#aaf? ,,congress #a/ ,session ,h4 ,r4 #bfi ,,an ,,act ,to reau?orize c]ta9 programs "u ! ,public ,heal? ,s]vice ,act & ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to public heal? security & all-haz>ds prep>$ness & response1 to cl>ify ! regulatory framework ) respect to c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,division ,a--,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,sec4 #ajj4 ,ref]5ces 9 division4 ,title ,i--,/r5g!n+ ! national heal? security /rategy ,sec4 #aja4 ,national ,heal? ,security ,/rategy4 ,title ,,ii--,improv+ prep>$ness & response ,sec4 #bja4 ,improv+ b5*m>ks & /&>ds = prep>$ness & response4 ,sec4 #bjb4 ,am5dm5ts to prep>$ness & response programs4 ,sec4 #bjc4 ,regional heal? c>e em]g5cy prep>$ness & response sy/ems4 ,sec4 #bjd4 ,milit>y & civilian p>tn]%ip = trauma read9ess4 ,sec4 #bje4 ,public heal? & heal? c>e sy/em situational aw>5ess & biosurveillance capabilities4 ,sec4 #bjf4 ,/r5g!n+ & support+ ! public heal? em]g5cy rapid response fund4 ,sec4 #bjg4 ,improv+ all-haz>ds prep>$ness & response by public heal? em]g5cy volunte]s4 ,sec4 #bjh4 ,cl>ify+ ,/ate liability law = volunte] heal? c>e pr(essionals4 ,sec4 #bji4 ,report on adequate national blood supply4 ,sec4 #baj4 ,report on ! public heal? prep>$ness & response capabilities & capacities ( hospitals1 long-t]m c>e facilities1 & o!r heal? c>e facilities4 ,title ,,iii--,rea*+ all communities ,sec4 #cja4 ,/r5g!n+ & assess+ ! em]g5cy response work=ce4 ,sec4 #cjb4 ,heal? sy/em infra/ructure to improve prep>$ness & response4 ,sec4 #cjc4 ,consid]ations = at-risk individuals4 ,sec4 #cjd4 ,improv+ em]g5cy prep>$ness & response consid]ations = *ildr54 ,sec4 #cje4 ,national advisory committees on disa/]s4 ,sec4 #cjf4 ,guidance = p>ticipation 9 ex]cises & drills4 ,title ,,iv--,prioritiz+ a ?reat-bas$ approa* ,sec4 #dja4 ,assi/ant ,secret>y = ,prep>$ness & ,response4 ,sec4 #djb4 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise4 ,sec4 #djc4 ,/rategic ,national ,/ockpile4 ,sec4 #djd4 ,prep>+ = p&emic influ5za1 antimicrobial resi/ance1 & o!r significant ?reats4 ,sec4 #dje4 ,report+ on ! ,f$]al ,select ,ag5t ,program4 ,title ,v--,increas+ communication 9 m$ical c\nt]measure advanc$ rese>* & developm5t ,sec4 #eja4 ,m$ical c\nt]measure budget plan4 ,sec4 #ejb4 ,mat]ial ?reat & m$ical c\nt]measure notifications4 ,sec4 #ejc4 ,availability ( regulatory managem5t plans4 ,sec4 #ejd4 ,! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority & ! ,bio,shield ,special ,res]ve ,fund4 ,sec4 #eje4 ,additional /rategies = combat+ antibiotic resi/ance4 ,title ,,vi--,advanc+ te*nologies = m$ical c\nt]measures ,sec4 #fja4 ,adm9i/ration ( c\nt]measures4 ,sec4 #fjb4 ,updat+ def9itions ( o!r transactions4 ,sec4 #fjc4 ,m$ical c\nt]measure ma/] files4 ,sec4 #fjd4 ,animal rule report4 ,sec4 #fje4 ,review ( ! b5efits ( g5omic eng9e]+ te*nologies & _! pot5tial role 9 national security4 ,sec4 #fjf4 ,report on vacc9es developm5t4 ,sec4 #fjg4 ,/r5g!n+ mosquito abatem5t = safety & heal?4 ,title ,,vii--,miscellane\s provisions ,sec4 #gja4 ,reau?orizations & ext5sions4 ,sec4 #gjb4 ,location ( mat]ials 9 ! /ockpile4 ,sec4 #gjc4 ,cyb]security4 ,sec4 #gjd4 ,/rategy & report4 ,sec4 #gje4 ,te*nical am5dm5ts4 ,division ,b--,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m ,sec4 #ajjj4 ,%ort title2 ref]5ces 9 division4 ,title ,i--,,otc ,drug ,review ,sec4 #ajja4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application4 ,sec4 #ajjb4 ,misbr&+4 ,sec4 #ajjc4 ,drugs exclud$ f ! ov]-!-c\nt] drug review4 ,sec4 #ajjd4 ,treatm5t ( ,sunscre5 ,innovation ,act4 ,sec4 #ajje4 ,annual update to ,congress on appropriate p$iatric indication = c]ta9 ,,otc c\gh & cold drugs4 ,sec4 #ajjf4 ,te*nical corrections4 ,title ,,ii--,us] ,fees ,sec4 #bjja4 ,%ort title2 f9d+4 ,sec4 #bjjb4 ,fees relat+ to ov]-!-c\nt] drugs4 ,a ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation #ajj4 ,ref]5ces 9 division ,except z o!rwise specifi$-- 7#a7 am5dm5ts made by ?is division to a section or o!r provision ( law are am5dm5ts to su* section or o!r provision ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq472 & 7#b7 any ref]5ce to ?is ,act conta9$ 9 ?is division %all be treat$ z ref]r+ only to ! provisions ( ?is division4 ,i ,/r5g!n+ ! national heal? security /rategy #aja4 ,national ,heal? ,security ,/rategy ,section #bhjb 7#db ,u4,s4,c4 #cjj;hh-#a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ #bjad & ins]t+ #bjah2 & 7ii7 by /rik+ ! second s5t5ce & ins]t+ ! foll[+3 ,su* ,national ,heal? ,security ,/rategy %all describe pot5tial em]g5cy heal? security ?reats & id5tify ! process = a*iev+ ! prep>$ness goals describ$ 9 subsection 7b7 to be prep>$ to id5tify & respond to su* ?reats & %all be consi/5t ) ! national prep>$ness goal 7z describ$ 9 section #ejd7;a77#ai7 ( ! ,homel& ,security ,act ( #bjjb71 ! ,national ,incid5t ,managem5t ,sy/em 7z def9$ 9 section #eja7g7 ( su* ,act71 & ! ,national ,response ,plan develop$ pursuant to section #ejd ( su* ,act1 or any successor plan42 7,b7 9 p>agraph 7#b71 by ins]t+ be=e ! p]iod at ! end ( ! second s5t5ce ! foll[+3 1 & an analysis ( any *anges to ! evid5ce-bas$ b5*m>ks & objective /&>ds "u sections #cai;,c-#a & #cai;,c-#b2 & 7,c7 9 p>agraph 7#c7-- 7i7 by /rik+ #bjji & ins]t+ #bjbb2 7ii7 by ins]t+ 7includ+ gaps 9 ! environm5tal heal? & animal heal? work=ces1 z applicable71 describ+ ! /atus ( su* work=ce aft] gaps 9 su* work=ce2 7iii7 by /rik+ & id5tify+ /rategies & ins]t+ id5tify+ /rategies2 & 7iv7 by ins]t+ be=e ! p]iod at ! end 1 & id5tify+ curr5t capabilities to meet ! requirem5ts ( section #bhjc2 & 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by /rik+ & inve/igation & ins]t+ inve/igation1 & relat$ in=mation te*nology activities2 7ii7 9 subp>agraph 7,b71 by /rik+ & decontam9ation & ins]t+ decontam9ation1 relevant heal? c>e s]vices & supplies1 & transportation & disposal ( m$ical wa/e2 & 7iii7 by add+ at ! end ! foll[+3 7,e7 ,response to environm5tal haz>ds4 2 7,b7 9 p>agraph 7#c7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ includ+ m5tal heal? & ins]t+ includ+ ph>macies1 m5tal heal? facilities12 & 7ii7 9 subp>agraph 7,f71 by ins]t+ or exposures to ag5ts t c\ld cause a public heal? em]g5cy be=e ! p]iod2 7,c7 9 p>agraph 7#e71 by ins]t+ & o!r applicable compacts aft] ,compact2 & 7,d7 by add+ at ! end ! foll[+3 7#i7 ,zoonotic disease1 food1 & agriculture ,improv+ coord9ation among ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial entities 7includ+ ?r\gh consultation ) ! ,secret>y ( ,agriculture7 to prev5t1 detect1 & respond to outbreaks ( plant or animal disease 7includ+ zoonotic disease7 t c\ld compromise national security result+ f a delib]ate attack1 a naturally occurr+ ?reat1 ! int5tional adult]ation ( food1 or o!r public heal? ?reats1 tak+ into acc\nt int]actions betwe5 animal heal?1 human heal?1 & animals' & humans' %>$ environm5t z directly relat$ to public heal? em]g5cy prep>$ness & response capabilities1 z applicable4 7#aj7 ,global heal? security ,assess+ curr5t or pot5tial heal? security ?reats f abroad to in=m dome/ic public heal? prep>$ness & response capabilities4 4 ,,ii ,improv+ prep>$ness & response #bja4 ,improv+ b5*m>ks & /&>ds = prep>$ness & response 7a7 ,evaluat+ measurable evid5ce-,bas$ b5*m>ks & objective /&>ds ,section #cai;,c-#a 7#db ,u4,s4,c4 #bdg;d-#c;a7 is am5d$ by ins]t+ aft] subsection 7j7 ! foll[+3 7k7 ,evaluation 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai & e #b ye>s !reaft]1 ! ,secret>y %all conduct an evaluation ( ! evid5ce-bas$ b5*m>ks & objective /&>ds requir$ "u subsection 7g74 ,su* evaluation %all be submitt$ to ! congressional committees ( jurisdiction toge!r ) ! ,national ,heal? ,security ,/rategy "u section #bhjb1 at su* "t z su* /rategy is submitt$4 7#b7 ,cont5t ,! evaluation "u ?is p>agraph %all include-- 7,a7 a review ( evid5ce-bas$ b5*m>ks & objective /&>ds1 & associat$ metrics & t>gets2 7,b7 a discussion ( *anges to any evid5ce-bas$ b5*m>ks & objective /&>ds1 & ! effect ( su* *anges on ! ability to track :e!r entities are meet+ or mak+ progress t[>d ! goals "u ?is section &1 to ! ext5t practicable1 ! applicable goals ( ! ,national ,heal? ,security ,/rategy "u section #bhjb2 7,c7 a description ( am\nts receiv$ by eligible entities describ$ 9 subsection 7b7 & section #cai;,c-#b7;b71 & am\nts receiv$ by subrecipi5ts & ! effect ( su* fund+ on meet+ evid5ce-bas$ b5*m>ks & objective /&>ds2 & 7,d7 recomm5dations1 z applicable & appropriate1 to improve evid5ce-bas$ b5*m>ks & objective /&>ds to m accurately assess ! ability ( entities receiv+ aw>ds "u ?is section to bett] a*ieve ! goals "u ?is section & section #bhjb4 4 7b7 ,evaluat+ ! p>tn]%ip = ,/ate & regional hospital prep>$ness ,section #cai;,c-#b7;i77#a7 7#db ,u4,s4,c4 #bdg-c;b7i77#a77 is am5d$ by /rik+ section #cai;,c-#a7;g71 7i71 & 7j7 & ins]t+ section #cai;,c-#a7;g71 7i71 7j71 & 7k74 #bjb4 ,am5dm5ts to prep>$ness & response programs 7a7 ,coop]ative agreem5t applications = improv+ ,/ate & local public heal? security ,section #cai;,c-#a 7#db ,u4,s4,c4 #bdg;d-#c;a7 is am5d$-- 7#a7 9 subsection 7a71 by ins]t+ 1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 aft] ! ,secret>y2 & 7#b7 9 subsection 7b77#b77;,a7-- 7,a7 9 clause 7vi71 by ins]t+ 1 includ+ public heal? ag5cies ) specific exp]tise t may be relevant to public heal? security1 su* z environm5tal heal? ag5cies1 aft] /akehold]s2 7,b7 by r$esignat+ clauses 7vii7 ?r\gh 7ix7 z clauses 7viii7 ?r\gh 7x72 7,c7 by ins]t+ aft] clause 7vi7 ! foll[+3 7vii7 a description ( h[1 z applicable1 su* entity may integrate in=mation to acc\nt = individuals ) behavioral heal? ne$s foll[+ a public heal? em]g5cy2 2 7,d7 9 clause 7ix71 z s r$esignat$1 by /rik+ 2 & & ins]t+ a semicolon2 & 7,e7 by add+ at ! end ! foll[+3 7xi7 a description ( h[ ! entity w p>tn] ) heal? c>e facilities1 includ+ hospitals & nurs+ homes & o!r long-t]m c>e facilities1 to promote & improve public heal? prep>$ness & response2 & 7xii7 a description ( h[1 z appropriate & practicable1 ! entity w include critical infra/ructure p>tn]s1 su* z utility companies )9 ! entity's jurisdiction1 9 plann+ pursuant to ?is subp>agraph to help ensure t critical infra/ructure w rema9 function+ dur+1 or return to function z soon z practicable aft]1 a public heal? em]g5cy2 4 7b7 ,exception relat+ to application ( c]ta9 requirem5ts 7#a7 ,9 g5]al ,section #cai;,c-#a7;g7 7#db ,u4,s4,c4 #bdg;d-#c;a7g77 is am5d$-- 7,a7 9 p>agraph 7#e7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ,beg9n+ ) fiscal ye> #bjji & ins]t+ ,beg9n+ ) fiscal ye> #bjai2 & 7ii7 9 subp>agraph 7,a7-- 7,i7 by /rik+ = ! imm$iately prec$+ fiscal ye> & ins]t+ = ei!r ( ! #b imm$iately prec$+ fiscal ye>s2 & 7,,ii7 by /rik+ #bjjh & ins]t+ #bjah2 & 7,b7 9 p>agraph 7#f71 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,9 g5]al ,! am\nts describ$ 9 ?is p>agraph are ! foll[+ am\nts t are payable to an entity = activities describ$ 9 ?is section or section #cai;,c-#b3 7i7 ,= no m ?an #a ( ea* ( ! fir/ #b fiscal ye>s imm$iately foll[+ a fiscal ye> 9 :i* an entity exp]i5c$ a failure describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#e71 an am\nt equal to #aj p]c5t ( ! am\nt ! entity 0 eligible to receive = ! respective fiscal ye>4 7ii7 ,= no m ?an #a ( ! fir/ #b fiscal ye>s imm$iately foll[+ ! ?ird consecutive fiscal ye> 9 :i* an entity exp]i5c$ su* a failure1 9 lieu ( apply+ clause 7i71 an am\nt equal to #ae p]c5t ( ! am\nt ! entity 0 eligible to receive = ! respective fiscal ye>4 4 7#b7 ,effective date ,! am5dm5ts made by p>agraph 7#a7 %all apply ) respect to coop]ative agreem5ts aw>d$ on or aft] ! date ( enactm5t ( ?is ,act4 7c7 ,p>tn]%ip = ,/ate & regional hospital prep>$ness ,to improve surge capacity ,section #cai;,c-#b 7#db ,u4,s4,c4 #bdg;d-#c;b7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by ins]t+ 1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 aft] ,! ,secret>y2 & 7,b7 by /rik+ prep>$ness = public heal? em]g5cies & ins]t+ prep>$ness =1 & response to1 public heal? em]g5cies 9 accordance ) subsection 7c72 7#b7 9 subsection 7b77#a77;,a7-- 7,a7 by /rik+ p>tn]%ip consi/+ ( & ins]t+ coalition t includes2 7,b7 9 clause 7ii71 by /rik+ 2 & & ins]t+ a semicolon2 & 7,c7 by add+ at ! end ! foll[+3 7iv7 "o or m em]g5cy m$ical s]vice organizations or em]g5cy managem5t organizations2 & 2 7#c7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a77;,b71 by /rik+ p>tn]%ip ea* place x appe>s & ins]t+ coalition2 & 7,b7 9 p>agraph 7#b77;,c71 by /rik+ m$ical prep>$ness & ins]t+ prep>$ness & response2 7#d7 9 subsection 7f71 by /rik+ p>tn]%ip & ins]t+ coalition2 7#e7 9 subsection 7g77#b7-- 7,a7 by /rik+ ,p>tn]%ips & ins]t+ ,coalitions2 7,b7 by /rik+ p>tn]%ips & ins]t+ coalitions2 & 7,c7 by ins]t+ & response aft] prep>$ness2 & 7#f7 9 subsection 7i77#a7-- 7,a7 by /rik+ ,an entity & ins]t+ ,a coalition2 & 7,b7 by /rik+ su* p>tn]%ip & ins]t+ su* coalition4 7d7 ,public heal? security grants au?orization ( appropriations ,section #cai;,c-#a7;h77#a77;,a7 7#db ,u4,s4,c4 #bdg;d-#c;a7h77#a77;,a77 is am5d$ by /rik+ #fda1ijj1jjj = fiscal ye> #bjad & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ #fhe1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc = aw>ds pursuant to p>agraph 7#c7 7subject to ! au?ority ( ! ,secret>y to make aw>ds pursuant to p>agraphs 7#d7 & 7#e7744 7e7 ,p>tn]%ip = ,/ate & regional hospital prep>$ness au?orization ( appropriations ,section #cai;,c-#b7;j7 7#db ,u4,s4,c4 #bdg;d-#c;b7j77 is am5d$-- 7#a7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,9 g5]al 7,a7 ,au?orization ( appropriations ,= purposes ( c>ry+ out ?is section & section #cai;,c-#c1 9 accordance ) subp>agraph 7,b71 !re is au?oriz$ to be appropriat$ #che1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 7,b7 ,res]vation ( am\nts = regional sy/ems 7i7 ,9 g5]al ,subject to clause 7ii71 ( ! am\nt appropriat$ "u subp>agraph 7,a7 = a fiscal ye>1 ! ,secret>y may res]ve up to #e p]c5t = ! purpose ( c>ry+ out section #cai;,c-#c4 7ii7 ,res]vation cont+5t on cont9u$ appropriations = ?is section ,if = fiscal ye> #bjai or a subsequ5t fiscal ye>1 ! am\nt appropriat$ "u subp>agraph 7,a7 is su* t1 aft] application ( clause 7i71 ! am\nt rema9+ = ! purpose ( c>ry+ out ?is section w\ld be less ?an ! am\nt available = su* purpose = ! previ\s fiscal ye>1 ! am\nt t may be res]v$ "u clause 7i7 %all be r$uc$ su* t ! am\nt rema9+ = ! purpose ( c>ry+ out ?is section is n less ?an ! am\nt available = su* purpose = ! previ\s fiscal ye>4 7iii7 ,sunset ,! au?ority to res]ve am\nts "u clause 7i7 %all expire on ,septemb] #cj1 #bjbc4 2 7#b7 9 p>agraph 7#b71 by /rik+ p>agraph 7#a7 = a fiscal ye> & ins]t+ p>agraph 7#a77;,a7 = a fiscal ye> & n res]v$ = ! purpose describ$ 9 p>agraph 7#a77;,b77i72 & 7#c7 9 p>agraph 7#c77;,a71 by /rik+ p>agraph 7#a7 & n res]v$ "u p>agraph 7#b7 & ins]t+ p>agraph 7#a77;,a7 & n res]v$ "u p>agraph 7#a77;,b77i7 or 7#b74 #bjc4 ,regional heal? c>e em]g5cy prep>$ness & response sy/ems 7a7 ,9 g5]al ,"p ,b ( title ,,iii 7#db ,u4,s4,c4 #bdc et seq47 is am5d$ by ins]t+ aft] section #cai;,c-#b ! foll[+3 #cai;,c-#c4 ,guidel9es = regional heal? c>e em]g5cy prep>$ness & response sy/ems 7a7 ,purpose ,x is ! purpose ( ?is section to id5tify & provide guidel9es = regional sy/ems ( hospitals1 heal? c>e facilities1 & o!r public & private sector entities1 ) v>y+ levels ( capability to treat pati5ts & increase m$ical surge capacity dur+1 9 advance (1 & imm$iately foll[+ a public heal? em]g5cy1 includ+ ?reats pos$ by "o or m *emical1 biological1 radiological1 or nucle> ag5ts1 includ+ em]g+ infecti\s diseases4 7b7 ,guidel9es ,! ,assi/ant ,secret>y = ,prep>$ness & ,response1 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 ! ,commission] ( ,food & ,drugs1 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal?1 ! ,secret>y ( ,vet]ans ,affairs1 ! heads ( su* o!r ,f$]al ag5cies z ! ,secret>y det]m9es to be appropriate1 & ,/ate1 local1 ,tribal1 & t]ritorial public heal? (ficials1 %all1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section-- 7#a7 id5tify & develop a set ( guidel9es relat+ to practices & protocols = all-haz>ds public heal? em]g5cy prep>$ness & response = hospitals & heal? c>e facilities to provide appropriate pati5t c>e dur+1 9 advance (1 or imm$iately foll[+1 a public heal? em]g5cy1 result+ f "o or m *emical1 biological1 radiological1 or nucle> ag5ts1 includ+ em]g+ infecti\s diseases 7:i* may include exi/+ practices1 su* z trauma c>e & m$ical surge capacity & capabilities71 ) respect to-- 7,a7 a regional approa* to id5tify+ hospitals & heal? c>e facilities bas$ on v>y+ capabilities & capacity to treat pati5ts affect$ by su* em]g5cy1 includ+-- 7i7 ! mann] 9 :i* ! sy/em w coord9ate ) & integrate ! p>tn]%ips & heal? c>e coalitions e/abli%$ "u section #cai;,c-#b7;b72 & 7ii7 in=m+ & educat+ appropriate fir/ respond]s & heal? c>e supply *a9 p>tn]s ( ! regional em]g5cy prep>$ness & response capabilities & m$ical surge capacity ( su* hospitals & heal? c>e facilities 9 ! community2 7,b7 physical & te*nological infra/ructure1 laboratory capacity1 /aff+1 blood supply1 & o!r supply *a9 ne$s1 tak+ into acc\nt resili5cy1 geographic consid]ations1 & rural consid]ations2 7,c7 protocols or be/ practices = ! safety & p]sonal protection ( work]s :o h&le human rema9s & heal? c>e work]s 7includ+ ) respect to protective equipm5t & supplies1 wa/e managem5t processes1 & decontam9ation71 %>+ ( specializ$ exp]i5ce among ! heal? c>e work=ce1 behavioral heal?1 psy*ological resili5ce1 & tra9+ ( ! work=ce1 z applicable2 7,d7 9 a mann] t all[s = disease conta9m5t 7)9 ! mean+ ( section #bhjb7;b77#b77;,b771 coord9at$ m$ical triage1 treatm5t1 & transportation ( pati5ts1 bas$ on pati5t m$ical ne$ 7includ+ pati5ts 9 rural areas71 to ! appropriate hospitals or heal? c>e facilities )9 ! regional sy/em or1 z applicable & appropriate1 betwe5 sy/ems 9 diff]5t ,/ates or regions2 & 7,e7 ! ne$s ( *ildr5 & o!r at-risk individuals2 7#b7 make su* guidel9es available on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a mann] t does n compromise national security2 & 7#c7 update su* guidel9es z appropriate1 includ+ bas$ on input receiv$ pursuant to subsections 7c7 & 7e7 & in=mation result+ f applicable reports requir$ "u ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai 7includ+ any am5dm5ts made by su* ,act71 to address new & em]g+ public heal? ?reats4 7c7 ,consid]ations ,9 id5tify+1 develop+1 & updat+ guidel9es "u subsection 7b71 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all-- 7#a7 include input f hospitals & heal? c>e facilities 7includ+ heal? c>e coalitions "u section #cai;,c-#b71 ,/ate1 local1 ,tribal1 & t]ritorial public heal? dep>tm5ts1 & heal? c>e or subject matt] exp]ts 7includ+ exp]ts ) relevant exp]tise 9 *emical1 biological1 radiological1 or nucle> ?reats1 includ+ em]g+ infecti\s diseases71 z ! ,assi/ant ,secret>y det]m9es appropriate1 to meet ! goals "u section #bhjb7;b77#c72 7#b7 consult & engage ) appropriate heal? c>e provid]s & pr(essionals1 includ+ physicians1 nurses1 fir/ respond]s1 heal? c>e facilities 7includ+ hospitals1 prim>y c>e cl9ics1 community heal? c5t]s1 m5tal heal? facilities1 ambulatory c>e facilities1 & d5tal heal? facilities71 ph>macies1 em]g5cy m$ical provid]s1 trauma c>e provid]s1 environm5tal heal? ag5cies1 public heal? laboratories1 poison control c5t]s1 blood banks1 tissue banks1 & o!r exp]ts t ! ,assi/ant ,secret>y det]m9es appropriate1 to meet ! goals "u section #bhjb7;b77#c72 7#c7 consid] fe$back relat$ to f9ancial implications = hospitals1 heal? c>e facilities1 public heal? ag5cies1 laboratories1 blood banks1 tissue banks1 & o!r entities engag$ 9 regional prep>$ness plann+ to implem5t & foll[ su* guidel9es1 z applicable2 & 7#d7 consid] f9ancial requirem5ts & pot5tial inc5tives = entities to prep>e =1 & respond to1 public heal? em]g5cies z "p ( ! regional heal? c>e em]g5cy prep>$ness & response sy/em4 7d7 ,te*nical assi/ance ,! ,assi/ant ,secret>y = ,prep>$ness & ,response1 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal?1 may provide te*nical assi/ance & consultation t[>d meet+ ! guidel9es describ$ 9 subsection 7b74 7e7 ,demon/ration project = regional heal? c>e prep>$ness & response sy/ems 7#a7 ,9 g5]al ,! ,assi/ant ,secret>y = ,prep>$ness & ,response may e/abli% a demon/ration project pursuant to ! developm5t & implem5tation ( guidel9es "u subsection 7b7 to aw>d grants to improve m$ical surge capacity = all haz>ds1 build & integrate regional m$ical response capabilities1 improve specialty c>e exp]tise = all-haz>ds response1 & coord9ate m$ical prep>$ness & response across ,/ate1 local1 ,tribal1 t]ritorial1 & regional jurisdictions4 7#b7 ,sunset ,! au?ority "u ?is subsection %all expire on ,septemb] #cj1 #bjbc4 4 7b7 ,,gao report to ,congress 7#a7 ,report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is subsection z ! ,comptroll] ,g5]al7 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,f9ance ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives1 a report on ! ext5t to :i* hospitals & heal? c>e facilities h implem5t$ ! recomm5d$ guidel9es "u section #cai;,c-#c7;b7 ( ! ,public ,heal? ,s]vice ,act 7z add$ by subsection 7a771 includ+ an analysis & evaluation ( any *all5ges hospitals or heal? c>e facilities exp]i5c$ 9 implem5t+ su* guidel9es4 7#b7 ,cont5t ,! ,comptroll] ,g5]al %all include 9 ! report "u p>agraph 7#a7-- 7,a7 data on ! prep>$ness & response capabilities t h be5 in=m$ by ! guidel9es "u section #cai;,c-#c7;b7 ( ! ,public ,heal? ,s]vice ,act to improve regional em]g5cy heal? c>e prep>$ness & response capability1 includ+ hospital & heal? c>e facility capacity & m$ical surge capabilities to prep>e =1 & respond to1 public heal? em]g5cies2 & 7,b7 recomm5dations to r$uce gaps 9 inc5tives = regional heal? p>tn]s1 includ+ hospitals & heal? c>e facilities1 to improve capacity & m$ical surge capabilities to prep>e =1 & respond to1 public heal? em]g5cies1 consi/5t ) subsection 7a71 :i* may include consid]ation ( facilities p>ticipat+ 9 programs "u section #cai;,c-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 or 9 programs "u ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7includ+ innovative heal? c>e deliv]y & paym5t models71 & input f private sector f9ancial in/itutions4 7#c7 ,consultation ,9 c>ry+ out p>agraphs 7#a7 & 7#b71 ! ,comptroll] ,g5]al %all consult ) ! heads ( appropriate ,f$]al ag5cies1 includ+-- 7,a7 ! ,assi/ant ,secret>y = ,prep>$ness & ,response2 7,b7 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion2 7,c7 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7,d7 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use2 7,e7 ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal?2 & 7,f7 ! ,secret>y ( ,vet]ans ,affairs4 7c7 ,annual reports ,section #cai;,c-#b7;i77#a7 7#db ,u4,s4,c4 #bdg;d-#c;b7i77#a77 is am5d$ by ins]t+ aft] ! fir/ s5t5ce ! foll[+3 ,9 submitt+ reports "u ?is p>agraph1 a coalition %all include in=mation on ! progress t ! coalition has made t[>d ! implem5tation ( section #cai;,c-#c 7or b>ri]s to progress1 if any744 7d7 ,national heal? security /rategy incorporation ( regionaliz$ em]g5cy prep>$ness & response ,subp>agraph 7,g7 ( section #bhjb7;b77#c7 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#c77 is am5d$ to read z foll[s3 7,g7 ,optimiz+ a coord9at$ & flexible approa* to ! em]g5cy response & m$ical surge capacity ( hospitals1 o!r heal? c>e facilities1 critical c>e1 trauma c>e 7:i* may include trauma c5t]s71 & em]g5cy m$ical sy/ems4 4 7e7 ,improv+ ,/ate & local public heal? security 7#a7 ,/ate & local security ,section #cai;,c-#a7;e7 7#db ,u4,s4,c4 #bdg;d-#c;a7e77 is am5d$ by /rik+ 1 & local em]g5cy plans4 & ins]t+ 1 local em]g5cy plans1 & any regional heal? c>e em]g5cy prep>$ness & response sy/em e/abli%$ pursuant to ! applicable guidel9es "u section #cai;,c-#c44 7#b7 ,p>tn]%ips ,section #cai;,c-#b7;d77#a77;,a7 7#db ,u4,s4,c4 #bdg;d-#c;b7d77#a77;,a77 is am5d$-- 7,a7 9 clause 7i71 by /rik+ 2 & & ins]t+ 22 7,b7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7,c7 by ins]t+ aft] clause 7i7 ! foll[+3 7ii7 among "o or m facilities 9 a regional heal? c>e em]g5cy sy/em "u section #cai;,c-#c2 & 4 #bjd4 ,milit>y & civilian p>tn]%ip = trauma read9ess ,title ,,xii 7#db ,u4,s4,c4 #cjj;d et seq47 is am5d$ by add+ at ! end ! foll[+ new "p3 ,i ,milit>y & ,civilian ,p>tn]%ip = ,trauma ,read9ess ,grant ,program #abia4 ,milit>y & ,civilian ,p>tn]%ip = ,trauma ,read9ess ,grant ,program 7a7 ,milit>y trauma team placem5t program 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response & 9 consultation ) ! ,secret>y ( ,def5se1 %all aw>d grants to n m ?an #bj eligible high-acuity trauma c5t]s to enable milit>y trauma teams to provide1 on a full-"t basis1 trauma c>e & relat$ acute c>e at su* trauma c5t]s4 7#b7 ,limitations ,9 ! case ( a grant aw>d$ "u p>agraph 7#a7 to an eligible high-acuity trauma c5t]1 su* grant-- 7,a7 %all be = a p]iod ( at lea/ #c ye>s & n m ?an #e ye>s 7& may be r5ew$ at ! end ( su* p]iod72 & 7,b7 %all be 9 an am\nt t does n exce$ #a1jjj1jjj p] ye>4 7#c7 ,availability ( funds ,not)/&+ section #aeeb ( title #ca1 ,unit$ ,/ates ,code1 or any o!r provision ( law1 funds available to ! ,secret>y = obligation = a grant "u ?is subsection %all rema9 available = exp5diture = #ajj days aft] ! la/ day ( ! p]=mance p]iod ( su* grant4 7b7 ,milit>y trauma c>e provid] placem5t program 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response & 9 consultation ) ! ,secret>y ( ,def5se1 %all aw>d grants to eligible trauma c5t]s to enable milit>y trauma c>e provid]s to provide trauma c>e & relat$ acute c>e at su* trauma c5t]s4 7#b7 ,limitations ,9 ! case ( a grant aw>d$ "u p>agraph 7#a7 to an eligible trauma c5t]1 su* grant-- 7,a7 %all be = a p]iod ( at lea/ #a ye> & n m ?an #c ye>s 7& may be r5ew$ at ! end ( su* p]iod72 & 7,b7 %all be 9 an am\nt t does n exce$1 9 a ye>-- 7i7 #ajj1jjj = ea* milit>y trauma c>e provid] t is a physician at su* eligible trauma c5t]2 & 7ii7 #ej1jjj = ea* o!r milit>y trauma c>e provid] at su* eligible trauma c5t]4 7c7 ,grant requirem5ts 7#a7 ,deploym5t & public heal? em]g5cies ,z a condition ( receipt ( a grant "u ?is section1 a grant recipi5t %all agree to all[ milit>y trauma c>e provid]s provid+ c>e pursuant to su* grant to-- 7,a7 be deploy$ by ! ,secret>y ( ,def5se = milit>y op]ations1 = tra9+1 or = response to a mass casualty incid5t2 & 7,b7 be deploy$ by ! ,secret>y ( ,def5se1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 = response to a public heal? em]g5cy pursuant to section #cai4 7#b7 ,use ( funds ,grants aw>d$ "u ?is section to an eligible trauma c5t] may be us$ to tra9 & incorporate milit>y trauma c>e provid]s into su* trauma c5t]1 includ+ incorporation into op]ational ex]cises & tra9+ drills relat$ to public heal? em]g5cies1 exp5ditures = malpractice insurance1 (fice space1 in=mation te*nology1 specialty education & sup]vision1 trauma programs1 rese>*1 & applicable lic5se fees = su* milit>y trauma c>e provid]s4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to affect any o!r provision ( law t preempts ,/ate lic5s+ requirem5ts = heal? c>e pr(essionals1 includ+ ) respect to milit>y trauma c>e provid]s4 7e7 ,report+ requirem5ts 7#a7 ,report to ! secret>y & ! secret>y ( def5se ,ea* eligible trauma c5t] or eligible high-acuity trauma c5t] aw>d$ a grant "u subsection 7a7 or 7b7 = a ye> %all submit to ! ,secret>y & ! ,secret>y ( ,def5se a report = su* ye> t includes in=mation on-- 7,a7 ! numb] & types ( trauma cases manag$ by milit>y trauma teams or milit>y trauma c>e provid]s pursuant to su* grant dur+ su* ye>2 7,b7 ! ability to