#aad? ,,congress #b;d ,session ,9 ! ,h\se ( ,repres5tatives1 ,u4 ,s41 ,novemb] #cj1 #bjaf ,,h\se ,,am5dm5t ,,to ,,s5ate ,,am5dm5t3 ,t ! ,h\se agree to ! am5dm5t ( ! ,s5ate to ! bill 7,h4,r4 #cd7 entitl$ ,an ,act to au?orize & /r5g!n ! tsunami detection1 =eca/1 w>n+1 rese>*1 & mitigation program ( ! ,national ,oceanic & ,atmosph]ic ,adm9i/ration1 & = o!r purposes41 ) ! foll[+ ,9 lieu ( ! matt] propos$ to be add$ aft] ! enact+ clause1 ins]t ! foll[+3 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! #ba/ ,c5tury ,cures ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,division ,a--#ba/ ,c5tury ,cures ,sec4 #ajjj4 ,%ort title4 ,title ,i--,innovation ,projects & ,/ate ,responses to ,opioid ,abuse ,sec4 #ajja4 ,,nih innovation projects4 ,sec4 #ajjb4 ,,fda innovation projects4 ,sec4 #ajjc4 ,acc\nt = ! /ate response to ! opioid abuse crisis4 ,sec4 #ajjd4 ,budget>y treatm5t4 ,title ,,ii--,discov]y ,subtitle ,a--,national ,in/itutes ( ,heal? ,reau?orization ,sec4 #bjja4 ,national ,in/itutes ( ,heal? ,reau?orization4 ,sec4 #bjjb4 ,,eureka prize competitions4 ,subtitle ,b--,advanc+ precision m$ic9e ,sec4 #bjaa4 ,precision ,m$ic9e ,initiative4 ,sec4 #bjab4 ,privacy protection = human rese>* subjects4 ,sec4 #bjac4 ,protection ( id5tifiable & s5sitive in=mation4 ,sec4 #bjad4 ,data %>+4 ,subtitle ,c--,support+ "y em]g+ sci5ti/s ,sec4 #bjba4 ,inve/+ 9 ! next g5]ation ( rese>*]s4 ,sec4 #bjbb4 ,improvem5t ( loan repaym5t program4 ,subtitle ,d--,national ,in/itutes ( ,heal? plann+ & adm9i/ration ,sec4 #bjca4 ,national ,in/itutes ( ,heal? /rategic plan4 ,sec4 #bjcb4 ,tri5nial reports4 ,sec4 #bjcc4 ,increas+ acc\ntability at ! ,national ,in/itutes ( ,heal?4 ,sec4 #bjcd4 ,r$uc+ adm9i/rative burd5 = rese>*]s4 ,sec4 #bjce4 ,exemption = ! ,national ,in/itutes ( ,heal? f ! ,pap]work ,r$uction ,act requirem5ts4 ,sec4 #bjcf4 ,high-risk1 high-rew>d rese>*4 ,sec4 #bjcg4 ,national ,c5t] = ,advanc+ ,translational ,sci5ces4 ,sec4 #bjch4 ,collaboration & coord9ation to enhance rese>*4 ,sec4 #bjci4 ,enhanc+ ! rigor & reproducibility ( sci5tific rese>*4 ,sec4 #bjdj4 ,improv+ m$ical rehabilitation rese>* at ! ,national ,in/itutes ( ,heal?4 ,sec4 #bjda4 ,task =ce on rese>* specific to pregnant wom5 & lactat+ wom54 ,sec4 #bjdb4 ,/reaml9+ ,national ,in/itutes ( ,heal? report+ requirem5ts4 ,sec4 #bjdc4 ,reimbursem5t = rese>* sub/ances & liv+ organisms4 ,sec4 #bjdd4 ,s5se ( ,congress on increas$ inclusion ( und]repres5t$ populations 9 cl9ical trials4 ,subtitle ,e--,advancem5t ( ! ,national ,in/itutes ( ,heal? rese>* & data access ,sec4 #bjea4 ,te*nical updates to cl9ical trials database4 ,sec4 #bjeb4 ,compliance activities reports4 ,sec4 #bjec4 ,updates to policies to improve data4 ,sec4 #bjed4 ,consultation4 ,subtitle ,f--,facilitat+ collaborative rese>* ,sec4 #bjfa4 ,national neurological conditions surveillance sy/em4 ,sec4 #bjfb4 ,tick-borne diseases4 ,sec4 #bjfc4 ,access+1 %>+1 & us+ heal? data = rese>* purposes4 ,subtitle ,g--,promot+ p$iatric rese>* ,sec4 #bjga4 ,national p$iatric rese>* network4 ,sec4 #bjgb4 ,global p$iatric cl9ical /udy network4 ,title ,,iii--,developm5t ,subtitle ,a--,pati5t-,focus$ ,drug ,developm5t ,sec4 #cjja4 ,pati5t exp]i5ce data4 ,sec4 #cjjb4 ,pati5t-focus$ drug developm5t guidance4 ,sec4 #cjjc4 ,/reaml9+ pati5t input4 ,sec4 #cjjd4 ,report on pati5t exp]i5ce drug developm5t4 ,subtitle ,b--,advanc+ new drug !rapies ,sec4 #cjaa4 ,qualification ( drug developm5t tools4 ,sec4 #cjab4 ,t>get$ drugs = r>e diseases4 ,sec4 #cjac4 ,reau?orization ( program to enc\rage treatm5ts = r>e p$iatric diseases4 ,sec4 #cjad4 ,,gao /udy ( priority review v\*] programs4 ,sec4 #cjae4 ,am5dm5ts to ! ,orphan ,drug grants4 ,sec4 #cjaf4 ,grants = /udy+ cont9u\s drug manufactur+4 ,subtitle ,c--,mod]n ,trial ,design & ,evid5ce ,developm5t ,sec4 #cjba4 ,novel cl9ical trial designs4 ,sec4 #cjbb4 ,real _w evid5ce4 ,sec4 #cjbc4 ,protection ( human rese>* subjects4 ,sec4 #cjbd4 ,in=m$ cons5t waiv] or alt]ation = cl9ical inve/igations4 ,subtitle ,d--,pati5t access to !rapies & in=mation ,sec4 #cjca4 ,summ>y level review4 ,sec4 #cjcb4 ,exp&$ access policy4 ,sec4 #cjcc4 ,accel]at$ approval = reg5]ative advanc$ !rapies4 ,sec4 #cjcd4 ,guidance reg>d+ devices us$ 9 ! recov]y1 isolation1 or deliv]y ( reg5]ative advanc$ !rapies4 ,sec4 #cjce4 ,report on reg5]ative advanc$ !rapies4 ,sec4 #cjcf4 ,/&>ds = reg5]ative m$ic9e & reg5]ative advanc$ !rapies4 ,sec4 #cjcg4 ,heal? c>e economic in=mation4 ,sec4 #cjch4 ,comb9ation product innovation4 ,subtitle ,e--,antimicrobial innovation & /ew>d%ip ,sec4 #cjda4 ,antimicrobial resi/ance monitor+4 ,sec4 #cjdb4 ,limit$ population pa?way4 ,sec4 #cjdc4 ,prescrib+ au?ority4 ,sec4 #cjdd4 ,susceptibility te/ int]pretive crit]ia = microorganisms2 antimicrobial susceptibility te/+ devices4 ,subtitle ,f--,m$ical device innovations ,sec4 #cjea4 ,break?r\gh devices4 ,sec4 #cjeb4 ,humanit>ian device exemption4 ,sec4 #cjec4 ,recognition ( /&>ds4 ,sec4 #cjed4 ,c]ta9 class ,i & class ,,ii devices4 ,sec4 #cjee4 ,classification panels4 ,sec4 #cjef4 ,in/itutional review bo>d flexibility4 ,sec4 #cjeg4 ,,clia waiv] improvem5ts4 ,sec4 #cjeh4 ,lea/ burd5some device review4 ,sec4 #cjei4 ,clean+ in/ructions & validation data requirem5t4 ,sec4 #cjfj4 ,cl>ify+ m$ical s(tw>e regulation4 ,subtitle ,g--,improv+ ,sci5tific ,exp]tise & ,outrea* at ,,fda ,sec4 #cjga4 ,silvio ,o4 ,conte ,s5ior ,biom$ical ,rese>* & ,biom$ical ,product ,assessm5t ,s]vice4 ,sec4 #cjgb4 ,hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel4 ,sec4 #cjgc4 ,e/abli%m5t ( ,food & ,drug ,adm9i/ration ,int]c5t] ,in/itutes4 ,sec4 #cjgd4 ,sci5tific engagem5t4 ,sec4 #cjge4 ,drug surveillance4 ,sec4 #cjgf4 ,reagan-,udall ,f\ndation = ! ,food & ,drug ,adm9i/ration4 ,subtitle ,h--,m$ical c\nt]measures innovation ,sec4 #cjha4 ,m$ical c\nt]measure guidel9es4 ,sec4 #cjhb4 ,cl>ify+ ,,b>da contract+ au?ority4 ,sec4 #cjhc4 ,c\nt]measure budget plan4 ,sec4 #cjhd4 ,m$ical c\nt]measures innovation4 ,sec4 #cjhe4 ,/reaml9+ ,project ,bio,shield procurem5t4 ,sec4 #cjhf4 ,enc\rag+ treatm5ts = ag5ts t pres5t a national security ?reat4 ,sec4 #cjhg4 ,pap]work ,r$uction ,act waiv] dur+ a public heal? em]g5cy4 ,sec4 #cjhh4 ,cl>ify+ ,food & ,drug ,adm9i/ration em]g5cy use au?orization4 ,subtitle ,i--,vacc9e ,access1 ,c]ta9ty1 & ,innovation ,sec4 #cjia4 ,pr$ictable review timel9es ( vacc9es by ! ,advisory ,committee on ,immunization ,practices4 ,sec4 #cjib4 ,review ( processes & consi/5cy ( ,advisory ,committee on ,immunization ,practices recomm5dations4 ,sec4 #cjic4 ,enc\rag+ vacc9e innovation4 ,subtitle ,j--,te*nical corrections ,sec4 #caja4 ,te*nical corrections4 ,sec4 #cajb4 ,complet$ /udies4 ,title ,,iv--,deliv]y ,sec4 #djja4 ,assi/+ doctors & hospitals 9 improv+ quality ( c>e = pati5ts4 ,sec4 #djjb4 ,transp>5t report+ on usability1 security1 & functionality4 ,sec4 #djjc4 ,int]op]ability4 ,sec4 #djjd4 ,in=mation block+4 ,sec4 #djje4 ,lev]ag+ electronic heal? records to improve pati5t c>e4 ,sec4 #djjf4 ,emp[]+ pati5ts & improv+ pati5t access to _! electronic heal? in=mation4 ,sec4 #djjg4 ,,gao /udy on pati5t mat*+4 ,sec4 #djjh4 ,,gao /udy on pati5t access to heal? in=mation4 ,sec4 #djji4 ,improv+ ,m$ic>e local cov]age det]m9ations4 ,sec4 #djaj4 ,m$ic>e ph>maceutical & te*nology ombudsman4 ,sec4 #djaa4 ,m$ic>e site-(-s]vice price transp>5cy4 ,sec4 #djab4 ,teleheal? s]vices 9 ,m$ic>e4 ,title ,v--,sav+s ,sec4 #ejja4 ,sav+s 9 ! ,m$ic>e ,improvem5t ,fund4 ,sec4 #ejjb4 ,m$icaid reimbursem5t to ,/ates = durable m$ical equipm5t4 ,sec4 #ejjc4 ,p5alties = violations ( grants1 contracts1 & o!r agreem5ts4 ,sec4 #ejjd4 ,r$uc+ ov]paym5ts ( infusion drugs4 ,sec4 #ejje4 ,increas+ ov]sight ( t]m9ation ( ,m$icaid provid]s4 ,sec4 #ejjf4 ,requir+ publication ( fee-=-s]vice provid] directory4 ,sec4 #ejjg4 ,fairness 9 ,m$icaid supplem5tal ne$s tru/s4 ,sec4 #ejjh4 ,elim9at+ ,f$]al f9ancial p>ticipation ) respect to exp5ditures "u ,m$icaid = ag5ts us$ = cosmetic purposes or hair gr[?4 ,sec4 #ejji4 ,am5dm5t to ! ,prev5tion & ,public ,heal? ,fund4 ,sec4 #ejaj4 ,/rategic ,petroleum ,res]ve drawd[n4 ,sec4 #ejaa4 ,rescission ( portion ( ,,aca t]ritory fund+4 ,sec4 #ejab4 ,m$ic>e cov]age ( home infusion !rapy4 ,division ,b--,help+ ,families 9 ,m5tal ,heal? ,crisis ,sec4 #fjjj4 ,%ort title4 ,title ,,vi--,/r5g!n+ ,lead]%ip & ,acc\ntability ,subtitle ,a--,lead]%ip ,sec4 #fjja4 ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use4 ,sec4 #fjjb4 ,/r5g!n+ ! lead]%ip ( ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration4 ,sec4 #fjjc4 ,*ief ,m$ical ,(fic]4 ,sec4 #fjjd4 ,improv+ ! quality ( behavioral heal? programs4 ,sec4 #fjje4 ,/rategic plan4 ,sec4 #fjjf4 ,bi5nial report conc]n+ activities & progress4 ,sec4 #fjjg4 ,au?orities ( c5t]s = m5tal heal? s]vices1 sub/ance abuse prev5tion1 & sub/ance abuse treatm5t4 ,sec4 #fjjh4 ,advisory c\ncils4 ,sec4 #fjji4 ,pe] review4 ,subtitle ,b--,ov]sight & acc\ntability ,sec4 #fjba4 ,improv+ ov]sight ( m5tal & sub/ance use disord]s programs ?r\gh ! ,assi/ant ,secret>y = ,plann+ & ,evaluation4 ,sec4 #fjbb4 ,report+ = protection & advocacy organizations4 ,sec4 #fjbc4 ,,gao /udy4 ,subtitle ,c--,int]dep>tm5tal ,s]i\s ,m5tal ,illness ,coord9at+ ,committee ,sec4 #fjca4 ,int]dep>tm5tal ,s]i\s ,m5tal ,illness ,coord9at+ ,committee4 ,title ,,vii--,,ensur+ ,,m5tal ,,& ,,sub/ance ,,use ,,disord]s ,,prev5tion1 ,,treatm5t1 ,,& ,,recov]y ,,programs ,,keep ,,pace ,,) ,,sci5ce ,,& ,,te*nology ,sec4 #gjja4 ,enc\rag+ innovation & evid5ce-bas$ programs4 ,sec4 #gjjb4 ,promot+ access to in=mation on evid5ce-bas$ programs & practices4 ,sec4 #gjjc4 ,priority m5tal heal? ne$s ( regional & national significance4 ,sec4 #gjjd4 ,priority sub/ance use disord] treatm5t ne$s ( regional & national significance4 ,sec4 #gjje4 ,priority sub/ance use disord] prev5tion ne$s ( regional & national significance4 ,title ,,viii--,,support+ ,,/ate ,,prev5tion ,,activities ,,& ,,responses ,,to ,,m5tal ,,heal? ,,& ,,sub/ance ,,use ,,disord] ,,ne$s ,sec4 #hjja4 ,community m5tal heal? s]vices block grant4 ,sec4 #hjjb4 ,sub/ance abuse prev5tion & treatm5t block grant4 ,sec4 #hjjc4 ,additional provisions relat$ to ! block grants4 ,sec4 #hjjd4 ,/udy ( di/ribution ( funds "u ! sub/ance abuse prev5tion & treatm5t block grant & ! community m5tal heal? s]vices block grant4 ,title ,,ix--,,promot+ ,,access ,,to ,,m5tal ,,heal? ,,& ,,sub/ance ,,use ,,disord] ,,c>e ,subtitle ,a--,help+ ,individuals & ,families ,sec4 #ijja4 ,grants = treatm5t & recov]y = homeless individuals4 ,sec4 #ijjb4 ,grants = jail div]sion programs4 ,sec4 #ijjc4 ,promot+ integration ( prim>y & behavioral heal? c>e4 ,sec4 #ijjd4 ,projects = assi/ance 9 transition f homelessness4 ,sec4 #ijje4 ,national ,suicide ,prev5tion ,lifel9e ,program4 ,sec4 #ijjf4 ,connect+ individuals & families ) c>e4 ,sec4 #ijjg4 ,/r5g!n+ community crisis response sy/ems4 ,sec4 #ijjh4 ,g>rett ,lee ,smi? ,memorial ,act reau?orization4 ,sec4 #ijji4 ,adult suicide prev5tion4 ,sec4 #ijaj4 ,m5tal heal? aw>5ess tra9+ grants4 ,sec4 #ijaa4 ,s5se ( ,congress on prioritiz+ ,am]ican ,indians & ,alaska ,native y\? )9 suicide prev5tion programs4 ,sec4 #ijab4 ,evid5ce-bas$ practices = old] adults4 ,sec4 #ijac4 ,national viol5t dea? report+ sy/em4 ,sec4 #ijad4 ,assi/$ outpati5t treatm5t4 ,sec4 #ijae4 ,ass]tive community treatm5t grant program4 ,sec4 #ijaf4 ,sob] tru? on prev5t+ und]age dr9k+ reau?orization4 ,sec4 #ijag4 ,c5t] & program repeals4 ,subtitle ,b--,/r5g!n+ ! ,heal? ,c>e ,work=ce ,sec4 #ijba4 ,m5tal & behavioral heal? education & tra9+ grants4 ,sec4 #ijbb4 ,/r5g!n+ ! m5tal & sub/ance use disord]s work=ce4 ,sec4 #ijbc4 ,cl>ification on curr5t eligibility = loan repaym5t programs4 ,sec4 #ijbd4 ,m9ority fell[%ip program4 ,sec4 #ijbe4 ,liability protections = heal? pr(essional volunte]s at community heal? c5t]s4 ,sec4 #ijbf4 ,reports4 ,subtitle ,c--,m5tal ,heal? on ,campus ,improvem5t ,sec4 #ijca4 ,m5tal heal? & sub/ance use disord] s]vices on campus4 ,sec4 #ijcb4 ,int]ag5cy ,work+ ,gr\p on ,college ,m5tal ,heal?4 ,sec4 #ijcc4 ,improv+ m5tal heal? on college campuses4 ,title ,x--,/r5g!n+ ,m5tal & ,sub/ance ,use ,disord] ,c>e = ,*ildr5 & ,adolesc5ts ,sec4 #ajjja4 ,programs = *ildr5 ) a s]i\s emotional di/urbance4 ,sec4 #ajjjb4 ,increas+ access to p$iatric m5tal heal? c>e4 ,sec4 #ajjjc4 ,sub/ance use disord] treatm5t & e>ly int]v5tion s]vices = *ildr5 & adolesc5ts4 ,sec4 #ajjjd4 ,*ildr5's recov]y f trauma4 ,sec4 #ajjje4 ,scre5+ & treatm5t = mat]nal depression4 ,sec4 #ajjjf4 ,infant & e>ly *ildhood m5tal heal? promotion1 int]v5tion1 & treatm5t4 ,title ,,xi--,compassionate communication on ,,hipaa ,sec4 #aajja4 ,s5se ( ,congress4 ,sec4 #aajjb4 ,confid5tiality ( records4 ,sec4 #aajjc4 ,cl>ification on p]mitt$ uses & disclosures ( protect$ heal? in=mation4 ,sec4 #aajjd4 ,developm5t & dissem9ation ( model tra9+ programs4 ,title ,,xii--,m$icaid ,m5tal ,heal? ,cov]age ,sec4 #abjja4 ,rule ( con/ruction relat$ to ,m$icaid cov]age ( m5tal heal? s]vices & prim>y c>e s]vices furni%$ on ! same day4 ,sec4 #abjjb4 ,/udy & report relat$ to ,m$icaid manag$ c>e regulation4 ,sec4 #abjjc4 ,guidance on opportunities = innovation4 ,sec4 #abjjd4 ,/udy & report on ,m$icaid em]g5cy psy*iatric demon/ration project4 ,sec4 #abjje4 ,provid+ ,,epsdt s]vices to *ildr5 9 ,i,m,ds4 ,sec4 #abjjf4 ,electronic visit v]ification sy/em requir$ = p]sonal c>e s]vices & home heal? c>e s]vices "u ,m$icaid4 ,title ,,xiii--,m5tal ,heal? ,p>ity ,sec4 #acjja4 ,enhanc$ compliance ) m5tal heal? & sub/ance use disord] cov]age requirem5ts4 ,sec4 #acjjb4 ,action plan = enhanc$ en=cem5t ( m5tal heal? & sub/ance use disord] cov]age4 ,sec4 #acjjc4 ,report on inve/igations reg>d+ p>ity 9 m5tal heal? & sub/ance use disord] b5efits4 ,sec4 #acjjd4 ,,gao /udy on p>ity 9 m5tal heal? & sub/ance use disord] b5efits4 ,sec4 #acjje4 ,in=mation & aw>5ess on eat+ disord]s4 ,sec4 #acjjf4 ,education & tra9+ on eat+ disord]s4 ,sec4 #acjjg4 ,cl>ification ( exi/+ p>ity rules4 ,title ,,xiv--,m5tal heal? & safe communities ,subtitle ,a--,m5tal heal? & safe communities ,sec4 #adjja4 ,law en=cem5t grants = crisis int]v5tion teams1 m5tal heal? purposes4 ,sec4 #adjjb4 ,assi/$ outpati5t treatm5t programs4 ,sec4 #adjjc4 ,f$]al drug & m5tal heal? c\rts4 ,sec4 #adjjd4 ,m5tal heal? 9 ! judicial sy/em4 ,sec4 #adjje4 ,=5sic ass]tive community treatm5t initiatives4 ,sec4 #adjjf4 ,assi/ance = individuals transition+ out ( sy/ems4 ,sec4 #adjjg4 ,co-occurr+ sub/ance abuse & m5tal heal? *all5ges 9 drug c\rts4 ,sec4 #adjjh4 ,m5tal heal? tra9+ = ,f$]al uni=m$ s]vices4 ,sec4 #adjji4 ,advanc+ m5tal heal? z "p ( (f5d] re5try4 ,sec4 #adjaj4 ,s*ool m5tal heal? crisis int]v5tion teams4 ,sec4 #adjaa4 ,active-%oot] tra9+ = law en=cem5t4 ,sec4 #adjab4 ,co-occurr+ sub/ance abuse & m5tal heal? *all5ges 9 resid5tial sub/ance abuse treatm5t programs4 ,sec4 #adjac4 ,m5tal heal? & drug treatm5t alt]natives to inc>c]ation programs4 ,sec4 #adjad4 ,national crim9al ju/ice & m5tal heal? tra9+ & te*nical assi/ance4 ,sec4 #adjae4 ,improv+ ,dep>tm5t ( ,ju/ice data collection on m5tal illness involv$ 9 crime4 ,sec4 #adjaf4 ,reports on ! numb] ( m5tally ill (f5d]s 9 prison4 ,sec4 #adjag4 ,codification ( due process = det]m9ations by secret>y ( vet]ans affairs ( m5tal capacity ( b5efici>ies4 ,sec4 #adjah4 ,reau?orization ( appropriations4 ,subtitle ,b--,compreh5sive ,ju/ice & ,m5tal ,heal? ,sec4 #adjba4 ,sequ5tial int]cept model4 ,sec4 #adjbb4 ,prison & jails4 ,sec4 #adjbc4 ,all[able uses4 ,sec4 #adjbd4 ,law en=cem5t tra9+4 ,sec4 #adjbe4 ,f$]al law en=cem5t tra9+4 ,sec4 #adjbf4 ,,gao report4 ,sec4 #adjbg4 ,evid5ce bas$ practices4 ,sec4 #adjbh4 ,transp>5cy1 program acc\ntability1 & enhancem5t ( local au?ority4 ,sec4 #adjbi4 ,grant acc\ntability4 ,division ,c--,increas+ ,*oice1 ,access1 & ,quality 9 ,heal? ,c>e = ,am]icans ,sec4 #aejjj4 ,%ort title4 ,title ,,xv--,provisions ,relat+ to ,m$ic>e ,"p ,a ,sec4 #aejja4 ,developm5t ( ,m$ic>e ,,hcpcs v]sion ( ,,ms-,,drg codes = simil> hospital s]vices4 ,sec4 #aejjb4 ,e/abli%+ b5efici>y equity 9 ! ,m$ic>e hospital readmission program4 ,sec4 #aejjc4 ,five-ye> ext5sion ( ! rural community hospital demon/ration program4 ,sec4 #aejjd4 ,regulatory relief = ,l,t,c,hs4 ,sec4 #aejje4 ,sav+s f ,,ipps ,,macra pay-= ?r\gh n apply+ docum5tation & cod+ adju/m5ts4 ,sec4 #aejjf4 ,ext5sion ( c]ta9 ,,lt* ,m$ic>e paym5t rules4 ,sec4 #aejjg4 ,application ( rules on ! calculation ( hospital l5g? ( /ay to all ,l,t,c,hs4 ,sec4 #aejjh4 ,*ange 9 ,m$ic>e classification = c]ta9 hospitals4 ,sec4 #aejji4 ,tempor>y exception to ! application ( ! ,m$ic>e ,,lt* site neutral provisions = c]ta9 sp9al cord specialty hospitals4 ,sec4 #aejaj4 ,tempor>y ext5sion to ! application ( ! ,m$ic>e ,,lt* site neutral provisions = c]ta9 dis*>ges ) sev]e w\nds4 ,title ,,xvi--,provisions ,relat+ to ,m$ic>e ,"p ,b ,sec4 #afjja4 ,cont9u+ ,m$ic>e paym5t "u ,,hopd prospective paym5t sy/em = s]vices furni%$ by mid-build (f-campus outpati5t dep>tm5ts ( provid]s4 ,sec4 #afjjb4 ,treatm5t ( canc] hospitals 9 (f-campus outpati5t dep>tm5t ( a provid] policy4 ,sec4 #afjjc4 ,treatm5t ( eligible pr(essionals 9 ambulatory surgical c5t]s = mean+ful use & ,,mips4 ,sec4 #afjjd4 ,cont9u+ ,access to ,hospitals ,act ( #bjaf4 ,sec4 #afjje4 ,delay ( implem5tation ( ,m$ic>e fee s*$ule adju/m5ts = :eel*air accessories & seat+ sy/ems :5 us$ 9 conjunction ) complex rehabilitation te*nology 7,,crt7 :eel*airs4 ,sec4 #afjjf4 ,all[+ physical !rapi/s to utilize locum t55s arrangem5ts "u ,m$ic>e4 ,sec4 #afjjg4 ,ext5sion ( ! transition to new paym5t rates = durable m$ical equipm5t "u ! ,m$ic>e program4 ,sec4 #afjjh4 ,requirem5ts 9 det]m9+ adju/m5ts us+ in=mation f competitive bidd+ programs4 ,title ,,xvii--,o!r ,m$ic>e ,provisions ,sec4 #agjja4 ,delay 9 au?ority to t]m9ate contracts = ,m$ic>e ,advantage plans fail+ to a*ieve m9imum quality rat+s4 ,sec4 #agjjb4 ,requirem5t = enrollm5t data report+ = ,m$ic>e4 ,sec4 #agjjc4 ,updat+ ! ,welcome to ,m$ic>e package4 ,sec4 #agjjd4 ,no paym5t = items & s]vices furni%$ by newly enroll$ provid]s or suppli]s )9 a tempor>y moratorium area4 ,sec4 #agjje4 ,pres]vation ( ,m$ic>e b5efici>y *oice "u ,m$ic>e ,advantage4 ,sec4 #agjjf4 ,all[+ end-/age r5al disease b5efici>ies to *oose a ,m$ic>e ,advantage plan4 ,sec4 #agjjg4 ,improvem5ts to ! assignm5t ( b5efici>ies "u ! ,m$ic>e ,%>$ ,sav+s ,program4 ,title ,,xviii--,o!r ,provisions ,sec4 #ahjja4 ,exception f gr\p heal? plan requirem5ts = qualifi$ small employ] heal? reimbursem5t arrangem5ts4 ,a #ba/ ,c5tury ,cures #ajjj4 ,%ort title ,?is ,division may be cit$ z ! #ba/ ,c5tury ,cures ,act4 ,i ,innovation ,projects & ,/ate ,responses to ,opioid ,abuse #ajja4 ,,nih innovation projects 7a7 ,9 g5]al ,! ,director ( ! ,national ,in/itutes ( ,heal? 7ref]r$ to 9 ?is section z ! ,director ( ,,nih7 %all use any funds appropriat$ pursuant to ! au?orization ( appropriations 9 subsection 7b77#c7 to c>ry out ! ,national ,in/itutes ( ,heal? innovation projects describ$ 9 subsection 7b77#d7 7ref]r$ to 9 ?is section z ! ,,nih ,innovation ,projects74 7b7 ,national in/itutes ( heal? innovation acc\nt 7#a7 ,e/abli%m5t ( ,,nih innovation acc\nt ,!re is e/abli%$ 9 ! ,treasury an acc\nt1 to be kn[n z ! ,,nih ,innovation ,acc\nt 7ref]r$ to 9 ?is subsection z ! ,acc\nt71 = purposes ( c>ry+ out ! ,,nih ,innovation ,projects describ$ 9 p>agraph 7#d74 7#b7 ,transf] ( direct sp5d+ sav+s 7,a7 ,9 g5]al ,! foll[+ am\nts %all be transf]r$ to ! ,acc\nt f ! g5]al fund ( ! ,treasury3 7i7 ,= fiscal ye> #bjag1 #ceb1jjj1jjj4 7ii7 ,= fiscal ye> #bjah1 #dif1jjj1jjj4 7iii7 ,= fiscal ye> #bjai1 #gaa1jjj1jjj4 7iv7 ,= fiscal ye> #bjbj1 #dib1jjj1jjj4 7v7 ,= fiscal ye> #bjba1 #djd1jjj1jjj4 7vi7 ,= fiscal ye> #bjbb1 #dif1jjj1jjj4 7vii7 ,= fiscal ye> #bjbc1 #a1jhe1jjj1jjj4 7viii7 ,= fiscal ye> #bjbd1 #djg1jjj1jjj4 7ix7 ,= fiscal ye> #bjbe1 #abg1jjj1jjj4 7x7 ,= fiscal ye> #bjbf1 #bbf1jjj1jjj4 7,b7 ,am\nts deposit$ ,any am\nts transf]r$ "u subp>agraph 7,a7 %all rema9 unavailable 9 ! ,acc\nt until su* am\nts are appropriat$ pursuant to p>agraph 7#c74 7#c7 ,appropriations 7,a7 ,au?orization ( appropriations ,= ea* ( ! fiscal ye>s #bjag ?r\gh #bjbf1 !re is au?oriz$ to be appropriat$ f ! ,acc\nt to ! ,director ( ,,nih1 = ! purpose ( c>ry+ out ! ,,nih ,innovation ,projects1 an am\nt n to exce$ ! total am\nt transf]r$ to ! ,acc\nt "u p>agraph 7#b77;,a71 to rema9 available until exp5d$4 7,b7 ,(fsett+ future appropriations ,= any ( fiscal ye>s #bjag ?r\gh #bjbf1 = any discretion>y appropriation "u ! head+ ,,nih ,innovation ,acc\nt provid$ to ! ,director ( ,,nih pursuant to ! au?orization ( appropriations "u subp>agraph 7,a7 = ! purpose ( c>ry+ out ! ,,nih ,innovation ,projects1 ! total am\nt ( su* appropriations = ! applicable fiscal ye> 7n to exce$ ! total am\nt rema9+ 9 ! ,acc\nt7 %all be subtract$ f ! e/imate ( discretion>y budget au?ority & ! result+ outlays = any e/imate "u ! ,congressional ,budget & ,imp\ndm5t ,control ,act ( #aigd or ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe1 & ! am\nt transf]r$ to ! ,acc\nt %all be r$uc$ by ! same am\nt4 7#d7 ,,nih innovation projects ,,nih ,innovation ,projects au?oriz$ to be fund$ "u ?is section %all consi/ ( ! foll[+ &1 ( ! total am\nts au?oriz$ to be appropriat$ "u p>agraph 7#c71 !re are au?oriz$ to be appropriat$ to ea* su* project a total am\nt n to exce$ ! foll[+1 ov] ! p]iod ( fiscal ye>s #bjag ?r\gh #bjbf3 7,a7 ,= ! ,precision ,m$ic9e ,initiative1 includ+ = ! advancem5t ( a cohort ( individuals to support ! goals ( ! ,precision ,m$ic9e ,initiative1 n to exce$ a total ( #a1dee1jjj1jjj1 z foll[s3 7i7 ,= fiscal ye> #bjag1 #dj1jjj1jjj4 7ii7 ,= fiscal ye> #bjah1 #ajj1jjj1jjj4 7iii7 ,= fiscal ye> #bjai1 #ahf1jjj1jjj4 7iv7 ,= fiscal ye> #bjbj1 #adi1jjj1jjj4 7v7 ,= fiscal ye> #bjba1 #aji1jjj1jjj4 7vi7 ,= fiscal ye> #bjbb1 #aej1jjj1jjj4 7vii7 ,= fiscal ye> #bjbc1 #dai1jjj1jjj4 7viii7 ,= fiscal ye> #bjbd1 #bce1jjj1jjj4 7ix7 ,= fiscal ye> #bjbe1 #cf1jjj1jjj4 7x7 ,= fiscal ye> #bjbf1 #ca1jjj1jjj4 7,b7 ,= ! ,bra9 ,rese>* ?r\gh ,advanc+ ,innovative ,neurote*nologies ,initiative 7kn[n z ! ,,bra9 ,initiative71 n to exce$ a total ( #a1eaa1jjj1jjj1 z foll[s3 7i7 ,= fiscal ye> #bjag1 #aj1jjj1jjj4 7ii7 ,= fiscal ye> #bjah1 #hf1jjj1jjj4 7iii7 ,= fiscal ye> #bjai1 #aae1jjj1jjj4 7iv7 ,= fiscal ye> #bjbj1 #adj1jjj1jjj4 7v7 ,= fiscal ye> #bjba1 #ajj1jjj1jjj4 7vi7 ,= fiscal ye> #bjbb1 #aeb1jjj1jjj4 7vii7 ,= fiscal ye> #bjbc1 #dej1jjj1jjj4 7viii7 ,= fiscal ye> #bjbd1 #agb1jjj1jjj4 7ix7 ,= fiscal ye> #bjbe1 #ia1jjj1jjj4 7x7 ,= fiscal ye> #bjbf1 #aie1jjj1jjj4 7,c7 ,to support canc] rese>*1 su* z ! developm5t ( canc] vacc9es1 ! developm5t ( m s5sitive diagno/ic te/s = canc]1 immuno!rapy & ! developm5t ( comb9ation !rapies1 & rese>* t has ! pot5tial to trans=m ! sci5tific field1 t has inh]5tly high] risk1 & t seeks to address major *all5ges relat$ to canc]1 n to exce$ a total ( #a1hjj1jjj1jjj1 z foll[s3 7i7 ,= fiscal ye> #bjag1 #cjj1jjj1jjj4 7ii7 ,= fiscal ye> #bjah1 #cjj1jjj1jjj4 7iii7 ,= fiscal ye> #bjai1 #djj1jjj1jjj4 7iv7 ,= fiscal ye> #bjbj1 #aie1jjj1jjj4 7v7 ,= fiscal ye> #bjba1 #aie1jjj1jjj4 7vi7 ,= fiscal ye> #bjbb1 #aid1jjj1jjj4 7vii7 ,= fiscal ye> #bjbc1 #baf1jjj1jjj4 7,d7 ,= ! ,national ,in/itutes ( ,heal?1 9 coord9ation ) ! ,food & ,drug ,adm9i/ration1 to aw>d grants & contracts = cl9ical rese>* to fur!r ! field ( reg5]ative m$ic9e us+ adult /em cells1 includ+ autolog\s /em cells1 = :i* grants & contracts %all be cont+5t ^u ! recipi5t mak+ available non-,f$]al contributions t[>d ! co/s ( su* rese>* 9 an am\nt n less ?an #a = ea* #a ( ,f$]al funds provid$ 9 ! aw>d1 n to exce$ a total ( #cj1jjj1jjj1 z foll[s3 7i7 ,= fiscal ye> #bjag1 #b1jjj1jjj4 7ii7 ,= ea* ( fiscal ye>s #bjah & #bjai1 #aj1jjj1jjj4 7iii7 ,= fiscal ye> #bjbj1 #h1jjj1jjj4 7iv7 ,= ea* ( fiscal ye>s #bjba ?r\gh #bjbf1 #j4 7c7 ,acc\ntability & ov]sight 7#a7 ,"w plan 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ,,nih %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 a "w plan includ+ ! propos$ allocation ( funds au?oriz$ to be appropriat$ pursuant to subsection 7b77#c7 = ea* ( fiscal ye>s #bjag ?r\gh #bjbf = ! ,,nih ,innovation ,projects & ! cont5ts describ$ 9 subp>agraph 7,b74 7,b7 ,cont5ts ,! "w plan submitt$ "u subp>agraph 7,a7 %all include-- 7i7 recomm5dations f ! ,advisory ,committee describ$ 9 subp>agraph 7,c72 7ii7 ! am\nt ( money to be obligat$ or exp5d$ 9 ea* fiscal ye> = ea* ,,nih ,innovation ,project2 7iii7 a description & ju/ification ( ea* su* project2 & 7iv7 a description ( h[ ea* su* project supports ! /rategic rese>* priorities id5tifi$ 9 ! ,,nih ,/rategic ,plan "u subsection 7m7 ( section #djb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb71 z add$ by section #bjca4 7,c7 ,recomm5dations ,prior to submitt+ ! "w plan "u ?is p>agraph1 ! ,director ( ,,nih %all seek recomm5dations f ! ,advisory ,committee to ! ,director ( ,,nih appo9t$ "u section #bbb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bag;a7 on-- 7i7 ! allocations ( funds appropriat$ pursuant to ! au?orization ( appropriations "u subsection 7b77#c7 = ea* ( fiscal ye>s #bjag ?r\gh #bjbf2 & 7ii7 on ! cont5ts ( ! propos$ "w plan4 7#b7 ,reports 7,a7 ,annual reports ,n lat] ?an ,octob] #a ( ea* ( fiscal ye>s #bjah ?r\gh #bjbg1 ! ,director ( ,,nih %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 a report includ+-- 7i7 ! am\nt ( money obligat$ or exp5d$ 9 ! prior fiscal ye> = ea* ,,nih ,innovation ,project2 7ii7 a description ( any su* project us+ funds provid$ pursuant to ! au?orization ( appropriations "u subsection 7b77#c72 & 7iii7 :e!r su* projects are advanc+ ! /rategic rese>* priorities id5tifi$ 9 ! ,,nih ,/rategic ,plan "u subsection 7m7 ( section #djb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb71 z add$ by section #bjca4 7,b7 ,additional reports ,at ! reque/ ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions or ! ,committee on ,appropriations ( ! ,s5ate1 or ! ,committee on ,en]gy & ,comm]ce or ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 ! ,director ( ,,nih %all provide an update 9 ! =m ( te/imony & any additional reports to ! respective congressional committee reg>d+ ! allocation ( fund+ "u ?is section or ! description ( ! ,,nih ,innovation ,projects4 7d7 ,limitations ,not)/&+ any transf] au?ority au?oriz$ by ?is ,act or any appropriations ,act1 any funds made available pursuant to ! au?orization ( appropriations "u subsection 7b77#c7 may n be us$ = any purpose o!r ?an a ,,nih ,innovation ,project4 7e7 ,sunset ,?is section %all expire on ,septemb] #cj1 #bjbf4 #ajjb4 ,,fda innovation projects 7a7 ,9 g5]al ,! ,commission] ( ,food & ,drugs 7ref]r$ to 9 ?is section z ! ,commission]7 %all use any funds appropriat$ pursuant to ! au?orization ( appropriations "u subsection 7b77#c7 to c>ry out ! activities describ$ 9 subsection 7b77#d74 7b7 ,,fda innovation acc\nt 7#a7 ,e/abli%m5t ( ,,fda innovation acc\nt ,!re is e/abli%$ 9 ! ,treasury an acc\nt1 to be kn[n z ! ,,fda ,innovation ,acc\nt 7ref]r$ to 9 ?is subsection z ! ,acc\nt71 = purposes ( c>ry+ out ! activities describ$ 9 p>agraph 7#d74 7#b7 ,transf] ( direct sp5d+ sav+s 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjag ?r\gh #bjbe1 ! foll[+ am\nts %all be transf]r$ to ! ,acc\nt f ! g5]al fund ( ! ,treasury3 7i7 ,= fiscal ye> #bjag1 #bj1jjj1jjj4 7ii7 ,= fiscal ye> #bjah1 #fj1jjj1jjj4 7iii7 ,= fiscal ye> #bjai1 #gj1jjj1jjj4 7iv7 ,= fiscal ye> #bjbj1 #ge1jjj1jjj4 7v7 ,= fiscal ye> #bjba1 #gj1jjj1jjj4 7vi7 ,= fiscal ye> #bjbb1 #ej1jjj1jjj4 7vii7 ,= fiscal ye> #bjbc1 #ej1jjj1jjj4 7viii7 ,= fiscal ye> #bjbd1 #ej1jjj1jjj4 7ix7 ,= fiscal ye> #bjbe1 #ee1jjj1jjj4 7,b7 ,am\nts deposit$ ,any am\nts transf]r$ "u subp>agraph 7,a7 %all rema9 unavailable 9 ! ,acc\nt until su* am\nts are appropriat$ pursuant to p>agraph 7#c74 7#c7 ,appropriations 7,a7 ,au?orization ( appropriations ,= ea* ( ! fiscal ye>s #bjag ?r\gh #bjbe1 !re is au?oriz$ to be appropriat$ f ! ,acc\nt to ! ,commission]1 = ! purpose ( c>ry+ out ! activities describ$ 9 p>agraph 7#e71 an am\nt n to exce$ ! total am\nt transf]r$ to ! ,acc\nt "u p>agraph 7#b77;,a71 to rema9 available until exp5d$4 7,b7 ,(fsett+ future appropriations ,= any ( fiscal ye>s #bjag ?r\gh #bjbe1 = any discretion>y appropriation "u ! head+ ,,fda ,innovation ,acc\nt provid$ to ! ,commission] pursuant to ! au?orization ( appropriations "u subp>agraph 7,a7 = ! purpose ( c>ry+ out ! projects activities describ$ 9 p>agraph 7#d71 ! total am\nt ( su* appropriations 9 ! applicable fiscal ye> 7n to exce$ ! total am\nt rema9+ 9 ! ,acc\nt7 %all be subtract$ f ! e/imate ( discretion>y budget au?ority & ! result+ outlays = any e/imate "u ! ,congressional ,budget & ,imp\ndm5t ,control ,act ( #aigd or ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe1 & ! am\nt transf]r$ to ! ,acc\nt %all be r$uc$ by ! same am\nt4 7#d7 ,,fda activities ,! activities au?oriz$ to be fund$ "u ?is section are ! activities "u subtitles ,a ?r\gh ,f 7includ+ ! am5dm5ts made by su* subtitles7 ( title ,,iii ( ?is ,act & section #ajad ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #cjgc ( ?is ,act4 7c7 ,acc\ntability & ov]sight 7#a7 ,"w plan 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,commission] %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 a "w plan includ+ ! propos$ allocation ( funds appropriat$ pursuant to ! au?orization ( appropriations "u subsection 7b77#c7 = ea* ( fiscal ye>s #bjag ?r\gh #bjbe & ! cont5ts describ$ 9 subp>agraph 7,b74 7,b7 ,cont5ts ,! "w plan submitt$ "u subp>agraph 7,a7 %all include-- 7i7 recomm5dations f ! ,advisory ,committee describ$ 9 subp>agraph 7,c72 7ii7 ! am\nt ( money to be obligat$ or exp5d$ 9 ea* fiscal ye> = ea* activity describ$ 9 subsection 7b77#d72 & 7iii7 a description & ju/ification ( ea* su* project activity4 7,c7 ,recomm5dations ,prior to submitt+ ! "w plan "u ?is p>agraph1 ! ,commission] %all seek recomm5dations f ! ,sci5ce ,bo>d to ! ,food & ,drug ,adm9i/ration1 on ! propos$ allocation ( funds appropriat$ pursuant to ! au?orization ( appropriations "u subsection 7b77#c7 = ea* ( fiscal ye>s #bjag ?r\gh #bjbe & on ! cont5ts ( ! propos$ "w plan4 7#b7 ,reports 7,a7 ,annual reports ,n lat] ?an ,octob] #a ( ea* ( fiscal ye>s #bjah ?r\gh #bjbf1 ! ,commission] %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 a report includ+-- 7i7 ! am\nt ( money obligat$ or exp5d$ 9 ! prior fiscal ye> = ea* activity describ$ 9 subsection 7b77#d72 7ii7 a description ( all su* activities us+ funds provid$ pursuant to ! au?orization ( appropriations "u subsection 7b77#c72 & 7iii7 h[ ! activities are advanc+ public heal?4 7,b7 ,additional reports ,at ! reque/ ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions or ! ,committee on ,appropriations ( ! ,s5ate1 or ! ,committee on ,en]gy & ,comm]ce or ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 ! ,commission] %all provide an update 9 ! =m ( te/imony & any additional reports to ! respective congressional committee reg>d+ ! allocation ( fund+ "u ?is section or ! description ( ! activities und]tak5 ) su* fund+4 7d7 ,limitations ,not)/&+ any transf] au?ority au?oriz$ by ?is ,act or any appropriations ,act1 any funds made available pursuant to ! au?orization ( appropriations 9 subsection 7b77#c7 %all n be us$ = any purpose o!r ?an an activity describ$ 9 subsection 7b77#d74 7e7 ,sunset ,?is section %all expire on ,septemb] #cj1 #bjbe4 #ajjc4 ,acc\nt = ! /ate response to ! opioid abuse crisis 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all use any funds appropriat$ pursuant to ! au?orization ( appropriations "u subsection 7b7 to c>ry out ! grant program describ$ 9 subsection 7c7 = purposes ( address+ ! opioid abuse crisis )9 ! ,/ates4 7b7 ,acc\nt = ! /ate response to ! opioid abuse crisis 7#a7 ,e/abli%m5t ,!re is e/abli%$ 9 ! ,treasury an acc\nt1 to be kn[n z ! ,acc\nt ,= ! ,/ate ,response to ! ,opioid ,abuse ,crisis 7ref]r$ to 9 ?is subsection z ! ,acc\nt71 to c>ry out ! opioid grant program describ$ 9 subsection 7c74 7#b7 ,transf] ( direct sp5d+ sav+s 7,a7 ,9 g5]al ,! foll[+ am\nts %all be transf]r$ to ! ,acc\nt f ! g5]al fund ( ! ,treasury3 7i7 ,= fiscal ye> #bjag1 #ejj1jjj1jjj4 7ii7 ,= fiscal ye> #bjah1 #ejj1jjj1jjj4 7,b7 ,am\nts deposit$ ,any am\nts transf]r$ "u subp>agraph 7,a7 %all rema9 unavailable 9 ! ,acc\nt until su* am\nts are appropriat$ pursuant to p>agraph 7#c74 7#c7 ,appropriations 7,a7 ,au?orization ( appropriations ,9 ea* ( ! fiscal ye>s #bjag & #bjah1 !re is au?oriz$ to be appropriat$ f ! ,acc\nt to ! ,secret>y1 = ! grant program describ$ 9 subsection 7c71 an am\nt n to exce$ ! total am\nt transf]r$ to ! ,acc\nt "u p>agraph 7#b77;,a71 to rema9 available until exp5d$4 7,b7 ,(fsett+ future appropriations ,9 ea* ( fiscal ye>s #bjag & #bjah1 = any discretion>y appropriation "u ! head+ ,acc\nt ,= ! ,/ate ,response to ! ,opioid ,abuse ,crisis = ! grant program describ$ 9 subsection 7c71 ! total am\nt ( su* appropriations 9 ! applicable fiscal ye> 7n to exce$ ! total am\nt rema9+ 9 ! ,acc\nt7 %all be subtract$ f ! e/imate ( discretion>y budget au?ority & ! result+ outlays = any e/imate "u ! ,congressional ,budget & ,imp\ndm5t ,control ,act ( #aigd or ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe1 & ! am\nt transf]r$ to ! ,acc\nt %all be r$uc$ by ! same am\nt4 7c7 ,opioid grant program 7#a7 ,/ate response to ! opioid abuse crisis ,subject to ! availability ( appropriations1 ! ,secret>y %all aw>d grants to ,/ates = ! purpose ( address+ ! opioid abuse crisis )9 su* ,/ates1 9 accordance ) subp>agraph 7,b74 ,9 aw>d+ su* grants1 ! ,secret>y %all give pref]5ce to ,/ates ) an incid5ce or preval5ce ( opioid use disord]s t is sub/antially high] relative to o!r ,/ates4 7#b7 ,opioid grants ,grants aw>d$ to a ,/ate "u ?is subsection %all be us$ = c>ry+ out activities t supplem5t activities p]ta9+ to opioids und]tak5 by ! ,/ate ag5cy responsible = adm9i/]+ ! sub/ance abuse prev5tion & treatm5t block grant "u subp>t ,,ii ( "p ,b ( title ,,xix ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#ba et seq471 :i* may include public heal?-relat$ activities su* z ! foll[+3 7,a7 ,improv+ ,/ate prescription drug monitor+ programs4 7,b7 ,implem5t+ prev5tion activities1 & evaluat+ su* activities to id5tify effective /rategies to prev5t opioid abuse4 7,c7 ,tra9+ = heal? c>e practition]s1 su* z be/ practices = prescrib+ opioids1 pa9 managem5t1 recogniz+ pot5tial cases ( sub/ance abuse1 ref]ral ( pati5ts to treatm5t programs1 & ov]dose prev5tion4 7,d7 ,support+ access to heal? c>e s]vices1 includ+ ^? s]vices provid$ by ,f$]ally c]tifi$ opioid treatm5t programs or o!r appropriate heal? c>e provid]s to treat sub/ance use disord]s4 7,e7 ,o!r public heal?-relat$ activities1 z ! ,/ate det]m9es appropriate1 relat$ to address+ ! opioid abuse crisis )9 ! ,/ate4 7d7 ,acc\ntability & ov]sight ,a ,/ate receiv+ a grant "u subsection 7c7 %all include 9 a report relat$ to sub/ance abuse submitt$ to ! ,secret>y pursuant to section #aidb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#eb71 a description (-- 7#a7 ! purposes = :i* ! grant funds receiv$ by ! ,/ate "u su* subsection = ! prec$+ fiscal ye> 7 exp5d$ & a description ( ! activities ( ! ,/ate "u ! program2 & 7#b7 ! ultimate recipi5ts ( am\nts provid$ to ! ,/ate 9 ! grant4 7e7 ,limitations ,any funds made available pursuant to ! au?orization ( appropriations "u subsection 7b7-- 7#a7 not)/&+ any transf] au?ority 9 any appropriations ,act1 %all n be us$ = any purpose o!r ?an ! grant program 9 subsection 7c72 & 7#b7 %all be subject to ! same requirem5ts z sub/ance abuse prev5tion & treatm5t programs "u titles ,v & ,,xix ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa et seq41 #cjjw et seq474 7f7 ,sunset ,?is section %all expire on ,septemb] #cj1 #bjbf4 #ajjd4 ,budget>y treatm5t 7a7 ,/atutory paygo scorec>ds ,! budget>y effects ( division ,a ( ?is ,act %all n be ent]$ on ei!r ,,paygo scorec>d ma9ta9$ pursuant to section #d7;d7 ( ! ,/atutory ,pay-,z-,y-,g ,act ( #bjaj4 7b7 ,s5ate paygo scorec>ds ,! budget>y effects ( division ,a ( ?is ,act %all n be ent]$ on any ,,paygo scorec>d ma9ta9$ = purposes ( section #bja ( ,s4 ,con4 ,res4 #ba 7#aaj? ,congress74 7c7 ,res]vation ( sav+s ,none ( ! funds 9 ! ,,nih ,innovation ,acc\nt1 ! ,,fda ,innovation ,acc\nt1 or ! ,acc\nt ,= ! ,/ate ,response to ! ,opioid ,abuse ,crisis e/abli%$ by ?is title %all be made available except to ! ext5t provid$ 9 advance 9 appropriations ,acts1 & legislation or an ,act t resc9ds or r$uces am\nts 9 su* acc\nts %all n be e/imat$ z a r$uction 9 direct sp5d+ "u ! ,congressional ,budget & ,imp\ndm5t ,control ,act ( #aigd or ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe4 ,,ii ,discov]y ,a ,national ,in/itutes ( ,heal? ,reau?orization #bjja4 ,national ,in/itutes ( ,heal? ,reau?orization ,section #djb;,a7a77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb;a7a77#a77 is am5d$-- 7#a7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,c71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraphs3 7,d7 #cd1hea1jjj1jjj = fiscal ye> #bjah2 7,e7 #ce1ehe1hga1jjj = fiscal ye> #bjai2 & 7,f7 #cf1dgb1ddb1gge = fiscal ye> #bjbj4 4 #bjjb4 ,,eureka prize competitions 7a7 ,9 g5]al ,pursuant to ! au?orities & processes e/abli%$ "u section #bd ( ! ,/ev5son-,wydl] ,te*nology ,innovation ,act ( #aihj 7#ae ,u4,s4,c4 #cgai71 ! ,director ( ! ,national ,in/itutes ( ,heal? %all support prize competitions = "o or bo? ( ! foll[+ goals3 7#a7 ,id5tify+ & fund+ areas ( biom$ical sci5ce t c\ld realize significant advancem5ts ?r\gh a prize competition4 7#b7 ,improv+ heal? outcomes1 p>ticul>ly ) respect to human diseases & conditions-- 7,a7 = :i* public & private inve/m5t 9 rese>* is disproportionately small relative to ,f$]al ,gov]nm5t exp5ditures on prev5tion & treatm5t activities ) respect to su* diseases & conditions1 su* t ,f$]al exp5ditures on heal? programs w\ld be r$uc$2 7,b7 t are s]i\s & repres5t a significant disease burd5 9 ! ,unit$ ,/ates2 or 7,c7 = :i* !re is pot5tial = significant return on inve/m5t to ! ,unit$ ,/ates4 7b7 ,track+2 report+ ,! ,director ( ! ,national ,in/itutes ( ,heal? %all-- 7#a7 collect in=mation on-- 7,a7 ! effect ( innovations fund$ ?r\gh ! prize competitions "u ?is section 9 advanc+ biom$ical sci5ce or improv+ heal? outcomes pursuant to subsection 7a72 & 7,b7 ! effect ( ! innovations on ,f$]al exp5ditures2 & 7#b7 include ! in=mation collect$ "u p>agraph 7#a7 9 ! tri5nial report "u section #djc ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc7 7z am5d$ by section #bjcb74 ,b ,advanc+ precision m$ic9e #bjaa4 ,precision ,m$ic9e ,initiative ,"p ,h ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi et seq47 is am5d$ by add+ at ! end ! foll[+3 #dih;,e4 ,precision ,m$ic9e ,initiative 7a7 ,9 g5]al ,! ,secret>y is enc\rag$ to e/abli% & c>ry out an initiative1 to be kn[n z ! ,precision ,m$ic9e ,initiative 79 ?is section ref]r$ to z ! ,initiative71 to augm5t ef=ts to address disease prev5tion1 diagnosis1 & treatm5t4 7b7 ,compon5ts ,! ,initiative describ$ "u subsection 7a7 may include-- 7#a7 develop+ a network ( sci5ti/s to assi/ 9 c>ry+ out ! purposes ( ! ,initiative2 7#b7 develop+ new approa*es = address+ sci5tific1 m$ical1 public heal?1 & regulatory sci5ce issues2 7#c7 apply+ g5omic te*nologies1 su* z :ole g5omic sequ5c+1 to provide data on ! molecul> basis ( disease2 7#d7 collect+ in=mation volunt>ily provid$ by a div]se cohort ( individuals t c be us$ to bett] und]/& heal? & disease2 & 7#e7 o!r activities to advance ! goals ( ! ,initiative1 z ! ,secret>y det]m9es appropriate4 7c7 ,au?ority ( ! secret>y ,9 c>ry+ out ?is section1 ! ,secret>y may-- 7#a7 coord9ate ) ! ,secret>y ( ,en]gy1 private indu/ry1 & o!rs1 z ! ,secret>y det]m9es appropriate1 to id5tify & address ! advanc$ sup]comput+ & o!r advanc$ te*nology ne$s = ! ,initiative2 7#b7 develop & utilize public-private p>tn]%ips2 & 7#c7 lev]age exi/+ data s\rces4 7d7 ,requirem5ts ,9 ! implem5tation ( ! ,initiative "u subsection 7a71 ! ,secret>y %all-- 7#a7 ensure ! collaboration ( ! ,national ,in/itutes ( ,heal?1 ! ,food & ,drug ,adm9i/ration1 ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 & ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7#b7 comply ) exi/+ laws & regulations = ! protection ( human subjects involv$ 9 rese>*1 includ+ ! protection ( p>ticipant privacy2 7#c7 implem5t policies & me*anisms = appropriate secure data %>+ across sy/ems t include protections = privacy & security ( data2 7#d7 consid] ! div]sity ( ! cohort to ensure inclusion ( a broad range ( p>ticipants1 includ+ consid]ation ( biological1 social1 & o!r det]m9ants ( heal? t contribute to heal? disp>ities2 7#e7 ensure t only au?oriz$ individuals may access controll$ or s5sitive1 id5tifiable biological mat]ial & associat$ in=mation collect$ or /or$ 9 connection ) ! ,initiative2 & 7#f7 on ! appropriate ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 id5tify any entities ) access to su* in=mation & provide in=mation ) respect to ! purpose ( su* access1 a summ>y ( ! rese>* project = :i* su* access is grant$1 z applicable1 & a description ( ! biological mat]ial & associat$ in=mation to :i* ! entity has access4 7e7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all submit a report on ! relevant data access policies & proc$ures to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 ,su* report %all include /eps ! ,secret>y has tak5 to consult ) exp]ts or o!r heads ( dep>tm5ts or ag5cies ( ! ,f$]al ,gov]nm5t 9 ! developm5t ( su* policies4 4 #bjab4 ,privacy protection = human rese>* subjects 7a7 ,9 g5]al ,subsection 7d7 ( section #cja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda7 is am5d$ to read z foll[s3 7d7 7#a7 7,a7 ,if a p]son is engag$ 9 biom$ical1 behavioral1 cl9ical1 or o!r rese>*1 9 :i* id5tifiable1 s5sitive in=mation is collect$ 7includ+ rese>* on m5tal heal? & rese>* on ! use & effect ( alcohol & o!r psy*oactive drugs71 ! ,secret>y1 9 coord9ation ) o!r ag5cies1 z applicable-- 7i7 %all issue to su* p]son a c]tificate ( confid5tiality to protect ! privacy ( individuals :o are ! subjects ( su* rese>* if ! rese>* is fund$ :olly or 9 "p by ! ,f$]al ,gov]nm5t2 & 7ii7 may1 ^u application by a p]son engag$ 9 rese>*1 issue to su* p]son a c]tificate ( confid5tiality to protect ! privacy ( su* individuals if ! rese>* is n s fund$4 7,b7 ,except z provid$ 9 subp>agraph 7,c71 any p]son to :om a c]tificate is issu$ "u subp>agraph 7,a7 to protect ! privacy ( individuals describ$ 9 su* subp>agraph %all n disclose or provide to any o!r p]son n connect$ ) ! rese>* ! "n ( su* an individual or any in=mation1 docum5t1 or biospecim5 t conta9s id5tifiable1 s5sitive in=mation ab\t su* an individual & t 0 creat$ or compil$ = purposes ( ! rese>*4 7,c7 ,! disclosure prohibition 9 subp>agraph 7,b7 %all n apply to disclosure or use t is-- 7i7 requir$ by ,f$]al1 ,/ate1 or local laws1 exclud+ in/ances describ$ 9 subp>agraph 7,d72 7ii7 necess>y = ! m$ical treatm5t ( ! individual to :om ! in=mation1 docum5t1 or biospecim5 p]ta9s & made ) ! cons5t ( su* individual2 7iii7 made ) ! cons5t ( ! individual to :om ! in=mation1 docum5t1 or biospecim5 p]ta9s2 or 7iv7 made = ! purposes ( o!r sci5tific rese>* t is 9 compliance ) applicable ,f$]al regulations gov]n+ ! protection ( human subjects 9 rese>*4 7,d7 ,any p]son to :om a c]tificate is issu$ "u subp>agraph 7,a7 to protect ! privacy ( an individual describ$ 9 su* subp>agraph %all n1 9 any ,f$]al1 ,/ate1 or local civil1 crim9al1 adm9i/rative1 legislative1 or o!r proce$+1 disclose or provide ! "n ( su* individual or any su* in=mation1 docum5t1 or biospecim5 t conta9s id5tifiable1 s5sitive in=mation ab\t ! individual & t 0 creat$ or compil$ = purposes ( ! rese>*1 except 9 ! circum/ance describ$ 9 subp>agraph 7,c77iii74 7,e7 ,id5tifiable1 s5sitive in=mation protect$ "u subp>agraph 7,a71 & all copies !re(1 %all be immune f ! legal process1 & %all n1 )\t ! cons5t ( ! individual to :om ! in=mation p]ta9s1 be admissible z evid5ce or us$ = any purpose 9 any action1 suit1 or o!r judicial1 legislative1 or adm9i/rative proce$+4 7,f7 ,id5tifiable1 s5sitive in=mation collect$ by a p]son to :om a c]tificate has be5 issu$ "u subp>agraph 7,a71 & all copies !re(1 %all be subject to ! protections af=d$ by ?is section = p]petuity4 7,g7 ,! ,secret>y %all take /eps to m9imize ! burd5 to rese>*]s1 /reaml9e ! process1 & r$uce ! "t x takes to comply ) ! requirem5ts ( ?is subsection4 7#b7 ,! ,secret>y %all coord9ate ) ! heads ( o!r applicable ,f$]al ag5cies to ensure t su* dep>tm5ts h policies 9 place ) respect to ! issuance ( a c]tificate ( confid5tiality pursuant to p>agraph 7#a7 & o!r requirem5ts ( ?is subsection4 7#c7 ,no?+ 9 ?is subsection %all be con/ru$ to limit ! access ( an individual :o is a subject ( rese>* to in=mation ab\t himself or h]self collect$ dur+ su* individual's p>ticipation 9 ! rese>*4 7#d7 ,= purposes ( ?is subsection1 ! t]m id5tifiable1 s5sitive in=mation means in=mation t is ab\t an individual & t is ga!r$ or us$ dur+ ! c\rse ( rese>* describ$ 9 p>agraph 7#a77;,a7 &-- 7,a7 ?r\gh :i* an individual is id5tifi$2 or 7,b7 = :i* !re is at lea/ a v small risk1 z det]m9$ by curr5t sci5tific practices or /ati/ical me?ods1 t "s comb9ation ( ! in=mation1 a reque/ = ! in=mation1 & o!r available data s\rces c\ld be us$ to d$uce ! id5tity ( an individual4 4 7b7 ,applicability ,beg9n+ #ahj days aft] ! date ( enactm5t ( ?is ,act1 all p]sons engag$ 9 rese>* & au?oriz$ by ! ,secret>y ( ,heal? & ,human ,s]vices to protect in=mation "u section #cja7;d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda7;d77 prior to ! date ( enactm5t ( ?is ,act %all be subject to ! requirem5ts ( su* section 7z am5d$ by ?is ,act74 #bjac4 ,protection ( id5tifiable & s5sitive in=mation ,section #cja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda7 is am5d$ by add+ at ! end ! foll[+3 7f7 7#a7 ,! ,secret>y may exempt f disclosure "u section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code1 biom$ical in=mation t is ab\t an individual & t is ga!r$ or us$ dur+ ! c\rse ( biom$ical rese>* if-- 7,a7 an individual is id5tifi$2 or 7,b7 !re is at lea/ a v small risk1 z det]m9$ by curr5t sci5tific practices or /ati/ical me?ods1 t "s comb9ation ( ! in=mation1 ! reque/1 & o!r available data s\rces c\ld be us$ to d$uce ! id5tity ( an individual4 7#b7 7,a7 ,ea* det]m9ation ( ! ,secret>y "u p>agraph 7#a7 to exempt in=mation f disclosure %all be made 9 writ+ & accompani$ by a /atem5t ( ! basis = ! det]m9ation4 7,b7 ,ea* su* det]m9ation & /atem5t ( basis %all be available to ! public1 ^u reque/1 ?r\gh ! ,(fice ( ! ,*ief ,,foia ,(fic] ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#c7 ,no?+ 9 ?is subsection %all be con/ru$ to limit a rese>* p>ticipant's access to in=mation ab\t su* p>ticipant collect$ dur+ ! p>ticipant's p>ticipation 9 ! rese>*4 4 #bjad4 ,data %>+ 7a7 ,9 g5]al ,section #djb7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;b77 is am5d$-- 7#a7 9 p>agraph 7#bc71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#bd71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] p>agraph 7#bd7 ! foll[+3 7#be7 may require recipi5ts ( ,national ,in/itutes ( ,heal? aw>ds to %>e sci5tific data1 to ! ext5t feasible1 g5]at$ f su* ,national ,in/itutes ( ,heal? aw>ds 9 a mann] t is consi/5t ) all applicable ,f$]al laws & regulations1 includ+ su* laws & regulations = ! protection (-- 7,a7 human rese>* p>ticipants1 includ+ ) respect to privacy1 security1 in=m$ cons5t1 & protect$ heal? in=mation2 & 7,b7 propriet>y int]e/s1 confid5tial comm]cial in=mation1 & ! intellectual prop]ty rights ( ! fund+ recipi5t4 4 7b7 ,confid5tiality ,no?+ 9 ! am5dm5ts made by subsection 7a7 au?orizes ! ,secret>y ( ,heal? & ,human ,s]vices to disclose any in=mation t is a trade secret1 or o!r privileg$ or confid5tial in=mation1 describ$ 9 section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code1 or be con/ru$ to require recipi5ts ( grants or coop]ative agreem5ts ?r\gh ! ,national ,in/itutes ( ,heal? to %>e su* in=mation4 ,c ,support+ "y em]g+ sci5ti/s #bjba4 ,inve/+ 9 ! next g5]ation ( rese>*]s 7a7 ,9 g5]al ,"p ,a ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq47 is am5d$ by add+ at ! end ! foll[+3 #djd,m4 ,next g5]ation ( rese>*]s 7a7 ,next ,g5]ation ( ,rese>*]s ,initiative ,!re %all be e/abli%$ )9 ! ,(fice ( ! ,director ( ! ,national ,in/itutes ( ,heal?1 ! ,next ,g5]ation ( ,rese>*]s ,initiative 7ref]r$ to 9 ?is section z ! ,initiative71 ?r\gh :i* ! ,director %all coord9ate all policies & programs )9 ! ,national ,in/itutes ( ,heal? t are focus$ on promot+ & provid+ opportunities = new rese>*]s & e>li] rese>* indep5d5ce4 7b7 ,activities ,! ,director ( ! ,national ,in/itutes ( ,heal?1 ?r\gh ! ,initiative %all-- 7#a7 promote policies & programs )9 ! ,national ,in/itutes ( ,heal? t are focus$ on improv+ opportunities = new rese>*]s & promot+ e>li] rese>* indep5d5ce1 includ+ exi/+ policies & programs1 z appropriate2 7#b7 develop1 modify1 or prioritize policies1 z ne$$1 )9 ! ,national ,in/itutes ( ,heal? to promote opportunities = new rese>*]s & e>li] rese>* indep5d5ce1 su* z policies to increase opportunities = new rese>*]s to receive fund+1 enhance tra9+ & m5tor%ip programs = rese>*]s1 & enhance work=ce div]sity2 7#c7 coord9ate1 z appropriate1 ) relevant ag5cies1 pr(essional & academic associations1 academic in/itutions1 & o!rs1 to improve & update exi/+ in=mation on ! biom$ical rese>* work=ce 9 ord] to in=m programs relat$ to ! tra9+1 recruitm5t1 & ret5tion ( biom$ical rese>*]s2 & 7#d7 c>ry out o!r activities1 includ+ evaluation & ov]sight ( exi/+ programs1 z appropriate1 to promote ! developm5t ( ! next g5]ation ( rese>*]s & e>li] rese>* indep5d5ce4 4 7b7 ,consid]ation ( recomm5dations ,9 c>ry+ out activities "u section #djd,m7b7 ( ! ,public ,heal? ,s]vice ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all take into consid]ation ! recomm5dations made by ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e z "p ( ! compreh5sive /udy on policies affect+ ! next g5]ation ( rese>*]s "u ! ,dep>tm5t ( ,heal? & ,human ,s]vices ,appropriations ,act1 #bjaf 7,public ,law #aad-aac71 & submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 ) respect to any actions tak5 by ! ,national ,in/itutes ( ,heal? bas$ on ! recomm5dations n lat] ?an #b ye>s aft] ! completion ( ! /udy requir$ pursuant to ! ,dep>tm5t ( ,heal? & ,human ,s]vices ,appropriations ,act1 #bjaf4 #bjbb4 ,improvem5t ( loan repaym5t program 7a7 ,intramural loan repaym5t program ,section #dhg;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhh-a7 is am5d$-- 7#a7 by am5d+ ! section head+ to read z foll[s3 ,intramural loan repaym5t program2 7#b7 9 subsection 7a7-- 7,a7 by /rik+ ,! ,secret>y %all c>ry out a program & ins]t+ ,! ,director ( ! ,national ,in/itutes ( ,heal? %all1 z appropriate & bas$ on work=ce & sci5tific priorities1 c>ry out a program ?r\gh ! subcategories li/$ 9 subsection 7b77#a7 7or modifi$ subcategories z provid$ = 9 subsection 7b77#b772 7,b7 by /rik+ conduct & ins]t+ conduct rese>*2 7,c7 by /rik+ rese>* ) respect to acquir$ immune defici5cy syndrome2 & 7,d7 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 7#c7 by r$esignat+ subsection 7b7 z subsection 7d72 7#d7 by ins]t+ aft] subsection 7a71 ! foll[+3 7b7 ,subcategories ( rese>* 7#a7 ,9 g5]al ,9 c>ry+ out ! program "u subsection 7a71 ! ,director ( ! ,national ,in/itutes ( ,heal?-- 7,a7 %all cont9ue to focus on-- 7i7 g5]al rese>*2 7ii7 rese>* on acquir$ immune defici5cy syndrome2 & 7iii7 cl9ical rese>* conduct$ by appropriately qualifi$ heal? pr(essional :o are f disadvantag$ backgr\nds2 & 7,b7 may focus on an area ( em]g+ sci5tific or work=ce ne$4 7#b7 ,elim9ation or e/abli%m5t ( subcategories ,! ,director ( ! ,national ,in/itutes ( ,heal? may elim9ate "o or m subcategories provid$ = 9 p>agraph 7#a7 due to *anges 9 work=ce or sci5tific ne$s relat$ to biom$ical rese>*4 ,! ,director may e/abli% o!r subcategory areas bas$ on work=ce & sci5tific priorities if ! total numb] ( subcategories does n exce$ ! numb] ( subcategories li/$ 9 p>agraph 7#a74 7c7 ,limitation ,! ,director ( ! ,national ,in/itutes ( ,heal? may n ent] into a contract ) a heal? pr(essional pursuant to subsection 7a7 unless su* pr(essional has a sub/antial am\nt ( education loans relative to income 7z det]m9$ pursuant to guidel9es issu$ by ! ,director74 2 & 7#e7 by add+ at ! end ! foll[+3 7e7 ,availability ( appropriations ,am\nts available = c>ry+ out ?is section %all rema9 available until ! expiration ( ! second fiscal ye> beg9n+ aft] ! fiscal ye> = :i* su* am\nts are made available4 4 7b7 ,extramural loan repaym5t program ,section #dhg;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhh-b7 is am5d$-- 7#a7 by am5d+ ! section head+ to read z foll[s3 ,extramural loan repaym5t program2 7#b7 9 subsection 7a7-- 7,a7 by /rik+ ,! ,secret>y1 9 consultation ) ! ,director ( ! ,eunice ,k5n$y ,%riv] ,national ,in/itute ( ,*ild ,heal? & ,human ,developm5t1 %all e/abli% a program & ins]t+ ,9 g5]al4--,! ,director ( ! ,national ,in/itutes ( ,heal? %all1 z appropriate & bas$ on work=ce & sci5tific priorities1 c>ry out a program ?r\gh ! subcategories li/$ 9 subsection 7b77#a7 7or modifi$ subcategories z provid$ = 9 subsection 7b77#b7712 7,b7 by /rik+ 7includ+ graduate /ud5ts72 7,c7 by /rik+ ) respect to contraception1 or ) respect to inf]tility12 & 7,d7 by /rik+ s]vice1 n m ?an #ce1jjj & ins]t+ rese>*1 n m ?an #ej1jjj2 7#c7 by r$esignat+ subsections 7b7 & 7c7 z subsections 7d7 & 7e71 respectively2 7#d7 by ins]t+ aft] subsection 7a71 ! foll[+3 7b7 ,subcategories ( rese>* 7#a7 ,9 g5]al ,9 c>ry+ out ! program "u subsection 7a71 ! ,director ( ! ,national ,in/itutes ( ,heal?-- 7,a7 %all cont9ue to focus on-- 7i7 contraception or inf]tility rese>*2 7ii7 p$iatric rese>*1 includ+ p$iatric ph>macological rese>*2 7iii7 m9ority heal? disp>ities rese>*2 7iv7 cl9ical rese>*2 & 7v7 cl9ical rese>* conduct$ by appropriately qualifi$ heal? pr(essional :o are f disadvantag$ backgr\nds2 & 7,b7 may focus on an area ( em]g+ sci5tific or work=ce ne$4 7#b7 ,elim9ation or e/abli%m5t ( subcategories ,! ,director ( ! ,national ,in/itutes ( ,heal? may elim9ate "o or m subcategories provid$ = 9 p>agraph 7#a7 due to *anges 9 work=ce or sci5tific ne$s relat$ to biom$ical rese>*4 ,! ,director may e/abli% o!r subcategory areas bas$ on work=ce & sci5tific priorities if ! total numb] ( subcategories does n exce$ ! numb] ( subcategories li/$ 9 p>agraph 7#a74 7c7 ,limitation ,! ,director ( ! ,national ,in/itutes ( ,heal? may n ent] into a contract ) a heal? pr(essional pursuant to subsection 7a7 unless su* pr(essional has a sub/antial am\nt ( education loans relative to income 7z det]m9$ pursuant to guidel9es issu$ by ! ,director74 2 7#e7 9 subsection 7d7 7z s r$esignat$71 by /rik+ ,! provisions & ins]t+ ,applicability ( c]ta9 provisions reg>d+ obligat$ s]vice4--,! provisions2 & 7#f7 9 subsection 7e7 7z s r$esignat$71 by /rik+ ,am\nts & ins]t+ ,availability ( appropriations4--,am\nts4 7c7 ,te*nical & con=m+ am5dm5ts ,title ,,iv ( ! ,public ,heal? ,s]vice ,act is am5d$-- 7#a7 by /rik+ section #dfdz-#e 7#db ,u4,s4,c4 #bhet-#b72 7#b7 by /rik+ section #dhg;,c 7#db ,u4,s4,c4 #bhh-c72 7#c7 by /rik+ section #dhg;,e 7#db ,u4,s4,c4 #bhh-e72 7#d7 by /rik+ section #dhg;,f 7#db ,u4,s4,c4 #bhh-e;a71 z add$ by section #bje ( ,public ,law #ajf-eje1 relat+ to loan repaym5t = cl9ical rese>*]s2 & 7#e7 by /rik+ section #dhg;,f 7#db ,u4,s4,c4 #bhh-f71 z add$ by section #ajjb7;b7 ( ,public ,law #ajf-caj relat+ to p$iatric rese>* loan repaym5t4 7d7 ,,gao report ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on ! ef=ts ( ! ,national ,in/itutes ( ,heal? to attract1 reta91 & develop em]g+ sci5ti/s1 includ+ und]repres5t$ individuals 9 ! sci5ces1 su* z wom51 racial & e?nic m9orities1 & o!r gr\ps4 ,su* report %all include an analysis ( ! impact ( ! additional au?ority provid$ to ! ,secret>y ( ,heal? & ,human ,s]vices "u ?is ,act to address work=ce %ortages & gaps 9 priority rese>* areas1 includ+ :i* c5t]s & rese>* areas (f]$ loan repaym5t program p>ticipants ! increas$ aw>d am\nt4 ,d ,national ,in/itutes ( ,heal? plann+ & adm9i/ration #bjca4 ,national ,in/itutes ( ,heal? /rategic plan 7a7 ,/rategic plan ,section #djb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7 is am5d$-- 7#a7 9 subsection 7b77#e71 by ins]t+ be=e ! semicolon ! foll[+3 1 & ?r\gh ! developm5t1 implem5tation1 & updat+ ( ! /rategic plan develop$ "u subsection 7m72 & 7#b7 by add+ at ! end ! foll[+3 7m7 ,national ,in/itutes ( ,heal? /rategic plan 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 & at lea/ e #f ye>s !reaft]1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all develop & submit to ! appropriate committees ( ,congress & po/ on ! ,int]net website ( ! ,national ,in/itutes ( ,heal?1 a coord9at$ /rategy 7to be kn[n z ! ,national ,in/itutes ( ,heal? ,/rategic ,plan7 to provide direction to ! biom$ical rese>* inve/m5ts made by ! ,national ,in/itutes ( ,heal?1 to facilitate collaboration across ! in/itutes & c5t]s1 to lev]age sci5tific opportunity1 & to advance biom$ic9e4 7#b7 ,requirem5ts ,! /rategy "u p>agraph 7#a7 %all-- 7,a7 id5tify /rategic rese>* priorities & objectives across biom$ical rese>*1 includ+-- 7i7 an assessm5t ( ! /ate ( biom$ical & behavioral rese>*1 includ+ areas ( opportunity ) respect to basic1 cl9ical1 & translational rese>*2 7ii7 priorities & objectives to advance ! treatm5t1 cure1 & prev5tion ( heal? conditions2 7iii7 em]g+ sci5tific opportunities1 ris+ public heal? *all5ges1 & sci5tific k gaps2 & 7iv7 ! id5tification ( ne>-1 mid-1 & long-t]m sci5tific ne$s2 7,b7 consid]1 9 c>ry+ out subp>agraph 7,a7-- 7i7 disease burd5 9 ! ,unit$ ,/ates & ! pot5tial = return on inve/m5t to ! ,unit$ ,/ates2 7ii7 r>e diseases & conditions2 7iii7 biological1 social1 & o!r det]m9ants ( heal? t contribute to heal? disp>ities2 & 7iv7 o!r factors ! ,director ( ,national ,in/itutes ( ,heal? det]m9es appropriate2 7,c7 include multi-in/itute priorities1 includ+ coord9ation ( rese>* among in/itutes & c5t]s2 7,d7 include /rategic priorities = fund+ rese>* ?r\gh ! ,common ,fund1 9 accordance ) section #djb;,a7c77#a77;,c72 7,e7 address ! ,national ,in/itutes ( ,heal?'s propos$ & ongo+ activities relat$ to tra9+ & ! biom$ical work=ce2 & 7,f7 describe opportunities = collaboration ) o!r ag5cies & dep>tm5ts1 z appropriate4 7#c7 ,use ( plans ,/rategic plans develop$ & updat$ by ! national rese>* in/itutes & national c5t]s ( ! ,national ,in/itutes ( ,heal? %all be prep>$ regul>ly & 9 su* a mann] t su* plans w be in=m$ by ! /rategic plans develop$ & updat$ "u ?is subsection4 ,su* plans develop$ by & updat$ by ! national rese>* in/itutes & national c5t]s %all h a common template4 7#d7 ,consultation ,! ,director ( ,national ,in/itutes ( ,heal? %all develop ! /rategic plan "u p>agraph 7#a7 9 consultation ) ! directors ( ! national rese>* in/itutes & national c5t]s1 rese>*]s1 pati5t advocacy gr\ps1 & indu/ry lead]s4 4 7b7 ,con=m+ am5dm5t ,section #djb;,a7c77#a77;,c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb;a7c77#a77;,c77 is am5d$ by /rik+ ,n lat] ?an ,june #a1 #bjjg1 & e #b ye>s !reaft]1 & ins]t+ ,z "p ( ! ,national ,in/itutes ( ,heal? ,/rategic ,plan requir$ "u section #djb7m714 7c7 ,/rategic plan ,section #dib;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b7;a77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,/rategic plann+ 7,a7 ,9 g5]al ,! directors ( ! national in/itutes & national c5t]s %all consult at lea/ once annually ) ! ,director ( ! ,national ,in/itute on ,m9ority ,heal? & ,heal? ,disp>ities & ! ,director ( ! ,(fice ( ,rese>* on ,wom5's ,heal? reg>d+ objectives ( ! national in/itutes & national c5t]s to ensure t future activities by su* in/itutes & c5t]s take into acc\nt wom5 & m9orities & are focus$ on r$uc+ heal? disp>ities4 7,b7 ,/rategic plans ,any /rategic plan issu$ by a national in/itute or national c5t] %all include details on ! objectives describ$ 9 subp>agraph 7,a74 4 #bjcb4 ,tri5nial reports ,section #djc ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ ,bi5nial & ins]t+ ,tri5nial 2 & 7#b7 9 subsection 7a7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ bi5nial & ins]t+ tri5nial2 7,b7 by am5d+ p>agraph 7#c7 to read z foll[s3 7#c7 ,a description ( intra-,national ,in/itutes ( ,heal? activities1 includ+-- 7,a7 id5tification ( ! p]c5tage ( funds made available by ea* national rese>* in/itute & national c5t] ) respect to ea* applicable fiscal ye> = conduct+ or support+ rese>* t involves collaboration betwe5 ! in/itute or c5t] & #a or m o!r national rese>* in/itutes or national c5t]s2 & 7,b7 recomm5dations = promot+ coord9ation ( in=mation among ! c5t]s ( excell5ce4 2 7,c7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,b71 by /rik+ demographic v>iables & o!r v>iables & ins]t+ demographic v>iables1 includ+ biological & social v>iables & relevant age categories 7su* z p$iatric subgr\ps71 & det]m9ants ( heal?12 & 7ii7 9 subp>agraph 7,c77v7-- 7,i7 by /rik+ demographic v>iables & su* & ins]t+ demographic v>iables1 includ+ relevant age categories 7su* z p$iatric subgr\ps71 in=mation submitt$ by ea* national rese>* in/itute & national c5t] to ! ,director ( ,national ,in/itutes ( ,heal? "u section #dib;,b7f71 & su*2 & 7,,ii7 by /rik+ 7reg>d+ inclusion ( wom5 & m9orities 9 cl9ical rese>*7 & ins]t+ & o!r applicable requirem5ts reg>d+ inclusion ( demographic gr\ps2 & 7,d7 9 p>agraph 7#f7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ! foll[+3 & ins]t+ ! foll[+--2 7ii7 9 subp>agraph 7,a7-- 7,i7 by /rik+ ,an evaluation & ins]t+ an evaluation2 & 7,,ii7 by /rik+ ! p]iod & ins]t+ 2 &2 7iii7 by /rik+ subp>agraphs 7,b7 & 7,d72 7iv7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,b72 & 7v7 9 subp>agraph 7,b71 z r$esignat$ by clause 7iv71 by /rik+ ,recomm5dations & ins]t+ recomm5dations4 #bjcc4 ,increas+ acc\ntability at ! ,national ,in/itutes ( ,heal? 7a7 ,appo9tm5t & t]ms ( directors ( national rese>* in/itutes & national c5t]s ,subsection 7a7 ( section #dje ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd7 is am5d$ to read z foll[s3 7a7 ,appo9tm5t 7#a7 ,9 g5]al ,! ,director ( ! ,national ,canc] ,in/itute %all be appo9t$ by ! ,presid5t1 & ! ,directors ( ! o!r national rese>* in/itutes & national c5t]s %all be appo9t$ by ! ,secret>y1 act+ ?r\gh ! ,director ( ,national ,in/itutes ( ,heal?4 ,ea* ,director ( a national rese>* in/itute or national c5t] %all report directly to ! ,director ( ,national ,in/itutes ( ,heal?4 7#b7 ,appo9tm5t 7,a7 ,t]m ,a ,director ( a national rese>* in/itute or national c5t] :o is appo9t$ by ! ,secret>y1 act+ ?r\gh ! ,director ( ,national ,in/itutes ( ,heal?1 %all be appo9t$ = #e ye>s4 7,b7 ,reappo9tm5t ,at ! end ( ! t]m ( a ,director ( a national rese>* in/itute or national c5t]1 ! ,director may be reappo9t$ 9 accordance ) /&>ds applicable to ! relevant appo9tm5t me*anism4 ,!re %all be no limit on ! numb] ( t]ms t a ,director may s]ve4 7,c7 ,vacancies ,if ! (fice ( a ,director ( a national rese>* in/itute or national c5t] becomes vacant be=e ! end ( su* ,director's t]m1 ! ,director appo9t$ to fill ! vacancy %all be appo9t$ = a #e-ye> t]m />t+ on ! date ( su* appo9tm5t4 7,d7 ,curr5t directors ,ea* ,director ( a national rese>* in/itute or national c5t] :o is s]v+ on ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act %all be deem$ to be appo9t$ = a #e-ye> t]m "u ?is subsection beg9n+ on su* date ( enactm5t4 7,e7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to limit ! au?ority ( ! ,secret>y or ! ,director ( ,national ,in/itutes ( ,heal? to t]m9ate ! appo9tm5t ( a director ref]r$ to 9 subp>agraph 7,a7 be=e ! expiration ( su* director's #e-ye> t]m4 7,f7 ,nature ( appo9tm5t ,appo9tm5ts & reappo9tm5ts "u ?is subsection %all be made on ! basis ( ability & exp]i5ce z x relates to ! mission ( ! ,national ,in/itutes ( ,heal? & its compon5ts1 includ+ compliance ) any legal requirem5t t ! ,secret>y or ,director ( ,national ,in/itutes ( ,heal? det]m9es relevant4 7#c7 ,nonapplication ( c]ta9 provision ,! re/rictions conta9$ 9 section #bjb ( ! ,dep>tm5ts ( ,labor1 ,heal? & ,human ,s]vices1 & ,education1 & ,relat$ ,ag5cies ,appropriations ,act1 #aiic 7,public ,law #ajb-cid2 #db ,u4,s4,c4 #bch;f note7 relat$ to consultants & individual sci5ti/s appo9t$ = limit$ p]iods ( "t %all n apply to ,directors appo9t$ "u ?is subsection4 4 7b7 ,review ( c]ta9 aw>ds by directors ,section #dje7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd7;b77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,be=e an aw>d is made by a national rese>* in/itute or by a national c5t] = a grant = a rese>* program or project 7commonly ref]r$ to z an ,r-s]ies grant71 o!r ?an an aw>d con/itut+ a noncompetitive r5ewal ( su* a grant1 or a noncompetitive adm9i/rative supplem5t to su* a grant1 ! ,director ( su* national rese>* in/itute or national c5t] %all1 consi/5t ) ! pe] review process-- 7,a7 review & make ! f9al decision ) respect to mak+ ! aw>d2 & 7,b7 take into consid]ation1 z appropriate-- 7i7 ! mission ( ! national rese>* in/itute or national c5t] & ! sci5tific priorities id5tifi$ 9 ! /rategic plan "u section #djb7m72 7ii7 programs or projects fund$ by o!r ag5cies on simil> rese>* topics2 & 7iii7 advice by /aff & ! advisory c\ncil or bo>d ( su* national rese>* in/itute or national c5t]4 4 7c7 ,report on duplication 9 ,f$]al biom$ical rese>* ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y71 %all1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 submit a report to ,congress on ef=ts to prev5t & elim9ate duplicative biom$ical rese>* t is n necess>y = sci5tific purposes4 ,su* report %all-- 7#a7 describe ! proc$ures 9 place to id5tify su* duplicative rese>*1 includ+ proc$ures = monitor+ rese>* applications & fund$ rese>* aw>ds to prev5t unnecess>y duplication2 7#b7 describe ! /eps tak5 to improve ! proc$ures describ$ 9 p>agraph 7#a71 9 response to relevant recomm5dations made by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates2 7#c7 describe h[ ! ,secret>y op]ationally di/+ui%es necess>y & appropriate sci5tific replication f unnecess>y duplication2 & 7#d7 provide examples ( in/ances :]e ! ,secret>y has id5tifi$ unnecess>ily duplicative rese>* & ! /eps tak5 to elim9ate ! unnecess>y duplication4 #bjcd4 ,r$uc+ adm9i/rative burd5 = rese>*]s 7a7 ,plan ,prep>ation & implem5tation ( measures ,to r$uce adm9i/rative burd5s 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all-- 7,a7 lead a review by rese>* fund+ ag5cies ( all regulations & policies relat$ to ! disclosure ( f9ancial conflicts ( int]e/1 includ+ ! m9imum ?re%old = report+ f9ancial conflicts ( int]e/2 7,b7 make revisions1 z appropriate1 to h>monize exi/+ policies & r$uce adm9i/rative burd5 on rese>*]s :ile ma9ta9+ ! integrity & cr$ibility ( rese>* f9d+s & protections ( human p>ticipants2 & 7,c7 conf] ) ! ,(fice ( ! ,inspector ,g5]al ab\t ! activities ( su* (fice relat$ to f9ancial conflicts ( int]e/ involv+ rese>* fund+ ag5cies4 7#b7 ,consid]ations ,9 updat+ policies "u p>agraph 7#a77;,b71 ! ,secret>y %all consid]-- 7,a7 modify+ ! timel9es = ! report+ ( f9ancial conflicts ( int]e/ to j-9-"t in=mation by in/itutions receiv+ grant or coop]ative agreem5t fund+ f ! ,national ,in/itutes ( ,heal?2 7,b7 ensur+ t f9ancial int]e/ disclosure report+ requirem5ts are appropriate =1 & relevant to1 aw>ds t w directly fund rese>*1 :i* may include modification ( ! def9ition ( ! t]m inve/igator = purposes ( ! regulations & policies describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a72 & 7,c7 updat+ any applicable tra9+ modules ( ! ,national ,in/itutes ( ,heal? relat$ to ,f$]al f9ancial int]e/ disclosure4 7b7 ,monitor+ ( subrecipi5ts ( fund+ f ! national in/itutes ( heal? ,! ,director ( ! ,national ,in/itutes ( ,heal? 7ref]r$ to 9 ?is section z ! ,director ( ,national ,in/itutes ( ,heal?7 %all implem5t measures to r$uce ! adm9i/rative burd5s relat$ to monitor+ ( subrecipi5ts ( grants by prim>y aw>dees ( fund+ f ! ,national ,in/itutes ( ,heal?1 :i* may incorporate f9d+s & recomm5dations f exi/+ & ongo+ activities4 ,su* measures may include1 z appropriate-- 7#a7 an exemption f subrecipi5t monitor+ requirem5ts1 ^u reque/ f ! prim>y aw>dees1 provid$ t-- 7,a7 ! subrecipi5t is subject to ,f$]al audit requirem5ts pursuant to ! ,uni=m ,guidance ( ! ,(fice ( ,managem5t & ,budget2 7,b7 ! prim>y aw>dee conducts1 pursuant to guidance ( ! ,national ,in/itutes ( ,heal?1 a pre-aw>d evaluation ( ea* subrecipi5t's risk ( noncompliance ) ,f$]al /atutes & regulations1 ! conditions ( ! subaw>d1 & any recurr+ audit f9d+s2 & 7,c7 su* exemption does n absolve ! prim>y aw>dee ( liability = misconduct by subrecipi5ts2 & 7#b7 ! implem5tation ( alt]native grant /ructures t obviate ! ne$ = subrecipi5t monitor+1 :i* may include collaborative grant models all[+ = multiple prim>y aw>dees4 7c7 ,report+ ( f9ancial exp5ditures ,! ,secret>y1 9 consultation ) ! ,director ( ,national ,in/itutes ( ,heal?1 %all evaluate f9ancial exp5diture report+ proc$ures & requirem5ts = recipi5ts ( fund+ f ! ,national ,in/itutes ( ,heal? & take action1 z appropriate1 to avoid duplication betwe5 dep>tm5t & ag5cy proc$ures & requirem5ts & m9imize burd5 to fund+ recipi5ts4 7d7 ,animal c>e & use 9 rese>* ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ,national ,in/itutes ( ,heal?1 9 collaboration ) ! ,secret>y ( ,agriculture & ! ,commission] ( ,food & ,drugs1 %all complete a review ( applicable regulations & policies = ! c>e & use ( laboratory animals & make revisions1 z appropriate1 to r$uce adm9i/rative burd5 on inve/igators :ile ma9ta9+ ! integrity & cr$ibility ( rese>* f9d+s & protection ( rese>* animals4 ,9 c>ry+ out ?is ef=t1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all seek ! input ( exp]ts1 z appropriate4 ,! ,director ( ! ,national ,in/itutes ( ,heal? %all-- 7#a7 id5tify ways to ensure su* regulations & policies are n inconsi/5t1 ov]lapp+1 or unnecess>ily duplicative1 includ+ ) respect to inspection & review requirem5ts by ,f$]al ag5cies & accr$it+ associations2 7#b7 take /eps to elim9ate or r$uce id5tifi$ inconsi/5cies1 ov]lap1 or duplication among su* regulations & policies2 & 7#c7 take o!r actions1 z appropriate1 to improve ! coord9ation ( regulations & policies ) respect to rese>* ) laboratory animals4 7e7 ,docum5tation ( p]sonnel exp5ses ,! ,secret>y %all cl>ify ! applicability ( ! requirem5ts "u ! ,(fice ( ,managem5t & ,budget ,uni=m ,guidance = managem5t & c]tification sy/ems adopt$ by entities receiv+ ,f$]al rese>* grants ?r\gh ! ,dep>tm5t ( ,heal? & ,human ,s]vices reg>d+ docum5tation ( p]sonnel exp5ses1 includ+ cl>ification ( ! ext5t to :i* any flexibility to su* requirem5ts specifi$ 9 su* ,uni=m ,guidance applies to entities receiv+ grants ?r\gh ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7f7 ,rese>* policy bo>d 7#a7 ,e/abli%m5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,(fice ( ,managem5t & ,budget %all e/abli% an advisory committee1 to be kn[n z ! ,rese>* ,policy ,bo>d 7ref]r$ to 9 ?is subsection z ! ,bo>d71 to provide ,f$]al ,gov]nm5t (ficials ) in=mation on ! effects ( regulations relat$ to ,f$]al rese>* requirem5ts4 7#b7 ,memb]%ip 7,a7 ,9 g5]al ,! ,bo>d %all include n m ?an #aj ,f$]al memb]s1 includ+ ea* ( ! foll[+ ,f$]al memb]s or _! designees3 7i7 ,! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs ( ! ,(fice ( ,managem5t & ,budget4 7ii7 ,! ,director ( ! ,(fice ( ,sci5ce & ,te*nology ,policy4 7iii7 ,! ,secret>y ( ,heal? & ,human ,s]vices4 7iv7 ,! ,director ( ! ,national ,sci5ce ,f\ndation4 7v7 ,! secret>ies & directors ( o!r dep>tm5ts & ag5cies t support or regulate sci5tific rese>*1 z det]m9$ by ! ,director ( ! ,(fice ( ,managem5t & ,budget4 7,b7 ,non-,f$]al memb]s ,! ,bo>d %all be compris$ ( n less ?an #i & n m ?an #ab repres5tatives ( academic rese>* in/itutions1 o!r private1 nonpr(it rese>* in/itutions1 or o!r nonpr(it organizations ) relevant exp]tise4 ,su* memb]s %all be appo9t$ by a =mal process1 to be e/abli%$ by ! ,director ( ! ,(fice ( ,managem5t & ,budget1 9 consultation ) ! ,f$]al memb]%ip1 & t incorporates-- 7i7 nom9ation by memb]s ( ! nonpr(it sci5tific rese>* community1 includ+ academic rese>* in/itutions2 & 7ii7 proc$ures to fill memb]%ip positions vacat$ be=e ! end ( a memb]'s t]m4 7#c7 ,purpose & responsibilities ,! ,bo>d %all make recomm5dations reg>d+ ! modification & h>monization ( regulations & policies hav+ simil> purposes across rese>* fund+ ag5cies to ensure t ! adm9i/rative burd5 ( su* rese>* policy & regulation is m9imiz$ to ! greate/ ext5t possible & consi/5t ) ma9ta9+ responsible ov]sight ( f$]ally fund$ rese>*4 ,activities ( ! ,bo>d may include-- 7,a7 provid+ ?or\gh & in=m$ analysis ( regulations & policies2 7,b7 id5tify+ negative or adv]se consequ5ces ( exi/+ policies & mak+ actionable recomm5dations reg>d+ possible improvem5t ( su* policies2 7,c7 mak+ recomm5dations ) respect to ef=ts )9 ! ,f$]al ,gov]nm5t to improve coord9ation ( regulation & policy relat$ to rese>*2 7,d7 creat+ a =um = ! discussion ( rese>* policy or regulatory gaps1 *all5ges1 cl>ification1 or h>monization ( su* policies or regulation1 & be/ practices2 & 7,e7 conduct+ ongo+ assessm5t & evaluation ( regulatory burd51 includ+ developm5t ( metrics1 p]iodic measurem5t1 & id5tification ( process improvem5ts & policy *anges4 7#d7 ,exp]t subcommittees ,! ,bo>d may =m tempor>y exp]t subcommittees1 z appropriate1 to develop timely analysis on press+ issues & assi/ ! ,bo>d 9 anticipat+ future regulatory *all5ges1 includ+ *all5ges em]g+ f new sci5tific advances4 7#e7 ,report+ requirem5ts ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 & once !reaft]1 ! ,bo>d %all submit a report to ! ,director ( ! ,(fice ( ,managem5t & ,budget1 ! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs ( ! ,(fice ( ,managem5t & ,budget1 ! ,director ( ! ,(fice ( ,sci5ce & ,te*nology ,policy1 ! heads ( relevant ,f$]al dep>tm5ts & ag5cies1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives conta9+ =mal recomm5dations on ! conceptualization1 developm5t1 h>monization1 & reconsid]ation ( sci5tific rese>* policy1 includ+ ! regulatory b5efits & burd5s4 7#f7 ,sunset ,! ,bo>d %all t]m9ate on ,septemb] #cj1 #bjba4 7#g7 ,,gao report ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct an indep5d5t evaluation ( ! activities c>ri$ out by ! ,bo>d pursuant to ?is subsection & submit to ! appropriate committees ( ,congress a report reg>d+ ! results ( ! indep5d5t evaluation4 ,su* report %all review & assess ! ,bo>d's activities ) respect to ! responsibilities describ$ 9 p>agraph 7#c74 #bjce4 ,exemption = ! ,national ,in/itutes ( ,heal? f ! ,pap]work ,r$uction ,act requirem5ts ,section #cja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda71 z am5d$ by section #bjac1 is fur!r am5d$ by add+ at ! end ! foll[+3 7g7 ,sub*apt] ,i ( *apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! volunt>y collection ( in=mation dur+ ! conduct ( rese>* by ! ,national ,in/itutes ( ,heal?4 4 #bjcf4 ,high-risk1 high-rew>d rese>* 7a7 ,9 g5]al ,section #djb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb71 z am5d$ by section #bjca1 is fur!r am5d$ by add+ at ! end ! foll[+3 7n7 ,unique rese>* initiatives 7#a7 ,9 g5]al ,! ,director ( ,,nih may approve1 aft] consid]ation ( a proposal "u p>agraph 7#b77;,a71 reque/s by ! national rese>* in/itutes & c5t]s1 or program (fic]s )9 ! ,(fice ( ! ,director to engage 9 transactions o!r ?an a contract1 grant1 or coop]ative agreem5t ) respect to projects t c>ry out-- 7,a7 ! ,precision ,m$ic9e ,initiative "u section #dih;,e2 or 7,b7 section #djb7;b77#g71 except t n m ?an #ej p]c5t ( ! funds available = a fiscal ye> ?r\gh ! ,common ,fund "u section #djb;,a7c77#a7 = purposes ( c>ry+ out su* section #djb7;b77#g7 may be us$ to engage 9 su* o!r transactions4 7#b7 ,requirem5ts ,! au?ority provid$ "u ?is subsection may be us$ to conduct or support high impact cutt+-edge rese>* describ$ 9 p>agraph 7#a7 us+ ! o!r transactions au?ority describ$ 9 su* p>agraph if ! in/itute1 c5t]1 or (fice-- 7,a7 submits a proposal to ! ,director ( ,,nih = ! use ( su* au?ority be=e conduct+ or support+ ! rese>*1 includ+ :y ! use ( su* au?ority is ess5tial to promot+ ! success ( ! project2 7,b7 receives approval = ! use ( su* au?ority f ! ,director ( ,,nih2 & 7,c7 = ea* ye> 9 :i* ! in/itute1 c5t]1 or (fice has us$ su* au?ority 9 accordance ) ?is subsection1 submits a report to ! ,director ( ,,nih on ! activities ( ! in/itute1 c5t]1 or (fice relat+ to su* rese>*4 4 7b7 ,report to ,congress ,n lat] ?an ,septemb] #cj1 #bjbj1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all conduct an evaluation ( ! activities "u subsection 7n7 ( section #djb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb71 z add$ by subsection 7a71 & submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on ! results ( su* evaluation4 7c7 ,duties ( directors ( in/itutes ,section #dje7;b77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd7;b77#a77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,c7 ?r\gh 7,l7 z subp>agraphs 7,d7 ?r\gh 7,m71 respectively2 & 7#b7 by ins]t+ aft] subp>agraph 7,b71 ! foll[+3 7,c7 %all1 z appropriate1 conduct & support rese>* t has ! pot5tial to trans=m ! sci5tific field1 has inh]5tly high] risk1 & t seeks to address major curr5t *all5ges2 4 #bjcg4 ,national ,c5t] = ,advanc+ ,translational ,sci5ces 7a7 ,9 g5]al ,section #dgi7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhg7;b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ phase ,,iia & ins]t+ phase ,,iib2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ phase ,,iib & ins]t+ phase ,,iii2 7,b7 9 subp>agraph 7,a71 by /rik+ phase ,,iib & ins]t+ phase ,,iii2 7,c7 9 subp>agraph 7,b71 by /rik+ phase ,,iia & ins]t+ phase ,,iib2 & 7,d7 9 subp>agraph 7,c71 by /rik+ phase ,,iib & ins]t+ phase ,,iii4 7b7 ,increas$ transp>5cy ,section #dgi ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhg7 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 7#d77;,d71 by /rik+ & at ! end2 7,b7 9 p>agraph 7#e71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7,c7 by add+ at ! end ! foll[+3 7#f7 ! me?ods & tools1 if any1 t h be5 develop$ s9ce ! la/ bi5nial report 0 prep>$2 & 7#g7 ! me?ods & tools1 if any1 t h be5 develop$ & are be+ utiliz$ by ! ,food & ,drug ,adm9i/ration to support m$ical product reviews4 2 & 7#b7 by add+ at ! end ! foll[+3 7d7 ,inclusion ( li/ ,! fir/ bi5nial report submitt$ "u ?is section aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act %all include a complete li/ ( all ( ! me?ods & tools1 if any1 :i* h be5 develop$ by rese>* support$ by ! ,c5t]4 7e7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any in=mation t is a trade secret1 or o!r privileg$ or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 #bjch4 ,collaboration & coord9ation to enhance rese>* 7a7 ,rese>* priorities2 collaborative rese>* projects ,section #djb7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;b77 is am5d$-- 7#a7 by am5d+ p>agraph 7#d7 to read z foll[s3 7#d7 %all assemble accurate data to be us$ to assess rese>* priorities1 includ+-- 7,a7 in=mation to bett] evaluate sci5tific opportunity1 public heal? burd5s1 & progress 9 r$uc+ heal? disp>ities2 & 7,b7 data on /udy populations ( cl9ical rese>*1 fund$ by or conduct$ at ea* national rese>* in/itute & national c5t]1 :i*-- 7i7 specifies ! inclusion (-- 7,i7 wom52 7,,ii7 memb]s ( m9ority gr\ps2 7,,iii7 relevant age categories1 includ+ p$iatric subgr\ps2 & 7,,iv7 o!r demographic v>iables z ! ,director ( ! ,national ,in/itutes ( ,heal? det]m9es appropriate2 7ii7 is disaggregat$ by rese>* area1 condition1 & disease categories2 & 7iii7 is to be made publicly available on ! ,int]net website ( ! ,national ,in/itutes ( ,heal?2 2 & 7#b7 9 p>agraph 7#h7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & at ! end2 & 7,b7 by add+ at ! end ! foll[+3 7,c7 fo/] collaboration betwe5 cl9ical rese>* projects fund$ by ! respective national rese>* in/itutes & national c5t]s t-- 7i7 conduct rese>* involv+ human subjects2 & 7ii7 collect simil> data2 & 7,d7 enc\rage ! collaboration describ$ 9 subp>agraph 7,c7 to-- 7i7 all[ = an increase 9 ! numb] ( subjects /udi$2 & 7ii7 utilize div]se /udy populations1 ) special consid]ation to biological1 social1 & o!r det]m9ants ( heal? t contribute to heal? disp>ities2 4 7b7 ,report+ ,section #dib;,b7f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b7;f77 is am5d$-- 7#a7 by /rik+ bi5nial ea* place su* t]m appe>s & ins]t+ tri5nial2 7#b7 by /rik+ ,! advisory c\ncil & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,! advisory c\ncil 2 & 7#c7 by add+ at ! end ! foll[+3 7#b7 ,cont5ts ,ea* tri5nial report prep>$ by an advisory c\ncil ( ea* national rese>* in/itute z describ$ 9 p>agraph 7#a7 %all include ea* ( ! foll[+3 7,a7 ,! numb] ( wom5 includ$ z subjects1 & ! proportion ( subjects t are wom51 9 any project ( cl9ical rese>* conduct$ dur+ ! applicable report+ p]iod1 disaggregat$ by categories ( rese>* area1 condition1 or disease1 & acc\nt+ = s+le-sex /udies4 7,b7 ,! numb] ( memb]s ( m9ority gr\ps includ$ z subjects1 & ! proportion ( subjects t are memb]s ( m9ority gr\ps1 9 any project ( cl9ical rese>* conduct$ dur+ ! applicable report+ p]iod1 disaggregat$ by categories ( rese>* area1 condition1 or disease & acc\nt+ = s+le-race & s+le-e?nicity /udies4 7,c7 ,= ! applicable report+ p]iod1 ! numb] ( projects ( cl9ical rese>* t include wom5 & memb]s ( m9ority gr\ps & t-- 7i7 h be5 complet$ dur+ su* report+ p]iod2 & 7ii7 are be+ c>ri$ out dur+ su* report+ p]iod & h n be5 complet$4 7,d7 ,! numb] ( /udies complet$ dur+ ! applicable report+ p]iod = :i* report+ has be5 submitt$ 9 accordance ) subsection 7c77#b77;,a74 4 7c7 ,coord9ation ,section #dhf7;c77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhg;d7c77#b77 is am5d$ by /rik+ designees & ins]t+ s5ior-level /aff designees4 7d7 ,9 g5]al ,"p ,a ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq471 z am5d$ by section #bjba1 is fur!r am5d$ by add+ at ! end ! foll[+3 #djd,n4 ,population focus$ rese>* ,! ,director ( ! ,national ,in/itutes ( ,heal? %all1 z appropriate1 enc\rage ef=ts to improve rese>* relat$ to ! heal? ( sexual & g5d] m9ority populations1 includ+ by-- 7#a7 facilitat+ increas$ p>ticipation ( sexual & g5d] m9ority populations 9 cl9ical rese>* support$ by ! ,national ,in/itutes ( ,heal?1 & report+ on su* p>ticipation1 z applicable2 7#b7 facilitat+ ! developm5t ( valid & reliable me?ods = rese>* relevant to sexual & g5d] m9ority populations2 & 7#c7 address+ me?odological *all5ges4 4 7e7 ,report+ 7#a7 ,9 g5]al ,! ,secret>y1 9 collaboration ) ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all z appropriate-- 7,a7 cont9ue to support rese>* = ! developm5t ( appropriate measures relat$ to report+ heal? in=mation ab\t sexual & g5d] m9ority populations2 & 7,b7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 dissem9ate & make public su* measures4 7#b7 ,national academy ( m$ic9e recomm5dations ,9 develop+ ! measures describ$ 9 p>agraph 7#a77;,a71 ! ,secret>y %all take into acc\nt recomm5dations made by ! ,national ,academy ( ,m$ic9e4 7f7 ,improv+ coord9ation relat$ to m9ority heal? & heal? disp>ities ,section #dfdz-#c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhet7 is am5d$-- 7#a7 by r$esignat+ subsection 7h71 relat+ to int]ag5cy coord9ation1 t foll[s subsection 7j7 z subsection 7k72 & 7#b7 9 subsection 7k7 7z s r$esignat$7-- 7,a7 9 ! subsection head+1 by /rik+ ,int]ag5cy & ins]t+ ,intra-,national ,in/itutes ( ,heal?2 7,b7 by /rik+ z ! prim>y ,f$]al (ficials & ins]t+ z ! prim>y ,f$]al (ficial2 7,c7 by ins]t+ a comma aft] review2 7,d7 by /rik+ ,in/itutes & ,c5t]s ( ! ,national ,in/itutes ( ,heal? & ins]t+ national rese>* in/itutes & national c5t]s2 & 7,e7 by add+ at ! end ! foll[+3 ,! ,director ( ! ,in/itute may fo/] p>tn]%ips betwe5 ! national rese>* in/itutes & national c5t]s & may enc\rage ! fund+ ( collaborative rese>* projects to a*ieve ! goals ( ! ,national ,in/itutes ( ,heal? t are relat$ to m9ority heal? & heal? disp>ities44 7g7 ,basic rese>* 7#a7 ,develop+ policies ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? 7ref]r$ to 9 ?is section z ! ,director ( ! ,national ,in/itutes ( ,heal?71 tak+ into consid]ation ! recomm5dations develop$ "u section #bjci1 %all develop policies = projects ( basic rese>* fund$ by ,national ,in/itutes ( ,heal? to assess-- 7,a7 relevant biological v>iables includ+ sex1 z appropriate2 & 7,b7 h[ diff]5ces betwe5 male & female cells1 tissues1 or animals may be exam9$ & analyz$4 7#b7 ,revis+ policies ,! ,director ( ! ,national ,in/itutes ( ,heal? may update or revise ! policies develop$ "u p>agraph 7#a7 z appropriate4 7#c7 ,consultation & outrea* ,9 develop+1 updat+1 or revis+ ! policies "u ?is section1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all-- 7,a7 consult )-- 7i7 ! ,(fice ( ,rese>* on ,wom5's ,heal?2 7ii7 ! ,(fice ( ,laboratory ,animal ,welf>e2 & 7iii7 appropriate memb]s ( ! sci5tific & academic communities2 & 7,b7 conduct outrea* to solicit fe$back f memb]s ( ! sci5tific & academic communities on ! influ5ce ( sex z a v>iable 9 basic rese>*1 includ+ fe$back on :5 x is appropriate = projects ( basic rese>* involv+ cells1 tissues1 or animals to include bo? male & female cells1 tissues1 or animals4 7#d7 ,additional requirem5ts ,! ,director ( ! ,national ,in/itutes ( ,heal? %all-- 7,a7 ensure t projects ( basic rese>* fund$ by ! ,national ,in/itutes ( ,heal? are conduct$ 9 accordance ) ! policies develop$1 updat$1 or revis$ "u ?is section1 z applicable2 & 7,b7 enc\rage t ! results ( su* rese>*1 :5 publi%$ or report$1 be disaggregat$ z appropriate ) respect to ! analysis ( any sex diff]5ces4 7h7 ,cl9ical rese>* 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal?1 9 consultation ) ! ,director ( ! ,(fice ( ,rese>* on ,wom5's ,heal? & ! ,director ( ! ,national ,in/itute on ,m9ority ,heal? & ,heal? ,disp>ities1 %all update ! guidel9es e/abli%$ "u section #dib;,b7d7 ( ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b7;d77 9 accordance ) p>agraph 7#b74 7#b7 ,requirem5ts ,! updat$ guidel9es describ$ 9 p>agraph 7#a7 %all-- 7,a7 reflect ! sci5ce reg>d+ sex diff]5ces2 7,b7 improve adh]5ce to ! requirem5ts "u section #dib;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b71 includ+ ! report+ requirem5ts "u subsection 7f7 ( su* section2 & 7,c7 cl>ify ! circum/ances "u :i* /udies %\ld be design$ to support ! conduct ( analyses to detect significant diff]5ces 9 ! int]v5tion effect due to demographic factors relat$ to section #dib;,b ( ! ,public ,heal? ,s]vice ,act1 includ+ 9 ! abs5ce ( prior /udies t demon/rate a diff]5ce 9 /udy outcomes on ! basis ( su* factors & consid]+ ! effects ( ! abs5ce ( su* analyses on ! availability ( data relat$ to demographic diff]5ces4 7i7 ,appropriate age gr\p+s 9 cl9ical rese>* 7#a7 ,input f exp]ts ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all conv5e a work%op ( exp]ts on p$iatric & old] populations to provide input on-- 7,a7 appropriate age gr\ps to be includ$ 9 rese>* /udies involv+ human subjects2 & 7,b7 acceptable ju/ifications = exclud+ p>ticipants f a range ( age gr\ps f human subjects rese>* /udies4 7#b7 ,policy updates ,n lat] ?an #ahj days aft] ! conclusion ( ! work%op "u p>agraph 7#a71 ! ,director ( ! ,national ,in/itutes ( ,heal? %all make a det]m9ation ) respect to :e!r ! policies ( ! ,national ,in/itutes ( ,heal? on ! inclusion ( relevant age gr\ps 9 cl9ical /udies ne$ to be updat$1 & %all update su* policies z appropriate4 ,9 mak+ ! det]m9ation1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all take into consid]ation :e!r su* policies-- 7,a7 address ! consid]ation ( age z an inclusion v>iable 9 rese>* involv+ human subjects2 & 7,b7 id5tify ! crit]ia = ju/ification = any age-relat$ exclusions 9 su* rese>*4 7#c7 ,public ,availability ( ,f9d+s & ,conclusions ,! ,director ( ! ,national ,in/itutes ( ,heal? %all-- 7,a7 make ! f9d+s & conclusions result+ f ! work%op "u p>agraph 7#a7 & updates to policies 9 accordance ) p>agraph 7#b71 z applicable1 available to ! public on ! ,int]net website ( ! ,national ,in/itutes ( ,heal?2 & 7,b7 ensure t age-relat$ data report$ 9 ! tri5nial report "u section #djc ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc7 7z am5d$ by section #bjcb7 are made available to ! public on ! ,int]net website ( ! ,national ,in/itutes ( ,heal?4 #bjci4 ,enhanc+ ! rigor & reproducibility ( sci5tific rese>* 7a7 ,e/abli%m5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all conv5e a work+ gr\p "u ! ,advisory ,committee to ! ,director ( ! ,national ,in/itutes ( ,heal? 7ref]r$ to 9 ?is section z ! ,advisory ,committee71 appo9t$ "u section #bbb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bag;a71 to develop & issue recomm5dations ?r\gh ! ,advisory ,committee = a =mal policy1 :i* may incorporate or be in=m$ by relevant exi/+ & ongo+ activities1 to enhance rigor & reproducibility ( sci5tific rese>* fund$ by ! ,national ,in/itutes ( ,heal?4 7b7 ,consid]ations ,9 develop+ & issu+ recomm5dations ?r\gh ! ,advisory ,committee "u subsection 7a71 ! work+ gr\p e/abli%$ "u su* subsection %all consid]1 z appropriate-- 7#a7 precl9ical exp]im5t design1 includ+ analysis ( sex z a biological v>iable2 7#b7 cl9ical exp]im5t design1 includ+-- 7,a7 ! div]sity ( populations /udi$ = cl9ical rese>*1 ) respect to biological1 social1 & o!r det]m9ants ( heal? t contribute to heal? disp>ities2 7,b7 ! circum/ances "u :i* summ>y in=mation reg>d+ biological1 social1 & o!r factors t contribute to heal? disp>ities %\ld be report$2 & 7,c7 ! circum/ances "u :i* cl9ical /udies1 includ+ cl9ical trials1 %\ld conduct an analysis ( ! data collect$ dur+ ! /udy on ! basis ( biological1 social1 & o!r factors t contribute to heal? disp>ities2 7#c7 applicable levels ( rigor 9 /ati/ical me?ods1 me?odology1 & analysis2 7#d7 data & in=mation %>+ 9 accordance ) applicable privacy laws & regulations2 & 7#e7 any o!r matt] ! work+ gr\p det]m9es relevant4 7c7 ,policies ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all consid] ! recomm5dations develop$ by ! work+ gr\p & issu$ by ! ,advisory ,committee "u subsection 7a7 & develop or update policies z appropriate4 7d7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all issue a report to ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives reg>d+ recomm5dations develop$ "u subsection 7a7 & any subsequ5t policy *anges implem5t$1 to enhance rigor & reproducibility 9 sci5tific rese>* fund$ by ! ,national ,in/itutes ( ,heal?4 7e7 ,confid5tiality ,no?