,,ib ,union ,cal5d> ,no4 #bgg #aag? ,,congress #b;d ,session ,h4 ,r4 #eehe ,report ,no4 #aag-cfe ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,octob] #ae1 #bjba,ms4 ,e%oo introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,june #ac1 #bjbb;,additional sponsors3 ,ms4 ,l(gr51 ,ms4 ,roybal-,all>d1 ,mr4 ,?ompson ( ,cali=nia1 ,mr4 ,huffman1 ,mr4 ,co/a1 ,mr4 ,suozzi1 ,ms4 ,johnson ( ,texas1 ,mr4 ,mi*ael ,f4 ,doyle ( ,p5nsylvania1 ,ms4 ,wass]man ,s*ultz1 ,mr4 ,mc,govern1 ,mr4 ,c>twright1 ,mrs4 ,flet*]1 ,mr4 ,crd5as1 ,ms4 ,craig1 ,mrs4 ,trahan1 ,mr4 ,pascrell1 ,mr4 ,c\rtney1 ,mr4 ,p]lmutt]1 ,ms4 ,ross1 ,mr4 ,mc,nerney1 ,mrs4 ,napolitano1 ,mr4 ,pet]s1 ,ms4 ,b>ragn1 ,mr4 ,lev9 ( ,cali=nia1 ,mr4 ,tonko1 ,ms4 ,s*ri]1 ,ms4 ,blunt ,ro*e/]1 ,mr4 ,khanna1 ,ms4 ,*u1 ,mr4 ,de,saulnier1 ,mr4 ,s*iff1 ,ms4 ,spei]1 ,mr4 ,aguil>1 ,mr4 ,trone1 ,ms4 ,mc,collum1 ,mr4 ,s*rad]1 ,ms4 ,jacobs ( ,cali=nia1 ,mr4 ,quigley1 ,mr4 ,m\lton1 ,mr4 ,wel*1 ,mr4 ,ru%1 ,ms4 ,s*ak[sky1 ,ms4 ,ku/]1 ,ms4 ,kelly ( ,ill9ois1 ,mrs4 ,d+ell1 ,ms4 ,matsui1 ,ms4 ,ca/or ( ,florida1 ,mr4 ,o',hall]an1 ,ms4 ,de,gette1 ,mr4 ,upton1 ,ms4 ,sewell1 ,mr4 ,s>banes1 ,ms4 ,cl>ke ( ,new ,york1 ,mr4 ,morelle1 ,mr4 ,grijalva1 ,mr4 ,nadl]1 ,mr4 ,mc,eachin1 ,mr4 ,soto1 ,mr4 ,c>bajal1 ,mr4 ,bi%op ( ,georgia1 ,mr4 ,fitzpatrick1 ,mr4 ,lawson ( ,florida1 ,mr4 ,burgess1 ,mr4 ,coh51 ,ms4 ,williams ( ,georgia1 & ,ms4 ,br[n ( ,ohio ,june #ac1 #bjbb,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be printed,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic,for text ( introduc$ bill1 see copy ( bill z introduc$ on ,octob] #ae1 #bjba ,a ,,bill ,to e/abli% ! ,advanc$ ,rese>* ,projects ,ag5cy-,heal?1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,advanc$ ,rese>* ,projects ,ag5cy-,heal? ,act or ! ,,arpa-,h ,act4 #b4 ,advanc$ rese>* projects ag5cy-heal? ,title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq47 is am5d$ by add+ at ! end ! foll[+3 ,j ,advanc$ ,rese>* ,projects ,ag5cy-,heal? #dii;,a4 ,advanc$ ,rese>* ,projects ,ag5cy-,heal? 7a7 ,e/abli%m5t ,!re is e/abli%$1 z an indep5d5t op]at+ division )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,advanc$ ,rese>* ,projects ,ag5cy-,heal? 79 ?is "p ref]r$ to z ,,arpa-,h74 ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is "p1 ! ,secret>y %all transf] all functions1 p]sonnel1 missions1 activities1 au?orities1 & funds ( ! ,advanc$ ,rese>* ,projects ,ag5cy = ,heal? )9 ! ,national ,in/itutes ( ,heal?1 z 9 exi/5ce on ! date ( enactm5t ( ?is "p1 to ,,arpa-,h e/abli%$ by ! prec$+ s5t5ce4 7b7 ,goals & me?ods 7#a7 ,goals ,! goals ( ,,arpa-,h %all be to-- 7,a7 fo/] ! developm5t ( new1 break?r\gh capabilities1 te*nologies1 sy/ems1 & plat=ms to accel]ate innovations 9 heal? & m$ic9e t are n be+ met by ,f$]al programs or private entities2 7,b7 revolutionize detection1 diagnosis1 mitigation1 prev5tion1 treatm5t1 & cur+ ( s]i\s diseases & m$ical conditions ?r\gh ! developm5t ( trans=mative heal? te*nologies2 7,c7 promote high-risk1 high-rew>d innovation = ! developm5t & translation ( trans=mative heal? te*nologies2 & 7,d7 contribute to ensur+ ! ,unit$ ,/ates ma9ta9s-- 7i7 global lead]%ip 9 sci5ce & innovation2 7ii7 ! highe/ quality ( life & heal? = its citiz5s2 & 7iii7 an aggressive ag5da = innovations to address global heal? ?reats t place ,unit$ ,/ates citiz5s at risk4 7#b7 ,me?ods ,,arpa-,h %all a*ieve ! goals specifi$ 9 p>agraph 7#a7 by-- 7,a7 discov]+1 id5tify+1 & promot+ revolution>y advances 9 heal? sci5ces2 7,b7 translat+ sci5tific discov]ies into trans=mative heal? te*nologies2 7,c7 provid+ res\rces & support to create plat=m capabilities t draw on multiple discipl9es2 7,d7 us+ rese>*]s 9 a wide range ( discipl9es1 includ+ ! life sci5ces1 ! physical sci5ces1 eng9e]+1 & ! computational sci5ces2 7,e7 deliv]+ advanc$ pro(s ( concept t demon/rate pot5tially cl9ically mean+ful advances2 7,f7 develop+ new capabilities1 advanc$ computational tools1 pr$ictive models1 or analytical te*niques to id5tify pot5tial t>gets & te*nological /rategies = e>ly disease detection & int]v5tion2 7,g7 accel]at+ trans=mational te*nological advances 9 areas ) limit$ te*nical c]ta9ty2 & 7,h7 prioritiz+ inve/m5ts bas$ on su* consid]ations z-- 7i7 sci5tific opportunity & uniqu5ess ( fit to ! /rategies & op]at+ practices ( ,,arpa-,h2 7ii7 ! effect on disease burd51 includ+ unmet pati5t ne$1 quality & disp>ity gaps1 & ! pot5tial to preempt progression ( s]i\s disease2 & 7iii7 ! effect on ! fiscal liability ( ! ,f$]al ,gov]nm5t ) respect to heal? c>e & ! ability to r$uce ! co/ ( c>e ?r\gh innovation4 7c7 ,director 7#a7 ,9 g5]al ,! ,presid5t %all appo9t ) ! advice & cons5t ( ! ,s5ate1 a director ( ,,arpa-,h 79 ?is "p ref]r$ to z ! ,director74 7#b7 ,qualifications ,! ,director %all be an individual :o1 by reason ( pr(essional backgr\nd & exp]i5ce1 is especially qualifi$ to manage-- 7,a7 rese>* & advanc$ developm5t programs2 & 7,b7 l>ge-scale1 high-risk initiatives ) respect to heal? rese>* & te*nology developm5t across multiple sectors1 includ+ g5]at+ trans=mative heal? te*nologies & improv+ heal? outcomes = pati5ts4 7#c7 ,relation%ip to secret>y ,! ,director %all report directly to ! ,secret>y4 7#d7 ,duties ,! duties ( ! ,director %all include ! foll[+3 7,a7 ,approve & t]m9ate ! projects & programs ( ,,arpa-,h4 7,b7 ,set rese>* & developm5t priorities ) respect to ! goals specifi$ 9 subsection 7b7 & manage ! budget ( ,,arpa-,h4 7,c7 ,develop fund+ crit]ia & assess ! success ( programs ?r\gh ! e/abli%m5t ( te*nical mile/ones4 7,d7 ,advance ! goals "u subsection 7b71 ?r\gh consid]ation ( ! advice ( ! ,,arpa-,h ,int]ag5cy ,rese>* ,c\ncil e/abli%$ "u subsection 7q74 7,e7 ,solicit data1 z ne$$1 f ! ,national ,in/itutes ( ,heal? & o!r relevant entities4 7,f7 ,coord9ate ) ! ,director ( ! ,national ,in/itutes ( ,heal? to ensure t ! programs ( ,,arpa-,h build on1 & are in=m$ by1 sci5tific rese>* support$ by ! ,national ,in/itutes ( ,heal?4 7,g7 ,coord9ate ) ! heads ( ,f$]al ag5cies &1 to ! ext5t practicable1 ensure t ! activities ( ,,arpa-,h supplem5t 7& d n supplant7 ! ef=ts ( o!r ,f$]al ag5cies4 7,h7 ,ensure ,,arpa-,h does n provide fund+ = a project unless ! program manag] det]m9es t ! project meets ! goals describ$ 9 subsection 7b77#a74 7#e7 ,t]m ,! ,director-- 7,a7 %all be appo9t$ = a #e-ye> t]m2 & 7,b7 may be reappo9t$ = #a consecutive #e-ye> t]m4 7#f7 ,autonomy ( ag5cy reg>d+ recomm5dations & te/imony ,no (fic] or ag5cy ( ! ,unit$ ,/ates %all h any au?ority to require ! ,director or any o!r (fic] ( ,,arpa-,h to submit legislative recomm5dations1 or te/imony or comm5ts on legislation1 to any (fic] or ag5cy ( ! ,unit$ ,/ates = approval1 comm5ts1 or review prior to ! submission ( su* recomm5dations1 te/imony1 or comm5ts to ! ,congress1 if su* recomm5dations1 te/imony1 or comm5ts to ! ,congress include a /atem5t indicat+ t ! views express$ !re9 are ^? ( ! ,director or su* (fic]1 & d n necess>ily reflect ! views ( ! ,presid5t or ano!r ag5cy4 7#g7 ,delegation ( au?ority ,! ,director may delegate to any duly au?oriz$ employee1 repres5tative1 or ag5t any p[] ve/$ 9 ! ,director by law1 except t ! ,director may n delegate ! p[] to appo9t ! ,deputy ,director "u p>agraph 7#h74 7#h7 ,deputy ,director ,! ,director %all appo9t a deputy director to s]ve z ! fir/ assi/ant to ! (fice4 7d7 ,application ( ,pap]work ,r$uction ,act ,! ,director may waive ! requirem5ts ( sub*apt] ,i ( *apt] #ce ( title #dd1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,pap]work ,r$uction ,act7 ) respect to ! me?ods describ$ 9 subsection 7b77#b74 7e7 ,protection ( in=mation ,! foll[+ types ( in=mation collect$ by ,,arpa-,h f recipi5ts ( f9ancial assi/ance aw>ds %all be consid]$ comm]cial & f9ancial in=mation obta9$ f a p]son & privileg$ or confid5tial & n subject to disclosure "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code3 7#a7 ,plans = comm]cialization ( te*nologies develop$ "u ! aw>d1 includ+ bus9ess plans1 te*nology-to m>ket plans1 m>ket /udies1 & co/ & p]=mance models4 7#b7 ,inve/m5ts provid$ to an aw>dee f ?ird p>ties 7su* z v5ture capital firms1 h$ge funds1 & private equity firms71 includ+ am\nts & ! p]c5tage ( own]%ip ( ! aw>dee provid$ 9 return = ! inve/m5ts4 7#c7 ,additional f9ancial support t ! aw>dee-- 7,a7 plans to inve/ or has inve/$ 9 ! te*nology develop$ "u ! aw>d2 or 7,b7 is seek+ f ?ird p>ties4 7#d7 ,rev5ue f ! lic5s+ or sale ( new products or s]vices result+ f rese>* conduct$ "u ! aw>d4 7f7 ,%>+ in=mation ) ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,! ,director %all timely %>e relevant in=mation ) ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices t may help to exp$ite det]m9ations ( cov]age ( trans=mative heal? te*nologies develop$ by ,,arpa-,h4 7g7 ,exp$it+ break?r\ghs ?r\gh coop]ation ) ! ,food & ,drug ,adm9i/ration 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs & 9 consultation ) ! ,director1 may take actions to facilitate translation ( trans=mative heal? te*nology into tangible solutions = pati5ts & to exp$ite developm5t ( drugs1 devices1 & biological products1 includ+ ?r\gh-- 7,a7 help+ to ensure t drug1 device1 or biological product developm5t programs1 9 z effici5t a mann] z possible1 ga!r ! noncl9ical & cl9ical data necess>y to advanc+ ! developm5t ( su* products & to obta9+ _! approval1 lic5sure1 or cle>ance1 z applicable1 by ! ,food & ,drug ,adm9i/ration "u sections #eje1 #eaj7k71 & #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & section #cea ( ?is ,act2 7,b7 exp$it+ review ( inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 review ( inve/igational device exemptions "u section #ebj7;g7 ( su* ,act1 & review ( applications = approval1 lic5sure1 & cle>ance ( drugs1 devices1 or biological products "u sections #eje1 #eaj7k71 & #eae ( su* ,act1 & section #cea ( ?is ,act2 & 7,c7 meet+ at appropriate int]vals ) ! ,director & any memb] ( ! ,,arpa-,h ,int]ag5cy ,rese>* ,c\ncil to discuss ! developm5t /atus ( drugs1 devices1 or biological products & projects t are ! highe/ priorities to ,,arpa-,h1 unless ! ,director & ! ,commission] ( ,food & ,drugs det]m9e t any su* meet+s are n necess>y4 7#b7 ,relation to o!rwise au?oriz$ activities ( ! ,,fda ,! au?ority specifi$ 9 p>agraph 7#a7 %all n be con/ru$ z limit+ ! au?ority ( ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 ) respect to ! review & approval1 cle>ance1 au?orization = em]g5cy use1 or lic5sure ( drugs1 devices1 or biological products "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act4 7#c7 ,reimbursem5t ,! ,director1 us+ funds made available to ,,arpa-,h1 may reimburse ! ,food & ,drug ,adm9i/ration = exp5ditures made by ! ,food & ,drug ,adm9i/ration = activities c>ri$ out "u ?is section t h be5 id5tifi$ by ! ,commission] ( ,food & ,drugs & ! ,director z be+ c>ri$ out by ! ,food & ,drug ,adm9i/ration4 7h7 ,aw>ds 7#a7 ,9 g5]al ,9 c>ry+ out ?is section1 ! ,director may make aw>ds includ+-- 7,a7 grants & coop]ative agreem5ts1 :i* %all-- 7i7 be subject to ! uni=m adm9i/rative requirem5ts1 co/ pr9ciples1 & audit requirem5ts = ,f$]al aw>ds conta9$ 9 "p #bjj ( title #b1 ,code ( ,f$]al ,regulations 7or successor