ma9ta9 ! integration ( ! milit>y trauma provid]s or teams ( provid]s z "p ( ! trauma c5t]1 includ+ ! f9ancial effect ( su* grant on ! trauma c5t]2 7,c7 ! educational effect on resid5t tra9ees 9 c5t]s :]e milit>y trauma teams are assign$2 7,d7 any rese>* conduct$ dur+ su* ye> support$ by su* grant2 & 7,e7 any o!r in=mation requir$ by ! ,secret>ies = ! purpose ( evaluat+ ! effect ( su* grant4 7#b7 ,report to congress ,n less ?an once e #b ye>s1 ! ,secret>y1 9 consultation ) ! ,secret>y ( ,def5se1 %all submit a report to ! congressional committees ( jurisdiction t includes in=mation on ! effect ( plac+ milit>y trauma c>e provid]s 9 trauma c5t]s aw>d$ grants "u ?is section on-- 7,a7 ma9ta9+ milit>y trauma c>e provid]s' read9ess & ability to respond to & treat battlefield injuries2 7,b7 provid+ heal? c>e to civilian trauma pati5ts 9 urban & rural sett+s2 7,c7 ! capability ( trauma c5t]s & milit>y trauma c>e provid]s to increase m$ical surge capacity1 includ+ z a result ( a l>ge-scale ev5t2 7,d7 ! ability ( grant recipi5ts to ma9ta9 ! integration ( ! milit>y trauma provid]s or teams ( provid]s z "p ( ! trauma c5t]2 7,e7 ef=ts to incorporate milit>y trauma c>e provid]s into op]ational ex]cises & tra9+ & drills = public heal? em]g5cies2 & 7,f7 ! capability ( milit>y trauma c>e provid]s to p>ticipate z "p ( a m$ical response dur+ or 9 advance ( a public heal? em]g5cy1 z det]m9$ by ! ,secret>y1 or a mass casualty incid5t4 7f7 ,def9itions ,= purposes ( ?is "p3 7#a7 ,eligible high-acuity trauma c5t] ,! t]m eligible high-acuity trauma c5t] means a ,level ,i trauma c5t] t satisfies ea* ( ! foll[+3 7,a7 ,su* trauma c5t] has an agreem5t ) ! ,secret>y ( ,def5se to enable milit>y trauma teams to provide trauma c>e & relat$ acute c>e at su* trauma c5t]4 7,b7 ,at lea/ #bj p]c5t ( pati5ts treat$ at su* trauma c5t] 9 ! mo/ rec5t #c-mon? p]iod = :i* data are available are treat$ = a major trauma at su* trauma c5t]4 7,c7 ,su* trauma c5t] utilizes a risk-adju/$ b5*m>k+ sy/em & metrics to measure p]=mance1 quality1 & pati5t outcomes4 7,d7 ,su* trauma c5t] is an academic tra9+ c5t]-- 7i7 affiliat$ ) a m$ical s*ool2 7ii7 t ma9ta9s resid5cy programs & fell[%ips 9 critical trauma specialties & subspecialties1 & provides education & sup]vision ( milit>y trauma team memb]s accord+ to ^? specialties & subspecialties2 & 7iii7 t und]takes rese>* 9 ! prev5tion & treatm5t ( traumatic injury4 7,e7 ,su* trauma c5t] s]ves z a m$ical & public heal? prep>$ness & response lead] = its community1 su* z by p>ticipat+ 9 a p>tn]%ip = ,/ate & regional hospital prep>$ness e/abli%$ "u section #cai;,c-#b or #cai;,c-#c4 7#b7 ,eligible trauma c5t] ,! t]m eligible trauma c5t] means a ,level ,i1 ,,ii1 or ,,iii trauma c5t] t satisfies ea* ( ! foll[+3 7,a7 ,su* trauma c5t] has an agreem5t ) ! ,secret>y ( ,def5se to enable milit>y trauma c>e provid]s to provide trauma c>e & relat$ acute c>e at su* trauma c5t]4 7,b7 ,su* trauma c5t] utilizes a risk-adju/$ b5*m>k+ sy/em & metrics to measure p]=mance1 quality1 & pati5t outcomes4 7,c7 ,su* trauma c5t] demon/rates a ne$ = integrat$ milit>y trauma c>e provid]s to ma9ta9 or improve ! trauma cl9ical capability ( su* trauma c5t]4 7#c7 ,major trauma ,! t]m major trauma means an injury t is great] ?an or equal to #ae on ! injury sev]ity score4 7#d7 ,milit>y trauma team ,! t]m milit>y trauma team means a complete milit>y trauma team consi/+ ( milit>y trauma c>e provid]s4 7#e7 ,milit>y trauma c>e provid] ,! t]m milit>y trauma c>e provid] means a memb] ( ! ,arm$ ,=ces :o furni%es em]g5cy1 critical c>e1 & o!r trauma acute c>e s]vices 7includ+ a physician1 surgeon1 physician assi/ant1 nurse1 nurse practition]1 respiratory !rapi/1 flight p>am$ic1 combat m$ic1 or enli/$ m$ical te*nician7 or o!r milit>y trauma c>e provid] z ! ,secret>y det]m9es appropriate4 7g7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #aa1ejj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 4 #bje4 ,public heal? & heal? c>e sy/em situational aw>5ess & biosurveillance capabilities 7a7 ,facilities1 capacities1 & biosurveillance capabilities ,section #cai;,d 7#db ,u4,s4,c4 #bdg;d-#d7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ ,revitaliz+ & ins]t+ ,facilities & capacities (2 7#b7 9 subsection 7a7-- 7,a7 9 ! subsection head+1 by /rik+ ,facilities2 capacities & ins]t+ ,9 g5]al2 7,b7 9 p>agraph 7#a71 by /rik+ & improv$ & ins]t+ 1 improv$1 & appropriately ma9ta9$2 7,c7 9 p>agraph 7#c71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ exp&1 enhance1 & improve & ins]t+ exp&1 improve1 enhance1 & appropriately ma9ta92 & 7,d7 by add+ at ! end ! foll[+3 7#d7 ,/udy ( res\rces = facilities & capacities ,n lat] ?an ,june #a1 #bjbb1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ,f$]al sp5d+ 9 fiscal ye>s #bjac ?r\gh #bjah = activities au?oriz$ "u ?is subsection4 ,su* /udy %all include a review & assessm5t ( obligations & exp5ditures directly relat$ to ea* activity "u p>agraphs 7#b7 & 7#c71 includ+ a specific acc\nt+ (1 & del9eation betwe51 obligations & exp5ditures incurr$ = ! con/ruction1 r5ovation1 equipp+1 & security upgrades ( facilities & associat$ contracts "u ?is subsection1 & ! obligations & exp5ditures incurr$ to e/abli% & improve ! situational aw>5ess & biosurveillance network "u subsection 7b71 & %all id5tify ! ag5cy or ag5cies incurr+ su* obligations & exp5ditures4 2 7#c7 9 subsection 7b7-- 7,a7 9 ! subsection head+1 by /rik+ national & ins]t+ ,e/abli%m5t ( sy/ems ( public heal?2 7,b7 9 p>agraph 7#a77;,b71 by ins]t+ immunization in=mation sy/ems1 aft] c5t]s12 7,c7 9 p>agraph 7#b7-- 7i7 by ins]t+ develop a plan to1 & aft] ,! ,secret>y %all2 & 7ii7 by ins]t+ & 9 a =m readily usable = analytical approa*es aft] 9 a secure mann]2 & 7,d7 by am5d+ p>agraph 7#c7 to read z foll[s3 7#c7 ,/&>ds 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 ! ,secret>y1 9 coop]ation ) heal? c>e provid]s1 ,/ate1 local1 ,tribal1 & t]ritorial public heal? (ficials1 & relevant ,f$]al ag5cies 7includ+ ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology & ! ,national ,in/itute ( ,/&>ds & ,te*nology71 %all1 z necess>y1 adopt te*nical & report+ /&>ds1 includ+ /&>ds = int]op]ability z def9$ by section #cjjj1 = networks "u p>agraph 7#a7 & update su* /&>ds z necess>y4 ,su* /&>ds %all be made available on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 9 a mann] t does n compromise national security4 7,b7 ,def]5ce to /&>ds developm5t organizations ,9 adopt+ & implem5t+ /&>ds "u ?is subsection & subsection 7c71 ! ,secret>y %all give def]5ce to /&>ds publi%$ by /&>ds developm5t organizations & volunt>y cons5sus-bas$ /&>ds entities4 2 7#d7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,reau?orization ,act ( #bjac1 ! ,secret>y & ins]t+ ,! ,secret>y2 7ii7 by ins]t+ 1 & improve z applicable & appropriate1 aft] %all e/abli%2 7iii7 by /rik+ ( rapid & ins]t+ (1 rapid2 & 7iv7 by /rik+ su* connectivity & ins]t+ su* int]op]ability2 7,b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,coord9ation & consultation ,9 e/abli%+ & improv+ ! network "u p>agraph 7#a71 ! ,secret>y %all-- 7,a7 facilitate coord9ation among ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices t provide1 or h ! pot5tial to provide1 in=mation & data to1 & analyses =1 ! situational aw>5ess & biosurveillance network "u p>agraph 7#a71 includ+ coord9ation among relevant ag5cies relat$ to heal? c>e s]vices1 ! facilitation ( heal? in=mation ex*ange 7includ+ ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology71 & public heal? em]g5cy prep>$ness & response2 & 7,b7 consult ) ! ,secret>y ( ,agriculture1 ! ,secret>y ( ,comm]ce 7& ! ,director ( ! ,national ,in/itute ( ,/&>ds & ,te*nology71 ! ,secret>y ( ,def5se1 ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,vet]ans ,affairs1 & ! heads ( o!r ,f$]al ag5cies1 z ! ,secret>y det]m9es appropriate4 2 7,c7 9 p>agraph 7#c7-- 7i7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,e7 z clauses 7i7 ?r\gh 7v71 respectively1 & adju/+ ! m>g9s accord+ly2 7ii7 9 clause 7iv71 z s r$esignat$-- 7,i7 by ins]t+ immunization in=mation sy/ems1 aft] poison control12 & 7,,ii7 by /rik+ & cl9ical laboratories & ins]t+ 1 cl9ical laboratories1 & public environm5tal heal? ag5cies2 7iii7 by /rik+ ,! network & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,! network 2 & 7iv7 by add+ at ! end ! foll[+3 7,b7 ,review ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai & e #f ye>s !reaft]1 ! ,secret>y %all conduct a review ( ! elem5ts describ$ 9 subp>agraph 7,a74 ,su* review %all include a discussion ( ! addition ( any elem5ts pursuant to clause 7v71 includ+ elem5ts add$ to advanc+ new te*nologies1 & id5tify any *all5ges 9 ! incorporation ( elem5ts "u subp>agraph 7,a74 ,! ,secret>y %all provide su* review to ! congressional committees ( jurisdiction4 2 7,d7 9 p>agraph 7#e7-- 7i7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,d7 z clauses 7i7 ?r\gh 7iv71 respectively1 & adju/+ ! m>g9s accord+ly2 7ii7 by /rik+ ,9 e/abli%+ & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,9 e/abli%+ 2 7iii7 by add+ at ! end ! foll[+3 7,b7 ,public meet+ 7i7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 ! ,secret>y %all conv5e a public meet+ = purposes ( discuss+ & provid+ input on ! pot5tial goals1 functions1 & uses ( ! network describ$ 9 p>agraph 7#a7 & incorporat+ ! elem5ts describ$ 9 p>agraph 7#c77;,a74 7ii7 ,exp]ts ,! public meet+ %all include repres5tatives ( relevant ,f$]al ag5cies 7includ+ repres5tatives f ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology & ! ,national ,in/itute ( ,/&>ds & ,te*nology72 ,/ate1 local1 ,tribal1 & t]ritorial public heal? (ficials2 /akehold]s ) exp]tise 9 biosurveillance & situational aw>5ess2 /akehold]s ) exp]tise 9 capabilities relevant to biosurveillance & situational aw>5ess1 su* z exp]ts 9 in=matics & data analytics 7includ+ exp]ts 9 pr$iction1 model+1 or =eca/+72 & o!r repres5tatives z ! ,secret>y det]m9es appropriate4 7iii7 ,topics ,su* public meet+ %all include a discussion (-- 7,i7 data elem5ts1 includ+ m9imal or ess5tial data elem5ts1 t are volunt>ily provid$ = su* network1 :i* may include elem5ts f public heal? & public & private heal? c>e entities1 to ! ext5t practicable2 7,,ii7 /&>ds & implem5tation specifications t may improve ! collection1 analysis1 & int]pretation ( data dur+ a public heal? em]g5cy2 7,,iii7 /rategies to enc\rage ! access1 ex*ange1 & use ( in=mation2 7,,iv7 consid]ations = ,/ate1 local1 ,tribal1 & t]ritorial capabilities & infra/ructure relat$ to data ex*ange & int]op]ability2 7,v7 privacy & security protections provid$ at ! ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial levels1 & by nongov]nm5tal /akehold]s2 & 7,,vi7 opportunities = ! incorporation ( innovative te*nologies to improve ! network4 2 & 7iv7 9 subp>agraph 7,a71 z s designat$ by clause 7ii7-- 7,i7 9 clause 7i71 z s r$esignat$-- 7aa7 by /rik+ z det]m9$ & ins]t+ z adopt$2 & 7bb7 by ins]t+ & ! ,national ,in/itute ( ,/&>ds & ,te*nology aft] ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology2 7,,ii7 9 clause 7iii71 z s r$esignat$1 by /rik+ 2 & & ins]t+ a semicolon2 7,,iii7 9 clause 7iv71 z s r$esignat$1 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7v7 pilot te/ /&>ds & implem5tation specifications1 consi/5t ) ! process describ$ 9 section #cjjb7;b77#c77;,c71 :i* ,/ate1 local1 ,tribal1 & t]ritorial public heal? entities may utilize1 on a volunt>y basis1 z a "p ( ! network4 2 7,e7 by r$esignat+ p>agraph 7#f7 z p>agraph 7#g72 7,f7 by ins]t+ aft] p>agraph 7#e7 ! foll[+3 7#f7 ,/rategy & implem5tation plan 7,a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 ! ,secret>y %all submit to ! congressional committees ( jurisdiction a coord9at$ /rategy & an accompany+ implem5tation plan t-- 7i7 is in=m$ by ! public meet+ "u p>agraph 7#e77;,b72 7ii7 includes a review & assessm5t ( exi/+ capabilities ( ! network & relat$ infra/ructure1 includ+ input provid$ by ! public meet+ "u p>agraph 7#e77;,b72 7iii7 id5tifies & demon/rates ! measurable /eps ! ,secret>y w c>ry out to-- 7,i7 develop1 implem5t1 & evaluate ! network describ$ 9 p>agraph 7#a71 utiliz+ elem5ts describ$ 9 p>agraph 7#c77;,a72 7,,ii7 mod]nize & enhance biosurveillance activities1 includ+ /rategies to include innovative te*nologies & analytical approa*es 7includ+ pr$iction & =eca/+ = p&emics & all-haz>ds7 f public & private entities2 7,,iii7 improve in=mation %>+1 coord9ation1 & communication among disp>ate biosurveillance sy/ems support$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+ ! id5tification ( me?ods to improve acc\ntability1 bett] utilize res\rces & work=ce capabilities1 & incorporate innovative te*nologies )9 & across ag5cies2 & 7,,iv7 te/ & evaluate capabilities ( ! int]op]able network ( sy/ems to improve situational aw>5ess & biosurveillance capabilities2 7iv7 includes p]=mance measures & ! metrics by :i* p]=mance measures w be assess$ ) respect to ! measurable /eps "u clause 7iii72 & 7v7 e/abli%es dates by :i* ea* measurable /ep "u clause 7iii7 w be implem5t$4 7,b7 ,annual budget plan ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai & on an annual basis !reaft]1 9 accordance ) ! /rategy & implem5tation plan "u ?is p>agraph1 ! ,secret>y %all1 tak+ into acc\nt recomm5dations provid$ by ! ,national ,biodef5se ,sci5ce ,bo>d1 develop a budget plan bas$ on ! /rategy & implem5tation plan "u ?is section4 ,su* budget plan %all include-- 7i7 a summ>y ( res\rces previ\sly exp5d$ to e/abli%1 improve1 & utilize ! nationwide public heal? situational aw>5ess & biosurveillance network "u p>agraph 7#a72 7ii7 e/imates ( co/s & res\rces ne$$ to e/abli% & improve ! network "u p>agraph 7#a7 accord+ to ! /rategy & implem5tation plan "u subp>agraph 7,a72 7iii7 ! id5tification ( gaps & ineffici5cies 9 nationwide public heal? situational aw>5ess & biosurveillance capabilities1 res\rces1 & au?orities ne$$ to address su* gaps2 & 7iv7 a /rategy to m9imize & address su* gaps & improve ineffici5cies4 2 7,g7 9 p>agraph 7#g71 z s r$esignat$-- 7i7 9 subp>agraph 7,a71 by ins]t+ 7tak+ into acc\nt zoonotic disease1 includ+ gaps 9 sci5tific und]/&+ ( ! int]actions betwe5 human1 animal1 & environm5tal heal?7 aft] human heal?2 7ii7 9 subp>agraph 7,b7-- 7,i7 by ins]t+ & gaps 9 surveillance programs aft] surveillance programs2 & 7,,ii7 by /rik+ 2 & & ins]t+ a semicolon2 7iii7 9 subp>agraph 7,c7-- 7,i7 by ins]t+ 1 animal heal? organizations relat$ to zoonotic disease1 aft] heal? c>e entities2 & 7,,ii7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+3 7,d7 provide recomm5dations to ! ,secret>y on policies & proc$ures to complete ! /eps describ$ 9 ?is p>agraph 9 a mann] t is consi/5t ) section #bhjb4 2 & 7,h7 by add+ at ! end ! foll[+3 7#h7 ,situational aw>5ess & biosurveillance z a national security priority ,! ,secret>y1 on a p]iodic basis z applicable & appropriate1 %all meet ) ! ,director ( ,national ,intellig5ce to in=m ! developm5t & capabilities ( ! nationwide public heal? situational aw>5ess & biosurveillance network4 2 7#e7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a7-- 7i7 by ins]t+ environm5tal heal? ag5cies1 aft] public heal? ag5cies12 & 7ii7 by ins]t+ immunization programs1 aft] poison control c5t]s12 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ aft] subp>agraph 7,c7 ! foll[+3 7,d7 an implem5tation plan t may include measurable /eps to a*ieve ! purposes describ$ 9 p>agraph 7#a74 2 & 7,c7 by /rik+ p>agraph 7#e7 & ins]t+ ! foll[+3 7#e7 ,te*nical assi/ance ,! ,secret>y may provide te*nical assi/ance to ,/ates1 localities1 ,tribes1 & t]ritories or a consortium ( ,/ates1 localities1 ,tribes1 & t]ritories receiv+ an aw>d "u ?is subsection reg>d+ int]op]ability & ! te*nical /&>ds set =? by ! ,secret>y4 2 7#f7 by r$esignat+ subsections 7f7 & 7g7 z subsections 7i7 & 7j71 respectively2 & 7#g7 by ins]t+ aft] subsection 7e7 ! foll[+3 7f7 ,p]sonnel au?orities 7#a7 ,specially qualifi$ p]sonnel ,9 addition to any o!r p]sonnel au?orities1 to c>ry out subsections 7b7 & 7c71 ! ,secret>y may-- 7,a7 appo9t highly qualifi$ individuals to sci5tific or pr(essional positions at ! ,c5t]s = ,disease ,control & ,prev5tion1 n to exce$ #cj su* employees at any "t 7specific to positions au?oriz$ by ?is subsection71 ) exp]tise 9 capabilities relevant to biosurveillance & situational aw>5ess1 su* z exp]ts 9 in=matics & data analytics 7includ+ exp]ts 9 pr$iction1 model+1 or =eca/+71 & o!r relat$ sci5tific or te*nical fields2 & 7,b7 comp5sate individuals appo9t$ "u subp>agraph 7,a7 9 ! same mann] & subject to ! same t]ms & conditions 9 :i* individuals appo9t$ "u #iijc ( title #e1 ,unit$ ,/ates ,code1 are comp5sat$1 )\t reg>d to ! provisions ( *apt] #ea & sub*apt] ,,iii ( *apt] #ec ( su* title relat+ to classification & ,g5]al ,s*$ule pay rates4 7#b7 ,limitations ,! ,secret>y %all ex]cise ! au?ority "u p>agraph 7#a7 9 a mann] t is consi/5t ) ! limitations describ$ 9 section #cai;,f-#a7;e77#b74 7g7 ,timel9e ,! ,secret>y %all accompli% ! purposes "u subsections 7b7 & 7c7 no lat] ?an ,septemb] #cj1 #bjbc1 & %all provide a ju/ification to ! congressional committees ( jurisdiction = any miss$ or delay$ implem5tation ( measurable /eps id5tifi$ "u subsection 7c77#f77;,a77iii74 7h7 ,indep5d5t evaluation ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct an indep5d5t evaluation & submit to ! ,secret>y & ! congressional committees ( jurisdiction a report conc]n+ ! activities conduct$ "u subsections 7b7 & 7c71 & provide recomm5dations1 z applicable & appropriate1 on necess>y improvem5ts to ! biosurveillance & situational aw>5ess network4 4 7b7 ,au?orization ( appropriations ,subsection 7i7 ( section #cai;,d 7#db ,u4,s4,c4 #bdg;d-#d71 z r$esignat$ by subsection 7a77#f71 is am5d$ by /rik+ #ach1cjj1jjj = ea* ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #afa1hjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 7c7 ,biological ?reat detection report ,! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 coord9ation ) ! ,secret>y ( ,def5se & ! ,secret>y ( ,homel& ,security1 n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 report to ! ,committee on ,en]gy & ,comm]ce1 ! ,committee on ,arm$ ,s]vices1 & ! ,committee on ,homel& ,security ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions1 ! ,committee on ,arm$ ,s]vices1 & ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ( ! ,s5ate on ! /ate ( ,f$]al biological ?reat detection ef=ts1 includ+ ! foll[+3 7#a7 ,an id5tification ( te*nological1 op]ational1 & programmatic successes & failures ( dome/ic detection programs support$ by ,f$]al dep>tm5ts & ag5cies = int5tionally introduc$ or accid5tally releas$ biological ?reat ag5ts & naturally occurr+ infecti\s diseases4 7#b7 ,a description ( ,f$]al ef=ts to facilitate ! ex*ange ( in=mation relat$ to ! in=mation describ$ 9 p>agraph 7#a7 among ,f$]al dep>tm5ts & ag5cies t utilize biological ?reat detection te*nology4 7#c7 ,a description ( ! capabilities ( detection sy/ems 9 use by ,f$]al dep>tm5ts & ag5cies includ+ ! capability to-- 7,a7 rapidly detect1 id5tify1 *>act]ize1 & confirm ! pres5ce ( biological ?reat ag5ts2 7,b7 recov] live biological ag5ts f collection devices2 7,c7 det]m9e ! geographical di/ribution ( biological ag5ts2 7,d7 det]m9e ! ext5t ( environm5tal contam9ation & p]si/5ce ( biological ag5ts2 & 7,e7 provide advanc$ molecul> diagno/ics to ,/ate1 local1 ,tribal1 & t]ritorial public heal? & o!r laboratories t support biological ?reat detection activities4 7#d7 ,a description ( ,f$]al int]ag5cy coord9ation relat$ to biological ?reat detection4 7#e7 ,a description ( ef=ts by ,f$]al dep>tm5ts & ag5cies t utilize biological ?reat detection te*nology to collaborate ) ,/ate1 local1 ,tribal1 & t]ritorial public heal? laboratories & o!r us]s ( biological ?reat detection sy/ems1 includ+ collaboration reg>d+ ! developm5t (-- 7,a7 biological ?reat detection requirem5ts or /&>ds2 7,b7 a /&>diz$ integration /rategy2 7,c7 tra9+ requirem5ts or guidel9es2 7,d7 guidel9es = a coord9at$ public heal? response1 includ+ prep>$ness capabilities1 &1 z applicable1 = coord9ation ) public heal? surveillance sy/ems2 & 7,e7 a coord9at$ environm5tal rem$iation plan1 z applicable4 7#f7 ,recomm5dations relat$ to rese>*1 advanc$ rese>*1 developm5t1 & procurem5t = ,f$]al dep>tm5ts & ag5cies to improve & enhance biological ?reat detection sy/ems1 includ+ recomm5dations on ! transf] ( biological ?reat detection te*nology among ,f$]al dep>tm5ts & ag5cies1 z necess>y & appropriate4 #bjf4 ,/r5g!n+ & support+ ! public heal? em]g5cy rapid response fund ,section #cai 7#db ,u4,s4,c4 #bdg;d7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 ! fir/ s5t5ce1 by ins]t+ or if ! ,secret>y det]m9es !re is ! significant pot5tial = a public heal? em]g5cy1 to all[ ! ,secret>y to rapidly respond to ! imm$iate ne$s result+ f su* public heal? em]g5cy or pot5tial public heal? em]g5cy be=e ! p]iod2 & 7ii7 by ins]t+ ,! ,secret>y %all plan = ! exp$it$ di/ribution ( funds to appropriate ag5cies & entities4 aft] ! fir/ s5t5ce2 7,b7 by r$esignat+ p>agraph 7#b7 z p>agraph 7#c72 7,c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,uses ,! ,secret>y may use am\nts 9 ! ,fund e/abli%$ "u p>agraph 7#a71 to-- 7,a7 facilitate coord9ation betwe5 & among ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial entities & public & private heal? c>e entities t ! ,secret>y det]m9es may be affect$ by a public heal? em]g5cy or pot5tial public heal? em]g5cy ref]r$ to 9 p>agraph 7#a7 7includ+ communication ( su* entities ) relevant int]national entities1 z applicable72 7,b7 make grants1 provide = aw>ds1 ent] into contracts1 & conduct supportive inve/igations p]ta9+ to a public heal? em]g5cy or pot5tial public heal? em]g5cy1 includ+ fur!r support+ programs "u section #cai;,c-#a1 #cai;,c-#b1 or #cai;,c-#c2 7,c7 facilitate & accel]ate1 z applicable1 advanc$ rese>* & developm5t ( security c\nt]measures 7z def9$ 9 section #cai;,f-#b71 qualifi$ c\nt]measures 7z def9$ 9 section #cai;,f-#a71 or qualifi$ p&emic or epidemic products 7z def9$ 9 section #cai;,f-#c71 t are applicable to ! public heal? em]g5cy or pot5tial public heal? em]g5cy "u p>agraph 7#a72 7,d7 /r5g!n biosurveillance capabilities & laboratory capacity to id5tify1 collect1 & analyze in=mation reg>d+ su* public heal? em]g5cy or pot5tial public heal? em]g5cy1 includ+ ! sy/ems "u section #cai;,d2 7,e7 support initial em]g5cy op]ations & assets relat$ to prep>ation & deploym5t ( int]mitt5t disa/] response p]sonnel "u section #bhab & ! ,m$ical ,res]ve ,corps "u section #bhac2 & 7,f7 c>ry out o!r activities1 z ! ,secret>y det]m9es applicable & appropriate4 2 & 7,d7 by ins]t+ aft] p>agraph 7#c71 z s r$esignat$1 ! foll[+3 7#d7 ,review ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 ! ,secret>y1 9 coord9ation ) ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 %all conduct a review ( ! ,fund "u ?is section & provide recomm5dations to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives on policies to improve su* ,fund = ! uses describ$ 9 p>agraph 7#b74 7#e7 ,,gao report ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7,a7 conduct a review ( ! ,fund "u ?is section1 includ+ its uses & ! res\rces available 9 ! ,fund2 & 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* review1 includ+ recomm5dations relat$ to su* review1 z applicable4 2 & 7#b7 9 subsection 7c7-- 7,a7 by ins]t+ rapidly respond to public heal? em]g5cies or pot5tial public heal? em]g5cies & aft] us$ to2 & 7,b7 by /rik+ section4 & ins]t+ ,act or funds o!rwise provid$ = em]g5cy response44 #bjg4 ,improv+ all-haz>ds prep>$ness & response by public heal? em]g5cy volunte]s 7a7 ,9 g5]al ,section #cai;,i 7#db ,u4,s4,c4 #bdg;d-#g;b7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ ,heal? ,pr(essions ,volunte]s & ins]t+ ,volunte] ,heal? ,pr(essional2 7#b7 9 subsection 7a71 by add+ at ! end ! foll[+3 ,su* heal? c>e pr(essionals may include memb]s ( ! ,national ,disa/] ,m$ical ,sy/em1 memb]s ( ! ,m$ical ,res]ve ,corps1 & individual heal? c>e pr(essionals42 7#c7 9 subsection 7i71 by add+ at ! end ! foll[+3 ,9 ord] to in=m ! developm5t ( su* me*anisms by ,/ates1 ! ,secret>y %all make available in=mation & mat]ial provid$ by ,/ates t h develop$ me*anisms to waive ! application ( lic5s+ requirem5ts to applicable heal? pr(essionals seek+ to provide m$ical s]vices dur+ a public heal? em]g5cy4 ,su* in=mation %all be made publicly available 9 a mann] t does n compromise national security42 & 7#d7 9 subsection 7k71 by /rik+ #bjad ?r\gh #bjah & ins]t+ #bjai ?r\gh #bjbc4 7b7 ,all-,haz>ds ,public ,heal? ,em]g5cy ,prep>$ness & ,response ,plan ,section #cai;,c-#a7;b77#b77;,a77iv7 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#b77;,a77iv77 is am5d$ to read z foll[s3 7iv7 a description ( ! me*anism ! entity w implem5t to utilize ! ,em]g5cy ,managem5t ,assi/ance ,compact1 or o!r mutual aid agreem5t1 = m$ical & public heal? mutual aid1 &1 z appropriate1 ! activities su* entity w implem5t pursuant to section #cai;,i to improve enrollm5t & coord9ation ( volunte] heal? c>e pr(essionals seek+ to provide m$ical s]vices dur+ a public heal? em]g5cy1 :i* may include-- 7,i7 provid+ a public me?od ( communication = purposes ( volunte] coord9ation 7su* z a phone numb]72 7,,ii7 provid+ = optional regi/ration to p>ticipate 9 volunte] s]vices dur+ processes relat$ to ,/ate m$ical lic5s+1 regi/ration1 or c]tification or r5ewal ( su* lic5s+1 regi/ration1 or c]tification2 or 7,,iii7 o!r me*anisms z ! ,/ate det]m9es appropriate2 4 #bjh4 ,cl>ify+ ,/ate liability law = volunte] heal? c>e pr(essionals 7a7 ,9 g5]al ,title ,,ii 7#db ,u4,s4,c4 #bjb et seq47 is am5d$ by ins]t+ aft] section #bbd ! foll[+3 #bbe4 ,heal? c>e pr(essionals assi/+ dur+ a public heal? em]g5cy 7a7 ,limitation on liability ,not)/&+ any o!r provision ( law1 a heal? c>e pr(essional :o is a memb] ( ! ,m$ical ,res]ve ,corps "u section #bhac or :o is includ$ 9 ! ,em]g5cy ,sy/em = ,advance ,regi/ration ( ,volunte] ,heal? ,pr(essionals "u section #cai;,i & :o-- 7#a7 is respond+-- 7,a7 to a public heal? em]g5cy det]m9$ "u section #cai7;a71 dur+ ! initial p]iod ( n m ?an #ij days 7z det]m9$ by ! ,secret>y7 ( ! public heal? em]g5cy det]m9ation 7exclud+ any p]iod cov]$ by a r5ewal ( su* det]m9ation72 or 7,b7 to a major disa/] or an em]g5cy z decl>$ by ! ,presid5t "u section #dja ( ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act 7#db ,u4,s4,c4 #eagj7 or "u section #bja ( ! ,national ,em]g5cies ,act 7#ej ,u4,s4,c4 #afba7 dur+ ! initial p]iod ( su* decl>ation2 7#b7 is alleg$ to be liable = an act or omission-- 7,a7 dur+ ! initial p]iod ( a det]m9ation or decl>ation describ$ 9 p>agraph 7#a7 & relat$ to ! treatm5t ( individuals 9 ne$ ( heal? c>e s]vices due to su* public heal? em]g5cy1 major disa/]1 or em]g5cy2 7,b7 9 ! ,/ate or ,/ates = :i* su* det]m9ation or decl>ation is made2 7,c7 9 ! heal? c>e pr(essional's capacity z a memb] ( ! ,m$ical ,res]ve ,corps or a pr(essional includ$ 9 ! ,em]g5cy ,sy/em = ,advance ,regi/ration ( ,volunte] ,heal? ,pr(essionals "u section #cai;,i2 & 7,d7 9 ! c\rse ( provid+ s]vices t are )9 ! scope ( ! lic5se1 regi/ration1 or c]tification ( ! pr(essional1 z def9$ by ! ,/ate ( lic5sure1 regi/ration1 or c]tification2 & 7#c7 prior to ! r5d]+ ( su* act or omission1 0 au?oriz$ by ! ,/ate's au?orization ( deploy+ su* ,/ate's ,em]g5cy ,sy/em = ,advance ,regi/ration ( ,volunte] ,heal? ,pr(essionals describ$ 9 section #cai;,i or ! ,m$ical ,res]ve ,corps e/abli%$ "u section #bhac1 to provide heal? c>e s]vices1 %all be subject only to ! ,/ate liability laws ( ! ,/ate 9 :i* su* act or omission occurr$1 9 ! same mann] & to ! same ext5t z a simil> heal? c>e pr(essional :o is a resid5t ( su* ,/ate w\ld be subject to su* ,/ate laws1 except ) respect to ! lic5sure1 regi/ration1 & c]tification ( su* individual4 7b7 ,volunte] protection act ,no?