+ 9 ?is section au?orizes ! ,secret>y ( ,heal? & ,human ,s]vices to disclose any in=mation t is a trade secret1 or o!r privileg$ or confid5tial in=mation1 describ$ 9 section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 #bjdj4 ,improv+ m$ical rehabilitation rese>* at ! ,national ,in/itutes ( ,heal? 7a7 ,9 g5]al ,section #deb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhe;g-#d7 is am5d$-- 7#a7 9 subsection 7b71 by /rik+ conduct & support & ins]t+ conduct1 support1 & coord9ation2 7#b7 9 subsection 7c77#a77;,c71 by /rik+ ( ! ,c5t] & ins]t+ )9 ! ,c5t]2 7#c7 9 subsection 7d7-- 7,a7 by /rik+ 7d77#a7 ,9 consultation & all t foll[s ?r\gh ! end ( p>agraph 7#a7 & ins]t+ ! foll[+3 7d7 7#a7 ,! ,director ( ! ,c5t]1 9 consultation ) ! ,director ( ! ,in/itute1 ! coord9at+ committee e/abli%$ "u subsection 7e71 & ! advisory bo>d e/abli%$ "u subsection 7f71 %all develop a compreh5sive plan 7ref]r$ to 9 ?is section z ! ,rese>* ,plan7 = ! conduct1 support1 & coord9ation ( m$ical rehabilitation rese>*4 2 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by /rik+ 2 & & ins]t+ a semicolon2 7ii7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,c7 include goals & objectives = conduct+1 support+1 & coord9at+ m$ical rehabilitation rese>*1 consi/5t ) ! purpose describ$ 9 subsection 7b74 2 7,c7 by /rik+ p>agraph 7#d7 & ins]t+ ! foll[+3 7#d7 ,! ,director ( ! ,c5t]1 9 consultation ) ! ,director ( ! ,in/itute1 ! coord9at+ committee e/abli%$ "u subsection 7e71 & ! advisory bo>d e/abli%$ "u subsection 7f71 %all revise & update ! ,rese>* ,plan p]iodically1 z appropriate1 or n less ?an e #e ye>s4 ,n lat] ?an #cj days aft] ! ,rese>* ,plan is s revis$ & updat$1 ! ,director ( ! ,c5t] %all transmit ! revis$ & updat$ ,rese>* ,plan to ! ,presid5t1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,d7 by add+ at ! end ! foll[+3 7#e7 ,! ,director ( ! ,c5t]1 9 consultation ) ! ,director ( ! ,in/itute1 %all1 prior to revis+ & updat+ ! ,rese>* ,plan1 prep>e a report = ! coord9at+ committee e/abli%$ "u subsection 7e7 & ! advisory bo>d e/abli%$ "u subsection 7f7 t describes & analyzes ! progress dur+ ! prec$+ fiscal ye> 9 a*iev+ ! goals & objectives describ$ 9 p>agraph 7#b77;,c7 & includes exp5ditures = rehabilitation rese>* at ! ,national ,in/itutes ( ,heal?4 ,! report %all include recomm5dations = revis+ & updat+ ! ,rese>* ,plan1 & su* initiatives z ! ,director ( ! ,c5t] & ! ,director ( ! ,in/itute det]m9e appropriate4 ,9 prep>+ ! report1 ! ,director ( ! ,c5t] & ! ,director ( ! ,in/itute %all consult ) ! ,director ( ! ,national ,in/itutes ( ,heal?4 2 7#d7 9 subsection 7e7-- 7,a7 9 p>agraph 7#b71 by ins]t+ p]iodically ho/ a sci5tific conf]5ce or work%op on m$ical rehabilitation rese>* & aft] ,! ,coord9at+ ,committee %all2 & 7,b7 9 p>agraph 7#c71 by ins]t+ ! ,director ( ! ,division ( ,program ,coord9ation1 ,plann+1 & ,/rategic ,initiatives )9 ! ,(fice ( ! ,director ( ! ,national ,in/itutes ( ,heal?1 aft] %all be compos$ (2 7#e7 9 subsection 7f77#c77;,b7-- 7,a7 by r$esignat+ clauses 7ix7 ?r\gh 7xi7 z clauses 7x7 ?r\gh 7xii71 respectively2 & 7,b7 by ins]t+ aft] clause 7viii7 ! foll[+3 7ix7 ,! ,director ( ! ,division ( ,program ,coord9ation1 ,plann+1 & ,/rategic ,initiatives4 2 & 7#f7 by add+ at ! end ! foll[+3 7g7 7#a7 ,! ,secret>y & ! heads ( o!r ,f$]al ag5cies %all jo9tly review ! programs c>ri$ out 7or propos$ to be c>ri$ out7 by ea* su* (ficial ) respect to m$ical rehabilitation rese>* &1 z appropriate1 ent] into agreem5ts prev5t+ duplication among su* programs4 7#b7 ,! ,secret>y %all1 z appropriate1 ent] into int]ag5cy agreem5ts relat+ to ! coord9ation ( m$ical rehabilitation rese>* conduct$ by ag5cies ( ! ,national ,in/itutes ( ,heal? & o!r ag5cies ( ! ,f$]al ,gov]nm5t4 7h7 ,= purposes ( ?is section1 ! t]m m$ical rehabilitation rese>* means ! sci5ce ( me*anisms & int]v5tions t prev5t1 improve1 re/ore1 or replace lo/1 und]develop$1 or det]iorat+ function4 4 7b7 ,con=m+ am5dm5t ,section #c ( ! ,national ,in/itutes ( ,heal? ,am5dm5ts ( #aiij 7#db ,u4,s4,c4 #bhe;g-#d note7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ ,9 ,g5]al4--2 & 7#b7 by /rik+ subsection 7b74 #bjda4 ,task =ce on rese>* specific to pregnant wom5 & lactat+ wom5 7a7 ,task =ce on rese>* specific to pregnant wom5 & lactat+ wom5 7#a7 ,e/abli%m5t ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all e/abli% a task =ce1 9 accordance ) ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app471 to be kn[n z ! ,task ,=ce on ,rese>* ,specific to ,pregnant ,wom5 & ,lactat+ ,wom5 79 ?is section ref]r$ to z ! ,task ,=ce74 7#b7 ,duties ,! ,task ,=ce %all provide advice & guidance to ! ,secret>y reg>d+ ,f$]al activities relat$ to id5tify+ & address+ gaps 9 k & rese>* reg>d+ safe & effective !rapies = pregnant wom5 & lactat+ wom51 includ+ ! developm5t ( su* !rapies & ! collaboration on & coord9ation ( su* activities4 7#c7 ,memb]%ip 7,a7 ,f$]al memb]s ,! ,task ,=ce %all be compos$ ( ea* ( ! foll[+ ,f$]al memb]s1 or ! designees ( su* memb]s3 7i7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7ii7 ,! ,director ( ! ,national ,in/itutes ( ,heal?1 ! ,director ( ! ,eunice ,k5n$y ,%riv] ,national ,in/itute ( ,*ild ,heal? & ,human ,developm5t1 & ! directors ( su* o!r appropriate national rese>* in/itutes4 7iii7 ,! ,commission] ( ,food & ,drugs4 7iv7 ,! ,director ( ! ,(fice on ,wom5's ,heal?4 7v7 ,! ,director ( ! ,national ,vacc9e ,program ,(fice4 7vi7 ,! head ( any o!r rese>*-relat$ ag5cy or dep>tm5t n describ$ 9 clauses 7i7 ?r\gh 7v7 t ! ,secret>y det]m9es appropriate1 :i* may include ! ,dep>tm5t ( ,vet]ans ,affairs & ! ,dep>tm5t ( ,def5se4 7,b7 ,non-,f$]al memb]s ,! ,task ,=ce %all be compos$ ( ea* ( ! foll[+ non-,f$]al memb]s1 includ+-- 7i7 repres5tatives f relevant m$ical societies ) subject matt] exp]tise on pregnant wom51 lactat+ wom51 or *ildr52 7ii7 nonpr(it organizations ) exp]tise relat$ to ! heal? ( wom5 & *ildr52 7iii7 relevant indu/ry repres5tatives2 & 7iv7 o!r repres5tatives1 z appropriate4 7,c7 ,limitations ,! non-,f$]al memb]s describ$ 9 subp>agraph 7,b7 %all-- 7i7 compose n m ?an "o-half1 & n less ?an "o-?ird1 ( ! total memb]%ip ( ! ,task ,=ce2 & 7ii7 be appo9t$ by ! ,secret>y4 7#d7 ,t]m9ation 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! ,task ,=ce %all t]m9ate on ! date t is #b ye>s aft] ! date on :i* ! ,task ,=ce is e/abli%$ "u p>agraph 7#a74 7,b7 ,ext5sion ,! ,secret>y may ext5d ! op]ation ( ! ,task ,=ce = "o additional #b-ye> p]iod foll[+ ! #b-ye> p]iod describ$ 9 subp>agraph 7,a71 if ! ,secret>y det]m9es t ! ext5sion is appropriate = c>ry+ out ! purpose ( ?is section4 7#e7 ,meet+s ,! ,task ,=ce %all meet n less ?an #b times ea* ye> & %all conv5e public meet+s1 z appropriate1 to fulfill its duties "u p>agraph 7#b74 7#f7 ,task =ce report to congress ,n lat] ?an #ah mon?s aft] ! date on :i* ! ,task ,=ce is e/abli%$ "u p>agraph 7#a71 ! ,task ,=ce %all prep>e & submit to ! ,secret>y1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t includes ea* ( ! foll[+3 7,a7 ,a plan to id5tify & address gaps 9 k & rese>* reg>d+ safe & effective !rapies = pregnant wom5 & lactat+ wom51 includ+ ! developm5t ( su* !rapies4 7,b7 ,e?ical issues surr\nd+ ! inclusion ( pregnant wom5 & lactat+ wom5 9 cl9ical rese>*4 7,c7 ,effective communication /rategies ) heal? c>e provid]s & ! public on in=mation relevant to pregnant wom5 & lactat+ wom54 7,d7 ,id5tification ( ,f$]al activities1 includ+-- 7i7 ! /ate ( rese>* on pregnancy & lactation2 7ii7 recomm5dations = ! coord9ation (1 & collaboration on rese>* relat$ to pregnant wom5 & lactat+ wom52 7iii7 dissem9ation ( rese>* f9d+s & in=mation relevant to pregnant wom5 & lactat+ wom5 to provid]s & ! public2 & 7iv7 exi/+ ,f$]al ef=ts & programs to improve ! sci5tific und]/&+ ( ! heal? impacts on pregnant wom51 lactat+ wom51 & relat$ bir? & p$iatric outcomes1 includ+ ) respect to ph>macok9etics1 ph>macodynamics1 & toxicities4 7,e7 ,recomm5dations to improve ! developm5t ( safe & effective !rapies = pregnant wom5 & lactat+ wom54 7b7 ,confid5tiality ,no?+ 9 ?is section %all au?orize ! ,secret>y ( ,heal? & ,human ,s]vices to disclose any in=mation t is a trade secret1 or o!r privileg$ or confid5tial in=mation1 describ$ 9 section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 7c7 ,updat+ protections = pregnant wom5 & lactat+ wom5 9 rese>* 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 consid]+ any recomm5dations ( ! ,task ,=ce available at su* "t & 9 consultation ) ! heads ( relevant ag5cies ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all1 z appropriate1 update regulations & guidance1 z applicable1 reg>d+ ! inclusion ( pregnant wom5 & lactat+ wom5 9 cl9ical rese>*4 7#b7 ,crit]ia = exclud+ pregnant or lactat+ wom5 ,9 updat+ any regulations or guidance describ$ 9 p>agraph 7#a71 ! ,secret>y %all consid] any appropriate crit]ia to be us$ by in/itutional review bo>ds & individuals review+ grant proposals = exclud+ pregnant wom5 or lactat+ wom5 z a /udy population requir+ additional protections f p>ticipat+ 9 human subject rese>*4 #bjdb4 ,/reaml9+ ,national ,in/itutes ( ,heal? report+ requirem5ts 7a7 ,trans-,national ,in/itutes ( ,heal? rese>* report+ ,section #djb;,a7c77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb;a7c77#b77 is am5d$-- 7#a7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,report+ ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( #ba/ ,c5tury ,cures ,act1 ! head ( ea* national rese>* in/itute or national c5t] %all submit to ! ,director ( ! ,national ,in/itutes ( ,heal? a report1 to be includ$ 9 ! tri5nial report "u section #djc1 on ! am\nt made available by ! in/itute or c5t] = conduct+ or support+ rese>* t involves collaboration betwe5 ! in/itute or c5t] & #a or m o!r national rese>* in/itutes or national c5t]s4 2 & 7#b7 9 subp>agraphs 7,d7 & 7,e7 by /rik+ 7,b77i7 ea* place x appe>s & ins]t+ 7,b74 7b7 ,fraud & abuse report+ ,section #djc;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc;a-#a7 is am5d$-- 7#a7 by /rik+ subsection 7b72 7#b7 by r$esignat+ subsection 7c7 z subsection 7b72 & 7#c7 9 subsection 7b7 7z s r$esignat$71 by /rik+ subsections 7a7 & 7b7 & ins]t+ subsection 7a74 7c7 ,doctoral degrees report+ ,section #djc;,c7a77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc;a-#b7;a77#b77 is am5d$ by /rik+ 7n includ+ any leaves ( abs5ce74 7d7 ,vacc9e report+ ,section #djd;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc;d7 is am5d$-- 7#a7 by /rik+ subsection 7b72 & 7#b7 by /rik+ 7a7 ,developm5t ( ,new ,vacc9es4--,! ,secret>y & ins]t+ ,! ,secret>y4 7e7 ,national c5t] = advanc+ translational sci5ces ,section #dgi7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhg7;c77 is am5d$-- 7#a7 9 ! subsection head+1 by /rik+ ,annual & ins]t+ ,bi5nial2 & 7#b7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ an annual report & ins]t+ a report on a bi5nial basis4 7f7 ,review ( c5t]s ( excell5ce 7#a7 ,repeal ,section #djd;,h ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc;j7 is repeal$4 7#b7 ,con=m+ am5dm5t ,section #cii;,,ee7c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj-d7;c77 is am5d$ by /rik+ #cii;,,cc1 #djd;,h1 & ins]t+ #cii;,,cc4 7g7 ,rapid ,,hiv te/ report ,section #ejb7;a7 ( ! ,ryan ,:ite ,,c>e ,act ,am5dm5ts ( #bjjj 7#db ,u4,s4,c4 #cjj;cc note7 is am5d$-- 7#a7 by /rik+ p>agraph 7#b72 & 7#b7 by r$esignat+ p>agraph 7#c7 z p>agraph 7#b74 7h7 ,national ,in/itute ( ,nurs+ ,rese>* 7#a7 ,repeal ,section #dfd,y ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bheq-#c7 is repeal$4 7#b7 ,con=m+ am5dm5t ,section #dfd,x7g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bheq-#b7;g77 is am5d$ by /rik+ bi5nial report made "u section #dfd,y1 & ins]t+ tri5nial report made "u section #djc4 #bjdc4 ,reimbursem5t = rese>* sub/ances & liv+ organisms ,section #cja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda71 z am5d$ by section #bjce1 is fur!r am5d$-- 7#a7 9 ! flu% matt] at ! end ( subsection 7a7-- 7,a7 by r$esignat+ su* matt] z subsection 7h77#a72 & 7,b7 by mov+ su* matt] s z to appe> at ! end ( su* section2 & 7#b7 9 subsection 7h7 7z s r$esignat$71 by add+ at ! end ! foll[+3 7#b7 ,:]e rese>* sub/ances & liv+ organisms are made available "u p>agraph 7#a7 ?r\gh contractors1 ! ,secret>y may direct su* contractors to collect paym5ts on behalf ( ! ,secret>y = ! co/s incurr$ to make available su* sub/ances & organisms & to =w>d am\nts s collect$ to ! ,secret>y1 9 ! "t & mann] specifi$ by ! ,secret>y4 7#c7 ,am\nts collect$ "u p>agraph 7#b7 %all be cr$it$ to ! appropriations acc\nts t incurr$ ! co/s to make available ! rese>* sub/ances & liv+ organisms involv$1 & %all rema9 available until exp5d$ = c>ry+ out activities "u su* acc\nts4 4 #bjdd4 ,s5se ( ,congress on increas$ inclusion ( und]repres5t$ populations 9 cl9ical trials ,x is ! s5se ( ,congress t ! ,national ,in/itute on ,m9ority ,heal? & ,heal? ,disp>ities %\ld include )9 its /rategic plan "u section #djb7m7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7m77 ways to increase repres5tation ( und]repres5t$ populations 9 cl9ical trials4 ,e ,advancem5t ( ! ,national ,in/itutes ( ,heal? rese>* & data access #bjea4 ,te*nical updates to cl9ical trials database ,section #djb7;j77#b77;,d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j77#b77;,d77 is am5d$-- 7#a7 9 clause 7ii77,i71 by ins]t+ be=e ! semicolon 1 unless ! responsible p>ty affirmatively reque/s t ! ,director ( ! ,national ,in/itutes ( ,heal? publicly po/ su* cl9ical trial in=mation = an applicable device cl9ical trial prior to su* date ( cle>ance or approval2 & 7#b7 by add+ at ! end ! foll[+3 7iii7 ,option to make c]ta9 cl9ical trial in=mation available e>li] ,! ,director ( ! ,national ,in/itutes ( ,heal? %all in=m responsible p>ties ( ! option to reque/ t cl9ical trial in=mation = an applicable device cl9ical trial be publicly po/$ prior to ! date ( cle>ance or approval1 9 accordance ) clause 7ii77,i74 7iv7 ,comb9ation products ,an applicable cl9ical trial = a product t is a comb9ation ( drug1 device1 or biological product %all be consid]$-- 7,i7 an applicable drug cl9ical trial1 if ! ,secret>y det]m9es "u section #ejc7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act t ! prim>y mode ( action ( su* product is t ( a drug or biological product2 or 7,,ii7 an applicable device cl9ical trial1 if ! ,secret>y det]m9es "u su* section t ! prim>y mode ( action ( su* product is t ( a device4 4 #bjeb4 ,compliance activities reports 7a7 ,def9itions ,9 ?is section3 7#a7 ,applicable cl9ical trial ,! t]m applicable cl9ical trial has ! mean+ giv5 ! t]m 9 section #djb7;j7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j774 7#b7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 7b7 ,report on activities ,to enc\rage compliance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal? & 9 collaboration ) ! ,commission] ( ,food & ,drugs1 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report t describes education & outrea*1 guidance1 en=cem5t1 & o!r activities und]tak5 to enc\rage compliance ) section #djb7;j7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j774 7c7 ,reports on cl9ical trials 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! f9al compliance date "u ! f9al rule implem5t+ section #djb7;j7 ( ! ,public ,heal? ,s]vice ,act1 & e #b ye>s !reaft] = ! next #d ye>s1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal? & 9 collaboration ) ! ,commission] ( ,food & ,drugs1 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report describ+-- 7,a7 ! total numb] ( applicable cl9ical trials ) complete data bank regi/ration in=mation regi/]$ dur+ ! p]iod = :i* ! report is be+ prep>$ 7brok5 d[n by ea* ye> ( su* report+ p]iod72 7,b7 ! total numb] ( applicable cl9ical trials regi/]$ dur+ ! p]iod = :i* ! report is be+ prep>$ = :i* results h be5 submitt$ to ! data bank 7brok5 d[n by ea* ye> ( su* report+ p]iod72 7,c7 ! activities und]tak5 by ! ,secret>y to educate responsible p]sons ab\t data bank regi/ration & results submission requirem5ts1 includ+ ?r\gh issuance ( guidance docum5ts1 in=mational meet+s1 & tra9+ sessions2 & 7,d7 ! activities describ$ 9 ! report submitt$ "u subsection 7b74 7#b7 ,actions to en=ce compliance ,aft] ! ,secret>y has und]tak5 ! educational activities describ$ 9 p>agraph 7#a77;,c71 ! ,secret>y %all include 9 subsequ5t reports submitt$ "u p>agraph 7#a7 ! numb] ( actions tak5 by ! ,secret>y dur+ ! p]iod = :i* ! report is be+ prep>$ to en=ce compliance ) data bank regi/ration & results submission requirem5ts4 #bjec4 ,updates to policies to improve data ,section #dib;,b7c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b7;c77 is am5d$-- 7#a7 by /rik+ ,9 ! case & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,9 ! case 2 & 7#b7 by add+ at ! end ! foll[+3 7#b7 ,report+ requirem5ts ,= any new & compet+ project ( cl9ical rese>* subject to ! requirem5ts "u ?is section t receives a grant aw>d #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 or any date !reaft]1 = :i* a valid analysis is provid$ "u p>agraph 7#a7-- 7,a7 & :i* is an applicable cl9ical trial z def9$ 9 section #djb7;j71 ! entity conduct+ su* cl9ical rese>* %all submit ! results ( su* valid analysis to ! cl9ical trial regi/ry data bank exp&$ "u section #djb7;j77#c71 & ! ,director ( ! ,national ,in/itutes ( ,heal? %all1 z appropriate1 consid] :e!r su* entity has compli$ ) ! report+ requirem5t describ$ 9 ?is subp>agraph 9 aw>d+ any future grant to su* entity1 includ+ pursuant to section #djb7;j77#e77;,a77ii7 :5 applicable2 & 7,b7 ! ,director ( ! ,national ,in/itutes ( ,heal? %all enc\rage ! report+ ( ! results ( su* valid analysis describ$ 9 p>agraph 7#a7 ?r\gh any additional means det]m9$ appropriate by ! ,director4 4 #bjed4 ,consultation ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all consult ) relevant ,f$]al ag5cies1 includ+ ! ,food & ,drug ,adm9i/ration1 ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 & ! ,national ,in/itutes ( ,heal?1 z well z o!r /akehold]s 7includ+ pati5ts1 rese>*]s1 physicians1 indu/ry repres5tatives1 & develop]s ( heal? in=mation te*nology7 to receive recomm5dations ) respect to enhancem5ts to ! cl9ical trial regi/ry data bank "u section #djb7;j7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j771 includ+ ) respect to usability1 functionality1 & se>* capability4 ,f ,facilitat+ collaborative rese>* #bjfa4 ,national neurological conditions surveillance sy/em ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by ins]t+ aft] section #cii,s ! foll[+3 #cii,s-#a4 ,surveillance ( neurological diseases 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) o!r ag5cies z ! ,secret>y det]m9es1 %all1 z appropriate-- 7#a7 enhance & exp& infra/ructure & activities to track ! epidemiology ( neurological diseases2 & 7#b7 incorporate in=mation obta9$ ?r\gh su* activities into an integrat$ surveillance sy/em1 :i* may consi/ ( or include a regi/ry1 to be kn[n z ! ,national ,neurological ,conditions ,surveillance ,sy/em4 7b7 ,rese>* ,! ,secret>y %all ensure t ! ,national ,neurological ,conditions ,surveillance ,sy/em is design$ 9 a mann] t facilitates fur!r rese>* on neurological diseases4 7c7 ,cont5t ,9 c>ry+ out subsection 7a71 ! ,secret>y-- 7#a7 %all provide = ! collection & /orage ( in=mation on ! incid5ce & preval5ce ( neurological diseases 9 ! ,unit$ ,/ates2 7#b7 to ! ext5t practicable1 %all provide = ! collection & /orage ( o!r available in=mation on neurological diseases1 includ+ in=mation relat$ to p]sons liv+ ) neurological diseases :o *oose to p>ticipate1 su* z-- 7,a7 demographics1 su* z age1 race1 e?nicity1 sex1 geographic location1 family hi/ory1 & o!r in=mation1 z appropriate2 7,b7 risk factors t may be associat$ ) neurological diseases1 su* z g5etic & environm5tal risk factors & o!r in=mation1 z appropriate2 & 7,c7 diagnosis & progression m>k]s2 7#c7 may provide = ! collection & /orage ( in=mation relevant to analysis on neurological diseases1 su* z in=mation conc]n+-- 7,a7 ! natural hi/ory ( ! diseases2 7,b7 ! prev5tion ( ! diseases2 7,c7 ! detection1 managem5t1 & treatm5t approa*es = ! diseases2 & 7,d7 ! developm5t ( outcomes measures2 7#d7 may address issues id5tifi$ dur+ ! consultation process "u subsection 7d72 & 7#e7 initially may address a limit$ numb] ( neurological diseases4 7d7 ,consultation ,9 c>ry+ out ?is section1 ! ,secret>y %all consult ) individuals ) appropriate exp]tise1 :i* may include-- 7#a7 epidemiologi/s ) exp]i5ce 9 disease surveillance or regi/ries2 7#b7 repres5tatives ( national volunt>y heal? associations t-- 7,a7 focus on neurological diseases2 & 7,b7 h demon/rat$ exp]i5ce 9 rese>*1 c>e1 or pati5t s]vices2 7#c7 heal? in=mation te*nology exp]ts or o!r in=mation managem5t speciali/s2 7#d7 cl9icians ) exp]tise 9 neurological diseases2 & 7#e7 rese>* sci5ti/s ) exp]i5ce conduct+ translational rese>* or utiliz+ surveillance sy/ems = sci5tific rese>* purposes4 7e7 ,grants ,! ,secret>y may aw>d grants to1 or ent] into contracts or coop]ative agreem5ts )1 public or private nonpr(it entities to c>ry out activities "u ?is section4 7f7 ,coord9ation ) o!r f$]al1 /ate1 & local ag5cies ,subject to subsection 7h71 ! ,secret>y %all-- 7#a7 make in=mation & analysis 9 ! ,national ,neurological ,conditions ,surveillance ,sy/em available1 z appropriate-- 7,a7 to ,f$]al dep>tm5ts & ag5cies1 su* z ! ,national ,in/itutes ( ,heal? & ! ,dep>tm5t ( ,vet]ans ,affairs2 & 7,b7 to ,/ate & local ag5cies2 & 7#b7 id5tify1 build ^u1 lev]age1 & coord9ate among exi/+ data & surveillance sy/ems1 surveys1 regi/ries1 & o!r ,f$]al public heal? infra/ructure1 :]ev] practicable4 7g7 ,public access ,subject to subsection 7h71 ! ,secret>y %all ensure t in=mation & analysis 9 ! ,national ,neurological ,conditions ,surveillance ,sy/em are available1 z appropriate1 to ! public1 includ+ rese>*]s4 7h7 ,privacy ,! ,secret>y %all ensure t in=mation & analysis 9 ! ,national ,neurological ,conditions ,surveillance ,sy/em are made available only to ! ext5t p]mitt$ by applicable ,f$]al & ,/ate law1 & 9 a mann] t protects p]sonal privacy1 to ! ext5t requir$ by applicable ,f$]al & ,/ate privacy law1 at a m9imum4 7i7 ,reports 7#a7 ,report on in=mation & analyses ,n lat] ?an #a ye> aft] ! date on :i* any sy/em is e/abli%$ "u ?is section1 ! ,secret>y %all submit an int]im report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives reg>d+ aggregate in=mation collect$ pursuant to ?is section & epidemiological analyses1 z appropriate4 ,su* report %all be po/$ on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & %all be updat$ bi5nially4 7#b7 ,implem5tation report ,n lat] ?an #d ye>s aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all submit a report to ! ,congress conc]n+ ! implem5tation ( ?is section4 ,su* report %all include in=mation on-- 7,a7 ! developm5t & ma9t5ance ( ! ,national ,neurological ,conditions ,surveillance ,sy/em2 7,b7 ! type ( in=mation collect$ & /or$ 9 ! surveillance sy/em2 7,c7 ! use & availability ( su* in=mation1 includ+ guidel9es = su* use2 & 7,d7 ! use & coord9ation ( databases t collect or ma9ta9 in=mation on neurological diseases4 7j7 ,def9ition ,9 ?is section1 ! t]m national volunt>y heal? association means a national nonpr(it organization ) *apt]s1 o!r affiliat$ organizations1 or networks 9 ,/ates ?r\gh\t ! ,unit$ ,/ates ) exp]i5ce s]v+ ! population ( individuals ) neurological disease & h demon/rat$ exp]i5ce 9 neurological disease rese>*1 c>e1 & pati5t s]vices4 7k7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #e1jjj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #bjfb4 ,tick-borne diseases 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all cont9ue to conduct or support epidemiological1 basic1 translational1 & cl9ical rese>* relat$ to vector-borne diseases1 includ+ tick-borne diseases4 7b7 ,reports ,! ,secret>y %all ensure t ea* tri5nial report "u section #djc ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc7 7z am5d$ by section #bjcb7 includes in=mation on actions und]tak5 by ! ,national ,in/itutes ( ,heal? to c>ry out subsection 7a7 ) respect to tick-borne diseases4 7c7 ,tick-borne diseases work+ gr\p 7#a7 ,e/abli%m5t ,! ,secret>y %all e/abli% a work+ gr\p1 to be kn[n z ! ,tick-,borne ,disease ,work+ ,gr\p 7ref]r$ to 9 ?is section z ! ,work+ ,gr\p71 compris$ ( repres5tatives ( appropriate ,f$]al ag5cies & o!r non-,f$]al entities1 to provide exp]tise & to review all ef=ts )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices relat$ to all tick-borne diseases1 to help ensure int]ag5cy coord9ation & m9imize ov]lap1 & to exam9e rese>* priorities4 7#b7 ,responsibilities ,! work+ gr\p %all-- 7,a7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 develop or update a summ>y (-- 7i7 ongo+ tick-borne disease rese>*1 includ+ rese>* relat$ to causes1 prev5tion1 treatm5t1 surveillance1 diagnosis1 diagno/ics1 duration ( illness1 & int]v5tion = individuals ) tick-borne diseases2 7ii7 advances made pursuant to su* rese>*2 7iii7 ,f$]al activities relat$ to tick-borne diseases1 includ+-- 7,i7 epidemiological activities relat$ to tick-borne diseases2 & 7,,ii7 basic1 cl9ical1 & translational tick-borne disease rese>* relat$ to ! pa?og5esis1 prev5tion1 diagnosis1 & treatm5t ( tick-borne diseases2 7iv7 gaps 9 tick-borne disease rese>* describ$ 9 clause 7iii77,,ii72 7v7 ! ,work+ ,gr\p's meet+s requir$ "u p>agraph 7#d72 & 7vi7 ! comm5ts receiv$ by ! ,work+ ,gr\p2 7,b7 make recomm5dations to ! ,secret>y reg>d+ any appropriate *anges or improvem5ts to su* activities & rese>*2 & 7,c7 solicit input f ,/ates1 localities1 & nongov]nm5tal entities1 includ+ organizations repres5t+ pati5ts1 heal? c>e provid]s1 rese>*]s1 & indu/ry reg>d+ sci5tific advances1 rese>* que/ions1 surveillance activities1 & em]g+ /ra9s 9 species ( pa?og5ic organisms4 7#c7 ,memb]%ip ,! memb]s ( ! work+ gr\p %all repres5t a div]sity ( sci5tific discipl9es & views & %all be compos$ ( ! foll[+ memb]s3 7,a7 ,f$]al memb]s ,sev5 ,f$]al memb]s1 consi/+ ( "o or m repres5tatives ( ea* ( ! foll[+3 7i7 ,! ,(fice ( ! ,assi/ant ,secret>y = ,heal?4 7ii7 ,! ,food & ,drug ,adm9i/ration4 7iii7 ,! ,c5t]s = ,disease ,control & ,prev5tion4 7iv7 ,! ,national ,in/itutes ( ,heal?4 7v7 ,su* o!r ag5cies & (fices ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices z ! ,secret>y det]m9es appropriate4 7,b7 ,non-,f$]al public memb]s ,sev5 non-,f$]al public memb]s1 consi/+ ( repres5tatives ( ! foll[+ categories3 7i7 ,physicians & o!r m$ical provid]s ) exp]i5ce 9 diagnos+ & treat+ tick-borne diseases4 7ii7 ,sci5ti/s or rese>*]s ) exp]tise4 7iii7 ,pati5ts & _! family memb]s4 7iv7 ,nonpr(it organizations t advocate = pati5ts ) respect to tick-borne diseases4 7v7 ,o!r individuals ^: exp]tise is det]m9$ by ! ,secret>y to be b5eficial to ! function+ ( ! ,work+ ,gr\p4 7#d7 ,meet+s ,! ,work+ ,gr\p %all meet n less ?an twice ea* ye>4 7#e7 ,report+ ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 & e #b ye>s !reaft] until t]m9ation ( ! ,work+ ,gr\p pursuant to p>agraph 7#g71 ! ,work+ ,gr\p %all-- 7,a7 submit a report on its activities "u p>agraph 7#b77;,a7 & any recomm5dations "u p>agraph 7#b77;,b7 to ! ,secret>y1 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 & 7,b7 make su* report publicly available on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#f7 ,applicability ( ,,faca ,! ,work+ ,gr\p %all be treat$ z an advisory committee subject to ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 7#g7 ,sunset ,! ,work+ ,gr\p "u ?is section %all t]m9ate #f ye>s aft] ! date ( enactm5t ( ?is ,act4 #bjfc4 ,access+1 %>+1 & us+ heal? data = rese>* purposes 7a7 ,guidance relat$ to ,remote ,access ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all issue guidance cl>ify+ t subp>agraph 7,b7 ( section #afd4eab7;i77#a77;ii7 ( "p #afd ( ! ,rule 7prohibit+ ! removal ( protect$ heal? in=mation by a rese>*]7 does n prohibit remote access to heal? in=mation by a rese>*] = su* purposes z describ$ 9 section #afd4eab7;i77#a77;ii7 ( "p #afd ( ! ,rule s long z-- 7#a7 at a m9imum1 security & privacy safegu>ds1 consi/5t ) ! requirem5ts ( ! ,rule1 are ma9ta9$ by ! cov]$ entity & ! rese>*]2 & 7#b7 ! protect$ heal? in=mation is n copi$ or o!rwise reta9$ by ! rese>*]4 7b7 ,guidance relat$ to ,/reaml9+ ,au?orization ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue guidance on ! foll[+3 7#a7 ,au?orization = use & disclosure ( heal? in=mation ,cl>ification ( ! circum/ances "u :i* ! au?orization = ! use or disclosure ( protect$ heal? in=mation1 ) respect to an individual1 = future rese>* purposes conta9s a suffici5t description ( ! purpose ( ! use or disclosure1 su* z if ! au?orization-- 7,a7 suffici5tly describes ! purposes su* t x w\ld be reasonable = ! individual to expect t ! protect$ heal? in=mation c\ld be us$ or disclos$ = su* future rese>*2 7,b7 ei!r-- 7i7 /ates t ! au?orization w expire on a p>ticul> date or on ! occurr5ce ( a p>ticul> ev5t2 or 7ii7 /ates t ! au?orization w rema9 valid unless & until x is revok$ by ! individual2 & 7,c7 provides in/ruction to ! individual on h[ to revoke su* au?orization at any "t4 7#b7 ,rem9d] ( ! "r to revoke ,cl>ification ( ! circum/ances "u :i* x is appropriate to provide an individual ) an annual notice or rem9d] t ! individual has ! "r to revoke su* au?orization4 7#c7 ,revocation ( au?orization ,cl>ification ( appropriate me*anisms by :i* an individual may revoke an au?orization = future rese>* purposes1 su* z describ$ 9 p>agraph 7#a77;,c74 7c7 ,work+ gr\p on protect$ heal? in=mation = rese>* 7#a7 ,e/abli%m5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all conv5e a work+ gr\p to /udy & report on ! uses & disclosures ( protect$ heal? in=mation = rese>* purposes1 "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,public ,law #ajd-aia74 7#b7 ,memb]s ,! work+ gr\p %all include repres5tatives (-- 7,a7 relevant ,f$]al ag5cies1 includ+ ! ,national ,in/itutes ( ,heal?1 ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,food & ,drug ,adm9i/ration1 & ! ,(fice = ,civil ,rights2 7,b7 ! rese>* community2 7,c7 pati5ts2 7,d7 exp]ts 9 civil rights1 su* z privacy rights2 7,e7 develop]s ( heal? in=mation te*nology2 7,f7 exp]ts 9 data privacy & security2 7,g7 heal? c>e provid]s2 7,h7 bioe?ici/s2 & 7,i7 o!r exp]ts & entities1 z ! ,secret>y det]m9es appropriate4 7#c7 ,report ,n lat] ?an #a ye> aft] ! date on :i* ! work+ gr\p is conv5$ "u p>agraph 7#a71 ! work+ gr\p %all conduct a review & submit a report to ! ,secret>y conta9+ recomm5dations on :e!r ! uses & disclosures ( protect$ heal? in=mation = rese>* purposes %\ld be modifi$ to all[ protect$ heal? in=mation to be available1 z appropriate1 = rese>* purposes1 includ+ /udies to obta9 g5]alizable k1 :ile protect+ individuals' privacy rights4 ,9 conduct+ ! review & mak+ recomm5dations1 ! work+ gr\p %all-- 7,a7 address1 at a m9imum-- 7i7 ! appropriate mann] & tim+ ( au?orization1 includ+ :e!r additional notification to ! individual %\ld be requir$ :5 ! individual's protect$ heal? in=mation w be us$ or disclos$ = su* rese>*2 7ii7 opportunities = individuals to set pref]5ces on ! mann] 9 :i* _! protect$ heal? in=mation is us$ 9 rese>*2 7iii7 opportunities = pati5ts to revoke au?orization2 7iv7 notification to individuals ( a brea* 9 privacy2 7v7 exi/+ gaps 9 /atute1 regulation1 or policy relat$ to protect+ ! privacy ( individuals1 & 7vi7 exi/+ b>ri]s to rese>* relat$ to ! curr5t re/rictions on ! uses & disclosures ( protect$ heal? in=mation2 & 7,b7 consid]1 at a m9imum-- 7i7 expectations & pref]5ces on h[ an individual's protect$ heal? in=mation is %>$ & us$2 7ii7 issues relat$ to specific subgr\ps ( p1 su* z *ildr51 inc>c]at$ individuals1 & individuals ) a cognitive or intellectual disability impact+ capacity to cons5t2 7iii7 relevant ,f$]al & ,/ate laws2 7iv7 models ( facilitat+ data access & levels ( data access1 includ+ data segm5tation1 :]e applicable2 7v7 pot5tial impacts ( disclosure & non-disclosure ( protect$ heal? in=mation on access to heal? c>e s]vices2 & 7vi7 ! pot5tial uses ( su* data4 7#d7 ,report submission ,! ,secret>y %all submit ! report "u p>agraph 7#c7 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & %all po/ su* report on ! appropriate ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#e7 ,t]m9ation ,! work+ gr\p conv5$ "u p>agraph 7#a7 %all t]m9ate ! day aft] ! report "u p>agraph 7#c7 is submitt$ to ,congress & made public 9 accordance ) p>agraph 7#d74 7d7 ,def9itions ,9 ?is section3 7#a7 ,! rule ,ref]5ces to ! ,rule ref] to "p #afj or "p #afd1 z appropriate1 ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7#b7 ,"p #afd ,ref]5ces to a specifi$ section ( "p #afd1 ref] to su* specifi$ section ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or any successor section74 ,g ,promot+ p$iatric rese>* #bjga4 ,national p$iatric rese>* network ,section #dji;,d7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd;h7d77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ 9 consultation ) ! ,director ( ! ,eunice ,k5n$y ,%riv] ,national ,in/itute ( ,*ild ,heal? & ,human ,developm5t & 9 collaboration ) o!r appropriate national rese>* in/itutes & national c5t]s t c>ry out activities involv+ p$iatric rese>*1 may provide = ! e/abli%m5t ( & ins]t+ 9 collaboration ) ! national rese>* in/itutes & national c5t]s t c>ry out activities involv+ p$iatric rese>*1 %all support2 & 7#b7 9 p>agraph 7#b77;,a7 & ! fir/ s5t5ce ( p>agraph 7#b77;,e71 by /rik+ may ea* place su* t]m appe>s & ins]t+ %all4 #bjgb4 ,global p$iatric cl9ical /udy network ,x is ! s5se ( ,congress t-- 7#a7 ! ,national ,in/itutes ( ,heal? %\ld enc\rage a global p$iatric cl9ical /udy network by provid+ grants1 contracts1 or coop]ative agreem5ts to support new & e>ly /age inve/igators :o p>ticipate 9 ! global p$iatric cl9ical /udy network2 7#b7 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %\ld engage ) cl9ical inve/igators & appropriate au?orities outside ( ! ,unit$ ,/ates1 includ+ au?orities 9 ! ,european ,union1 dur+ ! =mation ( ! global p$iatric cl9ical /udy network to enc\rage ! p>ticipation ( su* inve/igator & au?orities2 & 7#c7 once a global p$iatric cl9ical /udy network is e/abli%$ & becomes op]ational1 ! ,secret>y %\ld cont9ue to enc\rage & facilitate ! p>ticipation ( cl9ical inve/igators & appropriate au?orities outside ( ! ,unit$ ,/ates1 includ+ 9 ! ,european ,union1 to p>ticipate 9 ! network ) ! goal ( enhanc+ ! global rea* ( ! network4 ,,iii ,developm5t ,a ,pati5t-,focus$ ,drug ,developm5t #cjja4 ,pati5t exp]i5ce data ,section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 ! subsection head+1 by /rik+ ,9 g5]al & ins]t+ ,pati5t ,engagem5t 9 ,drugs & ,devices2 7,b7 by r$esignat+ p>agraphs 7#a7 & 7#b7 z subp>agraphs 7,a7 & 7,b71 respectively1 & mov+ su* subp>agraphs #b ems to ! "r2 & 7,c7 by /rik+ ,! ,secret>y & ins]t+ ! foll[+3 7#a7 ,9 ,g5]al ,! ,secret>y 2 7#b7 by r$esignat+ subsections 7b7 ?r\gh 7e7 z p>agraphs 7#b7 ?r\gh 7#e71 respectively1 & mov+ su* p>agraphs #b ems to ! "r2 & 7#c7 by add+ at ! end ! foll[+3 7b7 ,/atem5t ( pati5t exp]i5ce 7#a7 ,9 g5]al ,foll[+ ! approval ( an application t 0 submitt$ "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act at lea/ #ahj days aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all make public a brief /atem5t reg>d+ ! pati5t exp]i5ce data & relat$ in=mation1 if any1 submitt$ & review$ z "p ( su* application4 7#b7 ,data & in=mation ,! data & in=mation ref]r$ to 9 p>agraph 7#a7 are-- 7,a7 pati5t exp]i5ce data2 7,b7 in=mation on pati5t-focus$ drug developm5t tools2 & 7,c7 o!r relevant in=mation1 z det]m9$ by ! ,secret>y4 7c7 ,pati5t exp]i5ce data ,= purposes ( ?is section1 ! t]m pati5t exp]i5ce data includes data t-- 7#a7 are collect$ by any p]sons 7includ+ pati5ts1 family memb]s & c>egiv]s ( pati5ts1 pati5t advocacy organizations1 disease rese>* f\ndations1 rese>*]s1 & drug manufactur]s72 & 7#b7 are int5d$ to provide in=mation ab\t pati5ts' exp]i5ces ) a disease or condition1 includ+-- 7,a7 ! impact ( su* disease or condition1 or a relat$ !rapy1 on pati5ts' lives2 & 7,b7 pati5t pref]5ces ) respect to treatm5t ( su* disease or condition4 4 #cjjb4 ,pati5t-focus$ drug developm5t guidance 7a7 ,publication ( guidance docum5ts ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all develop a plan to issue draft & f9al v]sions ( "o or m guidance docum5ts1 ov] a p]iod ( #e ye>s1 reg>d+ ! collection ( pati5t exp]i5ce data1 & ! use ( su* data & relat$ in=mation 9 drug developm5t4 ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue a draft v]sion ( at lea/ "o su* guidance docum5t4 ,n lat] ?an #ah mon?s aft] ! public comm5t p]iod on ! draft guidance ends1 ! ,secret>y %all issue a revis$ draft guidance or f9al guidance4 7b7 ,pati5t exp]i5ce data ,= purposes ( ?is section1 ! t]m pati5t exp]i5ce data has ! mean+ giv5 su* t]m 9 section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #cjja74 7c7 ,cont5ts ,! guidance docum5ts describ$ 9 subsection 7a7 %all address-- 7#a7 me?odological approa*es t a p]son seek+ to collect pati5t exp]i5ce data = submission to1 & propos$ use by1 ! ,secret>y 9 regulatory decisionmak+ may use1 t are relevant & objective & ensure t su* data are accurate & repres5tative ( ! int5d$ population1 includ+ me?ods to collect mean+ful pati5t input ?r\gh\t ! drug developm5t process & me?odological consid]ations = data collection1 report+1 managem5t1 & analysis2 7#b7 me?odological approa*es t may be us$ to develop & id5tify :at is mo/ important to pati5ts ) respect to burd5 ( disease1 burd5 ( treatm5t1 & ! b5efits & risks 9 ! managem5t ( ! pati5t's disease2 7#c7 approa*es to id5tify+ & develop+ me?ods to measure impacts to pati5ts t w help facilitate collection ( pati5t exp]i5ce data 9 cl9ical trials2 7#d7 me?odologies1 /&>ds1 & te*nologies to collect & analyze cl9ical outcome assessm5ts = purposes ( regulatory decisionmak+2 7#e7 h[ a p]son seek+ to develop & submit propos$ draft guidance relat+ to pati5t exp]i5ce data = consid]ation by ! ,secret>y may submit su* propos$ draft guidance to ! ,secret>y2 7#f7 ! =mat & cont5t requir$ = submissions "u ?is section to ! ,secret>y1 includ+ ) respect to ! in=mation describ$ 9 p>agraph 7#a72 7#g7 h[ ! ,secret>y int5ds to respond to submissions ( in=mation describ$ 9 p>agraph 7#a71 if applicable1 includ+ any timeframe = response :5 su* submission is n "p ( a regulatory application or o!r submission t has an associat$ timeframe = response2 & 7#h7 h[ ! ,secret>y1 if appropriate1 anticipates us+ relevant pati5t exp]i5ce data & relat$ in=mation1 includ+ ) respect to ! /ructur$ risk-b5efit assessm5t framework describ$ 9 section #eje7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d771 to in=m regulatory decisionmak+4 #cjjc4 ,/reaml9+ pati5t input ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! collection ( in=mation to :i* a response is volunt>y1 t is initiat$ by ! ,secret>y "u section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 7z am5d$ by section #cjja7 or section #cjjb4 #cjjd4 ,report on pati5t exp]i5ce drug developm5t ,n lat] ?an ,june #a ( #bjba1 #bjbf1 & #bjca1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all prep>e & publi% on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration a report assess+ ! use ( pati5t exp]i5ce data 9 regulatory decisionmak+1 9 p>ticul> ) respect to ! review ( pati5t exp]i5ce data & in=mation on pati5t-focus$ drug developm5t tools z "p ( applications approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774 ,b ,advanc+ new drug !rapies #cjaa4 ,qualification ( drug developm5t tools 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejf;,f ! foll[+ new section3 #ejg4 ,qualification ( drug developm5t tools 7a7 ,process = qualification 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a process = ! qualification ( drug developm5t tools = a propos$ context ( use "u :i*-- 7,a7 7i7 a reque/or initiates su* process by submitt+ a lett] ( int5t to ! ,secret>y2 & 7ii7 ! ,secret>y accepts or decl9es to accept su* lett] ( int5t2 7,b7 7i7 if ! ,secret>y accepts ! lett] ( int5t1 a reque/or submits a qualification plan to ! ,secret>y2 & 7ii7 ! ,secret>y accepts or decl9es to accept ! qualification plan2 & 7,c7 7i7 if ! ,secret>y accepts ! qualification plan1 ! reque/or submits to ! ,secret>y a full qualification package2 7ii7 ! ,secret>y det]m9es :e!r to accept su* qualification package = review2 & 7iii7 if ! ,secret>y accepts su* qualification package = review1 ! ,secret>y conducts su* review 9 accordance ) ?is section4 7#b7 ,acceptance & review ( submissions 7,a7 ,9 g5]al ,subp>agraphs 7,b71 7,c71 & 7,d7 %all apply ) respect to ! treatm5t ( a lett] ( int5t1 a qualification plan1 or a full qualification package submitt$ "u p>agraph 7#a7 7ref]r$ to 9 ?is p>agraph z qualification submissions74 7,b7 ,acceptance factors2 nonacceptance ,! ,secret>y %all det]m9e :e!r to accept a qualification submission bas$ on factors :i* may include ! sci5tific m]it ( ! qualification submission4 ,a det]m9ation n to accept a submission "u p>agraph 7#a7 %all n be con/ru$ z a f9al det]m9ation by ! ,secret>y "u ?is section reg>d+ ! qualification ( a drug developm5t tool = its propos$ context ( use4 7,c7 ,prioritization ( qualification review ,! ,secret>y may prioritize ! review ( a full qualification package submitt$ "u p>agraph 7#a7 ) respect to a drug developm5t tool1 bas$ on factors det]m9$ appropriate by ! ,secret>y1 includ+-- 7i7 z applicable1 ! sev]ity1 r>ity1 or preval5ce ( ! disease or condition t>get$ by ! drug developm5t tool & ! availability or lack ( alt]native treatm5ts = su* disease or condition2 & 7ii7 ! id5tification1 by ! ,secret>y or by biom$ical rese>* consortia & o!r exp]t /akehold]s1 ( su* a drug developm5t tool & its propos$ context ( use z a public heal? priority4 7,d7 ,engagem5t ( ext]nal exp]ts ,! ,secret>y may1 = purposes ( ! review ( qualification submissions1 ?r\gh ! use ( coop]ative agreem5ts1 grants1 or o!r appropriate me*anisms1 consult ) biom$ical rese>* consortia & may consid] ! recomm5dations ( su* consortia ) respect to ! review ( any qualification plan submitt$ "u p>agraph 7#a7 or ! review ( any full qualification package "u p>agraph 7#c74 7#c7 ,review ( full qualification package ,! ,secret>y %all-- 7,a7 conduct a compreh5sive review ( a full qualification package accept$ "u p>agraph 7#a77;,c72 & 7,b7 det]m9e :e!r ! drug developm5t tool at issue is qualifi$ = its propos$ context ( use4 7#d7 ,qualification ,! ,secret>y %all det]m9e :e!r a drug developm5t tool is qualifi$ = a propos$ context ( use bas$ on ! sci5tific m]it ( a full qualification package review$ "u p>agraph 7#c74 7b7 ,effect ( qualification 7#a7 ,9 g5]al ,a drug developm5t tool det]m9$ to be qualifi$ "u subsection 7a77#d7 = a propos$ context ( use specifi$ by ! reque/or may be us$ by any p]son 9 su* context ( use = ! purposes describ$ 9 p>agraph 7#b74 7#b7 ,use ( a drug developm5t tool ,subject to p>agraph 7#c71 a drug developm5t tool qualifi$ "u ?is section may be us$ =-- 7,a7 support+ or obta9+ approval or lic5sure 7z applicable7 ( a drug or biological product 7includ+ 9 accordance ) section #ejf7;c77 "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7,b7 support+ ! inve/igational use ( a drug or biological product "u section #eje7;i7 ( ?is ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act4 7#c7 ,rescission or modification 7,a7 ,9 g5]al ,! ,secret>y may resc9d or modify a det]m9ation "u ?is section to qualify a drug developm5t tool if ! ,secret>y det]m9es t ! drug developm5t tool is n appropriate = ! propos$ context ( use specifi$ by ! reque/or4 ,su* a det]m9ation may be bas$ on new in=mation t calls into "q ! basis = su* qualification4 7,b7 ,meet+ = review ,if ! ,secret>y resc9ds or modifies "u subp>agraph 7,a7 a det]m9ation to qualify a drug developm5t tool1 ! reque/or involv$ %all1 on reque/1 be grant$ a meet+ ) ! ,secret>y to discuss ! basis ( ! ,secret>y's decision to resc9d or modify ! det]m9ation be=e ! effective date ( ! rescission or modification4 7c7 ,transp>5cy 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 ! ,secret>y %all make publicly available1 & update on at lea/ a biannual basis1 on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration ! foll[+3 7,a7 ,in=mation ) respect to ea* qualification submission "u ! qualification process "u subsection 7a71 includ+-- 7i7 ! /age ( ! review process applicable to ! submission2 7ii7 ! date ( ! mo/ rec5t *ange 9 /age /atus2 7iii7 :e!r ext]nal sci5tific exp]ts 7 utiliz$ 9 ! developm5t ( a qualification plan or ! review ( a full qualification package2 & 7iv7 submissions f reque/ors "u ! qualification process "u subsection 7a71 includ+ any data & evid5ce conta9$ 9 su* submissions1 & any updates to su* submissions4 7,b7 ,! ,secret>y's =mal writt5 det]m9ations 9 response to su* qualification submissions4 7,c7 ,any rescissions or modifications "u subsection 7b77#c7 ( a det]m9ation to qualify a drug developm5t tool4 7,d7 ,summ>y reviews t docum5t conclusions & recomm5dations = det]m9ations to qualify drug developm5t tools "u subsection 7a74 7,e7 ,a compreh5sive li/ (-- 7i7 all drug developm5t tools qualifi$ "u subsection 7a72 & 7ii7 all surrogate endpo9ts :i* 7 ! basis ( approval or lic5sure 7z applicable7 ( a drug or biological product 7includ+ 9 accordance ) section #ejf7;c77 "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,relation to ,trade ,secrets ,act ,in=mation made publicly available by ! ,secret>y "u p>agraph 7#a7 %all be consid]$ a disclosure au?oriz$ by law = purposes ( section #aije ( title #ah1 ,unit$ ,/ates ,code4 7#c7 ,applicability ,no?+ 9 ?is section %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any in=mation conta9$ 9 an application submitt$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act t is confid5tial comm]cial or trade secret in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$-- 7#a7 to alt] ! /&>ds ( evid5ce "u subsection 7c7 or 7d7 ( section #eje1 includ+ ! sub/antial evid5ce /&>d 9 su* subsection 7d71 or "u section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable72 or 7#b7 to limit ! au?ority ( ! ,secret>y to approve or lic5se products "u ?is ,act or ! ,public ,heal? ,s]vice ,act1 z applicable 7z 9 effect be=e ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act74 7e7 ,def9itions ,9 ?is section3 7#a7 ,biom>k] ,! t]m biom>k]-- 7,a7 means a *>act]i/ic 7su* z a physiologic1 pa?ologic1 or anatomic *>act]i/ic or measurem5t7 t is objectively measur$ & evaluat$ z an indicator ( normal biologic processes1 pa?ologic processes1 or biological responses to a !rapeutic int]v5tion2 & 7,b7 includes a surrogate endpo9t4 7#b7 ,biom$ical rese>* consortia ,! t]m biom$ical rese>* consortia means collaborative gr\ps t may take ! =m ( public-private p>tn]%ips & may include gov]nm5t ag5cies1 in/itutions ( high] education 7z def9$ 9 section #aja7;a7 ( ! ,high] ,education ,act ( #aife71 pati5t advocacy gr\ps1 indu/ry repres5tatives1 cl9ical & sci5tific exp]ts1 & o!r relevant entities & individuals4 7#c7 ,cl9ical outcome assessm5t ,! t]m cl9ical outcome assessm5t means-- 7,a7 a measurem5t ( a pati5t's symptoms1 ov]all m5tal /ate1 or ! effects ( a disease or condition on h[ ! pati5t functions2 & 7,b7 includes a pati5t-report$ outcome4 7#d7 ,context ( use ,! t]m context ( use means1 ) respect to a drug developm5t tool1 ! circum/ances "u :i* ! drug developm5t tool is to be us$ 9 drug developm5t & regulatory review4 7#e7 ,drug developm5t tool ,! t]m drug developm5t tool includes-- 7,a7 a biom>k]2 7,b7 a cl9ical outcome assessm5t2 & 7,c7 any o!r me?od1 mat]ial1 or measure t ! ,secret>y det]m9es aids drug developm5t & regulatory review = purposes ( ?is section4 7#f7 ,pati5t-report$ outcome ,! t]m pati5t-report$ outcome means a measurem5t bas$ on a report f a pati5t reg>d+ ! /atus ( ! pati5t's heal? condition )\t am5dm5t or int]pretation ( ! pati5t's report by a cl9ician or any o!r p]son4 7#g7 ,qualification ,! t]ms qualification & qualifi$ mean a det]m9ation by ! ,secret>y t a drug developm5t tool & its propos$ context ( use c be reli$ ^u to h a specific int]pretation & application 9 drug developm5t & regulatory review "u ?is ,act4 7#h7 ,reque/or ,! t]m reque/or means an entity or entities1 includ+ a drug sponsor or a biom$ical rese>* consortia1 seek+ to qualify a drug developm5t tool = a propos$ context ( use "u ?is section4 7#i7 ,surrogate endpo9t ,! t]m surrogate endpo9t means a m>k]1 su* z a laboratory measurem5t1 radiographic image1 physical sign1 or o!r measure1 t is n itself a direct measurem5t ( cl9ical b5efit1 &-- 7,a7 is kn[n to pr$ict cl9ical b5efit & c\ld be us$ to support traditional approval ( a drug or biological product2 or 7,b7 is reasonably likely to pr$ict cl9ical b5efit & c\ld be us$ to support ! accel]at$ approval ( a drug or biological product 9 accordance ) section #ejf7;c74 4 7b7 ,guidance 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all1 9 consultation ) biom$ical rese>* consortia 7z def9$ 9 subsection 7e7 ( section #ejg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a77 & o!r int]e/$ p>ties ?r\gh a collaborative public process1 issue guidance to implem5t su* section #ejg t-- 7,a7 provides a conceptual framework describ+ appropriate /&>ds & sci5tific approa*es to support ! developm5t ( biom>k]s del9eat$ "u ! taxonomy e/abli%$ "u p>agraph 7#c72 7,b7 ) respect to ! qualification process "u su* section #ejg-- 7i7 describes ! requirem5ts t entities seek+ to qualify a drug developm5t tool "u su* section %all obs]ve :5 engag+ 9 su* process2 7ii7 outl9es reasonable timeframes = ! ,secret>y's review ( lett]s1 qualification plans1 or full qualification packages submitt$ "u su* process2 & 7iii7 e/abli%es a process by :i* su* entities or ! ,secret>y may consult ) biom$ical rese>* consortia & o!r individuals & entities ) exp]t k & insights t may assi/ ! ,secret>y 9 ! review ( qualification plans & full qualification submissions "u su* section2 & 7,c7 includes su* o!r in=mation z ! ,secret>y det]m9es appropriate4 7#b7 ,tim+ ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all issue draft guidance "u p>agraph 7#a7 on ! implem5tation ( section #ejg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a774 ,! ,secret>y %all issue f9al guidance on ! implem5tation ( su* section n lat] ?an #f mon?s aft] ! date on :i* ! comm5t p]iod = ! draft guidance closes4 7#c7 ,taxonomy 7,a7 ,9 g5]al ,= purposes ( in=m+ guidance "u ?is subsection1 ! ,secret>y %all1 9 consultation ) biom$ical rese>* consortia & o!r int]e/$ p>ties ?r\gh a collaborative public process1 e/abli% a taxonomy = ! classification ( biom>k]s 7& relat$ sci5tific concepts7 = use 9 drug developm5t4 7,b7 ,public availability ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all make su* taxonomy publicly available 9 draft =m = public comm5t4 ,! ,secret>y %all f9alize ! taxonomy n lat] ?an #a ye> aft] ! close ( ! public comm5t p]iod4 7c7 ,meet+ & report 7#a7 ,meet+ ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all conv5e a public meet+ to describe & solicit public input reg>d+ ! qualification process "u section #ejg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 7#b7 ,report ,n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all make publicly available on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration a report4 ,su* report %all include1 ) respect to ! qualification process "u section #ejg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 in=mation on-- 7,a7 ! numb] ( reque/s submitt$1 z a lett] ( int5t1 = qualification ( a drug developm5t tool 7z def9$ 9 subsection 7e7 ( su* section #ejg72 7,b7 ! numb] ( su* reque/s accept$ & det]m9$ to be eligible = submission ( a qualification plan or full qualification package 7z su* t]ms are def9$ 9 subsection 7e7 ( su* section #ejg71 respectively2 7,c7 ! numb] ( su* reque/s = :i* ext]nal sci5tific exp]ts 7 utiliz$ 9 ! developm5t ( a qualification plan or review ( a full qualification package2 7,d7 ! numb] ( qualification plans & full qualification packages1 respectively1 submitt$ to ! ,secret>y2 & 7,e7 ! drug developm5t tools qualifi$ ?r\gh su* qualification process1 specifi$ by type ( tool1 su* z a biom>k] or cl9ical outcome assessm5t 7z su* t]ms are def9$ 9 subsection 7e7 ( su* section #ejg74 #cjab4 ,t>get$ drugs = r>e diseases ,sub*apt] ,b ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;aa et seq47 is am5d$ by ins]t+ aft] section #ebi ! foll[+3 #ebi;,a4 ,t>get$ drugs = r>e diseases 7a7 ,purpose ,! purpose ( ?is section1 ?r\gh ! approa* provid$ = 9 subsection 7b71 is to-- 7#a7 facilitate ! developm5t1 review1 & approval ( g5etically t>get$ drugs & v>iant prote9 t>get$ drugs to address an unmet m$ical ne$ 9 "o or m pati5t subgr\ps1 includ+ subgr\ps ( pati5ts ) diff]5t mutations ( a g5e1 ) respect to r>e diseases or conditions t are s]i\s or life-?reat5+2 & 7#b7 maximize ! use ( sci5tific tools or me?ods1 includ+ surrogate endpo9ts & o!r biom>k]s1 = su* purposes4 7b7 ,lev]ag+ ( data f previ\sly approv$ drug application or applications ,! ,secret>y may1 consi/5t ) applicable /&>ds = approval "u ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 all[ ! sponsor ( an application "u section #eje7;b77#a7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = a g5etically t>get$ drug or a v>iant prote9 t>get$ drug to rely ^u data & in=mation-- 7#a7 previ\sly develop$ by ! same sponsor 7or ano!r sponsor t has provid$ ! sponsor ) a contractual "r ( ref]5ce to su* data & in=mation72 & 7#b7 submitt$ by a sponsor describ$ 9 p>agraph 7#a7 9 support ( "o or m previ\sly approv$ applications t 7 submitt$ "u section #eje7;b77#a7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 = a drug t incorporates or utilizes ! same or simil> g5etically t>get$ te*nology z ! drug or drugs t are ! subject ( an application or applications describ$ 9 p>agraph 7#b7 or = a v>iant prote9 t>get$ drug t is ! same or incorporates or utilizes ! same v>iant prote9 t>get$ drug1 z ! drug or drugs t are ! subject ( an application or applications describ$ 9 p>agraph 7#b74 7c7 ,def9itions ,= purposes ( ?is section-- 7#a7 ! t]m g5etically t>get$ drug means a drug t-- 7,a7 is ! subject ( an application "u section #eje7;b77#a7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = ! treatm5t ( a r>e disease or condition 7z su* t]m is def9$ 9 section #ebf7 t is s]i\s or life-?reat5+2 7,b7 may result 9 ! modulation 7includ+ suppression1 up-regulation1 or activation7 ( ! function ( a g5e or its associat$ g5e product2 & 7,c7 incorporates or utilizes a g5etically t>get$ te*nology2 7#b7 ! t]m g5etically t>get$ te*nology means a te*nology compris+ non-replicat+ nucleic acid or analog\s comp\nds ) a common or simil> *emi/ry t is int5d$ to treat "o or m pati5t subgr\ps1 includ+ subgr\ps ( pati5ts ) diff]5t mutations ( a g5e1 ) ! same disease or condition1 includ+ a disease or condition due to o!r v>iants 9 ! same g5e2 & 7#c7 ! t]m v>iant prote9 t>get$ drug means a drug t-- 7,a7 is ! subject ( an application "u section #eje7;b77#a7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = ! treatm5t ( a r>e disease or condition 7z su* t]m is def9$ 9 section #ebf7 t is s]i\s or life-?reat5+2 7,b7 modulates ! function ( a product ( a mutat$ g5e :]e su* mutation is responsible 9 :ole or 9 "p = a giv5 disease or condition2 & 7,c7 is int5d$ to treat "o or m pati5t subgr\ps1 includ+ subgr\ps ( pati5ts ) diff]5t mutations ( a g5e1 ) ! same disease or condition4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to-- 7#a7 alt] ! au?ority ( ! ,secret>y to approve drugs pursuant to ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act 7z au?oriz$ prior to ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act71 includ+ ! /&>ds ( evid5ce1 & applicable conditions1 = approval "u su* applicable ,act2 or 7#b7 conf] any new rights1 beyond ^? au?oriz$ "u ?is ,act or ! ,public ,heal? ,s]vice ,act prior to enactm5t ( ?is section1 ) respect to ! p]missibility ( a sponsor ref]5c+ in=mation conta9$ 9 ano!r application submitt$ "u section #eje7;b77#a7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 4 #cjac4 ,reau?orization ( program to enc\rage treatm5ts = r>e p$iatric diseases 7a7 ,9 ,g5]al ,section #ebi7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7b77 is am5d$ by /rik+ p>agraph 7#e7 & ins]t+ ! foll[+3 7#e7 ,t]m9ation ( au?ority ,! ,secret>y may n aw>d any priority review v\*]s "u p>agraph 7#a7 aft] ,septemb] #cj1 #bjbj1 unless ! r>e p$iatric disease product application-- 7,a7 is = a drug t1 n lat] ?an ,septemb] #cj1 #bjbj1 is designat$ "u subsection 7d7 z a drug = a r>e p$iatric disease2 & 7,b7 is1 n lat] ?an ,septemb] #cj1 #bjbb1 approv$ "u section #eje7;b77#a7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 4 7b7 ,report ,! ,advanc+ ,hope ,act ( #bjaf 7,public ,law #aad-bbi7 is am5d$ by /rik+ section #c4 #cjad4 ,,gao /udy ( priority review v\*] programs 7a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! ,comptroll] ,g5]al7 %all conduct a /udy address+ ! effectiv5ess & ov]all impact ( ! foll[+ priority review v\*] programs1 includ+ any su* programs am5d$ or e/abli%$ by ?is ,act3 7#a7 ,! neglect$ tropical disease priority review v\*] program "u section #ebd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn74 7#b7 ,! r>e p$iatric disease priority review v\*] program "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff74 7#c7 ,! m$ical c\nt]measure priority review v\*] program "u section #efe;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #cjhf4 7b7 ,issuance ( report ,n lat] ?an ,janu>y #ca1 #bjbj1 ! ,comptroll] ,g5]al %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 "u subsection 7a74 7c7 ,cont5ts ( reports ,! report submitt$ "u subsection 7b7 %all address-- 7#a7 = ea* drug = :i* a priority review v\*] has be5 aw>d$ z ( initiation ( ! /udy-- 7,a7 ! indications = :i* ! drug is approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c771 pursuant to an application "u section #eje7;b77#a7 ( su* ,act1 or lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a772 7,b7 :e!r1 & to :at ext5t1 ! v\*] impact$ ! sponsor's decision to develop ! drug2 & 7,c7 :e!r1 & to :at ext5t1 ! approval or lic5sure ( ! drug1 z applicable & appropriate-- 7i7 address$ a global unmet ne$ relat$ to ! treatm5t or prev5tion ( a neglect$ tropical disease1 includ+ :e!r ! sponsor ( a drug coord9at$ ) int]national developm5t organizations2 7ii7 address$ an unmet ne$ relat$ to ! treatm5t ( a r>e p$iatric disease2 or 7iii7 affect$ ! ,nation's prep>$ness aga9/ a *emical1 biological1 radiological1 or nucle> ?reat1 includ+ naturally occurr+ ?reats2 7#b7 = ea* drug = :i* a priority review v\*] has be5 us$-- 7,a7 ! indications = :i* su* drug is approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c771 pursuant to an application "u section #eje7;b77#a7 ( su* ,act1 or lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 7,b7 ! value ( ! v\*]1 if transf]r$2 & 7,c7 ! l5g? ( "t betwe5 ! date on :i* ! v\*] 0 aw>d$ & ! date on :i* ! v\*] 0 us$2 & 7#c7 an analysis ( ! priority review v\*] programs describ$ 9 subsection 7a71 includ+-- 7,a7 ! res\rces us$ by ! ,food & ,drug ,adm9i/ration 9 review+ drugs = :i* v\*]s 7 us$1 includ+ ! effect ( ! programs on ! ,food & ,drug ,adm9i/ration's review ( drugs = :i* priority review v\*]s 7 n aw>d$ or us$2 7,b7 :e!r any improvem5ts to su* programs are necess>y to appropriately t>get inc5tives = ! developm5t ( drugs t w\ld likely n o!rwise be develop$1 or develop$ 9 z timely a mann]1 &1 z applicable & appropriate-- 7i7 address global unmet ne$s relat$ to ! treatm5t or prev5tion ( neglect$ tropical diseases1 includ+ 9 c\ntries 9 :i* neglect$ tropical diseases are endemic2 or 7ii7 address unmet ne$s relat$ to ! treatm5t ( r>e p$iatric diseases2 & 7,c7 :e!r ! sunset ( ! r>e p$iatric disease program & m$ical c\nt]measure program has _h an impact on ! program1 includ+ any pot5tial un9t5d$ consequ5ces4 7d7 ,protection ( national security ,! ,comptroll] ,g5]al %all conduct ! /udy & issue reports "u ?is section 9 a mann] t does n compromise national security4 #cjae4 ,am5dm5ts to ! ,orphan ,drug grants ,section #e ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 defray+ ! co/s ( develop+ drugs = r>e diseases or conditions1 includ+ qualifi$ te/+ exp5ses1 2 & 7#b7 9 subsection 7b77#a7-- 7,a7 9 subp>agraph 7,a77ii71 by /rik+ 8&0 aft] ! semicolon2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 82 &02 & 7,c7 by add+ at ! end ! foll[+3 7,c7 prospectively plann$ & design$ obs]vational /udies & o!r analyses conduct$ to assi/ 9 ! und]/&+ ( ! natural hi/ory ( a r>e disease or condition & 9 ! developm5t ( a !rapy1 includ+ /udies & analyses to-- 7i7 develop or validate a drug developm5t tool relat$ to a r>e disease or condition2 or 7ii7 und]/& ! full spectrum ( ! disease manife/ations1 includ+ describ+ g5otypic & ph5otypic v>iability & id5tify+ & def9+ di/9ct subpopulations affect$ by a r>e disease or condition4 4 #cjaf4 ,grants = /udy+ cont9u\s drug manufactur+ 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices may aw>d grants to in/itutions ( high] education & nonpr(it organizations = ! purpose ( /udy+ & recomm5d+ improvem5ts to ! process ( cont9u\s manufactur+ ( drugs & biological products & simil> innovative monitor+ & control te*niques4 7b7 ,def9itions ,9 ?is section-- 7#a7 ! t]m drug has ! mean+ giv5 su* t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#b7 ! t]m biological product has ! mean+ giv5 su* t]m 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i772 & 7#c7 ! t]m in/itution ( high] education has ! mean+ giv5 su* t]m 9 section #aja7;a7 ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja7;a774 ,c ,mod]n ,trial ,design & ,evid5ce ,developm5t #cjba4 ,novel cl9ical trial designs 7a7 ,proposals = use ( novel cl9ical trial designs = drugs & biological products ,= purposes ( assi/+ sponsors 9 incorporat+ complex adaptive & o!r novel trial designs into propos$ cl9ical protocols & applications = new drugs "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 & biological products "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all conduct a public meet+ & issue guidance 9 accordance ) subsection 7b74 7b7 ,guidance address+ use ( novel cl9ical trial designs 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all update or issue guidance address+ ! use ( complex adaptive & o!r novel trial design 9 ! developm5t & regulatory review & approval or lic5sure = drugs & biological products4 7#b7 ,cont5ts ,! guidance "u p>agraph 7#a7 %all address-- 7,a7 ! use ( complex adaptive & o!r novel trial designs1 includ+ h[ su* cl9ical trials propos$ or submitt$ help to satisfy ! sub/antial evid5ce /&>d "u section #eje7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d772 7,b7 h[ sponsors may obta9 fe$back f ! ,secret>y on te*nical issues relat$ to model+ & simulations prior to-- 7i7 completion ( su* model+ or simulations2 or 7ii7 ! submission ( result+ in=mation to ! ,secret>y2 7,c7 ! types ( quantitative & qualitative in=mation t %\ld be submitt$ = review2 & 7,d7 recomm5d$ analysis me?odologies4 7#c7 ,public meet+ ,prior to updat+ or issu+ ! guidance requir$ by p>agraph 7#a71 ! ,secret>y %all consult ) /akehold]s1 includ+ repres5tatives ( regulat$ indu/ry1 academia1 pati5t advocacy organizations1 consum] gr\ps1 & disease rese>* f\ndations1 ?r\gh a public meet+ to be held n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7#d7 ,tim+ ,! ,secret>y %all update or issue a draft v]sion ( ! guidance requir$ by p>agraph 7#a7 n lat] ?an #ah mon?s aft] ! date ( ! public meet+ requir$ by p>agraph 7#c7 & f9alize su* guidance n lat] ?an #a ye> aft] ! date on :i* ! public comm5t p]iod = ! draft guidance closes4 #cjbb4 ,real _w evid5ce ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #eje;,e 7#ba ,u4,s4,c4 #cee;f7 ! foll[+3 #eje;,f4 ,utiliz+ real _w evid5ce 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a program to evaluate ! pot5tial use ( real _w evid5ce-- 7#a7 to help to support ! approval ( a new indication = a drug approv$ "u section #eje7;c72 & 7#b7 to help to support or satisfy po/approval /udy requirem5ts4 7b7 ,real _w evid5ce def9$ ,9 ?is section1 ! t]m real _w evid5ce means data reg>d+ ! usage1 or ! pot5tial b5efits or risks1 ( a drug d]iv$ f s\rces o!r ?an r&omiz$ cl9ical trials4 7c7 ,program framework 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all e/abli% a draft framework = implem5tation ( ! program "u ?is section4 7#b7 ,cont5ts ( framework ,! framework %all include in=mation describ+-- 7,a7 ! s\rces ( real _w evid5ce1 includ+ ongo+ safety surveillance1 obs]vational /udies1 regi/ries1 claims1 & pati5t-c5t]$ outcomes rese>* activities2 7,b7 ! gaps 9 data collection activities2 7,c7 ! /&>ds & me?odologies = collection & analysis ( real _w evid5ce2 & 7,d7 ! priority areas1 rema9+ *all5ges1 & pot5tial pilot opportunities t ! program e/abli%$ "u ?is section w address4 7#c7 ,consultation 7,a7 ,9 g5]al ,9 develop+ ! program framework "u ?is subsection1 ! ,secret>y %all consult ) regulat$ indu/ry1 academia1 m$ical pr(essional organizations1 repres5tatives ( pati5t advocacy organizations1 consum] organizations1 disease rese>* f\ndations1 & o!r int]e/$ p>ties4 7,b7 ,process ,! consultation "u subp>agraph 7,a7 may be c>ri$ out ?r\gh approa*es su* z-- 7i7 a public-private p>tn]%ip ) ! entities describ$ 9 su* subp>agraph 9 :i* ! ,secret>y may p>ticipate2 7ii7 a contract1 grant1 or o!r arrangem5t1 z ! ,secret>y det]m9es appropriate1 ) su* a p>tn]%ip or an indep5d5t rese>* organization2 or 7iii7 public work%ops ) ! entities describ$ 9 su* subp>agraph4 7d7 ,program implem5tation ,! ,secret>y %all1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act & 9 accordance ) ! framework e/abli%$ "u subsection 7c71 implem5t ! program to evaluate ! pot5tial use ( real _w evid5ce4 7e7 ,guidance = indu/ry ,! ,secret>y %all-- 7#a7 utilize ! program e/abli%$ "u subsection 7a71 its activities1 & any subsequ5t pilots or writt5 reports1 to in=m a guidance = indu/ry on-- 7,a7 ! circum/ances "u :i* sponsors ( drugs & ! ,secret>y may rely on real _w evid5ce = ! purposes describ$ 9 p>agraphs 7#a7 & 7#b7 ( subsection 7a72 & 7,b7 ! appropriate /&>ds & me?odologies = collection & analysis ( real _w evid5ce submitt$ = su* purposes2 7#b7 n lat] ?an #e ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 issue draft guidance = indu/ry z describ$ 9 p>agraph 7#a72 & 7#c7 n lat] ?an #ah mon?s aft] ! close ( ! public comm5t p]iod = ! draft guidance describ$ 9 p>agraph 7#b71 issue revis$ draft guidance or f9al guidance4 7f7 ,rule ( con/ruction 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 no?+ 9 ?is section prohibits ! ,secret>y f us+ real _w evid5ce = purposes n specifi$ 9 ?is section1 provid$ ! ,secret>y det]m9es t suffici5t basis exi/s = any su* nonspecifi$ use4 7#b7 ,/&>ds ( evid5ce & ,secret>y's au?ority ,?is section %all n be con/ru$ to alt]-- 7,a7 ! /&>ds ( evid5ce "u-- 7i7 subsection 7c7 or 7d7 ( section #eje1 includ+ ! sub/antial evid5ce /&>d 9 su* subsection 7d72 or 7ii7 section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act2 or 7,b7 ! ,secret>y's au?ority to require po/approval /udies or cl9ical trials1 or ! /&>ds ( evid5ce "u :i* /udies or trials are evaluat$4 4 #cjbc4 ,protection ( human rese>* subjects 7a7 ,9 g5]al ,9 ord] to simplify & facilitate compliance by rese>*]s ) applicable regulations = ! protection ( human subjects 9 rese>*1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all1 to ! ext5t practicable & consi/5t ) o!r /atutory provisions1 h>monize diff]5ces betwe5 ! ,,hhs ,human ,subject ,regulations & ! ,,fda ,human ,subject ,regulations 9 accordance ) subsection 7b74 7b7 ,avoid+ regulatory duplication & unnecess>y delays ,! ,secret>y %all1 z appropriate-- 7#a7 make su* modifications to ! provisions ( ! ,,hhs ,human ,subject ,regulations1 ! ,,fda ,human ,subject ,regulations1 & ! vuln]able populations rules z may be necess>y-- 7,a7 to r$uce regulatory duplication & unnecess>y delays2 7,b7 to mod]nize su* provisions 9 ! context ( multisite & coop]ative rese>* projects2 & 7,c7 to protect vuln]able populations1 incorporate local consid]ations1 & support community engagem5t ?r\gh me*anisms su* z consultation ) local rese>*]s & human rese>* protection programs1 9 a mann] consi/5t ) subp>agraph 7,b72 & 7#b7 ensure t human subject rese>* t is subject to ! ,,hhs ,human ,subject ,regulations & to ! ,,fda ,human ,subject ,regulations may-- 7,a7 use jo9t or %>$ review2 7,b7 rely ^u ! review (-- 7i7 an indep5d5t in/itutional review bo>d2 or 7ii7 an in/itutional review bo>d ( an entity o!r ?an ! sponsor ( ! rese>*2 or 7,c7 use simil> arrangem5ts to avoid duplication ( ef=t4 7c7 ,consultation ,9 h>moniz+ or modify+ regulations or guidance "u ?is section1 ! ,secret>y %all consult ) /akehold]s 7includ+ rese>*]s1 academic organizations1 hospitals1 in/itutional rese>* bo>ds1 ph>maceutical1 biote*nology1 & m$ical device develop]s1 cl9ical rese>* organizations1 pati5t gr\ps1 & o!rs74 7d7 ,tim+ ,! ,secret>y %all complete ! h>monization describ$ 9 subsection 7a7 n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act4 7e7 ,progress report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ,congress a report on ! progress made t[>d complet+ su* h>monization4 7f7 ,def9itions 7#a7 ,human subject regulations ,9 ?is section3 7,a7 ,,fda human subject regulations ,! t]m ,,fda ,human ,subject ,regulations means ! provisions ( p>ts #ej1 #ef1 #cab1 & #hab ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,b7 ,,hhs human subject regulations ,! t]m ,,hhs ,human ,subject ,regulations means ! provisions ( subp>t ,a ( "p #df ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,c7 ,vuln]able population rules ,! t]m vuln]able population rules means-- 7i7 except 9 ! case ( rese>* describ$ 9 clause 7ii71 ! provisions ( subp>ts ,b ?r\gh ,d ( "p #df1 ,code ( ,f$]al ,regulations 7or any successor regulations72 & 7ii7 9 ! case ( rese>* t is subject to ,,fda ,human ,subject ,regulations1 ! provisions applicable to vuln]able populations "u "p #ef ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations7 & subp>t ,d ( "p #ej ( su* title #ba 7or any successor regulations74 7#b7 ,in/itutional review bo>d def9$ ,9 ?is section1 ! t]m in/itutional review bo>d has ! mean+ t applies to ! t]m in/itutional review bo>d "u ! ,,hhs ,human ,subject ,regulations4 #cjbd4 ,in=m$ cons5t waiv] or alt]ation = cl9ical inve/igations 7a7 ,devices ,section #ebj7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77#c77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ except :]e subject to su* conditions z ! ,secret>y may prescribe1 ! inve/igator & ins]t+ ! foll[+3 8except :]e1 subject to su* conditions z ! ,secret>y may prescribe-- 7i7 ! propos$ cl9ical te/+ poses no m ?an m9imal risk to ! human subject & includes appropriate safegu>ds to protect ! rights1 safety1 & welf>e ( ! human subject2 or 7ii7 ! inve/igator 2 & 7#b7 9 ! matt] foll[+ subp>agraph 7,d71 by /rik+ subp>agraph 7,d7 & ins]t+ subp>agraph 7,d77ii74 7b7 ,drugs ,section #eje7;i77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77#d77 is am5d$ by /rik+ except :]e x is n feasible or x is contr>y to ! be/ int]e/s ( su* human be+s & ins]t+ except :]e x is n feasible1 x is contr>y to ! be/ int]e/s ( su* human be+s1 or ! propos$ cl9ical te/+ poses no m ?an m9imal risk to su* human be+s & includes appropriate safegu>ds z prescrib$ to protect ! rights1 safety1 & welf>e ( su* human be+s4 ,d ,pati5t access to !rapies & in=mation #cjca4 ,summ>y level review 7a7 ,,ffdca ,section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 is am5d$ by add+ at ! end ! foll[+3 7#e7 7,a7 ,! ,secret>y may rely ^u qualifi$ data summ>ies to support ! approval ( a supplem5tal application1 ) respect to a qualifi$ indication = a drug1 submitt$ "u subsection 7b71 if su* supplem5tal application complies ) subp>agraph 7,b74 7,b7 ,a supplem5tal application is eligible = review z describ$ 9 subp>agraph 7,a7 only if-- 7i7 !re is exi/+ data available & acceptable to ! ,secret>y demon/rat+ ! safety ( ! drug2 & 7ii7 all data us$ to develop ! qualifi$ data summ>ies are submitt$ to ! ,secret>y z "p ( ! supplem5tal application4 7,c7 ,! ,secret>y %all po/ on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration & update annually-- 7i7 ! numb] ( applications review$ solely "u subp>agraph 7,a7 or section #cea7;a77#b77;,e7 ( ! ,public ,heal? ,s]vice ,act2 7ii7 ! av]age "t = completion ( review "u subp>agraph 7,a7 or section #cea7;a77#b77;,e7 ( ! ,public ,heal? ,s]vice ,act2 7iii7 ! av]age "t = review ( supplem5tal applications :]e ! ,secret>y did n use review flexibility "u subp>agraph 7,a7 or section #cea7;a77#b77;,e7 ( ! ,public ,heal? ,s]vice ,act2 & 7iv7 ! numb] ( applications review$ "u subp>agraph 7,a7 or section #cea7;a77#b77;,e7 ( ! ,public ,heal? ,s]vice ,act = :i* ! ,secret>y made use ( full data sets 9 addition to ! qualifi$ data summ>y4 7,d7 ,9 ?is p>agraph-- 7i7 ! t]m qualifi$ indication means an indication = a drug t ! ,secret>y det]m9es to be appropriate = summ>y level review "u ?is p>agraph2 & 7ii7 ! t]m qualifi$ data summ>y means a summ>y ( cl9ical data t demon/rates ! safety & effectiv5ess ( a drug ) respect to a qualifi$ indication4 4 7b7 ,,phsa ,section #cea7;a77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77#b77 is am5d$ by add+ at ! end ! foll[+3 7,e7 7i7 ,! ,secret>y may rely ^u qualifi$ data summ>ies to support ! approval ( a supplem5tal application1 ) respect to a qualifi$ indication = a drug1 submitt$ "u ?is subsection1 if su* supplem5tal application complies ) ! requirem5ts ( subp>agraph 7,b7 ( section #eje7;c77#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7ii7 ,9 ?is subp>agraph1 ! t]ms qualifi$ indication & qualifi$ data summ>y h ! mean+s giv5 su* t]ms 9 section #eje7;c77#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 #cjcb4 ,exp&$ access policy ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #efa 7#ba ,u4,s4,c4 #cfj;bbb7 ! foll[+3 #efa;,a4 ,exp&$ access policy requir$ = inve/igational drugs 7a7 ,9 g5]al ,! manufactur] or di/ributor ( "o or m inve/igational drugs = ! diagnosis1 monitor+1 or treatm5t ( "o or m s]i\s diseases or conditions %all make available ! policy ( ! manufactur] or di/ributor on evaluat+ & respond+ to reque/s submitt$ "u section #efa7;b7 = provision ( su* a drug4 7b7 ,public availability ( exp&$ access policy ,! policies "u subsection 7a7 %all be made public & readily available1 su* z by po/+ su* policies on a publicly available ,int]net website4 ,su* policies may be g5]ally applicable to all inve/igational drugs ( su* manufactur] or di/ributor4 7c7 ,cont5t ( policy ,a policy describ$ 9 subsection 7a7 %all include-- 7#a7 contact in=mation = ! manufactur] or di/ributor to facilitate communication ab\t reque/s describ$ 9 subsection 7a72 7#b7 proc$ures = mak+ su* reque/s2 7#c7 ! g5]al crit]ia ! manufactur] or di/ributor w use to evaluate su* reque/s = individual pati5ts1 & = responses to su* reque/s2 7#d7 ! l5g? ( "t ! manufactur] or di/ributor anticipates w be necess>y to ackn[l$ge receipt ( su* reque/s2 & 7#e7 a hyp]l9k or o!r ref]5ce to ! cl9ical trial record conta9+ in=mation ab\t ! exp&$ access = su* drug t is requir$ "u section #djb7;j77#b77;,a77ii77,,ii77gg7 ( ! ,public ,heal? ,s]vice ,act4 7d7 ,no gu>antee ( access ,! po/+ ( policies by manufactur]s & di/ributors "u subsection 7a7 %all n s]ve z a gu>antee ( access to any specific inve/igational drug by any individual pati5t4 7e7 ,revis$ policy ,no?+ 9 ?is section %all prev5t a manufactur] or di/ributor f revis+ a policy requir$ "u ?is section at any "t4 7f7 ,application ,?is section %all apply to a manufactur] or di/ributor ) respect to an inve/igational drug beg9n+ on ! lat] (-- 7#a7 ! date t is #fj cal5d> days aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act2 or 7#b7 ! fir/ initiation ( a phase #b or phase #c /udy 7z su* t]ms are def9$ 9 section #cab4ba7;b7 & 7c7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 ) respect to su* inve/igational drug4 4 #cjcc4 ,accel]at$ approval = reg5]ative advanc$ !rapies 7a7 ,9 g5]al ,section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is am5d$-- 7#a7 by transf]r+ subsection 7e7 7relat+ to con/ruction7 s t x appe>s be=e subsection 7f7 7relat+ to aw>5ess ef=ts72 & 7#b7 by add+ at ! end ! foll[+3 7g7 ,reg5]ative advanc$ !rapy 7#a7 ,9 g5]al ,! ,secret>y1 at ! reque/ ( ! sponsor ( a drug1 %all facilitate an effici5t developm5t program =1 & exp$ite review (1 su* drug if ! drug qualifies z a reg5]ative advanc$ !rapy "u ! crit]ia describ$ 9 p>agraph 7#b74 7#b7 ,crit]ia ,a drug is eligible = designation z a reg5]ative advanc$ !rapy "u ?is subsection if-- 7,a7 ! drug is a reg5]ative m$ic9e !rapy 7z def9$ 9 p>agraph 7#h772 7,b7 ! drug is int5d$ to treat1 modify1 rev]se1 or cure a s]i\s or life-?reat5+ disease or condition2 & 7,c7 prelim9>y cl9ical evid5ce indicates t ! drug has ! pot5tial to address unmet m$ical ne$s = su* a disease or condition4 7#c7 ,reque/ = designation ,! sponsor ( a drug may reque/ ! ,secret>y to designate ! drug z a reg5]ative advanc$ !rapy concurr5tly )1 or at any "t aft]1 submission ( an application = ! inve/igation ( ! drug "u section #eje7;i7 ( ?is ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act4 7#d7 ,designation ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u p>agraph 7#c71 ! ,secret>y %all det]m9e :e!r ! drug t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 p>agraph 7#b74 ,if ! ,secret>y det]m9es t ! drug meets ! crit]ia1 ! ,secret>y %all designate ! drug z a reg5]ative advanc$ !rapy & %all take su* actions z are appropriate "u p>agraph 7#a74 ,if ! ,secret>y det]m9es t a drug does n meet ! crit]ia = su* designation1 ! ,secret>y %all include ) ! det]m9ation a writt5 description ( ! rationale = su* det]m9ation4 7#e7 ,actions ,! sponsor ( a reg5]ative advanc$ !rapy %all be eligible = ! actions to exp$ite developm5t & review ( su* !rapy "u subsection 7a77#c77;,b71 includ+ e>ly int]actions to discuss any pot5tial surrogate or int]m$iate endpo9t to be us$ to support ! accel]at$ approval ( an application = ! product "u subsection 7c74 7#f7 ,access to exp$it$ approval pa?ways ,an application = a reg5]ative advanc$ !rapy "u section #eje7;b77#a7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act may be-- 7,a7 eligible = priority review1 z describ$ 9 ! ,manual ( ,policies & ,proc$ures ( ! ,food & ,drug ,adm9i/ration & goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjab2 & 7,b7 eligible = accel]at$ approval "u subsection 7c71 z agre$ ^u pursuant to subsection 7a77#c77;,b71 ?r\gh1 z appropriate-- 7i7 surrogate or int]m$iate endpo9ts reasonably likely to pr$ict long-t]m cl9ical b5efit2 or 7ii7 reliance ^u data obta9$ f a mean+ful numb] ( sites1 includ+ ?r\gh expansion to additional sites1 z appropriate4 7#g7 ,po/approval requirem5ts ,! sponsor ( a reg5]ative advanc$ !rapy t is grant$ accel]at$ approval & is subject to ! po/approval requirem5ts "u subsection 7c7 may1 z appropriate1 fulfill su* requirem5ts1 z ! ,secret>y may require1 ?r\gh-- 7,a7 ! submission ( cl9ical evid5ce1 cl9ical /udies1 pati5t regi/ries1 or o!r s\rces ( real _w evid5ce1 su* z electronic heal? records2 7,b7 ! collection ( l>g] confirmatory data sets1 z agre$ ^u pursuant to subsection 7a77#c77;,b72 or 7,c7 po/approval monitor+ ( all pati5ts treat$ ) su* !rapy prior to approval ( ! !rapy4 7#h7 ,def9ition ,= purposes ( ?is section1 ! t]m reg5]ative m$ic9e !rapy includes cell !rapy1 !rapeutic tissue eng9e]+ products1 human cell & tissue products1 & comb9ation products us+ any su* !rapies or products1 except = ^? regulat$ solely "u section #cfa ( ! ,public ,heal? ,s]vice ,act & "p #abga ( title #ba1 ,code ( ,f$]al ,regulations4 4 7b7 ,rule ( con/ruction ,no?+ 9 ?is section & ! am5dm5ts made by ?is section %all be con/ru$ to alt] ! au?ority ( ! ,secret>y ( ,heal? & ,human ,s]vices-- 7#a7 to approve drugs pursuant to ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 & section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 z au?oriz$ prior to ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 includ+ ! /&>ds ( evid5ce1 & applicable conditions1 = approval "u su* ,acts2 or 7#b7 to alt] ! au?ority ( ! ,secret>y to require po/approval /udies pursuant to su* ,acts1 z au?oriz$ prior to ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act4 7c7 ,con=m+ am5dm5t ,section #ejf7;e77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;e77#a77 is am5d$ by ins]t+ & ! #ba/ ,c5tury ,cures ,act aft] ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act4 #cjcd4 ,guidance reg>d+ devices us$ 9 ! recov]y1 isolation1 or deliv]y ( reg5]ative advanc$ !rapies 7a7 ,draft guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue draft guidance cl>ify+ h[1 9 ! context ( reg5]ative advanc$ !rapies1 ! ,secret>y w evaluate devices us$ 9 ! recov]y1 isolation1 or deliv]y ( reg5]ative advanc$ !rapies4 ,9 do+ s1 ! ,secret>y %all specifically address-- 7#a7 h[ ! ,food & ,drug ,adm9i/ration int5ds to simplify & /reaml9e regulatory requirem5ts = comb9ation device & cell or tissue products2 7#b7 :at1 if any1 int5d$ uses or specific attributes w\ld result 9 a device us$ ) a reg5]ative !rapy product to be classifi$ z a class ,,iii device2 7#c7 :5 ! ,food & ,drug ,adm9i/ration consid]s x is necess>y1 if ev]1 = ! int5d$ use ( a device to be limit$ to a specific int5d$ use ) only "o p>ticul> type ( cell2 & 7#d7 application ( ! lea/ burd5some approa* to demon/rate h[ a device may be us$ ) m ?an "o cell type4 7b7 ,f9al guidance ,n lat] ?an #ab mon?s aft] ! close ( ! p]iod = public comm5t on ! draft guidance "u subsection 7a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all f9alize su* guidance4 #cjce4 ,report on reg5]ative advanc$ !rapies 7a7 ,report to ,congress ,be=e ,m>* #a ( ea* cal5d> ye>1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 ) respect to ! previ\s cal5d> ye>1 submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on-- 7#a7 ! numb] & type ( applications = approval ( reg5]ative advanc$ !rapies fil$1 approv$ or lic5s$ z applicable1 )drawn1 or d5i$2 & 7#b7 h[ _m ( su* applications or !rapies1 z applicable1 7 grant$ accel]at$ approval or priority review4 7b7 ,reg5]ative ,advanc$ ,!rapy ,9 ?is section1 ! t]m reg5]ative advanc$ !rapy has ! mean+ giv5 su* t]m 9 section #ejf7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #cjcc ( ?is ,act4 #cjcf4 ,/&>ds = reg5]ative m$ic9e & reg5]ative advanc$ !rapies ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejf;,f ! foll[+3 #ejf;,g4 ,/&>ds = reg5]ative m$ic9e & reg5]ative advanc$ !rapies 7a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y1 9 consultation ) ! ,national ,in/itute ( ,/&>ds & ,te*nology & /akehold]s 7includ+ reg5]ative m$ic9e & advanc$ !rapies manufactur]s & cl9ical trial sponsors1 contract manufactur]s1 academic in/itutions1 practic+ cl9icians1 reg5]ative m$ic9e & advanc$ !rapies indu/ry organizations1 & /&>d sett+ organizations71 %all facilitate an ef=t to coord9ate & prioritize ! developm5t ( /&>ds & cons5sus def9ition ( t]ms1 ?r\gh a public process1 to support1 ?r\gh regulatory pr$ictability1 ! developm5t1 evaluation1 & review ( reg5]ative m$ic9e !rapies & reg5]ative advanc$ !rapies1 includ+ ) respect to ! manufactur+ processes & controls ( su* products4 7b7 ,activities 7#a7 ,9 g5]al ,9 c>ry+ out ?is section1 ! ,secret>y %all cont9ue to-- 7,a7 id5tity opportunities to help advance ! developm5t ( reg5]ative m$ic9e !rapies & reg5]ative advanc$ !rapies2 7,b7 id5tify opportunities = ! developm5t ( laboratory regulatory sci5ce rese>* & docum5t>y /&>ds t ! ,secret>y det]m9es w\ld help support ! developm5t1 evaluation1 & review ( reg5]ative m$ic9e !rapies & reg5]ative advanc$ !rapies ?r\gh regulatory pr$ictability2 & 7,c7 "w ) /akehold]s1 su* z ^? describ$ 9 subsection 7a71 z appropriate1 9 ! developm5t ( su* /&>ds4 7#b7 ,regulations & guidance ,n lat] ?an #a ye> aft] ! developm5t ( /&>ds z describ$ 9 subsection 7a71 ! ,secret>y %all review relevant regulations & guidance &1 ?r\gh a public process1 update su* regulations & guidance z ! ,secret>y det]m9es appropriate4 7c7 ,def9itions ,= purposes ( ?is section1 ! t]ms reg5]ative m$ic9e !rapy & reg5]ative advanc$ !rapy h ! mean+s giv5 su* t]ms 9 section #ejf7;g74 4 #cjcg4 ,heal? c>e economic in=mation ,section #ejb7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;a77 is am5d$-- 7#a7 by /rik+ 7a7 ,if its & ins]t+ 7a77#a7 ,if its2 7#b7 by /rik+ a =mul>y committee1 or o!r simil> entity1 9 ! c\rse ( ! committee or ! entity c>ry+ out its responsibilities = ! selection ( drugs = manag$ c>e or o!r simil> organizations & ins]t+ a payor1 =mul>y committee1 or o!r simil> entity ) k & exp]tise 9 ! area ( heal? c>e economic analysis1 c>ry+ out its responsibilities = ! selection ( drugs = cov]age or reimbursem5t2 7#c7 by /rik+ directly relates & ins]t+ relates2 7#d7 by /rik+ & is bas$ on compet5t & reliable sci5tific evid5ce4 ,! requirem5ts set =? 9 section #eje7;a7 or 9 section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act %all n apply to heal? c>e economic in=mation provid$ to su* a committee or entity 9 accordance ) ?is p>agraph & ins]t+ 1 is bas$ on compet5t & reliable sci5tific evid5ce1 & includes1 :]e applicable1 a conspicu\s & prom95t /atem5t describ+ any mat]ial diff]5ces betwe5 ! heal? c>e economic in=mation & ! label+ approv$ = ! drug "u section #eje or "u section #cea ( ! ,public ,heal? ,s]vice ,act4 ,! requirem5ts set =? 9 section #eje7;a7 or 9 subsections 7a7 & 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act %all n apply to heal? c>e economic in=mation provid$ to su* a payor1 committee1 or entity 9 accordance ) ?is p>agraph2 & 7#e7 by /rik+ ,9 ?is p>agraph1 ! t]m & all t foll[s & ins]t+ ! foll[+3 7#b7 7,a7 ,= purposes ( ?is p>agraph1 ! t]m heal? c>e economic in=mation means any analysis 7includ+ ! cl9ical data1 inputs1 cl9ical or o!r assumptions1 me?ods1 results1 & o!r compon5ts und]ly+ or compris+ ! analysis7 t id5tifies1 measures1 or describes ! economic consequ5ces1 :i* may be bas$ on ! sep>ate or aggregat$ cl9ical consequ5ces ( ! repres5t$ heal? outcomes1 ( ! use ( a drug4 ,su* analysis may be comp>ative to ! use ( ano!r drug1 to ano!r heal? c>e int]v5tion1 or to no int]v5tion4 7,b7 ,su* t]m does n include any analysis t relates only to an indication t is n approv$ "u section #eje or "u section #cea ( ! ,public ,heal? ,s]vice ,act = su* drug4 4 #cjch4 ,comb9ation product innovation 7a7 ,9 g5]al ,section #ejc7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 is am5d$-- 7#a7 by /rik+ p>agraph 7#c72 7#b7 by r$esignat+ p>agraph 7#b7 z p>agraph 7#g72 7#c7 by r$esignat+ p>agraphs 7#d7 & 7#e7 z p>agraphs 7#h7 & 7#i71 respectively2 7#d7 by /rik+ 7g77#a7 & all t foll[s ?r\gh ! end ( p>agraph 7#a7 & ins]t+ ! foll[+3 7g7 7#a7 7,a7 ,! ,secret>y %all1 9 accordance ) ?is subsection1 assign a prim>y ag5cy c5t] to regulate products t con/itute a comb9ation ( a drug1 device1 or biological product4 7,b7 ,! ,secret>y %all conduct ! prem>ket review ( any comb9ation product "u a s+le application1 :5ev] appropriate4 7,c7 ,= purposes ( ?is subsection1 ! t]m prim>y mode ( action means ! s+le mode ( action ( a comb9ation product expect$ to make ! greate/ contribution to ! ov]all int5d$ !rapeutic effects ( ! comb9ation product4 7,d7 ,! ,secret>y %all det]m9e ! prim>y mode ( action ( ! comb9ation product4 ,if ! ,secret>y det]m9es t ! prim>y mode ( action is t (-- 7i7 a drug 7o!r ?an a biological product71 ! ag5cy c5t] *>g$ ) prem>ket review ( drugs %all h prim>y jurisdiction2 7ii7 a device1 ! ag5cy c5t] *>g$ ) prem>ket review ( devices %all h prim>y jurisdiction2 or 7iii7 a biological product1 ! ag5cy c5t] *>g$ ) prem>ket review ( biological products %all h prim>y jurisdiction4 7,e7 ,9 det]m9+ ! prim>y mode ( action ( a comb9ation product1 ! ,secret>y %all n det]m9e t ! prim>y mode ( action is t ( a drug or biological product solely because ! comb9ation product has any *emical action )9 or on ! human body4 7,f7 ,if a sponsor ( a comb9ation product disagrees ) ! det]m9ation "u subp>agraph 7,d7-- 7i7 su* sponsor may reque/1 & ! ,secret>y %all provide1 a sub/antive rationale to su* sponsor t ref]5ces sci5tific evid5ce provid$ by ! sponsor & any o!r sci5tific evid5ce reli$ ^u by ! ,secret>y to support su* det]m9ation2 & 7ii7 7,i7 ! sponsor ( ! comb9ation product may propose "o or m /udies 7:i* may be noncl9ical1 cl9ical1 or bo?7 to e/abli% ! relevance1 if any1 ( ! *emical action 9 a*iev+ ! prim>y mode ( action ( su* product2 7,,ii7 if ! sponsor proposes any su* /udies1 ! ,secret>y & ! sponsor ( su* product %all collaborate & seek to rea* agreem5t1 )9 a reasonable "t ( su* proposal1 n to exce$ #ij cal5d> days1 on ! design ( su* /udies2 & 7,,iii7 if an agreem5t is rea*$ "u subclause 7,,ii7 & ! sponsor conducts "o or m ( su* /udies1 ! ,secret>y %all consid] ! data result+ f any su* /udy :5 reevaluat+ ! det]m9ation ( ! prim>y mode ( action ( su* product1 & unless & until su* reevaluation has occurr$ & ! ,secret>y issues a new det]m9ation1 ! det]m9ation ( ! ,secret>y "u subp>agraph 7,d7 %all rema9 9 effect4 7#b7 7,a7 7i7 ,to e/abli% cl>ity & c]ta9ty = ! sponsor1 ! sponsor ( a comb9ation product may reque/ a meet+ on su* comb9ation product4 ,if ! ,secret>y concludes t a det]m9ation ( ! prim>y mode ( action pursuant to p>agraph 7#a77;,d7 is necess>y1 ! sponsor may reque/ su* meet+ only aft] ! ,secret>y makes su* det]m9ation4 ,if ! sponsor submits a writt5 meet+ reque/1 ! ,secret>y %all1 n lat] ?an #ge cal5d> days aft] receiv+ su* reque/1 meet ) ! sponsor ( su* comb9ation product4 7ii7 ,a meet+ "u clause 7i7 may-- 7,i7 address ! /&>ds & requirem5ts = m>ket approval or cle>ance ( ! comb9ation product2 7,,ii7 address o!r issues relevant to su* comb9ation product1 su* z requirem5ts relat$ to po/m>ket modification ( su* comb9ation product & good manufactur+ practices applicable to su* comb9ation product2 & 7,,iii7 id5tify elem5ts "u subclauses 7,i7 & 7,,ii7 t may be m appropriate = discussion & agreem5t ) ! ,secret>y at a lat] date giv5 t sci5tific or o!r in=mation is n available1 or agreem5t is o!rwise n feasible reg>d+ su* elem5ts1 at ! "t a reque/ = su* meet+ is made4 7iii7 ,any agreem5t "u ?is subp>agraph %all be 9 writ+ & made "p ( ! adm9i/rative record by ! ,secret>y4 7iv7 ,any su* agreem5t %all rema9 9 effect1 except-- 7,i7 ^u ! writt5 agreem5t ( ! ,secret>y & ! sponsor or applicant2 or 7,,ii7 pursuant to a decision by ! director ( ! review+ division ( ! prim>y ag5cy c5t]1 or a p]son m s5ior ?an su* director1 9 consultation ) consult+ c5t]s & ! ,(fice1 z appropriate1 t an issue ess5tial to det]m9+ :e!r ! /&>d = m>ket cle>ance or o!r applicable /&>d "u ?is ,act or ! ,public ,heal? ,s]vice ,act applicable to ! comb9ation product has be5 id5tifi$ s9ce ! agreem5t 0 rea*$1 or t deviat+ f ! agreem5t is o!rwise ju/ifiable bas$ on sci5tific evid5ce1 = public heal? reasons4 7#c7 ,= purposes ( conduct+ ! prem>ket review ( a comb9ation product t conta9s an approv$ con/itu5t "p describ$ 9 p>agraph 7#d71 ! ,secret>y may require t ! sponsor ( su* comb9ation product submit to ! ,secret>y only data or in=mation t ! ,secret>y det]m9es is necess>y to meet ! /&>d = cle>ance or approval1 z applicable1 "u ?is ,act or ! ,public ,heal? ,s]vice ,act1 includ+ any increm5tal risks & b5efits pos$ by su* comb9ation product1 us+ a risk-bas$ approa* & tak+ into acc\nt any prior f9d+ ( safety & effectiv5ess or sub/antial equival5ce = ! approv$ con/itu5t "p reli$ ^u by ! applicant 9 accordance ) p>agraph 7#e74 7#d7 ,= purposes ( p>agraph 7#c71 an approv$ con/itu5t "p is-- 7,a7 a drug con/itu5t "p ( a comb9ation product be+ review$ 9 a s+le application or reque/ "u section #eae1 #eaj7k71 or #eac7;f77#b7 7submitt$ 9 accordance ) p>agraph 7#e771 t is an approv$ drug1 provid$ su* application or reque/ complies ) p>agraph 7#e72 7,b7 a device con/itu5t "p approv$ "u section #eae t is ref]5c$ by ! sponsor & t is available = use by ! ,secret>y "u section #ebj7;h77#d72 or 7,c7 any con/itu5t "p t 0 previ\sly approv$1 cle>$1 or classifi$ "u section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ?is ,act = :i* ! sponsor has a "r ( ref]5ce or any con/itu5t "p t is a nonprescription drug1 z def9$ 9 section #gfj7;a77#b74 7#e7 7,a7 ,if an application is submitt$ "u section #eae or #eaj7k7 or a reque/ is submitt$ "u section #eac7;f77#b71 consi/5t ) any det]m9ation made "u p>agraph 7#a77;,d71 = a comb9ation product conta9+ z a con/itu5t "p an approv$ drug-- 7i7 ! application or reque/ %all include ! c]tification or /atem5t describ$ 9 section #eje7;b77#b72 & 7ii7 ! applicant or reque/] %all provide notice z describ$ 9 section #eje7;b77#c74 7,b7 ,= purposes ( ?is p>agraph & p>agraph 7#d71 ! t]m approv$ drug means an active +r$i5t-- 7i7 t 0 9 an application previ\sly approv$ "u section #eje7;c72 7ii7 :]e su* application is reli$ ^u by ! applicant submitt+ ! application or reque/ describ$ 9 subp>agraph 7,a72 7iii7 = :i* full reports ( inve/igations t h be5 made to %[ :e!r su* drug is safe = use & :e!r su* drug is effective 9 use 7 n conduct$ by or = ! applicant submitt+ ! application or reque/ describ$ 9 subp>agraph 7,a72 & 7iv7 = :i* ! applicant submitt+ ! application or reque/ describ$ 9 subp>agraph 7,a7 has n obta9$ a "r ( ref]5ce or use f ! p]son by or = :om ! inve/igations describ$ 9 clause 7iii7 7 conduct$4 7,c7 ,! foll[+ provisions %all apply ) respect to an application or reque/ describ$ 9 subp>agraph 7,a7 to ! same ext5t & 9 ! same mann] z if su* application or reque/ 7 an application describ$ 9 section #eje7;b77#b7 t ref]5c$ ! approv$ drug3 7i7 ,subp>agraphs 7,a71 7,b71 7,c71 & 7,d7 ( section #eje7;c77#c74 7ii7 ,clauses 7ii71 7iii71 & 7iv7 ( section #eje7;c77#c77;,e74 7iii7 ,subsections 7b7 & 7c7 ( section #eje;,a4 7iv7 ,section #eje;,e7a74 7v7 ,section #ebg7;a74 7,d7 ,not)/&+ any o!r provision ( ?is subsection1 an application or reque/ = classification = a comb9ation product describ$ 9 subp>agraph 7,a7 %all be consid]$ an application submitt$ "u section #eje7;b77#b7 = purposes ( section #bga7;e77#b77;,a7 ( title #ce1 ,unit$ ,/ates ,code4 7#f7 ,no?