nology =1 ! detection1 *>act]ization1 & sequ5c+ ( pa?og5s4 7c7 ,c5t]s ( excell5ce 7#a7 ,9 g5]al ,! ,secret>y %all1 z appropriate1 aw>d grants1 contracts1 or coop]ative agreem5ts to public heal? ag5cies = ! e/abli%m5t or op]ation ( c5t]s ( excell5ce to promote innovation 9 pa?og5 g5omics & molecul> epidemiology to improve ! control ( & response to pa?og5s t may cause a public heal? em]g5cy4 ,su* c5t]s %all1 z appropriate-- 7,a7 id5tify & evaluate ! use ( g5omics1 or o!r relat$ te*nologies t may advance public heal? prep>$ness & response2 7,b7 improve ! id5tification1 developm5t1 & use ( tools = integrat+ & analyz+ g5omic & epidemiologic data2 7,c7 assi/ ) g5omic surveillance (1 & response to1 infecti\s diseases1 includ+ analysis ( pa?og5 g5omic data2 7,d7 conduct appli$ rese>* to improve public heal? surveillance (1 & response to1 infecti\s diseases ?r\gh innovation 9 pa?og5 g5omics & molecul> epidemiology2 & 7,e7 develop & provide tra9+ mat]ials = exp]ts 9 ! fields ( g5omics1 microbiology1 bio9=matics1 epidemiology1 & o!r fields1 z appropriate4 7#b7 ,requirem5ts ,to be eligible = an aw>d "u p>agraph 7#a71 an entity %all submit to ! ,secret>y an application conta9+ su* in=mation z ! ,secret>y may require1 includ+ a description ( h[ ! entity w p>tn]1 z applicable1 ) academic in/itutions or a consortium ( academic p>tn]s t h relevant exp]tise1 su* z microbial g5omics1 molecul> epidemiology1 or ! application ( bio9=matics or /ati/ics4 7d7 ,au?orization ,= purposes ( c>ry+ out ?is section1 !re are au?oriz$ to be appropriat$ #age1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 4 #bac4 ,support+ public heal? data availability & access 7a7 ,designation ( public heal? data /&>ds ,section #bhbc7;a77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#cc7;a77#b77 is am5d$-- 7#a7 by /rik+ ,9 c>ry+ out & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,9 c>ry+ out 2 & 7#b7 by /rik+ %all1 z appropriate & & ins]t+ %all1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act12 & 7#c7 by add+ at ! end ! foll[+3 7,b7 ,selection ( data & te*nology /&>ds ,! /&>ds designat$ z describ$ 9 subp>agraph 7,a7 may include /&>ds to improve-- 7i7 ! ex*ange ( electronic heal? in=mation =-- 7,i7 electronic case report+2 7,,ii7 syndromic surveillance2 7,,iii7 report+ ( vital /ati/ics2 & 7,,iv7 report+ te/ ord]s & results electronically1 includ+ f laboratories2 7ii7 automat$ electronic report+ to relevant public heal? data sy/ems ( ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7iii7 su* o!r use cases z ! ,secret>y det]m9es appropriate4 7,c7 ,no duplicative ef=ts 7i7 ,9 g5]al ,9 c>ry+ out ! requirem5ts ( ?is p>agraph1 ! ,secret>y1 9 consultation ) ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 may use input ga!r$ 7includ+ input & recomm5dations ga!r$ f ! ,heal? ,in=mation ,te*nology ,advisory ,committee71 & mat]ials develop$1 prior to ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act4 7ii7 ,previ\sly adopt$ /&>ds ,! data & te*nology /&>ds designat$ pursuant to ?is p>agraph may include ! adoption ( /&>ds previ\sly adopt$ by ! ,secret>y pursuant to section #cjjd4 7,d7 ,privacy & security ,no?+ 9 ?is p>agraph %all be con/ru$ z modify+ applicable ,f$]al or ,/ate in=mation privacy or security law4 4 7b7 ,/udy on laboratory in=mation /&>ds 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology %all conduct a /udy to review ! use ( /&>ds = electronic ord]+ & report+ ( laboratory te/ results4 7#b7 ,areas ( conc5tration ,9 conduct+ ! /udy "u p>agraph 7#a71 ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology %all-- 7,a7 det]m9e ! ext5t to :i* cl9ical laboratories are us+ /&>ds = electronic ord]+ & report+ ( laboratory te/ results2 7,b7 assess tr5ds 9 laboratory compliance ) /&>ds = ord]+ & report+ laboratory te/ results & ! effect ( su* tr5ds on ! int]op]ability ( laboratory data ) public heal? data sy/ems2 7,c7 id5tify *all5ges relat$ to collection & report+ ( demographic & o!r data elem5ts ) respect to laboratory te/ results2 7,d7 id5tify any *all5ges associat$ ) us+ or comply+ ) /&>ds & report+ laboratory te/ results ) data elem5ts id5tifi$ 9 /&>ds = electronic ord]+ & report+ ( su* results2 & 7,e7 review o!r relevant areas det]m9$ appropriate by ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology4 7#c7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conc]n+ ! f9d+s ( ! /udy conduct$ "u p>agraph 7#a74 7c7 ,support+ in=mation %>+ ?r\gh data use agreem5ts 7#a7 ,int]ag5cy data use agreem5ts )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices = public heal? em]g5cies 7,a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all1 z appropriate1 facilitate ! developm5t (1 or updates to1 memor&a ( und]/&+1 data use agreem5ts1 or o!r applicable int]ag5cy agreem5ts reg>d+ appropriate access1 ex*ange1 & use ( public heal? data betwe5 ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,(fice ( ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 o!r relevant ag5cies or (fices )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 & o!r relevant ,f$]al ag5cies1 9 ord] to prep>e =1 id5tify1 monitor1 & respond to decl>$ or pot5tial public heal? em]g5cies4 7,b7 ,requirem5ts ,9 c>ry+ out activities pursuant to subp>agraph 7,a71 ! ,secret>y %all-- 7i7 ensure t ! agreem5ts & memor&a ( und]/&+ describ$ 9 su* subp>agraph-- 7,i7 address ! me?ods ( grant+ access to data held by "o ag5cy or (fice ) ano!r to support ! respective missions ( su* ag5cies or (fices2 7,,ii7 consid] m9imum necess>y pr9ciples ( data %>+ = appropriate use2 7,,iii7 include appropriate privacy & cyb]security protections2 & 7,,iv7 are subject to regul> updates1 z appropriate2 7ii7 collaborate ) ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,(fice ( ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,(fice ( ! ,*ief ,in=mation ,(fic]1 &1 z appropriate1 ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 & o!r entities )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 & 7iii7 consid] ! t]ms & conditions ( any exi/+ data use agreem5ts ) o!r public or private entities & any ne$ = updates to su* exi/+ agreem5ts1 consi/5t ) p>agraph 7#b74 7#b7 ,data use agreem5ts ) ext]nal entities ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 may update memor&a ( und]/&+1 data use agreem5ts1 or o!r applicable agreem5ts & contracts to improve appropriate access1 ex*ange1 & use ( public heal? data betwe5 ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,(fice ( ! ,assi/ant ,secret>y = ,prep>$ness & ,response & ext]nal entities1 includ+ ,/ate1 ,tribal1 & t]ritorial heal? dep>tm5ts1 laboratories1 hospitals & o!r heal? c>e provid]s1 electronic heal? records v5dors1 & o!r entities1 z applicable & appropriate1 9 ord] to prep>e =1 id5tify1 monitor1 & respond to decl>$ or pot5tial public heal? em]g5cies4 7#c7 ,report ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on ! /atus ( ! agreem5ts "u ?is subsection4 7d7 ,improv+ in=mation %>+ & availability ( public heal? data ,"p ,a ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 #caj;,b4 ,improv+ in=mation %>+ & availability ( public heal? data 7a7 ,9 g5]al ,! ,secret>y may1 9 consultation ) ,/ate1 local1 & ,tribal public heal? (ficials1 c>ry out activities to improve ! availability ( appropriate & applicable public heal? data relat$ to communicable diseases1 & in=mation %>+ betwe51 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 & su* ,/ate1 local1 & ,tribal public heal? (ficials1 :i* may include su* data f-- 7#a7 heal? c>e provid]s & facilities2 7#b7 public heal? & cl9ical laboratories2 & 7#c7 ,/ate1 local1 & ,tribal heal? dep>tm5ts4 7b7 ,cont5t1 =m1 & mann] ,! ,secret>y %all1 consi/5t ) ! requirem5ts ( ?is section1 "w ) su* (ficials & relevant /akehold]s to provide in=mation on ! cont5t1 =m1 & mann] 9 :i* su* data may mo/ effectively support ! ability ( ,/ate1 local1 & ,tribal heal? dep>tm5ts to respond to su* communicable diseases1 includ+ relat$ to ! collection & report+ ( demographic & o!r relevant data elem5ts4 7c7 ,decreas$ burd5 ,9 facilitat+ ! coord9ation ( ef=ts "u subsection 7a71 ! ,secret>y %all make reasonable ef=ts to limit report$ public heal? data to ! m9imum necess>y in=mation ne$$ to accompli% ! int5d$ public heal? surveillance purpose4 7d7 ,exemption ( c]ta9 public heal? data f disclosure ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 may exempt f disclosure "u section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code1 public heal? data t are ga!r$ "u ?is section if-- 7#a7 an individual is id5tifi$ ?r\gh su* data2 or 7#b7 !re is at lea/ a v small risk1 z det]m9$ by curr5t sci5tific practices or /ati/ical me?ods1 t "s comb9ation ( ! in=mation1 ! reque/1 & o!r available data s\rces or ! application ( te*nology c\ld be us$ to d$uce ! id5tity ( an individual4 4 7e7 ,improv+ public heal? data collection 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all aw>d grants1 contracts1 or coop]ative agreem5ts to eligible entities = purposes ( id5tify+1 develop+1 or dissem9at+ be/ practices 9 ! collection ( electronic heal? in=mation & ! use ( designat$ data /&>ds & implem5tation specifications to improve ! quality & complet5ess ( data1 includ+ demographic data1 collect$1 access$1 or us$ = public heal? purposes & to address heal? disp>ities & relat$ heal? outcomes4 7#b7 ,eligible entities ,to be eligible to receive an aw>d "u ?is subsection an entity %all-- 7,a7 be a heal? c>e provid]1 academic m$ical c5t]1 community-bas$ organization1 ,/ate1 local gov]nm5tal entity1 ,indian ,tribe or ,tribal organization 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self ,det]m9ation & ,education ,assi/ance ,act 7#be ,u4,s4,c4 #ecjd771 urban ,indian organization 7z def9$ 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act 7#be ,u4,s4,c4 #afjc771 or o!r appropriate public or private nonpr(it entity1 or a consortia ( any su* entities2 & 7,b7 submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7#c7 ,activities ,entities receiv+ aw>ds "u ?is subsection %all use su* aw>d to develop & te/ be/ practices = tra9+ heal? c>e provid]s to use /&>ds & implem5tation specifications t assi/ 9 ! capture1 access1 ex*ange1 & use ( electronic heal? in=mation1 includ+ demographic in=mation1 disability /atus1 vet]an /atus1 h\s+ /atus1 functional /atus1 & o!r data elem5ts4 ,su* activities %all include1 at a m9imum-- 7,a7 improv+1 und]/&+1 & us+ data /&>ds & implem5tation specifications2 7,b7 develop+ or id5tify+ me?ods to improve communication ) pati5ts 9 a culturally- & l+ui/ically-appropriate mann]1 includ+ to bett] capture in=mation relat$ to demographics ( su* individuals2 7,c7 develop+ me?ods = accurately categoriz+ & record+ pati5t responses us+ available data /&>ds2 7,d7 educat+ provid]s reg>d+ ! utility ( su* in=mation = public heal? purposes & ! importance ( accurate collection & record+ ( su* data2 & 7,e7 o!r activities1 z ! ,secret>y det]m9es appropriate4 7#d7 ,report+ 7,a7 ,report+ by aw>d recipi5ts ,ea* recipi5t ( an aw>d "u ?is subsection %all submit to ! ,secret>y a report on ! results ( be/ practices id5tifi$1 develop$1 or dissem9at$ ?r\gh su* aw>d4 7,b7 ,report to congress ,n lat] ?an #a ye> aft] ! completion ( ! program "u ?is subsection1 ! ,secret>y %all submit a report to ,congress on ! success ( be/ practices develop$ "u su* program1 opportunities = fur!r dissem9ation ( su* be/ practices1 & recomm5dations = improv+ ! capture1 access1 ex*ange1 & use ( in=mation to improve public heal? & r$uce heal? disp>ities4 7#e7 ,non-duplication ( ef=ts ,! ,secret>y %all ensure t ! activities & programs c>ri$ out "u ?is subsection are free ( unnecess>y duplication ( ef=t4 7#f7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ #aj1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbe to c>ry out ?is subsection4 #bad4 ,epidemic =eca/+ & outbreak analytics ,title ,,xxviii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh et seq471 z am5d$ by section #bab1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bhbe4 ,epidemic =eca/+ & outbreak analytics 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all cont9ue activities relat$ to ! developm5t ( infecti\s disease outbreak analysis capabilities to enhance ! pr$iction1 model+1 & =eca/+ ( pot5tial public heal? em]g5cies & o!r infecti\s disease outbreaks1 :i* may include activities to support prep>$ness =1 & response to1 su* em]g5cies & outbreaks4 ,9 c>ry+ out ?is subsection1 ! ,secret>y %all id5tify /rategies to include & lev]age1 z appropriate1 ! capabilities to public & private entities1 :i* may include conduct+ su* activities ?r\gh collaborative p>tn]%ips ) public & private entities1 includ+ academic in/itutions1 & o!r ,f$]al ag5cies1 consi/5t ) section #cai;,d1 z applicable4 7b7 ,consid]ations ,9 c>ry+ out subsection 7a71 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 may consid] public heal? data &1 z appropriate1 o!r data s\rces relat$ to ! transmission ( su* infecti\s diseases t affect prep>$ness =1 or response to1 public heal? em]g5cies & infecti\s disease outbreaks4 7c7 ,annual reports ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 & annually !reaft] = ea* ( ! subsequ5t #d ye>s1 ! ,secret>y %all prep>e & submit a report1 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 reg>d+ an update on progress on activities conduct$ "u ?is section to develop infecti\s disease outbreak analysis capabilities & any additional in=mation relevant to su* ef=ts4 4 #bae4 ,report on ,,cdc data portal 7a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives reg>d+ public heal? data mod]nization initiatives1 surveillance inve/m5ts1 & public heal? data report+ mod]nization initiatives "u ?is ,act 7includ+ ! am5dm5ts made by ?is ,act7 & ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq471 & provide recomm5dations on ! feasibility ( ! use ( a web-bas$ in=mation te*nology plat=m 7ref]r$ to 9 ?is section z ! plat=m7 = ! /reaml9+ ( exi/+ volunt>y submissions ( public heal? data = all ,/ate1 local1 ,tribal1 & t]ritorial entities t report su* data to ! ,c5t]s = ,disease ,control & ,prev5tion1 & :e!r su* plat=m w\ld r$uce ! report+ burd5 = su* entities4 7b7 ,requirem5ts ,! report "u subsection 7a7 %all address ! ext5t to :i* ! submission ( su* data to ! plat=m may-- 7#a7 support coord9ation )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7#b7 provide appropriate in=mation among & betwe5 ,/ate1 ,tribal1 local1 & t]ritorial public heal? (ficials2 7#c7 lev]age private sector te*nologies2 & 7#d7 provide = ! /reaml9+ ( data report+ to ! greate/ ext5t possible4 #baf4 ,public heal? data transp>5cy 7a7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue a report assess+ practices1 objectives1 & associat$ progress & *all5ges 9 a*iev+ su* objectives1 ( ! ,c5t]s ( ,disease ,control & ,prev5tion ) respect to ! collection & dissem9ation ( public heal? data relat$ to a public heal? em]g5cy decl>$ "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 or a pot5tial public heal? em]g5cy4 7b7 ,plan ,n lat] ?an #ahj days foll[+ ! issuance ( ! report pursuant to p>agraph 7#a71 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a plan t %all include-- 7#a7 /eps to improve ! timely report+ & dissem9ation ( public heal? data relat$ to a public heal? em]g5cy decl>$ "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 or a pot5tial public heal? em]g5cy t is collect$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 includ+ any associat$ b>ri]s2 7#b7 recomm5dations to ,congress reg>d+ gaps 9 su* practices & objectives describ$ 9 subsection 7a72 & 7#c7 consid]ations reg>d+ ! requirem5ts & limitations ( data use agreem5ts = su* purposes1 z applicable4 ,c ,revitaliz+ ! public heal? work=ce #bba4 ,improv+ recruitm5t & ret5tion ( ! frontl9e public heal? work=ce 7a7 ,9 g5]al ,section #ggf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bie;f-#a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ supply ( & ins]t+ supply (1 & enc\rage recruitm5t & ret5tion (12 & 7,b7 by /rik+ ,f$]al12 7#b7 9 subsection 7b7-- 7,a7 by am5d+ p>agraph 7#a77;,a7 to read z foll[s3 7#a7 7,a7 7i7 be accept$ = enrollm5t1 or be enroll$1 z a /ud5t 9 an accr$it$ in/itution ( high] education or s*ool ( public heal? 9 ! f9al seme/] 7or equival5t7 ( a program lead+ to a c]tificate or degree1 includ+ a ma/]'s or doctoral degree1 9 public heal?1 epidemiology1 laboratory sci5ces1 data sy/ems1 data sci5ce1 data analytics1 in=matics1 /ati/ics1 or ano!r subject matt] relat$ to public heal?2 & 7ii7 be employ$ by1 or h accept$ employm5t )1 a ,/ate1 local1 or ,tribal public heal? ag5cy1 or a relat$ tra9+ fell[%ip at su* ,/ate1 local1 or ,tribal public heal? ag5cy1 z recogniz$ by ! ,secret>y1 to comm5ce ^u graduation2 or 2 & 7,b7 9 p>agraph 7#a77;,b7-- 7i7 9 clause 7i7-- 7,i7 by /rik+ accr$it$ educational in/itution 9 a ,/ate or t]ritory & ins]t+ accr$it$ in/itution ( high] education or s*ool ( public heal?2 & 7,,ii7 by /rik+ a public heal? or heal? pr(essions degree or c]tificate & ins]t+ a c]tificate or degree1 includ+ a ma/]'s or doctoral degree1 9 public heal?1 epidemiology1 laboratory sci5ces1 data sy/ems1 data sci5ce1 data analytics1 in=matics1 /ati/ics1 or ano!r subject matt] relat$ to public heal?2 & 7ii7 9 clause 7ii7-- 7,i7 by /rik+ ,f$]al12 & 7,,ii7 by /rik+ fell[%ip1 & ins]t+ fell[%ip at su* ,/ate1 local1 or ,tribal public heal? ag5cy12 7#c7 9 subsection 7c77#b7-- 7,a7 by /rik+ ,f$]al12 & 7,b7 by /rik+ equal to ! great] (-- & all t foll[s ?r\gh ! end ( subp>agraph 7,b7 & ins]t+ ( at lea/ #c consecutive ye>s22 7#d7 9 subsection 7d7-- 7,a7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,9 g5]al ,a loan repaym5t provid$ = an individual "u a writt5 contract "u ! ,program %all consi/ ( paym5t1 9 accordance ) p>agraph 7#b71 = ! individual t[>d ! out/&+ pr9cipal & int]e/ on education loans incurr$ by ! individual 9 ! pursuit ( ! relevant degree or c]tificate describ$ 9 subsection 7b77#a7 9 accordance ) ! t]ms ( ! contract4 2 & 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ ,= ea* ye> & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,= ea* ye> 2 7ii7 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 7iii7 by /rik+ #aje1jjj & ins]t+ #aej1jjj2 & 7iv7 by add+ at ! end ! foll[+3 7,b7 ,consid]ations ,! ,secret>y may take action 9 mak+ aw>ds "u ?is section to ensure t-- 7i7 an appropriate proportion ( contracts are aw>d$ to individuals :o are eligible to p>ticipate 9 ! program pursuant to subsection 7b77#a77;,a72 & 7ii7 contracts aw>d$ "u ?is section are equitably di/ribut$ among-- 7,i7 ! geographical regions ( ! ,unit$ ,/ates2 7,,ii7 local1 ,/ate1 & ,tribal public heal? dep>tm5ts2 & 7,,iii7 su* public heal? dep>tm5ts "u subclause 7,,ii7 s]v+ rural & urban areas4 2 7#e7 9 subsection 7e71 by /rik+ receiv+ a degree or c]tificate f a heal? pr(essions or o!r relat$ s*ool & ins]t+ ) a contract to s]ve "u subsection 7c72 7#f7 9 subsection 7f71 by add+ at ! end ! foll[+3 ,9 ! ev5t t a p>ticipant fails to ei!r beg9 or complete ! obligat$ s]vice requirem5t ( ! loan repaym5t contract "u ?is section1 ! ,secret>y may waive or susp5d ei!r ! unfulfill$ s]vice or ! assess$ damages z provid$ = "u section #cch;,e7d71 z appropriate42 7#g7 by r$esignat+ subsection 7g7 z subsection 7h72 7#h7 by ins]t+ aft] subsection 7f7 ! foll[+3 7g7 ,eligible loans ,! loans eligible = repaym5t "u ?is section are ea* ( ! foll[+3 7#a7 ,any loan = education or tra9+ = employm5t by a heal? dep>tm5t4 7#b7 ,any loan "u "p ,e ( title ,,viii 7relat+ to nurs+ /ud5t loans74 7#c7 ,any ,f$]al ,direct ,/af=d ,loan1 ,f$]al ,direct ,,plus ,loan1 ,f$]al ,direct ,unsubsidiz$ ,/af=d ,loan1 or ,f$]al ,direct ,consolidation ,loan 7z su* t]ms are us$ 9 section #dee ( ! ,high] ,education ,act ( #aife74 7#d7 ,any ,f$]al ,p]k9s ,loan "u "p ,e ( title ,i ( ! ,high] ,education ,act ( #aife4 7#e7 ,any o!r ,f$]al loan1 z ! ,secret>y det]m9es appropriate4 2 7#i7 9 subsection 7h71 z s r$esignat$1 by /rik+ #aie1jjj1jjj = fiscal ye> #bjaj1 & su* sums z may be necess>y = ea* ( fiscal ye>s #bjaa ?r\gh #bjae & ins]t+ su* sums z may be necess>y = ea* ( fiscal ye>s #bjbb ?r\gh #bjbe2 & 7#aj7 by /rik+ tribal ea* place su* t]m appe>s & ins]t+ ,tribal4 7b7 ,,gao /udy on public heal? work=ce ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7#a7 conduct an evaluation ( :at is kn[n ab\t ! public heal? work=ce 9 ! ,unit$ ,/ates1 :i* %all address-- 7,a7 exi/+ gaps 9 ! ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial public heal? work=ce1 includ+ positions t may be requir$ to prep>e =1 & respond to1 a public heal? em]g5cy su* z ,,covid-#ai2 7,b7 *all5ges associat$ ) ! hir+1 recruitm5t1 & ret5tion ( ! ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial public heal? work=ce2 & 7,c7 ,f$]al ef=ts to improve hir+1 recruitm5t1 & ret5tion ( ! public heal? work=ce2 & 7#b7 submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on su* review4 #bbb4 ,aw>ds to support community heal? work]s & community heal? 7a7 ,9 g5]al ,section #cii,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g-#aa7 is am5d$-- 7#a7 by am5d+ ! section head+ to read z foll[s3 ,aw>ds to support community heal? work]s & community heal?2 7#b7 by am5d+ subsection 7a7 to read z foll[s3 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 %all aw>d grants1 contracts1 or coop]ative agreem5ts to eligible entities to promote positive heal? behaviors & outcomes = populations 9 m$ically und]s]v$ communities by lev]ag+ community heal? work]s1 includ+ by address+ ongo+ & long]-t]m community heal? ne$s1 & by build+ ! capacity ( ! community heal? work] work=ce4 ,su* grants1 contracts1 & coop]ative agreem5ts %all be aw>d$ 9 alignm5t & coord9ation ) exi/+ fund+ arrangem5ts support+ community heal? work]s4 2 7#c7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a7-- 7i7 by /rik+ ,grants aw>d$ & ins]t+ ,subject to any requirem5ts = ! scope ( lic5sure1 regi/ration1 or c]tification ( a community heal? work] "u applicable ,/ate law1 grants1 contracts1 & coop]ative agreem5ts aw>d$2 & 7ii7 by /rik+ support community heal? work]s2 7,b7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#e7 z p>agraphs 7#d7 ?r\gh 7#f71 respectively2 7,c7 by /rik+ p>agraphs 7#a7 & 7#b7 & ins]t+ ! foll[+3 7#a7 recruit1 hire1 tra91 & reta9 community heal? work]s t reflect ! ne$s ( ! community2 7#b7 support community heal? work]s 9 provid+ education & outrea*1 9 a community sett+1 reg>d+-- 7,a7 heal? conditions preval5t 9-- 7i7 m$ically und]s]v$ communities 7z def9$ 9 section #gii;,b71 p>ticul>ly racial & e?nic m9ority populations2 & 7ii7 o!r su* at-risk populations or geographic areas t may require additional support dur+ public heal? em]g5cies1 :i* may include c\nties id5tifi$ by ! ,secret>y us+ applicable measures develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or o!r ,f$]al ag5cies2 & 7,b7 address+ social det]m9ants ( heal? & elim9at+ heal? disp>ities1 includ+ by-- 7i7 promot+ aw>5ess ( s]vices & res\rces to increase access to heal? c>e1 m5tal heal? & sub/ance use disord] s]vices1 *ild s]vices1 te*nology1 h\s+ s]vices1 educational s]vices1 nutrition s]vices1 employm5t s]vices1 & o!r s]vices2 & 7ii7 assi/+ 9 conduct+ individual & community ne$s assessm5ts2 7#c7 educate community memb]s1 includ+ reg>d+ effective /rategies to promote heal?y behaviors2 2 7,d7 9 p>agraph 7#d71 z s r$esignat$1 by /rik+ to educate & ins]t+ educate2 7,e7 9 p>agraph 7#e71 z s r$esignat$-- 7i7 by /rik+ to id5tify & ins]t+ id5tify2 7ii7 by /rik+ heal?c>e ag5cies & ins]t+ heal? c>e ag5cies2 & 7iii7 by /rik+ heal?c>e s]vices & to elim9ate duplicative c>e2 or & ins]t+ heal? c>e s]vices & to /reaml9e c>e1 includ+ s]v+ z a liaison betwe5 communities & heal? c>e ag5cies2 &2 & 7,f7 9 p>agraph 7#f71 z s r$esignat$-- 7i7 by /rik+ to educate1 guide1 & provide & ins]t+ support community heal? work]s 9 educat+1 guid+1 or provid+2 & 7ii7 by /rik+ mat]nal heal? & pr5atal c>e & ins]t+ *ronic diseases1 mat]nal heal?1 pr5atal1 & po/p>tum c>e 9 ord] to improve mat]nal & infant heal? outcomes2 7#d7 9 subsection 7c71 by /rik+ ,ea* eligible entity & all t foll[s ?r\gh accompani$ by & ins]t+ ,to be eligible to receive an aw>d "u subsection 7a71 an entity %all prep>e & submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+2 7#e7 9 subsection 7d7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ aw>d+ grants & ins]t+ mak+ aw>ds2 7,b7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 propose to s]ve-- 7,a7 areas ) populations t h a high rate ( *ronic disease1 infant mortality1 or mat]nal morbidity & mortality2 7,b7 l[-income populations1 includ+ m$ically und]s]v$ populations 7z def9$ 9 section #ccj7;b77#c772 7,c7 populations resid+ 9 heal? pr(essional %ortage areas 7z def9$ 9 section #ccb7;a772 7,d7 populations resid+ 9 mat]nity c>e heal? pr(essional t>get areas id5tifi$ "u section #ccb7k72 or 7,e7 rural or traditionally und]s]v$ populations1 includ+ racial & e?nic m9ority populations or l[-income populations2 2 7,c7 9 p>agraph 7#b71 by /rik+ 2 & & ins]t+ 1 includ+ rural populations & racial & e?nic m9ority populations22 7,d7 9 p>agraph 7#c71 by /rik+ ) community heal? work]s4 & ins]t+ & e/abli%$ relation%ips ) community heal? work]s 9 ! communities expect$ to be s]v$ by ! program2 & 7,e7 by add+ at ! end ! foll[+3 7#d7 develop a plan = provid+ s]vices to ! ext5t practicable1 9 ! language & cultural context mo/ appropriate to individuals expect$ to be s]v$ by ! program2 & 7#e7 propose to use evid5ce-in=m$ or evid5ce-bas$ practices1 z applicable & appropriate4 2 7#f7 9 subsection 7e7-- 7,a7 by /rik+ community heal? work] programs & ins]t+ eligible entities2 & 7,b7 by /rik+ & "o-/op deliv]y sy/ems "u section #aba7;e7 & ins]t+ 1 heal? pr(essions s*ools1 m9ority-s]v+ in/itutions 7def9$1 = purposes ( ?is subsection1 z in/itutions & programs describ$ 9 section #cbf7;e77#a7 ( ! ,high] ,education ,act ( #aife & in/itutions describ$ 9 section #cga7;a7 ( su* ,act71 area heal? education c5t]s "u section #gea ( ?is ,act1 & "o-/op deliv]y sy/ems "u section #aba2 7#g7 by /rik+ subsections 7f71 7g71 7h71 7i71 & 7j7 & ins]t+ ! foll[+3 7f7 ,te*nical assi/ance ,! ,secret>y may provide to eligible entities t receive aw>ds "u subsection 7a7 te*nical assi/ance ) respect to plann+1 developm5t1 & op]ation ( community heal? work] programs au?oriz$ or support$ "u ?is section4 7g7 ,dissem9ation ( be/ practices ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act1 ! ,secret>y %all1 bas$ on activities c>ri$ out "u ?is section & 9 consultation ) relevant /akehold]s1 id5tify & dissem9ate evid5ce-bas$ or evid5ce-in=m$ practices reg>d+ recruitm5t & ret5tion ( community heal? work]s & p>apr(essionals to address ongo+ public heal? & community heal? ne$s1 & to prep>e =1 & respond to1 future public heal? em]g5cies4 7h7 ,report to ,congress ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conc]n+ ! effectiv5ess ( ! program "u ?is section 9 address+ ongo+ public heal? & community heal? ne$s4 ,su* report %all include recomm5dations reg>d+ any improvem5ts to su* program1 includ+ recomm5dations = h[ to improve recruitm5t1 tra9+1 & ret5tion ( ! community heal? work=ce4 7i7 ,au?orization ( appropriations ,= purposes ( c>ry+ out ?is section1 !re are au?oriz$ to be appropriat$ su* sums z may be necess>y = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 2 7#h7 by r$esignat+ subsection 7k7 z subsection 7j72 & 7#i7 9 subsection 7j71 z s r$esignat$-- 7,a7 by /rik+ p>agraphs 7#a71 7#b71 & 7#d72 7,b7 by r$esignat+ p>agraph 7#c7 z p>agraph 7#a72 7,c7 9 p>agraph 7#a71 z s r$esignat$-- 7i7 by /rik+ entity 7includ+ a ,/ate or public subdivision ( a ,/ate & ins]t+ entity1 includ+ a ,/ate or political subdivision ( a ,/ate1 an ,indian ,tribe or ,tribal organization1 an urban ,indian organization1 a community-bas$ organization2 & 7ii7 by /rik+ z def9$ 9 section #ahfa7;aa7 ( ! ,social ,security ,act77 & ins]t+ 7z def9$ 9 section #ahfa7;aa77#d7 ( ! ,social ,security ,act72 & 7,d7 by add+ at ! end ! foll[+3 7#b7 ,indian ,tribe2 ,tribal organization ,! t]ms ,indian ,tribe & ,tribal organization h ! mean+s giv5 ! t]ms ,indian tribe & tribal organization1 respectively1 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act4 7#c7 ,urban ,indian organization ,! t]m urban ,indian organization has ! mean+ giv5 su* t]m 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act4 4 7b7 ,,gao /udy & report ,n lat] ?an #a ye> aft] ! date ( submission ( ! report "u subsection 7h7 ( section #cii,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g-#aa71 z am5d$ by subsection 7a71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! program au?oriz$ "u su* section #cii,v1 includ+ a review ( ! ef=ts ( ! ,secret>y ( ,heal? & ,human ,s]vices to coord9ate su* program ) applicable programs ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration to ensure !re is no unnecess>y duplication ( ef=ts among su* programs1 & id5tification ( any areas ( duplication4 #bbc4 ,improv+ public heal? em]g5cy response capacity 7a7 ,c]ta9 appo9tm5ts to support public heal? em]g5cy responses ,section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 is am5d$ by add+ at ! end ! foll[+3 7g7 ,c]ta9 appo9tm5ts ,to support public heal? em]g5cy responses 7#a7 ,9 g5]al ,9 ord] to support ! initial response to a public heal? em]g5cy decl>$ by ! ,secret>y "u ?is section1 ! ,secret>y may1 subject to p>agraph 7#b7 & )\t reg>d to sections #ccji ?r\gh #ccah ( title #e1 ,unit$ ,/ates ,code1 appo9t individuals directly to positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices = :i* ! ,secret>y has provid$ public notice 9 ord] to-- 7,a7 address a critical hir+ ne$ directly relat$ to respond+ to a public heal? em]g5cy decl>$ by ! ,secret>y "u ?is section2 or 7,b7 address a sev]e %ortage ( c&idates t impacts ! op]ational capacity ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices to respond 9 ! ev5t ( a public heal? em]g5cy decl>$ by ! ,secret>y "u ?is section4 7#b7 ,numb] ( appo9tm5ts ,ea* fiscal ye> 9 :i* ! ,secret>y makes a det]m9ation ( a public heal? em]g5cy "u subsection 7a7 7n includ+ a r5ewal71 ! ,secret>y may directly appo9t n m ?an-- 7,a7 #djj individuals "u p>agraph 7#a77;,a72 & 7,b7 #ajj individuals "u p>agraph 7#a77;,b74 7#c7 ,comp5sation ,! annual rate ( basic pay ( an individual appo9t$ "u ?is subsection %all be det]m9$ 9 accordance ) *apt] #ea & sub*apt] ,,iii ( *apt] #ec ( title #e1 ,unit$ ,/ates ,code4 7#d7 ,report+ ,! ,secret>y %all e/abli% & ma9ta9 records reg>d+ ! use ( ! au?ority "u ?is subsection1 includ+-- 7,a7 ! numb] ( positions fill$ ?r\gh su* au?ority2 7,b7 ! types ( appo9tm5ts ( su* positions2 7,c7 ! titles1 occupational s]ies1 & grades ( su* positions2 7,d7 ! numb] ( positions publicly notic$ to be fill$ "u su* au?ority2 7,e7 ! numb] ( qualifi$ applicants :o apply = su* positions2 7,f7 ! qualification crit]ia = su* positions2 & 7,g7 ! demographic in=mation ( individuals appo9t$ to su* positions4 7#e7 ,notification to ,congress ,9 ! ev5t ! ,secret>y1 )9 a s+le fiscal ye>1 directly appo9ts m ?an #ej p]c5t ( ! individuals all[able "u ei!r subp>agraph 7,a7 or 7,b7 ( p>agraph 7#b71 ! ,secret>y %all1 n lat] ?an #ae days aft] ! date ( su* action1 notify ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 ,su* notification %all1 9 a mann] t protects p]sonal privacy1 to ! ext5t requir$ by applicable ,f$]al & ,/ate privacy law1 at a m9imum1 include-- 7,a7 in=mation on ea* su* appo9tm5t )9 su* fiscal ye>2 7,b7 a description ( h[ ea* su* position relates to ! requirem5ts ( subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a72 & 7,c7 ! additional numb] ( p]sonnel1 if any1 ! ,secret>y anticipates to be necess>y to adequately support a response to a public heal? em]g5cy decl>$ "u ?is section us+ ! au?orities describ$ 9 p>agraph 7#a7 )9 su* fiscal ye>4 7#f7 ,reports to ,congress ,n lat] ?an ,septemb] #cj1 #bjbc1 & annually !reaft] = ea* fiscal ye> 9 :i* ! au?ority "u ?is subsection is us$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+ ! total numb] ( appo9tm5ts fill$ "u ?is subsection )9 ! fiscal ye> & a description ( h[ ! positions relate to ! requirem5ts ( subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a74 7#g7 ,sunset ,! au?ority "u ?is subsection %all expire on ,septemb] #cj1 #bjbh4 4 7b7 ,,gao report ,n lat] ?an #a ye> aft] ! issuance ( ! initial report "u subsection 7g77#f7 ( section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d71 z add$ by subsection 7a71 & aga9 #ahj days aft] ! date on :i* ! au?ority provid$ "u section #cai7;g7 ( su* ,act expires pursuant to p>agraph 7#g7 ( su* section1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! use ( ! au?ority provid$ "u su* section4 ,su* report %all1 9 a mann] t protects p]sonal privacy1 at a m9imum1 include in=mation on-- 7#a7 ! numb] ( positions publicly notic$ & fill$ "u ! au?ority ( ea* ( subp>agraphs 7,a7 & 7,b7 ( su* section #cai7;g77#a72 7#b7 ! occupational s]ies1 grades1 & types ( appo9tm5ts ( su* positions2 7#c7 h[ su* positions relat$ to address+ a ne$ or %ortage describ$ 9 subp>agraph 7,a7 or 7,b7 ( su* section2 7#d7 h[ ! ,secret>y ( ,heal? & ,human ,s]vices made appo9tm5t decisions "u ea* ( subp>agraphs 7,a7 & 7,b7 ( su* section2 7#e7 s\rces us$ to id5tify c&idates = fill+ su* positions2 7#f7 ! numb] ( individuals appo9t$ "u ea* su* subp>agraph2 7#g7 aggregat$ demographic in=mation relat$ to individuals appo9t$ "u ea* su* subp>agraph2 & 7#h7 any *all5ges1 limitations1 or gaps relat$ to ! use ( ! au?ority "u ea* su* subp>agraph & any relat$ recomm5dations to address su* *all5ges1 limitations1 or gaps4 #bbd4 ,ext5sion ( au?orities to support heal? pr(essional volunte]s at community heal? c5t]s ,section #bbd7q7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcc7q77 is am5d$ by /rik+ p>agraph 7#f74 #bbe4 ,increas+ educational opportunities = alli$ heal? pr(essions ,section #gee7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bid;e7b77 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,increas+ educational opportunities 9 physical !rapy1 occupational !rapy1 respiratory !rapy1 audiology1 & spee*-language pa?ology pr(essions1 :i* may include (f]+ s*ol>%ips or /ip5ds & c>ry+ out o!r activities to improve ret5tion1 = individuals f disadvantag$ backgr\nds or individuals :o are und]repres5t$ 9 su* pr(essions4 4 #bbf4 ,public ,heal? ,s]vice ,corps annual & sick leave 7a7 ,9 g5]al ,section #bai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #baj-a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ ,res]ve ,corps & ins]t+ ,ready ,res]ve ,corps2 & 7,b7 by /rik+ 3 ,provid$1 ,t su* regulations %all n au?orize annual leave to be accumulat$ 9 excess ( sixty days2 7#b7 by ins]t+ aft] subsection 7a7 ! foll[+3 7b7 ,! regulations describ$ 9 subsection 7a7 may au?orize accumulat$ annual leave ( n m ?an #abj days = any commission$ (fic] ( ! ,regul> ,corps or (fic] ( ! ,ready ,res]ve ,corps on active duty4 2 & 7#c7 by r$esignat+ subsection 7d7 z subsection 7c74 7b7 ,application ,! am5dm5ts made by subsection 7a7 %all apply ) respect to accumulat$ annual leave 7z def9$ 9 section #bai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #baj-a77 t a commission$ (fic] ( ! ,regul> ,corps or (fic] ( ! ,ready ,res]ve ,corps on active duty w\ld1 b = ! regulations describ$ 9 su* section1 lose at ! end ( fiscal ye> #bjbb or a subsequ5t fiscal ye>4 ,d ,improv+ public heal? responses #bca4 ,c5t]s = public heal? prep>$ness & response 7a7 ,9 g5]al ,section #cai;,f ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f7 is am5d$-- 7#a7 by /rik+ subsection 7d7 & ins]t+ ! foll[+3 7d7 ,c5t]s = ,public ,heal? ,prep>$ness & ,response 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 may aw>d grants1 contracts1 or coop]ative agreem5ts to in/itutions ( high] education1 includ+ accr$it$ s*ools ( public heal?1 or o!r nonpr(it private entities