regulations72 & 7ii7 include ! total l9e-item & itemiz$ indirect facilities & adm9i/rative co/s t %all be made publicly available & publi%$ 9 a ma*9e-readable =mat2 7,b7 contracts subject to ! ,f$]al ,acquisition ,regulation2 7,c7 multi-ye> contracts "u section #cijc ( title #da1 ,unit$ ,/ates ,code2 7,d7 prizes2 & 7,e7 o!r transactions4 7#b7 ,exemptions = c]ta9 requirem5ts ,rese>* fund$ by ,,arpa-,h %all n be subject to ! requirem5ts ( section #djf7;a77#c77;,a77ii7 or section #dib4 7i7 ,facilities au?ority 7#a7 ,9 g5]al ,! ,director may acquire 7by pur*ase1 lease1 condemnation1 or o!rwise71 con/ruct1 improve1 repair1 op]ate1 & ma9ta9 su* real & p]sonal prop]ty z may be necess>y to c>ry out ?is section4 7#b7 ,lease ( nonexcess prop]ty ,! ,director may ent] into a lease "u ?is section ) any p]son or entity 7includ+ ano!r dep>tm5t or ag5cy ( ! ,f$]al ,gov]nm5t or an entity ( a ,/ate or local gov]nm5t7 ) reg>d to any nonexcess real prop]ty & relat$ p]sonal prop]ty "u ! jurisdiction ( ! ,director4 7#c7 ,utilization ( lease funds 7,a7 ,9 g5]al ,! ,director may utilize1 )\t fur!r appropriation1 am\nts ( ca% consid]ation receiv$ = a lease ent]$ into "u ?is subsection to cov] ! full co/s to ,,arpa-,h 9 connection ) ! lease4 ,funds receiv$ z su* ca% consid]ation %all rema9 available until exp5d$4 7,b7 ,capital revitalization & improvem5ts ,( any am\nts ( ca% consid]ation receiv$ "u ?is subsection t are n utiliz$ 9 accordance ) subp>agraph 7,a71 )\t fur!r appropriation-- 7i7 #ce p]c5t %all-- 7,i7 be deposit$ 9 a capital asset acc\nt to be e/abli%$ by ! ,director2 7,,ii7 be available = ma9t5ance1 capital revitalization1 & improvem5ts ( ! real prop]ty assets & relat$ p]sonal prop]ty "u ! jurisdiction ( ! ,director2 & 7,,iii7 rema9 available until exp5d$2 & 7ii7 ! rema9+ #fe p]c5t %all be available to ! respective c5t] or facility ( ,,arpa-,h engag$ 9 ! lease ( nonexcess real prop]ty1 & %all rema9 available until exp5d$ = ma9t5ance1 capital revitalization1 & improvem5ts ( ! real prop]ty assets & relat$ p]sonal prop]ty at ! respective c5t] or facility subject to ! concurr5ce ( ! ,director4 7,c7 ,no utilization = daily op]at+ co/s ,am\nts utiliz$ "u subp>agraph 7,b7 may n be utiliz$ = daily op]at+ co/s4 7#d7 ,locations 7,a7 ,9 g5]al ,,arpa-,h1 includ+ its headqu>t]s1 %all n be locat$ on any "p ( ! exi/+ ,national ,in/itutes ( ,heal? campuses4 7,b7 ,consid]ations ,9 det]m9+ ! location ( facilities1 ! ,director %all make a fair & op5 consid]ation (-- 7i7 ! *>act]i/ics ( ! int5d$ location2 & 7ii7 ! ext5t to :i* su* location w facilitate advancem5t ( ! goals & me?ods specifi$ 9 subsection 7b74 7j7 ,p]sonnel 7#a7 ,9 g5]al ,! ,director may-- 7,a7 make & resc9d appo9tm5ts ( sci5tific1 eng9e]+1 m$ical1 & pr(essional p]sonnel1 :i* may include tempor>y or "t-limit$ appo9tm5ts z det]m9$ by ! ,director to fulfill ! mission ( ,,arpa-,h1 )\t reg>d to any provision 9 title #e1 ,unit$ ,/ates ,code1 gov]n+ appo9tm5ts & removals "u ! civil s]vice laws1 & fix ! base pay comp5sation ( su* p]sonnel at a rate to be det]m9$ by ! ,director1 up to ! am\nt ( annual comp5sation 7exclud+ exp5ses7 specifi$ 9 section #ajb ( title #c1 ,unit$ ,/ates ,code2 & 7,b7 contract ) private recruit+ firms = ! hir+ ( qualifi$ /aff ref]5c$ 9 subp>agraph 7,a74 7#b7 ,additional /aff ,! ,director may use1 to ! same ext5t & 9 ! same mann] z ! ,secret>y1 all au?orities 9 exi/5ce on ! date ( ! enactm5t ( ?is section t are provid$ to ! ,secret>y to hire adm9i/rative1 f9ancial1 contracts1 legislative affairs1 in=mation te*nology1 e?ics1 & communications /aff1 & su* o!r /aff z may be id5tifi$ by ! ,director z necess>y to c>ry out ?is section4 7#c7 ,additional consid]ations ,9 appo9t+ p]sonnel "u ?is subsection1 ! ,director-- 7,a7 may contract ) private entities2 7,b7 %all make ef=ts to recruit & reta9 a div]se work=ce1 includ+ individuals und]repres5t$ 9 sci5ce & m$ic9e & racial & e?nic m9orities 7z long z su* ef=ts comply ) applicable ,f$]al civil rights law72 & 7,c7 %all recruit program manag]s ) exp]tise 9 a wide range ( relevant discipl9es1 includ+ life sci5ces1 ! physical sci5ces1 eng9e]+1 & ! computational sci5ces4 7#d7 ,additional hir+ au?ority ,to ! ext5t ne$$ to c>ry out ! au?orities ve/$ by p>agraph 7#a71 ! ,director may utilize hir+ au?orities "u sections #ccga ?r\gh #ccgf ( title #e1 ,unit$ ,/ates ,code1 to /aff ,,arpa-,h ) employees f o!r ,f$]al ag5cies1 ,/ate & local gov]nm5ts1 ,indian ,tribes & ,tribal organizations1 in/itutions ( high] education1 & o!r organizations1 z describ$ 9 su* sections4 7#e7 ,exi/+ au?orities ,! au?orities grant$ by ?is section are-- 7,a7 9 addition to exi/+ au?orities grant$ to ! ,secret>y2 & 7,b7 are n int5d$ to sup]s$e or modify any exi/+ au?orities4 7#f7 ,au?ority to accept ,f$]al detailees ,! ,director may accept (fic]s or employees ( ! ,unit$ ,/ates or memb]s ( ! uni=m$ s]vice on a detail f an elem5t ( ! ,f$]al ,gov]nm5t on a reimbursable or a nonreimbursable basis1 z jo9tly agre$ to by ! heads ( ! receiv+ & detail+ elem5ts1 = a p]iod n to exce$ #c ye>s4 7k7 ,program manag]s 7#a7 ,9 g5]al ,! ,director %all appo9t program manag]s = #c-ye> t]ms 7& may reappo9t su* program manag]s = #a consecutive #c-ye> t]m7 = ! programs c>ri$ out by ,,arpa-,h4 7#b7 ,duties ,a program manag] %all-- 7,a7 e/abli%1 9 consultation ) ! ,director or ,deputy ,director1 rese>* & developm5t goals = programs1 includ+ timel9es & mile/ones1 & make su* goals available to ! public2 7,b7 collaborate ) exp]ts f ! ,national ,in/itutes ( ,heal? & o!r ,f$]al ag5cies & exp]ts 9 relevant sci5tific fields to id5tify rese>* & developm5t gaps & opportunities2 7,c7 conv5e work%ops & meet+s1 z ne$$1 ) entities su* z pati5ts1 pati5t advocacy gr\ps1 practition]s1 pr(essional societies1 & o!r /akehold]s to solicit input on programs & goals2 7,d7 manage applications & proposals1 ?r\gh ! appropriate (ficials = mak+ grants1 coop]ative agreem5ts1 contracts1 prizes1 & o!r transaction aw>ds = advanc$ rese>* t may %[ p>ticul> promise1 especially 9 areas 9 :i* ! private sector & ! ,f$]al ,gov]nm5t h n und]tak5 suffici5t rese>*2 7,e7 issue fund+ opportunity ann\ncem5ts1 us+ uni=m adm9i/rative processes1 z appropriate2 7,f7 select1 on ! basis ( m]it1 ea* ( ! projects to be support$ "u a program c>ri$ out by ,,arpa-,h1 & tak+ into consid]ation-- 7i7 ! sci5tific & te*nical m]it ( ! propos$ project2 7ii7 ! capabilities ( ! applicants to successfully c>ry out ! propos$ project2 7iii7 ! unmet ne$s or ability to improve heal? outcomes )9 pati5t populations2 7iv7 future comm]cial applications ( ! project or ! feasibility ( p>tn]+ ) "o or m comm]cial entities2 7v7 ! pot5tial = int]discipl9>ity ( ! approa* ( ! project2 & 7vi7 su* o!r crit]ia z e/abli%$ by ! ,director2 7,g7 conduct project reviews )9 #ah mon?s ( fund+ aw>ds to id5tify mile/ones & monitor progress ( su* mile/ones ) respect to ea* project & prior to disbursem5t ( new funds2 7,h7 provide recomm5dations to ! ,director ) respect to advanc+ ! goals specifi$ 9 subsection 7b72 7,i7 cultivate opportunities = ! comm]cial application or community use ( successful projects1 includ+ ?r\gh ! e/abli%m5t ( p>tn]%ips betwe5 or among aw>dees2 7,j7 id5tify innovative co/-%>+ arrangem5ts = ,,arpa-,h projects2 7,k7 provide recomm5dations to exp&1 re/ructure1 or t]m9ate rese>* p>tn]%ips or projects2 & 7,l7 ensure t-- 7i7 animal /udies meet ! ,f$]al animal rese>* requirem5ts pursuant ( ! ,public ,heal? ,s]vice ,policy on ,humane ,c>e & ,use ( ,laboratory ,animals2 & 7ii7 applications apply /ati/ical model+ approa*es & appropriately ju/ify animal sample sizes to meet project goals4 7l7 ,reports & evaluation 7#a7 ,annual report 7,a7 ,9 g5]al ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 & ea* fiscal ye> !reaft]1 ! ,director %all submit a report on ! actions und]tak51 & results g5]at$1 by ,,arpa-,h1 includ+-- 7i7 a description ( projects support$ by ,,arpa-,h 9 ! previ\s fiscal ye> & :e!r su* projects are meet+ ! goals develop$ by ! ,director pursuant to subsection 7c77#d77;,c72 7ii7 a description ( projects t]m9at$ 9 ! previ\s fiscal ye>1 & ! reason = su* t]m9ation2 7iii7 a description ( programs />t+ 9 ! next fiscal ye>1 z available2 7iv7 activities conduct$ 9 coord9ation ) o!r ,f$]al ag5cies2 7v7 an analysis ( ! ext5t ( coord9ation conduct$ pursuant to subsections 7c77#d77;,f7 & 7f71 includ+ successes & b>ri]s ) respect to a*iev+ ! goals "u subsection 7b72 7vi7 a description ( ! demographic 7includ+ racial & g5d]7 div]sity if available ( direct recipi5ts & p]=m]s 9 fund$ projects & ( ! ,,arpa-,h work=ce2 & 7vii7 a disclosure by ! rew>d recipi5ts ( :e!r ! pr9cipal inve/igators nam$ on ! aw>d p>ticipate 9 =eign tal5t programs1 includ+ ! provision ( copies ( all grants1 contracts1 or o!r agreem5ts relat$ to su* programs1 & o!r support+ docum5tation relat$ to su* programs1 z a condition ( receipt ( ,f$]al extramural biom$ical rese>* fund+ aw>d$4 7,b7 ,submission to ,congress ,! report "u subp>agraph 7,a7 %all be submitt$ to-- 7i7 ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives2 & 7ii7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate4 7#b7 ,evaluation 7,a7 ,9 g5]al ,n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all ent] into an agreem5t ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e "u :i* ! ,national ,academies agree to /udy & evaluate :e!r ,,arpa-,h is meet+ ! goals specifi$ 9 subsection 7b74 7,b7 ,submission ( results ,! agreem5t ent]$ into "u subp>agraph 7,a7 %all require ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e to submit ! results ( ! evaluation conduct$ "u su* agreem5t to ! ,secret>y1 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 7m7 ,/rategic plan ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 & e #c ye>s !reaft]1 ! ,director %all provide to ! relevant committees ( ,congress a /rategic plan describ+ h[ ,,arpa-,h w c>ry out inve/m5ts ea* fiscal ye> 9 ! foll[+ #c-ye> p]iod4 7n7 ,indep5d5t review ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 & e #c ye>s !reaft]1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct an indep5d5t review ( ! rese>* portfolio ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+ ,,arpa-,h1 ! ,national ,in/itutes ( ,heal?1 ! ,food & ,drug ,adm9i/ration1 & ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority-- 7#a7 to assess ! degree ( unnecess>y duplication ( exi/+ ,f$]al programs & projects2 & 7#b7 to make recomm5dations reg>d+ any pot5tial reorganization1 consolidation1 or t]m9ation ( su* programs & projects4 7o7 ,prioritization ,! ,director %all-- 7#a7 prioritize aw>d+ grants1 coop]ative agreem5ts1 contracts1 prizes1 & o!r transaction aw>ds to dome/ic recipi5ts conduct+ ! rese>* on trans=mative heal? te*nology 9 ! ,unit$ ,/ates2 7#b7 z appropriate & practicable1 ensure t nondome/ic recipi5ts ( any grants1 coop]ative agreem5ts1 contracts1 prizes1 & o!r transactions "u ?is section are conduct+ rese>* 9 collaboration ) a dome/ic recipi5t2 7#c7 n aw>d any grants1 coop]ative agreem5ts1 contracts1 prizes1 & o!r transactions to nondome/ic recipi5ts subject to malign =eign influ5ce or organiz$ "u ! laws ( a