+ 9 ?is subsection %all be con/ru$ z prohibit+ a sponsor f submitt+ sep>ate applications = ! con/itu5t p>ts ( a comb9ation product1 unless ! ,secret>y det]m9es t a s+le application is necess>y4 2 7#e7 9 p>agraph 7#h7 7z r$esignat$ by p>agraph 7#c77-- 7,a7 9 subp>agraph 7,c7-- 7i7 by am5d+ clause 7i7 to read z foll[s3 7i7 ,9 c>ry+ out ?is subsection1 ! ,(fice %all help to ensure timely & effective prem>ket review t involves m ?an "o ag5cy c5t] by coord9at+ su* reviews1 ov]see+ ! timel9ess ( su* reviews1 & ov]see+ ! alignm5t ( fe$back reg>d+ su* reviews4 2 7ii7 9 clause 7ii71 by ins]t+ & alignm5t aft] ! timel9ess ea* place x appe>s2 & 7iii7 by add+ at ! end ! foll[+ new clauses3 7iii7 ,! ,(fice %all ensure t1 ) respect to a comb9ation product1 a designat$ p]son or p]sons 9 ! prim>y ag5cy c5t] is ! prim>y po9t or po9ts ( contact = ! sponsor ( su* comb9ation product4 ,! ,(fice %all also coord9ate communications to & f any consult+ c5t] involv$ 9 su* prem>ket review1 if reque/$ by su* prim>y ag5cy c5t] or any su* consult+ c5t]4 ,ag5cy communications & commitm5ts1 to ! ext5t consi/5t ) o!r provisions ( law & ! requirem5ts ( all affect$ ag5cy c5t]s1 f ! prim>y ag5cy c5t] %all be consid]$ z communication f ! ,secret>y on behalf ( all ag5cy c5t]s involv$ 9 ! review4 7iv7 ,! ,(fice %all1 ) respect to ! prem>ket review ( a comb9ation product-- 7,i7 ensure t any meet+ betwe5 ! ,secret>y & ! sponsor ( su* product is att5d$ by ea* ag5cy c5t] involv$ 9 ! review1 z appropriate2 7,,ii7 ensure t ea* consult+ ag5cy c5t] has complet$ its prem>ket review & provid$ ! results ( su* review to ! prim>y ag5cy c5t] 9 a timely mann]2 & 7,,iii7 ensure t ea* consult+ c5t] foll[s ! guidance describ$ 9 clause 7vi7 & advises1 z appropriate1 on o!r relevant regulations1 guidances1 & policies4 7v7 ,9 seek+ ag5cy action ) respect to a comb9ation product1 ! sponsor ( su* product-- 7,i7 %all id5tify ! product z a comb9ation product2 & 7,,ii7 may reque/ 9 writ+ ! p>ticipation ( repres5tatives ( ! ,(fice 9 meet+s relat$ to su* comb9ation product1 or to h ! ,(fice o!rwise engage on su* regulatory matt]s conc]n+ ! comb9ation product4 7vi7 ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 & aft] a public comm5t p]iod ( n less ?an #fj cal5d> days1 ! ,secret>y %all issue a f9al guidance t describes-- 7,i7 ! /ructur$ process = manag+ pre-submission int]actions ) sponsors develop+ comb9ation products2 7,,ii7 ! be/ practices = ensur+ t ! fe$back 9 su* pre-submission int]actions repres5ts ! ,ag5cy's be/ advice bas$ on ! in=mation provid$ dur+ su* pre-submission int]actions2 7,,iii7 ! in=mation t is requir$ to be submitt$ ) a meet+ reque/ "u p>agraph 7#b71 h[ su* meet+s relate to o!r types ( meet+s 9 ! ,food & ,drug ,adm9i/ration1 & ! =m & cont5t ( any agreem5t rea*$ ?r\gh a meet+ "u su* p>agraph 7#b72 2 & 7,b7 9 subp>agraph 7,g7-- 7i7 9 ! matt] prec$+ clause 7i71 by ins]t+ 7except ) respect to clause 7iv71 beg9n+ n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act7 aft] enactm5t ( ?is p>agraph2 7ii7 9 clause 7ii71 by /rik+ & at ! end2 7iii7 9 clause 7iii71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+ new clause3 7iv7 id5tify+ ! p]c5tage ( comb9ation products = :i* a dispute resolution1 ) respect to prem>ket review1 0 reque/$ by ! comb9ation product's sponsor4 2 & 7#f7 9 p>agraph 7#i7 7z r$esignat$ by p>agraph 7#c77-- 7,a7 9 subp>agraph 7,c7-- 7i7 9 clause 7i71 by /rik+ ! comma at ! end & ins]t+ a semicolon2 7ii7 9 clause 7ii71 by /rik+ 1 & at ! end & ins]t+ a semicolon2 7iii7 9 clause 7iii71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+3 7iv7 de novo classification "u section #eac7;a77#a74 2 & 7,b7 by add+ at ! end ! foll[+3 7,d7 ,! t]ms prem>ket review & reviews include all activities ( ! ,food & ,drug ,adm9i/ration conduct$ prior to approval or cle>ance ( an application1 notification1 or reque/ = classification submitt$ "u section #eje1 #eaj7k71 #eac7;f77#b71 #eae1 or #ebj ( ?is ,act or "u section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ ) respect to inve/igational use ( ! product4 4 7b7 ,in=mation = approval ( comb9ation products ,section #ebj7;h77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7h77#d77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ ,any in=mation & ins]t+ 8,subject to subp>agraph 7,c71 any in=mation02 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,no in=mation conta9$ 9 an application = prem>ket approval fil$ ) ! ,secret>y pursuant to section #eae7;c7 may be us$ to approve or cle> any application submitt$ "u section #eae or #eaj7k7 or to classify a product "u section #eac7;f77#b7 = a comb9ation product conta9+ z a con/itu5t "p an approv$ drug 7z def9$ 9 section #ejc7;g77#e77;,b77 unless-- 7i7 ! application includes ! c]tification or /atem5t ref]5c$ 9 section #ejc7;g77#e77;,a72 7ii7 ! applicant provides notice z describ$ 9 section #ejc7;g77#e77;,a72 & 7iii7 ! ,secret>y's approval ( su* application is subject to ! provisions 9 section #ejc7;g77#e77;,c74 4 7c7 ,v>iations ,f ,,cgmp ,/reaml9$ ,approa* ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all id5tify types ( comb9ation products & manufactur+ processes ) respect to :i* ! ,secret>y proposes t good manufactur+ processes may be adopt$ t v>y f ! requirem5ts set =? 9 section #d4d ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations7 or t ! ,secret>y proposes c satisfy ! requirem5ts 9 section #d4d ?r\gh alt]native or /reaml9$ me*anisms4 ,! ,secret>y %all id5tify su* types1 v>iations f su* requirem5ts1 & su* me*anisms1 9 a propos$ li/ publi%$ 9 ! ,f$]al ,regi/]4 ,aft] a public comm5t p]iod reg>d+ ! appropriate good manufactur+ practices = su* types1 ! ,secret>y %all publi% a f9al li/ 9 ! ,f$]al ,regi/]1 not)/&+ section #eec ( title #e1 ,unit$ ,/ates ,code4 ,! ,secret>y %all evaluate su* types1 v>iations1 & me*anisms us+ a risk-bas$ approa*4 ,! ,secret>y %all p]iodically review su* f9al li/4 ,e ,antimicrobial innovation & /ew>d%ip #cjda4 ,antimicrobial resi/ance monitor+ 7a7 ,9 g5]al ,section #cai;,e ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is am5d$-- 7#a7 by r$esignat+ subsections 7f7 & 7g7 z subsections 7l7 & 7m71 respectively2 & 7#b7 by ins]t+ aft] subsection 7e71 ! foll[+3 7f7 ,monitor+ at ,f$]al heal? c>e facilities ,! ,secret>y %all enc\rage report+ on aggregate antimicrobial drug use & antimicrobial resi/ance to antimicrobial drugs & ! implem5tation ( antimicrobial /ew>d%ip programs by heal? c>e facilities ( ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,vet]ans ,affairs1 & ! ,indian ,heal? ,s]vice & %all provide te*nical assi/ance to ! ,secret>y ( ,def5se & ! ,secret>y ( ,vet]ans ,affairs1 z appropriate & ^u reque/4 7g7 ,report on antimicrobial resi/ance 9 humans & use ( antimicrobial drugs ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 & annually !reaft]1 ! ,secret>y %all prep>e & make publicly available data & in=mation conc]n+-- 7#a7 aggregate national & regional tr5ds ( antimicrobial resi/ance 9 humans to antimicrobial drugs1 includ+ su* drugs approv$ "u section #ejf7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7#b7 antimicrobial /ew>d%ip1 :i* may include summ>ies ( ,/ate ef=ts to address antimicrobial resi/ance 9 humans to antimicrobial drugs & antimicrobial /ew>d%ip2 & 7#c7 coord9ation betwe5 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,commission] ( ,food & ,drugs ) respect to ! monitor+ (-- 7,a7 any applicable resi/ance "u p>agraph 7#a72 & 7,b7 drugs approv$ "u section #ejf7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7h7 ,in=mation relat$ to antimicrobial /ew>d%ip programs ,! ,secret>y %all1 z appropriate1 dissem9ate guidance1 educational mat]ials1 or o!r appropriate mat]ials relat$ to ! developm5t & implem5tation ( evid5ce-bas$ antimicrobial /ew>d%ip programs or practices at heal? c>e facilities1 su* z nurs+ homes & o!r long-t]m c>e facilities1 ambulatory surgical c5t]s1 dialysis c5t]s1 outpati5t cl9ics1 & hospitals1 includ+ community & rural hospitals4 7i7 ,support+ /ate-,bas$ activities ,to combat antimicrobial resi/ance ,! ,secret>y %all cont9ue to "w ) ,/ate & local public heal? dep>tm5ts on /atewide or regional programs relat$ to antimicrobial resi/ance4 ,su* ef=ts may include activities to relat$ to-- 7#a7 id5tify+ patt]ns ( bact]ial & fungal resi/ance 9 humans to antimicrobial drugs2 7#b7 prev5t+ ! spread ( bact]ial & fungal infections t are resi/ant to antimicrobial drugs2 & 7#c7 promot+ antimicrobial /ew>d%ip4 7j7 ,antimicrobial ,resi/ance & ,/ew>d%ip activities 7#a7 ,9 g5]al ,= ! purposes ( support+ /ew>d%ip activities1 exam9+ *anges 9 antimicrobial resi/ance1 & evaluat+ ! effectiv5ess ( section #ejf7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 ! ,secret>y %all-- 7,a7 provide a me*anism = facilities to report data relat$ to _! antimicrobial /ew>d%ip activities 7includ+ analyz+ ! outcomes ( su* activities72 & 7,b7 evaluate-- 7i7 antimicrobial resi/ance data us+ a /&>diz$ approa*2 & 7ii7 tr5ds 9 ! utilization ( drugs approv$ "u su* section #ejf7;h7 ) respect to pati5t populations4 7#b7 ,use ( sy/ems ,! ,secret>y %all use available sy/ems1 includ+ ! ,national ,heal?c>e ,safety ,network or o!r sy/ems id5tifi$ by ! ,secret>y1 to fulfill ! requirem5ts or conduct activities "u ?is section4 7k7 ,antimicrobial ,= purposes ( subsections 7f7 ?r\gh 7j71 ! t]m antimicrobial includes any antibact]ial or antifungal drugs1 & may include drugs t elim9ate or inhibit ! gr[? ( o!r microorganisms1 z appropriate4 4 7b7 ,availability ( data ,! ,secret>y %all make ! data collect$ pursuant to ?is subsection public4 ,no?+ 9 ?is subsection %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any in=mation t is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 #cjdb4 ,limit$ population pa?way ,section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef71 z am5d$ by section #cjcc1 is fur!r am5d$ by add+ at ! end ! foll[+3 7h7 ,limit$ population pa?way = antibact]ial & antifungal drugs 7#a7 ,9 g5]al ,! ,secret>y may approve an antibact]ial or antifungal drug1 alone or 9 comb9ation ) "o or m o!r drugs1 z a limit$ population drug pursuant to ?is subsection only if-- 7,a7 ! drug is int5d$ to treat a s]i\s or life-?reat5+ infection 9 a limit$ population ( pati5ts ) unmet ne$s2 7,b7 ! /&>ds = approval "u section #eje7;c7 & 7d71 or ! /&>ds = lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable1 are met2 & 7,c7 ! ,secret>y receives a writt5 reque/ f ! sponsor to approve ! drug z a limit$ population drug pursuant to ?is subsection4 7#b7 ,b5efit-risk consid]ation ,! ,secret>y's det]m9ation ( safety & effectiv5ess ( an antibact]ial or antifungal drug %all reflect ! b5efit-risk pr(ile ( su* drug 9 ! int5d$ limit$ population1 tak+ into acc\nt ! sev]ity1 r>ity1 or preval5ce ( ! infection ! drug is int5d$ to treat & ! availability or lack ( alt]native treatm5t 9 su* limit$ population4 ,su* drug may be approv$ "u ?is subsection not)/&+ a lack ( evid5ce to fully e/abli% a favorable b5efit-risk pr(ile 9 a population t is broad] ?an ! int5d$ limit$ population4 7#c7 ,additional requirem5ts ,a drug approv$ "u ?is subsection %all be subject to ! foll[+ requirem5ts1 9 addition to any o!r applicable requirem5ts ( ?is ,act3 7,a7 ,label+ ,to indicate t ! safety & effectiv5ess ( a drug approv$ "u ?is subsection has be5 demon/rat$ only ) respect to a limit$ population-- 7i7 all label+ & adv]tis+ ( an antibact]ial or antifungal drug approv$ "u ?is subsection %all conta9 ! /atem5t ,limit$ ,population 9 a prom95t mann] & adjac5t to1 & n m prom95t ?an-- 7,i7 ! propriet>y "n ( su* drug1 if any2 or 7,,ii7 if !re is no propriet>y "n1 ! e/abli%$ "n ( ! drug1 if any1 z def9$ 9 section #ejc7;e77#c71 or1 9 ! case ( a drug t is a biological product1 ! prop] "n1 z def9$ by regulation2 & 7ii7 ! prescrib+ in=mation = ! drug requir$ by section #bja4eg ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation7 %all also include ! foll[+ /atem5t3 ,?is drug is indicat$ = use 9 a limit$ & specific population ( pati5ts44 7,b7 ,promotional mat]ial ,! sponsor ( an antibact]ial or antifungal drug subject to ?is subsection %all submit to ! ,secret>y copies ( all promotional mat]ials relat$ to su* drug at lea/ #cj cal5d> days prior to dissem9ation ( ! mat]ials4 7#d7 ,o!r programs ,a sponsor ( a drug t seeks approval ( a drug "u ?is subsection may also seek designation or approval1 z applicable1 ( su* drug "u o!r applicable sections or subsections ( ?is ,act or ! ,public ,heal? ,s]vice ,act4 7#e7 ,guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all issue draft guidance describ+ crit]ia1 processes1 & o!r g5]al consid]ations = demon/rat+ ! safety & effectiv5ess ( limit$ population antibact]ial & antifungal drugs4 ,! ,secret>y %all publi% f9al guidance )9 #ah mon?s ( ! close ( ! public comm5t p]iod on su* draft guidance4 ,! ,secret>y may approve antibact]ial & antifungal drugs "u ?is subsection prior to issu+ guidance "u ?is p>agraph4 7#f7 ,advice ,! ,secret>y %all provide prompt advice to ! sponsor ( a drug = :i* ! sponsor seeks approval "u ?is subsection to enable ! sponsor to plan a developm5t program to obta9 ! necess>y data = su* approval1 & to conduct any additional /udies t w\ld be requir$ to ga9 approval ( su* drug = use 9 a broad] population4 7#g7 ,t]m9ation ( limitations ,if1 aft] approval ( a drug "u ?is subsection1 ! ,secret>y approves a broad] indication = su* drug "u section #eje7;b7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 ! ,secret>y may remove any po/m>ket+ conditions1 includ+ requirem5ts ) respect to label+ & review ( promotional mat]ials "u p>agraph 7#c71 applicable to ! approval ( ! drug "u ?is subsection4 7#h7 ,rules ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to alt] ! au?ority ( ! ,secret>y to approve drugs pursuant to ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ ! /&>ds ( evid5ce & applicable conditions = approval "u su* ,acts1 ! /&>ds ( approval ( a drug "u su* ,acts1 or to alt] ! au?ority ( ! ,secret>y to monitor drugs pursuant to su* ,acts4 7#i7 ,report+ & acc\ntability 7,a7 ,bi5nial report+ ,! ,secret>y %all report to ,congress n less (t5 ?an once e #b ye>s on ! numb] ( reque/s = approval1 & ! numb] ( approvals1 ( an antibact]ial or antifungal drug "u ?is subsection4 7,b7 ,,gao report ,n lat] ?an ,decemb] #bjba1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate a report on ! coord9ation ( activities requir$ "u section #cai;,e ( ! ,public ,heal? ,s]vice ,act4 ,su* report %all include a review ( su* activities1 & ! ext5t to :i* ! use ( ! pa?way e/abli%$ "u ?is subsection has /reaml9$ prem>ket approval = antibact]ial or antifungal drugs = limit$ populations1 if su* pa?way has function$ z int5d$1 if su* pa?way has help$ provide = safe & effective treatm5t = pati5ts1 if su* prem>ket approval w\ld be appropriate = o!r categories ( drugs1 & if ! au?orities "u ?is subsection h affect$ antibact]ial or antifungal resi/ance4 4 #cjdc4 ,prescrib+ au?ority ,no?+ 9 ?is subtitle1 or an am5dm5t made by ?is subtitle1 %all be con/ru$ to re/rict ! prescrib+ ( antimicrobial drugs or o!r products1 includ+ drugs approv$ "u subsection 7h7 ( section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 7z add$ by section #cjdb71 by heal? c>e pr(essionals1 or to limit ! practice ( heal? c>e4 #cjdd4 ,susceptibility te/ int]pretive crit]ia = microorganisms2 antimicrobial susceptibility te/+ devices 7a7 ,9 g5]al ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #eaa ! foll[+3 #eaa;,a4 ,susceptibility te/ int]pretive crit]ia = microorganisms 7a7 ,purpose2 ,id5tification ( crit]ia 7#a7 ,purpose ,! purpose ( ?is section is to cl>ify ! ,secret>y's au?ority to-- 7,a7 effici5tly update susceptibility te/ int]pretive crit]ia = antimicrobial drugs :5 necess>y = public heal?1 due to1 among o!r ?+s1 ! con/ant evolution ( microorganisms t leads to ! developm5t ( resi/ance to drugs t h be5 effective 9 decreas+ morbidity & mortality = pati5ts1 :i* w>rants unique managem5t ( antimicrobial drugs t is inappropriate = mo/ o!r drugs 9 ord] to delay or prev5t ! developm5t ( fur!r resi/ance to exi/+ !rapies2 7,b7 provide = public notice ( ! availability ( recogniz$ int]pretive crit]ia & int]pretive crit]ia /&>ds2 & 7,c7 cle> "u section #eaj7k71 classify "u section #eac7;f77#b71 or approve "u section #eae1 antimicrobial susceptibility te/+ devices utiliz+ updat$1 recogniz$ susceptibility te/ int]pretive crit]ia to *>act]ize ! 9 vitro susceptibility ( p>ticul> bact]ia1 fungi1 or o!r microorganisms1 z applicable1 to antimicrobial drugs4 7#b7 ,id5tification ( crit]ia ,! ,secret>y %all id5tify appropriate susceptibility te/ int]pretive crit]ia ) respect to antimicrobial drugs-- 7,a7 if su* crit]ia are available on ! date ( approval ( ! drug "u section #eje ( ?is ,act or lic5sure ( ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable71 ^u su* approval or lic5sure2 or 7,b7 if su* crit]ia are unavailable on su* date1 on ! date on :i* su* crit]ia are available = su* drug4 7#c7 ,bases = initial id5tification ,! ,secret>y %all id5tify appropriate susceptibility te/ int]pretive crit]ia "u p>agraph 7#b71 bas$ on ! ,secret>y's review (1 to ! ext5t available & relevant-- 7,a7 precl9ical & cl9ical data1 includ+ ph>macok9etic1 ph>macodynamic1 & epidemiological data2 7,b7 ! relation%ip ( susceptibility te/ int]pretive crit]ia to morbidity & mortality associat$ ) ! disease or condition = :i* su* drug is us$2 & 7,c7 su* o!r evid5ce & in=mation z ! ,secret>y consid]s appropriate4 7b7 ,susceptibility te/ ,int]pretive ,crit]ia ,website 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all e/abli%1 & ma9ta9 !reaft]1 on ! website ( ! ,food & ,drug ,adm9i/ration1 a d$icat$ website t conta9s a li/ ( any appropriate new or updat$ susceptibility te/ int]pretive crit]ia /&>ds & int]pretive crit]ia 9 accordance ) p>agraph 7#b7 7ref]r$ to 9 ?is section z ! ,int]pretive ,crit]ia ,website74 7#b7 ,li/+ ( susceptibility te/ int]pretive crit]ia /&>ds & int]pretive crit]ia 7,a7 ,9 g5]al ,! li/ describ$ 9 p>agraph 7#a7 %all consi/ ( any new or updat$ susceptibility te/ int]pretive crit]ia /&>ds t are-- 7i7 e/abli%$ by a nationally or int]nationally recogniz$ /&>d developm5t organization t-- 7,i7 e/abli%es & ma9ta9s proc$ures to address pot5tial conflicts ( int]e/ & ensure transp>5t decisionmak+2 7,,ii7 holds op5 meet+s to ensure t !re is an opportunity = public input by int]e/$ p>ties1 & e/abli%es & ma9ta9s processes to ensure t su* input is consid]$ 9 decisionmak+2 & 7,,iii7 p]mits its /&>ds to be made publicly available1 ?r\gh ! ,national ,libr>y ( ,m$ic9e or ano!r simil> s\rce acceptable to ! ,secret>y2 & 7ii7 recogniz$ 9 :ole1 or 9 "p1 by ! ,secret>y "u subsection 7c74 7,b7 ,o!r li/ ,! ,int]pretive ,crit]ia ,website %all1 9 addition to ! li/ describ$ 9 subp>agraph 7,a71 include a li/ ( int]pretive crit]ia1 if any1 t ! ,secret>y has det]m9$ to be appropriate ) respect to legally m>ket$ antimicrobial drugs1 :]e-- 7i7 ! ,secret>y does n recognize1 9 :ole or 9 "p1 an int]pretive crit]ia /&>d describ$ "u subp>agraph 7,a7 o!rwise applicable to su* a drug2 7ii7 ! ,secret>y )draws "u subsection 7c77#a77;,a7 recognition ( a /&>d1 9 :ole or 9 "p1 o!rwise applicable to su* a drug2 7iii7 ! ,secret>y approves an application "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable1 ) respect to m>ket+ ( su* a drug = :i* !re are no relevant int]pretive crit]ia includ$ 9 a /&>d recogniz$ by ! ,secret>y "u subsection 7c72 or 7iv7 because ! *>act]i/ics ( su* a drug diff] f o!r drugs ) ! same active +r$i5t1 ! int]pretive crit]ia ) respect to su* drug-- 7,i7 diff] f o!rwise applicable int]pretive crit]ia includ$ 9 a /&>d li/$ "u subp>agraph 7,a7 or int]pretive crit]ia o!rwise li/$ "u ?is subp>agraph2 & 7,,ii7 are det]m9$ by ! ,secret>y to be appropriate = ! drug4 7,c7 ,requir$ /atem5ts ,! ,int]pretive ,crit]ia ,website %all include /atem5ts convey+-- 7i7 t ! website provides in=mation ab\t ! 9 vitro susceptibility ( bact]ia1 fungi1 or o!r microorganisms1 z applicable to a c]ta9 drug 7or drugs72 7ii7 t-- 7,i7 ! safety & efficacy ( su* drugs 9 treat+ cl9ical infections due to su* bact]ia1 fungi1 or o!r microorganisms1 z applicable1 may or may n h be5 e/abli%$ 9 adequate & well-controll$ cl9ical trials 9 ord] = ! susceptibility in=mation describ$ 9 clause 7i7 to be includ$ on ! website2 & 7,,ii7 ! cl9ical significance ( su* susceptibility in=mation 9 su* in/ances is unkn[n2 7iii7 t ! approv$ product label+ = specific drugs provides ! uses = :i* ! ,secret>y has approv$ ! product2 & 7iv7 any o!r in=mation t ! ,secret>y det]m9es appropriate to adequately convey ! mean+ ( ! data support+ ! recognition or li/+ ( susceptibility te/ int]pretive crit]ia /&>ds or susceptibility te/ int]pretive crit]ia includ$ on ! website4 7#c7 ,notice ,n lat] ?an ! date on :i* ! ,int]pretive ,crit]ia ,website is e/abli%$1 ! ,secret>y %all publi% a notice ( t e/abli%m5t 9 ! ,f$]al ,regi/]4 7#d7 ,inapplicability ( misbr&+ provision ,! inclusion 9 ! approv$ label+ ( an antimicrobial drug ( a ref]5ce or hyp]l9k to ! ,int]pretive ,crit]ia ,website1 9 & ( itself1 %all n cause ! drug to be misbr&$ 9 violation ( section #ejb4 7#e7 ,trade secrets & confid5tial in=mation ,no?+ 9 ?is section %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any in=mation t is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 7c7 ,recognition ( susceptibility te/ int]pretive crit]ia 7#a7 ,evaluation & publication 7,a7 ,9 g5]al ,beg9n+ on ! date ( ! e/abli%m5t ( ! ,int]pretive ,crit]ia ,website1 & at lea/ e #f mon?s !reaft]1 ! ,secret>y %all-- 7i7 evaluate any appropriate new or updat$ susceptibility te/ int]pretive crit]ia /&>ds e/abli%$ by a nationally or int]nationally recogniz$ /&>d developm5t organization describ$ 9 subsection 7b77#b77;,a77i72 & 7ii7 publi% on ! public website ( ! ,food & ,drug ,adm9i/ration a notice-- 7,i7 )draw+ recognition ( any diff]5t susceptibility te/ int]pretive crit]ia /&>d1 9 :ole or 9 "p2 7,,ii7 recogniz+ ! new or updat$ /&>ds2 7,,iii7 recogniz+ "o or m p>ts ( ! new or updat$ int]pretive crit]ia specifi$ 9 su* a /&>d & decl9+ to recognize ! rema9d] ( su* /&>d2 & 7,,iv7 mak+ any necess>y updates to ! li/s "u subsection 7b77#b74 7,b7 ,^u approval ( a drug ,^u ! approval ( an initial or supplem5tal application = an antimicrobial drug "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable1 :]e su* approval is bas$ on susceptibility te/ int]pretive crit]ia :i* diff] f ^? conta9$ 9 a /&>d recogniz$1 or f ^? o!rwise li/$1 by ! ,secret>y pursuant to ?is subsection1 or = :i* !re are no relevant int]pretive crit]ia /&>ds recogniz$1 or int]pretive crit]ia o!rwise li/$1 by ! ,secret>y pursuant to ?is subsection1 ! ,secret>y %all update ! li/s "u subp>agraphs 7,a7 & 7,b7 ( subsection 7b77#b7 to include ! susceptibility te/ int]pretive crit]ia ^u :i* su* approval 0 bas$4 7#b7 ,bases = updat+ int]pretive crit]ia /&>ds ,9 evaluat+ new or updat$ susceptibility te/ int]pretive crit]ia /&>ds "u p>agraph 7#a77;,a71 ! ,secret>y may consid]-- 7,a7 ! ,secret>y's det]m9ation t su* a /&>d is n applicable to a p>ticul> drug because ! *>act]i/ics ( ! drug diff] f o!r drugs ) ! same active +r$i5t2 7,b7 in=mation provid$ by int]e/$ ?ird p>ties1 includ+ public comm5t on ! annual compilation ( notices publi%$ "u p>agraph 7#c72 7,c7 any bases us$ to id5tify susceptibility te/ int]pretive crit]ia "u subsection 7a77#b72 & 7,d7 su* o!r in=mation or factors z ! ,secret>y det]m9es appropriate4 7#c7 ,annual compilation ( notices ,ea* ye>1 ! ,secret>y %all compile ! notices publi%$ "u p>agraph 7#a77;,a7 & publi% su* compilation 9 ! ,f$]al ,regi/] & provide = public comm5t4 ,if ! ,secret>y receives comm5ts1 ! ,secret>y %all review su* comm5ts &1 if ! ,secret>y det]m9es appropriate1 update pursuant to ?is subsection susceptibility te/ int]pretive crit]ia /&>ds or crit]ia-- 7,a7 recogniz$ by ! ,secret>y "u ?is subsection2 or 7,b7 o!rwise li/$ on ! ,int]pretive ,crit]ia ,website "u subsection 7b77#b74 7#d7 ,relation to section #ead7;c7 ,any susceptibility te/ int]pretive /&>d recogniz$ "u ?is subsection or any crit]ia o!rwise li/$ "u subsection 7b77#b77;,b7 %all be deem$ to be recogniz$ z a /&>d by ! ,secret>y "u section #ead7;c77#a74 7#e7 ,volunt>y use ( int]pretive crit]ia ,no?+ 9 ?is section prohibits a p]son f seek+ approval or cle>ance ( a drug or device1 or *anges to ! drug or ! device1 on ! basis ( susceptibility te/ int]pretive crit]ia :i* diff] f ^? conta9$ 9 a /&>d recogniz$1 or f ^? o!rwise li/$1 by ! ,secret>y pursuant to subsection 7b77#b74 7d7 ,antimicrobial drug label+ 7#a7 ,drugs m>ket$ prior to e/abli%m5t ( ,int]pretive ,crit]ia ,website 7,a7 ,9 g5]al ,) respect to an antimicrobial drug lawfully introduc$ or deliv]$ = introduction into int]/ate comm]ce = comm]cial di/ribution be=e ! e/abli%m5t ( ! ,int]pretive ,crit]ia ,website1 a hold] ( an approv$ application "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable1 = ea* su* drug1 n lat] ?an #a ye> aft] e/abli%m5t ( ! ,int]pretive ,crit]ia ,website describ$ 9 subsection 7b77#a71 %all remove susceptibility te/ int]pretive crit]ia1 if any1 & relat$ in=mation f ! approv$ drug label+ & replace x ) a ref]5ce to ! ,int]pretive ,crit]ia ,website4 7,b7 ,label+ *anges ,! label+ *anges requir$ by ?is section %all be consid]$ a m9or *ange "u section #cad4gj ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations7 t may be implem5t$ ?r\gh docum5tation 9 ! next applicable annual report4 7#b7 ,drugs m>ket$ subsequ5t to e/abli%m5t ( ,int]pretive ,crit]ia ,website ,) respect to antimicrobial drugs approv$ on or aft] ! date ( ! e/abli%m5t ( ! ,int]pretive ,crit]ia ,website describ$ 9 subsection 7b77#a71 ! label+ = su* a drug %all include1 9 lieu ( susceptibility te/ int]pretive crit]ia & relat$ in=mation1 a ref]5ce to su* ,website4 7e7 ,special condition = m>ket+ ( antimicrobial susceptibility te/+ devices 7#a7 ,9 g5]al ,not)/&+ sections #eja1 #ejb1 #eje1 #eaj1 #eac1 & #eae1 if ! conditions specifi$ 9 p>agraph 7#b7 are met 79 addition to o!r applicable provisions "u ?is *apt]7 ) respect to an antimicrobial susceptibility te/+ device describ$ 9 subsection 7f77#a71 ! ,secret>y may au?orize ! m>ket+ ( su* device = a use describ$ 9 su* subsection4 7#b7 ,conditions applicable to antimicrobial susceptibility te/+ devices ,! conditions specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,! device is us$ to make a det]m9ation ( susceptibility us+ susceptibility te/ int]pretive crit]ia t are-- 7i7 includ$ 9 a /&>d recogniz$ by ! ,secret>y "u subsection 7c72 or 7ii7 o!rwise li/$ on ! ,int]pretive ,crit]ia ,website "u subsection 7b77#b74 7,b7 ,! label+ ( su* device includes /atem5ts convey+-- 7i7 t ! device provides in=mation ab\t ! 9 vitro susceptibility ( bact]ia1 fungi1 or o!r microorganisms1 z applicable to antimicrobial drugs2 7ii7 t-- 7,i7 ! safety & efficacy ( su* drugs 9 treat+ cl9ical infections due to su* bact]ia1 fungi1 or o!r microorganisms1 z applicable1 may or may n h be5 e/abli%$ 9 adequate & well-controll$ cl9ical trials 9 ord] = ! device to report ! susceptibility ( su* bact]ia1 fungi1 or o!r microorganisms1 z applicable1 to su* drugs2 & 7,,ii7 ! cl9ical significance ( su* susceptibility in=mation 9 ^? in/ances is unkn[n2 7iii7 t ! approv$ label+ = drugs te/$ us+ su* a device provides ! uses = :i* ! ,secret>y has approv$ su* drugs2 & 7iv7 any o!r in=mation ! ,secret>y det]m9es appropriate to adequately convey ! mean+ ( ! data support+ ! recognition or li/+ ( susceptibility te/ int]pretive crit]ia /&>ds or susceptibility te/ int]pretive crit]ia describ$ 9 subp>agraph 7,a74 7,c7 ,! antimicrobial susceptibility te/+ device meets all o!r requirem5ts to be cle>$ "u section #eaj7k71 classifi$ "u section #eac7;f77#b71 or approv$ "u section #eae4 7f7 ,def9itions ,9 ?is section3 7#a7 ,! t]m antimicrobial susceptibility te/+ device means a device t utilizes susceptibility te/ int]pretive crit]ia to det]m9e & report ! 9 vitro susceptibility ( c]ta9 microorganisms to a drug 7or drugs74 7#b7 ,! t]m qualifi$ infecti\s disease product means a qualifi$ infecti\s disease product designat$ "u section #eje;,e7d74 7#c7 ,! t]m susceptibility te/ int]pretive crit]ia means-- 7,a7 "o or m specific num]ical values :i* *>act]ize ! susceptibility ( bact]ia or o!r microorganisms to ! drug te/$2 & 7,b7 relat$ categorizations ( su* susceptibility1 includ+ categorization ( ! drug z susceptible1 int]m$iate1 resi/ant1 or su* o!r t]m z ! ,secret>y det]m9es appropriate4 7#d7 7,a7 ,! t]m antimicrobial drug means1 subject to subp>agraph 7,b71 a sy/emic antibact]ial or antifungal drug t-- 7i7 is int5d$ = human use 9 ! treatm5t ( a disease or condition caus$ by a bact]ium or fungus2 7ii7 may include a qualifi$ infecti\s disease product designat$ "u section #eje;,e7d72 & 7iii7 is subject to section #ejc7;b77#a74 7,b7 ,if provid$ by ! ,secret>y ?r\gh regulations1 su* t]m may include-- 7i7 drugs o!r ?an sy/emic antibact]ial & antifungal drugs2 & 7ii7 biological products 7z su* t]m is def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act7 to ! ext5t su* products exhibit antimicrobial activity4 7#e7 ,! t]m int]pretive crit]ia /&>d means a compilation ( susceptibility te/ int]pretive crit]ia develop$ by a /&>d developm5t organization t meets ! crit]ia set =? 9 subsection 7b77#b77;,a77i74 7g7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to-- 7#a7 alt] ! /&>ds ( evid5ce "u subsection 7c7 or 7d7 ( section #eje 7includ+ ! sub/antial evid5ce /&>d "u section #eje7;d77 or "u section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable72 or 7#b7 ) respect to cle>+ devices "u section #eaj7k71 classify+ devices "u section #eac7;f77#b71 or approv+ devices "u section #eae-- 7,a7 apply ) respect to any drug1 device1 or biological product1 9 any context o!r ?an an antimicrobial drug & an antimicrobial susceptibility te/+ device t uses susceptibility te/ int]pretive crit]ia to *>act]ize & report ! susceptibility ( c]ta9 bact]ia1 fungi1 or o!r microorganisms1 z applicable1 to su* drug to reflect pati5t morbidity & mortality 9 accordance ) ?is section2 or 7,b7 unless specifically /at$1 h any effect on au?orities provid$ "u o!r sections ( ?is ,act1 includ+ any regulations issu$ "u su* sections4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,repeal ( prior relat$ au?ority ,section #aaaa ( ! ,food & ,drug ,adm9i/ration ,am5dm5ts ,act ( #bjjg 7#db ,u4,s4,c4 #bdg;d-#e;a71 relat+ to id5tification ( cl9ically susceptible conc5trations ( antimicrobials1 is repeal$4 7#b7 ,addition to categories ( misbr&$ drugs ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7dd7 ,if x is an antimicrobial drug1 z def9$ 9 section #eaa;,a7f71 & its label+ fails to con=m ) ! requirem5ts "u section #eaa;,a7d74 4 7#c7 ,recognition ( int]pretive crit]ia /&>d z device /&>d ,section #ead7;c77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c77#a77;,a77 is am5d$ by ins]t+ aft] ! ,secret>y %all1 by publication 9 ! ,f$]al ,regi/] ! foll[+3 7or1 ) respect to a susceptibility te/ int]pretive crit]ia /&>d "u section #eaa;,a1 by po/+ on ! ,int]pretive ,crit]ia ,website 9 accordance ) su* section74 7c7 ,report to congress ,n lat] ?an #b ye>s 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 on ! progress made 9 implem5t+ section #eaa;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a71 z add$ by subsection 7a74 7d7 ,reque/s = updates to ,int]pretive ,crit]ia ,website ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! collection ( in=mation f int]e/$ p>ties reg>d+ updat+ ! li/s e/abli%$ "u section #eaa;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & po/$ on ! ,int]pretive ,crit]ia ,website e/abli%$ "u section #eaa;,a7c7 ( su* ,act4 ,f ,m$ical device innovations #cjea4 ,break?r\gh devices 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #eae;,b1 z add$ by section #cjcd7;b71 ! foll[+3 #eae;,c4 ,break?r\gh devices 7a7 ,purpose ,! purpose ( ?is section is to enc\rage ! ,secret>y1 & provide ! ,secret>y ) suffici5t au?ority1 to apply effici5t & flexible approa*es to exp$ite ! developm5t (1 & prioritize ! ,food & ,drug ,adm9i/ration's review (1 devices t repres5t break?r\gh te*nologies4 7b7 ,e/abli%m5t ( program ,! ,secret>y %all e/abli% a program to exp$ite ! developm5t (1 & provide = ! priority review =1 devices1 z det]m9$ by ! ,secret>y-- 7#a7 t provide = m effective treatm5t or diagnosis ( life-?reat5+ or irrev]sibly debilitat+ human disease or conditions2 & 7#b7 7,a7 t repres5t break?r\gh te*nologies2 7,b7 = :i* no approv$ or cle>$ alt]natives exi/2 7,c7 t (f] significant advantages ov] exi/+ approv$ or cle>$ alt]natives1 includ+ ! pot5tial1 comp>$ to exi/+ approv$ alt]natives1 to r$uce or elim9ate ! ne$ = hospitalization1 improve pati5t quality ( life1 facilitate pati5ts' ability to manage _! own c>e 7su* z ?r\gh self-direct$ p]sonal assi/ance71 or e/abli% long-t]m cl9ical effici5cies2 or 7,d7 ! availability ( :i* is 9 ! be/ int]e/ ( pati5ts4 7c7 ,reque/ = designation ,a sponsor ( a device may reque/ t ! ,secret>y designate su* device = exp$it$ developm5t & priority review "u ?is section4 ,any su* reque/ = designation may be made at any "t prior to ! submission ( an application "u section #eae7;c71 a notification "u section #eaj7k71 or a petition = classification "u section #eac7;f77#b74 7d7 ,designation ,process 7#a7 ,9 g5]al ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u subsection 7c71 ! ,secret>y %all det]m9e :e!r ! device t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 subsection 7b74 ,if ! ,secret>y det]m9es t ! device meets ! crit]ia1 ! ,secret>y %all designate ! device = exp$it$ developm5t & priority review4 7#b7 ,review ,review ( a reque/ "u subsection 7c7 %all be und]tak5 by a team t is compos$ ( exp]i5c$ /aff & s5ior manag]s ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,)drawal ,! ,secret>y may n )draw a designation grant$ "u ?is section on ! basis ( ! crit]ia "u subsection 7b7 no long] apply+ because ( ! subsequ5t cle>ance or approval ( ano!r device t-- 7,a7 0 designat$ "u ?is section2 or 7,b7 0 giv5 priority review "u section #eae7;d77#e71 z 9 effect prior to ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act4 7e7 ,exp$it$ ,developm5t & ,priority ,review 7#a7 ,actions ,= purposes ( exp$it+ ! developm5t & review ( devices designat$ "u subsection 7d7 ! ,secret>y %all-- 7,a7 assign a team ( /aff1 includ+ a team lead] ) appropriate subject matt] exp]tise & exp]i5ce1 = ea* device = :i* a reque/ is submitt$ "u subsection 7c72 7,b7 provide = ov]sight ( ! team by s5ior ag5cy p]sonnel to facilitate ! effici5t developm5t ( ! device & ! effici5t review ( any submission describ$ 9 subsection 7c7 = ! device2 7,c7 adopt an effici5t process = timely dispute resolution2 7,d7 provide = int]active & timely communication ) ! sponsor ( ! device dur+ ! developm5t program & review process2 7,e7 exp$ite ! ,secret>y's review ( manufactur+ & quality sy/ems compliance1 z applicable2 7,f7 disclose to ! sponsor1 n less ?an #e bus9ess days 9 advance1 ! topics ( any consultation ! ,secret>y int5ds to und]take ) ext]nal exp]ts or an advisory committee conc]n+ ! sponsor's device & provide ! sponsor ! opportunity to recomm5d su* ext]nal exp]ts2 7,g7 provide = advisory committee input1 z ! ,secret>y det]m9es appropriate 7includ+ 9 response to ! reque/ ( ! sponsor7 = applications submitt$ "u section #eae7;c72 & 7,h7 assign /aff to be available )9 a reasonable "t to address que/ions by in/itutional review committees conc]n+ ! conditions & cl9ical te/+ requirem5ts applicable to ! inve/igational use ( ! device pursuant to an exemption "u section #ebj7;g74 7#b7 ,additional actions ,9 addition to ! actions describ$ 9 p>agraph 7#a71 = purposes ( exp$it+ ! developm5t & review ( devices designat$ "u subsection 7d71 ! ,secret>y1 9 collaboration ) ! device sponsor1 may1 z appropriate-- 7,a7 coord9ate ) ! sponsor reg>d+ e>ly agreem5t on a data developm5t plan2 7,b7 take /eps to ensure t ! design ( cl9ical trials is z effici5t & flexible z practicable1 :5 sci5tifically appropriate2 7,c7 facilitate1 :5 sci5tifically appropriate1 exp$it$ & effici5t developm5t & review ( ! device ?r\gh utilization ( timely po/m>ket data collection ) reg>d to application = approval "u section #eae7;c72 & 7,d7 agree 9 writ+ to cl9ical protocols t ! ,secret>y w consid] b9d+ on ! ,secret>y & ! sponsor1 subject to-- 7i7 *anges to su* protocols agre$ to 9 writ+ by ! sponsor & ! ,secret>y2 or 7ii7 a decision1 made by ! director ( ! (fice responsible = review+ ! device submission1 t a sub/antial sci5tific issue ess5tial to det]m9+ ! safety or effectiv5ess ( su* device exi/s1 provid$ t su* decision is 9 writ+1 & is made only aft] ! ,secret>y provides to ! device sponsor or applicant an opportunity = a meet+ at :i* ! director & ! sponsor or applicant are pres5t & at :i* ! director docum5ts ! sub/antial sci5tific issue4 7f7 ,priority ,review ,guidance 7#a7 ,cont5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all issue guidance on ! implem5tation ( ?is section4 ,su* guidance %all-- 7,a7 set =? ! process by :i* a p]son may seek a designation "u subsection 7d72 7,b7 provide a template = reque/s "u subsection 7c72 7,c7 id5tify ! crit]ia ! ,secret>y w use 9 evaluat+ a reque/ = designation "u ?is section2 & 7,d7 id5tify ! crit]ia & processes ! ,secret>y w use to assign a team ( /aff1 includ+ team lead]s1 to review devices designat$ = exp$it$ developm5t & priority review1 includ+ any tra9+ requir$ = su* p]sonnel to ensure effective & effici5t review4 7#b7 ,process ,prior to f9aliz+ ! guidance "u p>agraph 7#a71 ! ,secret>y %all seek public comm5t on a propos$ guidance4 7g7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to affect-- 7#a7 ! crit]ia & /&>ds = evaluat+ an application pursuant to section #eae7;c71 a report & reque/ = classification "u section #eac7;f77#b71 or a report "u section #eaj7k71 includ+ ! recognition ( valid sci5tific evid5ce z describ$ 9 section #eac7;a77#c77;,b7 & consid]ation & application ( ! lea/ burd5some means ( evaluat+ device effectiv5ess or demon/rat+ sub/antial equival5ce betwe5 devices ) diff]+ te*nological *>act]i/ics1 z applicable2 7#b7 ! au?ority ( ! ,secret>y ) respect to cl9ical holds "u section #ebj7;g77#h77;,a72 7#c7 ! au?ority ( ! ,secret>y to act on an application pursuant to section #eae7;d7 be=e completion ( an e/abli%m5t inspection1 z ! ,secret>y det]m9es appropriate2 or 7#d7 ! au?ority ( ! ,secret>y ) respect to po/m>ket surveillance "u sections #eai7;h7 & #ebb4 4 7b7 ,docum5tation & review ( significant decisions ,section #eag;,a7a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77#a77 is am5d$ by ins]t+ a reque/ = designation "u section #eae;,c1 aft] application "u section #eae14 7c7 ,t]m9ation ( previ\s program 7#a7 ,9 g5]al ,section #eae7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77 is am5d$-- 7,a7 by /rik+ p>agraph 7#e72 & 7,b7 by r$esignat+ p>agraph 7#f7 z p>agraph 7#e74 7#b7 ,con=m+ am5dm5t ,section #gcg7e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetics ,act 7#ba ,u4,s4,c4 #cgi;i7#e77 is am5d$ by /rik+ #eae7;d77#f7 & ins]t+ #eae7;d77#e74 7d7 ,report ,on ,janu>y #a1 #bjai1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives-- 7#a7 on ! program "u section #eae;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 9 br++ safe & effective devices includ$ 9 su* program to pati5ts z soon z possible2 & 7#b7 t includes recomm5dations1 if any1 to /r5g!n ! program to bett] meet pati5t device ne$s 9 a mann] z timely z possible4 #cjeb4 ,humanit>ian device exemption 7a7 ,9 g5]al ,section #ebj7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is am5d$-- 7#a7 9 p>agraph 7#a7 by /rik+ few] ?an #d1jjj & ins]t+ n m ?an #h1jjj2 7#b7 9 p>agraph 7#b77;,a7 by /rik+ few] ?an #d1jjj & ins]t+ n m ?an #h1jjj2 & 7#c7 9 p>agraph 7#f77;,a77ii71 by /rik+ #d1jjj & ins]t+ #h1jjj4 7b7 ,guidance docum5t on probable b5efit ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all publi% a draft guidance t def9es ! crit]ia = e/abli%+ probable b5efit z t t]m is us$ 9 section #ebj7m77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#b77;,c774 #cjec4 ,recognition ( /&>ds 7a7 ,9 g5]al ,section #ead7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ aft] subp>agraph 7,b7 ! foll[+ new subp>agraphs3 7,c7 7i7 ,any p]son may submit a reque/ = recognition "u subp>agraph 7,a7 ( all or "p ( an appropriate /&>d e/abli%$ by a nationally or int]nationally recogniz$ /&>d organization4 7ii7 ,n lat] ?an #fj cal5d> days aft] ! ,secret>y receives su* a reque/1 ! ,secret>y %all-- 7,i7 make a det]m9ation to recognize all1 "p1 or none ( ! /&>d t is ! subject ( ! reque/2 & 7,,ii7 issue to ! p]son :o submitt$ su* reque/ a response 9 writ+ t /ates ! ,secret>y's rationale = t det]m9ation1 includ+ ! sci5tific1 te*nical1 regulatory1 or o!r basis = su* det]m9ation4 7iii7 ,! ,secret>y %all make a response issu$ "u clause 7ii77,,ii7 publicly available1 9 su* a mann] z ! ,secret>y det]m9es appropriate4 7iv7 ,! ,secret>y %all take su* actions z may be necess>y to implem5t all or "p ( a /&>d recogniz$ "u clause 7ii77,i71 9 accordance ) subp>agraph 7,a74 7,d7 ,! ,secret>y %all make publicly available1 9 su* mann] z ! ,secret>y det]m9es appropriate1 ! rationale = recognition "u subp>agraph 7,a7 ( all1 "p1 or none ( a /&>d1 includ+ ! sci5tific1 te*nical1 regulatory1 or o!r basis = ! decision reg>d+ su* recognition4 2 & 7#b7 by add+ at ! end ! foll[+3 7#d7 ,! ,secret>y %all provide to all employees ( ! ,food & ,drug ,adm9i/ration :o review prem>ket submissions = devices p]iodic tra9+ on ! concept & use ( recogniz$ /&>ds = purposes ( meet+ a prem>ket submission requirem5t or o!r applicable requirem5t "u ?is ,act1 includ+ /&>ds relevant to an employee's area ( device review4 4 7b7 ,guidance ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all review & update1 if necess>y1 previ\sly publi%$ guidance & /&>d op]at+ proc$ures id5tify+ ! pr9ciples = recogniz+ /&>ds1 & = )draw+ ! recognition ( /&>ds1 "u section #ead7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c771 tak+ into acc\nt ! exp]i5ce ) & reliance on a /&>d by =eign regulatory au?orities & ! device indu/ry1 & :e!r recognition ( a /&>d w promote h>monization among regulatory au?orities 9 ! regulation ( devices4 #cjed4 ,c]ta9 class ,i & class ,,ii devices 7a7 ,class i devices ,section #eaj7l7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77 is am5d$-- 7#a7 by /rik+ ,a report "u subsection 7k7 & ins]t+ 7#a7 ,a report "u subsection 7k72 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,n lat] ?an #abj cal5d> days aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act & at lea/ once e #e ye>s !reaft]1 z ! ,secret>y det]m9es appropriate1 ! ,secret>y %all id5tify1 ?r\gh publication 9 ! ,f$]al ,regi/]1 any type ( class ,i device t ! ,secret>y det]m9es no long] requires a report "u subsection 7k7 to provide reasonable assurance ( safety & effectiv5ess4 ,^u su* publication-- 7,a7 ea* type ( class ,i device s id5tifi$ %all be exempt f ! requirem5t = a report "u subsection 7k72 & 7,b7 ! classification regulation applicable to ea* su* type ( device %all be deem$ am5d$ to incorporate su* exemption4 4 7b7 ,class ,,ii devices ,section #eaj7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7m77 is am5d$-- 7#a7 by /rik+ 7m77#a7 & all t foll[s ?r\gh by ! ,secret>y4 & ins]t+ ! foll[+3 7m7 7#a7 ,! ,secret>y %all-- 7,a7 n lat] ?an #ij days aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act & at lea/ once e #e ye>s !reaft]1 z ! ,secret>y det]m9es appropriate-- 7i7 publi% 9 ! ,f$]al ,regi/] a notice t conta9s a li/ ( ea* type ( class ,,ii device t ! ,secret>y det]m9es no long] requires a report "u subsection 7k7 to provide reasonable assurance ( safety & effectiv5ess2 & 7ii7 provide = a p]iod ( n less ?an #fj cal5d> days = public comm5t beg9n+ on ! date ( ! publication ( su* notice2 & 7,b7 n lat] ?an #baj cal5d> days aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 publi% 9 ! ,f$]al ,regi/] a li/ repres5t+ ! ,secret>y's f9al det]m9ation ) respect to ! devices conta9$ 9 ! li/ publi%$ "u subp>agraph 7,a74 2 & 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ #a day aft] ! date ( publication ( a li/ "u ?is subsection1 & ins]t+ #a cal5d> day aft] ! date ( publication ( ! f9al li/ "u p>agraph 7#a77;,b712 & 7,b7 by /rik+ #cj-;day p]iod & ins]t+ #fj-;cal5d>-day p]iod2 & 7,c7 by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,^u ! publication ( ! f9al li/ "u p>agraph 7#a77;,b7-- 7,a7 ea* type ( class ,,ii device s li/$ %all be exempt f ! requirem5t = a report "u subsection 7k72 & 7,b7 ! classification regulation applicable to ea* su* type ( device %all be deem$ am5d$ to incorporate su* exemption4 4 #cjee4 ,classification panels 7a7 ,classification panels ,p>agraph 7#e7 ( section #eac7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is am5d$-- 7#a7 by /rik+ 7#e7 & ins]t+ 7#e77;,a72 & 7#b7 by add+ at ! end ! foll[+3 7,b7 ,:5 a device is specifically ! subject ( review by a classification panel1 ! ,secret>y %all-- 7i7 ensure t adequate exp]tise is repres5t$ on ! classification panel to assess-- 7,i7 ! disease or condition :i* ! device is int5d$ to cure1 treat1 mitigate1 prev5t1 or diagnose2 & 7,,ii7 ! te*nology ( ! device2 & 7ii7 provide an opportunity = ! p]son ^: device is specifically ! subject ( panel review to provide recomm5dations on ! exp]tise ne$$ among ! vot+ memb]s ( ! panel4 7,c7 ,= purposes ( subp>agraph 7,b77i71 ! t]m adequate exp]tise means t ! memb]%ip ( ! classification panel includes-- 7i7 two or m vot+ memb]s1 ) a specialty or o!r exp]tise cl9ically relevant to ! device "u review2 & 7ii7 at lea/ "o vot+ memb] :o is kn[l$geable ab\t ! te*nology ( ! device4 7,d7 ,! ,secret>y %all provide an annual opportunity = pati5ts1 repres5tatives ( pati5ts1 & sponsors ( m$ical device submissions to provide recomm5dations = individuals ) appropriate exp]tise to fill vot+ memb] positions on classification panels4 4 7b7 ,panel review process ,section #eac7;b77#f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77#f77 is am5d$-- 7#a7 9 subp>agraph 7,a77iii71 by ins]t+ be=e ! p]iod at ! end 1 includ+1 subject to ! discretion ( ! panel *airp]son1 by designat+ a repres5tative :o w be provid$ a "t dur+ ! panel meet+ to address ! panel = ! purpose ( correct+ mis/atem5ts ( fact or provid+ cl>ify+ in=mation1 & p]mitt+ ! p]son or repres5tative to call on exp]ts )9 ! p]son's organization to address su* specific issues 9 ! "t provid$2 & 7#b7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+ new subp>agraph3 7,b7 7i7 ,any meet+ ( a classification panel ) respect to ! review ( a device %all-- 7,i7 provide adequate "t = initial pres5tations by ! p]son ^: device is specifically ! subject ( su* review & by ! ,secret>y2 & 7,,ii7 enc\rage free & op5 p>ticipation by all int]e/$ p]sons4 7ii7 ,foll[+ ! initial pres5tations describ$ 9 clause 7i71 ! panel may-- 7,i7 pose que/ions to a designat$ repres5tative describ$ 9 subp>agraph 7,a77iii72 & 7,,ii7 consid] ! responses to su* que/ions 9 ! panel's review ( ! device4 4 #cjef4 ,in/itutional review bo>d flexibility ,section #ebj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is am5d$-- 7#a7 9 subsection 7g77#c7-- 7,a7 9 subp>agraph 7,a77i7-- 7i7 by /rik+ local2 & 7ii7 by /rik+ :i* has be52 & 7,b7 9 subp>agraph 7,b71 by /rik+ a local in/itutional & ins]t+ an in/itutional2 & 7#b7 9 subsection 7m77#d7-- 7,a7 by /rik+ subp>agraph 7,a7 & ins]t+ ! foll[+3 7,a7 9 facilities 9 :i* cl9ical te/+ ( devices is sup]vis$ by an in/itutional review committee e/abli%$ 9 accordance ) ! regulations ( ! ,secret>y2 & 2 7,b7 9 subp>agraph 7,b71 by /rik+ a local in/itutional & ins]t+ an in/itutional2 & 7,c7 9 ! matt] foll[+ subp>agraph 7,b71 by /rik+ local4 #cjeg4 ,,clia waiv] improvem5ts 7a7 ,draft revis$ guidance ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all publi% a draft guidance t-- 7#a7 revises ,section ,v4 ,demon/rat+ ,insignificant ,risk ( an ,errone\s ,result - ,accuracy ( ! guidance entitl$ ,recomm5dations = ,cl9ical ,laboratory ,improvem5t ,am5dm5ts ( #aihh 7,,clia7 ,waiv] ,applications = ,manufactur]s ( ,9 ,vitro ,diagno/ic ,devices & dat$ ,janu>y #cj1 #bjjh2 & 7#b7 includes ! appropriate use ( comp>able p]=mance betwe5 a waiv$ us] & a mod]ately complex laboratory us] to demon/rate accuracy4 7b7 ,f9al revis$ guidance ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all f9alize ! draft guidance publi%$ "u subsection 7a7 n lat] ?an #a ye> aft] ! comm5t p]iod = su* draft guidance closes4 #cjeh4 ,lea/ burd5some device review 7a7 ,9 g5]al ,section #eac ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is am5d$ by add+ at ! end ! foll[+3 7j7 ,tra9+ & ov]sight ( lea/ burd5some requirem5ts 7#a7 ,! ,secret>y %all-- 7,a7 ensure t ea* employee ( ! ,food & ,drug ,adm9i/ration :o is involv$ 9 ! review ( prem>ket submissions1 includ+ sup]visors1 receives tra9+ reg>d+ ! mean+ & implem5tation ( ! lea/ burd5some requirem5ts "u subsections 7a77#c77;,d7 & 7i77#a77;,d7 ( ?is section & section #eae7;c77#e72 & 7,b7 p]iodically assess ! implem5tation ( ! lea/ burd5some requirem5ts1 includ+ ! employee tra9+ "u subp>agraph 7,a71 to ensure t ! lea/ burd5some requirem5ts are fully & consi/5tly appli$4 7#b7 ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ombudsman = any organizational unit ( ! ,food & ,drug ,adm9i/ration responsible = ! prem>ket review ( devices %all-- 7,a7 conduct an audit ( ! tra9+ describ$ 9 p>agraph 7#a77;,a71 includ+ ! effectiv5ess ( su* tra9+ 9 implem5t+ ! lea/ burd5some requirem5ts2 7,b7 include 9 su* audit int]views ( p]sons :o are repres5tatives ( ! device indu/ry reg>d+ _! exp]i5ces 9 ! device prem>ket review process1 includ+ ) respect to ! application ( lea/ burd5some concepts to prem>ket review & decisionmak+2 7,c7 include 9 su* audit a li/ ( ! measurem5t tools ! ,secret>y uses to assess ! implem5tation ( ! lea/ burd5some requirem5ts1 includ+ "u p>agraph 7#a77;,b7 & section #eag;,a7a77#c71 & may also provide fe$back on ! effectiv5ess ( su* tools 9 ! implem5tation ( ! lea/ burd5some requirem5ts2 7,d7 summ>ize ! f9d+s ( su* audit 9 a f9al audit report2 & 7,e7 )9 #cj cal5d> days ( completion ( su* f9al audit report1 make su* f9al audit report available-- 7i7 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 & 7ii7 on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration4 4 7b7 ,prem>ket applications ,section #eae7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7c77 is am5d$ by add+ at ! end ! foll[+3 7#e7 7,a7 ,9 reque/+ additional in=mation ) respect to an application "u ?is section1 ! ,secret>y %all consid] ! lea/ burd5some appropriate means necess>y to demon/rate a reasonable assurance ( device safety & effectiv5ess4 7,b7 ,= purposes ( subp>agraph 7,a71 ! t]m necess>y means ! m9imum requir$ in=mation t w\ld support a det]m9ation by ! ,secret>y t an application provides a reasonable assurance ( ! safety & effectiv5ess ( ! device4 7,c7 ,= purposes ( ?is p>agraph1 ! ,secret>y %all consid] ! role ( po/m>ket in=mation 9 det]m9+ ! lea/ burd5some means ( demon/rat+ a reasonable assurance ( device safety & effectiv5ess4 7,d7 ,no?+ 9 ?is p>agraph alt]s ! /&>ds = prem>ket approval ( a device4 4 7c7 ,rationale = significant decisions reg>d+ devices ,section #eag;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,application ( lea/ burd5some requirem5ts ,! sub/antive summ>y requir$ "u ?is subsection %all include a brief /atem5t reg>d+ h[ ! lea/ burd5some requirem5ts 7 consid]$ & appli$ consi/5t ) section #eac7;i77#a77;,d71 section #eac7;a77#c77;,d71 & section #eae7;c77#e71 z applicable4 4 #cjei4 ,clean+ in/ructions & validation data requirem5t 7a7 ,9 g5]al ,section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is am5d$ by add+ at ! end ! foll[+3 7q7 ,reusable m$ical devices 7#a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all id5tify & publi% a li/ ( reusable device types = :i* reports "u subsection 7k7 are requir$ to include-- 7,a7 in/ructions = use1 :i* h be5 validat$ 9 a mann] specifi$ by ! ,secret>y2 & 7,b7 validation data1 ! types ( :i* %all be specifi$ by ! ,secret>y2 reg>d+ clean+1 dis9fection1 & /]ilization1 & = :i* a sub/antial equival5ce det]m9ation may be bas$4 7#b7 ,revision ( li/ ,! ,secret>y %all revise ! li/ "u p>agraph 7#b71 z ! ,secret>y det]m9es appropriate1 ) notice 9 ! ,f$]al ,regi/]4 7#c7 ,cont5t ( reports ,reports "u subsection 7k7 t are submitt$ aft] ! publication ( ! li/ describ$ 9 p>agraph 7#a71 = devices or types ( devices includ$ on su* li/1 %all include su* in/ructions = use & validation data4 4 7b7 ,device modifications ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue f9al guidance reg>d+ :5 a prem>ket notification "u section #eaj7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77 is requir$ to be submitt$ = a modification or *ange to a legally m>ket$ device4 ,su* f9al guidance %all be issu$ n lat] ?an #a ye> aft] ! date on :i* ! comm5t p]iod closes = ! draft guidance on su* subject4 #cjfj4 ,cl>ify+ m$ical s(tw>e regulation 7a7 ,9 g5]al ,section #ebj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is am5d$ by add+ at ! end ! foll[+3 7o7 ,regulation ( m$ical & c]ta9 decisions support s(tw>e 7#a7 ,! t]m device1 z def9$ 9 section #bja7;h71 %all n include a s(tw>e function t is int5d$-- 7,a7 = adm9i/rative support ( a heal? c>e facility1 includ+ ! process+ & ma9t5ance ( f9ancial records1 claims or bill+ in=mation1 appo9tm5t s*$ules1 bus9ess analytics1 in=mation ab\t pati5t populations1 admissions1 practice & inv5tory managem5t1 analysis ( hi/orical claims data to pr$ict future utilization or co/-effectiv5ess1 det]m9ation ( heal? b5efit eligibility1 population heal? managem5t1 & laboratory workfl[2 7,b7 = ma9ta9+ or enc\rag+ a heal?y life/yle & is unrelat$ to ! diagnosis1 cure1 mitigation1 prev5tion1 or treatm5t ( a disease or condition2 7,c7 to s]ve z electronic pati5t records1 includ+ pati5t-provid$ in=mation1 to ! ext5t t su* records are int5d$ to transf]1 /ore1 conv]t =mats1 or display ! equival5t ( a pap] m$ical *>t1 s long z-- 7i7 su* records 7 creat$1 /or$1 transf]r$1 or review$ by heal? c>e pr(essionals1 or by individuals work+ "u sup]vision ( su* pr(essionals2 7ii7 su* records are "p ( heal? in=mation te*nology t is c]tifi$ "u section #cjja7;c77#e7 ( ! ,public ,heal? ,s]vice ,act2 & 7iii7 su* function is n int5d$ to int]pret or analyze pati5t records1 includ+ m$ical image data1 = ! purpose ( ! diagnosis1 cure1 mitigation1 prev5tion1 or treatm5t ( a disease or condition2 7,d7 = transf]r+1 /or+1 conv]t+ =mats1 or display+ cl9ical laboratory te/ or o!r device data & results1 f9d+s by a heal? c>e pr(essional ) respect to su* data & results1 g5]al in=mation ab\t su* f9d+s1 & g5]al backgr\nd in=mation ab\t su* laboratory te/ or o!r device1 unless su* function is int5d$ to int]pret or analyze cl9ical laboratory te/ or o!r device data1 results1 & f9d+s2 or 7,e7 unless ! function is int5d$ to acquire1 process1 or analyze a m$ical image or a signal f an 9 vitro diagno/ic device or a patt]n or signal f a signal acquisition sy/em1 = ! purpose (-- 7i7 display+1 analyz+1 or pr9t+ m$ical in=mation ab\t a pati5t or o!r m$ical in=mation 7su* z pe]-review$ cl9ical /udies & cl9ical practice guidel9es72 7ii7 support+ or provid+ recomm5dations to a heal? c>e pr(essional ab\t prev5tion1 diagnosis1 or treatm5t ( a disease or condition2 & 7iii7 enabl+ su* heal? c>e pr(essional to indep5d5tly review ! basis = su* recomm5dations t su* s(tw>e pres5ts s t x is n ! int5t t su* heal? c>e pr(essional rely prim>ily on any ( su* recomm5dations to make a cl9ical diagnosis or treatm5t decision reg>d+ an individual pati5t4 7#b7 ,9 ! case ( a product ) multiple functions t conta9s-- 7,a7 at lea/ "o s(tw>e function t meets ! crit]ia "u p>agraph 7#a7 or t o!rwise does n meet ! def9ition ( device "u section #bja7;h72 & 7,b7 at lea/ "o function t does n meet ! crit]ia "u p>agraph 7#a7 & t o!rwise meets ! def9ition ( a device "u section #bja7;h71 ! ,secret>y %all n regulate ! s(tw>e function ( su* product describ$ 9 subp>agraph 7,a7 z a device4 ,not)/&+ ! prec$+ s5t5ce1 :5 assess+ ! safety & effectiv5ess ( ! device function or functions ( su* product describ$ 9 subp>agraph 7,b71 ! ,secret>y may assess ! impact t ! s(tw>e function or functions describ$ 9 subp>agraph 7,a7 h on su* device function or functions4 7#c7 7,a7 ,not)/&+ p>agraph 7#a71 a s(tw>e function describ$ 9 subp>agraph 7,c71 7,d71 or 7,e7 ( p>agraph 7#a7 %all n be exclud$ f ! def9ition ( device "u section #bja7;h7 if-- 7i7 ! ,secret>y makes a f9d+ t use ( su* s(tw>e function w\ld be reasonably likely to h s]i\s adv]se heal? consequ5ces2 & 7ii7 ! s(tw>e function has be5 id5tifi$ 9 a f9al ord] issu$ by ! ,secret>y "u subp>agraph 7,b74 7,b7 ,subp>agraph 7,a7 %all apply only if ! ,secret>y-- 7i7 publi%es a notification & propos$ ord] 9 ! ,f$]al ,regi/]2 7ii7 includes 9 su* notification ! ,secret>y's f9d+1 includ+ ! rationale & id5tification ( ! evid5ce on :i* su* f9d+ 0 bas$1 z describ$ 9 subp>agraph 7,a77i72 & 7iii7 provides = a p]iod ( n less ?an #cj cal5d> days = public comm5t be=e issu+ a f9al ord] or )draw+ su* propos$ ord]4 7,c7 ,9 mak+ a f9d+ "u subp>agraph 7,a77i7 ) respect to a s(tw>e function1 ! ,secret>y %all consid]-- 7i7 ! likelihood & sev]ity ( pati5t h>m if ! s(tw>e function 7 to n p]=m z int5d$2 7ii7 ! ext5t to :i* ! s(tw>e function is int5d$ to support ! cl9ical judgm5t ( a heal? c>e pr(essional2 7iii7 :e!r !re is a reasonable opportunity = a heal? c>e pr(essional to review ! basis ( ! in=mation or treatm5t recomm5dation provid$ by ! s(tw>e function2 & 7iv7 ! int5d$ us] & us] environm5t1 su* z :e!r a heal? c>e pr(essional w use a s(tw>e function ( a type describ$ 9 subp>agraph 7,e7 ( p>agraph 7#a74 7#d7 ,no?+ 9 ?is subsection %all be con/ru$ z limit+ ! au?ority ( ! ,secret>y to-- 7,a7 ex]cise en=cem5t discretion z to any device subject to regulation "u ?is ,act2 7,b7 regulate s(tw>e us$ 9 ! manufacture & transfusion ( blood & blood compon5ts to assi/ 9 ! prev5tion ( disease 9 humans2 or 7,c7 regulate s(tw>e z a device "u ?is ,act if su* s(tw>e meets ! crit]ia "u section #eac7;a77#a77;,c74 4 7b7 ,reports ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y71 aft] consultation ) ag5cies & (fices ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices involv$ 9 heal? in=mation te*nology1 %all publi% a report1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act & e #b ye>s !reaft]1 t-- 7#a7 includes input f outside exp]ts1 su* z repres5tatives ( pati5ts1 consum]s1 heal? c>e provid]s1 />tup companies1 heal? plans or o!r ?ird-p>ty pay]s1 v5ture capital inve/ors1 in=mation te*nology v5dors1 heal? in=mation te*nology v5dors1 small bus9esses1 pur*as]s1 employ]s1 & o!r /akehold]s ) relevant exp]tise1 z det]m9$ by ! ,secret>y2 7#b7 exam9es in=mation available to ! ,secret>y on any risks & b5efits to heal? associat$ ) s(tw>e functions describ$ 9 section #ebj7o77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 7z am5d$ by subsection 7a772 & 7#c7 summ>izes f9d+s reg>d+ ! impact ( su* s(tw>e functions on pati5t safety1 includ+ be/ practices to promote safety1 education1 & compet5cy relat$ to su* functions4 7c7 ,classification ( accessories ,section #eac7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is am5d$ by add+ at ! end ! foll[+3 7#i7 ,! ,secret>y %all classify an accessory "u ?is section bas$ on ! int5d$ use ( ! accessory1 not)/&+ ! classification ( any o!r device ) :i* su* accessory is int5d$ to be us$4 4 7d7 ,con=m+ am5dm5t ,section #bja7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h77 is am5d$ by add+ at ! end ! foll[+3 ,! t]m device does n include s(tw>e functions exclud$ pursuant to section #ebj7o744 ,g ,improv+ ,sci5tific ,exp]tise & ,outrea* at ,,fda #cjga4 ,silvio ,o4 ,conte ,s5ior ,biom$ical ,rese>* & ,biom$ical ,product ,assessm5t ,s]vice 7a7 ,hir+ & ret5tion au?ority ,section #bbh ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcg7 is am5d$-- 7#a7 9 ! section head+1 by ins]t+ & ,biom$ical ,product ,assessm5t aft] ,rese>*2 7#b7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 by /rik+ ,silvio ,o4 ,conte ,s5ior ,biom$ical ,rese>* ,s]vice1 n to exce$ #ejj memb]s & ins]t+ ,silvio ,o4 ,conte ,s5ior ,biom$ical ,rese>* & ,biom$ical ,product ,assessm5t ,s]vice 79 ?is section ref]r$ to z ! ,s]vice71 n to exce$ #b1jjj memb]s1 ! purpose ( :i* is to recruit & reta9 out/&+ & qualifi$ sci5tific & te*nical exp]ts 9 ! fields ( biom$ical rese>*1 cl9ical rese>* evaluation1 & biom$ical product assessm5t2 7,b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,! au?ority e/abli%$ 9 p>agraph 7#a7 may n be con/ru$ to require ! ,secret>y to r$uce ! numb] ( employees s]v+ "u any o!r employm5t sy/em 9 ord] to (fset ! numb] ( memb]s s]v+ 9 ! ,s]vice4 2 & 7,c7 by add+ at ! end ! foll[+3 7#c7 ,! ,secret>y %all assign exp]ts "u ?is section to ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices tak+ into acc\nt ! ne$ = ! exp]tise ( su* exp]t4 2 7#c7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ or cl9ical rese>* evaluation & ins]t+ 1 cl9ical rese>* evaluation1 or biom$ical product assessm5t2 & 7,b7 9 p>agraph 7#a71 by ins]t+ or a doctoral or ma/]'s level degree 9 eng9e]+1 bio9=matics1 or a relat$ or em]g+ field1 aft] ! comma2 7#d7 9 subsection 7d77#b71 by /rik+ & %all n exce$ ! rate payable = level ,i ( ! ,executive ,s*$ule unless approv$ by ! ,presid5t "u section #ecgg7;d77#b7 ( title #e1 ,unit$ ,/ates ,code & ins]t+ & %all n exce$ ! am\nt ( annual comp5sation 7exclud+ exp5ses7 specifi$ 9 section #ajb ( title #c1 ,unit$ ,/ates ,code2 7#e7 by /rik+ subsection 7e72 & 7#f7 by r$esignat+ subsections 7f7 & 7g7 z subsections 7e7 & 7f71 respectively4 7b7 ,,gao /udy 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy ( ! effectiv5ess ( ! am5dm5ts to section #bbh ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcg7 made by subsection 7a7 & ! impact ( su* am5dm5ts1 if any1 on all ag5cies or dep>tm5ts ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 &1 n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 %all submit a report bas$ on su* /udy to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 7#b7 ,cont5t ( /udy & report ,! /udy & report "u p>agraph 7#a7 %all include an exam9ation ( ! ext5t to :i* recruitm5t & ret5tion ( out/&+ & qualifi$ sci5tific1 m$ical1 or te*nical exp]ts 9 ! fields ( biom$ical rese>*1 cl9ical rese>* evaluation1 & biom$ical product assessm5t h improv$ or o!rwise h be5 affect$ by ! am5dm5ts to section #bbh ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcg7 made by subsection 7a71 includ+ by det]m9+1 dur+ ! p]iod betwe5 ! date ( enactm5t ( ?is ,act & ! completion ( ! /udy-- 7,a7 ! total numb] ( memb]s recruit$ & reta9$ "u ! ,s5ior ,biom$ical ,rese>* & ,biom$ical ,product ,assessm5t ,s]vice "u su* section #bbh1 & ! effect ( increas+ ! numb] ( memb]s eligible = su* ,s]vice2 7,b7 ! numb] ( memb]s ( su* ,s5ior ,biom$ical ,rese>* & ,biom$ical ,product ,assessm5t ,s]vice hir$ ) a doctoral level degree 9 biom$ic9e or a relat$ field1 & ! numb] ( su* memb]s hir$ ) a doctoral or ma/]'s level degree 9 eng9e]+1 bio9=matics1 or a relat$ or em]g+ field2 & 7,c7 ! numb] ( ,s5ior ,biom$ical ,rese>* & ,biom$ical ,product ,assessm5t ,s]vice memb]s t h be5 hir$ by ea* ag5cy or dep>tm5t ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 & h[ su* ,dep>tm5t assigns su* memb]s to ea* ag5cy or dep>tm5t4 #cjgb4 ,hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel 7a7 ,9 g5]al ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #gad 7#ba ,u4,s4,c4 #cgi;d-#c7 ! foll[+3 #gad;,a4 ,hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel 7a7 ,9 g5]al ,! ,secret>y may1 not)/&+ title #e1 ,unit$ ,/ates ,code1 gov]n+ appo9tm5ts 9 ! competitive s]vice1 appo9t out/&+ & qualifi$ c&idates to sci5tific1 te*nical1 or pr(essional positions t support ! developm5t1 review1 & regulation ( m$ical products4 ,su* positions %all be )9 ! competitive s]vice4 7b7 ,comp5sation 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 includ+ any requirem5t ) respect to ,g5]al ,s*$ule pay rates "u sub*apt] ,,iii ( *apt] #ec ( title #e1 ,unit$ ,/ates ,code1 & consi/5t ) ! requirem5ts ( p>agraph 7#b71 ! ,commission] ( ,food & ,drugs may det]m9e & set-- 7,a7 ! annual rate ( pay ( any individual appo9t$ "u subsection 7a72 & 7,b7 = purposes ( reta9+ qualifi$ employees1 ! annual rate ( pay = any qualifi$ sci5tific1 te*nical1 or pr(essional p]sonnel appo9t$ to a position describ$ 9 subsection 7a7 be=e ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act4 7#b7 ,limitation ,! annual rate ( pay e/abli%$ pursuant to p>agraph 7#a7 may n exce$ ! am\nt ( annual comp5sation 7exclud+ exp5ses7 specifi$ 9 section #ajb ( title #c1 ,unit$ ,/ates ,code4 7#c7 ,public availability ,! annual rate ( pay provid$ to an individual 9 accordance ) ?is section %all be publicly available in=mation4 7c7 ,rule ( con/ruction ,! au?orities "u ?is section %all n be con/ru$ to affect ! au?ority provid$ "u section #gad4 7d7 ,report on work=ce plann+ 7#a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all submit a report on work=ce plann+ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives t exam9es ! ext5t to :i* ! ,food & ,drug ,adm9i/ration has a critical ne$ = qualifi$ individuals = sci5tific1 te*nical1 or pr(essional positions1 includ+-- 7,a7 an analysis ( ! work=ce ne$s at ! ,food & ,drug ,adm9i/ration & ! ,secret>y's /rategic plan = address+ su* ne$s1 includ+ ?r\gh use ( ! au?ority "u ?is section2 & 7,b7 a recruitm5t & ret5tion plan = hir+ qualifi$ sci5tific1 te*nical1 & pr(essional c&idates1 :i* may include ! use (-- 7i7 recruitm5t ?r\gh nongov]nm5tal recruitm5t or placem5t ag5cies2 7ii7 recruitm5t ?r\gh academic in/itutions2 7iii7 recruitm5t or hir+ bonuses1 if applicable2 7iv7 recruitm5t us+ t>get$ direct hir+ au?orities2 & 7v7 ret5tion ( qualifi$ sci5tific1 te*nical1 & pr(essional employees us+ ! au?ority "u ?is section1 or o!r applicable au?orities ( ! ,secret>y4 7#b7 ,recomm5dations ,! report "u p>agraph 7#a7 may include ! recomm5dations ( ! ,commission] ( ,food & ,drugs t w\ld help ! ,food & ,drug ,adm9i/ration to bett] recruit & reta9 qualifi$ individuals = sci5tific1 te*nical1 or pr(essional positions at ! ag5cy4 4 7b7 ,,gao /udy & report 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy ( ! ability ( ! ,food & ,drug ,adm9i/ration to hire1 tra91 & reta9 qualifi$ sci5tific1 te*nical1 & pr(essional /aff1 n includ+ contractors1 necess>y to fulfill ! mission ( ! ,food & ,drug ,adm9i/ration to protect & promote public heal?4 ,n lat] ?an ,janu>y #a1 #bjbb1 ! ,comptroll] ,g5]al %all submit a report on su* /udy to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 7#b7 ,cont5ts ( /udy ,! ,comptroll] ,g5]al %all include 9 ! /udy & report "u p>agraph 7#a7-- 7,a7 in=mation ab\t ! progress ( ! ,food & ,drug ,adm9i/ration 9 recruit+ & reta9+ qualifi$ sci5tific1 te*nical1 & pr(essional /aff out/&+ 9 ! field ( biom$ical rese>*1 cl9ical rese>* evaluation1 & biom$ical product assessm5t2 7,b7 ! ext5t to :i* critical /aff+ ne$s exi/ at ! ,food & ,drug ,adm9i/ration1 & b>ri]s to hir+1 tra9+1 & reta9+ qualifi$ /aff1 if any2 7,c7 an exam9ation ( ! recruitm5t & ret5tion /rategies ( ! ,food & ,drug ,adm9i/ration1 includ+ exam9+ any /rategic work=ce plan1 focus$ on improv+ sci5tific1 te*nical1 & pr(essional /aff recruitm5t & ret5tion2 & 7,d7 recomm5dations = pot5tial improvem5ts t w\ld address /aff+ ne$s ( ! ,food & ,drug ,adm9i/ration4 #cjgc4 ,e/abli%m5t ( ,food & ,drug ,adm9i/ration ,int]c5t] ,in/itutes 7a7 ,9 g5]al ,*apt] ,x ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is am5d$ by add+ at ! end ! foll[+3 #ajad4 ,food & ,drug ,adm9i/ration ,int]c5t] ,in/itutes 7a7 ,9 g5]al ,! ,secret>y %all e/abli% "o or m ,int]c5t] ,in/itutes )9 ! ,food & ,drug ,adm9i/ration 7ref]r$ to 9 ?is section z an ,in/itute7 = a major disease area or areas4 ,) respect to ! major disease area ( focus ( an ,in/itute1 su* ,in/itute %all develop & implem5t processes = coord9ation ( activities1 z applicable to su* major disease area or areas1 among ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 & ! ,c5t] = ,devices & ,radiological ,heal? 7= ! purposes ( ?is section1 ref]r$ to z ! ,c5t]s74 ,su* activities may include-- 7#a7 coord9ation ( /aff f ! ,c5t]s ) div]se product exp]tise 9 ! diagnosis1 cure1 mitigation1 treatm5t1 or prev5tion ( ! specific diseases relevant to ! major disease area ( focus ( ! ,in/itute2 7#b7 /reaml9+1 :]e appropriate1 ! review ( m$ical products to diagnose1 cure1 mitigate1 treat1 or prev5t ! specific diseases relevant to ! major disease area ( focus ( ! ,in/itute1 apply+ relevant /&>ds "u sections #eje1 #eaj7k71 #eac7;f77#b71 & #eae ( ?is ,act & section #cea ( ! ,public ,heal? ,s]vice ,act1 & o!r applicable au?orities2 7#c7 promotion ( sci5tific programs )9 ! ,c5t]s relat$ to ! major disease area ( focus ( ! ,in/itute2 7#d7 developm5t ( programs & enhancem5t ( /rategies to recruit1 tra91 & provide cont9u+ education opportunities = ! p]sonnel ( ! ,c5t]s ) exp]tise relat$ to ! major disease area ( focus ( ! ,in/itute2 7#e7 enhancem5t ( ! int]actions ( ! ,c5t]s ) pati5ts1 sponsors1 & ! ext]nal biom$ical community reg>d+ ! major disease area ( focus ( ! ,in/itute2 & 7#f7 facilitation ( ! collaborative relation%ips ( ! ,c5t]s ) o!r ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices reg>d+ ! major disease area ( focus ( ! ,in/itute4 7b7 ,public process ,! ,secret>y %all provide a p]iod = public comm5t dur+ ! "t t ea* ,in/itute is be+ implem5t$4 7c7 ,tim+ ,! ,secret>y %all e/abli% at lea/ "o ,in/itute "u subsection 7a7 be=e ! date t is #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act4 7d7 ,t]m9ation ( in/itutes ,! ,secret>y may t]m9ate any ,in/itute e/abli%$ pursuant to ?is section if ! ,secret>y det]m9es su* ,in/itute is no long] b5efitt+ ! public heal?4 ,n less ?an #fj days prior to s t]m9at+ an ,in/itute1 ! ,secret>y %all provide public notice1 includ+ ! rationale = su* t]m9ation4 4 7b7 ,te*nical am5dm5ts ,*apt] ,x ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is am5d$-- 7#a7 by r$esignat+ section #ajab z section #ajac2 & 7#b7 by r$esignat+ ! second section #ajaa 7) respect to improv+ ! tra9+ ( ,/ate1 local1 t]ritorial1 & tribal food safety (ficials71 z add$ by section #bji7;a7 ( ! ,,fda ,food ,safety ,mod]nization ,act 7,public ,law #aaa-cec71 z section #ajab4 #cjgd4 ,sci5tific engagem5t 7a7 ,9 g5]al ,sci5tific meet+s t are att5d$ by sci5tific or m$ical p]sonnel1 or o!r pr(essionals1 ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices = :om att5dance at su* meet+ is directly relat$ to _! pr(essional duties & ! mission ( ! ,dep>tm5t-- 7#a7 %all n be consid]$ conf]5ces = ! purposes ( comply+ ) ,f$]al report+ requirem5ts conta9$ 9 annual appropriations ,acts or 9 ?is section2 & 7#b7 %all n be consid]$ conf]5ces = purposes ( a re/riction conta9$ 9 an annual appropriations ,act1 bas$ on ,(fice ( ,managem5t & ,budget ,memor&um ,m-#ab-ab or any o!r regulation re/rict+ travel to su* meet+4 7b7 ,limitation ,no?+ 9 ?is section %all be con/ru$ to exempt travel = sci5tific meet+s f ,f$]al regulations relat+ to travel4 7c7 ,reports ,n lat] ?an #ij days aft] ! end ( ! fiscal ye>1 ea* op]at+ division ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all prep>e1 & po/ on an ,int]net website ( ! op]at+ division1 an annual report on sci5tific meet+ att5dance & relat$ travel sp5d+ = ea* fiscal ye>4 ,su* report %all include-- 7#a7 g5]al in=mation conc]n+ ! sci5tific meet+ activities involv$2 7#b7 in=mation conc]n+ ! total am\nt exp5d$ = su* meet+s2 7#c7 a description ( all su* meet+s t 7 att5d$ by sci5tific or m$ical p]sonnel1 or o!r pr(essionals1 ( ea* su* op]at+ division :]e ! total am\nt exp5d$ by ! op]at+ division associat$ ) ea* su* meet+ 7 9 excess ( #cj1jjj1 includ+-- 7,a7 ! total am\nt ( meet+ exp5ses incurr$ by ! op]at+ division = su* meet+2 7,b7 ! location ( su* meet+2 7,c7 ! date ( su* meet+2 7,d7 a brief explanation on h[ su* meet+ advanc$ ! mission ( ! op]at+ division2 & 7,e7 ! total numb] ( individuals ^: travel exp5ses or o!r sci5tific meet+ exp5ses 7 paid by ! op]at+ division2 & 7#d7 ) respect to any su* meet+ :]e ! total exp5ses to ! op]at+ division exce$$ #aej1jjj1 a description ( ! exceptional circum/ances t necessitat$ ! exp5diture ( su* am\nts4 #cjge4 ,drug surveillance 7a7 ,new drugs ,section #eje7k77#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7k77#e771 z am5d$ by section #bjgd1 is fur!r am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ 1 bi-weekly scre5+ & ins]t+ scre5+s2 7#b7 9 subp>agraph 7,b71 z r$esignat$ by section #bjgd7a77;,c71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,c7 make available on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration-- 7i7 guidel9es1 develop$ ) input f exp]ts qualifi$ by sci5tific tra9+ & exp]i5ce to evaluate ! safety & effectiv5ess ( drugs1 t detail be/ practices = drug safety surveillance us+ ! ,adv]se ,ev5t ,report+ ,sy/em2 & 7ii7 crit]ia = public po/+ ( adv]se ev5t signals4 4 7b7 ,,fa]s revision ,section #eje7r77#b77;,d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7r77#b77;,d77 is am5d$ by /rik+ 1 by #ah mon?s & all t foll[s ?r\gh ! semicolon at ! end ( ! subp>agraph & ins]t+ & mak+ publicly available on ! ,int]net website e/abli%$ "u p>agraph 7#a7 be/ practices = drug safety surveillance activities = drugs approv$ "u ?is section or section #cea ( ! ,public ,heal? ,s]vice ,act24 7c7 ,risk evaluation & mitigation /rategies ,section #eje-a7;f77#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f77#e77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ or o!r advisory committee aft] 7or successor committee72 & 7#b7 9 subp>agraph 7,b71 by /rik+ at lea/ annually1 & ins]t+ p]iodically4 #cjgf4 ,reagan-,udall ,f\ndation = ! ,food & ,drug ,adm9i/ration 7a7 ,bo>d ( ,directors 7#a7 ,composition & size ,section #ggj7;d77#a77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#a77;,c77 is am5d$-- 7,a7 by r$esignat+ clause 7ii7 z clause 7iii72 7,b7 by ins]t+ aft] clause 7i7 ! foll[+3 7ii7 ,additional memb]s ,! ,bo>d1 ?r\gh am5dm5ts to ! bylaws ( ! ,f\ndation1 may provide t ! numb] ( vot+ memb]s ( ! ,bo>d %all be a numb] 7to be specifi$ 9 su* am5dm5t7 great] ?an #ad4 ,any ,bo>d positions t are e/abli%$ by any su* am5dm5t %all be appo9t$ 7by majority vote7 by ! individuals :o1 z ( ! date ( su* am5dm5t1 are vot+ memb]s ( ! ,bo>d & p]sons s appo9t$ may repres5t any ( ! categories specifi$ 9 subclauses 7,i7 ?r\gh 7,v7 ( clause 7i71 s long z no m ?an #cj p]c5t ( ! total vot+ memb]s ( ! ,bo>d 7includ+ memb]s ^: positions are e/abli%$ by su* am5dm5t7 are repres5tatives ( ! g5]al ph>maceutical1 device1 food1 cosmetic1 & biote*nology indu/ries4 2 & 7,c7 9 clause 7iii77,i71 z r$esignat$ by subp>agraph 7,a71 by /rik+ ,! ex (ficio memb]s %all ensure & ins]t+ ,! ex (ficio memb]s1 act+ pursuant to clause 7i71 & ! ,bo>d1 act+ pursuant to clause 7ii71 %all ensure4 7#b7 ,f$]al employees all[$ to s]ve on ,bo>d ,clause 7iii77,,ii7 ( section #ggj7;d77#a77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#a77;,c771 z r$esignat$ by p>agraph 7#a77;,a71 is am5d$ by add+ at ! end ! foll[+3 ,= purposes ( ?is section1 ! t]m employee ( ! ,f$]al ,gov]nm5t does n include a special ,gov]nm5t employee1 z t t]m is def9$ 9 section #bjb7;a7 ( title #ah1 ,unit$ ,/ates ,code44 7#c7 ,/agg]$ t]ms ,subp>agraph 7,a7 ( section #ggj7;d77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#c77 is am5d$ to read z foll[s3 7,a7 ,t]m ,! t]m ( (fice ( ea* memb] ( ! ,bo>d appo9t$ "u p>agraph 7#a77;,c77i71 & ! t]m ( (fice ( any memb] ( ! ,bo>d ^: position is e/abli%$ pursuant to p>agraph 7#a77;,c77ii71 %all be #d ye>s1 except t-- 7i7 ! t]ms ( (fices = ! memb]s ( ! ,bo>d initially appo9t$ "u p>agraph 7#a77;,c77i7 %all expire on a /agg]$ basis z det]m9$ by ! ex (ficio memb]s2 & 7ii7 ! t]ms ( (fice = ! p]sons initially appo9t$ to positions e/abli%$ pursuant to p>agraph 7#a77;,c77ii7 may be made to expire on a /agg]$ basis1 z det]m9$ by ! individuals :o1 z ( ! date ( ! am5dm5t e/abli%+ su* positions1 are memb]s ( ! ,bo>d4 4 7b7 ,executive ,director comp5sation ,section #ggj7;g77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7g77#b77 is am5d$ by /rik+ b %all n be great] ?an ! comp5sation ( ! ,commission]4 7c7 ,sep>ation ( ,funds ,section #ggj7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7m77 is am5d$ by /rik+ are held 9 sep>ate acc\nts f funds receiv$ f entities "u subsection 7i7 & ins]t+ are manag$ z individual programmatic funds "u subsection 7i71 accord+ to be/ acc\nt+ practices4 ,h ,m$ical c\nt]measures innovation #cjha4 ,m$ical c\nt]measure guidel9es ,section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is am5d$-- 7#a7 9 subsection 7a71 by add+ at ! end ! foll[+3 7#c7 ,utilization guidel9es ,! ,secret>y %all ensure timely & accurate recomm5d$ utilization guidel9es = qualifi$ c\nt]measures 7z def9$ 9 section #cai;,f-#a71 qualifi$ p&emic & epidemic products 7z def9$ 9 section #cai;,f-#c71 & security c\nt]measures 7z def9$ 9 subsection 7c771 includ+ = su* products 9 ! /ockpile4 2 & 7#b7 9 subsection 7g7-- 7,a7 by am5d+ p>agraph 7#d7 to read z foll[s3 7#d7 ,report on security c\nt]measure procurem5t ,n lat] ?an ,m>* #a ( ea* ye> 9 :i* ! ,secret>y det]m9es t ! am\nt ( funds available = procurem5t ( security c\nt]measures is less ?an #a1ejj1jjj1jjj1 ! ,secret>y %all submit to ! ,committee on ,appropriations & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,appropriations & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report detail+ ! am\nt ( su* funds available = procurem5t & ! impact su* am\nt ( fund+ w h-- 7,a7 9 meet+ ! security c\nt]measure ne$s id5tifi$ "u ?is section2 & 7,b7 on ! annual ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise & ,/rategy ,implem5tation ,plan 7pursuant to section #bhaa7;d774 4 #cjhb4 ,cl>ify+ ,,b>da contract+ au?ority 7a7 ,9 g5]al ,section #cai;,f-#b7;g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7g77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,cl>ification on contract+ au?ority ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 %all c>ry out ! programs fund$ by ! special res]ve fund 7= ! procurem5t ( security c\nt]measures "u subsection 7c7 & = c>ry+ out section #cai,l71 includ+ ! execution ( procurem5t contracts1 grants1 & coop]ative agreem5ts pursuant to ?is section & section #cai,l4 4 7b7 ,,b>da contract+ au?ority ,section #cai,l7c77#c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;c7 is am5d$ by ins]t+ 1 includ+ ! execution ( procurem5t contracts1 grants1 & coop]ative agreem5ts pursuant to ?is section be=e ! p]iod4 #cjhc4 ,c\nt]measure budget plan ,section #bhaa7;b77#g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#g77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ! fir/ s5t5ce & ins]t+ ,develop1 & update n lat] ?an ,m>* #a ( ea* ye>1 a coord9at$ #e-ye> budget plan bas$ on ! m$ical c\nt]measure priorities describ$ 9 subsection 7d71 includ+ ) respect to *emical1 biological1 radiological1 & nucle> ag5t or ag5ts t may pres5t a ?reat to ! ,nation1 includ+ su* ag5ts t are novel or em]g+ infecti\s diseases1 & ! correspond+ ef=ts to develop qualifi$ c\nt]measures 7z def9$ 9 section #cai;,f-#a71 security c\nt]measures 7z def9$ 9 section #cai;,f-#b71 & qualifi$ p&emic or epidemic products 7z def9$ 9 section #cai;,f-#c7 = ea* su* ?reat42 7#b7 9 subp>agraph 7,c71 by /rik+ 2 & & ins]t+ a semicolon2 7#c7 9 subp>agraph 7,d71 by /rik+ to ! appropriate committees ( ,congress ^u reque/4 & ins]t+ 1 n lat] ?an ,m>* #ae ( ea* ye>1 to ! ,committee on ,appropriations & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,appropriations & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 &2 & 7#d7 by add+ at ! end ! foll[+3 7,e7 n lat] ?an ,m>* #ae ( ea* ye>1 be made publicly available 9 a mann] t does n compromise national security4 4 #cjhd4 ,m$ical c\nt]measures innovation ,section #cai,l7c77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77 is am5d$ by add+ at ! end ! foll[+3 7,e7 ,m$ical c\nt]measures innovation p>tn] 7i7 ,9 g5]al ,to support ! purposes describ$ 9 p>agraph 7#b71 ! ,secret>y1 act+ ?r\gh ! ,director ( ,,b>da1 may ent] into an agreem5t 7includ+ ?r\gh ! use ( grants1 contracts1 coop]ative agreem5ts1 or o!r transactions z describ$ 9 p>agraph 7#e77 ) an indep5d5t1 nonpr(it entity to-- 7,i7 fo/] & accel]ate ! developm5t & innovation ( m$ical c\nt]measures & te*nologies t may assi/ advanc$ rese>* & ! developm5t ( qualifi$ c\nt]measures & qualifi$ p&emic or epidemic products1 includ+ ?r\gh ! use ( /rategic v5ture capital practices & me?ods2 7,,ii7 promote ! developm5t ( new & promis+ te*nologies t address urg5t m$ical c\nt]measure ne$s1 z id5tifi$ by ! ,secret>y2 7,,iii7 address unmet public heal? ne$s t are directly relat$ to m$ical c\nt]measure requirem5ts1 su* z novel antimicrobials = multidrug resi/ant organisms & multiuse plat=m te*nologies = diagno/ics1 prophylaxis1 vacc9es1 & !rapeutics2 & 7,,iv7 provide exp]t consultation & advice to fo/] viable m$ical c\nt]measure innovators1 includ+ help+ qualifi$ c\nt]measure innovators navigate unique indu/ry *all5ges ) respect to develop+ *emical1 biological1 radiological1 & nucle> c\nt]measure products4 7ii7 ,eligibility 7,i7 ,9 g5]al ,to be eligible to ent] into an agreem5t "u clause 7i7 an entity %all-- 7aa7 be an indep5d5t1 nonpr(it entity2 7bb7 h a demon/rat$ record ( be+ able to create l9kages betwe5 innovators & inve/ors & lev]age su* p>tn]%ips & res\rces = ! purpose ( address+ id5tifi$ /rategic ne$s ( ! ,f$]al ,gov]nm5t2 7cc7 h exp]i5ce 9 promot+ novel te*nology innovation2 7dd7 be problem-driv5 & solution-focus$ bas$ on ! ne$s1 requirem5ts1 & problems id5tifi$ by ! ,secret>y "u clause 7iv72 7ee7 demon/rate ! ability1 or ! pot5tial ability1 to promote ! developm5t ( m$ical c\nt]measure products2 7ff7 demon/rate exp]tise1 or ! capacity to develop or acquire exp]tise1 relat$ to te*nical & regulatory consid]ations ) respect to m$ical c\nt]measures2 & 7gg7 n be )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7,,ii7 ,p>tn]+ exp]i5ce ,9 select+ an entity ) :i* to ent] into an agreem5t "u clause 7i71 ! ,secret>y %all place a high value on ! demon/rat$ exp]i5ce ( ! entity 9 p>tn]+ ) ! ,f$]al ,gov]nm5t to meet id5tifi$ /rategic ne$s4 7iii7 ,n ag5cy ,an entity t ent]s into an agreem5t "u clause 7i7 %all n be deem$ to be a ,f$]al ag5cy = any purpose1 includ+ = any purpose "u title #e1 ,unit$ ,/ates ,code4 7iv7 ,direction ,pursuant to an agreem5t ent]$ into "u ?is subp>agraph1 ! ,secret>y1 act+ ?r\gh ! ,director ( ,,b>da1 %all provide direction to ! entity t ent]s into an agreem5t "u clause 7i74 ,z "p ( ?is agreem5t ! ,director ( ,,b>da %all-- 7,i7 communicate ! m$ical c\nt]measure ne$s1 requirem5ts1 & problems to be address$ by ! entity "u ! agreem5t2 7,,ii7 develop a description ( "w to be p]=m$ by ! entity "u ! agreem5t2 7,,iii7 provide te*nical fe$back & appropriate ov]sight ov] "w c>ri$ out by ! entity "u ! agreem5t1 includ+ subsequ5t developm5t & p>tn]%ips consi/5t ) ! ne$s & requirem5ts set =? 9 ?is subp>agraph2 7,,iv7 ensure fair consid]ation ( products develop$ "u ! agreem5t 9 ord] to ma9ta9 competition to ! maximum practical ext5t1 z applicable & appropriate "u applicable provisions ( ?is section2 & 7,v7 ensure1 z a condition ( ! agreem5t t ! entity-- 7aa7 has 9 place a compreh5sive set ( policies t demon/rate a commitm5t to transp>5cy & acc\ntability2 7bb7 protects aga9/ conflicts ( int]e/ ?r\gh a compreh5sive set ( policies t address pot5tial conflicts ( int]e/1 e?ics1 disclosure1 & report+ requirem5ts2 7cc7 provides mon?ly acc\nt+ on ! use ( funds provid$ "u su* agreem5t2 & 7dd7 provides on a qu>t]ly basis1 reports reg>d+ ! progress made t[>d meet+ ! id5tifi$ ne$s set =? 9 ! agreem5t4 7v7 ,supplem5t n supplant ,activities c>ri$ out "u ?is subp>agraph %all supplem5t1 & n supplant1 o!r activities c>ri$ out "u ?is section4 7vi7 ,no e/abli%m5t ( entity ,to prev5t unnecess>y duplication & t>get res\rces effectively1 no?+ 9 ?is subp>agraph %all be con/ru$ to au?orize ! ,secret>y to e/abli% )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices an entity = ! purposes ( c>ry+ out ?is subp>agraph4 7vii7 ,transp>5cy & ov]sight ,^u reque/1 ! ,secret>y %all provide to ,congress ! in=mation provid$ to ! ,secret>y "u clause 7iv77,v77dd74 7viii7 ,indep5d5t evaluation ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct an indep5d5t evaluation1 & submit to ! ,secret>y & ! appropriate committees ( ,congress a report1 conc]n+ ! activities conduct$ "u ?is subp>agraph4 ,su* report %all include recomm5dations ) respect to any agreem5t or activities c>ri$ out pursuant to ?is subp>agraph4 7ix7 ,sunset ,?is subp>agraph %all h no =ce or effect aft] ,septemb] #cj1 #bjbb4 4 #cjhe4 ,/reaml9+ ,project ,bio,shield procurem5t ,section #cai;,f-#b7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7c77 is am5d$-- 7#a7 9 p>agraph 7#d77;,a77ii71 by /rik+ make a recomm5dation "u p>agraph 7#f7 t ! special res]ve fund z def9$ 9 subsection 7h7 be made available = ! procurem5t ( su* c\nt]measure & ins]t+ & subject to ! availability ( appropriations1 make available ! special res]ve fund z def9$ 9 subsection 7h7 = procurem5t ( su* c\nt]measure1 z applicable2 7#b7 9 p>agraph 7#f7-- 7,a7 by /rik+ subp>agraphs 7,a71 7,b71 & 7,e72 7,b7 by r$esignat+ subp>agraphs 7,c7 & 7,d7 z subp>agraphs 7,a7 & 7,b71 respectively2 7,c7 by am5d+ subp>agraph 7,a71 z s r$esignat$1 to read z foll[s3 7,a7 ,notice to appropriate congressional committees ,! ,secret>y %all notify ! ,committee on ,appropriations & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,appropriations & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives ( ea* decision to make available ! special res]ve fund z def9$ 9 subsection 7h7 = procurem5t ( a security c\nt]measure1 includ+1 :]e available1 ! numb] (1 ! nature (1 & o!r in=mation conc]n+ pot5tial suppli]s ( su* c\nt]measure1 & :e!r o!r pot5tial suppli]s ( ! same or simil> c\nt]measures 7 consid]$ & reject$ = procurem5t "u ?is section & ! reasons = ea* su* rejection4 2 & 7,d7 9 ! head+1 by /rik+ ,recomm5dation = presid5t's approval & ins]t+ ,recomm5dations = procurem5t2 & 7#c7 9 p>agraph 7#g7-- 7,a7 by /rik+ subp>agraphs 7,a7 & 7,b7 & ins]t+ ! foll[+3 7,a7 ,paym5ts f special res]ve fund ,! special res]ve fund z def9$ 9 subsection 7h7 %all be available = paym5ts made by ! ,secret>y to a v5dor = procurem5t ( a security c\nt]measure 9 accordance ) ! provisions ( ?is p>agraph4 2 & 7,b7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,b74 #cjhf4 ,enc\rag+ treatm5ts = ag5ts t pres5t a national security ?reat ,sub*apt] ,e ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is am5d$ by ins]t+ aft] section #efe ! foll[+3 #efe;,a4 ,priority review to enc\rage treatm5ts = ag5ts t pres5t national security ?reats 7a7 ,def9itions ,9 ?is section3 7#a7 ,human drug application ,! t]m human drug application has ! mean+ giv5 su* t]m 9 section #gce7a74 7#b7 ,priority review ,! t]m priority review1 ) respect to a human drug application1 means review & action by ! ,secret>y on su* application n lat] ?an #f mon?s aft] receipt by ! ,secret>y ( su* application1 z describ$ 9 ! ,manual ( ,policies & ,proc$ures 9 ! ,food & ,drug ,adm9i/ration & goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act4 7#c7 ,priority review v\*] ,! t]m priority review v\*] means a v\*] issu$ by ! ,secret>y to ! sponsor ( a mat]ial ?reat m$ical c\nt]measure application t entitles ! hold] ( su* v\*] to priority review ( a s+le human drug application submitt$ "u section #eje7;b77#a7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act aft] ! date ( approval ( ! mat]ial ?reat m$ical c\nt]measure application4 7#d7 ,mat]ial ?reat m$ical c\nt]measure application ,! t]m mat]ial ?reat m$ical c\nt]measure application means an application t-- 7,a7 is a human drug application = a drug int5d$ = use-- 7i7 to prev5t1 or treat h>m f a biological1 *emical1 radiological1 or nucle> ag5t id5tifi$ z a mat]ial ?reat "u section #cai;,f-#b7;c77#b77;,a77ii7 ( ! ,public ,heal? ,s]vice ,act2 or 7ii7 to mitigate1 prev5t1 or treat h>m f a condition t may result 9 adv]se heal? consequ5ces or dea? & may be caus$ by adm9i/]+ a drug1 or biological product aga9/ su* ag5t2 & 7,b7 ! ,secret>y det]m9es eligible = priority review2 7,c7 is approv$ aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act2 & 7,d7 is = a human drug1 no active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 ( :i* has be5 approv$ 9 any o!r application "u section #eje7;b77#a7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 7b7 ,priority review v\*] 7#a7 ,9 g5]al ,! ,secret>y %all aw>d a priority review v\*] to ! sponsor ( a mat]ial ?reat m$ical c\nt]measure application ^u approval by ! ,secret>y ( su* mat]ial ?reat m$ical c\nt]measure application4 7#b7 ,transf]ability ,! sponsor ( a mat]ial ?reat m$ical c\nt]measure application t receives a priority review v\*] "u ?is section may transf] 7includ+ by sale7 ! entitlem5t to su* v\*] to a sponsor ( a human drug = :i* an application "u section #eje7;b77#a7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act w be submitt$ aft] ! date ( ! approval ( ! mat]ial ?reat m$ical c\nt]measure application4 ,!re is no limit on ! numb] ( times a priority review v\*] may be transf]r$ be=e su* v\*] is us$4 7#c7 ,notification 7,a7 ,9 g5]al ,! sponsor ( a human drug application %all notify ! ,secret>y n lat] ?an #ij cal5d> days prior to submission ( ! human drug application t is ! subject ( a priority review v\*] ( an int5t to submit ! human drug application1 includ+ ! date on :i* ! sponsor int5ds to submit ! application4 ,su* notification %all be a legally b9d+ commitm5t to pay = ! us] fee to be assess$ 9 accordance ) ?is section4 7,b7 ,transf] aft] notice ,! sponsor ( a human drug application t provides notification ( ! int5t ( su* sponsor to use ! v\*] = ! human drug application "u subp>agraph 7,a7 may transf] ! v\*] aft] su* notification is provid$1 if su* sponsor has n yet submitt$ ! human drug application describ$ 9 ! notification4 7c7 ,priority review us] fee 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a us] fee program "u :i* a sponsor ( a human drug application t is ! subject ( a priority review v\*] %all pay to ! ,secret>y a fee det]m9$ "u p>agraph 7#b74 ,su* fee %all be 9 addition to any fee requir$ to be submitt$ by ! sponsor "u *apt] ,,vii4 7#b7 ,fee am\nt ,! am\nt ( ! priority review us] fee %all be det]m9$ ea* fiscal ye> by ! ,secret>y & bas$ on ! av]age co/ incurr$ by ! ag5cy 9 ! review ( a human drug application subject to priority review 9 ! previ\s fiscal ye>4 7#c7 ,annual fee sett+ ,! ,secret>y %all e/abli%1 be=e ! beg9n+ ( ea* fiscal ye> beg9n+ aft] ,septemb] #cj1 #bjaf1 = t fiscal ye>1 ! am\nt ( ! priority review us] fee4 7#d7 ,paym5t 7,a7 ,9 g5]al ,! priority review us] fee requir$ by ?is subsection %all be due ^u ! submission ( a human drug application "u section #eje7;b77#a7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = :i* ! priority review v\*] is us$4 7,b7 ,complete application ,an application describ$ "u subp>agraph 7,a7 = :i* ! sponsor reque/s ! use ( a priority review v\*] %all be consid]$ incomplete if ! fee requir$ by ?is subsection & all o!r applicable us] fees are n paid 9 accordance ) ! ,secret>y's proc$ures = pay+ su* fees4 7,c7 ,no waiv]s1 exemptions1 r$uctions1 or refunds ,! ,secret>y may n grant a waiv]1 exemption1 r$uction1 or refund ( any fees due & payable "u ?is section4 7#e7 ,(fsett+ collections ,fees collect$ pursuant to ?is subsection = any fiscal ye>-- 7,a7 %all be deposit$ & cr$it$ z (fsett+ collections to ! acc\nt provid+ appropriations to ! ,food & ,drug ,adm9i/ration2 & 7#f7 %all n be collect$ = any fiscal ye> except to ! ext5t provid$ 9 advance 9 appropriation ,acts4 7d7 ,notice ( ,issuance ( ,v\*] & ,approval ( ,products ,"u ,v\*] ,! ,secret>y %all publi% a notice 9 ! ,f$]al ,regi/] & on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration n lat] ?an #cj cal5d> days aft] ! occurr5ce ( ea* ( ! foll[+3 7#a7 ,! ,secret>y issues a priority review v\*] "u ?is section4 7#b7 ,! ,secret>y approves a drug pursuant to an application submitt$ "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = :i* ! sponsor ( ! application us$ a priority review v\*] issu$ "u ?is section4 7e7 ,eligibility = o!r programs ,no?