+ 9 ?is section %all be con/ru$ to affect an individual's "r to protections "u ! ,volunte] ,protection ,act ( #aiig4 7c7 ,preemption ,?is section %all sup]s$e ! laws ( any ,/ate t w\ld subject a heal? c>e pr(essional describ$ 9 subsection 7a7 to ! liability laws ( any ,/ate o!r ?an ! ,/ate liability laws to :i* su* individual is subject pursuant to su* subsection4 7d7 ,def9itions ,9 ?is section3 7#a7 ,! t]m heal? c>e pr(essional means an individual lic5s$1 regi/]$1 or c]tifi$ "u ,f$]al or ,/ate laws or regulations to provide heal? c>e s]vices4 7#b7 ,! t]m heal? c>e s]vices means any s]vices provid$ by a heal? c>e pr(essional1 or by any individual work+ "u ! sup]vision ( a heal? c>e pr(essional1 t relate to-- 7,a7 ! diagnosis1 prev5tion1 or treatm5t ( any human disease or impairm5t2 or 7,b7 ! assessm5t or c>e ( ! heal? ( human be+s4 7e7 ,effective date 7#a7 ,9 g5]al ,?is section %all take effect #ij days aft] ! date ( ! enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai4 7#b7 ,application ,?is section %all apply to a claim = h>m only if ! act or omission t caus$ su* h>m occurr$ on or aft] ! effective date describ$ 9 p>agraph 7#a74 4 7b7 ,,gao /udy ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a review (-- 7#a7 ! numb] ( heal? c>e provid]s :o regi/] "u ! ,em]g5cy ,sy/em = ,advance ,regi/ration ( ,volunte] ,heal? ,pr(essionals "u section #cai;,i ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;b7 9 advance to provide s]vices dur+ a public heal? em]g5cy2 7#b7 ! numb] ( heal? c>e provid]s :o are cr$5tial$ to provide s]vices dur+ ! p]iod ( a public heal? em]g5cy decl>ation1 includ+ ^? :o are cr$5tial$ ?\gh programs e/abli%$ 9 ! ,em]g5cy ,sy/em = ,advance ,regi/ration ( ,volunte] ,heal? ,pr(essionals "u su* section #cai;,i & ^? cr$5tial$ by au?orities )9 ! ,/ate 9 :i* ! em]g5cy occurr$2 7#c7 ! av]age "t to v]ify ! cr$5tials ( a heal? c>e provid] dur+ ! p]iod ( a public heal? em]g5cy decl>ation1 includ+ ! av]age "t pursuant to ! ,em]g5cy ,sy/em = ,advance ,regi/ration ( ,volunte] ,heal? ,pr(essionals "u su* section #cai;,i & = an individual's cr$5tials to be v]ifi$ by an au?ority )9 ! ,/ate2 & 7#d7 ! ,em]g5cy ,sy/em = ,advance ,regi/ration ( ,volunte] ,heal? ,pr(essionals program 9 ,/ates1 includ+ :e!r physician or m$ical gr\ps1 associations1 or o!r relevant provid] organizations utilize su* program = purposes ( volunte]+ dur+ public heal? em]g5cies4 #bji4 ,report on adequate national blood supply ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report conta9+ recomm5dations relat$ to ma9ta9+ an adequate national blood supply1 includ+-- 7#a7 *all5ges associat$ ) ! cont9u\s recruitm5t ( blood donors 7includ+ ^? newly eligible to donate72 7#b7 ensur+ ! adequacy ( ! blood supply 9 ! case ( public heal? em]g5cies2 7#c7 implem5tation ( ! transfusion transmission monitor+ sy/em2 & 7#d7 o!r measures to promote safety & innovation1 su* z ! developm5t1 use1 or implem5tation ( new te*nologies1 processes1 & proc$ures to improve ! safety & reliability ( ! blood supply4 #baj4 ,report on ! public heal? prep>$ness & response capabilities & capacities ( hospitals1 long-t]m c>e facilities1 & o!r heal? c>e facilities 7a7 ,/udy 7#a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all ent] into an agreem5t ) an appropriate entity to conduct a /udy reg>d+ ! public heal? prep>$ness & response capabilities & m$ical surge capacities ( hospitals1 long-t]m c>e facilities1 & o!r heal? c>e facilities to prep>e =1 & respond to1 public heal? em]g5cies1 includ+ natural disa/]s4 7#b7 ,consultation ,9 conduct+ ! /udy "u p>agraph 7#a71 ! entity %all consult ) ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial public heal? (ficials 7z appropriate71 & heal? c>e provid]s & facilities ) exp]i5ce 9 public heal? prep>$ness & response activities4 7#c7 ,evaluation ,! /udy "u p>agraph 7#a7 %all include-- 7,a7 an evaluation ( ! curr5t b5*m>ks & objective /&>ds1 z applicable1 relat$ to programs t support hospitals1 long-t]m c>e facilities1 & o!r heal? c>e facilities1 & _! effect on improv+ public heal? prep>$ness & response capabilities & m$ical surge capacities1 includ+ ! ,hospital ,prep>$ness ,program1 ! ,public ,heal? ,em]g5cy ,prep>$ness coop]ative agreem5ts1 & ! ,regional ,heal? ,c>e ,em]g5cy ,prep>$ness & ,response ,sy/ems "u section #cai;,c-#c ( ! ,public ,heal? ,s]vice ,act 7z add$ by section #bjc72 7,b7 ! id5tification ( gaps 9 prep>$ness1 includ+ ) respect to su* b5*m>ks & objective /&>ds1 su* z ^? id5tifi$ dur+ rec5t public heal? em]g5cies1 = hospitals1 long-t]m c>e facilities1 & o!r heal? c>e facilities to address future pot5tial public heal? ?reats2 7,c7 an evaluation ( coord9ation ef=ts betwe5 ! recipi5ts ( ,f$]al fund+ = programs describ$ 9 subp>agraph 7,a7 & entities ) exp]tise 9 em]g5cy p[] sy/ems & o!r critical infra/ructure p>tn]s dur+ a public heal? em]g5cy1 to ensure a function+ critical infra/ructure1 to ! greate/ ext5t practicable1 dur+ a public heal? em]g5cy2 7,d7 an evaluation ( coord9ation ef=ts betwe5 ! recipi5ts ( ,f$]al fund+ = programs describ$ 9 subp>agraph 7,a7 & environm5tal heal? ag5cies ) exp]tise 9 em]g5cy prep>$ness & response plann+ = hospitals1 long-t]m c>e facilities1 & o!r heal? c>e facilities2 & 7,e7 an evaluation ( curr5t public heal? prep>$ness & response capabilities & m$ical surge capacities relat$ to at-risk individuals dur+ public heal? em]g5cies1 includ+ an id5tification ( gaps 9 su* prep>$ness z !y relate to su* individuals4 7b7 ,report 7#a7 ,9 g5]al ,! agreem5t "u subsection 7a7 %all require ! entity to submit to ! ,secret>y ( ,heal? & ,human ,s]vices & ! congressional committees ( jurisdiction1 n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 a report on ! results ( ! /udy conduct$ pursuant to ?is section4 7#b7 ,cont5ts ,! report "u p>agraph 7#a7 %all-- 7,a7 describe ! f9d+s & conclusions ( ! evaluation conduct$ pursuant to subsection 7a72 & 7,b7 provide recomm5dations = improv+ public heal? prep>$ness & response capability & m$ical surge capacity = hospitals1 long-t]m c>e facilities1 & o!r heal? c>e facilities1 includ+-- 7i7 improv+ ! exi/+ b5*m>ks & objective /&>ds = ! ,f$]al grant programs describ$ 9 subsection 7a77#c77;,a7 or develop+ new b5*m>ks & /&>ds = su* programs2 & 7ii7 id5tify+ be/ practices = improv+ public heal? prep>$ness & response programs & m$ical surge capacity at hospitals1 long-t]m c>e facilities1 & o!r heal? c>e facilities1 includ+ recomm5dations = ! evaluation "u subp>agraphs 7,c7 & 7,d7 ( subsection 7a77#c74 ,,iii ,rea*+ all communities #cja4 ,/r5g!n+ & assess+ ! em]g5cy response work=ce 7a7 ,national ,disa/] ,m$ical ,sy/em 7#a7 ,/r5g!n+ ! ,national ,disa/] ,m$ical ,sy/em ,clause 7ii7 ( section #bhab7;a77#c77;,a7 7#db ,u4,s4,c4 #cjj;hh-#aa7;a77#c77;,a77 is am5d$ to read z foll[s3 7ii7 be pres5t at locations1 & = limit$ p]iods ( "t1 specifi$ by ! ,secret>y on ! basis t ! ,secret>y has det]m9$ t a location is at risk ( a public heal? em]g5cy dur+ ! "t specifi$1 or !re is a significant pot5tial = a public heal? em]g5cy4 4 7#b7 ,review ( ! national disa/] m$ical sy/em ,section #bhab7;b77#b7 7#db ,u4,s4,c4 #cjj;hh-#aa7;b77#b77 is am5d$ to read z foll[s3 7#b7 ,jo9t review & m$ical surge capacity /rategic plan 7,a7 ,review ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 ! ,secret>y1 9 coord9ation ) ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,def5se1 & ! ,secret>y ( ,vet]ans ,affairs1 %all conduct a jo9t review ( ! ,national ,disa/] ,m$ical ,sy/em4 ,su* review %all include-- 7i7 an evaluation ( m$ical surge capacity1 z describ$ 9 section #bhjc7;a72 7ii7 an assessm5t ( ! available work=ce ( ! int]mitt5t disa/] response p]sonnel describ$ 9 subsection 7c72 7iii7 ! capacity ( ! work=ce describ$ 9 clause 7ii7 to respond to all haz>ds1 includ+ capacity to simultane\sly respond to multiple public heal? em]g5cies & ! capacity to respond to a nationwide public heal? em]g5cy2 7iv7 ! effectiv5ess ( ef=ts to recruit1 reta91 & tra9 su* work=ce2 & 7v7 gaps t may exi/ 9 su* work=ce & recomm5dations = address+ su* gaps4 7,b7 ,updates ,z "p ( ! ,national ,heal? ,security ,/rategy "u section #bhjb1 ! ,secret>y %all update ! f9d+s f ! review "u subp>agraph 7,a7 & provide recomm5dations to modify ! policies ( ! ,national ,disa/] ,m$ical ,sy/em z necess>y4 4 7#c7 ,notification ( %ortage ,section #bhab7;c7 7#db ,u4,s4,c4 #cjj;hh-#aa7;c77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,notification ,n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es ! numb] ( int]mitt5t disa/]-response p]sonnel ( ! ,national ,disa/] ,m$ical ,sy/em is insuffici5t to address a public heal? em]g5cy or pot5tial public heal? em]g5cy1 ! ,secret>y %all submit to ! congressional committees ( jurisdiction a notification detail+-- 7,a7 ! impact su* %ortage c\ld h on meet+ public heal? ne$s & em]g5cy m$ical p]sonnel ne$s dur+ a public heal? em]g5cy2 & 7,b7 any id5tifi$ measures to address su* %ortage4 7#d7 ,c]ta9 appo9tm5ts 7,a7 ,9 g5]al ,if ! ,secret>y det]m9es t ! numb] ( int]mitt5t disa/] response p]sonnel )9 ! ,national ,disa/] ,m$ical ,sy/em "u ?is section is insuffici5t to address a public heal? em]g5cy or pot5tial public heal? em]g5cy1 ! ,secret>y may appo9t c&idates directly to p]sonnel positions = int]mitt5t disa/] response )9 su* sy/em4 ,! ,secret>y %all provide updates on ! numb] ( vacant or unfill$ positions )9 su* sy/em to ! congressional committees ( jurisdiction ea* qu>t] = :i* ?is au?ority is 9 effect4 7,b7 ,sunset ,! au?ority "u ?is p>agraph %all expire on ,septemb] #cj1 #bjba4 4 7#d7 ,au?orization ( appropriations ,section #bhab7;g7 7#db ,u4,s4,c4 #cjj;hh-#aa7;g77 is am5d$ by /rik+ #eb1gjj1jjj = ea* ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #eg1djj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 7b7 ,volunte] m$ical res]ve corps 7#a7 ,9 g5]al ,section #bhac7;a7 7#db ,u4,s4,c4 #db ,u4,s4,c4 #cjj;hh-#ae7;a77 is am5d$ by /rik+ ! second s5t5ce & ins]t+ ,! ,secret>y may appo9t a ,director to head ! ,corps & ov]see ! activities ( ! ,corps *apt]s t exi/ at ! ,/ate1 local1 ,tribal1 & t]ritorial levels44 7#b7 ,au?orization ( appropriations ,section #bhac7;i7 7#db ,u4,s4,c4 #cjj;hh-#ae7;i77 is am5d$ by /rik+ #bjad ?r\gh #bjah & ins]t+ #bjai ?r\gh #bjbc4 7c7 ,/r5g!n+ ! ,epidemic ,intellig5ce ,s]vice ,section #cag;,f 7#db ,u4,s4,c4 ,sec4 #bdg;b-#g7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 by ins]t+ or prep>$ness & response activities1 includ+ rapid response to public heal? em]g5cies & significant public heal? ?reats aft] conduct prev5tion activities2 & 7ii7 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 & 7,b7 9 p>agraph 7#b77;,b71 by /rik+ #c ye>s & ins]t+ #b ye>s2 & 7#b7 9 subsection 7c7-- 7,a7 by /rik+ ,= ! purpose ( c>ry+ out ?is section & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,= ! purpose ( c>ry+ out ?is section1 except z describ$ 9 p>agraph 7#b7 2 & 7,b7 by add+ at ! end ! foll[+3 7#b7 ,epidemic intellig5ce s]vice program ,= purposes ( c>ry+ out ?is section ) respect to qualifi$ heal? pr(essionals s]v+ 9 ! ,epidemic ,intellig5ce ,s]vice1 z au?oriz$ "u section #cag;,g1 !re is au?oriz$ to be appropriat$ #a1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 4 7d7 ,s]vice b5efit = ,national ,disa/] ,m$ical ,sy/em volunte]s 7#a7 ,9 g5]al ,section #bhab7;c7 7#db ,u4,s4,c4 #cjj;hh-#aa7;c771 z am5d$ by subsection 7a77#c71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#e7 ,s]vice b5efit ,individuals appo9t$ to s]ve "u ?is subsection %all be consid]$ eligible = b5efits "u "p ,l ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh4 ,! ,secret>y %all provide notification to any eligible individual ( any effect su* designation may h on o!r b5efits = :i* su* individual is eligible1 includ+ b5efits f private entities4 4 7#b7 ,public safety (fic] b5efits ,section #abjd7i7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#cd ,u4,s4,c4 #ajbhd7i77 is am5d$-- 7,a7 9 subp>agraph 7,c77ii71 by /rik+ or at ! end2 7,b7 9 subp>agraph 7,d71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7,c7 by ins]t+ aft] subp>agraph 7,d7 ! foll[+3 7,e7 an individual appo9t$ to ! ,national ,disa/] ,m$ical ,sy/em "u section #bhab ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7 :o is p]=m+ (ficial duties ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 if ^? (ficial duties are-- 7i7 relat$ to respond+ to a public heal? em]g5cy or pot5tial public heal? em]g5cy1 or o!r activities = :i* ! ,secret>y ( ,heal? & ,human ,s]vices has activat$ su* ,national ,disa/] ,m$ical ,sy/em2 & 7ii7 det]m9$ by ! ,secret>y ( ,heal? & ,human ,s]vices to be haz>d\s4 4 7#c7 ,sunset ,! am5dm5ts made by p>agraphs 7#a7 & 7#b7 %all cease to h =ce or effect on ,octob] #a1 #bjba4 7e7 ,mission read9ess report to ,congress 7#a7 ,report ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is section1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is subsection z ! ,comptroll] ,g5]al7 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report on ! m$ical surge capacity ( ! ,unit$ ,/ates 9 ! ev5t ( a public heal? em]g5cy1 includ+ ! capacity & capability ( ! curr5t heal? c>e work=ce to prep>e =1 & respond to1 ! full range ( public heal? em]g5cies or pot5tial public heal? em]g5cies1 & recomm5dations to address any gaps id5tifi$ 9 su* work=ce4 7#b7 ,cont5ts ,! ,comptroll] ,g5]al %all include 9 ! report "u p>agraph 7#a7-- 7,a7 ! numb] ( heal? c>e provid]s :o h volunte]$ to provide heal? c>e s]vices dur+ a public heal? em]g5cy1 includ+ memb]s ( ! ,national ,disa/] ,m$ical ,sy/em1 ! ,disa/] ,m$ical ,assi/ant ,teams1 ! ,m$ical ,res]ve ,corps1 & o!r volunte] heal? c>e pr(essionals 9 ! v]ification network pursuant to section #cai;,i ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;b72 7,b7 ! capacity ( ! work=ce describ$ 9 subp>agraph 7,a7 to respond to a public heal? em]g5cy or pot5tial public heal? em]g5cy1 includ+ ! capacity to respond to multiple concurr5t public heal? em]g5cies & ! capacity to respond to a nationwide public heal? em]g5cy2 7,c7 ! prep>$ness & response capabilities & mission read9ess ( ! work=ce describ$ 9 subp>agraph 7,a7 tak+ into acc\nt areas ( heal? c>e exp]tise & consid]ations = at-risk individuals 7z def9$ 9 section #bhjb7;b77#d77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d77;,b7772 7,d7 an assessm5t ( ! effectiv5ess ( ef=ts to recruit1 reta91 & tra9 su* work=ce2 & 7,e7 id5tification ( gaps t may exi/ 9 su* work=ce & recomm5dations = address+ su* gaps1 ! ext5t to :i* ! ,assi/ant ,secret>y = ,prep>$ness & ,response plans to address su* gaps1 & any recomm5dations f ! ,comptroll] ,g5]al to address su* gaps4 #cjb4 ,heal? sy/em infra/ructure to improve prep>$ness & response 7a7 ,coord9ation ( prep>$ness ,section #bhaa7;b77#e7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#e77 is am5d$ by add+ at ! end ! foll[+3 ,su* logi/ical support %all include work+ ) o!r relevant ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial public heal? (ficials & private sector entities to id5tify ! critical infra/ructure assets1 sy/ems1 & networks ne$$ = ! prop] function+ ( ! heal? c>e & public heal? sectors t ne$ to be ma9ta9$ ?r\gh any em]g5cy or disa/]1 includ+ entities capable ( assi/+ )1 respond+ to1 & mitigat+ ! effect ( a public heal? em]g5cy1 includ+ a public heal? em]g5cy det]m9$ by ! ,secret>y pursuant to section #cai7;a7 or an em]g5cy or major disa/] decl>$ by ! ,presid5t "u ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act or ! ,national ,em]g5cies ,act1 includ+ by e/abli%+ me?ods to ex*ange critical in=mation & deliv] products consum$ or us$ to pres]ve1 protect1 or su/a9 life1 heal?1 or safety1 & %>+ ( specializ$ exp]tise44 7b7 ,manufactur+ ,capacity ,section #bhaa7;d77#b77;,c7 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77#b77;,c77 is am5d$ by ins]t+ 1 & ancill>y m$ical supplies to assi/ ) ! utilization ( su* c\nt]measures or products1 aft] products4 7c7 ,evaluation ( b>ri]s to rapid deliv]y ( m$ical c\nt]measures 7#a7 ,rapid deliv]y /udy ,! ,assi/ant ,secret>y = ,prep>$ness & ,response may conduct a /udy on issues t h ! pot5tial to adv]sely affect ! h&l+ & rapid deliv]y ( m$ical c\nt]measures to individuals dur+ public heal? em]g5cies occurr+ 9 ! ,unit$ ,/ates4 7#b7 ,notice to congress ,n lat] ?an #i mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all notify ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate if ! ,assi/ant ,secret>y = ,prep>$ness & ,response does n plan to conduct ! /udy "u p>agraph 7#a7 & %all provide su* committees a summ>y explanation = su* decision4 7#c7 ,report to ,congress ,n lat] ?an #a ye> aft] ! ,assi/ant ,secret>y = ,prep>$ness & ,response conducts ! /udy "u p>agraph 7#a71 su* ,assi/ant ,secret>y %all submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate conta9+ ! f9d+s ( su* /udy4 #cjc4 ,consid]ations = at-risk individuals 7a7 ,at-,risk individuals 9 ! ,national ,heal? ,security ,/rategy ,section #bhjb7;b77#d77;,b7 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d77;,b77 is am5d$-- 7#a7 by /rik+ ?is section & sections #cai;,c-#a1 #cai;,f1 & #cai,l1 & ins]t+ ?is ,act12 & 7#b7 by /rik+ special & ins]t+ access or functional4 7b7 ,c\nt]measure consid]ations ,section #cai,l7c77#f7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#f77 is am5d$-- 7#a7 by /rik+ eld]ly & ins]t+ old] adults2 & 7#b7 by ins]t+ ) relevant *>act]i/ics t w>rant consid]ation dur+ ! process ( rese>*+ & develop+ su* c\nt]measures & products be=e ! p]iod4 7c7 ,biosurveillance ( em]g+ public heal? ?reats ,section #bhad is am5d$-- 7#a7 9 p>agraph 7#g71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 p>agraph 7#h71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#i7 facilitate coord9ation to ensure t1 9 implem5t+ ! situational aw>5ess & biosurveillance network "u section #cai;,d1 ! ,secret>y consid]s incorporat+ data & in=mation f ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial public heal? (ficials & entities relevant to detect+ em]g+ public heal? ?reats t may affect at-risk individuals1 su* z pregnant & po/p>tum wom5 & infants1 includ+ adv]se heal? outcomes ( su* populations relat$ to su* em]g+ public heal? ?reats4 4 #cjd4 ,improv+ em]g5cy prep>$ness & response consid]ations = *ildr5 ,"p ,b ( title ,,iii 7#db ,u4,s4,c4 #bdc et seq47 is am5d$ by ins]t+ aft] section #cai;,d ! foll[+3 #cai;,d-#a4 ,*ildr5's prep>$ness unit 7a7 ,enhanc+ em]g5cy prep>$ness = *ildr5 ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion 7ref]r$ to 9 ?is subsection z ! ,director71 %all ma9ta9 an int]nal team ( exp]ts1 to be kn[n z ! ,*ildr5's ,prep>$ness ,unit 7ref]r$ to 9 ?is subsection z ! ,unit71 to "w collaboratively to provide guidance on ! consid]ations =1 & ! specific ne$s (1 *ildr5 be=e1 dur+1 & aft] public heal? em]g5cies4 ,! ,unit %all in=m ! ,director reg>d+ em]g5cy prep>$ness & response ef=ts p]ta9+ to *ildr5 at ! ,c5t]s = ,disease ,control & ,prev5tion4 7b7 ,exp]tise ,! team describ$ 9 subsection 7a7 %all include "o or m p$iatricians1 :i* may be a developm5tal-behavioral p$iatrician1 & may also include behavioral sci5ti/s1 *ild psy*ologi/s1 epidemiologi/s1 bio/ati/icians1 heal? communications /aff1 & individuals ) o!r areas ( exp]tise1 z ! ,secret>y det]m9es appropriate4 7c7 ,duties ,! team describ$ 9 subsection 7a7 may-- 7#a7 assi/ ,/ate1 local1 ,tribal1 & t]ritorial em]g5cy plann+ & response activities relat$ to *ildr51 :i* may include develop+1 id5tify+1 & %>+ be/ practices2 7#b7 provide te*nical assi/ance1 tra9+1 & consultation to ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial public heal? (ficials to improve prep>$ness & response capabilities ) respect to ! ne$s ( *ildr51 includ+ provid+ su* te*nical assi/ance1 tra9+1 & consultation to eligible entities 9 ord] to support ! a*ievem5t ( measurable evid5ce-bas$ b5*m>ks & objective /&>ds applicable to sections #cai;,c-#a & #cai;,c-#b2 7#c7 improve ! utilization ( me?ods to incorporate ! ne$s ( *ildr5 9 plann+ = & respond+ to a public heal? em]g5cy1 includ+ public aw>5ess ( su* me?ods2 7#d7 coord9ate )1 & improve1 public-private p>tn]%ips1 su* z heal? c>e coalitions pursuant to sections #cai;,c-#b & #cai;,c-#c1 to address gaps & ineffici5cies 9 em]g5cy prep>$ness & response ef=ts = *ildr52 7#e7 provide exp]tise & input dur+ ! developm5t ( guidance & cl9ical recomm5dations to address ! ne$s ( *ildr5 :5 prep>+ =1 & respond+ to1 public heal? em]g5cies1 includ+ pursuant to section #cai;,c-#c2 & 7#f7 c>ry out o!r duties relat$ to prep>$ness & response activities = *ildr51 z ! ,secret>y det]m9es appropriate4 4 #cje4 ,national advisory committees on disa/]s 7a7 ,reau?oriz+ ! ,national ,advisory ,committee on ,*ildr5 & ,disa/]s ,section #bhaa;,a 7#db ,u4,s4,c4 #cjj;hh-#aj;a7 is am5d$-- 7#a7 9 subsection 7b77#b71 by ins]t+ 1 m5tal & behavioral1 aft] m$ical2 7#b7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a71 by /rik+ #ae & ins]t+ #be2 & 7,b7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,requir$ non-,f$]al memb]s ,! ,secret>y1 9 consultation ) su* o!r heads ( ,f$]al ag5cies z may be appropriate1 %all appo9t to ! ,advisory ,committee "u p>agraph 7#a7 at lea/ #ac individuals1 includ+-- 7,a7 at lea/ #b non-,f$]al pr(essionals ) exp]tise 9 p$iatric m$ical disa/] plann+1 prep>$ness1 response1 or recov]y2 7,b7 at lea/ #b repres5tatives f ,/ate1 local1 ,tribal1 or t]ritorial ag5cies ) exp]tise 9 p$iatric disa/] plann+1 prep>$ness1 response1 or recov]y2 7,c7 at lea/ #d memb]s repres5t+ heal? c>e pr(essionals1 :i* may include memb]s ) exp]tise 9 p$iatric em]g5cy m$ic9e2 p$iatric trauma1 critical c>e1 or surg]y2 ! treatm5t ( p$iatric pati5ts affect$ by *emical1 biological1 radiological1 or nucle> ag5ts1 includ+ em]g+ infecti\s diseases2 p$iatric m5tal or behavioral heal? relat$ to *ildr5 affect$ by a public heal? em]g5cy2 or p$iatric prim>y c>e2 & 7,d7 o!r memb]s z ! ,secret>y det]m9es appropriate1 ( :om-- 7i7 at lea/ "o su* memb] %all repres5t a *ildr5's hospital2 7ii7 at lea/ "o su* memb] %all be an individual ) exp]tise 9 s*ools or *ild c>e sett+s2 7iii7 at lea/ "o su* memb] %all be an individual ) exp]tise 9 *ildr5 & y\? ) special heal? c>e ne$s2 & 7iv7 at lea/ "o su* memb] %all be an individual ) exp]tise 9 ! ne$s ( p>5ts or family c>egiv]s1 includ+ ! p>5ts or c>egiv]s ( *ildr5 ) disabilities4 7#c7 ,f$]al memb]s ,! ,advisory ,committee "u p>agraph 7#a7 %all include ! foll[+ ,f$]al memb]s or _! designees 7:o may be nonvot+ memb]s1 z det]m9$ by ! ,secret>y73 7,a7 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7,b7 ,! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority4 7,c7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7,d7 ,! ,commission] ( ,food & ,drugs4 7,e7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7,f7 ,! ,assi/ant ,secret>y ( ! ,adm9i/ration = ,*ildr5 & ,families4 7,g7 ,! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration4 7,h7 ,! ,adm9i/rator ( ! ,f$]al ,em]g5cy ,managem5t ,ag5cy4 7,i7 ,! ,adm9i/rator ( ! ,adm9i/ration = ,community ,liv+4 7,j7 ,! ,secret>y ( ,education4 7,k7 ,repres5tatives f su* ,f$]al ag5cies 7su* z ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration & ! ,dep>tm5t ( ,homel& ,security7 z ! ,secret>y det]m9es appropriate to fulfill ! duties ( ! ,advisory ,committee "u subsections 7b7 & 7c74 7#d7 ,t]m ( appo9tm5t ,ea* memb] ( ! ,advisory ,committee appo9t$ "u p>agraph 7#b7 %all s]ve = a t]m ( #c ye>s1 except t ! ,secret>y may adju/ ! t]ms ( ! ,advisory ,committee appo9tees s]v+ on ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 or appo9tees :o are initially appo9t$ aft] su* date ( enactm5t1 9 ord] to provide = a /agg]$ t]m ( appo9tm5t = all memb]s4 7#e7 ,consecutive appo9tm5ts2 maximum t]ms ,a memb] appo9t$ "u p>agraph 7#b7 may s]ve n m ?an #c t]ms on ! ,advisory ,committee1 & n m ?an #b ( su* t]ms may be s]v$ consecutively4 2 7#c7 9 subsection 7e71 by add+ at ! end ,at lea/ "o meet+ p] ye> %all be an 9-p]son meet+42 7#d7 by r$esignat+ subsection 7f7 z subsection 7g72 7#e7 by ins]t+ aft] subsection 7e7 ! foll[+3 7f7 ,coord9ation ,! ,secret>y %all coord9ate duties & activities au?oriz$ "u ?is section 9 accordance ) section #bhaa;,d4 2 & 7#f7 9 subsection 7g71 z s r$esignat$1 by /rik+ #bjah & ins]t+ #bjbc4 7b7 ,au?oriz+ ! ,national ,advisory ,committee on ,s5iors & ,disa/]s ,subtitle ,b ( title ,,xxviii 7#db ,u4,s4,c4 #cjj;hh et seq47 is am5d$ by ins]t+ aft] section #bhaa;,a ! foll[+3 #bhaa;,b4 ,national ,advisory ,committee on ,s5iors & ,disa/]s 7a7 ,e/abli%m5t ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,homel& ,security & ! ,secret>y ( ,vet]ans ,affairs1 %all e/abli% an advisory committee to be kn[n z ! ,national ,advisory ,committee on ,s5iors & ,disa/]s 7ref]r$ to 9 ?is section z ! ,advisory ,committee74 7b7 ,duties ,! ,advisory ,committee %all-- 7#a7 provide advice & consultation ) respect to ! activities c>ri$ out pursuant to section #bhad1 z applicable & appropriate2 7#b7 evaluate & provide input ) respect to ! m$ical & public heal? ne$s ( s5iors relat$ to prep>ation =1 response to1 & recov]y f all-haz>ds em]g5cies2 & 7#c7 provide advice & consultation ) respect to ,/ate em]g5cy prep>$ness & response activities relat+ to s5iors1 includ+ relat$ drills & ex]cises pursuant to ! prep>$ness goals "u section #bhjb7;b74 7c7 ,additional duties ,! ,advisory ,committee may provide advice & recomm5dations to ! ,secret>y ) respect to s5iors & ! m$ical & public heal? grants & coop]ative agreem5ts z applicable to prep>$ness & response activities "u ?is title & title ,,iii4 7d7 ,memb]%ip 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) su* o!r heads ( ag5cies z appropriate1 %all appo9t n m ?an #ag memb]s to ! ,advisory ,committee4 ,9 appo9t+ su* memb]s1 ! ,secret>y %all ensure t ! total memb]%ip ( ! ,advisory ,committee is an odd numb]4 7#b7 ,requir$ memb]s ,! ,advisory ,committee %all include ,f$]al memb]s or _! designees 7:o may be nonvot+ memb]s1 z det]m9$ by ! ,secret>y7 & non-,f$]al memb]s1 z foll[s3 7,a7 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7,b7 ,! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority4 7,c7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7,d7 ,! ,commission] ( ,food & ,drugs4 7,e7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7,f7 ,! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7,g7 ,! ,adm9i/rator ( ! ,adm9i/ration = ,community ,liv+4 7,h7 ,! ,adm9i/rator ( ! ,f$]al ,em]g5cy ,managem5t ,ag5cy4 7,i7 ,! ,"u ,secret>y = ,heal? ( ! ,dep>tm5t ( ,vet]ans ,affairs4 7,j7 ,at lea/ #b non-,f$]al heal? c>e pr(essionals ) exp]tise 9 g]iatric m$ical disa/] plann+1 prep>$ness1 response1 or recov]y4 7,k7 ,at lea/ #b repres5tatives ( ,/ate1 local1 ,tribal1 or t]ritorial ag5cies ) exp]tise 9 g]iatric disa/] plann+1 prep>$ness1 response1 or recov]y4 7,l7 ,repres5tatives ( su* o!r ,f$]al ag5cies 7su* z ! ,dep>tm5t ( ,en]gy & ! ,dep>tm5t ( ,homel& ,security7 z ! ,secret>y det]m9es necess>y to fulfill ! duties ( ! ,advisory ,committee4 7e7 ,meet+s ,! ,advisory ,committee %all meet n less frequ5tly ?an biannually4 ,at lea/ "o meet+ p] ye> %all be an 9-p]son meet+4 7f7 ,coord9ation ,! ,secret>y %all coord9ate duties & activities au?oriz$ "u ?is section 9 accordance ) section #bhaa;,d4 7g7 ,sunset 7#a7 ,9 g5]al ,! ,advisory ,committee %all t]m9ate on ,septemb] #cj1 #bjbc4 7#b7 ,ext5sion ( committee ,n lat] ?an ,octob] #a1 #bjbb1 ! ,secret>y %all submit to ,congress a recomm5dation on :e!r ! ,advisory ,committee %\ld be ext5d$4 4 7c7 ,national advisory committee on individuals ) disabilities & disa/]s ,subtitle ,b ( title ,,xxviii 7#db ,u4,s4,c4 #cjj;hh et seq471 z am5d$ by subsection 7b71 is fur!r am5d$ by ins]t+ aft] section #bhaa;,b ! foll[+3 #bhaa;,c4 ,national advisory committee on individuals ) disabilities & disa/]s 7a7 ,e/abli%m5t ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,homel& ,security1 %all e/abli% a national advisory committee to be kn[n z ! ,national ,advisory ,committee on ,individuals ) ,disabilities & ,disa/]s 7ref]r$ to 9 ?is section z ! ,advisory ,committee74 7b7 ,duties ,! ,advisory ,committee %all-- 7#a7 provide advice & consultation ) respect to activities c>ri$ out pursuant to section #bhad1 z applicable & appropriate2 7#b7 evaluate & provide input ) respect to ! m$ical1 public heal?1 & accessibility ne$s ( individuals ) disabilities relat$ to prep>ation =1 response to1 & recov]y f all-haz>ds em]g5cies2 & 7#c7 provide advice & consultation ) respect to ,/ate em]g5cy prep>$ness & response activities1 includ+ relat$ drills & ex]cises pursuant to ! prep>$ness goals "u section #bhjb7;b74 7c7 ,memb]%ip 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) su* o!r heads ( ag5cies & dep>tm5ts z appropriate1 %all appo9t n m ?an #ag memb]s to ! ,advisory ,committee4 ,9 appo9t+ su* memb]s1 ! ,secret>y %all ensure t ! total memb]%ip ( ! ,advisory ,committee is an odd numb]4 7#b7 ,requir$ memb]s ,! ,advisory ,committee %all include ,f$]al memb]s or _! designees 7:o may be nonvot+ memb]s1 z det]m9$ by ! ,secret>y7 & non-,f$]al memb]s1 z foll[s3 7,a7 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7,b7 ,! ,adm9i/rator ( ! ,adm9i/ration = ,community ,liv+4 7,c7 ,! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority4 7,d7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7,e7 ,! ,commission] ( ,food & ,drugs4 7,f7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7,g7 ,! ,adm9i/rator ( ! ,f$]al ,em]g5cy ,managem5t ,ag5cy4 7,h7 ,! ,*air ( ! ,national ,c\ncil on ,disability4 7,i7 ,! ,*air ( ! ,unit$ ,/ates ,access ,bo>d4 7,j7 ,! ,"u ,secret>y = ,heal? ( ! ,dep>tm5t ( ,vet]ans ,affairs4 7,k7 ,at lea/ #b non-,f$]al heal? c>e pr(essionals ) exp]tise 9 disability accessibility be=e1 dur+1 & aft] disa/]s1 m$ical & mass c>e disa/] plann+1 prep>$ness1 response1 or recov]y4 7,l7 ,at lea/ #b repres5tatives f ,/ate1 local1 ,tribal1 or t]ritorial ag5cies ) exp]tise 9 disa/] plann+1 prep>$ness1 response1 or recov]y = individuals ) disabilities4 7,m7 ,at lea/ #b individuals ) a disability ) exp]tise 9 disa/] plann+1 prep>$ness1 response1 or recov]y = individuals ) disabilities4 7d7 ,meet+s ,! ,advisory ,committee %all meet n less frequ5tly ?an biannually4 ,at lea/ "o meet+ p] ye> %all be an 9-p]son meet+4 7e7 ,disability def9$ ,= purposes ( ?is section1 ! t]m disability has ! mean+ giv5 su* t]m 9 section #c ( ! ,am]icans ) ,disabilities ,act ( #aiij4 7f7 ,coord9ation ,! ,secret>y %all coord9ate duties & activities au?oriz$ "u ?is section 9 accordance ) section #bhaa;,d4 7g7 ,sunset 7#a7 ,9 g5]al ,! ,advisory ,committee %all t]m9ate on ,septemb] #cj1 #bjbc4 7#b7 ,recomm5dation ,n lat] ?an ,octob] #a1 #bjbb1 ! ,secret>y %all submit to ,congress a recomm5dation on :e!r ! ,advisory ,committee %\ld be ext5d$4 4 7d7 ,advisory committee coord9ation ,subtitle ,b ( title ,,xxviii 7#db ,u4,s4,c4 #cjj;hh et seq471 z am5d$ by subsection 7c71 is fur!r am5d$ by ins]t+ aft] section #bhaa;,c ! foll[+3 #bhaa;,d4 ,advisory committee coord9ation 7a7 ,9 g5]al ,! ,secret>y %all coord9ate duties & activities au?oriz$ "u sections #bhaa;,a1 #bhaa;,b1 & #bhaa;,c1 & make ef=ts to r$uce unnecess>y or duplicative report+1 or unnecess>y duplicative meet+s & recomm5dations "u su* sections1 z practicable4 ,memb]s ( ! advisory committees au?oriz$ "u su* sections1 or _! designees1 %all annually meet to coord9ate any recomm5dations1 z appropriate1 t may be simil>1 duplicative1 or ov]lapp+ ) respect to address+ ! ne$s ( *ildr51 s5iors1 & individuals ) disabilities dur+ public heal? em]g5cies4 ,if su* coord9ation occurs ?r\gh an 9-p]son meet+1 x %all n be consid]$ ! requir$ 9-p]son meet+s "u any ( sections #bhaa;,a7e71 #bhaa;,b7e71 or #bhaa;,c7d74 7b7 ,coord9ation & alignm5t ,! ,secret>y1 act+ ?r\gh ! employee designat$ pursuant to section #bhad1 %all align prep>$ness & response programs or activities to address simil>1 dual1 or ov]lapp+ ne$s ( *ildr51 s5iors1 & individuals ) disabilities1 & any *all5ges 9 prep>+ = & respond+ to su* ne$s4 7c7 ,notification ,! ,secret>y %all annually notify ! congressional committees ( jurisdiction reg>d+ ! /eps tak5 to coord9ate1 z appropriate1 ! recomm5dations "u ?is section1 & provide a summ>y description ( su* coord9ation4 4 #cjf4 ,guidance = p>ticipation 9 ex]cises & drills ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue f9al guidance reg>d+ ! ability ( p]sonnel fund$ by programs au?oriz$ "u ?is ,act 7includ+ ! am5dm5ts made by ?is ,act7 to p>ticipate 9 drills & op]ational ex]cises relat$ to all-haz>ds m$ical & public heal? prep>$ness & response4 ,su* drills & op]ational ex]cises may include activities t incorporate m$ical surge capacity plann+1 m$ical c\nt]measure di/ribution & adm9i/ration1 & prep>+ = & respond+ to id5tifi$ ?reats = t region4 ,su* p]sonnel may include ,/ate1 local1 ,tribal1 & t]ritorial public heal? dep>tm5t or ag5cy p]sonnel fund$ "u ?is ,act 7includ+ ! am5dm5ts made by ?is ,act74 ,! ,secret>y %all consult ) ! ,dep>tm5t ( ,homel& ,security1 ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,vet]ans ,affairs1 & o!r applicable ,f$]al dep>tm5ts & ag5cies z necess>y & appropriate 9 ! developm5t ( su* guidance4 ,! ,secret>y %all make ! guidance available on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 ,,iv ,prioritiz+ a ?reat-bas$ approa* #dja4 ,assi/ant ,secret>y = ,prep>$ness & ,response ,section #bhaa7;b7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ utilize exp]i5ce relat$ to public heal? em]g5cy prep>$ness & response1 biodef5se1 m$ical c\nt]measures1 & o!r relevant topics to aft] %all2 & 7#b7 9 p>agraph 7#d71 by add+ at ! end ! foll[+3 7,i7 ,?reat aw>5ess ,coord9ate ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,director ( ,national ,intellig5ce1 ! ,secret>y ( ,homel& ,security1 ! ,assi/ant to ! ,presid5t = ,national ,security ,affairs1 ! ,secret>y ( ,def5se1 & o!r relevant ,f$]al (ficials1 su* z ! ,secret>y ( ,agriculture1 to ma9ta9 a curr5t assessm5t ( national security ?reats & in=m prep>$ness & response capabilities bas$ on ! range ( ! ?reats t h ! pot5tial to result 9 a public heal? em]g5cy4 4 #djb4 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise 7a7 ,9 g5]al ,title ,,xxviii is am5d$ by ins]t+ aft] section #bhaa 7#db ,u4,s4,c4 #cjj;hh-#aj7 ! foll[+3 #bhaa-a4 ,public heal? em]g5cy m$ical c\nt]measures ent]prise 7a7 ,9 g5]al ,! ,secret>y %all e/abli% ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise 7ref]r$ to 9 ?is section z ! ,,phemce74 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response %all s]ve z *air ( ! ,,phemce4 7b7 ,memb]s ,! ,,phemce %all include ea* ( ! foll[+ memb]s1 or ! designee ( su* memb]s3 7#a7 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7#b7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7#c7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7#d7 ,! ,commission] ( ,food & ,drugs4 7#e7 ,! ,secret>y ( ,def5se4 7#f7 ,! ,secret>y ( ,homel& ,security4 7#g7 ,! ,secret>y ( ,agriculture4 7#h7 ,! ,secret>y ( ,vet]ans ,affairs4 7#i7 ,! ,director ( ,national ,intellig5ce4 7#aj7 ,repres5tatives ( any o!r ,f$]al ag5cy1 :i* may include ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 ! ,director ( ! ,/rategic ,national ,/ockpile1 ! ,director ( ! ,national ,in/itute ( ,all]gy & ,infecti\s ,diseases1 & ! ,director ( ! ,(fice ( ,public ,heal? ,prep>$ness & ,response1 z ! ,secret>y det]m9es appropriate4 7c7 ,functions 7#a7 ,9 g5]al ,! functions ( ! ,,phemce %all include ! foll[+3 7,a7 ,utilize a process to make recomm5dations to ! ,secret>y reg>d+ rese>*1 advanc$ rese>*1 developm5t1 procurem5t1 /ockpil+1 deploym5t1 di/ribution1 & utilization ) respect to c\nt]measures1 z def9$ 9 section #cai;,f-#b7;c71 includ+ prioritization bas$ on ! heal? security ne$s ( ! ,unit$ ,/ates4 ,su* recomm5dations %all be in=m$ by1 :5 available & practicable1 ! ,national ,heal? ,security ,/rategy pursuant to section #bhjb1 ! ,/rategic ,national ,/ockpile ne$s pursuant to section #cai;,f-#b1 & assessm5ts ( curr5t national security ?reats1 includ+ *emical1 biological1 radiological1 & nucle> ?reats1 includ+ em]g+ infecti\s diseases4 ,9 ! ev5t t memb]s ( ! ,,phemce d n agree ^u a recomm5dation1 ! ,secret>y %all provide a det]m9ation reg>d+ su* recomm5dation4 7,b7 ,id5tify national heal? security ne$s1 includ+ gaps 9 public heal? prep>$ness & response relat$ to c\nt]measures & *all5ges to address+ su* ne$s 7includ+ any regulatory *all5ges71 & support alignm5t ( c\nt]measure procurem5t ) recomm5dations to address su* ne$s "u subp>agraph 7,a74 7,c7 ,assi/ ! ,secret>y 9 develop+ /rategies relat$ to logi/ics1 deploym5t1 di/ribution1 disp5s+1 & use ( c\nt]measures t may be applicable to ! activities ( ! /rategic national /ockpile "u section #cai;,f-#b7;a74 7,d7 ,provide consultation = ! developm5t ( ! /rategy & implem5tation plan "u section #bhaa7;d74 7#b7 ,input ,9 c>ry+ out subp>agraphs 7,b7 & 7,c7 ( p>agraph 7#a71 ! ,,phemce %all solicit & consid] input f ,/ate1 local1 ,tribal1 & t]ritorial public heal? dep>tm5ts or (ficials1 z appropriate4 4 7b7 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise ,/rategy & ,implem5tation ,plan ,section #bhaa7;d7 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subsection1 & e ye> !reaft] & ins]t+ ,n lat] ?an ,m>* #ae1 #bjbj1 & bi5nially !reaft]2 & 7,b7 by /rik+ ,director ( ! ,biom$ical & all t foll[s ?r\gh ,food & ,drugs & ins]t+ ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise e/abli%$ "u section #bhaa-a2 & 7#b7 9 p>agraph 7#b77;,j77v71 by /rik+ "o-ye> p]iod & ins]t+ #b-ye> p]iod4 #djc4 ,/rategic ,national ,/ockpile 7a7 ,9 g5]al ,section #cai;,f-#b7;a7 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#b7 & 7#c7 z p>agraphs 7#c7 & 7#d71 respectively2 & 7#b7 9 p>agraph 7#a7-- 7,a7 by ins]t+ ! ,assi/ant ,secret>y = ,prep>$ness & ,response & aft] collaboration )2 7,b7 by ins]t+ & optimize aft] provide =2 7,c7 by ins]t+ &1 z in=m$ by exi/+ recomm5dations (1 or consultations )1 ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measure ,ent]prise e/abli%$ "u section #bhaa-a1 make necess>y additions or modifications to ! cont5ts ( su* /ockpile or /ockpiles bas$ on ! review conduct$ "u p>agraph 7#b7 be=e ! p]iod ( ! fir/ s5t5ce2 & 7,d7 by /rik+ ! second s5t5ce2 7#c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,?reat-bas$ review 7,a7 ,9 g5]al ,! ,secret>y %all conduct an annual ?reat-bas$ review 7tak+ into acc\nt at-risk individuals7 ( ! cont5ts ( ! /ockpile "u p>agraph 7#a71 includ+ non-ph>maceutical supplies1 &1 9 consultation ) ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise e/abli%$ "u section #bhaa-a1 review cont5ts )9 ! /ockpile & assess :e!r su* cont5ts are consi/5t ) ! recomm5dations made pursuant to section #bhaa-a7;c77#a77;,a74 ,su* review %all be submitt$ on ,june #ae1 #bjai1 & on ,m>* #ae ( ea* ye> !reaft]1 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 9 a mann] t does n compromise national security4 7,b7 ,additions1 modifications1 & repl5i%m5ts ,ea* annual ?reat-bas$ review "u subp>agraph 7,a7 %all1 = ea* new or modifi$ c\nt]measure procurem5t or repl5i%m5t1 provide-- 7i7 in=mation reg>d+-- 7,i7 ! quantities ( ! additional or modifi$ c\nt]measure procur$ =1 or contract$ to be procur$ =1 ! /ockpile2 7,,ii7 plann+ consid]ations = appropriate manufactur+ capacity & capability to meet ! goals ( su* additions or modifications 7)\t disclos+ propriet>y in=mation71 includ+ consid]ation ( ! effect su* additions or modifications may h on ! availability ( su* products & ancill>y m$ical supplies 9 ! heal? c>e sy/em2 7,,iii7 ! pres5ce or lack ( a comm]cial m>ket = ! c\nt]measure at ! "t ( procurem5t2 7,,iv7 ! em]g5cy heal? security ?reat or ?reats su* c\nt]measure procurem5t is int5d$ to address1 includ+ :e!r su* procurem5t is consi/5t ) meet+ em]g5cy heal? security ne$s associat$ ) su* ?reat or ?reats2 7,v7 an assessm5t ( :e!r ! em]g5cy heal? security ?reat or ?reats describ$ 9 subclause 7,,iv7 c\ld be address$ 9 a mann] t bett] utilizes ! res\rces ( ! /ockpile & p]mits ! greate/ possible increase 9 ! level ( em]g5cy prep>$ness to address su* ?reats2 7,,vi7 :e!r su* c\nt]measure is repl5i%+ an expir+ or expir$ c\nt]measure1 is a diff]5t c\nt]measure ) ! same indication t is replac+ an expir+ or expir$ c\nt]measure1 or is a new addition to ! /ockpile2 7,,vii7 a description ( h[ su* additions or modifications align ) project$ inve/m5ts "u previ\s c\nt]measures budget plans "u section #bhaa7;b77#g71 includ+ expect$ life-cycle co/s1 exp5ditures relat$ to c\nt]measure procurem5t to address ! ?reat or ?reats describ$ 9 subclause 7,,iv71 repl5i%m5t dates 7includ+ ! ability to ext5d ! maximum %elf life ( a c\nt]measure71 & ! manufactur+ capacity requir$ to repl5i% su* c\nt]measure2 & 7,,viii7 appropriate protocols & processes = ! deploym5t1 di/ribution1 or disp5s+ ( ! c\nt]measure at ! ,/ate & local level1 includ+ plans = relevant capabilities ( ,/ate & local entities to disp5se1 di/ribute1 & adm9i/] ! c\nt]measure2 & 7ii7 an assurance1 :i* ne$ n be provid$ 9 advance ( procurem5t1 t = ea* c\nt]measure procur$ or repl5i%$ "u ?is subsection1 ! ,secret>y complet$ a review address+ ea* item li/$ "u ?is subsection 9 advance ( su* procurem5t or repl5i%m5t4 2 7#d7 9 p>agraph 7#c71 z s r$esignat$-- 7,a7 9 subp>agraph 7,a71 by ins]t+ & ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise e/abli%$ "u section #bhaa-a be=e ! semicolon2 7,b7 9 subp>agraph 7,c71 by ins]t+ 1 & ! availability1 deploym5t1 disp5s+1 & adm9i/ration ( c\nt]measures be=e ! semicolon2 7,c7 by am5d+ subp>agraph 7,e7 to read z foll[s3 7,e7 devise plans = effective & timely supply-*a9 managem5t ( ! /ockpile1 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,secret>y ( ,transportation1 ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,vet]ans ,affairs1 & ! heads ( o!r appropriate ,f$]al ag5cies2 ,/ate1 local1 ,tribal1 & t]ritorial ag5cies2 & ! public & private heal? c>e infra/ructure1 z applicable1 tak+ into acc\nt ! manufactur+ capacity & o!r available s\rces ( products & appropriate alt]natives to supplies 9 ! /ockpile2 2 7,d7 9 subp>agraph 7,g71 by /rik+ 2 & & ins]t+ a semicolon2 7,e7 9 subp>agraph 7,h71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7,f7 by add+ at ! end ! foll[+3 7,i7 ensure t ea* c\nt]measure or product "u consid]ation = procurem5t pursuant to ?is subsection receives ! same consid]ation reg>dless ( :e!r su* c\nt]measure or product receives or _h receiv$ fund+ "u section #cai,l1 includ+ ) respect to :e!r ! c\nt]measure or product is mo/ appropriate to meet ! em]g5cy heal? security ne$s ( ! ,unit$ ,/ates2 & 7,j7 provide assi/ance1 includ+ te*nical assi/ance1 to ma9ta9 & improve ,/ate & local public heal? prep>$ness capabilities to di/ribute & disp5se m$ical c\nt]measures & products f ! /ockpile1 z appropriate4 2 & 7#e7 by add+ at ! end ! foll[+3 7#e7 ,,gao report 7,a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 & e #e ye>s !reaft]1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a review ( any *anges to ! cont5ts or managem5t ( ! /ockpile s9ce ,janu>y #a1 #bjae4 ,su* review %all include-- 7i7 an assessm5t ( ! compreh5siv5ess & complet5ess ( ea* annual ?reat-bas$ review "u p>agraph 7#b71 includ+ :e!r all newly procur$ or repl5i%$ c\nt]measures )9 ! /ockpile 7 describ$ 9 ea* annual review1 & :e!r1 consi/5t ) p>agraph 7#b77;,b71 ! ,secret>y conduct$ ! necess>y int]nal review 9 advance ( su* procurem5t or repl5i%m5t2 7ii7 an assessm5t ( :e!r ! ,secret>y e/abli%$ heal? security & sci5ce-bas$ ju/ifications1 & a description ( su* ju/ifications = procurem5t decisions relat$ to heal? security ne$s ) respect to ! id5tifi$ ?reat1 = additions or modifications to ! /ockpile bas$ on ! in=mation provid$ 9 su* reviews "u p>agraph 7#b77;,b71 includ+ :e!r su* review 0 conduct$ prior to procurem5t1 modification1 or repl5i%m5t2 7iii7 an assessm5t ( ! plans develop$ by ! ,secret>y = ! deploym5t1 di/ribution1 & disp5s+ ( c\nt]measures procur$1 modifi$1 or repl5i%$ "u p>agraph 7#a71 includ+ :e!r su* plans 7 develop$ prior to procurem5t1 modification1 or repl5i%m5t2 7iv7 an acc\nt+ ( c\nt]measures procur$1 modifi$1 or repl5i%$ "u p>agraph 7#a7 t receiv$ advanc$ rese>* & developm5t fund+ f ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority2 7v7 an analysis ( h[ su* procurem5t decisions made progress t[>d meet+ em]g5cy heal? security ne$s relat$ to ! id5tifi$ ?reats = c\nt]measures add$1 modifi$1 or repl5i%$ "u p>agraph 7#a72 7vi7 a description ( ! res\rces exp5d$ relat$ to ! procurem5t ( c\nt]measures 7includ+ additions1 modifications1 & repl5i%m5ts7 9 ! /ockpile1 & h[ su* exp5ditures relate to ! ability ( ! /ockpile to meet em]g5cy heal? security ne$s2 7vii7 an assessm5t ( ! ext5t to :i* additions1 modifications1 & repl5i%m5ts review$ "u p>agraph 7#b7 align ) previ\s relevant reports or reviews by ! ,secret>y or ! ,comptroll] ,g5]al2 7viii7 ) respect to any *ange 9 ! ,f$]al organizational managem5t ( ! /ockpile1 an assessm5t & comp>ison ( ! processes affect$ by su* *ange1 includ+ plann+ = pot5tial c\nt]measure deploym5t1 di/ribution1 or disp5s+ capabilities & processes relat$ to procurem5t decisions1 use ( /ockpil$ c\nt]measures1 & use ( res\rces = su* activities2 & 7ix7 an assessm5t ( :e!r ! processes & proc$ures describ$ by ! ,secret>y pursuant to section #djc7;b7 ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai are suffici5t to ensure c\nt]measures & products "u consid]ation = procurem5t pursuant to subsection 7a7 receive ! same consid]ation reg>dless ( :e!r su* c\nt]measures & products receive or _h receiv$ fund+ "u section #cai,l1 includ+ ) respect to :e!r su* c\nt]measures & products are mo/ appropriate to meet ! em]g5cy heal? security ne$s ( ! ,unit$ ,/ates4 7,b7 ,submission ,n lat] ?an #f mon?s aft] complet+ a classifi$ v]sion ( ! review "u subp>agraph 7,a71 ! ,comptroll] ,g5]al %all submit an unclassifi$ v]sion ( ! review to ! congressional committees ( jurisdiction4 4 7b7 ,additional report+ ,9 ! fir/ ?reat-bas$ review submitt$ aft] ! date ( enactm5t ( ?is ,act pursuant to p>agraph 7#b7 ( section #cai;,f-#b7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a771 z am5d$ by subsection 7a71 ! ,secret>y %all include a description ( ! processes & proc$ures ?r\gh :i* ! ,director ( ! ,/rategic ,national ,/ockpile & ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority coord9ate ) respect to c\nt]measures & products procur$ "u su* section #cai;,f-#b7;a71 includ+ su* processes & proc$ures 9 place to ensure c\nt]measures & products "u consid]ation = procurem5t pursuant to su* section #cai;,f-#b7;a7 receive ! same consid]ation reg>dless ( :e!r su* c\nt]measures or products receive or _h receiv$ fund+ "u section #cai,l ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e71 & :e!r su* c\nt]measures & products are ! mo/ appropriate to meet ! em]g5cy heal? security ne$s ( ! ,unit$ ,/ates4 7c7 ,au?orization ( appropriations1 /rategic national /ockpile ,section #cai;,f-#b7;f77#a7 7#db ,u4,s4,c4 #bdg;d-#f;b7f77#a77 is am5d$ by /rik+ #ecc1hjj1jjj = ea* ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #faj1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc1 to rema9 available until exp5d$4 #djd4 ,prep>+ = p&emic influ5za1 antimicrobial resi/ance1 & o!r significant ?reats 7a7 ,/rategic initiatives ,section #cai,l7c77#d7 7#bdg;d-#g;e7c77#d77 is am5d$ by add+ at ! end ! foll[+3 7,f7 ,/rategic initiatives ,! ,secret>y1 act+ ?r\gh ! ,director ( ,,b>da1 may implem5t /rategic initiatives1 includ+ by build+ on exi/+ programs & by aw>d+ contracts1 grants1 & coop]ative agreem5ts1 or ent]+ into o!r transactions1 to support innovative c&idate products 9 precl9ical & cl9ical developm5t t address priority1 naturally occurr+ & man-made ?reats t1 z det]m9$ by ! ,secret>y1 pose a significant level ( risk to national security bas$ on ! *>act]i/ics ( a *emical1 biological1 radiological or nucle> ?reat1 or exi/+ capabilities to respond to su* a ?reat 7includ+ m$ical response & treatm5t capabilities & manufactur+ infra/ructure74 ,su* initiatives %all accel]ate & support ! advanc$ rese>*1 developm5t1 & procurem5t ( c\nt]measures & products1 z applicable1 to address areas includ+-- 7i7 *emical1 biological1 radiological1 or nucle> ?reats1 includ+ em]g+ infecti\s diseases1 = :i* insuffici5t approv$1 lic5s$1 or au?oriz$ c\nt]measures exi/1 or = :i* su* ?reat1 or ! result ( an exposure to su* ?reat1 may become resi/ant to c\nt]measures or exi/+ c\nt]measures may be r5d]$ ineffective2 7ii7 ?reats t consi/5tly exi/ or cont9ually circulate & h a significant pot5tial to become a p&emic1 su* z p&emic influ5za1 :i* may include ! advanc$ rese>* & developm5t1 manufactur+1 & appropriate /ockpil+ ( qualifi$ p&emic or epidemic products1 & products1 te*nologies1 or processes to support ! advanc$ rese>* & developm5t ( su* c\nt]measures 7includ+ multiuse plat=m te*nologies = diagno/ics1 vacc9es1 & !rapeutics2 virus se$s2 cl9ical trial lots2 novel virus /ra9s2 & antig5 & adjuvant mat]ial72 & 7iii7 ?reats t may result prim>ily or second>ily f a *emical1 biological1 radiological1 or nucle> ag5t1 or em]g+ infecti\s diseases1 & :i* may pres5t increas$ treatm5t complications su* z ! occurr5ce ( resi/ance to available c\nt]measures or pot5tial c\nt]measures1 includ+ antimicrobial resi/ant pa?og5s4 4 7b7 ,protection ( national security f ?reats ,section #bhaa 7#db ,u4,s4,c4 #cjj;hh-#aj7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,protection ( national security f ?reats 7#a7 ,9 g5]al ,9 c>ry+ out subsection 7b77#c71 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all implem5t /rategic initiatives or activities to address ?reats1 includ+ p&emic influ5za & :i* may include a *emical1 biological1 radiological1 or nucle> ag5t 7includ+ any su* ag5t ) a significant pot5tial to become a p&emic71 t pose a significant level ( risk to public heal? & national security bas$ on ! *>act]i/ics ( su* ?reat4 ,su* initiatives %all include activities to-- 7,a7 accel]ate & support ! advanc$ rese>*1 developm5t1 manufactur+ capacity1 procurem5t1 & /ockpil+ ( c\nt]measures1 includ+ initiatives "u section #cai,l7c77#d77;,f72 7,b7 support ! developm5t & manufactur+ ( virus se$s1 cl9ical trial lots1 & /ockpiles ( novel virus /ra9s2 & 7,c7 ma9ta9 or improve prep>$ness activities1 includ+ = p&emic influ5za4 7#b7 ,au?orization ( appropriations 7,a7 ,9 g5]al ,to c>ry out ?is subsection1 !re is au?oriz$ to be appropriat$ #bej1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 7,b7 ,supplem5t1 n supplant ,am\nts appropriat$ "u ?is p>agraph %all be us$ to supplem5t & n supplant funds provid$ "u sections #cai,l7d7 & #cai;,f-#b7;g74 7,c7 ,docum5tation requir$ ,! ,assi/ant ,secret>y = ,prep>$ness & ,response1 9 accordance ) subsection 7b77#g71 %all docum5t am\nts exp5d$ = purposes ( c>ry+ out ?is subsection1 includ+ am\nts appropriat$ "u ! head+ ,public ,heal? & ,social ,s]vices ,em]g5cy ,fund "u ! head+ ,(fice ( ! ,secret>y "u title ,,ii ( division ,h ( ! ,consolidat$ ,appropriations ,act1 #bjah 7,public ,law #aae-ada7 & allocat$ to c>ry+ out section #cai,l7c77#d77;,f74 4 #dje4 ,report+ on ! ,f$]al ,select ,ag5t ,program ,section #cea;,a7k7 7#db ,u4,s4,c4 #bfb;a7k77 is am5d$-- 7#a7 by /rik+ ,! ,secret>y & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,! ,secret>y 2 & 7#b7 by add+ at ! end ! foll[+3 7#b7 ,implem5tation ( recomm5dations ( ! f$]al exp]ts security advisory panel & ! fa/ track action committee on select ag5t regulations 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 ! ,secret>y %all report to ! congressional committees ( jurisdiction on ! implem5tation ( recomm5dations ( ! ,f$]al ,exp]ts ,security ,advisory ,panel conc]n+ ! select ag5t program4 7,b7 ,cont9u$ updates ,! ,secret>y %all report to ! congressional committees ( jurisdiction annually foll[+ ! submission ( ! report "u subp>agraph 7,a7 until ! recomm5dations describ$ 9 su* subp>agraph are fully implem5t$1 or a ju/ification is provid$ = ! delay 91 or lack (1 implem5tation4 4 ,v ,increas+ communication 9 m$ical c\nt]measure advanc$ rese>* & developm5t #eja4 ,m$ical c\nt]measure budget plan ,section #bhaa7;b77#g7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#g77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ,m>* #a & ins]t+ ,m>* #ae2 7#b7 9 subp>agraph 7,a7-- 7,a7 9 clause 7ii71 by /rik+ 2 & & ins]t+ 22 & 7,b7 by /rik+ clause 7iii7 & ins]t+ ! foll[+3 7iii7 procurem5t1 /ockpil+1 ma9t5ance1 & pot5tial repl5i%m5t 7includ+ manufactur+ capabilities7 ( all products 9 ! ,/rategic ,national ,/ockpile2 7iv7 ! availability ( te*nologies t may assi/ 9 ! advanc$ rese>* & developm5t ( c\nt]measures & opportunities to use su* te*nologies to accel]ate & navigate *all5ges unique to c\nt]measure rese>* & developm5t2 & 7v7 pot5tial deploym5t1 di/ribution1 & utilization ( m$ical c\nt]measures2 developm5t ( cl9ical guidance & em]g5cy use in/ructions = ! use ( m$ical c\nt]measures2 &1 z applicable1 pot5tial po/deploym5t activities relat$ to m$ical c\nt]measures2 2 7#c7 by r$esignat+ subp>agraphs 7,d7 & 7,e7 z subp>agraphs 7,e7 & 7,f71 respectively2 & 7#d7 by ins]t+ aft] subp>agraph 7,c71 ! foll[+3 7,d7 id5tify ! full range ( anticipat$ m$ical c\nt]measure ne$s relat$ to rese>* & developm5t1 procurem5t1 & /ockpil+1 includ+ ! pot5tial ne$ = indications1 dos+1 & adm9i/ration te*nologies1 & o!r c\nt]measure ne$s z applicable & appropriate2 4 #ejb4 ,mat]ial ?reat & m$ical c\nt]measure notifications 7a7 ,congressional notification ( mat]ial ?reat det]m9ation ,section #cai;,f-#b7;c77#b77;,c7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#b77;,c77 is am5d$ by /rik+ ,! ,secret>y & ! ,homel& ,security ,secret>y %all promptly notify ! appropriate committees ( ,congress & ins]t+ ,! ,secret>y & ! ,secret>y ( ,homel& ,security %all s5d to ,congress1 on an annual basis1 all curr5t mat]ial ?reat det]m9ations & %all promptly notify ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,homel& ,security ( ! ,h\se ( ,repres5tatives4 7b7 ,contract+ communication ,section #cai;,f-#b7;c77#g77;,b77ii77,,iii7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#g77;,b77ii77,,iii77 is am5d$ by add+ at ! end ! foll[+3 ,! ,secret>y %all notify ! v5dor )9 #ij days ( a det]m9ation by ! ,secret>y to r5ew1 ext5d1 or t]m9ate su* contract44 #ejc4 ,availability ( regulatory managem5t plans ,section #efe7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;f77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#f7 z p>agraphs 7#d7 ?r\gh 7#g71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 ,publication ,! ,secret>y %all make available on ! int]net website ( ! ,food & ,drug ,adm9i/ration in=mation reg>d+ regulatory managem5t plans1 includ+-- 7,a7 ! process by :i* an applicant may submit a reque/ = a regulatory managem5t plan2 7,b7 ! timeframe by :i* ! ,secret>y is requir$ to respond to su* reque/2 7,c7 ! in=mation requir$ = ! submission ( su* reque/2 7,d7 a description ( ! types ( developm5t mile/ones & p]=mance t>gets t c\ld be discuss$ & includ$ 9 su* plans2 & 7,e7 contact in=mation = beg9n+ ! regulatory managem5t plan process4 2 7#c7 9 p>agraph 7#f71 z s r$esignat$1 9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7 by /rik+ p>agraph 7#d77;,a7 & ins]t+ p>agraph 7#e77;,a72 & 7,b7 by /rik+ p>agraph 7#d77;,b7 & ins]t+ p>agraph 7#e77;,b72 & 7#d7 9 p>agraph 7#g77;,a71 z s r$esignat$1 by /rik+ p>agraph 7#c77;,a7 & ins]t+ p>agraph 7#d77;,a74 #ejd4 ,! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority & ! ,bio,shield ,special ,res]ve ,fund 7a7 ,bio,shield special res]ve fund ,section #cai;,f-#b7;g77#a7 7#db ,u4,s4,c4 #bdg;d-#f;b7g77#a77 is am5d$-- 7#a7 by /rik+ #b1hjj1jjj1jjj = ! p]iod ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #g1ajj1jjj1jjj = ! p]iod ( fiscal ye>s #bjai ?r\gh #bjbh1 to rema9 available until exp5d$2 & 7#b7 by /rik+ ! second s5t5ce4 7b7 ,! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority ,section #cai,l7d77#b7 7#db ,u4,s4,c4 #bdg;d-#g;e7d77#b77 is am5d$ by /rik+ #dae1jjj1jjj = ea* ( fiscal ye>s #bjad ?r\gh #bjah & ins]t+ #faa1gjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 #eje4 ,additional /rategies = combat+ antibiotic resi/ance 7a7 ,advisory c\ncil ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 may cont9ue ! ,presid5tial ,advisory ,c\ncil on ,combat+ ,antibiotic-,resi/ant ,bact]ia1 ref]r$ to 9 ?is section z ! ,advisory ,c\ncil4 7b7 ,duties ,! ,advisory ,c\ncil %all advise & provide in=mation & recomm5dations to ! ,secret>y reg>d+ programs & policies int5d$ to r$uce or combat antibiotic-resi/ant bact]ia t may pres5t a public heal? ?reat & improve capabilities to prev5t1 diagnose1 mitigate1 or treat su* resi/ance4 ,su* advice1 in=mation1 & recomm5dations may be relat$ to improv+-- 7#a7 ! effectiv5ess ( antibiotics2 7#b7 rese>* & advanc$ rese>* on1 & ! developm5t (1 improv$ & innovative me?ods = combat+ or r$uc+ antibiotic resi/ance1 includ+ new treatm5ts1 rapid po9t-(-c>e diagno/ics1 alt]natives to antibiotics1 includ+ alt]natives to animal antibiotics1 & antimicrobial /ew>d%ip activities2 7#c7 surveillance ( antibiotic-resi/ant bact]ial infections1 includ+ publicly available & up-to-date in=mation on resi/ance to antibiotics2 7#d7 education = heal? c>e provid]s & ! public ) respect to up-to-date in=mation on antibiotic resi/ance & ways to r$uce or combat su* resi/ance to antibiotics relat$ to humans & animals2 7#e7 me?ods to prev5t or r$uce ! transmission ( antibiotic-resi/ant bact]ial infections1 includ+ /ew>d%ip programs2 & 7#f7 coord9ation ) respect to int]national ef=ts 9 ord] to in=m & advance ,unit$ ,/ates capabilities to combat antibiotic resi/ance4 7c7 ,meet+s & coord9ation 7#a7 ,meet+s ,! ,advisory ,c\ncil %all meet n less ?an biannually &1 to ! ext5t practicable1 9 coord9ation ) meet+s ( ! ,antimicrobial ,resi/ance ,task ,=ce e/abli%$ 9 section #cai;,e7a7 ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,coord9ation ,! ,advisory ,c\ncil %all1 to ! greate/ ext5t practicable1 coord9ate activities c>ri$ out by ! ,c\ncil ) ! ,antimicrobial ,resi/ance ,task ,=ce e/abli%$ "u section #cai;,e7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#e7;a774 7d7 ,,faca ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 %all apply to ! activities & duties ( ! ,advisory ,c\ncil4 7e7 ,ext5sion ( ,advisory ,c\ncil ,n lat] ?an ,octob] #a1 #bjbb1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a recomm5dation on :e!r ! ,advisory ,c\ncil %\ld be ext5d$1 & 9 addition1 id5tify :e!r !re are o!r committees1 c\ncils1 or task =ces t h ov]lapp+ or simil> duties to t ( ! ,advisory ,c\ncil1 & :e!r su* committees1 c\ncils1 or task =ces %\ld be comb9$1 includ+ ) respect to section #cai;,e7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#e7;a774 ,,vi ,advanc+ te*nologies = m$ical c\nt]measures #fja4 ,adm9i/ration ( c\nt]measures ,section #cai,l7c77#d77;,d77iii7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,d77iii77 is am5d$ by /rik+ & plat=m te*nologies & ins]t+ plat=m te*nologies1 te*nologies to adm9i/] c\nt]measures1 & te*nologies to improve /orage & transportation ( c\nt]measures4 #fjb4 ,updat+ def9itions ( o!r transactions ,section #cai,l 7#db ,u4,s4,c4 #bdg;d-#g;e7 is am5d$-- 7#a7 9 subsection 7a77#c71 by /rik+ 1 su* z & all t foll[s ?r\gh ,code2 & 7#b7 9 subsection 7c77#e77;,a7-- 7,a7 9 clause 7i71 by /rik+ "u ?is subsection & all t foll[s ?r\gh ,code & ins]t+ 7z def9$ 9 subsection 7a77#c77 "u ?is subsection2 & 7,b7 9 clause 7ii7-- 7i7 by am5d+ subclause 7,i7 to read z foll[s3 7,i7 ,9 g5]al ,to ! maximum ext5t practicable1 competitive proc$ures %all be us$ :5 ent]+ into transactions to c>ry out projects "u ?is subsection4 2 & 7ii7 9 subclause 7,,ii7-- 7,i7 by /rik+ #bj1jjj1jjj & ins]t+ #ajj1jjj1jjj2 7,,ii7 by /rik+ s5ior procurem5t executive = ! ,dep>tm5t 7z designat$ = purpose ( section #af7;c7 ( ! ,(fice ( ,f$]al ,procurem5t ,policy ,act 7#da ,u4,s4,c4 #dad7;c777 & ins]t+ ,assi/ant ,secret>y = ,f9ancial ,res\rces2 & 7,,iii7 by /rik+ s5ior procurem5t executive "u & ins]t+ ,assi/ant ,secret>y = ,f9ancial ,res\rces "u4 #fjc4 ,m$ical c\nt]measure ma/] files 7a7 ,9 g5]al ,! purpose ( ?is section 7includ+ section #efe;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7b77 is to support & advance ! developm5t or manufacture ( security c\nt]measures1 qualifi$ c\nt]measures1 & qualifi$ p&emic or epidemic products by facilitat+ & enc\rag+ submission ( data & in=mation to support ! developm5t ( su* products1 & ?r\gh cl>ify+ ! au?ority to cross-ref]5ce to data & in=mation previ\sly submitt$ to ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 includ+ data & in=mation submitt$ to m$ical c\nt]measure ma/] files or o!r ma/] files4 7b7 ,m$ical c\nt]measure ma/] files ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #efe;,a ! foll[+3 #efe;,b4 ,m$ical c\nt]measure ma/] files 7a7 ,applicability ( ref]5ce 7#a7 ,9 g5]al ,a p]son may submit data & in=mation 9 a ma/] file to ! ,secret>y ) ! int5t to ref]5ce1 or to au?orize1 9 writ+1 ano!r p]son to ref]5ce1 su* data or in=mation to support a m$ical c\nt]measure submission 7includ+ a supplem5t or am5dm5t to any su* submission71 )\t requir+ ! ma/] file hold] to disclose ! data & in=mation to any su* p]sons au?oriz$ to ref]5ce ! ma/] file4 ,su* data & in=mation %all be available = ref]5ce by ! ma/] file hold] or by a p]son au?oriz$ by ! ma/] file hold]1 9 accordance ) applicable privacy & confid5tiality protocols & regulations4 7#b7 ,ref]5ce ( c]ta9 ma/] files ,9 ! case t data or in=mation )9 a m$ical c\nt]measure ma/] file is us$ only to support ! conditional approval ( an application fil$ "u section #ega1 su* ma/] file may be reli$ ^u to support ! effectiv5ess ( a product t is ! subject ( a subsequ5t m$ical c\nt]measure submission only if su* application is supplem5t$ by additional data or in=mation to support review & approval 9 a mann] consi/5t ) ! /&>ds applicable to su* review & approval = su* c\nt]measure1 qualifi$ c\nt]measure1 or qualifi$ p&emic or epidemic product4 7b7 ,m$ical c\nt]measure ma/] file cont5t 7#a7 ,9 g5]al ,a ma/] file "u ?is section may include data or in=mation to support-- 7,a7 ! developm5t ( m$ical c\nt]measure submissions to support ! approval1 lic5sure1 classification1 cle>ance1 conditional approval1 or au?orization ( "o or m security c\nt]measures1 qualifi$ c\nt]measures1 or qualifi$ p&emic or epidemic products2 & 7,b7 ! manufacture ( security c\nt]measures1 qualifi$ c\nt]measures1 or qualifi$ p&emic or epidemic products4 7#b7 ,requir$ updates ,! ,secret>y may require1 z appropriate1 t ! ma/] file hold] ensure t ! cont5ts ( su* ma/] file are updat$ dur+ ! "t su* ma/] file is ref]5c$ = a m$ical c\nt]measure submission4 7c7 ,sponsor ref]5ce 7#a7 ,9 g5]al ,ea* incorporation ( data or in=mation )9 a m$ical c\nt]measure ma/] file %all describe ! incorporat$ mat]ial 9 a mann] 9 :i* ! ,secret>y det]m9es appropriate & t p]mits ! review ( su* in=mation )9 su* ma/] file )\t necessitat+ resubmission ( su* data or in=mation4 ,ma/] files %all be submitt$ 9 an electronic =mat 9 accordance ) sections #eab7;b77#d71 #ega7;a77#d71 & #gde;,a1 z applicable1 & z specifi$ 9 applicable guidance4 7#b7 ,ref]5ce by a ma/] file hold] ,a ma/] file hold] t is ! sponsor ( a m$ical c\nt]measure submission %all notify ! ,secret>y 9 writ+ ( ! int5t to ref]5ce ! m$ical c\nt]measure ma/] file z a "p ( ! submission4 7#c7 ,ref]5ce by an au?oriz$ p]son ,a p]son submitt+ an application = review may1 :]e ! ,secret>y det]m9es appropriate1 incorporate by ref]5ce all or "p ( ! cont5ts ( a m$ical c\nt]measure ma/] file1 if ! ma/] file hold] au?orizes ! incorporation 9 writ+4 7d7 ,ackn[l$gm5t ( & reliance ^u a ma/] file by ! ,secret>y 7#a7 ,9 g5]al ,! ,secret>y %all provide ! ma/] file hold] ) a writt5 notification indicat+ t ! ,secret>y has review$ & reli$ ^u specifi$ data or in=mation )9 a ma/] file & ! purposes = :i* su* data or in=mation 0 incorporat$ by ref]5ce if ! ,secret>y has review$ & reli$ ^u su* specifi$ data or in=mation to support ! approval1 classification1 conditional approval1 cle>ance1 lic5sure1 or au?orization ( a security c\nt]measure1 qualifi$ c\nt]measure1 or qualifi$ p&emic or epidemic product4 ,! ,secret>y may rely ^u ! data & in=mation )9 ! m$ical c\nt]measure ma/] file = :i* su* writt5 notification 0 provid$ 9 additional applications1 z applicable & appropriate & ^u ! reque/ ( ! ma/] file hold] s notifi$ 9 writ+ or by an au?oriz$ p]son ( su* hold]4 7#b7 ,c]ta9 applications ,if ! ,secret>y has review$ & reli$ ^u specifi$ data or in=mation )9 a m$ical c\nt]measure ma/] file to support ! conditional approval ( an application "u section #ega to subsequ5tly support ! approval1 cle>ance1 lic5sure1 or au?orization ( a security c\nt]measure1 qualifi$ c\nt]measure1 or qualifi$ p&emic or epidemic product1 ! ,secret>y %all provide a brief writt5 description to ! ma/] file hold] reg>d+ ! elem5ts ( ! application fulfill$ by ! data or in=mation )9 ! ma/] file & h[ su* data or in=mation conta9$ 9 su* application meets ! /&>ds ( evid5ce "u subsection 7c7 or 7d7 ( section #eje1 subsection 7d7 ( section #eab1 or section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable71 :i* %all n include any trade secret or confid5tial comm]cial in=mation4 7e7 ,rules ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to-- 7#a7 limit ! au?ority ( ! ,secret>y to approve1 lic5se1 cle>1 conditionally approve1 or au?orize drugs1 biological products1 or devices pursuant to1 z applicable1 ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act 7z su* applicable ,act is 9 effect on ! day be=e ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai71 includ+ ! /&>ds ( evid5ce1 & applicable conditions1 = approval "u ! applicable ,act2 7#b7 alt] ! /&>ds ( evid5ce ) respect to approval1 lic5sure1 or cle>ance1 z applicable1 ( drugs1 biological products1 or devices "u ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+1 z applicable1 ! sub/antial evid5ce /&>ds "u sections #eje7;d7 & #eab7;d7 or ?is ,act & section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act2 or 7#c7 alt] ! au?ority ( ! ,secret>y "u ?is ,act or ! ,public ,heal? ,s]vice ,act to det]m9e ! types ( data or in=mation previ\sly submitt$ by a sponsor or any o!r p]son t may be incorporat$ by ref]5ce 9 an application1 reque/1 or notification = a drug1 biological product1 or device submitt$ "u sections #eje7;i71 #eje7;b71 #eje7;j71 #eab7;b77#a71 #eab7;b77#b71 #eab7;j71 #efd1 #ega1 #ebj7;g71 #eae7;c71 #eac7;f77#b71 or #eaj7k7 ( ?is ,act1 or subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ a supplem5t or am5dm5t to any su* submission1 & ! requirem5ts associat$ ) su* ref]5ce4 7f7 ,def9itions ,9 ?is section3 7#a7 ,! t]m ma/] file hold] means a p]son :o submits data & in=mation to ! ,secret>y ) ! int5t to ref]5ce or au?orize ano!r p]son to ref]5ce su* data or in=mation to support a m$ical c\nt]measure submission1 z describ$ 9 subsection 7a74 7#b7 ,! t]m m$ical c\nt]measure submission means an inve/igational new drug application "u section #eje7;i71 a new drug application "u section #eje7;b71 or an abbreviat$ new drug application "u section #eje7;j7 ( ?is ,act1 a biological product lic5se application "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act or a biosimil> biological product lic5se application "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act1 a new animal drug application "u section #eab7;b77#a7 or abbreviat$ new animal drug application "u section #eab7;b77#b71 an application = conditional approval ( a new animal drug "u section #ega1 an inve/igational device application "u section #ebj7;g71 an application ) respect to a device "u section #eae7;c71 a reque/ = classification ( a device "u section #eac7;f77#b71 a notification ) respect to a device "u section #eaj7k71 or a reque/ = an em]g5cy use au?orization "u section #efd to support-- 7,a7 ! approval1 lic5sure1 classification1 cle>ance1 conditional approval1 or au?orization ( a security c\nt]measure1 qualifi$ c\nt]measure1 or qualifi$ p&emic or epidemic product2 or 7,b7 a new indication to an approv$ security c\nt]measure1 qualifi$ c\nt]measure1 or qualifi$ p&emic or epidemic product4 7#c7 ,! t]ms qualifi$ c\nt]measure1 security c\nt]measure1 & qualifi$ p&emic or epidemic product h ! mean+s giv5 su* t]ms 9 sections #cai;,f-#a1 #cai;,f-#b1 & #cai;,f-#c1 respectively1 ( ! ,public ,heal? ,s]vice ,act4 4 7c7 ,/akehold] ,input ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs & 9 consultation ) ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 %all solicit input f /akehold]s1 includ+ /akehold]s develop+ security c\nt]measures1 qualifi$ c\nt]measures1 or qualifi$ p&emic or epidemic products1 & /akehold]s develop+ te*nologies to assi/ 9 ! developm5t ( su* c\nt]measures ) respect to h[ ! ,food & ,drug ,adm9i/ration c advance ! use ( tools & te*nologies to support & advance ! developm5t or manufacture ( security c\nt]measures1 qualifi$ c\nt]measures1 & qualifi$ p&emic or epidemic products1 includ+ ?r\gh reliance on cross-ref]5c$ data & in=mation conta9$ )9 ma/] files & submissions previ\sly submitt$ to ! ,secret>y z set =? 9 section #efe;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7b74 7d7 ,guidance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all publi% draft guidance ab\t h[ reliance on cross-ref]5c$ data & in=mation conta9$ )9 ma/] files "u section #efe;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7b7 or submissions o!rwise submitt$ to ! ,secret>y may be us$ = specific tools or te*nologies 7includ+ plat=m te*nologies7 t h ! pot5tial to support & advance ! developm5t or manufacture ( security c\nt]measures1 qualifi$ c\nt]measures1 & qualifi$ p&emic or epidemic products4 ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all publi% ! f9al guidance n lat] ?an #c ye>s aft] ! enactm5t ( ?is ,act4 #fjd4 ,animal rule report 7a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! application ( ! requirem5ts "u subsections 7c7 & 7d7 ( section #efe ( ! ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7 7ref]r$ to 9 ?is section z ! animal rule7 z a compon5t ( m$ical c\nt]measure advanc$ developm5t "u ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority & regulatory review by ! ,food & ,drug ,adm9i/ration4 ,9 conduct+ su* /udy1 ! ,comptroll] ,g5]al %all exam9e ! foll[+3 7#a7 ,! ext5t to :i* advanc$ developm5t & review ( a m$ical c\nt]measure are coord9at$ betwe5 ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority & ! ,food & ,drug ,adm9i/ration1 includ+ activities t facilitate appropriate & effici5t design ( /udies to support approval1 lic5sure1 & au?orization "u ! animal rule1 consi/5t ) ! recomm5dations 9 ! animal rule guidance1 issu$ pursuant to section #efe7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c77 & entitl$ ,product ,developm5t ,"u ! ,animal ,rule3 ,guidance = ,indu/ry 7issu$ 9 ,octob] #bjae71 to resolve discrepancies 9 ! design ( adequate & well-controll$ efficacy /udies conduct$ 9 animal models relat$ to ! provision ( sub/antial evid5ce ( effectiv5ess = ! product approv$1 lic5s$1 or au?oriz$ "u ! animal rule4 7#b7 ,! consi/5cy ( ! application ( ! animal rule among & betwe5 review divisions )9 ! ,food & ,drug ,adm9i/ration4 7#c7 ,! flexibility pursuant to ! animal rule to address v>iations 9 c\nt]measure developm5t & review processes1 includ+ ! ext5t to :i* qualifi$ animal models are adopt$ & us$ )9 ! ,food & ,drug ,adm9i/ration 9 regulatory decisionmak+ ) respect to m$ical c\nt]measures4 7#d7 ,! ext5t to :i* ! guidance issu$ "u section #efe7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c771 entitl$1 ,product ,developm5t ,"u ! ,animal ,rule3 ,guidance = ,indu/ry 7issu$ 9 ,octob] #bjae71 has assi/$ 9 a*iev+ ! purposes describ$ 9 p>agraphs 7#a71 7#b71 & 7#c74 7b7 ,consultations ,9 conduct+ ! /udy "u subsection 7a71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all consult )-- 7#a7 ! ,f$]al ag5cies responsible = advanc+1 review+1 & procur+ m$ical c\nt]measures1 includ+ ! ,(fice ( ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 ! ,food & ,drug ,adm9i/ration1 & ! ,dep>tm5t ( ,def5se2 7#b7 manufactur]s involv$ 9 ! rese>* & developm5t ( m$ical c\nt]measures to address biological1 *emical1 radiological1 or nucle> ?reats2 & 7#c7 o!r biodef5se /akehold]s1 z applicable4 7c7 ,report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a7 & recomm5dations to improve ! application & consi/5cy ( ! requirem5ts "u subsections 7c7 & 7d7 ( section #efe ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7 to support & exp$ite ! rese>* & developm5t ( m$ical c\nt]measures1 z applicable4 7d7 ,protection ( national security ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct ! /udy & issue ! assessm5t & report "u ?is section 9 a mann] t does n compromise national security4 #fje4 ,review ( ! b5efits ( g5omic eng9e]+ te*nologies & _! pot5tial role 9 national security 7a7 ,meet+ 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 conv5e a meet+ to discuss ! pot5tial role advancem5ts 9 g5omic eng9e]+ te*nologies 7includ+ g5ome edit+ te*nologies7 may h 9 advanc+ national heal? security4 ,su* meet+ %all be held 9 a mann] t does n compromise national security4 7#b7 ,att5dees ,! att5dees ( ! meet+ "u p>agraph 7#a7-- 7,a7 %all include-- 7i7 repres5tatives f ! ,(fice ( ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,national ,in/itutes ( ,heal?1 ! ,c5t]s = ,disease ,control & ,prev5tion1 & ! ,food & ,drug ,adm9i/ration2 & 7ii7 repres5tatives f academic1 private1 & nonpr(it entities ) exp]tise 9 g5ome eng9e]+ te*nologies1 bioph>maceuticals1 m$ic9e1 or biodef5se1 & o!r relevant /akehold]s2 & 7,b7 may include-- 7i7 o!r repres5tatives f ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 z ! ,secret>y det]m9es appropriate2 & 7ii7 repres5tatives f ! ,dep>tm5t ( ,homel& ,security1 ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,agriculture1 & o!r dep>tm5ts1 z ! ,secret>y may reque/ = ! meet+4 7#c7 ,topics ,! meet+ "u p>agraph 7#a7 %all include a discussion (-- 7,a7 ! curr5t /ate ( ! sci5ce ( g5omic eng9e]+ te*nologies relat$ to national heal? security1 includ+-- 7i7 m$ical c\nt]measure developm5t1 includ+ pot5tial effici5cies 9 ! developm5t pa?way & detection te*nologies2 & 7ii7 ! int]national & dome/ic regulation ( products utiliz+ g5ome edit+ te*nologies2 & 7,b7 national security implications1 includ+-- 7i7 capabilities ( ! ,unit$ ,/ates to lev]age g5omic eng9e]+ te*nologies z a "p ( ! m$ical c\nt]measure ent]prise1 includ+ curr5t applicable rese>*1 developm5t1 & application ef=ts und]way )9 ! ,dep>tm5t ( ,def5se2 7ii7 ! pot5tial = /ate & non-/ate actors to utilize g5omic eng9e]+ te*nologies z a national heal? security ?reat2 & 7iii7 security measures to monitor & assess ! pot5tial ?reat t may result f utilization ( g5omic eng9e]+ te*nologies & relat$ te*nologies = ! purpose ( compromis+ national heal? security4 7b7 ,report ,n lat] ?an #bgj days aft] ! meet+ describ$ 9 subsection 7a7 is held1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all issue a report to ! congressional committees ( jurisdiction on ! topics discuss$ at su* meet+1 & provide recomm5dations1 z applicable1 to utilize innovations 9 g5omic eng9e]+ 7includ+ g5ome edit+7 & relat$ te*nologies z a "p ( prep>$ness & response activities to advance national heal? security4 ,su* report %all be issu$ 9 a mann] t does n compromise national security4 #fjf4 ,report on vacc9es developm5t ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report describ+ ef=ts & activities to coord9ate ) o!r c\ntries & int]national p>tn]s dur+ rec5t public heal? em]g5cies ) respect to ! rese>* & advanc$ rese>* on1 & developm5t (1 qualifi$ p&emic or epidemic products 7z def9$ 9 section #cai;,f-#c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;d774 ,su* report may include in=mation reg>d+ relevant "w c>ri$ out "u section #cai,l7c77#e77;,e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#e77;,e771 ?r\gh public-private p>tn]%ips1 & ?r\gh collaborations ) o!r c\ntries to assi/ ) or exp$ite ! rese>* & developm5t ( qualifi$ p&emic or epidemic products4 ,su* report %all n include in=mation t may compromise national security4 #fjg4 ,/r5g!n+ mosquito abatem5t = safety & heal? 7a7 ,reau?orization ( mosquito abatem5t = safety & heal? program ,section #cag,s 7#db ,u4,s4,c4 #bdg;b-#ba7 is am5d$-- 7#a7 9 subsection 7a77#a77;,b7-- 7,a7 by ins]t+ includ+ programs to address em]g+ infecti\s mosquito-borne diseases1 aft] subdivisions = control programs12 & 7,b7 by ins]t+ or improv+ exi/+ control programs be=e ! p]iod at ! end2 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 by ins]t+ 1 includ+ improvem5t1 aft] op]ation2 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a7-- 7,i7 9 clause 7ii71 by /rik+ or at ! end2 7,,ii7 9 clause 7iii71 by /rik+ ! semicolon at ! end & ins]t+ 1 includ+ an em]g+ infecti\s mosquito-borne disease t pres5ts a s]i\s public heal? ?reat2 or2 & 7,,iii7 by add+ at ! end ! foll[+3 7iv7 a public heal? em]g5cy due to ! incid5ce or preval5ce ( a mosquito-borne disease t pres5ts a s]i\s public heal? ?reat2 2 & 7ii7 by am5d+ subp>agraph 7,d7 to read z foll[s3 7,d7 7i7 is locat$ 9 a ,/ate t has receiv$ a grant "u subsection 7a72 or 7ii7 t demon/rates to ! ,secret>y t ! control program is consi/5t ) exi/+ ,/ate mosquito control plans or policies1 or o!r applicable ,/ate prep>$ness plans4 2 7,c7 9 p>agraph 7#d77;,c71 by /rik+ t extraord9>y & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ! foll[+3 8t-- 7i7 extraord9>y economic conditions 9 ! political subdivision or consortium ( political subdivisions involv$ ju/ify ! waiv]2 or 7ii7 ! geographical area cov]$ by a political subdivision or consortium = a grant "u p>agraph 7#a7 has an extreme mosquito control ne$ due to-- 7,i7 ! size or d5sity ( ! pot5tially impact$ human population2 7,,ii7 ! size or d5sity ( a mosquito population t requires height5$ control2 or 7,,iii7 ! sev]ity ( ! mosquito-borne disease1 su* t expect$ s]i\s adv]se heal? outcomes = ! human population ju/ify ! waiv]4 2 & 7,d7 by am5d+ p>agraph 7#f7 to read z foll[s3 7#f7 ,numb] ( grants ,a political subdivision or a consortium ( political subdivisions may n receive m ?an "o grant "u p>agraph 7#a74 2 & 7#c7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a7 by /rik+ = fiscal ye> #bjjc1 & su* sums z may be necess>y = ea* ( fiscal ye>s #bjjd ?r\gh #bjjg & ins]t+ = ea* ( fiscal ye>s #bjai ?r\gh #bjbc2 7,b7 9 p>agraph 7#b71 by /rik+ ! ,public ,heal? ,security & ,biot]rorism ,prep>$ness & ,response ,act ( #bjjb & ins]t+ ?is ,act & o!r m$ical & public heal? prep>$ness & response laws2 & 7,c7 9 p>agraph 7#c7-- 7i7 9 ! p>agraph head+1 by /rik+ #bjjd & ins]t+ #bjai2 & 7ii7 by /rik+ #bjjd1 & ins]t+ #bjai14 7b7 ,epidemiology-,laboratory capacity grants ,section #bhba 7#db ,u4,s4,c4 #cjj;hh-#ca7 is am5d$-- 7#a7 9 subsection 7a77#a71 by ins]t+ 1 includ+ mosquito & o!r vector-borne diseases1 aft] infecti\s diseases2 & 7#b7 9 subsection 7b71 by /rik+ #bjaj ?r\gh #bjac & ins]t+ #bjai ?r\gh #bjbc4 ,,vii ,miscellane\s provisions #gja4 ,reau?orizations & ext5sions 7a7 ,vet]ans ,affairs ,section #haag7;g7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ #bjad ?r\gh #bjah & ins]t+ #bjai ?r\gh #bjbc4 7b7 ,vacc9e track+ & di/ribution ,section #cai;,a7e7 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is am5d$ by /rik+ #bjad ?r\gh #bjah & ins]t+ #bjai ?r\gh #bjbc4 7c7 ,tempor>y reassignm5t ,section #cai7;e77#h7 7#db ,u4,s4,c4 #bdg;d7e77#h77 is am5d$ by /rik+ #bjah & ins]t+ #bjbc4 7d7 ,/rategic ,innovation ,p>tn] ,section #cai,l7c77#d77;,e77ix7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,e77ix77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbc4 7e7 ,limit$ antitru/ exemption 7#a7 ,9 g5]al ,section #dje ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,act 7,public ,law #aji-dag2 #db ,u4,s4,c4 #bdg;d-#f;a note7 is am5d$-- 7,a7 9 subsection 7a77#a77;,a7-- 7i7 by /rik+ ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 & ins]t+ ,secret>y2 7ii7 by /rik+ ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b77 7z am5d$ by ?is ,act2 7iii7 by /rik+ ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;a77 7z am5d$ by ?is ,act2 & 7iv7 by /rik+ ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;d72 7,b7 9 subsection 7b71 by /rik+ #ab-ye> & ins]t+ #ag-ye>2 7,c7 by r$esignat+ su* section #dje z section #cai,l-#a2 & 7,d7 by transf]r+ su* section #cai,l-#a1 z r$esignat$1 to ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq471 to appe> aft] section #cai,l ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#g;e74 7#b7 ,con=m+ am5dm5t ,! table ( cont5ts 9 section #a7;b7 ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,act 7,public ,law #aji-dag7 is am5d$ by /rik+ ! item relat$ to section #dje4 7f7 ,inapplicability ( c]ta9 provisions ,subsection 7e77#a7 ( section #cai,l 7#db ,u4,s4,c4 #bdg;d-#g;e7e77#a77 is am5d$-- 7#a7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,nondisclosure ( in=mation 7i7 ,9 g5]al ,in=mation describ$ 9 clause 7ii7 %all be deem$ to be in=mation describ$ 9 section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code4 7ii7 ,in=mation describ$ ,! in=mation describ$ 9 ?is clause is in=mation relevant to programs ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices t c\ld compromise national security & reveal significant & n o!rwise publicly kn[n vuln]abilities ( exi/+ m$ical or public heal? def5ses aga9/ *emical1 biological1 radiological1 or nucle> ?reats1 & is compris$ (-- 7,i7 specific te*nical data or sci5tific in=mation t is creat$ or obta9$ dur+ ! c\nt]measure & product advanc$ rese>* & developm5t c>ri$ out "u subsection 7c72 7,,ii7 in=mation p]ta9+ to ! location security1 p]sonnel1 & rese>* mat]ials & me?ods ( high-conta9m5t laboratories conduct+ rese>* ) select ag5ts1 tox9s1 or o!r ag5ts ) a mat]ial ?reat det]m9ation "u section #cai;,f-#b7;c77#b72 or 7,,iii7 security & vuln]ability assessm5ts4 2 7#b7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,d72 7#c7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+3 7,c7 ,report+ ,"o ye> aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai1 & annually !reaft]1 ! ,secret>y %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on ! numb] ( in/ances 9 :i* ! ,secret>y has us$ ! au?ority "u ?is subsection to )hold in=mation f disclosure1 z well z ! nature ( any reque/ "u section #eeb ( title #e1 ,unit$ ,/ates ,code t 0 d5i$ us+ su* au?ority4 2 & 7#d7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ #ab & ins]t+ #ag4 #gjb4 ,location ( mat]ials 9 ! /ockpile ,subsection 7d7 ( section #cai;,f-#b 7#db ,u4,s4,c4 #bdg;d-#f;b7 is am5d$ to read z foll[s3 7d7 ,disclosures ,no ,f$]al ag5cy may disclose "u section #eeb ( title #e1 ,unit$ ,/ates ,code any in=mation id5tify+ ! location at :i* mat]ials 9 ! /ockpile describ$ 9 subsection 7a7 are /or$1 or o!r in=mation reg>d+ ! cont5ts or deploym5t capability ( ! /ockpile t c\ld compromise national security4 4 #gjc4 ,cyb]security 7a7 ,/rategy = public heal? prep>$ness & response to cyb]security ?reats 7#a7 ,/rategy ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all prep>e & submit to ! relevant committees ( ,congress a /rategy = public heal? prep>$ness & response to address cyb]security ?reats 7z def9$ 9 section #ajb ( ,cyb]security ,in=mation ,%>+ ,act ( #bjae 7#f ,u4,s4,c4 #aeja77 t pres5t a ?reat to national heal? security4 ,su* /rategy %all include-- 7,a7 id5tify+ ! duties1 functions1 & prep>$ness goals = :i* ! ,secret>y is responsible 9 ord] to prep>e = & respond to su* cyb]security ?reats1 includ+ metrics by :i* to measure success 9 meet+ prep>$ness goals2 7,b7 id5tify+ gaps 9 public heal? capabilities to a*ieve su* prep>$ness goals2 & 7,c7 /rategies to address id5tifi$ gaps & /r5g!n public heal? em]g5cy prep>$ness & response capabilities to address su* cyb]security ?reats4 7#b7 ,protection ( national security ,! ,secret>y %all make su* /rategy available to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & o!r congressional committees ( jurisdiction1 9 a mann] t does n compromise national security4 7b7 ,coord9ation ( prep>$ness = & response to all-,haz>ds public heal? em]g5cies ,subp>agraph 7,d7 ( section #bhaa7;b77#d7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#d77 is am5d$ to read z foll[s3 7,d7 ,policy coord9ation & /rategic direction ,provide integrat$ policy coord9ation & /rategic direction1 be=e1 dur+1 & foll[+ public heal? em]g5cies1 ) respect to all matt]s relat$ to ,f$]al public heal? & m$ical prep>$ness & execution & deploym5t ( ! ,f$]al response = public heal? em]g5cies & incid5ts cov]$ by ! ,national ,response ,plan describ$ 9 section #ejd7;a77#f7 ( ! ,homel& ,security ,act ( #bjjb 7#f ,u4,s4,c4 #cad7;a77#f771 or any successor plan2 & su* ,f$]al responses cov]$ by ! ,national ,cyb]security ,incid5t ,response ,plan develop$ "u section #bbh7;c7 ( ! ,homel& ,security ,act ( #bjjb 7#f ,u4,s4,c4 #adi7;c771 includ+ public heal? em]g5cies or incid5ts relat$ to cyb]security ?reats t pres5t a ?reat to national heal? security4 4 #gjd4 ,/rategy & report ,n lat] ?an #ad days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 coord9ation ) ! ,assi/ant ,secret>y = ,prep>$ness & ,response & ! ,assi/ant ,secret>y = ! ,adm9i/ration on ,*ildr5 & ,families or o!r appropriate (fice1 & 9 collaboration ) o!r dep>tm5ts1 z appropriate1 %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & o!r relevant congressional committees-- 7#a7 a =mal /rategy1 includ+ int]dep>tm5tal actions & ef=ts to reunify *ildr5 ) _! p>5ts or gu>dians1 9 all cases 9 :i* su* *ildr5 h be5 sep>at$ f _! p>5ts or gu>dians z a result ( ! initiative ann\nc$ on ,april #f1 #bjah1 & due to prosecution "u section #bge7;a7 ( ! ,immigration & ,nationality ,act 7#h ,u4,s4,c4 #acbe7;a771 if ! p>5t or gu>dian *ooses su* reunification & ! *ild-- 7,a7 0 sep>at$ f a p>5t or gu>dian & plac$ into a facility fund$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7,b7 z ( ! date ( ! enactm5t ( ?is ,act1 rema9s 9 ! c>e ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 & 7,c7 c be safely reunit$ ) su* p>5t or gu>dian2 & 7#b7 a report on *all5ges & defici5cies relat$ to ! ov]sight (1 & c>e =1 unaccompani$ ali5 *ildr5 & appropriately reunit+ su* *ildr5 ) _! p>5ts or gu>dians1 & ! actions tak5 to address any *all5ges & defici5cies relat$ to unaccompani$ ali5 *ildr5 9 ! cu/ody ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+ defici5cies id5tifi$ & publicly report$ by ,congress1 ! ,gov]nm5t ,acc\ntability ,(fice1 or ! inspectors g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices or o!r ,f$]al dep>tm5ts4 #gje4 ,te*nical am5dm5ts 7a7 ,public ,heal? ,s]vice ,act ,title ,,iii 7#db ,u4,s4,c4 #bda et seq47 is am5d$-- 7#a7 9 p>agraphs 7#a7 & 7#e7 ( section #cai;,f-#a7;a7 7#db ,u4,s4,c4 #bdg;d-#f;a7a771 by /rik+ section #cai;,f7h7 ea* place su* t]m appe>s & ins]t+ section #cai;,f7e72 & 7#b7 9 section #cai,k7a7 7#db ,u4,s4,c4 #bdg;d-#g;d7a771 by /rik+ section #cai;,f7h77#d7 & ins]t+ section #cai;,f7e77#d74 7b7 ,public heal? security grants ,section #cai;,c-#a7;b77#b7 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,c71 by /rik+ individuals11 & ins]t+ individuals12 & 7#b7 9 subp>agraph 7,f71 by /rik+ make satisfactory annual improvem5t & describe & ins]t+ makes satisfactory annual improvem5t & describes4 7c7 ,em]g5cy use in/ructions ,subp>agraph 7,a7 ( section #efd;,a7e77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7e77#b77 is am5d$ by /rik+ subsection 7a77#a77;,c77i7 & ins]t+ subsection 7a77#a77;,c74 7d7 ,products held = em]g5cy use ,section #efd;,b7#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;b7 is am5d$-- 7#a7 9 subp>agraph 7,b71 by ins]t+ a comma aft] #eje2 & 7#b7 9 subp>agraph 7,c71 by ins]t+ or section #efd;,a be=e ! p]iod at ! end4 7e7 ,transp>5cy ,section #ejg7;c77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceg7;c77#c77 is am5d$-- 7#a7 by /rik+ ,no?+ 9 & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,no?+ 9 2 7#b7 by ins]t+ or direct+ aft] au?oriz+2 7#c7 by /rik+ disclose any & ins]t+ 8disclose-- 7i7 any 2 7#d7 by /rik+ ! p]iod & ins]t+ 2 or2 & 7#e7 by add+ at ! end ! foll[+3 7ii7 9 ! case ( a drug developm5t tool t may be us$ to support ! developm5t ( a qualifi$ c\nt]measure1 security c\nt]measure1 or qualifi$ p&emic or epidemic product1 z def9$ 9 sections #cai;,f-#a1 #cai;,f-#b1 & #cai;,f-#c1 respectively1 ( ! ,public ,heal? ,s]vice ,act1 any in=mation t ! ,secret>y det]m9es has a significant pot5tial to affect national security4 7,b7 ,public ackn[l$gm5t ,9 ! case t ! ,secret>y1 pursuant to subp>agraph 7,a77ii71 does n make in=mation publicly available1 ! ,secret>y %all provide on ! int]net website ( ! ,food & ,drug ,adm9i/ration an ackn[l$gm5t ( ! in=mation t has n be5 disclos$1 pursuant to subp>agraph 7,a77ii74 4 ,b ,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m #ajjj4 ,%ort title2 ref]5ces 9 division 7a7 ,%ort title ,?is division may be cit$ z ! ,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m ,act ( #bjai4 7b7 ,ref]5ces ,except z o!rwise specifi$1 any ref]5ce to ?is ,act conta9$ 9 ?is division %all be treat$ z ref]r+ only to ! provisions ( ?is division4 ,i ,,otc ,drug ,review #ajja4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #eje;,f ( su* ,act 7#ba ,u4,s4,c4 #cee;g7 ! foll[+3 #eje;,g4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application 7a7 ,nonprescription drugs m>ket$ )\t an approv$ application ,nonprescription drugs m>ket$ )\t an approv$ drug application "u section #eje1 z ( ! date ( ! enactm5t ( ?is section1 %all be treat$ 9 accordance ) ?is subsection4 7#a7 ,drugs subject to a f9al monograph2 category ,i drugs subject to a t5tative f9al monograph ,a drug is deem$ to be g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 n a new drug "u section #bja7p71 & n subject to section #ejc7;b77#a71 if-- 7,a7 ! drug is-- 7i7 9 con=mity ) ! requirem5ts = nonprescription use ( a f9al monograph issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations 7except z provid$ 9 p>agraph 7#b771 ! g5]al requirem5ts = nonprescription drugs1 & conditions or requirem5ts "u subsections 7b71 7c71 & 7k72 & 7ii7 except z p]mitt$ by an ord] issu$ "u subsection 7b7 or1 9 ! case ( a m9or *ange 9 ! drug1 9 con=mity ) an ord] issu$ "u subsection 7c71 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 has be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b72 or 7,b7 ! drug is-- 7i7 classifi$ 9 category ,i = safety & effectiv5ess "u a t5tative f9al monograph t is ! mo/ rec5tly applicable proposal or det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7ii7 9 con=mity ) ! propos$ requirem5ts = nonprescription use ( su* t5tative f9al monograph1 any applicable subsequ5t det]m9ation by ! ,secret>y1 ! g5]al requirem5ts = nonprescription drugs1 & conditions or requirem5ts "u subsections 7b71 7c71 & 7k72 & 7iii7 except z p]mitt$ by an ord] issu$ "u subsection 7b7 or1 9 ! case ( a m9or *ange 9 ! drug1 9 con=mity ) an ord] issu$ "u subsection 7c71 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 has be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b74 7#b7 ,treatm5t ( sunscre5 drugs ,) respect to sunscre5 drugs subject to ?is section1 ! applicable requirem5ts 9 t]ms ( con=mity ) a f9al monograph1 = purposes ( p>agraph 7#a77;,a77i71 %all be ! requirem5ts specifi$ 9 "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations1 z publi%$ on ,may #ba1 #aiii1 beg9n+ on page #bgfhg ( volume #fd ( ! ,f$]al ,regi/]1 except t ! applicable requirem5ts gov]n+ effectiv5ess & label+ %all be ^? specifi$ 9 section #bja4cbg ( title #ba1 ,code ( ,f$]al ,regulations4 7#c7 ,category ,,iii drugs subject to a t5tative f9al monograph2 category ,i drugs subject to propos$ monograph or advance notice ( propos$ rulemak+ ,a drug t is n describ$ 9 p>agraph 7#a71 7#b71 or 7#d7 is n requir$ to be ! subject ( an application approv$ "u section #eje1 & is n subject to section #ejc7;b77#a71 if-- 7,a7 ! drug is-- 7i7 classifi$ 9 category ,,iii = safety or effectiv5ess 9 ! preamble ( a propos$ rule e/abli%+ a t5tative f9al monograph t is ! mo/ rec5tly applicable proposal or det]m9ation = su* drug issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7ii7 9 con=mity )-- 7,i7 ! conditions ( use1 includ+ indication & dosage /r5g?1 if any1 describ$ = su* category ,,iii drug 9 su* preamble or 9 an applicable subsequ5t propos$ rule2 7,,ii7 ! propos$ requirem5ts = drugs classifi$ 9 su* t5tative f9al monograph 9 category ,i 9 ! mo/ rec5tly propos$ rule e/abli%+ requirem5ts relat$ to su* t5tative f9al monograph & 9 any f9al rule e/abli%+ requirem5ts t are applicable to ! drug2 & 7,,iii7 ! g5]al requirem5ts = nonprescription drugs & conditions or requirem5ts "u subsection 7b7 or 7k72 & 7iii7 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 _h be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b72 or 7,b7 ! drug is-- 7i7 classifi$ 9 category ,i = safety & effectiv5ess "u a propos$ monograph or advance notice ( propos$ rulemak+ t is ! mo/ rec5tly applicable proposal or det]m9ation = su* drug issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7ii7 9 con=mity ) ! requirem5ts = nonprescription use ( su* propos$ monograph or advance notice ( propos$ rulemak+1 any applicable subsequ5t det]m9ation by ! ,secret>y1 ! g5]al requirem5ts = nonprescription drugs1 & conditions or requirem5ts "u subsection 7b7 or 7k72 & 7iii7 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 has be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b74 7#d7 ,category ,,ii drugs deem$ new drugs ,a drug t is classifi$ 9 category ,,ii = safety or effectiv5ess "u a t5tative f9al monograph or t is subject to a det]m9ation to be n g5]ally recogniz$ z safe & effective 9 a propos$ rule t is ! mo/ rec5tly applicable proposal issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 %all be deem$ to be a new drug "u section #bja7p71 misbr&$ "u section #ejb7;ee71 & subject to ! requirem5t = an approv$ new drug application "u section #eje beg9n+ on ! day t is #ahj cal5d> days aft] ! date ( ! enactm5t ( ?is section1 unless1 be=e su* day1 ! ,secret>y det]m9es t x is 9 ! int]e/ ( public heal? to ext5d ! p]iod dur+ :i* ! drug may be m>ket$ )\t su* an approv$ new drug application4 7#e7 ,drugs n ,,grase deem$ new drugs ,a drug t ! ,secret>y has det]m9$ n to be g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 "u a f9al det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 %all be deem$ to be a new drug "u section #bja7p71 misbr&$ "u section #ejb7;ee71 & subject to ! requirem5t = an approv$ new drug application "u section #eje4 7#f7 ,o!r drugs deem$ new drugs ,except z provid$ 9 subsection 7m71 a drug is deem$ to be a new drug "u section #bja7p7 & misbr&$ "u section #ejb7;ee7 if ! drug-- 7,a7 is n subject to section #ejc7;b77#a72 & 7,b7 is n describ$ 9 p>agraph 7#a71 7#b71 7#c71 7#d71 or 7#e71 or subsection 7b77#a77;,b74 7b7 ,adm9i/rative ord]s 7#a7 ,9 g5]al 7,a7 ,det]m9ation ,! ,secret>y may1 on ! initiative ( ! ,secret>y or at ! reque/ ( "o or m reque/ors1 issue an adm9i/rative ord] det]m9+ :e!r !re are conditions "u :i* a specific drug1 a class ( drugs1 or a comb9ation ( drugs1 is det]m9$ to be-- 7i7 n subject to section #ejc7;b77#a72 & 7ii7 g5]ally recogniz$ z safe & effective "u section #bja7p77#a74 7,b7 ,effect ,a drug or comb9ation ( drugs %all be deem$ to n require approval "u section #eje if su* drug or comb9ation ( drugs-- 7i7 is det]m9$ by ! ,secret>y to meet ! conditions specifi$ 9 clauses 7i7 & 7ii7 ( subp>agraph 7,a72 7ii7 is m>ket$ 9 con=mity ) an adm9i/rative ord] "u ?is subsection2 7iii7 meets ! g5]al requirem5ts = nonprescription drugs2 & 7iv7 meets ! requirem5ts "u subsections 7c7 & 7k74 7,c7 ,/&>d ,! ,secret>y %all f9d t a drug is n g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 if-- 7i7 ! evid5ce %[s t ! drug is n g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 or 7ii7 ! evid5ce is inadequate to %[ t ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a74 7#b7 ,adm9i/rative ord]s initiat$ by ! secret>y 7,a7 ,9 g5]al ,9 issu+ an adm9i/rative ord] "u p>agraph 7#a7 ^u ! ,secret>y's initiative1 ! ,secret>y %all-- 7i7 make reasonable ef=ts to notify in=mally1 n lat] ?an #b bus9ess days be=e ! issuance ( ! propos$ ord]1 ! sponsors ( drugs :o h a li/+ 9 effect "u section #eaj7;j7 = ! drugs or comb9ation ( drugs t w be subject to ! adm9i/rative ord]2 7ii7 aft] any su* reasonable ef=ts ( notification-- 7,i7 issue a propos$ adm9i/rative ord] by publi%+ x on ! website ( ! ,food & ,drug ,adm9i/ration & include 9 su* ord] ! reasons = ! issuance ( su* ord]2 & 7,,ii7 publi% a notice ( availability ( su* propos$ ord] 9 ! ,f$]al ,regi/]2 7iii7 except z provid$ 9 subp>agraph 7,b71 provide = a public comm5t p]iod ) respect to su* propos$ ord] ( n less ?an #de cal5d> days2 & 7iv7 if1 aft] completion ( ! proce$+s specifi$ 9 clauses 7i7 ?r\gh 7iii71 ! ,secret>y det]m9es t x is appropriate to issue a f9al adm9i/rative ord]-- 7,i7 issue ! f9al adm9i/rative ord]1 toge!r ) a detail$ /atem5t ( reasons1 :i* ord] %all n take effect until ! "t = reque/+ judicial review "u p>agraph 7#c77;,d77ii7 has expir$2 7,,ii7 publi% a notice ( su* f9al adm9i/rative ord] 9 ! ,f$]al ,regi/]2 7,,iii7 af=d reque/ors ( drugs t w be subject to su* ord] ! opportunity = =mal dispute resolution up to ! level ( ! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 :i* initially mu/ be reque/$ )9 #de cal5d> days ( ! issuance ( ! ord]1 &1 = subsequ5t levels ( appeal1 )9 #cj cal5d> days ( ! prior decision2 & 7,,iv7 except ) respect to drugs describ$ 9 p>agraph 7#c77;,b71 ^u completion ( ! =mal dispute resolution proc$ure1 in=m ! p]sons :i* s\ght su* dispute resolution ( _! "r to reque/ a he>+4 7,b7 ,exceptions ,:5 issu+ an adm9i/rative ord] "u p>agraph 7#a7 on ! ,secret>y's initiative propos+ to det]m9e t a drug describ$ 9 subsection 7a77#c7 is n g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 ! ,secret>y %all foll[ ! proc$ures 9 subp>agraph 7,a71 except t-- 7i7 ! propos$ ord] %all include notice (-- 7,i7 ! g5]al categories ( data ! ,secret>y has det]m9$ necess>y to e/abli% t ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 & 7,,ii7 ! =mat = submissions by int]e/$ p]sons2 7ii7 ! ,secret>y %all provide = a public comm5t p]iod ( no less ?an #ahj cal5d> days ) respect to su* propos$ ord]1 except :5 ! ,secret>y det]m9es1 = good cause1 t a %ort] p]iod is 9 ! int]e/ ( public heal?2 & 7iii7 any p]son :o submits data 9 su* comm5t p]iod %all include a c]tification t ! p]son has submitt$ all evid5ce creat$1 obta9$1 or receiv$ by t p]son t is bo? )9 ! categories ( data id5tifi$ 9 ! propos$ ord] & relevant to a det]m9ation z to :e!r ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a74 7#c7 ,he>+s2 judicial review 7,a7 ,9 g5]al ,only a p]son :o p>ticipat$ 9 ea* /age ( =mal dispute resolution "u subclause 7,,iii7 ( p>agraph 7#b77;,a77iv7 ( an adm9i/rative ord] ) respect to a drug may reque/ a he>+ conc]n+ a f9al adm9i/rative ord] issu$ "u su* p>agraph ) respect to su* drug4 ,if a he>+ is s\ght1 su* p]son mu/ submit a reque/ = a he>+1 :i* %all be bas$ solely on in=mation 9 ! adm9i/rative record1 to ! ,secret>y n lat] ?an #cj cal5d> days aft] receiv+ notice ( ! f9al decision ( ! =mal dispute resolution proc$ure4 7,b7 ,no he>+ requir$ ) respect to ord]s relat+ to c]ta9 drugs 7i7 ,9 g5]al ,! ,secret>y %all n be requir$ to provide notice & an opportunity = a he>+ pursuant to p>agraph 7#b77;,a77iv7 if ! f9al adm9i/rative ord] involv$ relates to a drug-- 7,i7 t is describ$ 9 subsection 7a77#c77;,a72 & 7,,ii7 ) respect to :i* no human or non-human data /udies relevant to ! safety or effectiv5ess ( su* drug h be5 submitt$ to ! adm9i/rative record s9ce ! issuance ( ! mo/ rec5t t5tative f9al monograph relat+ to su* drug4 7ii7 ,human data /udies & non-human data def9$ ,9 ?is subp>agraph3 7,i7 ,! t]m human data /udies means cl9ical trials ( safety or effectiv5ess 7includ+ actual use /udies71 ph>macok9etics /udies1 or bioavailability /udies4 7,,ii7 ,! t]m non-human data means data f te/+ o!r ?an ) human subjects :i* provides in=mation conc]n+ safety or effectiv5ess4 7,c7 ,he>+ proc$ures 7i7 ,d5ial ( reque/ = he>+ ,if ! ,secret>y det]m9es t in=mation submitt$ 9 a reque/ = a he>+ "u subp>agraph 7,a7 ) respect to a f9al adm9i/rative ord] issu$ "u p>agraph 7#b77;,a77iv7 does n id5tify ! exi/5ce ( a g5u9e & sub/antial "q ( mat]ial fact1 ! ,secret>y may d5y su* reque/4 ,9 mak+ su* a det]m9ation1 ! ,secret>y may consid] only in=mation & data t are bas$ on relevant & reliable sci5tific pr9ciples & me?odologies4 7ii7 ,s+le he>+ = multiple relat$ reque/s ,if m ?an "o reque/ = a he>+ is submitt$ ) respect to ! same adm9i/rative ord] "u subp>agraph 7,a71 ! ,secret>y may direct t a s+le he>+ be conduct$ 9 :i* all p]sons ^: he>+ reque/s 7 grant$ may p>ticipate4 7iii7 ,presid+ (fic] ,! presid+ (fic] ( a he>+ reque/$ "u subp>agraph 7,a7 %all-- 7,i7 be designat$ by ! ,secret>y2 7,,ii7 n be an employee ( ! ,c5t] = ,drug ,evaluation & ,rese>*2 & 7,,iii7 n h be5 previ\sly involv$ 9 ! developm5t ( ! adm9i/rative ord] involv$ or proce$+s relat+ to t adm9i/rative ord]4 7iv7 ,rights ( p>ties to he>+ ,! p>ties to a he>+ reque/$ "u subp>agraph 7,a7 %all h ! "r to pres5t te/imony1 includ+ te/imony ( exp]t witnesses1 & to cross-exam9e witnesses pres5t$ by o!r p>ties4 ,:]e appropriate1 ! presid+ (fic] may require t cross-exam9ation by p>ties repres5t+ sub/antially ! same int]e/s be consolidat$ to promote effici5cy & avoid duplication4 7v7 ,f9al decision 7,i7 ,at ! conclusion ( a he>+ reque/$ "u subp>agraph 7,a71 ! presid+ (fic] ( ! he>+ %all issue a decision conta9+ f9d+s ( fact & conclusions ( law4 ,! decision ( ! presid+ (fic] %all be f9al4 7,,ii7 ,! f9al decision may n take effect until ! p]iod "u subp>agraph 7,d77ii7 = submitt+ a reque/ = judicial review ( su* decision expires4 7,d7 ,judicial review ( f9al adm9i/rative ord] 7i7 ,9 g5]al ,! proc$ures describ$ 9 section #eje7;h7 %all apply ) respect to judicial review ( f9al adm9i/rative ord]s issu$ "u ?is subsection 9 ! same mann] & to ! same ext5t z su* section applies to an ord] describ$ 9 su* section except t ! judicial review %all be tak5 by fil+ 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates 9 lieu ( ! appellate c\rts specifi$ 9 su* section4 7ii7 ,p]iod to submit a reque/ = judicial review ,a p]son eligible to reque/ a he>+ "u ?is p>agraph & seek+ judicial review ( a f9al adm9i/rative ord] issu$ "u ?is subsection %all file su* reque/ = judicial review n lat] ?an #fj cal5d> days aft] ! late/ (-- 7,i7 ! date on :i* notice ( su* ord] is publi%$2 7,,ii7 ! date on :i* a he>+ ) respect to su* ord] is d5i$ "u subp>agraph 7,b7 or 7,c77i72 7,,iii7 ! date on :i* a f9al decision is made foll[+ a he>+ "u subp>agraph 7,c77v72 or 7,,iv7 if no he>+ is reque/$1 ! date on :i* ! "t = reque/+ a he>+ expires4 7#d7 ,exp$it$ proc$ure ) respect to adm9i/rative ord]s initiat$ by ! ,secret>y 7,a7 ,imm95t haz>d to ! public heal? 7i7 ,9 g5]al ,9 ! case ( a det]m9ation by ! ,secret>y t a drug1 class ( drugs1 or comb9ation ( drugs subject to ?is section poses an imm95t haz>d to ! public heal?1 ! ,secret>y1 aft] fir/ mak+ reasonable ef=ts to notify1 n lat] ?an #dh h\rs be=e issuance ( su* ord] "u ?is subp>agraph1 sponsors :o h a li/+ 9 effect "u section #eaj7;j7 = su* drug or comb9ation ( drugs-- 7,i7 may issue an int]im f9al adm9i/rative ord] = su* drug1 class ( drugs1 or comb9ation ( drugs "u p>agraph 7#a71 toge!r ) a detail$ /atem5t ( ! reasons = su* ord]2 7,,ii7 %all publi% 9 ! ,f$]al ,regi/] a notice ( availability ( any su* ord]2 & 7,,iii7 %all provide = a public comm5t p]iod ( at lea/ #de cal5d> days ) respect to su* int]im f9al ord]4 7ii7 ,nondelegation ,! ,secret>y may n delegate ! au?ority to issue an int]im f9al adm9i/rative ord] "u ?is subp>agraph4 7,b7 ,safety label+ *anges 7i7 ,9 g5]al ,9 ! case ( a det]m9ation by ! ,secret>y t a *ange 9 ! label+ ( a drug1 class ( drugs1 or comb9ation ( drugs subject to ?is section is reasonably expect$ to mitigate a significant or unreasonable risk ( a s]i\s adv]se ev5t associat$ ) use ( ! drug1 ! ,secret>y may-- 7,i7 make reasonable ef=ts to notify in=mally1 n lat] ?an #dh h\rs be=e ! issuance ( ! int]im f9al ord]1 ! sponsors ( drugs :o h a li/+ 9 effect "u section #eaj7;j7 = su* drug or comb9ation ( drugs2 7,,ii7 aft] reasonable ef=ts ( notification1 issue an int]im f9al adm9i/rative ord] 9 accordance ) p>agraph 7#a7 to require su* *ange1 toge!r ) a detail$ /atem5t ( ! reasons = su* ord]2 7,,iii7 publi% 9 ! ,f$]al ,regi/] a notice ( availability ( su* ord]2 & 7,,iv7 provide = a public comm5t p]iod ( at lea/ #de cal5d> days ) respect to su* int]im f9al ord]4 7ii7 ,cont5t ( ord] ,an int]im f9al ord] issu$ "u ?is subp>agraph ) respect to ! label+ ( a drug may provide = new w>n+s & o!r in=mation requir$ = safe use ( ! drug4 7,c7 ,effective date ,an ord] "u subp>agraph 7,a7 or 7,b7 %all take effect on a date specifi$ by ! ,secret>y4 7,d7 ,f9al ord] ,aft] ! completion ( ! proce$+s 9 subp>agraph 7,a7 or 7,b71 ! ,secret>y %all-- 7i7 issue a f9al ord] 9 accordance ) p>agraph 7#a72 7ii7 publi% a notice ( availability ( su* f9al adm9i/rative ord] 9 ! ,f$]al ,regi/]2 & 7iii7 af=d sponsors ( su* drugs t w be subject to su* an ord] ! opportunity = =mal dispute resolution up to ! level ( ! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 :i* mu/ initially be )9 #de cal5d> days ( ! issuance ( ! ord]1 & = subsequ5t levels ( appeal1 )9 #cj cal5d> days ( ! prior decision4 7,e7 ,he>+s ,a sponsor ( a drug subject to a f9al ord] issu$ "u subp>agraph 7,d7 & t p>ticipat$ 9 ea* /age ( =mal dispute resolution "u clause 7iii7 ( su* subp>agraph may reque/ a he>+ on su* ord]4 ,! provisions ( subp>agraphs 7,a71 7,b71 & 7,c7 ( p>agraph 7#c71 o!r ?an p>agraph 7#c77;,c77v77,,ii71 %all apply ) respect to a he>+ on su* ord] 9 ! same mann] & to ! same ext5t z su* provisions apply ) respect to a he>+ on an adm9i/rative ord] issu$ "u p>agraph 7#b77;,a77iv74 7,f7 ,tim+ 7i7 ,f9al ord] & he>+ ,! ,secret>y %all-- 7,i7 n lat] ?an #f mon?s aft] ! date on :i* ! comm5t p]iod closes "u subp>agraph 7,a7 or 7,b71 issue a f9al ord] 9 accordance ) p>agraph 7#a72 & 7,,ii7 n lat] ?an #ab mon?s aft] ! date on :i* su* f9al ord] is issu$1 complete any he>+ "u subp>agraph 7,e74 7ii7 ,dispute resolution reque/ ,! ,secret>y %all specify 9 an int]im f9al ord] issu$ "u subp>agraph 7,a7 or 7,b7 su* %ort] p]iods = reque/+ dispute resolution "u subp>agraph 7,d77iii7 z are necess>y to meet ! requirem5ts ( ?is subp>agraph4 7,g7 ,judicial review ,a f9al ord] issu$ pursuant to subp>agraph 7,f7 %all be subject to judicial review 9 accordance ) p>agraph 7#c77;,d74 7#e7 ,adm9i/rative ord] initiat$ at ! reque/ ( a reque/or 7,a7 ,9 g5]al ,9 issu+ an adm9i/rative ord] "u p>agraph 7#a7 at ! reque/ ( a reque/or ) respect to c]ta9 drugs1 classes ( drugs1 or comb9ations ( drugs-- 7i7 ! ,secret>y %all1 aft] receiv+ a reque/ "u ?is subp>agraph1 det]m9e :e!r ! reque/ is suffici5tly complete & =matt$ to p]mit a sub/antive review2 7ii7 if ! ,secret>y det]m9es t ! reque/ is suffici5tly complete & =matt$ to p]mit a sub/antive review1 ! ,secret>y %all-- 7,i7 file ! reque/2 & 7,,ii7 initiate proce$+s ) respect to issu+ an adm9i/rative ord] 9 accordance ) p>agraphs 7#b7 & 7#c72 & 7iii7 except z provid$ 9 p>agraph 7#f71 if ! ,secret>y det]m9es t a reque/ does n meet ! requirem5ts = fil+ or is n suffici5tly complete & =matt$ to p]mit a sub/antive review1 ! reque/or may dem& t ! reque/ be fil$ ov] prote/1 & ! ,secret>y %all initiate proce$+s to review ! reque/ 9 accordance ) p>agraph 7#b77;,a74 7,b7 ,reque/ to initiate proce$+s 7i7 ,9 g5]al ,a reque/or seek+ an adm9i/rative ord] "u p>agraph 7#a7 ) respect to c]ta9 drugs1 classes ( drugs1 or comb9ations ( drugs1 %all submit to ! ,secret>y a reque/ to initiate proce$+s = su* ord] 9 ! =m & mann] z specifi$ by ! ,secret>y4 ,su* reque/or may submit a reque/ "u ?is subp>agraph = ! issuance ( an adm9i/rative ord]-- 7,i7 det]m9+ :e!r a drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 exempt f section #ejc7;b77#a71 & n requir$ to be ! subject ( an approv$ application "u section #eje2 or 7,,ii7 det]m9+ :e!r a *ange to a condition ( use ( a drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 exempt f section #ejc7;b77#a71 & n requir$ to be ! subject ( an approv$ application "u section #eje1 if1 abs5t su* a *ang$ condition ( use1 su* drug is-- 7aa7 g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 9 accordance ) subsection 7a77#a71 7a77#b71 or an ord] "u ?is subsection2 or 7bb7 subject to subsection 7a77#c71 b only if su* reque/or initiates su* reque/ 9 conjunction ) a reque/ = ! ,secret>y to det]m9e :e!r su* drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 :i* is fil$ by ! ,secret>y "u subp>agraph 7,a77ii74 7ii7 ,exception ,! ,secret>y is n requir$ to complete review ( a reque/ = a *ange describ$ 9 clause 7i77,,ii7 if ! ,secret>y det]m9es t !re is an inadequate basis to f9d ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 "u p>agraph 7#a7 & issues a f9al ord] ann\nc+ t det]m9ation4 7iii7 ,)drawal ,! reque/or may )draw a reque/ "u ?is p>agraph1 accord+ to ! proc$ures set =? pursuant to subsection 7d77#b77;,b74 ,not)/&+ any o!r provision ( ?is section1 if su* reque/ is )drawn1 ! ,secret>y may cease proce$+s "u ?is subp>agraph4 7,c7 ,exclusivity 7i7 ,9 g5]al ,a f9al adm9i/rative ord] issu$ 9 response to a reque/ "u ?is section %all h ! effect ( au?oriz+ solely ! ord] reque/or 7or ! lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* ord]71 = a p]iod ( #ah mon?s foll[+ ! effective date ( su* f9al ord] & beg9n+ on ! date ! reque/or may lawfully m>ket su* drugs pursuant to ! ord]1 to m>ket drugs-- 7,i7 incorporat+ *anges describ$ 9 clause 7ii72 & 7,,ii7 subject to ! limitations "u clause 7iv74 7ii7 ,*anges describ$ ,a *ange describ$ 9 ?is clause is a *ange subject to an ord] specifi$ 9 clause 7i71 :i*-- 7,i7 provides = a drug to conta9 an active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 n previ\sly incorporat$ 9 a drug describ$ 9 clause 7iii72 or 7,,ii7 provides = a *ange 9 ! conditions ( use ( a drug1 = :i* new human data /udies conduct$ or sponsor$ by ! reque/or 7or = :i* ! reque/or has an exclusive "r ( ref]5ce7 7 ess5tial to ! issuance ( su* ord]4 7iii7 ,drugs describ$ ,! drugs describ$ 9 ?is clause are drugs-- 7,i7 specifi$ 9 subsection 