malign =eign c\ntry2 & 7#d7 9 accordance ) ! requirem5ts ( *apt] #cc ( title #da1 ,unit$ ,/ates ,code1 & ! ,f$]al ,acquisition ,regulation1 only aw>d grants1 coop]ative agreem5ts1 contracts1 prizes1 & o!r transactions to individual p]sons t d n h m ?an #c ongo+ concurr5t grants1 coop]ative agreem5ts1 contracts1 prizes1 & o!r transactions "u ?is section4 7p7 ,additional consultation ,9 c>ry+ out ?is section1 ! ,director may consult )-- 7#a7 ! ,presid5t's ,c\ncil ( ,advisors on ,sci5ce & ,te*nology2 7#b7 pe]s 9 ! sci5tific community1 includ+ academia & indu/ry2 7#c7 an exi/+ advisory committee provid+ advice to ! ,secret>y or ! head ( any op]at+ or /aff division ( ! ,dep>tm5t2 7#d7 a new int]ag5cy rese>* c\ncil organiz$ to support ! programs ( ,,arpa-,h & to provide advice & assi/ance on-- 7,a7 specific program tasks2 or 7,b7 ! ov]all direction ( ,,arpa-,h2 & 7#e7 any o!r entity ! ,director may deem appropriate4 7q7 ,,arpa-,h ,int]ag5cy ,rese>* ,c\ncil 7#a7 ,9 g5]al ,! ,director %all e/abli% an int]ag5cy advisory committee to be kn[n z ! ,,arpa-,h ,int]ag5cy ,rese>* ,c\ncil 7ref]r$ to 9 ?is subsection z ! ,rese>* ,c\ncil74 7#b7 ,memb]%ip ,! ,rese>* ,c\ncil may include any or all ( ! foll[+ memb]s1 or designees3 7,a7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7,b7 ,! ,director ( ,national ,c5t] = ,advanc+ ,translational ,sci5ces4 7,c7 ,! ,director ( ,(fice ( ,sci5ce & ,te*nology ,policy4 7,d7 ,! ,commission] ( ,food & ,drugs4 7,e7 ,! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority4 7,f7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7,g7 ,! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7,h7 ,! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality4 7,i7 ,! ,director ( ! ,(fice ( ,m9ority ,heal?4 7,j7 ,! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration4 7,k7 ,! ,director ( ! ,def5se ,advanc$ ,rese>* ,projects ,ag5cy4 7,l7 ,! ,director ( ! ,national ,sci5ce ,f\ndation4 7,m7 ,! ,director ( ! ,(fice ( ,sci5ce ( ! ,dep>tm5t ( ,en]gy4 7,n7 ,! ,director ( ! ,advanc$ ,rese>* ,projects ,ag5cy-,en]gy4 7,o7 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7,p7 ,repres5tatives ( any ,f$]al ag5cy ) subject matt] exp]tise t ! ,director det]m9es is necess>y = ! successful completion ( a project c>ri$ out pursuant to ?is section4 7,q7 ,any o!r entity ! ,director may deem appropriate4 7#c7 ,duties ,! ,rese>* ,c\ncil %all advise ! ,director1 includ+ by-- 7,a7 mak+ recomm5dations on-- 7i7 rese>* priorities t w provide ! greate/ return on inve/m5t ) respect to improv+ human heal?2 7ii7 avoid+ duplication ( ef=ts 9 ! ,f$]al ,gov]nm5t2 & 7iii7 improv+ coord9ation ) o!r ,f$]al ag5cies2 & 7,b7 id5tify+ & develop+ /rategies to address regulatory1 reimbursem5t1 & m>ket b>ri]s to comm]cialization or adoption ( trans=mative heal? te*nologies1 includ+ te*nologies int5d$ to preempt s]i\s disease4 7#d7 ,advisory nature ,! function ( ! ,rese>* ,c\ncil %all be advisory 9 nature4 ,no?+ 9 ?is subsection %all be con/ru$ z grant+ ! ,rese>* ,c\ncil au?ority ov] any activities or functions ( ,,arpa-,h4 7#e7 ,meet+s ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 & e fiscal ye> !reaft]1 ! ,director %all conv5e meet+s ( ! ,rese>* ,c\ncil1 includ+ conf]5ces or work%ops1 z ne$$4 ,! ,rese>* ,c\ncil may function ?r\gh e/abli%$ or ad hoc committees1 task =ces1 or int]ag5cy gr\ps to-- 7,a7 %>e in=mation on heal? innovations fund$ by ,,arpa-,h2 & 7,b7 receive input on areas ( p>ticul> promise = ,,arpa-,h projects4 7r7 ,te*nology transf] (fice ,! ,director may e/abli% )9 ,,arpa-,h an ,(fice ( ,te*nology ,transf] to facilitate1 :]e appropriate1 ! transf] ( f$]ally-own$ or f$]ally-orig9at$ te*nology to recipi5ts ( an aw>d "u ?is