+ 9 ?is section precludes a sponsor :o seeks a priority review v\*] "u ?is section f p>ticipat+ 9 any o!r inc5tive program1 includ+ "u ?is ,act1 except t no sponsor ( a mat]ial ?reat m$ical c\nt]measure application may receive m ?an "o priority review v\*] issu$ "u any section ( ?is ,act ) respect to su* drug4 7f7 ,relation to o!r provisions ,! provisions ( ?is section %all supplem5t1 n supplant1 any o!r provisions ( ?is ,act or ! ,public ,heal? ,s]vice ,act t enc\rage ! developm5t ( m$ical c\nt]measures4 7g7 ,sunset ,! ,secret>y may n aw>d any priority review v\*]s "u subsection 7b7 aft] ,octob] #a1 #bjbc4 4 #cjhg4 ,pap]work ,r$uction ,act waiv] dur+ a public heal? em]g5cy ,section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,det]m9ation ) respect to pap]work r$uction act waiv] dur+ a public heal? em]g5cy 7#a7 ,det]m9ation ,if ! ,secret>y det]m9es1 aft] consultation ) su* public heal? (ficials z may be necess>y1 t-- 7,a7 7i7 ! crit]ia set =? = a public heal? em]g5cy "u p>agraph 7#a7 or 7#b7 ( subsection 7a7 has be5 met2 or 7ii7 a disease or disord]1 includ+ a novel & em]g+ public heal? ?reat1 is significantly likely to become a public heal? em]g5cy2 & 7,b7 ! circum/ances ( su* public heal? em]g5cy1 or pot5tial = su* significantly likely public heal? em]g5cy1 includ+ ! specific prep>ation = & response to su* public heal? em]g5cy or ?reat1 necessitate a waiv] f ! requirem5ts ( sub*apt] ,i ( *apt] #ce ( title #dd1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,pap]work ,r$uction ,act71 !n ! requirem5ts ( su* sub*apt] ,i ) respect to volunt>y collection ( in=mation %all n be applicable dur+ ! imm$iate inve/igation (1 & response to1 su* public heal? em]g5cy dur+ ! p]iod ( su* public heal? em]g5cy or ! p]iod ( "t necess>y to det]m9e if a disease or disord]1 includ+ a novel & em]g+ public heal? ?reat1 w become a public heal? em]g5cy z provid$ = 9 ?is p>agraph4 ,! requirem5ts ( su* sub*apt] ,i ) respect to volunt>y collection ( in=mation %all n be applicable dur+ ! imm$iate po/response review reg>d+ su* public heal? em]g5cy if su* imm$iate po/response review does n exce$ a reasonable l5g? ( "t4 7#b7 ,transp>5cy ,if ! ,secret>y det]m9es t a waiv] is necess>y "u p>agraph 7#a71 ! ,secret>y %all promptly po/ on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices a brief ju/ification = su* waiv]1 ! anticipat$ p]iod ( "t su* waiv] w be 9 effect1 & ! ag5cies & (fices )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to :i* su* waiv] %all apply1 & update su* in=mation po/$ on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 z applicable4 7#c7 ,effectiv5ess ( waiv] ,any waiv] "u ?is subsection %all take effect on ! date on :i* ! ,secret>y po/s in=mation on ! ,int]net website z provid$ = 9 ?is subsection4 7#d7 ,t]m9ation ( waiv] ,^u det]m9+ t ! circum/ances necessitat+ a waiv] "u p>agraph 7#a7 no long] exi/1 ! ,secret>y %all promptly update ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices to reflect ! t]m9ation ( su* waiv]4 7#e7 ,limitations 7,a7 ,p]iod ( waiv] ,! p]iod ( a waiv] "u p>agraph 7#a7 %all n exce$ ! p]iod ( "t = ! relat$ public heal? em]g5cy1 includ+ a public heal? em]g5cy decl>$ pursuant to subsection 7a71 & any imm$iate po/response review reg>d+ ! public heal? em]g5cy consi/5t ) ! requirem5ts ( ?is subsection4 7,b7 ,subsequ5t compliance ,an initiative subject to a waiv] "u p>agraph 7#a7 t is ongo+ aft] ! date on :i* ! waiv] expires1 %all be subject to ! requirem5ts ( sub*apt] ,i ( *apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 & ! ,secret>y %all ensure t compliance ) su* requirem5ts occurs 9 z timely a mann] z possible bas$ on ! applicable circum/ances1 b n to exce$ #cj cal5d> days aft] ! expiration ( ! applicable waiv]4 4 #cjhh4 ,cl>ify+ ,food & ,drug ,adm9i/ration em]g5cy use au?orization 7a7 ,au?orization = m$ical products = use 9 em]g5cies ,section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is am5d$-- 7#a7 9 subsection 7a77#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ or #eae & ins]t+ #eab1 or #eae2 & 7ii7 by ins]t+ or conditionally approv$ "u section #ega ( ?is ,act aft] ,public ,heal? ,s]vice ,act2 & 7,b7 9 subp>agraph 7,b71 by ins]t+ conditionally approv$ "u section #ega1 aft] approv$1 ea* place ! t]m appe>s2 7#b7 9 subsection 7b77#d71 by /rik+ ! second comma aft] det]m9ation2 7#c7 9 subsection 7e77#c77;,b71 by /rik+ section #ejc7;b7 & ins]t+ subsection 7b7 or 7f7 ( section #ejc or "u section #ejd2 7#d7 9 subsection 7f77#b7-- 7,a7 by ins]t+ 1 or an animal to :i*1 aft] to a pati5t to :om2 & 7,b7 by ins]t+ or by ! vet]9>ian c>+ = su* animal1 z applicable aft] att5d+ physician2 7#e7 9 subsection 7g77#a71 by ins]t+ conditional approval "u section #ega1 aft] approval12 7#f7 9 subsection 7h77#a71 by /rik+ or section #ebj7;g7& ins]t+ #eab7;j71 or #ebj7;g72 & 7#g7 9 subsection 7k71 by /rik+ section #ebj7;g71& ins]t+ #eab7;j71 or #ebj7;g74 7b7 ,new animal drugs ,section #eab7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7a77#a77 is am5d$-- 7#a7 9 subp>agraph 7,b71 by /rik+ or at ! end2 7#b7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7#c7 by ins]t+ aft] subp>agraph 7,c7 ! foll[+3 7,d7 !re is 9 effect an au?orization pursuant to section #efd ) respect to su* use or int5d$ use ( su* drug1 & su* drug1 its label+1 & su* use con=m to any conditions ( su* au?orization4 4 7c7 ,em]g5cy use ( m$ical products ,section #efd;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7 is am5d$-- 7#a7 9 subsection 7a77#a77;,a71 by ins]t+ 1 conditionally approv$ "u section #ega1 aft] *apt]2 & 7#b7 9 subsection 7d71 by /rik+ sections #ejc7;b7 & #ebj7;e7 & ins]t+ subsections 7b7 & 7f7 ( section #ejc1 section #ejd1 & section #ebj7;e74 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#b77 is am5d$-- 7#a7 9 subp>agraph 7,a7-- 7,a7 by ins]t+ or conditionally approv$ "u section #ega ( ?is ,act aft] ,public ,heal? ,s]vice ,act2 & 7,b7 by /rik+ or #eae & ins]t+ #eab1 or #eae2 & 7#b7 9 subp>agraph 7,b71 by /rik+ or #ebj & ins]t+ #eab1 or #ebj4 ,i ,vacc9e ,access1 ,c]ta9ty1 & ,innovation #cjia4 ,pr$ictable review timel9es ( vacc9es by ! ,advisory ,committee on ,immunization ,practices 7a7 ,consid]ation ( new vacc9es ,^u ! lic5sure ( any vacc9e or any new indication = a vacc9e1 ! ,advisory ,committee on ,immunization ,practices 79 ?is section ref]r$ to z ! ,advisory ,committee7 %all1 z appropriate1 consid] ! use ( ! vacc9e at its next regul>ly s*$ul$ meet+4 7b7 ,additional in=mation ,if ! ,advisory ,committee does n make a recomm5dation ) respect to ! use ( a vacc9e at ! ,advisory ,committee's fir/ regul>ly s*$ul$ meet+ aft] ! lic5sure ( ! vacc9e or any new indication = ! vacc9e1 ! ,advisory ,committee %all provide an update on ! /atus ( su* committee's review4 7c7 ,consid]ation = break?r\gh !rapies & = pot5tial use dur+ public heal? em]g5cy ,! ,advisory ,committee %all make recomm5dations ) respect to ! use ( c]ta9 vacc9es 9 a timely mann]1 z appropriate1 includ+ vacc9es t-- 7#a7 are designat$ z a break?r\gh !rapy "u section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 & lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 or 7#b7 c\ld be us$ 9 a public heal? em]g5cy4 7d7 ,def9ition ,9 ?is section1 ! t]ms ,advisory ,committee on ,immunization ,practices & ,advisory ,committee mean ! ,advisory ,committee on ,immunization ,practices e/abli%$ by ! ,secret>y pursuant to section #bbb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bag;a71 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion404 #cjib4 ,review ( processes & consi/5cy ( ,advisory ,committee on ,immunization ,practices recomm5dations 7a7 ,review ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all conduct a review ( ! processes us$ by ! ,advisory ,committee on ,immunization ,practices 9 =mulat+ & issu+ recomm5dations p]ta9+ to vacc9es1 includ+ ) respect to consi/5cy4 7b7 ,consid]ations ,! review "u subsection 7a7 %all include an assessm5t (-- 7#a7 ! crit]ia us$ to evaluate new & exi/+ vacc9es1 includ+ ! id5tification ( any areas = :i* flexibility 9 evaluat+ su* crit]ia is necess>y & ! reason = su* flexibility2 7#b7 ! ,grad+ ( ,recomm5dations1 ,assessm5t1 ,developm5t1 & ,evaluation 7,,grade7 approa* to ! review & analysis ( sci5tific & economic data1 includ+ ! sci5tific basis = su* approa*2 & 7#c7 ! ext5t to :i* ! processes us$ by ! "w gr\ps ( ! ,advisory ,committee on ,immunization ,practices are consi/5t among su* gr\ps1 includ+ ! id5tification ( reasons = any v>iation4 7c7 ,/akehold]s ,9 c>ry+ out ! review "u subsection 7a71 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all solicit input f vacc9e /akehold]s4 7d7 ,report ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all submit to ! appropriate committees ( ! ,congress1 & make publicly available1 a report on ! results ( ! review "u subsection 7a71 includ+ any recomm5dations on improv+ ! consi/5cy ( ! processes describ$ 9 su* subsection4 7e7 ,def9ition ,9 ?is section1 ! t]m ,advisory ,committee on ,immunization ,practices means ! ,advisory ,committee on ,immunization ,practices e/abli%$ by ! ,secret>y ( ,heal? & ,human ,s]vices pursuant to section #bbb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bag;a71 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 #cjic4 ,enc\rag+ vacc9e innovation 7a7 ,vacc9e meet+s ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all ensure t appropriate /aff )9 ! relevant c5t]s & divisions ( ! ,(fice ( ,infecti\s ,diseases1 & o!rs1 z appropriate1 coord9ate ) respect to ! public heal? ne$s1 epidemiology1 & program plann+ & implem5tation consid]ations relat$ to immunization1 includ+ ) reg>d to meet+s ) /akehold]s relat$ to su* topics4 7b7 ,report on vacc9e innovation 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>y71 9 collaboration ) appropriate ag5cies or (fices )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+ ! ,national ,in/itutes ( ,heal?1 ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,food & ,drug ,adm9i/ration1 & ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & po/ publicly on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 a report on ways to promote innovation 9 ! developm5t ( vacc9es t m9imize ! burd5 ( infecti\s disease4 7#b7 ,cont5ts ,! report describ$ 9 p>agraph 7#a7 %all review ! curr5t /atus ( vacc9e developm5t &1 z appropriate-- 7,a7 consid] ! optimal process to det]m9e :i* vacc9es w\ld be b5eficial to public heal? & h[ in=mation on su* vacc9es is dissem9at$ to key /akehold]s2 7,b7 exam9e & id5tify :e!r ob/acles exi/ t inhibit ! developm5t ( b5eficial vacc9es2 & 7,c7 make recomm5dations ab\t h[ be/ to remove any ob/acles id5tifi$ "u subp>agraph 7,b7 9 ord] to promote & inc5tivize vacc9e innovation & developm5t4 7#c7 ,consultation ,9 prep>+ ! report "u ?is subsection1 ! ,secret>y may consult )-- 7,a7 repres5tatives ( relevant ,f$]al ag5cies & dep>tm5ts1 includ+ ! ,dep>tm5t ( ,def5se & ! ,dep>tm5t ( ,vet]ans ,affairs2 7,b7 academic rese>*]s2 7,c7 develop]s & manufactur]s ( vacc9es2 7,d7 m$ical & public heal? practition]s2 7,e7 repres5tatives ( pati5t1 policy1 & advocacy organizations2 & 7,f7 repres5tatives ( o!r entities1 z ! ,secret>y det]m9es appropriate4 7c7 ,updates relat$ to mat]nal immunization 7#a7 ,additional vacc9es ,section #baad7;e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#ad7;e77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,vacc9es recomm5d$ = use 9 pregnant wom5 ,! ,secret>y %all revise ! ,vacc9e ,injury ,table includ$ 9 subsection 7a71 ?r\gh ! process describ$ 9 subsection 7c71 to include vacc9es recomm5d$ by ! ,c5t]s = ,disease ,control & ,prev5tion = r\t9e adm9i/ration 9 pregnant wom5 & ! in=mation describ$ 9 subp>agraphs 7,b7 & 7,c7 ( p>agraph 7#b7 ) respect to su* vacc9es4 4 7#b7 ,petition cont5t ,section #baaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,mat]nal immunization 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 = purposes ( ?is subtitle1 bo? a woman :o receiv$ a cov]$ vacc9e :ile pregnant & any *ild :o 0 9 ut]o at ! "t su* woman receiv$ ! vacc9e %all be consid]$ p]sons to :om ! cov]$ vacc9e 0 adm9i/]$ & p]sons :o receiv$ ! cov]$ vacc9e4 7#b7 ,def9ition ,z us$ 9 ?is subsection1 ! t]m *ild %all h ! mean+ giv5 t t]m by subsections 7a7 & 7b7 ( section #h ( title #a1 ,unit$ ,/ates ,code1 except t1 = purposes ( ?is subsection1 su* section #h %all be appli$ z if ! t]m include 9 subsection 7a7 ( su* section 7 replac$ ) ! t]m mean4 4 7#c7 ,petition]s ,section #baaa7;b77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7;b77#b77 is am5d$ by add+ ,a cov]$ vacc9e adm9i/]$ to a pregnant woman %all con/itute m ?an "o adm9i/ration1 "o to ! "m & "o to ea* *ild 7z su* t]m is def9$ 9 subsection 7f77#b77 :o 0 9 ut]o at ! "t su* woman 0 adm9i/]$ ! vacc9e4 at ! end4 ,j ,te*nical corrections #caja4 ,te*nical corrections 7a7 ,,ffdca 7#a7 ,ref]5ces ,except z o!rwise expressly provid$1 :5ev] 9 ?is subsection an am5dm5t is express$ 9 t]ms ( an am5dm5t to a section or o!r provision1 ! ref]5ce %all be consid]$ to be made to t section or o!r provision ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7#b7 ,am5dm5ts 7,a7 ,prohibit$ ,acts ,section #cja7r7 7#ba ,u4,s4,c4 #cca7r77 is am5d$ by ins]t+ 1 drug1 aft] device ea* place ! t]m appe>s4 7,b7 ,new ,drugs ,section #eje 7#ba ,u4,s4,c4 #cee7 is am5d$-- 7i7 9 subsection 7d71 9 ! la/ s5t5ce1 by /rik+ prem>ket approval & ins]t+ m>ket+ approval2 & 7ii7 9 subsection 7q77#e77;,a71 by /rik+ subsection 7b77#b7 or 7j7 ( ! ,act or #cea7k7 & ins]t+ subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k74 7,c7 ,risk evaluation & mitigation /rategies ,section #eje-a7;h77#ba ,u4,s4,c4 #cee-a7;h77 is am5d$-- 7i7 9 p>agraph 7#b77;,a77iii7-- 7,i7 9 ! clause head+1 by /rik+ label & ins]t+ label+2 7,,ii7 by /rik+ label ea* place ! t]m appe>s & ins]t+ label+2 & 7,,iii7 by /rik+ sponsor & ins]t+ responsible p]son2 & 7ii7 9 p>agraph 7#h71 by /rik+ & 7#g74 & ins]t+ & 7#g74 7,d7 ,p$iatric /udy plans ,section #eje;,b 7#ba ,u4,s4,c4 #cee;c7 is am5d$-- 7i7 9 subsection 7e7-- 7,i7 9 p>agraph 7#b7-- 7aa7 9 subp>agraph 7,a71 by ins]t+ /udy aft] initial p$iatric ea* place ! t]m appe>s2 & 7bb7 9 subp>agraph 7,b71 9 ! subp>agraph head+1 by /rik+ initial plan & ins]t+ initial p$iatric /udy plan2 7,,ii7 9 p>agraph 7#e71 9 ! p>agraph head+1 by ins]t+ agre$ initial p$iatric /udy be=e plan2 & 7,,iii7 9 p>agraph 7#f71 by /rik+ agre$ initial p$iatric plan & ins]t+ agre$ initial p$iatric /udy plan2 & 7ii7 9 subsection 7f77#a71 by ins]t+ & any significant am5dm5ts to su* plans1 aft] agre$ initial p$iatric /udy plans14 7,e7 ,discont9uance or int]ruption 9 ! production ( live-sav+ drugs ,section #ejf;,c 7#ba ,u4,s4,c4 #cef;c7 is am5d$-- 7i7 9 subsection 7c71 by /rik+ discont9uation & ins]t+ discont9uance2 & 7ii7 9 subsection 7g77#a71 by /rik+ section #eje7;j7 t c\ld help & ins]t+ section #eje7;j71 t c\ld help4 7,f7 ,annual report+ on drug %ortages ,section #ejf;,c-#a7;a7 7#ba ,u4,s4,c4 #cca7;a77 is am5d$1 9 ! matt] be=e p>agraph 7#a7-- 7i7 by /rik+ ,n lat] ?an ! end ( cal5d> ye> #bjac1 & n lat] ?an ! end ( ea* cal5d> ye> !reaft]1 & ins]t+ ,n lat] ?an ,m>* #ca ( ea* cal5d> ye>1 2 & 7ii7 by ins]t+ 1 ) respect to ! prec$+ cal5d> ye>1 aft] a report4 7,g7 ,drug %ortage li/ ,section #ejf;,e7b77#c77;,e7 7#ba ,u4,s4,c4 #cef;e7b77#c77;,e77 is am5d$ by /rik+ discont9uation & ins]t+ discont9uance4 7,h7 ,inspections ( e/abli%m5ts ,section #eaj7;h7 7#ba ,u4,s4,c4 #cfj7;h77 is am5d$-- 7i7 9 p>agraph 7#d71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ e/abli%+ ! risk-bas$ s*$ul$ & ins]t+ e/abli%+ a risk-bas$ s*$ule2 & 7ii7 9 p>agraph 7#f7-- 7,i7 9 subp>agraph 7,a71 by /rik+ fiscal & ins]t+ cal5d> ea* place ! t]m appe>s2 & 7,,ii7 9 subp>agraph 7,b71 by /rik+ an active +r$i5t ( a drug1 a f9i%$ drug product1 or an excipi5t ( a drug & ins]t+ an active +r$i5t ( a drug or a f9i%$ drug product4 7,i7 ,classification ( devices int5d$ = human use ,section #eac7;f77#b77;,a7 7#ba ,u4,s4,c4 #cfj;c7f77#b77;,a77 is am5d$-- 7i7 9 clause 7i71 by /rik+ )9 #cj days2 & 7ii7 9 clause 7iv71 by /rik+ l[-mod]ate & ins]t+ l[ to mod]ate4 7,j7 ,prem>ket approval ,section #eae7;a77#a7 7#ba ,u4,s4,c4 #cfj;e7a77#a77 is am5d$ by /rik+ subject to a an ord] & ins]t+ subject to an ord]4 7,k7 ,program to improve ! device recall sy/em ,section #eah;,a 7#ba ,u4,s4,c4 #cfj;h-#a7 is am5d$-- 7i7 by /rik+ subsection 7c72 & 7ii7 by r$esignat+ subsection 7d7 z subsection 7c74 7,l7 ,unique device id5tifi] ,section #eai7;f7 7#ba ,u4,s4,c4 #cfj;i7f77 is am5d$ by /rik+ & life su/a9+ & ins]t+ or life su/a9+4 7,m7 ,priority review to enc\rage treatm5ts = tropical diseases ,section #ebd7;c77#d77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7c77#d77;,a77 is am5d$ by /rik+ ,s]vices ,act & ins]t+ ,s]vice ,act4 7,n7 ,priority review = qualifi$ infecti\s disease products ,section #ebd;,a 7#ba ,u4,s4,c4 #cfjn-#a7 is am5d$-- 7i7 by /rik+ ,if ! ,secret>y & ins]t+ ! foll[+3 7a7 ,9 ,g5]al ,if ! ,secret>y 2 7ii7 by /rik+ any & ins]t+ ! fir/2 & 7iii7 by add+ at ! end ! foll[+3 7b7 ,con/ruction ,no?+ 9 ?is section %all prohibit ! ,secret>y f giv+ priority review to a human drug application or efficacy supplem5t submitt$ = approval "u section #eje7;b7 t o!rwise meets ! crit]ia = ! ,secret>y to grant priority review4 4 7,o7 ,consultation ) ext]nal exp]ts on r>e diseases1 t>get$ !rapies1 & g5etic t>get+ ( treatm5ts ,section #efi7;a77#b77;,a7 7#ba ,u4,s4,c4 #cfj;bbb-#h7;a77#b77;,a77 is am5d$1 9 ! fir/ s5t5ce1 by /rik+ subsection 7c7 & ins]t+ subsection 7b74 7,p7 ,optimiz+ global cl9ical trials ,section #efi;,a7c7 7#ba ,u4,s4,c4 #cfj;bbb-#h;a7c77 is am5d$ by ins]t+ or "u ! ,public ,heal? ,s]vice ,act aft] ?is ,act4 7,q7 ,use ( cl9ical inve/igation data f outside ! ,unit$ ,/ates ,section #efi;,b 7#ba ,u4,s4,c4 #cfj;bbb-#h;b7 is am5d$ by /rik+ drug or device & ins]t+ drug1 biological product1 or device ea* place ! t]m appe>s4 7,r7 ,m$ical gases def9itions ,section #ege7a77;,h7 7#ba ,u4,s4,c4 #cfj;ddd7#a77;,h77 is am5d$-- 7i7 by ins]t+ = a new drug aft] any p]iod ( exclusivity2 & 7ii7 by ins]t+ or any p]iod ( exclusivity = a new animal drug "u section #eab7;c77#b77;,f71 aft] section #eje;,a14 7,s7 ,regulation ( m$ical gases ,section #egf7;a7 7#ba ,u4,s4,c4 #cfj;ddd-#a7;a77 is am5d$-- 7i7 9 ! matt] prec$+ subp>agraph 7,a7 ( p>agraph 7#a71 by ins]t+ :o seeks to initially introduce or deliv] = introduction a designat$ m$ical gas into int]/ate comm]ce aft] any p]son2 & 7ii7 9 p>agraph 7#c7-- 7,i7 9 subp>agraph 7,a7-- 7aa7 9 clause 7i77,,viii71 by ins]t+ = a new drug aft] any p]iod ( exclusivity2 & 7bb7 9 clause 7ii71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ ! be=e f9al use2 & 7,,ii7 9 subp>agraph 7,b7-- 7aa7 9 clause 7i71 by ins]t+ = a new drug aft] any p]iod ( exclusivity2 & 7bb7 9 clause 7ii71 by ins]t+ a comma aft] drug product4 7,t7 ,inapplicability ( drug fees to designat$ m$ical gases ,section #egg 7#ba ,u4,s4,c4 #cfj;ddd-#b7 is am5d$ by ins]t+ or #gdj7;a7 aft] section #gcf7;a74 7,u7 ,conflicts ( int]e/ ,section #gab7;e77#a77;,b7 7#ba ,u4,s4,c4 #cgi;d-#a7;e77#a77;,b77 is am5d$ by /rik+ s]vices & ins]t+ s]vice4 7,v7 ,au?ority to assess & use biosimil> biological product fees ,section #gdd;,h7a7 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is am5d$-- 7i7 9 p>agraph 7#a77;,a77v71 by /rik+ ,biosimil>s ,us] ,fee ,act ( #bjab & ins]t+ ,biosimil> ,us] ,fee ,act ( #bjab2 & 7ii7 9 p>agraph 7#b77;,b71 by /rik+ ,biosimil>s ,us] ,fee ,act ( #bjab & ins]t+ ,biosimil> ,us] ,fee ,act ( #bjab4 7,w7 ,regi/ration ( comm]cial import]s 7i7 ,am5dm5t ,section #hja7s77#b7 7#ba ,u4,s4,c4 #cha7s77#b77 is am5d$ by add+ at ! end ! foll[+3 7,d7 ,effective date ,9 e/abli%+ ! effective date ( ! regulations "u subp>agraph 7,a71 ! ,secret>y %all1 9 consultation ) ! ,secret>y ( ,homel& ,security act+ ?r\gh ,u4,s4 ,cu/oms & ,bord] ,protection1 z det]m9$ appropriate by ! ,secret>y ( ,heal? & ,human ,s]vices1 provide a reasonable p]iod ( "t = an import] ( a drug to comply ) good import] practices1 tak+ into acc\nt diff]5ces among import]s & types ( imports1 includ+ bas$ on ! level ( risk pos$ by ! import$ product4 4 7ii7 ,con=m+ am5dm5t ,section #gad ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add2 #abf ,/at4 #ajgd7 is am5d$ by /rik+ subsection 7d74 7,x7 ,recognition ( =eign gov]nm5t inspections ,section #hji7;a77#b7 7#ba ,u4,s4,c4 #chd;e7a77#b77 is am5d$ by /rik+ conduction & ins]t+ conduct+4 7b7 ,,fdasia 7#a7 ,f9d+s relat+ to drug approval ,section #ija7;a77#a77;,a7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add2 #ba ,u4,s4,c4 #cef note7 is am5d$ by /rik+ s]i\s & life-?reat5+ diseases & ins]t+ s]i\s or life-?reat5+ diseases4 7#b7 ,report+ ( inclusion ( demographic subgr\ps ,section #ijg ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add2 #abf ,/at4 #ajib1 #ajic7 is am5d$-- 7,a7 9 ! section head+1 by /rik+ ,biologics 9 ! head+ & ins]t+ ,biological ,products2 & 7,b7 9 subsection 7a77#b77;,b71 by /rik+ applications = new drug applications & ins]t+ new drug applications4 7#c7 ,combat+ prescription drug abuse ,section #aabb ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add2 #abf ,/at4 #aaab1 #aaac7 is am5d$-- 7,a7 9 subsection 7a77#b71 by /rik+ dep5dance & ins]t+ dep5d5ce2 & 7,b7 9 subsection 7c71 by /rik+ promulgate & ins]t+ issue4 #cajb4 ,complet$ /udies ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$-- 7#a7 9 section #eje7k77#e7 7#ba ,u4,s4,c4 #cee7k77#e77-- 7,a7 9 subp>agraph 7,a71 by ins]t+ & aft] ! semicolon2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,b72 7#b7 9 section #eje;,a 7#ba ,u4,s4,c4 #cee;a71 by /rik+ subsection 7p72 7#c7 9 section #eje;,b 7#ba ,u4,s4,c4 #cee;c7-- 7,a7 by /rik+ subsection 7l72 & 7,b7 by r$esignat+ subsection 7m7 z subsection 7l72 & 7#d7 9 section #ebc 7#ba ,u4,s4,c4 #cfjm71 by /rik+ subsection 7d74 ,,iv ,deliv]y #djja4 ,assi/+ doctors & hospitals 9 improv+ quality ( c>e = pati5ts 7a7 ,9 g5]al ,! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7title ,,xiii ( division ,a ( ,public ,law #aaa-e7 is am5d$-- 7#a7 by add+ at ! end ( "p #a ( subtitle ,a ! foll[+3 #acajc4 ,assi/+ doctors & hospitals 9 improv+ quality ( c>e = pati5ts 7a7 ,r$uction 9 burd5s goal ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 9 consultation ) provid]s ( heal? s]vices1 heal? c>e suppli]s ( s]vices1 heal? c>e pay]s1 heal? pr(essional societies1 heal? in=mation te*nology develop]s1 heal? c>e quality organizations1 heal? c>e accr$itation organizations1 public heal? entities1 ,/ates1 & o!r appropriate entities1 %all1 9 accordance ) subsection 7b7-- 7#a7 e/abli% a goal ) respect to ! r$uction ( regulatory or adm9i/rative burd5s 7su* z docum5tation requirem5ts7 relat+ to ! use ( electronic heal? records2 7#b7 develop a /rategy = meet+ ! goal e/abli%$ "u p>agraph 7#a72 & 7#c7 develop recomm5dations = meet+ ! goal e/abli%$ "u p>agraph 7#a74 7b7 ,/rategy & recomm5dations 7#a7 ,9 g5]al ,to a*ieve ! goal e/abli%$ "u subsection 7a77#a71 ! ,secret>y1 9 consultation ) ! entities describ$ 9 su* subsection1 %all1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 develop a /rategy & recomm5dations to meet ! goal 9 accordance ) ?is subsection4 7#b7 ,/rategy ,! /rategy develop$ "u p>agraph 7#a7 %all address ! regulatory & adm9i/rative burd5s 7su* z docum5tation requirem5ts7 relat+ to ! use ( electronic heal? records4 ,su* /rategy %all include broad public comm5t & %all prioritize-- 7,a7 7i7 inc5tives = mean+ful use ( c]tifi$ ,,ehr te*nology = eligible pr(essionals & hospitals "u sections #ahdh7;a77#g7 & #ahhf7;b77#c77;,b77ix71 respectively1 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g71 #acieww7b77#c77;,b77ix772 7ii7 ! program = mak+ paym5ts "u section #aijc7;a77#c77;,f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7a77#c77;,f77 to enc\rage ! adoption & use ( c]tifi$ ,,ehr te*nology by ,m$icaid provid]s2 7iii7 ! ,m]it-bas$ ,inc5tive ,paym5t ,sy/em "u section #ahdh7q7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q772 7iv7 alt]native paym5t models 7z def9$ 9 section #ahcc7z77#c77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7z77#c77;,c772 7v7 ! ,hospital ,value-,bas$ ,pur*as+ ,program "u section #ahhf7o7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7o772 & 7vi7 o!r value-bas$ paym5t programs1 z ! ,secret>y det]m9es appropriate2 7,b7 heal? in=mation te*nology c]tification2 7,c7 /&>ds & implem5tation specifications1 z appropriate2 7,d7 activities t provide individuals access to _! electronic heal? in=mation2 7,e7 activities relat$ to protect+ ! privacy ( electronic heal? in=mation2 7,f7 activities relat$ to protect+ ! security ( electronic heal? in=mation2 7,g7 activities relat$ to facilitat+ heal? & cl9ical rese>*2 7,h7 activities relat$ to public heal?2 7,i7 activities relat$ to align+ & simplify+ quality measures across ,f$]al programs & o!r pay]s2 7,j7 activities relat$ to report+ cl9ical data = adm9i/rative purposes2 & 7,k7 o!r areas1 z ! ,secret>y det]m9es appropriate4 7#c7 ,recomm5dations ,! recomm5dations develop$ "u p>agraph 7#a7 %all address-- 7,a7 actions t improve ! cl9ical docum5tation exp]i5ce2 7,b7 actions t improve pati5t c>e2 7,c7 actions to be tak5 by ! ,secret>y & by o!r entities2 & 7,d7 o!r areas1 z ! ,secret>y det]m9es appropriate1 to r$uce ! report+ burd5 requir$ ( heal? c>e provid]s4 7#d7 ,,faca ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 %all n apply to ! developm5t ( ! goal1 /rategies1 or recomm5dations describ$ 9 ?is section4 7c7 ,application ( c]ta9 regulatory requirem5ts ,a physician 7z def9$ 9 section #ahfa7r77#a7 ( ! ,social ,security ,act71 to ! ext5t consi/5t ) applicable ,/ate law1 may delegate electronic m$ical record docum5tation requirem5ts specifi$ 9 regulations promulgat$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices to a p]son p]=m+ a scribe function :o is n su* physician if su* physician has sign$ & v]ifi$ ! docum5tation4 2 & 7#b7 9 ! table ( cont5ts 9 section #acjja7;b71 by ins]t+ aft] ! item relat+ to section #acajb ! foll[+3 #acajc4 ,assi/+ doctors & hospitals 9 improv+ ! quality & c>e = pati5ts4 4 7b7 ,c]tification ( heal? in=mation te*nology = m$ical specialties & sites ( s]vice ,section #cjja7;c77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77#e77 is am5d$ by add+ at ! end ! foll[+3 7,c7 ,heal? in=mation te*nology = m$ical specialties & sites ( s]vice 7i7 ,9 g5]al ,! ,national ,coord9ator %all enc\rage1 keep1 or recognize1 ?r\gh exi/+ au?orities1 ! volunt>y c]tification ( heal? in=mation te*nology "u ! program develop$ "u subp>agraph 7,a7 = use 9 m$ical specialties & sites ( s]vice = :i* no su* te*nology is available or :]e m te*nological advancem5t or integration is ne$$4 7ii7 ,specific m$ical specialties ,! ,secret>y %all accept public comm5t on specific m$ical specialties & sites ( s]vice1 9 addition to ^? describ$ 9 clause 7i71 = ! purpose ( select+ additional specialties & sites ( s]vice z necess>y4 7iii7 ,heal? in=mation te*nology = p$iatrics ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y1 9 consultation ) relevant /akehold]s1 %all make recomm5dations = ! volunt>y c]tification ( heal? in=mation te*nology = use by p$iatric heal? provid]s to support ! heal? c>e ( *ildr54 ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all adopt c]tification crit]ia "u section #cjjd to support ! volunt>y c]tification ( heal? in=mation te*nology = use by p$iatric heal? provid]s to support ! heal? c>e ( *ildr54 4 7c7 ,mean+ful use /ati/ics 7#a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,,hit ,advisory ,committee ( ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 a report conc]n+ atte/ation /ati/ics = ! ,m$ic>e & ,m$icaid ,,ehr ,mean+ful ,use ,inc5tive programs to assi/ 9 in=m+ /&>ds adoption & relat$ practices4 ,su* /ati/ics %all include atte/ation in=mation del9eat$ by ,/ate1 includ+1 to ! ext5t practicable1 ! numb] ( provid]s :o did n meet ! m9imum crit]ia necess>y to atte/ = ! ,m$ic>e & ,m$icaid ,,ehr ,mean+ful ,use ,inc5tive programs = a cal5d> ye>1 & %all be made publicly available on ! ,int]net website ( ! ,secret>y on at lea/ a qu>t]ly basis4 7#b7 ,au?ority to alt] =mat ,! ,secret>y ( ,heal? & ,human ,s]vices may alt] ! =mat ( ! reports on ! atte/ation ( eligible heal? c>e pr(essionals foll[+ ! fir/ p]=mance ye> ( ! ,m]it-bas$ ,inc5tive ,paym5t ,sy/em to acc\nt = *anges aris+ f ! implem5tation ( su* paym5t sy/em4 #djjb4 ,transp>5t report+ on usability1 security1 & functionality 7a7 ,enhancem5ts to c]tification ,section #cjja7;c77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa71 z am5d$ by section #djja7;b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7,d7 ,conditions ( c]tification ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y1 ?r\gh notice & comm5t rulemak+1 %all require1 z a condition ( c]tification & ma9t5ance ( c]tification = programs ma9ta9$ or recogniz$ "u ?is p>agraph1 consi/5t ) o!r conditions & requirem5ts "u ?is title1 t ! heal? in=mation te*nology develop] or entity-- 7i7 does n take any action t con/itutes in=mation block+ z def9$ 9 section #cjbb7;a72 7ii7 provides assurances satisfactory to ! ,secret>y t su* develop] or entity1 unless = legitimate purposes specifi$ by ! ,secret>y1 w n take any action describ$ 9 clause 7i7 or any o!r action t may inhibit ! appropriate ex*ange1 access1 & use ( electronic heal? in=mation2 7iii7 does n prohibit or re/rict communication reg>d+-- 7,i7 ! usability ( ! heal? in=mation te*nology2 7,,ii7 ! int]op]ability ( ! heal? in=mation te*nology2 7,,iii7 ! security ( ! heal? in=mation te*nology2 7,,iv7 relevant in=mation reg>d+ us]s' exp]i5ces :5 us+ ! heal? in=mation te*nology2 7,v7 ! bus9ess practices ( develop]s ( heal? in=mation te*nology relat$ to ex*ang+ electronic heal? in=mation2 & 7,,vi7 ! mann] 9 :i* a us] ( ! heal? in=mation te*nology has us$ su* te*nology2 7iv7 has publi%$ application programm+ int]faces & all[s heal? in=mation f su* te*nology to be access$1 ex*ang$1 & us$ )\t special ef=t ?r\gh ! use ( application programm+ int]faces or successor te*nology or /&>ds1 z provid$ = "u applicable law1 includ+ provid+ access to all data elem5ts ( a pati5t's electronic heal? record to ! ext5t p]missible "u applicable privacy laws2 7v7 has successfully te/$ ! real _w use ( ! te*nology = int]op]ability 7z def9$ 9 section #cjjj7 9 ! type ( sett+ 9 :i* su* te*nology w\ld be m>ket$2 7vi7 provides to ! ,secret>y an atte/ation t ! develop] or entity-- 7,i7 has n engag$ 9 any ( ! conduct describ$ 9 clause 7i72 7,,ii7 has provid$ assurances satisfactory to ! ,secret>y 9 accordance ) clause 7ii72 7,,iii7 does n prohibit or re/rict communication z describ$ 9 clause 7iii72 7,,iv7 has publi%$ in=mation 9 accordance ) clause 7iv72 7,v7 ensures t its te*nology all[s = heal? in=mation to be ex*ang$1 access$1 & us$1 9 ! mann] describ$ 9 clause 7iv72 & 7,,vi7 has und]tak5 real _w te/+ z describ$ 9 clause 7v72 & 7vii7 submits report+ crit]ia 9 accordance ) section #cjji;,a7b74 4 7,e7 ,compliance ) conditions ( c]tification ,! ,secret>y may enc\rage compliance ) ! conditions ( c]tification describ$ 9 subp>agraph 7,d7 & take action to disc\rage noncompliance1 z appropriate4 4 7b7 ,,ehr significant h>d%ip exception 7#a7 ,application to eligible pr(essionals 7,a7 ,9 case ( dec]tification ,section #ahdh7;a77#g77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g77;,b77 is am5d$ by ins]t+ aft] ! fir/ s5t5ce ! foll[+ new s5t5ce3 ,! ,secret>y %all exempt an eligible pr(essional f ! application ( ! paym5t adju/m5t "u subp>agraph 7,a7 ) respect to a ye>1 subject to annual r5ewal1 if ! ,secret>y det]m9es t compliance ) ! requirem5t = be+ a mean+ful ,,ehr us] is n possible because ! c]tifi$ ,,ehr te*nology us$ by su* pr(essional has be5 dec]tifi$ "u a program kept or recogniz$ pursuant to section #cjja7;c77#e7 ( ! ,public ,heal? ,s]vice ,act44 7,b7 ,cont9u$ application "u ,,mips ,section #ahdh7o77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7o77#b77;,d77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,! provisions ( subp>agraphs 7,b7 & 7,d7 ( subsection 7a77#g71 %all apply to assessm5ts ( ,,mips eligible pr(essionals "u subsection 7q7 ) respect to ! p]=mance category describ$ 9 subsection 7q77#b77;,a77iv7 9 an appropriate mann] :i* may be simil> to ! mann] 9 :i* su* provisions apply ) respect to paym5t adju/m5ts made "u subsection 7a77#g77;,a744 7#b7 ,application to eligible hospitals ,section #ahhf7;b77#c77;,b77ix77,,ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,b77ix77,,ii77 is am5d$ by ins]t+ aft] ! fir/ s5t5ce ! foll[+ new s5t5ce3 ,! ,secret>y %all exempt an eligible hospital f ! application ( ! paym5t adju/m5t "u subclause 7,i7 ) respect to a fiscal ye>1 subject to annual r5ewal1 if ! ,secret>y det]m9es t compliance ) ! requirem5t = be+ a mean+ful ,,ehr us] is n possible because ! c]tifi$ ,,ehr te*nology us$ by su* hospital is dec]tifi$ "u a program kept or recogniz$ pursuant to section #cjja7;c77#e7 ( ! ,public ,heal? ,s]vice ,act44 7c7 ,electronic heal? record report+ program ,subtitle ,a ( title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq47 is am5d$ by add+ at ! end ! foll[+3 #cjji;,a4 ,electronic heal? record report+ program 7a7 ,report+ crit]ia 7#a7 ,conv5+ ( /akehold]s ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all conv5e /akehold]s1 z describ$ 9 p>agraph 7#b71 = ! purpose ( develop+ ! report+ crit]ia 9 accordance ) p>agraph 7#c74 7#b7 ,developm5t ( report+ crit]ia ,! report+ crit]ia "u ?is subsection %all be develop$ ?r\gh a public1 transp>5t process t reflects input f relevant /akehold]s1 includ+-- 7,a7 heal? c>e provid]s1 includ+ prim>y c>e & specialty c>e heal? c>e pr(essionals2 7,b7 hospitals & hospital sy/ems2 7,c7 heal? in=mation te*nology develop]s2 7,d7 pati5ts1 consum]s1 & _! advocates2 7,e7 data %>+ networks1 su* z heal? in=mation ex*anges2 7,f7 au?oriz$ c]tification bodies & te/+ laboratories2 7,g7 security exp]ts2 7,h7 relevant manufactur]s ( m$ical devices2 7,i7 exp]ts 9 heal? in=mation te*nology m>ket economics2 7,j7 public & private entities engag$ 9 ! evaluation ( heal? in=mation te*nology p]=mance2 7,k7 quality organizations1 includ+ ! cons5sus bas$ entity describ$ 9 section #ahij ( ! ,social ,security ,act2 7,l7 exp]ts 9 human factors eng9e]+ & ! measurem5t ( us]-c5t]$ design2 & 7,m7 o!r entities or individuals1 z ! ,secret>y det]m9es appropriate4 7#c7 ,consid]ations = report+ crit]ia ,! report+ crit]ia develop$ "u ?is subsection-- 7,a7 %all include measures t reflect categories includ+-- 7i7 security2 7ii7 usability & us]-c5t]$ design2 7iii7 int]op]ability2 7iv7 con=mance to c]tification te/+2 & 7v7 o!r categories1 z appropriate to measure ! p]=mance ( electronic heal? record te*nology2 7,b7 may include categories su* z-- 7i7 enabl+ ! us] to ord] & view ! results ( laboratory te/s1 imag+ te/s1 & o!r diagno/ic te/s2 7ii7 submitt+1 edit+1 & retriev+ data f regi/ries su* z cl9ician-l$ cl9ical data regi/ries2 7iii7 access+ & ex*ang+ in=mation & data f & ?r\gh heal? in=mation ex*anges2 7iv7 access+ & ex*ang+ in=mation & data f m$ical devices2 7v7 access+ & ex*ang+ in=mation & data held by ,f$]al1 ,/ate1 & local ag5cies & o!r applicable entities useful to a heal? c>e provid] or o!r applicable us] 9 ! fur!rance ( pati5t c>e2 7vi7 access+ & ex*ang+ in=mation f o!r heal? c>e provid]s or applicable us]s2 7vii7 access+ & ex*ang+ pati5t g5]at$ in=mation2 7viii7 provid+ ! pati5t or an au?oriz$ designee ) a complete copy ( _! heal? in=mation f an electronic record 9 a computable =mat2 7ix7 provid+ accurate pati5t in=mation = ! correct pati5t1 includ+ ex*ang+ su* in=mation1 & avoid+ ! duplication ( pati5ts records2 & 7x7 o!r categories reg>d+ p]=mance1 accessibility1 z ! ,secret>y det]m9es appropriate2 & 7,c7 %all be design$ to ensure t small & />tup heal? in=mation te*nology develop]s are n unduly disadvantag$ by ! report+ crit]ia4 7#d7 ,modifications ,aft] ! report+ crit]ia h be5 develop$ "u p>agraph 7#c71 ! ,secret>y may conv5e /akehold]s & conduct a public comm5t p]iod = ! purpose ( modify+ ! report+ crit]ia develop$ "u su* p>agraph4 7b7 ,p>ticipation ,z a condition ( ma9ta9+ c]tification "u section #cjja7;c77#e77;,d71 a develop] ( c]tifi$ electronic heal? records %all submit to an appropriate recipi5t ( a grant1 contract1 or agreem5t "u subsection 7c77#a7 responses to ! crit]ia develop$ "u subsection 7a71 ) respect to all c]tifi$ te*nology (f]$ by su* develop]4 7c7 ,report+ program 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all aw>d grants1 contracts1 or agreem5ts to indep5d5t entities on a competitive basis to support ! conv5+ ( /akehold]s z describ$ 9 subsection 7a77#b71 collect ! in=mation requir$ to be report$ 9 accordance ) ! crit]ia e/abli%$ z describ$ subsection 7a77#c71 & develop & implem5t a process 9 accordance ) p>agraph 7#e7 & report su* in=mation to ! ,secret>y4 7#b7 ,applications ,an indep5d5t entity t seeks a grant1 contract1 or agreem5t "u ?is subsection %all submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may reasonably require1 includ+ a description (-- 7,a7 ! propos$ me?od = review+ & summ>iz+ in=mation ga!r$ bas$ on report+ crit]ia e/abli%$ "u subsection 7a72 7,b7 if applicable1 ! int5d$ focus on a specific subset ( c]tifi$ electronic heal? record te*nology us]s1 su* z heal? c>e provid]s1 includ+ prim>y c>e1 specialty c>e1 & c>e provid$ 9 rural sett+s2 hospitals & hospital sy/ems2 & pati5ts1 consum]s1 & pati5ts & consum] advocates2 7,c7 ! plan = widely di/ribut+ reports describ$ 9 p>agraph 7#f72 7,d7 ! p]iod = :i* ! grant1 contract1 or agreem5t is reque/$1 :i* may be up to #b ye>s2 & 7,e7 ! budget = report+ program p>ticipation1 & :e!r ! eligible indep5d5t entity int5ds to cont9ue p>ticipation aft] ! p]iod ( ! grant1 contract1 or agreem5t4 7#c7 ,consid]ations = indep5d5t entities ,9 aw>d+ grants1 contracts1 & agreem5ts "u p>agraph 7#a71 ! ,secret>y %all give priority to indep5d5t entities ) appropriate exp]tise 9 heal? in=mation te*nology usability1 int]op]ability1 & security 7especially entities ) su* exp]tise 9 electronic heal? records7 ) respect to-- 7,a7 heal? c>e provid]s1 includ+ prim>y c>e1 specialty c>e1 & c>e provid$ 9 rural sett+s2 7,b7 hospitals & hospital sy/ems2 & 7,c7 pati5ts1 consum]s1 & pati5t & consum] advocates4 7#d7 ,limitations 7,a7 ,assessm5t & r$et]m9ation ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act & e #b ye>s !reaft]1 ! ,secret>y1 9 consultation ) /akehold]s1 %all-- 7i7 assess p]=mance ( ! recipi5ts ( ! grants1 contracts1 & agreem5ts "u p>agraph 7#a7 bas$ on quality & usability ( reports describ$ 9 p>agraph 7#f72 & 7ii7 re-det]m9e grants1 contracts1 & agreem5ts z necess>y4 7,b7 ,prohibitions on ,p>ticipation ,! ,secret>y may n aw>d a grant1 contract1 or coop]ative agreem5t "u p>agraph 7#a7 to-- 7i7 a proprietor ( c]tifi$ heal? in=mation te*nology or a bus9ess affiliate ( su* a proprietor2 7ii7 a develop] ( c]tifi$ heal? in=mation te*nology2 or 7iii7 a ,/ate or local gov]nm5t ag5cy4 7#e7 ,fe$back ,bas$ on report+ crit]ia e/abli%$ "u subsection 7a71 ! recipi5ts ( grants1 contracts1 & agreem5ts "u p>agraph 7#a7 %all develop & implem5t a process to collect & v]ify confid5tial fe$back on su* crit]ia f-- 7,a7 heal? c>e provid]s1 pati5ts1 & o!r us]s ( c]tifi$ electronic heal? record te*nology2 & 7,b7 develop]s ( c]tifi$ electronic heal? record te*nology4 7#f7 ,reports 7,a7 ,developm5t ( reports ,ea* recipi5t ( a grant1 contract1 or agreem5t "u p>agraph 7#a7 %all report on ! in=mation report$ to su* recipi5t pursuant to subsection 7a7 & ! us] fe$back collect$ "u p>agraph 7#e7 by prep>+ summ>y reports & detail$ reports ( su* in=mation4 7,b7 ,di/ribution ( reports ,ea* recipi5t ( a grant1 contract1 or agreem5t "u p>agraph 7#a7 %all submit ! reports prep>$ "u subp>agraph 7,a7 to ! ,secret>y = public di/ribution 9 accordance ) subsection 7d74 7d7 ,publication ,! ,secret>y %all di/ribute widely1 z appropriate1 & publi%1 on ! ,int]net website ( ! ,(fice ( ! ,national ,coord9ator-- 7#a7 ! report+ crit]ia develop$ "u subsection 7a72 & 7#b7 ! summ>y & detail$ reports "u subsection 7c77#f74 7e7 ,review ,ea* recipi5t ( a grant1 contract1 or agreem5t "u p>agraph 7#a7 %all develop & implem5t a process ?r\gh :i* p>ticipat+ electronic heal? record te*nology develop]s may review & recomm5d *anges to ! reports creat$ "u subsection 7c77#f7 = products develop$ by su* develop] prior to ! publication ( su* report "u subsection 7d74 7f7 ,additional res\rces ,! ,secret>y may provide additional res\rces on ! ,int]net website ( ! ,(fice ( ! ,national ,coord9ator to bett] in=m consum]s ( heal? in=mation te*nology4 ,su* reports may be c>ri$ out ?r\gh p>tn]%ips ) private organizations ) appropriate exp]tise4 4 7d7 ,au?orization ( ,appropriations ,!re is au?oriz$ to be appropriat$ #ae1jjj1jjj = purposes ( c>ry+ out subp>agraph 7,d7 ( section #cjja7;c77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7 7z add$ by subsection 7a77 & section #cjji;,a ( ! ,public ,heal? ,s]vice ,act 7z add$ by subsection 7b771 includ+ = purposes ( adm9i/]+ any contracts1 grants1 or agreem5ts1 to rema9 available until exp5d$4 #djjc4 ,int]op]ability 7a7 ,def9ition ,section #cjjj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj7 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#aj7 ?r\gh 7#ad71 z p>agraphs 7#aa7 ?r\gh 7#ae71 respectively2 & 7#b7 by ins]t+ aft] p>agraph 7#i7 ! foll[+3 7#aj7 ,int]op]ability ,! t]m int]op]ability1 ) respect to heal? in=mation te*nology1 means su* heal? in=mation te*nology t-- 7,a7 enables ! secure ex*ange ( electronic heal? in=mation )1 & use ( electronic heal? in=mation f1 o!r heal? in=mation te*nology )\t special ef=t on ! "p ( ! us]2 7,b7 all[s = complete access1 ex*ange1 & use ( all electronically accessible heal? in=mation = au?oriz$ use "u applicable ,/ate or ,f$]al law2 & 7,c7 does n con/itute in=mation block+ z def9$ 9 section #cjbb7;a74 4 7b7 ,support = int]op]able network ex*ange ,section #cjja7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77 is am5d$ by add+ at ! end ! foll[+3 7#i7 ,support = int]op]able networks ex*ange 7,a7 ,9 g5]al ,! ,national ,coord9ator %all1 9 collaboration ) ! ,national ,in/itute ( ,/&>ds & ,te*nology & o!r relevant ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 = ! purpose ( ensur+ full network-to-network ex*ange ( heal? in=mation1 conv5e public-private & public-public p>tn]%ips to build cons5sus & develop or support a tru/$ ex*ange framework1 includ+ a common agreem5t among heal? in=mation networks nationally4 ,su* conv5tion may occur at a frequ5cy det]m9$ appropriate by ! ,secret>y4 7,b7 ,e/abli%+ a tru/$ ex*ange framework 7i7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,national ,coord9ator %all conv5e appropriate public & private /akehold]s to develop or support a tru/$ ex*ange framework = tru/ policies & practices & = a common agreem5t = ex*ange betwe5 heal? in=mation networks4 ,! common agreem5t may include-- 7,i7 a common me?od = au!nticat+ tru/$ heal? in=mation network p>ticipants2 7,,ii7 a common set ( rules = tru/$ ex*ange2 7,,iii7 organizational & op]ational policies to enable ! ex*ange ( heal? in=mation among networks1 includ+ m9imum conditions = su* ex*ange to occur2 & 7,,iv7 a process = fil+ & adjudicat+ noncompliance ) ! t]ms ( ! common agreem5t4 7ii7 ,te*nical assi/ance ,! ,national ,coord9ator1 9 collaboration ) ! ,national ,in/itute ( ,/&>ds & ,te*nology1 %all provide te*nical assi/ance on h[ to implem5t ! tru/$ ex*ange framework & common agreem5t "u ?is p>agraph4 7iii7 ,pilot te/+ ,! ,national ,coord9ator1 9 consultation ) ! ,national ,in/itute ( ,/&>ds & ,te*nology1 %all provide = ! pilot te/+ ( ! tru/$ ex*ange framework & common agreem5t e/abli%$ or support$ "u ?is subsection 7z au?oriz$ "u section #acbja ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act74 ,! ,national ,coord9ator1 9 consultation ) ! ,national ,in/itute ( ,/&>ds & ,te*nology1 may delegate pilot te/+ activities "u ?is clause to indep5d5t entities ) appropriate exp]tise4 7,c7 ,publication ( a tru/$ ex*ange framework & common agreem5t ,n lat] ?an #a ye> aft] conv5+ /akehold]s "u subp>agraph 7,a71 ! ,national ,coord9ator %all publi% on its public ,int]net website1 & 9 ! ,f$]al regi/]1 ! tru/$ ex*ange framework & common agreem5t develop$ or support$ "u subp>agraph 7,b74 ,su* tru/$ ex*ange framework & common agreem5t %all be publi%$ 9 a mann] t protects propriet>y & security in=mation1 includ+ trade secrets & any o!r protect$ intellectual prop]ty4 7,d7 ,directory ( p>ticipat+ heal? in=mation networks 7i7 ,9 g5]al ,n lat] ?an #b ye>s aft] conv5+ /akehold]s "u subp>agraph 7,a71 & annually !reaft]1 ! ,national ,coord9ator %all publi% on its public ,int]net website a li/ ( ! heal? in=mation networks t h adopt$ ! common agreem5t & are capable ( tru/$ ex*ange pursuant to ! common agreem5t develop$ or support$ "u p>agraph 7,b74 7ii7 ,process ,! ,secret>y %all1 ?r\gh notice & comm5t rulemak+1 e/abli% a process = heal? in=mation networks t volunt>ily elect to adopt ! tru/$ ex*ange framework & common agreem5t to atte/ to su* adoption ( ! framework & agreem5t4 7,e7 ,application ( ! tru/$ ex*ange framework & common agreem5t ,z appropriate1 ,f$]al ag5cies contract+ or ent]+ into agreem5ts ) heal? in=mation ex*ange networks may require t z ea* su* network upgrades heal? in=mation te*nology or tru/ & op]ational practices1 su* network may adopt1 :]e available1 ! tru/$ ex*ange framework & common agreem5t publi%$ "u subp>agraph 7,c74 7,f7 ,rule ( con/ruction 7i7 ,g5]al adoption ,no?+ 9 ?is p>agraph %all be con/ru$ to require a heal? in=mation network to adopt ! tru/$ ex*ange framework or common agreem5t4 7ii7 ,adoption :5 ex*ange ( in=mation is )9 network ,no?+ 9 ?is p>agraph %all be con/ru$ to require a heal? in=mation network to adopt ! tru/$ ex*ange framework or common agreem5t = ! ex*ange ( electronic heal? in=mation betwe5 p>ticipants ( ! same network4 7iii7 ,exi/+ frameworks & agreem5ts ,! tru/$ ex*ange framework & common agreem5t publi%$ "u subp>agraph 7,c7 %all take into acc\nt exi/+ tru/$ ex*ange frameworks & agreem5ts us$ by heal? in=mation networks to avoid ! disruption ( exi/+ ex*anges betwe5 p>ticipants ( heal? in=mation networks4 7iv7 ,application by ,f$]al ag5cies ,not)/&+ clauses 7i71 7ii71 & 7iii71 ,f$]al ag5cies may require ! adoption ( ! tru/$ ex*ange framework & common agreem5t publi%$ "u subp>agraph 7,c7 = heal? in=mation ex*anges contract+ ) or ent]+ into agreem5ts pursuant to subp>agraph 7,e74 7v7 ,consid]ation ( ongo+ "w ,9 c>ry+ out ?is p>agraph1 ! ,secret>y %all ensure ! consid]ation ( activities c>ri$ out by public & private organizations relat$ to ex*ange betwe5 heal? in=mation ex*anges to avoid duplication ( ef=ts4 4 7c7 ,provid] digital contact in=mation index 7#a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all1 directly or ?r\gh a p>tn]%ip ) a private entity1 e/abli% a provid] digital contact in=mation index to provide digital contact in=mation = heal? pr(essionals & heal? facilities4 7#b7 ,use ( exi/+ index ,9 e/abli%+ ! initial index "u p>agraph 7#a71 ! ,secret>y may utilize an exi/+ provid] directory to make su* digital contact in=mation available4 7#c7 ,contact in=mation ,an index e/abli%$ "u ?is subsection %all ensure t contact in=mation is available at ! individual heal? c>e provid] level & at ! heal? facility or practice level4 7#d7 ,rule ( con/ruction 7,a7 ,9 g5]al ,! purpose ( ?is subsection is to enc\rage ! ex*ange ( electronic heal? in=mation by provid+ ! mo/ useful1 reliable1 & compreh5sive index ( provid]s possible4 ,9 fur!r+ su* purpose1 ! ,secret>y %all include all heal? pr(essionals & heal? facilities applicable to provide a useful1 reliable1 & compreh5sive index = use 9 ! ex*ange ( heal? in=mation4 7,b7 ,limitation ,9 no case %all exclusion f ! index ( provid]s be us$ z a measure to a*ieve objectives o!r ! objectives describ$ 9 subp>agraph 7,a74 7d7 ,/&>ds developm5t organizations ,section #cjjd ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#ad7 is am5d$ by add+ at ! end ! foll[+3 7c7 ,def]5ce to /&>ds developm5t organizations ,9 adopt+ & implem5t+ /&>ds "u ?is section1 ! ,secret>y %all give def]5ce to /&>ds publi%$ by /&>ds developm5t organizations & volunt>y cons5sus-bas$ /&>ds bodies4 4 7e7 ,heal? ,in=mation ,te*nology advisory committee 7#a7 ,9 g5]al ,title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj et seq47 is am5d$ by /rik+ sections #cjjb 7#db ,u4,s4,c4 #cjj;jj-#ab7 & #cjjc 7#db ,u4,s4,c4 #cjj;jj-#ac7 & ins]t+ ! foll[+3 #cjjb4 ,heal? in=mation te*nology advisory committee 7a7 ,e/abli%m5t ,!re is e/abli%$ a ,heal? ,in=mation ,te*nology ,advisory ,committee 7ref]r$ to 9 ?is section z ! ,,hit ,advisory ,committee7 to recomm5d to ! ,national ,coord9ator1 consi/5t ) ! implem5tation ( ! /rategic plan describ$ 9 section #cjja7;c77#c71 policies1 &1 = purposes ( adoption "u section #cjjd1 /&>ds1 implem5tation specifications1 & c]tification crit]ia1 relat+ to ! implem5tation ( a heal? in=mation te*nology infra/ructure1 nationally & locally1 t advances ! electronic access1 ex*ange1 & use ( heal? in=mation4 ,su* ,committee %all s]ve to unify ! roles (1 & replace1 ! ,,hit ,policy ,committee & ! ,,hit ,/&>ds ,committee1 z 9 exi/5ce be=e ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act4 7b7 ,duties 7#a7 ,recomm5dations on policy framework to advance an int]op]able heal? in=mation te*nology infra/ructure 7,a7 ,9 g5]al ,! ,,hit ,advisory ,committee %all recomm5d to ! ,national ,coord9ator a policy framework = adoption by ! ,secret>y consi/5t ) ! /rategic plan "u section #cjja7;c77#c7 = advanc+ ! t>get areas describ$ 9 ?is subsection4 ,su* policy framework %all seek to prioritize a*iev+ advancem5ts 9 ! t>get areas specifi$ 9 subp>agraph 7,b7 ( p>agraph 7#b7 & may1 to ! ext5t consi/5t ) ?is section1 incorporate policy recomm5dations made by ! ,,hit ,policy ,committee1 z 9 exi/5ce be=e ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act4 7,b7 ,updates ,! ,,hit ,advisory ,committee %all propose updates to su* recomm5dations to ! policy framework & make new recomm5dations1 z appropriate4 7#b7 ,g5]al duties & t>get areas 7,a7 ,9 g5]al ,! ,,hit ,advisory ,committee %all recomm5d to ! ,national ,coord9ator = purposes ( adoption "u section #cjjd1 /&>ds1 implem5tation specifications1 & c]tification crit]ia & an ord] ( priority = ! developm5t1 h>monization1 & recognition ( su* /&>ds1 specifications1 & c]tification crit]ia4 ,su* recomm5dations %all include recomm5d$ /&>ds1 ar*itectures1 & s(tw>e s*emes = access to electronic individually id5tifiable heal? in=mation across disp>ate sy/ems includ+ us] vett+1 au!ntication1 privilege managem5t1 & access control4 7,b7 ,priority t>get areas ,= purposes ( ?is section1 ! ,,hit ,advisory ,committee %all make recomm5dations "u subp>agraph 7,a7 ) respect to at lea/ ea* ( ! foll[+ t>get areas3 7i7 ,a*iev+ a heal? in=mation te*nology infra/ructure1 nationally & locally1 t all[s = ! electronic access1 ex*ange1 & use ( heal? in=mation1 includ+ ?r\gh te*nology t provides accurate pati5t in=mation = ! correct pati5t1 includ+ ex*ang+ su* in=mation1 & avoids ! duplication ( pati5t records4 7ii7 ,! promotion & protection ( privacy & security ( heal? in=mation 9 heal? in=mation te*nology1 includ+ te*nologies t all[ = an acc\nt+ ( disclosures & protections aga9/ disclosures ( individually id5tifiable heal? in=mation made by a cov]$ entity = purposes ( treatm5t1 paym5t1 & heal? c>e op]ations 7z su* t]ms are def9$ = purposes ( ! regulation promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif71 includ+ = ! segm5tation & protection f disclosure ( specific & s5sitive individually id5tifiable heal? in=mation ) ! goal ( m9imiz+ ! reluctance ( pati5ts to seek c>e4 7iii7 ,! facilitation ( secure access by an individual to su* individual's protect$ heal? in=mation & access to su* in=mation by a family memb]1 c>egiv]1 or gu>dian act+ on behalf ( a pati5t1 includ+ due to age-relat$ & o!r disability1 cognitive impairm5t1 or dem5tia4 7iv7 ,subject to subp>agraph 7,d71 any o!r t>get area t ! ,,hit ,advisory ,committee id5tifies z an appropriate t>get area to be consid]$ "u ?is subp>agraph4 7,c7 ,additional t>get areas ,= purposes ( ?is section1 ! ,,hit ,advisory ,committee may make recomm5dations "u subp>agraph 7,a71 9 addition to areas describ$ 9 subp>agraph 7,b71 ) respect to any ( ! foll[+ areas3 7i7 ,! use ( heal? in=mation te*nology to improve ! quality ( heal? c>e1 su* z by promot+ ! coord9ation ( heal? c>e & improv+ cont9uity ( heal? c>e among heal? c>e provid]s1 r$uc+ m$ical errors1 improv+ population heal?1 r$uc+ *ronic disease1 & advanc+ rese>* & education4 7ii7 ,! use ( te*nologies t address ! ne$s ( *ildr5 & o!r vuln]able populations4 7iii7 ,! use ( electronic sy/ems to ensure ! compreh5sive collection ( pati5t demographic data1 includ+ at a m9imum1 race1 e?nicity1 prim>y language1 & g5d] in=mation4 7iv7 ,! use ( self-s]vice1 telem$ic9e1 home heal? c>e1 & remote monitor+ te*nologies4 7v7 ,! use ( te*nologies t meet ! ne$s ( div]se populations4 7vi7 ,! use ( te*nologies t support-- 7,i7 data = use 9 quality & public report+ programs2 7,,ii7 public heal?2 or 7,,iii7 drug safety4 7vii7 ,! use ( te*nologies t all[ individually id5tifiable heal? in=mation to be r5d]$ unusable1 unreadable1 or indeciph]able to unau?oriz$ individuals :5 su* in=mation is transmitt$ 9 a heal? in=mation network or transport$ outside ( ! secure facilities or sy/ems :]e ! disclos+ cov]$ entity is responsible = security conditions4 7viii7 ,! use ( a c]tifi$ heal? in=mation te*nology = ea* individual 9 ! ,unit$ ,/ates4 7,d7 ,au?ority = tempor>y additional priority t>get areas ,= purposes ( subp>agraph 7,b77iv71 ! ,,hit ,advisory ,committee may id5tify an area to be consid]$ = purposes ( recomm5dations "u ?is subsection z a t>get area describ$ 9 subp>agraph 7,b7 if-- 7i7 ! area is s id5tifi$ = purposes ( respond+ to new circum/ances t h aris5 9 ! heal? in=mation te*nology community t affect ! int]op]ability1 privacy1 or security ( heal? in=mation1 or affect pati5t safety2 & 7ii7 at lea/ #cj days prior to treat+ su* area z if x 7 a t>get area describ$ 9 subp>agraph 7,b71 ! ,national ,coord9ator provides adequate notice to ,congress ( ! int5t to treat su* area z s describ$4 7,e7 ,focus ( ,committee ,"w ,x is ! s5se ( ,congress t ! ,,hit ,advisory ,committee %all focus its "w on ! priority areas describ$ 9 subp>agraph 7,b7 be=e proce$+ to o!r "w "u subp>agraph 7,c74 7#c7 ,rules relat+ to recomm5dations = /&>ds1 implem5tation specifications1 & c]tification crit]ia 7,a7 ,9 g5]al ,! ,,hit ,advisory ,committee %all recomm5d to ! ,national ,coord9ator /&>ds1 implem5tation specifications1 & c]tification crit]ia describ$ 9 subsection 7a71 :i* may include /&>ds1 implem5tation specifications1 & c]tification crit]ia t h be5 develop$1 h>moniz$1 or recogniz$ by ! ,,hit ,advisory ,committee or pr$ecessor committee4 ,! ,,hit ,advisory ,committee %all update su* recomm5dations & make new recomm5dations z appropriate1 includ+ 9 response to a notification s5t "u section #cjjd7;a77#b77;,b74 ,su* recomm5dations %all be consi/5t ) ! late/ recomm5dations made by ! ,committee4 7,b7 ,h>monization ,! ,,hit ,advisory ,committee may recognize h>moniz$ or updat$ /&>ds f an entity or entities = ! purpose ( h>moniz+ or updat+ /&>ds & implem5tation specifications 9 ord] to a*ieve uni=m & consi/5t implem5tation ( ! /&>ds & implem5tation specification4 7,c7 ,pilot te/+ ( /&>ds & implem5tation specifications ,9 ! developm5t1 h>monization1 or recognition ( /&>ds & implem5tation specifications1 ! ,,hit ,advisory ,committee = purposes ( recomm5dations "u p>agraph 7#b77;,b71 %all1 z appropriate1 provide = ! te/+ ( su* /&>ds & specifications by ! ,national ,in/itute = ,/&>ds & ,te*nology "u section #acbja7;a7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act4 7,d7 ,consi/5cy ,! /&>ds1 implem5tation specifications1 & c]tification crit]ia recomm5d$ "u p>agraph 7#b77;,b7 %all be consi/5t ) ! /&>ds = in=mation transactions & data elem5ts adopt$ pursuant to section #aagc ( ! ,social ,security ,act4 7,e7 ,special rule relat$ to int]op]ability ,any recomm5dation made by ! ,,hit ,advisory ,committee aft] ! date ( ! enactm5t ( ?is subp>agraph ) respect to int]op]ability ( heal? in=mation te*nology %all be consi/5t ) int]op]ability z describ$ 9 section #cjjj4 7#d7 ,=um ,! ,,hit ,advisory ,committee %all s]ve z a =um = ! p>ticipation ( a broad range ( /akehold]s ) specific exp]tise 9 policies1 includ+ te*nical exp]tise1 relat+ to ! matt]s describ$ 9 p>agraphs 7#a71 7#b71 & 7#c7 to provide input on ! developm5t1 h>monization1 & recognition ( /&>ds1 implem5tation specifications1 & c]tification crit]ia necess>y = ! developm5t & adoption ( heal? in=mation te*nology infra/ructure nationally & locally t all[s = ! electronic access1 ex*ange1 & use ( heal? in=mation4 7#e7 ,s*$ule ,n lat] ?an #cj days aft] ! date on :i* ! ,,hit ,advisory ,committee fir/ meets1 su* ,,hit ,advisory ,committee %all develop a s*$ule = ! assessm5t ( policy recomm5dations develop$ "u p>agraph 7#a74 ,! ,,hit ,advisory ,committee %all update su* s*$ule annually4 ,! ,secret>y %all publi% su* s*$ule 9 ! ,f$]al ,regi/]4 7#f7 ,public input ,! ,,hit ,advisory ,committee %all conduct op5 public meet+s & develop a process to all[ = public comm5t on ! s*$ule describ$ 9 p>agraph 7#e7 & recomm5dations describ$ 9 ?is subsection4 ,"u su* process comm5ts %all be submitt$ 9 a timely mann] aft] ! date ( publication ( a recomm5dation "u ?is subsection4 7c7 ,measur$ progress 9 advanc+ priority areas 7#a7 ,9 g5]al ,= purposes ( ?is section1 ! ,national ,coord9ator1 9 collaboration ) ! ,secret>y1 %all e/abli%1 & update z appropriate1 objectives & b5*m>ks = advanc+ & measur+ ! advancem5t ( ! priority t>get areas describ$ 9 subsection 7b77#b77;,b74 7#b7 ,annual progress reports on advanc+ int]op]ability 7,a7 ,9 g5]al ,! ,,hit ,advisory ,committee1 9 consultation ) ! ,national ,coord9ator1 %all annually submit to ! ,secret>y & ,congress a report on ! progress made dur+ ! prec$+ fiscal ye> 9-- 7i7 a*iev+ a heal? in=mation te*nology infra/ructure1 nationally & locally1 t all[s = ! electronic access1 ex*ange1 & use ( heal? in=mation2 & 7ii7 meet+ ! objectives & b5*m>ks describ$ 9 p>agraph 7#a74 7,b7 ,cont5t ,ea* su* report %all include1 = a fiscal ye>-- 7i7 a description ( ! "w conduct$ by ! ,,hit ,advisory ,committee dur+ ! prec$+ fiscal ye> ) respect to ! areas describ$ 9 subsection 7b77#b77;,b72 7ii7 an assessm5t ( ! /atus ( ! infra/ructure describ$ 9 subp>agraph 7,a71 includ+ ! ext5t to :i* electronic heal? in=mation is appropriately & readily available to enhance ! access1 ex*ange1 & ! use ( electronic heal? in=mation betwe5 us]s & across te*nology (f]$ by diff]5t develop]s2 7iii7 ! ext5t to :i* advancem5ts h be5 a*iev$ ) respect to areas describ$ 9 subsection 7b77#b77;,b72 7iv7 an analysis id5tify+ exi/+ gaps 9 policies & res\rces =-- 7,i7 a*iev+ ! objectives & b5*m>ks e/abli%$ "u p>agraph 7#a72 & 7,,ii7 fur!r+ int]op]ability ?r\gh\t ! heal? in=mation te*nology infra/ructure2 7v7 recomm5dations = address+ ! gaps id5tifi$ 9 clause 7iii72 & 7vi7 a description ( additional initiatives z ! ,,hit ,advisory ,committee & ,national ,coord9ator det]m9e appropriate4 7#c7 ,significant advancem5t det]m9ation ,! ,secret>y %all p]iodically1 bas$ on ! reports submitt$ "u ?is subsection1 review ! t>get areas describ$ 9 subsection 7b77#b77;,b71 &1 bas$ on ! objectives & b5*m>ks e/abli%$ "u p>agraph 7#a71 ! ,secret>y %all det]m9e if significant advancem5t has be5 a*iev$ ) respect to su* an area4 ,su* det]m9ation %all be tak5 into consid]ation by ! ,,hit ,advisory ,committee :5 det]m9+ to :at ext5t ! ,committee makes recomm5dations = an area o!r ?an an area describ$ 9 subsection 7b77#b77;,b74 7d7 ,memb]%ip & op]ations 7#a7 ,9 g5]al ,! ,national ,coord9ator %all take a lead+ position 9 ! e/abli%m5t & op]ations ( ! ,,hit ,advisory ,committee4 7#b7 ,memb]%ip ,! memb]%ip ( ! ,,hit ,advisory ,committee %all-- 7,a7 include at lea/ #be memb]s1 ( :i*-- 7i7 no few] ?an #b memb]s are advocates = pati5ts or consum]s ( heal? in=mation te*nology2 7ii7 #c memb]s are appo9t$ by ! ,secret>y1 #a ( :om %all be appo9t$ to repres5t ! ,dep>tm5t ( ,heal? & ,human ,s]vices & #a ( :om %all be a public heal? (ficial2 7iii7 #b memb]s are appo9t$ by ! majority lead] ( ! ,s5ate2 7iv7 #b memb]s are appo9t$ by ! m9ority lead] ( ! ,s5ate2 7v7 #b memb]s are appo9t$ by ! ,speak] ( ! ,h\se ( ,repres5tatives2 7vi7 #b memb]s are appo9t$ by ! m9ority lead] ( ! ,h\se ( ,repres5tatives2 & 7vii7 su* o!r memb]s are appo9t$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates2 & 7,b7 at lea/ reflect provid]s1 ancill>y heal? c>e work]s1 consum]s1 pur*as]s1 heal? plans1 heal? in=mation te*nology develop]s1 rese>*]s1 pati5ts1 relevant ,f$]al ag5cies1 & individuals ) te*nical exp]tise on heal? c>e quality1 sy/em functions1 privacy1 security1 & on ! electronic ex*ange & use ( heal? in=mation1 includ+ ! use /&>ds = su* activity4 7#c7 ,p>ticipation ,! memb]s ( ! ,,hit ,advisory ,committee %all repres5t a balance among v>i\s sectors ( ! heal? c>e sy/em s t no s+le sector unduly influ5ces ! recomm5dations ( ! ,committee4 7#d7 ,t]ms 7,a7 ,9 g5]al ,! t]ms ( ! memb]s ( ! ,,hit ,advisory ,committee %all be = #c ye>s1 except t ! ,secret>y %all designate /agg]$ t]ms ( ! memb]s fir/ appo9t$4 7,b7 ,vacancies ,any memb] appo9t$ to fill a vacancy 9 ! memb]%ip ( ! ,,hit ,advisory ,committee t occurs prior to ! expiration ( ! t]m = :i* ! memb]'s pr$ecessor 0 appo9t$ %all be appo9t$ only = ! rema9d] ( t t]m4 ,a memb] may s]ve aft] ! expiration ( t memb]'s t]m until a successor has be5 appo9t$4 ,a vacancy 9 ! ,,hit ,advisory ,committee %all be fill$ 9 ! mann] 9 :i* ! orig9al appo9tm5t 0 made4 7,c7 ,limits ,memb]s ( ! ,,hit ,advisory ,committee %all be limit$ to two #c-ye> t]ms1 = a total ( n to exce$ #f ye>s ( s]vice on ! ,committee4 7#e7 ,outside involvem5t ,! ,,hit ,advisory ,committee %all ensure an opportunity = ! p>ticipation 9 activities ( ! ,committee ( outside advisors1 includ+ individuals ) exp]tise 9 ! developm5t ( policies & /&>ds = ! electronic ex*ange & use ( heal? in=mation1 includ+ 9 ! areas ( heal? in=mation privacy & security4 7#f7 ,quorum ,a majority ( ! memb]s ( ! ,,hit ,advisory ,committee %all con/itute a quorum = purposes ( vot+1 b a less] numb] ( memb]s may meet & hold he>+s4 7#g7 ,consid]ation ,! ,national ,coord9ator %all ensure t ! relevant & available recomm5dations & comm5ts f ! ,national ,committee on ,vital & ,heal? ,/ati/ics are consid]$ 9 ! developm5t ( policies4 7#h7 ,assi/ance ,= ! purposes ( c>ry+ out ?is section1 ! ,secret>y may provide or ensure t f9ancial assi/ance is provid$ by ! ,,hit ,advisory ,committee to defray 9 :ole or 9 "p any memb]%ip fees or dues *>g$ by su* ,committee to ^? consum] advocacy gr\ps & n-=-pr(it entities t "w 9 ! public int]e/ z a p>ty ( _! mission4 7e7 ,application ( ,,faca ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app471 o!r ?an section #ad ( su* ,act1 %all apply to ! ,,hit ,advisory ,committee4 7f7 ,publication ,! ,secret>y %all provide = publication 9 ! ,f$]al ,regi/] & ! po/+ on ! ,int]net website ( ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology ( all policy recomm5dations made by ! ,,hit ,advisory ,committee "u ?is section4 4 7#b7 ,te*nical & con=m+ am5dm5ts ,title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj et seq47 is am5d$-- 7,a7 by /rik+-- 7i7 ,,hit ,policy ,committee & ,,hit ,/&>ds ,committee ea* place t su* t]ms appe> 7o!r ?an )9 ! t]m ,,hit ,policy ,committee & ! ,,hit ,/&>ds ,committee or )9 ! t]m ,,hit ,policy ,committee or ! ,,hit ,/&>ds ,committee7 & ins]t+ ,,hit ,advisory ,committee2 7ii7 ,,hit ,policy ,committee & ! ,,hit ,/&>ds ,committee ea* place t su* t]m appe>s & ins]t+ ,,hit ,advisory ,committee2 & 7iii7 ,,hit ,policy ,committee or ! ,,hit ,/&>ds ,committee ea* place t su* t]m appe>s & ins]t+ ,,hit ,advisory ,committee2 7,b7 9 section #cjjj 7#db ,u4,s4,c4 #cjj;jj7-- 7i7 by /rik+ p>agraphs 7#g7 & 7#h7 & r$esignat+ p>agraphs 7#i7 ?r\gh 7#ad7 z p>agraphs 7#h7 ?r\gh 7#ac71 respectively2 & 7ii7 by ins]t+ aft] p>agraph 7#f7 ! foll[+ p>agraph3 7#g7 ,hit advisory committee ,! t]m ,,hit ,advisory ,committee means su* ,committee e/abli%$ "u section #cjjb7;a74 2 7,c7 9 section #cjja7;c7 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77-- 7i7 9 p>agraph 7#a77;,a71 by /rik+ "u section #cjjc & ins]t+ "u section #cjjb2 7ii7 9 p>agraph 7#b71 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,hit advisory committee ,! ,national ,coord9ator %all be a lead+ memb] 9 ! e/abli%m5t & op]ations ( ! ,,hit ,advisory ,committee & %all s]ve z a liaison betwe5 t ,committee & ! ,f$]al ,gov]nm5t4 2 7,d7 9 section #cjjd7;b77#c7 7#db ,u4,s4,c4 #cjj;jj-#ad7;b77#c771 by /rik+ #cjjc7;b77#b7 & ins]t+ #cjjb7;b77#d72 7,e7 9 section #cjjg7;b7 7#db ,u4,s4,c4 #cjj;jj-#ag7;b771 by /rik+ #cjjc7;a7 & ins]t+ #cjjb7;a77#b72 & 7,f7 9 section #cjjh 7#db ,u4,s4,c4 #cjj;jj-#ah7-- 7i7 9 subsection 7b71 by /rik+ or #cjjc2 & 7ii7 9 subsection 7c71 by /rik+ #cjjc7;b77#a77;,a7 & ins]t+ #cjjb7;b77#b74 7#c7 ,transition to ! ,,hit advisory committee ,! ,secret>y ( ,heal? & ,human ,s]vices %all provide = an ord]ly & timely transition to ! ,,hit ,advisory ,committee e/abli%$ "u am5dm5ts made by ?is section4 7f7 ,priorities = ,adoption ( ,/&>ds1 ,implem5tation ,specifications1 & ,c]tification crit]ia ,title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj et seq471 z am5d$ by subsection 7e71 is fur!r am5d$ by ins]t+ aft] section #cjjb ! foll[+3 #cjjc4 ,sett+ priorities = /&>ds adoption 7a7 ,id5tify+ priorities 7#a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date on :i* ! ,,hit ,advisory ,committee fir/ meets1 ! ,national ,coord9ator %all p]iodically conv5e ! ,,hit ,advisory ,committee to-- 7,a7 id5tify priority uses ( heal? in=mation te*nology1 focus+ on priorities-- 7i7 aris+ f ! implem5tation ( ! inc5tive programs = ! mean+ful use ( c]tifi$ ,,ehr te*nology1 ! ,m]it-bas$ ,inc5tive ,paym5t ,sy/em1 ,alt]native ,paym5t ,models1 ! ,hospital ,value-,bas$ ,pur*as+ ,program1 & any o!r value-bas$ paym5t program det]m9$ appropriate by ! ,secret>y2 7ii7 relat$ to ! quality ( pati5t c>e2 7iii7 relat$ to public heal?2 7iv7 relat$ to cl9ical rese>*2 7v7 relat$ to ! privacy & security ( electronic heal? in=mation2 7vi7 relat$ to innovation 9 ! field ( heal? in=mation te*nology2 7vii7 relat$ to pati5t safety2 7viii7 relat$ to ! usability ( heal? in=mation te*nology2 7ix7 relat$ to individuals' access to electronic heal? in=mation2 & 7x7 o!r priorities det]m9$ appropriate by ! ,secret>y2 7,b7 id5tify exi/+ /&>ds & implem5tation specifications t support ! use & ex*ange ( electronic heal? in=mation ne$$ to meet ! priorities id5tifi$ 9 subp>agraph 7,a72 & 7,c7 publi% a report summ>iz+ ! f9d+s ( ! analysis conduct$ "u subp>agraphs 7,a7 & 7,b7 & make appropriate recomm5dations4 7#b7 ,prioritization ,9 id5tify+ su* /&>ds & implem5tation specifications "u p>agraph 7#a77;,b71 ! ,,hit ,advisory ,committee %all prioritize /&>ds & implem5tation specifications develop$ by cons5sus-bas$ /&>ds developm5t organizations4 7#c7 ,guidel9es = review ( exi/+ /&>ds & specifications ,9 consultation ) ! cons5sus-bas$ entity describ$ 9 section #ahij ( ! ,social ,security ,act & o!r appropriate ,f$]al ag5cies1 ! analysis ( exi/+ /&>ds "u p>agraph 7#a77;,b7 %all include an evaluation ( ! ne$ = a core set ( common data elem5ts & associat$ value sets to enhance ! ability ( c]tifi$ heal? in=mation te*nology to capture1 use1 & ex*ange /ructur$ electronic heal? in=mation4 7b7 ,review ( adopt$ /&>ds 7#a7 ,9 g5]al ,beg9n+ #e ye>s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act & e #c ye>s !reaft]1 ! ,national ,coord9ator %all conv5e /akehold]s to review ! exi/+ set ( adopt$ /&>ds & implem5tation specifications & make recomm5dations ) respect to :e!r to-- 7,a7 ma9ta9 ! use ( su* /&>ds & implem5tation specifications2 or 7,b7 phase out su* /&>ds & implem5tation specifications4 7#b7 ,priorities ,! ,,hit ,advisory ,committee1 9 collaboration ) ! ,national ,in/itute = ,/&>ds & ,te*nology1 %all annually & ?r\gh ! use ( public input1 review & publi% priorities = ! use ( heal? in=mation te*nology1 /&>ds1 & implem5tation specifications to support ^? priorities4 7c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to prev5t ! use or adoption ( novel /&>ds t improve ^u ! exi/+ heal? in=mation te*nology infra/ructure & facilitate ! secure ex*ange ( heal? in=mation4 4 #djjd4 ,in=mation block+ ,subtitle ,c ( title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#ea et seq47 is am5d$ by add+ at ! end ! foll[+3 #cjbb4 ,in=mation block+ 7a7 ,def9ition 7#a7 ,9 g5]al ,9 ?is section1 ! t]m in=mation block+ means a practice t-- 7,a7 except z requir$ by law or specifi$ by ! ,secret>y pursuant to rulemak+ "u p>agraph 7#c71 is likely to int]f]e )1 prev5t1 or mat]ially disc\rage access1 ex*ange1 or use ( electronic heal? in=mation2 & 7,b7 7i7 if conduct$ by a heal? in=mation te*nology develop]1 ex*ange1 or network1 su* develop]1 ex*ange1 or network kn[s1 or %\ld "k1 t su* practice is likely to int]f]e )1 prev5t1 or mat]ially disc\rage ! access1 ex*ange1 or use ( electronic heal? in=mation2 or 7ii7 if conduct$ by a heal? c>e provid]1 su* provid] kn[s t su* practice is unreasonable & is likely to int]f]e )1 prev5t1 or mat]ially disc\rage access1 ex*ange1 or use ( electronic heal? in=mation4 7#b7 ,practices describ$ ,! in=mation block+ practices describ$ 9 p>agraph 7#a7 may include-- 7,a7 practices t re/rict au?oriz$ access1 ex*ange1 or use "u applicable ,/ate or ,f$]al law ( su* in=mation = treatm5t & o!r p]mitt$ purposes "u su* applicable law1 includ+ transitions betwe5 c]tifi$ heal? in=mation te*nologies2 7,b7 implem5t+ heal? in=mation te*nology 9 non/&>d ways t are likely to sub/antially increase ! complexity or burd5 ( access+1 ex*ang+1 or us+ electronic heal? in=mation2 & 7,c7 implem5t+ heal? in=mation te*nology 9 ways t are likely to-- 7i7 re/rict ! access1 ex*ange1 or use ( electronic heal? in=mation ) respect to export+ complete in=mation sets or 9 transition+ betwe5 heal? in=mation te*nology sy/ems2 or 7ii7 lead to fraud1 wa/e1 or abuse1 or imp$e innovations & advancem5ts 9 heal? in=mation access1 ex*ange1 & use1 includ+ c>e deliv]y enabl$ by heal? in=mation te*nology4 7#c7 ,rulemak+ ,! ,secret>y1 ?r\gh rulemak+1 %all id5tify reasonable & necess>y activities t d n con/itute in=mation block+ = purposes ( p>agraph 7#a74 7#d7 ,no en=cem5t be=e exception id5tifi$ ,! t]m in=mation block+ does n include any practice or conduct occurr+ prior to ! date t is #cj days aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act4 7#e7 ,consultation ,! ,secret>y may consult ) ! ,f$]al ,trade ,commission 9 promulgat+ regulations "u ?is subsection1 to ! ext5t t su* regulations def9e practices t are necess>y to promote competition & consum] welf>e4 7#f7 ,application ,! t]m in=mation block+1 ) respect to an individual or entity1 %all n include an act or practice o!r ?an an act or practice committ$ by su* individual or entity4 7#g7 ,cl>ification ,9 c>ry+ out ?is section1 ! ,secret>y %all ensure t heal? c>e provid]s are n p5aliz$ = ! failure ( develop]s ( heal? in=mation te*nology or o!r entities (f]+ heal? in=mation te*nology to su* provid]s to ensure t su* te*nology meets ! requirem5ts to be c]tifi$ "u ?is title4 7b7 ,inspector g5]al au?ority 7#a7 ,9 g5]al ,! inspector g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,inspector ,g5]al7 may inve/igate any claim t-- 7,a7 a heal? in=mation te*nology develop] ( c]tifi$ heal? in=mation te*nology or o!r entity (f]+ c]tifi$ heal? in=mation te*nology-- 7i7 submitt$ a false atte/ation "u section #cjja7;c77#e77;,d77vii72 or 7ii7 engag$ 9 in=mation block+2 7,b7 a heal? c>e provid] engag$ 9 in=mation block+2 or 7,c7 a heal? in=mation ex*ange or network engag$ 9 in=mation block+4 7#b7 ,p5alties 7,a7 ,develop]s1 networks1 & ex*anges ,any individual or entity describ$ 9 subp>agraph 7,a7 or 7,c7 ( p>agraph 7#a7 t ! ,inspector ,g5]al1 foll[+ an inve/igation conduct$ "u ?is subsection1 det]m9es to h committ$ in=mation block+ %all be subject to a civil monet>y p5alty det]m9$ by ! ,secret>y = all su* violations id5tifi$ ?r\gh su* inve/igation1 :i* may n exce$ #a1jjj1jjj p] violation4 ,su* det]m9ation %all take into acc\nt factors su* z ! nature & ext5t ( ! in=mation block+ & h>m result+ f su* in=mation block+1 includ+1 :]e applicable1 ! numb] ( pati5ts affect$1 ! numb] ( provid]s affect$1 & ! numb] ( days ! in=mation block+ p]si/$4 7,b7 ,provid]s ,any individual or entity describ$ 9 subp>agraph 7,b7 ( p>agraph 7#a7 det]m9$ by ! ,inspector ,g5]al to h committ$ in=mation block+ %all be ref]r$ to ! appropriate ag5cy to be subject to appropriate dis9c5tives us+ au?orities "u applicable ,f$]al law1 z ! ,secret>y sets =? ?r\gh notice & comm5t rulemak+4 7,c7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil money p5alty appli$ "u ?is p>agraph 9 ! same mann] z su* provisions apply to a civil money p5alty or proce$+ "u su* section #aabh;,a7a74 7,d7 ,recov]$ p5alty funds ,! am\nts recov]$ "u ?is p>agraph %all be allocat$ z foll[s3 7i7 ,annual op]at+ exp5ses ,ea* ye> foll[+ ! e/abli%m5t ( ! au?ority "u ?is subsection1 ! ,(fice ( ! ,inspector ,g5]al %all provide to ! ,secret>y an e/imate ( ! co/s to c>ry out inve/igations "u ?is section4 ,su* e/imate may include reasonable res]ves to acc\nt = v>iance 9 annual am\nts recov]$ "u ?is p>agraph4 ,!re is au?oriz$ to be appropriat$ = purposes ( c>ry+ out ?is section an am\nt equal to ! am\nt specifi$ 9 su* e/imate = ! fiscal ye>4 7ii7 ,application to o!r programs ,! am\nts recov]$ "u ?is p>agraph & rema9+ aft] am\nts are made available "u clause 7i7 %all be transf]r$ to ! ,f$]al ,hospital ,insurance ,tru/ ,fund "u section #ahag ( ! ,social ,security ,act & ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda ( su* ,act1 9 su* proportion z ! ,secret>y det]m9es appropriate4 7,e7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to ! ,(fice ( ! ,inspector ,g5]al to c>ry out ?is section #aj1jjj1jjj1 to rema9 available until exp5d$4 7#c7 ,resolution ( claims 7,a7 ,9 g5]al ,! ,(fice ( ! ,inspector ,g5]al1 if su* ,(fice det]m9es t a consultation reg>d+ ! heal? privacy & security rules promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 w resolve an in=mation block+ claim1 may ref] su* in/ances ( in=mation block+ to ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices = resolution4 7,b7 ,limitation on liability ,if a heal? c>e provid] or heal? in=mation te*nology develop] makes in=mation available bas$ on a good fai? reliance on consultations ) ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices pursuant to a ref]ral "u subp>agraph 7,a71 ) respect to su* in=mation1 ! heal? c>e provid] or develop] %all n be liable = su* disclosure or disclosures made pursuant to subp>agraph 7,a74 7c7 ,id5tify+ b>ri]s ,to ex*ange ( c]tifi$ heal? in=mation te*nology 7#a7 ,tru/$ ex*ange def9$ ,9 ?is section1 ! t]m tru/$ ex*ange ) respect to c]tifi$ electronic heal? records means t ! c]tifi$ electronic heal? record te*nology has ! te*nical capability to enable secure heal? in=mation ex*ange betwe5 us]s & multiple c]tifi$ electronic heal? record te*nology sy/ems4 7#b7 ,guidance ,! ,national ,coord9ator1 9 consultation ) ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all issue guidance on common legal1 gov]nance1 & security b>ri]s t prev5t ! tru/$ ex*ange ( electronic heal? in=mation4 7#c7 ,ref]ral ,! ,national ,coord9ator & ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices may ref] to ! ,inspector ,g5]al in/ances or patt]ns ( refusal to ex*ange heal? in=mation ) an individual or entity us+ c]tifi$ electronic heal? record te*nology t is te*nically capable ( tru/$ ex*ange & "u conditions :5 ex*ange is legally p]missible4 7d7 ,additional provisions 7#a7 ,in=mation %>+ provisions ,! ,national ,coord9ator may s]ve z a te*nical consultant to ! ,inspector ,g5]al & ! ,f$]al ,trade ,commission = purposes ( c>ry+ out ?is section4 ,! ,national ,coord9ator may1 not)/&+ any o!r provision ( law1 %>e in=mation relat$ to claims or inve/igations "u subsection 7b7 ) ! ,f$]al ,trade ,commission = purposes ( su* inve/igations & %all %>e in=mation ) ! ,inspector ,g5]al1 z requir$ by law4 7#b7 ,protection f disclosure ( in=mation ,any in=mation t is receiv$ by ! ,national ,coord9ator 9 connection ) a claim or sugge/ion ( possible in=mation block+ & t c\ld reasonably be expect$ to facilitate id5tification ( ! s\rce ( ! in=mation-- 7,a7 %all n be disclos$ by ! ,national ,coord9ator except z may be necess>y to c>ry out ! purpose ( ?is section2 7,b7 %all be exempt f m&atory disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 z provid$ by subsection 7b77#c7 ( su* section2 & 7,c7 may be us$ by ! ,inspector ,g5]al or ,f$]al ,trade ,commission = report+ purposes to ! ext5t t su* in=mation c\ld n reasonably be expect$ to facilitate id5tification ( ! s\rce ( su* in=mation4 7#c7 ,/&>diz$ process 7,a7 ,9 g5]al ,! ,national ,coord9ator %all implem5t a /&>diz$ process = ! public to submit reports on claims (-- 7i7 heal? in=mation te*nology products or develop]s ( su* products 7or o!r entities (f]+ su* products to heal? c>e provid]s7 n be+ int]op]able or result+ 9 in=mation block+2 7ii7 actions describ$ 9 subsection 7b77#a7 t result 9 in=mation block+ z describ$ 9 subsection 7a72 & 7iii7 any o!r act describ$ 9 subsection 7a74 7,b7 ,collection ( in=mation ,! /&>diz$ process implem5t$ "u subp>agraph 7,a7 %all provide = ! collection ( su* in=mation z ! orig9at+ in/itution1 location1 type ( transaction1 sy/em & v]sion1 time/amp1 t]m9at+ in/itution1 locations1 sy/em & v]sion1 failure notice1 & o!r relat$ in=mation4 7#d7 ,nonduplication ( p5alty /ructures ,9 c>ry+ out ?is subsection1 ! ,secret>y %all1 to ! ext5t possible1 ensure t p5alties d n duplicate p5alty /ructures t w\ld o!rwise apply ) respect to in=mation block+ & ! type ( individual or entity involv$ z ( ! day be=e ! date ( ! enactm5t ( ?is section4 4 #djje4 ,lev]ag+ electronic heal? records to improve pati5t c>e 7a7 ,requirem5t relat+ to regi/ries 7#a7 ,9 g5]al ,to be c]tifi$ 9 accordance ) title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj et seq471 electronic heal? records %all be capable ( transmitt+ to1 & :]e applicable1 receiv+ & accept+ data f1 regi/ries 9 accordance ) /&>ds recogniz$ by ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 includ+ cl9ician-l$ cl9ical data regi/ries1 t are also c]tifi$ to be te*nically capable ( receiv+ & accept+ f1 & :]e applicable1 transmitt+ data to c]tifi$ electronic heal? record te*nology 9 accordance ) su* /&>ds4 7#b7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to require ! c]tification ( regi/ries beyond ! te*nical capability to ex*ange data 9 accordance ) applicable recogniz$ /&>ds4 7b7 ,def9ition ,= purposes ( ?is ,act1 ! t]m cl9ician-l$ cl9ical data regi/ry means a cl9ical data repository-- 7#a7 t is e/abli%$ & op]at$ by a cl9ician-l$ or controll$1 tax-exempt 7pursuant to section #eja7;c7 ( ! ,int]nal ,rev5ue ,code ( #aihf71 pr(essional society or o!r simil> cl9ician-l$ or -controll$ organization1 or su* organization's controll$ affiliate1 devot$ to ! c>e ( a population def9$ by a p>ticul> disease1 condition1 exposure or !rapy2 7#b7 t is design$ to collect detail$1 /&>diz$ data on an ongo+ basis = m$ical proc$ures1 s]vices1 or !rapies = p>ticul> diseases1 conditions1 or exposures2 7#c7 t provides fe$back to p>ticipants :o submit reports to ! repository2 7#d7 t meets /&>ds = data quality includ+-- 7,a7 sy/ematically collect+ cl9ical & o!r heal? c>e data1 us+ /&>diz$ data elem5ts & hav+ proc$ures 9 place to v]ify ! complet5ess & validity ( ^? data2 & 7,b7 be+ subject to regul> data *ecks or audits to v]ify complet5ess & validity2 & 7#e7 t provides ongo+ p>ticipant tra9+ & support4 7c7 ,treatm5t ( heal? in=mation te*nology develop]s ) respect to pati5t safety organizations 7#a7 ,9 g5]al ,9 apply+ "p ,c ( title ,,ix ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bii;b-#ba et seq471 a heal? in=mation te*nology develop] %all be treat$ z a provid] 7z def9$ 9 section #iba ( su* ,act7 = purposes ( report+ & conduct+ pati5t safety activities conc]n+ improv+ cl9ical c>e ?r\gh ! use ( heal? in=mation te*nology t c\ld result 9 improv$ pati5t safety1 heal? c>e quality1 or heal? c>e outcomes4 7#b7 ,report ,n lat] ?an #d ye>s 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 ( ,repres5tatives1 a report conc]n+ be/ practices & curr5t tr5ds volunt>ily provid$1 )\t id5tify+ individual provid]s or disclos+ or us+ protect$ heal? in=mation or individually id5tifiable in=mation1 by pati5t safety organizations to improve ! integration ( heal? in=mation te*nology into cl9ical practice4 #djjf4 ,emp[]+ pati5ts & improv+ pati5t access to _! electronic heal? in=mation 7a7 ,use ( heal? in=mation ex*anges = pati5t access ,section #cjji ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#ai7 is am5d$ by add+ at ! end ! foll[+3 7c7 ,promot+ pati5t access to electronic heal? in=mation ?r\gh heal? in=mation ex*anges 7#a7 ,9 g5]al ,! ,secret>y %all use exi/+ au?orities to enc\rage p>tn]%ips betwe5 heal? in=mation ex*ange organizations & networks & heal? c>e provid]s1 heal? plans1 & o!r appropriate entities ) ! goal ( (f]+ pati5ts access to _! electronic heal? in=mation 9 a s+le1 longitud9al =mat t is easy to und]/&1 secure1 & may be updat$ automatically4 7#b7 ,education ( provid]s ,! ,secret>y1 9 coord9ation ) ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all-- 7,a7 educate heal? c>e provid]s on ways ( lev]ag+ ! capabilities ( heal? in=mation ex*anges 7or o!r relevant plat=ms7 to provide pati5ts ) access to _! electronic heal? in=mation2 7,b7 cl>ify misund]/&+s by heal? c>e provid]s ab\t us+ heal? in=mation ex*anges 7or o!r relevant plat=ms7 = pati5t access to electronic heal? in=mation2 & 7,c7 to ! ext5t practicable1 educate provid]s ab\t heal? in=mation ex*anges 7or o!r relevant plat=ms7 t employ "s or all ( ! capabilities describ$ 9 p>agraph 7#a74 7#c7 ,requirem5ts ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y1 9 coord9ation ) ! ,(fice = ,civil ,rights1 %all issue guidance to heal? in=mation ex*anges relat$ to be/ practices to ensure t ! electronic heal? in=mation provid$ to pati5ts is-- 7,a7 private & secure2 7,b7 accurate2 7,c7 v]ifiable2 & 7,d7 :]e a pati5t's au?orization to ex*ange in=mation is requir$ by law1 easily ex*ang$ pursuant to su* au?orization4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to preempt ,/ate laws applicable to pati5t cons5t = ! access ( in=mation ?r\gh a heal? in=mation ex*ange 7or o!r relevant plat=m7 t provide protections to pati5ts t are great] ?an ! protections o!rwise provid$ = "u applicable ,f$]al law4 7d7 ,ef=ts ,to promote access to heal? in=mation ,! ,national ,coord9ator & ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all jo9tly promote pati5t access to heal? in=mation 9 a mann] t w\ld ensure t su* in=mation is available 9 a =m conv5i5t = ! pati5t1 9 a reasonable mann]1 )\t burd5+ ! heal? c>e provid] involv$4 7e7 ,accessibility ( pati5t records 7#a7 ,accessibility & updat+ ( in=mation 7,a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,national ,coord9ator1 %all promote policies t ensure t a pati5t's electronic heal? in=mation is accessible to t pati5t & ! pati5t's designees1 9 a mann] t facilitates communication ) ! pati5t's heal? c>e provid]s & o!r individuals1 includ+ rese>*]s1 consi/5t ) su* pati5t's cons5t4 7,b7 ,updat+ education on access+ & ex*ang+ p]sonal heal? in=mation ,to promote aw>5ess t an individual has a "r ( access to inspect1 obta9 a copy (1 & transmit to a ?ird p>ty a copy ( su* individual's protect$ heal? in=mation pursuant to ! ,heal? ,in=mation ,portability & ,acc\ntability ,act1 ,privacy ,rule 7subp>t ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations71 ! ,director ( ! ,(fice = ,civil ,rights1 9 consultation ) ! ,national ,coord9ator1 %all assi/ individuals & heal? c>e provid]s 9 und]/&+ a pati5t's rights to access & protect p]sonal heal? in=mation "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,public ,law #ajd-aia71 includ+ provid+ be/ practices = reque/+ p]sonal heal? in=mation 9 a computable =mat1 includ+ us+ pati5t portals or ?ird-p>ty applications & common cases :5 a provid] is p]mitt$ to ex*ange & provide access to heal? in=mation4 4 7#b7 ,c]tify+ usability = pati5ts ,9 c>ry+ out c]tification programs "u section #cjja7;c77#e71 ! ,national ,coord9ator may require t-- 7,a7 ! c]tification crit]ia support-- 7i7 pati5t access to _! electronic heal? in=mation1 includ+ 9 a s+le longitud9al =mat t is easy to und]/&1 secure1 & may be updat$ automatically2 7ii7 ! pati5t's ability to electronically communicate pati5t-report$ in=mation 7su* z family hi/ory & m$ical hi/ory72 & 7iii7 pati5t access to _! p]sonal electronic heal? in=mation = rese>* at ! option ( ! pati5t2 & 7,b7 ! ,,hit ,advisory ,committee develop & prioritize /&>ds1 implem5tation specifications1 & c]tification crit]ia requir$ to help support pati5t access to electronic heal? in=mation1 pati5t usability1 & support = te*nologies t (f] pati5ts access to _! electronic heal? in=mation 9 a s+le1 longitud9al =mat t is easy to und]/&1 secure1 & may be updat$ automatically4 4 7b7 ,access to in=mation 9 an electronic =mat ,section #acdje7;e7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agice7 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ & at ! end2 7#b7 by r$esignat+ p>agraph 7#b7 z p>agraph 7#c72 & 7#c7 by ins]t+ aft] p>agraph 7#a71 ! foll[+3 7#b7 if ! individual makes a reque/ to a bus9ess associate = access to1 or a copy (1 protect$ heal? in=mation ab\t ! individual1 or if an individual makes a reque/ to a bus9ess associate to grant su* access to1 or transmit su* copy directly to1 a p]son or entity designat$ by ! individual1 a bus9ess associate may provide ! individual ) su* access or copy1 :i* may be 9 an electronic =m1 or grant or transmit su* access or copy to su* p]son or entity designat$ by ! individual2 & 4 #djjg4 ,,gao /udy on pati5t mat*+ 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy to-- 7#a7 review ! policies & activities ( ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology & o!r relevant /akehold]s1 :i* may include /&>ds developm5t organizations1 exp]ts 9 ! te*nical aspects ( heal? in=mation te*nology1 heal? in=mation te*nology develop]s1 provid]s ( heal? s]vices1 heal? c>e suppli]s1 heal? c>e pay]s1 heal? c>e quality organizations1 ,/ates1 heal? in=mation te*nology policy exp]ts1 & o!r appropriate entities1 to ensure appropriate pati5t mat*+ to protect pati5t privacy & security ) respect to electronic heal? records & ! ex*ange ( electronic heal? in=mation2 & 7#b7 survey ongo+ ef=ts relat$ to ! policies & activities describ$ 9 p>agraph 7#a7 & ! effectiv5ess ( su* ef=ts occurr+ 9 ! private sector4 7b7 ,areas ( conc5tration ,9 conduct+ ! /udy "u subsection 7a71 ! ,comptroll] ,g5]al %all-- 7#a7 evaluate curr5t me?ods us$ 9 c]tifi$ electronic heal? records = pati5t mat*+ bas$ on p]=mance relat$ to factors su* z-- 7,a7 ! privacy ( pati5t in=mation2 7,b7 ! security ( pati5t in=mation2 7,c7 improv+ mat*+ rates2 7,d7 r$uc+ mat*+ errors2 & 7,e7 r$uc+ duplicate records2 & 7#b7 det]m9e :e!r ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology c\ld improve pati5t mat*+ by tak+ /eps includ+-- 7,a7 def9+ additional data elem5ts to assi/ 9 pati5t data mat*+2 7,b7 agree+ on a requir$ m9imum set ( elem5ts t ne$ to be collect$ & ex*ang$2 7,c7 requir+ electronic heal? records to h ! ability to make c]ta9 fields requir$ & use specific /&>ds2 & 7,d7 o!r options recomm5d$ by ! relevant /akehold]s consult$ pursuant to subsection 7a74 7c7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ! appropriate committees ( ,congress a report conc]n+ ! f9d+s ( ! /udy conduct$ "u subsection 7a74 #djjh4 ,,gao /udy on pati5t access to heal? in=mation 7a7 ,/udy 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! ,comptroll] ,g5]al7 %all build on prior ,gov]nm5t ,acc\ntability ,(fice /udies & o!r lit]ature review & conduct a /udy to review pati5t access to _! own protect$ heal? in=mation1 includ+ b>ri]s to su* pati5t access & complications or difficulties provid]s exp]i5ce 9 provid+ access to pati5ts4 ,9 conduct+ su* /udy1 ! ,comptroll] ,g5]al %all consid] ! increase 9 adoption ( heal? in=mation te*nology & ! increas+ preval5ce ( protect$ heal? in=mation t is ma9ta9$ electronically4 7#b7 ,areas ( conc5tration ,9 conduct+ ! review "u p>agraph 7#a71 ! ,comptroll] ,g5]al %all consid]-- 7,a7 in/ances :5 cov]$ entities *>ge individuals1 includ+ pati5ts1 ?ird p>ties1 & heal? c>e provid]s1 = record reque/s1 includ+ records t are reque/$ 9 an electronic =mat2 7,b7 examples ( ! am\nts & types ( fees *>g$ to individuals = record reque/s1 includ+ in/ances :5 ! record is reque/$ to be transmitt$ to a ?ird p>ty2 7,c7 ! ext5t to :i* cov]$ entities are unable to provide ! access reque/$ by individuals 9 ! =m & =mat reque/$ by ! individual1 includ+ examples ( su* in/ances2 7,d7 in/ances 9 :i* ?ird p>ties may reque/ protect$ heal? in=mation ?r\gh pati5ts' individual "r ( access1 includ+ in/ances :]e su* reque/s may be us$ to circumv5t appropriate fees t may be *>g$ to ?ird p>ties2 7,e7 opportunities t p]mit cov]$ entities to *>ge appropriate fees to ?ird p>ties = pati5t records :ile provid+ pati5ts ) access to _! protect$ heal? in=mation at l[ or no co/2 7,f7 ! ability ( provid]s to di/+ui% betwe5 reque/s orig9at+ f an individual t require limitation to a co/-bas$ fee & reque/s orig9at+ f ?ird p>ties t may n be limit$ to co/-bas$ fees2 & 7,g7 o!r circum/ances t may inhibit ! ability ( provid]s to provide pati5ts ) access to _! records1 & ! ability ( pati5ts to ga9 access to _! records4 7b7 ,report ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit a report to ,congress on ! f9d+s ( ! /udy conduct$ "u subsection 7a74 #djji4 ,improv+ ,m$ic>e local cov]age det]m9ations 7a7 ,9 g5]al ,section #ahfb7l77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#e77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,local cov]age det]m9ations ,! ,secret>y %all require ea* ,m$ic>e adm9i/rative contractor t develops a local cov]age det]m9ation to make available on ! ,int]net website ( su* contractor & on ! ,m$ic>e ,int]net website1 at lea/ #de days be=e ! effective date ( su* det]m9ation1 ! foll[+ in=mation3 7i7 ,su* det]m9ation 9 its entirety4 7ii7 ,:]e & :5 ! propos$ det]m9ation 0 fir/ made public4 7iii7 ,hyp]l9ks to ! propos$ det]m9ation & a response to comm5ts submitt$ to ! contractor ) respect to su* propos$ det]m9ation4 7iv7 ,a summ>y ( evid5ce t 0 consid]$ by ! contractor dur+ ! developm5t ( su* det]m9ation & a li/ ( ! s\rces ( su* evid5ce4 7v7 ,an explanation ( ! rationale t supports su* det]m9ation4 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply ) respect to local cov]age det]m9ations t are propos$ or revis$ on or aft] ! date t is #ahj days aft] ! date ( enactm5t ( ?is ,act4 #djaj4 ,m$ic>e ph>maceutical & te*nology ombudsman ,section #ahjh ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#i7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7d7 ,ph>maceutical & te*nology ombudsman 7#a7 ,9 g5]al ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y %all provide = a ph>maceutical & te*nology ombudsman )9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices :o %all receive & respond to compla9ts1 grievances1 & reque/s t-- 7,a7 are f entities t manufacture ph>maceutical1 biote*nology1 m$ical device1 or diagno/ic products t are cov]$ or = :i* cov]age is be+ s\ght "u ?is title2 & 7,b7 are ) respect to cov]age1 cod+1 or paym5t "u ?is title = su* products4 7#b7 ,application ,! second s5t5ce ( subsection 7c77#b7 %all apply to ! ombudsman "u subp>agraph 7,a7 9 ! same mann] z su* s5t5ce applies to ! ,m$ic>e ,b5efici>y ,ombudsman "u subsection 7c74 4 #djaa4 ,m$ic>e site-(-s]vice price transp>5cy ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7t7 ,site-(-,s]vice price transp>5cy 7#a7 ,9 g5]al ,9 ord] to facilitate price transp>5cy ) respect to items & s]vices = :i* paym5t may be made ei!r to a hospital outpati5t dep>tm5t or to an ambulatory surgical c5t] "u ?is title1 ! ,secret>y %all1 = #bjah & ea* ye> !reaft]1 make available to ! public via a se>*able ,int]net website1 ) respect to an appropriate numb] ( su* items & s]vices-- 7,a7 ! e/imat$ paym5t am\nt = ! item or s]vice "u ! outpati5t dep>tm5t fee s*$ule "u subsection 7t7 ( section #ahcc & ! ambulatory surgical c5t] paym5t sy/em "u subsection 7i7 ( su* section2 & 7,b7 ! e/imat$ am\nt ( b5efici>y liability applicable to ! item or s]vice4 7#b7 ,calculation ( e/imat$ b5efici>y liability ,= purposes ( p>agraph 7#a77;,b71 ! e/imat$ am\nt ( b5efici>y liability1 ) respect to an item or s]vice1 is ! am\nt = su* item or s]vice = :i* an individual :o does n h cov]age "u a ,m$ic>e supplem5tal policy c]tifi$ "u section #ahhb or any o!r supplem5tal insurance cov]age is responsible4 7#c7 ,implem5tation ,9 c>ry+ out ?is subsection1 ! ,secret>y-- 7,a7 %all include 9 ! notice describ$ 9 section #ahjd7;a7 a notification ( ! availability ( ! e/imat$ am\nts made available "u p>agraph 7#a72 & 7,b7 may utilize me*anisms 9 exi/5ce on ! date ( enactm5t ( ?is subsection1 su* z ! portion ( ! ,int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices on :i* in=mation comp>+ physician p]=mance is po/$ 7commonly ref]r$ to z ! ,physician ,comp>e ,int]net website71 to make available su* e/imat$ am\nts "u su* p>agraph4 7#d7 ,fund+ ,= purposes ( implem5t+ ?is subsection1 ! ,secret>y %all provide = ! transf]1 f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt1 ( #f1jjj1jjj = fiscal ye> #bjag1 to rema9 available until exp5d$4 4 #djab4 ,teleheal? s]vices 9 ,m$ic>e 7a7 ,provision ( in=mation by ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all provide to ! committees ( jurisdiction ( ! ,h\se ( ,repres5tatives & ! ,s5ate in=mation on ! foll[+3 7#a7 ,! populations ( ,m$ic>e b5efici>ies1 su* z ^? :o are dually eligible = ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 & ! ,m$icaid program "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 & ^? ) *ronic conditions1 ^: c>e may be improv$ mo/ 9 t]ms ( quality & effici5cy by ! expansion1 9 a mann] t meets or exce$s ! exi/+ 9-p]son /&>d ( c>e "u ! ,m$ic>e program "u su* title ,,xviii1 ( teleheal? s]vices "u section #ahcd7m77#d7 ( su* ,act 7#db ,u4,s4,c4 #aciem7m77#d774 7#b7 ,activities by ! ,c5t] = ,m$ic>e & ,m$icaid ,innovation :i* exam9e ! use ( teleheal? s]vices 9 models1 projects1 or initiatives fund$ ?r\gh section #aaae;,a ( su* ,act 7#db ,u4,s4,c4 #acae;a74 7#c7 ,! types ( high-volume s]vices 7& relat$ diagnoses7 "u su* title ,,xviii :i* might be suitable to be furni%$ us+ teleheal?4 7#d7 ,b>ri]s t might prev5t ! expansion ( teleheal? s]vices "u section #ahcd7m77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77 beyond su* s]vices t are 9 effect z ( ! date ( enactm5t ( ?is ,act4 7b7 ,provision ( in=mation by ,med,p,a,c ,n lat] ?an ,m>* #ae1 #bjah1 ! ,m$ic>e ,paym5t ,advisory ,commission e/abli%$ "u section #ahje ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#f7 %all1 us+ quantitative & qualitative rese>* me?ods1 provide in=mation to ! committees ( jurisdiction ( ! ,h\se ( ,repres5tatives & ! ,s5ate t id5tifies-- 7#a7 ! teleheal? s]vices = :i* paym5t c be made1 z ( ! date ( enactm5t ( ?is ,act1 "u ! fee-=-s]vice program "u p>ts ,a & ,b ( title ,,xviii ( su* ,act2 7#b7 ! teleheal? s]vices = :i* paym5t c be made1 z ( su* date1 "u private heal? insurance plans2 & 7#c7 ) respect to s]vices id5tifi$ "u p>agraph 7#b7 b n "u p>agraph 7#a71 ways 9 :i* paym5t = su* s]vices might be incorporat$ into su* fee-=-s]vice program 7includ+ any recomm5dations = ways to accompli% ?is incorporation74 7c7 ,s5se ( ,congress ,x is ! s5se ( ,congress t-- 7#a7 eligible orig9at+ sites %\ld be exp&$ beyond ^? orig9at+ sites describ$ 9 section #ahcd7m77#d77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c772 & 7#b7 any expansion ( teleheal? s]vices "u ! ,m$ic>e program "u title ,,xviii ( su* ,act %\ld-- 7,a7 recognize t telem$ic9e is ! deliv]y ( safe1 effective1 quality heal? c>e s]vices1 by a heal? c>e provid]1 us+ te*nology z ! mode ( c>e deliv]y2 7,b7 meet or exce$ ! conditions ( cov]age & paym5t ) respect to ! ,m$ic>e program if ! s]vice 0 furni%$ 9 p]son1 includ+ /&>ds ( c>e1 unless specifically address$ 9 subsequ5t legislation2 & 7,c7 involve cl9ically appropriate means to furni% su* s]vices4 ,v ,sav+s #ejja4 ,sav+s 9 ! ,m$ic>e ,improvem5t ,fund ,section #ahih7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;iii7b77#a771 z am5d$ by section #gjd7;h7 ( ! ,compreh5sive ,addiction & ,recov]y ,act ( #bjaf1 is am5d$ by /rik+ #adj1jjj1jjj & ins]t+ #bgj1jjj1jjj4 #ejjb4 ,m$icaid reimbursem5t to ,/ates = durable m$ical equipm5t ,section #aijc7;i77#bg7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#bg77 is am5d$ by /rik+ ,janu>y #a1 #bjai & ins]t+ ,janu>y #a1 #bjah4 #ejjc4 ,p5alties = violations ( grants1 contracts1 & o!r agreem5ts 7a7 ,9 g5]al ,section #aabh;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 is am5d$ by add+ at ! end ! foll[+ new subsections3 7o7 ,any p]son 7includ+ an organization1 ag5cy1 or o!r entity1 b exclud+ a program b5efici>y1 z def9$ 9 subsection 7q77#d77 t1 ) respect to a grant1 contract1 or o!r agreem5t = :i* ! ,secret>y provides fund+-- 7#a7 kn[+ly pres5ts or causes to be pres5t$ a specifi$ claim 7z def9$ 9 subsection 7r77 "u su* grant1 contract1 or o!r agreem5t t ! p]son kn[s or %\ld "k is false or fraudul5t2 7#b7 kn[+ly makes1 uses1 or causes to be made or us$ any false /atem5t1 omission1 or misrepres5tation ( a mat]ial fact 9 any application1 proposal1 bid1 progress report1 or o!r docum5t t is requir$ to be submitt$ 9 ord] to directly or indirectly receive or reta9 funds provid$ 9 :ole or 9 "p by su* ,secret>y pursuant to su* grant1 contract1 or o!r agreem5t2 7#c7 kn[+ly makes1 uses1 or causes to be made or us$1 a false record or /atem5t mat]ial to a false or fraudul5t specifi$ claim "u su* grant1 contract1 or o!r agreem5t2 7#d7 kn[+ly makes1 uses1 or causes to be made or us$1 a false record or /atem5t mat]ial to an obligation 7z def9$ 9 subsection 7s77 to pay or transmit funds or prop]ty to su* ,secret>y ) respect to su* grant1 contract1 or o!r agreem5t1 or kn[+ly conceals or kn[+ly & improp]ly avoids or decreases an obligation to pay or transmit funds or prop]ty to su* ,secret>y ) respect to su* grant1 contract1 or o!r agreem5t2 or 7#e7 fails to grant timely access1 ^u reasonable reque/ 7z def9$ by su* ,secret>y 9 regulations71 to ! ,inspector ,g5]al ( ! ,dep>tm5t1 = ! purpose ( audits1 inve/igations1 evaluations1 or o!r /atutory functions ( su* ,inspector ,g5]al 9 matt]s involv+ su* grants1 contracts1 or o!r agreem5ts2 %all be subject1 9 addition to any o!r p5alties t may be prescrib$ by law1 to a civil money p5alty 9 cases "u p>agraph 7#a71 ( n m ?an #aj1jjj = ea* specifi$ claim2 9 cases "u p>agraph 7#b71 n m ?an #ej1jjj = ea* false /atem5t1 omission1 or misrepres5tation ( a mat]ial fact2 9 cases "u p>agraph 7#c71 n m ?an #ej1jjj = ea* false record or /atem5t2 9 cases "u p>agraph 7#d71 n m ?an #ej1jjj = ea* false record or /atem5t or #aj1jjj = ea* day t ! p]son kn[+ly conceals or kn[+ly & improp]ly avoids or decreases an obligation to pay2 or 9 cases "u p>agraph 7#e71 n m ?an #ae1jjj = ea* day ( ! failure describ$ 9 su* p>agraph4 ,9 addition1 9 cases "u p>agraphs 7#a7 & 7#c71 su* a p]son %all be subject to an assessm5t ( n m ?an #c times ! am\nt claim$ 9 ! specifi$ claim describ$ 9 su* p>agraph 9 lieu ( damages su/a9$ by ! ,unit$ ,/ates or a specifi$ ,/ate ag5cy because ( su* specifi$ claim1 & 9 cases "u p>agraphs 7#b7 & 7#d71 su* a p]son %all be subject to an assessm5t ( n m ?an #c times ! total am\nt ( ! funds describ$ 9 p>agraph 7#b7 or 7#d71 respectively 7or1 9 ! case ( an obligation to transmit prop]ty to ! ,secret>y describ$ 9 p>agraph 7#d71 ( ! value ( ! prop]ty describ$ 9 su* p>agraph7 9 lieu ( damages su/a9$ by ! ,unit$ ,/ates or a specifi$ ,/ate ag5cy because ( su* case4 ,9 addition1 ! ,secret>y may make a det]m9ation 9 ! same proce$+ to exclude ! p]son f p>ticipation 9 ! ,f$]al heal? c>e programs 7z def9$ 9 section #aabh;,b7f77#a77 & to direct ! appropriate ,/ate ag5cy to exclude ! p]son f p>ticipation 9 any ,/ate heal? c>e program4 7p7 ,! provisions ( subsections 7c71 7d71 7g71 & 7h7 %all apply to a civil money p5alty or assessm5t "u subsection 7o7 9 ! same mann] z su* provisions apply to a p5alty1 assessm5t1 or proce$+ "u subsection 7a74 ,9 apply+ subsection 7d71 ea* ref]5ce to a claim "u su* subsection %all be treat$ z includ+ a ref]5ce to a specifi$ claim 7z def9$ 9 subsection 7r774 7q7 ,= purposes ( ?is subsection & subsections 7o7 & 7p73 7#a7 ,! t]m ,dep>tm5t means ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#b7 ,! t]m mat]ial means hav+ a natural t5d5cy to influ5ce1 or be capable ( influ5c+1 ! paym5t or receipt ( money or prop]ty4 7#c7 ,! t]m o!r agreem5t includes a coop]ative agreem5t1 s*ol>%ip1 fell[%ip1 loan1 subsidy1 paym5t = a specifi$ use1 donation agreem5t1 aw>d1 or subaw>d 7reg>dless ( :e!r "o or m ( ! p]sons ent]+ into ! agreem5t is a contractor or subcontractor74 7#d7 ,! t]m program b5efici>y means1 9 ! case ( a grant1 contract1 or o!r agreem5t design$ to accompli% ! objective ( aw>d+ or o!rwise furni%+ b5efits or assi/ance to individuals & = :i* ! ,secret>y provides fund+1 an individual :o applies =1 or :o receives1 su* b5efits or assi/ance f su* grant1 contract1 or o!r agreem5t4 ,su* t]m does n include1 ) respect to su* grant1 contract1 or o!r agreem5t1 an (fic]1 employee1 or ag5t ( a p]son or entity t receives su* grant or t ent]s into su* contract or o!r agreem5t4 7#e7 ,! t]m recipi5t includes a subrecipi5t or subcontractor4 7#f7 ,! t]m specifi$ ,/ate ag5cy means an ag5cy ( a ,/ate gov]nm5t e/abli%$ or designat$ to adm9i/] or sup]vise ! adm9i/ration ( a grant1 contract1 or o!r agreem5t fund$ 9 :ole or 9 "p by ! ,secret>y4 7r7 ,= purposes ( ?is section1 ! t]m specifi$ claim means any application1 reque/1 or dem& "u a grant1 contract1 or o!r agreem5t = money or prop]ty1 :e!r or n ! ,unit$ ,/ates or a specifi$ ,/ate ag5cy has title to ! money or prop]ty1 t is n a claim 7z def9$ 9 subsection 7i77#b77 & t-- 7#a7 is pres5t$ or caus$ to be pres5t$ to an (fic]1 employee1 or ag5t ( ! ,dep>tm5t or ag5cy !re(1 or ( any specifi$ ,/ate ag5cy2 or 7#b7 is made to a contractor1 grantee1 or any o!r recipi5t if ! money or prop]ty is to be sp5t or us$ on ! ,dep>tm5t's behalf or to advance a ,dep>tm5t program or int]e/1 & if ! ,dep>tm5t-- 7,a7 provides or has provid$ any portion ( ! money or prop]ty reque/$ or dem&$2 or 7,b7 w reimburse su* contractor1 grantee1 or o!r recipi5t = any portion ( ! money or prop]ty :i* is reque/$ or dem&$4 7s7 ,= purposes ( subsection 7o71 ! t]m obligation means an e/abli%$ duty1 :e!r or n fix$1 aris+ f an express or impli$ contractual1 grantor-grantee1 or lic5sor-lic5see relation%ip1 = a fee-bas$ or simil> relation%ip1 f /atute or regulation1 or f ! ret5tion ( any ov]paym5t4 4 7b7 ,con=m+ am5dm5ts ,section #aabh;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 is am5d$-- 7#a7 9 subsection 7e71 by ins]t+ or specifi$ claim aft] claim 9 ! fir/ s5t5ce2 & 7#b7 9 subsection 7f7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a7-- 7i7 by ins]t+ or specifi$ claim 7z def9$ 9 subsection 7r77 aft] di/rict :]e ! claim2 & 7ii7 by ins]t+ 7or1 ) respect to a p]son describ$ 9 subsection 7o71 ! p]son7 aft] claimant2 & 7,b7 9 ! matt] foll[+ p>agraph 7#d71 by ins]t+ 7or1 9 ! case ( a p5alty or assessm5t "u subsection 7o71 by a specifi$ ,/ate ag5cy 7z def9$ 9 subsection 7q77#f771 aft] or a ,/ate ag5cy4 #ejjd4 ,r$uc+ ov]paym5ts ( infusion drugs 7a7 ,treatm5t ( infusion drugs furni%$ ?r\gh durable m$ical equipm5t ,section #ahdb7o77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7o77#a77 is am5d$-- 7#a7 9 subp>agraph 7,c71 by ins]t+ 7& includ+ a drug or biological describ$ 9 subp>agraph 7,d77i7 furni%$ on or aft] ,janu>y #a1 #bjag7 aft] #bjje2 & 7#b7 9 subp>agraph 7,d7-- 7,a7 by /rik+ infusion drugs & ins]t+ infusion drugs or biologicals ea* place x appe>s2 & 7,b7 9 clause 7i7-- 7i7 by /rik+ #bjjd & ins]t+ #bjjd1 & be=e ,janu>y #a1 #bjag2 & 7ii7 by /rik+ = su* drug4 7b7 ,non9clusion ( ,,dme infusion drugs "u ,,dme competitive acquisition programs 7#a7 ,9 g5]al ,section #ahdg7;a77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b77;,a77 is am5d$-- 7,a7 by /rik+ & exclud+ & ins]t+ 1 exclud+2 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & exclud+ drugs & biologicals describ$ 9 section #ahdb7o77#a77;,d74 7#b7 ,con=m+ am5dm5t ,section #ahdb7o77#a77;,d77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7o77#a77;,d77ii77 is am5d$ by /rik+ #bjjg & ins]t+ #bjjg1 & be=e ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act44 #ejje4 ,increas+ ov]sight ( t]m9ation ( ,m$icaid provid]s 7a7 ,increas$ ov]sight & report+ 7#a7 ,/ate report+ requirem5ts ,section #aijb7kk7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77 is am5d$-- 7,a7 by r$esignat+ p>agraph 7#h7 z p>agraph 7#i72 & 7,b7 by ins]t+ aft] p>agraph 7#g7 ! foll[+ new p>agraph3 7#h7 ,provid] t]m9ations 7,a7 ,9 g5]al ,beg9n+ on ,july #a1 #bjah1 9 ! case ( a notification "u subsection 7a77#da7 ) respect to a t]m9ation = a reason specifi$ 9 section #dee4aja ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on ,novemb] #a1 #bjae7 or = any o!r reason specifi$ by ! ,secret>y1 ( ! p>ticipation ( a provid] ( s]vices or any o!r p]son "u ! ,/ate plan 7or "u a waiv] ( ! plan71 ! ,/ate1 n lat] ?an #cj days aft] ! effective date ( su* t]m9ation1 submits to ! ,secret>y ) respect to any su* provid] or p]son1 z appropriate-- 7i7 ! "n ( su* provid] or p]son2 7ii7 ! provid] type ( su* provid] or p]son2 7iii7 ! specialty ( su* provid]'s or p]son's practice2 7iv7 ! date ( bir?1 ,social ,security numb]1 national provid] id5tifi] 7if applicable71 ,f$]al taxpay] id5tification numb]1 & ! ,/ate lic5se or c]tification numb] ( su* provid] or p]son 7if applicable72 7v7 ! reason = ! t]m9ation2 7vi7 a copy ( ! notice ( t]m9ation s5t to ! provid] or p]son2 7vii7 ! date on :i* su* t]m9ation is effective1 z specifi$ 9 ! notice2 & 7viii7 any o!r in=mation requir$ by ! ,secret>y4 7,b7 ,effective date def9$ ,= purposes ( ?is p>agraph1 ! t]m effective date means1 ) respect to a t]m9ation describ$ 9 subp>agraph 7,a71 ! lat] (-- 7i7 ! date on :i* su* t]m9ation is effective1 z specifi$ 9 ! notice ( su* t]m9ation2 or 7ii7 ! date on :i* all appeal rights applicable to su* t]m9ation h be5 exhau/$ or ! timel9e = any su* appeal has expir$4 4 7#b7 ,contract requirem5t = manag$ c>e entities ,section #aicb7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;d77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,contract requirem5t = manag$ c>e entities ,) respect to any contract ) a manag$ c>e entity "u section #aijc7m7 or #aije7t77#c7 7z applicable71 no lat] ?an ,july #a1 #bjah1 su* contract %all include a provision t provid]s ( s]vices or p]sons t]m9at$ 7z describ$ 9 section #aijb7kk77#h77 f p>ticipation "u ?is title1 title ,,xviii1 or title ,,xxi %all be t]m9at$ f p>ticipat+ "u ?is title z a provid] 9 any network ( su* entity t s]ves individuals eligible to receive m$ical assi/ance "u ?is title4 4 7#c7 ,t]m9ation ,notification ,database ,section #aijb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7ll7 ,t]m9ation notification database ,9 ! case ( a provid] ( s]vices or any o!r p]son ^: p>ticipation "u ?is title or title ,,xxi is t]m9at$ 7z describ$ 9 subsection 7kk77#h771 ! ,secret>y %all1 n lat] ?an #cj days aft] ! date on :i* ! ,secret>y is notifi$ ( su* t]m9ation "u subsection 7a77#da7 7z applicable71 review su* t]m9ation &1 if ! ,secret>y det]m9es appropriate1 include su* t]m9ation 9 any database or simil> sy/em develop$ pursuant to section #fdja7;b77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #acie;cc note2 ,public ,law #aaa-adh74 4 7#d7 ,no ,f$]al funds = items & s]vices furni%$ by t]m9at$ provid]s ,section #aijc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7 is am5d$-- 7,a7 9 subsection 7i77#b7-- 7i7 9 subp>agraph 7,a71 by /rik+ ! comma at ! end & ins]t+ a semicolon2 7ii7 9 subp>agraph 7,b71 by /rik+ or at ! end2 & 7iii7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 beg9n+ on ,july #a1 #bjah1 "u ! plan by any provid] ( s]vices or p]son ^: p>ticipation 9 ! ,/ate plan is t]m9at$ 7z describ$ 9 section #aijb7kk77#h77 aft] ! date t is #fj days aft] ! date on :i* su* t]m9ation is includ$ 9 ! database or o!r sy/em "u section #aijb7ll72 or 2 & 7,b7 9 subsection 7m71 by ins]t+ aft] p>agraph 7#b7 ! foll[+ new p>agraph3 7#c7 ,no paym5t %all be made "u ?is title to a ,/ate ) respect to exp5ditures incurr$ by ! ,/ate = paym5t = s]vices provid$ by a manag$ c>e entity 7z def9$ "u section #aicb7;a77#a77 "u ! ,/ate plan "u ?is title 7or "u a waiv] ( ! plan7 unless ! ,/ate-- 7,a7 beg9n+ on ,july #a1 #bjah1 has a contract ) su* entity t complies ) ! requirem5t specifi$ 9 section #aicb7;d77#e72 & 7,b7 beg9n+ on ,janu>y #a1 #bjah1 complies ) ! requirem5t specifi$ 9 section #aicb7;d77#f77;,a74 4 7#e7 ,developm5t ( uni=m t]m9ology = reasons = provid] t]m9ation ,n lat] ?an ,july #a1 #bjag1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) ! heads ( ,/ate ag5cies adm9i/]+ ,/ate ,m$icaid plans 7or waiv]s ( su* plans71 issue regulations e/abli%+ uni=m t]m9ology to be us$ ) respect to specify+ reasons "u subp>agraph 7,a77v7 ( p>agraph 7#h7 ( section #aijb7kk7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk771 z add$ by p>agraph 7#a71 = ! t]m9ation 7z describ$ 9 su* p>agraph 7#h77 ( ! p>ticipation ( c]ta9 provid]s 9 ! ,m$icaid program "u title ,,xix ( su* ,act or ! ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi ( su* ,act4 7#f7 ,con=m+ am5dm5t ,section #aijb7;a77#da7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#da77 is am5d$ by /rik+ provide t :5ev] & ins]t+ provide1 9 accordance ) subsection 7kk77#h7 7z applicable71 t :5ev]4 7b7 ,increas+ availability ( ,m$icaid provid] in=mation 7#a7 ,,ffs provid] enrollm5t ,section #aijb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is am5d$ by ins]t+ aft] p>agraph 7#gg7 ! foll[+ new p>agraph3 7#gh7 provide t1 n lat] ?an ,janu>y #a1 #bjag1 9 ! case ( a ,/ate t pursuant to its ,/ate plan or waiv] ( ! plan = m$ical assi/ance pays = m$ical assi/ance on a fee-=-s]vice basis1 ! ,/ate %all require ea* provid] furni%+ items & s]vices to1 or ord]+1 prescrib+1 ref]r+1 or c]tify+ eligibility =1 s]vices = individuals eligible to receive m$ical assi/ance "u su* plan to enroll ) ! ,/ate ag5cy & provide to ! ,/ate ag5cy ! provid]'s id5tify+ in=mation1 includ+ ! "n1 specialty1 date ( bir?1 ,social ,security numb]1 national provid] id5tifi] 7if applicable71 ,f$]al taxpay] id5tification numb]1 & ! ,/ate lic5se or c]tification numb] ( ! provid] 7if applicable72 4 7#b7 ,manag$ c>e provid] enrollm5t ,section #aicb7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;d771 z am5d$ by subsection 7a77#b71 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,enrollm5t ( p>ticipat+ provid]s 7,a7 ,9 g5]al ,beg9n+ n lat] ?an ,janu>y #a1 #bjah1 a ,/ate %all require t1 9 ord] to p>ticipate z a provid] 9 ! network ( a manag$ c>e entity t provides s]vices to1 or ord]s1 prescribes1 ref]s1 or c]tifies eligibility = s]vices =1 individuals :o are eligible = m$ical assi/ance "u ! ,/ate plan "u ?is title 7or "u a waiv] ( ! plan7 & :o are enroll$ ) ! entity1 ! provid] is enroll$ consi/5t ) section #aijb7kk7 ) ! ,/ate ag5cy adm9i/]+ ! ,/ate plan "u ?is title4 ,su* enrollm5t %all include provid+ to ! ,/ate ag5cy ! provid]'s id5tify+ in=mation1 includ+ ! "n1 specialty1 date ( bir?1 ,social ,security numb]1 national provid] id5tifi]1 ,f$]al taxpay] id5tification numb]1 & ! ,/ate lic5se or c]tification numb] ( ! provid]4 7,b7 ,rule ( con/ruction ,no?+ 9 subp>agraph 7,a7 %all be con/ru$ z requir+ a provid] describ$ 9 su* subp>agraph to provide s]vices to individuals :o are n enroll$ ) a manag$ c>e entity "u ?is title4 4 7c7 ,coord9ation ) ,,*ip 7#a7 ,9 g5]al ,section #bajg7;e77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;gg7e77#a77 is am5d$-- 7,a7 by r$esignat+ subp>agraphs 7,b71 7,c71 7,d71 7,e71 7,f71 7,g71 7,h71 7,i71 7,j71 7,k71 7,l71 7,m71 7,n71 & 7,o7 z subp>agraphs 7,d71 7,e71 7,f71 7,g71 7,h71 7,i71 7,j71 7,k71 7,m71 7,n71 7,o71 7,p71 7,q71 & 7,r71 respectively2 7,b7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+ new subp>agraphs3 7,b7 ,section #aijb7;a77#ci7 7relat+ to t]m9ation ( p>ticipation ( c]ta9 provid]s74 7,c7 ,section #aijb7;a77#gh7 7relat+ to enrollm5t ( provid]s p>ticipat+ 9 ,/ate plans provid+ m$ical assi/ance on a fee-=-s]vice basis74 2 7,c7 by ins]t+ aft] subp>agraph 7,k7 7z r$esignat$ by subp>agraph 7,a77 ! foll[+ new subp>agraph3 7,l7 ,section #aijc7m77#c7 7relat+ to limitation on paym5t ) respect to manag$ c>e74 2 & 7,d7 9 subp>agraph 7,p7 7z r$esignat$ by subp>agraph 7,a771 by /rik+ 7a77#b77;,c7 & 7h7 & ins]t+ 7a77#b77;,c7 7relat+ to ,indian enrollm5t71 7d77#e7 7relat+ to contract requirem5t = manag$ c>e entities71 7d77#f7 7relat+ to enrollm5t ( provid]s p>ticipat+ ) a manag$ c>e entity71 & 7h7 7relat+ to special rules ) respect to ,indian enrollees1 ,indian heal? c>e provid]s1 & ,indian manag$ c>e entities74 7#b7 ,exclud+ f ,m$icaid provid]s exclud$ f ,,*ip ,section #aijb7;a77#ci7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#ci77 is am5d$ by /rik+ title ,,xviii or any o!r ,/ate plan "u ?is title & ins]t+ title ,,xviii1 any o!r ,/ate plan "u ?is title 7or waiv] ( ! plan71 or any ,/ate *ild heal? plan "u title ,,xxi 7or waiv] ( ! plan7 & su* t]m9ation is includ$ by ! ,secret>y 9 any database or simil> sy/em develop$ pursuant to section #fdja7;b77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ z *ang+ or limit+ ! appeal rights ( provid]s or ! process = appeals ( ,/ates "u ! ,social ,security ,act4 7e7 ,,oig report ,n lat] ?an ,m>* #ca1 #bjbj1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all submit to ,congress a report on ! implem5tation ( ! am5dm5ts made by ?is section4 ,su* report %all include ! foll[+3 7#a7 ,an assessm5t ( ! ext5t to :i* provid]s :o are includ$ "u subsection 7ll7 ( section #aijb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 7z add$ by subsection 7a77#c77 9 ! database or simil> sy/em ref]r$ to 9 su* subsection are t]m9at$ 7z describ$ 9 p>agraph 7#h7 ( subsection 7kk7 ( su* section1 z add$ by subsection 7a77#a77 f p>ticipation 9 all ,/ate plans "u title ,,xix ( su* ,act 7or waiv]s ( su* plans74 7#b7 ,in=mation on ! am\nt ( ,f$]al f9ancial p>ticipation paid to ,/ates "u section #aijc ( su* ,act 9 violation ( ! limitation on su* paym5t specifi$ 9 subp>agraph 7,d7 ( subsection 7i77#b7 ( su* section & p>agraph 7#c7 ( subsection 7m7 ( su* section1 z add$ by subsection 7a77#d74 7#c7 ,an assessm5t ( ! ext5t to :i* contracts ) manag$ c>e entities "u title ,,xix ( su* ,act comply ) ! requirem5t specifi$ 9 p>agraph 7#e7 ( section #aicb7;d7 ( su* ,act1 z add$ by subsection 7a77#b74 7#d7 ,an assessm5t ( ! ext5t to :i* provid]s h be5 enroll$ "u section #aijb7;a77#gh7 or #aicb7;d77#f77;,a7 ( su* ,act 7#db ,u4,s4,c4 #acif;a7a77#gh71 #acifu-#b7;d77#f77;,a77 ) ,/ate ag5cies adm9i/]+ ,/ate plans "u title ,,xix ( su* ,act 7or waiv]s ( su* plans74 #ejjf4 ,requir+ publication ( fee-=-s]vice provid] directory 7a7 ,9 g5]al ,section #aijb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is am5d$-- 7#a7 9 p>agraph 7#ha71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#hb71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] p>agraph 7#hb7 ! foll[+ new p>agraph3 7#hc7 provide t1 n lat] ?an ,janu>y #a1 #bjag1 9 ! case ( a ,/ate plan 7or waiv] ( ! plan7 t provides m$ical assi/ance on a fee-=-s]vice basis or ?r\gh a prim>y c>e case-managem5t sy/em describ$ 9 section #aiae7;b77#a7 7o!r ?an a prim>y c>e case managem5t entity 7z def9$ by ! ,secret>y771 ! ,/ate %all publi% 7& update on at lea/ an annual basis7 on ! public website ( ! ,/ate ag5cy adm9i/]+ ! ,/ate plan1 a directory ( ! physicians describ$ 9 subsection 7mm7 &1 at ,/ate option1 o!r provid]s describ$ 9 su* subsection t-- 7,a7 includes-- 7i7 ) respect to ea* su* physician or provid]-- 7,i7 ! "n ( ! physician or provid]2 7,,ii7 ! specialty ( ! physician or provid]2 7,,iii7 ! address at :i* ! physician or provid] provides s]vices2 & 7,,iv7 ! telephone numb] ( ! physician or provid]2 & 7ii7 ) respect to any su* physician or provid] p>ticipat+ 9 su* a prim>y c>e case-managem5t sy/em1 in=mation reg>d+-- 7,i7 :e!r ! physician or provid] is accept+ z new pati5ts individuals :o receive m$ical assi/ance "u ?is title2 & 7,,ii7 ! physician's or provid]'s cultural & l+ui/ic capabilities1 includ+ ! languages spok5 by ! physician or provid] or by ! skill$ m$ical int]pret] provid+ int]pretation s]vices at ! physician's or provid]'s (fice2 & 7,b7 may include1 at ,/ate option1 ) respect to ea* su* physician or provid]-- 7i7 ! ,int]net website ( su* physician or provid]2 or 7ii7 :e!r ! physician or provid] is accept+ z new pati5ts individuals :o receive m$ical assi/ance "u ?is title4 4 7b7 ,directory physician or provid] describ$ ,section #aijb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a71 z am5d$ by section #ejje7;a77#c71 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7mm7 ,directory physician or provid] describ$ ,a physician or provid] describ$ 9 ?is subsection is-- 7#a7 9 ! case ( a physician or provid] ( a provid] type = :i* ! ,/ate ag5cy1 z a condition on receiv+ paym5t = items & s]vices furni%$ by ! physician or provid] to individuals eligible to receive m$ical assi/ance "u ! ,/ate plan1 requires ! enrollm5t ( ! physician or provid] ) ! ,/ate ag5cy1 a physician or a provid] t-- 7,a7 is enroll$ ) ! ag5cy z ( ! date on :i* ! directory is publi%$ or updat$ 7z applicable7 "u subsection 7a77#hc72 & 7,b7 receiv$ paym5t "u ! ,/ate plan 9 ! #ab-mon? p]iod prec$+ su* date2 & 7#b7 9 ! case ( a physician or provid] ( a provid] type = :i* ! ,/ate ag5cy does n require su* enrollm5t1 a physician or provid] t receiv$ paym5t "u ! ,/ate plan 7or a waiv] ( ! plan7 9 ! #ab-mon? p]iod prec$+ ! date on :i* ! directory is publi%$ or updat$ 7z applicable7 "u subsection 7a77#hc74 4 7c7 ,rule ( con/ruction 7#a7 ,9 g5]al ,! am5dm5t made by subsection 7a7 %all n be con/ru$ to apply 9 ! case ( a ,/ate 7z def9$ = purposes ( title ,,xix ( ! ,social ,security ,act7 9 :i* all ! individuals enroll$ 9 ! ,/ate plan "u su* title 7or "u a waiv] ( su* plan71 o!r ?an individuals describ$ 9 p>agraph 7#b71 are enroll$ ) a m$icaid manag$ c>e organization 7z def9$ 9 section #aijc7m77#a77;,a7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77#a77;,a7771 includ+ prepaid inpati5t heal? plans & prepaid ambulatory heal? plans 7z def9$ by ! ,secret>y ( ,heal? & ,human ,s]vices74 7#b7 ,individuals describ$ ,an individual describ$ 9 ?is p>agraph is an individual :o is an ,indian 7z def9$ 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act 7#be ,u4,s4,c4 #afjc77 or an ,alaska ,native4 7d7 ,exception = ,/ate legislation ,9 ! case ( a ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 :i* ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es requires ,/ate legislation 9 ord] = ! respective plan to meet "o or m additional requirem5ts impos$ by am5dm5ts made by ?is section1 ! respective plan %all n be reg>d$ z fail+ to comply ) ! requirem5ts ( su* title solely on ! basis ( its failure to meet su* an additional requirem5t be=e ! fir/ day ( ! fir/ cal5d> qu>t] beg9n+ aft] ! close ( ! fir/ regul> session ( ! ,/ate legislature t beg9s aft] ! date ( enactm5t ( ?is ,act4 ,= purposes ( ! previ\s s5t5ce1 9 ! case ( a ,/ate t has a #b-ye> legislative session1 ea* ye> ( ! session %all be consid]$ to be a sep>ate regul> session ( ! ,/ate legislature4 #ejjg4 ,fairness 9 ,m$icaid supplem5tal ne$s tru/s 7a7 ,9 g5]al ,section #aiag7;d77#d77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifp7d77#d77;,a77 is am5d$ by ins]t+ ! individual1 aft] = ! b5efit ( su* individual by4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply to tru/s e/abli%$ on or aft] ! date ( ! enactm5t ( ?is ,act4 #ejjh4 ,elim9at+ ,f$]al f9ancial p>ticipation ) respect to exp5ditures "u ,m$icaid = ag5ts us$ = cosmetic purposes or hair gr[? 7a7 ,9 g5]al ,section #aijc7;i77#ba7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#ba77 is am5d$ by ins]t+ section #aibg7;d77#b77;,c7 7relat+ to drugs :5 us$ = cosmetic purposes or hair gr[?71 except :]e m$ically necess>y1 & aft] drugs describ$ 94 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply ) respect to cal5d> qu>t]s beg9n+ on or aft] ! date ( ! enactm5t ( ?is ,act4 #ejji4 ,am5dm5t to ! ,prev5tion & ,public ,heal? ,fund ,section #djjb7;b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #cjju-#aa7;b77 is am5d$-- 7#a7 9 p>agraph 7#c71 by /rik+ #a1bej1jjj1jjj & ins]t+ #ijj1jjj1jjj2 7#b7 9 p>agraph 7#d71 by /rik+ #a1ejj1jjj1jjj & ins]t+ #a1jjj1jjj1jjj2 & 7#c7 by /rik+ p>agraph 7#e7 & ins]t+ ! foll[+3 7#e7 = fiscal ye> #bjbb1 #a1ejj1jjj1jjj2 7#f7 = fiscal ye> #bjbc1 #a1jjj1jjj1jjj2 7#g7 = fiscal ye> #bjbd1 #a1gjj1jjj1jjj2 & 7#h7 = fiscal ye> #bjbe & ea* fiscal ye> !reaft]1 #b1jjj1jjj1jjj4 4 #ejaj4 ,/rategic ,petroleum ,res]ve drawd[n 7a7 ,drawd[n & ,sale 7#a7 ,9 g5]al ,not)/&+ section #afa ( ! ,en]gy ,policy & ,cons]vation ,act 7#db ,u4,s4,c4 #fbda71 except z provid$ 9 subsections 7b7 & 7c71 ! ,secret>y ( ,en]gy %all drawd[n & sell f ! ,/rategic ,petroleum ,res]ve-- 7,a7 #aj1jjj1jjj b>rels ( crude oil dur+ fiscal ye> #bjag2 7,b7 #i1jjj1jjj b>rels ( crude oil dur+ fiscal ye> #bjah2 & 7,c7 #f1jjj1jjj b>rels ( crude oil dur+ fiscal ye> #bjai4 7#b7 ,deposit ( am\nts receiv$ f sale ,am\nts receiv$ f a sale "u p>agraph 7#a7 %all be deposit$ 9 ! g5]al fund ( ! ,treasury dur+ ! fiscal ye> 9 :i* ! sale occurs4 7b7 ,em]g5cy ,protection ,! ,secret>y %all n draw d[n & sell crude oil "u ?is section 9 quantities t w\ld limit ! au?ority to sell petroleum products "u section #afa7;h7 ( ! ,en]gy ,policy & ,cons]vation ,act 7#db ,u4,s4,c4 #fbda7;h77 9 ! full quantity au?oriz$ by t subsection4 7c7 ,/rategic ,petroleum drawd[n limitations ,subp>agraphs 7,c7 & 7,d7 ( section #afa7;h77#b7 ( ! ,en]gy ,policy & ,cons]vation ,act 7#db ,u4,s4,c4 #fbda7;h77#b77;,c7 & 7,d77 are bo? am5d$ by /rik+ #ejj1jjj1jjj & ins]t+ #dej1jjj1jjj4 #ejaa4 ,rescission ( portion ( ,,aca t]ritory fund+ ,( ! unobligat$ am\nts available "u section #acbc7;c77#a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjdc7;c77#a771 #dfd1jjj1jjj is resc9d$ imm$iately ^u ! date ( ! enactm5t ( ?is ,act4 #ejab4 ,m$ic>e cov]age ( home infusion !rapy 7a7 ,9 g5]al ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$-- 7#a7 9 subsection 7s77#b7-- 7,a7 by /rik+ & at ! end ( subp>agraph 7,,ee72 7,b7 by ins]t+ & at ! end ( subp>agraph 7,,ff72 & 7,c7 by ins]t+ at ! end ! foll[+ new subp>agraph3 7,,gg7 home infusion !rapy 7z def9$ 9 subsection 7iii77#a772 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7iii7 ,home ,infusion ,!rapy 7#a7 ,! t]m home infusion !rapy means ! items & s]vices describ$ 9 p>agraph 7#b7 furni%$ by a qualifi$ home infusion !rapy suppli] 7z def9$ 9 p>agraph 7#c77;,d77 :i* are furni%$ 9 ! individual's home 7z def9$ 9 p>agraph 7#c77;,b77 to an individual-- 7,a7 :o is "u ! c>e ( an applicable provid] 7z def9$ 9 p>agraph 7#c77;,a772 & 7,b7 ) respect to :om a plan prescrib+ ! type1 am\nt1 & duration ( infusion !rapy s]vices t are to be furni%$ su* individual has be5 e/abli%$ by a physician 7z def9$ 9 subsection 7r77#a77 & is p]iodically review$ by a physician 7z s def9$7 9 coord9ation ) ! furni%+ ( home infusion drugs 7z def9$ 9 p>agraph 7#c77;,c77 "u "p ,b4 7#b7 ,! items & s]vices describ$ 9 ?is p>agraph are ! foll[+3 7,a7 ,pr(essional s]vices1 includ+ nurs+ s]vices1 furni%$ 9 accordance ) ! plan4 7,b7 ,tra9+ & education 7n o!rwise paid = z durable m$ical equipm5t 7z def9$ 9 subsection 7n771 remote monitor+1 & monitor+ s]vices = ! provision ( home infusion !rapy & home infusion drugs furni%$ by a qualifi$ home infusion !rapy suppli]4 7#c7 ,= purposes ( ?is subsection3 7,a7 ,! t]m applicable provid] means-- 7i7 a physician2 7ii7 a nurse practition]2 & 7iii7 a physician assi/ant4 7,b7 ,! t]m home means a place ( resid5ce us$ z ! home ( an individual 7z def9$ = purposes ( subsection 7n774 7,c7 ,! t]m home infusion drug means a p>5t]al drug or biological adm9i/]$ intrav5\sly1 or subcutane\sly = an adm9i/ration p]iod ( #ae m9utes or m1 9 ! home ( an individual ?r\gh a pump t is an item ( durable m$ical equipm5t 7z def9$ 9 subsection 7n774 ,su* t]m does n include ! foll[+3 7i7 ,insul9 pump sy/ems4 7ii7 ,a self-adm9i/]$ drug or biological on a self-adm9i/]$ drug exclusion li/4 7,d7 7i7 ,! t]m qualifi$ home infusion !rapy suppli] means a ph>macy1 physician1 or o!r provid] ( s]vices or suppli] lic5s$ by ! ,/ate 9 :i* ! ph>macy1 physician1 or provid] or s]vices or suppli] furni%es items or s]vices & t-- 7,i7 furni%es infusion !rapy to individuals ) acute or *ronic conditions requir+ adm9i/ration ( home infusion drugs2 7,,ii7 ensures ! safe & effective provision & adm9i/ration ( home infusion !rapy on a #g-;day-a-week1 #bd-;h\r-a-day basis2 7,,iii7 is accr$it$ by an organization designat$ by ! ,secret>y pursuant to section #ahcd7u77#e72 & 7,,iv7 meets su* o!r requirem5ts z ! ,secret>y det]m9es appropriate1 tak+ into acc\nt ! /&>ds ( c>e = home infusion !rapy e/abli%$ by ,m$ic>e ,advantage plans "u "p ,c & 9 ! private sector4 7ii7 ,a qualifi$ home infusion !rapy suppli] may subcontract ) a ph>macy1 physician1 provid] ( s]vices1 or suppli] to meet ! requirem5ts ( ?is subp>agraph4 4 7b7 ,paym5t & relat$ requirem5ts = home infusion !rapy ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem71 z am5d$ by section #djaa1 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7u7 ,paym5t & relat$ requirem5ts = home infusion !rapy 7#a7 ,paym5t 7,a7 ,s+le paym5t 7i7 ,9 g5]al ,subject to clause 7iii7 & subp>agraphs 7,b7 & 7,c71 ! ,secret>y %all implem5t a paym5t sy/em "u :i* a s+le paym5t is made "u ?is title to a qualifi$ home infusion !rapy suppli] = items & s]vices describ$ 9 subp>agraphs 7,a7 & 7,b7 ( section #ahfa7;iii77#b77 furni%$ by a qualifi$ home infusion !rapy suppli] 7z def9$ 9 section #ahfa7;iii77#c77;,d77 9 coord9ation ) ! furni%+ ( home infusion drugs 7z def9$ 9 section #ahfa7;iii77#c77;,c77 "u ?is "p4 7ii7 ,unit ( s+le paym5t ,a unit ( s+le paym5t "u ! paym5t sy/em implem5t$ "u ?is subp>agraph is = ea* infusion drug adm9i/ration cal5d> day 9 ! individual's home4 ,! ,secret>y %all1 z appropriate1 e/abli% s+le paym5t am\nts = types ( infusion !rapy1 includ+ to take into acc\nt v>iation 9 utilization ( nurs+ s]vices by !rapy type4 7iii7 ,limitation ,! s+le paym5t am\nt det]m9$ "u ?is subp>agraph aft] application ( subp>agraph 7,b7 & p>agraph 7#c7 %all n exce$ ! am\nt det]m9$ "u ! fee s*$ule "u section #ahdh = infusion !rapy s]vices furni%$ 9 a cal5d> day if furni%$ 9 a physician (fice sett+1 except su* s+le paym5t %all n reflect m ?an #e h\rs ( infusion = a p>ticul> !rapy 9 a cal5d> day4 7,b7 ,requir$ adju/m5ts ,! ,secret>y %all adju/ ! s+le paym5t am\nt det]m9$ "u subp>agraph 7,a7 = home infusion !rapy s]vices "u section #ahfa7;iii77#a7 to reflect o!r factors su* z-- 7i7 a geographic wage index & o!r co/s t may v>y by region2 & 7ii7 pati5t acuity & complexity ( drug adm9i/ration4 7,c7 ,discretion>y adju/m5ts 7i7 ,9 g5]al ,subject to clause 7ii71 ! ,secret>y may adju/ ! s+le paym5t am\nt det]m9$ "u subp>agraph 7,a7 7aft] application ( subp>agraph 7,b77 to reflect outli] situations & o!r factors z ! ,secret>y det]m9es appropriate4 7ii7 ,requirem5t ( budget neutrality ,any adju/m5t "u ?is subp>agraph %all be made 9 a budget neutral mann]4 7#b7 ,consid]ations ,9 develop+ ! paym5t sy/em "u ?is subsection1 ! ,secret>y may consid] ! co/s ( furni%+ infusion !rapy 9 ! home1 consult ) home infusion !rapy suppli]s1 consid] paym5t am\nts = simil> items & s]vices "u ?is "p & "p ,a1 & consid] paym5t am\nts e/abli%$ by ,m$ic>e ,advantage plans "u "p ,c & 9 ! private insurance m>ket = home infusion !rapy 7includ+ av]age p] treatm5t day paym5t am\nts by type ( home infusion !rapy74 7#c7 ,annual updates 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! ,secret>y %all update ! s+le paym5t am\nt "u ?is subsection f ye> to ye> beg9n+ 9 #bjbb by increas+ ! s+le paym5t am\nt f ! prior ye> by ! p]c5tage increase 9 ! ,consum] ,price ,index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! prec$+ ye>4 7,b7 ,adju/m5t ,= ea* ye>1 ! ,secret>y %all r$uce ! p]c5tage increase describ$ 9 subp>agraph 7,a7 by ! productivity adju/m5t describ$ 9 section #ahhf7;b77#c77;,b77xi77,,ii74 ,! application ( ! prec$+ s5t5ce may result 9 a p]c5tage be+ less ?an #j4j = a ye>1 & may result 9 paym5t be+ less ?an su* paym5t rates = ! prec$+ ye>4 7#d7 ,au?ority to apply prior au?orization ,! ,secret>y may1 z det]m9$ appropriate by ! ,secret>y1 apply prior au?orization = home infusion !rapy s]vices "u section #ahfa7;iii77#a74 7#e7 ,accr$itation ( qualifi$ home infusion !rapy suppli]s 7,a7 ,factors = designation ( accr$itation organizations ,! ,secret>y %all consid] ! foll[+ factors 9 designat+ accr$itation organizations "u subp>agraph 7,b7 & 9 review+ & modify+ ! li/ ( accr$itation organizations designat$ pursuant to subp>agraph 7,c73 7i7 ,! ability ( ! organization to conduct timely reviews ( accr$itation applications4 7ii7 ,! ability ( ! organization to take into acc\nt ! capacities ( suppli]s locat$ 9 a rural area 7z def9$ 9 section #ahhf7;d77#b77;,d774 7iii7 ,:e!r ! organization has e/abli%$ reasonable fees to be *>g$ to suppli]s apply+ = accr$itation4 7iv7 ,su* o!r factors z ! ,secret>y det]m9es appropriate4 7,b7 ,designation ,n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y %all designate organizations to accr$it suppli]s furni%+ home infusion !rapy4 ,! li/ ( accr$itation organizations s designat$ may be modifi$ pursuant to subp>agraph 7,c74 7,c7 ,review & modification ( li/ ( accr$itation organizations 7i7 ,9 g5]al ,! ,secret>y %all review ! li/ ( accr$itation organizations designat$ "u subp>agraph 7,b7 tak+ into acc\nt ! factors "u subp>agraph 7,a74 ,tak+ into acc\nt ! results ( su* review1 ! ,secret>y may1 by regulation1 modify ! li/ ( accr$itation organizations designat$ "u subp>agraph 7,b74 7ii7 ,special rule = accr$itations done prior to removal f li/ ( designat$ accr$itation organizations ,9 ! case :]e ! ,secret>y removes an organization f ! li/ ( accr$itation organizations designat$ "u subp>agraph 7,b71 any suppli] t is accr$it$ by ! organization dur+ ! p]iod beg9n+ on ! date on :i* ! organization is designat$ z an accr$itation organization "u subp>agraph 7,b7 & end+ on ! date on :i* ! organization is remov$ f su* li/ %all be consid]$ to h be5 accr$it$ by an organization designat$ by ! ,secret>y "u subp>agraph 7,b7 = ! rema9+ p]iod su* accr$itation is 9 effect4 7,d7 ,rule = accr$itations made prior to designation ,9 ! case ( a suppli] t is accr$it$ be=e ,janu>y #a1 #bjba1 by an accr$itation organization designat$ by ! ,secret>y "u subp>agraph 7,b7 z ( ,janu>y #a1 #bjai1 su* suppli] %all be consid]$ to h be5 accr$it$ by an organization designat$ by ! ,secret>y "u su* p>agraph z ( ,janu>y #a1 #bjbc1 = ! rema9+ p]iod su* accr$itation is 9 effect4 7#f7 ,notification ( infusion !rapy options available prior to furni%+ home infusion !rapy ,prior to ! furni%+ ( home infusion !rapy to an individual1 ! physician :o e/abli%es ! plan describ$ 9 section #ahfa7;iii77#a7 = ! individual %all provide notification 79 a =m1 mann]1 & frequ5cy det]m9$ appropriate by ! ,secret>y7 ( ! options available 7su* z home1 physician's (fice1 hospital outpati5t dep>tm5t7 = ! furni%+ ( infusion !rapy "u ?is "p4 4 7c7 ,con=m+ am5dm5ts 7#a7 ,paym5t ref]5ce ,section #ahcc7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is am5d$-- 7,a7 by /rik+ & be=e 7,,aa72 & 7,b7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,bb7 ) respect to home infusion !rapy1 ! am\nt paid %all be an am\nt equal to #hj p]c5t ( ! less] ( ! actual *>ge = ! s]vices or ! am\nt det]m9$ "u section #ahcd7u74 7#b7 ,direct paym5t ,! fir/ s5t5ce ( section #ahdb7;b77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#f77 is am5d$-- 7,a7 by /rik+ & be=e 7,h72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,i7 9 ! case ( home infusion !rapy1 paym5t %all be made to ! qualifi$ home infusion !rapy suppli]4 7#c7 ,exclusion f home heal? s]vices ,section #ahfa7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7m77 is am5d$1 9 ! fir/ s5t5ce1 by ins]t+ ! foll[+ be=e ! p]iod at ! end3 & home infusion !rapy 7z def9$ 9 subsection 7iii77i774 7d7 ,effective date ,! am5dm5ts made by ?is section %all apply to items & s]vices furni%$ on or aft] ,janu>y #a1 #bjba4 ,b ,help+ ,families 9 ,m5tal ,heal? ,crisis #fjjj4 ,%ort title ,?is division may be cit$ z ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf4 ,,vi ,/r5g!n+ ,lead]%ip & ,acc\ntability ,a ,lead]%ip #fjja4 ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use 7a7 ,assi/ant ,secret>y ,section #eja7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa7c77 is am5d$ to read z foll[s3 7c7 ,assi/ant secret>y & deputy assi/ant secret>y 7#a7 ,assi/ant ,secret>y ,! ,adm9i/ration %all be head$ by an (ficial to be kn[n z ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use 7h]e9aft] 9 ?is title ref]r$ to z ! ,assi/ant ,secret>y7 :o %all be appo9t$ by ! ,presid5t1 by & ) ! advice & cons5t ( ! ,s5ate4 7#b7 ,deputy assi/ant secret>y ,! ,assi/ant ,secret>y1 ) ! approval ( ! ,secret>y1 may appo9t a ,deputy ,assi/ant ,secret>y & may employ & prescribe ! functions ( su* (fic]s & employees1 includ+ attorneys1 z are necess>y to adm9i/] ! activities to be c>ri$ out ?r\gh ! ,adm9i/ration4 4 7b7 ,transf] ( au?orities ,! ,secret>y ( ,heal? & ,human ,s]vices %all delegate to ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use all duties & au?orities t-- 7#a7 z ( ! day be=e ! date ( enactm5t ( ?is ,act1 7 ve/$ 9 ! ,adm9i/rator ( ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration2 & 7#b7 are n t]m9at$ by ?is ,act4 7c7 ,con=m+ am5dm5ts ,title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa et seq471 z am5d$ by ! previ\s provisions ( ?is section1 is fur!r am5d$-- 7#a7 by /rik+ ,adm9i/rator ( ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration ea* place x appe>s & ins]t+ ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use2 & 7#b7 by /rik+ ,adm9i/rator or ,adm9i/rator ea* place x appe>s 7includ+ 9 any head+s7 & ins]t+ ,assi/ant ,secret>y or ,assi/ant ,secret>y1 respectively1 except :]e ! t]m ,adm9i/rator appe>s-- 7,a7 9 ea* ( subsections 7e7 & 7f7 ( section #eja ( su* ,act 7#db ,u4,s4,c4 #bij;aa71 includ+ ! head+s ( su* subsections1 )9 ! t]m ,associate ,adm9i/rator2 7,b7 9 section #ejg7;b77#f7 ( su* ,act 7#db ,u4,s4,c4 #bij;bb7b77#f771 )9 ! t]m ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration2 7,c7 9 section #ejg7;b77#f7 ( su* ,act 7#db ,u4,s4,c4 #bij;bb7b77#f771 )9 ! t]m ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7,d7 9 section #eai;,b7c77#a77;,b7 ( su* ,act 7#db ,u4,s4,c4 #bij;bb-#be;b7c77#a77;,b771 )9 ! t]m ,adm9i/rator ( ! ,national ,highway ,traffic ,safety ,adm9i/ration2 or 7,e7 9 ea* ( sections #eai;,b7c77#a77;,b71 #ebj;,c7a71 & #ebj;,d7a7 ( su* ,act 7#db ,u4,s4,c4 #bij;bb-#be;b7c77#a77;,b71 #bij;bb-#cd7;a71 #bij;bb-#ce7;a771 )9 ! t]m ,adm9i/rator ( ! ,(fice ( ,juv5ile ,ju/ice & ,del9qu5cy ,prev5tion4 7d7 ,ref]5ces ,aft] execut+ subsections 7a71 7b71 & 7c71 any ref]5ce 9 /atute1 regulation1 or guidance to ! ,adm9i/rator ( ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration %all be con/ru$ to be a ref]5ce to ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use4 #fjjb4 ,/r5g!n+ ! lead]%ip ( ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration ,section #eja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa71 z am5d$ by section #fjja1 is fur!r am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 ! subsection head+1 by /rik+ ,ag5cies & ins]t+ ,c5t]s2 & 7,b7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ entities & ins]t+ ,c5t]s2 7#b7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ ag5cies ea* place ! t]m appe>s & ins]t+ ,c5t]s2 & 7ii7 by /rik+ su* ag5cy & ins]t+ su* ,c5t]2 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ ag5cies & ins]t+ ,c5t]s2 7ii7 by /rik+ ) respect to sub/ance abuse & ins]t+ ) respect to sub/ance use disord]s2 & 7iii7 by /rik+ & individuals :o are sub/ance abus]s & ins]t+ & individuals ) sub/ance use disord]s2 7,c7 9 p>agraph 7#e71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]2 7,d7 9 p>agraph 7#f7-- 7i7 by /rik+ ! ,c5t]s = ,disease ,control & ins]t+ ! ,c5t]s = ,disease ,control & ,prev5tion12 7ii7 by /rik+ ,adm9i/ration develop & ins]t+ ,adm9i/ration1 develop2 7iii7 by /rik+ ,,hiv or tub]culosis among sub/ance abus]s & individuals ) m5tal illness & ins]t+ ,,hiv1 hepatitis1 tub]culosis1 & o!r communicable diseases among individuals ) m5tal or sub/ance use disord]s12 & 7iv7 by /rik+ illnesses at ! end & ins]t+ diseases or disord]s2 7,e7 9 p>agraph 7#g71 by /rik+ abuse utiliz+ anti-addiction m$ications1 includ+ me?adone & ins]t+ use disord]s1 includ+ s]vices t utilize drugs or devices approv$ or cle>$ by ! ,food & ,drug ,adm9i/ration = ! treatm5t ( sub/ance use disord]s2 7,f7 9 p>agraph 7#h7-- 7i7 by /rik+ ,ag5cy = ,heal? ,c>e ,policy ,rese>* & ins]t+ ,ag5cy = ,heal?c>e ,rese>* & ,quality2 & 7ii7 by /rik+ treatm5t & prev5tion & ins]t+ prev5tion & treatm5t2 7,g7 9 p>agraph 7#i7-- 7i7 by ins]t+ & ma9t5ance aft] developm5t2 7ii7 by /rik+ ,ag5cy = ,heal? ,c>e ,policy ,rese>* & ins]t+ ,ag5cy = ,heal?c>e ,rese>* & ,quality2 & 7iii7 by /rik+ treatm5t & prev5tion s]vices & ins]t+ prev5tion1 treatm5t1 & recov]y support s]vices & are appropriately incorporat$ into programs c>ri$ out by ! ,adm9i/ration2 7,h7 9 p>agraph 7#aj71 by /rik+ abuse & ins]t+ use disord]2 7,i7 by /rik+ p>agraph 7#aa7 & ins]t+ ! foll[+3 7#aa7 "w ) relevant ag5cies ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices on integrat+ m5tal heal? promotion & sub/ance use disord] prev5tion ) g5]al heal? promotion & disease prev5tion & integrat+ m5tal & sub/ance use disord]s treatm5t s]vices ) physical heal? treatm5t s]vices2 2 7,j7 9 p>agraph 7#ac7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ?is title1 assure t & ins]t+ ?is title or "p ,b ( title ,,xix1 or grant programs o!rwise fund$ by ! ,adm9i/ration2 7ii7 9 subp>agraph 7,a7-- 7,i7 by ins]t+ require t be=e all grants2 & 7,,ii7 by /rik+ & at ! end2 7iii7 by r$esignat+ subp>agraph 7,b7 z subp>agraph 7,c72 7iv7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+3 7,b7 ensure t ! director ( ea* ,c5t] ( ! ,adm9i/ration consi/5tly docum5ts ! application ( crit]ia :5 aw>d+ grants & ! ongo+ ov]sight ( grantees aft] su* grants are aw>d$2 2 7v7 9 subp>agraph 7,c71 z s r$esignat$-- 7,i7 by ins]t+ require t be=e all grants2 & 7,,ii7 9 clause 7ii71 by ins]t+ & aft] ! semicolon at ! end2 & 7vi7 by add+ at ! end ! foll[+3 7,d7 in=m a ,/ate :5 any funds are aw>d$ ?r\gh su* a grant to any entity )9 su* ,/ate2 2 7,k7 9 p>agraph 7#af71 by /rik+ abuse & m5tal heal? in=mation & ins]t+ use disord] in=mation1 includ+ evid5ce-bas$ & promis+ be/ practices = prev5tion1 treatm5t1 & recov]y support s]vices = individuals ) m5tal & sub/ance use disord]s12 7,l7 9 p>agraph 7#ag7-- 7i7 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]2 & 7ii7 by /rik+ & at ! end2 7,m7 9 p>agraph 7#ah71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7,n7 by add+ at ! end ! foll[+3 7#ai7 consult ) ,/ate1 local1 & tribal gov]nm5ts1 nongov]nm5tal entities1 & individuals ) m5tal illness1 p>ticul>ly adults ) a s]i\s m5tal illness1 *ildr5 ) a s]i\s emotional di/urbance1 & ! family memb]s ( su* adults & *ildr51 ) respect to improv+ community-bas$ & o!r m5tal heal? s]vices2 7#bj7 collaborate ) ! ,secret>y ( ,def5se & ! ,secret>y ( ,vet]ans ,affairs to improve ! provision ( m5tal & sub/ance use disord] s]vices provid$ by ! ,dep>tm5t ( ,def5se & ! ,dep>tm5t ( ,vet]ans ,affairs to memb]s ( ! ,arm$ ,=ces1 vet]ans1 & ! family memb]s ( su* memb]s & vet]ans1 includ+ ?r\gh ! provision ( s]vices us+ ! teleheal? capabilities ( ! ,dep>tm5t ( ,def5se & ! ,dep>tm5t ( ,vet]ans ,affairs2 7#ba7 collaborate ) ! heads ( relevant ,f$]al ag5cies & dep>tm5ts1 ,/ates1 communities1 & nongov]nm5tal exp]ts to improve m5tal & sub/ance use disord]s s]vices = *ronically homeless individuals1 includ+ by design+ /rategies to provide su* s]vices 9 supportive h\s+2 7#bb7 "w ) ,/ates & o!r /akehold]s to develop & support activities to recruit & reta9 a work=ce address+ m5tal & sub/ance use disord]s2 7#bc7 collaborate ) ! ,attorney ,g5]al & repres5tatives ( ! crim9al ju/ice sy/em to improve m5tal & sub/ance use disord]s s]vices = individuals :o h be5 arre/$ or inc>c]at$2 7#bd7 aft] provid+ an opportunity = public input1 set /&>ds = grant programs "u ?is title = m5tal & sub/ance use disord]s s]vices & prev5tion programs1 :i* /&>ds may address-- 7,a7 ! capacity ( ! grantee to implem5t ! aw>d2 7,b7 requirem5ts = ! description ( ! program implem5tation approa*2 7,c7 ! ext5t to :i* ! grant plan submitt$ by ! grantee z "p ( its application mu/ expla9 h[ ! grantee w rea* ! population ( focus & provide a /atem5t ( ne$1 :i* may include in=mation on h[ ! grantee w increase access to s]vices & a description ( measurable objectives = improv+ outcomes2 7,d7 ! ext5t to :i* ! grantee mu/ collect & report on requir$ p]=mance measures2 & 7,e7 ! ext5t to :i* ! grantee is propos+ to use evid5ce-bas$ practices2 & 7#be7 advance1 ?r\gh exi/+ programs1 ! use ( p]=mance metrics1 includ+ ^? bas$ on ! recomm5dations on p]=mance metrics f ! ,assi/ant ,secret>y = ,plann+ & ,evaluation "u section #fjba7;d7 ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf4 2 & 7#c7 9 subsection 7m71 by add+ at ! end ! foll[+3 7#d7 ,em]g5cy response ,am\nts made available = c>ry+ out ?is subsection %all rema9 available ?r\gh ! end ( ! fiscal ye> foll[+ ! fiscal ye> = :i* su* am\nts are appropriat$4 4 #fjjc4 ,*ief ,m$ical ,(fic] ,section #eja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa71 z am5d$ by sections #fjja & #fjjb1 is fur!r am5d$-- 7#a7 by r$esignat+ subsections 7g7 ?r\gh 7j7 & subsections 7k7 ?r\gh 7o7 z subsections 7h7 ?r\gh 7k7 & subsections 7m7 ?r\gh 7q71 respectively2 7#b7 9 subsection 7e77#c77;,c71 by /rik+ subsection 7k7 & ins]t+ subsection 7m72 7#c7 9 subsection 7f77#b77;,c77iii71 by /rik+ subsection 7k7 & ins]t+ subsection 7m72 & 7#d7 by ins]t+ aft] subsection 7f7 ! foll[+3 7g7 ,*ief m$ical (fic] 7#a7 ,9 g5]al ,! ,assi/ant ,secret>y1 ) ! approval ( ! ,secret>y1 %all appo9t a ,*ief ,m$ical ,(fic] to s]ve )9 ! ,adm9i/ration4 7#b7 ,eligible c&idates ,! ,assi/ant ,secret>y %all select ! ,*ief ,m$ical ,(fic] f among individuals :o-- 7,a7 h a doctoral degree 9 m$ic9e or o/eopa?ic m$ic9e2 7,b7 h exp]i5ce 9 ! provision ( m5tal or sub/ance use disord] s]vices2 7,c7 h exp]i5ce work+ ) m5tal or sub/ance use disord] programs2 7,d7 h an und]/&+ ( biological1 psy*osocial1 & ph>maceutical treatm5ts ( m5tal or sub/ance use disord]s2 & 7,e7 are lic5s$ to practice m$ic9e 9 "o or m ,/ates4 7#c7 ,duties ,! ,*ief ,m$ical ,(fic] %all-- 7,a7 s]ve z a liaison betwe5 ! ,adm9i/ration & provid]s ( m5tal & sub/ance use disord]s prev5tion1 treatm5t1 & recov]y s]vices2 7,b7 assi/ ! ,assi/ant ,secret>y 9 ! evaluation1 organization1 integration1 & coord9ation ( programs op]at$ by ! ,adm9i/ration2 7,c7 promote evid5ce-bas$ & promis+ be/ practices1 includ+ culturally & l+ui/ically appropriate practices1 z appropriate1 = ! prev5tion & treatm5t (1 & recov]y f1 m5tal & sub/ance use disord]s1 includ+ s]i\s m5tal illness & s]i\s emotional di/urbances2 7,d7 p>ticipate 9 regul> /rategic plann+ ) ! ,adm9i/ration2 7,e7 coord9ate ) ! ,assi/ant ,secret>y = ,plann+ & ,evaluation to assess ! use ( p]=mance metrics to evaluate activities )9 ! ,adm9i/ration relat$ to m5tal & sub/ance use disord]s2 & 7,f7 coord9ate ) ! ,assi/ant ,secret>y to ensure m5tal & sub/ance use disord]s grant programs )9 ! ,adm9i/ration consi/5tly utilize appropriate p]=mance metrics & evaluation designs4 4 #fjjd4 ,improv+ ! quality ( behavioral heal? programs ,section #eje ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa-#d71 z am5d$ by section #fjja7;c71 is am5d$-- 7#a7 by /rik+ ! section designation & head+ & ins]t+ ! foll[+3 #eje4 ,c5t] = ,behavioral ,heal? ,/ati/ics & ,quality 2 7#b7 by r$esignat+ subsections 7a7 ?r\gh 7d7 z subsections 7b7 ?r\gh 7e71 respectively2 7#c7 be=e subsection 7b71 z r$esignat$ by p>agraph 7#b71 by ins]t+ ! foll[+3 7a7 ,9 g5]al ,! ,assi/ant ,secret>y %all ma9ta9 )9 ! ,adm9i/ration a ,c5t] = ,behavioral ,heal? ,/ati/ics & ,quality 79 ?is section ref]r$ to z ! ,c5t]74 ,! ,c5t] %all be head$ by a ,director 79 ?is section ref]r$ to z ! ,director7 appo9t$ by ! ,secret>y f among individuals ) ext5sive exp]i5ce & academic qualifications 9 rese>* & analysis 9 behavioral heal? c>e or relat$ fields4 2 7#d7 9 subsection 7b71 z r$esignat$ by p>agraph 7#b7-- 7,a7 by r$esignat+ p>agraphs 7#a7 & 7#b7 z subp>agraphs 7,a7 & 7,b71 respectively2 7,b7 by /rik+ ,! ,secret>y1 act+ & all t foll[s ?r\gh ye> on-- & ins]t+ ,! ,director %all-- 7#a7 coord9ate ! ,adm9i/ration's integrat$ data /rategy1 includ+ by collect+ data ea* ye> on-- 2 7,c7 9 ! subp>agraph 7,b71 z r$esignat$ by subp>agraph 7,a71 by /rik+ ,assi/ant ,secret>y & ins]t+ ,director2 & 7,d7 by add+ at ! end ! foll[+ new p>agraphs3 7#b7 provide /ati/ical & analytical support = activities ( ! ,adm9i/ration2 7#c7 recomm5d a core set ( p]=mance metrics to evaluate activities support$ by ! ,adm9i/ration2 & 7#d7 coord9ate ) ! ,assi/ant ,secret>y1 ! ,assi/ant ,secret>y = ,plann+ & ,evaluation1 & ! ,*ief ,m$ical ,(fic] appo9t$ "u section #eja7;g71 z appropriate1 to improve ! quality ( s]vices provid$ by programs ( ! ,adm9i/ration & ! evaluation ( activities c>ri$ out by ! ,adm9i/ration4 4 7#e7 9 subsection 7c71 z s r$esignat$-- 7,a7 by /rik+ ,) respect to ! activities & ins]t+ ,m5tal heal?4--,) respect to ! activities2 7,b7 by /rik+ ,assi/ant ,secret>y ea* place x appe>s & ins]t+ ,director2 & 7,c7 by /rik+ subsection 7a7 & ins]t+ subsection 7b77#a72 7#f7 9 subsection 7d71 z s r$esignat$-- 7,a7 by /rik+ ! subsection designation & all t foll[s ?r\gh ,) respect to ! activities & ins]t+ ! foll[+3 7d7 ,sub/ance abuse 7#a7 ,9 g5]al ,) respect to ! activities 2 7,b7 9 p>agraph 7#a7-- 7i7 9 ! matt] be=e subp>agraph 7,a7-- 7,i7 by /rik+ subsection 7a7 & ins]t+ subsection 7b77#a72 & 7,,ii7 by /rik+ ,assi/ant ,secret>y ea* place x appe>s & ins]t+ ,director2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ 9 coord9ation ) ! ,c5t]s = ,disease ,control & ,prev5tion be=e ! semicolon at ! end2 & 7,c7 9 p>agraph 7#b71 by /rik+ ,annual surveys & ins]t+ ,annual surveys2 public availability ( data4--,annual surveys2 & 7#g7 9 subsection 7e71 z s r$esignat$-- 7,a7 by /rik+ ,aft] consultation & ins]t+ ,consultation4--,aft] consultation2 & 7,b7 by /rik+ ,assi/ant ,secret>y %all develop & ins]t+ ,assi/ant ,secret>y %all use exi/+ /&>ds & be/ practices to develop4 #fjje4 ,/rategic plan ,section #eja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa71 z am5d$ by sections #fjja ?r\gh #fjjc1 is fur!r am5d$ by ins]t+ aft] subsection 7k71 z r$esignat$ by section #fjjc1 ! foll[+3 7l7 ,/rategic plan 7#a7 ,9 g5]al ,n lat] ?an ,septemb] #cj1 #bjah1 & e #d ye>s !reaft]1 ! ,assi/ant ,secret>y %all develop & c>ry out a /rategic plan 9 accordance ) ?is subsection = ! plann+ & op]ation ( activities c>ri$ out by ! ,adm9i/ration1 includ+ evid5ce-bas$ programs4 7#b7 ,coord9ation ,9 develop+ & c>ry+ out ! /rategic plan "u ?is subsection1 ! ,assi/ant ,secret>y %all take into consid]ation ! f9d+s & recomm5dations ( ! ,assi/ant ,secret>y = ,plann+ & ,evaluation "u section #fjba7;d7 ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf & ! report ( ! ,int]dep>tm5tal ,s]i\s ,m5tal ,illness ,coord9at+ ,committee "u section #fjca ( su* ,act4 7#c7 ,publication ( plan ,n lat] ?an ,septemb] #cj1 #bjah1 & e #d ye>s !reaft]1 ! ,assi/ant ,secret>y %all-- 7,a7 submit ! /rategic plan develop$ "u p>agraph 7#a7 to ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate2 & 7,b7 po/ su* plan on ! ,int]net website ( ! ,adm9i/ration4 7#d7 ,cont5ts ,! /rategic plan develop$ "u p>agraph 7#a7 %all-- 7,a7 id5tify /rategic priorities1 goals1 & measurable objectives = m5tal & sub/ance use disord]s activities & programs op]at$ & support$ by ! ,adm9i/ration1 includ+ priorities to prev5t or elim9ate ! burd5 ( m5tal & sub/ance use disord]s2 7,b7 id5tify ways to improve ! quality ( s]vices = individuals ) m5tal & sub/ance use disord]s1 & to r$uce homelessness1 arre/1 inc>c]ation1 viol5ce1 includ+ self-direct$ viol5ce1 & unnecess>y hospitalization ( individuals ) a m5tal or sub/ance use disord]1 includ+ adults ) a s]i\s m5tal illness or *ildr5 ) a s]i\s emotional di/urbance2 7,c7 ensure t programs provide1 z appropriate1 access to effective & evid5ce-bas$ prev5tion1 diagnosis1 int]v5tion1 treatm5t1 & recov]y s]vices1 includ+ culturally & l+ui/ically appropriate s]vices1 z appropriate1 = individuals ) a m5tal or sub/ance use disord]2 7,d7 id5tify opportunities to collaborate ) ! ,heal? ,res\rces & ,s]vices ,adm9i/ration to develop or improve-- 7i7 initiatives to enc\rage individuals to pursue c>e]s 7especially 9 rural & und]s]v$ areas & ) rural & und]s]v$ populations7 z psy*iatri/s1 includ+ *ild & adolesc5t psy*iatri/s1 psy*ologi/s1 psy*iatric nurse practition]s1 physician assi/ants1 cl9ical social work]s1 c]tifi$ pe] support speciali/s1 lic5s$ pr(essional c\nselors1 or o!r lic5s$ or c]tifi$ m5tal heal? or sub/ance use disord] pr(essionals1 includ+ su* pr(essionals specializ+ 9 ! diagnosis1 evaluation1 or treatm5t ( adults ) a s]i\s m5tal illness or *ildr5 ) a s]i\s emotional di/urbance2 & 7ii7 a /rategy to improve ! recruitm5t1 tra9+1 & ret5tion ( a work=ce = ! treatm5t ( individuals ) m5tal or sub/ance use disord]s1 or co-occurr+ disord]s2 7,e7 id5tify opportunities to improve collaboration ) ,/ates1 local gov]nm5ts1 communities1 & ,indian tribes & tribal organizations 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act72 & 7,f7 specify a /rategy to dissem9ate evid5ce-bas$ & promis+ be/ practices relat$ to prev5tion1 diagnosis1 e>ly int]v5tion1 treatm5t1 & recov]y s]vices relat$ to m5tal illness1 p>ticul>ly = adults ) a s]i\s m5tal illness & *ildr5 ) a s]i\s emotional di/urbance1 & = individuals ) a sub/ance use disord]4 4 #fjjf4 ,bi5nial report conc]n+ activities & progress 7a7 ,9 g5]al ,section #eja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa71 z s am5d$1 is fur!r am5d$ by am5d+ subsection 7m71 z r$esignat$ by section #fjjc1 to read z foll[s3 7m7 ,bi5nial report conc]n+ activities & progress ,n lat] ?an ,septemb] #cj1 #bjbj1 & e #b ye>s !reaft]1 ! ,assi/ant ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate1 & po/ on ! ,int]net website ( ! ,adm9i/ration1 a report conta9+ at a m9imum-- 7#a7 a review ( activities conduct$ or support$ by ! ,adm9i/ration1 includ+ progress t[>d /rategic priorities1 goals1 & objectives id5tifi$ 9 ! /rategic plan develop$ "u subsection 7l72 7#b7 an assessm5t ( programs & activities c>ri$ out by ! ,assi/ant ,secret>y1 includ+ ! ext5t to :i* programs & activities "u ?is title & "p ,b ( title ,,xix meet id5tifi$ goals & p]=mance measures develop$ = ! respective programs & activities2 7#c7 a description ( ! progress made 9 address+ gaps 9 m5tal & sub/ance use disord]s prev5tion1 treatm5t1 & recov]y s]vices & improv+ outcomes by ! ,adm9i/ration1 includ+ ) respect to s]i\s m5tal illnesses1 s]i\s emotional di/urbances1 & co-occurr+ disord]s2 7#d7 a description ( ! mann] 9 :i* ! ,adm9i/ration coord9ates & p>tn]s ) o!r ,f$]al ag5cies & dep>tm5ts relat$ to m5tal & sub/ance use disord]s1 includ+ activities relat$ to-- 7,a7 ! implem5tation & dissem9ation ( rese>* f9d+s into improv$ programs1 includ+ ) respect to h[ advances 9 s]i\s m5tal illness & s]i\s emotional di/urbance rese>* h be5 incorporat$ into programs2 7,b7 ! recruitm5t1 tra9+1 & ret5tion ( a m5tal & sub/ance use disord]s work=ce2 7,c7 ! integration ( m5tal disord] s]vices1 sub/ance use disord] s]vices1 & physical heal? s]vices2 7,d7 homelessness2 & 7,e7 vet]ans2 7#e7 a description ( ! mann] 9 :i* ! ,adm9i/ration promotes coord9ation by grantees "u ?is title1 & "p ,b ( title ,,xix1 ) ,/ate or local ag5cies2 & 7#f7 a description ( ! activities c>ri$ out "u section #eja;,a7e71 ) respect to m5tal & sub/ance use disord]s1 includ+-- 7,a7 ! numb] & a description ( grants aw>d$2 7,b7 ! total am\nt ( fund+ = grants aw>d$2 7,c7 a description ( ! activities support$ ?r\gh su* grants1 includ+ outcomes ( programs support$2 & 7,d7 in=mation on h[ ! ,national ,m5tal ,heal? & ,sub/ance ,use ,policy ,laboratory is consult+ ) ! ,assi/ant ,secret>y = ,plann+ & ,evaluation & collaborat+ ) ! ,c5t] = ,sub/ance ,abuse ,treatm5t1 ! ,c5t] = ,sub/ance ,abuse ,prev5tion1 ! ,c5t] = ,behavioral ,heal? ,/ati/ics & ,quality1 & ! ,c5t] = ,m5tal ,heal? ,s]vices to c>ry out su* activities2 & 7#g7 recomm5dations made by ! ,assi/ant ,secret>y = ,plann+ & ,evaluation "u section #fjba ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf to improve programs )9 ! ,adm9i/ration1 & actions tak5 9 response to su* recomm5dations to improve programs )9 ! ,adm9i/ration4 ,! ,assi/ant ,secret>y may meet report+ requirem5ts e/abli%$ "u ?is title by provid+ ! cont5ts ( su* reports z an add5dum to ! bi5nial report e/abli%$ "u ?is subsection1 not)/&+ ! timel9e ( o!r report+ requirem5ts 9 ?is title4 ,no?+ 9 ?is subsection %all be con/ru$ to alt] ! cont5t requirem5ts ( su* reports or au?orize ! ,assi/ant ,secret>y to alt] ! timel9e ( any su* reports to be less frequ5t ?an bi5nially1 unless z specifi$ 9 ?is title4 4 7b7 ,con=m+ am5dm5t ,section #ejh7p7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#a7p77 is am5d$ by /rik+ section #eja7k7 & ins]t+ section #eja7m74 #fjjg4 ,au?orities ( c5t]s = m5tal heal? s]vices1 sub/ance abuse prev5tion1 & sub/ance abuse treatm5t 7a7 ,c5t] = m5tal heal? s]vices ,section #ebj7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#ca7;b77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#ae7 z p>agraphs 7#d7 ?r\gh 7#af71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 collaborate ) ! ,director ( ! ,national ,in/itute ( ,m5tal ,heal? & ! ,*ief ,m$ical ,(fic]1 appo9t$ "u section #eja7;g71 to ensure t1 z appropriate1 programs relat$ to ! prev5tion & treatm5t ( m5tal illness & ! promotion ( m5tal heal? & recov]y support are c>ri$ out 9 a mann] t reflects ! be/ available sci5ce & evid5ce-bas$ practices1 includ+ culturally & l+ui/ically appropriate s]vices1 z appropriate2 2 7#c7 9 p>agraph 7#e71 z s r$esignat$1 by ins]t+ 1 includ+ ?r\gh programs t r$uce risk & promote resili5cy be=e ! semicolon2 7#d7 9 p>agraph 7#f71 z s r$esignat$1 by ins]t+ 9 collaboration ) ! ,director ( ! ,national ,in/itute ( ,m5tal ,heal?1 be=e develop2 7#e7 9 p>agraph 7#h71 z s r$esignat$1 by ins]t+ 1 increase mean+ful p>ticipation ( individuals ) m5tal illness 9 programs & activities ( ! ,adm9i/ration1 be=e & protect ! legal2 7#f7 9 p>agraph 7#aj71 z s r$esignat$1 by /rik+ pr(essional & p>apr(essional p]sonnel pursuant to section #cjc & ins]t+ heal? p>apr(essional p]sonnel & heal? pr(essionals2 7#g7 9 p>agraph 7#aa71 z s r$esignat$1 by ins]t+ & tele-m5tal heal? aft] rural m5tal heal?2 7#h7 9 p>agraph 7#ab71 z s r$esignat$1 by /rik+ e/abli% a cle>+h\se = m5tal heal? in=mation to assure ! widespread dissem9ation ( su* in=mation & ins]t+ dissem9ate m5tal heal? in=mation1 includ+ evid5ce-bas$ practices12 7#i7 9 p>agraph 7#ae71 z s r$esignat$1 by /rik+ & at ! end2 7#aj7 9 p>agraph 7#af71 z s r$esignat$1 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#aa7 by add+ at ! end ! foll[+3 7#ag7 ensure ! consi/5t docum5tation ( ! application ( crit]ia :5 aw>d+ grants & ! ongo+ ov]sight ( grantees aft] su* grants are aw>d$4 4 7b7 ,director ( ! c5t] = sub/ance abuse prev5tion ,section #eae ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#ba7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ (fice & ins]t+ c5t]2 7#b7 9 subsection 7a7-- 7,a7 by /rik+ an ,(fice & ins]t+ a ,c5t]2 & 7,b7 by /rik+ ,! ,(fice & ins]t+ ,! ,prev5tion ,c5t]2 & 7#c7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 by ins]t+ ?r\gh ! r$uction ( risk & ! promotion ( resili5cy be=e ! semicolon2 7,b7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#aa7 z p>agraphs 7#d7 ?r\gh 7#ab71 respectively2 7,c7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 collaborate ) ! ,director ( ! ,national ,in/itute on ,drug ,abuse1 ! ,director ( ! ,national ,in/itute on ,alcohol ,abuse & ,alcoholism1 & ,/ates to promote ! /udy ( sub/ance abuse prev5tion & ! dissem9ation & implem5tation ( rese>* f9d+s t w improve ! deliv]y & effectiv5ess ( sub/ance abuse prev5tion activities2 2 7,d7 9 p>agraph 7#d71 z s r$esignat$1 by /rik+ lit]ature on ! adv]se effects ( coca9e free base 7kn[n z crack7 & ins]t+ educational in=mation on ! effects ( drugs abus$ by individuals1 includ+ drugs t are em]g+ z abus$ drugs2 7,e7 9 p>agraph 7#f71 z s r$esignat$-- 7i7 by /rik+ sub/ance abuse c\nselors & ins]t+ heal? pr(essionals :o provide sub/ance use & misuse prev5tion & treatm5t s]vices2 & 7ii7 by /rik+ drug abuse education1 prev5tion1 & ins]t+ illicit drug use education & prev5tion2 7,f7 by am5d+ p>agraph 7#g71 z s r$esignat$1 to read z foll[s3 7#g7 9 coop]ation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 develop & dissem9ate educational mat]ials to increase aw>5ess = individuals at greate/ risk = sub/ance use disord]s to prev5t ! transmission ( communicable diseases1 su* z ,,hiv1 hepatitis1 tub]culosis1 & o!r communicable diseases2 2 7,g7 9 p>agraph 7#i71 z s r$esignat$-- 7i7 by /rik+ to disc\rage & ins]t+ t r$uce ! risk (2 & 7ii7 by ins]t+ be=e ! semicolon & promote resili5cy2 7,h7 9 p>agraph 7#aa71 z s r$esignat$1 by /rik+ & aft] ! semicolon2 7,i7 9 p>agraph 7#ab71 z s r$esignat$1 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7,j7 by add+ at ! end ! foll[+3 7#ac7 ensure ! consi/5t docum5tation ( ! application ( crit]ia :5 aw>d+ grants & ! ongo+ ov]sight ( grantees aft] su* grants are aw>d$2 & 7#ad7 assi/ & support ,/ates 9 prev5t+ illicit drug use1 includ+ em]g+ illicit drug use issues4 4 7c7 ,director ( ! c5t] = sub/ance abuse treatm5t ,section #ejg ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ treatm5t ( sub/ance abuse & ins]t+ treatm5t ( sub/ance use disord]s2 & 7,b7 by /rik+ abuse treatm5t sy/ems & ins]t+ use disord] treatm5t sy/ems2 & 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 by /rik+ abuse & ins]t+ use disord]2 7,b7 9 p>agraph 7#c71 by /rik+ abuse & ins]t+ use disord]2 7,c7 9 p>agraph 7#d71 by /rik+ individuals :o abuse drugs & ins]t+ individuals :o illicitly use drugs2 7,d7 9 p>agraph 7#i71 by /rik+ c>ri$ out by ! ,director2 7,e7 by /rik+ p>agraph 7#aj72 7,f7 by r$esignat+ p>agraphs 7#aa7 ?r\gh 7#ad7 z p>agraphs 7#aj7 ?r\gh 7#ac71 respectively2 7,g7 9 p>agraph 7#ab71 z s r$esignat$1 by /rik+ 2 & & ins]t+ a semicolon2 & 7,h7 by /rik+ p>agraph 7#ac71 z s r$esignat$1 & ins]t+ ! foll[+3 7#ac7 ensure ! consi/5t docum5tation ( ! application ( crit]ia :5 aw>d+ grants & ! ongo+ ov]sight ( grantees aft] su* grants are aw>d$2 & 7#ad7 "w ) ,/ates1 provid]s1 & individuals 9 recov]y1 & _! families1 to promote ! expansion ( recov]y support s]vices & sy/ems ( c>e ori5t$ t[>d recov]y4 4 #fjjh4 ,advisory c\ncils ,section #ejb7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,e71 by /rik+ & aft] ! semicolon2 7,b7 by r$esignat+ subp>agraph 7,f7 z subp>agraph 7,j72 & 7,c7 by ins]t+ aft] subp>agraph 7,e71 ! foll[+3 7,f7 ! ,*ief ,m$ical ,(fic]1 appo9t$ "u section #eja7;g72 7,g7 ! ,director ( ! ,national ,in/itute ( ,m5tal ,heal? = ! advisory c\ncils appo9t$ "u subsections 7a77#a77;,a7 & 7a77#a77;,d72 7,h7 ! ,director ( ! ,national ,in/itute on ,drug ,abuse = ! advisory c\ncils appo9t$ "u subsections 7a77#a77;,a71 7a77#a77;,b71 & 7a77#a77;,c72 7,i7 ! ,director ( ! ,national ,in/itute on ,alcohol ,abuse & ,alcoholism = ! advisory c\ncils appo9t$ "u subsections 7a77#a77;,a71 7a77#a77;,b71 & 7a77#a77;,c72 & 2 & 7#b7 9 p>agraph 7#c71 by add+ at ! end ! foll[+3 7,c7 ,n less ?an half ( ! memb]s ( ! advisory c\ncil appo9t$ "u subsection 7a77#a77;,d7-- 7i7 %all-- 7,i7 h a m$ical degree2 7,,ii7 h a doctoral degree 9 psy*ology2 or 7,,iii7 h an advanc$ degree 9 nurs+ or social "w f an accr$it$ graduate s*ool or be a c]tifi$ physician assi/ant2 & 7ii7 %all specialize 9 ! m5tal heal? field4 7,d7 ,n less ?an half ( ! memb]s ( ! advisory c\ncils appo9t$ "u subsections 7a77#a77;,b7 & 7a77#a77;,c7-- 7i7 %all-- 7,i7 h a m$ical degree2 7,,ii7 h a doctoral degree2 or 7,,iii7 h an advanc$ degree 9 nurs+1 public heal?1 behavioral or social sci5ces1 or social "w f an accr$it$ graduate s*ool or be a c]tifi$ physician assi/ant2 & 7ii7 %all h exp]i5ce 9 ! provision ( sub/ance use disord] s]vices or ! developm5t & implem5tation ( programs to prev5t sub/ance misuse4 4 #fjji4 ,pe] review ,section #ejd7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa-#c7;b77 is am5d$ by add+ at ! end ! foll[+3 ,9 ! case ( any su* pe] review gr\p t is review+ a grant1 coop]ative agreem5t1 or contract relat$ to m5tal illness treatm5t1 n less ?an half ( ! memb]s ( su* pe] review gr\p %all be lic5s$ & exp]i5c$ pr(essionals 9 ! prev5tion1 diagnosis1 or treatm5t (1 or recov]y f1 m5tal illness or co-occurr+ m5tal illness & sub/ance use disord]s & h a m$ical degree1 a doctoral degree 9 psy*ology1 or an advanc$ degree 9 nurs+ or social "w f an accr$it$ program1 & ! ,secret>y1 9 consultation ) ! ,assi/ant ,secret>y1 %all1 to ! ext5t possible1 ensure su* pe] review gr\ps include broad geographic repres5tation1 includ+ bo? urban & rural repres5tatives44 ,b ,ov]sight & acc\ntability #fjba4 ,improv+ ov]sight ( m5tal & sub/ance use disord]s programs ?r\gh ! ,assi/ant ,secret>y = ,plann+ & ,evaluation 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,assi/ant ,secret>y = ,plann+ & ,evaluation1 %all ensure effici5t & effective plann+ & evaluation ( m5tal & sub/ance use disord]s prev5tion & treatm5t programs & relat$ activities4 7b7 ,evaluation /rategy ,9 c>ry+ out subsection 7a71 ! ,assi/ant ,secret>y = ,plann+ & ,evaluation %all1 n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 develop a /rategy = conduct+ ongo+ evaluations t id5tifies priority programs to be evaluat$ by ! ,assi/ant ,secret>y = ,plann+ & ,evaluation & priority programs to be evaluat$ by o!r relevant (fices & ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 ,! /rategy %all-- 7#a7 include a plan = evaluat+ programs relat$ to m5tal & sub/ance use disord]s1 includ+ co-occurr+ disord]s1 across ag5cies1 z appropriate1 includ+ programs relat$ to-- 7,a7 prev5tion1 int]v5tion1 treatm5t1 & recov]y support s]vices1 includ+ su* s]vices = adults ) a s]i\s m5tal illness or *ildr5 ) a s]i\s emotional di/urbance2 7,b7 ! r$uction ( homelessness & inc>c]ation among individuals ) a m5tal or sub/ance use disord]2 & 7,c7 public heal? & heal? s]vices2 & 7#b7 include a plan = assess+ ! use ( p]=mance metrics to evaluate activities c>ri$ out by entities receiv+ grants1 contracts1 or coop]ative agreem5ts relat$ to m5tal & sub/ance use disord]s prev5tion & treatm5t s]vices "u title ,v or title ,,xix ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa et seq42 #db ,u4,s4,c4 #cjjw et seq474 7c7 ,consultation ,9 c>ry+ out ?is section1 ! ,assi/ant ,secret>y = ,plann+ & ,evaluation %all consult1 z appropriate1 ) ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 ! ,*ief ,m$ical ,(fic] ( ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration appo9t$ "u section #eja7;g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa7g771 z am5d$ by section #fjjc1 ! ,behavioral ,heal? ,coord9at+ ,c\ncil ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 o!r ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 & o!r relevant ,f$]al dep>tm5ts & ag5cies4 7d7 ,recomm5dations ,9 c>ry+ out ?is section1 ! ,assi/ant ,secret>y = ,plann+ & ,evaluation %all provide recomm5dations to ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 & ! ,congress on improv+ ! quality ( prev5tion & treatm5t programs & activities relat$ to m5tal & sub/ance use disord]s1 includ+ recomm5dations = ! use ( p]=mance metrics4 ,! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use %all include su* recomm5dations 9 ! bi5nial report requir$ by subsection #eja7m7 ( ! ,public ,heal? ,s]vice ,act1 z r$esignat$ by section #fjjc ( ?is ,act4 #fjbb4 ,report+ = protection & advocacy organizations 7a7 ,public availability ( reports ,section #aje7;a77#g7 ( ! ,protection & ,advocacy = ,individuals ) ,m5tal ,illness ,act 7#db ,u4,s4,c4 #ajhje7;a77#g77 is am5d$ by /rik+ is locat$ a report & ins]t+ is locat$1 & make publicly available1 a report4 7b7 ,detail$ acc\nt+ ,section #aad7;a7 ( ! ,protection & ,advocacy = ,individuals ) ,m5tal ,illness ,act 7#db ,u4,s4,c4 #ajhbd7;a77 is am5d$-- 7#a7 9 p>agraph 7#c71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#d71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#e7 us+ data f ! exi/+ requir$ annual program progress reports submitt$ by ea* sy/em fund$ "u ?is title1 a detail$ acc\nt+ = ea* su* sy/em ( h[ funds are sp5t1 disaggregat$ accord+ to :e!r ! funds 7 receiv$ f ! ,f$]al ,gov]nm5t1 ! ,/ate gov]nm5t1 a local gov]nm5t1 or a private entity4 4 #fjbc4 ,,gao /udy 7a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 %all conduct an indep5d5t evaluation1 & submit a report1 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 on programs fund$ by allotm5ts made "u title ,i ( ! ,protection & ,advocacy = ,individuals ) ,m5tal ,illness ,act 7#db ,u4,s4,c4 #ajhja et seq474 7b7 ,cont5ts ,! report & evaluation requir$ "u subsection 7a7 %all include-- 7#a7 a review ( ! programs describ$ 9 su* subsection t are c>ri$ out by ,/ate ag5cies & su* programs t are c>ri$ out by private1 nonpr(it organizations2 & 7#b7 a review ( ! compliance ( ! programs describ$ 9 subsection 7a7 ) /atutory & regulatory responsibilities1 su* z-- 7,a7 responsibilities relat+ to family engagem5t2 7,b7 responsibilities relat+ to ! grievance proc$ure = cli5ts or prospective cli5ts ( ! sy/em to assure t individuals ) m5tal illness h full access to ! s]vices ( ! sy/em1 = individuals :o h receiv$ or are receiv+ m5tal heal? s]vices1 & = family memb]s ( su* individuals ) m5tal illness1 or repres5tatives ( su* individuals or family memb]s1 to assure t ! eligible sy/em is op]at+ 9 compliance ) ! provisions ( ! ,protection & ,advocacy = ,individuals ) ,m5tal ,illness ,act1 z requir$ to be e/abli%$ by section #aje7;a77#i7 ( su* ,act 7#db ,u4,s4,c4 #ajhje7;a77#i772 7,c7 inve/igation ( alleg$ abuse & neglect ( p]sons ) m5tal illness2 7,d7 availability ( adequate m$ical & behavioral heal? treatm5t2 7,e7 d5ial ( rights = p]sons ) m5tal illness2 & 7,f7 compliance ) ! ,f$]al prohibition on lobby+4 ,c ,int]dep>tm5tal ,s]i\s ,m5tal ,illness ,coord9at+ ,committee #fjca4 ,int]dep>tm5tal ,s]i\s ,m5tal ,illness ,coord9at+ ,committee 7a7 ,e/abli%m5t 7#a7 ,9 g5]al ,n lat] ?an #c mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 or ! designee ( ! ,secret>y1 %all e/abli% a committee to be kn[n z ! ,int]dep>tm5tal ,s]i\s ,m5tal ,illness ,coord9at+ ,committee 79 ?is section ref]r$ to z ! ,committee74 7#b7 ,f$]al advisory committee act ,except z provid$ 9 ?is section1 ! provisions ( ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 %all apply to ! ,committee4 7b7 ,meet+s ,! ,committee %all meet n few] ?an #b times ea* ye>4 7c7 ,responsibilities ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & #e ye>s aft] su* date ( enactm5t1 ! ,committee %all submit to ,congress & any o!r relevant ,f$]al dep>tm5t or ag5cy a report includ+-- 7#a7 a summ>y ( advances 9 s]i\s m5tal illness & s]i\s emotional di/urbance rese>* relat$ to ! prev5tion (1 diagnosis (1 int]v5tion 91 & treatm5t & recov]y ( s]i\s m5tal illnesses1 s]i\s emotional di/urbances1 & advances 9 access to s]vices & support = adults ) a s]i\s m5tal illness or *ildr5 ) a s]i\s emotional di/urbance2 7#b7 an evaluation ( ! effect ,f$]al programs relat$ to s]i\s m5tal illness h on public heal?1 includ+ public heal? outcomes su* z-- 7,a7 rates ( suicide1 suicide attempts1 incid5ce & preval5ce ( s]i\s m5tal illnesses1 s]i\s emotional di/urbances1 & sub/ance use disord]s1 ov]dose1 ov]dose dea?s1 em]g5cy hospitalizations1 em]g5cy room bo>d+1 prev5table em]g5cy room visits1 int]action ) ! crim9al ju/ice sy/em1 homelessness1 & unemploym5t2 7,b7 increas$ rates ( employm5t & enrollm5t 9 educational & vocational programs2 7,c7 quality ( m5tal & sub/ance use disord]s treatm5t s]vices2 or 7,d7 any o!r crit]ia z may be det]m9$ by ! ,secret>y2 & 7#c7 specific recomm5dations = actions t ag5cies c take to bett] coord9ate ! adm9i/ration ( m5tal heal? s]vices = adults ) a s]i\s m5tal illness or *ildr5 ) a s]i\s emotional di/urbance4 7d7 ,committee ext5sion ,^u ! submission ( ! second report "u subsection 7c71 ! ,secret>y %all submit a recomm5dation to ,congress on :e!r to ext5d ! op]ation ( ! ,committee4 7e7 ,memb]%ip 7#a7 ,f$]al memb]s ,! ,committee %all be compos$ ( ! foll[+ ,f$]al repres5tatives1 or ! designees ( su* repres5tatives-- 7,a7 ! ,secret>y ( ,heal? & ,human ,s]vices1 :o %all s]ve z ! ,*air ( ! ,committee2 7,b7 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use2 7,c7 ! ,attorney ,g5]al2 7,d7 ! ,secret>y ( ,vet]ans ,affairs2 7,e7 ! ,secret>y ( ,def5se2 7,f7 ! ,secret>y ( ,h\s+ & ,urban ,developm5t2 7,g7 ! ,secret>y ( ,education2 7,h7 ! ,secret>y ( ,labor2 7,i7 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 & 7,j7 ! ,commission] ( ,social ,security4 7#b7 ,non-,f$]al memb]s ,! ,committee %all also include n less ?an #ad non-,f$]al public memb]s appo9t$ by ! ,secret>y ( ,heal? & ,human ,s]vices1 ( :i*-- 7,a7 at lea/ #b memb]s %all be an individual :o has receiv$ treatm5t = a diagnosis ( a s]i\s m5tal illness2 7,b7 at lea/ #a memb] %all be a p>5t or legal gu>dian ( an adult ) a hi/ory ( a s]i\s m5tal illness or a *ild ) a hi/ory ( a s]i\s emotional di/urbance2 7,c7 at lea/ #a memb] %all be a repres5tative ( a lead+ rese>*1 advocacy1 or s]vice organization = adults ) a s]i\s m5tal illness2 7,d7 at lea/ #b memb]s %all be-- 7i7 a lic5s$ psy*iatri/ ) exp]i5ce 9 treat+ s]i\s m5tal illnesses2 7ii7 a lic5s$ psy*ologi/ ) exp]i5ce 9 treat+ s]i\s m5tal illnesses or s]i\s emotional di/urbances2 7iii7 a lic5s$ cl9ical social work] ) exp]i5ce treat+ s]i\s m5tal illnesses or s]i\s emotional di/urbances2 or 7iv7 a lic5s$ psy*iatric nurse1 nurse practition]1 or physician assi/ant ) exp]i5ce 9 treat+ s]i\s m5tal illnesses or s]i\s emotional di/urbances2 7,e7 at lea/ #a memb] %all be a lic5s$ m5tal heal? pr(essional ) a specialty 9 treat+ *ildr5 & adolesc5ts ) a s]i\s emotional di/urbance2 7,f7 at lea/ #a memb] %all be a m5tal heal? pr(essional :o has rese>* or cl9ical m5tal heal? exp]i5ce 9 work+ ) m9orities2 7,g7 at lea/ #a memb] %all be a m5tal heal? pr(essional :o has rese>* or cl9ical m5tal heal? exp]i5ce 9 work+ ) m$ically und]s]v$ populations2 7,h7 at lea/ #a memb] %all be a ,/ate c]tifi$ m5tal heal? pe] support speciali/2 7,i7 at lea/ #a memb] %all be a judge ) exp]i5ce 9 adjudicat+ cases relat$ to crim9al ju/ice or s]i\s m5tal illness2 7,j7 at lea/ #a memb] %all be a law en=cem5t (fic] or corrections (fic] ) ext5sive exp]i5ce 9 int]fac+ ) adults ) a s]i\s m5tal illness1 *ildr5 ) a s]i\s emotional di/urbance1 or individuals 9 a m5tal heal? crisis2 & 7,k7 at lea/ #a memb] %all h exp]i5ce provid+ s]vices = homeless individuals & work+ ) adults ) a s]i\s m5tal illness1 *ildr5 ) a s]i\s emotional di/urbance1 or individuals 9 a m5tal heal? crisis4 7#c7 ,t]ms ,a memb] ( ! ,committee appo9t$ "u subsection 7e77#b7 %all s]ve = a t]m ( #c ye>s1 & may be reappo9t$ = #a or m additional #c-ye> t]ms4 ,any memb] appo9t$ to fill a vacancy = an unexpir$ t]m %all be appo9t$ = ! rema9d] ( su* t]m4 ,a memb] may s]ve aft] ! expiration ( ! memb]'s t]m until a successor has be5 appo9t$4 7f7 ,work+ gr\ps ,9 c>ry+ out its functions1 ! ,committee may e/abli% work+ gr\ps4 ,su* work+ gr\ps %all be compos$ ( ,committee memb]s1 or _! designees1 & may hold su* meet+s z are necess>y4 7g7 ,sunset ,! ,committee %all t]m9ate on ! date t is #f ye>s aft] ! date on :i* ! ,committee is e/abli%$ "u subsection 7a77#a74 ,,vii ,,ensur+ ,,m5tal ,,& ,,sub/ance ,,use ,,disord]s ,,prev5tion1 ,,treatm5t1 ,,& ,,recov]y ,,programs ,,keep ,,pace ,,) ,,sci5ce ,,& ,,te*nology #gjja4 ,enc\rag+ innovation & evid5ce-bas$ programs ,title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa et seq47 is am5d$ by ins]t+ aft] section #eja 7#db ,u4,s4,c4 #bij;aa7 ! foll[+3 #eja;,a4 ,national m5tal heal? & sub/ance use policy laboratory 7a7 ,9 g5]al ,!re %all be e/abli%$ )9 ! ,adm9i/ration a ,national ,m5tal ,heal? & ,sub/ance ,use ,policy ,laboratory 7ref]r$ to 9 ?is section z ! ,laboratory74 7b7 ,responsibilities ,! ,laboratory %all-- 7#a7 cont9ue to c>ry out ! au?orities & activities t 7 9 effect = ! ,(fice ( ,policy1 ,plann+1 & ,innovation z su* ,(fice exi/$ prior to ! date ( enactm5t ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf2 7#b7 id5tify1 coord9ate1 & facilitate ! implem5tation ( policy *anges likely to h a significant effect on m5tal heal?1 m5tal illness1 recov]y supports1 & ! prev5tion & treatm5t ( sub/ance use disord] s]vices2 7#c7 "w ) ! ,c5t] = ,behavioral ,heal? ,/ati/ics & ,quality to collect1 z appropriate1 in=mation f grantees "u programs op]at$ by ! ,adm9i/ration 9 ord] to evaluate & dissem9ate in=mation on evid5ce-bas$ practices1 includ+ culturally & l+ui/ically appropriate s]vices1 z appropriate1 & s]vice deliv]y models2 7#d7 provide lead]%ip 9 id5tify+ & coord9at+ policies & programs1 includ+ evid5ce-bas$ programs1 relat$ to m5tal & sub/ance use disord]s2 7#e7 p]iodically review programs & activities op]at$ by ! ,adm9i/ration relat+ to ! diagnosis or prev5tion (1 treatm5t =1 & recov]y f1 m5tal & sub/ance use disord]s to-- 7,a7 id5tify any su* programs or activities t are duplicative2 7,b7 id5tify any su* programs or activities t are n evid5ce-bas$1 effective1 or effici5t2 & 7,c7 =mulate recomm5dations = coord9at+1 elim9at+1 or improv+ programs or activities id5tifi$ "u subp>agraph 7,a7 or 7,b7 & m]g+ su* programs or activities into o!r successful programs or activities2 & 7#f7 c>ry out o!r activities z deem$ necess>y to cont9ue to enc\rage innovation & dissem9ate evid5ce-bas$ programs & practices4 7c7 ,evid5ce-,bas$ practices & s]vice deliv]y models 7#a7 ,9 g5]al ,9 c>ry+ out subsection 7b77#c71 ! ,laboratory-- 7,a7 may give pref]5ce to models t improve-- 7i7 ! coord9ation betwe5 m5tal heal? & physical heal? provid]s2 7ii7 ! coord9ation among su* provid]s & ! ju/ice & corrections sy/em2 & 7iii7 ! co/ effectiv5ess1 quality1 effectiv5ess1 & effici5cy ( heal? c>e s]vices furni%$ to adults ) a s]i\s m5tal illness1 *ildr5 ) a s]i\s emotional di/urbance1 or individuals 9 a m5tal heal? crisis2 & 7,b7 may include cl9ical protocols & practices t address ! ne$s ( individuals ) e>ly s]i\s m5tal illness4 7#b7 ,consultation ,9 c>ry+ out ?is section1 ! ,laboratory %all consult )-- 7,a7 ! ,*ief ,m$ical ,(fic] appo9t$ "u section #eja7;g72 7,b7 repres5tatives ( ! ,national ,in/itute ( ,m5tal ,heal?1 ! ,national ,in/itute on ,drug ,abuse1 & ! ,national ,in/itute on ,alcohol ,abuse & ,alcoholism1 on an ongo+ basis2 7,c7 o!r appropriate ,f$]al ag5cies2 7,d7 cl9ical & analytical exp]ts ) exp]tise 9 psy*iatric m$ical c>e & cl9ical psy*ological c>e1 heal? c>e managem5t1 education1 corrections heal? c>e1 & m5tal heal? c\rt sy/ems1 z appropriate2 & 7,e7 o!r individuals & ag5cies z det]m9$ appropriate by ! ,assi/ant ,secret>y4 7d7 ,deadl9e = beg9n+ implem5tation ,! ,laboratory %all beg9 implem5tation ( ?is section n lat] ?an ,janu>y #a1 #bjah4 7e7 ,promot+ innovation 7#a7 ,9 g5]al ,! ,assi/ant ,secret>y1 9 coord9ation ) ! ,laboratory1 may aw>d grants to ,/ates1 local gov]nm5ts1 ,indian tribes or tribal organizations 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 educational in/itutions1 & nonpr(it organizations to develop evid5ce-bas$ int]v5tions1 includ+ culturally & l+ui/ically appropriate s]vices1 z appropriate1 =-- 7,a7 evaluat+ a model t has be5 sci5tifically demon/rat$ to %[ promise1 b w\ld b5efit f fur!r appli$ developm5t1 =-- 7i7 enhanc+ ! prev5tion1 diagnosis1 int]v5tion1 & treatm5t (1 & recov]y f1 m5tal illness1 s]i\s emotional di/urbances1 sub/ance use disord]s1 & co-occurr+ illness or disord]s2 or 7ii7 integrat+ or coord9at+ physical heal? s]vices & m5tal & sub/ance use disord]s s]vices2 & 7,b7 exp&+1 replicat+1 or scal+ evid5ce-bas$ programs across a wid] area to enhance effective scre5+1 e>ly diagnosis1 int]v5tion1 & treatm5t ) respect to m5tal illness1 s]i\s m5tal illness1 s]i\s emotional di/urbances1 & sub/ance use disord]s1 prim>ily by-- 7i7 apply+ su* evid5ce-bas$ programs to ! deliv]y ( c>e1 includ+ by tra9+ /aff 9 effective evid5ce-bas$ treatm5ts2 or 7ii7 integrat+ su* evid5ce-bas$ programs into models ( c>e across specialties & jurisdictions4 7#b7 ,consultation ,9 aw>d+ grants "u ?is subsection1 ! ,assi/ant ,secret>y %all1 z appropriate1 consult ) ! ,*ief ,m$ical ,(fic]1 appo9t$ "u section #eja7;g71 ! advisory c\ncils describ$ 9 section #ejb1 ! ,national ,in/itute ( ,m5tal ,heal?1 ! ,national ,in/itute on ,drug ,abuse1 & ! ,national ,in/itute on ,alcohol ,abuse & ,alcoholism1 z appropriate4 7#c7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$-- 7,a7 to c>ry out p>agraph 7#a77;,a71 #g1jjj1jjj = ! p]iod ( fiscal ye>s #bjah ?r\gh #bjbj2 & 7,b7 to c>ry out p>agraph 7#a77;,b71 #g1jjj1jjj = ! p]iod ( fiscal ye>s #bjah ?r\gh #bjbj4 4 #gjjb4 ,promot+ access to in=mation on evid5ce-bas$ programs & practices ,"p ,d ( title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;dd et seq47 is am5d$ by ins]t+ aft] section #edc ( su* ,act 7#db ,u4,s4,c4 #bij;dd-#b7 ! foll[+3 #edc;,a4 ,promot+ access to in=mation on evid5ce-bas$ programs & practices 7a7 ,9 g5]al ,! ,assi/ant ,secret>y %all1 z appropriate1 improve access to reliable & valid in=mation on evid5ce-bas$ programs & practices1 includ+ in=mation on ! /r5g? ( evid5ce associat$ ) su* programs & practices1 relat$ to m5tal & sub/ance use disord]s = ,/ates1 local communities1 nonpr(it entities1 & o!r /akehold]s1 by po/+ on ! ,int]net website ( ! ,adm9i/ration in=mation on evid5ce-bas$ programs & practices t h be5 review$ by ! ,assi/ant ,secret>y 9 accordance ) ! requirem5ts ( ?is section4 7b7 ,applications 7#a7 ,application p]iod ,9 c>ry+ out subsection 7a71 ! ,assi/ant ,secret>y may e/abli% a p]iod = ! submission ( applications = evid5ce-bas$ programs & practices to be po/$ publicly 9 accordance ) subsection 7a74 7#b7 ,notice ,9 e/abli%+ ! application p]iod "u p>agraph 7#a71 ! ,assi/ant ,secret>y %all provide = ! public notice ( su* application p]iod 9 ! ,f$]al ,regi/]4 ,su* notice may solicit applications = evid5ce-bas$ programs & practices to address gaps 9 in=mation id5tifi$ by ! ,assi/ant ,secret>y1 ! ,national ,m5tal ,heal? & ,sub/ance ,use ,policy ,laboratory e/abli%$ "u section #eja;,a1 or ! ,assi/ant ,secret>y = ,plann+ & ,evaluation1 includ+ pursuant to ! evaluation & recomm5dations "u section #fjba ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf or priorities id5tifi$ 9 ! /rategic plan "u section #eja7l74 7c7 ,requirem5ts ,! ,assi/ant ,secret>y may e/abli% m9imum requirem5ts = ! applications submitt$ "u subsection 7b71 includ+ applications relat$ to ! submission ( rese>* & evaluation4 7d7 ,review & rat+ 7#a7 ,9 g5]al ,! ,assi/ant ,secret>y %all review applications prior to public po/+ 9 accordance ) subsection 7a71 & may prioritize ! review ( applications = evid5ce-bas$ programs & practices t are relat$ to topics includ$ 9 ! notice provid$ "u subsection 7b77#b74 7#b7 ,sy/em ,9 c>ry+ out p>agraph 7#a71 ! ,assi/ant ,secret>y may utilize a rat+ & review sy/em1 :i* may include in=mation on ! /r5g? ( evid5ce associat$ ) ! evid5ce-bas$ programs & practices & a rat+ ( ! me?odological rigor ( ! rese>* support+ ! applications4 7#c7 ,public access to metrics & rat+ ,! ,assi/ant ,secret>y %all make ! metrics us$ to evaluate applications "u ?is section1 & any result+ rat+s ( su* applications1 publicly available4 4 #gjjc4 ,priority m5tal heal? ne$s ( regional & national significance ,section #ebj;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#cb7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#d71 by ins]t+ be=e ! p]iod 1 :i* may include te*nical assi/ance c5t]s2 & 7,b7 9 ! flu% s5t5ce foll[+ p>agraph 7#d7-- 7i7 by ins]t+ 1 contracts1 be=e or coop]ative agreem5ts2 & 7ii7 by /rik+ ,indian tribes & tribal organizations & ins]t+ ,indian tribes or tribal organizations 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 heal? facilities1 or programs op]at$ by or 9 accordance ) a contract or grant ) ! ,indian ,heal? ,s]vice1 or2 & 7#b7 by am5d+ subsection 7f7 to read z foll[s3 7f7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section #cid1eej1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #gjjd4 ,priority sub/ance use disord] treatm5t ne$s ( regional & national significance ,section #eji ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#b7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ abuse & ins]t+ use disord]2 7,b7 9 p>agraph 7#c71 by ins]t+ be=e ! p]iod t p]mit ,/ates1 local gov]nm5ts1 communities1 & ,indian tribes & tribal organizations 7z ! t]ms ,indian tribes & tribal organizations are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act7 to focus on em]g+ tr5ds 9 sub/ance abuse & co-occurr5ce ( sub/ance use disord]s ) m5tal illness or o!r conditions2 & 7,c7 9 ! flu% s5t5ce foll[+ p>agraph 7#c7-- 7i7 by ins]t+ 1 contracts1 be=e or coop]ative agreem5ts2 & 7ii7 by /rik+ ,indian tribes & tribal organizations1 & ins]t+ ,indian tribes or tribal organizations 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 heal? facilities1 or programs op]at$ by or 9 accordance ) a contract or grant ) ! ,indian ,heal? ,s]vice1 or2 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 by /rik+ abuse & ins]t+ use disord]2 & 7,b7 9 p>agraph 7#b71 by /rik+ abuse & ins]t+ use disord]2 7#c7 9 subsection 7e71 by /rik+ abuse & ins]t+ use disord]2 & 7#d7 9 subsection 7f71 by /rik+ #cjj1jjj1jjj & all t foll[s ?r\gh ! p]iod & ins]t+ #ccc1hjf1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb44 #gjje4 ,priority sub/ance use disord] prev5tion ne$s ( regional & national significance ,section #eaf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#bb7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ abuse & ins]t+ use disord]2 7#b7 9 subsection 7a7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ abuse & ins]t+ use disord]2 7,b7 9 p>agraph 7#c71 by ins]t+ be=e ! p]iod 1 includ+ su* programs t focus on em]g+ drug abuse issues2 & 7,c7 9 ! flu% s5t5ce foll[+ p>agraph 7#c7-- 7i7 by ins]t+ 1 contracts1 be=e or coop]ative agreem5ts2 & 7ii7 by /rik+ ,indian tribes & tribal organizations1 & ins]t+ ,indian tribes or tribal organizations 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 heal? facilities1 or programs op]at$ by or 9 accordance ) a contract or grant ) ! ,indian ,heal? ,s]vice12 7#c7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 by /rik+ abuse & ins]t+ use disord]2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by /rik+ 2 & at ! end & ins]t+ 22 7ii7 9 subp>agraph 7,b7-- 7,i7 by /rik+ abuse & ins]t+ use disord]2 & 7,,ii7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,c7 sub/ance use disord] prev5tion among high-risk gr\ps4 2 7#d7 9 subsection 7e71 by /rik+ abuse & ins]t+ use disord]2 & 7#e7 9 subsection 7f71 by /rik+ #cjj1jjj1jjj & all t foll[s ?r\gh ! p]iod & ins]t+ #baa1adh1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb44 ,,viii ,,support+ ,,/ate ,,prev5tion ,,activities ,,& ,,responses ,,to ,,m5tal ,,heal? ,,& ,,sub/ance ,,use ,,disord] ,,ne$s #hjja4 ,community m5tal heal? s]vices block grant 7a7 ,=mula grants ,section #aiaa7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx7b77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#a7 ?r\gh 7#c7 z p>agraphs 7#b7 ?r\gh 7#d71 respectively2 & 7#b7 by ins]t+ be=e p>agraph 7#b7 7z s r$esignat$7 ! foll[+3 7#a7 provid+ community m5tal heal? s]vices = adults ) a s]i\s m5tal illness & *ildr5 ) a s]i\s emotional di/urbance z def9$ 9 accordance ) section #aiab7;c72 4 7b7 ,/ate plan ,section #aiab7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#c71 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,c7 z clauses 7i7 ?r\gh 7iii71 respectively1 & realign+ ! m>g9s accord+ly2 7#b7 by r$esignat+ p>agraphs 7#a7 ?r\gh 7#e7 z subp>agraphs 7,a7 ?r\gh 7,e71 respectively1 & realign+ ! m>g9s accord+ly2 7#c7 9 ! matt] prec$+ subp>agraph 7,a7 7z s r$esignat$71 by /rik+ ,) respect to & all t foll[s ?r\gh are z foll[s3 & ins]t+ ,9 accordance ) subsection 7a71 a ,/ate %all submit to ! ,secret>y a plan e two ye>s t1 at a m9imum1 includes ea* ( ! foll[+32 7#d7 by ins]t+ be=e subp>agraph 7,a7 7z s r$esignat$7 ! foll[+3 7#a7 ,sy/em ( c>e ,a description ( ! ,/ate's sy/em ( c>e t conta9s ! foll[+3 2 7#e7 by /rik+ subp>agraph 7,a7 7z s r$esignat$7 & ins]t+ ! foll[+3 7,a7 ,compreh5sive community-bas$ heal? sy/ems ,! plan %all-- 7i7 id5tify ! s+le ,/ate ag5cy to be responsible = ! adm9i/ration ( ! program "u ! grant1 includ+ any ?ird p>ty :o adm9i/]s m5tal heal? s]vices & is responsible = comply+ ) ! requirem5ts ( ?is "p ) respect to ! grant2 7ii7 provide = an organiz$ community-bas$ sy/em ( c>e = individuals ) m5tal illness1 & describe available s]vices & res\rces 9 a compreh5sive sy/em ( c>e1 includ+ s]vices = individuals ) co-occurr+ disord]s2 7iii7 include a description ( ! mann] 9 :i* ! ,/ate & local entities w coord9ate s]vices to maximize ! effici5cy1 effectiv5ess1 quality1 & co/-effectiv5ess ( s]vices & programs to produce ! be/ possible outcomes 7includ+ heal? s]vices1 rehabilitation s]vices1 employm5t s]vices1 h\s+ s]vices1 educational s]vices1 sub/ance use disord] s]vices1 legal s]vices1 law en=cem5t s]vices1 social s]vices1 *ild welf>e s]vices1 m$ical & d5tal c>e s]vices1 & o!r support s]vices to be provid$ ) ,f$]al1 ,/ate1 & local public & private res\rces7 ) o!r ag5cies to enable individuals receiv+ s]vices to function outside ( inpati5t or resid5tial in/itutions1 to ! maximum ext5t ( _! capabilities1 includ+ s]vices to be provid$ by local s*ool sy/ems "u ! ,individuals ) ,disabilities ,education ,act2 7iv7 include a description ( h[ ! ,/ate promotes evid5ce-bas$ practices1 includ+ ^? evid5ce-bas$ programs t address ! ne$s ( individuals ) e>ly s]i\s m5tal illness reg>dless ( ! age ( ! individual at onset1 provide compreh5sive individualiz$ treatm5t1 or integrate m5tal & physical heal? s]vices2 7v7 include a description ( case managem5t s]vices2 7vi7 include a description ( activities t seek to engage adults ) a s]i\s m5tal illness or *ildr5 ) a s]i\s emotional di/urbance & _! c>egiv]s :]e appropriate 9 mak+ heal? c>e decisions1 includ+ activities t enhance communication among individuals1 families1 c>egiv]s1 & treatm5t provid]s2 & 7vii7 z appropriate to1 & reflective (1 ! uses ! ,/ate proposes = ! block grant funds1 include-- 7,i7 a description ( ! activities int5d$ to r$uce hospitalizations & hospital /ays us+ ! block grant funds2 7,,ii7 a description ( ! activities int5d$ to r$uce incid5ts ( suicide us+ ! block grant funds2 7,,iii7 a description ( h[ ! ,/ate integrates m5tal heal? & prim>y c>e us+ ! block grant funds1 :i* may include provid+1 9 ! case ( individuals ) co-occurr+ m5tal & sub/ance use disord]s1 bo? m5tal & sub/ance use disord]s s]vices 9 prim>y c>e sett+s or arrangem5ts to provide prim>y & specialty c>e s]vices 9 community-bas$ m5tal & sub/ance use disord]s sett+s2 & 7,,iv7 a description ( recov]y & recov]y support s]vices = adults ) a s]i\s m5tal illness & *ildr5 ) a s]i\s emotional di/urbance4 2 7#f7 9 subp>agraph 7,b7 7z s r$esignat$7-- 7,a7 by /rik+ ,! plan conta9s & ins]t+ ,! plan %all conta92 & 7,b7 by /rik+ pres5ts quantitative t>gets to be a*iev$ 9 ! implem5tation ( ! sy/em describ$ 9 p>agraph 7#a7 & ins]t+ pres5t quantitative t>gets & outcome measures = programs & s]vices provid$ "u ?is subp>t2 7#g7 9 subp>agraph 7,c7 7z s r$esignat$7-- 7,a7 by /rik+ s]i\s emotional di/urbance 9 ! matt] prec$+ clause 7i7 7z s r$esignat$7 & all t foll[s ?r\gh sub/ance abuse s]vices 9 clause 7i7 7z s r$esignat$7 & ins]t+ ! foll[+3 a s]i\s emotional di/urbance 7z def9$ pursuant to subsection 7c771 ! plan %all provide = a sy/em ( integrat$ social s]vices1 educational s]vices1 *ild welf>e s]vices1 juv5ile ju/ice s]vices1 law en=cem5t s]vices1 & sub/ance use disord] s]vices2 7,b7 by /rik+ ,education ,act72 & ins]t+ ,education ,act742 & 7,c7 by /rik+ clauses 7ii7 & 7iii7 7z s r$esignat$72 7#h7 9 subp>agraph 