to e/abli% or ma9ta9 a network ( ,c5t]s = ,public ,heal? ,prep>$ness & ,response 7ref]r$ to 9 ?is subsection z ,c5t]s74 7#b7 ,eligibility ,to be eligible to receive an aw>d "u ?is subsection1 an entity %all submit to ! ,secret>y an application conta9+ su* in=mation z ! ,secret>y may require1 includ+ a description ( h[ ! entity w-- 7,a7 coord9ate relevant activities ) applicable ,/ate1 local1 & ,tribal heal? dep>tm5ts & (ficials1 heal? c>e facilities1 & heal? c>e coalitions to improve public heal? prep>$ness & response1 z in=m$ by ! public heal? prep>$ness & response ne$s ( ! community1 or communities1 involv$2 7,b7 prioritize ef=ts to implem5t evid5ce-in=m$ or evid5ce-bas$ practices to improve public heal? prep>$ness & response1 includ+ by help+ to r$uce ! transmission ( em]g+ infecti\s diseases2 & 7,c7 use funds aw>d$ "u ?is subsection1 includ+ by c>ry+ out any activities describ$ 9 p>agraph 7#c74 7#c7 ,use ( funds ,! ,c5t]s e/abli%$ or ma9ta9$ "u ?is subsection %all use funds aw>d$ "u ?is subsection to c>ry out activities to advance public heal? prep>$ness & response capabilities1 :i* may include-- 7,a7 id5tify+1 translat+1 & dissem9at+ promis+ rese>* f9d+s or /rategies into evid5ce-in=m$ or evid5ce-bas$ practices to in=m prep>$ness =1 & responses to1 *emical1 biological1 radiological1 or nucle> ?reats1 includ+ em]g+ infecti\s diseases1 & o!r public heal? em]g5cies1 :i* may include conduct+ rese>* relat$ to public heal? prep>$ness & response sy/ems2 7,b7 improv+ aw>5ess ( su* evid5ce-in=m$ or evid5ce-bas$ practices & o!r relevant sci5tific or public heal? in=mation among heal? c>e pr(essionals1 public heal? pr(essionals1 o!r /akehold]s1 & ! public1 includ+ ?r\gh ! developm5t1 evaluation1 & dissem9ation ( tra9+s & tra9+ mat]ials1 consi/5t ) section #bhjb7;b77#b71 z applicable & appropriate1 & ) consid]ation giv5 to exi/+ tra9+ mat]ials1 to support prep>$ness =1 & responses to1 su* ?reats2 7,c7 utiliz+ & exp&+ relevant te*nological & analytical capabilities to in=m public heal? & m$ical prep>$ness & response ef=ts2 7,d7 exp&+ activities1 includ+ ?r\gh public-private p>tn]%ips1 relat$ to public heal? prep>$ness & response1 includ+ p>ticipation 9 drills & ex]cises & tra9+ public heal? exp]ts1 z appropriate2 & 7,e7 provid+ te*nical assi/ance & exp]tise t relies on evid5ce-bas$ practices1 z applicable1 relat$ to responses to public heal? em]g5cies1 z appropriate1 to ,/ate1 local1 & ,tribal heal? dep>tm5ts & o!r entities pursuant to p>agraph 7#b77;,a74 7#d7 ,di/ribution ( aw>ds ,9 aw>d+ grants1 contracts1 or coop]ative agreem5ts "u ?is subsection1 ! ,secret>y %all support n few] ?an #aj ,c5t]s1 subject to ! availability ( appropriations1 & ensure t su* aw>ds are equitably di/ribut$ among ! geographical regions ( ! ,unit$ ,/ates4 2 & 7#b7 9 subsection 7f77#a77;,c71 by /rik+ 1 ( :i* #e1jjj1jjj %all be us$ to c>ry out p>agraphs 7#c7 ?r\gh 7#e7 ( su* subsection4 7b7 ,repeal ,section #cai;,g ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g7 is repeal$4 #bcb4 ,vacc9e di/ribution plans ,section #cai;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by ins]t+ 1 or o!r f$]ally pur*as$ vacc9e to address ano!r p&emic be=e ! p]iod at ! end ( ! fir/ s5t5ce2 & 7,b7 by ins]t+ or o!r p&emic be=e ! p]iod at ! end ( ! second s5t5ce2 & 7#b7 9 subsection 7d71 by ins]t+ or o!r p&emics aft] influ5za p&emics4 #bcc4 ,coord9ation & collaboration reg>d+ blood supply 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 or ! ,secret>y's designee1 %all-- 7#a7 ensure coord9ation & collaboration betwe5 relevant ,f$]al dep>tm5ts & ag5cies relat$ to ! safety & availability ( ! blood supply1 includ+-- 7,a7 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+ ! ,(fice ( ! ,assi/ant ,secret>y = ,heal?1 ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,food & ,drug ,adm9i/ration1 ! ,(fice ( ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,national ,in/itutes ( ,heal?1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 & ! ,heal? ,res\rces & ,s]vices ,adm9i/ration2 7,b7 ! ,dep>tm5t ( ,def5se2 & 7,c7 ! ,dep>tm5t ( ,vet]ans ,affairs2 & 7#b7 consult & communicate ) private /akehold]s1 includ+ blood collection e/abli%m5ts1 heal? c>e provid]s1 accr$itation organizations1 rese>*]s1 & pati5ts1 reg>d+ issues relat$ to ! safety & availability ( ! blood supply4 7b7 ,/reaml9+ blood donor input ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! collection ( in=mation to :i* a response is volunt>y & t is initiat$ by ! ,secret>y ( ,heal? & ,human ,s]vices to solicit in=mation f blood donors or pot5tial blood donors to support ! developm5t ( recomm5dations by ! ,secret>y conc]n+ blood donation4 ,,iii ,accel]at+ rese>* & c\nt]measure discov]y ,a ,fo/]+ rese>* & developm5t & improv+ coord9ation #cja4 ,rese>* & activities relat$ to 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 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 infection2 & 7#b7 9 consultation ) heal? pr(essional associations1 rese>*]s1 & o!r relevant exp]ts1 develop & in=m recomm5dations1 guidance1 & provide educational mat]ials = heal? c>e provid]s & ! g5]al public on ! long-t]m effects ( ,,s>s-,co,v-#b infection1 consi/5t ) ! f9d+s ( /udies & rese>* "u p>agraph 7#a74 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 ,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 #cjb4 ,rese>* c5t]s = pa?og5s ( p&emic conc]n ,subp>t #f ( "p ,c ( title ,,iv ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #ddg;,c 7#db ,u4,s4,c4 #bhe;f-#d7 ! foll[+3 #ddg;,d4 ,rese>* c5t]s = pa?og5s ( p&emic conc]n 7a7 ,9 g5]al ,! ,director ( ! ,in/itute1 9 collaboration1 z appropriate1 ) ! directors ( applicable in/itutes1 c5t]s1 & divisions ( ! ,national ,in/itutes ( ,heal?1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 & ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 %all e/abli% or cont9ue a multidiscipl9>y rese>* program to advance ! discov]y & precl9ical developm5t ( m$ical products = priority virus families & o!r viral pa?og5s ) a significant pot5tial to cause a p&emic1 ?r\gh support = rese>* c5t]s4 7b7 ,uses ( funds ,! ,director ( ! ,in/itute %all aw>d fund+ ?r\gh grants1 contracts1 or coop]ative agreem5ts to public or private entities to provide support = rese>* c5t]s describ$ 9 subsection 7a7 = ! purpose (-- 7#a7 conduct+ basic rese>* ?r\gh precl9ical developm5t ( new m$ical products or te*nologies1 includ+ plat=m te*nologies1 to address pa?og5s ( p&emic conc]n2 7#b7 id5tify+ pot5tial t>gets = !rapeutic c&idates1 includ+ antivirals1 to treat su* pa?og5s2 7#c7 id5tify+ exi/+ m$ical products ) ! pot5tial to address su* pa?og5s1 includ+ c&idates t c\ld be us$ 9 outpati5t sett+s2 & 7#d7 c>ry+ out or support+ o!r rese>* relat$ to m$ical products to address su* pa?og5s1 z det]m9$ appropriate by ! ,director4 7c7 ,coord9ation ,! ,director ( ! ,in/itute %all1 z appropriate1 provide = ! coord9ation ( activities among ! c5t]s describ$ 9 subsection 7a71 includ+ ?r\gh-- 7#a7 facilitat+ ! ex*ange ( in=mation & regul> communication among ! c5t]s1 z appropriate2 & 7#b7 requir+ ! p]iodic prep>ation & submission to ! ,director ( reports on ! activities ( ea* c5t]4 7d7 ,priority ,9 aw>d+ fund+ ?r\gh grants1 contracts1 or coop]ative agreem5ts "u subsection 7a71 ! ,director ( ! ,in/itute %all1 z appropriate1 give priority to applicants ) exi/+ frameworks & p>tn]%ips1 z applicable1 to support ! advancem5t ( su* rese>*4 7e7 ,collaboration ,! ,director ( ! ,in/itute %all-- 7#a7 collaborate ) ! heads ( o!r appropriate ,f$]al dep>tm5ts1 ag5cies1 & (fices ) respect to ! id5tification ( additional priority virus families & o!r viral pa?og5s ) a significant pot5tial to cause a p&emic2 & 7#b7 collaborate ) ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority ) respect to ! rese>* conduct$ by c5t]s describ$ 9 subsection 7a71 includ+1 z appropriate1 provid+ any updates on ! rese>* advancem5ts made by su* c5t]s1 id5tify+ any advanc$ rese>* & developm5t ne$s = su* c\nt]measures1 consi/5t ) section #cai,l7a77#f71 & tak+ into consid]ation exi/+ manufactur+ capacity & future capacity ne$s = su* m$ical products or te*nologies1 includ+ plat=m te*nologies1 support$ by ! c5t]s describ$ 9 subsection 7a74 7f7 ,supplem5t1 n supplant ,any support receiv$ by a c5t] describ$ 9 subsection 7a7 "u ?is section %all be us$ to supplem5t1 & n supplant1 o!r public or private support = activities au?oriz$ to be support$4 4 #cjc4 ,improv+ m$ical c\nt]measure rese>* coord9ation ,section #djb7;b7 9 ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;b77 is am5d$-- 7#a7 9 p>agraph 7#bd71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#be71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7#c7 by ins]t+ aft] p>agraph 7#be7 ! foll[+3 7#bf7 %all consult ) ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 & ! heads ( o!r ,f$]al ag5cies & (fices1 z appropriate1 reg>d+ rese>* ne$s to advance m$ical c\nt]measures to diagnose1 mitigate1 prev5t1 or treat h>m f any biological ag5t or tox91 includ+ em]g+ infecti\s diseases1 *emical1 radiological1 or nucle> ag5t t may cause a public heal? em]g5cy or o!r rese>* ne$s relat$ to em]g+ public heal? ?reats2 4 #cjd4 ,access+ specim5 samples & diagno/ic te/s 7a7 ,improv+ rese>* & developm5t ( m$ical c\nt]measures = novel pa?og5s 7#a7 ,sample access ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all make publicly available policies & proc$ures relat$ to public & private entities access+ specim5s (1 or specim5s conta9+1 pa?og5s or suitable surrogates =1 or alt]natives to1 su* pa?og5s z ! ,secret>y det]m9es appropriate to support public heal? prep>$ness & response activities or biom$ical rese>* = purposes ( ! developm5t & validation1 z applicable1 ( m$ical products to address em]g+ infecti\s diseases & = use to o!rwise respond to em]g+ infecti\s diseases4 ,su* policies & proc$ures %all take into acc\nt1 z appropriate1 any applicable exi/+ ,f$]al res\rces4 7#b7 ,guidance ,! ,secret>y %all issue guidance reg>d+ ! proc$ures = c>ry+ out p>agraph 7#a71 includ+-- 7,a7 ! me?od = reque/+ su* samples2 7,b7 consid]ations = sample availability & use ( suitable surrogates or alt]natives to su* pa?og5s1 z appropriate1 includ+ applicable safegu>d & security measures2 & 7,c7 in=mation requir$ to be provid$ 9 ord] to receive su* samples or suitable surrogates or alt]natives4 7b7 ,e>li] developm5t ( diagno/ic te/s ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #cai;,a 7#db ,u4,s4,c4 #bdg;d-#a7 ! foll[+3 #cai;,b4 ,e>li] developm5t ( diagno/ic te/s ,! ,secret>y may contract ) public & private entities1 z appropriate1 to increase capacity 9 ! rapid developm5t1 validation1 manufacture1 & dissem9ation ( 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 em]g+ 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 ,b ,improv+ biosafety & biosecurity #caa4 ,improv+ control & ov]sight ( select biological ag5ts & tox9s ,section #cea;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb;a7 is am5d$-- 7#a7 9 subsection 7b77#a71 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 prop] tra9+1 includ+ ) respect to notification requirem5ts "u ?is section1 (-- 7i7 individuals :o are involv$ 9 ! h&l+ & use ( su* ag5ts & tox9s1 includ+ appropriate skills to h&le su* ag5ts & tox9s2 7ii7 individuals ^: responsibilities r\t9ely place !m 9 close proximity to laboratory facilities 9 :i* su* ag5ts & tox9s are be+ transf]r$1 possess$1 or us$2 & 7iii7 individuals :o p]=m adm9i/rative or ov]sight functions ( ! facility relat$ to ! transf]1 possession1 or use ( su* ag5ts & tox9s on behalf ( regi/]$ p]sons2 2 7#b7 9 subsection 7e77#a71 by /rik+ 7includ+ ! risk ( use 9 dome/ic or int]national t]rorism7 & ins]t+ 7includ+ risks pos$ by ! release1 !ft1 or loss ( su* ag5t or tox91 or use 9 dome/ic or int]national t]rorism72 7#c7 9 subsection 7k7-- 7,a7 by r$esignat+ p>agraphs 7#a7 & 7#b7 z p>agraphs 7#b7 & 7#c71 respectively2 7,b7 by ins]t+ be=e p>agraph 7#b71 z s r$esignat$1 ! foll[+3 7#a7 ,notification ) respect to f$]al facilities ,9 ! ev5t ( ! release1 loss1 or !ft ( an ag5t or tox9 li/$ by ! ,secret>y pursuant to subsection 7a77#a71 or by ! ,secret>y ( ,agriculture pursuant to section #bab7;a77#a7 ( ! ,agricultural ,biot]rorism ,protection ,act ( #bjjb1 f or )9 a laboratory facility own$ or op]at$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 or o!r ,f$]al laboratory facility subject to ! requirem5ts ( ?is section1 ! ,secret>y1 9 a mann] t does n compromise national security1 %all-- 7,a7 n lat] ?an #gb h\rs aft] su* ev5t is report$ to ! ,secret>y1 notify ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives ( su* ev5t1 includ+-- 7i7 ! ,f$]al laboratory facility 9 :i* su* release1 loss1 or !ft occurr$2 & 7ii7 ! circum/ances ( su* release1 loss1 or !ft2 & 7,b7 n lat] ?an #ad days aft] su* notification1 update su* ,committees on-- 7i7 any actions tak5 or plann$ by ! ,secret>y to mitigate any pot5tial ?reat su* release1 loss1 or !ft may pose to public heal? & safety2 & 7ii7 any actions tak5 or plann$ by ! ,secret>y to review ! circum/ances ( su* release1 loss1 or !ft1 & prev5t simil> ev5ts4 2 & 7,c7 by am5d+ p>agraph 7#b71 z s r$esignat$1 to read z foll[s3 7#b7 ,annual report ,! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on an annual basis a report-- 7,a7 summ>iz+ ! numb] & nature ( notifications receiv$ "u subsection 7e77#h7 7relat+ to !ft or loss7 & subsection 7j7 7relat+ to releases71 dur+ ! prec$+ fiscal ye>2 7,b7 describ+ actions tak5 by ! ,secret>y to address su* incid5ts1 su* z any corrective action plans requir$ & /eps tak5 to promote adh]5ce to1 & compliance )1 safety & security be/ practices1 /&>ds1 & regulations2 & 7,c7 describ+ any gaps1 *all5ges1 or limitations ) respect to ensur+ t su* safety & security practices are consi/5tly appli$ & adh]$ to1 & actions tak5 to address su* gaps1 *all5ges1 or limitations4 2 & 7#d7 9 subsection 7m71 by /rik+ fiscal ye>s #bjjb ?r\gh #bjjg & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg4 #cab4 ,/rategy = ,f$]al high-conta9m5t laboratories 7a7 ,/rategy = ,f$]al high-,conta9m5t laboratories ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,(fice ( ,sci5ce & ,te*nology ,policy1 9 consultation ) relevant ,f$]al ag5cies & dep>tm5ts1 %all e/abli% a /rategy = ! managem5t1 ma9t5ance1 & ov]sight ( f$]ally-own$ laboratory facilities capable ( op]at+ at ,biosafety ,level #c or #d1 includ+ equival5t classification levels4 ,su* /rategy %all include-- 7#a7 a description ( ! roles & responsibilities ( relevant ,f$]al dep>tm5ts & ag5cies ) respect to ! managem5t1 ma9t5ance1 & ov]sight ( ,biosafety ,level #c or #d laboratory facilities2 7#b7 an assessm5t ( ! ne$s ( ! ,f$]al ,gov]nm5t ) respect to ,biosafety ,level #c or #d laboratory facilities2 7#c7 a summ>y ( exi/+ f$]ally-own$ ,biosafety ,level #c or #d laboratory facility capacity2 7#d7 a summ>y ( o!r ,biosafety ,level #c or #d laboratory facility capacity e/abli%$ ?r\gh ,f$]al funds2 7#e7 a description ( h[ ! capacity describ$ 9 p>agraphs 7#c7 & 7#d7 addresses ! ne$s ( ! ,f$]al ,gov]nm5t1 includ+-- 7,a7 h[ relevant ,f$]al dep>tm5ts & ag5cies coord9ate to provide access to appropriate laboratory facilities to r$uce unnecess>y duplication2 & 7,b7 any gaps 9 su* capacity relat$ to su* ne$s2 7#f7 a summ>y ( plans t are 9 place = ! ma9t5ance ( su* capacity1 z applicable & appropriate1 includ+ processes = det]m9+ :e!r to ma9ta9 or exp& su* capacity1 & a description ( h[ ! ,f$]al ,gov]nm5t w address rapid *anges 9 ! ne$ = su* capacity dur+ a public heal? em]g5cy2 & 7#g7 a description ( h[ ! heads ( relevant ,f$]al dep>tm5ts & ag5cies w coord9ate to ensure appropriate ov]sight ( f$]ally-own$ laboratory facility capacity & lev]age su* capacity1 z appropriate1 to fulfill ! ne$s ( multiple ,f$]al dep>tm5ts & ag5cies 9 ord] to r$uce unnecess>y duplication & improve collaboration )9 ! ,f$]al ,gov]nm5t4 #cac4 ,national ,sci5ce ,advisory ,bo>d = ,biosecurity 7a7 ,9 g5]al ,"p ,a ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq47 is am5d$ by add+ at ! end ! foll[+3 #djd,o4 ,national ,sci5ce ,advisory ,bo>d = ,biosecurity 7a7 ,e/abli%m5t ,! ,secret>y1 act+ ?r\gh ! ,director ( ,,nih1 %all e/abli% an advisory committee1 to be kn[n z ! ,national ,sci5ce ,advisory ,bo>d = ,biosecurity 7ref]r$ to 9 ?is section z ! ,bo>d74 7b7 ,duties 7#a7 ,9 g5]al ,! ,national ,sci5ce ,advisory ,bo>d = ,biosecurity ref]r$ to 9 section #bje ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,act 7,public ,law #aji-dag7 7ref]r$ to 9 ?is section z ! ,bo>d7 %all provide te*nical advice1 guidance1 or recomm5dations1 to relevant ,f$]al dep>tm5ts & ag5cies relat$ to biosafety & biosecurity ov]sight ( biom$ical rese>*1 includ+-- 7,a7 ov]sight ( f$]ally-conduct$ or f$]ally-support$ dual use biom$ical rese>*1 su* z ! review ( policies or frameworks us$ to assess & appropriately manage safety & security risks associat$ ) su* rese>*1 tak+ into consid]ation national security conc]ns1 ! pot5tial b5efits ( su* rese>*1 consid]ations relat$ to ! rese>* community1 transp>5cy1 & public availability ( in=mation1 & int]national rese>* collaboration2 & 7,b7 cont9u+ to c>ry out ! activities requir$ "u section #bje ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,act 7,public ,law #aji-dag74 7c7 ,consid]ations ,9 c>ry+ out ! duties "u subsection 7b71 ! ,bo>d may consid] /rategies to improve ! safety & security ( biom$ical rese>*1 includ+ ?r\gh-- 7#a7 lev]ag+ or us+ new te*nologies & sci5tific advancem5ts to r$uce safety & security risks associat$ ) su* rese>* & improve conta9m5t ( pa?og5s2 & 7#b7 outrea* to1 & education & tra9+ (1 rese>*]s1 laboratory p]sonnel1 & o!r appropriate individuals ) respect to safety & security risks associat$ ) su* rese>* & mitigation ( su* risks4 7d7 ,memb]%ip ,! ,bo>d %all be compos$ ( ! foll[+3 7#a7 ,non-vot+1 ex (ficio memb]s1 includ+ ! foll[+3 7,a7 ,at lea/ "o repres5tative ( ea* ( ! foll[+3 7i7 ,! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7ii7 ,! ,dep>tm5t ( ,def5se4 7iii7 ,! ,dep>tm5t ( ,agriculture4 7iv7 ,! ,dep>tm5t ( ,homel& ,security4 7v7 ,! ,dep>tm5t ( ,en]gy4 7vi7 ,! ,dep>tm5t ( ,/ate4 7vii7 ,! ,(fice ( ,sci5ce & ,te*nology ,policy4 7viii7 ,! ,(fice ( ! ,director ( ,national ,intellig5ce4 7,b7 ,repres5tatives ( su* o!r ,f$]al dep>tm5ts or ag5cies z ! ,secret>y det]m9es appropriate to c>ry out ! requirem5ts ( ?is section4 7#b7 ,individuals1 appo9t$ by ! ,secret>y1 ) exp]tise 9 biology1 infecti\s diseases1 public heal?1 e?ics1 national security1 & o!r fields1 z ! ,secret>y det]m9es appropriate1 :o %all s]ve z vot+ memb]s4 4 7b7 ,ord]ly transition ,! ,secret>y ( ,heal? & ,human ,s]vices %all take su* /eps z are necess>y to provide = ! ord]ly transition to ! au?ority ( ! ,national ,sci5ce ,advisory ,bo>d = ,biosecurity e/abli%$ "u section #djd,o ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 f any au?ority ( ! ,bo>d describ$ 9 section #bje ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,act 7,public ,law #aji-dag71 z 9 effect on ! day be=e ! date ( enactm5t ( ?is ,act4 7c7 ,application ,! requirem5ts "u section #djd,o ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 relat$ to ! mission1 activities1 or functions ( ! ,national ,sci5ce ,advisory ,bo>d = ,biosecurity %all n apply until ! completion ( any "w und]tak5 by su* ,bo>d be=e ! date ( enactm5t ( ?is ,act4 #cad4 ,rese>* to improve biosafety 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all1 z appropriate1 conduct or support rese>* to improve ! safe conduct ( biom$ical rese>* activities involv+ pa?og5s ( p&emic pot5tial or biological ag5ts or tox9s li/$ pursuant to section #cea;,a7a77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb;a7a77#a774 7b7 ,report ,n lat] ?an #e ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,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 ( any rese>* conduct$ or support$ "u ?is section1 any relevant f9d+s1 & /eps ! ,secret>y is tak+ to dissem9ate any su* f9d+s to support ! r$uction ( risks associat$ ) biom$ical rese>* involv+ pa?og5s ( p&emic pot5tial or biological ag5ts or tox9s li/$ pursuant to section #cea;,a7a77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb;a7a77#a774 #cae4 ,f$]ally-fund$ rese>* ) enhanc$ pa?og5s ( p&emic pot5tial 7a7 ,review & ov]sight ( enhanc$ pa?og5s ( p&emic pot5tial 7#a7 ,9 g5]al ,! ,director ( ! ,(fice ( ,sci5ce & ,te*nology ,policy 7ref]r$ to 9 ?is section z ! ,director71 9 consultation ) ! heads ( relevant ,f$]al dep>tm5ts & ag5cies1 %all-- 7,a7 n lat] ?an #a ye>s aft] ! date ( enactm5t ( ?is ,act-- 7i7 cont9ue or conduct a review ( exi/+ ,f$]al policies relat$ to rese>* propos$ = ,f$]al fund+ t may be reasonably anticipat$ to involve ! creation1 transf]1 or use ( pa?og5s ( p&emic pot5tial2 & 7ii7 e/abli% or update a ,f$]al policy = ! consi/5t review & ov]sight ( su* propos$ rese>* t appropriately consid]s ! risks associat$ )1 & pot5tial b5efits (1 su* rese>*2 & 7,b7 n less ?an e #d ye>s !reaft]1 review & update su* policy1 z necess>y & appropriate1 to ensure t su* policy fully acc\nts = relevant rese>* t may be reasonably anticipat$ to involve ! creation1 transf]1 or use ( enhanc$ pa?og5s ( p&emic pot5tial1 takes into consid]ation ! b5efits ( su* rese>*1 & supports ! mitigation ( relat$ risks4 7#b7 ,requirem5ts ,! policy e/abli%$ pursuant to p>agraph 7#a7 %all include-- 7,a7 a cle> scope to support ! consi/5t id5tification ( rese>* proposals subject to su* policy by relevant ,f$]al dep>tm5ts & ag5cies2 7,b7 a framework = su* reviews t acc\nts = safety1 security1 & e?ical consid]ations relat$ to ! creation1 transf]1 or use ( enhanc$ pa?og5s ( p&emic pot5tial2 7,c7 measures to enhance ! transp>5cy & public availability ( in=mation relat$ to su* rese>* activities 9 a mann] t does n compromise national security1 ! safety & security ( su* rese>* activities1 or any id5tifiable1 s5sitive in=mation ( relevant individuals2 & 7,d7 consi/5t proc$ures across relevant ,f$]al dep>tm5t & ag5cies to ensure t-- 7i7 propos$ rese>* t has be5 det]m9$ to h sci5tific & te*nical m]it & may be subject to su* policy is id5tifi$ & ref]r$ = review2 7ii7 subject$ rese>* activities conduct$ "u an aw>d1 includ+ activities und]tak5 by any subrecipi5ts ( su* aw>d1 are monitor$ regul>ly ?r\gh\t ! project p]iod to ensure compliance ) su* policy & ! t]ms & conditions ( su* aw>d2 & 7iii7 9 ! ev5t t f$]ally-fund$ rese>* activities n subject to su* policy produce unanticipat$ results relat$ to ! creation1 transf]1 or use ( enhanc$ pa?og5s ( p&emic pot5tial1 su* rese>* activities are id5tifi$ & appropriately review$ "u su* policy4 7#c7 ,cl>ification ,reviews requir$ pursuant to ?is section %all be 9 addition to any applicable requirem5ts = rese>* project applications requir$ "u ! ,public ,heal? ,s]vice ,act1 includ+ reviews requir$ "u section #dib ( su* ,act 7#db ,u4,s4,c4 #bhi;a71 z applicable1 or o!r applicable laws4 7b7 ,implem5tation 7#a7 ,9 g5]al ,! ,director %all direct all heads ( relevant ,f$]al dep>tm5ts & ag5cies to update1 mod]nize1 or promulgate applicable implem5t+ regulations & guidance to implem5t ! requirem5ts ( ?is section4 7#b7 ,updates ,consi/5t ) ! requirem5ts "u subsection 7a77#a77;,b71 ! ,director %all require all heads ( relevant ,f$]al dep>tm5ts & ag5cies to update su* policies consi/5t ) any *anges to ! policy e/abli%$ pursuant to subsection 7a77#a74 ,c ,prev5t+ undue =eign influ5ce 9 biom$ical rese>* #cba4 ,=eign tal5t programs ,! ,secret>y ( ,heal? & ,human ,s]vices %all require disclosure ( p>ticipation 9 =eign tal5t programs1 includ+ ! provision ( copies ( all grants1 contracts1 or o!r agreem5ts relat$ to su* programs1 & o!r support+ docum5tation relat$ to su* programs1 z a condition ( receipt ( ,f$]al extramural biom$ical rese>* fund+ aw>d$ ?r\gh ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 #cbb4 ,secur+ id5tifiable1 s5sitive in=mation 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 9 consultation ) ! ,director ( ,national ,intellig5ce1 ! ,secret>y ( ,/ate1 ! ,secret>y ( ,def5se1 & o!r national security exp]ts1 z appropriate1 %all ensure t biom$ical rese>* support$ or conduct$ by ! ,national ,in/itutes ( ,heal? & o!r relevant ag5cies & (fices )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices involv+ ! sequ5c+ ( human g5omic in=mation1 & collection1 analysis1 or /orage ( id5tifiable1 s5sitive in=mation1 z def9$ 9 section #cja7;d77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda7;d77#d771 is conduct$ 9 a mann] t appropriately consid]s national security risks1 includ+ national security implications relat$ to pot5tial misuse ( su* data4 ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all ensure t ! ,national ,in/itutes ( ,heal? & o!r relevant ag5cies & (fices )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 work+ ) ! heads ( ag5cies & national security exp]ts1 includ+ ! ,(fice ( ! ,national ,security )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices-- 7#a7 develop a compreh5sive framework = assess+ & manag+ su* national security risks t includes-- 7,a7 crit]ia = h[ & :5 to conduct risk assessm5ts = projects t may h national security implications2 7,b7 security controls & tra9+ = rese>*]s or entities1 includ+ pe] review]s1 t manage or h access to su* data2 & 7,c7 me?ods to incorporate risk-r$uction 9 ! process = fund+ su* projects t may h national security implications2 7#b7 n lat] ?an #a ye> aft] ! risk framework is develop$ "u p>agraph 7#a71 develop & implem5t controls to-- 7,a7 ensure t rese>*]s or entities t manage or h access to su* data h compli$ ) ! requirem5ts ( p>agraph 7#a7 & ongo+ requirem5ts ) su* p>agraph2 & 7,b7 ensure t data access committees review+ data access reque/s = projects t may h national security risks1 z appropriate1 include memb]s ) exp]tise 9 curr5t & em]g+ national security ?reats1 9 ord] to make appropriate decisions relat$ to access to su* id5tifiable1 s5sitive in=mation2 & 7#c7 n lat] ?an #b ye>s aft] ! risk framework is develop$ "u p>agraph 7#a71 update data access & %>+ policies relat$ to human g5omic data1 z appropriate1 bas$ on curr5t & em]g+ national security ?reats4 7b7 ,congressional brief+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all provide a brief+ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,select ,committee on ,intellig5ce ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,p]man5t ,select ,committee on ,intellig5ce ( ! ,h\se ( ,repres5tatives on ! activities requir$ "u subsection 7a74 #cbc4 ,duties ( ! ,director ,section #djb7;b7 9 ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;b771 z am5d$ by section #cjc1 is fur!r am5d$ by ins]t+ aft] p>agraph 7#bf7 7z add$ by section #cjc7 ! foll[+3 7#bg7 %all consult ) ! ,director ( ! ,(fice ( ,national ,security )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,director ( ,national ,intellig5ce1 ! ,director ( ! ,f$]al ,bureau ( ,inve/igation1 & ! heads ( o!r appropriate ag5cies on a regul> basis1 reg>d+ biom$ical rese>* conduct$ or support$ by ! ,national ,in/itutes ( ,heal? t may affect or be affect$ by matt]s ( national security2 7#bh7 %all ensure t recipi5ts ( aw>ds f ! ,national ,in/itutes ( ,heal?1 &1 z appropriate & practicable1 entities collaborat+ ) su* recipi5ts1 h 9 place & are adh]+ to appropriate te*nology practices & policies = ! security ( id5tifiable1 s5sitive in=mation1 includ+ in=mation collect$1 /or$1 or analyz$ by dome/ic & non-dome/ic entities2 & 7#bi7 %all ensure t recipi5ts ( aw>ds f ! ,national ,in/itutes ( ,heal? are 9 compliance ) ! t]ms & conditions ( su* aw>d1 :i* may include activities to support aw>5ess (1 & compliance )1 su* t]ms & conditions by any subrecipi5ts ( ! aw>d4 4 #cbd4 ,protect+ ,am]ica's biom$ical rese>* ent]prise 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 9 collaboration ) ,assi/ant to ! ,presid5t = ,national ,security ,affairs1 ! ,director ( ,national ,intellig5ce1 ! ,director ( ! ,f$]al ,bureau ( ,inve/igation1 & ! heads ( o!r relevant dep>tm5ts & ag5cies1 & 9 consultation ) rese>* in/itutions & rese>* advocacy organizations or o!r relevant exp]ts1 z appropriate1 %all-- 7#a7 id5tify ways to improve ! protection ( intellectual prop]ty & o!r propriet>y in=mation1 z well z id5tifiable1 s5sitive in=mation ( p>ticipants 9 biom$ical rese>* & developm5t1 f national security risks & o!r applicable ?reats1 includ+ ! id5tification ( gaps 9 policies & proc$ures 9 su* areas relat$ to biom$ical rese>* & developm5t support$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices & biom$ical rese>* support$ by o!r ag5cies z applicable1 & make recomm5dations to in/itutions ( high] education or o!r entities t h traditionally receiv$ ,f$]al fund+ = biom$ical rese>* to protect su* in=mation2 7#b7 id5tify or develop /rategies to prev5t1 mitigate1 & address national security ?reats 9 biom$ical rese>* & developm5t support$ by ! ,f$]al ,gov]nm5t1 includ+ su* ?reats associat$ ) =eign tal5t programs1 by c\ntries seek+ to exploit ,unit$ ,/ates te*nology & o!r propriet>y in=mation z x relates to su* biom$ical rese>* & developm5t2 7#c7 id5tify national security risks & pot5tial misuse ( propriet>y in=mation1 & id5tifiable1 s5sitive in=mation ( biom$ical rese>* p>ticipants & o!r applicable risks1 includ+ ) respect to pe] review1 & make recomm5dations = additional policies & proc$ures to protect su* in=mation2 7#d7 develop a framework to id5tify areas ( biom$ical rese>* & developm5t support$ by ! ,f$]al ,gov]nm5t t are em]g+ areas ( int]e/ = /ate actors & w\ld compromise national security if !y 7 to be subject$ to undue =eign influ5ce2 & 7#e7 regul>ly review recomm5dations or policies develop$ "u ?is section & make additional recomm5dations or updates1 z appropriate4 7b7 ,report to ,presid5t & to ,congress ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all prep>e & submit1 9 a mann] t does n compromise national security1 to ! ,presid5t & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,select ,committee on ,intellig5ce ( ! ,s5ate1 ! ,committee on ,en]gy & ,comm]ce & ! ,p]man5t ,select ,committee on ,intellig5ce ( ! ,h\se ( ,repres5tatives1 & o!r congressional committees z appropriate1 a report on ! f9d+s & recomm5dations pursuant to subsection 7a74 #cbe4 ,,gao ,/udy 7a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! ,comptroll] ,g5]al7 %all conduct a /udy to assess ! ext5t to :i* ! ,dep>tm5t ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,dep>tm5t7 utilizes or provides fund+ to entities t utilize su* funds = human g5omic sequ5c+ s]vices or g5etic s]vices 7z su* t]m is def9$ 9 section #bja7f7 ( ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh 7#db ,u4,s4,c4 #bjjj;ff7#f777 provid$ by entities1 or subsidi>ies ( su* entities1 organiz$ "u ! laws ( a c\ntry or c\ntries ( conc]n1 9 ! e/imation ( ! ,director ( ,national ,intellig5ce or ! head ( ano!r ,f$]al dep>tm5t or ag5cy1 z appropriate4 7b7 ,consid]ations ,9 c>ry+ out ! /udy "u ?is section1 ! ,comptroll] ,g5]al %all-- 7#a7 consid]-- 7,a7 ! ext5t to :i* ! c\ntry or c\ntries ( conc]n c\ld obta9 human g5omic in=mation ( citiz5s & resid5ts ( ! ,unit$ ,/ates f su* entities t sequ5ce1 analyze1 collect1 or /ore human g5omic in=mation & :i* ! ,director ( ,national ,intellig5ce or ! head ( ano!r ,f$]al dep>tm5t or ag5cy reasonably anticipates may use su* in=mation 9 a mann] inconsi/5t ) ! national security int]e/s ( ! ,unit$ ,/ates2 7,b7 :e!r ! ,dep>tm5t or recipi5t ( su* funds f ! ,dep>tm5t s\ght to provide fund+ to1 or to use1 dome/ic entities ) no su* ties to ! c\ntry or c\ntries ( conc]n = su* purposes & any b>ri]s to ! use ( dome/ic entities2 & 7,c7 :e!r data use agreem5ts1 data security measures1 & o!r su* measures tak5 by ! ,dep>tm5t or recipi5t ( su* funds f ! ,dep>tm5t are suffici5t to protect ! id5tifiable1 s5sitive in=mation ( ! p ( ! ,unit$ ,/ates & ! national security int]e/s ( ! ,unit$ ,/ates2 & 7#b7 make recomm5dations to address any vuln]abilities to ! ,unit$ ,/ates national security id5tifi$1 z appropriate4 7c7 ,e/imation ,9 conduct+ ! /udy "u ?is section1 ! ,comptroll] ,g5]al may1 z appropriate & necess>y to complete su* /udy1 inve/igate specific in/ances ( su* utilization ( g5etic sequ5c+ s]vices or g5etic s]vices1 z describ$ 9 subsection 7a71 to produce e/imates ( ! pot5tial preval5ce ( su* utilization among entities 9 receipt ( ,dep>tm5tal funds4 7d7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit a report on ! /udy "u ?is section1 9 a mann] t does n compromise national security1 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,select ,committee on ,intellig5ce ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce & ! ,p]man5t ,select ,committee on ,intellig5ce ( ! ,h\se ( ,repres5tatives4 ,! report %all be submitt$ 9 unclassifi$ =m1 to ! ext5t practicable1 b may include a classifi$ annex4 #cbf4 ,report on progress to address undue =eign influ5ce ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act & annually !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce 9 ! ,h\se ( ,repres5tatives1 9 a mann] t does n compromise national security1 a report on actions tak5 by su* ,secret>y-- 7#a7 to address cases ( noncompliance ) disclosure requirem5ts or rese>* misconduct relat$ to =eign influ5ce1 includ+-- 7,a7 ! numb] ( pot5tial noncompliance cases inve/igat$ by ! ,national ,in/itutes ( ,heal? or report$ to ! ,national ,in/itutes ( ,heal? by a rese>* in/itution1 includ+ relat+ to undisclos$ rese>* support1 undisclos$ conflicts ( int]e/ or o!r conflicts ( commitm5t1 & pe] review violations2 7,b7 ! numb] ( cases ref]r$ to ! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,(fice ( ,national ,security ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,f$]al ,bureau ( ,inve/igation1 or o!r law en=cem5t ag5cies2 7,c7 a description ( en=cem5t actions tak5 = noncompliance relat$ to undue =eign influ5ce2 & 7,d7 any o!r relevant in=mation2 & 7#b7 to prev5t1 address1 & mitigate in/ances ( noncompliance ) disclosure requirem5ts or rese>* misconduct relat$ to =eign influ5ce4 ,,iv ,mod]niz+ & /r5g!n+ ! supply *a9 = vital m$ical products #dja4 ,w>m base manufactur+ capacity = m$ical c\nt]measures 7a7 ,9 g5]al ,section #cai,l ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is am5d$-- 7#a7 9 subsection 7a77#f77;,b7-- 7,a7 by r$esignat+ clauses 7iv7 & 7v7 z clauses 7v7 & 7vi71 respectively2 7,b7 by ins]t+ aft] clause 7iii71 ! foll[+3 7iv7 activities to support1 ma9ta91 & improve dome/ic manufactur+ surge capacity & capabilities1 z appropriate1 includ+ ?r\gh ! utilization ( advanc$ manufactur+ & plat=m te*nologies1 to increase ! availability ( products t are or may become qualifi$ c\nt]measures or qualifi$ p&emic or epidemic products2 2 & 7,c7 9 clause 7vi7 7z s r$esignat$71 by ins]t+ manufactur+1 aft] improvem5t12 7#b7 9 subsection 7b7-- 7,a7 9 ! fir/ s5t5ce ( p>agraph 7#a71 by ins]t+ support = dome/ic manufactur+ surge capacity & capabilities1 aft] initiatives = innovation12 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7ii7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,d72 & 7iii7 by ins]t+ aft] subp>agraph 7,b71 ! foll[+3 7,c7 activities to support1 ma9ta91 & improve dome/ic manufactur+ surge capacity & capabilities1 z appropriate1 includ+ ?r\gh ! utilization ( advanc$ manufactur+ & plat=m te*nologies1 to increase ! availability ( products t are or may become qualifi$ c\nt]measures or qualifi$ p&emic or epidemic products2 & 2 7#c7 9 subsection 7c7-- 7,a7 9 p>agraph 7#b77;,b71 by ins]t+ be=e ! semicolon 1 includ+ ?r\gh ! e/abli%m5t & ma9t5ance ( dome/ic manufactur+ surge capacity & capabilities1 consi/5t ) subsection 7a77#f77;,b77iv72 7,b7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,a7-- 7,i7 9 clause 7i7-- 7aa7 9 subclause 7,i71 by /rik+ & at ! end2 & 7bb7 by add+ at ! end ! foll[+3 7,,iii7 facilitat+ su* communication1 z appropriate1 reg>d+ manufactur+ surge capacity & capabilities ) respect to qualifi$ c\nt]measures & qualifi$ p&emic or epidemic products to prep>e =1 or respond to1 a public heal? em]g5cy or pot5tial public heal? em]g5cy2 & 7,,iv7 facilitat+ su* communication1 z appropriate & 9 a mann] t does n compromise national security1 ) respect to pot5tial eligibility = ! mat]ial ?reat m$ical c\nt]measure priority review v\*] program "u section #efe;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 2 7,,ii7 9 clause 7ii77,,iii71 by /rik+ & at ! end2 7,,iii7 by r$esignat+ clause 7iii7 z clause 7iv72 & 7,,iv7 by ins]t+ aft] clause 7ii71 ! foll[+3 7iii7 communicate regul>ly ) entities 9 receipt ( an aw>d pursuant to subp>agraph 7,b77v71 & facilitate communication betwe5 su* entities & o!r entities 9 receipt ( an aw>d pursuant to subp>agraph 7,b77iv71 z appropriate1 = purposes ( plann+ & response reg>d+ ! availability ( c\nt]measures & ! ma9t5ance ( dome/ic manufactur+ surge capacity & capabilities1 includ+ any plann$ uses ( su* capacity & capabilities 9 ! ne>- & mid-t]m1 & id5tification ( any significant *all5ges relat$ to ! long-t]m ma9t5ance ( su* capacity & capabilities2 & 2 7ii7 9 subp>agraph 7,b7-- 7,i7 9 clause 7iii71 by /rik+ & at ! end2 7,,ii7 9 clause 7iv71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+3 7v7 aw>d contracts1 grants1 & coop]ative agreem5ts & ent] into o!r transactions to support1 ma9ta91 & improve dome/ic manufactur+ surge capacity & capabilities1 includ+ ?r\gh support+ flexible or advanc$ manufactur+1 to ensure t additional capacity is available to rapidly manufacture products t are or may become qualifi$ c\nt]measures or qualifi$ p&emic or epidemic products 9 ! ev5t ( a public heal? em]g5cy decl>ation or significant pot5tial = a public heal? em]g5cy4 2 7iii7 9 subp>agraph 7,c7-- 7,i7 9 clause 7i71 by /rik+ & at ! end2 7,,ii7 9 clause 7ii71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+3 7iii7 consult ) ! ,commission] ( ,food & ,drugs1 pursuant to section #efe7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 to ensure t facilities p]=m+ manufactur+1 pursuant to an aw>d "u subp>agraph 7,b77v71 are 9 compliance ) applicable requirem5ts "u su* ,act & ?is ,act1 z appropriate1 includ+ curr5t good manufactur+ practice pursuant to section #eja7;a77#b77;,b7 ( ! ,food1 ,drug1 & ,cosmetic ,act2 & 2 7iv7 9 subp>agraph 7,d77i71 by ins]t+ 1 includ+ to improve manufactur+ capacities & capabilities = m$ical c\nt]measures be=e ! semicolon2 7v7 9 subp>agraph 7,e77ix71 by /rik+ #bjbc & ins]t+ #bjbh2 & 7vi7 by add+ at ! end ! foll[+3 7,g7 ,annual reports by aw>d recipi5ts ,z a condition ( receiv+ an aw>d "u subp>agraph 7,b77v71 a recipi5t %all develop & submit to ! ,secret>y annual reports relat$ to ! ma9t5ance ( su* capacity & capabilities1 includ+ ensur+ t su* capacity & capabilities are able to support ! rapid manufacture ( c\nt]measures z requir$ by ! ,secret>y4 2 & 7,c7 9 p>agraph 7#e71 by add+ at ! end ! foll[+3 7,h7 ,support+ w>m-base & surge capacity & capabilities ,pursuant to an aw>d "u subp>agraph 7,b77v71 ! ,secret>y may make paym5ts = activities necess>y to ma9ta9 dome/ic manufactur+ surge capacity & capabilities support$ "u su* aw>d to ensure t su* capacity & capabilities are able to support ! rapid manufacture ( c\nt]measures z requir$ by ! ,secret>y to prep>e =1 or respond to1 an exi/+ or pot5tial public heal? em]g5cy or o!rwise address ?reats t pose a significant level ( risk to national security4 ,! ,secret>y may support ! utilization ( su* capacity & capabilities "u aw>ds = c\nt]measure & product advanc$ rese>* & developm5t1 z appropriate1 to provide = ! ma9t5ance ( su* capacity & capabilities4 2 & 7#d7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 by /rik+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subsection & ins]t+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act2 7,b7 9 p>agraph 7#b7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ?is subsection & ins]t+ ! ,,prev5t ,p&emics ,act2 7ii7 9 subp>agraph 7,b71 by /rik+ & at ! end2 & 7iii7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,d7 plans = ! ne>-1 mid-1 & long-t]m su/a9m5t ( manufactur+ activities c>ri$ out "u ?is section1 includ+ su* activities pursuant to subsection 7c77#e77;,h71 specific actions to regul>ly assess ! ability ( recipi5ts ( an aw>d "u subsection 7c77#d77;,b77v7 to rapidly manufacture c\nt]measures z requir$ by ! ,secret>y1 & recomm5dations to address *all5ges1 if any1 relat$ to su* activities4 4 #djb4 ,supply *a9 consid]ations = ! ,/rategic ,national ,/ockpile ,subclause 7,,ii7 ( section #cai;,f-#b7;a77#b77;,b77i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#b77;,b77i77 is am5d$ to read z foll[s3 7,,ii7 plann+ consid]ations = appropriate manufactur+ capacity & capability to meet ! goals ( su* additions or modifications 7)\t disclos+ propriet>y in=mation71 includ+-- 7aa7 consid]ation ( ! effect su* additions or modifications may h on ! availability ( su* products & ancill>y m$ical supplies on ! heal? c>e sy/em2 & 7bb7 an assessm5t ( ! curr5t supply *a9 = su* products1 includ+ in=mation on supply *a9 r$undancies1 any kn[n dome/ic manufactur+ capacity = su* products1 & any relat$ vuln]abilities2 4 #djc4 ,/rategic ,national ,/ockpile equipm5t ma9t5ance ,subp>agraph 7,d7 ( section #cai;,f-#b7;a77#c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c77 is am5d$ to read z foll[s3 7,d7 review & revise1 z appropriate1 ! cont5ts ( ! /ockpile on a regul> basis to ensure t-- 7i7 em]g+ ?reats1 advanc$ te*nologies1 & new c\nt]measures are adequately consid]$2 7ii7 ! pot5tial depletion ( c\nt]measures curr5tly 9 ! /ockpile is id5tifi$ & appropriately address$1 includ+ ?r\gh necess>y repl5i%m5t2 & 7iii7 su* cont5ts are 9 work+ condition or usable1 z applicable1 & are ready = deploym5t1 :i* may include conduct+ ma9t5ance s]vices on su* cont5ts ( ! /ockpile & dispos+ ( su* cont5ts t are no long] 9 work+ condition1 or usable1 z applicable2 4 #djd4 ,improv+ transp>5cy & pr$ictability ( processes ( ! ,/rategic ,national ,/ockpile 7a7 ,guidance ,n lat] ?an #fj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all issue guidance describ+ ! processes by :i* ! ,secret>y deploys ! cont5ts ( ! ,/rategic ,national ,/ockpile "u section #cai;,f-#b7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a771 or o!rwise di/ributes m$ical c\nt]measures1 z applicable1 to ,/ates1 t]ritories1 ,indian ,tribes & ,tribal organizations 7z su* t]ms are def9$ "u section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 & o!r applicable entities4 ,su* guidance %all include in=mation relat$ to processes by :i* to reque/ access to ! cont5ts ( ! ,/rategic ,national ,/ockpile1 factors consid]$ by ! ,secret>y :5 mak+ deploym5t or di/ribution decisions1 & processes & po9ts ( contact ?r\gh :i* entities may contact ! ,secret>y to address any issues relat$ to products reque/$ or receiv$ by su* entity f ! /ockpile1 & on o!r relevant topics4 7b7 ,annual meet+s ,section #cai;,f-#b7;a77#c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c77 is am5d$-- 7#a7 9 subp>agraph 7,i71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,j71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,k7 conv5e meet+s1 n less ?an once p] ye>1 ) repres5tatives f ,/ate1 local1 & ,tribal heal? dep>tm5ts or (ficials1 relevant indu/ries1 o!r ,f$]al ag5cies1 & o!r appropriate /akehold]s1 9 a mann] t does n compromise national security1 to coord9ate & %>e in=mation relat$ to ma9t5ance & use ( ! /ockpile1 includ+ a description ( future c\nt]measure ne$s & additions1 modifications1 & repl5i%m5ts ( ! cont5ts ( ! /ockpile1 & consid]ations relat$ to ! manufactur+ & procurem5t ( products consi/5t ) ! requirem5ts ( ! ,buy ,am]ican ,act ( #aicc1 z appropriate4 4 #dje4 ,improv+ supply *a9 flexibility = ! ,/rategic ,national ,/ockpile 7a7 ,9 g5]al ,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#c77;,f71 by /rik+ z requir$ by ! ,secret>y ( ,homel& ,security & ins]t+ at ! discretion ( ! ,secret>y1 9 consultation )1 or at ! reque/ (1 ! ,secret>y ( ,homel& ,security12 7,b7 by r$esignat+ p>agraphs 7#e7 & 7#f7 z p>agraphs 7#f7 & 7#g71 respectively2 7,c7 by ins]t+ aft] p>agraph 7#d7 ! foll[+3 7#e7 ,v5dor-manag$ inv5tory & w>m-base surge capacity 7,a7 ,9 g5]al ,= ! purposes ( ma9ta9+ ! /ockpile "u p>agraph 7#a7 & c>ry+ out proc$ures "u p>agraph 7#c71 ! ,secret>y may ent] into contracts or coop]ative agreem5ts ) v5dors1 :i* may include manufactur]s or di/ributors ( m$ical products1 ) respect to m$ical products int5d$ to be deliv]$ to ! own]%ip ( ! ,f$]al ,gov]nm5t4 ,ea* su* contract or coop]ative agreem5t %all be subject to su* t]ms & conditions z ! ,secret>y may specify1 includ+ t]ms & conditions ) respect to-- 7i7 procurem5t1 ma9t5ance1 /orage1 & deliv]y ( res]ve am\nts ( products "u su* contract or coop]ative agreem5t1 :i* may consid]1 z appropriate1 co/s ( transport+ & h&l+ su* products2 & 7ii7 ma9t5ance ( dome/ic manufactur+ capacity & capabilities ( su* products to ensure additional res]v$ production capacity & capabilities are available1 & t su* capacity & capabilities are able to support ! rapid manufacture1 pur*ase1 /orage1 & deliv]y ( su* products1 z requir$ by ! ,secret>y to prep>e =1 or respond to1 an exi/+ or pot5tial public heal? em]g5cy4 7,b7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act1 & annually !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 on any contracts or coop]ative agreem5ts ent]$ into "u subp>agraph 7,a7 = purposes ( e/abli%+ & ma9ta9+ v5dor-manag$ inv5tory or res]ve manufactur+ capacity & capabilities = products int5d$ = ! /ockpile1 includ+ a description (-- 7i7 ! am\nt ( ea* aw>d2 7ii7 ! recipi5t ( ea* aw>d2 7iii7 ! product or products cov]$ ?r\gh ea* aw>d2 & 7iv7 h[ ! ,secret>y works ) ea* recipi5t to ensure situational aw>5ess relat$ to ! manufactur+ capacity =1 or inv5tory (1 su* products & coord9ates ! di/ribution & deploym5t ( su* products1 z appropriate & applicable4 2 & 7,d7 9 subp>agraph 7,a7 ( p>agraph 7#f71 z s r$esignat$-- 7i7 9 clause 7viii71 by /rik+ 2 & & ins]t+ a semicolon2 7ii7 9 clause 7ix71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7x7 ) respect to reports issu$ 9 #bjbg or any subsequ5t ye>1 an assessm5t ( select$ contracts or coop]ative agreem5ts ent]$ into pursuant to p>agraph 7#e74 2 & 7#b7 9 subsection 7c77#b77;,c71 by /rik+ on an annual basis & ins]t+ n lat] ?an ,m>* #ae ( ea* ye>4 7b7 ,au?orization ( appropriations ,section #cai;,f-#b7;f77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7f77#a77 is am5d$ by /rik+ #faj1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #faj1jjj1jjj = ea* ( fiscal ye> #bjai ?r\gh #bjba1 & #gej1jjj1jjj = ea* ( fiscal ye>s #bjbb & #bjbc4 #djf4 ,reimbursem5t = c]ta9 supplies ,p>agraph 7#g7 ( section #cai;,f-#b7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a771 z s r$esignat$ by section #dje7;a77#a77;,b71 is am5d$ to read z foll[s3 7#g7 ,reimbursem5t = c]ta9 supplies 7,a7 ,9 g5]al ,! ,secret>y may1 at appropriate int]vals1 make available = pur*ase excess cont5ts procur$ =1 & ma9ta9$ )91 ! /ockpile "u p>agraph 7#a7 to any ,f$]al ag5cy or ,/ate1 local1 or ,tribal gov]nm5t4 ,! ,secret>y %all make su* cont5ts available = pur*ase only if-- 7i7 su* cont5ts are 9 excess ( :at is requir$ = appropriate ma9t5ance ( su* /ockpile2 7ii7 ! ,secret>y det]m9es t ! co/s = ma9ta9+ su* excess cont5ts are n appropriate to exp5d to meet ! ne$s ( ! /ockpile2 & 7iii7 ! ,secret>y det]m9es t su* action does n compromise national security & is 9 ! national int]e/4 7,b7 ,reimbursem5t & collection ,! ,secret>y may require reimbursem5t = cont5ts t are made available "u subp>agraph 7,a71 9 an am\nt t reflects ! co/ ( acquir+ & ma9ta9+ su* cont5ts & ! co/s incurr$ to make available su* cont5ts 9 ! "t & mann] specifi$ by ! ,secret>y4 ,am\nts collect$ "u ?is subsection %all be cr$it$ to ! appropriations acc\nt or fund t incurr$ ! co/s to procure su* cont5ts1 & %all rema9 available1 )\t fur!r appropriation1 until exp5d$1 = ! purposes ( ! appropriation acc\nt or fund s cr$it$4 7,c7 ,rule ( con/ruction ,?is p>agraph %all n be con/ru$ to preclude transf]s ( cont5ts 9 ! /ockpile "u o!r au?orities4 7,d7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,prev5t ,p&emics ,act1 & annually !reaft]1 ! ,secret>y %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 ! use ( ! au?ority provid$ "u ?is p>agraph1 includ+ details ( ea* action tak5 pursuant to ?is p>agraph1 ! acc\nt or fund to :i* any collect$ am\nts h be5 cr$it$1 & h[ ! ,secret>y has us$ su* am\nts4 7,e7 ,sunset ,! au?ority "u ?is p>agraph %all t]m9ate on ,septemb] #cj1 #bjbe4 4 #djg4 ,action report+ on /ockpile depletion ,section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d71 z am5d$ by section #bbc1 is fur!r am5d$ by add+ at ! end ! foll[+3 7h7 ,/ockpile depletion report+ ,! ,secret>y %all1 n lat] ?an #cj days aft] ! deploym5t ( cont5ts ( ! ,/rategic ,national ,/ockpile "u section #cai;,f-#b7;a7 to respond to a public heal? em]g5cy decl>$ by ! ,secret>y "u ?is section or an em]g5cy or major disa/] decl>$ by ! ,presid5t "u ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act1 & e #cj days !reaft] until ! expiration or t]m9ation ( su* public heal? em]g5cy1 em]g5cy1 or major disa/]1 submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives on-- 7#a7 ! deploym5t ( ! cont5ts ( ! /ockpile 9 response to ,/ate1 local1 & ,tribal reque/s2 7#b7 ! am\nt ( su* products t rema9 )9 ! /ockpile foll[+ su* deploym5t2 & 7#c7 plans to repl5i% su* products1 z appropriate1 includ+ relat$ timeframes & any b>ri]s or limitations to repl5i%m5t4 4 #djh4 ,provision ( m$ical c\nt]measures to ,indian programs & facilities 7a7 ,cl>ification ,section #cai;,f-#b7;a77#c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c77 is am5d$-- 7#a7 9 subp>agraph 7,c71 by /rik+ & local & ins]t+ local1 & ,tribal2 & 7#b7 9 subp>agraph 7 ,j71 by /rik+ & local & ins]t+ local1 & ,tribal4 7b7 ,di/ribution ( m$ical c\nt]measures to ,indian ,tribes ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by ins]t+ aft] section #cai;,f-#d ! foll[+3 #cai;,f-#e4 ,provision ( m$ical c\nt]measures to ,indian programs & facilities ,9 ! ev5t t ! ,secret>y deploys ! cont5ts ( ! ,/rategic ,national ,/ockpile "u section #cai;,f-#b7;a71 or o!rwise di/ributes m$ical c\nt]measures to ,/ates to respond to a public heal? em]g5cy decl>$ by ! ,secret>y "u section #cai1 ! ,secret>y %all1 9 consultation ) ! applicable ,/ates1 make su* cont5ts or c\nt]measures directly available to ,indian ,tribes & ,tribal organizations 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act 7#be ,u4,s4,c4 #ecjd71 :i* may include ?r\gh heal? programs or facilities op]at$ by ! ,indian ,heal? ,s]vice1 t are affect$ by su* public heal? em]g5cy4 4 #dji4 ,grants = ,/ate /rategic /ockpiles 7a7 ,section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is am5d$ by add+ at ! end ! foll[+3 7i7 ,pilot program ,to support ,/ate m$ical /ockpiles 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,assi/ant ,secret>y = ,prep>$ness & ,response & ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all aw>d grants or coop]ative agreem5ts to n few] ?an #e ,/ates1 or consortia ( ,/ates1 ) consid]ation giv5 to di/ribution among ! geographical regions ( ! ,unit$ ,/ates1 to e/abli%1 exp&1 or ma9ta9 a /ockpile ( appropriate drugs1 vacc9es & o!r biological products1 m$ical devices1 & o!r m$ical supplies det]m9$ by ! ,/ate to be necess>y to respond to a public heal? em]g5cy decl>$ by ! ,gov]nor ( a ,/ate or by ! ,secret>y "u section #cai1 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 ,act1 9 ord] to support ! prep>$ness goals describ$ 9 p>agraphs 7#b7 ?r\gh 7#f7 & 7#h7 ( section #bhjb7;b74 7#b7 ,requirem5ts 7,a7 ,application ,to be eligible to receive an aw>d "u p>agraph 7#a71 an entity %all prep>e1 9 consultation ) appropriate heal? c>e entities & heal? (ficials )9 ! jurisdiction ( su* ,/ate or ,/ates1 & submit to ! ,secret>y an application t conta9s su* in=mation z ! ,secret>y may require1 includ+-- 7i7 a plan = su* /ockpile1 consi/5t ) p>agraph 7#d71 includ+ a description ( ! activities su* entity w c>ry out "u ! agreem5t & an outl9e ( propos$ exp5ses2 & 7ii7 a description ( h[ su* entity w coord9ate ) relevant entities 9 receipt ( an aw>d "u section #cai;,c-#a or #cai;,c-#b pursuant to p>agraph 7#d71 includ+ ?r\gh promot+ alignm5t betwe5 ! /ockpile plan e/abli%$ pursuant to clause 7i7 & applicable plans t are e/abli%$ by su* entity pursuant to section #cai;,c-#a or #cai;,c-#b4 7,b7 ,mat*+ funds 7i7 ,subject to clause 7ii71 ! ,secret>y may n make an aw>d "u ?is subsection unless ! applicant agrees1 ) respect to ! co/s to be incurr$ by ! applicant 9 c>ry+ out ! purpose describ$ 9 ?is subsection1 to make available non-,f$]al contributions t[>d su* co/s 9 an am\nt equal to-- 7,i7 = ea* ( fiscal ye>s #bjbc & #bjbd1 n less ?an #a = ea* #bj ( ,f$]al funds provid$ 9 ! aw>d2 & 7,,ii7 = fiscal ye> #bjbe & ea* fiscal ye> !reaft]1 n less ?an #a = ea* #aj ( ,f$]al funds provid$ 9 ! aw>d4 7ii7 ,waiv] ,! ,secret>y may1 ^u ! reque/ ( a ,/ate1 waive ! requirem5t "u clause 7i71 9 :ole or 9 "p1 if ! ,secret>y det]m9es t extraord9>y economic conditions 9 ! ,/ate 9 ! fiscal ye> involv$ or 9 ! previ\s fiscal ye> ju/ify ! waiv]4 ,a waiv] provid$ by ! ,secret>y "u ?is subp>agraph %all apply only to ! fiscal ye> involv$4 7,c7 ,adm9i/rative exp5ses ,n m ?an #aj p]c5t ( am\nts receiv$ by an entity pursuant to an aw>d "u ?is subsection may be us$ = adm9i/rative exp5ses4 7#c7 ,lead entity ,an entity 9 receipt ( an aw>d "u p>agraph 7#a7 may designate a lead entity1 :i* may be a public or private entity1 z appropriate1 to manage ! /ockpile at ! direction ( ! ,/ate or consortium ( ,/ates4 7#d7 ,use ( funds ,an entity 9 receipt ( an aw>d "u p>agraph 7#a7 %all use su* funds to-- 7,a7 pur*ase1 /ore1 & ma9ta9 a /ockpile ( appropriate drugs1 vacc9es & o!r biological products1 m$ical