section 7o!r ?an ,f$]al ,gov]nm5t entities74 7s7 ,foll[-on production aw>d au?ority 7#a7 ,9 g5]al ,an o!r transaction ent]$ into by ! ,director "u subsection 7h77#a7 = a project may provide = ! aw>d ( a foll[-on production contract or transaction to ! p>ticipants 9 ! transaction by ,,arpa-,h or ano!r ,f$]al ag5cy4 ,= purposes ( ?is p>agraph1 su* an o!r transaction includes all individual subprojects aw>d$ "u ! transaction to a consortium ( ,unit$ ,/ates indu/ry & academic in/itutions4 7#b7 ,relation to competitive proc$ures ,a foll[-on production contract or transaction "u p>agraph 7#a7 may be aw>d$ to ! p>ticipants 9 ! transaction )\t ! use ( competitive proc$ures 7z def9$ 9 section #aeb ( title #da1 ,unit$ ,/ates ,code71 not)/&+ ! requirem5ts ( division ,c ( subtitle ,i ( su* title #da1 if-- 7,a7 competitive proc$ures 7 us$ = ! selection ( p>ties = p>ticipation 9 ! o!r transaction2 & 7,b7 ! p>ticipants 9 ! o!r transaction successfully complet$ ! project provid$ = 9 ! transaction4 7#c7 ,precondition ,a foll[-on production contract or transaction may be aw>d$ pursuant to ?is subsection :5 ! ,director det]m9es t an individual project or subproject z "p ( a consortium is successfully complet$ by ! p>ticipants4 7#d7 ,cl>ification ,aw>d ( a foll[-on production contract or transaction pursuant to ?is subsection %all n be made cont+5t ^u ! successful completion ( all activities )9 a consortium z a condition = an aw>d = foll[-on production ( a successfully complet$ project or subproject )9 t consortium4 7#e7 ,o!r au?orities ,contracts & transactions ent]$ into by ,,arpa-,h pursuant to ?is subsection may be aw>d$ pursuant to division ,c ( subtitle ,i ( title #da1 ,unit$ ,/ates ,code1 or "u su* proc$ures1 t]ms1 & conditions z ! ,director or head ( su* ag5cy may e/abli% by regulation4 7t7 ,rule ( con/ruction ,! au?orities "u ?is section1 ) respect to ! ,director1 are additional au?orities t d n sup]s$e or modify any exi/+ au?orities4 7u7 ,def9itions ,9 ?is "p3 7#a7 ,advanc$ pro(s ( concept ,! t]m advanc$ pro(s ( concept means data1 a prototype1 or o!r exp]im5tal evid5ce t-- 7,a7 may prec$e ! developm5t ( trans=mative heal? te*nologies2 & 7,b7 demon/rates ! feasibility ( a new concept4 7#b7 ,biological product ,! t]m biological product has ! mean+ giv5 su* t]m 9 section #cea7;i74 7#c7 ,dep>tm5t ,! t]m ,dep>tm5t means ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#d7 ,drug2 device ,! t]ms drug & device h ! mean+s giv5 su* t]ms 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7#e7 ,f$]al acquisition regulation ,! t]m ,f$]al ,acquisition ,regulation means ! ,f$]al ,acquisition ,regulation issu$ pursuant to section #acjc7;a77#a7 ( title #da1 ,unit$ ,/ates ,code4 7#f7 ,f$]al ag5cy ,! t]m ,f$]al ag5cy has ! mean+ giv5 su* t]m 9 section #ccga ( title #e1 ,unit$ ,/ates ,code4 7#g7 ,prize ,! t]m prize means a prize z su* t]m is us$ 9 section #bd ( ! ,/ev5son-,wydl] ,te*nology ,innovation ,act ( #aihj4 7#h7 ,trans=mative heal? te*nology ,! t]m trans=mative heal? te*nology means a drug1 biological product1 int]v5tion1 plat=m1 tool1 or device-- 7,a7 t %\ld be prioritiz$ to detect1 diagnose1 mitigate1 prev5t1 cure1 or treat a s]i\s disease or m$ical condition = :i* !re are unmet ne$s2 & 7,b7 = :i*-- 7i7 significant sci5tific unc]ta9ty & regulatory risk exi/2 or 7ii7 inc5tives 9 ! comm]cial m>ket are unlikely to result 9 ! adequate or timely developm5t ( su* drug1 biological product1 int]v5tion1 plat=m1 tool1 or device4 7v7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #ejj1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg1 to rema9 available until exp5d$4 4 ,june #ac1 #bjbb,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be pr9t$