7a77#a71 7a77#b71 or 7a77#c72 7,,ii7 subject to a f9al ord] issu$ "u ?is section2 7,,iii7 subject to a f9al sunscre5 ord] 7z def9$ 9 section #ehf7b77;,a772 or 7,,iv7 describ$ 9 subsection 7m77#a71 o!r ?an drugs subject to an active en=cem5t action "u *apt] ,,iii ( ?is ,act4 7iv7 ,limitations on exclusivity 7,i7 ,9 g5]al ,only "o #ah-mon? p]iod "u ?is subp>agraph %all be grant$1 "u ea* ord] describ$ 9 clause 7i71 ) respect to *anges 7to ! drug subject to su* ord]7 :i* are ei!r-- 7aa7 *anges describ$ 9 clause 7ii77,i71 relat+ to active +r$i5ts2 or 7bb7 *anges describ$ 9 clause 7ii77,,ii71 relat+ to conditions ( use4 7,,ii7 ,no exclusivity all[$ ,no exclusivity %all apply to *anges to a drug :i* are-- 7aa7 ! subject ( a ,ti] #b ,,otc monograph ord] reque/ 7z def9$ 9 section #gdd,l72 7bb7 safety-relat$ *anges1 z def9$ by ! ,secret>y1 or any o!r *anges ! ,secret>y consid]s necess>y to assure safe use2 or 7cc7 *anges relat$ to me?ods ( te/+ safety or efficacy4 7v7 ,new human data /udies def9$ ,9 ?is subp>agraph1 ! t]m new human data /udies means cl9ical trials ( safety or effectiv5ess 7includ+ actual use /udies71 ph>macok9etics /udies1 or bioavailability /udies1 ! results ( :i*-- 7,i7 h n be5 reli$ on by ! ,secret>y to support-- 7aa7 a propos$ or f9al det]m9ation t a drug describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 ( clause 7iii7 is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 or 7bb7 approval ( a drug t 0 approv$ "u section #eje2 & 7,,ii7 d n duplicate ! results ( ano!r /udy t 0 reli$ on by ! ,secret>y to support-- 7aa7 a propos$ or f9al det]m9ation t a drug describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 ( clause 7iii7 is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 or 7bb7 approval ( a drug t 0 approv$ "u section #eje4 7#f7 ,in=mation reg>d+ safe nonprescription m>ket+ & use z condition = fil+ a g5]ally recogniz$ z safe & effective reque/ 7,a7 ,9 g5]al ,9 response to a reque/ "u ?is section t a drug describ$ 9 subp>agraph 7,b7 be g5]ally recogniz$ z safe & effective1 ! ,secret>y-- 7i7 may file su* reque/1 if ! reque/ includes in=mation specifi$ "u subp>agraph 7,c7 ) respect to safe nonprescription m>ket+ & use ( su* drug2 or 7ii7 if ! reque/ fails to include in=mation specifi$ "u subp>agraph 7,c71 %all refuse to file su* reque/ & require t nonprescription m>ket+ ( ! drug be pursuant to a new drug application z describ$ 9 subp>agraph 7,d74 7,b7 ,drug describ$ ,a drug describ$ 9 ?is subp>agraph is a nonprescription drug :i* conta9s an active +r$i5t n previ\sly incorporat$ 9 a drug-- 7i7 specifi$ 9 subsection 7a77#a71 7a77#b71 or 7a77#c72 7ii7 subject to a f9al ord] "u ?is section2 or 7iii7 subject to a f9al sunscre5 ord] 7z def9$ 9 section #ehf7b77;,a774 7,c7 ,in=mation demon/rat+ prima facie safe nonprescription m>ket+ & use ,in=mation specifi$ 9 ?is subp>agraph1 ) respect to a reque/ describ$ 9 subp>agraph 7,a77i71 is-- 7i7 in=mation suffici5t = a prima facie demon/ration t ! drug subject to su* reque/ has a v]ifiable hi/ory ( be+ m>ket$ & safely us$ by consum]s 9 ! ,unit$ ,/ates z a nonprescription drug "u comp>able conditions ( use2 7ii7 if ! drug has n be5 previ\sly m>ket$ 9 ! ,unit$ ,/ates z a nonprescription drug1 in=mation suffici5t = a prima facie demon/ration t ! drug 0 m>ket$ & safely us$ "u comp>able conditions ( m>ket+ & use 9 a c\ntry li/$ 9 section #hjb7;b77#a77;,a7 or designat$ by ! ,secret>y 9 accordance ) section #hjb7;b77#a77;,b7-- 7,i7 = su* p]iod z ne$$ to provide reasonable assurances conc]n+ ! safe nonprescription use ( ! drug2 & 7,,ii7 dur+ su* "t 0 subject to suffici5t monitor+ by a regulatory body consid]$ acceptable by ! ,secret>y = su* monitor+ purposes1 includ+ = adv]se ev5ts associat$ ) nonprescription use ( ! drug2 or 7iii7 if ! ,secret>y det]m9es t in=mation describ$ 9 clause 7i7 or 7ii7 is n ne$$ to provide a prima facie demon/ration t ! drug c be safely m>ket$ & us$ z a nonprescription drug1 su* o!r in=mation ! ,secret>y det]m9es is suffici5t = su* purposes4 7,d7 ,m>ket+ pursuant to new drug application ,9 ! case ( a reque/ describ$ 9 subp>agraph 7,a77ii71 ! drug subject to su* reque/ may be resubmitt$ = fil+ only if-- 7i7 ! drug is m>ket$ z a nonprescription drug1 "u conditions ( use comp>able to ! conditions specifi$ 9 ! reque/1 = su* p]iod z ! ,secret>y det]m9es appropriate 7n to exce$ #e consecutive ye>s7 pursuant to an application approv$ "u section #eje2 & 7ii7 dur+ su* p]iod1 #a1jjj1jjj retail packages ( ! drug1 or an equival5t quantity z det]m9$ by ! ,secret>y1 7 di/ribut$ = retail sale1 z det]m9$ 9 su* mann] z ! ,secret>y f9ds appropriate4 7,e7 ,rule ( application ,except 9 ! case ( a reque/ involv+ a drug describ$ 9 section #ehf7i71 z 9 effect on ,janu>y #a1 #bjag1 if ! ,secret>y refuses to file a reque/ "u ?is p>agraph1 ! reque/or may n file su* reque/ ov] prote/ "u p>agraph 7#e77;,a77iii74 7#g7 ,packag+ ,an adm9i/rative ord] issu$ "u p>agraph 7#b71 7#d77;,a71 or 7#e7 may include requirem5ts = ! packag+ ( a drug to enc\rage use 9 accordance ) label+4 ,su* requirem5ts may include unit dose packag+1 requirem5ts = products int5d$ = use by p$iatric populations1 requirem5ts to r$uce risk ( h>m f unsup]vis$ +e/ion1 & o!r appropriate requirem5ts4 ,?is p>agraph does n au?orize ! ,food & ,drug ,adm9i/ration to require /&>ds or te/+ proc$ures z describ$ 9 "p #agjj ( title #af1 ,code ( ,f$]al ,regulations4 7#h7 ,f9al & t5tative f9al monographs = category ,i drugs deem$ f9al adm9i/rative ord]s 7,a7 ,9 g5]al ,a f9al monograph or t5tative f9al monograph describ$ 9 subp>agraph 7,b7 %all be deem$ to be a f9al adm9i/rative ord] "u ?is subsection & may be am5d$1 revok$1 or o!rwise modifi$ 9 accordance ) ! proc$ures ( ?is subsection4 7,b7 ,monographs describ$ ,= purposes ( subp>agraph 7,a71 a f9al monograph or t5tative f9al monograph is describ$ 9 ?is subp>agraph if x-- 7i7 e/abli%es conditions ( use = a drug describ$ 9 p>agraph 7#a7 or 7#b7 ( subsection 7a72 & 7ii7 repres5ts ! mo/ rec5tly promulgat$ v]sion ( su* conditions1 includ+ z modifi$1 9 :ole or 9 "p1 by any propos$ or f9al rule4 7,c7 ,deem$ ord]s include h>moniz+ te*nical am5dm5ts ,! deem$ e/abli%m5t ( a f9al adm9i/rative ord] "u subp>agraph 7,a7 %all be con/ru$ to include any te*nical am5dm5ts to su* ord] z ! ,secret>y det]m9es necess>y to ensure t su* ord] is appropriately h>moniz$1 9 t]ms ( t]m9ology or cross-ref]5ces1 ) ! applicable provisions ( ?is ,act 7& regulations !reund]7 & any o!r ord]s issu$ "u ?is section4 7c7 ,proc$ure = m9or *anges 7#a7 ,9 g5]al ,m9or *anges 9 ! dosage =m ( a drug t is describ$ 9 p>agraph 7#a7 or 7#b7 ( subsection 7a7 or ! subject ( an ord] issu$ "u subsection 7b7 may be made by a reque/or )\t ! issuance ( an ord] "u subsection 7b7 if-- 7,a7 ! reque/or ma9ta9s su* in=mation z is necess>y to demon/rate t ! *ange-- 7i7 w n affect ! safety or effectiv5ess ( ! drug2 & 7ii7 w n mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t 9 comp>ison to a suitable ref]5ce product2 & 7,b7 ! *ange is 9 con=mity ) ! requirem5ts ( an applicable adm9i/rative ord] issu$ by ! ,secret>y "u p>agraph 7#c74 7#b7 ,additional in=mation 7,a7 ,access to records ,a sponsor %all submit records reque/$ by ! ,secret>y relat+ to su* a m9or *ange "u section #gjd7;a77#d71 )9 #ae bus9ess days ( receiv+ su* a reque/1 or su* long] p]iod z ! ,secret>y may provide4 7,b7 ,insuffici5t in=mation ,if ! ,secret>y det]m9es t ! in=mation conta9$ 9 su* records is n suffici5t to demon/rate t ! *ange does n affect ! safety or effectiv5ess ( ! drug or mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t1 ! ,secret>y-- 7i7 may s in=m ! sponsor ( ! drug 9 writ+2 & 7ii7 if ! ,secret>y s in=ms ! sponsor1 %all provide ! sponsor ( ! drug ) a reasonable opportunity to provide additional in=mation4 7,c7 ,failure to submit suffici5t in=mation ,if ! sponsor fails to provide su* additional in=mation )9 a "t prescrib$ by ! ,secret>y1 or if ! ,secret>y det]m9es t su* additional in=mation does n demon/rate t ! *ange does n-- 7i7 affect ! safety or effectiv5ess ( ! drug2 or 7ii7 mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t 9 comp>ison to a suitable ref]5ce product1 ! drug z modifi$ is a new drug "u section #bja7p7 & %all be deem$ to be misbr&$ "u section #ejb7;ee74 7#c7 ,det]m9+ :e!r a *ange w affect safety or effectiv5ess 7,a7 ,9 g5]al ,! ,secret>y %all issue "o or m adm9i/rative ord]s specify+ requirem5ts = det]m9+ :e!r a m9or *ange made by a sponsor pursuant to ?is subsection w affect ! safety or effectiv5ess ( a drug or mat]ially affect ! ext5t ( absorption or o!r exposure to an active +r$i5t 9 ! drug 9 comp>ison to a suitable ref]5ce product1 toge!r ) guidance = apply+ ^? ord]s to specific dosage =ms4 7,b7 ,/&>d practices ,! ord]s & guidance issu$ by ! ,secret>y "u subp>agraph 7,a7 %all take into acc\nt relevant public /&>ds & /&>d practices = evaluat+ ! quality ( drugs1 & may take into acc\nt ! special ne$s ( populations1 includ+ *ildr54 7d7 ,confid5tiality ( in=mation submitt$ to ! ,secret>y 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 any in=mation1 includ+ reports ( te/+ conduct$ on ! drug or drugs involv$1 t is submitt$ by a reque/or 9 connection ) proce$+s on an ord] "u ?is section 7includ+ any m9or *ange "u subsection 7c77 & is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code1 %all n be disclos$ to ! public unless ! reque/or cons5ts to t disclosure4 7#b7 ,public availability 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ! ,secret>y %all-- 7i7 make any in=mation submitt$ by a reque/or 9 support ( a reque/ "u subsection 7b77#e77;,a7 available to ! public n lat] ?an ! date on :i* ! propos$ ord] is issu$2 & 7ii7 make any in=mation submitt$ by any o!r p]son ) respect to an ord] reque/$ 7or initiat$ by ! ,secret>y7 "u subsection 7b71 available to ! public ^u su* submission4 7,b7 ,limitations on public availability ,in=mation describ$ 9 subp>agraph 7,a7 %all n be made public if-- 7i7 ! in=mation p]ta9s to ph>maceutical quality in=mation1 unless su* in=mation is necess>y to e/abli% /&>ds "u :i* a drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 7ii7 ! in=mation is submitt$ 9 a reque/or-initiat$ reque/1 b ! reque/or )draws su* reque/1 9 accordance ) )drawal proc$ures e/abli%$ by ! ,secret>y1 be=e ! ,secret>y issues ! propos$ ord]2 7iii7 ! ,secret>y reque/s & obta9s ! in=mation "u subsection 7c7 & su* in=mation is n submitt$ 9 relation to an ord] "u subsection 7b72 or 7iv7 ! in=mation is ( ! type conta9$ 9 raw datasets4 7e7 ,updates to drug li/+ in=mation ,a sponsor :o makes a *ange to a drug subject to ?is section %all submit updat$ drug li/+ in=mation = ! drug 9 accordance ) section #eaj7;j7 )9 #cj cal5d> days ( ! date :5 ! drug is fir/ comm]cially m>ket$1 except t a sponsor :o 0 ! ord] reque/or ) respect to an ord] subject to subsection 7b77#e77;,c7 7or a lic5see1 assignee1 or successor 9 int]e/ ( su* reque/or7 %all submit updat$ drug li/+ in=mation on or be=e ! date :5 ! drug is fir/ comm]cially m>ket$4 7f7 ,approvals "u section #eje ,! provisions ( ?is section %all n be con/ru$ to preclude a p]son f seek+ or ma9ta9+ ! approval ( an application = a drug "u sections #eje7;b77#a71 #eje7;b77#b71 & #eje7;j74 ,a det]m9ation "u ?is section t a drug is n subject to section #ejc7;b77#a71 is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 & is n a new drug "u section #bja7p7 %all con/itute a f9d+ t ! drug is safe & effective t may be reli$ ^u = purposes ( an application "u section #eje7;b77#b71 s t ! applicant %all be requir$ to submit = purposes ( su* application only in=mation ne$$ to support any modification ( ! drug t is n cov]$ by su* det]m9ation "u ?is section4 7g7 ,public availability ( adm9i/rative ord]s ,! ,secret>y %all e/abli%1 ma9ta91 update 7z det]m9$ necess>y by ! ,secret>y b no less frequ5tly ?an annually71 & make publicly available1 ) respect to ord]s issu$ "u ?is section-- 7#a7 a repository ( ea* f9al ord] & int]im f9al ord] 9 effect1 includ+ ! complete text ( ! ord]2 & 7#b7 a li/+ ( all ord]s propos$ & "u developm5t "u subsection 7b77#b71 includ+-- 7,a7 a brief description ( ea* su* ord]2 & 7,b7 ! ,secret>y's expectations1 if res\rces p]mit1 = issuance ( propos$ ord]s ov] a #c-ye> p]iod4 7h7 ,developm5t advice to sponsors or reque/ors ,! ,secret>y %all e/abli% proc$ures "u :i* sponsors or reque/ors may meet ) appropriate (ficials ( ! ,food & ,drug ,adm9i/ration to obta9 advice on ! /udies & o!r in=mation necess>y to support submissions "u ?is section & o!r matt]s relevant to ! regulation ( nonprescription drugs & ! developm5t ( new nonprescription drugs "u ?is section4 7i7 ,p>ticipation ( multiple sponsors or reque/ors ,! ,secret>y %all e/abli% proc$ures to facilitate effici5t p>ticipation by multiple sponsors or reque/ors 9 proce$+s "u ?is section1 includ+ provision = jo9t meet+s ) multiple sponsors or reque/ors or ) organizations nom9at$ by sponsors or reque/ors to repres5t _! int]e/s 9 a proce$+4 7j7 ,electronic =mat ,all submissions "u ?is section %all be 9 electronic =mat4 7k7 ,effect on exi/+ regulations gov]n+ nonprescription drugs 7#a7 ,regulations ( g5]al applicability to nonprescription drugs ,except z provid$ 9 ?is subsection1 no?+ 9 ?is section sup]s$es regulations e/abli%+ g5]al requirem5ts = nonprescription drugs1 includ+ regulations ( g5]al applicability conta9$ 9 p>ts #bja1 #bej1 & #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 or any successor regulations4 ,! ,secret>y %all e/abli% or modify su* regulations by means ( rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,regulations e/abli%+ requirem5ts = specific nonprescription drugs 7,a7 ,! provisions ( section #caj4ede ( title #ba1 ,code ( ,f$]al ,regulations1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section1 %all be deem$ to be a f9al ord] "u subsection 7b74 7,b7 ,regulations 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section1 e/abli%+ requirem5ts = specific nonprescription drugs m>ket$ pursuant to ?is section 7includ+ su* requirem5ts 9 p>ts #bja & #bej ( title #ba1 ,code ( ,f$]al ,regulations71 %all be deem$ to be f9al ord]s "u subsection 7b71 only z !y apply to drugs-- 7i7 subject to p>agraph 7#a71 7#b71 7#c71 or 7#d7 ( subsection 7a72 or 7ii7 o!rwise subject to an ord] "u ?is section4 7#c7 ,)drawal ( regulations ,! ,secret>y %all )draw regulations e/abli%+ f9al monographs & ! proc$ures gov]n+ ! ov]-!-c\nt] drug review "u "p #ccj & o!r relevant p>ts ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section71 or make te*nical *anges to su* regulations to ensure con=mity ) appropriate t]m9ology & cross ref]5ces4 ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 any su* )drawal or te*nical *anges %all be made )\t public notice & comm5t & %all be effective ^u publication ?r\gh notice 9 ! ,f$]al ,regi/] 7or ^u su* date z specifi$ 9 su* notice74 7l7 ,guidance ,! ,secret>y %all issue guidance t specifies-- 7#a7 ! proc$ures & pr9ciples = =mal meet+s betwe5 ! ,secret>y & sponsors or reque/ors = drugs subject to ?is section2 7#b7 ! =mat & cont5t ( data submissions to ! ,secret>y "u ?is section2 7#c7 ! =mat ( electronic submissions to ! ,secret>y "u ?is section2 7#d7 consolidat$ proce$+s = appeal & ! proc$ures = su* proce$+s :]e appropriate2 & 7#e7 = m9or *anges 9 drugs1 recomm5dations on h[ to comply ) ! requirem5ts 9 ord]s issu$ "u subsection 7c77#c74 7m7 ,rule ( con/ruction 7#a7 ,9 g5]al ,?is section %all n affect ! treatm5t or /atus ( a nonprescription drug-- 7,a7 t is m>ket$ )\t an application approv$ "u section #eje z ( ! date ( ! enactm5t ( ?is section2 7,b7 t is n subject to an ord] issu$ "u ?is section2 & 7,c7 to :i* p>agraphs 7#a71 7#b71 7#c71 7#d71 or 7#e7 ( subsection 7a7 d n apply4 7#b7 ,treatm5t ( products previ\sly f\nd to be subject to "t & ext5t requirem5ts 7,a7 ,not)/&+ subsection 7a71 a drug describ$ 9 subp>agraph 7,b7 may only be lawfully m>ket$1 )\t an application approv$ "u section #eje1 pursuant to an ord] issu$ "u ?is section4 7,b7 ,a drug describ$ 9 ?is subp>agraph is a drug :i*1 prior to ! date ( ! enactm5t ( ?is section1 ! ,secret>y det]m9$ 9 a propos$ or f9al rule to be ineligible = review "u ! ,,otc drug review 7z su* phrase ,,otc drug review 0 us$ 9 section #ccj4ad ( title #ba1 ,code ( ,f$]al ,regulations1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section74 7#c7 ,pres]vation ( au?ority 7,a7 ,no?+ 9 p>agraph 7#a7 %all be con/ru$ to preclude or limit ! applicability ( any provision ( ?is ,act o!r ?an ?is section4 7,b7 ,no?+ 9 subsection 7a7 %all be con/ru$ to prohibit ! ,secret>y f issu+ an ord] "u ?is section f9d+ a drug to be n g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 z ! ,secret>y det]m9es appropriate4 7n7 ,inve/igational new drugs ,a drug is n subject to ?is section if an exemption = inve/igational use "u section #eje7;i7 is 9 effect = su* drug4 7o7 ,inapplicability ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to collections ( in=mation made "u ?is section4 7p7 ,inapplicability ( notice & comm5t rulemak+ & o!r requirem5ts ,! requirem5ts ( subsection 7b7 %all apply ) respect to ord]s issu$ "u ?is section in/ead ( ! requirem5ts ( sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7q7 ,def9itions ,9 ?is section3 7#a7 ,! t]m nonprescription drug ref]s to a drug n subject to ! requirem5ts ( section #ejc7;b77#a74 7#b7 ,! t]m sponsor ref]s to any p]son m>ket+1 manufactur+1 or process+ a drug t-- 7,a7 is li/$ pursuant to section #eaj7;j72 & 7,b7 is or w be subject to an adm9i/rative ord] "u ?is section ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,! t]m reque/or ref]s to any p]son or gr\p ( p]sons m>ket+1 manufactur+1 process+1 or develop+ a drug4 4 7b7 ,,gao /udy ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a /udy to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate address+ ! effectiv5ess & ov]all impact ( exclusivity "u section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 & section #ehf;,c ( su* ,act 7#ba ,u4,s4,c4 #cfj;fff-#c71 includ+ ! impact ( su* exclusivity on consum] access4 ,su* /udy %all include-- 7#a7 an analysis ( ! impact ( exclusivity "u su* section #eje;,g = nonprescription drug products1 includ+-- 7,a7 ! numb] ( nonprescription drug products t 7 grant$ exclusivity & ! indication = :i* ! nonprescription drug products 7 det]m9$ to be g5]ally recogniz$ z safe & effective2 7,b7 :e!r ! exclusivity = su* drug products 0 grant$ =-- 7i7 a new active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t72 or 7ii7 *anges 9 ! conditions ( use ( a drug1 = :i* new human data /udies conduct$ or sponsor$ by ! reque/or 7 ess5tial2 7,c7 :e!r1 & to :at ext5t1 ! exclusivity impact$ ! reque/or's or sponsor's decision to develop ! drug product2 7,d7 an analysis ( ! implem5tation ( ! exclusivity provision 9 su* section #eje;,g1 includ+-- 7i7 ! res\rces us$ by ! ,food & ,drug ,adm9i/ration2 7ii7 ! impact ( su* provision on innovation1 z well z rese>* & developm5t 9 ! nonprescription drug m>ket2 7iii7 ! impact ( su* provision on competition 9 ! nonprescription drug m>ket2 7iv7 ! impact ( su* provision on consum] access to nonprescription drug products2 7v7 ! impact ( su* provision on ! prices ( nonprescription drug products2 & 7vi7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #eje;,g h be5 suffici5t to enc\rage ! developm5t ( nonprescription drug products t w\ld likely n be o!rwise develop$1 or develop$ 9 z timely a mann]2 & 7,e7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #eje;,g h be5 suffici5t inc5tive to enc\rage innovation 9 ! nonprescription drug m>ket2 & 7#b7 an analysis ( ! impact ( exclusivity "u su* section #ehf;,c = sunscre5 +r$i5ts1 includ+-- 7,a7 ! numb] ( sunscre5 +r$i5ts t 7 grant$ exclusivity & ! specific +r$i5t t 0 det]m9$ to be g5]ally recogniz$ z safe & effective2 7,b7 :e!r1 & to :at ext5t1 ! exclusivity impact$ ! reque/or's or sponsor's decision to develop ! sunscre5 +r$i5t2 7,c7 :e!r1 & to :at ext5t1 ! sunscre5 +r$i5t grant$ exclusivity _h previ\sly be5 available outside ( ! ,unit$ ,/ates2 7,d7 an analysis ( ! implem5tation ( ! exclusivity provision 9 su* section #ehf;,c1 includ+-- 7i7 ! res\rces us$ by ! ,food & ,drug ,adm9i/ration2 7ii7 ! impact ( su* provision on innovation1 z well z rese>* & developm5t 9 ! sunscre5 m>ket2 7iii7 ! impact ( su* provision on competition 9 ! sunscre5 m>ket2 7iv7 ! impact ( su* provision on consum] access to sunscre5 products2 7v7 ! impact ( su* provision on ! prices ( sunscre5 products2 & 7vi7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #eje;,g h be5 utiliz$ by sunscre5 +r$i5t sponsors & :e!r su* process has be5 suffici5t to enc\rage ! developm5t ( sunscre5 +r$i5ts t w\ld likely n be o!rwise develop$1 or develop$ 9 z timely a mann]2 & 7,e7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #ehf;,c h be5 suffici5t inc5tive to enc\rage innovation 9 ! sunscre5 m>ket4 7c7 ,con=m+ am5dm5t ,section #gea7;d77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgir7d77#a77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7 by /rik+ f9al regulation promulgat$ & ins]t+ f9al ord] "u section #eje;,g2 & 7,b7 by /rik+ & n misbr&$2 & 7#b7 9 subp>agraph 7,a71 by /rik+ regulation 9 effect & ins]t+ regulation or ord] 9 effect4 #ajjb4 ,misbr&+ ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7ee7 ,if x is a nonprescription drug t is subject to section #eje;,g1 is n ! subject ( an application approv$ "u section #eje1 & does n comply ) ! requirem5ts "u section #eje;,g4 7ff7 ,if x is a drug & x 0 manufactur$1 prep>$1 propagat$1 comp\nd$1 or process$ 9 a facility = :i* fees h n be5 paid z requir$ by section #gdd,m4 4 #ajjc4 ,drugs exclud$ f ! ov]-!-c\nt] drug review 7a7 ,9 g5]al ,no?+ 9 ?is ,act 7or ! am5dm5ts made by ?is ,act7 %all apply to any nonprescription drug 7z def9$ 9 section #eje;,g7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act7 :i* 0 exclud$ by ! ,food & ,drug ,adm9i/ration f ! ,ov]-!-,c\nt] ,drug ,review 9 accordance ) ! p>agraph numb]$ #be on page #idff ( volume #cg ( ! ,f$]al ,regi/]1 publi%$ on ,may #aa1 #aigb4 7b7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to preclude or limit ! applicability ( any o!r provision ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #ajjd4 ,treatm5t ( ,sunscre5 ,innovation ,act 7a7 ,review ( nonprescription sunscre5 active +r$i5ts 7#a7 ,applicability ( section #eje;,g = p5d+ submissions 7,a7 ,9 g5]al ,a sponsor ( a nonprescription sunscre5 active +r$i5t or comb9ation ( nonprescription sunscre5 active +r$i5ts t1 z ( ! date ( enactm5t ( ?is ,act1 is subject to a propos$ sunscre5 ord] "u section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 may elect1 by means ( giv+ writt5 notification to ! ,secret>y ( ,heal? & ,human ,s]vices )9 #ahj cal5d> days ( ! enactm5t ( ?is ,act1 to transition into ! review ( su* +r$i5t or comb9ation ( +r$i5ts pursuant to ! process set out 9 section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act4 7,b7 ,election ex]cis$ ,^u receipt by ! ,secret>y ( ,heal? & ,human ,s]vices ( a timely notification "u subp>agraph 7,a7-- 7i7 ! propos$ sunscre5 ord] involv$ is deem$ to be a reque/ = an ord] "u subsection 7b7 ( section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act2 & 7ii7 su* ord] is deem$ to h be5 accept$ = fil+ "u subsection 7b77#f77;,a77i7 ( su* section #eje;,g4 7,c7 ,election n ex]cis$ ,if a notification "u subp>agraph 7,a7 is n receiv$ by ! ,secret>y ( ,heal? & ,human ,s]vices )9 #ahj cal5d> days ( ! date ( enactm5t ( ?is ,act1 ! review ( ! propos$ sunscre5 ord] describ$ 9 subp>agraph 7,a7-- 7i7 %all cont9ue "u section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c72 & 7ii7 %all n be eligible = review "u section #eje;,g1 add$ by section #ajja ( ?is ,act4 7#b7 ,def9itions ,9 ?is subsection1 ! t]ms sponsor1 nonprescription1 sunscre5 active +r$i5t1 & propos$ sunscre5 ord] h ! mean+s giv5 to ^? t]ms 9 section #ehf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff74 7b7 ,am5dm5ts to sunscre5 provisions 7#a7 ,f9al sunscre5 ord]s ,p>agraph 7#c7 ( section #ehf;,c7e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;e77 is am5d$ to read z foll[s3 7#c7 ,relation%ip to ord]s "u section #eje;,g ,a f9al sunscre5 ord] %all be deem$ to be a f9al ord] "u section #eje;,g4 4 7#b7 ,meet+s ,p>agraph 7#g7 ( section #ehf;,c7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;b77 is am5d$-- 7,a7 by /rik+ ,a sponsor may reque/ & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,a sponsor may reque/ 2 & 7,b7 by add+ at ! end ! foll[+3 7,b7 ,confid5tial meet+s ,a sponsor may reque/ "o or m confid5tial meet+s ) respect to a propos$ sunscre5 ord]1 includ+ a lett] deem$ to be a propos$ sunscre5 ord] "u p>agraph 7#c71 to discuss matt]s relat+ to data requirem5ts to support a g5]al recognition ( safety & effectiv5ess involv+ confid5tial in=mation & public in=mation relat$ to su* propos$ sunscre5 ord]1 z appropriate4 ,! ,secret>y %all conv5e a confid5tial meet+ ) su* sponsor 9 a reasonable "t p]iod4 ,if a sponsor reque/s m ?an "o confid5tial meet+ = ! same propos$ sunscre5 ord]1 ! ,secret>y may refuse to grant an additional confid5tial meet+ reque/ if ! ,secret>y det]m9es t su* additional confid5tial meet+ is n reasonably necess>y = ! sponsor to advance its propos$ sunscre5 ord]1 or if ! reque/ = a confid5tial meet+ fails to include suffici5t in=mation ^u :i* to base a sub/antive discussion4 ,! ,secret>y %all publi% a po/-meet+ summ>y ( ea* confid5tial meet+ "u ?is subp>agraph t does n disclose confid5tial comm]cial in=mation or trade secrets4 ,?is subp>agraph does n au?orize ! disclosure ( confid5tial comm]cial in=mation or trade secrets subject to #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 7#c7 ,exclusivity ,section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,exclusivity 7#a7 ,9 g5]al ,a f9al sunscre5 ord] %all h ! effect ( au?oriz+ solely ! ord] reque/or 7or ! lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* reque/ & li/$ "u p>agraph 7#e77 = a p]iod ( #ah mon?s1 to m>ket a sunscre5 +r$i5t "u ?is section incorporat+ *anges describ$ 9 p>agraph 7#b7 subject to ! limitations "u p>agraph 7#d71 beg9n+ on ! date ! reque/or 7or any lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* reque/ & li/$ "u p>agraph 7#e77 may lawfully m>ket su* sunscre5 +r$i5t pursuant to ! ord]4 7#b7 ,*anges describ$ ,a *ange describ$ 9 ?is p>agraph is a *ange subject to an ord] specifi$ 9 p>agraph 7#a7 t p]mits a sunscre5 to conta9 an active sunscre5 +r$i5t n previ\sly incorporat$ 9 a m>ket$ sunscre5 li/$ 9 p>agraph 7#c74 7#c7 ,m>ket$ sunscre5 ,! m>ket$ sunscre5 +r$i5ts describ$ 9 ?is p>agraph are sunscre5 +r$i5ts-- 7,a7 m>ket$ 9 accordance ) a f9al monograph = sunscre5 drug products set =? at "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations 7z publi%$ at #fd ,f$4 ,reg4 #bgfhg72 or 7,b7 m>ket$ 9 accordance ) a f9al ord] issu$ "u ?is section4 7#d7 ,limitations on exclusivity ,only "o #ah-mon? p]iod may be grant$ p] +r$i5t "u p>agraph 7#a74 7#e7 ,li/+ ( lic5sees1 assignees1 or successors 9 int]e/ ,reque/ors %all submit to ! ,secret>y at ! "t :5 a drug subject to su* reque/ is introduc$ or deliv]$ = introduction into int]/ate comm]ce1 a li/ ( lic5sees1 assignees1 or successors 9 int]e/ "u p>agraph 7#a74 4 7#d7 ,sunset provision ,sub*apt] ,i ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff et seq47 is am5d$ by add+ at ! end ! foll[+3 #ehf;,h4 ,sunset ,?is sub*apt] %all cease to be effective at ! end ( fiscal ye> #bjbb4 4 7#e7 ,treatm5t ( f9al sunscre5 ord] ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by /rik+ section #ehf;,e ( su* ,act 7#ba ,u4,s4,c4 #cfj;fff-#e74 7c7 ,treatm5t ( ,au?ority ,reg>d+ ,f9alization ( ,sunscre5 ,monograph 7#a7 ,9 g5]al 7,a7 ,revision ( f9al sunscre5 ord] ,n lat] ?an ,novemb] #bf1 #bjai1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all am5d & revise ! f9al adm9i/rative ord] conc]n+ nonprescription sunscre5 7ref]r$ to 9 ?is subsection z ! sunscre5 ord]7 = :i* ! cont5t1 prior to ! date ( enactm5t ( ?is ,act1 0 repres5t$ by ! f9al monograph = sunscre5 drug products set =? 