devices1 & o!r m$ical supplies to be us$ dur+ a public heal? em]g5cy1 major disa/]1 or em]g5cy describ$ 9 p>agraph 7#a71 9 su* numb]s1 types1 & am\nts z ! entity det]m9es necess>y1 consi/5t ) su* entity's /ockpile plan e/abli%$ pursuant to p>agraph 7#b77;,a77i72 7,b7 deploy ! /ockpile z requir$ by ! entity to respond to an actual or pot5tial public heal? em]g5cy1 major disa/]1 or o!r em]g5cy describ$ 9 p>agraph 7#a72 7,c7 repl5i% & make necess>y additions or modifications to ! cont5ts ( su* /ockpile1 includ+ to address pot5tial depletion2 7,d7 9 consultation ) ,f$]al1 ,/ate1 & local (ficials1 take into consid]ation ! availability1 deploym5t1 disp5s+1 & adm9i/ration requirem5ts ( m$ical products )9 ! /ockpile2 7,e7 ensure t proc$ures are foll[$ = inv5tory managem5t & acc\nt+1 & = ! physical security ( ! /ockpile1 z appropriate2 7,f7 review & revise1 z appropriate1 ! cont5ts ( ! /ockpile on a regul> basis to ensure t1 to ! ext5t practicable1 new te*nologies & m$ical products are consid]$2 7,g7 c>ry out ex]cises1 drills1 & o!r tra9+ = purposes ( /ockpile deploym5t1 disp5s+1 & adm9i/ration ( m$ical products1 & = purposes ( assess+ ! capability ( su* /ockpile to address ! m$ical supply ne$s ( public heal? em]g5cies1 major disa/]s1 or o!r em]g5cies describ$ 9 p>agraph 7#a7 ( v>y+ types & scales1 :i* may be conduct$ 9 accordance ) requirem5ts relat$ to ex]cises1 drills1 & o!r tra9+ = recipi5ts ( aw>ds "u section #cai;,c-#a or #cai;,c-#b1 z applicable2 & 7,h7 c>ry out o!r activities relat$ to ! ,/ate /rategic /ockpile z ! entity det]m9es appropriate1 to support ,/ate ef=ts to prep>e =1 & respond to1 public heal? ?reats4 7#e7 ,supplem5t n supplant ,aw>ds "u p>agraph 7#a7 %all supplem5t1 n supplant1 ! ma9t5ance & use ( ! ,/rategic ,national ,/ockpile by ! ,secret>y "u subsection 7a74 7#f7 ,guidance = ,/ates ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>y1 9 consultation ) ,/ates1 heal? (ficials1 & o!r relevant /akehold]s1 z appropriate1 %all issue guidance1 & update su* guidance z appropriate1 = ,/ates relat$ to ma9ta9+ & repl5i%+ a /ockpile ( m$ical products1 :i* may include /rategies & be/ practices relat$ to-- 7,a7 types ( m$ical products & m$ical supplies t are critical to respond to public heal? em]g5cies1 & may be appropriate = inclusion 9 a /ockpile by ,/ates1 ) consid]ation ( ?reats t require ! l>ge-scale & simultane\s deploym5t ( /ockpiles1 includ+ ! /ockpile ma9ta9$ by ! ,secret>y pursuant to subsection 7a71 & long-t]m public heal? & m$ical response ne$s2 7,b7 appropriate managem5t ( ! cont5ts ( a /ockpile1 includ+ managem5t by v5dors ( res]ve am\nts ( m$ical products & supplies int5d$ to be deliv]$ to ! own]%ip ( ! ,/ate & appropriate disposition ( excess products1 z applicable2 & 7,c7 ! procurem5t ( m$ical products & m$ical supplies consi/5t ) ! ,buy ,am]ican ,act ( #aicc4 7#g7 ,te*nical assi/ance ,! ,secret>y %all provide assi/ance to ,/ates1 includ+ te*nical assi/ance1 z appropriate1 9 e/abli%+1 ma9ta9+1 improv+1 & utiliz+ a m$ical /ockpile1 includ+ appropriate inv5tory managem5t & disposition ( products4 7#h7 ,report+ 7,a7 ,/ate reports ,ea* entity receiv+ an aw>d "u p>agraph 7#a7 %all update1 z appropriate1 ! plan e/abli%$ pursuant to p>agraph 7#b77;,a77i7 & submit to ! ,secret>y an annual report on implem5tation ( su* plan1 includ+ any *anges to ! cont5ts ( ! /ockpile support$ "u su* aw>d4 ,! ,secret>y %all use in=mation obta9$ f su* reports to in=m ! ma9t5ance & managem5t ( ! ,/rategic ,national ,/ockpile pursuant to subsection 7a74 7,b7 ,reports to congress ,n lat] ?an #a ye> aft] ! initial issuance ( aw>ds pursuant to p>agraph 7#a71 & annually !reaft] = ! duration ( ! program e/abli%$ "u ?is subsection1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on su* program1 includ+-- 7i7 ,f$]al & ,/ate exp5ditures to support /ockpiles "u su* program2 7ii7 activities conduct$ pursuant to p>agraph 7#d72 & 7iii7 any additional in=mation f ! ,/ates t ! ,secret>y det]m9es relevant4 7#i7 ,au?orization ( appropriations ,to c>ry out ?is subsection1 !re is au?oriz$ to be appropriat$ su* sums z may be necess>y = ea* ( fiscal ye>s #bjbc ?r\gh #bjbh4 4 7b7 ,,gao report ,n lat] ?an #c ye>s aft] ! date on :i* aw>ds are fir/ issu$ pursuant to subsection 7i77#a7 ( section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b71 z add$ by subsection 7a71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! ,/ate /ockpiles e/abli%$ or ma9ta9$ pursuant to ?is section4 ,su* report %all include an assessm5t (-- 7#a7 coord9ation & communication betwe5 ! ,secret>y ( ,heal? & ,human ,s]vices & entities 9 receipt ( an aw>d "u ?is section1 or a lead entity designat$ by su* entity2 7#b7 te*nical assi/ance provid$ by ! ,secret>y ( ,heal? & ,human ,s]vices to su* entities2 & 7#c7 ! impact ( su* /ockpiles on ! ability ( ! ,/ate to prep>e = & respond to a public heal? em]g5cy1 major disa/]1 or o!r em]g5cy describ$ 9 subsection 7i77#a7 ( section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b71 z add$ by subsection 7a71 includ+ ! availability & di/ribution ( items f su* ,/ate /ockpile to heal? c>e entities & o!r applicable entities4 ,v ,enhanc+ developm5t & combat+ %ortages ( m$ical products ,a ,developm5t & review #eja4 ,advanc+ qualifi$ infecti\s disease product innovation 7a7 ,9 g5]al ,section #eje;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 7#b71 by /rik+ 2 or & ins]t+ 22 7,b7 9 p>agraph 7#c71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+3 7#d7 an application pursuant to section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 2 7#b7 9 subsection 7d77#a71 by ins]t+ ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act aft] section #eje7;b72 & 7#c7 by am5d+ subsection 7g7 to read z foll[s3 7g7 ,qualifi$ infecti\s disease product ,! t]m qualifi$ infecti\s disease product means a drug1 includ+ an antibact]ial or antifungal drug or a biological product1 = human use t-- 7#a7 acts directly on bact]ia or fungi or on sub/ances produc$ by su* bact]ia or fungi2 & 7#b7 is int5d$ to treat a s]i\s or life-?reat5+ infection1 includ+ su* an infection caus$ by-- 7,a7 an antibact]ial or antifungal resi/ant pa?og51 includ+ novel or em]g+ infecti\s pa?og5s2 or 7,b7 qualify+ pa?og5s li/$ by ! ,secret>y "u subsection 7f74 4 7b7 ,priority review ,section #ebd;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn-#a7;a77 is am5d$ by ins]t+ ( ?is ,act1 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 t requires cl9ical data 7o!r ?an bioavailability /udies7 to demon/rate safety or effectiv5ess be=e ! p]iod4 #ejb4 ,mod]niz+ cl9ical trials 7a7 ,cl>ify+ ! use ( ,digital ,heal? ,te*nologies 9 ,cl9ical ,trials 7#a7 ,9 g5]al ,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 issue or revise draft guidance reg>d+ ! appropriate use ( validat$ digital heal? te*nologies 9 cl9ical trials to help improve recruitm5t =1 ret5tion 91 p>ticipation 91 & data collection dur+1 cl9ical trials1 & provide = novel cl9ical trial designs utiliz+ su* te*nology = purposes ( support+ ! developm5t (1 & review ( applications =1 drugs & devices4 ,n lat] ?an #ah mon?s aft] ! public comm5t p]iod on su* draft guidance ends1 ! ,secret>y %all issue a revis$ draft guidance or f9al guidance4 7#b7 ,cont5t ,! guidance describ$ 9 p>agraph 7#a7 %all include-- 7,a7 recomm5dations = data collection me?odologies by :i* sponsors may incorporate ! use ( digital heal? te*nologies 9 cl9ical trials to collect data remotely f trial p>ticipants2 7,b7 consid]ations = privacy & security protections = data collect$ dur+ a cl9ical trial1 includ+-- 7i7 recomm5dations = ! protection ( trial p>ticipant data t is collect$ or us$ 9 rese>*1 us+ digital heal? te*nologies2 7ii7 compliance ) ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 subp>t ,b ( "p #ej ( title #ba1 ,code ( ,f$]al ,regulations1 subp>t ,c ( "p #ef ( title #ba1 ,code ( ,f$]al ,regulations1 ! ,f$]al policy = ! protection ( human subjects "u subp>t ,a ( "p #df ( title #de1 ,code ( ,f$]al ,regulations 7commonly kn[n z ! ,common ,rule71 & "p #b ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations72 & 7iii7 recomm5dations = protection ( cl9ical trial p>ticipant data aga9/ cyb]security ?reats1 z applicable2 7,c7 consid]ations on data collection me?ods to help increase recruitm5t ( cl9ical trial p>ticipants & ! level ( p>ticipation ( su* p>ticipants1 r$uce burd5 on cl9ical trial p>ticipants1 & optimize data quality2 7,d7 recomm5dations = ! use ( electronic me?ods to obta9 in=m$ cons5t f cl9ical trial p>ticipants1 tak+ into consid]ation applicable ,f$]al law1 includ+ subp>t ,b ( "p #ej ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 &1 z appropriate1 ,/ate law2 7,e7 be/ practices = communication & e>ly engagem5t betwe5 sponsors & ! ,secret>y on ! developm5t ( data collection me?ods2 7,f7 ! appropriate =mat to submit su* data to ! ,secret>y2 7,g7 a description ( ! mann] 9 :i* ! ,secret>y may assess or evaluate data collect$ ?r\gh digital heal? te*nologies to support ! developm5t ( ! drug or device2 7,h7 recomm5dations reg>d+ ! data & in=mation ne$$ to demon/rate t a digital heal? te*nology is fit-=-purpose = a cl9ical trial1 & a description ( h[ ! ,secret>y w evaluate su* data & in=mation2 & 7,i7 recomm5dations = increas+ access to1 & ! use (1 digital heal? te*nologies 9 cl9ical trials to facilitate ! inclusion ( div]se & und]repres5t$ populations1 z appropriate1 includ+ consid]ations = access to1 & ! use (1 digital heal? te*nologies 9 cl9ical trials by p ) disabilities & p$iatric populations4 7b7 ,advanc+ dec5traliz$ cl9ical trials 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue or revise draft guidance to provide recomm5dations to cl>ify & advance ! use ( dec5traliz$ cl9ical trials to support ! developm5t ( drugs & devices & help improve trial p>ticipant engagem5t & advance ! use ( flexible & novel cl9ical trial designs4 ,n lat] ?an #ah mon?s aft] ! public comm5t p]iod on su* draft guidance ends1 ! ,secret>y %all issue a revis$ draft guidance or f9al guidance4 7#b7 ,cont5t ,! guidance describ$ 9 p>agraph 7#a7 %all include-- 7,a7 recomm5dations = me?ods ( remote data collection1 includ+ trial p>ticipant exp]i5ce data1 ?\gh ! use ( digital heal? te*nologies1 telem$ic9e1 local laboratories1 local heal? c>e provid]s1 or o!r options = data collection2 7,b7 consid]ations = sponsors to m9imize or r$uce burd5s = cl9ical trial p>ticipants associat$ ) p>ticipat+ 9 a cl9ical trial1 su* z ! use ( digital te*nologies1 telem$ic9e1 local laboratories1 local heal? c>e provid]s1 or o!r data collection or assessm5t options1 heal? c>e provid] home visits1 direct-to-p>ticipant %ipp+ ( inve/igational drugs & devices1 & electronic in=m$ cons5t1 z appropriate2 7,c7 recomm5dations reg>d+ conduct+ dec5traliz$ cl9ical trials to facilitate & enc\rage div]sity among ! cl9ical trial p>ticipants1 z appropriate2 7,d7 recomm5dations = /rategies & me?ods = recruit+1 reta9+1 & engag+ ) cl9ical trial p>ticipants1 includ+ communication reg>d+ ! role ( trial p>ticipants & community p>tn]s to facilitate cl9ical trial recruitm5t & engagem5t1 includ+ ) respect to div]se & und]repres5t$ populations1 z appropriate2 7,e7 consid]ations = review & ov]sight by sponsors & in/itutional review bo>ds1 includ+ remote trial ov]sight2 7,f7 recomm5dations = dec5traliz$ cl9ical trial protocol designs & processes = evaluat+ su* propos$ trial designs2 7,g7 recomm5dations = digital heal? te*nology & o!r remote assessm5t tools t may support dec5traliz$ cl9ical trials1 includ+ guidance on appropriate te*nological plat=ms & tools1 data collection & use1 data integrity1 & communication to cl9ical trial p>ticipants ?r\gh su* te*nology2 7,h7 a description ( ! mann] 9 :i* ! ,secret>y w assess or evaluate data collect$ )9 a dec5traliz$ cl9ical trial to support ! developm5t ( ! drug or device1 if ! mann] is diff]5t f t us$ = a non-dec5traliz$ trial2 7,i7 consid]ations = sponsors to validate digital te*nologies & e/abli% appropriate cl9ical endpo9ts = use 9 dec5traliz$ trials2 7,j7 consid]ations = privacy & security ( p]sonally id5tifiable in=mation ( trial p>ticipants2 & 7,k7 consid]ations = conduct+ cl9ical trials us+ c5traliz$ approa*es 9 conjunction ) dec5traliz$ approa*es4 7c7 ,seamless & concurr5t cl9ical trials 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue or revise draft guidance on ! use ( seamless1 concurr5t1 & o!r innovative cl9ical trial designs to support ! exp$it$ developm5t & review ( applications = drugs1 z appropriate4 ,n lat] ?an #ah mon?s aft] ! public comm5t p]iod on su* draft guidance ends1 ! ,secret>y %all issue a revis$ draft guidance or f9al guidance4 7#b7 ,cont5t ,! guidance describ$ 9 p>agraph 7#a7 %all include-- 7,a7 recomm5dations on ! use ( expansion cohorts & o!r seamless cl9ical trial designs to assess diff]5t aspects ( product c&idates 9 "o cont9u\s trial1 includ+ h[ su* cl9ical trial designs c be us$ z "p ( meet+ ! sub/antial evid5ce /&>d "u section #eje7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d772 7,b7 recomm5dations on ! use ( cl9ical trial designs t involve ! concurr5t conduct ( diff]5t or multiple cl9ical trial phases1 & ! concurr5t conduct ( precl9ical te/+1 to exp$ite ! developm5t ( new drugs & facilitate ! timely collection ( data2 7,c7 recomm5dations = h[ to /reaml9e trial logi/ics & facilitate ! effici5t collection & analysis ( cl9ical trial data1 includ+ any plann$ int]im analyses & h[ su* analyses c\ld be us$ to /reaml9e ! product developm5t & review processes2 7,d7 consid]ations to assi/ sponsors 9 ensur+ ! rights1 safety1 & welf>e ( cl9ical trial p>ticipants1 ma9ta9+ compliance ) good cl9ical practice regulations1 m9imiz+ risks to cl9ical trial data integrity1 & ensur+ ! reliability ( cl9ical trial results2 7,e7 recomm5dations = communication & e>ly engagem5t betwe5 sponsors & ! ,food & ,drug ,adm9i/ration on ! developm5t ( seamless1 concurr5t1 or o!r adaptive trial designs1 includ+ review (1 & fe$back on1 cl9ical trial protocols2 & 7,f7 a description ( ! mann] 9 :i* ! ,secret>y w assess or evaluate data collect$ ?r\gh seamless1 concurr5t1 or o!r adaptive trial designs to support ! developm5t ( ! drug4 7d7 ,int]national h>monization ,! ,secret>y %all "w ) =eign regulators pursuant to memor&a ( und]/&+ or o!r arrangem5ts gov]n+ ! ex*ange ( in=mation to facilitate int]national h>monization ( ! regulation & use ( dec5traliz$ cl9ical trials1 digital te*nology 9 cl9ical trials1 & seamless1 concurr5t1 & o!r adaptive or innovative cl9ical trial designs4 #ejc4 ,accel]at+ c\nt]measure developm5t & review ,section #efe ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7 is am5d$ by add+ at ! end ! foll[+3 7h7 ,accel]at+ c\nt]measure developm5t & review dur+ an em]g5cy 7#a7 ,accel]ation ( c\nt]measure developm5t & review ,! ,secret>y may1 at ! reque/ ( ! sponsor ( a c\nt]measure1 dur+ a dome/ic1 milit>y1 or public heal? em]g5cy or mat]ial ?reat describ$ 9 section #efd;,a7a77#a77;,c71 exp$ite ! developm5t & review ( c\nt]measures t are int5d$ to address su* dome/ic1 milit>y1 or public heal? em]g5cy or mat]ial ?reat = approval1 lic5sure1 cle>ance1 or au?orization "u ?is title or section #cea ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,actions ,! actions to exp$ite ! developm5t & review ( a c\nt]measure "u p>agraph 7#a7 may include ! foll[+3 7,a7 ,exp$it$ review ( submissions made by sponsors ( c\nt]measures to ! ,food & ,drug ,adm9i/ration1 includ+ roll+ submissions ( c\nt]measure applications & o!r submissions4 7,b7 ,exp$it$ & increas$ engagem5t ) sponsors reg>d+ c\nt]measure developm5t & manufactur+1 includ+-- 7i7 hold+ meet+s ) ! sponsor & ! review team & provid+ timely advice to1 & int]active communication )1 ! sponsor reg>d+ ! developm5t ( ! c\nt]measure to ensure t ! developm5t program to ga!r ! noncl9ical & cl9ical data necess>y = approval1 lic5sure1 cle>ance1 or au?orization is z effici5t z practicable2 7ii7 involv+ s5ior manag]s & exp]i5c$ review /aff1 z appropriate1 9 a collaborative1 cross-discipl9>y review2 7iii7 assign+ a cross-discipl9>y project lead = ! review team to facilitate2 7iv7 tak+ /eps to ensure t ! design ( ! cl9ical trials is z effici5t z practicable1 :5 sci5tifically appropriate1 su* z by m9imiz+ ! numb] ( pati5ts expos$ to a pot5tially less efficaci\s treatm5t2 & 7v7 /reaml9+ ! review ( approv$1 lic5s$1 cle>$1 or au?oriz$ c\nt]measures to treat or prev5t new or em]g+ ?reats1 includ+ ! review ( any *anges to su* c\nt]measures4 7,c7 ,exp$it$ issuance ( guidance docum5ts & publication ( o!r regulatory in=mation reg>d+ c\nt]measure developm5t & manufactur+4 7,d7 ,o!r /eps to exp$ite ! developm5t & review ( a c\nt]measure application submitt$ = approval1 lic5sure1 cle>ance1 or au?orization1 z ! ,secret>y det]m9es appropriate4 7#c7 ,limitation ( effect ,no?+ 9 ?is subsection %all be con/ru$ to require ! ,secret>y to grant1 or take any o!r action relat$ to1 a reque/ ( a sponsor to exp$ite ! developm5t & review ( a c\nt]measure = approval1 lic5sure1 cle>ance1 or au?orization "u p>agraph 7#a74 4 #ejd4 ,?ird p>ty te/ evaluation dur+ em]g5cies 7a7 ,9 g5]al ,section #efe ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d71 z am5d$ by section #ejc1 is fur!r am5d$ by add+ at ! end ! foll[+3 7i7 ,?ird p>ty evaluation ( te/s us$ dur+ an em]g5cy 7#a7 ,9 g5]al ,= purposes ( conduct+ evaluations reg>d+ :e!r an 9 vitro diagno/ic product 7z def9$ 9 section #hji4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 = :i* a reque/ = em]g5cy use au?orization is submitt$ "u section #efd meets ! crit]ia = issuance ( su* au?orization1 ! ,secret>y may1 z appropriate1 consult ) p]sons ) appropriate exp]tise ) respect to su* evaluations or ent] into coop]ative agreem5ts or contracts ) su* p]sons "u :i* su* p]sons conduct su* evaluations & make su* recomm5dations1 includ+1 z appropriate1 evaluations & recomm5dations reg>d+ ! scope ( au?orization & conditions ( au?orization4 7#b7 ,requirem5ts reg>d+ evaluations & recomm5dations 7,a7 ,9 g5]al ,9 evaluat+ & mak+ recomm5dations to ! ,secret>y reg>d+ ! validity1 accuracy1 & reliability ( 9 vitro diagno/ic products1 z describ$ 9 p>agraph 7#a71 a p]son %all consid] & docum5t :e!r ! relevant crit]ia "u subsection 7c77#b7 ( section #efd = issuance ( au?orization "u su* section are met ) respect to ! 