7,d7 7z s r$esignat$71 by /rik+ plan describes & ins]t+ plan %all describe2 7#i7 9 subp>agraph 7,e7 7z s r$esignat$7-- 7,a7 9 ! subp>agraph head+ by /rik+ sy/ems & ins]t+ s]vices2 7,b7 9 ! fir/ s5t5ce1 by /rik+ plan describes & all t foll[s ?r\gh & provides = & ins]t+ plan %all describe ! f9ancial res\rces available1 ! exi/+ m5tal heal? work=ce1 & ! work=ce tra9$ 9 treat+ individuals ) co-occurr+ m5tal & sub/ance use disord]s1 & %all provide =2 & 7,c7 9 ! second s5t5ce-- 7i7 by /rik+ fur!r describes & ins]t+ %all fur!r describe2 & 7ii7 by /rik+ involv$4 & ins]t+ involv$1 & ! mann] 9 :i* ! ,/ate int5ds to comply ) ea* ( ! fund+ agreem5ts 9 ?is subp>t & subp>t ,,iii42 7#aj7 by /rik+ ! flu% matt] at ! end2 & 7#aa7 by add+ at ! end ! foll[+3 7#b7 ,goals & objectives ,! e/abli%m5t ( goals & objectives = ! p]iod ( ! plan1 includ+ t>gets & mile/ones t are int5d$ to be met1 & ! activities t w be und]tak5 to a*ieve ^? t>gets4 4 7c7 ,e>ly s]i\s m5tal illness ,section #aibj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#i7 is am5d$ by add+ at ! end ! foll[+3 7c7 ,e>ly s]i\s m5tal illness 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 a ,/ate %all exp5d n less ?an #aj p]c5t ( ! am\nt ! ,/ate receives = c>ry+ out ?is section = ea* fiscal ye> to support evid5ce-bas$ programs t address ! ne$s ( individuals ) e>ly s]i\s m5tal illness1 includ+ psy*otic disord]s1 reg>dless ( ! age ( ! individual at onset4 7#b7 ,/ate flexibility ,9 lieu ( exp5d+ #aj p]c5t ( ! am\nt ! ,/ate receives "u ?is section = a fiscal ye> z requir$ "u p>agraph 7#a71 a ,/ate may elect to exp5d n less ?an #bj p]c5t ( su* am\nt by ! end ( su* succe$+ fiscal ye>4 4 7d7 ,additional provisions ,section #aiae7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#d7;b77 is am5d$-- 7#a7 9 p>agraph 7#c7-- 7,a7 by /rik+ ,! ,secret>y & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,! ,secret>y 2 7,b7 by /rik+ p>agraph 7#a7 if & ins]t+ p>agraph 7#a7 9 :ole or 9 "p if2 7,c7 by /rik+ ,/ate ju/ify ! waiv]4 & ins]t+ ,/ate 9 ! fiscal ye> involv$ or 9 ! previ\s fiscal ye> ju/ify ! waiv]2 & 7,d7 by add+ at ! end ! foll[+3 7,b7 ,date c]ta9 = action ^u reque/ ,! ,secret>y %all approve or d5y a reque/ = a waiv] "u ?is p>agraph n lat] ?an #abj days aft] ! date on :i* ! reque/ is made4 7,c7 ,applicability ( waiv] ,a waiv] provid$ by ! ,secret>y "u ?is p>agraph %all be applicable only to ! fiscal ye> involv$4 2 & 7#b7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by ins]t+ aft] ! subp>agraph designation ! foll[+3 ,9 g5]al4--2 7ii7 by /rik+ ,9 mak+ a grant & ins]t+ ! foll[+3 7i7 ,det]m9ation ,9 mak+ a grant 2 & 7iii7 by ins]t+ at ! end ! foll[+3 7ii7 ,alt]native ,a ,/ate t has fail$ to comply ) p>agraph 7#a7 & w\ld o!rwise be subject to a r$uction 9 ! ,/ate's allotm5t "u section #aiaa may1 ^u reque/ by ! ,/ate1 9 lieu ( hav+ ! am\nt ( ! allotm5t "u section #aiaa = ! ,/ate r$uc$ = ! fiscal ye> ( ! grant1 agree to comply ) a negotiat$ agreem5t t is approv$ by ! ,secret>y & c>ri$ out 9 accordance ) guidel9es issu$ by ! ,secret>y4 ,if a ,/ate fails to ent] into or comply ) a negotiat$ agreem5t1 ! ,secret>y may take action "u ?is p>agraph or ! t]ms ( ! negotiat$ agreem5t4 2 & 7,b7 9 subp>agraph 7,b7-- 7i7 by ins]t+ aft] ! subp>agraph designation ! foll[+3 ,submission ( in=mation to ! ,secret>y4--2 & 7ii7 by /rik+ subp>agraph 7,a7 & ins]t+ subp>agraph 7,a77i74 7e7 ,application = grant ,section #aiag7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#f7;a77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #aida & ins]t+ #aidb7;a72 & 7#b7 9 p>agraph 7#e71 by /rik+ #aiae7;b77#c77;,b7 & ins]t+ #aiae7;b74 7f7 ,fund+ ,section #aibj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#i7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ section #eje & ins]t+ section #eje7;c72 & 7,b7 by /rik+ #dej1jjj1jjj & all t foll[s ?r\gh ! p]iod & ins]t+ #ecb1ega1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb42 & 7#b7 9 subsection 7b77#b7 by /rik+ sections #eje & & ins]t+ sections #eje7;c7 &4 #hjjb4 ,sub/ance abuse prev5tion & treatm5t block grant 7a7 ,=mula grants ,section #aiba7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#ba7;b77 is am5d$-- 7#a7 by ins]t+ c>ry+ out ! plan develop$ 9 accordance ) section #aicb7;b7 & = aft] = ! purpose (2 & 7#b7 by /rik+ abuse & ins]t+ use disord]s4 7b7 ,outrea* to p]sons :o inject drugs ,section #aibc7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#bc7;b77 is am5d$-- 7#a7 9 ! subsection head+1 by /rik+ reg>d+ intrav5\s sub/ance abuse & ins]t+ to p]sons :o inject drugs2 & 7#b7 by /rik+ = intrav5\s drug abuse & ins]t+ = p]sons :o inject drugs4 7c7 ,requirem5ts reg>d+ tub]culosis & human immunodefici5cy virus ,section #aibd ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#bd7 is am5d$-- 7#a7 9 subsection 7a77#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]s2 & 7,b7 9 subp>agraph 7,a71 by /rik+ su* abuse & ins]t+ su* disord]s2 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a77;,a71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]s2 7,b7 9 p>agraph 7#b71 by ins]t+ & ,prev5tion aft] ,disease ,control2 7,c7 9 p>agraph 7#c7-- 7i7 9 ! p>agraph head+1 by /rik+ abuse & ins]t+ use disord]s2 & 7ii7 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]s2 & 7,d7 9 p>agraph 7#f77;,b71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]s2 7#c7 by /rik+ subsection 7d72 & 7#d7 by r$esignat+ subsection 7e7 z subsection 7d74 7d7 ,gr\p homes ,section #aibe ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#be7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ recov]+ sub/ance abus]s & ins]t+ p]sons 9 recov]y f sub/ance use disord]s2 & 7#b7 9 subsection 7a71 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ recov]+ sub/ance abus]s & ins]t+ p]sons 9 recov]y f sub/ance use disord]s4 7e7 ,additional agreem5ts ,section #aibh ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#bh7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ 7relative to fiscal ye> #aiib72 7#b7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,pr(essional developm5t ,a fund+ agreem5t = a grant "u section #aiba is t ! ,/ate involv$ w ensure t prev5tion1 treatm5t1 & recov]y p]sonnel op]at+ 9 ! ,/ate's sub/ance use disord] prev5tion1 treatm5t1 & recov]y sy/ems h an opportunity to receive tra9+1 on an ongo+ basis1 conc]n+-- 7#a7 rec5t tr5ds 9 sub/ance use disord]s 9 ! ,/ate2 7#b7 improv$ me?ods & evid5ce-bas$ practices = provid+ sub/ance use disord] prev5tion & treatm5t s]vices2 7#c7 p]=mance-bas$ acc\ntability2 7#d7 data collection & report+ requirem5ts2 & 7#e7 any o!r matt]s t w\ld s]ve to fur!r improve ! deliv]y ( sub/ance use disord] prev5tion & treatm5t s]vices )9 ! ,/ate4 2 & 7#c7 9 subsection 7d77#a71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]s4 7f7 ,repeal ,section #aibi ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#bi7 is repeal$4 7g7 ,ma9t5ance ( ef=t ,section #aicj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#cj7 is am5d$-- 7#a7 9 subsection 7c77#a71 by /rik+ 9 ! ,/ate ju/ify ! waiv] & ins]t+ exi/ 9 ! ,/ate1 or any "p ( ! ,/ate1 to ju/ify ! waiv]2 & 7#b7 9 subsection 7d71 by ins]t+ at ! end ! foll[+3 7#c7 ,alt]native ,a ,/ate t has fail$ to comply ) ?is section & w\ld o!rwise be subject to a r$uction 9 ! ,/ate's allotm5t "u section #aiba1 may1 ^u reque/ by ! ,/ate1 9 lieu ( hav+ ! ,/ate's allotm5t "u section #aiba r$uc$1 agree to comply ) a negotiat$ agreem5t t is approv$ by ! ,secret>y & c>ri$ out 9 accordance ) guidel9es issu$ by ! ,secret>y4 ,if a ,/ate fails to ent] into or comply ) a negotiat$ agreem5t1 ! ,secret>y may take action "u ?is p>agraph or ! t]ms ( ! negotiat$ agreem5t4 4 7h7 ,re/rictions on exp5ditures ,section #aica7;b77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#ca7;b77#a77 is am5d$ by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]s4 7i7 ,application ,section #aicb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#cb7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ subsections 7c7 & 7d77#b7 & ins]t+ subsection 7c72 & 7,b7 9 p>agraph 7#e71 by /rik+ ! in=mation requir$ 9 section #aibi1 ! in=mation requir$ 9 section #aicj7;c77#b71 &2 7#b7 9 subsection 7b7-- 7,a7 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,9 ord] = a ,/ate to be 9 compliance ) subsection 7a77#f71 ! ,/ate %all submit to ! ,secret>y a plan t1 at a m9imum1 includes ! foll[+3 7,a7 ,a description ( ! ,/ate's sy/em ( c>e t-- 7i7 id5tifies ! s+le ,/ate ag5cy responsible = ! adm9i/ration ( ! program1 includ+ any ?ird p>ty :o adm9i/]s sub/ance use disord] s]vices & is responsible = comply+ ) ! requirem5ts ( ! grant2 7ii7 provides in=mation on ! ne$ = sub/ance use disord] prev5tion & treatm5t s]vices 9 ! ,/ate1 includ+ e/imates on ! numb] ( individuals :o ne$ treatm5t1 :o are pregnant wom51 wom5 ) dep5d5t *ildr51 individuals ) a co-occurr+ m5tal heal? & sub/ance use disord]1 p]sons :o inject drugs1 & p]sons :o are exp]i5c+ homelessness2 7iii7 provides aggregate in=mation on ! numb] ( individuals 9 treatm5t )9 ! ,/ate1 includ+ ! numb] ( su* individuals :o are pregnant wom51 wom5 ) dep5d5t *ildr51 individuals ) a co-occurr+ m5tal heal? & sub/ance use disord]1 p]sons :o inject drugs1 & p]sons :o are exp]i5c+ homelessness2 7iv7 provides a description ( ! sy/em t is available to provide s]vices by modality1 includ+ ! provision ( recov]y support s]vices2 7v7 provides a description ( ! ,/ate's compreh5sive /atewide prev5tion ef=ts1 includ+ ! numb] ( individuals be+ s]v$ 9 ! sy/em1 t>get populations1 & priority ne$s1 & provides a description ( ! am\nt ( funds f ! prev5tion set-aside exp5d$ on prim>y prev5tion2 7vi7 provides a description ( ! f9ancial res\rces available2 7vii7 describes ! exi/+ sub/ance use disord]s work=ce & work=ce tra9$ 9 treat+ co-occurr+ sub/ance use & m5tal disord]s2 7viii7 includes a description ( h[ ! ,/ate promotes evid5ce-bas$ practices2 & 7ix7 describes h[ ! ,/ate integrates sub/ance use disord] s]vices & prim>y heal? c>e1 :i* 9 ! case ( ^? individuals ) co-occurr+ m5tal heal? & sub/ance use disord]s may include provid+ bo? m5tal heal? & sub/ance use disord] s]vices 9 prim>y c>e sett+s or provid+ prim>y & specialty c>e s]vices 9 community-bas$ m5tal heal? & sub/ance use disord] s]vice sett+s4 7,b7 ,! e/abli%m5t ( goals & objectives = ! p]iod ( ! plan1 includ+ t>gets & mile/ones t are int5d$ to be met1 & ! activities t w be und]tak5 to a*ieve ^? t>gets4 7,c7 ,a description ( h[ ! ,/ate w comply ) ea* fund+ agreem5t = a grant "u section #aiba t is applicable to ! ,/ate1 includ+ a description ( ! mann] 9 :i* ! ,/ate int5ds to exp5d grant funds4 2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 ! p>agraph head+1 by /rik+ au?ority ( ,secret>y reg>d+ modifications & ins]t+ modifications2 7ii7 by /rik+ ,z a condition & ins]t+ ! foll[+3 7,a7 ,au?ority ( ,secret>y ,z a condition2 2 & 7iii7 by add+ at ! end ! foll[+3 7,b7 ,/ate reque/ = modification ,if ! ,/ate det]m9es t a modification to su* plan is necess>y1 ! ,/ate may reque/ ! ,secret>y to approve ! modification4 ,any su* modification %all be 9 accordance ) p>agraph 7#a7 & section #aida4 2 & 7,c7 9 p>agraph 7#c71 by ins]t+1 1 includ+ any modification "u p>agraph 7#b7 aft] subsection 7a77#f72 & 7#c7 9 subsection 7e77#b71 by /rik+ section #aibb7;c7 & ins]t+ section #aibb7;b74 7j7 ,def9itions ,section #aicd ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#cd7 is am5d$-- 7#a7 9 p>agraph 7#c71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]s2 & 7#b7 9 p>agraph 7#g71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]s4 7k7 ,fund+ ,section #aice ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#ce7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ section #eje & ins]t+ section #eje7;d72 & 7,b7 by /rik+ #b1jjj1jjj1jjj = fiscal ye> #bjja1 & su* sums z may be necess>y = ea* ( ! fiscal ye>s #bjjb & #bjjc & ins]t+ #a1heh1jgi1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb42 & 7#b7 9 subsection 7b77#a77;,b7 by /rik+ sections #eje & & ins]t+ sections #eje7;d7 &4 #hjjc4 ,additional provisions relat$ to ! block grants ,subp>t ,,iii ( "p ,b ( title ,,xix ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#ea et seq47 is am5d$-- 7#a7 9 section #aidc7;a77#c7 7#db ,u4,s4,c4 #cjjx-#ec7;a77#c771 by /rik+ section #eje & ins]t+ subsections 7c7 & 7d7 ( section #eje2 7#b7 9 section #aiec7;b7 7#db ,u4,s4,c4 #cjjx-#fc7;b771 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]2 & 7#c7 by add+ at ! end ! foll[+3 #aieg4 ,public heal? em]g5cies ,9 ! case ( a public heal? em]g5cy 7z det]m9$ "u section #cai71 ! ,secret>y1 on a ,/ate by ,/ate basis1 may1 z ! circum/ances ( ! em]g5cy reasonably require & = ! p]iod ( ! em]g5cy1 grant an ext5sion1 or waive application deadl9es or compliance ) any o!r requirem5t1 ( a grant au?oriz$ "u section #eba1 #aiaa1 or #aiba or an allotm5t au?oriz$ "u ,public ,law #ii-cai 7#db ,u4,s4,c4 #ajhja et seq474 #aieh4 ,jo9t applications ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 %all p]mit a jo9t application to be submitt$ = grants "u subp>t ,i & subp>t ,,ii ^u ! reque/ ( a ,/ate4 ,su* application may be jo9tly review$ & approv$ by ! ,secret>y ) respect to su* subp>ts1 consi/5t ) ! purposes & au?oriz$ activities ( ea* su* grant program4 ,a ,/ate submitt+ su* a jo9t application %all o!rwise meet ! requirem5ts ) respect to ea* su* subp>t4 4 #hjjd4 ,/udy ( di/ribution ( funds "u ! sub/ance abuse prev5tion & treatm5t block grant & ! community m5tal heal? s]vices block grant 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 %all ?r\gh a grant or contract1 or ?r\gh an agreem5t ) a ?ird p>ty1 conduct a /udy on ! =mulas = di/ribution ( funds "u ! sub/ance abuse prev5tion & treatm5t block grant1 & ! community m5tal heal? s]vices block grant1 "u "p ,b ( title ,,xix ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx et seq47 & recomm5d *anges if necess>y4 ,su* /udy %all include-- 7#a7 an analysis ( :e!r ! di/ributions "u su* block grants accurately reflect ! ne$ = ! s]vices "u ! grants 9 ! ,/ates2 7#b7 an exam9ation ( :e!r ! indices us$ "u ! =mulas = di/ribution ( funds "u su* block grants are appropriate1 & if n1 alt]natives recomm5d$ by ! ,secret>y2 7#c7 :]e recomm5dations are includ$ "u p>agraph 7#b7 = ! use ( diff]5t indices1 a description ( ! v>iables & data s\rces t %\ld be us$ to det]m9e ! indices2 7#d7 an evaluation ( ! v>iables & data s\rces t are be+ us$ = ea* ( ! indices involv$1 & :e!r su* v>iables & data s\rces accurately repres5t ! ne$ = s]vices1 ! co/ ( provid+ s]vices1 & ! ability ( ! ,/ates to pay = su* s]vices2 7#e7 ! effect t ! m9imum allotm5t requirem5ts = ea* su* block grant h on ea* ,/ate's f9al allotm5t & ! effect ( su* requirem5ts1 if any1 on ea* ,/ate's =mula-bas$ allotm5t2 7#f7 recomm5dations = modifications to ! m9imum allotm5t provisions to ensure an appropriate di/ribution ( funds2 & 7#g7 any o!r in=mation t ! ,secret>y det]m9es appropriate4 7b7 ,report ,n lat] ?an #b ye>s 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 ( ,repres5tatives1 a report conta9+ ! f9d+s & recomm5dations ( ! /udy conduct$ "u subsection 7a7 & ! /udy conduct$ "u section #ijjd7;g74 ,,ix ,,promot+ ,,access ,,to ,,m5tal ,,heal? ,,& ,,sub/ance ,,use ,,disord] ,,c>e ,a ,help+ ,individuals & ,families #ijja4 ,grants = treatm5t & recov]y = homeless individuals ,section #ejf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa-#e7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]2 7#b7 9 subsection 7b7-- 7,a7 9 p>agraphs 7#a7 & 7#c71 by /rik+ sub/ance abuse ea* place ! t]m appe>s & ins]t+ sub/ance use disord]2 & 7,b7 9 p>agraph 7#d71 by /rik+ sub/ance abuse & ins]t+ a sub/ance use disord]2 7#c7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a71 by /rik+ sub/ance abuse disord] & ins]t+ sub/ance use disord]2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by /rik+ sub/ance abuse & ins]t+ a sub/ance use disord]2 & 7ii7 9 subp>agraph 7,b71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]2 & 7#d7 9 subsection 7e71 by /rik+ 1 #ej1jjj1jjj = fiscal ye> #bjja1 & su* sums z may be necess>y = ea* ( ! fiscal ye>s #bjjb & #bjjc & ins]t+ #da1cjd1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 #ijjb4 ,grants = jail div]sion programs ,section #ebj;,g ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#ch7 is am5d$-- 7#a7 by /rik+ sub/ance abuse ea* place su* t]m appe>s & ins]t+ sub/ance use disord]2 7#b7 9 subsection 7a7-- 7,a7 by /rik+ ,indian tribes1 & tribal organizations & ins]t+ & ,indian tribes & tribal organizations 7z ! t]ms ,indian tribes & tribal organizations are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act72 & 7,b7 by ins]t+ or a heal? facility or program op]at$ by or 9 accordance ) a contract or grant ) ! ,indian ,heal? ,s]vice1 aft] entities12 7#c7 9 subsection 7c77#b77;,a77i71 by /rik+ ! be/ kn[n & ins]t+ evid5ce-bas$2 7#d7 by r$esignat+ subsections 7d7 ?r\gh 7i7 z subsections 7e7 ?r\gh 7j71 respectively2 7#e7 by ins]t+ aft] subsection 7c7 ! foll[+3 7d7 ,special consid]ation reg>d+ vet]ans ,9 aw>d+ grants "u subsection 7a71 ! ,secret>y %all1 z appropriate1 give special consid]ation to entities propos+ to use grant fund+ to support jail div]sion s]vices = vet]ans4 2 7#f7 9 subsection 7e71 z s r$esignat$-- 7,a7 9 p>agraph 7#c71 by /rik+ 2 & & ins]t+ a semicolon2 7,b7 9 p>agraph 7#d71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7#e7 develop programs to div]t individuals prior to book+ or arre/4 2 & 7#g7 9 subsection 7j71 z s r$esignat$1 by /rik+ #aj1jjj1jjj = fiscal ye> #bjja1 & su* sums z may be necess>y = fiscal ye>s #bjjb ?r\gh #bjjc & ins]t+ #d1bfi1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 #ijjc4 ,promot+ integration ( prim>y & behavioral heal? c>e ,section #ebj,k ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#db7 is am5d$ to read z foll[s3 #ebj,k4 ,integration inc5tive grants & coop]ative agreem5ts 7a7 ,def9itions ,9 ?is section3 7#a7 ,eligible entity ,! t]m eligible entity means a ,/ate1 or o!r appropriate ,/ate ag5cy1 9 collaboration ) #a or m qualifi$ community programs z describ$ 9 section #aiac7;b77#a7 or #a or m community heal? c5t]s z describ$ 9 section #ccj4 7#b7 ,integrat$ c>e ,! t]m integrat$ c>e means collaborative models or practices (f]+ m5tal & physical heal? s]vices1 :i* may include practices t %>e ! same space 9 ! same facility4 7#c7 ,special population ,! t]m special population means-- 7,a7 adults ) a m5tal illness :o h co-occurr+ physical heal? conditions or *ronic diseases2 7,b7 adults ) a s]i\s m5tal illness :o h co-occurr+ physical heal? conditions or *ronic diseases2 7,c7 *ildr5 & adolesc5ts ) a s]i\s emotional di/urbance ) co-occurr+ physical heal? conditions or *ronic diseases2 or 7,d7 individuals ) a sub/ance use disord]4 7b7 ,grants & coop]ative agreem5ts 7#a7 ,9 g5]al ,! ,secret>y may aw>d grants & coop]ative agreem5ts to eligible entities to support ! improvem5t ( integrat$ c>e = prim>y c>e & behavioral heal? c>e 9 accordance ) p>agraph 7#b74 7#b7 ,purposes ,a grant or coop]ative agreem5t aw>d$ "u ?is section %all be design$ to-- 7,a7 promote full integration & collaboration 9 cl9ical practices betwe5 prim>y & behavioral heal? c>e2 7,b7 support ! improvem5t ( integrat$ c>e models = prim>y c>e & behavioral heal? c>e to improve ! ov]all wellness & physical heal? /atus ( adults ) a s]i\s m5tal illness or *ildr5 ) a s]i\s emotional di/urbance2 & 7,c7 promote integrat$ c>e s]vices relat$ to scre5+1 diagnosis1 prev5tion1 & treatm5t ( m5tal & sub/ance use disord]s1 & co-occurr+ physical heal? conditions & *ronic diseases4 7c7 ,applications 7#a7 ,9 g5]al ,an eligible entity seek+ a grant or coop]ative agreem5t "u ?is section %all submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & accompani$ by su* in=mation z ! ,secret>y may require1 includ+ ! cont5ts describ$ 9 p>agraph 7#b74 7#b7 ,cont5ts ,! cont5ts describ$ 9 ?is p>agraph are-- 7,a7 a description ( a plan to a*ieve fully collaborative agreem5ts to provide s]vices to special populations2 7,b7 a docum5t t summ>izes ! policies1 if any1 t s]ve z b>ri]s to ! provision ( integrat$ c>e1 & ! specific /eps1 if applicable1 t w be tak5 to address su* b>ri]s2 7,c7 a description ( p>tn]%ips or o!r arrangem5ts ) local heal? c>e provid]s to provide s]vices to special populations2 7,d7 an agreem5t & plan to report to ! ,secret>y p]=mance measures necess>y to evaluate pati5t outcomes & facilitate evaluations across p>ticipat+ projects2 & 7,e7 a plan = su/a9ability beyond ! grant or coop]ative agreem5t p]iod "u subsection 7e74 7d7 ,grant & coop]ative agreem5t am\nts 7#a7 ,t>get am\nt ,! t>get am\nt t an eligible entity may receive = a ye> ?r\gh a grant or coop]ative agreem5t "u ?is section %all be #b1jjj1jjj4 7#b7 ,adju/m5t p]mitt$ ,! ,secret>y1 tak+ into consid]ation ! quality ( ! application & ! numb] ( eligible entities t receiv$ grants "u ?is section prior to ! date ( enactm5t ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf1 may adju/ ! t>get am\nt t an eligible entity may receive = a ye> ?r\gh a grant or coop]ative agreem5t "u ?is section4 7#c7 ,limitation ,an eligible entity receiv+ fund+ "u ?is section may n allocate m ?an #aj p]c5t ( funds aw>d$ "u ?is section to adm9i/rative functions1 & ! rema9+ am\nts %all be allocat$ to heal? facilities t provide integrat$ c>e4 7e7 ,duration ,a grant or coop]ative agreem5t "u ?is section %all be = a p]iod n to exce$ #e ye>s4 7f7 ,report on program outcomes ,an eligible entity receiv+ a grant or coop]ative agreem5t "u ?is section %all submit an annual report to ! ,secret>y t includes-- 7#a7 ! progress made to r$uce b>ri]s to integrat$ c>e z describ$ 9 ! entity's application "u subsection 7c72 & 7#b7 a description ( functional outcomes ( special populations1 includ+-- 7,a7 ) respect to adults ) a s]i\s m5tal illness1 p>ticipation 9 supportive h\s+ or indep5d5t liv+ programs1 att5dance 9 social & rehabilitative programs1 p>ticipation 9 job tra9+ opportunities1 satisfactory p]=mance 9 "w sett+s1 att5dance at s*$ul$ m$ical & m5tal heal? appo9tm5ts1 & compliance ) prescrib$ m$ication regimes2 7,b7 ) respect to individuals ) co-occurr+ m5tal illness & physical heal? conditions & *ronic diseases1 att5dance at s*$ul$ m$ical & m5tal heal? appo9tm5ts1 compliance ) prescrib$ m$ication regimes1 & p>ticipation 9 le>n+ opportunities relat$ to improv$ heal? & life/yle practices2 & 7,c7 ) respect to *ildr5 & adolesc5ts ) a s]i\s emotional di/urbance :o h co-occurr+ physical heal? conditions & *ronic diseases1 att5dance at s*$ul$ m$ical & m5tal heal? appo9tm5ts1 compliance ) prescrib$ m$ication regimes1 & p>ticipation 9 le>n+ opportunities at s*ool & extracurricul> activities4 7g7 ,te*nical assi/ance = prim>y-,behavioral heal? c>e integration 7#a7 ,9 g5]al ,! ,secret>y may provide appropriate in=mation1 tra9+1 & te*nical assi/ance to eligible entities t receive a grant or coop]ative agreem5t "u ?is section1 9 ord] to help su* entities meet ! requirem5ts ( ?is section1 includ+ assi/ance )-- 7,a7 developm5t & selection ( integrat$ c>e models2 7,b7 dissem9ation ( evid5ce-bas$ int]v5tions 9 integrat$ c>e2 7,c7 e/abli%m5t ( organizational practices to support op]ational & adm9i/rative success2 & 7,d7 o!r activities1 z ! ,secret>y det]m9es appropriate4 7#b7 ,additional dissem9ation ( te*nical in=mation ,! in=mation & res\rces provid$ by ! ,secret>y "u p>agraph 7#a7 %all1 z appropriate1 be made available to ,/ates1 political subdivisions ( ,/ates1 ,indian tribes or tribal organizations 7z def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 outpati5t m5tal heal? & addiction treatm5t c5t]s1 community m5tal heal? c5t]s t meet ! crit]ia "u section #aiac7;c71 c]tifi$ community behavioral heal? cl9ics describ$ 9 section #bbc ( ! ,protect+ ,access to ,m$ic>e ,act ( #bjad1 prim>y c>e organizations su* z ,f$]ally qualifi$ heal? c5t]s or rural heal? cl9ics z def9$ 9 section #ahfa7;aa7 ( ! ,social ,security ,act1 o!r community-bas$ organizations1 or o!r entities engag+ 9 integrat$ c>e activities1 z ! ,secret>y det]m9es appropriate4 7h7 ,au?orization ( ,appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #ea1hgh1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #ijjd4 ,projects = assi/ance 9 transition f homelessness 7a7 ,=mula grants to ,/ates ,section #eba ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;cc-#ba7 is am5d$ by /rik+ #aiia ?r\gh #aiid & ins]t+ #bjah ?r\gh #bjbb4 7b7 ,purpose ( grants ,section #ebb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;cc-#bb7 is am5d$-- 7#a7 9 subsection 7a77#a77;,b71 by /rik+ sub/ance abuse & ins]t+ a sub/ance use disord]2 7#b7 9 subsection 7b77#f71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]2 7#c7 9 subsection 7c71 by /rik+ sub/ance abuse & ins]t+ a sub/ance use disord]2 7#d7 9 subsection 7e7-- 7,a7 9 p>agraph 7#a71 by /rik+ sub/ance abuse & ins]t+ a sub/ance use disord]2 & 7,b7 9 p>agraph 7#b71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]2 7#e7 by /rik+ subsection 7g7 & r$esignat+ subsections 7h7 & 7i7 z 7g7 & 7h71 accord+ly2 & 7#f7 9 subsection 7g71 z r$esignat$ by p>agraph 7#e71 by /rik+ sub/ance abuse ea* place su* t]m appe>s & ins]t+ sub/ance use disord]4 7c7 ,description ( int5d$ exp5ditures ( grant ,section #ebg ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;cc-#bg7 is am5d$ by /rik+ sub/ance abuse ea* place su* t]m appe>s & ins]t+ sub/ance use disord]4 7d7 ,te*nical assi/ance ,section #ecj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;cc-#cj7 is am5d$ by /rik+ ?r\gh ! ,national ,in/itute ( ,m5tal ,heal?1 ! ,national ,in/itute ( ,alcohol ,abuse & ,alcoholism1 & ! ,national ,in/itute on ,drug ,abuse & ins]t+ act+ ?r\gh ! ,assi/ant ,secret>y4 7e7 ,def9itions ,section #ecd7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;cc-#cd7d77 is am5d$ to read z foll[s3 7#d7 ,sub/ance use disord] s]vices ,! t]m sub/ance use disord] s]vices has ! mean+ giv5 ! t]m sub/ance abuse s]vices 9 section #ccj7;h77#e77;,c74 4 7f7 ,fund+ ,section #ece7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;cc-#ce7;a77 is am5d$ by /rik+ #ge1jjj1jjj = ea* ( ! fiscal ye>s #bjja ?r\gh #bjjc & ins]t+ #fd1fce1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 7g7 ,/udy conc]n+ =mula 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use 7ref]r$ to 9 ?is section z ! ,assi/ant ,secret>y7 %all conduct a /udy conc]n+ ! =mula us$ "u section #ebd ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;cc-#bd7 = mak+ allotm5ts to ,/ates "u section #eba ( su* ,act 7#db ,u4,s4,c4 #bij;cc-#ba74 ,su* /udy %all include an evaluation ( quality indicators ( ne$ = purposes ( revis+ ! =mula = det]m9+ ! am\nt ( ea* allotm5t = ! fiscal ye>s foll[+ ! submission ( ! /udy4 7#b7 ,report ,9 accordance ) section #hjjd7;b71 ! ,assi/ant ,secret>y %all submit to ! committees ( ,congress describ$ 9 su* section a report conc]n+ ! results ( ! /udy conduct$ "u p>agraph 7#a74 #ijje4 ,national ,suicide ,prev5tion ,lifel9e ,program ,subp>t #c ( "p ,b ( title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#ca et seq47 is am5d$ by ins]t+ aft] section #ebj;,e-#b 7#db ,u4,s4,c4 #bij;bb-#cf;b7 ! foll[+3 #ebj;,e-#c4 ,national suicide prev5tion lifel9e program 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y1 %all ma9ta9 ! ,national ,suicide ,prev5tion ,lifel9e program 7ref]r$ to 9 ?is section z ! program71 au?oriz$ "u section #ebj;,a & 9 effect prior to ! date ( enactm5t ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf4 7b7 ,activities ,9 ma9ta9+ ! program1 ! activities ( ! ,secret>y %all include-- 7#a7 coord9at+ a network ( crisis c5t]s across ! ,unit$ ,/ates = provid+ suicide prev5tion & crisis int]v5tion s]vices to individuals seek+ help at any "t1 day or night2 7#b7 ma9ta9+ a suicide prev5tion hotl9e to l9k call]s to local em]g5cy1 m5tal heal?1 & social s]vices res\rces2 & 7#c7 consult+ ) ! ,secret>y ( ,vet]ans ,affairs to ensure t vet]ans call+ ! suicide prev5tion hotl9e h access to a specializ$ vet]ans' suicide prev5tion hotl9e4 7c7 ,au?orization ( ,appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #g1aih1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #ijjf4 ,connect+ individuals & families ) c>e ,subp>t #c ( "p ,b ( title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#ca et seq471 z am5d$ by section #ijje1 is fur!r am5d$ by ins]t+ aft] section #ebj;,e-#c ! foll[+3 #ebj;,e-#d4 ,treatm5t ref]ral r\t+ s]vice 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y1 %all ma9ta9 ! ,national ,treatm5t ,ref]ral ,r\t+ ,s]vice 7ref]r$ to 9 ?is section z ! ,r\t+ ,s]vice7 to assi/ individuals & families 9 locat+ m5tal & sub/ance use disord]s treatm5t provid]s4 7b7 ,activities ( ! secret>y ,to ma9ta9 ! ,r\t+ ,s]vice1 ! activities ( ! ,assi/ant ,secret>y %all include adm9i/]+-- 7#a7 a nationwide1 telephone numb] provid+ ye>-r\nd access to in=mation t is updat$ on a regul> basis reg>d+ local behavioral heal? provid]s & community-bas$ organizations 9 a mann] t is confid5tial1 )\t requir+ individuals to id5tify !mselves1 is 9 languages t include at lea/ ,engli% & ,spani%1 & is at no co/ to ! individual us+ ! ,r\t+ ,s]vice2 & 7#b7 an ,int]net website to provide a se>*able1 onl9e treatm5t s]vices locator ( behavioral heal? treatm5t provid]s & community-bas$ organizations1 :i* %all include in=mation on ! "n1 location1 contact in=mation1 & basic s]vices provid$ by su* provid]s & organizations4 7c7 ,remov+ practition] contact in=mation ,9 ! ev5t t ! ,int]net website describ$ 9 subsection 7b77#b7 conta9s in=mation on any qualifi$ practition] t is c]tifi$ to prescribe m$ication = opioid dep5d5cy "u section #cjc7;g77#b77;,b7 ( ! ,controll$ ,sub/ances ,act1 ! ,assi/ant ,secret>y-- 7#a7 %all provide an opportunity to su* practition] to h ! contact in=mation ( ! practition] remov$ f ! website at ! reque/ ( ! practition]2 & 7#b7 may evaluate o!r me?ods to p]iodically update ! in=mation display$ on su* website4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to prev5t ! ,assi/ant ,secret>y f us+ any unobligat$ am\nts o!rwise made available to ! ,adm9i/ration to ma9ta9 ! ,r\t+ ,s]vice4 4 #ijjg4 ,/r5g!n+ community crisis response sy/ems ,section #ebj;,f ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#cg7 is am5d$ to read z foll[s3 #ebj;,f4 ,/r5g!n+ community crisis response sy/ems 7a7 ,9 g5]al ,! ,secret>y %all aw>d competitive grants to-- 7#a7 ,/ate & local gov]nm5ts & ,indian tribes & tribal organizations1 to enhance community-bas$ crisis response sy/ems2 or 7#b7 ,/ates to develop1 ma9ta91 or enhance a database ( b$s at inpati5t psy*iatric facilities1 crisis /abilization units1 & resid5tial community m5tal heal? & resid5tial sub/ance use disord] treatm5t facilities1 = adults ) a s]i\s m5tal illness1 *ildr5 ) a s]i\s emotional di/urbance1 or individuals ) a sub/ance use disord]4 7b7 ,applications 7#a7 ,9 g5]al ,to receive a grant "u subsection 7a71 an entity %all submit to ! ,secret>y an application1 at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7#b7 ,community-bas$ crisis response plan ,an application = a grant "u subsection 7a77#a7 %all include a plan =-- 7,a7 promot+ integration & coord9ation betwe5 local public & private entities engag$ 9 crisis response1 includ+ fir/ respond]s1 em]g5cy heal? c>e provid]s1 prim>y c>e provid]s1 law en=cem5t1 c\rt sy/ems1 heal? c>e pay]s1 social s]vice provid]s1 & behavioral heal? provid]s2 7,b7 develop+ memor&a ( und]/&+ ) public & private entities to implem5t crisis response s]vices2 7,c7 address+ gaps 9 community res\rces = crisis int]v5tion & prev5tion2 & 7,d7 develop+ models = m9imiz+ hospital readmissions1 includ+ ?r\gh appropriate dis*>ge plann+4 7#c7 ,b$s database plan ,an application = a grant "u subsection 7a77#b7 %all include a plan = develop+1 ma9ta9+1 or enhanc+ a real-"t1 ,int]net-bas$ b$ database to collect1 aggregate1 & display in=mation ab\t b$s 9 inpati5t psy*iatric facilities & crisis /abilization units1 & resid5tial community m5tal heal? & resid5tial sub/ance use disord] treatm5t facilities to facilitate ! id5tification & designation ( facilities = ! tempor>y treatm5t ( individuals 9 m5tal or sub/ance use disord] crisis4 7c7 ,database requirem5ts ,a b$ database describ$ 9 ?is section is a database t-- 7#a7 includes in=mation on inpati5t psy*iatric facilities1 crisis /abilization units1 & resid5tial community m5tal heal? & resid5tial sub/ance use disord] facilities 9 ! ,/ate involv$1 includ+ contact in=mation = ! facility or unit2 7#b7 provides real-"t in=mation ab\t ! numb] ( b$s available at ea* facility or unit &1 = ea* available b$1 ! type ( pati5t t may be admitt$1 ! level ( security provid$1 & any o!r in=mation t may be necess>y to all[ = ! prop] id5tification ( appropriate facilities = treatm5t ( individuals 9 m5tal or sub/ance use disord] crisis2 & 7#c7 enables se>*es ( ! database to id5tify available b$s t are appropriate = ! treatm5t ( individuals 9 m5tal or sub/ance use disord] crisis4 7d7 ,evaluation ,an entity receiv+ a grant "u subsection 7a77#a7 %all submit to ! ,secret>y1 at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may reasonably require1 a report1 includ+ an evaluation ( ! effect ( su* grant on-- 7#a7 local crisis response s]vices & measures = individuals receiv+ crisis plann+ & e>ly int]v5tion supports2 7#b7 individuals report+ improv$ functional outcomes2 & 7#c7 individuals receiv+ regul> foll[up c>e foll[+ a crisis4 7e7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section1 #ab1ejj1jjj = ! p]iod ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #ijjh4 ,g>rett ,lee ,smi? ,memorial ,act reau?orization 7a7 ,suicide prev5tion te*nical assi/ance c5t] ,section #ebj;,c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#cd71 z am5d$ by section #fjja1 is fur!r am5d$-- 7#a7 9 ! section head+1 by /rik+ ,y\? int]ag5cy rese>*1 tra9+1 & te*nical assi/ance c5t]s & ins]t+ ,suicide prev5tion te*nical assi/ance c5t]2 7#b7 9 subsection 7a71 by /rik+ act+ ?r\gh ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use & all t foll[s ?r\gh ! p]iod at ! end ( p>agraph 7#b7 & ins]t+ act+ ?r\gh ! ,assi/ant ,secret>y1 %all e/abli% a rese>*1 tra9+1 & te*nical assi/ance res\rce c5t] to provide appropriate in=mation1 tra9+1 & te*nical assi/ance to ,/ates1 political subdivisions ( ,/ates1 f$]ally recogniz$ ,indian tribes1 tribal organizations1 in/itutions ( high] education1 public organizations1 or private nonpr(it organizations reg>d+ ! prev5tion ( suicide among all ages1 p>ticul>ly among gr\ps t are at a high risk = suicide42 7#c7 by /rik+ subsections 7b7 & 7c72 7#d7 by r$esignat+ subsection 7d7 z subsection 7b72 7#e7 9 subsection 7b71 z s r$esignat$-- 7,a7 9 ! subsection head+1 by /rik+ ,additional c5t] & ins]t+ ,responsibilities ( ! ,c5t]2 7,b7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,! additional rese>* & all t foll[s ?r\gh nonpr(it organizations = & ins]t+ ,! c5t] e/abli%$ "u subsection 7a7 %all conduct activities = ! purpose (2 7,c7 by /rik+ y\? suicide ea* place su* t]m appe>s & ins]t+ suicide2 7,d7 9 p>agraph 7#a7-- 7i7 by /rik+ ! developm5t or cont9uation ( & ins]t+ develop+ & cont9u+2 & 7ii7 by ins]t+ = all ages1 p>ticul>ly among gr\ps t are at a high risk = suicide be=e ! semicolon at ! end2 7,e7 9 p>agraph 7#b71 by ins]t+ = all ages1 p>ticul>ly among gr\ps t are at a high risk = suicide be=e ! semicolon at ! end2 7,f7 9 p>agraph 7#c71 by ins]t+ & tribal aft] /atewide2 7,g7 9 p>agraph 7#e71 by ins]t+ & prev5tion aft] int]v5tion2 7,h7 9 p>agraph 7#h71 by /rik+ 9 y\?2 7,i7 9 p>agraph 7#i71 by /rik+ & behavioral heal? & ins]t+ heal? & sub/ance use disord]2 & 7,j7 9 p>agraph 7#aj71 by ins]t+ conduct+ be=e o!r2 & 7#f7 by /rik+ subsection 7e7 & ins]t+ ! foll[+3 7c7 ,au?orization ( appropriations ,= ! purpose ( c>ry+ out ?is section1 !re are au?oriz$ to be appropriat$ #e1ihh1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 7d7 ,annual report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>y %all submit to ,congress a report on ! activities c>ri$ out by ! c5t] e/abli%$ "u subsection 7a7 dur+ ! ye> involv$1 includ+ ! pot5tial effects ( su* activities1 & ! ,/ates1 organizations1 & in/itutions t h work$ ) ! c5t]4 4 7b7 ,y\? suicide e>ly int]v5tion & prev5tion /rategies ,section #ebj;,e ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#cf7 is am5d$-- 7#a7 9 p>agraph 7#a7 ( subsection 7a7 & 9 subsection 7c71 by /rik+ sub/ance abuse ea* place su* t]m appe>s & ins]t+ sub/ance use disord]2 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b7-- 7i7 by /rik+ ensure t ea* ,/ate is aw>d$ only #a grant or coop]ative agreem5t "u ?is section & ins]t+ ensure t a ,/ate does n receive m ?an #a grant or coop]ative agreem5t "u ?is section at any #a "t2 & 7ii7 by /rik+ be5 aw>d$ & ins]t+ receiv$2 & 7,b7 by add+ aft] p>agraph 7#b7 ! foll[+3 7#c7 ,consid]ation ,9 aw>d+ grants "u ?is section1 ! ,secret>y %all take into consid]ation ! ext5t ( ! ne$ ( ! applicant1 includ+ ! incid5ce & preval5ce ( suicide 9 ! ,/ate & among ! populations ( focus1 includ+ rates ( suicide det]m9$ by ! ,c5t]s = ,disease ,control & ,prev5tion = ! ,/ate or population ( focus4 2 7#c7 9 subsection 7g77#b71 by /rik+ #b ye>s aft] ! date ( enactm5t ( ?is section1 & ins]t #b ye>s aft] ! date ( enactm5t ( ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf12 & 7#d7 by /rik+ subsection 7m7 & ins]t+ ! foll[+3 7m7 ,au?orization ( appropriations ,= ! purpose ( c>ry+ out ?is section1 !re are au?oriz$ to be appropriat$ #cj1jjj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #ijji4 ,adult suicide prev5tion ,subp>t #c ( "p ,b ( title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#ca et seq47 is am5d$ by add+ at ! end ! foll[+3 #ebj,l4 ,adult suicide prev5tion 7a7 ,grants 7#a7 ,9 g5]al ,! ,assi/ant ,secret>y %all aw>d grants to eligible entities describ$ 9 p>agraph 7#b7 to implem5t suicide prev5tion & int]v5tion programs1 = individuals :o are #be ye>s ( age or old]1 t are design$ to raise aw>5ess ( suicide1 e/abli% ref]ral processes1 & improve c>e & outcomes = su* individuals :o are at risk ( suicide4 7#b7 ,eligible entities ,to be eligible to receive a grant "u ?is section1 an entity %all be a community-bas$ prim>y c>e or behavioral heal? c>e sett+1 an em]g5cy dep>tm5t1 a ,/ate m5tal heal? ag5cy 7or ,/ate heal? ag5cy ) m5tal or behavioral heal? functions71 public heal? ag5cy1 a t]ritory ( ! ,unit$ ,/ates1 or an ,indian tribe or tribal organization 7z ! t]ms ,indian tribe & tribal organization are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act74 7#c7 ,use ( funds ,! grants aw>d$ "u p>agraph 7#a7 %all be us$ to implem5t programs1 9 accordance ) su* p>agraph1 t include "o or m ( ! foll[+ compon5ts3 7,a7 ,scre5+ = suicide risk1 suicide int]v5tion s]vices1 & s]vices = ref]ral = treatm5t = individuals at risk = suicide4 7,b7 ,implem5t+ evid5ce-bas$ practices to provide treatm5t = individuals at risk = suicide1 includ+ appropriate foll[up s]vices4 7,c7 ,rais+ aw>5ess & r$uc+ /igma ( suicide4 7b7 ,evaluations & te*nical assi/ance ,! ,assi/ant ,secret>y %all-- 7#a7 evaluate ! activities support$ by grants aw>d$ "u subsection 7a71 & dissem9ate1 z appropriate1 ! f9d+s f ! evaluation2 & 7#b7 provide appropriate in=mation1 tra9+1 & te*nical assi/ance1 z appropriate1 to eligible entities t receive a grant "u ?is section1 9 ord] to help su* entities to meet ! requirem5ts ( ?is section1 includ+ assi/ance ) selection & implem5tation ( evid5ce-bas$ int]v5tions & frameworks to prev5t suicide4 7c7 ,duration ,a grant "u ?is section %all be = a p]iod ( n m ?an #e ye>s4 7d7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section #cj1jjj1jjj = ! p]iod ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #ijaj4 ,m5tal heal? aw>5ess tra9+ grants ,section #ebj;,j ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#da7 is am5d$-- 7#a7 9 ! section head+1 by ins]t+ m5tal heal? aw>5ess be=e tra9+2 & 7#b7 9 subsection 7b7-- 7,a7 9 ! subsection head+1 by /rik+ illness & ins]t+ heal?2 7,b7 9 p>agraph 7#a71 by ins]t+ vet]ans1 law en=cem5t1 & o!r categories ( individuals1 z det]m9$ by ! ,secret>y1 aft] em]g5cy s]vices p]sonnel2 7,c7 9 p>agraph 7#e7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ to & ins]t+ = evid5ce-bas$ programs t provide tra9+ & education 9 accordance ) p>agraph 7#a7 on matt]s includ+2 & 7ii7 by /rik+ subp>agraphs 7,a7 ?r\gh 7,c7 & ins]t+ ! foll[+3 7,a7 recogniz+ ! signs & symptoms ( m5tal illness2 & 7,b7 7i7 res\rces available 9 ! community = individuals ) a m5tal illness & o!r relevant res\rces2 or 7ii7 safely de-escalat+ crisis situations involv+ individuals ) a m5tal illness4 2 & 7,d7 9 p>agraph 7#g71 by /rik+ 1 #be1jjj1jjj & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ #ad1fic1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb44 #ijaa4 ,s5se ( ,congress on prioritiz+ ,am]ican ,indians & ,alaska ,native y\? )9 suicide prev5tion programs 7a7 ,f9d+s ,! ,congress f9ds z foll[s3 7#a7 ,suicide is ! eigh? lead+ cause ( dea? among ,am]ican ,indians & ,alaska ,natives across all ages4 7#b7 ,among ,am]ican ,indians & ,alaska ,natives :o are #aj to #cd ye>s ( age1 suicide is ! second lead+ cause ( dea?4 7#c7 ,! suicide rate among ,am]ican ,indian & ,alaska ,native adolesc5ts & "y adults ages #ae to #cd 7#ag4i p] #ajj1jjj7 is approximately #a4c times high] ?an ! national av]age = t age gr\p 7#ac4c p] #ajj1jjj74 7b7 ,s5se ( congress ,x is ! s5se ( ,congress t ! ,secret>y ( ,heal? & ,human ,s]vices1 9 c>ry+ out suicide prev5tion & int]v5tion programs1 %\ld prioritize programs & activities = populations ) disproportionately high rates ( suicide1 su* z ,am]ican ,indians & ,alaska ,natives4 #ijab4 ,evid5ce-bas$ practices = old] adults ,section #ebj;,a7e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#cb7;e77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,g]iatric m5tal disord]s ,! ,secret>y %all1 z appropriate1 provide te*nical assi/ance to grantees reg>d+ evid5ce-bas$ practices = ! prev5tion & treatm5t ( g]iatric m5tal disord]s & co-occurr+ m5tal heal? & sub/ance use disord]s among g]iatric populations1 z well z dissem9ate in=mation ab\t su* evid5ce-bas$ practices to ,/ates & nongrantees ?r\gh\t ! ,unit$ ,/ates4 4 #ijac4 ,national viol5t dea? report+ sy/em ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 is enc\rag$ to improve1 p>ticul>ly ?r\gh ! inclusion ( additional ,/ates1 ! ,national ,viol5t ,dea? ,report+ ,sy/em z au?oriz$ by title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq474 ,p>ticipation 9 ! sy/em by ! ,/ates %all be volunt>y4 #ijad4 ,assi/$ outpati5t treatm5t ,section #bbd ( ! ,protect+ ,access to ,m$ic>e ,act ( #bjad 7#db ,u4,s4,c4 #bij;aa note7 is am5d$-- 7#a7 9 subsection 7e71 by /rik+ & #bjah1 & ins]t+ #bjah1 #bjai1 #bjbj1 #bjba1 & #bjbb12 & 7#b7 9 subsection 7g7-- 7,a7 9 p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbb2 & 7,b7 9 p>agraph 7#b71 by /rik+ is au?oriz$ to be appropriat$ to c>ry out ?is section #ae1jjj1jjj = ea* ( fiscal ye>s #bjae ?r\gh #bjah & ins]t+ are au?oriz$ to be appropriat$ to c>ry out ?is section #ae1jjj1jjj = ea* ( fiscal ye>s #bjae ?r\gh #bjag1 #bj1jjj1jjj = fiscal ye> #bjah1 #ai1jjj1jjj = ea* ( fiscal ye>s #bjai & #bjbj1 & #ah1jjj1jjj = ea* ( fiscal ye>s #bjba & #bjbb4 #ijae4 ,ass]tive community treatm5t grant program ,"p ,b ( title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb et seq471 z am5d$ by section #ijji1 is fur!r am5d$ by add+ at ! end ! foll[+3 #ebj,m4 ,ass]tive community treatm5t grant program 7a7 ,9 g5]al ,! ,assi/ant ,secret>y %all aw>d grants to eligible entities-- 7#a7 to e/abli% ass]tive community treatm5t programs = adults ) a s]i\s m5tal illness2 or 7#b7 to ma9ta9 or exp& su* programs4 7b7 ,eligible entities ,to be eligible to receive a grant "u ?is section1 an entity %all be a ,/ate1 political subdivision ( a ,/ate1 ,indian tribe or tribal organization 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 m5tal heal? sy/em1 heal? c>e facility1 or any o!r entity ! ,assi/ant ,secret>y deems appropriate4 7c7 ,special consid]ation ,9 select+ among applicants = a grant "u ?is section1 ! ,assi/ant ,secret>y may give special consid]ation to ! pot5tial ( ! applicant's program to r$uce hospitalization1 homelessness1 & involvem5t ) ! crim9al ju/ice sy/em :ile improv+ ! heal? & social outcomes ( ! pati5t4 7d7 ,additional activities ,! ,assi/ant ,secret>y %all-- 7#a7 n lat] ?an ! end ( fiscal ye> #bjba1 submit a report to ! appropriate congressional committees on ! grant program "u ?is section1 includ+ an evaluation (-- 7,a7 any co/ sav+s & public heal? outcomes su* z mortality1 suicide1 sub/ance use disord]s1 hospitalization1 & use ( s]vices2 7,b7 rates ( involvem5t ) ! crim9al ju/ice sy/em ( pati5ts2 7,c7 rates ( homelessness among pati5ts2 & 7,d7 pati5t & family satisfaction ) program p>ticipation2 & 7#b7 provide appropriate in=mation1 tra9+1 & te*nical assi/ance to grant recipi5ts "u ?is section to help su* recipi5ts to e/abli%1 ma9ta91 or exp& _! ass]tive community treatm5t programs4 7e7 ,au?orization ( appropriations 7#a7 ,9 g5]al ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #e1jjj1jjj = ! p]iod ( fiscal ye>s #bjah ?r\gh #bjbb4 7#b7 ,use ( c]ta9 funds ,( ! funds appropriat$ to c>ry out ?is section 9 any fiscal ye>1 n m ?an #e p]c5t %all be available to ! ,assi/ant ,secret>y = c>ry+ out subsection 7d74 4 #ijaf4 ,sob] tru? on prev5t+ und]age dr9k+ reau?orization ,section #eai;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#be;b7 is am5d$-- 7#a7 9 subsection 7c77#c71 by /rik+ fiscal ye> #bjjg & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ea* ( ! fiscal ye>s #bjah ?r\gh #bjbb42 7#b7 9 subsection 7d77#d71 by /rik+ fiscal ye> #bjjg & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ea* ( ! fiscal ye>s #bjah ?r\gh #bjbb42 7#c7 9 subsection 7e77#a77;,i71 by /rik+ fiscal ye> #bjjg & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ea* ( ! fiscal ye>s #bjah ?r\gh #bjbb42 7#d7 9 subsection 7f77#b71 by /rik+ #f1jjj1jjj = fiscal ye> #bjjg & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ #c1jjj1jjj = ea* ( ! fiscal ye>s #bjah ?r\gh #bjbb2 & 7#e7 by add+ at ! end ! foll[+ new subsection3 7g7 ,r$uc+ und]age dr9k+ ?r\gh scre5+ & brief int]v5tion 7#a7 ,grants to p$iatric heal? c>e provid]s to r$uce und]age dr9k+ ,! ,assi/ant ,secret>y may make grants to eligible entities to increase implem5tation ( practices = r$uc+ ! preval5ce ( alcohol use among individuals "u ! age ( #ba1 includ+ college /ud5ts4 7#b7 ,purposes ,grants "u ?is subsection %all be made to improve-- 7,a7 scre5+ *ildr5 & adolesc5ts = alcohol use2 7,b7 (f]+ brief int]v5tions to *ildr5 & adolesc5ts to disc\rage su* use2 7,c7 educat+ p>5ts ab\t ! dang]s (1 & me?ods ( disc\rag+1 su* use2 7,d7 diagnos+ & treat+ alcohol use disord]s2 & 7,e7 ref]r+ pati5ts1 :5 necess>y1 to o!r appropriate c>e4 7#c7 ,use ( funds ,an entity receiv+ a grant "u ?is subsection may use su* fund+ = ! purposes id5tifi$ 9 p>agraph 7#b7 by-- 7,a7 provid+ tra9+ to heal? c>e provid]s2 7,b7 dissem9at+ be/ practices1 includ+ culturally & l+ui/ically appropriate be/ practices1 z appropriate1 & develop+ & di/ribut+ mat]ials2 & 7,c7 support+ o!r activities1 z det]m9$ appropriate by ! ,assi/ant ,secret>y4 7#d7 ,application ,to be eligible to receive a grant "u ?is subsection1 an entity %all submit an application to ! ,assi/ant ,secret>y at su* "t1 & 9 su* mann]1 & accompani$ by su* in=mation z ! ,assi/ant ,secret>y may require4 ,ea* application %all include-- 7,a7 a description ( ! entity2 7,b7 a description ( activities to be complet$2 7,c7 a description ( h[ ! s]vices specifi$ 9 p>agraphs 7#b7 & 7#c7 w be c>ri$ out & ! qualifications = provid+ su* s]vices2 & 7,d7 a timel9e = ! completion ( su* activities4 7#e7 ,def9itions ,= ! purpose ( ?is subsection3 7,a7 ,brief int]v5tion ,! t]m brief int]v5tion means1 aft] scre5+ a pati5t1 provid+ ! pati5t ) brief advice & o!r brief motivational enhancem5t te*niques design$ to increase ! insight ( ! pati5t reg>d+ ! pati5t's alcohol use1 & any realiz$ or pot5tial consequ5ces ( su* use1 to effect ! desir$ relat$ behavioral *ange4 7,b7 ,*ildr5 & adolesc5ts ,! t]m *ildr5 & adolesc5ts means any p]son "u #ba ye>s ( age4 7,c7 ,eligible entity ,! t]m eligible entity means an entity consi/+ ( p$iatric heal? c>e provid]s & t is qualifi$ to support or provide ! activities id5tifi$ 9 p>agraph 7#b74 7,d7 ,p$iatric heal? c>e provid] ,! t]m p$iatric heal? c>e provid] means a provid] ( prim>y heal? c>e to individuals "u ! age ( #ba ye>s4 7,e7 ,scre5+ ,! t]m scre5+ means us+ validat$ pati5t int]view te*niques to id5tify & assess ! exi/5ce & ext5t ( alcohol use 9 a pati5t4 4 #ijag4 ,c5t] & program repeals ,"p ,b ( title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb et seq47 is am5d$ by /rik+ section #ejf;,b 7#db ,u4,s4,c4 #bij;aa-#e;b71 ! second section #ead 7#db ,u4,s4,c4 #bij;bb-#i7 relat+ to me?amphetam9e & amphetam9e treatm5t initiatives1 & ea* ( sections #ead;,a1 #eag1 #eai;,a1 #eai;,c1 #eai;,e1 #ebj;,b1 #ebj;,d1 & #ebj;,h 7#db ,u4,s4,c4 #bij;bb-#h1 #bij;bb-#bc1 #bij;bb-#be;a1 #bij;bb-#be;c1 #bij;bb-#be;e1 #bij;bb-#cc1 #bij;bb-#ce1 & #bij;bb-#ci74 ,b ,/r5g!n+ ! ,heal? ,c>e ,work=ce #ijba4 ,m5tal & behavioral heal? education & tra9+ grants ,section #gef ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bid;e-#a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ( high] education2 & 7,b7 by /rik+ p>agraphs 7#a7 ?r\gh 7#d7 & ins]t+ ! foll[+3 7#a7 accr$it$ in/itutions ( high] education or accr$it$ pr(essional tra9+ programs t are e/abli%+ or exp&+ int]n%ips or o!r field placem5t programs 9 m5tal heal? 9 psy*iatry1 psy*ology1 s*ool psy*ology1 behavioral p$iatrics1 psy*iatric nurs+ 7:i* may include ma/]'s & doctoral level programs71 social "w1 s*ool social "w1 sub/ance use disord] prev5tion & treatm5t1 m>riage & family !rapy1 occupational !rapy1 s*ool c\nsel+1 or pr(essional c\nsel+1 includ+ su* programs ) a focus on *ild & adolesc5t m5tal heal? & transitional-age y\?2 7#b7 accr$it$ doctoral1 int]n%ip1 & po/-doctoral resid5cy programs ( heal? s]vice psy*ology 7includ+ cl9ical psy*ology1 c\nsel+1 & s*ool psy*ology7 = ! developm5t & implem5tation ( int]discipl9>y tra9+ ( psy*ology graduate /ud5ts = provid+ behavioral heal? s]vices1 includ+ sub/ance use disord] prev5tion & treatm5t s]vices1 z well z ! developm5t ( faculty 9 heal? s]vice psy*ology2 7#c7 accr$it$ ma/]'s & doctoral degree programs ( social "w = ! developm5t & implem5tation ( int]discipl9>y tra9+ ( social "w graduate /ud5ts = provid+ behavioral heal? s]vices1 includ+ sub/ance use disord] prev5tion & treatm5t s]vices1 & ! developm5t ( faculty 9 social "w2 & 7#d7 ,/ate-lic5s$ m5tal heal? nonpr(it & =-pr(it organizations to enable su* organizations to pay = programs = pres]vice or 9-s]vice tra9+ 9 a behavioral heal?-relat$ p>apr(essional field ) pref]5ce = pres]vice or 9-s]vice tra9+ ( p>apr(essional *ild & adolesc5t m5tal heal? work]s4 2 7#b7 9 subsection 7b7-- 7,a7 by /rik+ p>agraph 7#e72 7,b7 by r$esignat+ p>agraphs 7#a7 ?r\gh 7#d7 z p>agraphs 7#b7 ?r\gh 7#e71 respectively2 7,c7 by ins]t+ be=e p>agraph 7#b71 z s r$esignat$1 ! foll[+3 7#a7 an ability to recruit & place ! /ud5ts describ$ 9 subsection 7a7 9 areas ) a high ne$ & high dem& population2 2 7,d7 9 p>agraph 7#c71 z s r$esignat$1 by /rik+ subsection 7a7 & ins]t+ p>agraph 7#b71 especially individuals ) m5tal disord] symptoms or diagnoses1 p>ticul>ly *ildr5 & adolesc5ts1 & transitional-age y\?2 7,e7 9 p>agraph 7#d71 z s r$esignat$1 by /rik+ 2 & ins]t+ 2 &2 & 7,f7 9 p>agraph 7#e71 z s r$esignat$1 by /rik+ 2 & & ins]t+ a p]iod2 7#c7 9 subsection 7c71 by /rik+ au?oriz$ "u subsection 7a77#a7 & ins]t+ aw>d$ "u p>agraphs 7#b7 & 7#c7 ( subsection 7a72 7#d7 by am5d+ subsection 7d7 to read z foll[s3 7d7 ,priority ,9 select+ grant recipi5ts "u ?is section1 ! ,secret>y %all give priority to-- 7#a7 programs t h demon/rat$ ! ability to tra9 psy*ology1 psy*iatry1 & social "w pr(essionals to "w 9 integrat$ c>e sett+s = purposes ( recipi5ts "u p>agraphs 7#a71 7#b71 & 7#c7 ( subsection 7a72 & 7#b7 programs = p>apr(essionals t emphasize ! role ( ! family & ! liv$ exp]i5ce ( ! consum] & family-p>apr(essional p>tn]%ips = purposes ( recipi5ts "u subsection 7a77#d74 2 & 7#e7 by /rik+ subsection 7e7 & ins]t+ ! foll[+3 7e7 ,report to ,congress ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf1 ! ,secret>y %all include 9 ! bi5nial report submitt$ to ,congress "u section #eja7m7 an assessm5t on ! effectiv5ess ( ! grants "u ?is section 9-- 7#a7 provid+ graduate /ud5ts support = exp]i5tial tra9+ 7int]n%ip or field placem5t72 7#b7 recruit+ /ud5ts int]e/$ 9 behavioral heal? practice2 7#c7 recruit+ /ud5ts 9 accordance ) subsection 7b77#a72 7#d7 develop+ & implem5t+ int]pr(essional tra9+ & integration )9 prim>y c>e2 7#e7 develop+ & implem5t+ accr$it$ field placem5ts & int]n%ips2 & 7#f7 collect+ data on ! numb] ( /ud5ts tra9$ 9 behavioral heal? c>e & ! numb] ( available accr$it$ int]n%ips & field placem5ts4 7f7 ,au?orization ( appropriations ,= ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 !re are au?oriz$ to be appropriat$ to c>ry out ?is section #ej1jjj1jjj1 to be allocat$ z foll[s3 7#a7 ,= grants describ$ 9 subsection 7a77#a71 #ae1jjj1jjj4 7#b7 ,= grants describ$ 9 subsection 7a77#b71 #ae1jjj1jjj4 7#c7 ,= grants describ$ 9 subsection 7a77#c71 #aj1jjj1jjj4 7#d7 ,= grants describ$ 9 subsection 7a77#d71 #aj1jjj1jjj4 4 #ijbb4 ,/r5g!n+ ! m5tal & sub/ance use disord]s work=ce ,"p ,d ( title ,,vii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bid et seq47 is am5d$ by add+ at ! end ! foll[+3 #gfj4 ,tra9+ demon/ration program 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a tra9+ demon/ration program to aw>d grants to eligible entities to support-- 7#a7 tra9+ = m$ical resid5ts & fell[s to practice psy*iatry & addiction m$ic9e 9 und]s]v$1 community-bas$ sett+s t integrate prim>y c>e ) m5tal & sub/ance use disord]s prev5tion & treatm5t s]vices2 7#b7 tra9+ = nurse practition]s1 physician assi/ants1 heal? s]vice psy*ologi/s1 & social work]s to provide m5tal & sub/ance use disord]s s]vices 9 und]s]v$ community-bas$ sett+s t integrate prim>y c>e & m5tal & sub/ance use disord]s s]vices2 & 7#c7 e/abli%+1 ma9ta9+1 or improv+ academic units or programs t-- 7,a7 provide tra9+ = /ud5ts or faculty1 includ+ ?r\gh cl9ical exp]i5ces & rese>*1 to improve ! ability to be able to recognize1 diagnose1 & treat m5tal & sub/ance use disord]s1 ) a special focus on addiction2 or 7,b7 develop evid5ce-bas$ practices or recomm5dations = ! design ( ! units or programs describ$ 9 subp>agraph 7,a71 includ+ curriculum cont5t /&>ds4 7b7 ,activities 7#a7 ,tra9+ = resid5ts & fell[s ,a recipi5t ( a grant "u subsection 7a77#a7-- 7,a7 %all use ! grant funds-- 7i7 7,i7 to plan1 develop1 & op]ate a tra9+ program = m$ical psy*iatry resid5ts & fell[s 9 addiction m$ic9e practic+ 9 eligible entities describ$ 9 subsection 7c77#a72 or 7,,ii7 to tra9 new psy*iatric resid5ts & fell[s 9 addiction m$ic9e to provide & exp& access to integrat$ m5tal & sub/ance use disord]s s]vices2 & 7ii7 to provide at lea/ #a tra9+ track t is-- 7,i7 a virtual tra9+ track t includes an 9-p]son rotation at a tea*+ heal? c5t] or 9 a community-bas$ sett+1 foll[$ by a virtual rotation 9 :i* ! resid5t or fell[ cont9ues to support ! c>e ( pati5ts at ! tea*+ heal? c5t] or 9 ! community-bas$ sett+ ?r\gh ! use ( heal? in=mation te*nology &1 z appropriate1 teleheal? s]vices2 7,,ii7 an 9-p]son tra9+ track t includes a rotation1 dur+ :i* ! resid5t or fell[ practices at a tea*+ heal? c5t] or 9 a community-bas$ sett+2 or 7,,iii7 an 9-p]son tra9+ track t includes a rotation dur+ :i* ! resid5t practices 9 a community-bas$ sett+ t specializes 9 ! treatm5t ( infants1 *ildr51 adolesc5ts1 or pregnant or po/p>tum wom52 & 7,b7 may use ! grant funds to provide additional support = ! adm9i/ration ( ! program or to meet ! co/s ( projects to e/abli%1 ma9ta91 or improve faculty developm5t1 or dep>tm5ts1 divisions1 or o!r units necess>y to implem5t su* tra9+4 7#b7 ,tra9+ = o!r provid]s ,a recipi5t ( a grant "u subsection 7a77#b7-- 7,a7 %all use ! grant funds to plan1 develop1 or op]ate a tra9+ program to provide m5tal & sub/ance use disord]s s]vices 9 und]s]v$1 community-bas$ sett+s1 z appropriate1 t integrate prim>y c>e & m5tal & sub/ance use disord]s prev5tion & treatm5t s]vices2 & 7,b7 may use ! grant funds to provide additional support = ! adm9i/ration ( ! program or to meet ! co/s ( projects to e/abli%1 ma9ta91 or improve faculty developm5t1 or dep>tm5ts1 divisions1 or o!r units necess>y to implem5t su* program4 7#c7 ,academic units or programs ,a recipi5t ( a grant "u subsection 7a77#c7 %all ent] into a p>tn]%ip ) organizations su* z an education accr$it+ organization 7su* z ! ,liaison ,committee on ,m$ical ,education1 ! ,accr$itation ,c\ncil = ,graduate ,m$ical ,education1 ! ,commission on ,o/eopa?ic ,college ,accr$itation1 ! ,accr$itation ,commission = ,education 9 ,nurs+1 ! ,commission on ,collegiate ,nurs+ ,education1 ! ,accr$itation ,c\ncil = ,ph>macy ,education1 ! ,c\ncil on ,social ,"w ,education1 ,am]ican ,psy*ological ,association ,commission on ,accr$itation1 or ! ,accr$itation ,review ,commission on ,education = ! ,physician ,assi/ant7 to c>ry out activities "u subsection 7a77#c74 7c7 ,eligible entities 7#a7 ,tra9+ = resid5ts & fell[s ,to be eligible to receive a grant "u subsection 7a77#a71 an entity %all-- 7,a7 be a consortium consi/+ (-- 7i7 at lea/ "o tea*+ heal? c5t]2 & 7ii7 ! sponsor+ in/itution 7or p>5t in/itution ( ! sponsor+ in/itution7 (-- 7,i7 a psy*iatry resid5cy program t is accr$it$ by ! ,accr$itation ,c\ncil ( ,graduate ,m$ical ,education 7or ! p>5t in/itution ( su* a program72 or 7,,ii7 a fell[%ip 9 addiction m$ic9e1 z det]m9$ appropriate by ! ,secret>y2 or 7,b7 be an entity describ$ 9 subp>agraph 7,a77ii7 t provides opportunities = resid5ts or fell[s to tra9 9 community-bas$ sett+s t integrate prim>y c>e ) m5tal & sub/ance use disord]s prev5tion & treatm5t s]vices4 7#b7 ,tra9+ = o!r provid]s ,to be eligible to receive a grant "u subsection 7a77#b71 an entity %all be-- 7,a7 a tea*+ heal? c5t] 7z def9$ 9 section #gdi;,a7f772 7,b7 a ,f$]ally qualifi$ heal? c5t] 7z def9$ 9 section #aije7l77#b77;,b7 ( ! ,social ,security ,act72 7,c7 a community m5tal heal? c5t] 7z def9$ 9 section #ahfa7;ff77#c77;,b7 ( ! ,social ,security ,act72 7,d7 a rural heal? cl9ic 7z def9$ 9 section #ahfa7;aa7 ( ! ,social ,security ,act72 7,e7 a heal? c5t] op]at$ by ! ,indian ,heal? ,s]vice1 an ,indian tribe1 a tribal organization1 or an urban ,indian organization 7z def9$ 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act72 or 7,f7 an entity ) a demon/rat$ record ( success 9 provid+ tra9+ = nurse practition]s1 physician assi/ants1 heal? s]vice psy*ologi/s1 & social work]s4 7#c7 ,academic units or programs ,to be eligible to receive a grant "u subsection 7a77#c71 an entity %all be a s*ool ( m$ic9e or o/eopa?ic m$ic9e1 a nurs+ s*ool1 a physician assi/ant tra9+ program1 a s*ool ( ph>macy1 a s*ool ( social "w1 an accr$it$ public or nonpr(it private hospital1 an accr$it$ m$ical resid5cy program1 or a public or private nonpr(it entity :i* ! ,secret>y has det]m9$ is capable ( c>ry+ out su* grant4 7d7 ,priority 7#a7 ,9 g5]al ,9 aw>d+ grants "u subsection 7a77#a7 or 7a77#b71 ! ,secret>y %all give priority to eligible entities t-- 7,a7 demon/rate suffici5t size1 scope1 & capacity to und]take ! requisite tra9+ ( an appropriate numb] ( psy*iatric resid5ts1 fell[s1 nurse practition]s1 physician assi/ants1 or social work]s 9 addiction m$ic9e p] ye> to meet ! ne$s ( ! area s]v$2 7,b7 demon/rate exp]i5ce 9 tra9+ provid]s to practice team-bas$ c>e t integrates m5tal & sub/ance use disord] prev5tion & treatm5t s]vices ) prim>y c>e 9 community-bas$ sett+s2 7,c7 demon/rate exp]i5ce 9 us+ heal? in=mation te*nology &1 z appropriate1 teleheal? to support-- 7i7 ! deliv]y ( m5tal & sub/ance use disord]s s]vices at ! eligible entities describ$ 9 subsections 7c77#a7 & 7c77#b72 & 7ii7 community heal? c5t]s 9 integrat+ prim>y c>e & m5tal & sub/ance use disord]s treatm5t2 or 7,d7 h ! capacity to exp& access to m5tal & sub/ance use disord]s s]vices 9 areas ) demon/rat$ ne$1 z det]m9$ by ! ,secret>y1 su* z tribal1 rural1 or o!r und]s]v$ communities4 7#b7 ,academic units or programs ,9 aw>d+ grants "u subsection 7a77#c71 ! ,secret>y %all give priority to eligible entities t-- 7,a7 h a record ( tra9+ ! greate/ p]c5tage ( m5tal & sub/ance use disord]s provid]s :o ent] & rema9 9 ^! fields or :o ent] & rema9 9 sett+s ) integrat$ prim>y c>e & m5tal & sub/ance use disord] prev5tion & treatm5t s]vices2 7,b7 h a record ( tra9+ individuals :o are f und]repres5t$ m9ority gr\ps1 includ+ native populations1 or f a rural or disadvantag$ backgr\nd2 7,c7 provide tra9+ 9 ! c>e ( vuln]able populations su* z infants1 *ildr51 adolesc5ts1 pregnant & po/p>tum wom51 old] adults1 homeless individuals1 victims ( abuse or trauma1 individuals ) disabilities1 & o!r gr\ps z def9$ by ! ,secret>y2 7,d7 tea* tra9ees ! skills to provide int]pr(essional1 integrat$ c>e ?r\gh collaboration among heal? pr(essionals2 or 7,e7 provide tra9+ 9 cultural compet5cy & heal? lit]acy4 7e7 ,duration ,grants aw>d$ "u ?is section %all be = a m9imum ( #e ye>s4 7f7 ,/udy & report 7#a7 ,/udy 7,a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 %all conduct a /udy on ! results ( ! demon/ration program "u ?is section4 7,b7 ,data submission ,n lat] ?an #ij days aft] ! completion ( ! fir/ ye> ( ! tra9+ program & ea* subsequ5t ye> t ! program is 9 effect1 ea* recipi5t ( a grant "u subsection 7a7 %all submit to ! ,secret>y su* data z ! ,secret>y may require = analysis = ! report describ$ 9 p>agraph 7#b74 7#b7 ,report to congress ,n lat] ?an #a ye> aft] receipt ( ! data describ$ 9 p>agraph 7#a77;,b71 ! ,secret>y %all submit to ,congress a report t includes-- 7,a7 an analysis ( ! effect ( ! demon/ration program "u ?is section on ! quality1 quantity1 & di/ribution ( m5tal & sub/ance use disord]s s]vices2 7,b7 an analysis ( ! effect ( ! demon/ration program on ! preval5ce ( untreat$ m5tal & sub/ance use disord]s 9 ! surr\nd+ communities ( heal? c5t]s p>ticipat+ 9 ! demon/ration2 & 7,c7 recomm5dations on :e!r ! demon/ration program %\ld be exp&$4 7g7 ,au?orization ( ,appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section #aj1jjj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #ijbc4 ,cl>ification on curr5t eligibility = loan repaym5t programs ,! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration %all cl>ify ! eligibility pursuant to section #cch;,b7b77#a77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bedl-#a7;b77#a77;,b77 ( *ild & adolesc5t psy*iatri/s = ! ,national ,heal? ,s]vice ,corps ,loan ,repaym5t ,program "u subp>t ,,iii ( "p ,d ( title ,,iii ( su* ,act 7#db ,u4,s4,c4 #bedl et seq474 #ijbd4 ,m9ority fell[%ip program ,title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa et seq47 is am5d$ by add+ at ! end ! foll[+3 ,k ,,m9ority ,,fell[%ip ,,program #eig4 ,fell[%ips 7a7 ,9 g5]al ,! ,secret>y %all ma9ta9 a program1 to be kn[n z ! ,m9ority ,fell[%ip ,program1 "u :i* ! ,secret>y %all aw>d fell[%ips1 :i* may include /ip5ds1 = ! purposes (-- 7#a7 increas+ ! k ( m5tal & sub/ance use disord]s practition]s on issues relat$ to prev5tion1 treatm5t1 & recov]y support = individuals :o are f racial & e?nic m9ority populations & :o h a m5tal or sub/ance use disord]2 7#b7 improv+ ! quality ( m5tal & sub/ance use disord] prev5tion & treatm5t s]vices deliv]$ to racial & e?nic m9ority populations2 & 7#c7 increas+ ! numb] ( culturally compet5t m5tal & sub/ance use disord]s pr(essionals :o tea*1 adm9i/] s]vices1 conduct rese>*1 & provide direct m5tal or sub/ance use disord] s]vices to racial & e?nic m9ority populations4 7b7 ,tra9+ cov]$ ,! fell[%ips aw>d$ "u subsection 7a7 %all be = po/baccalaureate tra9+ 7includ+ = ma/]'s & doctoral degrees7 = m5tal & sub/ance use disord] treatm5t pr(essionals1 includ+ 9 ! fields ( psy*iatry1 nurs+1 social "w1 psy*ology1 m>riage & family !rapy1 m5tal heal? c\nsel+1 & sub/ance use disord] & addiction c\nsel+4 7c7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #ab1ffi1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #ijbe4 ,liability protections = heal? pr(essional volunte]s at community heal? c5t]s ,section #bbd ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcc7 is am5d$ by add+ at ! end ! foll[+3 7q7 7#a7 ,= purposes ( ?is section1 a heal? pr(essional volunte] at a deem$ entity describ$ 9 subsection 7g77#d7 %all1 9 provid+ a heal? pr(essional s]vice eligible = fund+ "u section #ccj to an individual1 be deem$ to be an employee ( ! ,public ,heal? ,s]vice = a cal5d> ye> t beg9s dur+ a fiscal ye> = :i* a transf] 0 made "u p>agraph 7#d77;,c74 ,! prec$+ s5t5ce is subject to ! provisions ( ?is subsection4 7#b7 ,9 provid+ a heal? s]vice to an individual1 a heal? c>e practition] %all = purposes ( ?is subsection be consid]$ to be a heal? pr(essional volunte] at an entity describ$ 9 subsection 7g77#d7 if ! foll[+ conditions are met3 7,a7 ,! s]vice is provid$ to ! individual at ! facilities ( an entity describ$ 9 subsection 7g77#d71 or ?r\gh (fsite programs or ev5ts c>ri$ out by ! entity4 7,b7 ,! entity is sponsor+ ! heal? c>e practition] pursuant to p>agraph 7#c77;,b74 7,c7 ,! heal? c>e practition] does n receive any comp5sation = ! s]vice f ! individual1 ! entity describ$ 9 subsection 7g77#d71 or any ?ird-p>ty pay] 7includ+ reimbursem5t "u any insurance policy or heal? plan1 or "u any ,f$]al or ,/ate heal? b5efits program71 except t ! heal? c>e practition] may receive repaym5t f ! entity describ$ 9 subsection 7g77#d7 = reasonable exp5ses incurr$ by ! heal? c>e practition] 9 ! provision ( ! s]vice to ! individual1 :i* may include travel exp5ses to or f ! site ( s]vices4 7,d7 ,be=e ! s]vice is provid$1 ! heal? c>e practition] or ! entity describ$ 9 subsection 7g77#d7 po/s a cle> & conspicu\s notice at ! site :]e ! s]vice is provid$ ( ! ext5t to :i* ! legal liability ( ! heal? c>e practition] is limit$ pursuant to ?is subsection4 7,e7 ,at ! "t ! s]vice is provid$1 ! heal? c>e practition] is lic5s$ or c]tifi$ 9 accordance ) applicable ,f$]al & ,/ate laws reg>d+ ! provision ( ! s]vice4 7,f7 ,at ! "t ! s]vice is provid$1 ! entity describ$ 9 subsection 7g77#d7 ma9ta9s relevant docum5tation c]tify+ t ! heal? c>e practition] meets ! requirem5ts ( ?is subsection4 7#c7 ,subsection 7g7 7o!r ?an p>agraphs 7#c7 & 7#e77 & subsections 7h71 7i71 & 7l7 apply to a heal? c>e practition] = purposes ( ?is subsection to ! same ext5t & 9 ! same mann] z su* subsections apply to an (fic]1 gov]n+ bo>d memb]1 employee1 or contractor ( an entity describ$ 9 subsection 7g77#d71 subject to p>agraph 7#d71 & subject to ! foll[+3 7,a7 ,! fir/ s5t5ce ( p>agraph 7#a7 applies 9 lieu ( ! fir/ s5t5ce ( subsection 7g77#a77;,a74 7,b7 ,) respect to an entity describ$ 9 subsection 7g77#d71 a heal? c>e practition] is n a heal? pr(essional volunte] at su* entity unless ! entity sponsors ! heal? c>e practition]4 ,= purposes ( ?is subsection1 ! entity %all be consid]$ to be sponsor+ ! heal? c>e practition] if-- 7i7 ) respect to ! heal? c>e practition]1 ! entity submits to ! ,secret>y an application meet+ ! requirem5ts ( subsection 7g77#a77;,d72 & 7ii7 ! ,secret>y1 pursuant to subsection 7g77#a77;,e71 det]m9es t ! heal? c>e practition] is deem$ to be an employee ( ! ,public ,heal? ,s]vice4 7,c7 ,9 ! case ( a heal? c>e practition] :o is det]m9$ by ! ,secret>y pursuant to subsection 7g77#a77;,e7 to be a heal? pr(essional volunte] at su* entity1 ?is subsection applies to ! heal? c>e practition] 7) respect to s]vices p]=m$ on behalf ( ! entity sponsor+ ! heal? c>e practition] pursuant to subp>agraph 7,b77 = any cause ( action aris+ f an act or omission ( ! heal? c>e practition] occurr+ on or aft] ! date on :i* ! ,secret>y makes su* det]m9ation4 7,d7 ,subsection 7g77#a77;,f7 applies to a heal? c>e practition] = purposes ( ?is subsection only to ! ext5t t1 9 provid+ heal? s]vices to an individual1 ea* ( ! conditions specifi$ 9 p>agraph 7#b7 is met4 7#d7 7,a7 ,am\nts 9 ! fund e/abli%$ "u subsection 7k77#b7 %all be available = transf] "u subp>agraph 7,c7 = purposes ( c>ry+ out ?is subsection4 7,b7 7i7 ,n lat] ?an ,may #a ( ea* fiscal ye>1 ! ,attorney ,g5]al1 9 consultation ) ! ,secret>y1 %all submit to ! ,congress a report provid+ an e/imate ( ! am\nt ( claims 7toge!r ) relat$ fees & exp5ses ( witnesses7 t1 by reason ( ! acts or omissions ( heal? pr(essional volunte]s1 w be paid pursuant to ?is section dur+ ! cal5d> ye> t beg9s 9 ! foll[+ fiscal ye>4 7ii7 ,subsection 7k77#a77;,b7 applies to ! e/imate "u clause 7i7 reg>d+ heal? pr(essional volunte]s to ! same ext5t & 9 ! same mann] z su* subsection applies to ! e/imate "u su* subsection reg>d+ (fic]s1 gov]n+ bo>d memb]s1 employees1 & contractors ( entities describ$ 9 subsection 7g77#d74 7iii7 ,! report %all include a summ>y ( ! data reli$ ^u = ! e/imate 9 clause 7i71 includ+ ! numb] ( claims fil$ & paid f ! previ\s cal5d> ye>4 7,c7 ,n lat] ?an ,decemb] #ca ( ea* fiscal ye>1 ! ,secret>y %all transf] f ! fund "u subsection 7k77#b7 to ! appropriate acc\nts 9 ! ,treasury an am\nt equal to ! e/imate made "u subp>agraph 7,b7 = ! cal5d> ye> beg9n+ 9 su* fiscal ye>1 subject to ! ext5t ( am\nts 9 ! fund4 7#e7 7,a7 ,?is subsection %all take effect on ,octob] #a1 #bjag1 except z provid$ 9 subp>agraph 7,b7 & p>agraph 7#f74 7,b7 ,effective on ! date ( ! enactm5t ( ?is subsection-- 7i7 ! ,secret>y may issue regulations = c>ry+ out ?is subsection1 & ! ,secret>y may accept & consid] applications submitt$ pursuant to p>agraph 7#c77;,b72 & 7ii7 reports "u p>agraph 7#d77;,b7 may be submitt$ to ,congress4 7#f7 ,beg9n+ on ,octob] #a1 #bjbb1 ?is subsection %all cease to h any =ce or effect4 4 #ijbf4 ,reports 7a7 ,work=ce developm5t report 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 9 consultation ) ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 %all conduct a /udy & publicly po/ on ! appropriate ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices a report on ! adult & p$iatric m5tal heal? & sub/ance use disord] work=ce 9 ord] to in=m ,f$]al1 ,/ate1 & local ef=ts relat$ to work=ce enhancem5t4 7#b7 ,cont5ts ,! report "u ?is subsection %all conta9-- 7,a7 national & ,/ate-level projections ( ! supply & dem& ( ! m5tal heal? & sub/ance use disord] heal? work=ce1 disaggregat$ by pr(ession2 7,b7 an assessm5t ( ! m5tal heal? & sub/ance use disord] work=ce capacity1 /r5g?s1 & weaknesses z ( ! date ( ! report1 includ+ ! ext5t to :i* prim>y c>e provid]s are prev5t+1 scre5+1 or ref]r+ = m5tal & sub/ance use disord] s]vices2 7,c7 in=mation on tr5ds )9 ! m5tal heal? & sub/ance use disord] provid] work=ce1 includ+ ! numb] ( individuals expect$ to ent] ! m5tal heal? work=ce ov] ! next #e ye>s2 & 7,d7 any additional in=mation det]m9$ by ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 9 consultation ) ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 to be relevant to ! m5tal heal? & sub/ance use disord] provid] work=ce4 7b7 ,pe]-,support speciali/ programs 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on pe]-support speciali/ programs 9 up to #aj ,/ates t receive fund+ f ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration4 7#b7 ,cont5ts ( /udy ,9 conduct+ ! /udy "u p>agraph 7#a71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all exam9e & id5tify be/ practices1 9 ! ,/ates select$ pursuant to su* p>agraph1 relat$ to tra9+ & cr$5tial requirem5ts = pe]-support speciali/ programs1 su* z-- 7,a7 h\rs ( =mal "w or volunte] exp]i5ce relat$ to m5tal & sub/ance use disord]s conduct$ ?r\gh su* programs2 7,b7 types ( pe]-support speciali/ exams requir$ = su* programs 9 ! select$ ,/ates2 7,c7 codes ( e?ics us$ by su* programs 9 ! select$ ,/ates2 7,d7 requir$ or recomm5d$ skill sets = su* programs 9 ! select$ ,/ates2 & 7,e7 requirem5ts = cont9u+ education4 7#c7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! /udy conduct$ "u p>agraph 7#a74 ,c ,m5tal ,heal? on ,campus ,improvem5t #ijca4 ,m5tal heal? & sub/ance use disord] s]vices on campus ,section #ebj;,e-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#cf;b7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ & behavioral heal? & ins]t+ heal? & sub/ance use disord]2 7#b7 9 subsection 7a7-- 7,a7 by /rik+ ,s]vices1 & ins]t+ ,s]vices &2 7,b7 by /rik+ & behavioral heal? problems & ins]t+ heal? or sub/ance use disord]s2 7,c7 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]s2 & 7,d7 by add+ aft]1 suicide attempts1 ! foll[+3 prev5t m5tal & sub/ance use disord]s1 r$uce /igma1 & improve ! id5tification & treatm5t = /ud5ts at risk12 7#c7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ =-- & ins]t+ = "o or m ( ! foll[+32 & 7,b7 by /rik+ p>agraphs 7#a7 ?r\gh 7#f7 & ins]t+ ! foll[+3 7#a7 ,educat+ /ud5ts1 families1 faculty1 & /aff to increase aw>5ess ( m5tal & sub/ance use disord]s4 7#b7 ,! op]ation ( hotl9es4 7#c7 ,prep>+ in=mational mat]ial4 7#d7 ,provid+ outrea* s]vices to notify /ud5ts ab\t available m5tal & sub/ance use disord] s]vices4 7#e7 ,adm9i/]+ volunt>y m5tal & sub/ance use disord] scre5+s & assessm5ts4 7#f7 ,support+ ! tra9+ ( /ud5ts1 faculty1 & /aff to respond effectively to /ud5ts ) m5tal & sub/ance use disord]s4 7#g7 ,creat+ a network infra/ructure to l9k in/itutions ( high] education ) heal? c>e provid]s :o treat m5tal & sub/ance use disord]s4 7#h7 ,provid+ m5tal & sub/ance use disord]s prev5tion & treatm5t s]vices to /ud5ts1 :i* may include recov]y support s]vices & programm+ & e>ly int]v5tion1 treatm5t1 & managem5t1 includ+ ?r\gh ! use ( teleheal? s]vices4 7#i7 ,conduct+ rese>* ?r\gh a c\nsel+ or heal? c5t] at ! in/itution ( high] education involv$ reg>d+ improv+ ! behavioral heal? ( /ud5ts ?r\gh cl9ical s]vices1 outrea*1 prev5tion1 or academic success1 9 a mann] t is 9 compliance ) all applicable p]sonal privacy laws4 7#aj7 ,support+ /ud5t gr\ps on campus1 includ+ a?letic teams1 t engage 9 activities to educate /ud5ts1 includ+ activities to r$uce /igma surr\nd+ m5tal & behavioral disord]s1 & promote m5tal heal?4 7#aa7 ,employ+ appropriately tra9$ /aff4 7#ab7 ,develop+ & support+ evid5ce-bas$ & em]g+ be/ practices1 includ+ a focus on culturally & l+ui/ically appropriate be/ practices4 2 7#d7 9 subsection 7c77#e71 by /rik+ sub/ance abuse & ins]t+ sub/ance use disord]2 7#e7 9 subsection 7d7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,an in/itution ( high] education desir+ a grant "u ?is section & ins]t+ ,to be eligible to receive a grant "u ?is section1 an in/itution ( high] education2 7,b7 by /rik+ p>agraph 7#a7 & ins]t+-- 7#a7 ,a description ( ! population to be t>get$ by ! program c>ri$ out "u ! grant1 includ+ vet]ans :5ev] possible & appropriate1 & ( id5tifi$ m5tal & sub/ance use disord] ne$s ( /ud5ts at ! in/itution ( high] education4 2 7,c7 9 p>agraph 7#b71 by ins]t+ 1 :i* may include1 z appropriate & 9 accordance ) subsection 7b77#g71 a plan to seek input f relevant /akehold]s 9 ! community1 includ+ appropriate public & private entities1 9 ord] to c>ry out ! program "u ! grant be=e ! p]iod at ! end2 & 7,d7 by add+ aft] p>agraph 7#e7 ! foll[+ new p>agraphs3 7#f7 ,an outl9e ( ! objectives ( ! program c>ri$ out "u ! grant4 7#g7 ,= an in/itution ( high] education propos+ to use ! grant = an activity describ$ 9 p>agraph 7#h7 or 7#i7 ( subsection 7b71 a description ( ! policies & proc$ures ( ! in/itution ( high] education t are relat$ to applicable laws reg>d+ access to1 & %>+ (1 treatm5t records ( /ud5ts at any campus-bas$ m5tal heal? c5t] or p>tn] organization1 includ+ ! policies & ,/ate laws gov]n+ :5 su* records c be access$ & %>$ = non-treatm5t purposes & a description ( ! process us$ by ! in/itution ( high] education to notify /ud5ts ( ^! policies & proc$ures1 includ+ ! ext5t to :i* writt5 cons5t is requir$4 7#h7 ,an assurance t grant funds w be us$ to supplem5t & n supplant any o!r ,f$]al1 ,/ate1 or local funds available to c>ry out activities ( ! type c>ri$ out "u ! grant4 2 7#f7 9 subsection 7e77#a71 by /rik+ & behavioral heal? problems & ins]t+ heal? & sub/ance use disord]s2 7#g7 9 subsection 7f77#b7-- 7,a7 by /rik+ & behavioral heal? & ins]t+ heal? & sub/ance use disord]2 & 7,b7 by /rik+ suicide & sub/ance abuse & ins]t+ suicide & sub/ance use disord]s2 7#h7 by r$esignat+ subsection 7h7 z subsection 7i72 7#i7 by ins]t+ aft] subsection 7g7 ! foll[+ new subsection3 7h7 ,te*nical assi/ance ,! ,secret>y may provide te*nical assi/ance to grantees 9 c>ry+ out ?is section4 2 & 7#aj7 9 subsection 7i71 z r$esignat$ by p>agraph 7#h71 by /rik+ #e1jjj1jjj = fiscal ye> #bjje & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ #g1jjj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb44 #ijcb4 ,int]ag5cy ,work+ ,gr\p on ,college ,m5tal ,heal? 7a7 ,purpose ,x is ! purpose ( ?is section to provide = ! e/abli%m5t ( a ,college ,campus ,task ,=ce to discuss m5tal & behavioral heal? conc]ns on campuses ( in/itutions ( high] education4 7b7 ,e/abli%m5t ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all e/abli% a ,college ,campus ,task ,=ce 7ref]r$ to 9 ?is section z ! ,task ,=ce7 to discuss m5tal & behavioral heal? conc]ns on campuses ( in/itutions ( high] education4 7c7 ,memb]%ip ,! ,task ,=ce %all be compos$ ( a repres5tative f ea* ,f$]al ag5cy 7z appo9t$ by ! head ( ! ag5cy7 t has jurisdiction ov]1 or is affect$ by1 m5tal heal? & education policies & projects1 includ+-- 7#a7 ! ,dep>tm5t ( ,education2 7#b7 ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7#c7 ! ,dep>tm5t ( ,vet]ans ,affairs2 & 7#d7 su* o!r ,f$]al ag5cies z ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 9 consultation ) ! ,secret>y1 det]m9es to be appropriate4 7d7 ,duties ,! ,task ,=ce %all-- 7#a7 s]ve z a c5traliz$ me*anism to coord9ate a national ef=t to-- 7,a7 discuss & evaluate evid5ce & k on m5tal & behavioral heal? s]vices available to1 & ! preval5ce ( m5tal illness among1 ! age population ( /ud5ts att5d+ in/itutions ( high] education 9 ! ,unit$ ,/ates2 7,b7 det]m9e ! range ( effective1 feasible1 & compreh5sive actions to improve m5tal & behavioral heal? on campuses ( in/itutions ( high] education2 7,c7 exam9e & bett] address ! ne$s ( ! age population ( /ud5ts att5d+ in/itutions ( high] education deal+ ) m5tal illness2 7,d7 survey ,f$]al ag5cies to det]m9e :i* policies are effective 9 enc\rag+1 & h[ be/ to facilitate outrea* )\t duplicat+1 ef=ts relat+ to m5tal & behavioral heal? promotion2 7,e7 e/abli% specific goals )9 & across ,f$]al ag5cies = m5tal heal? promotion1 includ+ det]m9ations ( acc\ntability = rea*+ ^? goals2 7,f7 develop a /rategy = allocat+ responsibilities & ensur+ p>ticipation 9 m5tal & behavioral heal? promotion1 p>ticul>ly 9 ! case ( compet+ ag5cy priorities2 7,g7 coord9ate plans to communicate rese>* results relat+ to m5tal & behavioral heal? among/ ! age population ( /ud5ts att5d+ in/itutions ( high] education to enable report+ & outrea* activities to produce m useful & timely in=mation2 7,h7 provide a description ( evid5ce-bas$ practices1 model programs1 effective guidel9es1 & o!r /rategies = promot+ m5tal & behavioral heal? on campuses ( in/itutions ( high] education2 7,i7 make recomm5dations to improve ,f$]al ef=ts relat+ to m5tal & behavioral heal? promotion on campuses ( in/itutions ( high] education & to ensure ,f$]al ef=ts are consi/5t ) available /&>ds1 evid5ce1 & o!r programs 9 exi/5ce z ( ! date ( enactm5t ( ?is ,act2 7,j7 monitor ,f$]al progress 9 meet+ specific m5tal & behavioral heal? promotion goals z !y relate to sett+s ( in/itutions ( high] education2 & 7,k7 exam9e & dissem9ate be/ practices relat$ to intracampus %>+ ( treatm5t records2 7#b7 consult ) national organizations ) exp]tise 9 m5tal & behavioral heal?1 especially ^? organizations work+ ) ! age population ( /ud5ts att5d+ in/itutions ( high] education2 & 7#c7 consult ) & seek input f m5tal heal? pr(essionals work+ on campuses ( in/itutions ( high] education z appropriate4 7e7 ,meet+s 7#a7 ,9 g5]al ,! ,task ,=ce %all meet n few] ?an ?ree times ea* ye>4 7#b7 ,annual conf]5ce ,! ,secret>y %all sponsor an annual conf]5ce on m5tal & behavioral heal? 9 sett+s ( in/itutions ( high] education to enhance coord9ation1 build p>tn]%ips1 & %>e be/ practices 9 m5tal & behavioral heal? promotion1 data collection1 analysis1 & s]vices4 7f7 ,def9ition ,9 ?is section1 ! t]m in/itution ( high] education has ! mean+ giv5 su* t]m 9 section #aja ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja74 7g7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #a1jjj1jjj = ! p]iod ( fiscal ye>s #bjah ?r\gh #bjbb4 #ijcc4 ,improv+ m5tal heal? on college campuses ,"p ,d ( title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;dd et seq47 is am5d$ by add+ at ! end ! foll[+3 #edi4 ,m5tal & behavioral heal? outrea* & education on college campuses 7a7 ,purpose ,x is ! purpose ( ?is section to increase access to1 & r$uce ! /igma associat$ )1 m5tal heal? s]vices to ensure t /ud5ts at in/itutions ( high] education h ! support necess>y to successfully complete _! /udies4 7b7 ,national public education campaign ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y & 9 collaboration ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all conv5e an int]ag5cy1 public-private sector work+ gr\p to plan1 e/abli%1 & beg9 coord9at+ & evaluat+ a t>get$ public education campaign t is design$ to focus on m5tal & behavioral heal? on ! campuses ( in/itutions ( high] education4 ,su* campaign %all be design$ to-- 7#a7 improve ! g5]al und]/&+ ( m5tal heal? & m5tal disord]s2 7#b7 enc\rage help-seek+ behaviors relat+ to ! promotion ( m5tal heal?1 prev5tion ( m5tal disord]s1 & treatm5t ( su* disord]s2 7#c7 make ! connection betwe5 m5tal & behavioral heal? & academic success2 & 7#d7 assi/ ! g5]al public 9 id5tify+ ! e>ly w>n+ signs & r$uc+ ! /igma ( m5tal illness4 7c7 ,composition ,! work+ gr\p conv5$ "u subsection 7b7 %all include-- 7#a7 m5tal heal? consum]s1 includ+ /ud5ts & family memb]s2 7#b7 repres5tatives ( in/itutions ( high] education2 7#c7 repres5tatives ( national m5tal & behavioral heal? associations & associations ( in/itutions ( high] education2 7#d7 repres5tatives ( heal? promotion & prev5tion organizations at in/itutions ( high] education2 7#e7 repres5tatives ( m5tal heal? provid]s1 includ+ community m5tal heal? c5t]s2 & 7#f7 repres5tatives ( private-sector & public-sector gr\ps ) exp]i5ce 9 ! developm5t ( effective public heal? education campaigns4 7d7 ,plan ,! work+ gr\p "u subsection 7b7 %all develop a plan t-- 7#a7 t>gets promotional & educational ef=ts to ! age population ( /ud5ts at in/itutions ( high] education & individuals :o are employ$ 9 sett+s ( in/itutions ( high] education1 includ+ ?r\gh ! use ( r\ndtables2 7#b7 develops & proposes ! implem5tation ( rese>*-bas$ public heal? messages & activities2 7#c7 provides support = local ef=ts to r$uce /igma by us+ ! ,national ,heal? ,in=mation ,c5t] z a prim>y po9t ( contact = in=mation1 publications1 & s]vice program ref]rals2 & 7#d7 develops & proposes ! implem5tation ( a social m>ket+ campaign t is t>get$ at ! population ( /ud5ts att5d+ in/itutions ( high] education & individuals :o are employ$ 9 sett+s ( in/itutions ( high] education4 7e7 ,def9ition ,9 ?is section1 ! t]m in/itution ( high] education has ! mean+ giv5 su* t]m 9 section #aja ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja74 7f7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #a1jjj1jjj = ! p]iod ( fiscal ye>s #bjah ?r\gh #bjbb4 4 ,x ,/r5g!n+ ,m5tal & ,sub/ance ,use ,disord] ,c>e = ,*ildr5 & ,adolesc5ts #ajjja4 ,programs = *ildr5 ) a s]i\s emotional di/urbance 7a7 ,compreh5sive community m5tal heal? s]vices = *ildr5 ) a s]i\s emotional di/urbance ,section #efa7;a77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;ff7a77#a77 is am5d$ by ins]t+ 1 :i* may include ef=ts to id5tify & s]ve *ildr5 at risk be=e ! p]iod4 7b7 ,requirem5ts ) respect to c>ry+ out purpose ( grants ,section #efb7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;ff-#a7;b77 is am5d$ by /rik+ w n provide an individual ) access to ! sy/em if ! individual is m ?an #ba ye>s ( age & ins]t+ w provide an individual ) access to ! sy/em ?r\gh ! age ( #ba ye>s4 7c7 ,additional provisions ,section #efd7;f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;ff-#c7;f77 is am5d$ by ins]t+ 7& provide a copy to ! ,/ate involv$7 aft] to ! ,secret>y4 7d7 ,g5]al provisions ,section #efe ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;ff-#d7 is am5d$-- 7#a7 9 subsection 7b77#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ receiv+ a grant "u section #efa7;a7 & ins]t+ 1 reg>dless ( :e!r su* public entity is receiv+ a grant "u section #efa7;a72 & 7,b7 9 subp>agraph 7,b71 by /rik+ pursuant to & ins]t+ describ$ 92 7#b7 9 subsection 7d77#a71 by /rik+ n m ?an #ba ye>s ( age & ins]t+ ?r\gh ! age ( #ba ye>s2 & 7#c7 9 subsection 7f77#a71 by /rik+ #ajj1jjj1jjj = fiscal ye> #bjja1 & su* sums z may be necess>y = ea* ( ! fiscal ye>s #bjjb & #bjjc & ins]t+ #aai1jbf1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 #ajjjb4 ,increas+ access to p$iatric m5tal heal? c>e ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #ccj,l ( su* ,act 7#db ,u4,s4,c4 #bed;c-#ah7 ! foll[+ new section3 #ccj,m ,p$iatric m5tal heal? c>e access grants 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration & 9 coord9ation ) o!r relevant ,f$]al ag5cies1 %all aw>d grants to ,/ates1 political subdivisions ( ,/ates1 & ,indian tribes & tribal organizations 7= purposes ( ?is section1 z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act 7#be ,u4,s4,c4 #dej;b77 to promote behavioral heal? integration 9 p$iatric prim>y c>e by-- 7#a7 support+ ! developm5t ( /atewide or regional p$iatric m5tal heal? c>e teleheal? access programs2 & 7#b7 support+ ! improvem5t ( exi/+ /atewide or regional p$iatric m5tal heal? c>e teleheal? access programs4 7b7 ,program requirem5ts 7#a7 ,9 g5]al ,a p$iatric m5tal heal? c>e teleheal? access program ref]r$ to 9 subsection 7a71 ) respect to :i* a grant "u su* subsection may be us$1 %all-- 7,a7 be a /atewide or regional network ( p$iatric m5tal heal? teams t provide support to p$iatric prim>y c>e sites z an integrat$ team2 7,b7 support & fur!r develop organiz$ ,/ate or regional networks ( p$iatric m5tal heal? teams to provide consultative support to p$iatric prim>y c>e sites2 7,c7 conduct an assessm5t ( critical behavioral consultation ne$s among p$iatric provid]s & su* provid]s' pref]r$ me*anisms = receiv+ consultation1 tra9+1 & te*nical assi/ance2 7,d7 develop an onl9e database & communication me*anisms1 includ+ teleheal?1 to facilitate consultation support to p$iatric practices2 7,e7 provide rapid /atewide or regional cl9ical telephone or teleheal? consultations :5 reque/$ betwe5 ! p$iatric m5tal heal? teams & p$iatric prim>y c>e provid]s2 7,f7 conduct tra9+ & provide te*nical assi/ance to p$iatric prim>y c>e provid]s to support ! e>ly id5tification1 diagnosis1 treatm5t1 & ref]ral ( *ildr5 ) behavioral heal? conditions2 7,g7 provide in=mation to p$iatric provid]s ab\t1 & assi/ p$iatric provid]s 9 access+1 p$iatric m5tal heal? c>e provid]s1 includ+ *ild & adolesc5t psy*iatri/s1 & lic5s$ m5tal heal? pr(essionals1 su* z psy*ologi/s1 social work]s1 or m5tal heal? c\nselors & 9 s*$ul+ & conduct+ te*nical assi/ance2 7,h7 assi/ ) ref]rals to specialty c>e & community or behavioral heal? res\rces2 & 7,i7 e/abli% me*anisms = measur+ & monitor+ increas$ access to p$iatric m5tal heal? c>e s]vices by p$iatric prim>y c>e provid]s & exp&$ capacity ( p$iatric prim>y c>e provid]s to id5tify1 treat1 & ref] *ildr5 ) m5tal heal? problems4 7#b7 ,p$iatric m5tal heal? teams ,9 ?is subsection1 ! t]m p$iatric m5tal heal? team means a team consi/+ ( at lea/ "o case coord9ator1 at lea/ "o *ild & adolesc5t psy*iatri/1 & at lea/ "o lic5s$ cl9ical m5tal heal? pr(essional1 su* z a psy*ologi/1 social work]1 or m5tal heal? c\nselor4 ,su* a team may be regionally bas$4 7c7 ,application ,a ,/ate1 political subdivision ( a ,/ate1 ,indian tribe1 or tribal organization seek+ a grant "u ?is section %all submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require1 includ+ a plan = ! compreh5sive evaluation ( activities t are c>ri$ out ) funds receiv$ "u su* grant4 7d7 ,evaluation ,a ,/ate1 political subdivision ( a ,/ate1 ,indian tribe1 or tribal organization t receives a grant "u ?is section %all prep>e & submit an evaluation ( activities t are c>ri$ out ) funds receiv$ "u su* grant to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may reasonably require1 includ+ a process & outcome evaluation4 7e7 ,access to broadb& ,9 adm9i/]+ grants "u ?is section1 ! ,secret>y may coord9ate ) o!r ag5cies to ensure t fund+ opportunities are available to support access to reliable1 high-spe$ ,int]net = provid]s4 7f7 ,mat*+ requirem5t ,! ,secret>y may n aw>d a grant "u ?is section unless ! ,/ate1 political subdivision ( a ,/ate1 ,indian tribe1 or tribal organization involv$ agrees1 ) respect to ! co/s to be incurr$ by ! ,/ate1 political subdivision ( a ,/ate1 ,indian tribe1 or tribal organization 9 c>ry+ out ! purpose describ$ 9 ?is section1 to make available non-,f$]al contributions 79 ca% or 9 k9d7 t[>d su* co/s 9 an am\nt t is n less ?an #bj p]c5t ( ,f$]al funds provid$ 9 ! grant4 7g7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$1 #i1jjj1jjj = ! p]iod ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #ajjjc4 ,sub/ance use disord] treatm5t & e>ly int]v5tion s]vices = *ildr5 & adolesc5ts ,! fir/ section #ead ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#g71 relat+ to sub/ance abuse treatm5t s]vices = *ildr5 & adolesc5ts1 is am5d$-- 7#a7 9 ! section head+1 by /rik+ abuse treatm5t & ins]t+ use disord] treatm5t & e>ly int]v5tion2 7#b7 by /rik+ subsection 7a7 & ins]t+ ! foll[+3 7a7 ,9 g5]al ,! ,secret>y %all aw>d grants1 contracts1 or coop]ative agreem5ts to public & private nonpr(it entities1 includ+ ,indian tribes or tribal organizations 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 or heal? facilities or programs op]at$ by or 9 accordance ) a contract or grant ) ! ,indian ,heal? ,s]vice1 = ! purpose (-- 7#a7 provid+ e>ly id5tification & s]vices to meet ! ne$s ( *ildr5 & adolesc5ts :o are at risk ( sub/ance use disord]s2 7#b7 provid+ sub/ance use disord] treatm5t s]vices = *ildr51 includ+ *ildr5 & adolesc5ts ) co-occurr+ m5tal illness & sub/ance use disord]s2 & 7#c7 provid+ assi/ance to pregnant wom51 & p>5t+ wom51 ) sub/ance use disord]s1 9 obta9+ treatm5t s]vices1 l9k+ mo!rs to community res\rces to support indep5d5t family lives1 & /ay+ 9 recov]y s t *ildr5 are 9 safe1 /able home environm5ts & receive appropriate heal? c>e s]vices4 2 7#c7 9 subsection 7b7-- 7,a7 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 apply evid5ce-bas$ & co/-effective me?ods2 2 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ treatm5t2 & 7ii7 by ins]t+ sub/ance abuse1 aft] *ild welf>e12 7,c7 9 p>agraph 7#c71 by /rik+ sub/ance abuse disord]s & ins]t+ sub/ance use disord]s1 includ+ *ildr5 & adolesc5ts ) co-occurr+ m5tal illness & sub/ance use disord]s12 7,d7 9 p>agraph 7#e71 by /rik+ treatm5t2 & ins]t+ s]vices2 &2 7,e7 9 p>agraph 7#f71 by /rik+ sub/ance abuse treatm5t2 & & ins]t+ treatm5t42 & 7,f7 by /rik+ p>agraph 7#g72 & 7#d7 9 subsection 7f71 by /rik+ #dj1jjj1jjj & all t foll[s ?r\gh ! p]iod & ins]t+ #bi1fje1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb44 #ajjjd4 ,*ildr5's recov]y f trauma ,! fir/ section #ehb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;hh-#a2 relat+ to grants to address ! problems ( p]sons :o exp]i5ce viol5ce relat$ /ress7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ develop+ programs & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ! foll[+3 develop+ & ma9ta9+ programs t provide =-- 7#a7 ! cont9u$ op]ation ( ! ,national ,*ild ,traumatic ,/ress ,initiative 7ref]r$ to 9 ?is section z ! ,,nctsi71 :i* includes a coop]ative agreem5t ) a coord9at+ c5t]1 t focuses on ! m5tal1 behavioral1 & biological aspects ( psy*ological trauma response1 prev5tion ( ! long-t]m consequ5ces ( *ild trauma1 & e>ly int]v5tion s]vices & treatm5t to address ! long-t]m consequ5ces ( *ild trauma2 & 7#b7 ! developm5t ( k ) reg>d to evid5ce-bas$ practices = id5tify+ & treat+ m5tal1 behavioral1 & biological disord]s ( *ildr5 & y\? result+ f witness+ or exp]i5c+ a traumatic ev5t4 2 7#b7 9 subsection 7b7-- 7,a7 by /rik+ subsection 7a7 relat$ & ins]t+ subsection 7a77#b7 7relat$2 7,b7 by /rik+ treat+ disord]s associat$ ) psy*ological trauma & ins]t+ treat+ m5tal1 behavioral1 & biological disord]s associat$ ) psy*ological trauma72 & 7,c7 by /rik+ m5tal heal? ag5cies & programs t h e/abli%$ cl9ical & basic rese>* & ins]t+ univ]sities1 hospitals1 m5tal heal? ag5cies1 & o!r programs t h e/abli%$ cl9ical exp]tise & rese>*2 7#c7 by r$esignat+ subsections 7c7 ?r\gh 7g7 z subsections 7g7 ?r\gh 7k71 respectively2 7#d7 by ins]t+ aft] subsection 7b71 ! foll[+3 7c7 ,*ild outcome data ,! ,,nctsi coord9at+ c5t] describ$ 9 subsection 7a77#a7 %all collect1 analyze1 report1 & make publicly available1 z appropriate1 ,,nctsi-wide *ild treatm5t process & outcome data reg>d+ ! e>ly id5tification & deliv]y ( evid5ce-bas$ treatm5t & s]vices = *ildr5 & families s]v$ by ! ,,nctsi grantees4 7d7 ,tra9+ ,! ,,nctsi coord9at+ c5t] %all facilitate ! coord9ation ( tra9+ initiatives 9 evid5ce-bas$ & trauma-in=m$ treatm5ts1 int]v5tions1 & practices (f]$ to ,,nctsi grantees1 provid]s1 & p>tn]s4 7e7 ,dissem9ation & collaboration ,! ,,nctsi coord9at+ c5t] %all1 z appropriate1 collaborate )-- 7#a7 ! ,secret>y1 9 ! dissem9ation ( evid5ce-bas$ & trauma-in=m$ int]v5tions1 treatm5ts1 products1 & o!r res\rces to appropriate /akehold]s2 & 7#b7 appropriate ag5cies t conduct or fund rese>* )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 = purposes ( %>+ ,,nctsi exp]tise1 evaluation data1 & o!r activities1 z appropriate4 7f7 ,review ,! ,secret>y %all1 consi/5t ) ! pe]-review process1 ensure t ,,nctsi applications are review$ by appropriate exp]ts 9 ! field z "p ( a cons5sus-review process4 ,! ,secret>y %all include review crit]ia relat$ to exp]tise & exp]i5ce 9 *ild trauma & evid5ce-bas$ practices4 2 7#e7 9 subsection 7g7 7z s r$esignat$71 by /rik+ ) respect to c5t]s ( excell5ce are di/ribut$ equitably among ! regions ( ! c\ntry & ins]t+ are di/ribut$ equitably among ! regions ( ! ,unit$ ,/ates2 7#f7 9 subsection 7i7 7z s r$esignat$71 by /rik+ recipi5t may n exce$ #e ye>s & ins]t+ recipi5t %all n be less ?an #d ye>s1 b %all n exce$ #e ye>s2 & 7#g7 9 subsection 7j7 7z s r$esignat$71 by /rik+ #ej1jjj1jjj & all t foll[s ?r\gh #bjjf & ins]t+ #df1hhg1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 #ajjje4 ,scre5+ & treatm5t = mat]nal depression ,"p ,b ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdc et seq47 is am5d$ by ins]t+ aft] section #cag,l 7#db ,u4,s4,c4 #bdg;b-#ac7 ! foll[+3 #cag,l-#a4 ,scre5+ & treatm5t = mat]nal depression 7a7 ,grants ,! ,secret>y %all make grants to ,/ates to e/abli%1 improve1 or ma9ta9 programs = scre5+1 assessm5t1 & treatm5t s]vices1 includ+ culturally & l+ui/ically appropriate s]vices1 z appropriate1 = wom5 :o are pregnant1 or :o h giv5 bir? )9 ! prec$+ #ab mon?s1 = mat]nal depression4 7b7 ,application ,to seek a grant "u ?is section1 a ,/ate %all submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 ,at a m9imum1 any su* application %all include explanations (-- 7#a7 h[ a program1 or programs1 w increase ! p]c5tage ( wom5 scre5$ & treat$1 z appropriate1 = mat]nal depression 9 #a or m communities2 & 7#b7 h[ a program1 or programs1 if exp&$1 w\ld increase access to scre5+ & treatm5t s]vices = mat]nal depression4 7c7 ,priority ,9 aw>d+ grants "u ?is section1 ! ,secret>y may give priority to ,/ates propos+ to improve or enhance access to scre5+ s]vices = mat]nal depression 9 prim>y c>e sett+s4 7d7 ,use ( funds ,! activities eligible = fund+ ?r\gh a grant "u subsection 7a7-- 7#a7 %all include-- 7,a7 provid+ appropriate tra9+ to heal? c>e provid]s2 & 7,b7 provid+ in=mation to heal? c>e provid]s1 includ+ in=mation on mat]nal depression scre5+1 treatm5t1 & foll[up support s]vices1 & l9kages to community-bas$ res\rces2 & 7#b7 may include-- 7,a7 enabl+ heal? c>e provid]s 7includ+ ob/etrician-gynecologi/s1 p$iatricians1 psy*iatri/s1 m5tal heal? c>e provid]s1 & adult prim>y c>e cl9icians7 to provide or receive real-"t psy*iatric consultation 79-p]son or remotely7 to aid 9 ! treatm5t ( pregnant & p>5t+ wom52 7,b7 e/abli%+ l9kages ) & among community-bas$ res\rces1 includ+ m5tal heal? res\rces1 prim>y c>e res\rces1 & support gr\ps2 & 7,c7 utiliz+ teleheal? s]vices = rural areas & m$ically und]s]v$ areas 7z def9$ 9 section #ccj;,i7a774 7e7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #e1jjj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb4 4 #ajjjf4 ,infant & e>ly *ildhood m5tal heal? promotion1 int]v5tion1 & treatm5t ,"p ,q ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;h et seq47 is am5d$ by add+ at ! end ! foll[+3 #cii,z-#b4 ,infant & e>ly *ildhood m5tal heal? promotion1 int]v5tion1 & treatm5t 7a7 ,grants ,! ,secret>y %all-- 7#a7 aw>d grants to eligible entities to develop1 ma9ta91 or enhance infant & e>ly *ildhood m5tal heal? promotion1 int]v5tion1 & treatm5t programs1 includ+-- 7,a7 programs = infants & *ildr5 at significant risk ( develop+1 %[+ e>ly signs (1 or hav+ be5 diagnos$ ) m5tal illness1 includ+ a s]i\s emotional di/urbance2 & 7,b7 multig5]ational !rapy & o!r s]vices t support ! c>egiv+ relation%ip2 & 7#b7 ensure t programs fund$ ?r\gh grants "u ?is section are evid5ce-in=m$ or evid5ce-bas$ models1 practices1 & me?ods t are1 z appropriate1 culturally & l+ui/ically appropriate1 & c be replicat$ 9 o!r appropriate sett+s4 7b7 ,eligible *ildr5 & entities ,9 ?is section3 7#a7 ,eligible *ild ,! t]m eligible *ild means a *ild f bir? to n m ?an #ab ye>s ( age :o-- 7,a7 is at risk =1 %[s e>ly signs (1 or has be5 diagnos$ ) a m5tal illness1 includ+ a s]i\s emotional di/urbance2 & 7,b7 may b5efit f infant & e>ly *ildhood int]v5tion or treatm5t programs or specializ$ pres*ool or elem5t>y s*ool programs t are evid5ce-bas$ or t h be5 sci5tifically demon/rat$ to %[ promise b w\ld b5efit f fur!r appli$ developm5t4 7#b7 ,eligible entity ,! t]m eligible entity means a human s]vices ag5cy or nonpr(it in/itution t-- 7,a7 employs lic5s$ m5tal heal? pr(essionals :o h specializ$ tra9+ & exp]i5ce 9 infant & e>ly *ildhood m5tal heal? assessm5t1 diagnosis1 & treatm5t1 or is accr$it$ or approv$ by ! appropriate ,/ate ag5cy1 z applicable1 to provide = *ildr5 f infancy to #ab ye>s ( age m5tal heal? promotion1 int]v5tion1 or treatm5t s]vices2 & 7,b7 provides s]vices or programs describ$ 9 subsection 7a7 t are evid5ce-bas$ or t h be5 sci5tifically demon/rat$ to %[ promise b w\ld b5efit f fur!r appli$ developm5t4 7c7 ,application ,an eligible entity seek+ a grant "u subsection 7a7 %all submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7d7 ,use ( funds = e>ly int]v5tion & treatm5t programs ,an eligible entity may use am\nts aw>d$ "u a grant "u subsection 7a77#a7 to c>ry out ! foll[+3 7#a7 ,provide age-appropriate m5tal heal? promotion & e>ly int]v5tion s]vices or m5tal illness treatm5t s]vices1 :i* may include specializ$ programs1 = eligible *ildr5 at significant risk ( develop+1 %[+ e>ly signs (1 or hav+ be5 diagnos$ ) a m5tal illness1 includ+ a s]i\s emotional di/urbance4 ,su* s]vices may include social & behavioral s]vices z well z multig5]ational !rapy & o!r s]vices t support ! c>egiv+ relation%ip4 7#b7 ,provide tra9+ = heal? c>e pr(essionals ) exp]tise 9 infant & e>ly *ildhood m5tal heal? c>e ) respect to appropriate & relevant integration ) o!r discipl9es su* z prim>y c>e cl9icians1 e>ly int]v5tion speciali/s1 *ild welf>e /aff1 home visitors1 e>ly c>e & education provid]s1 & o!rs :o "w ) "y *ildr5 & families4 7#c7 ,provide m5tal heal? consultation to p]sonnel ( e>ly c>e & education programs 7includ+ lic5s$ or regulat$ c5t]-bas$ & home-bas$ *ild c>e1 home visit+1 pres*ool special education1 & e>ly int]v5tion programs7 :o "w ) *ildr5 & families4 7#d7 ,provide tra9+ = m5tal heal? cl9icians 9 infant & e>ly *ildhood 9 promis+ & evid5ce-bas$ practices & models = infant & e>ly *ildhood m5tal heal? treatm5t & e>ly int]v5tion1 includ+ ) reg>d to practices = id5tify+ & treat+ m5tal illness & behavioral disord]s ( infants & *ildr5 result+ f exposure or repeat$ exposure to adv]se *ildhood exp]i5ces or *ildhood trauma4 7#e7 ,provide age-appropriate assessm5t1 diagno/ic1 & int]v5tion s]vices = eligible *ildr51 includ+ e>ly m5tal heal? promotion1 int]v5tion1 & treatm5t s]vices4 7e7 ,mat*+ funds ,! ,secret>y may n aw>d a grant "u ?is section to an eligible entity unless ! eligible entity agrees1 ) respect to ! co/s to be incurr$ by ! eligible entity 9 c>ry+ out ! activities describ$ 9 subsection 7d71 to make available non-,f$]al contributions 79 ca% or 9 k9d7 t[>d su* co/s 9 an am\nt t is n less ?an #aj p]c5t ( ! total am\nt ( ,f$]al funds provid$ 9 ! grant4 7f7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #bj1jjj1jjj = ! p]iod ( fiscal ye>s #bjah ?r\gh #bjbb4 4 ,,xi ,compassionate communication on ,,hipaa #aajja4 ,s5se ( ,congress 7a7 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,accord+ to ! ,national ,survey on ,drug ,use & ,heal?1 9 #bjae1 !re 7 approximately #i1hjj1jjj adults 9 ! ,unit$ ,/ates ) s]i\s m5tal illness4 7#b7 ,! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration def9es ! t]m s]i\s m5tal illness z an illness affect+ individuals #ah ye>s ( age or old] z hav+1 at any "t 9 ! pa/ ye>1 a diagnosable m5tal1 behavioral1 or emotional disord] t results 9 s]i\s functional impairm5t & sub/antially int]f]es ) or limits "o or m major life activities4 7#c7 ,9 report+ on ! incid5ce ( s]i\s m5tal illness1 ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration includes major depression1 s*izophr5ia1 bipol> disord]1 & o!r m5tal disord]s t cause s]i\s impairm5t4 7#d7 ,adults ) a s]i\s m5tal illness are at a high] risk = *ronic physical illnesses & premature dea?4 7#e7 ,accord+ to ! ,_w ,heal? ,organization1 adults ) a s]i\s m5tal illness h lifespans t are #aj to #be ye>s %ort] ?an ^? )\t s]i\s m5tal illness4 ,! va/ majority ( ^! dea?s are due to *ronic physical m$ical conditions1 su* z c>diovascul>1 respiratory1 & infecti\s diseases1 z well z diabetes & hyp]t5sion4 7#f7 ,accord+ to ! ,_w ,heal? ,organization1 ! majority ( dea?s ( adults ) a s]i\s m5tal illness t are due to physical m$ical conditions are prev5table4 7#g7 ,support$ decision mak+ c facilitate c>e decisions 9 areas :]e s]i\s m5tal illness may impact ! capacity ( an individual to det]m9e a c\rse ( treatm5t :ile /ill all[+ ! individual to make decisions indep5d5tly4 7#h7 ,help %\ld be provid$ to adults ) a s]i\s m5tal illness to address _! acute or *ronic physical illnesses1 make in=m$ *oices ab\t treatm5t1 & und]/& & foll[ ?r\gh ) appropriate treatm5t4 7#i7 ,!re is confusion 9 ! heal? c>e community reg>d+ p]missible practices "u ! regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7commonly kn[n z ,,hipaa74 ,?is confusion may h9d] appropriate communication ( heal? c>e in=mation or treatm5t pref]5ces ) appropriate c>egiv]s4 7b7 ,s5se ( ,congress ,x is ! s5se ( ,congress t cl>ification is ne$$ reg>d+ ! privacy rule promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 reg>d+ exi/+ p]mitt$ uses & disclosures ( heal? in=mation by heal? c>e pr(essionals to communicate ) c>egiv]s ( adults ) a s]i\s m5tal illness to facilitate treatm5t4 #aajjb4 ,confid5tiality ( records ,n lat] ?an #a ye> aft] ! date on :i* ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is title ref]r$ to z ! ,secret>y7 fir/ f9alizes regulations updat+ "p #b ( title #db1 ,code ( ,f$]al ,regulations1 relat+ to confid5tiality ( alcohol & drug abuse pati5t records1 aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all conv5e relevant /akehold]s to det]m9e ! effect ( su* regulations on pati5t c>e1 heal? outcomes1 & pati5t privacy4 #aajjc4 ,cl>ification on p]mitt$ uses & disclosures ( protect$ heal? in=mation 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,(fice = ,civil ,rights1 %all ensure t heal? c>e provid]s1 pr(essionals1 pati5ts & _! families1 & o!rs involv$ 9 m5tal or sub/ance use disord] treatm5t h adequate1 accessible1 & easily compreh5sible res\rces relat+ to appropriate uses & disclosures ( protect$ heal? in=mation "u ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note74 7b7 ,guidance 7#a7 ,issuance ,9 c>ry+ out subsection 7a71 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all issue guidance cl>ify+ ! circum/ances "u :i*1 consi/5t ) regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif1 a heal? c>e provid] or cov]$ entity may use or disclose protect$ heal? in=mation4 7#b7 ,circum/ances address$ ,! guidance issu$ "u ?is section %all address circum/ances includ+ ^? t-- 7,a7 require ! cons5t ( ! pati5t2 7,b7 require provid+ ! pati5t ) an opportunity to object2 7,c7 are bas$ on ! ex]cise ( pr(essional judgm5t reg>d+ :e!r ! pati5t w\ld object :5 ! opportunity to object _c practicably be provid$ because ( ! incapacity ( ! pati5t or an em]g5cy treatm5t circum/ance2 & 7,d7 are det]m9$1 bas$ on ! ex]cise ( pr(essional judgm5t1 to be 9 ! be/ int]e/ ( ! pati5t :5 ! pati5t is n pres5t or o!rwise incapacitat$4 7#c7 ,communication ) family memb]s & c>egiv]s ,9 address+ ! circum/ances describ$ 9 p>agraph 7#b71 ! guidance issu$ "u ?is section %all cl>ify p]mitt$ uses or disclosures ( protect$ heal? in=mation = purposes (-- 7,a7 communicat+ ) a family memb] ( ! pati5t1 c>egiv] ( ! pati5t1 or o!r individual1 to ! ext5t t su* family memb]1 c>egiv]1 or individual is involv$ 9 ! c>e ( ! pati5t2 7,b7 9 ! case t ! pati5t is an adult1 communicat+ ) a family memb] ( ! pati5t1 c>egiv] ( ! pati5t1 or o!r individual involv$ 9 ! c>e ( ! pati5t2 7,c7 9 ! case t ! pati5t is a m9or1 communicat+ ) ! p>5t or c>egiv] ( ! pati5t2 7,d7 involv+ ! family memb]s or c>egiv]s ( ! pati5t1 or o!rs involv$ 9 ! pati5t's c>e or c>e plan1 includ+ facilitat+ treatm5t & m$ication adh]5ce2 7,e7 li/5+ to ! pati5t1 or receiv+ in=mation ) respect to ! pati5t f ! family or c>egiv] ( ! pati5t2 7,f7 communicat+ ) family memb]s ( ! pati5t1 c>egiv]s ( ! pati5t1 law en=cem5t1 or o!rs :5 ! pati5t pres5ts a s]i\s & imm95t ?reat ( h>m to self or o!rs2 & 7,g7 communicat+ to law en=cem5t & family memb]s or c>egiv]s ( ! pati5t ab\t ! admission ( ! pati5t to receive c>e at1 or ! release ( a pati5t f1 a facility = an em]g5cy psy*iatric hold or involunt>y treatm5t4 #aajjd4 ,developm5t & dissem9ation ( model tra9+ programs 7a7 ,initial programs & mat]ials ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) appropriate exp]ts1 %all id5tify ! foll[+ model programs & mat]ials1 or 79 ! case t no su* programs or mat]ials exi/7 recognize private or public entities to develop & dissem9ate ea* ( ! foll[+3 7#a7 ,model programs & mat]ials = tra9+ heal? c>e provid]s 7includ+ physicians1 em]g5cy m$ical p]sonnel1 psy*iatri/s1 includ+ *ild & adolesc5t psy*iatri/s1 psy*ologi/s1 c\nselors1 !rapi/s1 nurse practition]s1 physician assi/ants1 behavioral heal? facilities & cl9ics1 c>e manag]s1 & hospitals1 includ+ individuals su* z g5]al c\nsels or regulatory compliance /aff :o are responsible = e/abli%+ provid] privacy policies7 reg>d+ ! p]mitt$ uses & disclosures1 consi/5t ) ! /&>ds gov]n+ ! privacy & security ( individually id5tifiable heal? in=mation promulgat$ by ! ,secret>y "u "p ,c ( title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d et seq47 & regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 & su* "p ,c1 ( ! protect$ heal? in=mation ( pati5ts seek+ or und]go+ m5tal or sub/ance use disord] treatm5t4 7#b7 ,a model program & mat]ials = tra9+ pati5ts & _! families reg>d+ _! rights to protect & obta9 in=mation "u ! /&>ds & regulations specifi$ 9 p>agraph 7#a74 7b7 ,p]iodic updates ,! ,secret>y %all-- 7#a7 p]iodically review & update ! model programs & mat]ials id5tifi$ or develop$ "u subsection 7a72 & 7#b7 dissem9ate ! updat$ model programs & mat]ials to ! individuals describ$ 9 subsection 7a74 7c7 ,coord9ation ,! ,secret>y %all c>ry out ?is section 9 coord9ation ) ! ,director ( ! ,(fice = ,civil ,rights )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 & ! heads ( o!r relevant ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7d7 ,input ( c]ta9 entities ,9 id5tify+1 review+1 or updat+ ! model programs & mat]ials "u subsections 7a7 & 7b71 ! ,secret>y %all solicit ! input ( relevant national1 ,/ate1 & local associations2 m$ical societies2 lic5s+ bo>ds2 provid]s ( m5tal & sub/ance use disord] treatm5t2 organizations ) exp]tise on dome/ic viol5ce1 sexual assault1 eld] abuse1 & *ild abuse2 & organizations repres5t+ pati5ts & consum]s & ! families ( pati5ts & consum]s4 7e7 ,fund+ ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section-- 7#a7 #d1jjj1jjj = fiscal ye> #bjah2 7#b7 #b1jjj1jjj = ea* ( fiscal ye>s #bjai & #bjbj2 & 7#c7 #a1jjj1jjj = ea* ( fiscal ye>s #bjba & #bjbb4 ,,xii ,m$icaid ,m5tal ,heal? ,cov]age #abjja4 ,rule ( con/ruction relat$ to ,m$icaid cov]age ( m5tal heal? s]vices & prim>y c>e s]vices furni%$ on ! same day ,no?+ 9 title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 %all be con/ru$ z prohibit+ sep>ate paym5t "u ! ,/ate plan "u su* title 7or "u a waiv] ( ! plan7 = ! provision ( a m5tal heal? s]vice or prim>y c>e s]vice "u su* plan1 ) respect to an individual1 because su* s]vice is-- 7#a7 a prim>y c>e s]vice furni%$ to ! individual by a provid] at a facility on ! same day a m5tal heal? s]vice is furni%$ to su* individual by su* provid] 7or ano!r provid]7 at ! facility2 or 7#b7 a m5tal heal? s]vice furni%$ to ! individual by a provid] at a facility on ! same day a prim>y c>e s]vice is furni%$ to su* individual by su* provid] 7or ano!r provid]7 at ! facility4 #abjjb4 ,/udy & report relat$ to ,m$icaid manag$ c>e regulation 7a7 ,/udy ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all conduct a /udy on cov]age "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 ( s]vices provid$ ?r\gh a m$icaid manag$ c>e organization 7z def9$ 9 section #aijc7m7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77 or a prepaid inpati5t heal? plan 7z def9$ 9 section #dch4b ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation77 ) respect to individuals ov] ! age ( #ba & "u ! age ( #fe = ! treatm5t ( a m5tal heal? disord] 9 in/itutions = m5tal diseases 7z def9$ 9 section #aije7;i7 ( su* ,act 7#db ,u4,s4,c4 #acif;d7i7774 ,su* /udy %all include in=mation on ! foll[+3 7#a7 ,! ext5t to :i* ,/ates1 includ+ ! ,di/rict ( ,columbia & ea* t]ritory or possession ( ! ,unit$ ,/ates1 are provid+ capitat$ paym5ts to su* organizations or plans = enrollees :o are receiv+ s]vices 9 in/itutions = m5tal diseases4 7#b7 ,! numb] ( individuals receiv+ m$ical assi/ance "u a ,/ate plan "u su* title ,,xix1 or a waiv] ( su* plan1 :o receive s]vices 9 in/itutions = m5tal diseases ?r\gh su* organizations & plans4 7#c7 ,! range ( & av]age numb] ( mon?s1 & ! l5g? ( /ay dur+ su* mon?s1 t su* individuals are receiv+ su* s]vices 9 su* in/itutions4 7#d7 ,h[ su* organizations or plans det]m9e :5 to provide = ! furni%+ ( su* s]vices ?r\gh an in/itution = m5tal diseases 9 lieu ( o!r b5efits 7includ+ ! full range ( community-bas$ s]vices7 "u _! contract ) ! ,/ate ag5cy adm9i/]+ ! ,/ate plan "u su* title ,,xix1 or a waiv] ( su* plan1 to address psy*iatric or sub/ance use disord] treatm5t4 7#e7 ,! ext5t to :i* ! provision ( s]vices )9 su* in/itutions has affect$ ! capitat$ paym5ts = su* organizations or plans4 7b7 ,report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all submit to ,congress a report on ! /udy conduct$ "u subsection 7a74 #abjjc4 ,guidance on opportunities = innovation ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all issue a ,/ate ,m$icaid ,director lett] reg>d+ opportunities to design innovative s]vice deliv]y sy/ems1 includ+ sy/ems = provid+ community-bas$ s]vices1 = adults ) a s]i\s m5tal illness or *ildr5 ) a s]i\s emotional di/urbance :o are receiv+ m$ical assi/ance "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq474 ,! lett] %all include opportunities = demon/ration projects "u section #aaae ( su* ,act 7#db ,u4,s4,c4 #acae7 to improve c>e = su* adults & *ildr54 #abjjd4 ,/udy & report on ,m$icaid em]g5cy psy*iatric demon/ration project 7a7 ,collection ( in=mation ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all1 to ! ext5t practical & data is available1 ) respect to ea* ,/ate t has p>ticipat$ 9 ! demon/ration project e/abli%$ "u section #bgjg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #acif;a note71 collect f ea* su* ,/ate in=mation on ! foll[+3 7#a7 ,! numb] ( in/itutions = m5tal diseases 7z def9$ 9 section #aije7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7i777 & b$s 9 su* in/itutions t receiv$ paym5t = ! provision ( s]vices to individuals :o receive m$ical assi/ance "u a ,/ate plan "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 7or "u a waiv] ( su* plan7 ?r\gh ! demon/ration project 9 ea* su* ,/ate z comp>$ to ! total numb] ( in/itutions = m5tal diseases & b$s 9 ! ,/ate4 7#b7 ,! ext5t to :i* !re is a r$uction 9 exp5ditures "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 or o!r sp5d+ on ! full cont9uum ( physical or m5tal heal? c>e = individuals :o receive treatm5t 9 an in/itution = m5tal diseases "u ! demon/ration project1 includ+ outpati5t1 inpati5t1 em]g5cy1 & ambulatory c>e1 t is attributable to su* individuals receiv+ treatm5t 9 in/itutions = m5tal diseases "u ! demon/ration project4 7#c7 ,! numb] ( =5sic psy*iatric hospitals1 ! numb] ( b$s 9 su* hospitals1 & ! numb] ( =5sic psy*iatric b$s 9 o!r hospitals 9 su* ,/ate1 bas$ on ! mo/ rec5t data available1 to ! ext5t practical1 z det]m9$ by su* ,adm9i/rator4 7#d7 ,! am\nt ( any disproportionate %>e hospital paym5ts "u section #aibc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7 t in/itutions = m5tal diseases 9 ! ,/ate receiv$ dur+ ! p]iod beg9n+ on ,july #a1 #bjab1 & end+ on ,june #cj1 #bjae1 & ! ext5t to :i* ! demon/ration project r$uc$ ! am\nt ( su* paym5ts4 7#e7 ,! mo/ rec5t data reg>d+ all facilities or sites 9 ! ,/ate 9 :i* any adults ) a s]i\s m5tal illness :o are receiv+ m$ical assi/ance "u a ,/ate plan "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 7or "u a waiv] ( su* plan7 are treat$ dur+ ! p]iod ref]r$ to 9 p>agraph 7#d71 to ! ext5t practical1 z det]m9$ by ! ,adm9i/rator1 includ+-- 7,a7 ! types ( su* facilities or sites 7su* z an in/itution = m5tal diseases1 a hospital em]g5cy dep>tm5t1 or o!r inpati5t hospital72 7,b7 ! av]age l5g? ( /ay 9 su* a facility or site by su* an individual1 disaggregat$ by facility type2 & 7,c7 ! paym5t rate "u ! ,/ate plan 7or a waiv]s ( su* plan7 = s]vices furni%$ to su* an individual = t treatm5t1 disaggregat$ by facility type1 dur+ ! p]iod 9 :i* ! demon/ration project is 9 op]ation4 7#f7 ,! ext5t to :i* ! utilization ( hospital em]g5cy dep>tm5ts dur+ ! p]iod 9 :i* ! demon/ration project 0 is 9 op]ation diff]$1 ) respect to individuals :o are receiv+ m$ical assi/ance "u a ,/ate plan "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 7or "u a waiv] ( su* plan71 betwe5-- 7,a7 ^? individuals :o receiv$ treatm5t 9 an in/itution = m5tal diseases "u ! demon/ration project2 7,b7 ^? individuals :o met ! eligibility requirem5ts = ! demon/ration project b :o did n receive treatm5t 9 an in/itution = m5tal diseases "u ! demon/ration project2 & 7,c7 ^? adults ) a s]i\s m5tal illness :o did n meet su* eligibility requirem5ts & did n receive treatm5t = su* illness 9 an in/itution = m5tal diseases4 7b7 ,report ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report t summ>izes & analyzes ! in=mation collect$ "u subsection 7a74 ,su* report may be submitt$ z "p ( ! report requir$ "u section #bgjg7;f7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #acif;a note7 or sep>ately4 #abjje4 ,provid+ ,,epsdt s]vices to *ildr5 9 ,i,m,ds 7a7 ,9 g5]al ,section #aije7;a77#af7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77#af77 is am5d$-- 7#a7 by /rik+ effective ,janu>y #a1 #aigc & ins]t+ 7,a7 effective ,janu>y #a1 #aigc2 & 7#b7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 &1 7,b7 = individuals receiv+ s]vices describ$ 9 subp>agraph 7,a71 e>ly & p]iodic scre5+1 diagno/ic1 & treatm5t s]vices 7z def9$ 9 subsection 7r771 :e!r or n su* scre5+1 diagno/ic1 & treatm5t s]vices are furni%$ by ! provid] ( ! s]vices describ$ 9 su* subp>agraph4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all apply ) respect to items & s]vices furni%$ 9 cal5d> qu>t]s beg9n+ on or aft] ,janu>y #a1 #bjai4 #abjjf4 ,electronic visit v]ification sy/em requir$ = p]sonal c>e s]vices & home heal? c>e s]vices "u ,m$icaid 7a7 ,9 g5]al ,section #aijc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7 is am5d$ by ins]t+ aft] subsection 7k7 ! foll[+ new subsection3 7l7 7#a7 ,subject to p>agraphs 7#c7 & 7#d71 ) respect to any am\nt exp5d$ = p]sonal c>e s]vices or home heal? c>e s]vices requir+ an 9-home visit by a provid] t are provid$ "u a ,/ate plan "u ?is title 7or "u a waiv] ( ! plan7 & furni%$ 9 a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjai 7or1 9 ! case ( home heal? c>e s]vices1 on or aft] ,janu>y #a1 #bjbc71 unless a ,/ate requires ! use ( an electronic visit v]ification sy/em = su* s]vices furni%$ 9 su* qu>t] "u ! plan or su* waiv]1 ! ,f$]al m$ical assi/ance p]c5tage %all be r$uc$-- 7,a7 9 ! case ( p]sonal c>e s]vices-- 7i7 = cal5d> qu>t]s 9 #bjai & #bjbj1 by 4#be p]c5tage po9ts2 7ii7 = cal5d> qu>t]s 9 #bjba1 by 4#e p]c5tage po9ts2 7iii7 = cal5d> qu>t]s 9 #bjbb1 by 4#ge p]c5tage po9ts2 & 7iv7 = cal5d> qu>t]s 9 #bjbc & ea* ye> !reaft]1 by #a p]c5tage po9t2 & 7,b7 9 ! case ( home heal? c>e s]vices-- 7i7 = cal5d> qu>t]s 9 #bjbc & #bjbd1 by 4#be p]c5tage po9ts2 7ii7 = cal5d> qu>t]s 9 #bjbe1 by 4#e p]c5tage po9ts2 7iii7 = cal5d> qu>t]s 9 #bjbf1 by 4#ge p]c5tage po9ts2 & 7iv7 = cal5d> qu>t]s 9 #bjbg & ea* ye> !reaft]1 by #a p]c5tage po9t4 7#b7 ,subject to p>agraphs 7#c7 & 7#d71 9 implem5t+ ! requirem5t = ! use ( an electronic visit v]ification sy/em "u p>agraph 7#a71 a ,/ate %all-- 7,a7 consult ) ag5cies & entities t provide p]sonal c>e s]vices1 home heal? c>e s]vices1 or bo? "u ! ,/ate plan 7or "u a waiv] ( ! plan7 to ensure t su* sy/em-- 7i7 is m9imally burd5some2 7ii7 takes into acc\nt exi/+ be/ practices & electronic visit v]ification sy/ems 9 use 9 ! ,/ate2 & 7iii7 is conduct$ 9 accordance ) ! requirem5ts ( ,,hipaa privacy & security law 7z def9$ 9 section #cjji ( ! ,public ,heal? ,s]vice ,act72 7,b7 take into acc\nt a /akehold] process t includes input f b5efici>ies1 family c>egiv]s1 individuals :o furni% p]sonal c>e s]vices or home heal? c>e s]vices1 & o!r /akehold]s1 z det]m9$ by ! ,/ate 9 accordance ) guidance f ! ,secret>y2 & 7,c7 ensure t individuals :o furni% p]sonal c>e s]vices1 home heal? c>e s]vices1 or bo? "u ! ,/ate plan 7or "u a waiv] ( ! plan7 are provid$ ! opportunity = tra9+ on ! use ( su* sy/em4 7#c7 ,p>agraphs 7#a7 & 7#b7 %all n apply 9 ! case ( a ,/ate t1 z ( ! date ( ! enactm5t ( ?is subsection1 requires ! use ( any sy/em = ! electronic v]ification ( visits conduct$ z "p ( bo? p]sonal c>e s]vices & home heal? c>e s]vices1 s long z ! ,/ate cont9ues to require ! use ( su* sy/em ) respect to ! electronic v]ification ( su* visits4 7#d7 7,a7 ,9 ! case ( a ,/ate describ$ 9 subp>agraph 7,b71 ! r$uction "u p>agraph 7#a7 %all n apply-- 7i7 9 ! case ( p]sonal c>e s]vices1 = cal5d> qu>t]s 9 #bjai2 & 7ii7 9 ! case ( home heal? c>e s]vices1 = cal5d> qu>t]s 9 #bjbc4 7,b7 ,= purposes ( subp>agraph 7,a71 a ,/ate describ$ 9 ?is subp>agraph is a ,/ate t demon/rates to ! ,secret>y t ! ,/ate-- 7i7 has made a good fai? ef=t to comply ) ! requirem5ts ( p>agraphs 7#a7 & 7#b7 7includ+ by tak+ /eps to adopt ! te*nology us$ = an electronic visit v]ification sy/em72 & 7ii7 9 implem5t+ su* a sy/em1 has enc\nt]$ unavoidable sy/em delays4 7#e7 ,9 ?is subsection3 7,a7 ,! t]m electronic visit v]ification sy/em means1 ) respect to p]sonal c>e s]vices or home heal? c>e s]vices1 a sy/em "u :i* visits conduct$ z "p ( su* s]vices are electronically v]ifi$ ) respect to-- 7i7 ! type ( s]vice p]=m$2 7ii7 ! individual receiv+ ! s]vice2 7iii7 ! date ( ! s]vice2 7iv7 ! location ( s]vice deliv]y2 7v7 ! individual provid+ ! s]vice2 & 7vi7 ! "t ! s]vice beg9s & ends4 7,b7 ,! t]m home heal? c>e s]vices means s]vices describ$ 9 section #aije7;a77#g7 provid$ "u a ,/ate plan "u ?is title 7or "u a waiv] ( ! plan74 7,c7 ,! t]m p]sonal c>e s]vices means p]sonal c>e s]vices provid$ "u a ,/ate plan "u ?is title 7or "u a waiv] ( ! plan71 includ+ s]vices provid$ "u section #aije7;a77#bd71 #aiae7;c71 #aiae7;i71 #aiae7;j71 or #aiae7k7 or "u a wavi] "u section #aaae4 7#f7 7,a7 ,9 ! case 9 :i* a ,/ate requires p]sonal c>e s]vice & home heal? c>e s]vice provid]s to utilize an electronic visit v]ification sy/em op]at$ by ! ,/ate or a contractor on behalf ( ! ,/ate1 ! ,secret>y %all pay to ! ,/ate1 = ea* qu>t]1 an am\nt equal to #ij p] c5tum ( s mu* ( ! sums exp5d$ dur+ su* qu>t] z are attributable to ! design1 developm5t1 or in/allation ( su* sy/em1 & #ge p] c5tum ( s mu* ( ! sums = ! op]ation & ma9t5ance ( su* sy/em4 7,b7 ,subp>agraph 7,a7 %all n apply 9 ! case 9 :i* a ,/ate requires p]sonal c>e s]vice & home heal? c>e s]vice provid]s to utilize an electronic visit v]ification sy/em t is n op]at$ by ! ,/ate or a contractor on behalf ( ! ,/ate4 4 7b7 ,collection & dissem9ation ( be/ practices ,n lat] ?an ,janu>y #a1 #bjah1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 ) respect to electronic visit v]ification sy/ems 7z def9$ 9 subsection 7l77#e7 ( section #aijc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b71 z ins]t$ by subsection 7a771 collect & dissem9ate be/ practices to ,/ate ,m$icaid ,directors ) respect to-- 7#a7 tra9+ individuals :o furni% p]sonal c>e s]vices1 home heal? c>e s]vices1 or bo? "u ! ,/ate plan "u title ,,xix ( su* ,act 7or "u a waiv] ( ! plan7 on su* sy/ems & ! op]ation ( su* sy/ems & ! prev5tion ( fraud ) respect to ! provision ( p]sonal c>e s]vices or home heal? c>e s]vices 7z def9$ 9 su* subsection 7l77#e772 & 7#b7 ! provision ( notice & educational mat]ials to family c>egiv]s & b5efici>ies ) respect to ! use ( su* electronic visit v]ification sy/ems & o!r means to prev5t su* fraud4 7c7 ,rules ( con/ruction 7#a7 ,no employ]-employee relation%ip e/abli%$ ,no?+ 9 ! am5dm5t made by ?is section may be con/ru$ z e/abli%+ an employ]-employee relation%ip betwe5 ! ag5cy or entity t provides = p]sonal c>e s]vices or home heal? c>e s]vices & ! individuals :o1 "u a contract ) su* an ag5cy or entity1 furni% su* s]vices = purposes ( "p #eeb ( title #bi1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#b7 ,no p>ticul> or uni=m electronic visit v]ification sy/em requir$ ,no?+ 9 ! am5dm5t made by ?is section %all be con/ru$ to require ! use ( a p>ticul> or uni=m electronic visit v]ification sy/em 7z def9$ 9 subsection 7l77#e7 ( section #aijc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b71 z ins]t$ by subsection 7a77 by all ag5cies or entities t provide p]sonal c>e s]vices or home heal? c>e "u a ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7or "u a waiv] ( ! plan7 7#db ,u4,s4,c4 #acif et seq474 7#c7 ,no limits on provision ( c>e ,no?+ 9 ! am5dm5t made by ?is section may be con/ru$ to limit1 ) respect to p]sonal c>e s]vices or home heal? c>e s]vices provid$ "u a ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7or "u a waiv] ( ! plan7 7#db ,u4,s4,c4 #acif et seq471 provid] selection1 con/ra9 b5efici>ies' selection ( a c>egiv]1 or imp$e ! mann] 9 :i* c>e is deliv]$4 7#d7 ,no prohibition on ,/ate quality measures requirem5ts ,no?+ 9 ! am5dm5t made by ?is section %all be con/ru$ z prohibit+ a ,/ate1 9 implem5t+ an electronic visit v]ification sy/em 7z def9$ 9 subsection 7l77#e7 ( section #aijc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b71 z ins]t$ by subsection 7a771 f e/abli%+ requirem5ts relat$ to quality measures = su* sy/em4 ,,xiii ,m5tal ,heal? ,p>ity #acjja4 ,enhanc$ compliance ) m5tal heal? & sub/ance use disord] cov]age requirem5ts 7a7 ,compliance program guidance docum5t ,section #bgbf7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bf7;a77 is am5d$ by add+ at ! end ! foll[+3 7#f7 ,compliance program guidance docum5t 7,a7 ,9 g5]al ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf1 ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury1 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,labor1 & ! ,inspector ,g5]al ( ! ,dep>tm5t ( ! ,treasury1 %all issue a compliance program guidance docum5t to help improve compliance ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 & section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable4 ,9 c>ry+ out ?is p>agraph1 ! ,secret>ies may take into consid]ation ! #bjaf publication ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & ! ,dep>tm5t ( ,labor1 entitl$ ,w>n+ ,signs - ,plan or ,policy ,non-,quantitative ,treatm5t ,limitations 7,n,q,t,ls7 t ,require ,additional ,analysis to ,det]m9e ,m5tal ,heal? ,p>ity ,compliance4 7,b7 ,examples illu/rat+ compliance & noncompliance 7i7 ,9 g5]al ,! compliance program guidance docum5t requir$ "u ?is p>agraph %all provide illu/rative1 de-id5tifi$ examples 7t d n disclose any protect$ heal? in=mation or individually id5tifiable in=mation7 ( previ\s f9d+s ( compliance & noncompliance ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable1 bas$ on inve/igations ( violations ( su* sections1 includ+-- 7,i7 examples illu/rat+ requirem5ts = in=mation disclosures & nonquantitative treatm5t limitations2 & 7,,ii7 descriptions ( ! violations uncov]$ dur+ ! c\rse ( su* inve/igations4 7ii7 ,nonquantitative treatm5t limitations ,to ! ext5t t any example describ$ 9 clause 7i7 involves a f9d+ ( compliance or noncompliance ) reg>d to any requirem5t = nonquantitative treatm5t limitations1 ! example %all provide suffici5t detail to fully expla9 su* f9d+1 includ+ a full description ( ! crit]ia involv$ = approv+ m$ical & surgical b5efits & ! crit]ia involv$ = approv+ m5tal heal? & sub/ance use disord] b5efits4 7iii7 ,access to additional in=mation reg>d+ compliance ,9 develop+ & issu+ ! compliance program guidance docum5t requir$ "u ?is p>agraph1 ! ,secret>ies specifi$ 9 subp>agraph 7,a7-- 7,i7 %all ent] into int]ag5cy agreem5ts ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,labor1 & ! ,inspector ,g5]al ( ! ,dep>tm5t ( ! ,treasury to %>e f9d+s ( compliance & noncompliance ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable2 & 7,,ii7 %all seek to ent] into an agreem5t ) a ,/ate to %>e in=mation on f9d+s ( compliance & noncompliance ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable4 7,c7 ,recomm5dations ,! compliance program guidance docum5t %all include recomm5dations to advance compliance ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable1 & enc\rage ! developm5t & use ( int]nal controls to monitor adh]5ce to applicable /atutes1 regulations1 & program requirem5ts4 ,su* int]nal controls may include illu/rative examples ( nonquantitative treatm5t limitations on m5tal heal? & sub/ance use disord] b5efits1 :i* may fail to comply ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable1 9 relation to nonquantitative treatm5t limitations on m$ical & surgical b5efits4 7,d7 ,updat+ ! compliance program guidance docum5t ,! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury1 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,labor1 & ! ,inspector ,g5]al ( ! ,dep>tm5t ( ! ,treasury1 %all update ! compliance program guidance docum5t e #b ye>s to include illu/rative1 de-id5tifi$ examples 7t d n disclose any protect$ heal? in=mation or individually id5tifiable in=mation7 ( previ\s f9d+s ( compliance & noncompliance ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable4 4 7b7 ,additional guidance ,section #bgbf7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bf7;a771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#g7 ,additional guidance 7,a7 ,9 g5]al ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ! ,help+ ,families 9 ,m5tal ,heal? ,crisis ,re=m ,act ( #bjaf1 ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all issue guidance to gr\p heal? plans & heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age to assi/ su* plans & issu]s 9 satisfy+ ! requirem5ts ( ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable4 7,b7 ,disclosure 7i7 ,guidance = plans & issu]s ,! guidance issu$ "u ?is p>agraph %all include cl>ify+ in=mation & illu/rative examples ( me?ods t gr\p heal? plans & heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age may use = disclos+ in=mation to ensure compliance ) ! requirem5ts "u ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable1 7& any regulations promulgat$ pursuant to su* sections1 z applicable74 7ii7 ,docum5ts = p>ticipants1 b5efici>ies1 contract+ provid]s1 or au?oriz$ repres5tatives ,! guidance issu$ "u ?is p>agraph %all include cl>ify+ in=mation & illu/rative examples ( me?ods t gr\p heal? plans & heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age may use to provide any p>ticipant1 b5efici>y1 contract+ provid]1 or au?oriz$ repres5tative1 z applicable1 ) docum5ts conta9+ in=mation t ! heal? plans or issu]s are requir$ to disclose to p>ticipants1 b5efici>ies1 contract+ provid]s1 or au?oriz$ repres5tatives to ensure compliance ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable1 compliance ) any regulation issu$ pursuant to su* respective section1 or compliance ) any o!r applicable law or regulation4 ,su* guidance %all include in=mation t is comp>ative 9 nature ) respect to-- 7,i7 nonquantitative treatm5t limitations = bo? m$ical & surgical b5efits & m5tal heal? & sub/ance use disord] b5efits2 7,,ii7 ! processes1 /rategies1 evid5ti>y /&>ds1 & o!r factors us$ to apply ! limitations describ$ 9 subclause 7,i72 & 7,,iii7 ! application ( ! limitations describ$ 9 subclause 7,i7 to ensure t su* limitations are appli$ 9 p>ity ) respect to bo? m$ical & surgical b5efits & m5tal heal? & sub/ance use disord] b5efits4 7,c7 ,nonquantitative treatm5t limitations ,! guidance issu$ "u ?is p>agraph %all include cl>ify+ in=mation & illu/rative examples ( me?ods1 processes1 /rategies1 evid5ti>y /&>ds1 & o!r factors t gr\p heal? plans & heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age may use reg>d+ ! developm5t & application ( nonquantitative treatm5t limitations to ensure compliance ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable1 7& any regulations promulgat$ pursuant to su* respective section71 includ+-- 7i7 examples ( me?ods ( det]m9+ appropriate types ( nonquantitative treatm5t limitations ) respect to bo? m$ical & surgical b5efits & m5tal heal? & sub/ance use disord] b5efits1 includ+ nonquantitative treatm5t limitations p]ta9+ to-- 7,i7 m$ical managem5t /&>ds bas$ on m$ical necessity or appropriat5ess1 or :e!r a treatm5t is exp]im5tal or inve/igative2 7,,ii7 limitations ) respect to prescription drug =mul>y design2 & 7,,iii7 use ( fail-fir/ or /ep !rapy protocols2 7ii7 examples ( me?ods ( det]m9+-- 7,i7 network admission /&>ds 7su* z cr$5tial+72 & 7,,ii7 factors us$ 9 provid] reimbursem5t me?odologies 7su* z s]vice type1 geographic m>ket1 dem& = s]vices1 & provid] supply1 practice size1 tra9+1 exp]i5ce1 & lic5sure7 z su* factors apply to network adequacy2 7iii7 examples ( s\rces ( in=mation t may s]ve z evid5ti>y /&>ds = ! purposes ( mak+ det]m9ations reg>d+ ! developm5t & application ( nonquantitative treatm5t limitations2 7iv7 examples ( specific factors1 & ! evid5ti>y /&>ds us$ to evaluate su* factors1 us$ by su* plans or issu]s 9 p]=m+ a nonquantitative treatm5t limitation analysis2 7v7 examples ( h[ specific evid5ti>y /&>ds may be us$ to det]m9e :e!r treatm5ts are consid]$ exp]im5tal or inve/igative2 7vi7 examples ( h[ specific evid5ti>y /&>ds may be appli$ to ea* s]vice category or classification ( b5efits2 7vii7 examples ( me?ods ( rea*+ appropriate cov]age det]m9ations = new m5tal heal? or sub/ance use disord] treatm5ts1 su* z evid5ce-bas$ e>ly int]v5tion programs = individuals ) a s]i\s m5tal illness & types ( m$ical managem5t te*niques2 7viii7 examples ( me?ods ( rea*+ appropriate cov]age det]m9ations = :i* !re is an indirect relation%ip betwe5 ! cov]$ m5tal heal? or sub/ance use disord] b5efit & a traditional cov]$ m$ical & surgical b5efit1 su* z resid5tial treatm5t or hospitalizations involv+ volunt>y or involunt>y commitm5t2 & 7ix7 additional illu/rative examples ( me?ods1 processes1 /rategies1 evid5ti>y /&>ds1 & o!r factors = :i* ! ,secret>y det]m9es t additional guidance is necess>y to improve compliance ) ?is section1 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 z applicable4 7,d7 ,public comm5t ,prior to issu+ any f9al guidance "u ?is p>agraph1 ! ,secret>y %all provide a public comm5t p]iod ( n less ?an #fj days dur+ :i* any memb] ( ! public may provide comm5ts on a draft ( ! guidance4 4 7c7 ,availability ( plan in=mation 7#a7 ,solicitation ( public fe$back ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all solicit fe$back f ! public on h[ ! disclosure reque/ process = docum5ts conta9+ in=mation t heal? plans or heal? insurance issu]s are requir$ "u ,f$]al or ,/ate law to disclose to p>ticipants1 b5efici>ies1 contract+ provid]s1 or au?oriz$ repres5tatives to ensure compliance ) exi/+ m5tal heal? p>ity & addiction equity requirem5ts c be improv$ :ile cont9u+ to ensure consum]s' rights to access all in=mation requir$ by ,f$]al or ,/ate law to be disclos$4 7#b7 ,public availability ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all make su* fe$back publicly available4 7#c7 ,,naic ,! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all %>e fe$back obta9$ pursuant to p>agraph 7#a7 directly ) ! ,national ,association ( ,insurance ,commission]s to ! ext5t su* fe$back includes recomm5dations = ! developm5t ( simplifi$ in=mation disclosure tools to provide consi/5t in=mation = consum]s4 ,su* fe$back may be tak5 into consid]ation by ! ,national ,association ( ,insurance ,commission]s & o!r appropriate entities = ! volunt>y developm5t & volunt>y use ( common templates & o!r sample /&>diz$ =ms to improve consum] access to plan in=mation4 7d7 ,improv+ compliance 7#a7 ,9 g5]al ,9 ! case t ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 or ! ,secret>y ( ! ,treasury det]m9es t a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age has violat$1 at lea/ #e times1 section #bgbf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;a71 or section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 respectively1 ! appropriate ,secret>y %all audit plan docum5ts = su* heal? plan or issu] 9 ! plan ye> foll[+ ! ,secret>y's det]m9ation 9 ord] to help improve compliance ) su* section4 7#b7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to limit ! au?ority1 z 9 effect on ! day be=e ! date ( enactm5t ( ?is ,act1 ( ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 or ! ,secret>y ( ! ,treasury to audit docum5ts ( heal? plans or heal? insurance issu]s4 #acjjb4 ,action plan = enhanc$ en=cem5t ( m5tal heal? & sub/ance use disord] cov]age 7a7 ,public meet+ 7#a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a public meet+ ( /akehold]s describ$ 9 p>agraph 7#b7 to produce an action plan = improv$ ,f$]al & ,/ate coord9ation relat$ to ! en=cem5t ( section #bgbf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;a71 & section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 & any comp>able provisions ( ,/ate law 79 ?is section su* sections & provisions are collectively ref]r$ to z m5tal heal? p>ity & addiction equity requirem5ts74 7#b7 ,/akehold]s ,! /akehold]s describ$ 9 ?is p>agraph %all include ea* ( ! foll[+3 7,a7 ,! ,f$]al ,gov]nm5t1 includ+ repres5tatives f-- 7i7 ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7ii7 ! ,dep>tm5t ( ! ,treasury2 7iii7 ! ,dep>tm5t ( ,labor2 & 7iv7 ! ,dep>tm5t ( ,ju/ice4 7,b7 ,/ate gov]nm5ts1 includ+-- 7i7 ,/ate heal? insurance commission]s2 7ii7 appropriate ,/ate ag5cies1 includ+ ag5cies on public heal? or m5tal heal?2 & 7iii7 ,/ate attorneys g5]al or o!r repres5tatives ( ,/ate entities involv$ 9 ! en=cem5t ( m5tal heal? p>ity & addiction equity requirem5ts4 7,c7 ,repres5tatives f key /akehold] gr\ps1 includ+-- 7i7 ! ,national ,association ( ,insurance ,commission]s2 7ii7 heal? insurance issu]s2 7iii7 provid]s ( m5tal heal? & sub/ance use disord] treatm5t2 7iv7 employ]s2 & 7v7 pati5ts or _! advocates4 7b7 ,action plan ,n lat] ?an #f mon?s aft] ! conclusion ( ! public meet+ "u subsection 7a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all f9alize ! action plan describ$ 9 su* subsection & make x pla9ly available on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7c7 ,cont5t ,! action plan "u ?is section %all-- 7#a7 take into consid]ation ! recomm5dations ( ! ,m5tal ,heal? & ,sub/ance ,use ,disord] ,p>ity ,task ,=ce 9 its f9al report issu$ 9 ,octob] ( #bjaf1 & any subsequ5t ,f$]al & ,/ate actions 9 relation to su* recomm5dations2 7#b7 reflect ! input ( ! /akehold]s p>ticipat+ 9 ! public meet+ "u subsection 7a72 7#c7 id5tify specific /rategic objectives reg>d+ h[ ! v>i\s ,f$]al & ,/ate ag5cies *>g$ ) en=cem5t ( m5tal heal? p>ity & addiction equity requirem5ts w collaborate to improve en=cem5t ( su* requirem5ts2 7#d7 provide a timel9e = implem5t+ ! action plan2 & 7#e7 provide specific examples ( h[ su* objectives may be met1 :i* may include-- 7,a7 provid+ common educational in=mation & docum5ts1 su* z ! ,consum] ,guide to ,disclosure ,rights1 to pati5ts ab\t _! rights "u m5tal heal? p>ity & addiction equity requirem5ts2 7,b7 facilitat+ ! c5traliz$ collection (1 monitor+ (1 & response to pati5t compla9ts or inquiries relat+ to m5tal heal? p>ity & addiction equity requirem5ts1 :i* may be ?r\gh ! developm5t & adm9i/ration (-- 7i7 a s+le1 toll-free telephone numb]2 & 7ii7 a new p>ity website-- 7,i7 to help consum]s f9d ! appropriate ,f$]al or ,/ate ag5cy to assi/ ) _! p>ity compla9ts1 appeals1 & o!r actions2 & 7,,ii7 t takes into consid]ation1 b is n duplicative (1 ! p>ity beta site be+ te/$1 & releas$ = public comm5t1 by ! ,dep>tm5t ( ,heal? & ,human ,s]vices z ( ! date ( ! enactm5t ( ?is ,act2 7,c7 ,f$]al & ,/ate law en=cem5t ag5cies ent]+ into memor&a ( und]/&+ to bett] coord9ate en=cem5t responsibilities & in=mation %>+-- 7i7 includ+ :e!r su* ag5cies %\ld make ! results ( en=cem5t actions relat$ to m5tal heal? p>ity & addiction equity requirem5ts publicly available2 & 7ii7 :i* may include ,/ate ,policy ,academies on ,p>ity ,implem5tation = ,/ate ,(ficials & o!r =ums to br+ toge!r national exp]ts to provide te*nical assi/ance to teams ( ,/ate (ficials on /rategies to advance compliance ) m5tal heal? p>ity & addiction equity requirem5ts 9 bo? ! comm]cial m>ket1 & 9 ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act & ! ,/ate ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi ( su* ,act2 & 7,d7 recomm5dations to ! ,congress reg>d+ ! ne$ = additional legal au?ority to improve en=cem5t ( m5tal heal? p>ity & addiction equity requirem5ts1 includ+ ! ne$ = additional legal au?ority to ensure t nonquantitative treatm5t limitations are appli$1 & ! ext5t & frequ5cy ( ! applications ( su* limitations1 bo? to m$ical & surgical b5efits & to m5tal heal? & sub/ance use disord] b5efits 9 a comp>able mann]4 #acjjc4 ,report on inve/igations reg>d+ p>ity 9 m5tal heal? & sub/ance use disord] b5efits 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft] = ! subsequ5t #e ye>s1 ! ,assi/ant ,secret>y ( ,labor ( ! ,employee ,b5efits ,security ,adm9i/ration1 9 collaboration ) ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,secret>y ( ! ,treasury1 %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report summ>iz+ ! results ( all clos$ ,f$]al inve/igations complet$ dur+ ! prec$+ #ab-mon? p]iod ) f9d+s ( any s]i\s violation reg>d+ compliance ) m5tal heal? & sub/ance use disord] cov]age requirem5ts "u section #bgbf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;a71 & section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf4 7b7 ,cont5ts ,subject to subsection 7c71 a report "u subsection 7a7 %all1 ) respect to inve/igations describ$ 9 su* subsection1 include ea* ( ! foll[+3 7#a7 ,! numb] ( clos$ ,f$]al inve/igations conduct$ dur+ ! cov]$ report+ p]iod4 7#b7 ,ea* b5efit classification exam9$ by any su* inve/igation conduct$ dur+ ! cov]$ report+ p]iod4 7#c7 ,ea* subject matt]1 includ+ compliance ) requirem5ts = quantitative & nonquantitative treatm5t limitations1 ( any su* inve/igation conduct$ dur+ ! cov]$ report+ p]iod4 7#d7 ,a summ>y ( ! basis ( ! f9al decision r5d]$ = ea* clos$ inve/igation conduct$ dur+ ! cov]$ report+ p]iod t result$ 9 a f9d+ ( a s]i\s violation4 7c7 ,limitation ,any individually id5tifiable in=mation %all be exclud$ f reports "u subsection 7a7 consi/5t ) protections "u ! heal? privacy & security rules promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note74 #acjjd4 ,,gao /udy on p>ity 9 m5tal heal? & sub/ance use disord] b5efits ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury1 %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report detail+ ! ext5t to :i* gr\p heal? plans or heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age t provides bo? m$ical & surgical b5efits & m5tal heal? or sub/ance use disord] b5efits1 m$icaid manag$ c>e organizations ) a contract "u section #aijc7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m771 & heal? plans provid$ "u ! ,/ate ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;aa et seq47 comply ) section #bgbf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;a71 & section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf1 includ+-- 7#a7 h[ nonquantitative treatm5t limitations1 includ+ m$ical necessity crit]ia1 ( su* plans or issu]s comply ) su* sections2 7#b7 h[ ! responsible ,f$]al dep>tm5ts & ag5cies ensure t su* plans or issu]s comply ) su* sections1 includ+ an assessm5t ( h[ ! ,secret>y ( ,heal? & ,human ,s]vices has us$ its au?ority to conduct audits ( su* plans to ensure compliance2 7#c7 a review ( h[ ! v>i\s ,f$]al & ,/ate ag5cies responsible = en=c+ m5tal heal? p>ity requirem5ts h improv$ en=cem5t ( su* requirem5ts 9 accordance ) ! objectives & timel9e describ$ 9 ! action plan "u section #acjjb2 & 7#d7 recomm5dations = h[ additional en=cem5t1 education1 & coord9ation activities by responsible ,f$]al & ,/ate dep>tm5ts & ag5cies c\ld bett] ensure compliance ) su* sections1 includ+ recomm5dations reg>d+ ! ne$ = additional legal au?ority4 #acjje4 ,in=mation & aw>5ess on eat+ disord]s 7a7 ,in=mation ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,(fice on ,wom5's ,heal?1 may-- 7#a7 update in=mation1 relat$ fact %eets1 & res\rce li/s relat$ to eat+ disord]s t are available on ! public ,int]net website ( ! ,national ,wom5's ,heal? ,in=mation ,c5t] sponsor$ by ! ,(fice on ,wom5's ,heal?1 to include-- 7,a7 updat$ f9d+s & curr5t rese>* relat$ to eat+ disord]s1 z appropriate2 & 7,b7 in=mation ab\t eat+ disord]s1 includ+ in=mation relat$ to males & females2 7#b7 incorporate1 z appropriate1 & 9 coord9ation ) ! ,secret>y ( ,education1 in=mation f publicly available res\rces into appropriate obesity prev5tion programs develop$ by ! ,(fice on ,wom5's ,heal?2 & 7#c7 make publicly available 7?r\gh a public ,int]net website or o!r me?od7 in=mation1 relat$ fact %eets1 & res\rce li/s1 z updat$ "u p>agraph 7#a71 & ! in=mation incorporat$ into appropriate obesity prev5tion programs "u p>agraph 7#b74 7b7 ,aw>5ess ,! ,secret>y ( ,heal? & ,human ,s]vices may advance public aw>5ess on-- 7#a7 ! types ( eat+ disord]s2 7#b7 ! s]i\sness ( eat+ disord]s1 includ+ preval5ce1 comorbidities1 & physical & m5tal heal? consequ5ces2 7#c7 me?ods to id5tify1 int]v5e1 ref] = treatm5t1 & prev5t behaviors t may lead to ! developm5t ( eat+ disord]s2 7#d7 discrim9ation & bully+ bas$ on body size2 7#e7 ! effects ( m$ia on self-e/eem & body image2 & 7#f7 ! signs & symptoms ( eat+ disord]s4 #acjjf4 ,education & tra9+ on eat+ disord]s ,! ,secret>y ( ,heal? & ,human ,s]vices may facilitate ! id5tification ( model programs & mat]ials = educat+ & tra9+ heal? pr(essionals 9 effective /rategies to-- 7#a7 id5tify individuals ) eat+ disord]s2 7#b7 provide e>ly int]v5tion s]vices = individuals ) eat+ disord]s2 7#c7 ref] pati5ts ) eat+ disord]s = appropriate treatm5t2 7#d7 prev5t ! developm5t ( eat+ disord]s2 & 7#e7 provide appropriate treatm5t s]vices = individuals ) eat+ disord]s4 #acjjg4 ,cl>ification ( exi/+ p>ity rules ,if a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age provides cov]age = eat+ disord] b5efits1 includ+ resid5tial treatm5t1 su* gr\p heal? plan or heal? insurance issu] %all provide su* b5efits consi/5t ) ! requirem5ts ( section #bgbf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;a71 & section #ihab ( ! ,int]nal ,rev5ue ,code ( #aihf4 ,,xiv ,m5tal heal? & safe communities ,a ,m5tal heal? & safe communities #adjja4 ,law en=cem5t grants = crisis int]v5tion teams1 m5tal heal? purposes 7a7 ,edw>d ,byrne ,memorial ,ju/ice ,assi/ance ,grant ,program ,section #eja7;a77#a7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgea7;a77#a77 is am5d$ by add+ at ! end ! foll[+3 7,h7 ,m5tal heal? programs & relat$ law en=cem5t & corrections programs1 includ+ behavioral programs & crisis int]v5tion teams4 4 7b7 ,community ,ori5t$ ,polic+ ,s]vices ,program ,section #agja7;b7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgif;dd7b77 is am5d$-- 7#a7 9 p>agraph 7#ag71 by /rik+ & at ! end2 7#b7 by r$esignat+ p>agraph 7#ah7 z p>agraph 7#bb72 7#c7 by ins]t+ aft] p>agraph 7#ag7 ! foll[+3 7#ah7 to provide specializ$ tra9+ to law en=cem5t (fic]s to-- 7,a7 recognize individuals :o h a m5tal illness2 & 7,b7 prop]ly int]act ) individuals :o h a m5tal illness1 includ+ /rategies = v]bal de-escalation ( crises2 7#ai7 to e/abli% collaborative programs t enhance ! ability ( law en=cem5t ag5cies to address ! m5tal heal?1 behavioral1 & sub/ance abuse problems ( individuals enc\nt]$ by law en=cem5t (fic]s 9 ! l9e ( duty2 7#bj7 to provide specializ$ tra9+ to corrections (fic]s to recognize individuals :o h a m5tal illness2 7#ba7 to enhance ! ability ( corrections (fic]s to address ! m5tal heal? ( individuals "u ! c>e & cu/ody ( jails & prisons1 includ+ specializ$ tra9+ & /rategies = v]bal de-escalation ( crises2 & 2 & 7#d7 9 p>agraph 7#bb71 z r$esignat$1 by /rik+ ?r\gh 7#ag7 & ins]t+ ?r\gh 7#ba74 7c7 ,modifications to ! /aff+ = adequate fire & em]g5cy response grants ,section #cd7;a77#a77;,b7 ( ! ,f$]al ,fire ,prev5tion & ,control ,act ( #aigd 7#ae ,u4,s4,c4 #bbbi;a7a77#a77;,b77 is am5d$ by ins]t+ be=e ! p]iod at ! end ! foll[+3 & to provide specializ$ tra9+ to p>am$ics1 em]g5cy m$ical s]vices work]s1 & o!r fir/ respond]s to recognize individuals :o h m5tal illness & h[ to prop]ly int]v5e ) individuals ) m5tal illness1 includ+ /rategies = v]bal de-escalation ( crises4 #adjjb4 ,assi/$ outpati5t treatm5t programs 7a7 ,9 g5]al ,section #bbja ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgif;ii7 is am5d$ 9 p>agraph 7#b77;,b71 by ins]t+ be=e ! semicolon ! foll[+3 1 or c\rt-ord]$ assi/$ outpati5t treatm5t :5 ! c\rt has det]m9$ su* treatm5t to be necess>y4 7b7 ,def9itions ,section #bbjb ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgif;ii--#a7 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#b71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7#c7 ! t]m c\rt-ord]$ assi/$ outpati5t treatm5t means a program ?r\gh :i* a c\rt may ord] a treatm5t plan = an eligible pati5t t-- 7,a7 requires su* pati5t to obta9 outpati5t m5tal heal? treatm5t :ile ! pati5t is n curr5tly resid+ 9 a correctional facility or inpati5t treatm5t facility2 & 7,b7 is design$ to improve access & adh]5ce by su* pati5t to int5sive behavioral heal? s]vices 9 ord] to-- 7i7 av]t relapse1 repeat$ hospitalizations1 arre/1 inc>c]ation1 suicide1 prop]ty de/ruction1 & viol5t behavior2 & 7ii7 provide su* pati5t ) ! opportunity to live 9 a less re/rictive alt]native to inc>c]ation or involunt>y hospitalization2 & 7#d7 ! t]m eligible pati5t means an adult1 m5tally ill p]son :o1 z det]m9$ by a c\rt-- 7,a7 has a hi/ory ( viol5ce1 inc>c]ation1 or m$ically unnecess>y hospitalizations2 7,b7 )\t sup]vision & treatm5t1 may be a dang] to self or o!rs 9 ! community2 7,c7 is sub/antially unlikely to volunt>ily p>ticipate 9 treatm5t2 7,d7 may be unable1 = reasons o!r ?an indig5ce1 to provide = any ( 8 or h] basic ne$s1 su* z food1 clo?+1 %elt]1 heal?1 or safety2 7,e7 has a hi/ory ( m5tal illness or a condition t is likely to sub/antially det]iorate if ! p]son is n provid$ ) timely treatm5t2 or 7,f7 due to m5tal illness1 lacks capacity to fully und]/& or lacks judgm5t to make in=m$ decisions reg>d+ 8 or h] ne$ = treatm5t1 c>e1 or sup]vision4 4 #adjjc4 ,f$]al drug & m5tal heal? c\rts 7a7 ,def9itions ,9 ?is section-- 7#a7 ! t]m eligible (f5d] means a p]son :o-- 7,a7 7i7 previ\sly or curr5tly has be5 diagnos$ by a qualifi$ m5tal heal? pr(essional z hav+ a m5tal illness1 m5tal ret>dation1 or co-occurr+ m5tal illness & sub/ance abuse disord]s2 or 7ii7 manife/s obvi\s signs ( m5tal illness1 m5tal ret>dation1 or co-occurr+ m5tal illness & sub/ance abuse disord]s dur+ arre/ or conf9em5t or be=e any c\rt2 7,b7 comes into contact ) ! crim9al ju/ice sy/em or is arre/$ or *>g$ ) an (f5se t is n-- 7i7 a crime ( viol5ce1 z def9$ "u applicable ,/ate law or 9 section #caef ( title #ah1 ,unit$ ,/ates ,code2 or 7ii7 a s]i\s drug (f5se1 z def9$ 9 section #ibd7;e77#b77;,a7 ( title #ah1 ,unit$ ,/ates ,code2 & 7,c7 is det]m9$ by a judge to be eligible2 & 7#b7 ! t]m m5tal illness means a diagnosable m5tal1 behavioral1 or emotional disord]-- 7,a7 ( suffici5t duration to meet diagno/ic crit]ia )9 ! mo/ rec5t edition ( ! ,diagno/ic & ,/ati/ical ,manual ( ,m5tal ,disord]s publi%$ by ! ,am]ican ,psy*iatric ,association2 & 7,b7 t has result$ 9 functional impairm5t t sub/antially int]f]es ) or limits #a or m major life activities4 7b7 ,e/abli%m5t ( program ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,attorney ,g5]al %all e/abli% a pilot program to det]m9e ! effectiv5ess ( div]t+ eligible (f5d]s f ,f$]al prosecution1 ,f$]al probation1 or a ,bureau ( ,prisons facility1 & plac+ su* eligible (f5d]s 9 drug or m5tal heal? c\rts4 7c7 ,program specifications ,! pilot program e/abli%$ "u subsection 7b7 %all involve-- 7#a7 cont9u+ judicial sup]vision1 includ+ p]iodic review1 ( program p>ticipants :o h a sub/ance abuse problem or m5tal illness2 & 7#b7 ! integrat$ adm9i/ration ( s]vices & sanctions1 :i* %all include-- 7,a7 m&atory p]iodic te/+1 z appropriate1 = ! use ( controll$ sub/ances or o!r addictive sub/ances dur+ any p]iod ( sup]vis$ release or probation = ea* program p>ticipant2 7,b7 sub/ance abuse treatm5t = ea* program p>ticipant :o requires su* s]vices2 7,c7 div]sion1 probation1 or o!r sup]vis$ release ) ! possibility ( prosecution1 conf9em5t1 or inc>c]ation bas$ on noncompliance ) program requirem5ts or failure to %[ satisfactory progress t[>d complet+ program requirem5ts2 7,d7 programmatic (f5d] managem5t1 includ+ case managem5t1 & aft]c>e s]vices1 su* z relapse prev5tion1 heal? c>e1 education1 vocational tra9+1 job placem5t1 h\s+ placem5t1 & *ild c>e or o!r family support s]vices = ea* program p>ticipant :o requires su* s]vices2 7,e7 outpati5t or inpati5t m5tal heal? treatm5t1 z ord]$ by ! c\rt1 t c>ries ) x ! possibility ( dismissal ( *>ges or r$uc$ s5t5c+ ^u successful completion ( su* treatm5t2 7,f7 c5traliz$ case managem5t1 includ+-- 7i7 ! consolidation ( all cases1 includ+ violations ( probations1 ( ! program p>ticipant2 & 7ii7 coord9ation ( all m5tal heal? treatm5t plans & social s]vices1 includ+ life skills & vocational tra9+1 h\s+ & job placem5t1 education1 heal? c>e1 & relapse prev5tion = ea* program p>ticipant :o requires su* s]vices2 & 7,g7 cont9u+ sup]vision ( treatm5t plan compliance by ! program p>ticipant = a t]m n to exce$ ! maximum all[able s5t5ce or probation p]iod = ! *>g$ or relevant (f5se &1 to ! ext5t practicable1 cont9uity ( psy*iatric c>e at ! end ( ! sup]vis$ p]iod4 7d7 ,implem5tation2 duration ,! pilot program e/abli%$ "u subsection 7b7 %all be conduct$-- 7#a7 9 n less ?an #a ,unit$ ,/ates judicial di/rict1 designat$ by ! ,attorney ,g5]al 9 consultation ) ! ,director ( ! ,adm9i/rative ,(fice ( ! ,unit$ ,/ates ,c\rts1 z appropriate = ! pilot program2 & 7#b7 dur+ fiscal ye> #bjag ?r\gh fiscal ye> #bjba4 7e7 ,crit]ia = designation ,be=e mak+ a designation "u subsection 7d77#a71 ! ,attorney ,g5]al %all-- 7#a7 obta9 ! approval1 9 writ+1 ( ! ,unit$ ,/ates ,attorney = ! ,unit$ ,/ates judicial di/rict be+ designat$2 7#b7 obta9 ! approval1 9 writ+1 ( ! *ief judge = ! ,unit$ ,/ates judicial di/rict be+ designat$2 & 7#c7 det]m9e t ! ,unit$ ,/ates judicial di/rict be+ designat$ has adequate behavioral heal? sy/ems = treatm5t1 includ+ sub/ance abuse & m5tal heal? treatm5t4 7f7 ,assi/ance f o!r ,f$]al entities ,! ,adm9i/rative ,(fice ( ! ,unit$ ,/ates ,c\rts & ! ,unit$ ,/ates ,probation ,(fices %all provide su* assi/ance & c>ry out su* functions z ! ,attorney ,g5]al may reque/ 9 monitor+1 sup]vis+1 provid+ s]vices to1 & evaluat+ eligible (f5d]s plac$ 9 a drug or m5tal heal? c\rt "u ?is section4 7g7 ,reports ,! ,attorney ,g5]al1 9 consultation ) ! ,director ( ! ,adm9i/rative ,(fice ( ! ,unit$ ,/ates ,c\rts1 %all monitor ! drug & m5tal heal? c\rts "u ?is section1 & %all submit a report to ,congress on ! outcomes ( ! program at ! end ( ! p]iod describ$ 9 subsection 7d77#b74 #adjjd4 ,m5tal heal? 9 ! judicial sy/em ,"p ,v ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgif;ii et seq47 is am5d$ by ins]t+ at ! end ! foll[+3 #bbji4 ,m5tal heal? responses 9 ! judicial sy/em 7a7 ,pretrial scre5+ & sup]vision 7#a7 ,9 g5]al ,! ,attorney ,g5]al may aw>d grants to ,/ates1 units ( local gov]nm5t1 t]ritories1 ,indian ,tribes1 nonpr(it ag5cies1 or any comb9ation !re(1 to develop1 implem5t1 or exp& pretrial s]vices programs to improve ! id5tification & outcomes ( individuals ) m5tal illness4 7#b7 ,all[able uses ,grants aw>d$ "u ?is subsection may be may be us$ =-- 7,a7 behavioral heal? ne$s & risk scre5+ ( def5dants1 includ+ v]ification ( int]view in=mation1 m5tal heal? evaluation1 & crim9al hi/ory scre5+2 7,b7 assessm5t ( risk ( pretrial misconduct ?r\gh objective1 /ati/ically validat$ means1 & pres5tation to ! c\rt ( recomm5dations bas$ on su* assessm5t1 includ+ s]vices t w r$uce ! risk ( pre-trial misconduct2 7,c7 foll[up review ( def5dants unable to meet ! conditions ( pretrial release2 7,d7 evaluation ( process & results ( pre-trial s]vice programs2 7,e7 sup]vision ( def5dants :o are on pretrial release1 includ+ rem9d]s to def5dants ( s*$ul$ c\rt dates2 7,f7 report+ on process & results ( pretrial s]vices programs to relevant public & private m5tal heal? /akehold]s2 & 7,g7 data collection & analysis necess>y to make available in=mation requir$ = assessm5t ( risk4 7b7 ,behavioral heal? assessm5ts & int]v5tion 7#a7 ,9 g5]al ,! ,attorney ,g5]al may aw>d grants to ,/ates1 units ( local gov]nm5t1 t]ritories1 ,indian ,tribes1 nonpr(it ag5cies1 or any comb9ation !re(1 to develop1 implem5t1 or exp& a behavioral heal? scre5+ & assessm5t program framework = ,/ate or local crim9al ju/ice sy/ems4 7#b7 ,all[able uses ,grants aw>d$ "u ?is subsection may be us$ =-- 7,a7 promotion ( ! use ( validat$ assessm5t tools to gauge ! crim9og5ic risk1 sub/ance abuse ne$s1 & m5tal heal? ne$s ( individuals2 7,b7 initiatives to mat* ! risk factors & ne$s ( individuals to programs & practices associat$ ) rese>*-bas$1 positive outcomes2 7,c7 implem5t+ me?ods = id5tify+ & treat+ individuals :o are mo/ likely to b5efit f coord9at$ sup]vision & treatm5t /rategies1 & id5tify+ individuals :o c d well ) few] int]v5tions2 & 7,d7 collaborative decision-mak+ among ! heads ( crim9al ju/ice ag5cies1 m5tal heal? sy/ems1 judicial sy/ems1 sub/ance abuse sy/ems1 & o!r relevant sy/ems or ag5cies = det]m9+ h[ treatm5t & int5sive sup]vision s]vices %\ld be allocat$ 9 ord] to maximize b5efits1 & develop+ & utiliz+ capacity accord+ly4 7c7 ,use ( grant funds ,a ,/ate1 unit ( local gov]nm5t1 t]ritory1 ,indian ,tribe1 or nonpr(it ag5cy t receives a grant "u ?is section %all1 9 accordance ) subsection 7b77#b71 use grant funds = ! exp5ses ( a treatm5t program1 includ+-- 7#a7 sal>ies1 p]sonnel co/s1 equipm5t co/s1 & o!r co/s directly relat$ to ! op]ation ( ! program1 includ+ co/s relat+ to en=cem5t2 7#b7 paym5ts = treatm5t provid]s t are approv$ by ! ,/ate or ,indian ,tribe & lic5s$1 if necess>y1 to provide ne$$ treatm5t to program p>ticipants1 includ+ aft]c>e sup]vision1 vocational tra9+1 education1 & job placem5t2 & 7#c7 paym5ts to public & nonpr(it private entities t are approv$ by ! ,/ate or ,indian ,tribe & lic5s$1 if necess>y1 to provide alcohol & drug addiction treatm5t to (f5d]s p>ticipat+ 9 ! program4 7d7 ,supplem5t ( non-,f$]al funds 7#a7 ,9 g5]al ,grants aw>d$ "u ?is section %all be us$ to supplem5t1 & n supplant1 non-,f$]al funds t w\ld o!rwise be available = programs describ$ 9 ?is section4 7#b7 ,f$]al %>e ,! ,f$]al %>e ( a grant made "u ?is section may n exce$ #ej p]c5t ( ! total co/s ( ! program describ$ 9 an application "u subsection 7e74 7e7 ,applications ,to reque/ a grant "u ?is section1 a ,/ate1 unit ( local gov]nm5t1 t]ritory1 ,indian ,tribe1 or nonpr(it ag5cy %all submit an application to ! ,attorney ,g5]al 9 su* =m & conta9+ su* in=mation z ! ,attorney ,g5]al may reasonably require4 7f7 ,geographic di/ribution ,! ,attorney ,g5]al %all ensure t1 to ! ext5t practicable1 ! di/ribution ( grants "u ?is section is equitable & includes-- 7#a7 ea* ,/ate2 & 7#b7 a unit ( local gov]nm5t1 t]ritory1 ,indian ,tribe1 or nonpr(it ag5cy-- 7,a7 9 ea* ,/ate2 & 7,b7 9 rural1 suburban1 ,tribal1 & urban jurisdictions4 7g7 ,reports & evaluations ,= ea* fiscal ye>1 ea* grantee "u ?is section dur+ t fiscal ye> %all submit to ! ,attorney ,g5]al a report on ! effectiv5ess ( activities c>ri$ out us+ su* grant4 ,ea* report %all include an evaluation 9 su* =m & conta9+ su* in=mation z ! ,attorney ,g5]al may reasonably require4 ,! ,attorney ,g5]al %all specify ! dates on :i* su* reports %all be submitt$4 7h7 ,acc\ntability ,grants aw>d$ "u ?is section %all be subject to ! foll[+ acc\ntability provisions3 7#a7 ,audit requirem5t 7,a7 ,def9ition ,9 ?is p>agraph1 ! t]m unresolv$ audit f9d+ means a f9d+ 9 ! f9al audit report ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice "u subp>agraph 7,c7 t ! audit$ grantee has us$ grant funds = an unau?oriz$ exp5diture or o!rwise unall[able co/ t is n clos$ or resolv$ )9 #a ye> aft] ! date on :i* f9al audit report is issu$4 7,b7 ,audits ,beg9n+ 9 ! fir/ fiscal ye> beg9n+ aft] ! date ( enactm5t ( ?is section1 & 9 ea* fiscal ye> !reaft]1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice %all conduct audits ( grantees "u ?is section to prev5t wa/e1 fraud1 & abuse ( funds by grantees4 ,! ,inspector ,g5]al %all det]m9e ! appropriate numb] ( grantees to be audit$ ea* ye>4 7,c7 ,f9al audit report ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice %all submit to ! ,attorney ,g5]al a f9al report on ea* audit conduct$ "u subp>agraph 7,b74 7,d7 ,m&atory exclusion ,grantees "u ?is section ab\t :i* !re is an unresolv$ audit f9d+ %all n be eligible to receive a grant "u ?is section dur+ ! #b fiscal ye>s beg9n+ aft] ! end ( ! #a-ye> p]iod describ$ 9 subp>agraph 7,a74 7,e7 ,priority ,9 mak+ grants "u ?is section1 ! ,attorney ,g5]al %all give priority to applicants t did n h an unresolv$ audit f9d+ dur+ ! #c fiscal ye>s be=e submitt+ an application = a grant "u ?is section4 7,f7 ,reimbursem5t ,if an entity receives a grant "u ?is section dur+ ! #b-;fiscal-ye> p]iod dur+ :i* ! entity is prohibit$ f receiv+ grants "u subp>agraph 7,d71 ! ,attorney ,g5]al %all-- 7i7 deposit an am\nt equal to ! am\nt ( ! grant t 0 improp]ly aw>d$ to ! grantee into ! ,g5]al ,fund ( ! ,treasury2 & 7ii7 seek to rec\p ! co/s ( ! repaym5t "u clause 7i7 f ! grantee t 0 errone\sly aw>d$ grant funds4 7#b7 ,nonpr(it ag5cy requirem5ts 7,a7 ,def9ition ,= purposes ( ?is p>agraph & ! grant program "u ?is section1 ! t]m nonpr(it ag5cy means an organization t is describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf ,u4,s4,c4 #eja7;c77#c77 & is exempt f taxation "u section #eja7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf ,u4,s4,c4 #eja7;a774 7,b7 ,prohibition ,! ,attorney ,g5]al may n aw>d a grant "u ?is section to a nonpr(it ag5cy t holds money 9 an (f%ore acc\nt = ! purpose ( avoid+ pay+ ! tax describ$ 9 section #eaa7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf ,u4,s4,c4 #eaa7;a774 7,c7 ,disclosure ,ea* nonpr(it ag5cy t is aw>d$ a grant "u ?is section & uses ! proc$ures prescrib$ 9 regulations to create a rebuttable presumption ( reasonabl5ess = ! comp5sation ( its (fic]s1 directors1 tru/ees1 & key employees1 %all disclose to ! ,attorney ,g5]al1 9 ! application = ! grant1 ! process = det]m9+ su* comp5sation1 includ+ ! indep5d5t p]sons involv$ 9 review+ & approv+ su* comp5sation1 ! comp>ability data us$1 & contemporane\s sub/antiation ( ! delib]ation & decision4 ,^u reque/1 ! ,attorney ,g5]al %all make ! in=mation disclos$ "u ?is subp>agraph available = public inspection4 7#c7 ,conf]5ce exp5ditures 7,a7 ,limitation ,n m ?an #bj1jjj ( ! am\nts made available to ! ,dep>tm5t ( ,ju/ice to c>ry out ?is section may be us$ by ! ,attorney ,g5]al1 or by any individual or entity aw>d$ a grant "u ?is section to ho/1 or make any exp5ditures relat+ to1 a conf]5ce unless ! ,deputy ,attorney ,g5]al provides prior writt5 au?orization t ! funds may be exp5d$ to ho/ ! conf]5ce or make su* exp5diture4 7,b7 ,writt5 approval ,writt5 approval "u subp>agraph 7,a7 %all include a writt5 e/imate ( all co/s associat$ ) ! conf]5ce1 includ+ ! co/ ( all food1 bev]ages1 audio-visual equipm5t1 honor>ia = speak]s1 & ent]ta9m5t4 7,c7 ,report ,! ,deputy ,attorney ,g5]al %all submit an annual report to ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives on all conf]5ce exp5ditures approv$ "u ?is p>agraph4 7#d7 ,annual c]tification ,beg9n+ 9 ! fir/ fiscal ye> beg9n+ aft] ! date ( enactm5t ( ?is subsection1 ! ,attorney ,g5]al %all submit to ! ,committee on ! ,judici>y & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ! ,judici>y & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives an annual c]tification-- 7,a7 indicat+ :e!r-- 7i7 all f9al audit reports issu$ by ! ,(fice ( ! ,inspector ,g5]al "u p>agraph 7#a7 h be5 complet$ & review$ by ! appropriate ,assi/ant ,attorney ,g5]al or ,director2 7ii7 all m&atory exclusions requir$ "u p>agraph 7#a77;,d7 h be5 issu$2 & 7iii7 any reimbursem5ts requir$ "u p>agraph 7#a77;,f7 h be5 made2 & 7,b7 t includes a li/ ( any grantees exclud$ "u p>agraph 7#a77;,d7 f ! previ\s ye>4 7i7 ,prev5t+ duplicative grants 7#a7 ,9 g5]al ,be=e ! ,attorney ,g5]al aw>ds a grant to an applicant "u ?is section1 ! ,attorney ,g5]al %all comp>e ! possible grant ) any o!r grants aw>d$ to ! applicant "u ?is ,act to det]m9e :e!r ! grants are = ! same purpose4 7#b7 ,report ,if ! ,attorney ,g5]al aw>ds multiple grants to ! same applicant = ! same purpose1 ! ,attorney ,g5]al %all submit to ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives a report t includes-- 7,a7 a li/ ( all duplicate grants aw>d$1 includ+ ! total doll> am\nt ( any su* grants aw>d$2 & 7,b7 ! reason ! ,attorney ,g5]al aw>d$ ! duplicate grants4 4 #adjje4 ,=5sic ass]tive community treatm5t initiatives ,section #biia ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa7 is am5d$ by-- 7#a7 r$esignat+ subsection 7j7 z subsection 7o72 & 7#b7 ins]t+ aft] subsection 7i7 ! foll[+3 7j7 ,=5sic ,ass]tive ,community ,treatm5t 7,,fact7 ,initiative ,program 7#a7 ,9 g5]al ,! ,attorney ,g5]al may make grants to ,/ates1 units ( local gov]nm5t1 t]ritories1 ,indian ,tribes1 nonpr(it ag5cies1 or any comb9ation !re(1 to develop1 implem5t1 or exp& ,ass]tive ,community ,treatm5t initiatives to develop =5sic ass]tive community treatm5t 7ref]r$ to 9 ?is subsection z ,,fact7 programs t provide high int5sity s]vices 9 ! community = individuals ) m5tal illness ) involvem5t 9 ! crim9al ju/ice sy/em to prev5t future inc>c]ations4 7#b7 ,all[able uses ,grant funds aw>d$ "u ?is subsection may be us$ =-- 7,a7 multidiscipl9>y team initiatives = individuals ) m5tal illnesses ) crim9al ju/ice involvem5t t address crim9al ju/ice involvem5t z "p ( treatm5t protocols2 7,b7 ,,fact programs t involve m5tal heal? pr(essionals1 crim9al ju/ice ag5cies1 *emical dep5d5cy speciali/s1 nurses1 psy*iatri/s1 vocational speciali/s1 =5sic pe] speciali/s1 =5sic speciali/s1 & d$icat$ adm9i/rative support /aff :o "w toge!r to provide recov]y ori5t$1 #bd_/g wrap>\nd s]vices2 7,c7 s]vices su* z integrat$ evid5ce-bas$ practices = ! treatm5t ( co-occurr+ m5tal heal? & sub/ance-relat$ disord]s1 ass]tive outrea* & engagem5t1 community-bas$ s]vice provision at p>ticipants' resid5ce or 9 ! community1 psy*iatric rehabilitation1 recov]y ori5t$ s]vices1 s]vices to address crim9og5ic risk factors1 & community t5ure2 7,d7 paym5ts = treatm5t provid]s t are approv$ by ! ,/ate or ,indian ,tribe & lic5s$1 if necess>y1 to provide ne$$ treatm5t to eligible (f5d]s p>ticipat+ 9 ! program1 includ+ behavioral heal? s]vices & aft]c>e sup]vision2 & 7,e7 tra9+ = all ,,fact teams to promote high-fidelity practice pr9ciples & te*nical assi/ance to support effective & cont9u+ integration ) crim9al ju/ice ag5cy p>tn]s4 7#c7 ,supplem5t & n supplant ,grants made "u ?is subsection %all be us$ to supplem5t1 & n supplant1 non-,f$]al funds t w\ld o!rwise be available = programs describ$ 9 ?is subsection4 7#d7 ,applications ,to reque/ a grant "u ?is subsection1 a ,/ate1 unit ( local gov]nm5t1 t]ritory1 ,indian ,tribe1 or nonpr(it ag5cy %all submit an application to ! ,attorney ,g5]al 9 su* =m & conta9+ su* in=mation z ! ,attorney ,g5]al may reasonably require4 4 #adjjf4 ,assi/ance = individuals transition+ out ( sy/ems ,section #bigf7;f7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgigw7f77 is am5d$-- 7#a7 9 p>agraph 7#e71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#f71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7#g7 provide m5tal heal? treatm5t & transitional s]vices = ^? ) m5tal illnesses or ) co-occurr+ disord]s1 includ+ h\s+ placem5t or assi/ance2 & 4 #adjjg4 ,co-occurr+ sub/ance abuse & m5tal heal? *all5ges 9 drug c\rts ,"p ,,ee ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgigu et seq47 is am5d$-- 7#a7 9 section #biea7;a77#a7 7#db ,u4,s4,c4 #cgigu7a77#a771 by ins]t+ 1 includ+ co-occurr+ sub/ance abuse & m5tal heal? problems1 aft] problems2 & 7#b7 9 section #biei7;a7 7#db ,u4,s4,c4 #cgigu-#h7;a771 by ins]t+ 1 includ+ tra9+ = drug c\rt p]sonnel & (ficials on id5tify+ & address+ co-occurr+ sub/ance abuse & m5tal heal? problems aft] "p4 #adjjh4 ,m5tal heal? tra9+ = ,f$]al uni=m$ s]vices 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,def5se1 ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ,comm]ce %all provide ! foll[+ to ea* ( ! uni=m$ s]vices 7z t t]m is def9$ 9 section #aja ( title #aj1 ,unit$ ,/ates ,code7 "u _! direction3 7#a7 ,tra9+ programs ,programs t (f] specializ$ & compreh5sive tra9+ 9 proc$ures to id5tify & respond appropriately to incid5ts 9 :i* ! unique ne$s ( individuals ) m5tal illnesses are involv$4 7#b7 ,improv$ te*nology ,comput]iz$ in=mation sy/ems or te*nological improvem5ts to provide timely in=mation to ,f$]al law en=cem5t p]sonnel1 o!r bran*es ( ! uni=m$ s]vices1 & crim9al ju/ice sy/em p]sonnel to improve ! ,f$]al response to m5tally ill individuals4 7#c7 ,coop]ative programs ,! e/abli%m5t & expansion ( coop]ative ef=ts to promote public safety ?r\gh ! use ( effective int]v5tion ) respect to m5tally ill individuals enc\nt]$ by memb]s ( ! uni=m$ s]vices4 #adjji4 ,advanc+ m5tal heal? z "p ( (f5d] re5try 7a7 ,re5try demon/ration projects ,section #bigf7;f7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgigw7f771 z am5d$ by section #adjjf1 is am5d$-- 7#a7 9 p>agraph 7#c77;,c71 by ins]t+ m5tal heal? s]vices1 be=e drug treatm5t2 & 7#b7 by add+ at ! end ! foll[+3 7#h7 t>get (f5d]s ) hi/ories ( homelessness1 sub/ance abuse1 or m5tal illness1 includ+ a pr]elease assessm5t ( ! h\s+ /atus ( ! (f5d] & behavioral heal? ne$s ( ! (f5d] ) cle> coord9ation ) m5tal heal?1 sub/ance abuse1 & homelessness s]vices sy/ems to a*ieve /able & p]man5t h\s+ outcomes ) appropriate support s]vice4 4 7b7 ,m5tor+ grants ,section #baa7;b77#b7 ( ! ,second ,*ance ,act ( #bjjg 7#db ,u4,s4,c4 #ageca7;b77#b77 is am5d$ by ins]t+ 1 includ+ m5tal heal? c>e aft] community4 #adjaj4 ,s*ool m5tal heal? crisis int]v5tion teams ,section #bgja7;b7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;a7b77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#d7 & 7#e7 z p>agraphs 7#e7 & 7#f71 respectively2 & 7#b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,! developm5t & op]ation ( crisis int]v5tion teams t may include coord9ation ) law en=cem5t ag5cies & specializ$ tra9+ = s*ool (ficials 9 respond+ to m5tal heal? crises4 4 #adjaa4 ,active-%oot] tra9+ = law en=cem5t ,! ,attorney ,g5]al1 z "p ( ! ,prev5t+ ,viol5ce ,aga9/ ,law ,en=cem5t & ,ensur+ ,(fic] ,resili5ce & ,survivability ,initiative 7,,valor7 ( ! ,dep>tm5t ( ,ju/ice1 may provide safety tra9+ & te*nical assi/ance to local law en=cem5t ag5cies1 includ+ active-%oot] response tra9+4 #adjab4 ,co-occurr+ sub/ance abuse & m5tal heal? *all5ges 9 resid5tial sub/ance abuse treatm5t programs ,section #aija7;a7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgif;ff7a77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#b71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#c7 develop+ & implem5t+ specializ$ resid5tial sub/ance abuse treatm5t programs t id5tify & provide appropriate treatm5t to inmates ) co-occurr+ m5tal heal? & sub/ance abuse disord]s or *all5ges4 4 #adjac4 ,m5tal heal? & drug treatm5t alt]natives to inc>c]ation programs ,title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgaa et seq47 is am5d$ by /rik+ "p ,,cc & ins]t+ ! foll[+3 ,,cc ,m5tal heal? & drug treatm5t alt]natives to inc>c]ation programs #bija4 ,m5tal heal? & drug treatm5t alt]natives to inc>c]ation programs 7a7 ,def9itions ,9 ?is section-- 7#a7 ! t]m eligible entity means a ,/ate1 unit ( local gov]nm5t1 ,indian tribe1 or nonpr(it organization2 & 7#b7 ! t]m eligible p>ticipant means an individual :o-- 7,a7 comes into contact ) ! crim9al ju/ice sy/em or is arre/$ or *>g$ ) an (f5se t is n-- 7i7 a crime ( viol5ce1 z def9$ "u applicable ,/ate law or 9 section #caef ( title #ah1 ,unit$ ,/ates ,code2 or 7ii7 a s]i\s drug (f5se1 z def9$ 9 section #ibd7;e77#b77;,a7 ( title #ah1 ,unit$ ,/ates ,code2 7,b7 has a hi/ory (1 or a curr5t-- 7i7 sub/ance use disord]2 7ii7 m5tal illness2 or 7iii7 co-occurr+ m5tal illness & sub/ance use disord]2 & 7,c7 has be5 approv$ = p>ticipation 9 a program fund$ "u ?is section by ! relevant law en=cem5t ag5cy1 prosecut+ attorney1 def5se attorney1 probation (ficial1 corrections (ficial1 judge1 repres5tative ( a m5tal heal? ag5cy1 or repres5tative ( a sub/ance abuse ag5cy1 z requir$ by law4 7b7 ,program au?oriz$ ,! ,attorney ,g5]al may make grants to eligible entities to develop1 implem5t1 or exp& a treatm5t alt]native to inc>c]ation program = eligible p>ticipants1 includ+-- 7#a7 pre-book+ treatm5t alt]native to inc>c]ation programs1 includ+-- 7,a7 law en=cem5t tra9+ on sub/ance use disord]s1 m5tal illness1 & co-occurr+ m5tal illness & sub/ance use disord]s2 7,b7 receiv+ c5t]s z alt]natives to inc>c]ation ( eligible p>ticipants2 7,c7 specializ$ response units = calls relat$ to sub/ance use disord]s1 m5tal illness1 or co-occurr+ m5tal illness & sub/ance use disord]s2 & 7,d7 o!r arre/ & pre-book+ treatm5t alt]natives to inc>c]ation models2 or 7#b7 po/-book+ treatm5t alt]native to inc>c]ation programs1 includ+-- 7,a7 specializ$ cl9ical case managem5t2 7,b7 pre-trial s]vices relat$ to sub/ances use disord]s1 m5tal illness1 & co-occurr+ m5tal illness & sub/ance use disord]s2 7,c7 prosecutor & def5d] bas$ programs2 7,d7 specializ$ probation2 7,e7 treatm5t & rehabilitation programs2 & 7,f7 problem-solv+ c\rts1 includ+ m5tal heal? c\rts1 drug c\rts1 co-occurr+ m5tal heal? & sub/ance abuse c\rts1 ,,dwi c\rts1 & vet]ans treatm5t c\rts4 7c7 ,application 7#a7 ,9 g5]al ,an eligible entity desir+ a grant "u ?is section %all submit an application to ! ,attorney ,g5]al-- 7,a7 t meets ! crit]ia "u p>agraph 7#b72 & 7,b7 at su* "t1 9 su* mann]1 & accompani$ by su* in=mation z ! ,attorney ,g5]al may require4 7#b7 ,crit]ia ,an eligible entity1 9 submitt+ an application "u p>agraph 7#a71 %all-- 7,a7 provide ext5sive evid5ce ( collaboration ) ,/ate & local gov]nm5t ag5cies ov]see+ heal?1 community corrections1 c\rts1 prosecution1 sub/ance abuse1 m5tal heal?1 victims s]vices1 & employm5t s]vices1 & ) local law en=cem5t ag5cies2 7,b7 demon/rate consultation ) ! ,s+le ,/ate ,au?ority = ,sub/ance ,abuse ( ! ,/ate 7z t t]m is def9$ 9 section #bja7;e7 ( ! ,second ,*ance ,act ( #bjjg72 7,c7 demon/rate t evid5ce-bas$ treatm5t practices w be utiliz$2 & 7,d7 demon/rate t evid5ce-bas$ scre5+ & assessm5t tools w be us$ to place p>ticipants 9 ! treatm5t alt]native to inc>c]ation program4 7d7 ,requirem5ts ,ea* eligible entity aw>d$ a grant = a treatm5t alt]native to inc>c]ation program "u ?is section %all-- 7#a7 det]m9e ! t]ms & conditions ( p>ticipation 9 ! program by eligible p>ticipants1 tak+ into consid]ation ! collat]al consequ5ces ( an arre/1 prosecution or crim9al conviction2 7#b7 ensure t ea* sub/ance abuse & m5tal heal? treatm5t compon5t is lic5s$ & qualifi$ by ! relevant jurisdiction2 7#c7 = programs describ$ 9 subsection 7b77#b71 organize an en=cem5t unit compris$ ( appropriately tra9$ law en=cem5t pr(essionals "u ! sup]vision ( ! ,/ate1 ,tribal1 or local crim9al ju/ice ag5cy involv$1 ! duties ( :i* %all include-- 7,a7 ! v]ification ( addresses & o!r contact in=mation ( ea* eligible p>ticipant :o p>ticipates or desires to p>ticipate 9 ! program2 & 7,b7 if necess>y1 ! location1 appreh5sion1 arre/1 & return to cu/ody ( an eligible p>ticipant 9 ! program :o has abscond$ f ! facility ( a treatm5t provid] or has o!rwise significantly violat$ ! t]ms & conditions ( ! program1 consi/5t ) ,f$]al & ,/ate confid5tiality requirem5ts2 7#d7 notify ! relevant crim9al ju/ice entity if any eligible p>ticipant 9 ! program absconds f ! facility ( ! treatm5t provid] or o!rwise violates ! t]ms & conditions ( ! program1 consi/5t ) ,f$]al & ,/ate confid5tiality requirem5ts2 7#e7 submit p]iodic reports on ! progress ( treatm5t or o!r measur$ outcomes f p>ticipation 9 ! program ( ea* eligible p>ticipant 9 ! program to ! relevant ,/ate1 ,tribal1 or local crim9al ju/ice ag5cy1 includ+ m5tal heal? c\rts1 drug c\rts1 co-occurr+ m5tal heal? & sub/ance abuse c\rts1 ,,dwi c\rts1 & vet]ans treatm5t c\rts2 7#f7 describe ! evid5ce-bas$ me?odology & outcome measurem5ts t w be us$ to evaluate ! program1 & specifically expla9 h[ su* measurem5ts w provide valid measures ( ! impact ( ! program2 & 7#g7 describe h[ ! program c\ld be broadly replicat$ if demon/rat$ to be effective4 7e7 ,use ( funds ,an eligible entity %all use a grant receiv$ "u ?is section = exp5ses ( a treatm5t alt]native to inc>c]ation program1 includ+-- 7#a7 sal>ies1 p]sonnel co/s1 equipm5t co/s1 & o!r co/s directly relat$ to ! op]ation ( ! program1 includ+ ! en=cem5t unit2 7#b7 paym5ts = treatm5t provid]s t are approv$ by ! relevant ,/ate or ,tribal jurisdiction & lic5s$1 if necess>y1 to provide ne$$ treatm5t to eligible (f5d]s p>ticipat+ 9 ! program1 includ+ aft]c>e sup]vision1 vocational tra9+1 education1 & job placem5t2 & 7#c7 paym5ts to public & nonpr(it private entities t are approv$ by ! ,/ate or ,tribal jurisdiction & lic5s$1 if necess>y1 to provide alcohol & drug addiction treatm5t to eligible (f5d]s p>ticipat+ 9 ! program4 7f7 ,supplem5t n supplant ,an eligible entity %all use ,f$]al funds receiv$ "u ?is section only to supplem5t ! funds t w\ld1 9 ! abs5ce ( ^? ,f$]al funds1 be made available f o!r ,f$]al & non-,f$]al s\rces = ! activities describ$ 9 ?is section1 & n to supplant ^? funds4 ,! ,f$]al %>e ( a grant made "u ?is section may n exce$ #ej p]c5t ( ! total co/s ( ! program describ$ 9 an application "u subsection 7d74 7g7 ,geographic di/ribution ,! ,attorney ,g5]al %all ensure t1 to ! ext5t practicable1 ! geographical di/ribution ( grants "u ?is section is equitable & includes a grant to an eligible entity 9-- 7#a7 ea* ,/ate2 7#b7 rural1 suburban1 & urban areas2 & 7#c7 ,tribal jurisdictions4 7h7 ,reports & evaluations ,ea* fiscal ye>1 ea* recipi5t ( a grant "u ?is section dur+ t fiscal ye> %all submit to ! ,attorney ,g5]al a report on ! outcomes ( activities c>ri$ out us+ t grant 9 su* =m1 conta9+ su* in=mation1 & on su* dates z ! ,attorney ,g5]al %all specify4 7i7 ,acc\ntability ,all grants aw>d$ by ! ,attorney ,g5]al "u ?is section %all be subject to ! foll[+ acc\ntability provisions3 7#a7 ,audit requirem5t 7,a7 ,def9ition ,9 ?is p>agraph1 ! t]m unresolv$ audit f9d+ means a f9d+ 9 ! f9al audit report ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice t ! audit$ grantee has utiliz$ grant funds = an unau?oriz$ exp5diture or o!rwise unall[able co/ t is n clos$ or resolv$ )9 #ab mon?s f ! date on :i* ! f9al audit report is issu$4 7,b7 ,audits ,beg9n+ 9 ! fir/ fiscal ye> beg9n+ aft] ! date ( enactm5t ( ?is subsection1 & 9 ea* fiscal ye> !reaft]1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice %all conduct audits ( recipi5ts ( grants "u ?is section to prev5t wa/e1 fraud1 & abuse ( funds by grantees4 ,! ,inspector ,g5]al %all det]m9e ! appropriate numb] ( grantees to be audit$ ea* ye>4 7,c7 ,m&atory exclusion ,a recipi5t ( grant funds "u ?is section t is f\nd to h an unresolv$ audit f9d+ %all n be eligible to receive grant funds "u ?is section dur+ ! fir/ #b fiscal ye>s beg9n+ aft] ! end ( ! #ab-mon? p]iod describ$ 9 subp>agraph 7,a74 7,d7 ,priority ,9 aw>d+ grants "u ?is section1 ! ,attorney ,g5]al %all give priority to eligible applicants t did n h an unresolv$ audit f9d+ dur+ ! #c fiscal ye>s be=e submitt+ an application = a grant "u ?is section4 7,e7 ,reimbursem5t ,if an entity is aw>d$ grant funds "u ?is section dur+ ! #b-;fiscal-ye> p]iod dur+ :i* ! entity is b>r$ f receiv+ grants "u subp>agraph 7,c71 ! ,attorney ,g5]al %all-- 7i7 deposit an am\nt equal to ! am\nt ( ! grant funds t 7 improp]ly aw>d$ to ! grantee into ! ,g5]al ,fund ( ! ,treasury2 & 7ii7 seek to rec\p ! co/s ( ! repaym5t to ! fund f ! grant recipi5t t 0 errone\sly aw>d$ grant funds4 7#b7 ,nonpr(it organization requirem5ts 7,a7 ,def9ition ,= purposes ( ?is p>agraph & ! grant programs "u ?is "p1 ! t]m nonpr(it organization means an organization t is describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf & is exempt f taxation "u section #eja7;a7 ( su* ,code4 7,b7 ,prohibition ,! ,attorney ,g5]al may n aw>d a grant "u ?is "p to a nonpr(it organization t holds money 9 (f%ore acc\nts = ! purpose ( avoid+ pay+ ! tax describ$ 9 section #eaa7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf4 7,c7 ,disclosure ,ea* nonpr(it organization t is aw>d$ a grant "u ?is section & uses ! proc$ures prescrib$ 9 regulations to create a rebuttable presumption ( reasonabl5ess = ! comp5sation ( its (fic]s1 directors1 tru/ees1 & key employees1 %all disclose to ! ,attorney ,g5]al1 9 ! application = ! grant1 ! process = det]m9+ su* comp5sation1 includ+ ! indep5d5t p]sons involv$ 9 review+ & approv+ su* comp5sation1 ! comp>ability data us$1 & contemporane\s sub/antiation ( ! delib]ation & decision4 ,^u reque/1 ! ,attorney ,g5]al %all make ! in=mation disclos$ "u ?is subp>agraph available = public inspection4 7#c7 ,conf]5ce exp5ditures 7,a7 ,limitation ,no am\nts made available to ! ,dep>tm5t ( ,ju/ice "u ?is section may be us$ by ! ,attorney ,g5]al1 or by any individual or entity aw>d$ discretion>y funds ?r\gh a coop]ative agreem5t "u ?is section1 to ho/ or support any exp5diture = conf]5ces t uses m ?an #bj1jjj 9 funds made available by ! ,dep>tm5t ( ,ju/ice1 unless ! head ( ! relevant ag5cy or dep>tm5t1 provides prior writt5 au?orization t ! funds may be exp5d$ to ho/ ! conf]5ce4 7,b7 ,writt5 approval ,writt5 approval "u subp>agraph 7,a7 %all include a writt5 e/imate ( all co/s associat$ ) ! conf]5ce1 includ+ ! co/ ( all food1 bev]ages1 audio-visual equipm5t1 honor>ia = speak]s1 & ent]ta9m5t4 7,c7 ,report ,! ,deputy ,attorney ,g5]al %all submit an annual report to ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives on all conf]5ce exp5ditures approv$ "u ?is p>agraph4 7#d7 ,annual c]tification ,beg9n+ 9 ! fir/ fiscal ye> beg9n+ aft] ! date ( enactm5t ( ?is subsection1 ! ,attorney ,g5]al %all submit1 to ! ,committee on ! ,judici>y & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ! ,judici>y & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 an annual c]tification-- 7,a7 indicat+ :e!r-- 7i7 all audits issu$ by ! ,(fice ( ! ,inspector ,g5]al "u p>agraph 7#a7 h be5 complet$ & review$ by ! appropriate ,assi/ant ,attorney ,g5]al or ,director2 7ii7 all m&atory exclusions requir$ "u p>agraph 7#a77;,c7 h be5 issu$2 & 7iii7 all reimbursem5ts requir$ "u p>agraph 7#a77;,e7 h be5 made2 & 7,b7 t includes a li/ ( any grant recipi5ts exclud$ "u p>agraph 7#a7 f ! previ\s ye>4 7#e7 ,prev5t+ duplicative grants 7,a7 ,9 g5]al ,be=e ! ,attorney ,g5]al aw>ds a grant to an applicant "u ?is section1 ! ,attorney ,g5]al %all comp>e pot5tial grant aw>ds ) o!r grants aw>d$ "u ?is ,act to det]m9e if duplicate grant aw>ds are aw>d$ = ! same purpose4 7,b7 ,report ,if ! ,attorney ,g5]al aw>ds duplicate grants to ! same applicant = ! same purpose ! ,attorney ,g5]al %all submit to ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives a report t includes-- 7i7 a li/ ( all duplicate grants aw>d$1 includ+ ! total doll> am\nt ( any duplicate grants aw>d$2 & 7ii7 ! reason ! ,attorney ,g5]al aw>d$ ! duplicate grants4 4 #adjad4 ,national crim9al ju/ice & m5tal heal? tra9+ & te*nical assi/ance ,"p ,,hh ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa et seq47 is am5d$ by add+ at ! end ! foll[+3 #biib4 ,national crim9al ju/ice & m5tal heal? tra9+ & te*nical assi/ance 7a7 ,au?ority ,! ,attorney ,g5]al may make grants to eligible organizations to provide = ! e/abli%m5t ( a ,national ,crim9al ,ju/ice & ,m5tal ,heal? ,tra9+ & ,te*nical ,assi/ance ,c5t]4 7b7 ,eligible organization ,= purposes ( subsection 7a71 ! t]m eligible organization means a national nonpr(it organization t provides te*nical assi/ance & tra9+ to1 & has special exp]tise & broad1 national-level exp]i5ce 91 m5tal heal?1 crisis int]v5tion1 crim9al ju/ice sy/ems1 law en=cem5t1 translat+ evid5ce into practice1 tra9+1 & rese>*1 & education & support ( p ) m5tal illness & ! families ( su* individuals4 7c7 ,use ( funds ,any organization t receives a grant "u subsection 7a7 %all collaborate ) o!r grant recipi5ts to e/abli% & op]ate a ,national ,crim9al ,ju/ice & ,m5tal ,heal? ,tra9+ & ,te*nical ,assi/ance ,c5t] to-- 7#a7 provide law en=cem5t (fic] tra9+ reg>d+ m5tal heal? & work+ ) individuals ) m5tal illnesses1 ) an emphasis on de-escalation ( enc\nt]s betwe5 law en=cem5t (fic]s & ^? ) m5tal disord]s or 9 crisis1 :i* %all include support ! developm5t ( 9-p]son & te*nical in=mation ex*anges betwe5 sy/ems & ! individuals work+ 9 ^? sy/ems 9 support ( ! concepts id5tifi$ 9 ! tra9+2 7#b7 provide education1 tra9+1 & te*nical assi/ance = ,/ates1 ,indian tribes1 t]ritories1 units ( local gov]nm5t1 s]vice provid]s1 nonpr(it organizations1 probation or p>ole (fic]s1 prosecutors1 def5se attorneys1 em]g5cy response provid]s1 & corrections in/itutions to advance practice & k relat+ to m5tal heal? crisis & approa*es to m5tal heal? & crim9al ju/ice across sy/ems2 7#c7 provide tra9+ & be/ practices to m5tal heal? provid]s & crim9al ju/ice ag5cies relat+ to div]sion initiatives1 jail & prison /rategies1 re5try ( individuals ) m5tal illnesses into ! community1 & dispat* protocols & triage capabilities1 includ+ ! e/abli%m5t ( le>n+ sites2 7#d7 develop suicide prev5tion & crisis int]v5tion tra9+ & te*nical assi/ance = crim9al ju/ice ag5cies2 7#e7 develop a receiv+ c5t] sy/em & pilot /rategy t provides1 = a jurisdiction1 a s+le po9t ( entry into ! m5tal heal? & sub/ance abuse sy/em = assessm5ts & appropriate placem5t ( individuals exp]i5c+ a crisis2 7#f7 collect data & be/ practices 9 m5tal heal? & crim9al heal? & crim9al ju/ice initiatives & policies f grantees "u ?is "p1 o!r recipi5ts ( grants "u ?is section1 ,f$]al1 ,/ate1 & local ag5cies involv$ 9 ! provision ( m5tal heal? s]vices1 & nongov]nm5tal organizations involv$ 9 ! provision ( m5tal heal? s]vices2 7#g7 develop & dissem9ate to m5tal heal? provid]s & crim9al ju/ice ag5cies evaluation tools1 me*anisms1 & measures to bett] assess & docum5t p]=mance measures & outcomes relat+ to ! provision ( m5tal heal? s]vices2 7#h7 dissem9ate in=mation to ,/ates1 units ( local gov]nm5t1 crim9al ju/ice ag5cies1 law en=cem5t ag5cies1 & o!r relevant entities ab\t be/ practices1 policy /&>ds1 & rese>* f9d+s relat+ to ! provision ( m5tal heal? s]vices2 & 7#i7 provide education & support to individuals ) m5tal illness involv$ )1 or at risk ( involvem5t )1 ! crim9al ju/ice sy/em1 includ+ ! families ( su* individuals4 7d7 ,acc\ntability ,grants aw>d$ "u ?is section %all be subject to ! foll[+ acc\ntability provisions3 7#a7 ,audit requirem5t 7,a7 ,def9ition ,9 ?is p>agraph1 ! t]m unresolv$ audit f9d+ means a f9d+ 9 ! f9al audit report ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice "u subp>agraph 7,c7 t ! audit$ grantee has us$ grant funds = an unau?oriz$ exp5diture or o!rwise unall[able co/ t is n clos$ or resolv$ )9 #a ye> aft] ! date on :i* ! f9al audit report is issu$4 7,b7 ,audits ,beg9n+ 9 ! fir/ fiscal ye> beg9n+ aft] ! date ( enactm5t ( ?is section1 & 9 ea* fiscal ye> !reaft]1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice %all conduct audits ( grantees "u ?is section to prev5t wa/e1 fraud1 & abuse ( funds by grantees4 ,! ,inspector ,g5]al %all det]m9e ! appropriate numb] ( grantees to be audit$ ea* ye>4 7,c7 ,f9al audit report ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice %all submit to ! ,attorney ,g5]al a f9al report on ea* audit