9 "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect on ,may #ba1 #aiii74 7,b7 ,issuance ( revis$ sunscre5 ord]2 effective date ,a revis$ sunscre5 ord] describ$ 9 subp>agraph 7,a7 %all be-- 7i7 issu$ 9 accordance ) ! proc$ures describ$ 9 section #eje;,g7c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7ii7 issu$ 9 propos$ =m n lat] ?an ,may #bh1 #bjai2 7iii7 effective n lat] ?an ,novemb] #bf1 #bjbj2 & 7iv7 issu$ by ! ,secret>y at lea/ #a ye> prior to ! effective date ( ! revis$ ord]4 7#b7 ,reports ,if a revis$ sunscre5 ord] issu$ "u p>agraph 7#a7 does n include provisions relat$ to ! effectiv5ess ( v>i\s sun protection factor levels1 & does n address all dosage =ms kn[n to ! ,secret>y to be us$ 9 sunscre5s m>ket$ 9 ! ,unit$ ,/ates )\t a new drug application approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 ! ,secret>y %all submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate on ! rationale = omission ( su* provisions f su* ord]1 & a plan & timel9e to compile any in=mation necess>y to address su* provisions ?r\gh su* ord]4 7d7 ,treatm5t ( non-sunscre5 "t & ext5t applications 7#a7 ,9 g5]al ,any application describ$ 9 section #ehf;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#f7 t 0 submitt$ to ! ,secret>y pursuant to section #ccj4ad ( title #ba1 ,code ( ,f$]al ,regulations1 z su* provisions 7 9 effect imm$iately prior to ! date ( enactm5t date ( ?is ,act1 %all be ext+ui%$ z ( su* date ( enactm5t1 subject to p>agraph 7#b74 7#b7 ,ord] reque/ ,no?+ 9 p>agraph 7#a7 precludes ! submission ( an ord] reque/ "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act1 ) respect to a drug t 0 ! subject ( an application ext+ui%$ "u p>agraph 7#a74 #ajje4 ,annual update to ,congress on appropriate p$iatric indication = c]ta9 ,,otc c\gh & cold drugs 7a7 ,9 g5]al ,subject to subsection 7c71 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 annually submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a lett] describ+ ! progress ( ! ,food & ,drug ,adm9i/ration-- 7#a7 9 evaluat+ ! c\gh & cold monograph describ$ 9 subsection 7b7 ) respect to *ildr5 "u age #f2 & 7#b7 z appropriate1 revis+ su* c\gh & cold monograph to address su* *ildr5 ?r\gh ! ord] process "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act4 7b7 ,c\gh & cold monograph describ$ ,! c\gh & cold monograph describ$ 9 ?is subsection consi/s ( ! conditions "u :i* nonprescription drugs conta9+ antitussive1 expectorant1 nasal deconge/ant1 or antihi/am9e active +r$i5ts 7or comb9ations !re(7 are g5]ally recogniz$ z safe & effective1 z specifi$ 9 "p #cda ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect imm$iately prior to ! date ( enactm5t ( ?is ,act71 & includ$ 9 an ord] deem$ to be e/abli%$ "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #ajja ( ?is ,act4 7c7 ,duration ( au?ority ,! requirem5t "u subsection 7a7 %all t]m9ate z ( ! date ( a lett] submitt$ by ! ,secret>y ( ,heal? & ,human ,s]vices pursuant to su* subsection 9 :i* ! ,secret>y indicates t ! ,food & ,drug ,adm9i/ration has complet$ its evaluation & revis$1 9 a f9al ord]1 z applicable1 ! c\gh & cold monograph z describ$ 9 subsection 7a77#b74 #ajjf4 ,te*nical corrections 7a7 ,imports & exports ,section #hja7;e77#d77;,e77iii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77;,e77iii77 is am5d$ by /rik+ subp>agraph ea* place su* t]m appe>s & ins]t+ p>agraph4 7b7 ,,fda ,reau?orization ,act ( #bjag 7#a7 ,9 g5]al ,section #ije7;b77#d7 ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law#aae-eb7 is am5d$ by /rik+ ,section #gdd;,h7e77#b77;,b7 & ins]t+ ,section #gdd;,h7f77#b77;,b74 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all take effect z ( ! enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb74 ,,ii ,us] ,fees #bjja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,ov]-!-,c\nt] ,monograph ,us] ,fee ,act ( #bjai4 7b7 ,f9d+ ,! ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ to ,,otc monograph drug activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #aj ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjjb4 ,fees relat+ to ov]-!-c\nt] drugs ,sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is am5d$ by ins]t+ aft] "p #i ! foll[+3 #aj ,fees ,relat+ to ,ov]-!-,c\nt] ,drugs #gdd,l4 ,def9itions ,9 ?is "p3 7#a7 ,! t]m affiliate means a bus9ess entity t has a relation%ip ) a second bus9ess entity if1 directly or indirectly-- 7,a7 "o bus9ess entity controls1 or has ! p[] to control1 ! o!r bus9ess entity2 or 7,b7 a ?ird p>ty controls1 or has p[] to control1 bo? ( ! bus9ess entities4 7#b7 ,! t]m contract manufactur+ organization facility means an ,,otc monograph drug facility :]e nei!r ! own] ( su* manufactur+ facility nor any affiliate ( su* own] or facility sells ! ,,otc monograph drug produc$ at su* facility directly to :olesal]s1 retail]s1 or consum]s 9 ! ,unit$ ,/ates4 7#c7 ,! t]m co/s ( res\rces allocat$ = ,,otc monograph drug activities means ! exp5ses 9 connection ) ,,otc monograph drug activities =-- 7,a7 (fic]s & employees ( ! ,food & ,drug ,adm9i/ration1 contractors ( ! ,food & ,drug ,adm9i/ration1 advisory committees1 & co/s relat$ to su* (fic]s1 employees1 & committees & co/s relat$ to contracts ) su* contractors2 7,b7 managem5t ( in=mation1 & ! acquisition1 ma9t5ance1 & repair ( comput] res\rces2 7,c7 leas+1 ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture1 sci5tific equipm5t1 & o!r necess>y mat]ials & supplies2 & 7,d7 collect+ fees "u section #gdd,m & acc\nt+ = res\rces allocat$ = ,,otc monograph drug activities4 7#d7 ,! t]m ,,fda e/abli%m5t id5tifi] is ! unique numb] automatically g5]at$ by ,food & ,drug ,adm9i/ration's ,field ,accompli%m5ts & ,compliance ,track+ ,sy/em 7,,facts7 7or any successor sy/em74 7#e7 ,! t]m ,,otc monograph drug means a nonprescription drug )\t an approv$ new drug application :i* is gov]n$ by ! provisions ( section #eje;,g4 7#f7 ,! t]m ,,otc monograph drug activities means activities ( ! ,secret>y associat$ ) ,,otc monograph drugs & inspection ( facilities associat$ ) su* products1 includ+ ! foll[+ activities3 7,a7 ,! activities necess>y = review & evaluation ( ,,otc monographs & ,,otc monograph ord] reque/s1 includ+-- 7i7 ord]s propos+ or f9aliz+ applicable conditions ( use = ,,otc monograph drugs2 7ii7 ord]s affect+ /atus reg>d+ g5]al recognition ( safety & effectiv5ess ( an ,,otc monograph +r$i5t or comb9ation ( +r$i5ts "u specifi$ conditions ( use2 7iii7 all ,,otc monograph drug developm5t & review activities1 includ+ intra-ag5cy collaboration2 7iv7 regulation & policy developm5t activities relat$ to ,,otc monograph drugs2 7v7 developm5t ( product /&>ds = products subject to review & evaluation2 7vi7 meet+s ref]r$ to 9 section #eje;,g7i72 7vii7 review ( label+ prior to issuance ( ord]s relat$ to ,,otc monograph drugs or conditions ( use2 & 7viii7 regulatory sci5ce activities relat$ to ,,otc monograph drugs4 7,b7 ,inspections relat$ to ,,otc monograph drugs4 7,c7 ,monitor+ ( cl9ical & o!r rese>* conduct$ 9 connection ) ,,otc monograph drugs4 7,d7 ,safety activities ) respect to ,,otc monograph drugs1 includ+-- 7i7 collect+1 develop+1 & review+ safety in=mation on ,,otc monograph drugs1 includ+ adv]se ev5t reports2 7ii7 develop+ & us+ improv$ adv]se ev5t data-collection sy/ems1 includ+ in=mation te*nology sy/ems2 & 7iii7 develop+ & us+ improv$ analytical tools to assess pot5tial safety risks1 includ+ access to ext]nal databases4 7,e7 ,o!r activities necess>y = implem5tation ( section #eje;,g4 7#g7 ,! t]m ,,otc monograph ord] reque/ means a reque/ = an ord] submitt$ "u section #eje;,g7b77#e74 7#h7 ,! t]m ,ti] #a ,,otc monograph ord] reque/ means any ,,otc monograph ord] reque/ n det]m9$ to be a ,ti] #b ,,otc monograph ord] reque/4 7#i7 7,a7 ,! t]m ,ti] #b ,,otc monograph ord] reque/ means1 subject to subp>agraph 7,b71 an ,,otc monograph ord] reque/ =-- 7i7 ! reord]+ ( exi/+ in=mation 9 ! drug facts label ( an ,,otc monograph drug2 7ii7 ! addition ( in=mation to ! o!r in=mation section ( ! drug facts label ( an ,,otc monograph drug1 z limit$ by section #bja4ff7;c77#g7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7iii7 modification to ! directions = use section ( ! drug facts label ( an ,,otc monograph drug1 if su* *anges con=m to *anges made pursuant to section #eje;,g7c77#c77;,a72 7iv7 ! /&>dization ( ! conc5tration or dose ( a specific f9aliz$ +r$i5t )9 a p>ticul> f9aliz$ monograph2 7v7 a *ange to +r$i5t nom5clature to align ) nom5clature ( a /&>ds-sett+ organization2 or 7vi7 addition ( an int]*angeable t]m 9 accordance ) section #ccj4a ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,b7 ,! ,secret>y may1 bas$ on program implem5tation exp]i5ce or o!r factors f\nd appropriate by ! ,secret>y1 *>act]ize any ,,otc monograph ord] reque/ z a ,ti] #b ,,otc monograph ord] reque/ 7includ+ re*>act]iz+ a reque/ f ,ti] #a to ,ti] #b7 & publi% su* det]m9ation 9 a propos$ ord] issu$ pursuant to section #eje;,g4 7#aj7 7,a7 ,! t]m ,,otc monograph drug facility means a =eign or dome/ic bus9ess or o!r entity t-- 7i7 is-- 7,i7 "u "o managem5t1 ei!r direct or indirect2 & 7,,ii7 at "o geographic location or address engag$ 9 manufactur+ or process+ ! f9i%$ dosage =m ( an ,,otc monograph drug2 7ii7 includes a f9i%$ dosage =m manufactur] facility 9 a contractual relation%ip ) ! sponsor ( "o or m ,,otc monograph drugs to manufacture or process su* drugs2 & 7iii7 does n include a bus9ess or o!r entity ^: only manufactur+ or process+ activities are "o or m ( ! foll[+3 production ( cl9ical rese>* supplies1 te/+1 or placem5t ( out] packag+ on packages conta9+ multiple products1 = su* purposes z creat+ multipacks1 :5 ea* monograph drug product conta9$ )9 ! ov]packag+ is already 9 a f9al packag$ =m prior to placem5t 9 ! out] ov]packag+4 7,b7 ,= purposes ( subp>agraph 7,a77i77,,ii71 sep>ate build+s or locations )9 close proximity are consid]$ to be at "o geographic location or address if ! activities conduct$ 9 su* build+s or locations are-- 7i7 closely relat$ to ! same bus9ess ent]prise2 7ii7 "u ! sup]vision ( ! same local managem5t2 & 7iii7 "u a s+le ,,fda e/abli%m5t id5tifi] & capable ( be+ inspect$ by ! ,food & ,drug ,adm9i/ration dur+ a s+le inspection4 7,c7 ,if a bus9ess or o!r entity w\ld meet crit]ia specifi$ 9 subp>agraph 7,a71 b = be+ "u multiple managem5t1 ! bus9ess or o!r entity is deem$ to con/itute multiple facilities1 "o p] managem5t entity1 = purposes ( ?is p>agraph4 7#aa7 ,! t]m ,,otc monograph drug meet+ means any meet+ reg>d+ ! cont5t ( a propos$ ,,otc monograph ord] reque/4 7#ab7 ,! t]m p]son includes an affiliate ( a p]son4 7#ac7 ,! t]ms reque/or & sponsor h ! mean+s giv5 su* t]ms 9 section #eje;,g4 #gdd,m4 ,au?ority to assess & use ,,otc monograph fees 7a7 ,types ( fees ,beg9n+ ) fiscal ye> #bjai1 ! ,secret>y %all assess & collect fees 9 accordance ) ?is section z foll[s3 7#a7 ,facility fee 7,a7 ,9 g5]al ,ea* p]son t owns a facility id5tifi$ z an ,,otc monograph drug facility on ,decemb] #ca ( ! fiscal ye> or at any "t dur+ ! prec$+ #ab-mon? p]iod %all be assess$ an annual fee = ea* su* facility z det]m9$ "u subsection 7c74 7,b7 ,exceptions 7i7 ,a fee %all n be assess$ "u subp>agraph 7,a7 if ! id5tifi$ ,,otc monograph drug facility-- 7,i7 has ceas$ all activities relat$ to ,,otc monograph drugs prior to ,janu>y #ca1 #bjai1 = ! fir/ program ye>1 & ,decemb] #ca ( ! fiscal ye> = subsequ5t fiscal ye>s2 & 7,,ii7 has updat$ its regi/ration to reflect su* *ange "u ! requirem5ts = drug e/abli%m5t regi/ration set =? 9 section #eaj4 7ii7 ,! am\nt ( ! fee = a contract manufactur+ organization facility %all be equal to two-?irds ( ! am\nt ( ! fee = an ,,otc monograph drug facility t is n a contract manufactur+ organization facility4 7,c7 ,am\nt ,! am\nt ( fees e/abli%$ "u subp>agraph 7,a7 %all be e/abli%$ "u subsection 7c74 7,d7 ,due date 7i7 ,= fir/ program ye> ,= fiscal ye> #bjai1 ! facility fees requir$ "u subp>agraph 7,a7 %all be due #de cal5d> days aft] publication ( ! ,f$]al ,regi/] notice provid$ = "u subsection 7c77#d77;,a74 7ii7 ,subsequ5t fiscal ye>s ,= ea* fiscal ye> aft] fiscal ye> #bjai1 ! facility fees requir$ "u subp>agraph 7,a7 %all be due on ! lat] (-- 7,i7 ! fir/ bus9ess day ( ,june ( su* ye>2 or 7,,ii7 ! fir/ bus9ess day aft] ! enactm5t ( an appropriations ,act provid+ = ! collection & obligation ( fees "u ?is section = su* ye>4 7#b7 ,,otc monograph ord] reque/ fee 7,a7 ,9 g5]al ,ea* p]son t submits an ,,otc monograph ord] reque/ %all be subject to a fee = an ,,otc monograph ord] reque/4 ,! am\nt ( su* fee %all be-- 7i7 = a ,ti] #a ,,otc monograph ord] reque/1 #ejj1jjj1 adju/$ = inflation = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a77;,b772 & 7ii7 = a ,ti] #b ,,otc monograph ord] reque/1 #ajj1jjj adju/$ = inflation = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a77;,b774 7,b7 ,due date ,! ,,otc monograph ord] reque/ fees requir$ "u subp>agraph 7,a7 %all be due on ! date ( submission ( ! ,,otc monograph ord] reque/4 7,c7 ,exception = c]ta9 safety *anges ,a p]son :o is nam$ z ! reque/or 9 an ,,otc monograph ord] %all n be subject to a fee "u subp>agraph 7,a7 if ! ,secret>y f9ds t ! ,,otc monograph ord] reque/ seeks to *ange ! drug facts label+ ( an ,,otc monograph drug 9 a way t w\ld add to or /r5g!n-- 7i7 a contra9dication1 w>n+1 or precaution2 7ii7 a /atem5t ab\t risk associat$ ) misuse or abuse2 or 7iii7 an in/ruction ab\t dosage & adm9i/ration t is int5d$ to increase ! safe use ( ! ,,otc monograph drug4 7,d7 ,refund ( fee if ord] reque/ is recategoriz$ z a ,ti] #b ,,otc monograph ord] reque/ ,if ! ,secret>y det]m9es t an ,,otc monograph reque/ initially *>act]iz$ z ,ti] #a %all be re-*>act]iz$ z a ,ti] #b ,,otc monograph ord] reque/1 & ! reque/or has paid a ,ti] #a fee 9 accordance ) subp>agraph 7,a77i71 ! ,secret>y %all refund ! reque/or ! diff]5ce betwe5 ! ,ti] #a & ,ti] #b fees det]m9$ "u subp>agraphs 7,a77i7 & 7,a77ii71 respectively4 7,e7 ,refund ( fee if ord] reque/ refus$ = fil+ or )drawn be=e fil+ ,! ,secret>y %all refund #ge p]c5t ( ! fee paid "u subp>agraph 7,b7 = any ord] reque/ :i* is refus$ = fil+ or 0 )drawn be=e be+ accept$ or refus$ = fil+4 7,f7 ,fees = ord] reque/s previ\sly refus$ = fil+ or )drawn be=e fil+ ,an ,,otc monograph ord] reque/ t 0 submitt$ b 0 refus$ = fil+1 or 0 )drawn be=e be+ accept$ or refus$ = fil+1 %all be subject to ! full fee "u subp>agraph 7,a7 ^u be+ resubmitt$ or fil$ ov] prote/4 7,g7 ,refund ( fee if ord] reque/ )drawn ,if an ord] reque/ is )drawn aft] ! ord] reque/ 0 fil$1 ! ,secret>y may refund ! fee or a portion ( ! fee if no sub/antial "w 0 p]=m$ on ! ord] reque/ aft] ! application 0 fil$4 ,! ,secret>y %all h ! sole discretion to refund a fee or a portion ( ! fee "u ?is subp>agraph4 ,a det]m9ation by ! ,secret>y conc]n+ a refund "u ?is subp>agraph %all n be reviewable4 7#c7 ,refunds 7,a7 ,9 g5]al ,o!r ?an refunds provid$ pursuant to any ( subp>agraphs 7,d7 ?r\gh 7,g7 ( p>agraph 7#b71 ! ,secret>y %all n refund any fee paid "u p>agraph 7#a7 except z provid$ 9 subp>agraph 7,b74 7,b7 ,disputes conc]n+ fees ,to qualify = ! return ( a fee claim$ to h be5 paid 9 error "u p>agraph 7#a7 or 7#b71 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* return )9 #ahj cal5d> days aft] su* fee 0 paid4 7#d7 ,notice ,)9 ! timeframe specifi$ 9 subsection 7c71 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! am\nt ( ! fees "u p>agraph 7#a7 = su* fiscal ye>4 7b7 ,fee rev5ue am\nts 7#a7 ,fiscal ye> #bjai ,= fiscal ye> #bjai1 fees "u subsection 7a77#a7 %all be e/abli%$ to g5]ate a total facility fee rev5ue am\nt equal to ! sum (-- 7,a7 ! annual base rev5ue = fiscal ye> #bjai 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#b772 & 7,c7 additional direct co/ adju/m5ts 7z det]m9$ "u subsection 7c77#c774 7#b7 ,subsequ5t fiscal ye>s ,= ea* ( ! fiscal ye>s #bjbj ?r\gh #bjbc1 fees "u subsection 7a77#a7 %all be e/abli%$ to g5]ate a total facility fee rev5ue am\nt equal to ! sum (-- 7,a7 ! annual base rev5ue = ! fiscal ye> 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! inflation adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a772 7,c7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#b772 7,d7 additional direct co/ adju/m5ts 7z det]m9$ "u subsection 7c77#c772 & 7,e7 additional doll> am\nts = ea* fiscal ye> z foll[s3 7i7 #g1jjj1jjj = fiscal ye> #bjbj4 7ii7 #f1jjj1jjj = fiscal ye> #bjba4 7iii7 #g1jjj1jjj = fiscal ye> #bjbb4 7iv7 #c1jjj1jjj = fiscal ye> #bjbc4 7#c7 ,annual base rev5ue ,= purposes ( p>agraphs 7#a77;,a7 & 7#b77;,a71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be-- 7,a7 = fiscal ye> #bjai1 #h1jjj1jjj2 & 7,b7 = fiscal ye>s #bjbj ?r\gh #bjbc1 ! doll> am\nt ( ! total rev5ue am\nt e/abli%$ "u ?is subsection = ! previ\s fiscal ye>1 n includ+ any adju/m5ts made "u subsection 7c77#b7 or 7c77#c74 7c7 ,adju/m5ts2 annual fee sett+ 7#a7 ,inflation adju/m5t 7,a7 ,9 g5]al ,= purposes ( subsection 7b77#b77;,b71 ! doll> am\nt ( ! inflation adju/m5t to ! annual base rev5ue = fiscal ye> #bjbj & ea* subsequ5t fiscal ye> %all be equal to ! product (-- 7i7 su* annual base rev5ue = ! fiscal ye> "u subsection 7b77#b72 & 7ii7 ! inflation adju/m5t p]c5tage "u subp>agraph 7,c74 7,b7 ,,otc monograph ord] reque/ fees ,= purposes ( subsection 7a77#b71 ! doll> am\nt ( ! inflation adju/m5t to ! fee = ,,otc monograph ord] reque/s = fiscal ye> #bjbj & ea* subsequ5t fiscal ye> %all be equal to ! product (-- 7i7 ! applicable fee "u subsection 7a77#b7 = ! prec$+ fiscal ye>2 & 7ii7 ! inflation adju/m5t p]c5tage "u subp>agraph 7,c74 7,c7 ,inflation adju/m5t p]c5tage ,! inflation adju/m5t p]c5tage "u ?is subp>agraph = a fiscal ye> is equal to-- 7i7 = ea* ( fiscal ye>s #bjbj & #bjba1 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ! fir/ #c ye>s ( ! prec$+ #d ye>s ( available data2 & 7ii7 = ea* ( fiscal ye>s #bjbb & #bjbc1 ! sum (-- 7,i7 ! av]age annual p]c5t *ange 9 ! co/1 p] full-"t equival5t position ( ! ,food & ,drug ,adm9i/ration1 ( all p]sonnel comp5sation & b5efits paid ) respect to su* positions = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s1 multipli$ by ! proportion ( p]sonnel comp5sation & b5efits co/s to total co/s ( ,,otc monograph drug activities = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s2 & 7,,ii7 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ! fir/ #c ye>s ( ! prec$+ #d ye>s ( available data multipli$ by ! proportion ( all co/s o!r ?an p]sonnel comp5sation & b5efits co/s to total co/s ( ,,otc monograph drug activities = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s4 7#b7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjai & subsequ5t fiscal ye>s1 = purposes ( subsections 7b77#a77;,b7 & 7b77#b77;,c71 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraph 7#a71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide op]at+ res]ves ( c>ryov] us] fees = ,,otc monograph drug activities = n m ?an ! numb] ( weeks specifi$ 9 subp>agraph 7,b74 7,b7 ,numb] ( weeks ,! numb] ( weeks specifi$ 9 ?is subp>agraph is-- 7i7 #c weeks = fiscal ye> #bjai2 7ii7 #g weeks = fiscal ye> #bjbj2 7iii7 #aj weeks = fiscal ye> #bjba2 7iv7 #aj weeks = fiscal ye> #bjbb2 & 7v7 #aj weeks = fiscal ye> #bjbc4 7,c7 ,decrease ,if ! ,secret>y has c>ryov] balances = su* process 9 excess ( #aj weeks ( ! op]at+ res]ves ref]r$ to 9 subp>agraph 7,a71 ! ,secret>y %all decrease ! fee rev5ue & fees ref]r$ to 9 su* subp>agraph to provide = n m ?an #aj weeks ( su* op]at+ res]ves4 7,d7 ,rationale = adju/m5t ,if an adju/m5t "u ?is p>agraph is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u p>agraph 7#d7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 7#c7 ,additional direct co/ adju/m5t ,! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees = purposes ( subsection 7b77#b77;,d7 by an am\nt equal to-- 7,a7 #ad1jjj1jjj = fiscal ye> #bjai2 7,b7 #g1jjj1jjj = fiscal ye> #bjbj2 7,c7 #d1jjj1jjj = fiscal ye> #bjba2 7,d7 #c1jjj1jjj = fiscal ye> #bjbb2 & 7,e7 #c1jjj1jjj = fiscal ye> #bjbc4 7#d7 ,annual fee sett+ 7,a7 ,fiscal ye> #bjai ,! ,secret>y %all1 n lat] ?an ! second ,monday 9 ,m>* ( #bjai-- 7i7 e/abli% ,,otc monograph drug facility fees = fiscal ye> #bjai "u subsection 7a71 bas$ on ! rev5ue am\nt = su* ye> "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection2 & 7ii7 publi% fee rev5ue1 facility fees1 & ,,otc monograph ord] reque/s 9 ! ,f$]al ,regi/]4 7,b7 ,subsequ5t fiscal ye>s ,! ,secret>y %all1 n lat] ?an ! second ,monday 9 ,m>* ( ea* fiscal ye> t beg9s aft] ,septemb] #cj1 #bjai-- 7i7 e/abli% = ea* su* fiscal ye>1 bas$ on ! rev5ue am\nts "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection-- 7,i7 ,,otc monograph drug facility fees "u subsection 7a77#a72 & 7,,ii7 ,,otc monograph ord] reque/ fees "u subsection 7a77#b72 & 7ii7 publi% su* fee rev5ue am\nts1 facility fees1 & ,,otc monograph ord] reque/ fees 9 ! ,f$]al ,regi/]4 7d7 ,id5tification ( facilities ,ea* p]son t owns an ,,otc monograph drug facility %all submit to ! ,secret>y ! in=mation requir$ "u ?is subsection ea* ye>4 ,su* in=mation %all1 = ea* fiscal ye>-- 7#a7 be submitt$ z "p ( ! requirem5ts = drug e/abli%m5t regi/ration set =? 9 section #eaj2 & 7#b7 include = ea* su* facility1 at a m9imum1 id5tification ( ! facility's bus9ess op]ation z t ( an ,,otc monograph drug facility4 7e7 ,effect ( failure ,to pay fees 7#a7 ,,otc ,monograph ,drug ,facility ,fee 7,a7 ,9 g5]al ,failure to pay ! fee "u subsection 7a77#a7 )9 #bj cal5d> days ( ! due date z specifi$ 9 subp>agraph 7,d7 ( su* subsection %all result 9 ! foll[+3 7i7 ,! ,secret>y %all place ! facility on a publicly available arre>s li/4 7ii7 ,all ,,otc monograph drugs manufactur$ 9 su* a facility or conta9+ an +r$i5t manufactur$ 9 su* a facility %all be deem$ misbr&$ "u section #ejb7;ff74 7,b7 ,application ( p5alties ,! p5alties "u ?is p>agraph %all apply until ! fee e/abli%$ by subsection 7a77#a7 is paid4 7#b7 ,ord] reque/s ,an ,,otc monograph ord] reque/ submitt$ by a p]son subject to fees "u subsection 7a7 %all be consid]$ incomplete & %all n be accept$ = fil+ by ! ,secret>y until all fees ow$ by su* p]son "u ?is section h be5 paid4 7#c7 ,meet+s ,a p]son subject to fees "u ?is section %all be consid]$ ineligible = ,,otc monograph drug meet+s until all su* fees ow$ by su* p]son h be5 paid4 7f7 ,cr$it+ & availability ( fees 7#a7 ,9 g5]al ,fees au?oriz$ "u subsection 7a7 %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts4 ,su* fees are au?oriz$ to rema9 available until exp5d$4 ,su* sums z may be necess>y may be transf]r$ f ! ,food & ,drug ,adm9i/ration sal>ies & exp5ses appropriation acc\nt )\t fiscal ye> limitation to su* appropriation acc\nt = sal>ies & exp5ses ) su* fiscal ye> limitation4 ,! sums transf]r$ %all be available solely = ,,otc monograph drug activities4 7#b7 ,collections & appropriation ,acts 7,a7 ,9 g5]al ,subject to subp>agraph 7,c71 ! fees au?oriz$ by ?is section %all be collect$ & available 9 ea* fiscal ye> 9 an am\nt n to exce$ ! am\nt specifi$ 9 appropriation ,acts1 or o!rwise made available = obligation1 = su* fiscal ye>4 7,b7 ,use ( fees & limitation ,! fees au?oriz$ by ?is section %all be available to defray increases 9 ! co/s ( ! res\rces allocat$ = ,,otc monograph drug activities 7includ+ increases 9 su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* activities71 only if ! ,secret>y allocates = su* purpose an am\nt = su* fiscal ye> 7exclud+ am\nts f fees collect$ "u ?is section7 no less ?an #ab1jjj1jjj1 multipli$ by ! adju/m5t factor applicable to ! fiscal ye> involv$ "u subsection 7c77#a74 7,c7 ,compliance ,! ,secret>y %all be consid]$ to h met ! requirem5ts ( subp>agraph 7,b7 9 any fiscal ye> if ! co/s fund$ by appropriations & allocat$ = ,,otc monograph drug activities are n m ?an #ae p]c5t bel[ ! level specifi$ 9 su* subp>agraph4 7,d7 ,provision = e>ly paym5ts 9 subsequ5t ye>s ,paym5t ( fees au?oriz$ "u ?is section = a fiscal ye> 7aft] fiscal ye> #bjai71 prior to ! due date = su* fees1 may be accept$ by ! ,secret>y 9 accordance ) au?ority provid$ 9 advance 9 a prior ye> appropriations ,act4 7#c7 ,au?orization ( appropriations ,= ea* ( ! fiscal ye>s #bjai ?r\gh #bjbc1 !re is au?oriz$ to be appropriat$ = fees "u ?is section an am\nt equal to ! total am\nt ( fees assess$ = su* fiscal ye> "u ?is section4 7g7 ,collection ( unpaid fees ,9 any case :]e ! ,secret>y does n receive paym5t ( a fee assess$ "u subsection 7a7 )9 #cj cal5d> days aft] x is due1 su* fee %all be treat$ z a claim ( ! ,unit$ ,/ates ,gov]nm5t subject to sub*apt] ,,ii ( *apt] #cg ( title #ca1 ,unit$ ,/ates ,code4 7h7 ,con/ruction ,?is section may n be con/ru$ to require t ! numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 = (fic]s1 employ]s1 & advisory committees n engag$ 9 ,,otc monograph drug activities1 be r$uc$ to (fset ! numb] ( (fic]s1 employees1 & advisory committees s engag$4 #gdd,n4 ,reau?orization2 report+ requirem5ts 7a7 ,p]=mance report ,beg9n+ ) fiscal ye> #bjai1 & n lat] ?an #abj cal5d> days aft] ! end ( ea* fiscal ye> !reaft] = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conc]n+ ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals id5tifi$ 9 ! lett]s describ$ 9 section #bjja7;b7 ( ! ,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m ,act ( #bjai dur+ su* fiscal ye> & ! future plans ( ! ,food & ,drug ,adm9i/ration = meet+ su* goals4 7b7 ,fiscal report ,n lat] ?an #abj cal5d> days aft] ! end ( fiscal ye> #bjai & ea* subsequ5t fiscal ye> = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! implem5tation ( ! au?ority = su* fees dur+ su* fiscal ye> & ! use1 by ! ,food & ,drug ,adm9i/ration1 ( ! fees collect$ = su* fiscal ye>4 7c7 ,public availability ,! ,secret>y %all make ! reports requir$ "u subsections 7a7 & 7b7 available to ! public on ! int]net website ( ! ,food & ,drug ,adm9i/ration4 7d7 ,reau?orization 7#a7 ,consultation ,9 develop+ recomm5dations to pres5t to ! ,congress ) respect to ! goals describ$ 9 subsection 7a71 & plans = meet+ ! goals1 = ,,otc monograph drug activities = ! fir/ #e fiscal ye>s aft] fiscal ye> #bjbc1 & = ! reau?orization ( ?is "p = su* fiscal ye>s1 ! ,secret>y %all consult )-- 7,a7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7,b7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7,c7 sci5tific & academic exp]ts2 7,d7 heal? c>e pr(essionals2 7,e7 repres5tatives ( pati5t & consum] advocacy gr\ps2 & 7,f7 ! regulat$ indu/ry4 7#b7 ,public review ( recomm5dations ,aft] negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all-- 7,a7 pres5t ! recomm5dations develop$ "u p>agraph 7#a7 to ! congressional committees specifi$ 9 su* p>agraph2 7,b7 publi% su* recomm5dations 9 ! ,f$]al ,regi/]2 7,c7 provide = a p]iod ( #cj cal5d> days = ! public to provide writt5 comm5ts on su* recomm5dations2 7,d7 hold a meet+ at :i* ! public may pres5t its views on su* recomm5dations2 & 7,e7 aft] consid]ation ( su* public views & comm5ts1 revise su* recomm5dations z necess>y4 7#c7 ,transmittal ( recomm5dations ,n lat] ?an ,janu>y #ae1 #bjbc1 ! ,secret>y %all transmit to ! ,congress ! revis$ recomm5dations "u p>agraph 7#b71 a summ>y ( ! views & comm5ts receiv$ "u su* p>agraph1 & any *anges made to ! recomm5dations 9 response to su* views & comm5ts4 4 ,pass$ ! ,h\se ( ,repres5tatives ,janu>y #h1 #bjai4;,cl]k4