9 vitro diagno/ic product4 7,b7 ,writt5 recomm5dations ,recomm5dations made by a p]son "u ?is subsection %all be submitt$ to ! ,secret>y 9 writ+1 & %all include ! reasons = su* recomm5dation & o!r in=mation t may be reque/$ by ! ,secret>y4 7#c7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to require ! ,secret>y to consult )1 or ent] into coop]ative agreem5ts or contracts )1 p]sons z describ$ 9 p>agraph 7#a7 = purposes ( au?oriz+ an 9 vitro diagno/ic product or o!rwise affect+ ! em]g5cy use au?orization au?orities "u ?is section or section #efd4 4 7b7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all issue draft guidance on consultations ) p]sons "u subsection 7i7 ( section #efe ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d71 z add$ by subsection 7a71 includ+ consid]ations conc]n+ conflicts ( int]e/1 comp5sation arrangem5ts1 & in=mation %>+4 ,n lat] ?an #a ye> aft] ! public comm5t p]iod on su* draft guidance ends1 ! ,secret>y %all issue a revis$ draft guidance or f9al guidance4 #eje4 ,facilitat+ ! use ( real _w evid5ce ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue or revise exi/+ guidance on consid]ations = ! use ( real _w data & real _w evid5ce to support regulatory decision-mak+1 z foll[s3 7#a7 ,) respect to drugs1 su* guidance %all address ! use ( su* data & evid5ce to support ! approval ( a drug application "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or a biological product application "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 or to support an inve/igational use exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act4 ,su* guidance %all include consid]ations = ! inclusion1 9 su* applications1 ( real _w data & real _w evid5ce obta9$ z a result ( ! use ( drugs au?oriz$ = em]g5cy use "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 & consid]ations = /&>ds & me?odologies = collection & analysis ( real _w evid5ce includ$ 9 su* applications1 submissions1 or reque/s1 z appropriate4 7#b7 ,) respect to devices1 su* guidance %all address ! use ( su* data & evid5ce to support ! approval1 cle>ance1 or classification ( a device pursuant to an application or submission submitt$ "u section #eaj7k71 #eac7;f77#b71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c7f77#b71 #cfj;e71 or to support an inve/igational use exemption "u section #ebj7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7g774 ,su* guidance %all include consid]ations = ! inclusion1 9 su* applications1 submissions1 or reque/s1 ( real _w data & real _w evid5ce obta9$ z a result ( ! use ( devices au?oriz$ = em]g5cy use "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 & consid]ations = /&>ds & me?odologies = collection & analysis ( real _w evid5ce includ$ 9 su* applications1 submissions1 or reque/s1 z appropriate4 #ejf4 ,plat=m te*nologies 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #ejf;,j ( su* ,act 7#ba ,u4,s4,c4 #cef;j7 ! foll[+3 #ejf,k4 ,plat=m te*nologies 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a process = ! designation ( plat=m te*nologies t meet ! crit]ia describ$ 9 subsection 7b74 7b7 ,crit]ia ,a plat=m te*nology incorporat$ )9 or utiliz$ by a drug is eligible = designation z a designat$ plat=m te*nology "u ?is section if-- 7#a7 ! plat=m te*nology is incorporat$ 91 or utiliz$ by1 a drug approv$ "u section #eje ( ?is ,act or a biological product lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7#b7 prelim9>y evid5ce submitt$ by ! sponsor ( ! approv$ or lic5s$ drug describ$ 9 p>agraph 7#a71 or a sponsor t has be5 grant$ a "r ( ref]5ce to data submitt$ 9 ! application = su* drug1 demon/rates t ! plat=m te*nology has ! pot5tial to be incorporat$ 91 or utiliz$ by1 m ?an "o drug )\t an adv]se effect on quality1 manufactur+1 or safety2 & 7#c7 data or in=mation submitt$ by ! applicable p]son "u p>agraph 7#b7 indicates t incorporation or utilization ( ! plat=m te*nology has a reasonable likelihood to br+ significant effici5cies to ! drug developm5t or manufactur+ process & to ! review processes4 7c7 ,reque/ = designation ,a p]son may reque/ ! ,secret>y designate a plat=m te*nology z a designat$ plat=m te*nology concurr5tly )1 or at any "t aft]1 submission "u section #eje7;i7 ( ?is ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act = ! inve/igation ( a drug t incorporates or utilizes ! plat=m te*nology t is ! subject ( ! reque/4 7d7 ,designation 7#a7 ,9 g5]al ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u subsection 7c71 ! ,secret>y %all det]m9e :e!r ! plat=m te*nology t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 subsection 7b74 7#b7 ,designation ,if ! ,secret>y det]m9es t ! plat=m te*nology meets ! crit]ia describ$ 9 subsection 7b71 ! ,secret>y %all designate ! plat=m te*nology z a designat$ plat=m te*nology & may exp$ite ! developm5t & review ( any subsequ5t application submitt$ "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = a drug t uses or incorporates ! plat=m te*nology pursuant to subsection 7e71 z appropriate4 7#c7 ,det]m9ation n to designate ,if ! ,secret>y det]m9es t ! plat=m te*nology does n meet ! crit]ia "u subsection 7b71 ! ,secret>y %all include ) ! det]m9ation n to designate ! te*nology a writt5 description ( ! rationale = su* det]m9ation4 7#d7 ,revocation ( designation ,! ,secret>y may revoke a designation made "u p>agraph 7#b71 if ! ,secret>y det]m9es t ! designat$ plat=m te*nology no long] meets ! crit]ia describ$ 9 subsection 7b74 ,! ,secret>y %all communicate ! det]m9ation to revoke a designation to ! reque/+ sponsor 9 writ+1 includ+ a description ( ! rationale = su* det]m9ation4 7#e7 ,applicability ,no?+ 9 ?is section %all prev5t a product t uses or incorporates a designat$ plat=m te*nology f be+ eligible = exp$it$ approval pa?ways if x is o!rwise eligible "u ?is ,act or ! ,public ,heal? ,s]vice ,act4 7e7 ,actions ,! ,secret>y may take actions to exp$ite ! developm5t & review ( an application = a drug t incorporates or utilizes a designat$ plat=m te*nology1 includ+-- 7#a7 engag+ 9 e>ly int]actions ) ! sponsor to discuss ! use ( ! designat$ plat=m te*nology & :at is kn[n ab\t su* te*nology1 includ+ data previ\sly submitt$ t is relevant to e/abli%+1 z applicable1 safety or efficacy "u section #eje7;b7 ( ?is ,act or safety1 purity1 or pot5cy "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act2 7#b7 provid+ timely advice to1 & int]active communication )1 ! sponsor reg>d+ ! developm5t ( ! drug t proposes to use ! designat$ plat=m te*nology to ensure t ! developm5t program design$ to ga!r data necess>y = approval or lic5sure is z effici5t z practicable1 :i* may include hold+ meet+s ) ! sponsor & ! review team ?r\gh\t ! developm5t ( ! drug2 & 7#c7 consid]+ inspectional f9d+s1 includ+ prior f9d+s1 relat$ to ! manufacture ( a drug t incorporates or utilizes ! designat$ plat=m te*nology4 7f7 ,lev]ag+ data f designat$ plat=m te*nologies ,! ,secret>y %all1 consi/5t ) applicable /&>ds = approval1 au?orization1 or lic5sure "u ?is ,act & section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 all[ ! sponsor ( an application "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act or a reque/ = em]g5cy use au?orization "u section #efd1 9 ord] to support approval1 lic5sure1 or au?orization1 to ref]5ce or rely ^u data & in=mation )9 su* application or reque/ t incorporates or utilizes ! same or sub/antially simil> plat=m te*nology designat$ "u subsection 7d71 provid$ t-- 7#a7 su* data & in=mation 0 submitt$ by ! same sponsor1 pursuant to ! application = ! drug ) respect to :i* designation ( ! designat$ plat=m te*nology "u subsection 7d7 0 grant$2 or 7#b7 ! sponsor rely+ on su* data & in=mation receiv$ a "r ( ref]5ce to su* data & in=mation f ! sponsor describ$ 9 p>agraph 7#a74 7g7 ,*anges to a designat$ plat=m te*nology ,a sponsor ( "o or m applications approv$ "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = a drug or biological product t incorporates or utilizes ! same designat$ plat=m te*nology may submit a s+le supplem5tal application = ! same propos$ *anges to ! designat$ plat=m te*nology t is applicable to m ?an "o drug or biological product t incorporates or utilizes su* designat$ plat=m te*nology t may be cross ref]5c$ 9 o!r applications incorporat+ su* *ange4 ,su* application may include "o or m comp>ability protocols reg>d+ h[ su* *anges to ! plat=m te*nology w\ld be made = ea* applicable application4 7h7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all issue draft guidance on ! implem5tation ( ?is section4 ,su* guidance %all include examples ( drugs t c be manufactur$ us+ plat=m te*nologies1 includ+ drugs t conta9 or consi/ ( vectors & nucleic acids1 in=mation ab\t ! ,secret>y's review ( plat=m te*nologies1 in=mation reg>d+ submitt+ = designation1 consid]ation = p]sons submitt+ a reque/ = designation :o has be5 grant$ a "r ( ref]5ce1 ! implem5tation ( ! designat$ plat=m te*nology designation program1 effici5cies t may be a*iev$ 9 ! developm5t & review ( products t incorporate or utilize designat$ plat=m te*nologies1 & recomm5dations & requirem5ts = mak+ & report+ manufactur+ *anges to a designat$ plat=m te*nology 9 accordance ) section #ejf;,a4 7i7 ,def9itions ,= purposes ( ?is section3 7#a7 ,! t]m plat=m te*nology means-- 7,a7 a te*nology incorporat$ into a drug or biological product1 su* z a nucleic acid sequ5ce1 molecul> /ructure1 me*anism ( action1 deliv]y me?od1 or o!r te*nology ! ,secret>y det]m9es to be appropriate1 or comb9ation ( any su* te*nologies1 t-- 7i7 is ess5tial to ! *>act]ization ( ! drug or biological product2 & 7ii7 c be adapt$ =1 or incorporat$ or utiliz$ 91 m ?an "o drug or biological product %>+ common /ructural elem5ts2 or 7,b7 a /&>diz$ production or manufactur+ process t is us$ to create or develop m ?an "o drug %>+ common /ructural elem5ts t c be incorporat$ into multiple diff]5t drugs4 7#b7 ,! t]m designat$ plat=m te*nology means a plat=m te*nology t is designat$ z a plat=m te*nology "u subsection 7d74 7j7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to-- 7#a7 alt] ! au?ority ( ! ,secret>y to approve drugs pursuant to section #eje ( ?is ,act or lic5se biological products pursuant to section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ /&>ds ( evid5ce & applicable conditions = approval or lic5sure "u ! applicable ,act2 or 7#b7 conf] any new rights ) respect to ! p]missibility ( a sponsor ( an application = a drug product or biological product ref]5c+ in=mation conta9$ 9 ano!r application submitt$ by ! hold] ( an approv$ application "u section #eje7;c7 ( ?is ,act or ( a lic5se "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 4 7b7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 on ! plat=m te*nology designation program "u section #ejf,k ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 ,su* report %all include-- 7#a7 ! numb] ( reque/s = designation "u su* program2 7#b7 ! numb] ( designations "u su* program issu$1 active1 & revok$2 7#c7 ! res\rces requir$ to c>ry out su* program 7includ+ ! review "t us$ = full-"t equival5t employees72 7#d7 any effici5cies ga9$ 9 ! developm5t1 manufactur+1 & review processes associat$ ) su* designations2 & 7#e7 recomm5dations1 if any1 to /r5g!n ! program to bett] lev]age plat=m te*nologies t c be us$ 9 m ?an "o drug & meet pati5t ne$s 9 a mann] z timely z possible1 tak+ into consid]ation ! res\rces available to ! ,secret>y ( ,heal? & ,human ,s]vices = c>ry+ out su* program4 #ejg4 ,increas+ ,,eua decision transp>5cy ,section #efd7;h77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7;h77#a77 is am5d$-- 7#a7 by ins]t+ on ! int]net website ( ! ,food & ,drug ,adm9i/ration & aft] promptly publi%2 & 7#b7 by /rik+ application "u section #eje7;i71 #eab7;j71 or #ebj7;g71 ev5 if su* summ>y may indirectly reveal ! exi/5ce ( su* application & ins]t+ application1 reque/1 or submission "u ?is section or section #eje7;b71 #eje7;i71 #eje7;j71 #eab7;b71 #eab7;j71 #eab7n71 #eae1 #eaj7k71 #eac7;f77#b71 #ebj7;g71 #ebj7m71 #ega1 or #egb ( ?is ,act1 or section #cea7;a7 or #cea7k7 ( ! ,public ,heal? ,s]vice ,act1 ev5 if su* summ>y may reveal ! exi/5ce ( su* an application1 reque/1 or submission1 or data conta9$ 9 su* application1 reque/1 or submission4 #ejh4 ,improv+ ,,fda guidance & communication 7a7 ,,fda report & implem5tation ( good guidance practices ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all develop1 & publi% on ! website ( ! ,food & ,drug ,adm9i/ration-- 7#a7 a report id5tify+ be/ practices = ! effici5t prioritization1 developm5t1 issuance1 & use ( guidance docum5ts1 )9 c5t]s1 across ! ,food & ,drug ,adm9i/ration1 & across o!r applicable ag5cies2 & 7#b7 a plan = implem5tation ( su* be/ practices1 includ+ across o!r applicable ag5cies1 :i* %all address-- 7,a7 /reaml9+ developm5t & review ( guidance docum5ts )9 c5t]s & across ! ,food & ,drug ,adm9i/ration2 7,b7 /reaml9+ processes = regulatory submissions to ! ,food & ,drug ,adm9i/ration1 includ+ ?r\gh ! revision or issuance ( guidance docum5ts2 & 7,c7 implem5t+ innovative guidance developm5t processes & practices & transition+ or updat+ guidance issu$ dur+ ! ,,covid-#ai public heal? em]g5cy1 z appropriate4 7b7 ,report & implem5tation ( ,,fda be/ practices = communicat+ ) ext]nal /akehold]s ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all develop & publi% on ! website ( ! ,food & ,drug ,adm9i/ration a report on ! practices ( ! ,food & ,drug ,adm9i/ration to broadly communicate ) ext]nal /akehold]s1 o!r ?an ?r\gh guidance docum5ts1 :i* %all include-- 7#a7 a review ( ! types & me?ods ( public communication t ! ,food & ,drug ,adm9i/ration uses to communicate & int]act ) m$ical product sponsors & o!r ext]nal /akehold]s2 7#b7 ! id5tification ( be/ practices = ! effici5t developm5t1 issuance1 & use ( su* communications2 & 7#c7 a plan = implem5tation ( be/ practices = communication ) ext]nal /akehold]s1 :i* %all address-- 7,a7 advanc+ ! use ( innovative =ms ( communication1 includ+ novel docum5t types & =mats1 to provide increas$ regulatory cl>ity to product sponsors & o!r /akehold]s1 & advanc+ me?ods ( communicat+ & int]act+ ) m$ical product sponsors & o!r ext]nal /akehold]s1 includ+ ! use ( tools su* z product submission templates1 web9>s1 & frequ5tly ask$ que/ions communications2 7,b7 /reaml9+ processes = regulatory submissions2 & 7,c7 implem5t+ innovative communication developm5t processes & transition+ or updat+ communication practices us$ dur+ ! ,,covid-#ai public heal? em]g5cy1 z appropriate4 7c7 ,consultation ,9 develop+ & publi%+ ! report & implem5tation plan "u ?is section1 ! ,secret>y %all consult ) /akehold]s1 includ+ rese>*]s1 academic organizations1 ph>maceutical1 biote*nology1 & m$ical device develop]s1 cl9ical rese>* organizations1 cl9ical laboratories1 heal? c>e provid]s1 pati5t gr\ps1 & o!r appropriate /akehold]s4 7d7 ,mann] ( issuance ,= purposes ( c>ry+ out ?is section1 ! ,secret>y may update an exi/+ report or plan1 & may comb9e ! reports & implem5tation plans describ$ 9 subsections 7a7 & 7b7 into "o or m docum5ts4 7e7 ,tim+ ,! ,secret>y %all-- 7#a7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 publi% a draft ( ! reports & plans requir$ "u ?is section2 & 7#b7 n lat] ?an #ahj days aft] publication ( ! draft reports & plans "u p>agraph 7#a7-- 7,a7 publi% a f9al report & plan2 & 7,b7 beg9 implem5tation ( ! be/ practices pursuant to su* f9al plan4 #eji4 ,,gao /udy & report on hir+ *all5ges at ,,fda 7a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report assess+ ! policies1 practices1 processes1 & programs ( ! ,food & ,drug ,adm9i/ration ) respect to hir+1 recruit+1 & ret5tion1 & ! impact ( su* policies1 practices1 processes1 & programs on ! ag5cy's ability to c>ry out its public heal? mission1 includ+ ! ag5cy's ability to respond to ! ,,covid-#ai public heal? em]g5cy4 ,su* report may involve policies1 practices1 processes1 & programs ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & o!r ag5cies1 z applicable4 7b7 ,cont5t ( report ,! report requir$ "u subsection 7a7 %all include an assessm5t (-- 7#a7 *all5ges relat$ to ! effici5t hir+1 recruit+1 pr(essional developm5t1 & ret5tion ( ! ,food & ,drug ,adm9i/ration work=ce1 includ+1 z applicable1 ! end-to-end hir+ process1 "t to hire1 multiple hir+ au?orities1 sal>y levels1 vacancy rates1 & id5tification & availability ( c&idates ) necess>y exp]tise2 7#b7 causes ( ! *all5ges id5tifi$ "u p>agraph 7#a71 includ+ an analysis ( relevant policies1 practices1 processes1 programs1 organizational /ructure1 res\rces1 tra9+1 remote "w capabilities1 & data sy/ems2 7#c7 *all5ges fac+ ! ,food & ,drug ,adm9i/ration work=ce1 includ+ ) respect to workload1 div]sity1 employee engagem5t1 & morale2 7#d7 ! impact ( *all5ges id5tifi$ "u p>agraphs 7#a7 & 7#c7 on op]ations ( ! ,food & ,drug ,adm9i/ration1 includ+ on meet+ us] fee agreem5t p]=mance goals & inspection activities2 7#e7 any hir+ or ret5tion plans ( ! ,food & ,drug ,adm9i/ration1 & progress t[>ds implem5tation & ! metrics to measure success ( su* plans2 7#f7 successful or effici5t hir+ policies or au?orities1 includ+ any relevant hir+ au?orities t result$ 9 effici5t hir+ = vacant positions1 su* z tempor>y direct hir+ au?orities dur+ ! ,,covid-#ai public heal? em]g5cy response2 7#g7 :e!r policies1 practices1 processes1 & programs relat$ to hir+1 recruit+1 pr(essional developm5t1 & ret5tion are implem5t$ consi/5tly across ! ,food & ,drug ,adm9i/ration2 7#h7 recomm5dations to address *all5ges id5tifi$1 includ+ recomm5dations reg>d+ improvem5ts to policies1 practices1 processes1 & programs ( ! ,food & ,drug ,adm9i/ration ) respect to hir+1 recruit+1 pr(essional developm5t1 & ret5tion2 & 7#i7 *all5ges relat$ to hir+1 recruit+1 & reta9+ a qualifi$ work=ce to meet public heal? em]g5cy response ne$s1 includ+ any su* *all5ges id5tifi$ dur+ ! ,,covid-#ai public heal? em]g5cy4 ,b ,mitigat+ %ortages #eaa4 ,ensur+ regi/ration ( =eign drug & device manufactur]s 7a7 ,regi/ration ( c]ta9 =eign e/abli%m5ts ,section #eaj7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;i77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,! requirem5ts ( p>agraphs 7#a7 & 7#b7 %all apply reg>dless ( :e!r ! drug or device und]goes fur!r manufacture1 prep>ation1 propagation1 comp\nd+1 or process+ at a sep>ate e/abli%m5t outside ! ,unit$ ,/ates prior to be+ import$ or (f]$ = import into ! ,unit$ ,/ates4 4 7b7 ,updat+ regulations ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all update regulations1 z appropriate1 to implem5t ! am5dm5t made by subsection 7a74 #eab4 ,ext5d+ expiration dates = c]ta9 drugs 7a7 ,9 g5]al ,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 issue draft guidance1 or revise exi/+ guidance1 to address recomm5dations = sponsors ( applications submitt$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 reg>d+-- 7#a7 ! submission ( /ability te/+ data 9 su* applications1 includ+ consid]ations = data requirem5ts t c\ld be /reaml9$ or r$uc$ to facilitate fa/] review ( long] propos$ expiration dates2 7#b7 e/abli%+ 9 ! label+ ( drugs ! longe/ feasible expiration date sci5tifically support$ by su* data1 tak+ into consid]ation h[ ext5d$ expiration dates may-- 7,a7 help prev5t or mitigate drug %ortages2 & 7,b7 affect product quality2 & 7#c7 ! use ( innovative approa*es = drug & comb9ation product /ability model+ to support initial product expiration dates & expiration date ext5sions4 7b7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 & aga9 #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 t includes-- 7#a7 ! numb] ( drugs = :i* ! ,secret>y has reque/$ ! manufactur] make a label+ *ange reg>d+ ! expiration date2 & 7#b7 = ea* drug = :i* ! ,secret>y has reque/$ a label+ *ange ) respect to ! expiration date1 in=mation reg>d+ ! circum/ances ( su* reque/1 includ+-- 7,a7 ! "n & dose ( su* drug2 7,b7 ! rationale = ! reque/2 7,c7 :e!r ! drug1 at ! "t ( ! reque/1 0 li/$ on ! drug %ortage li/ "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 or 0 at risk ( %ortage2 7,d7 :e!r ! reque/ 0 made dur+ a public heal? em]g5cy decl>$ "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d72 & 7,e7 :e!r ! manufactur] made ! reque/$ *ange by ! reque/$ date1 & = in/ances :]e ! manufactur] does n make ! reque/$ *ange1 ! manufactur]'s ju/ification = n mak+ ! *ange1 if ! manufactur] agrees to provide su* ju/ification = inclusion 9 ! report4 #eac4 ,unann\nc$ =eign facility inspections pilot program 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all conduct a pilot program "u :i* ! ,secret>y increases ! conduct ( unann\nc$ inspections ( =eign human drug facilities & evaluates ! diff]5ces betwe5 inspections ( dome/ic & =eign human drug facilities1 includ+ ! impact ( ann\nc+ inspections to p]sons :o own or op]ate =eign human drug facilities 9 advance ( an inspection4 ,su* pilot program %all evaluate-- 7#a7 diff]5ces 9 ! numb] & type ( violations ( section #eja7;a77#b77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7;a77#b77;,b77 id5tifi$ dur+ unann\nc$ & ann\nc$ inspections ( =eign human drug facilities & any o!r significant diff]5ces betwe5 ea* type ( inspection2 7#b7 co/s & b5efits associat$ ) conduct+ ann\nc$ & unann\nc$ inspections ( =eign human drug facilities2 7#c7 b>ri]s to conduct+ unann\nc$ inspections ( =eign human drug facilities & any *all5ges to a*iev+ p>ity betwe5 dome/ic & =eign human drug facility inspections2 & 7#d7 approa*es = mitigat+ any negative effects ( conduct+ ann\nc$ inspections ( =eign human drug facilities4 7b7 ,pilot program initiation ,! ,secret>y %all initiate ! pilot program "u ?is section n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act4 7c7 ,report ,! ,secret>y %all1 n lat] ?an #ahj days foll[+ ! completion ( ! pilot program1 make available on ! website ( ! ,food & ,drug ,adm9i/ration a f9al report on ! pilot program "u ?is section1 includ+-- 7#a7 f9d+s & any associat$ recomm5dations ) respect to ! evaluation "u subsection 7a71 includ+ any recomm5dations to address id5tifi$ b>ri]s to conduct+ unann\nc$ inspections ( =eign human drug facilities2 7#b7 f9d+s & any associat$ recomm5dations reg>d+ h[ ! ,secret>y may a*ieve p>ity betwe5 dome/ic & =eign human drug inspections2 & 7#c7 ! numb] ( unann\nc$ inspections dur+ ! pilot t w\ld n be unann\nc$ "u exi/+ practices4 #ead4 ,combat+ c\nt]feit devices 7a7 ,prohibit$ acts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at ! end ! foll[+3 7fff7 7#a7 ,=g+1 c\nt]feit+1 simulat+1 or falsely repres5t+1 or )\t prop] au?ority us+ any m>k1 /amp1 tag1 label1 or o!r id5tification ^u any device or conta9]1 packag+1 or label+ !re( s z to r5d] su* device a c\nt]feit device4 7#b7 ,mak+1 sell+1 dispos+ (1 or keep+ 9 possession1 control1 or cu/ody1 or conceal+ any pun*1 die1 plate1 /one1 or o!r ?+ design$ to pr9t1 impr9t1 or reproduce ! tradem>k1 trade "n1 or o!r id5tify+ m>k or impr9t ( ano!r or any lik5ess ( any ( ! =ego+ ^u any device or conta9]1 packag+1 or label+ !re( s z to r5d] su* device a c\nt]feit device4 7#c7 ,! do+ ( any act :i* causes a device to be a c\nt]feit device1 or ! sale or disp5s+1 or ! hold+ = sale or disp5s+1 ( a c\nt]feit device4 4 7b7 ,p5alties ,section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is am5d$-- 7#a7 9 subsection 7b77#h71 by ins]t+ 1 or :o violates section #cja7;fff77#c7 by kn[+ly mak+1 sell+ or disp5s+1 or hold+ = sale or disp5s+1 a c\nt]feit device1 aft] a c\nt]feit drug2 & 7#b7 9 subsection 7c71 by ins]t+ 2 or 7#f7 = hav+ violat$ section #cja7;fff77#b7 if su* p]son act$ 9 good fai? & _h no reason to believe t use ( ! pun*1 die1 plate1 /one1 or o!r ?+ involv$ w\ld result 9 a device be+ a c\nt]feit device1 or = hav+ violat$ section #cja7;fff77#c7 if ! p]son do+ ! act or caus+ x to be done act$ 9 good fai? & _h no reason to believe t ! device 0 a c\nt]feit device be=e ! p]iod4 7c7 ,seizure ,section #cjd7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7;a77#b77 is am5d$-- 7#a7 by /rik+ 1 & 7,e7 & ins]t+ 1 7,e72 & 7#b7 by ins]t+ 1 7,f7 ,any device t is a c\nt]feit device1 7,g7 ,any conta9]1 packag+1 or label+ ( a c\nt]feit device1 & 7,h7 ,any pun*1 die1 plate1 /one1 label+1 conta9]1 or o!r ?+ us$ or design$ = use 9 mak+ a c\nt]feit device or devices be=e ! p]iod4 #eae4 ,/r5g!n+ m$ical device supply *a9s 7a7 ,9 g5]al ,section #ejf;,j ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7 is am5d$-- 7#a7 by r$esignat+ subsections 7h7 & 7i7 z subsections 7j7 & 7k71 respectively2 & 7#b7 by ins]t+ aft] subsection 7g7 ! foll[+3 7h7 ,risk managem5t plans ,ea* manufactur] ( a device t is critical to public heal?1 includ+ devices t are life-support+1 life-su/a9+1 or int5d$ = use 9 em]g5cy m$ical c>e1 %all develop1 ma9ta91 &1 z appropriate1 implem5t a r$undancy risk managem5t plan t id5tifies & evaluates risks to ! supply ( ! device1 z applicable1 = ea* e/abli%m5t 9 :i* su* device is manufactur$4 ,a risk managem5t plan "u ?is subsection-- 7#a7 may id5tify & evaluate risks to ! supply ( m ?an "o device1 or device category1 manufactur$ at ! same e/abli%m5t2 & 7#b7 %all be subject to inspection & copy+ by ! ,secret>y pursuant to section #gjd or at ! reque/ ( ! ,secret>y4 4 7b7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 & annually = #d ye>s !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! use ( in=mation manufactur]s submit pursuant to section #ejf;,j ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7 & applicable guidance issu$ ) respect to su* section4 #eaf4 ,prev5t+ m$ical device %ortages 7a7 ,notifications ,section #ejf;,j ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j71 z am5d$ by section #eae1 is fur!r am5d$-- 7#a7 9 ! flu% text at ! end ( subsection 7a71 by ins]t+ or ( any o!r circum/ance t is likely to lead to a mean+ful disruption 9 ! supply ( ! device or a %ortage ( ! device1 & !re is no o!r available device t c\ld reasonably be sub/itut$ = t device 9 ! ,unit$ ,/ates be=e ! p]iod2 7#b7 9 subsection 7f71 by ins]t+ or 7i7 aft] subsection 7a72 & 7#c7 by ins]t+ aft] subsection 7h71 z add$ by section #eae1 ! foll[+3 7i7 ,additional notifications ,! ,secret>y may receive notifications f a manufactur]s ( a device t is life-support+1 life-su/a9+1 or int5d$ = use 9 em]g5cy m$ical c>e or dur+ surg]y1 or any o!r device ! ,secret>y det]m9es to be critical to ! public heal?1 p]ta9+ to a p]man5t discont9uance 9 ! manufacture ( ! device 7except = any discont9uance z a result ( an approv$ modification ( ! device7 or an int]ruption ( ! manufacture ( ! device t is likely to lead to a mean+ful disruption 9 ! supply ( t device 9 ! ,unit$ ,/ates1 & ! reasons = su* discont9uance or int]ruption4 4 7b7 ,guidance on volunt>y notifications ( discont9uance or int]ruption ( device manufacture ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue draft guidance to facilitate volunt>y notifications "u subsection 7i7 ( section #ejf;,j ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j71 z add$ by subsection 7a74 ,su* guidance %all include a description ( circum/ances 9 :i* a volunt>y notification "u su* subsection 7i7 may be appropriate1 recomm5d$ timeframes )9 :i* sponsors %\ld submit su* a notification1 ! process = receiv+ su* notifications1 & actions ! ,secret>y may take to mitigate or prev5t a %ortage result+ f a discont9uance or int]ruption 9 ! manufacture ( a device = :i* su* notification is receiv$4 ,! ,secret>y %all issue f9al guidance n lat] ?an #a ye> aft] ! close ( ! comm5t p]iod = ! draft guidance4 #eag4 ,remote records assessm5ts = m$ical devices 7a7 ,factory inspection ,section #gjd7;a77#d77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77;,a77 is am5d$-- 7#a7 9 ! fir/ s5t5ce1 by ins]t+ or device aft] process+ ( a drug2 & 7#b7 9 ! second s5t5ce1 by /rik+ %all include & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ! foll[+3 8%all include-- 7,a7 a description ( ! records reque/$2 & 7,b7 a rationale = reque/+ su* in=mation 9 advance (1 or 9 lieu (1 an inspection4 4 7b7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue draft guidance describ+ circum/ances 9 :i* ! ,secret>y int5ds to issue reque/s = records or o!r in=mation 9 advance (1 or 9 lieu (1 an inspection1 processes = respond+ to su* reque/s electronically or 9 physical =m1 & factors ! ,secret>y int5ds to consid] 9 evaluat+ :e!r su* records are provid$ )9 a reasonable timeframe1 )9 reasonable limits1 & 9 a reasonable mann]1 acc\nt+ = res\rce & o!r limitations t may exi/1 includ+ = small bus9esses4 ,! ,secret>y %all issue f9al guidance n lat] ?an #a ye> aft] ! close ( ! comm5t p]iod = ! draft guidance4 #eah4 ,advanc$ manufactur+ te*nologies designation pilot program ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq471 z am5d$ by section #ejf1 is fur!r am5d$ by ins]t+ aft] section #ejf,k ! foll[+3 #ejf,l4 ,advanc$ manufactur+ te*nologies designation pilot program 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all initiate a pilot program "u :i* p]sons may reque/ designation ( an advanc$ manufactur+ te*nology z describ$ 9 subsection 7b74 7b7 ,designation process ,! ,secret>y %all e/abli% a process = ! designation "u ?is section ( me?ods ( manufactur+ drugs1 includ+ biological products1 & active ph>maceutical +r$i5ts ( su* drugs1 z advanc$ manufactur+ te*nologies4 ,a me?od ( manufactur+1 or a comb9ation ( manufactur+ me?ods1 is eligible = designation z an advanc$ manufactur+ te*nology if su* me?od or comb9ation ( me?ods incorporates a novel te*nology1 or uses an e/abli%$ te*nique or te*nology 9 a novel way1 t w sub/antially-- 7#a7 enhance drug quality2 or 7#b7 improve ! manufactur+ process = a drug & ma9ta9 drug quality1 includ+ by-- 7,a7 r$uc+ developm5t "t = a drug us+ ! designat$ manufactur+ me?od2 or 7,b7 increas+ or ma9ta9+ ! supply (-- 7i7 a drug t is life-support+1 life-su/a9+1 or ( critical importance to provid+ heal? c>e2 or 7ii7 a drug t is on ! drug %ortage li/ "u section #ejf;,e4 7c7 ,evaluation & designation ( an advanc$ manufactur+ te*nology 7#a7 ,submission ,a p]son :o reque/s designation ( a me?od ( manufactur+ z an advanc$ manufactur+ te*nology "u ?is section %all submit to ! ,secret>y data or in=mation demon/rat+ t ! me?od ( manufactur+ meets ! crit]ia describ$ 9 subsection 7b7 9 a p>ticul> context ( use4 ,! ,secret>y may facilitate ! developm5t & review ( su* data or in=mation by-- 7,a7 provid+ timely advice to1 & int]active communication )1 su* p]son reg>d+ ! developm5t ( ! me?od ( manufactur+2 & 7,b7 involv+ s5ior manag]s & exp]i5c$ /aff ( ! ,food & ,drug ,adm9i/ration1 z appropriate1 9 a collaborative1 cross-discipl9>y review ( ! me?od ( manufactur+1 z applicable4 7#b7 ,evaluation & designation ,n lat] ?an #ahj cal5d> days aft] ! receipt ( a reque/ "u p>agraph 7#a71 ! ,secret>y %all det]m9e :e!r to designate su* me?od ( manufactur+ z an advanc$ manufactur+ te*nology1 9 a p>ticul> context ( use1 bas$ on ! data & in=mation submitt$ "u p>agraph 7#a7 & ! crit]ia describ$ 9 subsection 7b74 7d7 ,review ( advanc$ manufactur+ te*nologies ,if ! ,secret>y designates a me?od ( manufactur+ z an advanc$ manufactur+ te*nology1 ! ,secret>y %all-- 7#a7 exp$ite ! developm5t & review ( an application submitt$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ supplem5tal applications1 = drugs t are manufactur$ us+ a designat$ advanc$ manufactur+ te*nology2 & 7#b7 all[ ! hold] ( an advanc$ te*nology designation1 or a p]son au?oriz$ by ! advanc$ manufactur+ te*nology designation hold]1 to ref]5ce or rely ^u1 9 an application submitt$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ a supplem5tal application1 data & in=mation ab\t ! designat$ advanc$ manufactur+ te*nology = use 9 manufactur+ drugs 9 ! same context ( use = :i* ! designation 0 grant$4 7e7 ,implem5tation & evaluation ( advanc$ manufactur+ te*nologies pilot 7#a7 ,public meet+ ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] a notice ( a public meet+1 to be held n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is section1 to discuss1 & obta9 input & recomm5dations f relevant /akehold]s reg>d+-- 7,a7 ! goals & scope ( ! pilot program1 & a suitable framework1 proc$ures1 & requirem5ts = su* program2 & 7,b7 ways 9 :i* ! ,food & ,drug ,adm9i/ration w support ! use ( advanc$ manufactur+ te*nologies & o!r innovative manufactur+ approa*es = drugs4 7#b7 ,pilot program guidance 7,a7 ,9 g5]al ,! ,secret>y %all-- 7i7 n lat] ?an #ahj days aft] ! public meet+ "u p>agraph 7#a71 issue draft guidance reg>d+ ! goals & implem5tation ( ! pilot program "u ?is section2 & 7ii7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section1 issue f9al guidance reg>d+ ! implem5tation ( su* program4 7,b7 ,cont5t ,! guidance describ$ 9 subp>agraph 7,a7 %all address-- 7i7 ! process by :i* a p]son may reque/ a designation "u subsection 7b72 7ii7 ! data & in=mation t a p]son reque/+ su* a designation is requir$ to submit "u subsection 7c71 & h[ ! ,secret>y int5ds to evaluate su* submissions2 7iii7 ! process to exp$ite ! developm5t & review ( applications "u subsection 7d72 & 7iv7 ! crit]ia describ$ 9 subsection 7b7 = eligibility = su* a designation4 7#c7 ,report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is section & annually !reaft]1 ! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conta9+ a description & evaluation ( ! pilot program be+ conduct$ "u ?is section1 includ+ ! types ( innovative manufactur+ approa*es support$ "u ! program4 ,su* report %all include ! foll[+3 7,a7 ,! numb] ( p]sons t h reque/$ designations & t h be5 grant$ designations4 7,b7 ,! numb] ( me?ods ( manufactur+ t h be5 ! subject ( designation reque/s & t h be5 grant$ designations4 7,c7 ,! av]age numb] ( cal5d> days = completion ( evaluations "u subsection 7c77#b74 7,d7 ,an analysis ( ! factors 9 data submissions t result 9 det]m9ations to designate & n to designate aft] evaluation "u subsection 7c77#b74 7,e7 ,! numb] ( applications receiv$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ supplem5tal applications1 t h includ$ an advanc$ manufactur+ te*nology designat$ "u ?is section1 & ! numb] ( su* applications approv$4 7f7 ,sunset ,! ,secret>y-- 7#a7 may n consid] any reque/s = designation submitt$ "u subsection 7c7 aft] ,octob] #a1 #bjbi2 & 7#b7 may cont9ue all activities "u ?is section ) respect to advanc$ manufactur+ te*nologies t 7 designat$ pursuant to subsection 7d7 prior to su* date1 if ! ,secret>y det]m9es su* activities are 9 ! int]e/ ( ! public heal?4 4 #eai4 ,te*nical corrections 7a7 ,te*nical corrections to ! ,,c>es ,act ,division ,a ( ! ,,c>es ,act 7,public ,law #aaf-acf7 is am5d$-- 7#a7 9 section #caaa7a71 by /rik+ 9 p>agraph 7#a7 & ins]t+ 9 ! matt] prec$+ p>agraph 7#a72 7#b7 9 section #caab7;d77#a71 by /rik+ & subp>agraphs 7,a7 & 7,b7 & ins]t+ z subp>agraphs 7,a7 & 7,b72 & 7#c7 9 section #caab7;e71 by /rik+ ,f$]al ,food1 ,drug1 ,cosmetic ,act & ins]t+ ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7b7 ,te*nical corrections to ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act relat$ to ! ,,c>es ,act 7#a7 ,section #ejf;,c ,section #ejf;,c7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7a77 is am5d$1 9 ! flu% text at ! end1 by /rik+ ! second comma aft] 9 ! ,unit$ ,/ates4 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all take effect z if includ$ 9 section #caab ( division ,a ( ! ,,c>es ,act 7,public ,law #aaf-acf74 7c7 ,o!r te*nical correction to ! ,f$]al food1 drug1 & cosmetic act ,section #eje;,b7f77#f77;,i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7f77#f77;,i77 is am5d$ by /rik+ subsection 7a77#c77;,b7 & ins]t+ subsection 7a77#d77;,c74