conduct$ "u subp>agraph 7,b74 7,d7 ,m&atory exclusion ,grantees "u ?is section ab\t :i* !re is an unresolv$ audit f9d+ %all n be eligible to receive a grant "u ?is section dur+ ! #b fiscal ye>s beg9n+ aft] ! end ( ! #a-ye> p]iod describ$ 9 subp>agraph 7,a74 7,e7 ,priority ,9 mak+ grants "u ?is section1 ! ,attorney ,g5]al %all give priority to applicants t did n h an unresolv$ audit f9d+ dur+ ! #c fiscal ye>s be=e submitt+ an application = a grant "u ?is section4 7,f7 ,reimbursem5t ,if an entity receives a grant "u ?is section dur+ ! #b-;fiscal-ye> p]iod dur+ :i* ! entity is prohibit$ f receiv+ grants "u subp>agraph 7,d71 ! ,attorney ,g5]al %all-- 7i7 deposit an am\nt equal to ! am\nt ( ! grant t 0 improp]ly aw>d$ to ! grantee into ! ,g5]al ,fund ( ! ,treasury2 & 7ii7 seek to rec\p ! co/s ( ! repaym5t "u clause 7i7 f ! grantee t 0 errone\sly aw>d$ grant funds4 7#b7 ,nonpr(it ag5cy requirem5ts 7,a7 ,def9ition ,= purposes ( ?is p>agraph & ! grant program "u ?is section1 ! t]m nonpr(it ag5cy means an organization t is describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf ,u4,s4,c4 #eja7;c77#c77 & is exempt f taxation "u section #eja7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf ,u4,s4,c4 #eja7;a774 7,b7 ,prohibition ,! ,attorney ,g5]al may n aw>d a grant "u ?is section to a nonpr(it ag5cy t holds money 9 an (f%ore acc\nt = ! purpose ( avoid+ pay+ ! tax describ$ 9 section #eaa7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf ,u4,s4,c4 #eaa7;a774 7,c7 ,disclosure ,ea* nonpr(it ag5cy t is aw>d$ a grant "u ?is section & uses ! proc$ures prescrib$ 9 regulations to create a rebuttable presumption ( reasonabl5ess = ! comp5sation ( its (fic]s1 directors1 tru/ees1 & key employees1 %all disclose to ! ,attorney ,g5]al1 9 ! application = ! grant1 ! process = det]m9+ su* comp5sation1 includ+ ! indep5d5t p]sons involv$ 9 review+ & approv+ su* comp5sation1 ! comp>ability data us$1 & contemporane\s sub/antiation ( ! delib]ation & decision4 ,^u reque/1 ! ,attorney ,g5]al %all make ! in=mation disclos$ "u ?is subp>agraph available = public inspection4 7#c7 ,conf]5ce exp5ditures 7,a7 ,limitation ,no am\nts made available to ! ,dep>tm5t ( ,ju/ice "u ?is section may be us$ by ! ,attorney ,g5]al1 or by any individual or entity aw>d$ discretion>y funds ?r\gh a coop]ative agreem5t "u ?is section1 to ho/ or support any exp5diture = conf]5ces t uses m ?an #bj1jjj 9 funds made available by ! ,dep>tm5t ( ,ju/ice1 unless ! head ( ! relevant ag5cy or dep>tm5t1 provides prior writt5 au?orization t ! funds may be exp5d$ to ho/ ! conf]5ce4 7,b7 ,writt5 approval ,writt5 approval "u subp>agraph 7,a7 %all include a writt5 e/imate ( all co/s associat$ ) ! conf]5ce1 includ+ ! co/ ( all food1 bev]ages1 audio-visual equipm5t1 honor>ia = speak]s1 & ent]ta9m5t4 7,c7 ,report ,! ,deputy ,attorney ,g5]al %all submit an annual report to ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives on all conf]5ce exp5ditures approv$ "u ?is p>agraph4 7#d7 ,annual c]tification ,beg9n+ 9 ! fir/ fiscal ye> beg9n+ aft] ! date ( enactm5t ( ?is subsection1 ! ,attorney ,g5]al %all submit to ! ,committee on ! ,judici>y & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ! ,judici>y & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives an annual c]tification-- 7,a7 indicat+ :e!r-- 7i7 all f9al audit reports issu$ by ! ,(fice ( ! ,inspector ,g5]al "u p>agraph 7#a7 h be5 complet$ & review$ by ! appropriate ,assi/ant ,attorney ,g5]al or ,director2 7ii7 all m&atory exclusions requir$ "u p>agraph 7#a77;,d7 h be5 issu$2 & 7iii7 any reimbursem5ts requir$ "u p>agraph 7#a77;,f7 h be5 made2 & 7,b7 t includes a li/ ( any grantees exclud$ "u p>agraph 7#a77;,d7 f ! previ\s ye>4 7#e7 ,prev5t+ duplicative grants 7,a7 ,9 g5]al ,be=e ! ,attorney ,g5]al aw>ds a grant to an applicant "u ?is section1 ! ,attorney ,g5]al %all comp>e pot5tial grant aw>ds ) o!r grants aw>d$ "u ?is ,act to det]m9e if duplicate grant aw>ds are aw>d$ = ! same purpose4 7,b7 ,report ,if ! ,attorney ,g5]al aw>ds duplicate grants to ! same applicant = ! same purpose ! ,attorney ,g5]al %all submit to ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives a report t includes-- 7i7 a li/ ( all duplicate grants aw>d$1 includ+ ! total doll> am\nt ( any duplicate grants aw>d$2 & 7ii7 ! reason ! ,attorney ,g5]al aw>d$ ! duplicate grants4 4 #adjae4 ,improv+ ,dep>tm5t ( ,ju/ice data collection on m5tal illness involv$ 9 crime 7a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 on or aft] ! date t is #ij days aft] ! date on :i* ! ,attorney ,g5]al promulgates regulations "u subsection 7b71 any data prep>$ by1 or submitt$ to1 ! ,attorney ,g5]al or ! ,director ( ! ,f$]al ,bureau ( ,inve/igation ) respect to ! incid5ces ( homicides1 law en=cem5t (fic]s kill$1 s]i\sly injur$1 & assault$1 or individuals kill$ or s]i\sly injur$ by law en=cem5t (fic]s %all include data ) respect to ! involvem5t ( m5tal illness 9 su* incid5ces1 if any4 7b7 ,regulations ,n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,attorney ,g5]al %all promulgate or revise regulations z necess>y to c>ry out subsection 7a74 #adjaf4 ,reports on ! numb] ( m5tally ill (f5d]s 9 prison 7a7 ,report on ! ,co/ ( ,treat+ ! ,m5tally ,ill 9 ! ,crim9al ,ju/ice ,sy/em ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report detail+ ! co/ ( imprisonm5t = individuals :o h s]i\s m5tal illness by ! ,f$]al ,gov]nm5t or a ,/ate or unit ( local gov]nm5t1 :i* %all include-- 7#a7 ! numb] & type ( crimes committ$ by individuals ) s]i\s m5tal illness ea* ye>2 & 7#b7 detail /rategies or ideas = prev5t+ crimes by ^? individuals ) s]i\s m5tal illness f occurr+4 7b7 ,def9ition ,= purposes ( ?is section1 ! ,attorney ,g5]al1 9 consultation ) ! ,assi/ant ,secret>y ( ,m5tal ,heal? & ,sub/ance ,use ,disord]s1 %all def9e s]i\s m5tal illness bas$ on ! ,heal? ,c>e ,re=m = ,am]icans ) ,sev]e ,m5tal ,illnesses3 ,report ( ! ,national ,advisory ,m5tal ,heal? ,c\ncil1 ,am]ican ,j\rnal ( ,psy*iatry #aiic2 #aej3addg-adfe4 #adjag4 ,codification ( due process = det]m9ations by secret>y ( vet]ans affairs ( m5tal capacity ( b5efici>ies 7a7 ,9 g5]al ,*apt] #ee ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by ins]t+ aft] section #eeja ! foll[+ new section3 #eeja;,a4 ,b5efici>ies' rights 9 m5tal compet5ce det]m9ations ,! ,secret>y may n make an adv]se det]m9ation conc]n+ ! m5tal capacity ( a b5efici>y to manage monet>y b5efits paid to or = ! b5efici>y by ! ,secret>y "u ?is title unless su* b5efici>y has be5 provid$ all ( ! foll[+1 subject to ! proc$ures & timel9es prescrib$ by ! ,secret>y = det]m9ations ( incompet5cy3 7#a7 ,notice ( ! propos$ adv]se det]m9ation & ! support+ evid5ce4 7#b7 ,an opportunity to reque/ a he>+4 7#c7 ,an opportunity to pres5t evid5ce1 includ+ an op9ion f a m$ical pr(essional or o!r p]son1 on ! capacity ( ! b5efici>y to manage monet>y b5efits paid to or = ! b5efici>y by ! ,secret>y "u ?is title4 7#d7 ,an opportunity to be repres5t$ at no exp5se to ! ,gov]nm5t 7includ+ by c\nsel7 at any su* he>+ & to br+ a m$ical pr(essional or o!r p]son to provide relevant te/imony at any su* he>+4 4 7b7 ,cl]ical am5dm5t ,! table ( sections at ! beg9n+ ( su* *apt] #ee is am5d$ by ins]t+ aft] ! item relat+ to section #eeja ! foll[+ new item3 #eeja;,a4 ,b5efici>ies' rights 9 m5tal compet5ce det]m9ations 4 7c7 ,effective date ,section #eeja;,a ( title #ch1 ,unit$ ,/ates ,code1 z add$ by subsection 7a71 %all apply to det]m9ations made by ! ,secret>y ( ,vet]ans ,affairs on or aft] ! date ( ! enactm5t ( ?is ,act4 #adjah4 ,reau?orization ( appropriations ,subsection 7o7 ( section #biia ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa71 z r$esignat$ by section #adjjf1 is am5d$-- 7#a7 9 p>agraph 7#a77;,c71 by /rik+ #bjji ?r\gh #bjad & ins]t+ #bjag ?r\gh #bjba2 & 7#b7 by add+ at ! end ! foll[+3 7#c7 ,limitation ,n m ?an #bj p]c5t ( ! funds au?oriz$ to be appropriat$ "u ?is section may be us$ = purposes describ$ 9 subsection 7i7 7relat+ to vet]ans74 4 ,b ,compreh5sive ,ju/ice & ,m5tal ,heal? #adjba4 ,sequ5tial int]cept model ,section #biia ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa71 z am5d$ by section #adjje1 is am5d$ by ins]t+ aft] subsection 7j71 ! foll[+3 7k7 ,sequ5tial int]cept grants 7#a7 ,def9ition ,9 ?is subsection1 ! t]m eligible entity means a ,/ate1 unit ( local gov]nm5t1 ,indian tribe1 or tribal organization4 7#b7 ,au?orization ,! ,attorney ,g5]al may make grants "u ?is subsection to an eligible entity = sequ5tial int]cept mapp+ & implem5tation 9 accordance ) p>agraph 7#c74 7#c7 ,sequ5tial int]cept mapp+2 implem5tation ,an eligible entity t receives a grant "u ?is subsection may use funds =-- 7,a7 sequ5tial int]cept mapp+1 :i*-- 7i7 %all consi/ (-- 7,i7 conv5+ m5tal heal? & crim9al ju/ice /akehold]s to-- 7aa7 develop a %>$ und]/&+ ( ! fl[ ( ju/ice-involv$ individuals ) m5tal illnesses ?r\gh ! crim9al ju/ice sy/em2 & 7bb7 id5tify opportunities = improv$ collaborative responses to ! risks & ne$s ( individuals describ$ 9 item 7aa72 & 7,,ii7 develop+ /rategies to address gaps 9 s]vices & br+ innovative & effective programs to scale along multiple int]cepts1 includ+-- 7aa7 em]g5cy & crisis s]vices2 7bb7 specializ$ police-bas$ responses2 7cc7 c\rt he>+s & disposition alt]natives2 7dd7 re5try f jails & prisons2 & 7ee7 community sup]vision1 treatm5t & support s]vices2 & 7ii7 may s]ve z a />t+ po9t = ! developm5t ( /rategic plans to a*ieve positive public heal? & safety outcomes2 & 7,b7 implem5tation1 :i* %all-- 7i7 be d]iv$ f ! /rategic plans describ$ 9 subp>agraph 7,a77ii72 & 7ii7 consi/ (-- 7,i7 hir+ & tra9+ p]sonnel2 7,,ii7 id5tify+ ! eligible entity's t>get population2 7,,iii7 provid+ s]vices & supports to r$uce unnecess>y p5etration into ! crim9al ju/ice sy/em2 7,,iv7 r$uc+ recidivism2 7,v7 evaluat+ ! impact ( ! eligible entity's approa*2 & 7,,vi7 plann+ = ! su/a9ability ( effective int]v5tions4 4 #adjbb4 ,prison & jails ,section #biia ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa7 is am5d$ by ins]t+ aft] subsection 7k71 z add$ by section #adjba1 ! foll[+3 7l7 ,correctional facilities 7#a7 ,def9itions 7,a7 ,correctional facility ,! t]m correctional facility means a jail1 prison1 or o!r det5tion facility us$ to h\se p :o h be5 arre/$1 deta9$1 held1 or convict$ by a crim9al ju/ice ag5cy or a c\rt4 7,b7 ,eligible inmate ,! t]m eligible inmate means an individual :o-- 7i7 is be+ held1 deta9$1 or inc>c]at$ 9 a correctional facility2 & 7ii7 manife/s obvi\s signs ( a m5tal illness or has be5 diagnos$ by a qualifi$ m5tal heal? pr(essional z hav+ a m5tal illness4 7#b7 ,correctional facility grants ,! ,attorney ,g5]al may aw>d grants to applicants to enhance ! capabilities ( a correctional facility-- 7,a7 to id5tify & scre5 = eligible inmates2 7,b7 to plan & provide-- 7i7 initial & p]iodic assessm5ts ( ! cl9ical1 m$ical1 & social ne$s ( inmates2 & 7ii7 appropriate treatm5t & s]vices t address ! m5tal heal? & sub/ance abuse ne$s ( inmates2 7,c7 to develop1 implem5t1 & enhance-- 7i7 po/-release transition plans = eligible inmates t1 9 a compreh5sive mann]1 coord9ate heal?1 h\s+1 m$ical1 employm5t1 & o!r appropriate s]vices & public b5efits2 7ii7 ! availability ( m5tal heal? c>e s]vices & sub/ance abuse treatm5t s]vices2 & 7iii7 alt]natives to solit>y conf9em5t & segregat$ h\s+ & m5tal heal? scre5+ & treatm5t = inmates plac$ 9 solit>y conf9em5t or segregat$ h\s+2 & 7,d7 to tra9 ea* employee ( ! correctional facility to id5tify & appropriately respond to incid5ts involv+ inmates ) m5tal heal? or co-occurr+ m5tal heal? & sub/ance abuse disord]s4 4 #adjbc4 ,all[able uses ,section #biia7;b77#e77;,i7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa7b77#e77;,i77 is am5d$ by add+ at ! end ! foll[+3 7v7 ,teams address+ frequ5t us]s ( crisis s]vices ,multidiscipl9>y teams t-- 7,i7 coord9ate1 implem5t1 & adm9i/] community-bas$ crisis responses & long-t]m plans = frequ5t us]s ( crisis s]vices2 7,,ii7 provide tra9+ on h[ to respond appropriately to ! unique issues involv+ frequ5t us]s ( crisis s]vices = public s]vice p]sonnel1 includ+ crim9al ju/ice1 m5tal heal?1 sub/ance abuse1 em]g5cy room1 heal?c>e1 law en=cem5t1 corrections1 & h\s+ p]sonnel2 7,,iii7 develop or support alt]natives to hospital & jail admissions = frequ5t us]s ( crisis s]vices t provide treatm5t1 /abilization1 & o!r appropriate supports 9 ! lea/ re/rictive1 yet appropriate1 environm5t2 & 7,,iv7 develop protocols & sy/ems among law en=cem5t1 m5tal heal?1 sub/ance abuse1 h\s+1 corrections1 & em]g5cy m$ical s]vice op]ations to provide coord9at$ assi/ance to frequ5t us]s ( crisis s]vices4 4 #adjbd4 ,law en=cem5t tra9+ ,section #biia7;h7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa7h77 is am5d$-- 7#a7 9 p>agraph 7#a71 by add+ at ! end ! foll[+3 7,f7 ,academy tra9+ ,to provide support = academy curricula1 law en=cem5t (fic] ori5tation programs1 cont9u+ education tra9+1 & o!r programs t tea* law en=cem5t p]sonnel h[ to id5tify & respond to incid5ts involv+ p]sons ) m5tal heal? disord]s or co-occurr+ m5tal heal? & sub/ance abuse disord]s4 2 & 7#b7 by add+ at ! end ! foll[+3 7#d7 ,priority consid]ation ,! ,attorney ,g5]al1 9 aw>d+ grants "u ?is subsection1 %all give priority to programs t law en=cem5t p]sonnel & memb]s ( ! m5tal heal? & sub/ance abuse pr(essions develop & adm9i/] coop]atively4 4 #adjbe4 ,f$]al law en=cem5t tra9+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,attorney ,g5]al %all provide direction & guidance = ! foll[+3 7#a7 ,tra9+ programs ,programs t (f] specializ$ & compreh5sive tra9+1 9 proc$ures to id5tify & appropriately respond to incid5ts 9 :i* ! unique ne$s ( individuals :o h a m5tal illness are involv$1 to fir/ respond]s & tactical units (-- 7,a7 ,f$]al law en=cem5t ag5cies2 & 7,b7 o!r ,f$]al crim9al ju/ice ag5cies su* z ! ,bureau ( ,prisons1 ! ,adm9i/rative ,(fice ( ! ,unit$ ,/ates ,c\rts1 & o!r ag5cies t ! ,attorney ,g5]al det]m9es appropriate4 7#b7 ,improv$ te*nology ,! e/abli%m5t (1 or improvem5t ( exi/+1 comput]iz$ in=mation sy/ems to provide timely in=mation to employees ( ,f$]al law en=cem5t ag5cies1 & ,f$]al crim9al ju/ice ag5cies to improve ! response ( su* employees to situations involv+ individuals :o h a m5tal illness4 #adjbf4 ,,gao report ,no lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 9 coord9ation ) ! ,attorney ,g5]al1 %all submit to ,congress a report on-- 7#a7 ! practices t ,f$]al fir/ respond]s1 tactical units1 & corrections (fic]s are tra9$ to use 9 respond+ to individuals ) m5tal illness2 7#b7 proc$ures to id5tify & appropriately respond to incid5ts 9 :i* ! unique ne$s ( individuals :o h a m5tal illness are involv$1 to ,f$]al fir/ respond]s & tactical units2 7#c7 ! application ( evid5ce-bas$ practices 9 crim9al ju/ice sett+s to bett] address individuals ) m5tal illnesses2 & 7#d7 recomm5dations on h[ ! ,dep>tm5t ( ,ju/ice c exp& & improve in=mation %>+ & dissem9ation ( be/ practices4 #adjbg4 ,evid5ce bas$ practices ,section #biia7;c7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa7c77 is am5d$-- 7#a7 9 p>agraph 7#c71 by /rik+ or at ! end2 7#b7 by r$esignat+ p>agraph 7#d7 z p>agraph 7#f72 & 7#c7 by ins]t+ aft] p>agraph 7#c71 ! foll[+3 7#d7 propose int]v5tions t h be5 %[n by empirical evid5ce to r$uce recidivism2 7#e7 :5 appropriate1 use validat$ assessm5t tools to t>get prelim9>ily qualifi$ (f5d]s ) a mod]ate or high risk ( recidivism & a ne$ = treatm5t & s]vices2 or 4 #adjbh4 ,transp>5cy1 program acc\ntability1 & enhancem5t ( local au?ority 7a7 ,9 g5]al ,section #biia7;a7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa7a77 is am5d$-- 7#a7 9 p>agraph 7#g7-- 7,a7 9 ! head+1 by /rik+ ,m5tal illness & ins]t+ ,m5tal illness2 m5tal heal? disord]2 & 7,b7 by /rik+ t]m m5tal illness means & ins]t+ t]ms m5tal illness & m5tal heal? disord] mean2 & 7#b7 by /rik+ p>agraph 7#i7 & ins]t+ ! foll[+3 7#i7 ,prelim9>ily qualifi$ (f5d] 7,a7 ,9 g5]al ,! t]m prelim9>ily qualifi$ (f5d] means an adult or juv5ile accus$ ( an (f5se :o-- 7i7 7,i7 previ\sly or curr5tly has be5 diagnos$ by a qualifi$ m5tal heal? pr(essional z hav+ a m5tal illness or co-occurr+ m5tal illness & sub/ance abuse disord]s2 7,,ii7 manife/s obvi\s signs ( m5tal illness or co-occurr+ m5tal illness & sub/ance abuse disord]s dur+ arre/ or conf9em5t or be=e any c\rt2 or 7,,iii7 9 ! case ( a vet]ans treatm5t c\rt provid$ "u subsection 7i71 has be5 diagnos$ )1 or manife/s obvi\s signs (1 m5tal illness or a sub/ance abuse disord] or co-occurr+ m5tal illness & sub/ance abuse disord]2 7ii7 has be5 unanim\sly approv$ = p>ticipation 9 a program fund$ "u ?is section by1 :5 appropriate-- 7,i7 ! relevant-- 7aa7 prosecut+ attorney2 7bb7 def5se attorney2 7cc7 probation or corrections (ficial2 & 7dd7 judge2 & 7,,ii7 a repres5tative f ! relevant m5tal heal? ag5cy describ$ 9 subsection 7b77#e77;,b77i72 7iii7 has be5 det]m9$1 by ea* p]son describ$ 9 clause 7ii7 :o is involv$ 9 approv+ ! adult or juv5ile = p>ticipation 9 a program fund$ "u ?is section1 to n pose a risk ( viol5ce to any p]son 9 ! program1 or ! public1 if select$ to p>ticipate 9 ! program2 & 7iv7 has n be5 *>g$ ) or convict$ (-- 7,i7 any sex (f5se 7z def9$ 9 section #aaa ( ! ,sex ,(f5d] ,regi/ration & ,notification ,act 7#db ,u4,s4,c4 #afiaa77 or any (f5se relat+ to ! sexual exploitation ( *ildr52 or 7,,ii7 murd] or assault ) int5t to commit murd]4 7,b7 ,det]m9ation ,9 det]m9+ :e!r to designate a def5dant z a prelim9>ily qualifi$ (f5d]1 ! relevant prosecut+ attorney1 def5se attorney1 probation or corrections (ficial1 judge1 & m5tal heal? or sub/ance abuse ag5cy repres5tative %all take into acc\nt-- 7i7 :e!r ! p>ticipation ( ! def5dant 9 ! program w\ld pose a sub/antial risk ( viol5ce to ! community2 7ii7 ! crim9al hi/ory ( ! def5dant & ! nature & sev]ity ( ! (f5se = :i* ! def5dant is *>g$2 7iii7 ! views ( any relevant victims to ! (f5se2 7iv7 ! ext5t to :i* ! def5dant w\ld b5efit f p>ticipation 9 ! program2 7v7 ! ext5t to :i* ! community w\ld realize co/ sav+s because ( ! def5dant's p>ticipation 9 ! program2 & 7vi7 :e!r ! def5dant satisfies ! eligibility crit]ia = program p>ticipation unanim\sly e/abli%$ by ! relevant prosecut+ attorney1 def5se attorney1 probation or corrections (ficial1 judge & m5tal heal? or sub/ance abuse ag5cy repres5tative4 4 7b7 ,te*nical & con=m+ am5dm5t ,section #bibg7b7 ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgigs-#f7b77 is am5d$ by /rik+ has ! mean+ giv5 t t]m 9 section #biia7;a74 & ins]t+ 8means an (f5se t-- 7,a7 does n h z an elem5t ! use1 attempt$ use1 or ?reat5$ use ( physical =ce aga9/ ! p]son or prop]ty ( ano!r2 or 7,b7 is n a felony t by its nature involves a sub/antial risk t physical =ce aga9/ ! p]son or prop]ty ( ano!r may be us$ 9 ! c\rse ( committ+ ! (f5se4 4 #adjbi4 ,grant acc\ntability ,section #biia ( title ,i ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa7 is am5d$ by ins]t+ aft] subsection 7l71 z add$ by section #adjbb1 ! foll[+3 7m7 ,acc\ntability ,all grants aw>d$ by ! ,attorney ,g5]al "u ?is section %all be subject to ! foll[+ acc\ntability provisions3 7#a7 ,audit requirem5t 7,a7 ,def9ition ,9 ?is p>agraph1 ! t]m unresolv$ audit f9d+ means a f9d+ 9 ! f9al audit report ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice t ! audit$ grantee has utiliz$ grant funds = an unau?oriz$ exp5diture or o!rwise unall[able co/ t is n clos$ or resolv$ )9 #ab mon?s f ! date :5 ! f9al audit report is issu$4 7,b7 ,audits ,beg9n+ 9 ! fir/ fiscal ye> beg9n+ aft] ! date ( enactm5t ( ?is subsection1 & 9 ea* fiscal ye> !reaft]1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice %all conduct audits ( recipi5ts ( grants "u ?is section to prev5t wa/e1 fraud1 & abuse ( funds by grantees4 ,! ,inspector ,g5]al %all det]m9e ! appropriate numb] ( grantees to be audit$ ea* ye>4 7,c7 ,m&atory exclusion ,a recipi5t ( grant funds "u ?is section t is f\nd to h an unresolv$ audit f9d+ %all n be eligible to receive grant funds "u ?is section dur+ ! fir/ #b fiscal ye>s beg9n+ aft] ! end ( ! #ab-mon? p]iod describ$ 9 subp>agraph 7,a74 7,d7 ,priority ,9 aw>d+ grants "u ?is section1 ! ,attorney ,g5]al %all give priority to eligible applicants t did n h an unresolv$ audit f9d+ dur+ ! #c fiscal ye>s be=e submitt+ an application = a grant "u ?is section4 7,e7 ,reimbursem5t ,if an entity is aw>d$ grant funds "u ?is section dur+ ! #b-;fiscal-ye> p]iod dur+ :i* ! entity is b>r$ f receiv+ grants "u subp>agraph 7,c71 ! ,attorney ,g5]al %all-- 7i7 deposit an am\nt equal to ! am\nt ( ! grant funds t 7 improp]ly aw>d$ to ! grantee into ! ,g5]al ,fund ( ! ,treasury2 & 7ii7 seek to rec\p ! co/s ( ! repaym5t to ! fund f ! grant recipi5t t 0 errone\sly aw>d$ grant funds4 7#b7 ,nonpr(it organization requirem5ts 7,a7 ,def9ition ,= purposes ( ?is p>agraph & ! grant programs "u ?is "p1 ! t]m nonpr(it organization means an organization t is describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf & is exempt f taxation "u section #eja7;a7 ( su* ,code4 7,b7 ,prohibition ,! ,attorney ,g5]al may n aw>d a grant "u ?is "p to a nonpr(it organization t holds money 9 (f%ore acc\nts = ! purpose ( avoid+ pay+ ! tax describ$ 9 section #eaa7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf4 7,c7 ,disclosure ,ea* nonpr(it organization t is aw>d$ a grant "u ?is section & uses ! proc$ures prescrib$ 9 regulations to create a rebuttable presumption ( reasonabl5ess = ! comp5sation ( its (fic]s1 directors1 tru/ees1 & key employees1 %all disclose to ! ,attorney ,g5]al1 9 ! application = ! grant1 ! process = det]m9+ su* comp5sation1 includ+ ! indep5d5t p]sons involv$ 9 review+ & approv+ su* comp5sation1 ! comp>ability data us$1 & contemporane\s sub/antiation ( ! delib]ation & decision4 ,^u reque/1 ! ,attorney ,g5]al %all make ! in=mation disclos$ "u ?is subp>agraph available = public inspection4 7#c7 ,conf]5ce exp5ditures 7,a7 ,limitation ,no am\nts made available to ! ,dep>tm5t ( ,ju/ice "u ?is section may be us$ by ! ,attorney ,g5]al1 or by any individual or entity aw>d$ discretion>y funds ?r\gh a coop]ative agreem5t "u ?is section1 to ho/ or support any exp5diture = conf]5ces t uses m ?an #bj1jjj 9 funds made available by ! ,dep>tm5t ( ,ju/ice1 unless ! head ( ! relevant ag5cy or dep>tm5t1 provides prior writt5 au?orization t ! funds may be exp5d$ to ho/ ! conf]5ce4 7,b7 ,writt5 approval ,writt5 approval "u subp>agraph 7,a7 %all include a writt5 e/imate ( all co/s associat$ ) ! conf]5ce1 includ+ ! co/ ( all food1 bev]ages1 audio-visual equipm5t1 honor>ia = speak]s1 & ent]ta9m5t4 7,c7 ,report ,! ,deputy ,attorney ,g5]al %all submit an annual report to ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives on all conf]5ce exp5ditures approv$ "u ?is p>agraph4 7#d7 ,annual c]tification ,beg9n+ 9 ! fir/ fiscal ye> beg9n+ aft] ! date ( enactm5t ( ?is subsection1 ! ,attorney ,g5]al %all submit1 to ! ,committee on ! ,judici>y & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ! ,judici>y & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 an annual c]tification-- 7,a7 indicat+ :e!r-- 7i7 all audits issu$ by ! ,(fice ( ! ,inspector ,g5]al "u p>agraph 7#a7 h be5 complet$ & review$ by ! appropriate ,assi/ant ,attorney ,g5]al or ,director2 7ii7 all m&atory exclusions requir$ "u p>agraph 7#a77;,c7 h be5 issu$2 & 7iii7 all reimbursem5ts requir$ "u p>agraph 7#a77;,e7 h be5 made2 & 7,b7 t includes a li/ ( any grant recipi5ts exclud$ "u p>agraph 7#a7 f ! previ\s ye>4 7n7 ,prev5t+ duplicative grants 7#a7 ,9 g5]al ,be=e ! ,attorney ,g5]al aw>ds a grant to an applicant "u ?is section1 ! ,attorney ,g5]al %all comp>e pot5tial grant aw>ds ) o!r grants aw>d$ "u ?is ,act to det]m9e if duplicate grant aw>ds are aw>d$ = ! same purpose4 7#b7 ,report ,if ! ,attorney ,g5]al aw>ds duplicate grants to ! same applicant = ! same purpose ! ,attorney ,g5]al %all submit to ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives a report t includes-- 7,a7 a li/ ( all duplicate grants aw>d$1 includ+ ! total doll> am\nt ( any duplicate grants aw>d$2 & 7,b7 ! reason ! ,attorney ,g5]al aw>d$ ! duplicate grants4 4 ,c ,increas+ ,*oice1 ,access1 & ,quality 9 ,heal? ,c>e = ,am]icans #aejjj4 ,%ort title ,?is division may be cit$ z ! ,increas+ ,*oice1 ,access1 & ,quality 9 ,heal? ,c>e = ,am]icans ,act4 ,,xv ,provisions ,relat+ to ,m$ic>e ,"p ,a #aejja4 ,developm5t ( ,m$ic>e ,,hcpcs v]sion ( ,,ms-,,drg codes = simil> hospital s]vices ,section #ahhf ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7t7 ,relat+ simil> inpati5t & outpati5t hospital s]vices 7#a7 ,developm5t ( ,,hcpcs v]sion ( ,,ms-,,drg codes ,n lat] ?an ,janu>y #a1 #bjah1 ! ,secret>y %all develop ,,hcpcs v]sions = ,,ms-,d,r,gs t are simil> to ! ,,icd-#aj-,,pcs = su* ,,ms-,d,r,gs su* t1 to ! ext5t possible1 ! ,,ms-,,drg assignm5t %all be simil> = a claim cod$ ) ! ,,hcpcs v]sion z an id5tical claim cod$ ) a ,,icd-#aj-,,pcs code4 7#b7 ,cov]age ( surgical ,,ms-,d,r,gs ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y %all develop ,,hcpcs v]sions ( ,,ms-,,drg codes = n few] ?an #aj surgical ,,ms-,d,r,gs4 7#c7 ,publication & dissem9ation ( ! ,,hcpcs v]sions ( ,,ms-,d,r,gs 7,a7 ,9 g5]al ,! ,secret>y %all develop a ,,hcpcs ,,ms-,,drg def9itions manual & s(tw>e t is simil> to ! def9itions manual & s(tw>e = ,,icd-#aj-,,pcs codes = su* ,,ms-,d,r,gs4 ,! ,secret>y %all po/ ! ,,hcpcs ,,ms-,,drg def9itions manual & s(tw>e on ! ,int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 ,! ,,hcpcs ,,ms-,,drg def9itions manual & s(tw>e %all be 9 ! public doma9 & available = use & r$i/ribution )\t *>ge4 7,b7 ,use ( previ\s analysis done by ,med,p,a,c ,9 develop+ ! ,,hcpcs ,,ms-,,drg def9itions manual & s(tw>e "u subp>agraph 7,a71 ! ,secret>y %all consult ) ! ,m$ic>e ,paym5t ,advisory ,commission & %all consid] ! analysis done by su* ,commission 9 translat+ outpati5t surgical claims into inpati5t surgical ,,ms-,d,r,gs 9 prep>+ *apt] #g 7relat+ to hospital %ort-/ay policy issues7 ( its ,m$ic>e & ! ,heal? ,c>e ,deliv]y ,sy/em report submitt$ to ,congress 9 ,june #bjae4 7#d7 ,def9ition & ref]5ce ,9 ?is subsection3 7,a7 ,,hcpcs ,! t]m ,,hcpcs means1 ) respect to hospital items & s]vices1 ! code "u ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em 7,,hcpcs7 7or a successor code7 = su* items & s]vices4 7,b7 ,,icd-#aj-,,pcs ,! t]m ,,icd-#aj-,,pcs means ! ,int]national ,classification ( ,diseases1 #aj? ,revision1 ,proc$ure ,cod+ ,sy/em1 & includes any subsequ5t revision ( su* ,int]national ,classification ( ,diseases1 ,proc$ure ,cod+ ,sy/em4 4 #aejjb4 ,e/abli%+ b5efici>y equity 9 ! ,m$ic>e hospital readmission program 7a7 ,transitional adju/m5t = dual eligible population ,section #ahhf7q77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7q77#c77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by ins]t+ subject to subp>agraph 7,d71 aft] purposes ( p>agraph 7#a712 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,transitional adju/m5t = dual eligibles 7i7 ,9 g5]al ,9 det]m9+ a hospital's adju/m5t factor "u ?is p>agraph = purposes ( mak+ paym5ts = dis*>ges occurr+ dur+ & aft] fiscal ye> #bjai1 & be=e ! application ( clause 7i7 ( subp>agraph 7,e71 ! ,secret>y %all assign hospitals to gr\ps 7z def9$ by ! ,secret>y "u clause 7ii77 & apply ! applicable provisions ( ?is subsection us+ a me?odology 9 a mann] t all[s = sep>ate comp>ison ( hospitals )9 ea* su* gr\p1 z det]m9$ by ! ,secret>y4 7ii7 ,def9+ gr\ps ,= purposes ( ?is subp>agraph1 ! ,secret>y %all def9e gr\ps ( hospitals1 bas$ on _! ov]all proportion1 ( ! inpati5ts :o are entitl$ to1 or enroll$ =1 b5efits "u "p ,a1 & :o are full-b5efit dual eligible individuals 7z def9$ 9 section #aice7;c77#f774 ,9 def9+ gr\ps1 ! ,secret>y %all consult ! ,m$ic>e ,paym5t ,advisory ,commission & may consid] ! analysis done by su* ,commission 9 prep>+ ! portion ( its report submitt$ to ,congress 9 ,june #bjac relat+ to readmissions4 7iii7 ,m9imiz+ report+ burd5 on hospitals ,9 c>ry+ out ?is subp>agraph1 ! ,secret>y %all n impose any additional report+ requirem5ts on hospitals4 7iv7 ,budget neutral design me?odology ,! ,secret>y %all design ! me?odology to implem5t ?is subp>agraph s t ! e/imat$ total am\nt ( r$uctions 9 paym5ts "u ?is subsection equals ! e/imat$ total am\nt ( r$uctions 9 paym5ts t w\ld o!rwise occur "u ?is subsection if ?is subp>agraph did n apply4 4 7b7 ,*anges 9 risk adju/m5t ,section #ahhf7q77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7q77#c771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,*anges 9 risk adju/m5t 7i7 ,consid]ation ( recomm5dations 9 ,,impact reports ,! ,secret>y may take into acc\nt ! /udies conduct$ & ! recomm5dations made by ! ,secret>y "u section #b7;d77#a7 ( ! ,,impact ,act ( #bjad 7,public ,law #aac-ahe2 #db ,u4,s4,c4 #acielll note7 ) respect to ! application "u ?is subsection ( risk adju/m5t me?odologies4 ,no?+ 9 ?is clause %all be con/ru$ z preclud+ consid]ation ( ! use ( gr\p+s ( hospitals4 7ii7 ,consid]ation ( exclusion ( pati5t cases bas$ on ,v or o!r appropriate codes ,9 promulgat+ regulations to c>ry out ?is subsection ) respect to dis*>ges occurr+ aft] fiscal ye> #bjah1 ! ,secret>y may consid] ! use ( ,v or o!r ,,icd-relat$ codes = removal ( a readmission4 ,! ,secret>y may consid] modify+ measures "u ?is subsection to incorporate ,v or o!r ,,icd-relat$ codes at ! same "t z o!r *anges are be+ made "u ?is subp>agraph4 7iii7 ,removal ( c]ta9 readmissions ,9 promulgat+ regulations to c>ry out ?is subsection1 ) respect to dis*>ges occurr+ aft] fiscal ye> #bjah1 ! ,secret>y may consid] removal z a readmission ( an admission t is classifi$ )9 "o or m ( ! foll[+3 transplants1 end-/age r5al disease1 burns1 trauma1 psy*osis1 or sub/ance abuse4 ,! ,secret>y may consid] modify+ measures "u ?is subsection to remove readmissions at ! same "t z o!r *anges are be+ made "u ?is subp>agraph4 4 7c7 ,med,p,a,c /udy on readmissions program ,! ,m$ic>e ,paym5t ,advisory ,commission %all conduct a /udy to review ov]all hospital readmissions describ$ 9 section #ahhf7q77#e77;,e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7q77#e77;,e77 & :e!r su* readmissions are relat$ to any *anges 9 outpati5t & em]g5cy s]vices furni%$4 ,! ,commission %all submit to ,congress a report on su* /udy 9 its report to ,congress 9 ,june #bjah4 #aejjc4 ,five-ye> ext5sion ( ! rural community hospital demon/ration program 7a7 ,ext5sion ,section #daj;,a ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7,public ,law #ajh-agc2 #db ,u4,s4,c4 #acieww note7 is am5d$-- 7#a7 9 subsection 7a77#e71 by /rik+ #e-ye> ext5sion p]iod & ins]t+ #aj-ye> ext5sion p]iod2 & 7#b7 9 subsection 7g7-- 7,a7 9 ! subsection head+1 by /rik+ ,five-,ye> & ins]t+ ,t5-,ye>2 7,b7 9 p>agraph 7#a71 by /rik+ additional #e-ye> & ins]t+ additional #aj-ye>2 7,c7 by /rik+ #e-ye> ext5sion p]iod & ins]t+ #aj-ye> ext5sion p]iod ea* place x appe>s2 7,d7 9 p>agraph 7#d77;,b7-- 7i7 9 ! matt] prec$+ clause 7i71 by ins]t+ ea* #e-ye> p]iod 9 aft] hospital dur+2 & 7ii7 9 clause 7i71 by ins]t+ ea* applicable #e-ye> p]iod 9 aft] ! fir/ day (2 & 7,e7 by add+ at ! end ! foll[+ new p>agraphs3 7#e7 ,o!r hospitals 9 demon/ration program ,dur+ ! second #e ye>s ( ! #aj-ye> ext5sion p]iod1 ! ,secret>y %all apply ! provisions ( p>agraph 7#d7 to rural community hospitals t are n describ$ 9 p>agraph 7#d7 b are p>ticipat+ 9 ! demon/ration program "u ?is section z ( ,decemb] #cj1 #bjad1 9 a simil> mann] z su* provisions apply to rural community hospitals describ$ 9 p>agraph 7#d74 7#f7 ,expansion ( demon/ration program to rural areas 9 any ,/ate 7,a7 ,9 g5]al ,! ,secret>y %all1 not)/&+ subsection 7a77#b7 or p>agraph 7#b7 ( ?is subsection1 n lat] ?an #abj days aft] ! date ( ! enactm5t ( ?is p>agraph1 issue a solicitation = applications to select up to ! maximum numb] ( additional rural community hospitals locat$ 9 any ,/ate to p>ticipate 9 ! demon/ration program "u ?is section = ! second #e ye>s ( ! #aj-ye> ext5sion p]iod )\t exce$+ ! limitation "u p>agraph 7#c7 ( ?is subsection4 7,b7 ,priority ,9 det]m9+ :i* rural community hospitals t submitt$ an application pursuant to ! solicitation "u subp>agraph 7,a7 to select = p>ticipation 9 ! demon/ration program1 ! ,secret>y-- 7i7 %all give priority to rural community hospitals locat$ 9 "o ( ! #bj ,/ates ) ! l[e/ population d5sities 7z det]m9$ by ! ,secret>y us+ ! #bjae ,/ati/ical ,ab/ract ( ! ,unit$ ,/ates72 & 7ii7 may consid]-- 7,i7 closures ( hospitals locat$ 9 rural areas 9 ! ,/ate 9 :i* ! rural community hospital is locat$ dur+ ! #e-ye> p]iod imm$iately prec$+ ! date ( ! enactm5t ( ?is p>agraph2 & 7,,ii7 ! population d5sity ( ! ,/ate 9 :i* ! rural community hospital is locat$4 4 7b7 ,*ange 9 tim+ = report ,subsection 7e7 ( su* section #daj;,a is am5d$-- 7#a7 by /rik+ ,n lat] ?an #f mon?s aft] ! completion ( ! demon/ration program "u ?is section & ins]t+ ,n lat] ?an ,augu/ #a1 #bjah2 & 7#b7 by /rik+ su* program & ins]t+ ! demon/ration program "u ?is section4 #aejjd4 ,regulatory relief = ,l,t,c,hs 7a7 ,te*nical *ange to ! ,m$ic>e long-,t]m c>e hospital moratorium exception 7#a7 ,9 g5]al ,section #aad7;d77#g7 ( ! ,m$ic>e1 ,m$icaid1 & ,,s*ip ,ext5sion ,act ( #bjjg 7#db ,u4,s4,c4 #acieww note71 z am5d$ by sections #cajf7;b7 & #ajcab7;b7 ( ,public ,law #aaa-adh1 section #abjf7;b77#b7 ( ! ,pa?way = ,,sgr ,re=m ,act ( #bjac 7division ,b ( ,public ,law #aac-fg71 & section #aab ( ! ,protect+ ,access to ,m$ic>e ,act ( #bjad 7,public ,law #aac-ic71 is am5d$ by /rik+ ,! moratorium "u p>agraph 7#a77;,a7 & ins]t+ ,any moratorium "u p>agraph 7#a74 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all take effect z if includ$ 9 ! enactm5t ( section #aab ( ! ,protect+ ,access to ,m$ic>e ,act ( #bjad4 7b7 ,modification to ,m$ic>e long-,t]m c>e hospital high co/ outli] paym5ts ,section #ahhf7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7m77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,treatm5t ( high co/ outli] paym5ts 7,a7 ,adju/m5t to ! /&>d ,f$]al paym5t rate = e/imat$ high co/ outli] paym5ts ,"u ! sy/em describ$ 9 p>agraph 7#a71 = fiscal ye>s beg9n+ on or aft] ,octob] #a1 #bjag1 ! ,secret>y %all r$uce ! /&>d ,f$]al paym5t rate z if ! e/imat$ aggregate am\nt ( high co/ outli] paym5ts = /&>d ,f$]al paym5t rate dis*>ges = ea* su* fiscal ye> w\ld be equal to #h p]c5t ( e/imat$ aggregate paym5ts = /&>d ,f$]al paym5t rate dis*>ges = ea* su* fiscal ye>4 7,b7 ,limitation on high co/ outli] paym5t am\nts ,not)/&+ subp>agraph 7,a71 ! ,secret>y %all set ! fix$ loss am\nt = high co/ outli] paym5ts su* t ! e/imat$ aggregate am\nt ( high co/ outli] paym5ts made = /&>d ,f$]al paym5t rate dis*>ges = fiscal ye>s beg9n+ on or aft] ,octob] #a1 #bjag1 %all be equal to #ii4fhge p]c5t ( #h p]c5t ( e/imat$ aggregate paym5ts = /&>d ,f$]al paym5t rate dis*>ges = ea* su* fiscal ye>4 7,c7 ,waiv] ( budget neutrality ,any r$uction 9 paym5ts result+ f ! application ( subp>agraph 7,b7 %all n be tak5 into acc\nt 9 apply+ any budget neutrality provision "u su* sy/em4 7,d7 ,no effect on site neutral high co/ outli] paym5t rate ,?is p>agraph %all n apply ) respect to ! computation ( ! applicable site neutral paym5t rate "u p>agraph 7#f74 4 #aejje4 ,sav+s f ,,ipps ,,macra pay-= ?r\gh n apply+ docum5tation & cod+ adju/m5ts ,section #g7;b77#a77;,b7 ( ! ,,tma1 ,ab/95ce ,education1 & ,,qi ,programs ,ext5sion ,act ( #bjjg 7,public ,law #aaj-ij71 z am5d$ by section #fca7;b7 ( ! ,am]ican ,taxpay] ,relief ,act ( #bjab 7,public ,law #aab-bdj7 & section #dad7a77;,b77iii7 ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7,public ,law #aad-aj71 is am5d$ 9 clause 7iii7 by /rik+ an increase ( #j4e p]c5tage po9ts = dis*>ges occurr+ dur+ ea* ( fiscal ye>s #bjah ?r\gh #bjbc & ins]t+ an increase ( #j4dehh p]c5tage po9ts = dis*>ges occurr+ dur+ fiscal ye> #bjah & #j4e p]c5tage po9ts = dis*>ges occurr+ dur+ ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 #aejjf4 ,ext5sion ( c]ta9 ,,lt* ,m$ic>e paym5t rules 7a7 #be-,p]c5t pati5t ?re%old paym5t adju/m5t ,section #aad7;c77#a77;,a7 ( ! ,m$ic>e1 ,m$icaid1 & ,,s*ip ,ext5sion ,act ( #bjjg 7#db ,u4,s4,c4 #acieww note71 z am5d$ by section #dcjb7;a7 ( division ,b ( ! ,am]ican ,recov]y & ,re9ve/m5t ,act 7,public ,law #aaa-e71 sections #cajf7;a7 & #ajcab7;a7 ( ,public ,law #aaa-adh1 & section #abjf7;b77#a77;,b7 ( ! ,pa?way = ,,sgr ,re=m ,act ( #bjac 7division ,b ( ,public ,law #aac-fg71 is am5d$ by /rik+ = a #i-ye> p]iod & ins]t+ ?r\gh ,june #cj1 #bjaf1 & = dis*>ges occurr+ on or aft] ,octob] #a1 #bjaf1 & be=e ,octob] #a1 #bjag4 7b7 ,paym5t = hospitals-,)9-,hospitals ,section #aad7;c77#b7 ( ! ,m$ic>e1 ,m$icaid1 & ,,s*ip ,ext5sion ,act ( #bjjg 7#db ,u4,s4,c4 #acieww note71 z am5d$ by section #dcjb7;a7 ( division ,b ( ! ,am]ican ,recov]y & ,re9ve/m5t ,act 7,public ,law #aaa-e71 sections #cajf7;a7 & #ajcab7;a7 ( ,public ,law #aaa-adh1 & section #abjf7;b77#a77;,a7 ( ! ,pa?way = ,,sgr ,re=m ,act ( #bjac 7division ,b ( ,public ,law #aac-fg71 is am5d$-- 7#a7 9 subp>agraph 7,a71 by ins]t+ or any simil> provision1 aft] ,regulations12 7#b7 9 subp>agraph 7,b7-- 7,a7 9 clause 7i71 by ins]t+ or any simil> provision1 aft] ,regulations12 & 7,b7 9 clause 7ii71 by ins]t+ 1 or any simil> provision1 aft] ,regulations2 & 7#c7 9 subp>agraph 7,c71 by /rik+ = a #i-ye> p]iod & ins]t+ ?r\gh ,june #cj1 #bjaf1 & = dis*>ges occurr+ on or aft] ,octob] #a1 #bjaf1 & be=e ,octob] #a1 #bjag4 #aejjg4 ,application ( rules on ! calculation ( hospital l5g? ( /ay to all ,l,t,c,hs 7a7 ,9 g5]al ,section #abjf7;a77#c7 ( ! ,pa?way = ,,sgr ,re=m ,act ( #bjac 7division ,b ( ,public ,law #aac-fg2 #db ,u4,s4,c4 #acieww note7 is am5d$-- 7#a7 by /rik+ subp>agraph 7,b72 7#b7 by /rik+ site neutral basis4-- & all t foll[s ?r\gh ,= dis*>ges occurr+ & ins]t+ site neutral basis4--,= dis*>ges occurr+2 7#c7 by /rik+ subject to subp>agraph 7,b712 & 7#d7 by r$esignat+ clauses 7i7 & 7ii7 z subp>agraphs 7,a7 & 7,b71 respectively1 & mov+ ea* ( su* subp>agraphs 7z s r$esignat$7 #b ems to ! left4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all be effective z if includ$ 9 ! enactm5t ( section #abjf7;a77#c7 ( ! ,pa?way = ,,sgr ,re=m ,act ( #bjac 7division ,b ( ,public ,law #aac-fg2 #db ,u4,s4,c4 #acieww note74 #aejjh4 ,*ange 9 ,m$ic>e classification = c]ta9 hospitals 7a7 ,9 g5]al ,subsection 7d77#a77;,b77iv7 ( section #ahhf ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 is am5d$-- 7#a7 9 subclause 7,i71 by /rik+ or at ! end2 7#b7 9 subclause 7,,ii7-- 7,a7 by /rik+ 1 or at ! end & ins]t+ a semicolon2 7,b7 by r$esignat+ su* subclause z clause 7vi7 & by mov+ x to imm$iately foll[ clause 7v72 & 7,c7 9 clause 7v71 by /rik+ ! semicolon at ! end & ins]t+ 1 or2 & 7#c7 by /rik+ 7iv77,i7 a hospital & ins]t+ 7iv7 a hospital4 7b7 ,con=m+ paym5t ref]5ces ,! second s5t5ce ( subsection 7d77#a77;,b7 ( su* section is am5d$-- 7#a7 by ins]t+ 7z 9 effect z ( su* date7 aft] clause 7iv72 & 7#b7 by ins]t+ 7or1 9 ! case ( a hospital describ$ 9 clause 7iv77,,ii71 z s 9 effect1 %all be classifi$ "u clause 7vi7 on & aft] ! effective date ( su* clause 7vi7 & = co/ report+ p]iods beg9n+ on or aft] ,janu>y #a1 #bjae1 %all n be subject to subsection 7m7 z ( ! date ( su* classification7 aft] s classifi$4 7c7 ,application 7#a7 ,9 g5]al ,= co/ report+ p]iods beg9n+ on or aft] ,janu>y #a1 #bjae1 9 ! case ( an applicable hospital 7z def9$ 9 p>agraph 7#c771 ! foll[+ %all apply3 7,a7 ,paym5t = inpati5t op]at+ co/s %all be made on a reasonable co/ basis 9 ! mann] provid$ 9 section #dab4ebf7;c77#c7 ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on ,janu>y #a1 #bjae7 & 9 any subsequ5t modifications4 7,b7 ,paym5t = capital co/s %all be made 9 ! mann] provid$ by section #dab4ebf7;c77#d7 ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on su* date74 7,c7 ,claims = paym5t = ,m$ic>e b5efici>ies :o are dis*>g$ on or aft] ,janu>y #a1 #bjag1 %all be process$ z claims :i* are paid on a reasonable co/ basis z describ$ 9 section #dab4ebf7;c7 ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on su* date74 7#b7 ,applicable hospital def9$ ,9 ?is subsection1 ! t]m applicable hospital means a hospital t is classifi$ "u clause 7iv77,,ii7 ( section #ahhf7;d77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#a77;,b77 on ! day be=e ! date ( ! enactm5t ( ?is ,act & :i* is classifi$ "u clause 7vi7 ( su* section1 z r$esignat$ & mov$ by subsection 7a71 on or aft] su* date ( enactm5t4 7d7 ,con=m+ te*nical am5dm5ts 7#a7 ,section #ahii;,b7a77#b77;,a77iv7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acielll7a77#b77;,a77iv77 is am5d$ by /rik+ #ahhf7;d77#a77;,b77iv77,,ii7 & ins]t+ #ahhf7;d77#a77;,b77vi74 7#b7 ,section #ahhf7m77#e77;,f7 ( su* ,act 7#db ,u4,s4,c4 #acieww7m77#e77;,f77 is am5d$ 9 ea* ( clauses 7i7 & 7ii7 by /rik+ 7d77#a77;,b77iv77,,ii7 & ins]t+ 7d77#a77;,b77vi74 #aejji4 ,tempor>y exception to ! application ( ! ,m$ic>e ,,lt* site neutral provisions = c]ta9 sp9al cord specialty hospitals 7a7 ,exception ,section #ahhf7m77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7m77#f77 is am5d$-- 7#a7 9 subp>agraph 7,a77i71 by /rik+ & 7,e7 & ins]t+ 1 7,e71 & 7,f72 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,tempor>y exception = c]ta9 sp9al cord specialty hospitals ,= dis*>ges 9 co/ report+ p]iods beg9n+ dur+ fiscal ye>s #bjah & #bjai1 subp>agraph 7,a77i7 %all n apply 7& paym5t %all be made to a long-t]m c>e hospital )\t reg>d to ?is p>agraph7 if su* dis*>ge is f a long-t]m c>e hospital t meets ea* ( ! foll[+ requirem5ts3 7i7 ,n-=-pr(it ,! long-t]m c>e hospital 0 a n-=-pr(it long-t]m c>e hospital on ,june #a1 #bjad1 z det]m9$ by co/ report data4 7ii7 ,prim>ily provid+ treatm5t = cata/rophic sp9al cord or acquir$ bra9 injuries or o!r p>alyz+ neuromuscul> conditions ,( ! dis*>ges 9 cal5d> ye> #bjac f ! long-t]m c>e hospital = :i* paym5t 0 made "u ?is section1 at lea/ #ej p]c5t 7 classifi$ "u ,,ms-,,lt*-,d,r,gs #bh1 #bi1 #eb1 #eg1 #eea1 #egc1 & #ifc4 7iii7 ,significant out-(-,/ate admissions 7,i7 ,9 g5]al ,! long-t]m c>e hospital dis*>g$ inpati5ts 7includ+ bo? individuals entitl$ to1 or enroll$ =1 b5efits "u ?is title & individuals n s entitl$ or enroll$7 dur+ fiscal ye> #bjad :o _h be5 admitt$ f at lea/ #bj ( ! #ej ,/ates1 det]m9$ by ! ,/ates ( resid5cy ( su* inpati5ts & bas$ on su* data submitt$ by ! hospital to ! ,secret>y z ! ,secret>y may require4 7,,ii7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t subclause 7,i7 by program in/ruction or o!rwise4 7,,iii7 ,non-application ( ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to data collect$ "u ?is clause4 4 7b7 ,/udy & report on ! /atus & viability ( c]ta9 sp9al cord specialty long-,t]m c>e hospitals 7#a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on long-t]m c>e hospitals describ$ 9 section #ahhf7m77#f77;,f7 ( ! ,social ,security ,act1 z add$ by subsection 7a74 ,su* report %all include an analysis ( ! foll[+3 7,a7 ,! impact on su* hospitals ( ! classification & facility lic5sure by ,/ate ag5cies ( su* hospitals4 7,b7 ,! ,m$ic>e paym5t rates = su* hospitals4 7,c7 ,data on ! numb] & heal? c>e ne$s ( ,m$ic>e b5efici>ies :o h be5 diagnos$ ) cata/rophic sp9al cord or acquir$ bra9 injuries or o!r p>alyz+ neuromuscul> conditions 7z describ$ )9 ! dis*>ge classifications specifi$ 9 clause 7ii7 ( su* section7 :o are receiv+ s]vices f su* hospitals4 7#b7 ,report ,n lat] ?an ,octob] #a1 #bjah1 ! ,comptroll] ,g5]al %all submit to ,congress a report on ! /udy conduct$ "u p>agraph 7#a71 includ+ recomm5dations = su* legislation & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 #aejaj4 ,tempor>y ext5sion to ! application ( ! ,m$ic>e ,,lt* site neutral provisions = c]ta9 dis*>ges ) sev]e w\nds 7a7 ,9 g5]al ,section #ahhf7m77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7m77#f771 z am5d$ by section #aejji1 is fur!r am5d$-- 7#a7 9 subp>agraph 7,a77i7 by /rik+ & 7,f7 & ins]t+ 7,f71 & 7,g72 7#b7 9 subp>agraph 7,e77i77,i77aa71 by /rik+ ! am5dm5t made & all t foll[s be=e ! semicolon & ins]t+ ! la/ s5t5ce ( subsection 7d77#a77;,b72 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,additional tempor>y exception = c]ta9 sev]e w\nd dis*>ges f c]ta9 long-t]m c>e hospitals 7i7 ,9 g5]al ,= a dis*>ge occurr+ 9 a co/ report+ p]iod beg9n+ dur+ fiscal ye> #bjah1 subp>agraph 7,a77i7 %all n apply 7& paym5t %all be made to a long-t]m c>e hospital )\t reg>d to ?is p>agraph7 if su* dis*>ge-- 7,i7 is f a long-t]m c>e hospital id5tifi$ by ! la/ s5t5ce ( subsection 7d77#a77;,b72 7,,ii7 is classifi$ "u ,,ms-,,lt*-,,drg #fjb1 #fjc1 #eci1 or #edj2 & 7,,iii7 is ) respect to an individual treat$ by a long-t]m c>e hospital = a sev]e w\nd4 7ii7 ,sev]e w\nd def9$ ,9 ?is subp>agraph1 ! t]m sev]e w\nd means a w\nd :i* is a /age #c w\nd1 /age #d w\nd1 un/ageable w\nd1 non-heal+ surgical w\nd1 or fi/ula z id5tifi$ 9 ! claim f ! long-t]m c>e hospital4 7iii7 ,w\nd def9$ ,9 ?is subp>agraph1 ! t]m w\nd means an injury involv+ division ( tissue or rupture ( ! integum5t or muc\s membrane ) exposure to ! ext]nal environm5t4 4 7c7 ,/udy & report to ,congress 7#a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all1 9 consultation ) relevant /akehold]s1 conduct a /udy on ! treatm5t ne$s ( individuals entitl$ to b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act or enroll$ "u "p ,b ( su* title :o require specializ$ w\nd c>e1 & ! co/1 = su* individuals & ! ,m$ic>e program "u su* title1 ( treat+ sev]e w\nds 9 rural & urban areas4 ,su* /udy %all include an assessm5t (-- 7,a7 access ( su* individuals to appropriate levels ( c>e = su* cases2 7,b7 ! pot5tial impact t section #ahhf7m77#f77;,a77i7 ( su* ,act 7#db ,u4,s4,c4 #acieww7m77#f77;,a77i77 w h on ! access1 quality1 & co/ ( c>e = su* individuals2 & 7,c7 h[ to appropriately pay = su* c>e "u ! ,m$ic>e program "u su* title4 7#b7 ,report ,n lat] ?an ,octob] #a1 #bjbj1 ! ,comptroll] ,g5]al %all submit to ,congress a report on ! /udy conduct$ "u p>agraph 7#a71 includ+ recomm5dations = su* legislation & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 ,,xvi ,provisions ,relat+ to ,m$ic>e ,"p ,b #afjja4 ,cont9u+ ,m$ic>e paym5t "u ,,hopd prospective paym5t sy/em = s]vices furni%$ by mid-build (f-campus outpati5t dep>tm5ts ( provid]s 7a7 ,9 g5]al ,section #ahcc7t77#ba7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ba77 is am5d$-- 7#a7 9 subp>agraph 7,b7-- 7,a7 9 clause 7i71 by /rik+ clause 7ii7 & ins]t+ ! subsequ5t provisions ( ?is subp>agraph2 & 7,b7 by add+ at ! end ! foll[+ new clauses3 7iii7 ,deem$ treatm5t = #bjag ,= purposes ( apply+ clause 7ii7 ) respect to applicable items & s]vices furni%$ dur+ #bjag1 a dep>tm5t ( a provid] 7z s def9$7 n describ$ 9 su* clause is deem$ to be bill+ "u ?is subsection ) respect to cov]$ ,,opd s]vices furni%$ prior to ,novemb] #b1 #bjae1 if ! ,secret>y receiv$ f ! provid] prior to ,decemb] #b1 #bjae1 an atte/ation 7pursuant to section #dac4fe7;b77#c7 ( title #db ( ! ,code ( ,f$]al ,regulations7 t su* dep>tm5t 0 a dep>tm5t ( a provid] 7z s def9$74 7iv7 ,alt]native exception beg9n+ ) #bjah ,= purposes ( p>agraph 7#a77;,b77v7 & ?is p>agraph ) respect to applicable items & s]vices furni%$ dur+ #bjah or a subsequ5t ye>1 ! t]m (f-campus outpati5t dep>tm5t ( a provid] also %all n include a dep>tm5t ( a provid] 7z s def9$7 t is n describ$ 9 clause 7ii7 if-- 7,i7 ! ,secret>y receives f ! provid] an atte/ation 7pursuant to su* section #dac4fe7;b77#c77 n lat] ?an ,decemb] #ca1 #bjaf 7or1 if lat]1 #fj days aft] ! date ( ! enactm5t ( ?is clause71 t su* dep>tm5t met ! requirem5ts ( a dep>tm5t ( a provid] specifi$ 9 section #dac4fe ( title #db ( ! ,code ( ,f$]al ,regulations2 7,,ii7 ! provid] includes su* dep>tm5t z "p ( ! provid] on its enrollm5t =m 9 accordance ) ! enrollm5t process "u section #ahff7;j72 & 7,,iii7 ! dep>tm5t met ! mid-build requirem5t ( clause 7v7 & ! ,secret>y receives1 n lat] ?an #fj days aft] ! date ( ! enactm5t ( ?is clause1 f ! *ief executive (fic] or *ief op]at+ (fic] ( ! provid] a writt5 c]tification t ! dep>tm5t met su* requirem5t4 7v7 ,mid-build requirem5t describ$ ,! mid-build requirem5t ( ?is clause is1 ) respect to a dep>tm5t ( a provid]1 t be=e ,novemb] #b1 #bjae1 ! provid] _h a b9d+ writt5 agreem5t ) an outside unrelat$ p>ty = ! actual con/ruction ( su* dep>tm5t4 7vii7 ,audit ,n lat] ?an ,decemb] #ca1 #bjah1 ! ,secret>y %all audit ! compliance ) requirem5ts ( clause 7iv7 ) respect to ea* dep>tm5t ( a provid] to :i* su* clause applies4 ,if ! ,secret>y f9ds z a result ( an audit "u ?is clause t ! applicable requirem5ts 7 n met ) respect to su* dep>tm5t1 ! dep>tm5t %all n be exclud$ f ! t]m (f-campus outpati5t dep>tm5t ( a provid] "u su* clause4 7viii7 ,implem5tation ,= purposes ( implem5t+ clauses 7iii7 ?r\gh 7vii73 7,i7 ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t su* clauses by program in/ruction or o!rwise4 7,,ii7 ,sub*apt] ,i ( *apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply4 7,,iii7 ,= purposes ( c>ry+ out ?is subp>agraph ) respect to clauses 7iii7 & 7iv7 7& clause 7vii7 ins(> z x relates to clause 7iv771 #aj1jjj1jjj %all be available f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda1 to rema9 available until ,decemb] #ca1 #bjah4 2 & 7#b7 9 subp>agraph 7,e71 by add+ at ! end ! foll[+ new clause3 7iv7 ,! det]m9ation ( an audit "u subp>agraph 7,b77vii74 4 7b7 ,effective date ,! am5dm5ts made by ?is section %all be effective z if includ$ 9 ! enactm5t ( section #fjc ( ! ,bip>tisan ,budget ,act ( #bjae 7,public ,law #aad-gd74 #afjjb4 ,treatm5t ( canc] hospitals 9 (f-campus outpati5t dep>tm5t ( a provid] policy 7a7 ,9 g5]al ,section #ahcc7t77#ba77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ba77;,b771 z am5d$ by section #afjja7;a71 is am5d$-- 7#a7 by ins]t+ aft] clause 7v7 ! foll[+ new clause3 7vi7 ,exclusion = c]ta9 canc] hospitals ,= purposes ( p>agraph 7#a77;,b77v7 & ?is p>agraph ) respect to applicable items & s]vices furni%$ dur+ #bjag or a subsequ5t ye>1 ! t]m (f-campus outpati5t dep>tm5t ( a provid] also %all n include a dep>tm5t ( a provid] 7z s def9$7 t is n describ$ 9 clause 7ii7 if ! provid] is a hospital describ$ 9 section #ahhf7;d77#a77;,b77v7 &-- 7,i7 9 ! case ( a dep>tm5t t met ! requirem5ts ( section #dac4fe ( title #db ( ! ,code ( ,f$]al ,regulations aft] ,novemb] #a1 #bjae1 & be=e ! date ( ! enactm5t ( ?is clause1 ! ,secret>y receives f ! provid] an atte/ation t su* dep>tm5t met su* requirem5ts n lat] ?an #fj days aft] su* date ( enactm5t2 or 7,,ii7 9 ! case ( a dep>tm5t t meets su* requirem5ts aft] su* date ( enactm5t1 ! ,secret>y receives f ! provid] an atte/ation t su* dep>tm5t meets su* requirem5ts n lat] ?an #fj days aft] ! date su* requirem5ts are fir/ met ) respect to su* dep>tm5t4 2 7#b7 9 clause 7vii71 by ins]t+ aft] ! fir/ s5t5ce ! foll[+3 ,n lat] ?an #b ye>s aft] ! date ! ,secret>y receives an atte/ation "u clause 7vi7 relat+ to compliance ( a dep>tm5t ( a provid] ) requirem5ts ref]r$ to 9 su* clause1 ! ,secret>y %all audit ! compliance ) su* requirem5ts ) respect to ! dep>tm5t42 & 7#c7 9 clause 7viii77,,iii71 by add+ at ! end ! foll[+3 ,= purposes ( c>ry+ out ?is subp>agraph ) respect to clause 7vi7 7& clause 7vii7 ins(> z x relates to su* clause71 #b1jjj1jjj %all be available f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda1 to rema9 available until exp5d$44 7b7 ,(fsett+ sav+s ,section #ahcc7t77#ah7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ah77 is am5d$-- 7#a7 9 subp>agraph 7,b71 by ins]t+ 1 subject to subp>agraph 7,c71 aft] %all2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,t>get ,,pcr adju/m5t ,9 apply+ section #dai4dc7;i7 ( title #db ( ! ,code ( ,f$]al ,regulations to implem5t ! appropriate adju/m5t "u ?is p>agraph = s]vices furni%$ on or aft] ,janu>y #a1 #bjah1 ! ,secret>y %all use a t>get ,,pcr t is #a4j p]c5tage po9ts less ?an ! t>get ,,pcr t w\ld o!rwise apply4 ,9 addition to ! p]c5tage po9t r$uction "u ! previ\s s5t5ce1 ! ,secret>y may consid] mak+ an additional p]c5tage po9t r$uction to su* t>get ,,pcr t takes into acc\nt paym5t rates = applicable items & s]vices describ$ 9 p>agraph 7#ba77;,c7 o!r ?an = s]vices furni%$ by hospitals describ$ 9 section #ahhf7;d77#a77;,b77v74 ,9 mak+ any budget neutrality adju/m5ts "u ?is subsection = #bjah or a subsequ5t ye>1 ! ,secret>y %all n take into acc\nt ! r$uc$ exp5ditures t result f ! application ( ?is subp>agraph4 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all be effective z if includ$ 9 ! enactm5t ( section #fjc ( ! ,bip>tisan ,budget ,act ( #bjae 7,public ,law #aad-gd74 #afjjc4 ,treatm5t ( eligible pr(essionals 9 ambulatory surgical c5t]s = mean+ful use & ,,mips ,section #ahdh7;a77#g77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g77;,d77 is am5d$-- 7#a7 by /rik+ hospital-bas$ eligible pr(essionals & all t foll[s ?r\gh ,no paym5t & ins]t+ ! foll[+3 hospital-bas$ & ambulatory surgical c5t]-bas$ eligible pr(essionals4-- 7i7 ,hospital-bas$ ,no paym5t 2 & 7#b7 by add+ at ! end ! foll[+ new clauses3 7ii7 ,ambulatory surgical c5t]-bas$ ,subject to clause 7iv71 no paym5t adju/m5t may be made "u subp>agraph 7,a7 = #bjag & #bjah 9 ! case ( an eligible pr(essional ) respect to :om sub/antially all ( ! cov]$ pr(essional s]vices furni%$ by su* pr(essional are furni%$ 9 an ambulatory surgical c5t]4 7iii7 ,det]m9ation ,! det]m9ation ( :e!r an eligible pr(essional is an eligible pr(essional describ$ 9 clause 7ii7 may be made on ! basis (-- 7,i7 ! site ( s]vice 7z def9$ by ! ,secret>y72 or 7,,ii7 an atte/ation submitt$ by ! eligible pr(essional4 ,det]m9ations made "u subclauses 7,i7 & 7,,ii7 %all be made )\t reg>d to any employm5t or bill+ arrangem5t betwe5 ! eligible pr(essional & any o!r suppli] or provid] ( s]vices4 7iv7 ,sunset ,clause 7ii7 %all no long] apply z ( ! fir/ ye> t beg9s m ?an #c ye>s aft] ! date on :i* ! ,secret>y det]m9es1 ?r\gh notice & comm5t rulemak+1 t c]tifi$ ,,ehr te*nology applicable to ! ambulatory surgical c5t] sett+ is available4 4 #afjjd4 ,cont9u+ ,access to ,hospitals ,act ( #bjaf 7a7 ,ext5sion ( en=cem5t in/ruction on sup]vision requirem5ts = outpati5t !rapeutic s]vices 9 critical access & small rural hospitals ?r\gh #bjaf ,section #a ( ,public ,law #aac-aih1 z am5d$ by section #a ( ,public ,law #aad-aab1 is am5d$-- 7#a7 9 ! head+1 by /rik+ #bjad & #bjae & ins]t+ #bjaf2 & 7#b7 by /rik+ & #bjae & ins]t+ 1 #bjae1 & #bjaf4 7b7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,m$ic>e ,paym5t ,advisory ,commission 7e/abli%$ "u section #ahje ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#f77 %all submit to ,congress a report analyz+ ! effect ( ! ext5sion ( ! en=cem5t in/ruction "u section #a ( ,public ,law #aac-aih1 z am5d$ by section #a ( ,public ,law #aad-aab & subsection 7a7 ( ?is section1 on ! access to heal? c>e by ,m$ic>e b5efici>ies1 on ! economic impact & ! impact ^u hospital /aff+ ne$s1 & on ! quality ( heal? c>e furni%$ to su* b5efici>ies4 #afjje4 ,delay ( implem5tation ( ,m$ic>e fee s*$ule adju/m5ts = :eel*air accessories & seat+ sy/ems :5 us$ 9 conjunction ) complex rehabilitation te*nology 7,,crt7 :eel*airs ,section #b7;a7 ( ! ,pati5t ,access & ,m$ic>e ,protection ,act 7#db ,u4,s4,c4 #acje note7 is am5d$ by /rik+ ,janu>y #a1 #bjag & ins]t+ ,july #a1 #bjag4 #afjjf4 ,all[+ physical !rapi/s to utilize locum t55s arrangem5ts "u ,m$ic>e 7a7 ,9 g5]al ,! fir/ s5t5ce ( section #ahdb7;b77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#f771 z am5d$ by section #ejab1 is fur!r am5d$-- 7#a7 by /rik+ & be=e 7,i72 & 7#b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,j7 9 ! case ( outpati5t physical !rapy s]vices furni%$ by physical !rapi/s 9 a heal? pr(essional %ortage area 7z def9$ 9 section #ccb7;a77#a77;,a7 ( ! ,public ,heal? ,s]vice ,act71 a m$ically und]s]v$ area 7z designat$ pursuant to section #ccj7;b77#c77;,a7 ( su* ,act71 or a rural area 7z def9$ 9 section #ahhf7;d77#b77;,d771 subp>agraph 7,d7 ( ?is s5t5ce %all apply to su* s]vices & !rapi/s 9 ! same mann] z su* subp>agraph applies to physicians' s]vices furni%$ by physicians4 7b7 ,effective date2 implem5tation 7#a7 ,effective date ,! am5dm5ts made by subsection 7a7 %all apply to s]vices furni%$ beg9n+ n lat] ?an six mon?s aft] ! date ( ! enactm5t ( ?is ,act4 7#b7 ,implem5tation ,! ,secret>y ( ,heal? & ,human ,s]vices may implem5t subp>agraph 7,j7 ( section #ahdb7;b77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#f771 z add$ by subsection 7a77#b71 by program in/ruction or o!rwise4 #afjjg4 ,ext5sion ( ! transition to new paym5t rates = durable m$ical equipm5t "u ! ,m$ic>e program 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all ext5d ! transition p]iod describ$ 9 clause 7i7 ( section #dad4baj7;g77#i7 ( title #db1 ,code ( ,f$]al ,regulations1 f ,june #cj1 #bjaf1 to ,decemb] #ca1 #bjaf 7) ! full implem5tation describ$ 9 clause 7ii7 ( su* section apply+ to items & s]vices furni%$ ) dates ( s]vice on or aft] ,janu>y #a1 #bjag74 7b7 ,/udy & report 7#a7 ,/udy 7,a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all conduct a /udy t exam9es ! impact ( applicable paym5t adju/m5ts ^u-- 7i7 ! numb] ( suppli]s ( durable m$ical equipm5t t1 on a date t is n be=e ,janu>y #a1 #bjaf1 & n lat] ?an ,decemb] #ca1 #bjaf1 ceas$ to conduct bus9ess z su* suppli]s2 & 7ii7 ! availability ( durable m$ical equipm5t1 dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjaf1 & end+ on ,decemb] #ca1 #bjaf1 to individuals entitl$ to b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or enroll$ "u "p ,b ( su* title4 7,b7 ,def9itions ,= purposes ( ?is subsection1 ! foll[+ def9itions apply3 7i7 ,suppli]2 durable m$ical equipm5t ,! t]ms suppli] & durable m$ical equipm5t h ! mean+s giv5 su* t]ms by section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex74 7ii7 ,applicable paym5t adju/m5t ,! t]m applicable paym5t adju/m5t means a paym5t adju/m5t describ$ 9 section #dad4baj7;g7 ( title #db1 ,code ( ,f$]al ,regulations1 t is phas$ 9 by p>agraph 7#i77;i7 ( su* section4 ,= purposes ( ! prec$+ s5t5ce1 a paym5t adju/m5t t is phas$ 9 pursuant to ! ext5sion "u subsection 7a7 %all be consid]$ a paym5t adju/m5t t is phas$ 9 by su* p>agraph 7#i77;i74 7#b7 ,report ,! ,secret>y ( ,heal? & ,human ,s]vices %all1 n lat] ?an ,janu>y #ab1 #bjag1 submit to ! ,committees on ,ways & ,means & on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & to ! ,committee on ,f9ance ( ! ,s5ate1 a report on ! f9d+s ( ! /udy conduct$ "u p>agraph 7#a74 #afjjh4 ,requirem5ts 9 det]m9+ adju/m5ts us+ in=mation f competitive bidd+ programs 7a7 ,9 g5]al ,section #ahcd7;a77#a77;,g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77#a77;,g77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,9 ! case ( items & s]vices furni%$ on or aft] ,janu>y #a1 #bjai1 9 mak+ any adju/m5ts "u clause 7ii7 or 7iii7 ( subp>agraph 7,f71 "u subsection 7h77#a77;,h77ii71 or "u section #ahdb7s77#c77;,b71 ! ,secret>y %all-- 7i7 solicit & take into acc\nt /akehold] input2 & 7ii7 take into acc\nt ! highe/ am\nt bid by a w9n+ suppli] 9 a competitive acquisition area & a comp>ison ( ea* ( ! foll[+ ) respect to non-competitive acquisition areas & competitive acquisition areas3 7,i7 ,! av]age travel di/ance & co/ associat$ ) furni%+ items & s]vices 9 ! area4 7,,ii7 ,! av]age volume ( items & s]vices furni%$ by suppli]s 9 ! area4 7,,iii7 ,! numb] ( suppli]s 9 ! area4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #ahcd7;h77#a77;,h77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,h77ii77 is am5d$ by /rik+ ! ,secret>y & ins]t+ subject to subsection 7a77#a77;,g71 ! ,secret>y4 7#b7 ,section #ahdb7s77#c77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7s77#c77;,b77 is am5d$ by /rik+ ! ,secret>y & ins]t+ subject to section #ahcd7;a77#a77;,g71 ! ,secret>y4 ,,xvii ,o!r ,m$ic>e ,provisions #agjja4 ,delay 9 au?ority to t]m9ate contracts = ,m$ic>e ,advantage plans fail+ to a*ieve m9imum quality rat+s 7a7 ,f9d+s ,consi/5t ) ! /udies provid$ "u ! ,,impact ,act ( #bjad 7,public ,law #aac-ahe71 x is ! int5t ( ,congress-- 7#a7 to cont9ue to /udy & reque/ input on ! effects ( socioeconomic /atus & dual-eligible populations on ! ,m$ic>e ,advantage ,,/>s rat+ sy/em be=e re=m+ su* sy/em ) ! input ( /akehold]s2 & 7#b7 p5d+ ! results ( su* /udies & input1 to provide = a tempor>y delay 9 au?ority ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7,,cms7 to t]m9ate ,m$ic>e ,advantage plan contracts solely on ! basis ( p]=mance ( plans "u ! ,,/>s rat+ sy/em4 7b7 ,delay 9 ,,ma contract t]m9ation au?ority = plans fail+ ,to a*ieve m9imum quality rat+s ,section #aheg7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;h77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,delay 9 contract t]m9ation au?ority = plans fail+ to a*ieve m9imum quality rat+ ,dur+ ! p]iod beg9n+ on ! date ( ! enactm5t ( ?is p>agraph & ?r\gh ! end ( plan ye> #bjah1 ! ,secret>y may n t]m9ate a contract "u ?is section ) respect to ! (f]+ ( an ,,ma plan by a ,m$ic>e ,advantage organization solely because ! ,,ma plan has fail$ to a*ieve a m9imum quality rat+ "u ! #e-/> rat+ sy/em "u section #ahec7o77#d74 4 #agjjb4 ,requirem5t = enrollm5t data report+ = ,m$ic>e ,section #ahgd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciekk7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7g7 ,requirem5t = enrollm5t data report+ 7#a7 ,9 g5]al ,ea* ye> 7beg9n+ ) #bjaf71 ! ,secret>y %all submit to ! ,committees on ,ways & ,means & ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance ( ! ,s5ate a report on ,m$ic>e enrollm5t data 7&1 9 ! case ( "p ,a1 on data on individuals receiv+ b5efits "u su* "p7 z ( a date 9 su* ye> specifi$ by ! ,secret>y4 ,su* data %all be pres5t$-- 7,a7 by ,congressional di/rict & ,/ate2 & 7,b7 9 a mann] t provides = su* data bas$ on-- 7i7 fee-=-s]vice enrollm5t 7z def9$ 9 p>agraph 7#b772 7ii7 enrollm5t "u "p ,c 7includ+ sep>ate = aggregate enrollm5t 9 ,,ma-,,pd plans & aggregate enrollm5t 9 ,,ma plans t are n ,,ma-,,pd plans72 & 7iii7 enrollm5t "u "p ,d4 7#b7 ,fee-=-s]vice enrollm5t def9$ ,= purpose ( p>agraph 7#a77;,b77i71 ! t]m fee-=-s]vice enrollm5t means aggregate enrollm5t 7includ+ receipt ( b5efits o!r ?an ?r\gh enrollm5t7 "u-- 7,a7 "p ,a only2 7,b7 "p ,b only2 & 7,c7 bo? "p ,a & "p ,b4 4 #agjjc4 ,updat+ ! ,welcome to ,m$ic>e package 7a7 ,9 g5]al ,n lat] ?an #ab mon?s aft] ! la/ day ( ! p]iod = ! reque/ ( in=mation describ$ 9 subsection 7b71 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 tak+ into consid]ation in=mation collect$ pursuant to subsection 7b71 update ! in=mation includ$ 9 ! ,welcome to ,m$ic>e package to include in=mation1 pres5t$ 9 a cle> & simple mann]1 ab\t options = receiv+ b5efits "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 includ+ ?r\gh ! orig9al m$ic>e fee-=-s]vice program "u p>ts ,a & ,b ( su* title 7#db ,u4,s4,c4 #acie;c et seq41 #db ,u4,s4,c4 #acie;j et seq471 ,m$ic>e ,advantage plans "u "p ,c ( su* title 7#db ,u4,s4,c4 #aciew-#ba et seq471 & prescription drug plans "u "p ,d ( su* title 7#db ,u4,s4,c4 #aciew-#aja et seq4774 ,! ,secret>y %all make subsequ5t updates to ! in=mation includ$ 9 ! ,welcome to ,m$ic>e package z appropriate4 7b7 ,reque/ = in=mation ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all reque/ in=mation1 includ+ recomm5dations1 f /akehold]s 7includ+ pati5t advocates1 issu]s1 & employ]s7 on in=mation includ$ 9 ! ,welcome to ,m$ic>e package1 includ+ p]t95t data & in=mation reg>d+ enrollm5t & cov]age = ,m$ic>e eligible individuals4 #agjjd4 ,no paym5t = items & s]vices furni%$ by newly enroll$ provid]s or suppli]s )9 a tempor>y moratorium area 7a7 ,m$ic>e ,section #ahff7;j77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7j77#g77 is am5d$-- 7#a7 9 ! p>agraph head+1 by ins]t+ 2 ,nonpaym5t be=e ! p]iod2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,nonpaym5t 7i7 ,9 g5]al ,no paym5t may be made "u ?is title or "u a program describ$ 9 subp>agraph 7,a7 ) respect to an item or s]vice describ$ 9 clause 7ii7 furni%$ on or aft] ,octob] #a1 #bjag4 7ii7 ,item or s]vice describ$ ,an item or s]vice describ$ 9 ?is clause is an item or s]vice furni%$-- 7,i7 )9 a geographic area ) respect to :i* a tempor>y moratorium impos$ "u subp>agraph 7,a7 is 9 effect2 & 7,,ii7 by a provid] ( s]vices or suppli] t meets ! requirem5ts ( clause 7iii74 7iii7 ,requirem5ts ,= purposes ( clause 7ii71 ! requirem5ts ( ?is clause are t a provid] ( s]vices or suppli]-- 7,i7 enrolls "u ?is title on or aft] ! effective date ( su* tempor>y moratorium2 & 7,,ii7 is )9 a category ( provid]s ( s]vices & suppli]s 7z describ$ 9 subp>agraph 7,a77 subject to su* tempor>y moratorium4 7iv7 ,prohibition on *>ges = specifi$ items or s]vices ,9 no case %all a provid] ( s]vices or suppli] describ$ 9 clause 7ii77,,ii7 *>ge an individual or o!r p]son = an item or s]vice describ$ 9 clause 7ii7 furni%$ on or aft] ,octob] #a1 #bjag1 to an individual entitl$ to b5efits "u "p ,a or enroll$ "u "p ,b or an individual "u a program specifi$ 9 subp>agraph 7,a74 4 7b7 ,con=m+ am5dm5ts 7#a7 ,m$icaid 7,a7 ,9 g5]al ,section #aijc7;i77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#b771 z am5d$ by section #ejje7;a77#d71 is fur!r am5d$-- 7i7 9 subp>agraph 7,c71 by /rik+ or at ! end2 & 7ii7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ) respect to any am\nt exp5d$ = su* an item or s]vice furni%$ dur+ cal5d> qu>t]s beg9n+ on or aft] ,octob] #a1 #bjag1 subject to section #aijb7kk77#d77;,a77ii77,,ii71 )9 a geographic area t is subject to a moratorium impos$ "u section #ahff7;j77#g7 by a provid] or suppli] t meets ! requirem5ts specifi$ 9 subp>agraph 7,c77iii7 ( su* section1 dur+ ! p]iod ( su* moratorium2 or 4 7,b7 ,exception ) respect to access ,section #aijb7kk77#d77;,a77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77#d77;,a77ii77 is am5d$ to read z foll[s3 7ii7 ,exceptions 7,i7 ,compliance ) moratorium ,a ,/ate %all n be requir$ to comply ) a tempor>y moratorium describ$ 9 clause 7i7 if ! ,/ate det]m9es t ! imposition ( su* tempor>y moratorium w\ld adv]sely impact b5efici>ies' access to m$ical assi/ance4 7,,ii7 ,,ffp available ,not)/&+ section #aijc7;i77#b77;,e71 paym5t may be made to a ,/ate "u ?is title ) respect to am\nts exp5d$ = items & s]vices describ$ 9 su* section if ! ,secret>y1 9 consultation ) ! ,/ate ag5cy adm9i/]+ ! ,/ate plan "u ?is title 7or a waiv] ( ! plan71 det]m9es t d5y+ paym5t to ! ,/ate pursuant to su* section w\ld adv]sely impact b5efici>ies' access to m$ical assi/ance4 4 7,c7 ,/ate plan requirem5t ) respect to limitation on *>ges to b5efici>ies ,section #aijb7kk77#d77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77#d77;,a77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iii7 ,limitation on *>ges to b5efici>ies ,) respect to any am\nt exp5d$ = items or s]vices furni%$ dur+ cal5d> qu>t]s beg9n+ on or aft] ,octob] #a1 #bjag1 ! ,/ate prohibits1 dur+ ! p]iod ( a tempor>y moratorium describ$ 9 clause 7i71 a provid] meet+ ! requirem5ts specifi$ 9 subp>agraph 7,c77iii7 ( section #ahff7;j77#g7 f *>g+ an individual or o!r p]son eligible to receive m$ical assi/ance "u ! ,/ate plan "u ?is title 7or a waiv] ( ! plan7 = an item or s]vice describ$ 9 section #aijc7;i77#b77;,e7 furni%$ to su* an individual4 4 7#b7 ,correct+ am5dm5ts to relat$ provisions 7,a7 ,section #ahff7;j7 ,section #ahff7;j7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7j77 is am5d$-- 7i7 9 p>agraph 7#a77;,a7-- 7,i7 by /rik+ p>agraph 7#d7 & ins]t+ p>agraph 7#e72 7,,ii7 by /rik+ moratoria 9 accordance ) p>agraph 7#e7 & ins]t+ moratoria 9 accordance ) p>agraph 7#g72 & 7,,iii7 by /rik+ p>agraph 7#f7 & ins]t+ p>agraph 7#i72 & 7ii7 by r$esignat+ ! second p>agraph 7#h7 7r$esignat$ by section #acjd7a7 ( ,public ,law #aaa-aeb7 z p>agraph 7#i74 7,b7 ,section #aijb7kk7 ,section #aijb7kk7 ( su* ,act 7#db ,u4,s4,c4 #acif;a7kk77 is am5d$-- 7i7 9 p>agraph 7#a71 by /rik+ section #ahhf7;j77#b7 & ins]t+ section #ahff7;j77#b72 7ii7 9 p>agraph 7#b71 by /rik+ section #ahhf7;j77#c7 & ins]t+ section #ahff7;j77#c72 7iii7 9 p>agraph 7#c71 by /rik+ section #ahhf7;j77#d7 & ins]t+ section #ahff7;j77#e72 & 7iv7 9 p>agraph 7#d77;,a71 by /rik+ section #ahhf7;j77#f7 & ins]t+ section #ahff7;j77#g74 #agjje4 ,pres]vation ( ,m$ic>e b5efici>y *oice "u ,m$ic>e ,advantage ,section #ahea7;e77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;e77#b77 is am5d$-- 7#a7 9 subp>agraph 7,c7-- 7,a7 9 ! head+1 by ins]t+ f #bjaa ?r\gh #bjah aft] #de-;day p]iod2 & 7,b7 by ins]t+ & end+ ) #bjah aft] beg9n+ ) #bjaa2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,cont9u\s op5 enrollm5t & dis5rollm5t = fir/ #c mon?s 9 #bjaf & subsequ5t ye>s 7i7 ,9 g5]al ,subject to clause 7ii7 & subp>agraph 7,d7-- 7,i7 9 ! case ( an ,,ma eligible individual :o is enroll$ 9 an ,,ma plan1 at any "t dur+ ! fir/ #c mon?s ( a ye> 7beg9n+ ) #bjai72 or 7,,ii7 9 ! case ( an individual :o fir/ becomes an ,,ma eligible individual dur+ a ye> 7beg9n+ ) #bjai7 & enrolls 9 an ,,ma plan1 dur+ ! fir/ #c mon?s dur+ su* ye> 9 :i* ! individual is an ,,ma eligible individual2 su* ,,ma eligible individual may *ange ! election "u subsection 7a77#a74 7ii7 ,limitation ( "o *ange dur+ op5 enrollm5t p]iod ea* ye> ,an individual may *ange ! election pursuant to clause 7i7 only once dur+ ! applicable #c-mon? p]iod describ$ 9 su* clause 9 ea* ye>4 ,! limitation "u ?is clause %all n apply to *anges 9 elections effect$ dur+ an annual1 coord9at$ election p]iod "u p>agraph 7#c7 or dur+ a special enrollm5t p]iod "u p>agraph 7#d74 7iii7 ,limit$ application to "p ,d ,clauses 7i7 & 7ii7 ( ?is subp>agraph %all only apply ) respect to *anges 9 enrollm5t 9 a prescription drug plan "u "p ,d 9 ! case ( an individual :o1 previ\s to su* *ange 9 enrollm5t1 is enroll$ 9 a ,m$ic>e ,advantage plan4 7iv7 ,limitations on m>ket+ ,pursuant to subsection 7j71 no unsolicit$ m>ket+ or m>ket+ mat]ials may be s5t to an individual describ$ 9 clause 7i7 dur+ ! cont9u\s op5 enrollm5t & dis5rollm5t p]iod e/abli%$ = ! individual "u su* clause1 not)/&+ m>ket+ guidel9es e/abli%$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 4 #agjjf4 ,all[+ end-/age r5al disease b5efici>ies to *oose a ,m$ic>e ,advantage plan 7a7 ,remov+ prohibition 7#a7 ,9 g5]al ,section #ahea7;a77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;a77#c77 is am5d$-- 7,a7 by /rik+ subp>agraph 7,b72 & 7,b7 by /rik+ eligible individual & all t foll[s ?r\gh ,9 ?is title1 subject to subp>agraph 7,b71 & ins]t+ eligible individual4--,9 ?is title14 7#b7 ,con=m+ am5dm5ts 7,a7 ,section #aheb7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;b77#a77 is am5d$-- 7i7 by /rik+ subp>agraph 7,b72 & 7ii7 by /rik+ ,b5efici>ies & all t foll[s ?r\gh ,a ,m$ic>e,*oice organization & ins]t+ ,b5efici>ies4--,a ,m$ic>e ,advantage organization4 7,b7 ,section #ahei7;b77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bh7;b77#f77 is am5d$1 9 ! la/ s5t5ce1 by /rik+ may waive & all t foll[s ?r\gh subp>agraph &4 7#c7 ,effective date ,! am5dm5ts made by ?is subsection %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba4 7b7 ,exclud+ co/s = kidney acquisitions f ,,ma b5*m>k ,section #ahec ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7 is am5d$-- 7#a7 9 subsection 7k7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ p>agraphs 7#b7 & 7#d7 & ins]t+ p>agraphs 7#b71 7#d71 & 7#e72 & 7ii7 9 subp>agraph 7,b77i71 by /rik+ p>agraphs 7#b7 & 7#d7 & ins]t+ p>agraphs 7#b71 7#d71 & 7#e72 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,exclusion ( co/s = kidney acquisitions f capitation rates ,aft] det]m9+ ! applicable am\nt = an area = a ye> "u p>agraph 7#a7 7beg9n+ ) #bjba71 ! ,secret>y %all adju/ su* applicable am\nt to exclude f su* applicable am\nt ! ,secret>y's e/imate ( ! /&>diz$ co/s = paym5ts = organ acquisitions = kidney transplants cov]$ "u ?is title 7includ+ exp5ses cov]$ "u section #ahha7;d77 9 ! area = ! ye>4 2 & 7#b7 9 subsection 7n77#b7-- 7,a7 9 subp>agraph 7,a77i71 by ins]t+ &1 = #bjba & subsequ5t ye>s1 ! exclusion ( paym5ts = organ acquisitions = kidney transplants f ! capitation rate z describ$ 9 subsection 7k77#e7 be=e ! semicolon at ! end2 7,b7 9 subp>agraph 7,e71 9 ! matt] prec$+ clause 7i71 by /rik+ subp>agraph 7,f7 & ins]t+ subp>agraphs 7,f7 & 7,g72 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,application ( kidney acquisitions adju/m5t ,! base paym5t am\nt specifi$ 9 subp>agraph 7,e7 = a ye> 7beg9n+ ) #bjba7 %all be adju/$ 9 ! same mann] "u p>agraph 7#e7 ( subsection 7k7 z ! applicable am\nt is adju/$ "u su* subsection4 4 7c7 ,,ffs cov]age ( kidney acquisitions 7#a7 ,9 g5]al ,section #aheb7;a77#a77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;a77#a77;,b77i77 is am5d$ by ins]t+ or cov]age = organ acquisitions = kidney transplants1 includ+ z cov]$ "u section #ahha7;d7 aft] hospice c>e4 7#b7 ,con=m+ am5dm5t ,section #ahea7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;i77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,,ffs paym5t = exp5ses = kidney acquisitions ,p>agraphs 7#a7 & 7#b7 %all n apply ) respect to exp5ses = organ acquisitions = kidney transplants describ$ 9 section #aheb7;a77#a77;,b77i74 4 7#c7 ,effective date ,! am5dm5ts made by ?is subsection %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba4 7d7 ,evaluation ( quality 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is subsection ref]r$ to z ! ,secret>y7 %all conduct an evaluation ( :e!r ! #e-/> rat+ sy/em bas$ on ! data collect$ "u section #aheb7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;e77 %\ld include a quality measure specifically relat$ to c>e = enrollees 9 ,m$ic>e ,advantage plans "u "p ,c ( title ,,xviii ( su* ,act det]m9$ to h end-/age r5al disease4 7#b7 ,public availability ,n lat] ?an ,april #a1 #bjbj1 ! ,secret>y %all po/ on ! ,int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ! results ( ! evaluation "u p>agraph 7#a74 7e7 ,report ,n lat] ?an ,decemb] #ca1 #bjbc1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is subsection ref]r$ to z ! ,secret>y7 %all submit to ,congress a report on ! impact ( ! provisions (1 & am5dm5ts made by1 ?is section ) respect to ! foll[+3 7#a7 ,sp5d+ "u-- 7,a7 ! orig9al ,m$ic>e fee-=-s]vice program "u p>ts ,a & ,b ( title ,,xviii ( ! ,social ,security ,act2 & 7,b7 ! ,m$ic>e ,advantage program "u "p ,c ( su* title4 7#b7 ,! numb] ( enrollees det]m9$ to h end-/age r5al disease-- 7,a7 9 ! orig9al ,m$ic>e fee-=-s]vice program2 & 7,b7 9 ! ,m$ic>e ,advantage program4 7#c7 ,! suffici5cy ( ! am\nt ( data "u ! orig9al ,m$ic>e fee-=-s]vice program = individuals det]m9$ to h end-/age r5al disease = purposes ( det]m9+ paym5t rates = end-/age r5al disease "u ! ,m$ic>e ,advantage program4 7f7 ,improvem5ts to risk adju/m5t "u m$ic>e advantage 7#a7 ,9 g5]al ,section #ahec7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7;a77#a77 is am5d$-- 7,a7 9 subp>agraph 7,c77i71 by /rik+ ,! ,secret>y & ins]t+ ,subject to subp>agraph 7,i71 ! ,secret>y2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,i7 ,improvem5ts to risk adju/m5t = #bjai & subsequ5t ye>s 7i7 ,9 g5]al ,9 ord] to det]m9e ! appropriate adju/m5t = heal? /atus "u subp>agraph 7,c77i71 ! foll[+ %all apply3 7,i7 ,tak+ into acc\nt total numb] ( diseases or conditions ,! ,secret>y %all take into acc\nt ! total numb] ( diseases or conditions ( an individual enroll$ 9 an ,,ma plan4 ,! ,secret>y %all make an additional adju/m5t "u su* subp>agraph z ! numb] ( diseases or conditions ( an individual increases4 7,,ii7 ,us+ at lea/ #b ye>s ( diagno/ic data ,! ,secret>y may use at lea/ #b ye>s ( diagnosis data4 7,,iii7 ,provid+ sep>ate adju/m5ts = dual eligible individuals ,) respect to individuals :o are dually eligible = b5efits "u ?is title & title ,,xix1 ! ,secret>y %all make sep>ate adju/m5ts = ea* ( ! foll[+3 7aa7 ,full-b5efit dual eligible individuals 7z def9$ 9 section #aice7;c77#f774 7bb7 ,su* individuals n describ$ 9 item 7aa74 7,,iv7 ,evaluation ( m5tal heal? & sub/ance use disord]s ,! ,secret>y %all evaluate ! impact ( includ+ additional diagnosis codes relat$ to m5tal heal? & sub/ance use disord]s 9 ! risk adju/m5t model4 7,v7 ,evaluation ( *ronic kidney disease ,! ,secret>y %all evaluate ! impact ( includ+ ! sev]ity ( *ronic kidney disease 9 ! risk adju/m5t model4 7,,vi7 ,evaluation ( paym5t rates = end-/age r5al disease ,! ,secret>y %all evaluate :e!r o!r factors 79 addition to ^? describ$ 9 subp>agraph 7,h77 %\ld be tak5 into consid]ation :5 comput+ paym5t rates "u su* subp>agraph4 7ii7 ,phas$-9 implem5tation ,! ,secret>y %all phase-9 any *anges to risk adju/m5t paym5t am\nts "u subp>agraph 7,c77i7 "u ?is subp>agraph ov] a #c-ye> p]iod1 beg9n+ ) #bjai1 ) su* *anges be+ fully implem5t$ = #bjbb & subsequ5t ye>s4 7iii7 ,opportunity = review & public comm5t ,! ,secret>y %all provide an opportunity = review ( ! propos$ *anges to su* risk adju/m5t paym5t am\nts "u ?is subp>agraph & a public comm5t p]iod ( n less ?an #fj days be=e implem5t+ su* *anges4 4 7#b7 ,/udies & reports 7,a7 ,reports on ! risk adju/m5t sy/em 7i7 ,m$pac evaluation & report 7,i7 ,evaluation ,! ,m$ic>e ,paym5t ,advisory ,commission %all conduct an evaluation ( ! impact ( ! provisions (1 & am5dm5ts made by1 ?is section on risk scores = enrollees 9 ,m$ic>e ,advantage plans "u "p ,c ( title ,,xviii ( ! ,social ,security ,act & paym5ts to ,m$ic>e ,advantage plans "u su* "p1 includ+ ! impact ( su* provisions & am5dm5ts on ! ov]all accuracy ( risk scores "u ! ,m$ic>e ,advantage program4 7,,ii7 ,report ,n lat] ?an ,july #a1 #bjbj1 ! ,m$ic>e ,paym5t ,advisory ,commission %all submit to ,congress a report on ! evaluation "u subclause 7,i71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,commission det]m9es appropriate4 7ii7 ,reports by secret>y ( heal? & human s]vices ,n lat] ?an ,decemb] #ca1 #bjah1 & e #c ye>s !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report on ! risk adju/m5t model & ! ,,esrd risk adju/m5t model "u ! ,m$ic>e ,advantage program "u "p ,c ( title ,,xviii ( ! ,social ,security ,act1 includ+ any revisions to ei!r su* model s9ce ! previ\s report4 ,su* report %all include in=mation on h[ su* revisions impact ! pr$ictive ratios "u ei!r su* model = gr\ps ( enrollees 9 ,m$ic>e ,advantage plans1 includ+ v high & v l[ co/ enrollees1 & gr\ps def9$ by ! numb] ( *ronic conditions ( enrollees4 7,b7 ,/udy & report on functional /atus 7i7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79 ?is subp>agraph ref]r$ to z ! ,comptroll] ,g5]al7 %all conduct a /udy on h[ to mo/ accurately measure ! functional /atus ( enrollees 9 ,m$ic>e ,advantage plans & :e!r ! use ( su* functional /atus w\ld improve ! accuracy ( risk adju/m5t paym5ts "u ! ,m$ic>e ,advantage program "u "p ,c ( title ,,xviii ( ! ,social ,security ,act4 ,su* /udy %all include an analysis ( ! *all5ges 9 collect+ & report+ functional /atus in=mation = ,m$ic>e ,advantage plans "u su* "p1 provid]s ( s]vices & suppli]s "u ! ,m$ic>e program1 & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7ii7 ,report ,n lat] ?an ,june #cj1 #bjah1 ! ,comptroll] ,g5]al %all submit to ,congress a report conta9+ ! results ( ! /udy "u clause 7i71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 #agjjg4 ,improvem5ts to ! assignm5t ( b5efici>ies "u ! ,m$ic>e ,%>$ ,sav+s ,program ,section #ahii7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;jjj7c77 is am5d$-- 7#a7 by /rik+ utilization ( prim>y & ins]t+ utilization (-- 7#a7 9 ! case ( p]=mance ye>s beg9n+ on or aft] ,april #a1 #bjab1 prim>y 2 7#b7 9 p>agraph 7#a71 z add$ by p>agraph 7#a7 ( ?is section1 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 9 ! case ( p]=mance ye>s beg9n+ on or aft] ,janu>y #a1 #bjai1 s]vices provid$ "u ?is title by a ,f$]ally qualifi$ heal? c5t] or rural heal? cl9ic 7z ^? t]ms are def9$ 9 section #ahfa7;aa771 z may be det]m9$ by ! ,secret>y4 4 ,,xviii ,o!r ,provisions #ahjja4 ,exception f gr\p heal? plan requirem5ts = qualifi$ small employ] heal? reimbursem5t arrangem5ts 7a7 ,am5dm5ts to ! ,int]nal ,rev5ue ,code ( #aihf & ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#a7 ,9 g5]al ,section #ihca ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new subsection3 7d7 ,exception = qualifi$ small employ] heal? reimbursem5t arrangem5ts 7#a7 ,9 g5]al ,= purposes ( ?is title 7except z provid$ 9 section #dihj;,i7f77#d7 & not)/&+ any o!r provision ( ?is title71 ! t]m gr\p heal? plan %all n include any qualifi$ small employ] heal? reimbursem5t arrangem5t4 7#b7 ,qualifi$ small employ] heal? reimbursem5t arrangem5t ,= purposes ( ?is subsection-- 7,a7 ,9 g5]al ,! t]m qualifi$ small employ] heal? reimbursem5t arrangem5t means an arrangem5t :i*-- 7i7 is describ$ 9 subp>agraph 7,b71 & 7ii7 is provid$ on ! same t]ms to all eligible employees ( ! eligible employ]4 7,b7 ,arrangem5t describ$ ,an arrangem5t is describ$ 9 ?is subp>agraph if-- 7i7 su* arrangem5t is fund$ solely by an eligible employ] & no sal>y r$uction contributions may be made "u su* arrangem5t1 7ii7 su* arrangem5t provides1 aft] ! employee provides pro( ( cov]age1 = ! paym5t (1 or reimbursem5t (1 an eligible employee = exp5ses = m$ical c>e 7z def9$ 9 section #bac7;d77 incurr$ by ! eligible employee or ! eligible employee's family memb]s 7z det]m9$ "u ! t]ms ( ! arrangem5t71 & 7iii7 ! am\nt ( paym5ts & reimbursem5ts describ$ 9 clause 7ii7 = any ye> d n exce$ #d1iej 7#aj1jjj 9 ! case ( an arrangem5t t also provides = paym5ts or reimbursem5ts = family memb]s ( ! employee74 7,c7 ,c]ta9 v>iation p]mitt$ ,= purposes ( subp>agraph 7,a77ii71 an arrangem5t %all n fail to be treat$ z provid$ on ! same t]ms to ea* eligible employee m]ely because ! employee's p]mitt$ b5efit "u su* arrangem5t v>ies 9 accordance ) ! v>iation 9 ! price ( an insurance policy 9 ! relevant individual heal? insurance m>ket bas$ on-- 7i7 ! age ( ! eligible employee 7&1 9 ! case ( an arrangem5t :i* cov]s m$ical exp5ses ( ! eligible employee's family memb]s1 ! age ( su* family memb]s71 or 7ii7 ! numb] ( family memb]s ( ! eligible employee ! m$ical exp5ses ( :i* are cov]$ "u su* arrangem5t4 ,! v>iation p]mitt$ "u ! prec$+ s5t5ce %all be det]m9$ by ref]5ce to ! same insurance policy ) respect to all eligible employees4 7,d7 ,rules relat+ to maximum doll> limitation 7i7 ,am\nt prorat$ 9 c]ta9 cases ,9 ! case ( an individual :o is n cov]$ by an arrangem5t = ! entire ye>1 ! limitation "u subp>agraph 7,b77iii7 = su* ye> %all be an am\nt :i* be>s ! same ratio to ! am\nt :i* w\ld 7b = ?is clause7 be 9 effect = su* individual = su* ye> "u subp>agraph 7,b77iii7 z ! numb] ( mon?s = :i* su* individual is cov]$ by ! arrangem5t = su* ye> be>s to #ab4 7ii7 ,inflation adju/m5t ,9 ! case ( any ye> beg9n+ aft] #bjaf1 ea* ( ! doll> am\nts 9 subp>agraph 7,b77iii7 %all be increas$ by an am\nt equal to-- 7,i7 su* doll> am\nt1 multipli$ by 7,,ii7 ! co/-(-liv+ adju/m5t det]m9$ "u section #a7;f77#c7 = ! cal5d> ye> 9 :i* ! taxable ye> beg9s1 det]m9$ by sub/itut+ cal5d> ye> #bjae = cal5d> ye> #aiib 9 subp>agraph 7,b7 !re(4 ,if any doll> am\nt increas$ "u ! prec$+ s5t5ce is n a multiple ( #ej1 su* doll> am\nt %all be r\nd$ to ! next l[e/ multiple ( #ej4 7#c7 ,o!r def9itions ,= purposes ( ?is subsection-- 7,a7 ,eligible employee ,! t]m eligible employee means any employee ( an eligible employ]1 except t ! t]ms ( ! arrangem5t may exclude f consid]ation employees describ$ 9 any clause ( section #aje7;h77#c77;,b7 7appli$ by sub/itut+ #ij days = #c ye>s 9 clause 7i7 !re(74 7,b7 ,eligible employ] ,! t]m eligible employ] means an employ] t-- 7i7 is n an applicable l>ge employ] z def9$ 9 section #dihj;,h7c77#b71 & 7ii7 does n (f] a gr\p heal? plan to any ( its employees4 7,c7 ,p]mitt$ b5efit ,! t]m p]mitt$ b5efit means1 ) respect to any eligible employee1 ! maximum doll> am\nt ( paym5ts & reimbursem5ts :i* may be made "u ! t]ms ( ! qualifi$ small employ] heal? reimbursem5t arrangem5t = ! ye> ) respect to su* employee4 7#d7 ,notice 7,a7 ,9 g5]al ,an employ] fund+ a qualifi$ small employ] heal? reimbursem5t arrangem5t = any ye> %all1 n lat] ?an #ij days be=e ! beg9n+ ( su* ye> 7or1 9 ! case ( an employee :o is n eligible to p>ticipate 9 ! arrangem5t z ( ! beg9n+ ( su* ye>1 ! date on :i* su* employee is fir/ s eligible71 provide a writt5 notice to ea* eligible employee :i* includes ! in=mation describ$ 9 subp>agraph 7,b74 7,b7 ,cont5ts ( notice ,! notice requir$ "u subp>agraph 7,a7 %all include ea* ( ! foll[+3 7i7 ,a /atem5t ( ! am\nt :i* w\ld be su* eligible employee's p]mitt$ b5efit "u ! arrangem5t = ! ye>4 7ii7 ,a /atem5t t ! eligible employee %\ld provide ! in=mation describ$ 9 clause 7i7 to any heal? insurance ex*ange to :i* ! employee applies = advance paym5t ( ! premium assi/ance tax cr$it4 7iii7 ,a /atem5t t if ! employee is n cov]$ "u m9imum ess5tial cov]age = any mon? ! employee may be subject to tax "u section #ejjj;,a = su* mon? & reimbursem5ts "u ! arrangem5t may be includible 9 gross income4 4 7#b7 ,limitation on exclusion f gross income ,section #ajf ( su* ,code is am5d$ by add+ at ! end ! foll[+3 7g7 ,qualifi$ small employ] heal? reimbursem5t arrangem5t ,= purposes ( ?is section & section #aje1 paym5ts or reimbursem5ts f a qualifi$ small employ] heal? reimbursem5t arrangem5t 7z def9$ 9 section #ihca7;d77 ( an individual = m$ical c>e 7z def9$ 9 section #bac7;d77 %all n be treat$ z paid or reimburs$ "u employ]-provid$ cov]age = m$ical exp5ses "u an accid5t or heal? plan if = ! mon? 9 :i* su* m$ical c>e is provid$ ! individual does n h m9imum ess5tial cov]age 7)9 ! mean+ ( section #ejjj;,a7f774 4 7#c7 ,coord9ation ) heal? insurance premium cr$it ,section #cf;,b7c7 ( su* ,code is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,special rules = qualifi$ small employ] heal? reimbursem5t arrangem5ts 7,a7 ,9 g5]al ,! t]m cov]age mon? %all n include any mon? ) respect to an employee 7or any sp\se or dep5d5t ( su* employee7 if = su* mon? ! employee is provid$ a qualifi$ small employ] heal? reimbursem5t arrangem5t :i* con/itutes af=dable cov]age4 7,b7 ,d5ial ( d\ble b5efit ,9 ! case ( any employee :o is provid$ a qualifi$ small employ] heal? reimbursem5t arrangem5t = any cov]age mon? 7det]m9$ )\t reg>d to subp>agraph 7,a771 ! cr$it o!rwise all[able "u subsection 7a7 to ! taxpay] = su* mon? %all be r$uc$ 7b n bel[ z]o7 by ! am\nt describ$ 9 subp>agraph 7,c77i77,,ii7 = su* mon?4 7,c7 ,af=dable cov]age ,= purposes ( subp>agraph 7,a71 a qualifi$ small employ] heal? reimbursem5t arrangem5t %all be treat$ z con/itut+ af=dable cov]age = a mon? if-- 7i7 ! excess (-- 7,i7 ! am\nt t w\ld be paid by ! employee z ! premium = su* mon? = self-only cov]age "u ! second l[e/ co/ silv] plan (f]$ 9 ! relevant individual heal? insurance m>ket1 ov] 7,,ii7 #aab ( ! employee's p]mitt$ b5efit 7z def9$ 9 section #ihca7;d77#c77;,c77 "u su* arrangem5t1 does n exce$-- 7ii7 #aab ( #i4e p]c5t ( ! employee's h\sehold income4 7,d7 ,qualifi$ small employ] heal? reimbursem5t arrangem5t ,= purposes ( ?is p>agraph1 ! t]m qualifi$ small employ] heal? reimbursem5t arrangem5t has ! mean+ giv5 su* t]m by section #ihca7;d77#b74 7,e7 ,cov]age = less ?an entire ye> ,9 ! case ( an employee :o is provid$ a qualifi$ small employ] heal? reimbursem5t arrangem5t = less ?an an entire ye>1 subp>agraph 7,c77i77,,ii7 %all be appli$ by sub/itut+ ! numb] ( mon?s dur+ ! ye> = :i* su* arrangem5t 0 provid$ = #ab4 7,f7 ,index+ ,9 ! case ( plan ye>s beg9n+ 9 any cal5d> ye> aft] #bjad1 ! ,secret>y %all adju/ ! #i4e p]c5t am\nt "u subp>agraph 7,c77ii7 9 ! same mann] z ! p]c5tages are adju/$ "u subsection 7b77#c77;,a77ii74 4 7#d7 ,application ( excise tax on high co/ employ]-sponsor$ heal? cov]age 7,a7 ,9 g5]al ,section #dihj;,i7f77#d7 ( su* ,code is am5d$ by add+ at ! end ! foll[+3 ,section #ihca7;d77#a7 %all n apply = purposes ( ?is section44 7,b7 ,det]m9ation ( co/ ( cov]age ,section #dihj;,i7d77#b7 ( su* ,code is am5d$ by r$esignat+ subp>agraph 7,d7 z subp>agraph 7,e7 & by ins]t+ aft] subp>agraph 7,c7 ! foll[+ new subp>agraph3 7,d7 ,qualifi$ small employ] heal? reimbursem5t arrangem5ts ,9 ! case ( applicable employ]-sponsor$ cov]age consi/+ ( cov]age "u any qualifi$ small employ] heal? reimbursem5t arrangem5t 7z def9$ 9 section #ihca7;d77#b771 ! co/ ( cov]age %all be equal to ! am\nt describ$ 9 section #fjea7;a77#ae74 4 7#e7 ,en=cem5t ( notice requirem5t ,section #ffeb ( su* ,code is am5d$ by add+ at ! end ! foll[+ new subsection3 7o7 ,failure to provide notices ) respect to qualifi$ small employ] heal? reimbursem5t arrangem5ts ,9 ! case ( ea* failure to provide a writt5 notice z requir$ by section #ihca7;d77#d71 unless x is %[n t su* failure is due to reasonable cause & n willful neglect1 !re %all be paid1 on notice & dem& ( ! ,secret>y & 9 ! same mann] z tax1 by ! p]son fail+ to provide su* writt5 notice1 an am\nt equal to #ej p] employee p] incid5t ( failure to provide su* notice1 b ! total am\nt impos$ on su* p]son = all su* failures dur+ any cal5d> ye> %all n exce$ #b1ejj4 4 7#f7 ,report+ 7,a7 ,w-#b report+ ,section #fjea7;a7 ( su* ,code is am5d$ by /rik+ & at ! end ( p>agraph 7#ac71 by /rik+ ! p]iod at ! end ( p>agraph 7#ad7 & ins]t+ 1 &1 & by ins]t+ aft] p>agraph 7#ad7 ! foll[+ new p>agraph3 7#ae7 ! total am\nt ( p]mitt$ b5efit 7z def9$ 9 section #ihca7;d77#c77;,c77 = ! ye> "u a qualifi$ small employ] heal? reimbursem5t arrangem5t 7z def9$ 9 section #ihca7;d77#b77 ) respect to ! employee4 4 7,b7 ,in=mation requir$ to be provid$ by ex*ange subsidy applicants ,section #adaa7;b77#c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act is am5d$ by r$esignat+ subp>agraph 7,b7 z subp>agraph 7,c7 & by ins]t+ aft] subp>agraph 7,a7 ! foll[+ new subp>agraph3 7,b7 ,c]ta9 individual heal? insurance policies obta9$ ?r\gh small employ]s ,! am\nt ( ! enrollee's p]mitt$ b5efit 7z def9$ 9 section #ihca7;d77#c77;,c7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 "u a qualifi$ small employ] heal? reimbursem5t arrangem5t 7z def9$ 9 section #ihca7;d77#b7 ( su* ,code74 4 7#g7 ,effective dates 7,a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is p>agraph1 ! am5dm5ts made by ?is subsection %all apply to ye>s beg9n+ aft] ,decemb] #ca1 #bjaf4 7,b7 ,transition relief ,! relief "u ,treasury ,notice #bjae-ag %all be treat$ z apply+ to any plan ye> beg9n+ on or be=e ,decemb] #ca1 #bjaf4 7,c7 ,coord9ation ) heal? insurance premium cr$it ,! am5dm5ts made by p>agraph 7#c7 %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjaf4 7,d7 ,employee notice 7i7 ,9 g5]al ,! am5dm5ts made by p>agraph 7#e7 %all apply to notices ) respect to ye>s beg9n+ aft] ,decemb] #ca1 #bjaf4 7ii7 ,transition relief ,= purposes ( section #ffeb7o7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7z add$ by ?is ,act71 a p]son %all n be treat$ z fail+ to provide a writt5 notice z requir$ by section #ihca7;d77#d7 ( su* ,code if su* notice is s provid$ n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is ,act4 7,e7 ,w-#b report+ ,! am5dm5ts made by p>agraph 7#f77;,a7 %all apply to cal5d> ye>s beg9n+ aft] ,decemb] #ca1 #bjaf4 7,f7 ,in=mation provid$ by ex*ange subsidy applicants 7i7 ,9 g5]al ,! am5dm5ts made by p>agraph 7#f77;,b7 %all apply to applications = enrollm5t made aft] ,decemb] #ca1 #bjaf4 7ii7 ,v]ification ,v]ification "u section #adaa ( ! ,pati5t ,protection & ,af=dable ,c>e ,act ( in=mation provid$ "u section #adaa7;b77#c77;,b7 ( su* ,act %all apply ) respect to mon?s beg9n+ aft] ,octob] #bjaf4 7iii7 ,transitional relief ,9 ! case ( an application = enrollm5t "u section #adaa7;b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act made be=e ,april #a1 #bjag1 ! requirem5t ( section #adaa7;b77#c77;,b7 ( su* ,act %all be treat$ z met if ! in=mation describ$ !re9 is provid$ n lat] ?an #cj days aft] ! date on :i* ! applicant receives ! notice describ$ 9 section #ihca7;d77#d7 ( ! ,int]nal ,rev5ue ,code ( #aihf4 7#h7 ,sub/antiation requirem5ts ,! ,secret>y ( ! ,treasury 7or 8 designee7 may issue sub/antiation requirem5ts z necess>y to c>ry out ?is subsection4 7b7 ,am5dm5ts to ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#a7 ,9 g5]al ,section #gcc7;a77#a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaia;b7a77#a77 is am5d$ by add+ at ! end ! foll[+3 ,su* t]m %all n include any qualifi$ small employ] heal? reimbursem5t arrangem5t 7z def9$ 9 section #ihca7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf744 7#b7 ,exception f cont9uation cov]age requirem5ts1 etc ,section #fjg7a7 ( su* ,act 7#bi ,u4,s4,c4 #aafg7a77 is am5d$ by add+ at ! end ! foll[+3 ,su* t]m %all n include any qualifi$ small employ] heal? reimbursem5t arrangem5t 7z def9$ 9 section #ihca7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf744 7#c7 ,effective date ,! am5dm5ts made by ?is subsection %all apply to plan ye>s beg9n+ aft] ,decemb] #ca1 #bjaf4 7c7 ,am5dm5ts to ! ,public ,heal? ,s]vice ,act 7#a7 ,9 g5]al ,section #bgia7;a77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;a77#a77 is am5d$ by add+ at ! end ! foll[+3 ,except = purposes ( "p ,c ( title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d et seq471 su* t]m %all n include any qualifi$ small employ] heal? reimbursem5t arrangem5t 7z def9$ 9 section #ihca7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf744 7#b7 ,exception f cont9uation cov]age requirem5ts ,section #bbjh7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;bb-#h7a77 is am5d$ by add+ at ! end ! foll[+3 ,su* t]m %all n include any qualifi$ small employ] heal? reimbursem5t arrangem5t 7z def9$ 9 section #ihca7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf744 7#c7 ,effective date ,! am5dm5ts made by ?is subsection %all apply to plan ye>s beg9n+ aft] ,decemb] #ca1 #bjaf4 ,cl]k4